[Federal Register Volume 81, Number 199 (Friday, October 14, 2016)]
[Proposed Rules]
[Pages 71029-71035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24650]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2008-0824; FRL-9952-75]
RIN 2070-ZA16
Tebufenozide; Proposed Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This document proposes to establish tolerances for residues of
tebufenozide in or on multiple commodities which are identified and
discussed later in this document and amend the existing tolerance for
almond, hulls under the Federal Food, Drug, and Cosmetic Act (FFDCA).
DATES: Comments must be received on or before December 13, 2016.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2008-0824, 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 Confidential Business
Information (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.
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. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked
[[Page 71030]]
will not be disclosed except in accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. This Proposal
EPA on its own initiative, under FFDCA section 408(e), 21 U.S.C.
346a(e), is proposing to establish tolerances for residues of the
insect growth regulator tebufenozide, in or on bushberry subgroup 13-
07B at 3.0 part per million (ppm); caneberry subgroup 13-07A at 3.0
ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome group 11-10 at
1.0 ppm; nut, tree, group 14-12 at 0.1 ppm; sugarcane, cane at 1.0 ppm;
sugarcane, molasses at 3.0 ppm; vegetable, fruiting, group 8-10 at 1.0
ppm. The Agency is also proposing to amend the existing tolerance for
almond, hulls to raise the tolerance from 25 ppm to 30 ppm. Further,
upon the establishment of these tolerances, the Agency is proposing to
delete the existing tolerances for apple; berry, group 13; fruit,
citrus, group 10; fruit, pome; nut, tree, group 14; pistachio;
vegetable, fruiting, group 8; and walnut since they will be superseded
by the newly established tolerances.
The EPA is proposing to establish tolerances on sugarcane, cane;
and sugarcane, molasses since permanent tolerances established in a
September 22, 1999 Final Rule in the Federal Register (64 FR 51251)
were later inadvertently removed from 40 CFR 180.482. See 67 FR 35045
(May 17, 2002). Additionally, EPA is proposing to convert several
existing crop group tolerances to updated crop group tolerances
consistent with its policy as stated in its most recent crop group
rulemaking. See 81 FR 26471, 26474 (May 3, 2016). EPA has stated that
it will convert tolerances for any pre-existing crop group to
tolerances with coverage under the revised crop group through the
registration review process and in the course of evaluating new uses
for a pesticide. Id. As part of the registration review for
tebufenozide, EPA considered the pesticide exposures to commodities
included in the updated crop groups and determined that they are safe.
Finally, in order to harmonize with Codex, the following tolerance
levels are proposed to be amended: fruit, citrus, group 10-10 will be
increased from 0.80 to 2.0 ppm; fruit, pome, group 11-10 will be
lowered from 1.5 to 1.0 ppm; and almond, hulls will be increased from
25 to 30 ppm.
III. 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 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, consistent with FFDCA
section 408(b)(2), for tolerances for residues of tebufenozide. EPA's
assessment of exposures and risks associated with establishing the
tolerance follows:
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
The toxic effects of tebufenozide in mammalian species arise
primarily from methemoglobinemia associated with denaturation of
hemoglobin and concomitant Heinz body formation in erythrocytes,
resulting in a rapid turnover of red blood cells with increased
hematopoiesis, splenic discoloration, and other spleen effects. This
type of toxicity is often typical of compounds with a hydrazine moiety,
and is consistent with the structure of tebufenozide. The hematologic
effects have been observed in all mammalian species tested to date
(rat, mouse, dog, and rabbit), with no indication of any significant
differences between sexes. There is no evidence that tebufenozide is
neurotoxic, or that it causes reproductive or developmental toxicity.
There is no indication of increased susceptibility of fetuses or pups
(effects occur above maternally toxic doses). There was no toxicity
noted in a 21-day dermal toxicity study and no immunotoxicity was
observed in immunotoxicity studies in both rats and mice. Tebufenozide
is classified as ``not likely to be carcinogenic to humans'' based on
lack of evidence of carcinogenicity in rats and mice and no evidence of
mutagenicity.
Specific information on the studies received and the nature of the
adverse effects caused by tebufenozide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Tebufenozide: Draft Human Health
Risk Assessment for Registration Review'' on pages 18-24 in docket ID
number EPA-HQ-OPP-2008-0824-0024.
B. 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 toxicology 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://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.
A summary of the toxicological endpoints for tebufenozide used for
[[Page 71031]]
human risk assessment is shown in Table 1 of this unit.
Table 1--Summary of Toxicological Doses and Endpoints for Tebufenozide for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
Point of departure and
Exposure/scenario uncertainty/safety RfD, PAD, LOC for risk Study and toxicological
factors assessment effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All populations) No appropriate endpoint attributable to a single dose was identified in the
toxicity database.
----------------------------------------------------------------------------
Chronic dietary (All populations).. NOAEL = 2.0 mg/kg/day. Chronic RfD = 0.02 mg/ 90-day and 1-year dog
kg/day. studies (Cocritical)
UFA = 10x LOAEL = 8.7 mg/kg/day
UFH = 10x............. ...................... based on decreases in body
FQPA SF = 1x.......... cPAD = 0.02 mg/kg/day. weight gains, alterations
in hematology parameters,
changes in organ weights,
and histopathological
lesions in the bone,
spleen, and liver.
----------------------------------------------------------------------------
Incidental oral short-term (1 to 30 NOAEL = 2.0 mg/kg/day. Residential LOC for 90-day and 1-year dog
days). MOE = 100. studies (Cocritical)
UFA = 10x
UFH = 10x.............
FQPA SF = 1x.......... ...................... LOAEL = 8.7 mg/kg/day
based on decreases in body
weight gains, alterations
in hematology parameters,
changes in organ weights,
and histopathological
lesions in the bone,
spleen, and liver.
----------------------------------------------------------------------------
Dermal (All durations)............. No dermal endpoint was selected based on a lack of systemic toxicity in the
dermal study and no concern for susceptibility.
----------------------------------------------------------------------------
Inhalation (All durations)......... Inhalation (or oral) Occupational LOC for 90-day and 1-year dog
study NOAEL= 2.0 mg/ MOE = 100. studies (Cocritical)
kg/day (inhalation
toxicity assumed to
be equivalent to oral
toxicity 100%).
UFA = 10x
UFH = 10x.............
FQPA SF = 1x.......... ...................... LOAEL = 8.7 mg/kg/day
based on decreases in body
weight gains, alterations
in hematology parameters,
changes in organ weights,
and histopathological
lesions in the bone,
spleen, and liver.
----------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation).. Classification: This chemical is classified as ``not likely'' to be a human
carcinogen. A cancer risk assessment is not required.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
level. PAD = population adjusted dose (c = chronic). RfD = reference dose. UF = uncertainty factor. UFA =
extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of
the human population (intraspecies).
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to tebufenozide, EPA considered exposure under the proposed
tolerances as well as all existing tebufenozide tolerances in 40 CFR
180.482. EPA assessed dietary exposures from tebufenozide 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.
No such effects were identified in the toxicological studies for
tebufenozide; therefore, a quantitative acute dietary exposure
assessment is unnecessary.
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the Dietary Exposure Evaluation Model software with
the Food Commodity Intake Database (DEEM-FCID) Version 3.16. This
software uses 2003-2008 food consumption data from the U.S. Department
of Agriculture's (USDA's) National Health and Nutrition Examination
Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in
food, EPA incorporated tolerance-level residues, average percent crop
treated (PCT) estimates for some commodities, and DEEM 7.81 default
processing factors as appropriate.
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that tebufenozide is classified as ``Not Likely to be
Carcinogenic 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 information in the dietary
assessment for tebufenozide; tolerance level residues were assumed for
all food commodities.
[[Page 71032]]
The Agency did use some PCT information for the dietary assessment.
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.
The Agency estimated the PCT for existing uses as follows:
blueberries: 10%; cabbage, caneberries, cauliflower, celery, lettuce,
parsley, pecans, peppers, tomatoes and walnuts: each at 5%; almonds,
broccoli, pistachios, spinach, and turnip roots: each at 2.5%; apples,
citrus, cotton, grapes and pears: each at 1%.
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 to 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%.
The Agency believes that the three conditions discussed in Unit
III.C.1.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. The Agency is reasonably certain that
the percentage of the food treated is not likely to be an
underestimation. 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 tebufenozide 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 tebufenozide in drinking water. These simulation models
take into account data on the physical, chemical, and fate/transport
characteristics of tebufenozide. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-water-exposure-models-used-pesticide.
The residues of concern in drinking water was recently updated to
include parent and metabolite RH-112651 for ground water and parent
plus 3 metabolites, RH-112651, RH-112703, and RH-96595 for surface
water. The Total Toxic Residues (TTR) approach was used, assuming
presence of parent tebufenozide plus all three of its major
metabolites, RH-112651, RH-112703, and RH-9659 in both ground and
surface water in its assessment of tebufenozide residues in drinking
water. Based on the Surface Water Concentration Calculator (SWCC) with
the Provisional Cranberry Model and Pesticide Root Zone Model for
Groundwater (PRZM-GW) model, the estimated drinking water
concentrations (EDWCs) of tebufenozide for chronic exposures are
estimated to be 105.8 parts per billion (ppb) for surface water and
107.2 ppb for ground water.
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 107 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).
Tebufenozide is currently registered for the following uses that
could result in residential exposures: Ornamentals in outdoor
residential areas. EPA assessed residential exposure using the
following assumptions: For adult handlers, it is assumed that
residential use will result in short-term (1 to 30 days) duration for
dermal and inhalation exposures. However, since a dermal hazard was not
identified, only the residential inhalation exposure from applications
to garden/trees via backpack sprayer was assessed. Although an
incidental oral endpoint was identified, incidental oral exposure is
not expected based on the on application to ornamentals in outdoor
residential areas.
Further information regarding EPA standard assumptions and generic
inputs for residential exposures may be found at http://www2.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's Office of Pesticide Programs (OPP) has previously developed
guidance documents for establishing common mechanism groups (CMGs)
(Guidance for Identifying Pesticide Chemicals and Other Substances that
have a Common Mechanism of Toxicity (1999)) and conducting cumulative
risk assessments (CRAs) (Guidance on Cumulative Risk Assessment of
Pesticide Chemicals that have a Common Mechanism of Toxicity (2002)).
In 2016, EPA's Office of Pesticide Programs released another guidance
document entitled Pesticide Cumulative Risk Assessment: Framework for
Screening Analysis. All three of these documents can be found at http://www.regulations.gov in docket ID EPA-HQ-OPP-2015-0422.
The agency has utilized this framework for tebufenozide and
determined that halofenozide, tebufenozide, and methoxyfenozide
(diacylhydrazines) form a candidate CMG. This group of pesticides is
[[Page 71033]]
considered a candidate CMG because they share characteristics to
support a testable hypothesis for a common mechanism of action.
Following this determination, the Agency conducted a screening-level
cumulative risk assessment consistent with the 2016 guidance document.
This screening assessment indicates that that cumulative dietary and
residential aggregate exposures for the diacylhydrazine candidate CMG,
including tebufenozide, are below EPA's levels of concern. The Agency's
screening level cumulative analysis can be found at http://www.regulations.gov in the document ``Diacylhydrazines Cumulative
Screening Risk Assessment: Methoxyfenozide and Tebufenozide'' in docket
ID number EPA-HQ-OPP-2008-0824.
D. 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 safety factor when
reliable data available to EPA support the choice of a different
factor.
2. Prenatal and postnatal sensitivity. The toxicology data for
tebufenozide provides no indication of enhanced sensitivity of infants
and children based on the results from developmental studies conducted
with rats and rabbits as well as two-generation reproduction studies
conducted with rats.
3. Conclusion. EPA has determined that reliable data show 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 tebufenozide is complete.
ii. There is no indication that tebufenozide is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that tebufenozide results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
iv. There are no residual uncertainties identified in the exposure
databases. The dietary exposure assessment used tolerance-level
residues and was only partially refined by use of PCT information. EPA
does not expect post-application exposures for infants and children.
EPA made conservative (protective) assumptions in the ground and
surface water modeling used to assess exposure to tebufenozide in
drinking water, which includes the use of the TTR approach. These
assessments will not underestimate the exposure and risks posed by
tebufenozide.
E. 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. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
tebufenozide is not expected to pose an acute risk.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
tebufenozide from food and water will utilize 37% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
tebufenozide is not expected.
3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Tebufenozide is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to tebufenozide. Using the
exposure assumptions described in this unit for short-term exposures,
EPA has concluded the combined short-term food, water, and residential
exposures result in an aggregate MOE of 550 for adults. Because EPA's
level of concern for tebufenozide is a MOE of 100 or below, this MOE is
not of concern.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level).
An intermediate-term adverse effect was identified; however,
tebufenozide 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
tebufenozide.
5. Aggregate cancer risk for US population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, tebufenozide 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 tebufenozide residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (high performance liquid
chromatography using ultraviolet detection (HPLC-UV)) 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 US
tolerances with international standards whenever possible, consistent
with US food safety standards and agricultural practices. EPA considers
the international
[[Page 71034]]
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 established MRLs for tebufenozide in or on sugarcane;
fruit, citrus, group 10-10; fruit, pome, group 11-10; and almond,
hulls. The proposed US tolerances would be harmonized with the Codex
MRLs.
C. International Trade Considerations
In this proposed rule, EPA is proposing to reduce the tolerance in
or on fruit, pome, group 11-10 from 1.5 to 1.0 ppm. The Agency is
proposing this reduction in order to harmonize with the Codex MRL. The
reduction is appropriate based on available data and residue levels
resulting from registered use patterns.
In accordance with the World Trade Organization's (WTO) Sanitary
and Phytosanitary Measures (SPS) Agreement, EPA will notify the WTO of
its intent to revise this tolerance. In addition, the SPS Agreement
requires that Members provide a ``reasonable interval'' between the
publication of a regulation subject to the Agreement and its entry into
force in order to allow time for producers in exporting Member
countries to adapt to the new requirement. Although the WTO has
determined that six months would be a reasonable interval, it has also
recognized that some circumstances may warrant implementation of a
regulation without the de facto six month implementation delay, e.g.,
where exporting countries can adapt to the new requirements within a
shorter interval. (Ref. 1 at 100).
EPA is proposing not to provide a reasonable interval between the
publication of this rule and the date it becomes effective because it
believes that exporting countries do not need time to adjust to the new
requirement. With very few exceptions, all of the global maximum
residue levels for tebufenozide on pome fruits are already at or below
EPA's proposed level of 1.0 ppm. Although Mexico allows 1.5 ppm on
crabapple, pear, and quince, Mexico defaults to the US tolerance
levels. Similarly, although Hong Kong has established a maximum residue
level of 1.5 ppm for pear and Asian pear, it has not exported those
fruits to the United States in the past 2 years. As a result, EPA
believes that a reasonable interval between the publication of this
rule and the effective date of these tolerances is not necessary and
proposes to make the reduction effective upon publication of the final
rule.
This proposed reduction in tolerance is not discriminatory; the
same food safety standard contained in the FFDCA applies equally to
domestically produced and imported foods.
V. Conclusion
EPA proposes to establish tolerances for residues of tebufenozide
in bushberry subgroup 13-07B at 3.0 ppm; caneberry subgroup 13-07A at
3.0 ppm; fruit, citrus, group 10-10 at 2.0 ppm; fruit, pome group 11-10
at 1.0 ppm; nut, tree, group 14-12 at 0.1 ppm; sugarcane, cane at 1.0
ppm; sugarcane, molasses at 3.0 ppm; and vegetable, fruiting, group 8-
10 at 1.0 ppm. The Agency is also proposing to amend the existing
tolerance for almond, hulls to raise the tolerance from 25 ppm to 30
ppm. Further, upon the establishment of these tolerances, the Agency is
proposing to delete the existing tolerances for apple; berry, group 13;
fruit, citrus, group 10; fruit, pome; nut, tree, group 14; pistachio;
vegetable, fruiting, group 8; and walnut since they will be superseded
by the newly established tolerances.
VI. References
Appellate Body Report, United States--Measures Affecting the
Production and Sale of Clove Cigarettes, 222-23, WT/DS406/AB/R (Apr.
4, 2012) (adopted Apr. 24, 2012) available at http://www.wto.org/english/tratop_e/dispu_e/406abr_e.pdf.
VII. Statutory and Executive Order Reviews
In this proposed rule in Unit II, EPA is proposing to establish
tolerances under FFDCA section 408(e), and also modify and revoke
specific tolerances established under FFDCA section 408. The Office of
Management and Budget (OMB) has exempted these types of actions (e.g.,
establishment and modification of a tolerance and tolerance revocation
for which extraordinary circumstances do not exist) from review under
Executive Order 12866, entitled ``Regulatory Planning and Review'' (58
FR 51735, October 4, 1993). Because this proposed rule has been
exempted from review under Executive Order 12866 due to its lack of
significance, this proposed rule 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). This proposed rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), or 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.). Nor does it require any
special considerations as required by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994); or OMB review or any other Agency action under Executive Order
13045, entitled ``Protection of Children from Environmental Health
Risks and Safety Risks'' (62 FR 19885, April 23, 1997). This proposed
rule 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). Pursuant to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency previously assessed whether
establishment of tolerances, exemptions from tolerances, raising of
tolerance levels, expansion of exemptions, or revocations might
significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
These analyses for tolerance establishments and modifications, and for
tolerance revocations were published in the Federal Register of May 4,
1981 (46 FR 24950) and December 17, 1997 (62 FR 66020) (FRL-5753-1),
respectively, and were provided to the Chief Counsel for Advocacy of
the Small Business Administration. In a memorandum dated May 25, 2001,
EPA determined that eight conditions must all be satisfied in order for
an import tolerance or tolerance exemption revocation to adversely
affect a significant number of small entity importers, and that there
is a negligible joint probability of all eight conditions holding
simultaneously with respect to any particular revocation. (This Agency
document is available in the docket of this proposed rule).
Furthermore, for the pesticide named in this proposed rule, the Agency
knows of no extraordinary circumstances that exist as to the present
proposed rule that would change EPA's previous analysis. Taking into
account this analysis, and
[[Page 71035]]
available information concerning the pesticides listed in this proposed
rule, the Agency hereby certifies that this proposed rule will not have
a significant negative economic impact on a substantial number of small
entities. Any comments about the Agency's determination should be
submitted to the EPA along with comments on the proposed rule, and will
be addressed prior to issuing a final rule. In addition, the Agency has
determined that this proposed rule will not have a substantial direct
effect on States, on the relationship between the national government
and the States, or on the distribution of power and responsibilities
among the various levels of government, as specified in Executive Order
13132, entitled ``Federalism'' (64 FR 43255, August 10, 1999).
Executive Order 13132 requires EPA to develop an accountable process to
ensure ``meaningful and timely input by State and local officials in
the development of regulatory policies that have federalism
implications.'' ``Policies that have federalism implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.'' This
proposed rule directly regulates growers, food processors, food
handlers, and food retailers, not States. This proposed rule does not
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of FFDCA section
408(n)(4). For these same reasons, the Agency has determined that this
proposed rule does not have any ``tribal implications'' as described in
Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000). Executive
Order 13175, requires EPA to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' is defined in the Executive order to include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal Government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.'' This proposed rule
will not have substantial direct effects on tribal governments, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
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 30, 2016.
Michael L. Goodis,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES
IN FOOD
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. Amend the table in Sec. 180.482(a)(1) as follows:
0
a. Remove the entries for ``Apple''; ``Berry group 13''; ``Fruit,
citrus, group 10''; ``Fruit, pome''; ``Nut, tree, group 14'';
``Pistachio''; ``Vegetable, fruiting, group 8''; and ``Walnut'';
0
b. Revise the entry for ``Almond, hulls''; and
0
c. Add alphabetically the entries for ``Bushberry subgroup 13-07B'';
``Caneberry subgroup 13-07A''; ``Fruit, citrus, group 10-10''; ``Fruit,
pome, group 11-10''; ``Nut, tree, group 14-12''; ``Sugarcane, cane'';
``Sugarcane, molasses''; and ``Vegetable, fruiting, group 8-10''.
The revisions and additions read as follows:
Sec. 180.482 Tebufenozide; tolerances for residues.
(a) * * *
(1) * * *
------------------------------------------------------------------------
Parts per
Commodity million
------------------------------------------------------------------------
Almond, hulls.............................................. 30
* * * * *
Bushberry subgroup 13-07B.................................. 3.0
* * * * *
Caneberry subgroup 13-07A.................................. 3.0
* * * * *
Fruit, citrus, group 10-10................................. 2.0
Fruit, pome, group 11-10................................... 1.0
* * * * *
Nut, tree, group 14-12..................................... 0.1
* * * * *
Sugarcane, cane............................................ 1.0
Sugarcane, molasses........................................ 3.0
* * * * *
Vegetable, fruiting, group 8-10............................ 1.0
* * * * *
------------------------------------------------------------------------
* * * * *
[FR Doc. 2016-24650 Filed 10-13-16; 8:45 am]
BILLING CODE 6560-50-P