[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17999]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Sedaxane; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes tolerances for residues of
sedaxane as a seed treatment for cotton, undelinted seed; cotton, gin
byproducts; and beet, sugar. Syngenta Crop Protection, LLC requested
these tolerances under the Federal Food, Drug, and Cosmetic Act
DATES: This regulation is effective July 22, 2015. Objections and
requests for hearings must be received on or before September 21, 2015,
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-2014-0354, 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: Susan Lewis, 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
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 EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 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-2014-0354 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
September 21, 2015. 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-2014-0354, 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
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. Summary of Petitioned-For Tolerance
In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4F8263) by Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box
18300, Greensboro, NC 27419. The petition requested that 40 CFR part
180 be amended by establishing tolerances for residues of the fungicide
methyl-1H-pyrazole-4-carboxamide, as a seed treatment for cotton,
undelinted seed at 0.01 parts per million (ppm); cotton, gin byproducts
at 0.01 ppm; and beet, sugar at 0.01 ppm. That document referenced a
summary of the petition prepared by Syngenta Crop Protection, LLC, the
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
Based upon review of the data supporting the petition, EPA has
altered the commodity name from ``beet, sugar'' to ``beet, sugar,
roots''. The reason for this change is explained in Unit IV.D.
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), and 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 for sedaxane including exposure
resulting from the tolerances established by this action. EPA's
assessment of exposures and risks associated with sedaxane 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 toxicological effects reported in the submitted animal
studies such as mitochondrial disintegration and glycogen depletion in
the liver are consistent with the pesticidal mode of action also being
the mode of toxic action in mammals. The rat is the most sensitive
species tested, and the main target tissue for sedaxane is the liver.
Sedaxane also caused thyroid hypertrophy/hyperplasia. In the acute
neurotoxicity (ACN) and sub-chronic neurotoxicity (SCN) studies,
sedaxane caused decreased activity, decreased muscle tone, decreased
rearing, and decreased grip strength. There are indications of
reproductive toxicity in rats such as decreased follicle counts, but
these effects did not result in reduced fertility. Offspring effects in
the reproduction study occurred at the same doses causing parental
effects, and do not indicate any quantitative or qualitative increase
in sensitivity in rat pups. In the rat, no adverse effects in fetuses
were seen in developmental toxicity studies at maternally toxic
doses. In the rabbit, fetal toxicity (increased unossified sternebrae
and 13th rudimentary ribs, decrease in fetal weights, increased numbers
of abortions) was observed at the same doses that produced toxicity in
the dams (abortions, decreased body weight gain/body weight loss,
reduced food consumption, defecation), and therefore does not indicate
any increased susceptibility. Sedaxane is tumorigenic in the liver in
the rat and mouse, and led to tumors in the thyroid and uterus in the
rat and was classified as ``likely to be carcinogenic to humans.''
Sedaxane was negative in the mutagenicity studies. The 28-day dermal
study did not show systemic toxicity at the limit dose of 1,000
milligrams/kilogram/day (mg/kg/day). Sedaxane has low acute toxicity by
the oral, dermal, and inhalation routes. It is not a dermal sensitizer,
causes no skin irritation and only slight eye irritation.
Specific information on the studies received and the nature of the
adverse effects caused by sedaxane 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 document ``Sedaxane. Human Health Risk
Assessment to Support New Seed Treatment Uses on Cotton and Sugar
Beet'' on pages 13-20 in docket ID number EPA-HQ-OPP-2014-0354.
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 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 (U/SF) are used in conjunction
with the POD to calculate a safe exposure level--generally referred to
as a population-adjusted dose (PAD) or a reference dose (RfD)--and a
safe margin of exposure (MOE). For non-threshold risks, the Agency
assumes that any amount of exposure will lead to some degree of risk.
Thus, the Agency estimates risk in terms of the probability of an
occurrence of the adverse effect expected in a lifetime. For more
information on the general principles EPA uses in risk characterization
and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
A summary of the toxicological endpoints for sedaxane used for
human risk assessment is shown in the Table of this unit.
Table--Summary of Toxicological Doses and Endpoints for Sedaxane for Use in Human Health Risk Assessment
Point of departure
Exposure/Scenario and uncertainty/ RfD, PAD, LOC for Study and toxicological effects
safety factors risk assessment
Acute dietary (All populations, NOAEL = 30 mg/kg/day Acute RfD = 0.30 mg/ Rat ACN Study.
including children and women 13- UFA = 10x........... kg/day. LOAEL = 250 mg/kg based on reduced
49 years of age). UFH = 10x........... aPAD = 0.30 mg/kg/ activity, decreased rearing,
FQPA SF = 1x........ day. initial inactivity, piloerection,
ruffled fur and recumbency,
decreased BW, decreased BWG and
food consumption (males). In
females, weakened condition,
swaying gait, and decreased
activity, reduced muscle tone,
decreased locomotor activity and
rearing. The weakened condition,
swaying gait and decreased
activity were observed on days 2-
7, while the other effects were
on day 1.
Chronic dietary (All populations) NOAEL= 11 mg/kg/day. Chronic RfD = 0.11 Chronic Rat Study.
UFA = 10x........... mg/kg/day. NOAEL= 11/14 mg/kg bw/day (male/
UFH = 10x........... cPAD = 0.11 mg/kg/ female).
FQPA SF = 1x........ day. LOAEL = 67/86 mg/kg bw/day (male/
female) based on decreased hind
limb grip strength increased
liver weight, increased
incidences of hepatocyte
hypertrophy and eosinophilic
foci, and thyroid follicular cell
hypertrophy, basophilic colloid,
epithelial desquamation and
increased phosphate levels
(males). In females it was based
on decreased body weight and body
weight gain, increased liver
weight and the same
histopathology noted above for
Cancer (Oral, dermal, inhalation) ``Likely to be Carcinogenic to Humans'' based on significant tumor increases
in two adequate rodent carcinogenicity studies. Q1* = 4.64 x 10 - 3 (mg/kg/
day)-1 (linear low-dose extrapolation model).
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. mg/kg/day =
milligram/kilogram/day. NOAEL = no-observed-adverse-effect-level. PAD = population adjusted dose (a = acute, 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).
Q1* = Linear cancer slope factor
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to sedaxane, EPA considered exposure under the petitioned-for
tolerances as well as all existing sedaxane tolerances in 40 CFR
180.665. EPA assessed dietary exposures from sedaxane in food as
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for sedaxane. In estimating acute
dietary exposure, EPA used food consumption information from the United
States Department of Agriculture (USDA) National Health and Nutrition
Examination Survey, What We Eat in America, (NHANES/WWEIA) conducted
from 2003-2008. As to residue levels in
food, EPA conducted a highly conservative acute dietary assessment
using tolerance-level residues and 100% crop treated assumptions for
ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA NHANES/
WWEIA conducted from 2003-2008. As to residue levels in food, EPA
conducted a partially refined chronic dietary assessment using
anticipated residue levels for all commodities and percent crop treated
iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that sedaxane should be classified as ``Likely to be
Carcinogenic to Humans'' and a linear approach has been used to
quantify cancer risk. Cancer risk was quantified using the same
estimates as discussed in Unit III.C.1.ii., Chronic exposure. A linear
low-dose extrapolation model (Q1*) = 4.64 x 10-3
(mg/kg/day)-1 was used to estimate cancer risk.
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. The Agency estimated the PCT for
existing uses as follows: For chronic and cancer dietary exposure
assessment, 100 PCT was assumed for all commodities except for soybeans
(51%), wheat (32%) and potato (67%), which incorporated average 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%.
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 sedaxane 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 sedaxane in drinking water. These simulation models take
into account data on the physical, chemical, and fate/transport
characteristics of sedaxane. Drinking water accounted for 95% of the
total dietary exposure to sedaxane. 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 FQPA Index Reservoir Screening Tool (FIRST) and
Pesticide Root Zone Model Ground Water (PRZM GW), the estimated
drinking water concentrations (EDWCs) of sedaxane for acute exposures
are estimated to be 4.1 parts per billion (ppb) for surface water and
22.0 ppb for ground water, for chronic exposures and cancer assessments
are estimated to be 1.2 ppb for surface water and 19.3 ppb for ground
Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For acute dietary risk
assessment, the water concentration value of 22.0 ppb was used to
assess the contribution to drinking water. For chronic and cancer
dietary risk assessment, the water concentration of value 19.3 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). Sedaxane is not
registered for any specific use patterns that would result in
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 sedaxane
to share a common mechanism of toxicity with any other substances, and
sedaxane does not appear to produce a toxic metabolite produced by
other substances. For the purposes of this tolerance action, therefore,
EPA has assumed that sedaxane 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.
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 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. There is no evidence for
increased susceptibility following prenatal and/or postnatal exposures
to sedaxane based on effects seen in developmental toxicity studies in
rabbits or rats. In range finding and definitive developmental toxicity
studies in rats, neither quantitative nor qualitative evidence of
increased susceptibility of fetuses to in utero exposure to sedaxane
was observed. In these studies, there were no single-dose effects.
There was no evidence of increased susceptibility in a 2-generation
reproduction study in rats following prenatal or postnatal exposure to
sedaxane. Clear NOAELs/LOAELs were established for the developmental
effects seen in rats and rabbits as well as for the offspring effects
seen in the 2-generation reproduction study. The dose-response
relationship for the effects of concern is well characterized. The
NOAEL used for the acute dietary risk assessment (30 mg/kg/day), based
on effects observed in the ACN study, is protective of the
developmental and offspring effects seen in rabbits and rats (NOAELs of
100-200 mg/kg/day). In addition, there is no evidence of neuropathology
or abnormalities in the development of the fetal nervous system from
the available toxicity studies conducted with sedaxane.
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
i. The toxicity database for sedaxane is complete.
ii. There is no indication that sedaxane is a neurotoxic chemical
and there is no need for a developmental neurotoxicity study or
additional UFs to account for neurotoxicity. Although sedaxane caused
changes in apical endpoints such as decreased activity, decreased
muscle tone, decreased rearing and decreased grip strength in the ACN
and SCN studies, EPA believes these effects do not support a finding
that sedaxane is a neurotoxicant. The observed effects in the ACN and
SCN studies were likely secondary to inhibition of mitochondrial energy
production caused by sedaxane. Furthermore, there was no corroborative
neuro-histopathology demonstrated in any study, even at the highest
doses tested (i.e., 2,000 mg/kg/day). Therefore, based on its chemical
structure, its pesticidal mode of action, and lack of evidence of
neuro-histopathology in any acute and repeated-dose toxicity study,
sedaxane does not demonstrate potential for neurotoxicity. Since
sedaxane did not demonstrate increased susceptibility to the young or
specific neurotoxicity, a developmental neurotoxicity (DNT) study is
iii. As discussed in Unit III.D.2., there is no evidence that
sedaxane 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 food exposure assessments are highly
conservative (acute) or only partially refined (chronic), resulting in
high-end estimates of dietary food exposure. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to sedaxane in drinking water. These assessments
will not underestimate the exposure and risks posed by sedaxane.
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. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food and water
to sedaxane will occupy 1.3% of the aPAD for all infants (<1 year old),
the population group receiving the greatest exposure.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
sedaxane from food and water will utilize 1% of the cPAD for all
infants (<1 year old), the population group receiving the greatest
exposure. There are no residential uses for sedaxane.
3. Short- and Intermediate-term risk. Short- and intermediate-term
aggregate exposure takes into account short-term residential exposure
plus chronic exposure to food and water (considered to be a background
A short- and intermediate-term adverse effect was identified;
however, sedaxane is not registered for any use patterns that would
result in short- or intermediate-term residential exposure. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. Because there
is no short- or 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 short-term risk), no further assessment of short- and
intermediate-term risk is necessary, and EPA relies on the chronic
dietary risk assessment for evaluating short- and intermediate-term
risk for sedaxane.
4. Aggregate cancer risk for U.S. population. The Agency has
classified sedaxane as ``Likely to be Carcinogenic to Humans'' based on
significant tumor increases in two adequate rodent carcinogenicity
studies. A cancer dietary risk assessment was conducted using a linear
low-dose extrapolation model (Q1*) = 4.64 x 10-3
(mg/kg/day)-1 which indicated a risk estimate to the U.S.
population as 2 x 10-6. EPA generally considers cancer risks
in the range of 10-6 or less to be negligible. The precision
that can be assumed for cancer risk estimates is best described by
rounding to the nearest integral order of magnitude on the log scale;
for example, risks falling between 3 x 10-7 and 3 x
10-6 are expressed as risks in the range of 10-6.
Considering the precision with which cancer hazard can be estimated,
the conservativeness of low-dose linear extrapolation, and the rounding
procedure described above in this unit, cancer risk should generally
not be assumed to exceed the
benchmark level of concern of the range of 10-6 until the
calculated risk exceeds approximately 3 x 10-6. This is
particularly the case where some conservatism is maintained in the
exposure assessment. Based on this approach, EPA considers the risks of
cancer from exposure to sedaxane to be negligible.
5. 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 sedaxane residues.
IV. Other Considerations
A. Analytical Enforcement Methodology
Adequate enforcement methodology (liquid chromatography/tandem mass
spectrometry (LC/MS/MS)) is available to enforce the tolerance
expression. A modification of the Quick, Easy, Cheap, Effective,
Rugged, and Safe (QuEChERS) method was developed for the determination
of residues of sedaxane (as its isomers SYN508210 and SYN508211) in/on
various crops. The sedaxane isomers (SYN508210 and SYN508211) are
quantitatively determined by LC/MS/MS. The validated limit of
quantitation (LOQ) reported in the method is 0.005 ppm for both
sedaxane isomers. A successful independent laboratory validation (ILV)
study was also conducted on the modified QuEChERS method using samples
of wheat green forage and wheat straw fortified with SYN508210 and
SYN508211 at 0.005 and 0.05 ppm. The analytical standard for sedaxane,
with an expiration date of February 28, 2018, is currently available in
the EPA National Pesticide Standards Repository.
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:
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 sedaxane.
C. Revisions to Petitioned-For Tolerances
Although the petitioner sought a tolerance for the commodity name
``beet, sugar'', EPA is establishing a tolerance for ``beet, sugar,
roots'' to be consistent with the general food and feed commodity
vocabulary EPA uses for tolerances and exemptions.
Therefore, tolerances are established for residues of sedaxane, N-
pyrazole-4-carboxamide, as a seed treatment for cotton, undelinted seed
at 0.01 ppm; cotton, gin byproducts at 0.01 ppm; and beet, sugar, roots
at 0.01 ppm.
VI. Statutory and Executive Order Reviews
This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. 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 on the basis
of a petition under FFDCA section 408(d), 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).
VII. 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
Dated: July 16, 2015.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.665, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:
Sec. 180.665 Sedaxane; tolerances for residues.
(a) * * *
* * * * *
Beet, sugar, roots........................................... 0.01
* * * * *
Cotton, undelinted seed...................................... 0.01
Cotton, gin byproducts....................................... 0.01
* * * * *
* * * * *
[FR Doc. 2015-17999 Filed 7-21-15; 8:45 am]
BILLING CODE 6560-50-P