Sedaxane; Pesticide Tolerances, 43323-43329 [2015-17999]
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Federal Register / Vol. 80, No. 140 / Wednesday, July 22, 2015 / Rules and Regulations
part 41)’’ and adding in its place
‘‘Uniform Administrative Requirements,
Cost Principles, and Audit
Requirements for Federal Awards under
2 CFR part 200’’.
PART 59—GRANTS TO STATES FOR
CONSTRUCTION OR ACQUISITION OF
STATE HOMES
19. The authority citation for part 59
continues to read as follows:
■
Authority: 38 U.S.C. 101, 501, 1710, 1742,
8105, 8131–8137.
§ 59.124
[Amended]
20. Amend § 59.124(a) by removing
‘‘Single Audit Act of 1984 (see part 41
of this chapter)’’ and adding in its place
‘‘Uniform Administrative Requirements,
Cost Principles, and Audit
Requirements for Federal Awards under
2 CFR part 200’’.
■
PART 61—VA HOMELESS PROVIDERS
GRANT AND PER DIEM PROGRAM
21. The authority citation for part 61
continues to read as follows:
■
Authority: 38 U.S.C. 501, 2001, 2002, 2011,
2012, 2061, 2064.
Subpart B—Capital Grants
§ 61.16
[Amended]
22. Amend § 61.16(a) by removing
‘‘OMB Circular A–122 as codified at 2
CFR part 230.’’ and adding in its place
‘‘the Uniform Administrative
Requirements, Cost Principles, and
Audit Requirements for Federal Awards
under 2 CFR part 200.’’.
Subpart E—Technical Assistance
Grants
23. Amend § 61.50 by revising
paragraph (b)(3)(i) to read as follows:
■
§ 61.50 Technical assistance grantsgeneral.
*
*
*
*
*
(b) * * *
(3) * * *
(i) Uniform Administrative
Requirements, Cost Principles, and
Audit Requirements for Federal Awards
under 2 CFR part 200;
*
*
*
*
*
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Subpart F—Awards, Monitoring, and
Enforcement of Agreements
[Amended]
24. Amend § 61.61(a) by removing
‘‘VA common grant rules at 38 CFR
parts 43 and 49 and the OMB Circulars,
including those cited in § 61.66.’’ and
adding in its place ‘‘Uniform
Administrative Requirements, Cost
■
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■
§ 61.66
*
Financial management.
(a) All recipients must comply with
applicable requirements of the Uniform
Administrative Requirements, Cost
Principles, and Audit Requirements for
Federal Awards under 2 CFR part 200.
(b) All entities receiving assistance
under this part must use a financial
management system that follows
generally accepted accounting
principles and meets the requirements
set forth under 2 CFR part 200. All
recipients must implement the
requirements of 2 CFR part 200 when
determining costs reimbursable under
all awards issued under this part.
(Authority: 38 U.S.C. 501)
§ 61.67
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26. Amend § 61.67:
a. In paragraph (c) by removing ‘‘38
CFR 49.32’’ and adding in its place ‘‘2
CFR part 200’’.
■ b. In paragraph (f) by removing ‘‘38
CFR 49.34’’ and adding in its place ‘‘2
CFR part 200’’.
■
■
27. The authority citation for part 62
continues to read as follows:
■
Authority: 38 U.S.C. 501, 2044, and as
noted in specific sections.
28. Amend § 62.70:
a. By revising paragraph (a).
b. In paragraph (b) by removing ‘‘OMB
Circular A–110, Subpart C, Section 21
(codified at 2 CFR 215.21) and 38 CFR
49.21.’’ and adding in its place ‘‘2 CFR
part 200.’’.
■ c. In paragraph (c) by removing ‘‘OMB
Circular A–122, Cost Principles for NonProfit Organizations, codified at 2 CFR
part 235.’’ and adding in its place ‘‘2
CFR part 200.’’.
The revision reads as follows:
■
■
■
§ 62.70 Financial management and
administrative costs.
(a) Grantees must comply with
applicable requirements of the Uniform
Administrative Requirements, Cost
Principles, and Audit Requirements for
Federal Awards under 2 CFR part 200.
*
*
*
*
*
PART 64—GRANTS FOR THE RURAL
VETERANS COORDINATION PILOT
(RVCP)
29. The authority citation for part 64
continues to read as follows:
■
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Authority: 38 U.S.C. 501, 523 note.
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30. Amend § 64.14 by revising
paragraph (b)(2) to read as follows:
§ 64.14
RVCP grant agreement.
*
*
*
*
(b) * * *
(2) Abide by the Uniform
Administrative Requirements, Cost
Principles, and Audit Requirements for
Federal Awards under 2 CFR part 200,
and 2 CFR parts 25 and 170, if
applicable.
*
*
*
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*
[FR Doc. 2015–17416 Filed 7–21–15; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0354; FRL–9930–84]
[Amended]
PART 62—SUPPORTIVE SERVICES
FOR VETERANS FAMILIES PROGRAM
■
§ 61.61
Principles, and Audit Requirements for
Federal Awards under 2 CFR part 200.’’.
■ 25. Revise § 61.66 to read as follows:
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Sedaxane; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
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
(FFDCA).
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 https://www.regulations.gov
or at the Office of Pesticide Programs
Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
Docket Center (EPA/DC), West William
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
20460–0001. The Public Reading Room
is open from 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
the visitor instructions and additional
information about the docket available
at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
SUMMARY:
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Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
DC 20460–0001; main telephone
number: (703) 305–7090; email address:
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. How can I get electronic access to
other related information?
You may access a frequently updated
electronic version of EPA’s tolerance
regulations at 40 CFR part 180 through
the Government Printing Office’s e-CFR
site at https://www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/
40tab_02.tpl.
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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
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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: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://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 sedaxane, N[2-[1,1′-bicyclopropyl]-2-ylphenyl]-3(difluoromethyl)-1-methyl-1H-pyrazole4-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, https://
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
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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 subchronic 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
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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-observedadverse-effect-level (LOAEL) from the
toxicity studies can be found at https://
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
43325
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 nonthreshold risks, the Agency assumes
that any amount of exposure will lead
to some degree of risk. Thus, the Agency
estimates risk in terms of the probability
of an occurrence of the adverse effect
expected in a lifetime. For more
information on the general principles
EPA uses in risk characterization and a
complete description of the risk
assessment process, see https://
www.epa.gov/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
Exposure/Scenario
Acute dietary (All populations,
including children and women
13–49 years of age).
Chronic dietary (All populations)
Cancer (Oral, dermal, inhalation).
Point of departure
and
uncertainty/safety
factors
RfD, PAD, LOC for
risk
assessment
NOAEL = 30 mg/kg/
day.
UFA = 10x ................
UFH = 10x ................
FQPA SF = 1x .........
Acute RfD = 0.30
mg/kg/day.
aPAD = 0.30 mg/kg/
day.
Study and toxicological effects
Rat ACN Study.
LOAEL = 250 mg/kg based on reduced activity, decreased
rearing, 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.
NOAEL= 11 mg/kg/
Chronic RfD = 0.11
Chronic Rat Study.
day.
mg/kg/day.
NOAEL= 11/14 mg/kg bw/day (male/female).
UFA = 10x ................ cPAD = 0.11 mg/kg/
LOAEL = 67/86 mg/kg bw/day (male/female) based on deUFH = 10x ................
day.
creased hind limb grip strength increased liver weight, inFQPA SF = 1x .........
creased 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 males.
‘‘Likely to be Carcinogenic to Humans’’ based on significant tumor increases in two adequate rodent carcinogenicity studies. Q1* = 4.64 × 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
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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.
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EPA assessed dietary exposures from
sedaxane 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.
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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
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food, EPA conducted a highly
conservative acute dietary assessment
using tolerance-level residues and 100%
crop treated assumptions for all
commodities.
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 data.
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 × 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
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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
estimates.
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.
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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
https://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 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 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 nonoccupational, 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 residential
exposure.
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
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EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
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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 findings:
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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 not
required.
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 2generation 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.
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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 exposure level).
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 × 10¥3 (mg/kg/
day)¥1 which indicated a risk estimate
to the U.S. population as 2 × 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 × 10¥7
and 3 × 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
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benchmark level of concern of the range
of 10¥6 until the calculated risk exceeds
approximately 3 × 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: residuemethods@
epa.gov.
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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
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15:06 Jul 21, 2015
Jkt 235001
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.
V. Conclusion
Therefore, tolerances are established
for residues of sedaxane, N-[2-[1,1′bicyclopropyl]-2-ylphenyl]-3(difluoromethyl)-1-methyl-1H-pyrazole4-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
PO 00000
Frm 00028
Fmt 4700
Sfmt 4700
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 recordkeeping
requirements.
Dated: July 16, 2015.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office
of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
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Regulatory Public Docket (OPP Docket)
in the Environmental Protection Agency
■ 1. The authority citation for part 180
Docket Center (EPA/DC), West William
continues to read as follows:
Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC
Authority: 21 U.S.C. 321(q), 346a and 371.
20460–0001. The Public Reading Room
■ 2. In § 180.665, add alphabetically the
is open from 8:30 a.m. to 4:30 p.m.,
following commodities to the table in
Monday through Friday, excluding legal
paragraph (a) to read as follows:
holidays. The telephone number for the
Public Reading Room is (202) 566–1744,
§ 180.665 Sedaxane; tolerances for
residues.
and the telephone number for the OPP
Docket is (703) 305–5805. Please review
(a) * * *
the visitor instructions and additional
Parts
information about the docket available
Commodity
per
at https://www.epa.gov/dockets.
million
FOR FURTHER INFORMATION CONTACT:
Susan Lewis, Registration Division
*
*
*
*
*
(7505P), Office of Pesticide Programs,
Beet, sugar, roots .........................
0.01 Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington,
*
*
*
*
*
DC 20460–0001; main telephone
Cotton, undelinted seed ...............
0.01
number: (703) 305–7090; email address:
Cotton, gin byproducts .................
0.01
RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
*
*
*
*
*
PART 180—[AMENDED]
*
*
*
*
I. General Information
*
[FR Doc. 2015–17999 Filed 7–21–15; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2014–0232; FRL–9929–57]
Novaluron; Pesticide Tolerances
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes
tolerances for residues of novaluron in
or on multiple commodities and
removes several existing tolerances
which are identified and discussed later
in this document. This regulation
additionally revises existing tolerances
in or on vegetable, cucurbit, group 9;
and plum, prune, dried. Interregional
Research Project Number 4 (IR–4)
requested these tolerances under the
Federal Food, Drug, and Cosmetic Act
(FFDCA).
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–2014–0232, is
available at https://www.regulations.gov
or at the Office of Pesticide Programs
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SUMMARY:
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15:06 Jul 21, 2015
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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 https://www.ecfr.gov/cgi-bin/textidx?&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–
PO 00000
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Fmt 4700
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43329
OPP–2014–0232 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–
2014–0232, by one of the following
methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be CBI or
other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW., Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at
https://www.epa.gov/dockets.
II. Summary of Petitioned-For
Tolerance
In the Federal Register of December
17, 2014 (79 FR 75107) (FRL–9918–90),
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 4E8241) by
Interregional Research Project Number 4
(IR–4), 500 College Road East, Suite 201
W., Princeton, NJ 08540. The petition
requested that 40 CFR part 180 be
amended by establishing tolerances for
residues of the insecticide novaluron,
(N-[[[3-chloro-4-[1,1,2-trifluoro-2(trifluoromethoxy)ethoxy]
phenyl]amino]carbonyl]-2,6-difluoro
benzamide), in or on avocado at 0.60
parts per million (ppm); carrot at 0.05
ppm; bean at 0.60 ppm; vegetable,
fruiting, group 8–10 at 1.0 ppm; fruit,
pome, group 11–10 at 2.0 ppm; cherry
subgroup 12–12A at 8.0 ppm; peach
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Agencies
[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Rules and Regulations]
[Pages 43323-43329]
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
[EPA-HQ-OPP-2014-0354; FRL-9930-84]
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
(FFDCA).
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 https://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is (202) 566-1744, and the telephone number for the OPP
Docket is (703) 305-5805. Please review the visitor instructions and
additional information about the docket available at https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs,
[[Page 43324]]
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
address: RDFRNotices@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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
sedaxane, N-[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-(difluoromethyl)-1-
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, https://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
[[Page 43325]]
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 https://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 https://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
males.
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
follows:
i. Acute exposure. Quantitative acute dietary exposure and risk
assessments are performed for a food-use pesticide, if a toxicological
study has indicated the possibility of an effect of concern occurring
as a result of a 1-day or single exposure.
Such effects were identified for 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
[[Page 43326]]
food, EPA conducted a highly conservative acute dietary assessment
using tolerance-level residues and 100% crop treated assumptions for
all commodities.
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
data.
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
estimates.
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 https://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
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 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
residential exposure.
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
[[Page 43327]]
EPA's efforts to determine which chemicals have a common mechanism of
toxicity and to evaluate the cumulative effects of such chemicals, see
EPA's Web site at https://www.epa.gov/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
findings:
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
not required.
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
exposure level).
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
[[Page 43328]]
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:
residuemethods@epa.gov.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. 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.
V. Conclusion
Therefore, tolerances are established for residues of sedaxane, N-
[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-(difluoromethyl)-1-methyl-1H-
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
recordkeeping requirements.
Dated: July 16, 2015.
G. Jeffrey Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
[[Page 43329]]
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. 180.665, add alphabetically the following commodities to
the table in paragraph (a) to read as follows:
Sec. 180.665 Sedaxane; tolerances for residues.
(a) * * *
------------------------------------------------------------------------
Parts
Commodity per
million
------------------------------------------------------------------------
* * * * *
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