[Federal Register Volume 78, Number 191 (Wednesday, October 2, 2013)]
[Rules and Regulations]
[Pages 60715-60720]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-23941]



40 CFR Part 180

[EPA-HQ-OPP-2012-0885; FRL-9397-8]

Sedaxane; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
sedaxane in or on potato and potato, wet peel. Syngenta Crop 
Protection, LLC requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective October 2, 2013. Objections and 
requests for hearings must be received on or before December 2, 2013, 
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-2012-0885, 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), EPA West 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: Lois Rossi, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 305-7090; email address: [email protected].


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-2012-0885 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
December 2, 2013. 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-2012-0885, 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, EPA/DC, (28221T), 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://

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www.epa.gov/dockets/contacts.htm. 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 December 19, 2012 (77 FR 75082) (FRL-
9372-6), 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 
2F8113) by Syngenta Crop Protection, Inc., Regulatory Affairs, P.O. Box 
18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR 
180.665 be amended by establishing tolerances for residues of the 
fungicide sedaxane, in or on potato at 0.02 parts per million (ppm) and 
potato, wet peel at 0.06 ppm. That document referenced a summary of the 
petition prepared by Syngenta Crop Protection, Inc., 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 
recommended that a different tolerance be set for potato, wet peel. The 
reasons for these changes are explained in Unit IV.C.

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 at the high 
dose, but these effects did not result in reduced fertility. In the 
rat, no adverse effects in fetuses were seen in developmental toxicity 
studies at maternally toxic doses. However, in the rabbit, fetal 
toxicity was observed at the same doses as the dams. Offspring effects 
in the reproduction study occurred at the same doses causing parental 
effects, thus there was no quantitative increase in sensitivity in rat 
pups. 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 are discussed in the final rule 
published in the Federal Register of June 20, 2012 (77; FR 36920) (FRL-

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 the NOAEL and LOEAL are identified. 
Uncertainty/safety factors are used in conjunction with the POD to 
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of 
exposure (MOE). For non-threshold risks, the Agency assumes that any 
amount of exposure will lead to some degree of risk. Thus, the Agency 
estimates risk in terms of the probability of an occurrence of the 
adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sedaxane used for 
human risk assessment is discussed in Unit B of the final rule 
published in the Federal Register of June 20, 2012 (77 FR 36920) (FRL-

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 2003-2008 
food consumption information from the U.S. Department of Agriculture's 
(USDA's) National Health and Nutrition Examination Survey, What We Eat 
in America (NHANES/WWEIA). As to residue levels in food, EPA conducted 
a highly conservative acute dietary risk

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assessment which used tolerance level residues and assumed that 100% of 
all commodities were treated.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA's 2003-
2008 NHANES/WWEIA. As to residue levels in food, EPA conducted a 
partially refined chronic dietary risk assessment which used 
anticipated residues and assumed 100 percent crop treated (PCT) for all 
commodities except for soybean, wheat, and potato, where average PCT 
estimates of 51, 32, and 67, respectively, were used, and modeled 
drinking water estimates were included.
    iii. Cancer. EPA assessed exposure for the purpose of estimating 
cancer risk assuming anticipated residues and 100 PCT for all 
commodities except for soybean, wheat, and potato, where average 
percent crop treated estimates of 51, 32, and 67, respectively, were 
used, and modeled drinking water estimates were included.
    iv. Anticipated residue 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% was 
assumed for all commodities except for soybeans (51%) and wheat (32%), 
which incorporated average PCT estimates. Average PCT estimates were 
also used for the proposed use on potato (67%).
    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.
    EPA did not use anticipated residue or PCT information in the acute 
dietary assessment for sedaxane. However, for the chronic and cancer 
dietary assessments, anticipated residues were used along with 100 PCT 
for all food commodities except for soybean, wheat, and potato, where 
average PCT estimates of 51, 32, and 67, respectively, were used, and 
modeled drinking water estimates were included.
    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. Further information regarding EPA drinking 
water models used in pesticide exposure assessment can be found at 
    Based on the Tier I Food Quality Protection Act (FQPA) Index 
Reservoir Screening Tool (FIRST) and Tier II pesticide root zone model 
PRZM-Groundwater (PRZM-GW Version 1.0, 12/11/2012), 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 
15.1 ppb for ground water. The water exposures for the chronic dietary 
and cancer assessments are estimated to be 1.2 ppb for surface water 
and 13 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 15.1 ppb was used to 
assess the contribution to drinking water. For chronic and cancer 
dietary risk assessment, the water concentration value of 13 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

[[Page 60718]]

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. 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 Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
    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. 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. The sedaxane toxicology database did not demonstrate evidence 
of neurotoxicity. Although sedaxane caused changes in endpoints such as 
decreased activity, decreased muscle tone, decreased rearing and 
decreased grip strength in the ACN study and reduced locomotor activity 
in the SCN study, 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, which is the pesticidal mode of action for 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 
    iii. 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 
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed as 
screening-level (acute) or partially-refined (chronic) assessments. 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.
    Sedaxane is a member of the pyrazole carboxamide fungicides. 
Metabolic processes involving cleavage of the linkage between the 
pyrazole and phenyl rings of these compounds have the potential to 
produce common pyrazole-metabolites. Indeed, confined rotational crops 
studies for sedaxane and isopyrazam demonstrate that low levels of 
three common metabolites form. However, due to the low levels of these 
compounds in rotational crops (<=0.01 ppm), and low concerns about 
their potential toxicity relative to parent molecules, any risks from 
aggregation of exposures to common metabolites across chemicals will be 
    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% of the aPAD for all populations.
    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 
populations. There are no residential uses for sedaxane.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Short- and 
intermediate-term adverse effects were identified; however, sedaxane is 
not registered for any use patterns that would result in short- or 
intermediate-term residential exposures. 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- or 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. Accordingly, a cancer dietary risk assessment was conducted, 
indicating a risk estimate of 1 x 10-6 for the U.S. 
population. EPA considers risks in the range of 1 x 10-6 to 
be negligible.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that

[[Page 60719]]

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 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. 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 June 30, 2014, 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: 
[email protected].

B. International Residue Limits

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

C. Revisions to Petitioned-For Tolerances

    The Agency determined that the tolerance level for potato, wet peel 
should be changed from the petitioned-for 0.06 ppm to 0.075 ppm based 
upon EPA's examination of the level of residues that may remain on 
potatoes following application of sedaxane at the maximum label rate 
and the average degree of sedaxane residue concentration in wet potato 

V. Conclusion

    Therefore, tolerances are established for residues of sedaxane, 
including its metabolites and degradates in or on potato; and potato, 
wet peel at 0.02 and 0.075 ppm respectively.

VI. Statutory and Executive Order Reviews

    This final rule 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 final rule has 
been exempted from review under Executive Order 12866, this final rule 
is not subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This final rule 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 tolerance in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (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: September 17, 2013.
Lois Rossi,
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) * * *

                                                            Parts  per
                        Commodity                             million
                                * * * * *
Potato..................................................           0.02
Potato, wet peel........................................           0.075
                                * * * * *

[[Page 60720]]

* * * * *

[FR Doc. 2013-23941 Filed 10-1-13; 8:45 am]