
[Federal Register Volume 77, Number 119 (Wednesday, June 20, 2012)]
[Rules and Regulations]
[Pages 36919-36924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-14957]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0615; FRL-9345-8]


Sedaxane; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
sedaxane in or on multiple food commodities which are identified and 
discussed later in this document. Syngenta Crop Protection, Inc. 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective June 20, 2012. Objections and 
requests for hearings must be received on or before August 20, 2012, 
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-2010-0615, is available at 
http:[sol][sol]www.regulations.gov or at the OPP Docket in the 
Environmental Protection Agency Docket Center (EPA/DC), located in EPA 
West, 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:[sol][sol]www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Heather Garvie, Registration Division, 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 
(703) 308-0034; email address: garvie.heather@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

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:[sol][sol]ecfr.gpoaccess.gov/cgi/
t/text/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-2010-0615 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 
August 20, 2012. Addresses for mail and hand delivery of objections

[[Page 36920]]

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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2010-0615, by one of the following methods:
ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2010-0615 by one of the following methods:
     Federal eRulemaking Portal: 
http:[sol][sol]www.regulations.gov. Follow the online instructions for 
submitting comments. Do not submit electronically any information you 
consider to be Confidential Business Information (CBI) or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 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:[sol][sol]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:[sol][sol]www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of August 11, 2010 (75 FR 48667) (FRL-8840-
6), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 
346a(d)(3), announcing the filing of a pesticide petition (PP 
0F7721) by Syngenta Crop Protection, Inc., Regulatory Affairs, 
P.O. Box 18300, Greensboro, NC 27419-8300. The petition requested that 
40 CFR part 180 be amended by establishing tolerances for residues of 
the fungicide sedaxane, in or on barley, grain, seed at 0.01 parts per 
million (ppm); barley, hay, seed at 0.05 ppm; barley, straw, seed at 
0.01 ppm; canola, seed at 0.01 ppm; oat, grain, seed at 0.01 ppm; rye, 
seed at 0.01 ppm; soybean, forage, seed at 0.06 ppm; soybean, hay, seed 
at 0.4 ppm; soybean, seed at 0.01 ppm; triticale, seed at 0.01 ppm; 
wheat, forage, seed at 0.02 ppm; wheat, grain, seed at 0.01 ppm; wheat, 
hay, seed at 0.07 ppm; and wheat, straw, seed at 0.01 ppm. That notice 
referenced a summary of the petition prepared by Syngenta Crop 
Protection, Inc., the registrant, which is available in the docket, 
http:[sol][sol]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 
modified the tolerances to correct commodity definitions and to 
recommend tolerances other than the proposed tolerances. 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, 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 qualitative 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 can be found at http://www.regulations.gov in document ``Sedaxane. Human Health Risk 
Assessment to Support New Seed Treatment Uses on Canola, Cereal Grains 
(Barley, Oat, Rye, Triticale, and Wheat), and Soybean'', dated February 
16, 2012, pages 37-77 in docket ID number EPA-HQ-OPP-2010-0615.

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

[[Page 36921]]

analysis of the doses in each toxicological study to determine the dose 
at which the NOAEL and the LOAEL of concern are identified. 
Uncertainty/safety factors (USFs) are used in conjunction with the POD 
to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for sedaxane used for 
human risk assessment is shown in the following Table.

    Table--Summary of Toxicological Doses and Endpoints for Sedaxane for Use in Human Health Risk Assessment
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                                    Point of departure
        Exposure/scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk assessment
----------------------------------------------------------------------------------------------------------------
Acute Dietary (general             NOAEL = 30 mg/kg/     Acute RfD = 0.30 mg/ Rat ACN Study.
 populations, including infants     day.                  kg/day.             NOAEL = 30 mg/kg.
 and children).                    UFA = 10x...........  aPAD = 0.30 mg/kg/   LOAEL = 250 mg/kg based on reduced
                                   UFH = 10x...........   day..                activity, decreased rearing,
                                   FQPA SF = 1x........                        initial inactivity, piloerection,
                                                                               ruffled fur and recumbency,
                                                                               decreased BW, decreased BWG and
                                                                               food consumption (males). In
                                                                               females, weakened condition,
                                                                               swaying gait, decreased activity,
                                                                               reduced muscle tone, and
                                                                               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/     Chronic RfD = 0.11   Chronic Rat Study.
                                    day.                  mg/kg/day.          NOAEL = 11/14 mg/kg bw/day male/
                                   UFA = 10x...........  cPAD = 0.11 mg/kg/    female.
                                   UFH = 10x...........   day..               LOAEL = 67/86 mg/kg bw/day male/
                                   FQPA SF = 1x........                        female in males 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 (male). In
                                                                               females, it was based on
                                                                               decreased body weight and body
                                                                               weight gain, increased liver
                                                                               weight and the same thyroid
                                                                               histopathology noted above for
                                                                               males.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)  Classification: ``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.
----------------------------------------------------------------------------------------------------------------
FQPA SF = Food Quality Protection Act Safety Factor. LOAEL = lowest-observed-adverse-effect-level. LOC = level
  of concern. mg/kg/day = milligram/kilogram/day. MOE = margin of exposure. NOAEL = no-observed-adverse-effect-
  level. PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. UF = uncertainty factor.
  UFA = extrapolation from animal to human (interspecies). UFDB = to account for the absence of data or other
  data deficiency. UFH = potential variation in sensitivity among members of the human population
  (intraspecies). BW = Body weight. BWG = Body weight gain.

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. 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 U.S. Department of Agriculture (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA conducted a 
highly conservative acute dietary risk assessment which used tolerance 
level residues and assumed 100 percent crop treated (PCT) for all 
commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA conducted a highly 
conservative chronic dietary risk assessment which used tolerance level 
residues and assumed 100 PCT for all commodities.
    iii. Cancer. EPA determines whether quantitative cancer exposure 
and risk assessments are appropriate for a food-use pesticide based on 
the weight of the evidence from cancer studies and other relevant data. 
If quantitative cancer risk assessment is appropriate, cancer risk may 
be quantified using a linear or nonlinear approach. If sufficient 
information on the carcinogenic mode of action is available, a 
threshold or nonlinear approach is used and a cancer RfD is calculated 
based on an earlier noncancer key event. If carcinogenic mode of action 
data are not available, or if the mode of action data determines a 
mutagenic mode of action, a default linear cancer slope factor approach 
is utilized. 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. This finding is based on significant tumor 
increases in two adequate rodent carcinogenicity studies. EPA assessed 
exposure for the purpose of estimating cancer risk

[[Page 36922]]

assuming tolerance level residues and 100 PCT for all commodities.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for sedaxane. 100 PCT were assumed for all food commodities.
    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 
http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST) and Tier 
II pesticide root zone model (PRZM) (grab working-level sampling, 
ground water (GW) (Prerelease Version), the estimated drinking water 
concentrations (EDWCs) of sedaxane for acute exposures are estimated to 
be 1.4 parts per billion (ppb) for surface water and 8.3 ppb for ground 
water. The water exposures for the chronic dietary and cancer 
assessments are estimated to be 0.9 ppb for surface water and 6.5 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 8.3 ppb was used to assess 
the contribution to drinking water. For chronic and cancer dietary risk 
assessment, the water concentration value of 6.5 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. 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 
factor.
    2. Prenatal and postnatal sensitivity. The toxicological database 
for sedaxane is complete with regard to prenatal and postnatal 
toxicity, and there are no residual uncertainties. 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. There is no evidence of 
neuropathology or abnormalities in the development of the fetal nervous 
system from the available toxicity studies conducted with 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).
    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 and includes the 
immunotoxicity study and neurotoxicity screening battery.
    ii. The sedaxane toxicology database did not demonstrate evidence 
of neurotoxicity. There are no specific concerns for neurotoxicity as 
the observed effects in the ACN and SCN studies were likely secondary 
to inhibition of mitochondrial energy production caused by sedaxane. 
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. There was no corroborative neuro-
histopathology demonstrated in any study, even at the highest doses 
tested (i.e., 2,000 mg/kg/day). 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 susceptibility to the young or specific neurotoxicity, a 
developmental neurotoxicity (DNT) study is not required.
    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 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. 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 population adjusted dose (aPAD) and chronic population adjusted 
dose (cPAD). For linear cancer risks, EPA calculates the lifetime 
probability of acquiring cancer given the estimated aggregate exposure. 
Short-term, intermediate-term, 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

[[Page 36923]]

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 insignificant.
    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-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). A short-term 
adverse effect was identified; however, sedaxane is not registered for 
any use patterns that would result in short-term residential exposure. 
Short-term risk is assessed based on short-term residential exposure 
plus chronic dietary exposure. Because there is no short-term 
residential exposure and chronic dietary exposure has already been 
assessed under the appropriately protective cPAD (which is at least as 
protective as the POD used to assess short-term risk), no further 
assessment of short-term risk is necessary, and EPA relies on the 
chronic dietary risk assessment for evaluating short-term risk for 
sedaxane.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). An intermediate-term adverse effect was identified; however, 
sedaxane is not registered for any use patterns that would result in 
intermediate-term residential exposure. Intermediate-term risk is 
assessed based on intermediate-term residential exposure plus chronic 
dietary exposure. Because there is no intermediate-term residential 
exposure and chronic dietary exposure has already been assessed under 
the appropriately protective cPAD (which is at least as protective as 
the POD used to assess intermediate-term risk), no further assessment 
of intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating intermediate-term risk for 
sedaxane.
    5. 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 7 x 10-7 for the US 
population. This assessment assumed tolerance level residues, 100 PCT 
for all commodities, and included modeled drinking water estimates.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to 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 April 2012, 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

    The tolerance levels for feedstuffs for soybean, forage; wheat, 
forage; wheat, hay; and barley, hay being established by EPA differ 
from those proposed in the tolerance petition submitted by Syngenta. 
The Agency used the Organization for Economic Cooperation and 
Development tolerance calculation procedures to determine that the 
following tolerance levels are needed: 0.05 for soybean, forage; 0.015 
for wheat, forage; 0.06 for wheat, hay; and 0.04 for barley, hay. The 
petitioner did not propose separate tolerances for feedstuffs derived 
from oat and rye, however, the Agency is establishing them as follows: 
Oat, forage at 0.015; oat, hay at 0.06; oat, straw at 0.01; rye, forage 
at 0.015; and rye, straw at 0.01. The wheat trials depict low but 
finite residues in forage, straw, and hay. Syngenta proposed, and EPA 
agrees, that tolerances are needed on these wheat feedstuffs. Because 
EPA is relying on magnitude of the residue data from wheat and barley 
to establish oat and rye tolerances, due to the crop similarities and 
identical use patterns, tolerances on oat and rye feedstuffs are needed 
as well. A separate tolerance for triticale is not required as wheat 
tolerances cover triticale by definition 40 CFR 180.1(g).

V. Conclusion

    Therefore, the following tolerances are established for residues of 
sedaxane, in or on wheat, grain at 0.01 ppm; barley, grain at 0.01 ppm; 
soybean, seed at 0.01 ppm; canola, seed at 0.01 ppm; oat, grain at 0.01 
ppm; rye, grain at 0.01 ppm; soybean, forage at 0.05 ppm; soybean, hay 
at 0.04 ppm; wheat, forage at 0.015 ppm; wheat, hay at 0.06 ppm; wheat, 
straw at 0.01 ppm; barley, hay at 0.04 ppm; barley, straw at 0.01 ppm; 
oat, forage at 0.015 ppm; oat, hay at 0.06 ppm; oat, straw at 0.01 ppm; 
rye, forage at 0.015 ppm and rye, straw at 0.01 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to a petition submitted to the

[[Page 36924]]

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) (Pub. L. 104-4).
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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: June 8, 2012.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

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. Section 180.665 is added to read as follows:


Sec.  180.665  Sedaxane; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide sedaxane, including its metabolites and degradates, in or on 
the commodities in the following table. Compliance with the tolerance 
levels specified in the following table is to be determined by 
measuring only sedaxane, N-[2-[1,1'-bicyclopropyl]-2-ylphenyl]-3-
(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide, as the sum of its 
cis- and trans-isomers in or on the commodity.

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Barley, grain..............................................        0.01
Barley, hay................................................        0.04
Barley, straw..............................................        0.01
Canola, seed...............................................        0.01
Oat, forage................................................        0.015
Oat, grain.................................................        0.01
Oat, hay...................................................        0.06
Oat, straw.................................................        0.01
Rye, forage................................................        0.015
Rye, grain.................................................        0.01
Rye, straw.................................................        0.01
Soybean, forage............................................        0.05
Soybean, hay...............................................        0.04
Soybean, seed..............................................        0.01
Wheat, forage..............................................        0.015
Wheat, grain...............................................        0.01
Wheat, hay.................................................        0.06
Wheat, straw...............................................        0.01
------------------------------------------------------------------------

     (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect inadvertent residues. [Reserved]

[FR Doc. 2012-14957 Filed 6-19-12; 8:45 am]
BILLING CODE 6560-50-P


