
[Federal Register Volume 78, Number 249 (Friday, December 27, 2013)]
[Rules and Regulations]
[Pages 78740-78746]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30874]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0509; FRL-9903-53]


Isopyrazam; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
isopyrazam in or on apple and peanut for which there are no 
accompanying United States registrations. Syngenta Crop Protection, 
Inc., requested these tolerances under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective December 27, 2013. Objections and 
requests for hearings must be received on or before February 25, 2014, 
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-2012-0509, 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.

[[Page 78741]]


FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; 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 http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the OCSPP 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

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-2012-0509 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 
February 25, 2014. 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-2012-0509, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave., NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of September 28, 2012 (77 FR 59578) (FRL-
9364-6), 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 
2E8039) by Syngenta Crop Protection, Inc., 410 Swing Rd., P.O. Box 
18300, Greensboro, NC 27419-8300. The petition requested that 40 CFR 
180.654 be amended by establishing tolerances for residues of the 
fungicide isopyrazam, in or on apple at 0.6 parts per million (ppm) and 
peanut at 0.01 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. Comments were 
received on the notice of filing. EPA's response to these comments is 
discussed in Unit IV.C.
    Based upon review of the data supporting the petition EPA has 
proposed a higher tolerance level for apple. The reason for this change 
is explained in Unit IV.D.
    There are no registered food uses for isopyrazam in the United 
States. These tolerances were requested in connection with use of 
isopyrazam on apples and peanuts grown outside the United States. These 
tolerances will allow apples and peanuts containing isopyrazam residues 
to be imported into the United States.

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 isopyrazam including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with isopyrazam 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.
    Subchronic and chronic oral toxicity studies in the rat, mouse, and 
dog demonstrate that the primary target organ for isopyrazam is the 
liver (increased organ weight and centrilobular hepatocyte 
hypertrophy). Liver toxicity is usually accompanied by reductions in 
bodyweight and food consumption.
    Isopyrazam did not cause reproductive toxicity. Effects seen in the 
offspring (bodyweight gain during lactation and increase liver weight 
at weaning) in the rat reproduction study

[[Page 78742]]

occurred at the same doses that cause general toxicity in the parents. 
Developmental effects described as small eyes and/or microphthalmia 
were observed in both the Himalayan and New Zealand rabbit strains. 
However, in the Himalayan strain, the intraocular abnormalities occur 
in the absence of maternal toxicity while in the New Zealand the ocular 
abnormalities occurred at doses that were maternally toxic. 
Developmental effects observed in the rat (increased post-implantation 
loss, reduced fetal weight and a slight retardation of ossification) 
occurred at doses that also produced maternal toxicity (mortality, 
decreased body weights, body weight gains, and food consumption).
    No evidence of specific neurotoxicity was seen in acute and 
subchronic oral neurotoxicity studies in rats. Clinical signs seen in 
two subchronic dog studies (side-to-side head wobble, ataxia, reduced 
stability) are consistent with neurotoxic effects. However detailed and 
specific neuropathological analyses were not conducted for the dog 
studies (i.e., functional observational battery, motor activity, 
detailed histopathology with special stains). Consequently, there is 
uncertainty regarding whether the effects seen in the dog studies are 
in fact signs of neurotoxicity. However, clear no observed adverse 
effect levels (NOAELs)/lowest adverse effect levels (LOAELs) were 
established for both subchronic dog studies. The point of departure 
selected for the acute dietary assessment is based on clinical signs 
seen on day 2 in one of four males in the subchronic dog study. This 
study provides the lowest NOAEL in the database (most sensitive 
endpoint) for a single dose effect. The dose used for the chronic 
dietary risk assessment is eight times lower than the dose at which 
clinical effects were seen at four weeks in the second subchronic dog 
study.
    There is no evidence of immunotoxicity based on a 28-day dietary 
immunotoxicity study in rats. The LOAEL for immunotoxicity was not 
identified and the NOAEL for immunotoxicity was 1,356 milligrams/
kilograms (mg/kg).
    Isopyrazam is classified as ``Likely to be Carcinogenic to Humans'' 
based on increased incidence of uterine endometrial adenocarcinomas and 
liver hepatocellular adenomas in female rats and increased incidence of 
thyroid follicular cell adenomas and/or carcinomas in male rats. 
Isopyrazam is not carcinogenic in the mouse. There is no evidence of 
genotoxicity, mutagenicity, or clastogenicity in the in vivo and in 
vitro studies. There are no structural relationships with other known 
carcinogens. A linear low-dose approach (Q1*) was used to 
extrapolate experimental animal tumor data for the quantification of 
human cancer risk.
    Isopyrazam is of low acute toxicity by the oral, dermal, and 
inhalation routes and is not a skin or eye irritant.
    Specific information on the studies received and the nature of the 
adverse effects caused by isopyrazam as well as the NOAEL and the LOAEL 
from the toxicity studies can be found at http://www.regulations.gov in 
the document ``Human Health Risk Assessment for the Establishment of 
Tolerances with No U.S. Registrations for Isopyrazam in/on Imported 
Apple and Peanut'' at pp. 14-18 in docket ID number EPA-HQ-OPP-2012-
0509.

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 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 used for human risk assessment is shown in Table 1 of 
this unit.

  Table 1--Summary of Toxicological Doses and Endpoints for Isopyrazam for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 RfD, PAD, level
                                   Point of       Uncertainty/    of concern for      Study and toxicological
      Exposure/scenario         departure (mg/    FQPA safety    risk assessment              effects
                                   kg/day)          factors        (mg/kg/day)
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Acute Dietary................  NOAEL= 30......  UFA = 10x......  Acute RfD =      Subchronic Toxicity--Dog.
(All populations)............                   UFH = 10x......   0.30.            LOAEL = 100 mg/kg/day based
                                                FQPA SF = 1x...  aPAD = 0.30....   on clinical signs (side-to-
                                                                                   side head wobble) in male
                                                                                   dogs.
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Chronic Dietary (All           NOAEL = 5.5....  UFA = 10x......  Chronic RfD =    Chronic Toxicity/
 populations).                                  UFH = 10x......   0.055.           Carcinogenicity--Rats. LOAEL
                                                FQPA SF = 1x...  cPAD = 0.055...   = 27.6 mg/kg/day based on
                                                                                   decreased body weight and
                                                                                   body weight gain in females;
                                                                                   increased incidences of
                                                                                   hepatocellular hypertrophy,
                                                                                   pigment in centrilobular
                                                                                   hepatocytes, eosinophilic
                                                                                   foci of altered hepatocytes,
                                                                                   vacuolation of centrilobular
                                                                                   hepatocytes, bile duct
                                                                                   hyperplasia, and bile duct
                                                                                   fibrosis in both sexes; and
                                                                                   brown pigment in the kidney
                                                                                   in females.
----------------------------------------------------------------------------------------------------------------

[[Page 78743]]

 
Cancer (All routes)..........  Classification: CARC classified isopyrazam as ``Likely to be Carcinogenic to
                                Humans'' based on increased liver and uterine endometrial epithelial tumors in
                                female rats and increased thyroid follicular cell tumors in male rats. A cancer
                                slope factor (Q1*) of 0.00629 (mg/kg/day)-1 was calculated based on an increase
                                in increase in liver tumors in female rats.
----------------------------------------------------------------------------------------------------------------
CARC = Cancer Assessment Review Committee. Food Quality Protection Act Safety Factor = FQPA SF. 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). Point of Departure = A data point or an estimated
  point that is derived from observed dose-response data and used to mark the beginning of extrapolation to
  determine risk associated with lower environmentally relevant human exposures. Q1* = Linear low-dose approach.
  RfD = reference dose. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH =
  potential variation in sensitivity among members of the human population (intraspecies).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to isopyrazam, EPA considered exposure under the petitioned-
for tolerances as well as all existing isopyrazam tolerances in 40 CFR 
180.654. EPA assessed dietary exposures from isopyrazam 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. In estimating acute dietary 
exposure, EPA used food consumption information from the U.S. 
Department of Agriculture (USDA) 2003-2008 National Health and 
Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). As 
to residue levels in food, maximum residues of isopyrazam (as the sum 
of its syn-isomer and anti-isomer) plus its tertiary alcohol metabolite 
(CSCD460260; as the sum of its syn-isomer (CSCD459488; free and 
conjugated) and anti-isomer (CSCD459489; free and conjugated)) from 
field trials reflecting maximum use rates and 100 percent crop treated 
(PCT) assumptions were used. Dietary Exposure Evaluation Model (DEEM) 
default processing factors were used for all processed commodities 
including dried apple (8.0), apple juice/cider (1.3), dried banana/
plantain (3.9), and peanut butter (1.89). In the absence of peanut 
processing data, the maximum theoretical concentration factor was used 
for peanut oil (2.8).
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment, EPA used the food consumption data from the USDA 2003-2008 
NHANES/WWEIA. As to residue levels in food, EPA used the same residue 
levels, processing factors and PCT assumptions as in the acute dietary 
exposure analysis.
    iii. Cancer. Isopyrazam is classified as ``Likely to be 
Carcinogenic to Humans'' based on increased liver and uterine 
endometrial epithelial tumors in female rats and increased thyroid 
follicular cell tumors in male rats. In the absence of mode of action 
data, a linear low dose extrapolation for cancer risk assessment was 
used. A cancer slope factor (Q1*) of 0.00629 (mg/kg/
day)-1 was used for the quantification of human cancer risk. 
In evaluating cancer risk, EPA used the same residue levels, processing 
factors, and PCT assumptions as the acute and chronic dietary exposure 
analyses.
    iv. Anticipated residue and PCT information. While EPA did not use 
PCT information in the dietary assessment for isopyrazam, anticipated 
residues were used. Maximum residues from field trials conducted at the 
maximum use rates were used to estimate residues of isopyrazam (as the 
sum of its syn-isomer and anti-isomer) plus its tertiary alcohol 
metabolite (CSCD460260; as the sum of its syn-isomer (CSCD459488; free 
and conjugated) and anti-isomer (CSCD459489; free and conjugated)). 
Analyses assumed 100 PCT and used DEEM default processing factors. In 
the absence of peanut processing data, the maximum theoretical 
concentration factor was used as a processing factor for peanut oil 
(2.8).
    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.
    2. Dietary exposure from drinking water. An assessment of residues 
in drinking water is not needed for isopyrazam because there is no 
drinking water exposure associated with the existing (banana) and 
proposed uses (apple and peanut) which are all non-domestic.
    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). Isopyrazam 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 isopyrazam to share a common mechanism of 
toxicity with any other substances, and isopyrazam does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
isopyrazam 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

[[Page 78744]]

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 Food Quality 
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA 
either retains the default value of 10X, or uses a different additional 
SF when reliable data available to EPA support the choice of a 
different factor.
    2. Prenatal and postnatal sensitivity. There are no residual 
uncertainties for pre- and/or post natal susceptibility even though 
qualitative susceptibility was observed in the range-finding 
developmental studies in rabbits. Developmental effects (eye 
abnormalities) were observed in the absence of maternal toxicity in two 
range finding developmental toxicity studies in the Himalayan rabbit. 
However, the eye effects were only observed at relatively high doses 
(200-400 mg/kg/day) with clear NOAELs/LOAELs established for the 
developmental effects. Developmental effects observed in the rat 
(reduced fetal weight and a slight retardation of ossification) 
occurred only at doses that also produced maternal toxicity (mortality, 
decreased body weights, body weight gains, and food consumption). There 
was no evidence of increased susceptibility in a 2-generation 
reproduction study following pre- or postnatal exposure to isopyrazam. 
There was also no evidence of neuropathology or abnormalities in the 
development of the fetal nervous system from the available toxicity 
studies conducted with isopyrazam. Clear NOAELs/LOAELs were established 
for the developmental effects observed in rats and rabbits as well as 
for the offspring effects (increased liver weights) seen in the 2-
generation reproduction study and a dose-response relationship for the 
effects of concern is well characterized. The dose used for the acute 
dietary risk assessment (30 mg/kg/day), based on effects seen in the 
subchronic dog study, is protective of the developmental effects seen 
in rats (44.5 mg/kg/day) and rabbits (200 mg/kg/day). Based on these 
considerations, there are no residual uncertainties for pre- and/or 
postnatal susceptibility
    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 isopyrazam is complete.
    ii. As discussed in Unit III.D.2, there are no residual 
uncertainties for pre-and/or postnatal susceptibility and thus, it is 
unnecessary to retain the 10X FQPA SF to adequately protect infants and 
children.
    iii. The dietary risk assessment is based on parent plus metabolite 
residues and will not underestimate dietary exposure to isopyrazam. For 
the acute, chronic and cancer dietary analyses, maximum residues of 
parent plus metabolite and 100 PCT assumptions were used for all 
treated commodities. There are no residual uncertainties identified in 
the exposure databases.

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 to 
isopyrazam will occupy 4.2% of the aPAD for children 1-2 years 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 
isopyrazam from food will utilize 6.1% of the cPAD for children 1-2 
years old, the population group receiving the greatest exposure.
    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). Isopyrazam is not 
registered in the United States. 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, 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 isopyrazam.
    4. Aggregate cancer risk for U.S. population. Using the exposure 
assumptions discussed in this unit for cancer exposure, the cancer 
dietary risk estimate for the U.S. population is 2 x 10-6.
    EPA generally considers cancer risks (expressed as the probability 
of an increased cancer case) in the range of 1 in 1 million (or 1 x 
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 logarithmic 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, cancer risk should generally not be assumed 
to exceed the benchmark level of concern of the range of 
10-6 until the calculated risk exceeds approximately 3 x 
10-6. This is particularly the case where some conservatism 
is maintained in the exposure assessment. For isopyrazam, EPA's 
exposure assessment assumes maximum residues of concern from field 
trials reflecting the maximum use rates, default processing factors, 
the maximum theoretical concentration for residues in peanut oil and 
100 PCT, which is highly conservative. Accordingly, EPA has concluded 
the cancer risk from exposure to isopyrazam falls within the range of 1 
x 10-6 and is thus 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 isopyrazam residues.

IV. Other Considerations

A. Analytical Enforcement Methodology.

    Adequate enforcement methodology (Method GRM006.01B) is available 
to enforce the tolerance expression. The

[[Page 78745]]

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). 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.
    No Codex or MRLs have been established for residues of isopyrazam 
in or on apple or peanut commodities.

C. Response to Comments

    EPA received a comment to the notice of filing which said that no 
residues of isopyrazam should be permitted on food. The Agency 
understands the commenter's concerns and recognizes that some 
individuals believe that pesticides should be banned on agricultural 
crops. However, the existing legal framework provided by FFDCA section 
408 states that tolerances may be set when persons seeking such 
tolerances or exemptions have demonstrated that the pesticide meets the 
safety standard imposed by that statute. This citizen's comment appears 
to be directed at the underlying statute and not EPA's implementation 
of it; the citizen has made no contention that EPA has acted in 
violation of the statutory framework.

D. Revisions to Petitioned-For Tolerances

    For the purposes of harmonization with a pending European Union MRL 
for residues of isopyrazam in or on pome fruit (0.7 mg/kg), EPA is 
establishing a tolerance of 0.70 ppm in or on apple in lieu of the 0.6 
ppm as requested by the petitioner. This increase to the proposed 
tolerance is supported by the data reviewed for the petition. No 
changes were made to the proposed tolerance for peanut.

V. Conclusion

    Therefore, tolerances are established for residues of isopyrazam in 
or on apple at 0.70 ppm and peanut at 0.01 ppm. The Agency is also 
revising the tolerance expression to clarify that determining 
compliance with the tolerance requires measuring both the syn-isomer 
and the anti-isomers of isopyrazam. This change is supported by the 
available enforcement method which sums the two isomers for the 
tolerance detection. The tolerance expression revision will not impact 
the current banana tolerance.

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 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 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: December 19, 2013.
Lois Rossi,
Director, Registration Division, 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. In Sec.  180.654:
0
a. Revise the introductory text in paragraph (a).
0
b. Add alphabetically the commodities ``Apple'' and ``Peanut'' to the 
table in paragraph (a).
0
c. Revise footnote one to the table in paragraph (a).

[[Page 78746]]

    The additions and revisions read as follows:


Sec.  180.654  Isopyrazam; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide isopyrazam, including its metabolites and degradates, in or 
on the commodities listed in the following table. Compliance with the 
tolerance levels specified in the following table is to be determined 
by measuring only isopyrazam (3-(difluoromethyl)-1-methyl-N-[1,2,3,4-
tetrahydro-9-(1-methylethyl)-1,4-methano-naphthalen-5-yl]-1H-pyrazole-
4-carboxamide), as the sum of its syn-isomer (3-(difluoromethyl)-1-
methyl-N-[(1RS, 4SR, 9RS)-1,2,3,4-tetrahydro-9-(1-methylethyl)-1,4-
methanonaphthalen-5-yl]-1H-pyrazole-4-carboxamide) and anti-isomer (3-
(difluoromethyl)-1-methyl-N-[(1RS, 4SR, 9SR)-1,2,3,4-tetrahydro-9-(1-
methylethyl)-1,4-methano-naphthalen-5-yl]-1H-pyrazole-4-carboxamide) in 
or on the commodity.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Apple \1\...................................................        0.70
 
                                * * * * *
Peanut \1\..................................................        0.01
------------------------------------------------------------------------
\1\ There are no U.S. registrations for use of isopyrazam on apple,
  banana, or peanut.

* * * * *

[FR Doc. 2013-30874 Filed 12-26-13; 8:45 am]
BILLING CODE 6560-50-P


