[Federal Register Volume 78, Number 44 (Wednesday, March 6, 2013)]
[Rules and Regulations]
[Pages 14461-14465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04813]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0357; FRL-9373-9]


Fenpyrazamine; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
fenpyrazamine in or on multiple commodities which are identified and 
discussed later in this document. Valent U.S.A. Corporation and 
Interregional Research Project Number 4 (IR-4) requested these 
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective March 6, 2013. Objections and 
requests for hearings must be received on or before May 6, 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-2011-0357, 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: Gene Benbow, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 347-0235; email address: [email protected].

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://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-2011-0357 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 
May 6, 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-2011-0357, 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 Confidential Business 
Information (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.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 July 6, 2011 (76 FR 39358) (FRL-8875-6) 
and of July 20, 2011 (76 FR 43233) (FRL-8880-1), EPA issued documents 
pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing 
the filing of pesticide petitions (PP 1F7841) by Valent U.S.A. 
Corporation, 1600 Riviera Ave., Suite 200, Walnut Creek, CA 94596 and 
PP 1E7850 by IR-4, 500 College Road East, Suite 201W, Princeton, NJ 
08540. The petitions requested that 40 CFR part 180 be amended by 
establishing tolerances for residues of the fungicide fenpyrazamine, S-
allyl 5-amino-2-isopropyl-4-(2-methylphenyl)-3-oxo-2,3-dihydropyrazole-
1-carbothioate, in or on: Almond at 0.02 parts per million (ppm); 
almond, hulls at 1.5 ppm; lettuce, head at 2.5 ppm; lettuce, leaf at 
2.5 ppm; small fruit vine climbing subgroup, except fuzzy kiwi fruit, 
crop subgroup 13-07F at 3.5 ppm; grape, juice at 7.0 ppm; grape, 
raisins at 4.5 ppm; low growing berry subgroup 13-07G at 3.0 ppm (PP 
1F7841); pistachio at 0.02 ppm; Caneberry subgroup 13-07A at 7.0 ppm; 
Bushberry subgroup 13-07B at 7.0 ppm; and ginseng at 0.80 ppm (PP 
1E7850). Those documents referenced a summary of the petitions prepared 
by Valent U.S.A. Corporation, the registrant, which are available in 
the docket, http://www.regulations.gov. There were no comments received 
in response to the notices of filing.
    Based upon review of the data supporting the petition, EPA has 
determined that the tolerances should be based upon parent 
fenpyrazamine only, has revised the tolerance levels for several 
commodities, and determined a tolerance is not needed for raisins. The 
reason for these changes is explained in Unit IV.D.

[[Page 14462]]

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 fenpyrazamine including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with fenpyrazamine 
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 principal toxicological findings for fenpyrazamine in repeated 
dose studies in rodents, rabbits, and dogs were reduced bodyweights/
bodyweight weight gains. In addition, thyroid follicular cell 
hypertrophy was observed in rats in the subchronic, chronic/
carcinogenicity and reproduction toxicity (parental animals only) 
studies. Although increased liver weights, hepatocellular hypertrophy, 
and alterations in hematology and clinical chemistry parameters were 
observed in several studies, they were not considered to be 
toxicologically relevant since the magnitude of the changes was within 
normal variability. The liver alterations were therefore considered 
adaptive rather than adverse effects.
    There was no evidence of increased susceptibility of developing 
organisms after in utero or post-natal exposure to fenpyrazamine in the 
developmental toxicity studies (rats and rabbits) or the multi-
generation reproduction toxicity study. In both the rat and rabbit 
developmental studies, maternal effects (decreased body weight) 
occurred at doses lower than or equal to those eliciting developmental 
effects (decreased fetal weight, skeletal variations in rats and late 
abortions and premature deliveries in rabbits). Since the late 
abortions and premature deliveries occurred at doses higher than the 
maternal LOAEL, this finding is not considered to be indicative of 
susceptibility. In the multi-generation reproduction toxicity study, 
thyroid toxicity was observed in parental animals at the same dose 
eliciting decreased body weights in the offspring. Reproductive effects 
manifested as decreases in implantations and increases in 
postimplantation loss occurred at a dose level approximately 4x higher 
than the parental and offspring LOAELs.
    The only potential sign of neurotoxicity was a decrease in total 
motor activity and total number of rearings observed in the acute 
neurotoxicity study in rats. However, given that the liver is the 
target tissue, these effects may be nonspecific effects secondary to 
general toxicity. These effects were not observed in the subchronic 
neurotoxicity or any other studies in the database.
    In a 28-day dermal toxicity study, no hazard was identified at the 
limit dose 1,000 milligrams/kilogram/day (mg/kg/day). Similarly, an 
immunotoxicity study in rats did not indicate that the immune system is 
a target for fenpyrazamine toxicity.
    Although an increase in the incidence of hepatocellular and thyroid 
follicular carcinomas was noted in the chronic/carcinogenicity study in 
rats, the concern for these findings is low based on the following 
weight of evidence considerations:
    1. The marginal increases occurred only at the high dose;
    2. There was no reduction in the latency period (i.e., tumors were 
seen only at the terminal sacrifice); and
    3. The incidences were only slightly outside the historical control 
range of the testing laboratories.
    In addition, no neoplastic lesions attributable to treatment were 
observed in the carcinogenicity study in mice and no indication of 
mutagenicity was noted in the mutagenicity battery. Based on this 
evidence, in accordance with the Agency's 2005 Guidelines for Cancer 
Risk Assessment, EPA classified fenpyrazamine as ``Not Likely to be 
Carcinogenic to Humans''.
    Specific information on the studies received and the nature of the 
adverse effects caused by fenpyrazamine 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 section 4.5.4 in the document ``Human Health 
Risk Assessment for the Section 3 Registration and Establishment of 
Tolerances on Almond, Small Fruit Climbing Subgroup 13-07F, Head and 
Leaf Lettuce, and Low Growing Berry Subgroup 13-07G, Bushberry Subgroup 
13-07B, Caneberry Subgroup 13-07A, Ginseng, and Pistachio'' in docket 
ID number EPA-HQ-OPP-2011-0357.

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 fenpyrazamine used for 
human risk assessment is shown in the following Table.

[[Page 14463]]



  Table--Summary of Toxicological Doses and Endpoints for Fenpyrazamine for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                    Point of departure
        Exposure/Scenario            and uncertainty/     RfD, PAD, LOC for     Study and toxicological effects
                                      safety factors       risk  assessment
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Acute dietary (General population  NOAEL = 80 mg/kg/day  Acute RfD = 0.8 mg/  Acute Neurotoxicity Screening
 including infants and children    UFA = 10x...........   kg/day               Battery--Rats.
 and females 13-49 years of age).  UFH = 10x...........  aPAD = 0.8 mg/kg/    LOAEL = based on a statistically
                                   FQPA SF = 1x........   day.                 significant decrease in total
                                                                               motor activity (total distance)
                                                                               in males at 400 and 2,000 mg/kg/
                                                                               day on day 1. Number of rearings
                                                                               was statistically decreased in
                                                                               males at 400 and 2,000 mg/kg/day,
                                                                               and in females at 2,000 mg/kg/day
                                                                               on day 1.
Chronic dietary (All populations)  NOAEL = 30 mg/kg/day  Chronic RfD = 0.3    Developmental Toxicity Study in
                                   UFA = 10x...........   mg/kg/day.           Rabbits.
                                   UFH = 10x...........  cPAD = 0.3 mg/kg/    Maternal LOAEL = 50 mg/kg/day
                                   FQPA SF = 1x........   day.                 [based on decreased body weight
                                                                               and food consumption].
Cancer (Oral, dermal, inhalation)  Fenpyrazamine is classified as ``Not Likely to be Carcinogenic to Humans``.
----------------------------------------------------------------------------------------------------------------
Point of Departure (POD) = 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. NOAEL = no observed adverse effect level. LOAEL = lowest observed adverse effect
  level. UF = uncertainty factor. UFA = extrapolation from animal to human (interspecies). UFH = potential
  variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor.
  PAD = population adjusted dose (a = acute, c = chronic). RfD = reference dose. LOC = level of concern. N/A =
  not applicable.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to fenpyrazamine, EPA considered exposure under the 
petitioned-for tolerances in 40 CFR 180. EPA assessed dietary exposures 
from fenpyrazamine 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 fenpyrazamine. In estimating acute dietary exposure, EPA used food 
consumption information from the 2003 to 2008 United States Department 
of Agriculture (USDA) National Health and Nutrition Examination Survey, 
What We Eat in America, (NHANES/WWEIA). For residue levels in food, EPA 
assumed 100 percent crop treated (PCT) and tolerance level residues of 
parent fenpyrazamine plus the maximum residue of S-2188-DC (expressed 
as parent fenpyrazamine) observed in the crop field trials for the 
proposed uses.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the 2003 to 2008 
United States Department of Agriculture (USDA) National Health and 
Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). 
For residue levels in food, EPA assumed 100 PCT and tolerance level 
residues of parent fenpyrazamine plus the maximum residue of S-2188-DC 
(expressed as parent fenpyrazamine) observed in the crop field trials 
for the proposed uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that fenpyrazamine does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue or PCT information in the dietary assessment for 
fenpyrazamine. Tolerance level residues and 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 fenpyrazamine in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of fenpyrazamine. 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 Tier 1 FQPA Index Reservoir Screening Tool (FIRST v. 
1.1.1, released March 26, 2008) for surface water and the Screening 
Concentration in Ground Water (SCI-GROW) model for ground water, the 
estimated drinking water concentrations (EDWCs) of fenpyrazamine for 
acute exposures are estimated to be 213.5 parts per billion (ppb) for 
surface water and 1.31 ppb for ground water. The chronic exposures are 
estimated to be 72.5 ppb for surface water and 1.31 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 213.5 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 72.5 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). Fenpyrazamine 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 
fenpyrazamine to share a common mechanism of toxicity with any other 
substances, and fenpyrazamine does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that fenpyrazamine 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

[[Page 14464]]

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. There is no evidence of 
increased pre- and/or postnatal susceptibility based on the results of 
the rat and rabbit prenatal developmental toxicity studies, and the rat 
2-generation reproductive toxicity study.
    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 fenpyrazamine is complete.
    ii. There is no evidence of increased pre- and/or postnatal 
susceptibility for fenpyrazamine.
    iii. There is no residual uncertainty in the exposure database for 
fenpyrazamine with respect to dietary (food and water) exposure. The 
dietary food exposure assessments were performed based on 100 PCT and 
tolerance-level residues of parent fenpyrazamine plus the maximum 
reside of the metabolite S-2188-DC, empirical concentration factors and 
default processing factors. EPA made conservative (protective) 
assumptions in the ground and surface water modeling used to assess 
exposure to fenpyrazamine in drinking water. These assessments will not 
underestimate the exposure and risks posed by fenpyrazamine.

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 
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. Since there are no residential 
uses proposed for fenpyrazamine, the aggregate risks are equal to the 
dietary and drinking water assessments.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to fenpyrazamine will occupy 9.2% 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 
fenpyrazamine from food and water will utilize 7.3% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term or 
intermediate-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level). Fenpyrazamine 
is not registered for any use patterns that would result in short-term 
or intermediate-term residential exposure. Short-term and intermediate-
term risk is assessed based on short-term or intermediate-term 
residential exposure plus chronic dietary exposure. Because there is no 
short-term 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-term or 
intermediate-term risk is necessary, and EPA relies on the chronic 
dietary risk assessment for evaluating short-term and intermediate-term 
risk for fenpyrazamine.
    4. Aggregate cancer risk for U.S. population. Based on the results 
of two adequate rodent carcinogenicity studies, fenpyrazamine is not 
expected to pose a cancer risk to humans.
    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 fenpyrazamine residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Parent fenpyrazamine only is the residue of concern for tolerance 
enforcement purposes. Valent U.S.A. Corporation has submitted the 
results of an independent laboratory validation (ILV) by liquid 
chromatography and mass spectrometry (LC/MS/MS), Method RM-45C-1, 
titled ``Determination of S-2188 and S-2188-DC in crops''. The method 
is considered adequate for enforcement of tolerances in plant 
commodities.
    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.
    Fenpyrazamine is a new active ingredient and MRLs have not been 
established by Codex, Canada, or Mexico for the commodities proposed 
for registration in the US.

C. Revisions to Petitioned-For Tolerances

    The Agency established parent fenpyrazamine only as the residue of 
concern for tolerance enforcement in plants and tolerances were 
recommended accordingly. These differ from the tolerances proposed by 
the registrant, which are based on residues of parent fenpyrazamine and 
the metabolite S-2188-DC expressed as fenpyrazamine. In addition, the 
Organization for the Economical Cooperation and Development (OECD) 
calculation procedures were used to estimate the tolerances and based 
on these procedures, the Agency has determined that the lettuce, head 
tolerance should be lowered from 2.0 to 1.5 ppm; lettuce, leaf from 2.5 
ppm to 2 ppm; Caneberry subgroup 13-07A from 7.0 ppm to 5 ppm; 
Bushberry subgroup 13-07B from 7.0 ppm to 5 ppm; small fruit vine 
climbing subgroup except fuzzy kiwi fruit, subgroup 13-07F from 3.5 ppm 
to 3 ppm; and grape, juice from 7.0 ppm to 4 ppm. Finally, the 
submitted grape processing data indicate that residues of parent 
fenpyrazamine only concentrate in raisins at 1.1x. Therefore, the 
concentration factor for raisin is not

[[Page 14465]]

high enough to justify the need of a separate tolerance for raisins.

V. Conclusion

    Therefore, tolerances are established for residues of 
fenpyrazamine, S-allyl 5-amino-2-isopropyl-4-(2-methylphenyl)-3-oxo-
2,3-dihydropyrazole-1-carbothioate, in or on Almond at 0.02 ppm; 
almond, hulls at 1.5 ppm; pistachio at 0.02 ppm; lettuce, head at 1.5 
ppm; lettuce, leaf at 2 ppm; Caneberry subgroup 13-07A at 5 ppm; 
Bushberry subgroup 13-07B at 5 ppm; small fruit vine climbing subgroup 
except fuzzy kiwi fruit, subgroup 13-07F at 3 ppm; grape, juice at 4 
ppm; low growing berry subgroup 13-07G at 3 ppm; and ginseng at 0.7 
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 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: February 21, 2013.
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. In subpart C, add Sec.  180.671 to read as follows:


Sec.  180.671  Fenpyrazamine; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
fungicide fenpyrazamine, in or on the following commodities. Compliance 
with the tolerance levels specified in the following table is to be 
determined by measuring only fenpyrazamine S-allyl 5-amino-2-isopropyl-
4-(2-methylphenyl)-3-oxo-2,3-dihydropyrazole-1-carbothioate, in or on 
the following commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Almond......................................................        0.02
Almond, hulls...............................................         1.5
Berry, low growing, subgroup 13-07G.........................           3
Bushberry subgroup 13-07B...................................           5
Caneberry subgroup 13-07A...................................           5
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup           3
 13-07F.....................................................
Ginseng.....................................................         0.7
Grape, juice................................................           4
Lettuce, head...............................................         1.5
Lettuce, leaf...............................................           2
Pistachio...................................................        0.02
------------------------------------------------------------------------

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

[FR Doc. 2013-04813 Filed 3-5-13; 8:45 am]
BILLING CODE 6560-50-P