[Federal Register Volume 77, Number 135 (Friday, July 13, 2012)]
[Rules and Regulations]
[Pages 41284-41291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17021]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0398; FRL-9352-2]


Azoxystrobin; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

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

DATES: This regulation is effective July 13, 2012. Objections and 
requests for hearings must be received on or before September 11, 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-2011-0398; FRL-9352-2, is 
available either electronically through http://www.regulations.gov or 
in hard copy 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://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division, 
(7505P) Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; 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. 
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.

[[Page 41285]]

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-2011-0398 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
September 11, 2012. 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 that does not contain 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 a copy of your non-CBI objection or 
hearing request, identified by docket ID number EPA-HQ-OPP-2011-0398, 
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), 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://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 Tolerances

    In the Federal Register of July 20, 2011 (76 FR 43231) (FRL-8880-
1), 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 1E7851) 
by Interregional Research Project Number 4 (IR-4), 500 College Road 
East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 
CFR 180.507 be amended by:
     Establishing tolerances for residues of the fungicide 
azoxystrobin, (methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-
yloxy]phenyl]-3-methoxyacrylate) and the Z isomer of azoxystrobin, 
(methyl (Z)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]pheny1]-3-
methoxyacrylate) in or on onion, bulb subgroup 3-07A at 1.0 parts per 
million (ppm); onion, green subgroup 3-07B, at 7.5 ppm; caneberry 
subgroup 13-07A, at 5.0 ppm; bushberry subgroup 13-07B, at 3.0 ppm; 
small fruit vine climbing subgroup, except fuzzy kiwifruit, 13-07F, at 
1.0 ppm; low growing berry subgroup 13-07G, except cranberry, at 10.0 
ppm; vegetable, fruiting, subgroup 8-10A, at 0.2 ppm; vegetable, 
fruiting, subgroups 8-10B, at 2.0 ppm; fruit, citrus, group 10-10, at 
10.0 ppm; rapeseed subgroup 20A, at 1.0 ppm; sunflower subgroup 20B, at 
0.5 ppm; cottonseed subgroup 20C, at 0.6 ppm; wasabi, at 50.0 ppm; and 
dragon fruit, at 2.0 ppm;
     Changing the tolerance for vegetable, tuberous and corm, 
subgroup 1C from 0.03 ppm to 6.0 ppm; and
     Upon approval of the tolerances above, by removing the 
established tolerances for onion, bulb at 1.0 ppm; onion, green at 7.5 
ppm; caneberry subgroup 13-A at 5.0 ppm; bushberry subgroup 13B at 3.0 
ppm; Juneberry at 3.0 ppm; lingonberry at 3.0 ppm; salal at 3.0 ppm; 
grape at 1.0 ppm; strawberry at 10.0 ppm; tomato at 0.2 ppm; vegetable, 
fruiting, group 8 except tomato at 2.0 ppm; fruit, citrus, group 10 at 
10.0 ppm; canola, seed at 1.0 ppm; cotton, undelinted seed at 0.6 ppm; 
crambe, seed at 0.5 ppm; flax, seed at 0.5 ppm; mustard, field, seed at 
0.5 ppm; mustard, Indian, seed at 0.5 ppm; mustard, seed at 0.5 ppm; 
rapeseed, Indian at 0.5 ppm; rapeseed, seed at 0.5 ppm; safflower, seed 
at 0.5 ppm; sunflower, seed at 0.5 ppm; potato at 0.03 ppm.
    In the Federal Register of November 9, 2011 (76 FR 69690) (FRL-
9325-1), 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 
1F7891) by Syngenta Crop Protection, LLC., P.O. Box 18300, Greensboro, 
NC 27419-8300. The petition requested that 40 CFR 180.507 be amended by 
establishing a tolerance for residues of the fungicide azoxystrobin, 
(methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-
methoxyacrylate) and the Z isomer of azoxystrobin, (methyl (Z)-2-[2-[6-
(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) in or on 
sugarcane at 0.2 ppm.
    The notices referenced summaries of the petitions prepared by 
Syngenta, the registrant, which are available in the docket, http://www.regulations.gov. There were no comments received in response to 
these notices of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the levels at which tolerances are being established for 
various commodities. The reason for these changes is 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 azoxystrobin including exposure 
resulting from the tolerances established by this action. EPA's 
assessment of exposures and risks associated with azoxystrobin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as

[[Page 41286]]

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.
    Azoxystrobin has low acute toxicity via the oral, dermal and 
inhalation routes of exposure. It is not an eye or skin irritant and is 
not a skin sensitizer. Dietary administration of azoxystrobin to rats 
resulted in decreased body weights, decreased food intake and 
utilization, increased diarrhea and other clinical toxicity 
observations (increased urinary incontinence, hunched postures and 
distended abdomens). In addition, liver effects characterized by 
increased liver weights, increases in alkaline phosphatase and gama 
glutamyltransferase, decreases in albumin, gross and histological 
lesions in the liver and bile ducts, were seen in rats. In dogs, 
effects on liver/biliary function were found after oral administration.
    In the acute neurotoxicity study in rats, increased incidence of 
diarrhea was observed at all dose levels tested including the lowest-
observed-adverse-effect-level (LOAEL). Decreased body weight/weight 
gain and food utilization was noted in the rat subchronic neurotoxicity 
study. There were no consistent indications of treatment-related 
neurotoxicity in either the acute or subchronic neurotoxicity studies.
    In the rat developmental toxicity study, diarrhea, urinary 
incontinence and salivation were observed in maternal animals; in the 
rabbit developmental toxicity study, maternal animals exhibited 
decreased body weight gain. No adverse treatment-related developmental 
effects were seen in either study. In the rat reproduction study, 
offspring and parental effects (decreased body weights and increased 
adjusted liver weights) were observed at the same dose.
    There was no evidence of carcinogenicity in rats and mice at 
acceptable dose levels. As a result, EPA has classified azoxystrobin as 
``not likely to be carcinogenic to humans.'' Azoxystrobin induced a 
weak mutagenic response in the mouse lymphoma assay, but the activity 
expressed in vitro is not expected to be expressed in whole animals.
    Specific information on the studies received and the nature of the 
adverse effects caused by azoxystrobin as well as the no-observed-
adverse-effect-level (NOAEL) and the LOAEL from the toxicity studies 
can be found at http://www.regulations.gov in docket ID number EPA-HQ-
OPP-2011-0398 on pages 38-40 of the document titled ``Azoxystrobin: 
Human Health Risk Assessment for Proposed Uses on Dragon Fruit, Wasabi, 
and Tuberous and Corm Vegetables (Subgroup 1C), and from the Revisions 
to Various Crop Groups (Onion Subgroups 3-07 A, B; Fruiting Vegetable 
Subgroups 8-10 A, B; Small Fruit and Berry Subgroups 13-07 A, B, F, G, 
Oilseeds Subgroups A, B, C; and Citrus Fruit Group 10-10).''

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

  Table--Summary of Toxicological Doses and Endpoints for Azoxystrobin for Use in Human Health Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                        Point of departure and
          Exposure/scenario               uncertainty/safety     RfD, PAD, LOC for risk  Study and toxicological
                                               factors                 assessment                effects
----------------------------------------------------------------------------------------------------------------
Acute dietary (All Populations)......  LOAEL = 200 mg/kg/day..  Acute RfD = 0.67 mg/kg/  Acute Neurotoxicity--
                                       UFA = 10x..............   day.                     Rat. LOAEL = 200 mg/kg/
                                       UFH = 10x..............  aPAD = 0.67 mg/kg/day..   day based on diarrhea
                                       FQPA SF = 3x UFL.......                            at 2-hours post dose
                                                                                          at all dose levels up
                                                                                          to and including to
                                                                                          LOAEL.
Chronic dietary (All Populations)....  NOAEL= 18 mg/kg/day....  Chronic RfD = 0.18 mg/   Combined Chronic
                                       UFA = 10x..............   kg/day.                  Toxicity/
                                       UFH = 10x..............  cPAD = 0.18 mg/kg/day..   Carcinogenicity
                                       FQPA SF = 1x...........                            Feeding Study--Rat.
                                                                                          LOAEL = 82.4/117 mg/kg/
                                                                                          day (M/F) based on
                                                                                          reduced body weights
                                                                                          in both sexes and bile
                                                                                          duct lesions in males.
Incidental oral short-term (1 to 30    NOAEL= 25 mg/kg/day....  LOC for MOE = 100......  Prenatal Developmental
 days).                                UFA = 10x..............                            Oral Toxicity--Rat.
                                       UFH = 10x..............                            LOAEL = 100 mg/kg/day
                                       FQPA SF = 1x...........                            based on increased
                                                                                          maternal diarrhea,
                                                                                          urinary incontinence,
                                                                                          and salivation.

[[Page 41287]]

 
Inhalation short-term (1 to 30 days).  Oral study NOAEL= 25 mg/ LOC for MOE = 100......  Prenatal Developmental
                                        kg/day (inhalation                                Oral Toxicity--Rat.
                                        absorption rate =                                 LOAEL = 100 mg/kg/day
                                        100%).                                            based on increased
                                       UFA = 10x..............                            maternal diarrhea,
                                       UFH = 10x..............                            urinary incontinence,
                                       FQPA SF = 1x...........                            and salivation.
----------------------------------------------------------------------------------------------------------------
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). UFH = potential variation in sensitivity among
  members of the human population (intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. mg/kg/day =
  milligrams/kilogram/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to azoxystrobin, EPA considered exposure under the petitioned-
for tolerances as well as all existing azoxystrobin tolerances in 40 
CFR 180.507. EPA assessed dietary exposures from azoxystrobin 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 azoxystrobin. 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, the acute dietary assessment used tolerance levels for 
all commodities, except citrus fruits where the highest residue from 
crop field trials was used, and 100 percent crop treated (PCT) for all 
commodities. Default processing factors were assumed except for where 
tolerances were established for processed 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, the chronic dietary 
analysis for azoxystrobin was conducted using tolerance levels and 
average PCT estimates when available. Default processing factors were 
assumed except for where tolerances were established for processed 
commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that azoxystrobin 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 percent crop treated (PCT) information. 
Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    Section 408(b)(2)(F) of FFDCA states that the Agency may use data 
on the actual percent of food treated for assessing chronic dietary 
risk only if:
     Condition a: The data used are reliable and provide a 
valid basis to show what percentage of the food derived from such crop 
is likely to contain the pesticide residue.
     Condition b: The exposure estimate does not underestimate 
exposure for any significant subpopulation group.
     Condition c: Data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area.
    In addition, the Agency must provide for periodic evaluation of any 
estimates used. To provide for the periodic evaluation of the estimate 
of PCT as required by FFDCA section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency estimated the PCT for existing uses as follows:
    Almonds, 25%; apricots, 10%; artichokes, 25%; asparagus, 2.5%; 
green beans, 10%; blackberries, 5%; blueberries, 10%; broccoli, 5%; 
cabbage, 10%; cantaloupes, 10%; carrots, 10%; cauliflower, 2.5%; 
celery, 10%; cherries, 5%; corn, 2.5%; cotton, 5%; cucumbers, 20%; dry 
beans/peas, 1%; garlic, 60%; grapefruit, 20%; grapes, 5%; hazelnuts 
(filberts), 5%; lettuce, 2.5%; onions, 10%; oranges, 5%; peaches, 5%; 
peanuts, 15%; green peas, 2.5%; pecans, 2.5%; peppers, 15%; pistachios, 
15%; potatoes, 35%; prunes, 2.5%; pumpkins, 20%; raspberries, 5%; rice, 
35%; soybeans, 2.5%; spinach, 10%; squash, 15%; strawberries, 30%; 
sugar beets, 5%; sweet corn, 10%; tangerines, 15%; tomatoes, 15%; 
walnuts, 1%; watermelon, 20%; wheat, 2.5%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (NASS), proprietary market surveys, and 
the National Pesticide Use Database for the chemical/crop combination 
for the most recent 6-7 years. EPA uses an average PCT for chronic 
dietary risk analysis. The average PCT figure for each existing use is 
derived by combining available public and private market survey data 
for that use, averaging across all observations, and rounding to the 
nearest 5%, except for those situations in which the average PCT is 
less than 1%. In those cases, 1% is used as the average PCT and 2.5% is 
used as the maximum PCT. EPA uses a maximum PCT for acute dietary risk 
analysis. The maximum PCT figure is the highest observed maximum value 
reported within the recent 6 years of available public and private 
market survey data for the existing use and rounded up to the nearest 
multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated

[[Page 41288]]

is not likely to be an underestimation. As to Conditions b and c, 
regional consumption information and consumption information for 
significant subpopulations is taken into account through EPA's 
computer-based model for evaluating the exposure of significant 
subpopulations including several regional groups. Use of this 
consumption information in EPA's risk assessment process ensures that 
EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
reliable information on the regional consumption of food to which 
azoxystrobin may be applied in a particular area.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for azoxystrobin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of azoxystrobin. 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 First Index Reservoir Screening Tool (FIRST), 
Screening Concentration in Ground Water (SCI-GROW), the Pesticide Root 
Zone Model (PRZM) and the Exposure Analysis Modeling System (EXAMS) 
models, the estimated drinking water concentrations (EDWCs) of 
azoxystrobin for acute exposures are estimated to be 173 parts per 
billion (ppb) and 33 ppb for chronic exposures. For ground water, the 
estimated drinking water concentration is 3.1 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 173 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 33 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).
    Azoxystrobin is currently registered for the following uses that 
could result in residential exposures: Outdoor residential (lawns, 
ornamentals, flower gardens, vegetables, fruit and nut trees, berries 
and vines) and recreational (golf courses, parks and athletic fields) 
sites. Additionally, it is registered for use on indoor carpets/other 
surfaces by non-commercial applicators, and in treated paints 
(preservative incorporation). EPA assessed residential exposure using 
the new 2012 updated residential standard operating procedures (SOPs) 
that are now used in all human health assessments. For residential 
handler exposure, the Agency assumed that most residential use will 
result in short-term (1 to 30 days) dermal and inhalation exposures. 
The worst-case scenario used was painting with an airless sprayer. 
Residential handlers are assumed to be wearing short-sleeved shirts, 
short pants, shoes and socks during application of azoxystrobin. 
Because there was no dermal endpoint chosen for azoxystrobin, 
residential handler risk from exposure to azoxystrobin was assessed for 
the inhalation route only.
    The Agency assumed that post-application exposure in residential 
settings is expected to be short-term in duration only. No dermal 
endpoint was chosen for azoxystrobin; therefore, a dermal post-
application risk assessment was not conducted. Residential post-
application inhalation exposure in outdoor settings is considered 
negligible; however, residential post-application inhalation exposure 
has been assessed. The scenarios evaluated were short-term post-
application inhalation (indoor), short-term incidental oral ingestion 
from treated indoor surfaces (hand-to-mouth vinyl/hard surfaces and 
carpet/textile surfaces), and short-term incidental oral ingestion from 
treated turf (hand-to-mouth, mouthing grass, and soil ingestion).
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    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 azoxystrobin to share a common mechanism of 
toxicity with any other substances, and azoxystrobin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
azoxystrobin 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 prenatal and postnatal 
toxicity database for azoxystrobin is complete and includes prenatal 
developmental toxicity studies in rats and rabbits and a 2-generation 
reproduction study in rats. In these studies, offspring toxicity was 
observed at equivalent or higher doses than those resulting in parental 
toxicity; thus, there is no evidence of increased susceptibility and 
there are no residual uncertainties with regard to prenatal and/or 
postnatal toxicity.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X for short-term, intermediate term, and chronic risk assessment. 
This determination is based on the following considerations:
    i. The toxicity database for azoxystrobin is complete except for 
immunotoxicity testing. Changes to 40 CFR part 158 make immunotoxicity 
testing (OPPTS Guideline 870.7800) required for pesticide registration; 
however, the existing data are sufficient for endpoint selection for 
exposure/risk assessment scenarios, and for evaluation of the 
requirements under the FQPA. There are no indications in the available 
studies that organs associated with immune function, such as the thymus 
and spleen, are affected by azoxystrobin and azoxystrobin does not 
belong to a class of chemicals (e.g., the organotins,

[[Page 41289]]

heavy metals, or halogenated aromatic hydrocarbons) that would be 
expected to be immunotoxic. Based on the above considerations in this 
unit, EPA does not believe that conducting the immunotoxicity study 
will result in a dose less than the point of departure already used in 
this risk assessment, and an additional database uncertainty factor 
(UF) for potential immunotoxicity does not need to be applied.
    ii. Clinical signs noted in the acute and subchronic neurotoxicity 
studies were not considered treatment related because of a lack of 
dose-response, inconsistency of observations at different time points, 
variability of pretreatment values and/or small magnitude of response. 
There is no need for a developmental neurotoxicity study or additional 
UFs to account for neurotoxicity.
    iii. There is no evidence that azoxystrobin results in increased 
susceptibility to in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. The acute dietary exposure assessment was performed based on 
tolerance-level residues for all crops except citrus, and the chronic 
dietary exposure assessment was performed based on tolerance level 
residues for all crops. The acute dietary assessment incorporated 100 
PCT information, and the chronic dietary exposure assessment was 
somewhat refined using PCT information for selected crops. EPA made 
conservative (protective) assumptions in the ground and surface water 
modeling used to assess exposure to azoxystrobin in drinking water. EPA 
used similarly conservative assumptions to assess post-application 
exposure of children as well as incidental oral exposure of toddlers. 
These assessments will not underestimate the exposure and risks posed 
by azoxystrobin.
    Despite these considerations supporting removal of the FQPA SF, EPA 
has retained the FQPA SF, reduced to 3X, in assessing acute dietary 
risk. An additional safety factor is needed for acute risk assessment 
to account for the use of a LOAEL from the acute neurotoxicity study in 
rats in deriving the acute reference dose used for assessing acute 
dietary exposure for all populations including infants and children. To 
account for the use of a LOAEL from the acute neurotoxicity study in 
rats, the Agency believes that a 3X FQPA SF (as opposed to a 10X) will 
be adequate to extrapolate a NOAEL in assessing acute risk and that no 
additional safety factor is needed for short-term, intermediate-term, 
and chronic risk assessment based on the following considerations:
     The effect seen (transient diarrhea seen in the rat) is of 
a nature that is relatively insignificant;
     The diarrhea was only seen in studies involving gavage 
dosing in the rat but not in repeat dosing through dietary 
administration in rats and mice, and not through gavage dosing in 
rabbits; and
     The very high dose level needed to reach the acute oral 
lethal dose (LD50) (>5,000 milligrams/kilogram (mg/kg)), and 
the overall low toxicity of azoxystrobin.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to azoxystrobin will occupy 42% of the aPAD for children 1 to 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 
azoxystrobin from food and water will utilize 16% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3., regarding 
residential use patterns, chronic residential exposure to residues of 
azoxystrobin is not expected.
    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).
    Azoxystrobin is currently registered for uses that could result in 
short-term residential exposure, and the Agency has determined that it 
is appropriate to aggregate chronic exposure through food and water 
with short-term residential exposures to azoxystrobin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 460 for adult 
males, 470 for females 13 to 49 years old and 200 for children 1 to 2 
years old. Because EPA's level of concern for azoxystrobin is a MOE of 
100 or below, these MOEs are not of concern.
    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, 
azoxystrobin 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 
azoxystrobin.
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, azoxystrobin is not expected to pose a cancer risk to humans.
    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 azoxystrobin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression and have been submitted to FDA for inclusion in 
the Pesticide Analytical Manual (PAM) Volume II: A gas chromatography 
method with nitrogen-phosphorus detection (GC/NPD), RAM 243/04, for the 
enforcement of tolerances for residues of azoxystrobin and its Z-isomer 
in crop commodities; and a GC/NPD method, RAM 255/01, for the 
enforcement of tolerances of azoxystrobin in livestock commodities. The 
methods may be requested from: Chief, Analytical Chemistry Branch, 
Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; 
telephone

[[Page 41290]]

number: (410) 305-2905; email address: [email protected].

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize 
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 following tolerances being established by this document are in 
harmony with the equivalent Codex MRLs are harmonized (Codex 
commodities in brackets): Caneberry subgroup 13-07A (berries and other 
small fruits, except cranberry, grapes and strawberry); berry, low 
growing, subgroup 13-07G, except cranberry (strawberries); sunflower 
subgroup 20B (sunflower seed); bushberry, subgroup 13-07B (berries and 
other small fruits, except cranberry, grapes and strawberry); 
cottonseed, subgroup 20C (cotton seed); fruit, citrus, group 10-10 
(citrus fruits); fruit, small vine climbing, except fuzzy kiwifruit, 
13-07F (grape); and pepper/eggplant subgroup 8-10B (fruiting vegetables 
other than cucurbits except mushrooms and sweet corn). The following 
tolerances could not be harmonized with Codex MRLs: Berry, low growing 
subgroup 13-07G, except cranberry (berries and other small fruits, 
except cranberry, grapes and strawberry); dragon fruit (mango); onion, 
bulb and green subgroups 3-07A & B (bulb vegetables); tomato subgroup 
8-10A (fruiting vegetables other than cucurbits except mushrooms and 
sweet corn); vegetable, tuberous and corm subgroup 1C (root and tuber 
vegetables); and wasabi fresh and dry (herbs, fresh and dry). The 
disharmony is caused by various issues, including different Codex 
classification for crop grouping, different calculation procedures for 
establishing MRLs, different use patterns, and different data sets. 
There are no Codex MRLs) for residues of azoxystrobin and its Z-isomer 
for sugarcane.

C. Revisions to Petitioned-For Tolerances

    Several of the tolerances have been revised from what was proposed 
in the initial petition. EPA is increasing the proposed crop group 
tolerances for bushberry, subgroup 13-07B; cottonseed subgroup 20C; 
citrus fruit, group 10-10; fruit, small vine climbing, except fuzzy 
kiwifruit subgroup 13-07F, and pepper/eggplant subgroup 8-10B to 
harmonize the numerical portion of the tolerance with the Codex MRL. 
Also, based on the Organization for Economic Cooperation and 
Development (OECD) calculation procedures for the current post-harvest 
potato use data, EPA increased the requested tolerance for vegetable, 
tuberous and corm, subgroup 1C from 6.0 ppm to 8.0 ppm. It should be 
noted that there is an existing tolerance on potato at 0.03 ppm that is 
based on foliar use. The substantial increase from 0.03 ppm to 8.0 ppm 
results from the post-harvest use, as opposed to the previous foliar-
only use.
    EPA is also revising some of the commodity definitions in the 
tolerance table to be consistent with EPA's preferred terms for food 
and feed.

V. Conclusion

    Therefore, tolerances are established for residues of azoxystrobin, 
(methyl (E)-2-[2-[6-(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-
methoxyacrylate) and the Z isomer of azoxystrobin, (methyl (Z)-2-[2-[6-
(2-cyanophenoxy)pyrimidin-4-yloxy]phenyl]-3-methoxyacrylate) in or on 
onion, bulb, subgroup 3-07A at 1.0 ppm; onion, green, subgroup 3-07B at 
7.5 ppm; tomato subgroup 8-10A at 0.2 ppm; pepper/eggplant subgroup 8-
10B at 3.0 ppm; fruit, citrus, group 10-10 at 15.0 ppm; caneberry 
subgroup 13-07A at 5.0 ppm; bushberry subgroup 13-07B at 5.0 ppm; 
fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13-07F at 
2.0 ppm; berry, low growing, subgroup 13-07G, except cranberry at 10.0 
ppm; rapeseed subgroup 20A at 1.0 ppm; sunflower subgroup 20B at 0.5 
ppm; cottonseed subgroup 20C at 0.7 ppm; wasabi, fresh at 50 ppm; 
wasabi, dry at 260 ppm; dragon fruit at 2.0 ppm; vegetable, tuberous 
and corm, subgroup 1C at 8.0 ppm, and sugarcane, cane at 0.2 ppm.
    And lastly, due to the tolerances established above by this 
document, the following existing tolerances are removed as unnecessary: 
Onion, bulb; onion, green; caneberry subgroup 13A; bushberry subgroup 
13B; Juneberry; lingonberry; salal; grape; strawberry; tomato; 
vegetable, fruiting, group 8 except tomato; fruit, citrus, group 10; 
canola, seed; cotton, undelinted seed; crambe, seed; flax, seed; 
mustard, field, seed; mustard, Indian, seed; mustard, seed; rapeseed, 
Indian; rapeseed, seed; safflower, seed; sunflower, seed; potato; okra.

 VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under FFDCA section 408(d) 
in response to petitions 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

[[Page 41291]]

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 U.S.C. 
804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 3, 2012.
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.  180.507 revise the table in paragraph (a)(1) to read as 
follows:


Sec.  180.507  Azoxystrobin; tolerances for residues.

    (a) * * *
    (1) * * *

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
Acerola.....................................................         2.0
Almond, hulls...............................................         4.0
Animal feed, nongrass, group 18, forage.....................          45
Animal feed, nongrass, group 18, hay........................         120
Artichoke, globe............................................         4.0
Asparagus...................................................        0.04
Atemoya.....................................................         2.0
Avocado.....................................................         2.0
Banana......................................................           *
Barley, bran................................................         6.0
Barley, forage..............................................          25
Barley, grain...............................................         3.0
Barley, hay.................................................        15.0
Barley, straw...............................................         7.0
Berry, low growing, subgroup 13-07G, except cranberry.......        10.0
Biriba......................................................         2.0
Brassica, head and stem, subgroup 5A........................         3.0
Brassica, leafy greens, subgroup 5B.........................          25
Bushberry subgroup 13-07B...................................         5.0
Caneberry subgroup 13-07A...................................         5.0
Canistel....................................................         2.0
Cherimoya...................................................         2.0
Cilantro, leaves............................................        30.0
Citrus, dried pulp..........................................        20.0
Citrus, oil.................................................        40.0
Corn, field, forage.........................................        12.0
Corn, field, grain..........................................        0.05
Corn, field, refined oil....................................         0.3
Corn, field, stover.........................................        25.0
Corn, pop, grain............................................        0.05
Corn, pop, stover...........................................        25.0
Corn, sweet, forage.........................................        12.0
Corn, sweet, kernel plus cob with husks removed.............        0.05
Corn, sweet, stover.........................................        25.0
Cotton, gin byproducts......................................          45
Cottonseed subgroup 20C.....................................         0.7
Cranberry...................................................        0.50
Custard apple...............................................         2.0
Dragon fruit................................................         2.0
Feijoa......................................................         2.0
Fruit, citrus, group 10-10..................................        15.0
Fruit, small vine climbing, except fuzzy kiwifruit, subgroup         2.0
 13-07F.....................................................
Fruit, stone, group 12......................................         1.5
Grain, aspirated fractions..................................         420
Grass, forage...............................................          15
Grass, hay..................................................          20
Guava.......................................................         2.0
Herb Subgroup 19A, dried leaves.............................         260
Herb Subgroup 19A, fresh leaves.............................          50
Hop, dried cones............................................        20.0
Ilama.......................................................         2.0
Jaboticaba..................................................         2.0
Jackfruit...................................................         2.0
Longan......................................................         2.0
Loquat......................................................         2.0
Lychee......................................................         2.0
Mango.......................................................         2.0
Nut, tree, group 14.........................................        0.02
Onion, bulb, subgroup 3-07A.................................         1.0
Onion, green, subgroup 3-07B................................         7.5
Papaya......................................................         2.0
Passionfruit................................................         2.0
Pawpaw......................................................         2.0
Pea and bean, dried shelled, except soybean, subgroup 6C....         0.5
Pea and bean, succulent shelled, subgroup 6B................         0.5
Peanut......................................................         0.2
Peanut, hay.................................................        15.0
Peanut, refined oil.........................................         0.6
Pepper/eggplant subgroup 8-10B..............................         3.0
Peppermint, tops............................................          30
Persimmon...................................................         2.0
Pistachio...................................................        0.50
Pulasan.....................................................         2.0
Rambutan....................................................         2.0
Rapeseed subgroup 20A.......................................         1.0
Rice, grain.................................................         5.0
Rice, hulls.................................................          20
Rice, straw.................................................          12
Rice, wild, grain...........................................         5.0
Sapodilla...................................................         2.0
Sapote, black...............................................         2.0
Sapote, mamey...............................................         2.0
Sapote, white...............................................         2.0
Sorghum, grain, forage......................................          25
Sorghum, grain, grain.......................................          11
Sorghum, grain, stover......................................          40
Soursop.....................................................         2.0
Soybean, hay................................................        55.0
Soybean, hulls..............................................         1.0
Soybean, seed...............................................         0.5
Spanish lime................................................         2.0
Spearmint, tops.............................................          30
Spice Subgroup 19B, except black pepper.....................          38
Star apple..................................................         2.0
Starfruit...................................................         2.0
Sugar apple.................................................         2.0
Sugarcane, cane.............................................         0.2
Sunflower subgroup 20B......................................         0.5
Tamarind....................................................         2.0
Tomato, paste...............................................         0.6
Tomato subgroup 8-10A.......................................         0.2
Turnip, greens..............................................          25
Vegetable, cucurbit, group 9................................         0.3
Vegetable, foliage of legume, group 7.......................        30.0
Vegetable, leafy, except brassica, group 4..................        30.0
Vegetable, leaves of root and tuber, group 2................        50.0
Vegetable, legume, edible podded, subgroup 6A, except                3.0
 soybean....................................................
Vegetable, root, subgroup 1A................................         0.5
Vegetable, tuberous and corm, subgroup 1C...................         8.0
Wasabi, dry.................................................         260
Wasabi, fresh...............................................          50
Watercress..................................................         3.0
Wax jambu...................................................         2.0
Wheat, bran.................................................        0.20
Wheat, forage...............................................          25
Wheat, grain................................................        0.10
Wheat, hay..................................................          15
Wheat, straw................................................         4.0
------------------------------------------------------------------------
* 2.0 (of which not more than 0.1 is contained in the pulp)

* * * * *
[FR Doc. 2012-17021 Filed 7-12-12; 8:45 am]
BILLING CODE 6560-50-P