
[Federal Register Volume 79, Number 151 (Wednesday, August 6, 2014)]
[Rules and Regulations]
[Pages 45693-45701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-18041]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0904; FRL-9912-92]


Bifenazate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
bifenazate in or on multiple commodities which are identified and 
discussed later in this document including tolerances with regional 
restrictions for timothy hay and timothy forage. In addition, this 
regulation removes existing tolerances on ``fruit, pome, group 11'' 
``vegetable, fruiting, group 8'' and existing time-limited tolerances 
for ``timothy, forage'' and ``timothy, hay'' that are superseded

[[Page 45694]]

by this action. The Interregional Research Project Number 4 (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act (FFDCA).

DATES: This regulation is effective August 6, 2014. Objections and 
requests for hearings must be received on or before October 6, 2014, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2010-0904, 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), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's 
tolerance regulations at 40 CFR part 180 through the Government 
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2010-0904 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 
October 6, 2014. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2010-0904, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of Wednesday, July 6, 2011 (76 FR 39358) 
(FRL-8875-6), EPA issued a document pursuant to FFDCA section 
408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
petition (PP1E7847) by the Interregional Research Project Number 4 (IR-
4), IR-4 Project Headquarters, 500 College Road East, Suite 201W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.572 be 
amended by establishing tolerances for residues of bifenazate: 
Hydrazine carboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl)-
methylethyl ester in or on fruit, pome, group 11-10 at 0.75 parts per 
million (ppm); herb, subgroup 19A dried leaves, except chervil, dried 
and chive, dried, at 140 ppm; herb, subgroup 19A, fresh leaves at 30 
ppm; timothy, forage at 140 ppm; timothy, hay at 120 ppm; and 
vegetable, fruiting, group 8-10 at 2.0 ppm. That document referenced a 
summary of the petition prepared by Chemtura Corporation, the 
registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
revised the proposed tolerance level and corrected the commodity 
definition for certain commodities, and revised the tolerance 
expression for bifenazate. The reasons for these changes are explained 
in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.''
    Consistent with FFDCA section 408(b)(2)(D), and the factors 
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on

[[Page 45695]]

aggregate exposure for bifenazate including exposure resulting from the 
tolerances established by this action. EPA's assessment of exposures 
and risks associated with bifenazate follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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.
    Bifenazate has low acute toxicity for the oral, dermal and 
inhalation routes of exposure. For subchronic oral exposures, the dog 
is the most sensitive species. For chronic oral exposures, the dog and 
the rat are equally sensitive.
    Subchronic and chronic studies in rats and dogs indicate that the 
liver and hematopoietic system (spleen and bone marrow with associated 
hematological findings) are the primary target organs in these species. 
Additional toxicity was seen in the kidney (dogs following chronic 
exposure) and adrenal cortex (male rats following subchronic exposure). 
Decreases in body weight, body-weight gain, and food consumption were 
also associated with liver and hematopoietic system toxicity in several 
studies.
    In the rat developmental toxicity study, the maternal effects 
consisted of clinical signs of toxicity, decreased body weight and 
body-weight gains, and reduced food consumption at the mid-dose. 
Increases in early fetal resorptions occurred at the same doses that 
caused maternal toxicity. In the rabbit developmental toxicity study, 
there were no maternal or developmental effects up to the highest dose 
tested (HDT). In the 2-generation rat reproduction study, the parental 
effects occurred at the mid-dose and consisted of decreased body weight 
and body-weight gains. There were no reproductive or offspring effects 
up to the HDT.
    In the acute neurotoxicity study, treatment related effects were 
seen only at the HDT, and consisted of decreased motor activity 
(rearing in females; center time in both sexes). In the subchronic 
neurotoxicity study, effects were also only seen at the HDT (34.5 
milligrams/kilogram/day (mg/kg/day) and consisted of decreased landing 
foot splay (males), decreased fore- and hindlimb grip strength (males), 
decreased motor activity measurements consisting of center times 
(females) and rearing activity (both sexes). The level of concern (LOC) 
for neurotoxicity in the bifenazate database is low however because;
     The observed effects are well characterized;
     They occur only at the highest doses tested; and
     They are protected for by the studies used in the endpoint 
selection.
    There were no observed toxicological effects in the immunotoxicity 
study up to the HDT.
    In the mouse carcinogenicity study, males and females were tested 
up to 225 ppm and 175 ppm, respectively, which elicited decreased body 
weight and body-weight gains in females. In male mice, there was an 
increase in the incidence of liver adenomas only, which was not 
considered statistically significant by pair-wise comparison. There 
also was no progression of the adenomas to carcinomas in males in this 
study. A full battery of mutagenicity studies were negative for 
mutagenic or clastogenic activity. Bifenazate is classified as ``not 
likely'' to be carcinogenic to humans.
    Specific information on the studies received and the nature of the 
adverse effects caused by bifenazate as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Bifenazate. Human-Health Risk 
Assessment. Section 3 Registration Request to Add New Uses on Timothy 
Forage and Hay; Herb, Subgroup 19A; and to Expand Existing Uses on Pome 
Fruit, Group 11, and Fruiting Vegetables, Group 8'', dated May 15, 
2014, page 40 in docket ID number EPA-HQ-OPP-2010-0904.

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

   Table--Summary of Toxicological Doses and Endpoints for Bifenazate 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 (Females 13-49 years of  NOAEL = 10 mg/kg/day...  Acute RfD = 0.1 mg/kg/   Prenatal Developmental
 age).                                 UFA = 10x..............   day.                     Toxicity--Rats
                                       UFH = 10x..............  aPAD = 0.1 mg/kg/day...   Developmental.
                                       FQPA SF = 1x...........                           LOAEL = 100 mg/kg/day
                                                                                          based on clinical
                                                                                          signs, decreased body
                                                                                          weight and food
                                                                                          consumption during the
                                                                                          dosing period.

[[Page 45696]]

 
Acute dietary (General population      NOAEL = 600 mg/kg/day..  Acute RfD = 6 mg/kg/day  Acute Neurotoxicity
 including infants and children).      UFA = 10x..............  aPAD = 6 mg/kg/day.....   Screening Battery--
                                       UFH = 10x..............                            Rats.
                                       FQPA SF = 1x...........                           LOAEL = 2,000 mg/kg/day
                                                                                          based on decreased
                                                                                          motor activity
                                                                                          (rearing in females).
Chronic dietary (All populations)....  NOAEL= 1.0 mg/kg/day...  Chronic RfD = 0.01 mg/   Chronic toxicity--Dogs.
                                       UFA = 10x..............   kg/day.                 LOAEL = 8.9/10.4 mg/kg/
                                       UFH = 10x..............  cPAD = 0.01 mg/kg/day..   day (M/F) based on
                                       FQPA SF = 1x...........                            changes in
                                                                                          hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in bone
                                                                                          marrow, liver, and
                                                                                          kidney in the one-year
                                                                                          dog feeding study.
                                       Co-critical Study......  .......................  Carcinogenicity Study-
                                       NOAEL = 1.5 mg/kg/day..                            Mouse.
                                       UFA = 10x..............                           LOAEL = 15.4 (M) mg/kg/
                                       UFH = 10x..............                            day based on
                                       FQPA SF = 1x...........                            hematology parameters
                                                                                          and possibly kidney
                                                                                          weights.
Incidental oral short-term (1 to 30    NOAEL= 0.9 mg/kg/day...  Residential LOC for MOE  90-Day Subchronic--
 days) and intermediate-term (1 to 6   UFA = 10x..............   = 100.                   Dogs.
 months).                              UFH = 10x..............                           LOAEL = 10.4 mg/kg/day
                                       FQPA SF = 1x...........                            based on based upon
                                                                                          changes in
                                                                                          hematological
                                                                                          parameters in both
                                                                                          sexes, increased
                                                                                          bilirubin in the urine
                                                                                          in males, increased
                                                                                          absolute and relative
                                                                                          liver weight in
                                                                                          females and liver
                                                                                          histopathological
                                                                                          effects in both sexes.
Dermal short-term (1 to 30 days) and   Dermal study. LOAEL =    Residential LOC for MOE  21-Day Dermal toxicity--
 intermediate-term (1 to 6 months).     80 mg/kg/day.            = 100.                   Rat.
                                       UFA = 10x..............                           LOAEL = 400 mg/kg/day
                                       UFH = 10x..............                            based on decreased
                                       FQPA SF = 1x...........                            body weight in
                                                                                          females, decreased
                                                                                          food consumption in
                                                                                          both sexes, increased
                                                                                          urinary ketones,
                                                                                          increased urinary
                                                                                          protein, increased
                                                                                          urinary specific
                                                                                          gravity, and decreased
                                                                                          urinary volume in both
                                                                                          sexes, and increased
                                                                                          incidence of extra
                                                                                          medullary
                                                                                          hematopoiesis in the
                                                                                          spleen in both sexes.
Inhalation short-term (1 to 30 days)   Rat NOAEL = 0.03 mg/L..  Residential LOC for MOE  28-Day Inhalation
 and intermediate-term (1 to 6         HEC = 0.0009 mg/L......   = 30.                    Toxicity--Rat LOAEL =
 months).                              HED = 0.14mg/kg bw/day.                            0.075 mg/L (M/F) on
                                       UFA = 3x...............                            dried red material
                                       UFH = 10x..............                            around the nose in
                                       FQPA SF = 1x...........                            females, lower body
                                                                                          weights and body-
                                                                                          weight gains,
                                                                                          decreased food
                                                                                          consumption, decreased
                                                                                          heart and thymus
                                                                                          weights in females,
                                                                                          increased incidences
                                                                                          of mild brown
                                                                                          pigmentation of the
                                                                                          spleen, and minimal to
                                                                                          mild degeneration of
                                                                                          the olfactory
                                                                                          epithelium within
                                                                                          nasal levels III, IV,
                                                                                          and V.
----------------------------------------------------------------------------------------------------------------
Cancer (Oral, dermal, inhalation)....     Bifenazate is classified as ``not likely to be a human carcinogen''.
----------------------------------------------------------------------------------------------------------------
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. Reference Dose = RfD. Male/Female = (M/F). 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). Human Equivalent Concentration (HEC) where HEC Calculations for Short- and Intermediate-term
  Residential Exposure: Assume residents will be exposed for 24 hrs/day and 7 days/week: HEC = NOAELstudy *
  (daily duration of exposureanimal/daily duration of exposurehuman) * (days/week of exposureanimal/days/week of
  exposurehuman) * RDDR.
 HEC = 0.03 mg/L * (6/24) * (5/7) * 0.175 = 0.00094 mg/L.

[[Page 45697]]

 
Human Equivalent Dose (HED). HED's route-to-route extrapolation converts human and animal values from mg/L
  concentrations to mg/kg oral-equivalent doses. The equation uses a single conversion factor to account for
  default body weights and respiratory volumes. An activity factor is used to account for increased exposure
  resulting from increased respiration. Using the HEC calculated (based upon terminal airway inflammation in
  males), a conversion of the inhalation concentration to a dose (mg/L to mg/kg/day) was conducted as follows:
 Human-Equivalent Dose (HED, mg/kg/day) = Dose (systemic HEC value, mg/L) x A x CF (L/hr/kg) x D (hours)
  x AF = mg/kg
Where: A = absorption: Ratio of deposition and absorption in respiratory tract compared to absorption by the
  oral route. CF = conversion Factor; a L/hr/kg factor which accounts for respiratory volume and body weight for
  a given species and strain. D = duration; duration of daily animal or human exposure (hours). AF = activity
  Factor; animal default is 1. The residential human equivalent dose for bifenazate is calculated as follows:
 Residential HED: (0.0009 mg/L) x 1 x 6 x 8 x 1 = 0.135 mg/kg/day.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to bifenazate, EPA considered exposure under the petitioned-
for tolerances as well as all existing bifenazate tolerances in 40 CFR 
180.572. EPA assessed dietary exposures from bifenazate in food as 
follows:
    i. Acute exposure. In conducting the acute dietary exposure 
assessment EPA used the Dietary Exposure Evaluation Model--Food 
Consumption Intake Database (DEEM-FCID, ver. 3.16), which incorporates 
consumption information from the United States Department of 
Agriculture's (USDA's) National Health and Nutrition Examination 
Survey, What We Eat in America, (NHANES/WWEIA). This dietary survey was 
conducted from 2003 to 2008.
    As to residue levels in food, the acute analysis for the general 
population, including infants and children, was unrefined and used 
tolerance-level residues and 100 PCT. The acute analysis for females 13 
to 49 years old was highly refined and incorporated data from the 
USDA's Pesticide Data Program (PDP), crop field trial data, and PCT 
estimates. DEEM (ver. 7.81) default processing factors were assumed for 
all commodities excluding apple juice, grape juice, and wine/sherry. 
The processing factors for these commodities were reduced to 1.0, based 
on data from processing studies.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the DEEM-FCID, ver. 3-16 which incorporates 
consumption information from the USDA NHANES/WWEIA; 2003-2008. As to 
residue levels in food, the chronic dietary exposure analysis for all 
population subgroups was partially refined and used tolerance-level 
residues and PCT estimates. DEEM default processing factors were 
assumed for all commodities excluding apple juice, grape juice, and 
wine/sherry. The processing factors for these commodities were reduced 
to 1.0 based on data from processing studies.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
classified bifenazate as ``not likely'' to be a human carcinogen. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk was not conducted.
    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 used PCT information as follows:
    Maximum PCT estimates were used in the acute dietary risk 
assessment: Almonds: 10%; apples: 5%; apricots: 10%; beans, green: 
2.5%; caneberries: 30%; cantaloupes: 2.5%; cherries: 5%; cucumbers: 5%; 
grapefruit: 5%; grapes: 20%; nectarines: 10%; oranges: 2.5%; peaches: 
20%; pears: 30%; pecans: 2.5%; peppers: 10%; pistachios: 2.5%; plums/
prunes: 20%; potatoes: 5%; pumpkins: 5%; squash: 2.5%; strawberries: 
65%; tomatoes: 10%; walnuts: 5%; and watermelon: 2.5%.
    The following average PCT estimates were used in the chronic 
dietary risk assessment: Almonds: 5%; apples: 5%; apricots: 5%; beans, 
green: 1%; caneberries: 25%; cantaloupes: 1%; cherries: 2.5%; 
cucumbers: 2.5%; grapefruit: 5%; grapes: 10%; nectarines: 5%; oranges: 
1%; peaches: 10%; pears: 15%; pecans: 1%; peppers: 5%; pistachios: 
2.5%; plums/prunes: 5%; potatoes: 5%; pumpkins: 2.5%; squash: 1%; 
strawberries: 45%; tomatoes: 5%; walnuts: 2.5%; and watermelon: 1%.
    In most cases, EPA uses available data from USDA/National 
Agricultural Statistics Service (USDA/NASS), proprietary market 
surveys, and the National Pesticide Use Database for the chemical/crop 
combination for the most recent 6-7 years. EPA uses an average PCT for 
chronic dietary risk analysis. The average PCT figure for each existing 
use is derived by combining available public and private market survey 
data for that use, averaging across all observations, and rounding to 
the nearest 5%, except for those situations in which the average PCT is 
less than one. In those cases, 1% is used as the average PCT and 2.5% 
is used as the maximum PCT. EPA uses a maximum PCT for acute dietary 
risk analysis. The maximum PCT figure is the highest observed maximum 
value reported within the recent 6 years of available public and 
private market survey data for the existing use and rounded up to the 
nearest multiple of 5%.
    The Agency believes that the three conditions discussed in Unit 
III.C.1.iv. have been met. With respect to Condition a, PCT estimates 
are derived from Federal and private market survey data, which are 
reliable and have a valid basis. The Agency is reasonably certain that 
the percentage of the food treated is not likely to be an 
underestimation. As to Conditions b and c, regional consumption 
information and consumption information for significant subpopulations 
is taken into account through EPA's computer-based model for evaluating 
the exposure of significant subpopulations including

[[Page 45698]]

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 bifenazate 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 bifenazate in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of bifenazate. 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) model and 
the dry bean application scenario (highest registered/proposed use 
rate) and the Screening Concentrations in Ground Water (SCI-GROW) 
model, the estimated drinking water concentrations (EDWCs) of 
bifenazate acute exposures are estimated to be 37.3 ppb for surface 
water and 0.014 ppb for ground water.
    For chronic exposures for non-cancer assessments are estimated to 
be 11.2 ppb for surface water and 0.014 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 
37.3 ppb was used to assess the contribution to drinking water.
    For chronic dietary risk assessment, the water concentration of 
value 11.2 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).
    Bifenazate is currently registered for the following uses that 
could result in residential exposures: Ornamental plants, including 
bedding plants, flowering plants, foliage plants, bulb crops 
perennials, trees, and shrubs. EPA assessed residential exposure using 
the following assumptions: There is a potential for short-term dermal 
and inhalation exposures by homeowners applying bifenazate. 
Intermediate-term exposures are not likely because of the intermittent 
nature of applications by homeowners.
    The residential handler exposure assessment estimates dermal and 
inhalation exposures for individuals using bifenazate on residential 
ornamentals. The quantitative exposure/risk assessment developed for 
residential handlers is based on the following scenarios:
    i. Mixing/loading/applying liquids with manually-pressurized 
handwand,
    ii. Mixing/loading/applying liquids with hose-end sprayer,
    iii. Mixing/loading/applying liquids with backpack, and
    iv. Mixing/loading/applying liquids with sprinkler can.
    Unit exposure values and estimates for area treated were taken from 
the 2012 Residential SOPs: Gardens and Trees. An aggregate risk index 
(ARI) was used since the LOCs for dermal exposure (100) and inhalation 
exposure (30) are different. The target ARI is 1; therefore, ARIs of 
less than 1 result in risk estimates of concern. The ARI was calculated 
as follows.
     Aggregate Risk Index (ARI) = 1 / [(Dermal LOC / Dermal 
MOE) + (Inhalation LOC / Inhalation MOE)]
    Short-term risk estimates for residential handlers are greatest for 
exposure scenarios ``hose-end sprayer'' and ``backpack'' resulting in 
ARIs of 80 and 66, respectively. Short-term dermal and inhalation risk 
estimates to residential handlers do not exceed EPA's LOC for all 
scenarios. All the ARIs are above 1 and do not exceed the Agency's LOC 
for all scenarios.
    Short-term dermal exposure and risk from residential post-
application have been assessed for bifenazate under the following 
scenarios, routes of exposure and lifestages:
     Gardens and Trees: adults (dermal) and children 6 to less 
than or equal 11 years old (dermal).
    These lifestages are not the only lifestages that could be 
potentially exposed for these post-application scenarios; however, the 
assessment of these lifestages is health protective for the exposures 
and risks for any other potentially exposed lifestages. All adult and 
children dermal post-application risk estimates for exposure to treated 
trees and gardens are not of concern (MOEs >= 100). Details of 
assumptions and factors the Agency applied in residential and 
residential post-application exposure assessments are detailed in the 
2012 Residential SOPs at http://www.epa.gov/pesticides/science/residential-exposure-sop.html.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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 bifenazate to share a common mechanism of 
toxicity with any other substances, and bifenazate does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
bifenazate 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 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 
toxicology database for bifenazate includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. In the rat developmental toxicity study, the maternal 
effects consisted of clinical signs of toxicity, decreased body weight 
and body-weight gains, and reduced food consumption at the mid-dose. 
Increases in early fetal resorptions occurred at the same doses that 
caused maternal toxicity. In the

[[Page 45699]]

rabbit developmental toxicity study, there were no maternal or 
developmental effects up to the HDT. In the 2-generation rat 
reproduction study, the parental effects occurred at the mid-dose and 
consisted of decreased body weight and body-weight gains. There were no 
reproductive or offspring effects up to the HDT.
    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 bifenazate is complete.
    ii. There is evidence of neurotoxicity in the bifenazate database. 
The level of concern for neurotoxic effects in children is low however 
because
     The observed effects are well characterized;
     They occur only at the highest doses tested; and
     They are protected for by the studies used in the endpoint 
selection.
    iii. There is no evidence that bifenazate results in increased 
susceptibility in in utero rats or rabbits in the pre- or postnatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The exposure databases are sufficient to determine the 
nature and magnitude of the residue in food and water. For acute 
exposure for the general population and chronic exposure, the dietary 
exposure analyses are unlikely to underestimate exposure as they 
incorporated tolerance-level residues, 100 PCT for acute exposure, PCT 
for chronic exposure, and modeled drinking water estimates. For acute 
analysis for females 13 to 49 years, the dietary analysis is unlikely 
to underestimate exposure as PDP, crop field trial data, PCT estimates 
and modeled drinking water estimates were utilized.
    EPA made conservative (protective) assumptions in the ground water 
and surface water modeling used to assess exposure to bifenazate in 
drinking water. The dietary food and drinking water exposure 
assessments will not underestimate the potential exposures for infants 
and children. The residential use (ornamentals) is not expected to 
result in post-application exposure to infants and children as well as 
incidental oral exposure of toddlers. The post-application exposure 
assessments are based upon the residential SOPs, which are based upon 
reasonable worst-case assumptions and are not expected to underestimate 
risk. These assessments will not underestimate the exposure and risks 
posed by bifenazate.

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 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 bifenazate will occupy <1.9% of the aPAD for children 1 to 2 years 
old, the population group receiving the greatest exposure. The acute 
dietary exposure estimates are not of concern to EPA (<100% aPAD) for 
the general U.S. population and all population subgroups
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
bifenazate from food and water will utilize 74% 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 
bifenazate is not expected.
    3. Short- and intermediate-term risks. Short- and intermediate-term 
aggregate exposures take into account short- and intermediate-term 
residential exposures plus chronic exposure to food and water 
(considered to be a background exposure level). Bifenazate is currently 
registered for uses that could result in short- and intermediate-term 
residential exposures.
    The short- and intermediate-term toxicological PODs for bifenazate 
are the same for each route of exposure. Therefore, for residential 
exposure scenarios, only short-term exposures were assessed, and are 
considered to be protective of intermediate-term exposure and risk.
    It was appropriate to aggregate postapplication dermal exposures 
with dietary (food and water) exposures. The dermal postapplication 
exposure to gardens and ornamentals scenario is the residential 
exposure scenario with the greatest risk estimate for both adults and 
children 6 <= 11 years old; therefore, the exposure estimates for this 
scenario are protective of any other exposure scenarios.
    For the adult and children 6 <= 11 years old short- and 
intermediate-term aggregate risk assessment, the MOE approach was used 
to estimate aggregate exposures as there are different PODs for oral 
and dermal routes of exposure but the LOC are the same. The chronic 
dietary exposure estimate for Adults 20-49 years old and Children 6-12 
years old were used in the aggregate risk estimate for adults and 
children 6 <= 11 years old, respectively.
    All of the adult and children 6 <= 11 years old chronic dietary + 
dermal aggregate risk estimates do not exceed EPA's LOC (MOEs >= 100).
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, bifenazate (classified as ``not likely'' to be a human 
carcinogen) is therefore 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 bifenazate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression.
    For plant commodities, high-performance liquid chromatography with 
oxidative coulometric electrochemical detector (HPLC/ELCD) Method UCC-
D2341 is available as a primary enforcement method for the combined 
residues of bifenazate and its metabolite D3598. The method has been 
forwarded to the United States Food and Drug Administration (FDA) for 
inclusion in the Pesticides Analytical Manual, Volume II (PAM II). The 
limit of quantification (LOQ) and limit of detection (LOD) of Method 
UCC-D2341 are 0.01 and 0.005 ppm, respectively. In addition, a liquid 
chromatographic system with tandem mass spectrometers (LC-MS/MS) method 
(NCL ME 245) was recently submitted as a confirmatory method and has 
been forwarded to FDA.
    For livestock commodities, HPLC methods with fluorescence detection 
or ELCD are available as primary methods for the enforcement of 
tolerances for residues of bifenazate and its regulated metabolites in 
livestock matrices. The methods have undergone a successful validation 
by the Agency and have been forwarded to FDA for inclusion in PAM

[[Page 45700]]

II. In addition, the LC-MS/MS Method NCL ME 259 was recently submitted 
as a confirmatory method, and this method was also forwarded to FDA. 
The validated LOQ was 0.01 ppm for each analyte. The LOD was reported 
as 0.005 ppm.
    The methods may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint United Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    There are currently no established Codex MRLs for bifenazate in/on 
herbs, and timothy forage and hay. Codex MRLs are established for pome 
fruits (0.7 ppm), chili peppers (3 ppm), sweet peppers (2 ppm) and 
tomato (0.5 ppm), but not for other members of Vegetable, fruiting, 
group 8-10.
    The U.S. is establishing a tolerance for Vegetable, fruiting, group 
8-10 at 4.0 ppm for residues of bifenazate (and its metabolite). There 
is an existing U.S. tolerance of 2 ppm for Vegetables, fruiting, crop, 
group 8. This tolerance was established in 2003 prior to the 
implementation of the Organization for Economic Co-Operation and 
Development (OECD) calculation procedures. In 2007 Codex established 
the MRLs for chili peppers, sweet peppers and tomato and relied on the 
U.S. field trial data. Codex chose not to establish a group tolerance 
for the fruiting vegetables but instead established separate Codex MRLs 
for tomato, peppers and chili peppers using the highest observed 
residue approach. The approach taken by Codex is not in line with how 
the U.S. establishes crop group tolerances. Further, using the OECD 
calculation procedures and based on data from bell and non-bell pepper 
studies conducted in the U.S., and tomato studies conducted in Canada 
and the U.S. results in the recommended tolerance of 4.0 ppm.
    EPA is establishing the U.S. tolerance for residue in or on pome 
fruit at 0.7 ppm, in harmonization with the established Codex MRL.

C. Revisions to Petitioned-For Tolerances

    After reviewing supporting data and information, EPA modified 
certain elements of the petition as proposed in the notice of filing, 
as follows:
    1. EPA corrected the proposed commodity definitions, ``Herb, 
subgroup 19A, fresh leaves'' and ``Herb, subgroup 19A, dried leaves, 
except chervil, dried and chive, dried'' to read ``Herb subgroup 19A, 
except chervil and chive'' to specify crop coverage and for accuracy 
and consistency in naming of commodities.
    2. Using the OECD tolerance-calculation procedures, the Agency 
modified proposed tolerance levels for certain commodities as follows:
    i. A proposed tolerance at 140 ppm for ``Herb, subgroup 19A, dried 
leaves, except chervil, dried and chive, dried'' was established for 
``Herb, subgroup 19A, except chervil and chive'' at 300 ppm, and
    ii. A proposed tolerance at 140 ppm on timothy, forage, was 
established at 200 ppm (tolerance with regional registrations), and a 
proposed tolerance of 120 ppm on timothy, hay, was established at 150 
ppm (tolerance with regional registrations).
    3. As petitioned-for, EPA is establishing tolerances with regional 
registrations for timothy, forage and timothy, hay for regional use in 
two counties, Eureka and Humboldt, in the State of Nevada. Applications 
of bifenazate can only be made to timothy that is intended for use as 
horse feed. Livestock feedstuffs are not derived from the proposed 
crops of the subject petition, except for timothy. The Agency is 
removing existing time-limited tolerances established for bifenazate 
under section 18 emergency exemptions for timothy, forage and timothy, 
hay at 50 ppm and 150 ppm, respectively, as they are superseded by this 
action.
    4. As previously stated, the U.S. tolerance for Vegetable, 
fruiting, group 8-10 is being changed to 4.0 ppm. This is based the use 
of the OECD calculation procedures on data from bell and non-bell 
pepper studies conducted in the United States, and tomato studies 
conducted in Canada and the United States.
    In addition, the Agency is revising the tolerance expressions for 
bifenazate tolerances in order to conform to current EPA policy as 
follows:
    5. 40 CFR Sec.  180.572(a)(1) is revised to read as follows: 
Tolerances are established for residues of bifenazate (1-methylethyl 2-
(4-methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) including its 
metabolites and degradates, in or on the commodities listed in the 
following table. Compliance with the tolerance levels specified are to 
be determined by measuring only the sum of bifenazate and its 
metabolite, diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 
1-methylethyl ester, (calculated as the stoichiometric equivalent of 
bifenazate) in or on food commodities, and
    6. The tolerance expression for 40 CFR Sec.  180.572(a)(2) is 
modified as follows: Tolerances are established for residues of 
bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) 
hydrazinecarboxylate) including its metabolites and degradates, in or 
on the commodities listed in the following table. Compliance with the 
tolerance levels specified are to be determined by measuring only the 
sum of bifenazate and its metabolites diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester; 1,1'-biphenyl, 4-
ol; and 1,1'-biphenyl, 4-oxysulfonic acid (calculated as the 
stoichiometric equivalent of bifenazate) in or on food commodities.

V. Conclusion

    Therefore, tolerances are established for residues of bifenazate 
(1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) 
including its metabolites and degradates, in or on Herb subgroup 19A, 
except chervil and chive at 300 ppm, Timothy, forage at 200 ppm, 
Timothy, hay at 150 ppm, Fruit, pome, group 11-10 at 0.7 ppm and 
Vegetable, fruiting, group 8-10 at 4.0 ppm. In addition, this 
regulation removes existing tolerances on ``fruit, pome, group 11'' 
``vegetable, fruiting, group 8'' and existing time-limited tolerances 
for ``timothy, forage'' and ``timothy, hay'' that are superseded by 
this action.

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

[[Page 45701]]

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: July 21, 2014.
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. Section 180.572 is amended as follows:
0
a. Revise the introductory text in paragraph (a)(1);
0
b. Alphabetically add commodities to the table in paragraph (a)(1);
0
c. Remove from the table in paragraph (a)(1) the entries for ``Fruit, 
pome, group 11'' and ``Vegetable, fruiting, group 8'';
0
d. Revise the introductory text in paragraph (a)(2);
0
e. Remove and reserve paragraph (b); and
0
f. Add paragraph (c) to read as follows:


Sec.  180.572  Bifenazate; tolerance for residues.

    (a) General. (1) Tolerances are established for residues of 
bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-
yl)hydrazinecarboxylate) including its metabolites and degradates, in 
or on the commodities listed in the following table. Compliance with 
the tolerance levels specified are to be determined by measuring only 
the sum of bifenazate and its metabolite, diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester, (calculated as the 
stoichiometric equivalent of bifenazate) in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             million
------------------------------------------------------------------------
 
                                * * * * *
Fruit, pome, group 11-10....................................         0.7
 
                                * * * * *
Herb, subgroup 19A, except chervil and chive................       300
 
                                * * * * *
Vegetable, fruiting, group 8-10.............................         4.0
 
                                * * * * *
------------------------------------------------------------------------

    (2) Tolerances are established for residues of bifenazate (1-
methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate) 
including its metabolites and degradates, in or on the commodities 
listed in the following table. Compliance with the tolerance levels 
specified are to be determined by measuring only the sum of bifenazate 
and its metabolites diazinecarboxylic acid, 2-(4-methoxy-[1,1'-
biphenyl]-3-yl), 1-methylethyl ester; 1,1'-biphenyl, 4-ol; and 1,1'-
biphenyl, 4-oxysulfonic acid (calculated as the stoichiometric 
equivalent of bifenazate) in or on the following food commodities:
* * * * *
    (b) Section 18 emergency exemptions. [Reserved]
    (c) Tolerances with regional registrations. Tolerances with 
regional registration, as defined in Sec.  180.1(l), are established 
for residues of bifenazate (1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-
3-yl)hydrazinecarboxylate) including its metabolites and degradates, in 
or on the commodities listed in the following table. Compliance with 
the tolerance levels specified are to be determined by measuring only 
the sum of bifenazate and its metabolite, diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester, (calculated as the 
stoichiometric equivalent of bifenazate) in or on the following food 
commodities:

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                              million
------------------------------------------------------------------------
Timothy, forage..............................................        200
Timothy, hay.................................................        150
------------------------------------------------------------------------

* * * * *
[FR Doc. 2014-18041 Filed 8-5-14; 8:45 am]
BILLING CODE 6560-50-P


