[Federal Register Volume 75, Number 169 (Wednesday, September 1, 2010)]
[Rules and Regulations]
[Pages 53586-53593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-21719]



40 CFR Part 180

[EPA-HQ-OPP-2009-0890; FRL-8840-9]

Bifenazate; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes tolerances for residues of 
bifenazate in or on multiple commodities which are identified and 
discussed later in this document. Interregional Research Project 
4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). This regulation additionally deletes 
the time-limited tolerance for potato, as the tolerance expired on 
December 31, 2006, and deletes the time-limited tolerances for tart 
cherry, soybean hulls, soybean meal, soybean refined oil, and soybean 
seed, as the tolerances expired on December 31, 2009.

DATES: This regulation is effective September 1, 2010. Objections and 
requests for hearings must be received on or before November 1, 2010, 
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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0890. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 

FOR FURTHER INFORMATION CONTACT: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington,

[[Page 53587]]

DC 20460-0001; telephone number: (703) 308-9367; e-mail address: 


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 

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.gpoaccess.gov/ecfr.

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-2009-0890 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 
November 1, 2010. 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 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-2009-0890, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of February 4, 2010 (75 FR 5790) (FRL-8807-
5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
9E7642) by Interregional Research Project 4 (IR-4), 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 the the insecticide bifenazate, (1-methylethyl 2-(4-
methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) and diazinecarboxylic 
acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester 
(expressed as bifenazate), in or on sugar apple, cherimoya, atemoya, 
custard apple, ilama, soursop, and biriba at 1.5 parts per million 
(ppm); avocado at 7.0 ppm; fruit, small, vine climbing subgroup 13-07F, 
except fuzzy kiwi fruit at 0.75 ppm; and berry, low growing, subgroup 
13-07G at 1.5 ppm. That notice 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 
changed the tolerances for sugar apple, cherimoya, atemoya, custard 
apple, ilama, soursop, and biriba from the proposed level of 1.5 ppm to 
1.6 ppm and for fruit, small, vine climbing subgroup 13-07F, except 
fuzzy kiwi tolerance from the proposed level of .75 ppm to 1.0 ppm. The 
reason for these changes is explained in Unit IV.D.

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 
    Consistent with section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 bifenazate including 
exposure resulting from the tolerances established by this action. 
EPA's assessment of exposures and risks associated with bifenazate 

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
    Bifenazate is not acutely toxic by the oral, inhalation, or dermal 
routes of exposure. It is minimally irritating to the eye and slightly-
irritating to the skin. Bifenazate is a dermal sensitizer by the 
Magnusson/Kligman method, but not the Buehler method. Subchronic

[[Page 53588]]

and chronic studies in rats and dogs indicate that the liver and 
hematopoietic system (spleen and/or bone marrow with associated 
hematological findings) are the primary target organs in these species, 
with additional toxicity in the kidney (chronic dog) and adrenal gland 
(male rats) also identified. Similarly, the hematopoietic system 
(spleen) was the primary target organ in the repeat-dose dermal 
toxicity study. Also associated with this toxicity in several studies 
were decreased body weight, body-weight gain, and food consumption. No 
evidence of carcinogenicity was seen in the rat and mouse studies and 
the Agency has classified bifenazate as ``not likely'' to be a human 
carcinogen by any relevant route of exposure. A full battery of 
mutagenicity studies were negative for mutagenic or clastogenic 
activity. The developmental studies in rats and rabbits did not 
demonstrate increased sensitivity of fetuses to bifenazate. Similarly, 
increased qualitative or quantitative susceptibility to offspring were 
not observed with bifenazate during pre- or postnatal development in 
the reproduction study. There was no evidence of neurotoxicity 
(clinical signs or neuropathology) in any of the toxicology studies 
conducted with bifenazate. Therefore, a bifenazate developmental 
neurotoxicity (DNT) study was not required by the Agency.
    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 the document titled ``Bifenazate (000586); 
Petition to Add New Uses on: Avocado, Tropical Fruits (Sugar Apple, 
Cherimoya, Atemoya, Custard Apple, Ilama, Soursop, and Biriba), Small 
Vine Climbing Fruit (Subgroup 13-07F), and Low-Growing Berry (Subgroup 
13-07G). HED Human-Health Risk Assessment,'' pp. 26-27 in docket ID 
number EPA-HQ-OPP-2009-0890.

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 (LOC) 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 the NOAEL and the LOAEL of concern are 
identified. Uncertainty/safety factors (U/SF) 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                            An acute dietary endpoint was not selected based on the absence of an
(all populations)....................               appropriate endpoint attributed to a single dose.
Chronic dietary                        NOAEL= 1.0 milligrams/   Chronic RfD = 0.01 mg/   Chronic Toxicity in
(All populations)....................   kilogram/day (mg/kg/     kg/day                   Dogs
                                        day) UFA = 10x          cPAD = 0.01 mg/kg/day..  LOAEL = 8.9/10.4 mg/kg/
                                       UFH = 10x..............                            day Male/Female (M/F)
                                       FQPA SF = 1x...........                            based on changes in
                                                                                          hematological and
                                                                                          clinical chemistry
                                                                                          parameters, and
                                                                                          histopathology in bone
                                                                                          marrow, liver, and
                                                                                          kidney in the 1-year
                                                                                          dog feeding study.
Incidental oral short-term             NOAEL= 10 mg/kg/day UFA  LOC for MOE <=100        Prenatal Developmental
(1 to 30 days).......................   = 10x                                             in Rats
                                       UFH = 10x..............                           Maternal LOAEL = 100 mg/
                                       FQPA SF = 1x...........                            kg/day based on
                                                                                          clinical signs,
                                                                                          decreased body weight
                                                                                          and food consumption
                                                                                          during the dosing
                                                                                          period in the rat
                                                                                          developmental study.
Incidental oral intermediate-term      NOAEL= 0.9 mg/kg/day     LOC for MOE <=100        90-Day Oral Toxicity
(1 to 6 months)......................   UFA= 10x                                          non-Rodents-Dog
                                       UFH= 10x...............                           LOAEL = 10.4/10.7 mg/kg/
                                       FQPA SF = 1x...........                            day (M/F) based on
                                                                                          changes in hematologic
                                                                                          parameters in the 90-
                                                                                          day subchronic dog

[[Page 53589]]

Short-, Intermediate- and Long-Term    Dermal study NOAEL = 80  LOC for MOE <=100        21-Day Dermal Toxicity-
 Dermal (1-30 days, 30 days- 6          mg/kg/day UFA = 10x                               Rat
 months, and 6 months to lifetime)     UFH = 10x..............                           LOAEL = 400 mg/kg/day
                                       FQPA SF = 1x...........                            based on decreased
                                                                                          body weight and food
                                                                                          hematologic effects,
                                                                                          increased spleen
                                                                                          weight and
                                                                                          hemapoiesis in the
                                                                                          spleen in the 21-day
                                                                                          dermal toxicity study
                                                                                          in rats.
Inhalation short-term                  Oral study NOAEL= 10 mg/ LOC for MOE <=100        Prenatal Developmental
(1 to 30 days).......................   kg/day (inhalation                                in Rats
                                        absorption rate =                                Maternal LOAEL = 100 mg/
                                        100%)                                             kg/day based on
                                       UFA = 10x..............                            clinical signs,
                                       UFH = 10x..............                            decreased body weight
                                       FQPA SF = 1x...........                            and food consumption
                                                                                          during the dosing
                                                                                          period in the rat
                                                                                          developmental study.
Cancer                                    Bifenazate is classified as ``not likely'' to be a human carcinogen.
(Oral, dermal, inhalation)...........
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. UFS = use of a short-term
  study for long-term risk assessment. UFDB = to account for the absence of data or other data deficiency. FQPA
  SF = Food Quality Protection Act Safety Factor.

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 
    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. No such effects were 
identified in the toxicological studies for bifenazate; therefore, a 
quantitative acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the United States 
Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey 
of Food Intake by Individuals (CSFII). As to residue levels in food, 
EPA assumed that all commodities, except squash, peach, tomato and 
milk, contained tolerance-level residues. For squash, peach and tomato, 
EPA assumed residues were present at average field trial levels. For 
milk, the tolerance level was adjusted upward to account for all of the 
residues of concern for risk assessment. Default processing factors 
were assumed for all commodities except apple juice, grape juice, wine/
sherry, tomato paste, and tomato puree. The processing factors for 
these commodities were based on data from processing studies. The 
chronic analysis also incorporated average percent crop treated (PCT) 
information for some registered commodities but assumed 100 PCT for the 
new uses.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has 
concluded that bifenazate does not pose a cancer risk to humans. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    Bifenazate contains hydrazine as part of its chemical structure. 
This side chain is structurally similar to unsymmetrical dimethyl 
hydrazine (UDMH), a category B2 animal carcinogen and possible human 
carcinogen. However, EPA has concluded that formation of free biphenyl 
hydrazine or other hydrazines is unlikely based on the results of 
submitted metabolism studies. The rat, livestock, and plant metabolism 
studies indicate that metabolism of bifenazate proceeds via oxidation 
of the hydrazine moiety of bifenazate to form D3598 (diazene). The 
D3598 is then metabolized to D1989 (methoxy biphenyl) and to bound 
residues by reaction with natural products. A radish metabolism study 
which specifically monitored for the formation of biphenyl hydrazine 
found none. Based on the results of the metabolism studies, especially 
the absence of biphenyl hydrazine in the radish metabolism study or in 
the excreta of rats in the rat metabolism study, EPA concluded that the 
formation of free hydrazines is unlikely. This conclusion is further 
supported by the lack of carcinogenic effects in the bifenazate 
carcinogenicity studies.
    iv. Anticipated residue and 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.

[[Page 53590]]

     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:
    Almond 5%; apple 5%; apricot 1%; cherry 1%; cucumber 1%; grape 5%; 
nectarine 5%; peach 10%; pear 10%; pecan 1%; pepper 1%; pistachio 1%; 
plum 5%; strawberry 30%; tomato 1%; walnut 1%; and watermelon 1%. One 
hundred PCT was assumed for all new uses and the remaining currently 
registered uses.
    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 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) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of bifenazate for 
chronic exposures for non-cancer assessments are estimated to be 11.2 
parts per billion (ppb) for surface water and 0.044 ppb for ground 
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. 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 residential non-dietary sites: 
Ornamental plants, including bedding plants, flowering plants, foliage 
plants, bulb crops, perennials, trees, and shrubs. There is a potential 
for short-term dermal and inhalation exposure of homeowners applying 
bifenazate on these sites. However, post-application exposures of 
adults and children from this use are expected to be negligible. 
Therefore, EPA assessed only short-term dermal and inhalation 
residential handler exposures for adults. Handler exposures were 
estimated assuming applications would be made using hose-end sprayers, 
since this application method is expected to result in higher exposures 
than other application methods, such as pump sprayers or similar 
devices. 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 website 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. There was no quantitative or qualitative evidence of 
increased susceptibility of rats or rabbit fetuses to in utero exposure 
in the developmental studies, nor of rats following prenatal/postnatal 
exposure in the 2-generation reproduction study.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 

[[Page 53591]]

were reduced to 1X. That decision is based on the following findings:
     There are no residual uncertainties in the toxicity 
database. The bifenazate toxicological database is complete with the 
exception of an inhalation study, acute and subchronic neurotoxicity 
studies and an immunotoxicity study. The immunotoxicity and acute and 
subchronic neurotoxicity studies are now required as a part of new data 
requirements in the 40 CFR part 158 for conventional pesticide 
registration and a 28-day inhalation study has not been submitted. 
However, the Agency does not believe that conducting these studies will 
result in a lower POD than that currently used for overall risk 
assessment, and therefore, a database uncertainty factor (UFDB) is not 
needed to account for lack of these studies for the following reasons:
     i. The toxicology database for bifenazate does not indicate that 
the immune system is the primary target organ. The observed effects on 
the immune system have been well characterized and were seen at dose(s) 
that produce evidence of overt systemic toxicity. These effects 
included increased spleen weight in females and histopathological 
changes in the spleen in males in a 90-day oral rat toxicity study, 
extramedullary hematopoiesis in the both sexes in a 21-day dermal 
toxicity study in rats, and changes in hematological parameters, 
clinical chemistry parameters in both sexes and histopathological 
effects in bone marrow (compensatory hyperplasia) in both sexes in a 1-
year chronic toxicity study.
    ii. The overall weight of evidence suggests that bifenazate does 
not directly target the immune system, and these findings may be due to 
secondary effect of overt systemic toxicity. Further, there is no 
evidence of neurotoxicity or neuropathology in the bifenazate database.
    iii. A 28-day inhalation study is not available; however, the EPA 
has determined that the additional FQPA SF is not needed. Residential 
inhalation risk was estimated by calculating exposure using the 
Agency's Residential Standard Operational Procedure (SOPs). For 
chemicals with low vapor pressure (7.5 x 10-5 mmHg or below 
for outdoor uses at 20-30[deg]C) these standard assumptions are 
expected to overestimate the exposure via the inhalation route. 
Bifenazate is such a compound and exposure through the inhalation route 
is expected to be minimal. Therefore, the risk estimate is conservative 
and is considered protective and the additional FQPA SF is not needed.
    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.
     There is no quantitative or qualitative evidence of 
increased susceptibility of rats or rabbit fetuses to in utero exposure 
in developmental studies, nor following prenatal/postnatal exposure to 
rats in the 2-generation reproduction study.
     A DNT is not required because there is no evidence of 
neurotoxicity or neuropathology in the bifenazate database.
     The dietary food and drinking water exposure assessments 
will not underestimate the potential exposures for infants and 
children; and the residential use (ornamentals) is not expected to 
result in post-application exposure to infants and children.

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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
bifenazate is not expected to pose an acute risk.
    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 81% 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-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).
    Bifenazate 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 bifenazate.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food, water, and residential 
exposures aggregated result in aggregate MOEs greater than or equal to 
1,800 for the U.S. population. The aggregate MOEs for adults take into 
consideration food and drinking water exposures as well as dermal and 
inhalation exposures of adults applying bifenazate to ornamentals in 
residential areas. Since residential exposure of infants and children 
is not expected, short-term aggregate risk for infants and children is 
the sum of the risk from food and water, which does not exceed the 
Agency's LOC.
    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 
    An intermediate-term adverse effect was identified; however, 
bifenazate 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 
    5. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent carcinogenicity 
studies, bifenazate 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 bifenazate residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology is available to enforce the 
tolerance expression. High-performance liquid chromatography (HPLC) 
Method UCC-D2341 is available as a primary enforcement method for 

[[Page 53592]]

of the combined residues of bifenazate and its metabolite, 
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate), in/on crop matrices. The 
method has undergone a successful validation and has been forwarded to 
the Food and Drug Administration (FDA) for inclusion in the Pesticide 
Analytical Manual (PAM) Volume II. In addition, a method utilizing a 
liquid chromatographic system with tandem mass spectrometers (LC/MS/MS) 
was recently submitted as a confirmatory method (Method NCL ME 245) and 
has been forwarded to FDA. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
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 or Mexican MRLs for 
bifenazate on the commodities included in the subject petition; 
however, Canadian MRLs are established for residues of bifenazate and 
its metabolite diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-
yl, 1-methylethyl ester in or on strawberry at 1.5 ppm, grapes at 1.0 
ppm and raisins at 1.2 ppm. Thus, the tolerance expression is 
harmonized; and the MRL/tolerance levels for residues in strawberry, 
raisins and grapes are harmonized.

C. Revisions to Petitioned-For Tolerances

    The residue data for sugar apple were entered into the Agency's 
tolerance spreadsheet using the Guidance for Setting Pesticide 
Tolerances Based on Field Trial Data SOP to determine an appropriate 
tolerance level. The results of this determination indicate that a 
tolerance level of 1.6 ppm is adequate for residues of bifenazate and 
its metabolite (expressed as bifenazate) in/on sugar apple rather than 
1.5 ppm as originally proposed. This determination is translated to 
cherimoya, atemoya, custard apple, ilama, soursop, and biriba for 
tolerance setting purposes.

V. Conclusion

    Therefore, tolerances are established for residues of bifenazate, 
(1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl)hydrazinecarboxylate) 
and diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate), in or on sugar apple, 
cherimoya, atemoya, custard apple, ilama, soursop, and biriba at 1.6 
ppm; avocado at 7.0 ppm; fruit, small, vine climbing subgroup 13-07F, 
except fuzzy kiwi fruit at 1.0 ppm; and berry, low growing, subgroup 
13-07G at 1.5 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this final rule has been 
exempted from review under Executive Order 12866, this final rule is 
not subject to Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled 
Protection of Children from Environmental Health Risks and Safety Risks 
(62 FR 19885, April 23, 1997). This final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Public Law 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 

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 20, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

[[Page 53593]]


1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

2. Section 180.572 is amended by:
i. Alphabetically adding commodities to the table in paragraph (a)(1), 
ii. Revising the table in paragraph (b), so the amendments to 
paragraphs (a)(1) and (b) read as follows:

Sec.  180.572  Bifenazate; tolerance for residues.

    (a)(1) * * *

                      Commodity                        Parts per million
                                * * * * *
Atemoya..............................................                1.6
Avocado..............................................                7.0
                                * * * * *
Berry, low-growing subgroup 13-07G...................                1.5
Biriba...............................................                1.6
                                * * * * *
Cherimoya............................................                1.6
                                * * * * *
Custard apple........................................                1.6
                                * * * * *
Fruit, small, vine climbing subgroup 13-07F, except                  1.0
 fuzzy kiwifruit.....................................
                                * * * * *
Ilama................................................                1.6
                                * * * * *
Soursop..............................................                1.6
                                * * * * *
Sugar apple..........................................                1.6
                                * * * * *

    (b) * * *

             Commodity              Parts per million   Revocation Date
Timothy, forage...................                 50           12/31/10
Timothy, hay......................                150           12/31/10

[FR Doc. 2010-21719 Filed 8-31-10; 8:45 am]