
[Federal Register: March 5, 2008 (Volume 73, Number 44)]
[Rules and Regulations]               
[Page 11831-11837]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr08-7]                         

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0302; FRL-8351-6]

 
Bifenazate; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for combined residues 
of bifenazate and its metabolite, diazinecarboxylic acid, 2-(4-methoxy-
[1,1'-biphenyl]-3-yl), 1-methylethyl ester (expressed as bifenazate), 
in or on acerola; black sapote; caneberry subgroup 13-07A; canistel; 
feijoa; guava; jaboticaba; longan; lychee; mango; papaya; passionfruit; 
pea and bean, succulent shelled, subgroup 6B; pulasan; rambutan; 
sapodilla; sapote, mamey; soybean, succulent shelled; Spanish lime; 
star apple; starfruit; vegetable, legume, edible-podded, subgroup 6A; 
and wax jambu. Interregional Research Project Number 4 (IR-4) requested 
these tolerances under the Federal Food, Drug, and Cosmetic Act 
(FFDCA). This regulation also deletes existing bifenazate tolerances on 
``pea, edible podded, succulent'' and ``pea, garden, succulent'', which 
are superseded by the new tolerances on ``vegetable, legume, edible-
podded, subgroup 6A'' and ``pea and bean, succulent shelled, subgroup 
6B'', respectively.

DATES: This regulation is effective March 5, 2008. Objections and 
requests for hearings must be received on or before May 5, 2008, 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-2007-0302. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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) 305-5805.

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

[[Page 11832]]

DC 20460-0001; telephone number: (703) 305-5218; e-mail address: 
stanton.susan@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. 
Potentially affected entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at http://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at http://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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-2007-0302 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk as required by 40 CFR part 178 on or 
before May 5, 2008.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0302, 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'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. Petition for Tolerance

    In the Federal Register of June 27, 2007 (72 FR 35237-35242) (FRL-
8133-4), 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 
6E7167) by Interregional Research Project Number 4 (IR-4), 500 College 
Road East, Suite 201 W, Princeton, NJ 08540-6635. The petition 
requested that 40 CFR 180.572 be amended by establishing tolerances for 
combined residues of the insecticide bifenazate, 1-methylethyl 2-(4-
methoxy[1,1'-biphenyl]-3-yl) hydrazinecarboxylate, and its metabolite, 
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate), in or on papaya, star 
apple, black sapote, mango, sapodilla, canistel, and sapote, mamey at 
6.0 parts per million (ppm); lychee, longan, Spanish lime, rambutan, 
and pulasan at 4.0 ppm; feijoa, guava, jaboticaba, wax jambu, 
starfruit, passionfruit, and acerola at 0.9 ppm; caneberry subgroup 13A 
at 6.0 ppm; wild raspberry at 6.0 ppm; edible podded legume vegetable, 
subgroup 6A at 4.0 ppm; succulent shelled pea and bean, subgroup 6B at 
0.3 ppm; and succulent shelled soybean at 0.3 ppm. That notice 
referenced a summary of the petition prepared by Chemtura Corporation, 
the registrant, which is available to the public 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 
modified many of the proposed tolerance levels and/or commodity terms. 
The reasons for these changes are explained in Unit V.

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. . . 
.'' These provisions were added to FFDCA by the Food Quality Protection 
Act (FQPA) of 1996.
    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 the petitioned-for 
tolerance for combined residues of bifenazate and its metabolite, 
diazinecarboxylic acid, 2-(4-methoxy-[1,1'-biphenyl]-3-yl), 1-
methylethyl ester (expressed as bifenazate), in or on acerola at 0.90 
ppm; black sapote at 7.0

[[Page 11833]]

ppm; caneberry subgroup 13-07A at 5.0 ppm; canistel at 7.0 ppm; feijoa 
at 0.90 ppm; guava at 0.90 ppm; jaboticaba at 0.90 ppm; longan at 5.0 
ppm; lychee at 5.0 ppm; sapote, mamey at 7.0 ppm; mango at 7.0 ppm; 
papaya at 7.0 ppm; passionfruit at 0.90 ppm; pea and bean, succulent 
shelled, subgroup 6B at 0.70 ppm; pulasan at 5.0 ppm; rambutan at 5.0 
ppm; sapodilla at 7.0 ppm; soybean, succulent shelled at 0.70 ppm; 
Spanish lime at 5.0 ppm; star apple at 7.0 ppm; starfruit at 0.90 ppm; 
vegetable, legume, edible-podded, subgroup 6A at 6.0 ppm; and wax jambu 
at 0.90 ppm. EPA's assessment of exposures and risks associated with 
establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. 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 ``PP 6E7167; Bifenazate; (000586) 
Petition for Establishment of Tolerances for Uses on Caneberry ... and 
Acerola. HED Human-Health Risk Assessment.'' The referenced document is 
available in the docket established by this action, which is described 
under ADDRESSES, and is identified as document number EPA-HQ-OPP-2007-
0302-0004 in that docket.
    The acute toxicity data for bifenazate indicate that it 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. 
The dermal sensitization data for bifenazate are equivocal; bifenazate 
was shown to be a sensitizer using the Magnusson/Kligman method but was 
non-sensitizing using the Buehler method.
    Subchronic 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 of 
bifenazate in these species, with additional toxicity observed in the 
kidney (chronic dog) and adrenal gland (male rats). 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 EPA has classified bifenazate as ``not likely'' 
to be a human carcinogen by any relevant route of exposure. A full 
battery of mutagenicity studies was 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 of 
offspring was not observed with bifenazate during prenatal 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.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which no adverse effects are observed (the 
NOAEL) in the toxicology study identified as appropriate for use in 
risk assessment. However, if a NOAEL cannot be determined, the lowest 
dose at which adverse effects of concern are identified (the LOAEL) is 
sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the LOC to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
risks by comparing aggregate exposure to the pesticide to the acute 
population adjusted dose (aPAD) and chronic population adjusted dose 
(cPAD). The aPAD and cPAD are calculated by dividing the LOC by all 
applicable UFs. Short-, intermediate-, and long-term risks are 
evaluated by comparing aggregate exposure to the LOC to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded.
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. 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/fedrgstr/EPA-PEST/1997/November/Day-26/
p30948.htm.
    A summary of the toxicological endpoints for bifenazate used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``PP 6E7167; Bifenazate; (000586) Petition for Establishment 
of Tolerances for Uses on Caneberry ... and Acerola. HED Human-Health 
Risk Assessment'' at page 11 in docket ID number EPA-HQ-OPP-2007-0302.

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. 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 USDA 1994-1996 
and 1998 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 all 
of the new uses.
    iii. Cancer. No evidence of carcinogenicity was seen in the cancer 
studies performed with bifenazate on rats and mice, and EPA has 
classified bifenazate as ``not likely'' to be a human carcinogen by any 
relevant route of exposure. Therefore, a cancer exposure assessment was 
not conducted.

[[Page 11834]]

    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 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 pursuant 
to section 408(f)(1) of FFDCA require 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 section 408(b)(2)(E) of FFDCA and authorized under 
section 408(f)(1) of FFDCA. Data will be required to be submitted no 
later than 5 years from the date of issuance of this tolerance.
    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:
    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 
such pesticide residue.
    b. The exposure estimate does not underestimate exposure for any 
significant subpopulation group.
    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 section 408(b)(2)(F) 
of FFDCA, EPA may require registrants to submit data on PCT.
    The Agency used PCT information in the chronic dietary exposure 
assessment as follows:
    Almond 1%; apple 1%; apricot 1%; cucumber 1%; grape 5%; nectarine 
5%; peach 10%; pear 10%; pecan 1%; pepper 1%; plum 5%; strawberry 25%; 
tomato 5%; walnut 1%; and watermelon 1%. 100 PCT was assumed for all 
new uses and the remaining currently registered uses.
    EPA uses an average PCT for chronic dietary risk analysis. The 
average PCT figure for each existing use is derived by combining 
available federal, state, and private market survey data for that use, 
averaging by year, averaging across all years, and rounding up to the 
nearest multiple of five percent except for those situations in which 
the average PCT is less than one. In those cases 1% is used as the 
average. In most cases, EPA uses available data from United States 
Department of Agriculture/National Agricultural Statistics Service 
(USDA/NASS), Proprietary Market Surveys, and the National Center for 
Food and Agriculture Policy (NCFAP) for the most recent 6 years.
    The Agency believes that the three conditions listed in this unit 
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 
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 lacks 
sufficient monitoring data to complete a comprehensive dietary exposure 
analysis and risk assessment for bifenazate in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the environmental fate 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 environmental concentrations (EECs) of bifenazate for chronic 
exposures are estimated to be 6.38 ppb for surface water and <0.001 ppb 
for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For the chronic dietary risk 
assessment, the water concentration of value 6.38 ppb was used to 
access 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. Handler exposures 
were estimated assuming applications would be made using hose-end 
sprayers, since this application method may result in higher exposures 
than other application methods, such as pump sprayers or similar 
devices.
    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

[[Page 11835]]

substances that have a common mechanism of toxicity.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to bifenazate and 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 not assumed that bifenazate has 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 of FFDCA provides that EPA shall apply 
an additional (``10X'') tenfold margin of safety for infants and 
children in the case of threshold effects to account for prenatal and 
postnatal toxicity and the completeness of the database on toxicity and 
exposure unless EPA determines based on reliable data that a different 
margin of safety will be safe for infants and children. This additional 
margin of safety is commonly referred to as the FQPA safety factor. In 
applying this provision, EPA either retains the default value of 10X 
when reliable data do not support the choice of a different factor, or, 
if reliable data are available, EPA uses a different additional FQPA 
safety factor value based on the use of traditional UFs and/or special 
FQPA safety factors, as appropriate.
    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 that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for bifenazate is complete.
    ii. There is no indication that bifenazate is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for neurotoxicity.
    iii. There is no evidence that bifenazate results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
study.
    iv. There are no residual uncertainties identified in the exposure 
databases. The chronic dietary food exposure assessment utilizes 
tolerance level residues or, for a few commodities, anticipated 
residues that are based on reliable field trial data. For several 
currently registered commodities, the chronic assessment also utilizes 
PCT data that have a valid basis and are considered to be reliable. 
Conservative ground water and surface water modeling estimates were 
used. These assessments will not underestimate the exposure and risks 
posed by bifenazate.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide to the aPAD and cPAD. The aPAD and 
cPAD are calculated by dividing the LOC by all applicable UFs. For 
linear cancer risks, EPA calculates the probability of additional 
cancer cases given aggregate exposure. Short-, intermediate-, and long-
term risks are evaluated by comparing aggregate exposure to the LOC to 
ensure that the MOE called for by the product of all applicable UFs is 
not exceeded.
    1. Acute risk. None of the toxicology studies available for 
bifenazate has indicated the possibility of an effect of concern 
occurring as a result of a 1-day or single exposure; therefore, acute 
risk is not expected.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
bifenazate from food and water will utilize 47% of the cPAD for 
children 1 to 2 years old, the population group with the greatest 
estimated exposure. Based on the use pattern, chronic residential 
exposure to residues of bifenazate is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Bifenazate is currently registered for use that could result in 
short-term residential exposure and the Agency has determined that it 
is appropriate to aggregate chronic food and water and short-term 
exposures for 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 of 3,900 for adults. 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 level of 
concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Bifenazate is not registered for use on any sites that would result 
in intermediate-term residential exposure. Therefore, the aggregate 
risk is the sum of the risk from food and water, which does not exceed 
the Agency's level of concern.
    5. Aggregate cancer risk for U.S. population. Bifenazate has been 
classified as ``not likely'' to be a human carcinogen by any relevant 
route of exposure and is, therefore, not expected to pose a cancer 
risk.
    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 
determination 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 methods may be requested from: Chief, 
Analytical Chemistry Branch,

[[Page 11836]]

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

    There are currently no established Codex, Canadian, or Mexican 
maximum residue limits (MRLs) for bifenazate in/on the commodities 
associated with this tolerance petition.

V. Conclusion

    IR-4 petitioned for a tolerance on caneberry subgroup 13A and a 
separate tolerance on wild raspberry, since wild raspberry was not 
included in the caneberry subgroup at the time of the petition. In the 
Federal Register of December 7, 2007 (72 FR 69150-69158) (FRL-8343-1), 
EPA issued a final rule that revised the crop grouping regulations. As 
part of this action, EPA expanded and revised berries group 13 and its 
subgroups. The caneberries subgroup was expanded to include wild 
raspberries and designated as caneberry subgroup 13-07A, but the 
representative commodities remained unchanged. EPA indicated in the 
December 7, 2007 final rule as well as the earlier May 23, 2007 
proposed rule (72 FR 28920-28930) (FRL-8126-1) that, for existing 
petitions for which a Notice of Filing had been published, the Agency 
would attempt to conform these petitions to the rule. Because the 
representative commodities for subgroups 13A and 13-07A are the same 
and residue data on these commodities support inclusion of wild 
raspberry in the revised subgroup 13-07A, EPA is establishing a 
tolerance on caneberry subgroup 13-07A.
    Based upon review of the data supporting PP 6E7167, EPA has also 
revised the proposed tolerance levels as follows: Increased the 
tolerance on papaya, star apple, black sapote, mango, sapodilla, 
canistel and sapote, mamey from 6.0 ppm to 7.0 ppm; increased the 
tolerance on lychee, longan, rambutan, Spanish lime and pulasan from 
4.0 ppm to 5.0 ppm; decreased the tolerance on caneberry subgroup 13-
07A from 6.0ppm to 5.0 ppm; increased the tolerance on vegetable, 
legume, edible-podded, subgroup 6A from 4.0 ppm to 6.0 ppm; and 
increased the tolerance on pea and bean, succulent shelled, subgroup 6B 
and soybean, succulent shelled from 4.0 ppm to 6.0 ppm . EPA revised 
these tolerance levels based on analyses of the residue field trial 
data using the Agency's Tolerance Spreadsheet in accordance with the 
Agency's Guidance for Setting Pesticide Tolerances Based on Field Trial 
Data Standard Operating Procedure (SOP).
    Therefore, the tolerances are established for combined residues of 
bifenazate, 1-methylethyl 2-(4-methoxy[1,1'-biphenyl]-3-yl) 
hydrazinecarboxylate and its metabolite, diazinecarboxylic acid, 2-(4-
methoxy-[1,1'-biphenyl]-3-yl), 1-methylethyl ester] (expressed as 
bifenazate), in or on acerola at 0.90 ppm; black sapote at 7.0 ppm; 
caneberry subgroup 13-07A at 5.0 ppm; canistel at 7.0 ppm; feijoa at 
0.90 ppm; guava at 0.90 ppm; jaboticaba at 0.90 ppm; longan at 5.0 ppm; 
lychee at 5.0 ppm; sapote, mamey at 7.0 ppm; mango at 7.0 ppm; papaya 
at 7.0 ppm; passionfruit at 0.90 ppm; pea and bean, succulent shelled, 
subgroup 6B at 0.70 ppm; pulasan at 5.0 ppm; rambutan at 5.0 ppm; 
sapodilla at 7.0 ppm; soybean, succulent shelled at 0.70 ppm; Spanish 
lime at 5.0 ppm; star apple at 7.0 ppm; starfruit at 0.90 ppm; 
vegetable, legume, edible-podded, subgroup 6A at 6.0 ppm; and wax jambu 
at 0.90 ppm.
    Tolerances currently exist for combined residues of bifenazate and 
its metabolite in or on pea, edible podded, succulent at 4.0 ppm and 
pea, garden, succulent at 0.20 ppm. These tolerances are no longer 
needed, since residues on these commodities will be covered by the new, 
higher tolerances being established on the edible-podded legume 
subgroup 6A at 6.0 ppm and on succulent shelled pea and bean subgroup 
6B at 0.70 ppm. Therefore, EPA is revoking these existing, redundant 
tolerances.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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 rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, 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 6, 2000) do not apply to this rule. In addition, This 
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 
note).

VII. Congressional Review Act

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

[[Page 11837]]

List of Subjects in 40 CFR Part 180

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

    Dated: February 22, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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 by removing the entries ``Pea, edible 
podded, succulent'' and ``Pea, garden, succulent'' in the table in 
paragraph (a)(1) and alphabetically adding the following commodities to 
read as follows:


Sec.  180.572  Bifenazate; tolerance for residues.

    (a) General. (1) * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
Acerola....................................................         0.90
                                * * * * *
Black sapote...............................................          7.0
Caneberry subgroup 13-07A..................................          5.0
Canistel...................................................          7.0
                                * * * * *
Feijoa.....................................................         0.90
                                * * * * *
Guave......................................................         0.90
                                * * * * *
Jaboticaba.................................................         0.90
Longan.....................................................          5.0
Lychee.....................................................          5.0
Mango......................................................          7.0
                                * * * * *
Papaya.....................................................          7.0
Passionfruit...............................................         0.90
Pea and bean, succulent shelled, subgroup 6B...............         0.70
                                * * * * *
Pulasan....................................................          5.0
Rambutan...................................................          5.0
Sapodilla..................................................          7.0
Sapote, mamey..............................................          7.0
                                * * * * *
Soybean, succulent shelled.................................         0.70
Spanish lime...............................................          5.0
                                * * * * *
Star apple.................................................          7.0
Starfruit..................................................         0.90
                                * * * * *
Vegetable, legume, edible-podded, subgroup 6A..............          6.0
                                * * * * *
Wax jambu..................................................         0.90
------------------------------------------------------------------------

* * * * *
[FR Doc. E8-4142 Filed 3-4-08; 8:45 am]

BILLING CODE 6560-50-S
