[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]
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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.
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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are superseded by the new tolerances on ``vegetable, legume, edible-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