[Federal Register Volume 62, Number 228 (Wednesday, November 26, 1997)]
[Rules and Regulations]
[Pages 62961-62970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30948]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300579; FRL-5754-7]
RIN 2070-AB78
Bifenthrin; Pesticide Tolerances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation establishes tolerances for residues of the
insecticide bifenthrin ((2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-
chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate), in or on the raw agricultural
commodities (RAC) cottonseed at 0.5 parts per million (ppm); corn,
grain (field, seed, and pop) at 0.05 ppm; corn, forage at 2.0 ppm;
corn, fodder at 5.0 ppm; hops, dried at 10.0 ppm; fat of cattle, goat,
hogs, horses, and sheep at 1.0 ppm; meat of cattle, goat, hogs, horses,
and sheep at 0.5 ppm; meat and meat by-products (mbyp) of cattle, goat,
hogs, horses, and sheep at 0.10 ppm, eggs at 0.05 ppm; milk, fat
(reflecting 0.1 ppm in whole milk) at 1.0 ppm; poultry, fat, meat, and
mbyp at 0.05 ppm. It also removes time limitations for tolerances for
residues of bifenthrin on the same commodities that expire on November
15, 1997. These tolerances were requested under pesticide petitions
(PP) 6F3453, 7F3546, and OE3921. FMC Corporation requested these
tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA), as
amended by the Food Quality Protection Act (FQPA) of 1996 (Pub. L. 104-
170).
DATES: This regulation is effective November 26, 1997. Objections and
requests for hearings must be received by EPA on or before January 26,
1998.
ADDRESSES: Written objections and hearing requests, identified by the
docket control number, [OPP-300579], must be submitted to: Hearing
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St.,
SW., Washington, DC 20460. Fees accompanying objections and hearing
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to:
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees),
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and
hearing requests filed with the Hearing Clerk identified by the docket
control number, [OPP-300579], must also be submitted to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. In person,
bring a copy of objections and hearing requests to Rm. 1132, CM #2,
1921 Jefferson Davis Hwy., Arlington, VA.
A copy of objections and hearing requests filed with the Hearing
Clerk may also be submitted electronically by sending electronic mail
(e-mail) to: opp-docket@epamail.epa.gov. Copies of objections and
hearing requests must be submitted as an ASCII file avoiding the use of
special characters and any form of encryption. Copies of objections and
hearing requests will also be accepted on disks in WordPerfect 5.1 file
format or ASCII file format. All copies of objections and hearing
requests in electronic form must be identified by the docket control
number [OPP-300579]. No Confidential Business Information (CBI) should
be submitted through e-mail. Electronic copies of objections and
hearing requests on this rule may be filed online at many Federal
Depository Libraries.
FOR FURTHER INFORMATION CONTACT: By mail: Adam Heyward, Registration
Division 7505C, Office of Pesticide Programs, Environmental Protection
Agency, 401 M St., SW., Washington, DC 20460. Office location,
telephone number, and e-mail address: Crystal Mall #2, 1921 Jefferson
Davis Hwy., Arlington, VA, (703) 305-5418, e-mail:
heyward.adam@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: On August 15, 1988, EPA established a time-
limited tolerance under section 408 of the FFDCA, 21 U.S.C. 346 a(d)
and 348 for residues of bifenthrin on cottonseed (53 FR 30678). As
additional crops were approved tolerances were also made time-limited.
These tolerances will expire on November 15, 1997. FMC Corporation, on
September 15, 1997, requested that the time limitations for
[[Page 62962]]
tolerances for residues of the insecticide bifenthrin in or on the
commodities mentioned above be removed based on environmental effects
data that they had submitted as a condition of registration. FMC
Corporation also submitted a summary of its petition as required under
the FFDCA as amended by the FQPA of 1996 (Pub. L. 104-170).
In the Federal Register of Friday, September 25, 1997 (62 FR 50337)
(FRL-5748-2), EPA issued a notice pursuant to section 408 of the FFDCA,
21 U.S.C. 346a(e) announcing the filing of pesticide petitions (PP
6F3453, 7F3546, and 0E3921) for tolerances by the FMC Corporation, 1735
Market Street, Philadelphia, PA 19103 and from the Interregional
Research Project No. 4 (IR-4), New Jersey Agricultural Experiment
Station, P.O. Box 231, Rutgers University, New Brunswick, NJ 08903.
This notice included a summary of the petitions prepared by the FMC
Corporation and the Interregional Research Project No. 4 (IR-4), the
registrants. There were no comments received in response to the notice
of filing.
The petitions requested that 40 CFR 180.442 be amended by removing
the time limitation for tolerances of the insecticide bifenthrin (2-
methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate in or on the raw
agricultural commodities cottonseed at 0.5 ppm; corn, grain (field,
seed, and pop) at 0.05 ppm; corn, forage at 2.0 ppm; corn, fodder at
5.0 ppm; hops, dried at 10.0 ppm; fat of cattle, goat, hogs, horses,
and sheep at 1.0 ppm; meat of cattle, goat, hogs, horses, and sheep at
0.5 ppm; meat and mbyp of cattle, goat, hogs, horses, and sheep at 0.10
ppm, eggs at 0.05 ppm; milk, fat (reflecting 0.1 ppm in whole milk) at
1.0 ppm, poultry, fat at 0.05 ppm, poultry, meat at 0.05 ppm, and
poultry mbyp at 0.05 ppm. Tolerances for corn (forage and fodder) and
livestock commodities were inadvertently not listed in the proposal
paragraph of the notice of filing but were included in the discussion
under Aggregate Exposure of the notice. These tolerances were
considered by EPA for risk assessment purposes.
The basis for time-limited tolerances that expire November 15,
1997, was given in the October 20, 1993 Federal Register (58 FR 54094).
These time-limited tolerances were predicated on the expiration of
pesticide product registrations that were made conditional due to lack
of certain ecological and environmental effects data. The rational for
using time-limited tolerances was to encourage pesticide manufacturers
to comply with the conditions of registration in a timely manner. There
is no regulatory requirement to make tolerances time-limited due to the
conditional status of a product registration under the Federal
Insecticide, Fungicide, Rodenticide Act (FIFRA) as amended. It is
current EPA policy to no longer establish time limitations on
tolerance(s) with expiration dates if none of the conditions of
registration have any bearing on human dietary risk. The current
petition action meets that condition and thus the expiration dates
associated with specific crop tolerances are being deleted.
I. Risk Assessment and Statutory Findings
New section 408(b)(2)(A)(i) of the 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) 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)
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. . ..''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides based primarily on toxicological studies using
laboratory animals. These studies address many adverse health effects,
including (but not limited to) reproductive effects, developmental
toxicity, toxicity to the nervous system, and carcinogenicity. Second,
EPA examines exposure to the pesticide through the diet (e.g., food and
drinking water) and through exposures that occur as a result of
pesticide use in residential settings.
A. Toxicity
1. Threshold and non-threshold effects. For many animal studies, a
dose response relationship can be determined, which provides a dose
that causes adverse effects (threshold effects) and doses causing no
observed effects (the ``no observed effect level'' or``NOEL'').
Once a study has been evaluated and the observed effects have been
determined to be threshold effects, EPA generally divides the NOEL from
the study with the lowest NOEL by an uncertainty factor (usually 100 or
more) to determine the Reference Dose (RfD). The RfD is a level at or
below which daily aggregate exposure over a lifetime will not pose
appreciable risks to human health. An uncertainty factor (sometimes
called a ``safety factor'') of 100 is commonly used since it is assumed
that people may be up to 10 times more sensitive to pesticides than the
test animals, and that one person or subgroup of the population (such
as infants and children) could be up to 10 times more sensitive to a
pesticide than another. In addition, EPA assesses the potential risks
to infants and children based on the weight of the evidence of the
toxicology studies and determines whether an additional uncertainty
factor is warranted. Thus, an aggregate daily exposure to a pesticide
residue at or below the RfD (expressed as 100 percent or less of the
RfD) is generally considered acceptable by EPA. EPA generally uses the
RfD to evaluate the chronic risks posed by pesticide exposure. For
shorter term risks, EPA calculates a margin of exposure (MOE) by
dividing the estimated human exposure into the NOEL from the
appropriate animal study. Commonly, EPA finds MOEs lower than 100 to be
unacceptable. This 100-fold MOE is based on the same rationale as the
100-fold uncertainty factor.
Lifetime feeding studies in two species of laboratory animals are
conducted to screen pesticides for cancer effects. When evidence of
increased cancer is noted in these studies, the Agency conducts a
weight of the evidence review of all relevant toxicological data
including short-term and mutagenicity studies and structure activity
relationship. Once a pesticide has been classified as a potential human
carcinogen, different types of risk assessments (e.g., linear low dose
extrapolations or MOE calculation based on the appropriate NOEL) will
be carried out based on the nature of the carcinogenic response and the
Agency's knowledge of its mode of action.
2. Differences in toxic effect due to exposure duration. The
toxicological effects of a pesticide can vary with different exposure
durations. EPA considers the entire toxicity data base, and based on
the effects seen for different durations and routes of exposure,
determines which risk assessments should be done to assure
[[Page 62963]]
that the public is adequately protected from any pesticide exposure
scenario. Both short and long durations of exposure are always
considered. Typically, risk assessments include ``acute,'' ``short-
term,'' ``intermediate-term,'' and ``chronic'' risks. These assessments
are defined by the Agency as follows.
Acute risk, by the Agency's definition, results from 1-day
consumption of food and water, and reflects toxicity which could be
expressed following a single oral exposure to the pesticide residues.
High-end exposure to food and water residues are typically assumed.
Short-term risk results from exposure to the pesticide for a period
of 1-7 days and therefore overlaps with the acute risk assessment.
Historically, this risk assessment was intended to address primarily
dermal and inhalation exposure which could result, for example, from
residential pesticide applications. However, since enaction of FQPA,
this assessment has been expanded to include both dietary and non-
dietary sources of exposure, and will typically consider exposure from
food, water, and residential uses when reliable data are available. In
this assessment, risks from average food and water exposure and high-
end residential exposure are aggregated. High-end exposures from all
three sources are not typically added because of the very low
probability of this occurring in most cases and because the other
conservative assumptions built into the assessment assure adequate
protection of public health. However, for cases in which high-end
exposure can reasonably be expected from multiple sources (e.g.,
frequent and widespread homeowner use in a specific geographical area),
multiple high-end risks will be aggregated and presented as part of the
comprehensive risk assessment/characterization. Since the toxicological
endpoint considered in this assessment reflects exposure over a period
of at least 7 days, an additional degree of conservatism is built into
the assessment; i.e. the risk assessment nominally covers 1-7 days
exposure, and the toxicological endpoint/NOEL is selected to be
adequate for at least 7 days of exposure. Toxicity results at lower
levels when the dosing duration is increased.
Intermediate-term risk results from exposure for 7 days to several
months. This assessment is handled in a manner similar to the short-
term risk assessment.
Chronic risk assessment describes risk which could result from
several months to a lifetime of exposure. For this assessment, risks
are aggregated considering average exposure from all sources for
representative population subgroups including infants and children.
B. Aggregate Exposure
In examining aggregate exposure, FFDCA section 408 requires that
EPA take into account available and reliable information concerning
exposure from the pesticide residue in the food in question, residues
in other foods for which there are tolerances, residues in groundwater
or surface water that is consumed as drinking water, and other non-
occupational exposures through pesticide use in gardens, lawns, or
buildings (residential and other indoor uses). Dietary exposure to
residues of a pesticide in a food commodity are estimated by
multiplying the average daily consumption of the food forms of that
commodity by the tolerance level or the anticipated pesticide residue
level. The Theoretical Maximum Residue Contribution (TMRC) is an
estimate of the level of residues consumed daily if each food item
contained pesticide residues equal to the tolerance. In evaluating food
exposures, EPA takes into account varying consumption patterns of major
identifiable subgroups of consumers, including infants and children.
The TMRC is a ``worst case'' estimate since it is based on the
assumptions that food contains pesticide residues at the tolerance
level and that 100 percent of the crop is treated by pesticides that
have established tolerances. If the TMRC exceeds the RfD or poses a
lifetime cancer risk that is greater than approximately one in a
million, EPA attempts to derive a more accurate exposure estimate for
the pesticide by evaluating additional types of information
(anticipated residue data and/or percent of crop treated data) which
show, generally, that pesticide residues in most foods when they are
eaten are well below established tolerances.
II. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(b)(2)(D), EPA has reviewed the
available scientific data and other relevant information in support of
this action, EPA has sufficient data to assess the hazards of
bifenthrin and to make a determination on aggregate exposure,
consistent with section 408(b)(2), on cottonseed at 0.5 ppm; corn,
grain (field, seed, and pop) at 0.05 ppm; corn, forage at 2.0 ppm;
corn, fodder at 5.0 ppm; hops, dried at 10.0 ppm; fat of cattle, goat,
hogs, horses, and sheep at 1.0 ppm; meat of cattle, goat, hogs, horses,
and sheep at 0.5 ppm; meat and mbyp of cattle, goat, hogs, horses, and
sheep at 0.10 ppm, eggs at 0.05 ppm; milk, fat (reflecting 0.1 ppm in
whole milk), poultry, fat at 0.05 ppm, poultry, meat at 0.05 ppm, and
poultry mbyp at 0.10 ppm. EPA's assessment of the dietary 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. The nature of the toxic effects caused by bifenthrin are
discussed below.
1. Acute toxicity. Acute toxicity studies with the technical grade
of the active ingredient bifenthrin: Oral LD50 in the rats
of 70.1 milligram/kilogram (mg/kg) (male) and 53.8 mg/kg (female):
Toxic category II, dermal LD50 in the rats of > 2000 mg/kg
(male and female): Toxic category II, primary dermal and eye showed no
irritation: Toxic category IV. Bifenthrin is not a dermal senstizer.
2. Mutagenicity. The following genotoxicity tests were all
negative: A Salmonella typhimurium reverse gene mutation assay, a mouse
lymphoma forward gene mutation assay (HGPRT locus), a mouse lymphoma
TO# assay, a CHO/HGPRT assay, an in vitro chromosomal
aberration assay in CHO cells, a rat bone marrow cytogenetic assay, and
2 unscheduled DNA synthesis assays in primary rat hepatocytes.
Bifenthrin tests positively both with and without metabolic activation
in the mouse lymphoma forward gene mutation assay (TO#).
There is also presumptive evidence that bifenthrin is mutagenic with
metabolic activation in the CHO gene mutation assay. However, this
study appears to be unacceptable at this time. All the other studies
tested negatively. The submitted studies satisfies both the pre 1991
and new mutagenicity test batteries. No further testing is required at
this time.
3. A 13-week feeding study in dogs (by capsule) of doses at nominal
dose levels of 0, 2.5, 5, 10, or 20 milligram/kilogram/day (mg/kg/day)
(equivalent to 2.21, 4.42, 8.84, and 17.7 mg/kg/day, based on percent
active ingredient (a.i.)) for 13 weeks. There was no mortality during
the study. There were no treatment-related changes noted in food
consumption, hematology, clinical chemistry, organ weight, gross or
microscopic parameters. In addition,
[[Page 62964]]
there were no treatment-related ophthalmological changes. Tremors were
noted in 3 dogs/sex at 4.42 mg/kg/day and in 4 dogs/sex at 8.84 and
17.7 mg/kg/day. Ataxia was noted in 4 dogs/sex at 8.84 and 17.7 mg/kg/
day and in one female at 4.42 mg/kg/day. Languidness occurred primarily
at 17.7 mg/kg/day in both sexes, but also occasionally at 8.84 mg/kg/
day. All of these symptoms occurred more frequently during the last 3
weeks of the study. Other dose-related clinical signs included
blinking, mydriasis, nystagmus, lacrimation, and polypnea. One high-
dose female appeared thin and/or dehydrated during the final weeks of
the study. A non-statistically significant, but possibly treatment-
related reduction in body weight (bwt) gain was noted in females at
17.7 mg/kg/day (0.6 kilogram (kg)) relative to the controls (1.3 kg).
None of the females at 8.84 or 17.7 mg/kg/day showed cyclic activity or
signs of estrus, but cyclic activity was observed in 2, 2, and 1 female
at 0, 2.21, and 4.42 mg/kg/day, respectively and \4/5\ showed signs of
estrus. The lowest observed effect level (LOEL) for this 13-week study
is 4.42 mg/kg/day based on the increased incidence of tremors in both
sexes. The NOEL is 2.21 mg/kg/day.
4. A 90-day feeding study in rats fed at doses of 0, 12, 50, 100,
and 200 ppm (0, 0.6, 2.5, 5, or 10 mg/kg/day) with a NOEL of 2.5 mg/kg/
day and LOEL of 5 mg/kg/day based on the increased incidence of tremors
in both sexes.
5. A 21-day study in rabbits exposed dermally to doses of 0, 25,
50, 100, or 500 mg/kg/day for 21 days with a systemic NOEL of 100 mg/
kg/day. Systemic LOEL is 500 mg/kg/day based on the loss of muscle
coordination in both sexes.
6. A 1-year chronic/carcinogenicity study in dogs was administered
in the diet at dose levels of 0, 0.75, 1.5, 3, or 5 mg/kg/day. No
mortality occurred during the study and there were no treatment-related
effects on bwt, food consumption, organ weights, and grossor
microscopic pathology. In addition, there were no treatment-related
ophthalmological changes. Tremors were noted in all males and females
at 5 mg/kg/day during weeks 15-29 and in \1/4\ males and \2/4\ females
at 3 mg/kg/day during weeks 16-23. A significant increase in platelets
was noted at 52 weeks in 5 mg/kg/day males. Serum sodium levels were
significantly increased in males at 3 and 5 mg/kg/day and serum
chloride was increased in males at 5mg/kg/day. The LOEL for this 52-
week study is 3 mg/kg/day based on the increased incidence of tremors
in both sexes. The NOEL is 1.5 mg/kg/day.
7. A chronic/carcinogenicity study in mice fed at doses of 0, 50,
200, 500, or 600 ppm (0, 2.5, 10, 25, or 30 mg/kg/day) in the diet for
87 weeks (males) or 92 weeks (females). Chronic LOEL is 10 mg/kg/day
based on the incidence of tremors in both sexes. Chronic NOEL is 2.5
mg/kg/day. Carcinogenic potential was evidenced by a statistically
significant increased trend for hemangiopericytomas in the urinary
bladders of males, a significant dose-related trend for combined
hepatocellular adenomas and carcinomas in males, and a significantly
higher incidence of combined lung adenomas and carcinomas in females.
8. Chronic/carcinogenicity study in rats was administered for in
the diet at doses of 0, 12, 50, 100, or 200 ppm (0, 0.6, 2.5, 5, or 10
mg/kg/day). Chronic LOEL is 5 mg/kg/day based on the increased
incidence of tremors in both sexes and possible increases in organ-to-
body weight ratios in males. Chronic NOEL is 2.5 mg/kg/day. Under the
conditions of this study, there was no evidence of carcinogenic
potential.
9. In a pilot developmental study in rats bifenthrin was
administered in the diet at dose levels of 0, 0.5, 1.0, 2.0, or 2.5 mg/
kg/day during days 6-15 of gestation. Three of 10 rats at 2.5 mg/kg/day
died on days 14-15. Tremors were noted in all 10 rats at 2.5 mg/kg/day
and in \9/10\ at 2.0 mg/kg/day. Mean bwt gains were depressed at 2.5
mg/kg/day throughout the study, and food consumption was 20 percent
lower at this dose level during days 6-13. There were no differences in
mean bwt gains or food consumption in the lower dose groups with
respect to the controls. There were no treatment-related differences
from controls in the number of implantations or litter size. The mean
number of resorptions was similar in the lower dose groups; at 2.5 mg/
kg/day it was somewhat higher, but this was attributable to an
excessive number of resorptions in a single rat. The maternal LOEL is
2.0 mg/kg/day based on sporadic tremors (gestation days 7-18) and 30
percent mortality at 2.5 mg/kg/day. The maternal NOEL is 1.0 mg/kg/day.
The developmental LOEL and NOEL were not determined; fetuses were not
examined.
10. A developmental study in rats given gavage doses of 0, 0.5,
1.0, or 2.0 mg/kg/day was administered. Developmental toxicity was
noted at 2.0 mg/kg/day and was characterized as an increased fetal and
litter incidence of hydroureter. Although not statistically
significant, the incidence of hydroureter was double that of the
vehicle control and the lower dose groups. Developmental LOEL is 2.0
mg/kg/day based on the increased fetal and litter incidence of
hydroureter. Developmental NOEL is 1.0 mg/kg/day. Maternal toxicity
NOEL was 1.0 mg/kg/day based on tremors at LOEL of 2.0 mg/kg/day.
11. A developmental study in rabbits given gavage doses of 0, 2.67,
4.0, or 8.0 mg/kg/day or with 3.0 gram/kilogram/day (g/kg/day) resulted
in no developmental toxicity observed under the conditions of the
study. The maternal NOEL is 2.67 mg/kg/day, based on head and forelimb
twitching at LOEL of 4.0 mg/kg/day. The developmental NOEL is
8.0 mg/kg/day, the highest dose tested.
12. A 2-generation reproduction study in rats fed diets containing
doses of 0, 30, 60, or 100 ppm (0, 1.5, 3 or 5 mg/kg/day). Systemic
LOEL is 5 mg/kg/day based on the incidence of tremors and marginally
lower bwts in P and F1 generation females during gestation
and lactation. Systemic NOEL is 3 mg/kg/day. A reproductive LOEL was
not observed. The reproductive NOEL is 5 mg/kg/day.
13. Animal metabolism. Metabolism studies in rats demonstrated that
distribution patterns and excretion rates in multiple oral dose studies
are similar to single-dose studies. Accumulation of unchanged compound
in fat upon chronic administration with slow elimination. Otherwise,
bifenthrin was rapidly metabolized and excreted. Unchanged bifenthrin
is the major residue component of toxicological concern in meat and
milk.
14. In a dermal absorption study, the following doses of
14C bifenthrin were administered dermally in aqueous
suspension: 49.2, 514, or 5253 g/rat. Bifenthrin is rapidly
absorbed into and through the skin, with a direct correlation between
the doses applied and the amount absorbed. Most of the label was
recovered within the skin at the application site. Average amounts of
activity absorbed at the skin site for each of the doses at the 0.5
hour sacrifice were 54.47 percent, 56.42 percent, and 52.54 percent;
and at the 24-hour sacrifice were 71.34 percent, 45.33 percent, and
53.63 percent.
15. No neurotoxicity studies are available. These studies will be
required under a special data call-in letter pursuant to section
3(c)(2)(B) of FIFRA. Although these data are lacking, EPA has
sufficient data to support these tolerances and these additional
studies will not significantly change its risk assessment.
B. Toxicological Endpoints
1. Acute toxicity. For the purposes of assessing acute dietary
risk, EPA has
[[Page 62965]]
used the maternal NOEL of 1.0 mg/kg/day from the oral developmental
toxicity study in rats. The maternal lowest effect level (LEL) of this
study is 2.0 mg/kg/day, which was based on tremors from day 7-17 of
dosing. This acute dietary endpoint is used to determine acute dietary
risks to all population subgroups.
2. Short- and intermediate-term toxicity. The maternal NOEL of 1.0
mg/kg/day from the oral developmental toxicity study in rats is also
used for short- and intermediate-term MOE calculations (as well as
acute, discussed in Unit II.B.1. of this preamble). The maternal LEL of
this study of 2.0 mg/kg/day was based on tremors from day 7-17 of
dosing, which was observed at this dose level in the pilot study. In
comparison to the other studies, tremors were observed at the earliest
time period with the lowest dose level in this study. A dermal
absorption rate of 25 percent was recommended based on the weight of
the evidence for structurally related pyrethroids. Although a 21-day
dermal study in the rabbit is available it was not used because the rat
is considered to be more sensitive than the rabbit based on comparison
of the maternal NOELs and LELs in the developmental studies.
For the inhalation endpoint, no appropriate studies were available.
EPA determined that the risk assessment should be inclusive of oral and
inhalation exposure components assuming 100 percent absorption via the
inhalation route. An aggregate oral and inhalation risk assessment is
appropriate due to the similarity in the toxicity endpoint
(neurotoxicity) seen in rats via these routes. The inhalation study
used for comparison purposes was an acute toxicity study in rats on the
25.1 percent formulation where tremors, convulsions, and loss of
hindlimb motor control was observed among other clinical signs of
toxicity.
3. Chronic toxicity. EPA has established the RfD for bifenthrin at
0.015 mg/kg/day. This RfD is based on a 1-year oral feeding study in
dogs with a NOEL of 1.5 mg/kg/day, based on intermittent tremors
observed at the LOEL of 3.0 mg/kg/day; an uncertainty factor of 100 is
used.
For chronic dermal occupational and residential exposure, EPA
recommended the NOEL of 1.5 mg/kg/day from the chronic oral study in
the dog with a dermal absorption rate of 25 percent. The LEL for the
dog study was 3.0 mg/kg/day based on intermittent tremors. The
recommended MOE is 100.
4. Carcinogenicity. Using its Guidelines for Carcinogen Risk
Assessment published September 24, 1986 (51 FR 33992) the
Carcinogenicity Peer Review Committee (CPRC) has classified bifenthrin
as a Group C chemical, possible human carcinogen, based on urinary
bladder tumors in mice, but did not recommend assignment of a cancer
potency factor Q* (Q star) for a linear quantitative cancer risk
assessment, instead, the CPRC recommended the RfD approach. Based on
CPRC's recommendation that the RfD approach be used to assess dietary
cancer risk, a quantitative linear dietary cancer risk assessment was
not performed. Human health risk concerns due to long term consumption
of bifenthrin residues are adequately addressed by the dietary risk
evaluation chronic exposure analysis using the RfD.
C. Exposures and Risks
1. From food and feed uses. Tolerances have been established (40
CFR 180.442) for the residues of bifenthrin in or on a variety of raw
agricultural commodities. Tolerances, in support of registrations,
currently exist for residues of bifenthrin on corn (grain, forage, and
fodder), cottonseed, hops, and livestock commodities. Risk assessments
were conducted by EPA to assess dietary exposures and risks from
bifenthrin as follows:
i. Acute exposure and risk. Acute dietary 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. The acute risk assessment used Monte
Carlo modeling incorporating anticipated residue and percent crop
treated refinements. The acute dietary (food only) MOE calculated at
the 99.9th percentile for the most highly exposed population subgroup
(children 1-6 years old) is 193. The MOE calculated at the 99.9th
percentile for the general U.S. population is 466. EPA concludes that
there is a reasonable certainty of no harm for MOE of 100 or greater.
Therefore, the acute dietary risk assessment for bifenthrin indicates a
reasonable certainty of no harm.
ii. Chronic exposure and risk. The chronic dietary exposure
assessment used anticipated residues and percent crop treated
information. The risk assessment resulted in use of 0.2 percent of the
RfD for the U.S. population and 0.3 percent of the most highly exposed
population subgroup (children 1-6 years old).
EPA notes that the acute dietary risk assessments used Monte Carlo
modeling (in accordance with Tier 3 of EPA June 1996 ``Acute Dietary
Exposure Assessment'' guidance document) incorporating anticipated
residues and percent crop treated refinements. The chronic dietary risk
assessment used percent crop treated information and anticipated
residues.
Section 408(b)(2)(E) authorizes EPA to consider available data and
information on the antipicated residue levels of pesticide chemicals
that have been measure in food. If EPA relies on such information, EPA
must require that data be provided 5 years after the tolerance is
established, modified or left in effect, and a demonstration must be
made to show that the levels in food are not above the levels
anticipated. Following the initial data submission, EPA is authorized
to require similar data on a time frame it deems appropriate. Section
408 (b)(2)(F) allows the Agency to use data on the actual percent of
crop treated when establishing a tolerance only where the Agency can
make the following findings:
(1) That the data used are reliable and provide a valid basis for
showing the percentage of food derived from a crop that is likely to
contain residues.
(2) That the exposure estimate does not underestimate the exposure
for any significant subpopulation.
(3) Where data on regional pesticide use and food consumption are
available, that the exposure estimate does not understate exposure for
any regional population. In addition, the Agency must provide for
periodic evaluation of any estimates used.
The percent of crop treated estimates for bifenthrin were derived
from Federal and market survey data. EPA considers these reliable. A
range of estimates are supplied by this data and the upper end of this
range was used for the exposure assessment. By using this upper end
estimate of percent of crop treated, the Agency is reasonably certain
that exposure is not understated for any significant subpopulation
group. Further, regional consumption information is taken into account
through EPA's computer-based model for evaluating the exposure of
significant subpopulations including several regional groups. Review of
this regional data allows the Agency to be reasonably certain that no
regional population is exposed to residue levels higher than those
estimated by the Agency. To meet the requirement for data on
anticipated residues, EPA will issue a Date Call-In (DCI) notice
pursuant to FFDCA section 408(f) requiring submission of data on
anticipated residues in conjunction with approval of the registration
under the FIFRA.
2. From drinking water. Laboratory and field data have demonstrated
that bifenthrin is immobile in soil and will
[[Page 62966]]
not leach into ground water. Other data show that bifenthrin is
virtually insoluble in water and extremely lipophilic. As a result, EPA
concludes that residues reaching surface waters from field runoff will
quickly absorb to sediment particles and be partitioned from the water
column. Further, a screening evaluation of leaching potential of a
typical pyrethroid was conducted using EPA's Pesticide Root Zone Model
(PRZM). Based on this screening assessment, the potential
concentrations of a pyrethroid in groundwater at depths of 1 and 2
meters are essentially zero (< 0.001="" parts="" per="" billion="" (ppb)).="" surface="" water="" concentrations="" for="" pyrethroids="" were="" estimated="" using="" przm2="" and="" exposure="" analysis="" modeling="" system="" (exams)="" using="" standard="" epa="" cotton="" runoff="" and="" mississippi="" pond="" scenarios.="" the="" maximum="" concentration="" predicted="" in="" the="" simulated="" pond="" was="" 0.052="" ppb.="" concentrations="" in="" actual="" drinking="" water="" would="" be="" much="" lower="" than="" the="" levels="" predicted="" in="" the="" hypothetical,="" small,="" stagnant="" farm="" pond="" model="" since="" drinking="" water="" derived="" from="" surface="" water="" would="" normally="" be="" treated="" before="" consumption.="" based="" on="" these="" analyses,="" the="" contribution="" of="" water="" to="" the="" dietary="" risk="" estimate="" is="" negligible.="" therefore,="" epa="" concludes="" that="" together="" these="" data="" indicate="" that="" residues="" are="" not="" expected="" to="" occur="" in="" drinking="" water.="" i.="" acute="" exposure="" and="" risk.="" the="" acute="" drinking="" water="" exposure="" and="" risk="" estimates="" are="" 0.000060="" mg/kg/day="" (moe="" 16,664)="" and="" 0.000115="" mg/kg/="" day="" (moe="" 8,658)="" for="" the="" overall="" population="" and="" non-nursing="" infants="">< 1="" year="" old="" respectively.="" ii.="" chronic="" exposure="" and="" risk.="" the="" chronic="" drinking="" water="" exposure="" and="" risk="" estimates="" are="" 0.000001="" mg/kg/day="" (0.0="" percent="" rfd="" utilized)="" and="" 0.000002="" mg/kg/day="" (0.0="" percent="" of="" rfd="" utilized)="" for="" the="" overall="" population="" and="" non-nursing="" infants="">< 1="" year="" old="" respectively.="" 3.="" from="" non-dietary="" exposure.="" bifenthrin="" is="" currently="" registered="" for="" use="" on="" the="" following="" residential="" non-food="" sites:="" general="" indoor/="" outdoor="" pest="" control,="" termiticide,="" ornamental="" plants="" and="" lawns="" around="" homes,="" park,="" recreation="" areas="" and="" athletic="" fields,="" and="" golf="" courses="" turf.="" application="" of="" this="" pesticide="" in="" and="" around="" these="" sites="" is="" mainly="" limited="" to="" commercial="" applicators.="" analyses="" were="" conducted="" which="" included="" an="" evaluation="" of="" potential="" non-dietary="" (residential)="" applicator,="" post-application="" and="" chronic="" dietary="" aggregate="" exposures="" associated="" with="" bifenthrin="" products="" used="" for="" residential="" flea="" infestation="" control="" and="" agricultural/commercial="" applications.="" the="" aggregate="" analysis="" conservatively="" assumes="" that="" a="" person="" is="" concurrently="" exposed="" to="" the="" same="" active="" ingredient="" via="" the="" use="" of="" consumer="" or="" professional="" flea="" infestation="" control="" products="" and="" to="" chronic="" level="" residues="" in="" the="" diet.="" in="" the="" case="" of="" potential="" non-dietary="" health="" risks,="" conservative="" point="" estimates="" of="" non-dietary="" exposures,="" expressed="" as="" total="" systemic="" absorbed="" dose="" (summed="" across="" inhalation="" and="" incidental="" ingestion="" routes)="" for="" each="" relevant="" product="" use="" category="" (i.e.="" lawn="" care)="" and="" receptor="" subpopulation="" (i.e.="" adults,="" children="" 1-6="" years="" old="" and="" infants="">< 1="" year="" old)="" are="" compared="" to="" the="" systemic="" absorbed="" dose="" noel="" for="" bifenthrin="" to="" provide="" estimates="" of="" the="" moes.="" based="" on="" the="" toxicity="" endpoints="" selected="" by="" epa="" for="" bifenthrin,="" inhalation="" and="" incidental="" oral="" ingestion="" absorbed="" doses="" were="" combined="" and="" compared="" to="" the="" relevant="" systemic="" noel="" for="" estimating="" moes.="" in="" the="" case="" of="" potential="" aggregate="" health="" risks,="" the="" above-="" mentioned="" conservative="" point="" estimates="" of="" inhalation="" and="" incidental="" ingestion="" non-dietary="" exposure="" (expressed="" as="" systemic="" absorbed="" dose)="" are="" combined="" with="" estimates="" (arithmetic="" mean="" values)="" of="" chronic="" average="" dietary="" (oral)="" absorbed="" doses.="" these="" aggregate="" absorbed="" dose="" estimates="" are="" also="" provided="" for="" adults,="" children="" 1-6="" years="" old="" and="" infants="">< 1="" year="" old.="" the="" combined="" or="" aggregated="" absorbed="" dose="" estimates="" (summed="" across="" non-dietary="" and="" chronic="" dietary)="" are="" then="" compared="" with="" the="" systemic="" absorbed="" dose="" noel="" to="" provide="" estimates="" of="" aggregate="" moes.="" the="" short="" and="" intermediate-term="" non-dietary="" and="" aggregate="" (non-="" dietary="" +="" chronic="" dietary="" (food="" and="" water)="" moes="" for="" bifenthrin="" indicate="" a="" substantial="" degree="" of="" safety.="" the="" total="" non-dietary="" (inhalation="" +="" incidental="" ingestion="" +="" dermal)="" moes="" for="" post-application="" exposure="" for="" the="" lawn="" care="" product="" evaluated="" was="" estimated="" to="" be=""> 51,000 for
adults, 1,900 for children 1-6 years old and 1,800 for infants < 1="" year.="" the="" aggregate="" moe="" (inhalation="" +="" incidental="" oral="" +="" dermal="" +="" chronic="" dietary,="" summed="" across="" all="" product="" use="" categories)="" was="" estimated="" to="" be="" 417="" for="" adults,="" 196="" for="" children="" 1-6="" years="" old="" and="" 200="" for="" infants="">< 1="" year="" old).="" it="" can="" be="" concluded="" that="" the="" potential="" non-dietary="" and="" aggregate="" (non-dietary="" +="" chronic="" dietary)="" exposures="" for="" bifenthrin="" are="" associated="" with="" substantial="" margins="" of="" safety.="" 4.="" cumulative="" exposure="" to="" substances="" with="" common="" mechanism="" of="" toxicity.="" section="" 408(b)(2)(d)(v)="" 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.''="" the="" agency="" believes="" that="" ``available="" information''="" in="" this="" context="" might="" include="" not="" only="" toxicity,="" chemistry,="" and="" exposure="" data="" but="" also="" scientific="" policies="" and="" methodologies="" for="" understanding="" common="" mechanisms="" of="" toxicity="" and="" conducting="" cumulative="" risk="" assessments.="" for="" most="" pesticides,="" although="" the="" agency="" has="" some="" information="" in="" its="" files="" that="" may="" turn="" out="" to="" be="" helpful="" in="" eventually="" determining="" whether="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" toxicity="" with="" any="" other="" substances,="" epa="" does="" not="" at="" this="" time="" have="" the="" methodologies="" to="" resolve="" the="" complex="" scientific="" issues="" concerning="" common="" mechanism="" of="" toxicity="" in="" a="" meaningful="" way.="" epa="" has="" begun="" a="" pilot="" process="" to="" study="" this="" issue="" further="" through="" the="" examination="" of="" particular="" classes="" of="" pesticides.="" the="" agency="" hopes="" that="" the="" results="" of="" this="" pilot="" process="" will="" increase="" the="" agency's="" scientific="" understanding="" of="" this="" question="" such="" that="" epa="" will="" be="" able="" to="" develop="" and="" apply="" scientific="" principles="" for="" better="" determining="" which="" chemicals="" have="" a="" common="" mechanism="" of="" toxicity="" and="" evaluating="" the="" cumulative="" effects="" of="" such="" chemicals.="" the="" agency="" anticipates,="" however,="" that="" even="" as="" its="" understanding="" of="" the="" science="" of="" common="" mechanisms="" increases,="" decisions="" on="" specific="" classes="" of="" chemicals="" will="" be="" heavily="" dependent="" on="" chemical="" specific="" data,="" much="" of="" which="" may="" not="" be="" presently="" available.="" although="" at="" present="" the="" agency="" does="" not="" know="" how="" to="" apply="" the="" information="" in="" its="" files="" concerning="" common="" mechanism="" issues="" to="" most="" risk="" assessments,="" there="" are="" pesticides="" as="" to="" which="" the="" common="" mechanism="" issues="" can="" be="" resolved.="" these="" pesticides="" include="" pesticides="" that="" are="" toxicologically="" dissimilar="" to="" existing="" chemical="" substances="" (in="" which="" case="" the="" agency="" can="" conclude="" that="" it="" is="" unlikely="" that="" a="" pesticide="" shares="" a="" common="" mechanism="" of="" activity="" with="" other="" substances)="" and="" pesticides="" that="" produce="" a="" common="" toxic="" metabolite="" (in="" which="" case="" common="" mechanism="" of="" activity="" will="" be="" assumed).="" epa="" does="" not="" have,="" at="" this="" time,="" available="" data="" to="" determine="" whether="" bifenthrin="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances="" or="" how="" to="" include="" this="" pesticide="" in="" acumulative="" risk="" assessment.="" unlike="" other="" pesticides="" for="" which="" epa="" has="" followed="" a="" cumulative="" risk="" approach="" based="" on="" a="" common="" mechanism="" of="" toxicity,="" bifenthrin="" does="" not="" appear="" to="" produce="" a="" toxic="" metabolite="" produced="" by="" other="" substances.="" for="" the="" purposes="" of="" this="" [[page="" 62967]]="" tolerance="" action,="" therefore,="" epa="" has="" not="" assumed="" that="" bifenthrin="" has="" a="" common="" mechanism="" of="" toxicity="" with="" other="" substances.="" d.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" u.s.="" population="" 1.="" acute="" risk.="" the="" acute="" aggregate="" risk="" assessment="" takes="" into="" account="" exposure="" from="" food="" and="" water.="" the="" acute="" aggregate="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" the="" u.s.="" population="" is="" 453.="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" a="" moe="" of="" 100="" or="" large.="" therefore,="" the="" agency="" has="" no="" acute="" aggregate="" concern="" due="" to="" exposure="" to="" bifenthrin="" through="" food="" and="" drinking="" water.="" 2.="" chronic="" risk.="" using="" the="" anticipated="" residue="" concentrations="" (arc)="" exposure="" assumptions="" described="" in="" unit="" ii.c.1.ii.="" of="" this="" preamble,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" bifenthrin="" from="" food="" and="" water="" will="" utilize="" 0.2="" percent="" of="" the="" rfd="" for="" the="" u.s.="" population.="" the="" major="" identifiable="" subgroup="" with="" the="" highest="" aggregate="" exposure="" is="" children="" 1-6="" year="" old="" (discussed="" in="" unit="" ii.f.="" of="" this="" preamble).="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100="" percent="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" therefore,="" epa="" does="" not="" expect="" the="" aggregate="" exposure="" to="" exceed="" 100="" percent="" of="" the="" rfd.="" epa="" concludes="" that="" there="" is="" a="" reasonable="" certainty="" that="" no="" harm="" will="" result="" from="" chronic="" aggregate="" exposure="" to="" bifenthrin="" residues.="" 3.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" as="" indicated="" above="" the="" non-dietary="" and="" chronic="" dietary="" moes="" was="" estimated="" to="" be="" 417="" for="" adults.="" e.="" aggregate="" cancer="" risk="" for="" u.s.="" population="" as="" indicated="" in="" unit="" ii.b.4.="" of="" this="" preamble,="" based="" on="" epa's="" recommendation="" that="" the="" rfd="" approach="" be="" used,="" a="" quantitative="" dietary="" cancer="" risk="" assessment="" was="" not="" performed.="" human="" health="" risk="" concerns="" due="" to="" long="" term="" consumption="" of="" bifenthrin="" residues="" are="" adequately="" addressed="" by="" the="" dietary="" risk="" evaluation="" chronic="" exposure="" analysis="" using="" the="" rfd.="" f.="" aggregate="" risks="" and="" determination="" of="" safety="" for="" infants="" and="" children="" 1.="" safety="" factor="" for="" infants="" and="" children--i.="" in="" general.="" in="" assessing="" the="" potential="" for="" additional="" sensitivity="" of="" infants="" and="" children="" to="" residues="" of="" bifenthrin,="" epa="" considered="" data="" from="" developmental="" toxicity="" studies="" in="" the="" rat="" and="" rabbit="" and="" a="" 2-generation="" reproduction="" study="" in="" the="" rat.="" the="" developmental="" toxicity="" studies="" are="" designed="" to="" evaluate="" adverse="" effects="" on="" the="" developing="" organism="" resulting="" from="" pesticide="" exposure="" during="" prenatal="" development="" to="" one="" or="" both="" parents.="" reproduction="" studies="" provide="" information="" relating="" to="" effects="" from="" exposure="" to="" the="" pesticide="" on="" the="" reproductive="" capability="" of="" mating="" animals="" and="" data="" on="" systemic="" toxicity.="" ffdca="" section="" 408="" provides="" that="" epa="" shall="" apply="" an="" additional="" 10-="" fold="" margin="" of="" safety="" for="" infants="" and="" children="" in="" the="" case="" of="" threshold="" effects="" to="" account="" for="" pre-="" and="" post-natal="" toxicity="" and="" the="" completeness="" of="" the="" data="" base="" unless="" epa="" determines="" that="" a="" different="" margin="" of="" safety="" will="" be="" safe="" for="" infants="" and="" children.="" margins="" of="" safety="" are="" incorporated="" into="" epa="" risk="" assessments="" either="" directly="" through="" use="" of="" a="" moe="" analysis="" or="" through="" using="" uncertainty="" (safety)="" factors="" in="" calculating="" a="" dose="" level="" that="" poses="" no="" appreciable="" risk="" to="" humans.="" epa="" believes="" that="" reliable="" data="" support="" using="" the="" standard="" moe="" and="" uncertainty="" factor="" (usually="" 100="" for="" combined="" inter-="" and="" intra-="" species="" variability)="" and="" not="" the="" additional="" 10-fold="" moe/uncertainty="" factor="" when="" epa="" has="" a="" complete="" data="" base="" under="" existing="" guidelines="" and="" when="" the="" severity="" of="" the="" effect="" in="" infants="" or="" children="" or="" the="" potency="" or="" unusual="" toxic="" properties="" of="" a="" compound="" do="" not="" raise="" concerns="" regarding="" the="" adequacy="" of="" the="" standard="" moe/safety="" factor.="" ii.="" developmental="" toxicity="" studies.="" in="" the="" rabbit="" developmental="" study,="" there="" were="" no="" developmental="" effects="" observed="" in="" the="" fetuses="" exposed="" to="" bifenthrin.="" the="" maternal="" noel="" was="" 2.67="" mg/kg/day="" based="" on="" head="" and="" forelimb="" twitching="" at="" the="" loel="" of="" 4="" mg/kg/day.="" in="" the="" rat="" developmental="" study,="" the="" maternal="" noel="" was="" 1="" mg/kg/day,="" based="" on="" tremors="" at="" the="" loel="" of="" 2="" mg/kg/day.="" the="" developmental="" (pup)="" noel="" was="" also="" 1="" mg/kg/day,="" based="" upon="" increased="" incidence="" of="" hydroureter="" at="" the="" loel="" 2="" mg/kg/day.="" there="" were="" \5/23\="" (22="" percent)="" litters="" affected="" (\5/="" 141\="" fetuses="" since="" each="" litter="" only="" had="" one="" affected="" fetus)="" in="" the="" 2="" mg/kg/day="" group,="" compared="" with="" zero="" in="" the="" control,="" 1="" and="" 0.5="" mg/kg/day="" groups.="" according="" to="" recent="" historical="" data="" (1992-1994)="" for="" this="" strain="" of="" rat,="" incidence="" of="" distended="" ureter="" averaged="" 11="" percent="" with="" a="" maximum="" incidence="" of="" 90="" percent.="" iii.="" reproductive="" toxicity="" study.="" in="" the="" rat="" reproduction="" study,="" parental="" toxicity="" occurred="" as="" decreased="" bwt="" at="" 5.0="" mg/kg/day="" with="" a="" noel="" of="" 3.0="" mg/kg/day.="" there="" were="" no="" developmental="" (pup)="" or="" reproductive="" effects="" up="" to="" 5.0="" mg/kg/day="" (highest="" dose="" tested).="" iv.="" pre-="" and="" post-natal="" sensitivity.--a.="" pre-natal.="" since="" there="" was="" not="" a="" dose-related="" finding="" of="" hydroureter="" in="" the="" rat="" developmental="" study="" and="" in="" the="" presence="" of="" similar="" incidences="" in="" the="" recent="" historical="" control="" data,="" the="" marginal="" finding="" of="" hydroureter="" in="" rat="" fetuses="" at="" 2="" mg/kg/day="" (in="" the="" presence="" of="" maternal="" toxicity)="" is="" not="" considered="" a="" significant="" developmental="" finding.="" nor="" does="" it="" provide="" sufficient="" evidence="" of="" a="" special="" dietary="" risk="" (either="" acute="" or="" chronic)="" for="" infants="" and="" children="" which="" would="" require="" an="" additional="" safety="" factor.="" b.="" post-natal.="" based="" on="" the="" absence="" of="" pup="" toxicity="" up="" to="" dose="" levels="" which="" produced="" toxicity="" in="" the="" parental="" animals,="" there="" is="" no="" evidence="" of="" special="" post-natal="" sensitivity="" to="" infants="" and="" children="" in="" the="" rat="" reproduction="" study.="" v.="" conclusion.="" the="" toxicological="" data="" base="" related="" to="" pre-="" and="" post-natal="" sensistivity="" is="" complete.="" based="" on="" the="" above,="" epa="" concludes="" that="" reliable="" data="" support="" use="" of="" the="" standard="" 100-fold="" uncertainty="" factor,="" and="" that="" an="" additional="" uncertainty="" factor="" is="" not="" needed="" to="" protect="" the="" safety="" of="" infants="" and="" children.="" 2.="" aggregate="" acute="" risk.="" the="" aggregate="" acute="" moe="" calculated="" at="" the="" 99.9th="" percentile="" for="" children="" age="" 1-6="" is="" 191.="" the="" agency="" has="" no="" cause="" for="" concern="" if="" total="" acute="" exposure="" calculated="" for="" the="" 99.9th="" percentile="" yields="" a="" moe="" of="" 100="" or="" larger.="" therefore,="" the="" agency="" has="" no="" acute="" aggregate="" concern="" due="" to="" exposure="" to="" bifenthrin="" through="" food="" and="" drinking="" water.="" 3.="" aggregate="" chronic="" risk.="" using="" the="" conservative="" exposure="" assumptions="" described="" above,="" epa="" has="" concluded="" that="" aggregate="" exposure="" to="" bifenthrin="" from="" food="" will="" utilize="" 0.3="" percent="" of="" the="" rfd="" for="" children="" 1-6="" years="" old.="" epa="" generally="" has="" no="" concern="" for="" exposures="" below="" 100="" percent="" of="" the="" rfd="" because="" the="" rfd="" represents="" the="" level="" at="" or="" below="" which="" daily="" aggregate="" dietary="" exposure="" over="" a="" lifetime="" will="" not="" pose="" appreciable="" risks="" to="" human="" health.="" 4.="" short-="" and="" intermediate-term="" risk.="" short-="" and="" intermediate-term="" aggregate="" exposure="" takes="" into="" account="" chronic="" dietary="" food="" and="" water="" (considered="" to="" be="" a="" background="" exposure="" level)="" plus="" indoor="" and="" outdoor="" residential="" exposure.="" as="" indicated="" above="" the="" non-dietary="" and="" chronic="" dietary="" moes="" was="" [[page="" 62968]]="" estimated="" to="" be="" 196="" for="" children="" 1-6="" year="" old="" and="" 200="" for="" infants="" (1="" year="" old).="" 5.="" special="" docket.="" the="" complete="" acute="" and="" chronic="" exposure="" analyses="" (including="" dietary,="" non-dietary,="" drinking="" water,="" and="" residential="" exposure,="" and="" analysis="" of="" exposure="" to="" infants="" and="" children)="" used="" for="" risk="" assessment="" purposes="" can="" be="" found="" in="" the="" special="" docket="" for="" the="" fqpa="" under="" the="" title="" ``risk="" assessment="" for="" extension="" of="" tolerances="" for="" synthetic="" pyrethroids.''="" further="" explanation="" regarding="" epa's="" decision="" regarding="" the="" additional="" safety="" factor="" can="" also="" be="" found="" in="" the="" special="" docket.="" therefore,="" it="" may="" be="" concluded="" that="" there="" is="" reasonable="" certainty="" that="" no="" harm="" will="" result="" to="" infants="" and="" children="" from="" aggregate="" exposure="" to="" bifenthrin="" residues.="" g.="" endocrine="" disruption="" epa="" is="" required="" to="" develop="" a="" screening="" program="" to="" determine="" whether="" certain="" substances="" (including="" all="" pesticides="" and="" inerts)="" ``may="" have="" an="" effect="" in="" humans="" that="" is="" similar="" to="" an="" effect="" produced="" by="" a="" naturally="" occurring="" estrogen,="" or="" such="" other="" endocrine="" effect....''="" the="" agency="" is="" currently="" working="" with="" interested="" stakeholders,="" including="" other="" government="" agencies,="" public="" interest="" groups,="" industry="" and="" research="" scientists="" in="" developing="" a="" screening="" and="" testing="" program="" and="" a="" priority="" setting="" scheme="" to="" implement="" this="" program.="" congress="" has="" allowed="" 3="" years="" from="" the="" passage="" of="" fqpa="" (august="" 3,="" 1999)="" to="" implement="" this="" program.="" at="" that="" time,="" epa="" may="" require="" further="" testing="" of="" this="" active="" ingredient="" and="" end="" use="" products="" for="" endocrine="" disrupter="" effects.="" iii.="" other="" considerations="" a.="" metabolism="" in="" plants="" and="" animals="" the="" metabolism="" of="" bifenthrin="" in="" plants="" and="" animals="" is="" adequately="" understood.="" studies="" have="" been="" conducted="" to="" delineate="" the="" metabolism="" of="" radio="" labelled="" bifenthrin="" in="" various="" crops="" and="" animals="" all="" showing="" similar="" results.="" the="" residue="" of="" concern="" is="" the="" parent="" compound="" only.="" b.="" nature="" of="" the="" residue="" nature="" of="" the="" residue="" studies="" in="" corn,="" ruminants="" and="" poultry="" for="" bifenthrin="" have="" been="" adequately="" defined.="" the="" epa="" health="" effect="" division="" (hed)="" metabolism="" committee="" concluded="" that="" only="" the="" parent="" compound="" should="" appear="" in="" the="" tolerance="" expression="" for="" corn="" grain,="" forage,="" fodder,="" ruminant,="" and="" poultry="" commodities.="" no="" special="" concern="" was="" expressed="" about="" the="" principal="" metabolite="" in="" corn,="" 4'-hydroxy="" bifenthrin.="" the="" metabolite="" typically="" is="" found="" in="" corn="" forage="" or="" fodder="" at="" about="" \1/10\="" the="" concentration="" of="" parent="" and="" is="" also="" a="" rat="" metabolite="" of="" bifenthrin.="" similarly,="" no="" concern="" was="" raised="" over="" biphenyl="" alcohol,="" the="" only="" metabolite="" predicted="" to="" be="" present="" in="" ruminant="" tissue="" in="" detectable="" concentrations.="" epa="" estimated="" that="" the="" maximum="" concentration="" of="" this="" metabolite="" in="" ruminant="" tissue="" would="" be="" 0.04="" ppm="" in="" fat.="" neither="" bifenthrin="" nor="" its="" metabolites="" are="" likely="" to="" be="" present="" in="" poultry="" and="" eggs="" in="" detectable="" concentrations.="" c.="" analytical="" enforcement="" methodology="" an="" enforcement="" method="" gas="" chromatography/electron="" capture="" detector="" (gc/ecd)="" for="" the="" determination="" of="" residues="" of="" bifenthrin="" in="" cottonseed="" has="" been="" sent="" to="" the="" fda="" for="" inclusion="" in="" pesticide="" analytical="" method="" ii="" (pam="" ii).="" additionally,="" epa="" has="" recently="" concluded="" that="" another="" method="" (method="" p-2550m,="" gc/ecd="" large="" bore="" fused="" silica="" column)="" is="" suitable="" as="" an="" enforcement="" method="" for="" the="" determination="" of="" bifenthrin="" residues="" in="" corn="" matrices.="" d.="" magnitude="" of="" residues="" crop="" field="" trial="" residue="" data="" from="" studies="" conducted="" at="" the="" maximum="" label="" rates="" for="" cotton,="" corn="" (field,="" seed,="" pop),="" strawberries,="" and="" hops="" show="" that="" the="" established="" bifenthrin="" tolerances="" on="" cottonseed="" of="" 0.5="" ppm,="" corn,="" grain="" (field,="" seed,="" and="" pop)="" of="" 0.05="" ppm,="" corn,="" fodder="" of="" 5.0="" ppm,="" corn,="" forage="" of="" 2.0="" ppm,="" strawberries="" of="" 3.0="" ppm,="" and="" hops,="" dried="" of="" 10.0="" ppm="" will="" not="" be="" exceeded="" when="" the="" bifenthrin="" products="" labeled="" for="" these="" uses="" are="" used="" as="" directed.="" f.="" international="" residue="" limits="" codex="" maximum="" residue="" levels="" (mrls)="" for="" bifenthrin="" have="" been="" established="" which="" are="" in="" harmony="" with="" the="" u.s.="" tolerances="" for="" cattle="" meat="" (0.5="" ppm),="" corn="" grain="" (0.05="" ppm),="" poultry="" fat="" (0.05="" ppm),="" poultry="" meat="" (0.05="" ppm),="" and="" poultry="" meat="" byproducts="" (0.05="" ppm).="" codex="" mrls="" have="" been="" established="" which="" exceed="" the="" u.s.="" tolerances="" for="" horse="" fat="" (10.0="" vs.="" 1.0="" ppm).="" codex="" mrls="" have="" been="" established="" which="" are="" below="" their="" u.s.="" counterparts="" for="" cattle="" fat="" (0.5="" vs="" 1.0="" ppm),="" cattle="" meat="" byproducts="" (0.05="" vs.="" 0.10="" ppm),="" corn="" forage="" (0.05="" vs.="" 2.0="" ppm),="" corn="" fodder="" (0.2="" vs.="" 5.0="" ppm),="" eggs="" (0.01="" vs.0.05="" ppm),="" and="" whole="" milk="" (0.05="" vs.="" 0.1="" ppm).="" as="" indicated="" above="" there="" are="" differences="" between="" the="" section="" 408="" tolerances="" and="" the="" codex="" mrl="" values="" for="" specific="" commodities.="" these="" differences="" could="" be="" caused="" by="" differences="" in="" methods="" used="" to="" establish="" tolerances,="" calculate="" animal="" feed="" dietary="" exposure,="" and="" as="" a="" result="" of="" different="" agricultural="" practices.="" epa="" will="" specifically="" address="" these="" differences="" when="" the="" pesticides="" are="" reregistered="" and="" the="" tolerances="" made="" permanent.="" no="" canadian="" mrls="" have="" been="" established="" for="" residues="" of="" bifenthrin.="" mexico="" has="" established="" a="" tolerance="" for="" residues="" of="" bifenthrin="" on="" cottonseed="" (0.5="" ppm)="" which="" is="" in="" harmony="" with="" the="" u.s.="" tolerance.="" iv.="" conclusion="" therefore,="" tolerances="" are="" established="" for="" bifenthrin="" (2-methyl="" [1,1'-biphenyl]-3-yl)="" methyl-3-(2-chloro-3,3,3,-trifluoro-1-propenyl)-="" 2,2-dimethylcyclopropanecarboxylate="" in="" or="" on="" cottonseed="" at="" 0.5="" ppm;="" corn,="" grain="" (field,="" seed,="" and="" pop)="" at="" 0.05="" ppm;="" corn,="" forage="" at="" 2.0="" ppm;="" corn,="" fodder="" at="" 5.0="" ppm;="" hops,="" dried="" at="" 10.0="" ppm;="" fat="" of="" cattle,="" goat,="" hogs,="" horses,="" and="" sheep="" at="" 1.0="" ppm;="" meat="" of="" cattle,="" goat,="" hogs,="" horses,="" and="" sheep="" at="" 0.5="" ppm;="" meat="" and="" meat="" by-products="" (mbyp)="" of="" cattle,="" goat,="" hogs,="" horses,="" and="" sheep="" at="" 0.10="" ppm,="" eggs="" at="" 0.05="" ppm;="" milk,="" fat="" (reflecting="" 0.1="" ppm="" in="" whole="" milk),="" poultry,="" fat="" at="" 0.05="" ppm,="" poultry,="" meat="" at="" 0.05="" ppm,="" and="" poultry="" mbyp="" at="" 0.10="" ppm.="" v.="" objections="" and="" hearing="" requests="" the="" new="" ffdca="" section="" 408(g)="" provides="" essentially="" the="" same="" process="" for="" persons="" to="" ``object''="" to="" a="" tolerance="" regulation="" issued="" by="" epa="" under="" new="" section="" 408(e)="" and="" (l)(6)="" as="" was="" provided="" in="" the="" old="" section="" 408="" and="" in="" section="" 409.="" however,="" the="" period="" for="" filing="" objections="" is="" 60="" days,="" rather="" than="" 30="" days.="" epa="" currently="" has="" procedural="" regulations="" which="" govern="" the="" submission="" of="" objections="" and="" hearing="" requests.="" these="" regulations="" will="" require="" some="" modification="" to="" reflect="" the="" new="" law.="" however,="" until="" those="" modifications="" can="" be="" made,="" epa="" will="" continue="" to="" use="" those="" procedural="" regulations="" with="" appropriate="" adjustments="" to="" reflect="" the="" new="" law.="" any="" person="" may,="" by="" january="" 26,="" 1998="" file="" written="" objections="" to="" any="" aspect="" of="" this="" regulation="" and="" may="" also="" request="" a="" hearing="" on="" those="" objections.="" objections="" and="" hearing="" requests="" must="" be="" filed="" with="" the="" hearing="" clerk,="" at="" the="" address="" given="" above="" (40="" cfr="" 178.20).="" a="" copy="" of="" the="" objections="" and/or="" hearing="" requests="" filed="" with="" the="" hearing="" clerk="" should="" be="" submitted="" to="" the="" opp="" docket="" for="" this="" rulemaking.="" the="" objections="" submitted="" must="" specify="" the="" provisions="" of="" the="" regulation="" deemed="" objectionable="" and="" the="" grounds="" for="" the="" objections="" (40="" cfr="" 178.25).="" each="" objection="" must="" be="" accompanied="" by="" the="" fee="" prescribed="" by="" [[page="" 62969]]="" 40="" cfr="" 180.33(i).="" if="" a="" hearing="" is="" requested,="" the="" objections="" must="" include="" a="" statement="" of="" the="" factual="" issues="" on="" which="" a="" hearing="" is="" requested,="" the="" requestor's="" contentions="" on="" such="" issues,="" and="" a="" summary="" of="" any="" evidence="" relied="" upon="" by="" the="" requestor="" (40="" cfr="" 178.27).="" a="" request="" for="" a="" hearing="" will="" be="" granted="" if="" the="" administrator="" determines="" that="" the="" material="" submitted="" shows="" the="" following:="" there="" is="" genuine="" and="" substantial="" issue="" of="" fact;="" there="" is="" a="" reasonable="" possibility="" that="" available="" evidence="" identified="" by="" the="" requestor="" would,="" if="" established,="" resolve="" one="" or="" more="" of="" such="" issues="" in="" favor="" of="" the="" requestor,="" taking="" into="" account="" uncontested="" claims="" or="" facts="" to="" the="" contrary;="" and="" resolution="" of="" the="" factual="" issues="" in="" the="" manner="" sought="" by="" the="" requestor="" would="" be="" adequate="" to="" justify="" the="" action="" requested="" (40="" cfr="" 178.32).="" information="" submitted="" in="" connection="" with="" an="" objection="" or="" hearing="" request="" may="" be="" claimed="" confidential="" by="" marking="" any="" part="" or="" all="" of="" that="" information="" as="" confidential="" business="" information="" (cbi).="" information="" so="" marked="" will="" not="" be="" disclosed="" except="" in="" accordance="" with="" procedures="" set="" forth="" in="" 40="" cfr="" part="" 2.="" a="" copy="" of="" the="" information="" that="" does="" not="" contain="" cbi="" must="" be="" submitted="" for="" inclusion="" in="" the="" public="" record.="" information="" not="" marked="" confidential="" may="" be="" disclosed="" publicly="" by="" epa="" without="" prior="" notice.="" vi.="" public="" record="" and="" electronic="" submissions="" epa="" has="" established="" a="" record="" for="" this="" rulemaking="" under="" docket="" control="" number="" [opp-300579]="" (including="" any="" comments="" and="" data="" submitted="" electronically).="" a="" public="" version="" of="" this="" record,="" including="" printed,="" paper="" versions="" of="" electronic="" comments,="" which="" does="" not="" include="" any="" information="" claimed="" as="" cbi,="" is="" available="" for="" inspection="" from="" 8:30="" a.m.="" to="" 4="" p.m.,="" monday="" through="" friday,="" excluding="" legal="" holidays.="" the="" public="" record="" is="" located="" in="" room="" 1132="" of="" the="" public="" information="" and="" records="" integrity="" branch,="" information="" resources="" and="" services="" division="" (7502c),="" office="" of="" pesticide="" programs,="" environmental="" protection="" agency,="" crystal="" mall="" #2,="" 1921="" jefferson="" davis="" highway,="" arlington,="" va.="" electronic="" comments="" may="" be="" sent="" directly="" to="" epa="" at:="">opp-docket@epamail.epa.gov.
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer any copies of objections and hearing requests
received electronically into printed, paper form as they are received
and will place the paper copies in the official rulemaking record which
will also include all comments submitted directly in writing. The
official rulemaking record is the paper record maintained at the
Virginia address in ``ADDRESSES'' at the beginning of this document.
VII. Regulatory Assessment Requirements
This final rule establishes tolerances under FFDCA section 408(d)
in response to petitions submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). 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., or impose any enforceable
duty or contain any unfunded mandate as described under Title II of the
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does
it require any prior consultation as specified by Executive Order
12875, entitled Enhancing the Intergovernmental Partnership (58 FR
58093, October 28, 1993), or special considerations as required by
Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994), or require OMB review in
accordance with Executive Order 13045, entitled Protection of Children
from Environmental Health Risks and Safety Risks (62 FR 19885, April
23, 1997).
In addition, since these tolerances are established on the basis of
a petition under FFDCA section 408(d), such as the tolerances 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. Nevertheless, the Agency has previously assessed
whether establishing tolerances, exemptions from tolerances, raising
tolerance levels or expanding exemptions might adversely impact small
entities and concluded, as a generic matter, that there is no adverse
economic impact. The factual basis for the Agency's generic
certification for tolerance actions published on May 4, 1981 (46 FR
24950), and was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
VIII. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted 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 General Accounting Office prior to publication of this rule in
today's Federal Register. This 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: November 14, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. Section 180.442 is amended by revising paragraph (a) and
removing the entire entry for ``Raspberries'' in the table in paragraph
(b) to read as follows:
Sec. 180.442 Bifenthrin; tolerances for residues.
(a) General. Tolerances are established for residues of bifenthrin
(2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate in or on the raw
agricultural commodities:
------------------------------------------------------------------------
Commodity Parts per million
------------------------------------------------------------------------
Cattle, fat.................................... 1.0
Cattle, mbyp................................... 0.10
Cattle, meat................................... 0.5
Corn, fodder................................... 5.0
Corn, forage................................... 2.0
Corn, grain (field, seed, and pop)............. 0.05
Cottonseed..................................... 0.5
Eggs........................................... 0.05
Goats, fat..................................... 1.0
Goats, mbyp.................................... 0.10
Goats, meat.................................... 0.5
Hogs, fat...................................... 1.0
Hogs, mbyp..................................... 0.10
Hogs, meat..................................... 0.5
Hops, dried.................................... 10.0
Horses, fat.................................... 1.0
Horses, mby.................................... 0.10
[[Page 62970]]
Horses, meat................................... 0.5
Milk, fat (reflecting 0.1 ppm in whole milk)... 1.0
Poultry, fat................................... 0.05
Poultry, mbyp.................................. 0.05
Poultry, meat.................................. 0.05
Sheep, fat..................................... 1.0
Sheep, mbyp.................................... 0.1
Sheep, meat.................................... 0.5
Strawberries................................... 3.0
------------------------------------------------------------------------
* * * * *
[FR Doc. 97-30948 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F
