[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: [email protected]. 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: 
[email protected].

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:
    [email protected].


    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
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*    *    *    *    *

[FR Doc. 97-30948 Filed 11-25-97; 8:45 am]
BILLING CODE 6560-50-F