[Federal Register Volume 62, Number 172 (Friday, September 5, 1997)]
[Rules and Regulations]
[Pages 46894-46900]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-23720]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300543; FRL-5740-6]
RIN 2070-AB78


Bifenthrin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of bifenthrin in or on canola seed. This action is in response 
to EPA's granting of an emergency exemption under section 18 of the 
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of 
the pesticide on canola in Idaho, Oregon, and Washington. This 
regulation establishes a maximum permissible level for residues of 
bifenthrin in this food commodity pursuant to section 408(l)(6) of the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996. The tolerance will expire and is revoked on 
September 30, 1998.

DATES: This regulation is effective September 5, 1997. Objections and 
requests for hearings must be received by EPA on or before November 4, 
1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300543], 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-300543], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7506C), 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-300543]. 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: Andrea Beard, 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) 308-9356, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: EPA, on its own initiative, pursuant to 
section 408(e) and (l)(6) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a(e) and (l)(6), is establishing a tolerance for 
residues of the insecticide bifenthrin, in or on canola seed at 0.5 
part per million (ppm). This tolerance will expire and is revoked on 
September 30, 1998. EPA will publish a document in the Federal Register 
to remove the revoked tolerance from the Code of Federal Regulations.

I. Background and Statutory Authority

    The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170) 
was signed into law August 3, 1996. FQPA amends both the Federal Food, 
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal 
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et 
seq. The FQPA amendments went into effect immediately. Among other 
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting 
activities under a new section 408 with a new

[[Page 46895]]

safety standard and new procedures. These activities are described 
below and discussed in greater detail in the final rule establishing 
the time-limited tolerance associated with the emergency exemption for 
use of propiconazole on sorghum (61 FR 58135, November 13, 1996)(FRL-
5572-9).
    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....''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' This provision was not 
amended by FQPA. EPA has established regulations governing such 
emergency exemptions in 40 CFR part 166.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment.
    Because decisions on section 18-related tolerances must proceed 
before EPA reaches closure on several policy issues relating to 
interpretation and implementation of the FQPA, EPA does not intend for 
its actions on such tolerance to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemption for Bifenthrin on Canola and FFDCA 
Tolerances

    The Applicants state that the events which brought about this 
emergency situation started in 1992, when significant numbers of 
cabbage aphid were first noted on the canola crop. Since then, numbers 
of this pest have continued to build to where economic damage has 
occurred in affected areas where bifenthrin was not applied. Registered 
materials do not adequately control aphids in canola, and several have 
the additional disadvantage of toxicity to beneficials. This situation 
has been especially severe during the years with mild wet winters, 
which allow high aphid carryover from the previous year, and delay 
planting so that flowering of the canola occurs when aphid populations 
are at their peak. EPA has authorized use of bifenthrin on canola for 
this situation for the past 2 years. EPA has authorized under FIFRA 
section 18 the use of bifenthrin on canola for control of aphids in 
Idaho, Oregon, and Washington. After having reviewed the submission, 
EPA concurs that emergency conditions exist for these states.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of bifenthrin in or on 
canola. In doing so, EPA considered the new safety standard in FFDCA 
section 408(b)(2), and EPA decided that the necessary tolerance under 
FFDCA section 408(l)(6) would be consistent with the new safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemption in order to address an urgent non-
routine situation and to ensure that the resulting food is safe and 
lawful, EPA is issuing this tolerance without notice and opportunity 
for public comment under section 408(e), as provided in section 
408(l)(6). Although this tolerance will expire and is revoked on 
September 30, 1998, under FFDCA section 408(l)(5), residues of the 
pesticide not in excess of the amounts specified in the tolerance 
remaining in or on canola seed after that date will not be unlawful, 
provided the pesticide is applied in a manner that was lawful under 
FIFRA. EPA will take action to revoke this tolerance earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because this tolerance is being approved under emergency conditions 
EPA has not made any decisions about whether bifenthrin meets EPA's 
registration requirements for use on canola or whether a permanent 
tolerance for this use would be appropriate. Under these circumstances, 
EPA does not believe that this tolerance serves as a basis for 
registration of bifenthrin by a State for special local needs under 
FIFRA section 24(c). Nor does this tolerance serve as the basis for any 
State other than Idaho, Oregon, and Washington to use this pesticide on 
this crop under section 18 of FIFRA without following all provisions of 
section 18 as identified in 40 CFR part 166. For additional information 
regarding the emergency exemption for bifenthrin, contact the Agency's 
Registration Division at the address provided above.

III. Risk Assessment and Statutory Findings

    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

[[Page 46896]]

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 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 3 
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% 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.
    Percent of crop treated estimates are derived from Federal and 
private market survey data. Typically, a range of estimates are 
supplied and the upper end of this range is assumed 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, to pesticide residues. For this 
pesticide, the most highly exposed population subgroup (Non-Nursing 
Infants, less than 1 year old) was not regionally based.

IV. 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), for a time-limited tolerance for 
residues of bifenthrin on canola seed at 0.5 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.

[[Page 46897]]

    1. Acute toxicity. The maternal NOEL of 1 mg/kg/day from the oral 
developmental toxicity study in rats is used for acute dietary risk 
assessments. The maternal LOEL of this study of 2 mg/kg/day was based 
on tremors from day 7-17 of dosing. This acute dietary endpoint is used 
to estimate dietary risks to all population subgroups.
     2. Short - and intermediate - term toxicity. The maternal NOEL of 
1 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 IV.A.1. above).
    3. Chronic toxicity. EPA has established the RfD for bifenthrin at 
0.015 milligrams/kilogram/day (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 at the LOEL of 3 mg/kg/day; an uncertainty factor 
of 100 is used.
    4. Carcinogenicity. OPP has classified bifenthrin as a Group C 
chemical (possible human carcinogen) based upon urinary bladder tumors 
in mice, but did not recommend assignment of a Q*.

B. 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 hops; strawberries; corn 
grain, forage, and fodder; cotton seed; and livestock commodities of 
cattle, goats, hogs, horses, sheep, and poultry. Additionally, time-
limited tolerances associated with emergency exemptions were recently 
established for broccoli, cauliflower, raspberries, and cucurbits. 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 one day or single exposure. [The acute risk assessment used 
anticipated residues for all commodities having bifenthrin tolerances, 
except for cucurbits and raspberries, for which tolerance level 
residues were used. For the most highly exposed population subgroup, 
children 1-6 years old, the resulting high-end exposure results in a 
dietary (food only) MOE of 33; at the 97th percentile the MOE is 111. 
For infants < 1 year old, the high-end exposure MOE is 50; at the 98th 
percentile it is 111. For the overall U.S. population, the high-end 
exposure MOE is 50; at the 99th percentile it is 111. The major portion 
of the estimated dietary exposure from bifenthrin is contributed 
through the tolerances for field corn and secondary residues in animal 
commodities resulting from feeding of the treated field corn. This 
assessment used the extremely conservative assumption that 100% of the 
field corn and livestock commodities would contain residues of 
bifenthrin. However, available data show that of the total field corn 
crop grown in the United States, only about 0.45 percent was actually 
treated with bifenthrin in 1994-96 (3-year average); it is expected 
that a similar percentage will be treated for the current year (1997), 
since this figure has generally remained consistent for the past 3 
years. Therefore, it is likely that the actual exposure is considerably 
less than the conservative estimates given here; if these estimates 
were refined using the Monte Carlo technique and incorporating actual 
percent of crop treated figures, EPA scientists believe that the MOEs 
would be increased to acceptable levels for the high-end consumer.
    ii. Short- and intermediate-term risk. The short- and intermediate-
term risk assessment used maximum anticipated residue levels for 
cotton, extrapolated residue levels for meat/milk/poultry/eggs, and air 
monitoring data collected from 15 homes in four states. Based on this 
data, the MOEs for children are calculated to be 280 for the average 
consumer and 250 for the high-end consumer. The MOEs for adults are 
calculated to be 450 for the average consumer and 390 for the high-end 
consumer. EPA generally has no concern for MOEs greater than 100, and 
thus these do not exceed EPA's level of concern.
    iii. Chronic exposure and risk. The chronic dietary (food only) 
risk assessment for bifenthrin was conducted using the extremely 
conservative TMRC exposure assumptions that 100% of canola commodities 
and all other commodities having bifenthrin tolerances will contain 
bifenthrin residues at tolerance levels. Based on this, EPA has 
concluded that dietary exposure to bifenthrin will utilize 29 percent 
of the RfD for the Overall US Population (4 percent of this attributed 
to canola). The major identifiable subgroup with the highest exposure 
is Non-Nursing Infants < 1 year old, at 62 percent of the RfD. This is 
further discussed below in the section on infants and children. EPA 
generally has no concern for exposure 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. Despite the potential for exposure to bifenthrin in 
drinking water, 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.
    2. From drinking water.  Because the Agency lacks sufficient water-
related exposure data to complete a comprehensive drinking water risk 
assessment for many pesticides, EPA has commenced and nearly completed 
a process to identify a reasonable yet conservative bounding figure for 
the potential contribution of water-related exposure to the aggregate 
risk posed by a pesticide. In developing the bounding figure, EPA 
estimated residue levels in water for a number of specific pesticides 
using various data sources. The Agency then applied the estimated 
residue levels, in conjunction with appropriate toxicological endpoints 
(RfD's or acute dietary NOEL's) and assumptions about body weight and 
consumption, to calculate, for each pesticide, the increment of 
aggregate risk contributed by consumption of contaminated water. While 
EPA has not yet pinpointed the appropriate bounding figure for exposure 
from contaminated water, the ranges the Agency is continuing to examine 
are all below the level that would cause bifenthrin to exceed the RfD 
if the tolerance being considered in this document were granted. The 
Agency has therefore concluded that the potential exposures associated 
with bifenthrin in water, even at the higher levels the Agency is 
considering as a conservative upper bound, would not prevent the Agency 
from determining that there is a reasonable certainty of no harm if the 
tolerance is granted.
    3. From non-dietary exposure. Bifenthrin is currently only 
registered for residential non-food use as a termiticide. Based on 
information referred to above regarding short- and intermediate-term 
exposure, this use is not expected to result in risks that exceed 
levels of concern. Therefore, reasonable certainty of no harm is 
expected from exposure through non-dietary, non-occupational routes.
    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

[[Page 46898]]

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 a cumulative 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 tolerance action, therefore, 
EPA has not assumed that bifenthrin has a common mechanism of toxicity 
with other substances.

C. Aggregate Risks and Determination of Safety for U.S. Population

    1. Acute risk. For the overall U.S. population, the calculated MOE 
value (for food only) is 50. For the most highly exposed subgroup, 
children 1 - 6 years old, the MOE for food is 33. As stated above, EPA 
believes that with percent of crop treated (particularly for field 
corn, the major contributor) incorporated in a Monte Carlo analysis, 
MOEs for all population subgroups will be acceptable. Although 
theoretically there is the potential for exposure to bifenthrin in 
drinking water, EPA does not expect that exposure would result in 
aggregate MOEs (food plus water) that would exceed the levels of 
concern for acute dietary exposure. Therefore, EPA concludes that there 
is reasonable certainty that no harm will result from acute exposure to 
bifenthrin.
    2. Chronic risk. Using the TMRC exposure assumptions described 
above, EPA has concluded that aggregate exposure to bifenthrin from 
food will utilize 29 of the RfD for the U.S. population. The major 
identifiable subgroup with the highest aggregate exposure is non-
nursing infants < 1 year old, discussed below. EPA generally has no 
concern for exposures below 100% 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. Despite the 
potential for exposure to bifenthrin in drinking water and from non-
dietary, non-occupational exposure, EPA does not expect the aggregate 
exposure to exceed 100% 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. Based on bifenthrin not being registered for 
indoor residential or pet uses, EPA concludes that the aggregate short- 
and intermediate-term risks do not exceed levels of concern, and that 
there is reasonable certainty that no harm will result.

D. 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 two-
generation reproduction study in the rat. The developmental toxicity 
studies are designed to evaluate adverse effects on the developing 
organism resulting from maternal pesticide exposure during gestation. 
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 
tenfold 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 database 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 100-
fold safety factor (usually 100 for combined inter- and intra-species 
variability)) and not the additional tenfold safety 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 of 2 mg/kg/day. There were 5/23 (22%) of the 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, background incidence of distended ureter averaged 11% with a 
maximum incidence of 90%.
    iii. Reproductive toxicity study. In the rat reproduction study, 
parental toxicity occurred as decreased body weight 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).

[[Page 46899]]

    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. 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. Acute risk. EPA believes that residential exposures are more 
appropriately included in the short-term exposure scenario, and thus 
estimates acute risk from dietary exposure only. EPA concluded that 
aggregate dietary acute risk (food plus water) would not exceed levels 
of concern. This is discussed in greater detail above.
    3. Chronic risk. Using the conservative exposure assumptions 
described above, EPA has concluded that aggregate exposure to 
bifenthrin from food will utilize from 20 to 62 percent of the RfD for 
infants and children. EPA generally has no concern for exposures below 
100% 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. Despite the potential for exposure 
to bifenthrin in drinking water and from non-dietary, non-occupational 
exposure, EPA does not expect the aggregate exposure to exceed 100% of 
the RfD. EPA concludes that there is a reasonable certainty that no 
harm will result to infants and children from aggregate exposure to 
bifenthrin residues.
    4. Short- or intermediate-term risk. The estimated short- and 
intermediate-term risks do not exceed EPA's levels of concern for 
children. MOEs for children are calculated to be 280 for the average 
consumer and 250 for the high-end consumer, discussed in greater detail 
above.

V. Other Considerations

A. Metabolism In Plants and Animals

    The metabolism of bifenthrin in canola is adequately understood for 
the purposes of these tolerances. The residue of concern is the parent 
compound only.

B. Analytical Enforcement Methodology

    There is a practical analytical method for detecting and measuring 
levels of bifenthrin in or on food with a limit of detection that 
allows monitoring of food with residues at or above the levels set in 
this tolerance document (Gas chromatography with Electron Capture 
Detection, analytical method P-2132M, PP#0E3921; MRID#41658601). EPA 
has provided information on this method to Food and Drug 
Administration. The method is available to anyone who is interested 
from OPP's Health Effects Division, 7509C Office of Pesticide Programs, 
Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.

C. Magnitude of Residues

    Residues of bifenthrin are not likely to exceed 0.5 ppm in or on 
canola seed, meal , and refined oil as a result of the proposed use. 
Secondary residues in animal commodities are not expected to exceed 
already established tolerances.

D. International Residue Limits

    There are no Codex, Canadian, or Mexican residue limits for 
residues of bifenthrin in or on canola seed, meal, or refined oil.

E. Rotational Crop Restrictions

    The confined rotational crop data requirements for bifenthrin have 
been satisfied. The following rotation instructions are required: (1) 
Leafy vegetables and root crops may be rotated 30 days following the 
final application of bifenthrin; (2) Crops for which bifenthrin 
tolerances exist may be rotated at any time; and (3) All other crops 
may be rotated 7 months following the final application of bifenthrin .

VI. Conclusion

    Therefore, the tolerance is established for residues of bifenthrin 
in canola seed at 0.5 ppm.

VII. 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 November 4, 1997, 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 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.

VIII. Public Record

    EPA has established a record for this rulemaking under docket 
control number [OPP-300543] (including any comments and data submitted 
electronically). A public version of this

[[Page 46900]]

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 (7506C), 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.

IX. Regulatory Assessment Requirements

    This final rule establishes a time-limited tolerance under FFDCA 
section 408(d). 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 and exemptions that are 
established under FFDCA section 408 (l)(6), such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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.

X. 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: August 26, 1997.

Peter Caulkins,

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. In Sec. 180.442, by alphabetically inserting the following item 
into the table in paragraph (b) to read as follows:


Sec. 180.442  Bifenthrin; tolerances for residues.

*       *        *       *       *
    (b) *    *    *

                                                                        
------------------------------------------------------------------------
                                                          Expiration/   
            Commodity              Parts per million    Revocation Date 
------------------------------------------------------------------------
Canola, Seed....................  0.5                 9/30/98           
                                                                        
         *        *        *        *        *        *        *        
------------------------------------------------------------------------

*       *        *       *       *

[FR Doc. 97-23720 Filed 9-4-97; 8:45 am]
BILLING CODE 6560-50-F