[Federal Register Volume 62, Number 109 (Friday, June 6, 1997)]
[Rules and Regulations]
[Pages 30996-31002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-14721]



[[Page 30996]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300495; FRL-5719-3]
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 time-limited tolerances for 
residues of the pesticide bifenthrin in or on the raw agricultural 
commodity crop group, cucurbits (Crop Group 9 - cucumbers, melons, and 
squash), and in or on the raw agricultural commodity raspberries, in 
connection with EPA's granting of emergency exemptions under section 18 
of the Federal Insecticide, Fungicide, and Rodenticide Act authorizing 
use of bifenthrin on cucurbits in California, Arizona, and Texas; and 
use of bifenthrin on raspberries in Oregon and Washington. This 
regulation establishes maximum permissible levels for residues of 
bifenthrin on these commodities pursuant to section 408(l)(6) of the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996. These tolerances will expire and are revoked on 
April 30, 1998 (cucurbits) and September 30, 1997 (raspberries).

DATES: This regulation becomes effective June 6, 1997. Objections and 
requests for hearings must be received by EPA on August 5, 1997.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300495], 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 
document control number, [OPP ], should 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-300495]. 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 (7505W), Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail: 
Sixth Floor, Crystal Station #1, 2800 Jefferson Davis Highway, 
Arlington, VA 22202. (703) 308-8791, 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 tolerances for 
residues of the pesticide ((2-methyl  [1,1'-biphenyl]-3-yl)  methyl-3-
(2-chloro-3,3,3,-trifluoro-1-propenyl)  -2,2-
dimethylcyclopropanecarboxylate), also referred to in this document as 
bifenthrin, in or on cucurbits at 1.0 ppm, and in or on raspberries at 
3.0 ppm. These tolerances will expire and be revoked on April 30, 1998 
(cucurbits) and September 30, 1997 (raspberries). EPA will publish 
documents in the Federal Register to remove the revoked tolerances 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 FFDCA, 21 
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. Among other things, FQPA 
amends FFDCA to bring all EPA pesticide tolerance-setting activities 
under a new section 408 with a new 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) 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 tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.

II. Emergency Exemptions for Bifenthrin and FFDCA Tolerances

    Bifenthrin on cucurbits. From November 1996 - January 1997, 
requests were received from the California Department of Pesticide 
Regulation, and the Arizona and Texas Departments of Agriculture, 
(hereafter referred to as the Applicants) for specific exemptions under 
FIFRA section 18 for the use of

[[Page 30997]]

bifenthrin to control whiteflies in cucurbits. The Applicants state 
that an emergency situation is present due to this recently introduced 
pest, its devastating effects on the cucurbit crop, and its resistance 
to registered alternatives. The Applicants state that this pest can 
have devastating effects on growers' production and revenue. After 
having reviewed their submission, EPA concurs that an emergency 
condition exists. EPA has authorized under FIFRA section 18, the use of 
bifenthrin on cucurbits for control of whiteflies.
    Bifenthrin on raspberries. In February 1997, requests were received 
from the Oregon and Washington Departments of Agriculture (hereafter 
referred to as the Applicants) for specific exemptions under FIFRA 
section 18 for the use of bifenthrin to control weevils in raspberries. 
The Applicants state that an emergency situation is present due to 
these pests developing resistance to available alternatives, and the 
low tolerance for weevil contamination in raspberries. Rejection by the 
processors of contaminated raspberries can lead to significant losses 
in revenue for the growers. After having reviewed their submission, EPA 
concurs that an emergency condition exists. EPA has authorized under 
FIFRA section 18, the use of bifenthrin on raspberries for control of 
weevils.
    As part of its assessment of these emergency exemptions, EPA 
assessed the potential risks presented by residues of bifenthrin in or 
on cucurbits and raspberries. In doing so, EPA considered the new 
safety standard in FFDCA section 408(b)(2), and EPA decided that the 
necessary tolerances under FFDCA section 408(l)(6) would be consistent 
with the new safety standard and with FIFRA section 18. These 
tolerances for bifenthrin will permit the marketing of cucurbits and 
raspberries treated in accordance with the provisions of the section 18 
emergency exemptions. Consistent with the need to move quickly on the 
emergency exemptions, in order to address urgent non-routine 
situations, and to ensure that the resulting food is safe and lawful, 
EPA is issuing these tolerances without notice and opportunity for 
public comment under section 408(e) as provided in section 408(l)(6). 
Although these tolerances will expire and are revoked on April 30, 1998 
(cucurbits) and September 30, 1997 (raspberries), under FFDCA section 
408(l)(5), residues of bifenthrin not in excess of the amount specified 
in the tolerances remaining in or on cucurbits or raspberries after the 
dates specified above will not be unlawful, provided the pesticide is 
applied during the term of, and in accordance with all the conditions 
of, the emergency exemptions. EPA will take action to revoke these 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    EPA has not made any decisions about whether bifenthrin meets the 
requirements for registration under FIFRA section 3 for use on 
cucurbits and raspberries, or whether permanent tolerances for these 
uses would be appropriate. This action by EPA does not serve as a basis 
for registration of bifenthrin by a State for special local needs under 
FIFRA section 24(c). Nor does this action serve as the basis for any 
State other than those specified in this document to use this product 
on cucurbits or raspberries under section 18 of FIFRA without following 
all provisions of section 18 as identified in 40 CFR 180.166. For 
additional information regarding the emergency exemptions, 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. For many 
of these 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% 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 
hundredfold MOE is based on the same rationale as the hundredfold 
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.
    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, and other non-
occupational exposures, such as where residues leach into 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. 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

[[Page 30998]]

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.

IV. Aggregate Risk Assessment and Determination of Safety

A. Toxicological Profile

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
these actions. EPA has evaluated the available toxicology data and 
considered its validity, completeness, and reliability as well as the 
relationship of the result 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 risk. The maternal NOEL of 1 mg/kg/day from the oral 
developmental toxicity study in rats is used for acute dietary risk 
estimates. The maternal LEL 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 
determine acute dietary risks to all population subgroups.
    2.  Short- and intermediate-term risk. 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 (1) above). The maternal LEL of this study of 2 mg/kg/day 
was based on tremors from day 7-17 of dosing.
    3. Chronic risk. Based on available chronic toxicity data, the OPP 
has established the RfD for bifenthrin at 0.015 mg/kg/day. The RfD is 
based on a 1-year oral feeding study in dogs with a NOEL of 1.5 mg/kg/
day and an uncertainty factor of 100, based on intermittent tremors 
observed at the LEL of 3 mg/kg/day.
    4. Cancer risk. OPP 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. Aggregate Exposure

    In examining aggregate exposure, FQPA directs EPA to consider 
available information concerning exposures from the pesticide residue 
in food and all other non-occupational exposures. The primary non-food 
sources of exposure the Agency looks at include drinking water (whether 
from groundwater or surface water), and exposure through pesticide use 
in gardens, lawns, or buildings (residential and other indoor uses). In 
evaluating food exposures, EPA takes into account varying consumption 
patterns of major identifiable subgroups of consumers, including 
infants and children.
    Tolerances for residues of bifenthrin are currently expressed as 2-
methyl  [1,1'-biphenyl]-3-yl)  methyl-3-(2-chloro-3,3,3,-trifluoro-1-
propenyl)  -2,2-dimethylcyclopropanecarboxylate. Tolerances currently 
exist for residues on hops; strawberries; corn grain, forage and 
fodder; cotton seed; and livestock commodities of cattle, goats, hogs, 
horses, sheep, and poultry (see 40 CFR 180.442).
    1. Acute exposure. 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. Drinking water is also considered a component of 
the acute dietary exposure; however, EPA generally will not include 
residential or other non-dietary exposure as a component of the acute 
exposure assessment. Theoretically, it is also possible that a 
residential, or other non-dietary exposure could be combined with the 
acute total dietary exposure form food and water. However, the Agency 
does not believe that aggregating multiple exposure to large amounts of 
pesticide residues in the residential environment via multiple products 
and routes for a one day exposure is a reasonably probable event. It is 
highly unlikely that, in one day, an individual would have multiple 
high-end exposures to the same pesticide by treating their lawn and 
garden, treating their house via crack and crevice application, 
swimming in a pool, and be maximally exposed in the food and water 
consumed. Additionally, the concept of an acute exposure as a single 
exposure does not allow for including post-application exposures, in 
which residues decline over a period of days after application. 
Therefore, the Agency believes that residential exposures are more 
appropriately included in the short-term exposure scenario. Thus, the 
Agency estimates acute risk from dietary exposure only. EPA concluded 
that aggregate dietary risk (food plus drinking water) would not exceed 
levels of concern.
    2. Short- and intermediate-term exposure. Short- and intermediate-
term aggregate exposure takes into account chronic dietary food and 
water (considered to be a background exposure) plus indoor and outdoor 
residential exposure. The only use that could result in a residential 
exposure is the one registered use for bifenthrin as a termiticide. EPA 
evaluated information contained in a risk characterization document 
produced by the California Environmental Protection Agency, concerning 
the use of bifenthrin as a subterranean termiticide. This document 
characterized the risks to residents of houses treated with bifenthrin, 
from aggregate residential and acute dietary exposure. Exposure was 
calculated based on exposure data collected from indoor air monitoring 
data, with the absorbed dose from residential exposure converted to an 
oral equivalent, for comparison with the NOEL derived from an oral 
dosing study. Dietary exposure assessment assumed maximum anticipated 
residue levels resulting from the registration on cotton, and secondary 
meat/milk/poultry expected residue levels were extrapolated based on 
feeding studies. Although the California risk assessment document did 
not include dietary exposure resulting from bifenthrin use oin corn and 
hops, because of the low tolerance for corn grain (0.05 ppm) and low 
consumption for hops and strawberries, it is the best scientific 
judgment of EPA scientiest that addition of these commodities would not 
sufficiently lower the MOEs to levels of concern. Based on this risk 
characterization document produced by the California Environmental 
Protection Agency, aggregate short- and intermediate-term risks do not 
exceed EPA's level of concern.
    3. Chronic exposure. The Agency identified chronic exposure as 
appropriate for aggregate risk assessment. The aggregate chronic risk 
is equal to the sum of the chronic risk from exposure from food + water 
+ residential (indoor + outdoor) uses.
    i. Dietary food exposure. For purposes of assessing the potential 
dietary exposure under this tolerance, EPA used tolerance level 
residues and 100% of crop treated to estimate the TMRC from all 
established food uses for bifenthrin and the proposed uses on cucurbits 
and raspberries. There are no cucurbit or raspberry animal feed items 
so no additional dietary livestock dietary burden will result from 
these section 18

[[Page 30999]]

uses. Therefore, existing meat/milk/poultry tolerances are adequate.
    ii. Drinking water exposure. Based on the available studies used in 
EPA's assessment of environmental risk, bifenthrin is moderately 
persistent and not mobile. There is no established Maximum 
Concentration Level for residues of bifenthrin in drinking water. No 
health advisory levels for bifenthrin in drinking water have been 
established. The ``Pesticides in Groundwater Database'' (EPA 734-12-92-
001, September 1992) does not contain any information for bifenthrin.
    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, 
cancer potency factors (Q*s), 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 consumption of contaminated water, the ranges the 
Agency is continuing to examine are all well below the level that would 
cause bifenthrin to exceed the RfD if the tolerances 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 tolerances are granted.
    iii. Non-dietary, non-occupational exposure. Bifenthrin is not 
registered for any residential outdoor uses so no exposure from this 
route is expected. However, bifenthrin is registered for residential 
use as a termiticide, and the Agency has concluded that a chronic 
exposure scenario may exist with respect to this use. The Agency 
estimates that aggregate risk (food plus drinking water plus 
residential) would not exceed the RfD for bifenthrin.

C. 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 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, EPA has 
considered only risks from bifenthrin. Therefore, EPA has not assumed 
that bifenthrin has a common mechanism of toxicity with other 
substances.

D. Safety Determinations for U.S. Population

    1. Acute risk. The acute risk assessment used anticipated residues 
for all commodities having bifenthrin tolerances, except for cucurbits 
and raspberries, for which proposed tolerance level residues were used. 
Additionally, the assessment assumed that 100% of the commodities for 
which there are tolerances, would contain residues of bifenthrin at 
these levels. For the most highly exposed population subgroup, children 
1 - 6 years old, the high-end exposure results in a dietary (food only) 
MOE of 40; 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 U.S. population, the high-end exposure MOE is 67; 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 assumptin 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 U.S., 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 three years. Therefore, it is unlikely that the 
actual exposure is considerably less than the conservative estimates 
given here; if these estimates were refined using actual percent of 
crop treated figures, EPA scientists believe that the MOEs would be 
increased to acceptable levels for the high-end consumer.
    2. 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

[[Page 31000]]

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.
    3. Chronic risk. Using the conservative TMRC exposure assumptions 
described above, EPA has concluded that aggregate dietary exposure to 
bifenthrin will utilize 25% of the RfD for the U.S. population. The 
major identifiable subgroup with the highest aggregate exposure is Non-
Nursing Infants (<1 year old), at 58% of the RfD. This is further 
discussed below in the section on infants and children. EPA generally 
has no concern for exposure 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, 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 aggregate exposure to bifenthrin residues.

E. Determination of Safety for Infants and Children

    In assessing the adequacy of the standard uncertainty factor for 
bifenthrin, EPA considered data from developmental toxicity studies in 
the rat and rabbit, and a two-generation reproductive 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 
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 MOE 
(usually 100x for combined inter- and intra-species variability) and 
not the additional tenfold MOE/uncertainty 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.
    1. Developmental toxicity studies--a. Rabbit study. 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.
    b. Rat study. 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%) 
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% with a maximum incidence of 90%.
    c. Pre-natal sensitivity. 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. Based on the above, 
EPA concludes that reliable data support use of the standard 
hundredfold MOE/uncertainty factor, and that an additional MOE/ 
uncertainty factor is not needed to protect the safety of infants and 
children.
    2. Reproductive toxicity study--a. Rat 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).
    b. Post-natal sensitivity. 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.
    3. Acute risk. The 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 drinking water) would not 
exceed levels of concern. Acute risk is discussed in detail in Units 
IV.B.1 and IV.D.1 of this document.
    4. Short- and intermediate-term risk. The estimated short- and 
intermediate-term risk 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. This is discussed in 
greater detail in Units IV.B.2. and IV.D.2. of this document.
    5. Chronic risk. EPA generally has no concern for exposures below 
100% of the RfD because the RfD represents the level at of below which 
daily aggregate dietary exposure over a lifetime will not pose 
appreciable risks to hyuman health. Despite the potential for exposure 
in drinking water, EPA has concluded that the percentage of the RfD 
that will be utilized by dietary exposure (including drinking water 
exposure) to residues of bifenthrin does not exceed 100% for any of the 
population subgroups. Using the conservative exposure assmuptions 
descibed agove, EPA has concluded that aggregate exposure to bifenthrin 
from food will utilize 58% of the RfD for Non-Nursing Infants, the 
population subgroup with the largest percentage of the RfD occupied. 
Therefore, taking into account the completeness and reliability of the 
toxicity data and the conservative exposure assessment, EPA concludes 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to bifenthrin residues.

V. Other Considerations

A. Metabolism in Plants and Animals

    The metabolism of bifenthrin in cucurbits, raspberries, and animal 
commodities 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 (Gas Chromatography with Electron Capture Detection (GC/
ECD) analytical method P-2132M, PP0E3921, 
MRID41658601). EPA has provided information on this method to

[[Page 31001]]

FDA. The method is available to anyone who is interested in pesticide 
residue enforcement from: By mail, Calvin Furlow, Public Inormation and 
Records Integrity Branch, Information Resources and Services Division 
(7506C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St. SW., Washington, DC 20460. Office location and telephone 
number: Crystal Mall #2, Rm. 1128, 1921 Jefferson Davis Hwy., 
Arlington, VA, 703-305-5805.

C. Magnitude of Residues

    Residues of bifenthrin are not likely to exceed 1.0 ppm in or on 
cucurbits, or 3.0 ppm in or on raspberries, as a result of the proposed 
uses. No animal feed items are associated with either use; therefore, 
no secondary residues in meat, milk, poultry, and eggs are expected to 
result.

D. Rotational Crop Restrictions

    The confined rotational crop data requirements for bifenthrin have 
been satisfied. The following rotation instructions are required:
    a. Leafy vegetables and root crops may be rotated 30 days following 
the final application of bifenthrin.
    b. Crops for which bifenthrin tolerances exist may be rotated at 
any time.
    c. All other crops may be rotated seven months following the final 
application of bifenthrin. There are no rotational crop considerations 
associated with raspberries.

E. International Residue Limits

    There are no Codex, Canadian, or Mexican residue limits for 
residues of bifenthrin in or on cucurbits or raspberries.

VI. Conclusion

    Therefore, tolerances in connection with the FIFRA section 18 
emergency exemptions are established for residues of bifenthrin in or 
on cucurbits at 1.0 ppm, and raspberries at 3.0 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 August 5, 1997, file written objections to any 
aspect of this regulation (including the automatic revocation 
provision) 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 Docket

    The official record for this rulemaking, as well as the public 
version, has been established for this rulemaking under docket control 
number [OPP-300495] (including comments and data submitted 
electronically as described below). 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 official rulemaking record is located at the Virginia 
address in ADDRESSES at the beginning of this document.
    Electronic comments can 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. Comment and data 
will also be accepted on disks in Wordperfect 5.1 file format or ASCII 
file format. All comments and data in electronic form must be 
identified by the docket number [OPP-300495]. Electronic comments on 
this rule may be filed online at many Federal Depository Libraries.

IX. Regulatory Assessment Requirements

    Under Executive Order 12566 (58 FR 51735, October 4, 1993), this 
action is not a ``significant regulatory action'' and, since this 
action does not impose any information collection requirements as 
defined by the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., it is 
not subject to review by the Office of Management and Budget. In 
addition, this action does not impose any enforceable duty, or contain 
any unfunded mandates as described in the Unfunded Mandates Reform Act 
of 1995 (Pub. L. 104-4), or require prior consultation with state 
officials as specified by Executive Order 12875 (58 FR 58093, October 
28, 1993), entitled Enhancing the Intergovernmental Partnership, or 
special considerations as required by Executive Order 12898 (59 FR 
7629, February 16, 1994).
    Because FFDCA section 408(l)(6) permits establishment of this 
regulation without a notice of proposed rulemaking, the regulatory 
flexibility analysis requirements of the Regulatory Flexibility Act, 5 
U.S.C. 604(a), do not apply. Nonetheless, the Agency has previously 
assessed whether establishing tolerances or exemptions from tolerance, 
raising tolerance levels, or expanding exemptions adversely impact 
small entities and concluded, as a generic matter, that there is no 
adverse impact. (46 FR 24950, May 4, 1981).
    Under 5 U.S.C. 801(a)(1)(A) of the Small Business Regulatory 
Enforcement Fairness Act of 1996 (Title II of Pub. L. 104-121, 110 
Stat. 847), EPA 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 the rule in today's Federal Register.

[[Page 31002]]

This rule 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 record 
keeping requirements.

    Dated: May 22, 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. By revising Sec. 180.442 to read as follows:


Sec. 180.442  Bifenthrin; tolerances for residues.

    (a) General. Tolerances are established for residues of the 
pyrethroid 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 following commodities:

------------------------------------------------------------------------
                                                  Expiration/Revocation 
          Commodity           Parts per million            Date         
------------------------------------------------------------------------
Cattle, fat.................                1.0                 11/15/97
Cattle, mbyp................               0.10                 11/15/97
Cattle, meat................                0.5                 11/15/97
Corn, fodder................                5.0                 11/15/97
Corn, forage................                2.0                 11/15/97
Corn, grain (field, seed,                                               
 and pop)...................               0.05                 11/15/97
Cottonseed..................                0.5                 11/15/97
Eggs........................               0.05                 11/15/97
Goats, fat..................                1.0                 11/15/97
Goats, mbyp.................               0.10                 11/15/97
Goats, meat.................                0.5                 11/15/97
Hogs, fat...................                1.0                 11/15/97
Hogs, mbyp..................               0.10                 11/15/97
Hogs, meat..................                0.5                 11/15/97
Hops, dried.................               10.0                 11/15/97
Horses, fat.................                1.0                 11/15/97
Horses, mbyp................               0.10                 11/15/97
Horses, meat................                0.5                 11/15/97
Milk, fat (reflecting 0.1                                               
 ppm in whole milk).........                1.0                 11/15/97
Poultry, fat................               0.05                 11/15/97
Poultry, mbyp...............               0.05                 11/15/97
Poultry, meat...............               0.05                 11/15/97
Sheep, fat..................                1.0                 11/15/97
Sheep, mbyp.................               0.10                 11/15/97
Sheep, meat.................                0.5                 11/15/97
Strawberries................               3.00                     None
------------------------------------------------------------------------

    (b) Section 18 emergency exemptions. Time limited tolerances are 
established 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 connection with use of the 
pesticide under section 18 emergency exemptions granted by EPA. The 
tolerances will expire and are revoked on the dates specified in the 
following table.

------------------------------------------------------------------------
                                                  Expiration/Revocation 
          Commodity           Parts per million            Date         
------------------------------------------------------------------------
Broccoli....................                0.1                  1/31/98
Cauliflower.................               0.05                  1/31/98
Raspberries.................                3.0                  9/30/97
Vegetables, cucurbits.......                1.0                  4/30/98
------------------------------------------------------------------------

    (c) Tolerances with regional registrations. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]

[FR Doc. 97-14721 Filed 6-5-97; 8:45 am]
BILLING CODE 6560-50-F