[Federal Register Volume 65, Number 134 (Wednesday, July 12, 2000)]
[Rules and Regulations]
[Pages 42863-42871]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17618]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301018; FRL-6595-1]
RIN 2070-AB78


Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes tolerances for residues of 
bifenthrin in or on caneberry subgroup, grape, head lettuce and 
peppers, bell and non-bell. The Interregional Research Project (IR-4) 
requested these tolerances under the Federal Food, Drug, and Cosmetic 
Act, as amended by the Food Quality Protection Act of 1996.

DATES: This regulation is effective July 12, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301018 
must be received by EPA on or before September 11, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VI. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301018 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW.,Washington, DC 20460; 
telephone number: (703) 305-7610; and e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------


[[Page 42864]]

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically.You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301018. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of December 22, 1999 (64 FR 71772) (FRL-
6396-2), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as amended by the 
Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170) 
announcing the filing of pesticide petitions (PP) for tolerances by IR-
4, New Jersey Agricultural Experiment Station, P.O. Box 231, Rutgers 
University, New Brunswick, NJ 08903. This notice included a summary of 
the petitions prepared by FMC Corporation, the registrant. There were 
no comments received in response to the notice of filing.
    The petitions requested that 40 CFR 180.442 be amended by 
establishing tolerances for residues of the insecticide bifenthrin, (2-
methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3-trifluoro-1-
propenyl)-2,2-dimethylcyclopropane carboxylate, in or on the following 
commodities:
    (1) PP 9E6016 proposed a tolerance for grape at 0.2 ppm.
    (2) PP 9E6030 proposed a tolerance for peppers, bell and non-bell 
at 0.5 ppm.
    (3) PP 9E6031 proposed a tolerance for head lettuce at 2.0 ppm, 
subsequently revised in this final rule to 3.0 ppm.
    (4) PP 9E6034 proposed a tolerance for the caneberry at 1.0 ppm.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue....''
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. For further discussion of the 
regulatory requirements of section 408 and a complete description of 
the risk assessment process, see the final rule on Bifenthrin Pesticide 
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).

III. 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 and to 
make a determination on aggregate exposure, consistent with section 
408(b)(2), for tolerances for residues of bifenthrin on caneberry 
subgroup at 1.0 ppm, grape at 0.2 ppm, head lettuce at 3.0 ppm, and 
peppers, bell and non-bell at 0.5 ppm. EPA's assessment of exposures 
and risks associated with establishing the tolerances 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 in this unit as well as the no observed adverse effect level 
(NOAEL) and the lowest observed adverse effect level (LOAEL) from the 
toxicity studies reviewed.

            Table 1.--Subchronic, Chronic and Other Toxicity
------------------------------------------------------------------------
         Guideline No./Study Type                     Results
------------------------------------------------------------------------
870.3700a Prenatal developmental in        Maternal NOAEL = 1 mg/kg/day
 rodents.                                   LOAEL = 2 mg/kg/day based on
                                            tremors
                                            Developmental NOAEL = 1 mg/
                                            kg/day
                                            LOAEL = 24 mg/kg/day based
                                            on increased incidence of
                                            hydroureter
------------------------------------------------------------------------
870.3700b Prenatal developmental in        Maternal NOAEL = 2.67 mg/kg/
 nonrodents.                                day
                                            LOAEL = 4 mg/kg/day based on
                                            head and forelimb twitching
                                            No Developmental effects
                                            observed
------------------------------------------------------------------------

[[Page 42865]]

 
870.3800 Reproduction and fertility        Parental/Systemic NOAEL = 3
 effects.                                   mg/kg/day
                                            LOAEL = 5 mg/kg/day
                                           Reproductive NOAEL = 5 mg/kg/
                                            day
                                            LOAEL = no reproductive
                                            effects observed at the
                                            highest dose tested (5 mg/kg/
                                            day)
                                            Offspring NOAEL = 5 mg/kg/
                                            day
                                            LOAEL = no adverse effects
                                            observed at the highest dose
                                            tested (5 mg/kg/day)
------------------------------------------------------------------------
870.4100b Chronic toxicity dogs..........  NOAEL = 1.5 mg/kg/day
                                            LOAEL = 3 mg/kg/day based on
                                            increased incidence of
                                            tremors in both sexes
------------------------------------------------------------------------
870.4200 Carcinogenicity rats............  NOAEL = 2.5 mg/kg/day
                                            LOAEL = 5 mg/kg/day based on
                                            increased incidence of
                                            tremors in both sexes and
                                            possible increases in organ-
                                            to-body weight ratios in
                                            males. There was no evidence
                                            of carcinogenicity.
------------------------------------------------------------------------
870.4300 Carcinogenicity mice............  NOAEL = 2.5 mg/kg/day
                                            LOAEL = 10 mg/kg/day based
                                            on incidence of tremors in
                                            both sexes. Carcinogenic
                                            potential was evidenced by
                                            statistically significant
                                            increased trend for
                                            hemangiopericytomas in the
                                            urinary bladders of males, a
                                            significant dose-related
                                            trend for combined
                                            hepatocellular adenomas and
                                            carcinomas in males, and a
                                            significantly higher
                                            incidence of combined lung
                                            adenomas and carcinomas in
                                            females.
------------------------------------------------------------------------
Gene Mutation............................   A gene mutation in
                                            Salmonella (Ames) was
                                            negative.
------------------------------------------------------------------------
Cytogenetics.............................   Chromosomal aberrations in
                                            Chinese hamster ovary and
                                            rat bone marrow cells were
                                            negative.
------------------------------------------------------------------------
Other Effects............................  HGPRT locus mutation in mouse
                                            lymphoma cells and
                                            unscheduled DNA synthesis in
                                            rat hepatocytes were
                                            negative.
------------------------------------------------------------------------
870.7485 Metabolism and pharmacokinetics.  Metabolism studies in rats
                                            demonstrated that
                                            distribution patterns and
                                            excretion rates in multiple
                                            oral dose studies are
                                            similar to single-dose
                                            studies. There was an
                                            accumulation of unchanged
                                            compound in fat upon chronic
                                            administration with slow
                                            elimination. Otherwise,
                                            bifenthrin was rapidly
                                            metabolized and excreted.
                                            Unchanged bifenthrin is the
                                            major residue component of
                                            toxicological concern in
                                            meat and milk.
------------------------------------------------------------------------
870.7600 Dermal penetration..............  Dermal absorption rate is 25%
------------------------------------------------------------------------

B. Toxicological Endpoints

    The dose at which the NOAEL from the toxicology study identified as 
appropriate for use in risk assessment is used to estimate the 
toxicological level of concern (LOC). However, the lowest dose at which 
adverse effects of concern are identified (the LOAEL) is sometimes used 
for risk assessment if no NOAEL was achieved in the toxicology study 
selected. An uncertainty factor (UF) is applied to reflect 
uncertainties inherent in the extrapolation from laboratory animal data 
to humans and in the variations in sensitivity among members of the 
human population as well as other unknowns. An UF of 100 is routinely 
used, 10X to account for interspecies differences and 10X for intra 
species differences.
    For dietary risk assessment (other than cancer) the Agency uses the 
UF to calculate an acute or chronic reference dose (acute RfD or 
chronic RfD) where the RfD is equal to the NOAEL divided by the 
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is 
retained due to concerns unique to the FQPA, this additional factor is 
applied to the RfD by dividing the RfD by such additional factor. The 
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a 
modification of the RfD to accommodate this type of FQPA Safety Factor.
    For non-dietary risk assessments (other than cancer) the UF is used 
to determine the LOC. For example, when 100 is the appropriate UF (10X 
to account for interspecies differences and 10X for intraspecies 
differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to 
exposures (margin of exposure (MOE) = NOAEL/exposure) is calculated and 
compared to the LOC.
    The linear default risk methodology (Q*) is the primary 
method currently used by the Agency to quantify carcinogenic risk. The 
Q* approach assumes that any amount of exposure will lead to 
some degree of cancer risk. A Q* is calculated and used to 
estimate risk which represents a probability of occurrence of 
additional cancer cases (e.g., risk is expressed as 1  x  
10-6 or one in a million). Under certain specific 
circumstances, MOE calculations will be used for the carcinogenic risk 
assessment. In this non-linear approach, a ``point of departure'' is 
identified below which carcinogenic effects are not expected. The point 
of departure is typically a NOAEL based on an endpoint related to 
cancer effects though it may be a different value derived from the dose 
response curve. To estimate risk, a ratio of the point of departure to 
exposure (MOEcancer = point of departure/exposures) is 
calculated.

      Table 2.--Summary of Toxicological Dose and Endpoints for bifenthrin for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
                                                                 FQPA SF* and Level of
          Exposure Scenario               Dose Used in Risk         Concern for Risk     Study and Toxicological
                                            Assessment, UF             Assessment                Effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary general population       NOAEL =1.0 mg/kg/day      aPAD = acute RfD        Rat developmental LOAEL
 including infants and children.        UF = 100..............    FQPA SF =       = 2 mg/kg/day based on
                                        Acute RfD = 0.01 mg/kg/  0.01 mg/kg/day           tremors in dams during
                                        day.                                              and post dosing
                                        FQPA SF = 1X..........
---------------------------------------------------------------                            FQPA SF =
-----------------------------------------------------------------------------------------

[[Page 42866]]

 
---------------------------------------------------------------
---------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
\*\ The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns
  unique to the FQPA.

C. Exposure Assessment

    1. Dietary exposure 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 including tolerances on plants 
ranging from 0.05 ppm for corn grain (field, seed, and pop) to 10 ppm 
on dried hops. Tolerances are also established on animal commodities 
ranging from 0.05 ppm on eggs to 1.0 ppm in milk fat (reflecting 0.1 
ppm in whole milk). Risk assessments were conducted by EPA to assess 
dietary exposures from bifenthrin in food as follows:
    i. 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 1-day or 
single exposure. The Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the acute 
exposure assessments: In this acute analysis, probabilistic Monte Carlo 
analysis (Tier 3) was used. For those foods identified by EPA as 
single-serving commodities, the Monte Carlo simulation is based on 
iterative sampling from individual residue values from field trial data 
reflecting maximum application rates and minimum preharvest intervals. 
For those foods considered to be blended or processed, mean field trial 
residues were calculated. For those samples which contained residues at 
or below the limit of detection (LOD), \1/2\ of the LOD was used. It 
was assumed that 100% of the following crops were treated with 
bifenthrin: artichoke, bananas, Brassica vegetable, caneberry, canola, 
citrus, cucurbits, eggplants, garden peas, grape, head lettuce, lima 
beans, peanuts, pears, peppers, potatoes, snap beans, and sweet corn. 
Processing factors for grapes were calculated using concentration 
factors (grape juice = 1.2X, raisins = 4.2X). Secondary residues for 
meat and milk were not affected by adding the uses on peppers, lettuce, 
grape, and caneberry since no animal feed items are associated with 
these crops.
    ii. Chronic exposure. In conducting this chronic dietary risk 
assessment the Dietary Exposure Evaluation Model (DEEM) 
analysis evaluated the individual food consumption as reported by 
respondents in the USDA 1994-1996 nationwide Continuing Surveys of Food 
Intake by Individuals (CSFII) and accumulated exposure to the chemical 
for each commodity. The following assumptions were made for the chronic 
exposure assessments: Anticipated residue values which were determined 
from field trial data conducted at maximum label conditions of maximum 
application rates and minimum preharvest intervals. Mean anticipated 
residue values were calculated. One hundred percent of crop treated was 
assumed for all crops except hops (43%) and cottonseed-oil and 
cottonseed-meal (4%). Secondary residues for meat and milk were not 
affected by the new proposed uses.
    Section 408(b)(2)(E) authorizes EPA to use available data and 
information on the anticipated residue levels of pesticide residues in 
food and the actual levels of pesticide chemicals that have been 
measured in food. If EPA relies on such information, EPA must require 
that data be provided 5 years after the tolerance is established, 
modified, or left in effect, demonstrating that the levels in food are 
not above the levels anticipated. Following the initial data 
submission, EPA is authorized to require similar data on a time frame 
it deems appropriate. As required by section 408(b)(2)(E), EPA will 
issue a data call-in for information relating to anticipated residues 
to be submitted no later than 5 years from the date of issuance of this 
tolerance.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated for assessing chronic dietary risk only 
if the Agency can make the following findings: Condition 1, that the 
data used are reliable and provide a valid basis to show what 
percentage of the food derived from such crop is likely to contain such 
pesticide residue; Condition 2, that the exposure estimate does not 
underestimate exposure for any significant subpopulation group; and 
Condition 3, if data are available on pesticide use and food 
consumption in a particular area, the exposure estimate does not 
understate exposure for the population in such area. In addition, the 
Agency must provide for periodic evaluation of any estimates used. To

[[Page 42867]]

provide for the periodic evaluation of the estimate of percent crop 
treated (PCT) as required by section 408(b)(2)(F), EPA may require 
registrants to submit data on PCT.
    The Agency believes that the three conditions listed above have 
been met. With respect to Condition 1, PCT estimates are derived from 
Federal and private market survey data, which are reliable and have a 
valid basis. EPA uses a weighted average PCT for chronic dietary 
exposure estimates. This weighted average PCT figure is derived by 
averaging State-level data for a period of up to 10 years, and 
weighting for the more robust and recent data. A weighted average of 
the PCT reasonably represents a person's dietary exposure over a 
lifetime, and is unlikely to underestimate exposure to an individual 
because of the fact that pesticide use patterns (both regionally and 
nationally) tend to change continuously over time, such that an 
individual is unlikely to be exposed to more than the average PCT over 
a lifetime. For acute dietary exposure estimates, EPA uses an estimated 
maximum PCT. The exposure estimates resulting from this approach 
reasonably represent the highest levels to which an individual could be 
exposed, and are unlikely to underestimate an individual's acute 
dietary exposure. The Agency is reasonably certain that the percentage 
of the food treated is not likely to be an underestimation. As to 
Conditions 2 and 3, regional consumption information and consumption 
information for significant subpopulations is taken into account 
through EPA's computer-based model for evaluating the exposure of 
significant subpopulations including several regional groups. Use of 
this consumption information in EPA's risk assessment process ensures 
that EPA's exposure estimate does not understate exposure for any 
significant subpopulation group and allows the Agency to be reasonably 
certain that no regional population is exposed to residue levels higher 
than those estimated by the Agency. Other than the data available 
through national food consumption surveys, EPA does not have available 
information on the regional consumption of food to which bifenthrin may 
be applied in a particular area.
    2.Dietary exposure from drinking water. The Agency lacks sufficient 
monitoring exposure data to complete a comprehensive dietary exposure 
analysis and risk assessment for bifenthrin in drinking water. Because 
the Agency does not have comprehensive monitoring data, drinking water 
concentration estimates are made by reliance on simulation or modeling 
taking into account data on the physical characteristics of bifenthrin.
    The Agency uses the Generic Estimated Environmental Concentration 
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System 
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and 
Screening Concentration in ground water (SCI-GROW) model, which 
predicts pesticide concentrations in groundwater. In general, EPA will 
use GENEEC (a tier 1 model) before using PRZM/EXAMS (a tier 2 model) 
for a screening-level assessment for surface water. The GENEEC model is 
a subset of the PRZM/EXAMS model that uses a specific high-end runoff 
scenario for pesticides. GENEEC incorporates a farm pond scenario, 
while PRZM/EXAMS incorporate an index reservoir environment in place of 
the previous pond scenario. The PRZM/EXAMS model includes a percent 
crop area factor as an adjustment to account for the maximum percent 
crop coverage within a watershed or drainage basin.
    None of these models include consideration of the impact processing 
(mixing, dilution, or treatment) of raw water for distribution as 
drinking water would likely have on the removal of pesticides from the 
source water. The primary use of these models by the Agency at this 
stage is to provide a coarse screen for sorting out pesticides for 
which it is highly unlikely that drinking water concentrations would 
ever exceed human health levels of concern.
    Since the models used are considered to be screening tools in the 
risk assessment process, the Agency does not use estimated 
environmental concentrations (EECs) from these models to quantify 
drinking water exposure and risk as a percent of the Reference dose or 
percent of the population adjusted dose. Instead drinking water levels 
of comparison (DWLOCs) are calculated and used as a point of comparison 
against the model estimates of a pesticide's concentration in water. 
DWLOCs are theoretical upper limits on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food, and from residential uses. Since DWLOCs address total aggregate 
exposure to bifenthrin they are further discussed in the aggregate risk 
sections below.
    Based on the GENEEC and the SCI-GROW models the EECs of bifenthrin 
in surface water and ground water for acute exposures are estimated to 
be 0.10 parts per billion (ppb) for surface water and 0.006 ppb for 
ground water. The EECs for chronic exposures are estimated to be 0.032 
ppb for surface water and 0.006 ppb for ground water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). Bifenthrin is 
currently registered for use on the following residential non-dietary 
sites: lawns to control flea infestation, pets and as a termiticide. 
Registered termiticide use of bifenthrin constitutes a chronic exposure 
scenario, however, the exposure is considered negligible, considering 
the application technique of the termiticide use (buried underground) 
and the fact that vapor pressure of bifenthrin is extremely low. The 
Agency conducted a residential exposure assessment for the lawn care 
uses of bifenthrin. This risk assessment is based on post-application 
to treated lawns (turf use), a worst case scenario estimate of 
residential exposure. An assessment of applicator exposure was not 
included since the registered products are primarily limited to 
commercial use and, therefore, applied by professional lawn care 
operators. Inhalation, dermal and oral non-dietary routes of exposure 
were evaluated by this short- and intermediate-term risk assessment. 
For adults, the routes of exposure from these registered residential 
uses include dermal and inhalation, and for infants and children, the 
routes of exposure include dermal, inhalation, and oral (non-dietary).
    4. Cumulative exposure to substances with a 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.''
    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. For information regarding EPA's efforts to 
determine which chemicals have a common mechanism

[[Page 42868]]

of toxicity and to evaluate the cumulative effects of such chemicals, 
see the final rule for Bifenthrin Pesticide Tolerances (62 FR 62961, 
November 26, 1997).

D. Safety Factor for Infants and Children

    1. Safety factor for infants and children--i. In general. 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 prenatal and postnatal toxicity and the completeness of the 
data base on toxicity and exposure 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 margin of exposure (MOE) analysis or through 
using uncertainty (safety) factors in calculating a dose level that 
poses no appreciable risk to humans.
    ii. Developmental toxicity studies. See summary of developmental 
toxicity studies in Unit IIIA. Toxicological Profile.
    iii. Reproductive toxicity study. See summary of reproduction 
toxicity studies in Unit IIIA. Toxicological profile.
    iv. Conclusion. There is a complete toxicity data base for 
bifenthrin and exposure data are complete or are estimated based on 
data that reasonably accounts for potential exposures. The FQPA Safety 
Factor for enhanced sensitivity of infants and children was reduced 
from 10X to 1X.

E. Aggregate Risks and Determination of Safety

    To estimate total aggregate exposure to a pesticide from food, 
drinking water, and residential uses, the Agency calculates DWLOCs 
which are used as a point of comparison against the model estimates of 
a pesticide's concentration in water (EECs). DWLOC values are not 
regulatory standards for drinking water. DWLOCs are theoretical upper 
limits on a pesticide's concentration in drinking water in light of 
total aggregate exposure to a pesticide in food and residential uses. 
In calculating a DWLOC, the Agency determines how much of the 
acceptable exposure (i.e., the PAD) is available for exposure through 
drinking water e.g., allowable chronic water exposure (mg/kg/day) = 
cPAD-(average food + residential exposure). This allowable exposure 
through drinking water is used to calculate a DWLOC. A DWLOC will vary 
depending on the toxic endpoint, drinking water consumption, and body 
weights. Default body weights and consumption values as used by the 
U.S. EPA's Office of Water are used to calculate DWLOCs: 2L/70 kg 
(adult male), 2L/60 kg (adult female), and 1L/10 kg (child). Default 
body weights and drinking water consumption values vary on an 
individual basis. This variation will be taken into account in more 
refined screening-level and quantitative drinking water exposure 
assessments. Different populations will have different DWLOCs. 
Generally, a DWLOC is calculated for each type of risk assessment used: 
acute, short-term, intermediate-term, chronic, and cancer.
    When EECs for surface water and groundwater are less than the 
calculated DWLOCs, EPA concludes with reasonable certainty that 
exposures to the pesticide in drinking water (when considered along 
with other sources of exposure for which EPA has reliable data) would 
not result in unacceptable levels of aggregate human health risk at 
this time. Because EPA considers the aggregate risk resulting from 
multiple exposure pathways associated with a pesticide's uses, levels 
of comparison in drinking water may vary as those uses change. If new 
uses are added in the future, EPA will reassess the potential impacts 
of residues of the pesticide in drinking water as a part of the 
aggregate risk assessment process.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary (food only) exposure to 
bifenthrin will occupy 60% of the aPAD for the U.S. population, 40% of 
the aPAD for females 13 years and older, 75% of the aPAD for infants (1 
year old) and 99.7% of the aPAD for children (1 to 6 years old). In 
addition, there is potential for acute dietary exposure to bifenthrin 
in drinking water. Despite this potential and after calculating DWLOCs 
and comparing them to the EECs for surface and ground water, EPA does 
not expect the aggregate exposure to exceed 100% of the aPAD.

                      Table 3.--Aggregate Risk Assessment for Acute Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
                                                                              Surface      Ground
              Population Subgroup                  aPAD (mg/     % aPAD     Water EEC    Water EEC       Acute
                                                     kg)         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................         0.01           60         0.10        0.006          140
----------------------------------------------------------------------------------------------------------------
Females 13 years and older.....................         0.01           40         0.10        0.006          180
----------------------------------------------------------------------------------------------------------------
children (1 to 6 years old)....................         0.01         99.7         0.10        0.006          0.3
----------------------------------------------------------------------------------------------------------------

    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to 
bifenthrin from food will utilize 3.0% of the cPAD for the U.S. 
population, and 8.2% of the cPAD for children (1 to 6 years old), the 
subpopulation at greatest risk. Bifenthrin is also registered for 
residential use on outdoor lawn/gardens, inside households, pets and as 
a termiticide. Based on the use pattern, chronic residential exposure 
to residues of the bifenthrin is not expected. In addition, there is 
potential for chronic dietary exposure to bifenthrin in drinking water. 
After calculating the DWLOCs and comparing them to the EECs for surface 
and ground water, EPA does not expect the aggregate exposure to exceed 
100% of the cPAD.

               Table 4.--Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
                                                                             Surface       Ground
              Population Subgroup                cPAD mg/kg/     % cPAD     Water EEC    Water EEC     Chronic
                                                     day         (Food)       (ppb)        (ppb)     DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population................................        0.015          3.0        0.032        0.032          530
----------------------------------------------------------------------------------------------------------------

[[Page 42869]]

 
Females (13 yrs. and above)....................        0.015          3.0        0.032        0.032          450
----------------------------------------------------------------------------------------------------------------
children (1 to 6 years old)....................        0.015          3.0        0.032        0.032          140
----------------------------------------------------------------------------------------------------------------

    3. Short-term risk. Short-term aggregate exposure takes into 
account residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level). Bifenthrin is currently 
registered for use that could result in short- and intermediate-term 
residential exposure. Registered termiticide use of bifenthrin 
constitutes a chronic exposure scenario; however, the exposure is 
considered negligible. The Agency has determined that it is appropriate 
to aggregate chronic food and water and short- and intermediate-term 
non-dietary exposures for bifenthrin.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded that food (water not included) and 
residential exposures aggregated result in aggregate MOEs of 940 for 
adults, 350 for children ages 1 to 6 years old, and 470 for infants 
less than 1 year old based on chronic food and residential use, e.g., 
turf representing the worst case residential exposure scenario. These 
aggregate MOEs do not exceed the Agency's level of concern for 
aggregate exposure to food and residential uses. In addition, short-
term DWLOCs were calculated and compared to the EECs for chronic 
exposure of bifenthrin in ground and surface water. After calculating 
DWLOCs and comparing them to the EECs for surface and ground water, EPA 
does not expect short-term aggregate exposure to exceed the Agency's 
level of concern.

                    Table 5.--Aggregate Risk Assessment for Short-Term Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
                                                               Aggregate
                                                  Aggregate     Level of     Surface       Ground     Short-Term
              Population Subgroup                MOE (Food +    Concern     Water EEC    Water EEC   DWLOC (ppb)
                                                Residential)     (LOC)        (ppb)        (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population...............................           940          100        0.032        0.006          320
----------------------------------------------------------------------------------------------------------------
Children 1 to 6 yrs. old......................           350          100        0.032        0.006           71
----------------------------------------------------------------------------------------------------------------

    Applying the same exposure assumptions as above for short-term 
exposure, and after calculating DWLOCs and comparing them to the EECs 
for surface and ground water, EPA does not expect intermediate-term 
aggregate exposure to exceed the Agency's level of concern.

                Table 6.--Aggregate Risk Assessment for Intermediate-Term Exposure to Bifenthrin
----------------------------------------------------------------------------------------------------------------
                                                             Aggregate
                                                Aggregate     Level of     Surface       Ground    Intermediate-
             Population Subgroup               MOE (Food +    Concern     Water EEC    Water EEC     Term DWLOC
                                              Residential)     (LOC)        (ppb)        (ppb)         (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population.............................           940          100        0.032        0.006           480
----------------------------------------------------------------------------------------------------------------
Children 1 to 6 yrs. old....................           350          100        0.032        0.006           107
----------------------------------------------------------------------------------------------------------------

    4. Aggregate cancer risk for U.S. population. A quantitative 
(Q1*) dietary cancer risk assessment was not performed. 
Dietary risk concerns due to long-term consumption of bifenthrin are 
adequately addressed by the DEEM chronic exposure analysis 
using the chronic RfD. For the U.S. population, only 3.0% of the cPAD 
(cRfD) is occupied by chronic food exposure. Based on a comparison of 
the calculated DWLOCs and the estimated exposure to bifenthrin in 
drinking water (0.032 g/L), the Agency does not expect the 
chronic aggregate exposure to exceed 100% of the cPAD (cRfD) for 
adults. Thus, EPA concludes with reasonable certainty that the 
carcinogenic risk is within acceptable limits.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, and to infants and children from aggregate 
exposure to bifenthrin residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methods are available for determination of the 
regulated bifenthrin residue in plants. The data gathering method for 
pepper, lettuce, grapes, and caneberry is FMC method P-2132M, with a 
limit of quantitation of 0.05 ppm (given as 0.055 in some cases). This 
method is a variation of two other methods which have been submitted 
for inclusion in PAM II (FMC's Methods P-1031 and RAN-0140. This method 
has been adequately validated and is adequate for data collection. The 
method may be requested from: Calvin Furlow, PRRIB, IRSD (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, 1200 
Pennsylvania Ave., NW, Washington, DC 20460; telephone number: (703) 
305-5229; e-mail address: [email protected].

[[Page 42870]]

B. International Residue Limits

    No Codex, Canadian, or Mexican maximum residue levels (MRL) have 
been established for residues of bifenthrin in/on bell or non-bell 
peppers, head lettuce, grape, or caneberries. International 
harmonization is therefore not an issue for these tolerances.

V. Conclusion

    Therefore, the tolerances are established for residues of 
bifenthrin, (2-methyl [1,1'-biphenyl]-3-yl) methyl-3-(2-chloro-3,3,3-
trifluoro-1-propenyl)-2,2-dimethylcyclopropane carboxylate, in or on 
caneberry crop subgroup 13A at 1.0 ppm, grape at 0.2 ppm, head lettuce 
at 3.0 ppm and peppers at 0.5 ppm.

VI. Objections and Hearing Requests

    Under section 408(g) of the FFDCA, as amended by the FQPA, any 
person may file an objection to any aspect of this regulation and may 
also request a hearing on those objections. The EPA procedural 
regulations which govern the submission of objections and requests for 
hearings appear in 40 CFR part 178. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301018 in the subject line on the 
first page of your submission. All requests must be in writing, and 
must be mailed or delivered to the Hearing Clerk on or before September 
11, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as 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.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
    EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VI.A., you 
should also send a copy of your request to the PIRIB for its inclusion 
in the official record that is described in Unit I.B.2. Mail your 
copies, identified by docket control number OPP-301018, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
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(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

VII. Regulatory Assessment Requirements

    This final rule establishes a tolerance under FFDCA section 408(d) 
in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). 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) (Public Law 104-4). Nor 
does it require any prior consultation as specified by Executive Order 
13084, entitled Consultation and Coordination with Indian Tribal 
Governments (63 FR 27655, May 19, 1998); 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,

[[Page 42871]]

1994); or require OMB review or any Agency action under Executive Order 
13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks (62 FR 19885, April 23, 1997). This action does not 
involve any technical standards that would require Agency consideration 
of voluntary consensus standards pursuant to section 12(d) of the 
National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. This action 
does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4).

VIII. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: June 29, 2000.
James Jones,
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. 321(q), (346a) and 371.

    2. Section 180.442 is amended by alphabetically adding commodities 
to the table in paragraph (a) to read as follows:


Sec. 180.442  Bifenthrin; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                                                              Parts per
                         Commodity                             million
------------------------------------------------------------------------
 
                      *      *      *      *      *
Caneberry subgroup.........................................          1.0
 
                      *      *      *      *      *
Grape......................................................          0.2
 
                      *      *      *      *      *
Lettuce, head..............................................          3.0
 
                      *      *      *      *      *
Pepper, bell...............................................          0.5
Peppers, non-bell..........................................          0.5
 
                      *      *      *      *      *
------------------------------------------------------------------------

    *      *      *      *      *
[FR Doc. 00-17618 Filed 7-11-00; 8:45 am]
BILLING CODE 6560-50-F