[Federal Register Volume 64, Number 125 (Wednesday, June 30, 1999)]
[Rules and Regulations]
[Pages 35051-35058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16575]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300888; FRL-6089-9]
RIN 2070-AB78


Bifenthrin; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes tolerances for residues of the 
insecticide bifenthrin, (2-methyl[1,1'-biphenyl]-3-yl) methyl-3-(2-
chloro-3,3,3-trifluoro-1- propenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the food commodities: cabbage 
at 4.0 part per million (ppm); the cucurbit vegetable crop group (Crop 
Group 9) at 0.4 ppm; edible- podded legume vegetable subgroup (Crop 
Subgroup 6A) at 0.6 ppm; eggplant at 0.05 ppm; globe artichoke at 1.0 
ppm; head and stem Brassica subgroup (Crop Subgroup 5A), except 
cabbage, at 0.6 ppm; rapeseed at 0.05 ppm, succulent shelled pea and 
bean subgroup (Crop Subgroup 6B) at 0.05 ppm; sweet corn kernel plus 
cob with husk removed at 0.05 ppm; and corn forage at 3.0 ppm. The 
Interregional Research Project (IR-4) and FMC Corporation 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 June 30, 1999. Objections and 
requests for hearings must be received by EPA on or before August 30, 
1999.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300888], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300888], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may 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 5.1/6.1 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-300888]. 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: Hoyt Jamerson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. Office 
location, telephone number, and e-mail address: Rm. 272, Crystal Mall 
#2, 1921 Jefferson Davis Hwy., Arlington, VA, (703) 308-9368, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 7, 1998 
(63 FR 53902) (FRL-6026-3), and May 19, 1999 (64 FR 27262) (FRL-6079-
8), EPA issued notices 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 for tolerances by the Interregional 
Research Project Number 4 (IR-4), New Jersey Agricultural Experimental 
Station, P.O. Box 231, Rutgers University, New Brunswick, NJ, and FMC 
Corporation, 1753 Market Street, Philadelphia, PA 19103. These notices 
included summaries of the petitions prepared by FMC Corporation, the 
registrant. There were no comments received in response to the notices 
of filing.
    The petitions requested that 40 CFR 180.442 be amended by 
establishing tolerances for residues of the insecticide bifenthrin, in 
or on various food commodities, as follows:
    1. IR-4 petition 6E4629 proposes the establishment of a tolerance 
for globe artichoke at 1.0 ppm. IR-4 first proposed the tolerance for 
the commodity ``artichokes,'' but the petition was amended to specify 
the food commodity as ``globe artichoke.''

[[Page 35052]]

    2. IR-4 petition 6E4760 proposes the establishment of a tolerance 
for the cucurbit vegetable crop group at 0.4 ppm.
    3. IR-4 petition 8E4993 proposes the establishment of a tolerance 
for the edible-podded legume vegetable subgroup at 0.6 ppm. The initial 
proposal was for a tolerance for the edible- podded legume vegetable 
group at 0.2 ppm. Based on EPA's review of the field residue data 
submitted by IR-4, the petition was revised by the petitioner to 
propose the tolerance at 0.6 ppm.
    4. IR-4 petition 8E5009 proposes the establishment of a tolerance 
for eggplant at 0.05 ppm.
    5. IR-4 petition 9E5084 proposes the establishment of a tolerance 
for rapeseed (including canola and crambe seed) at 0.05 ppm.
    6. IR-4 petition 9E5064 proposes the establishment of a tolerance 
for succulent shelled pea and bean subgroup at 0.05 ppm.
    7. IR-4 petition 9E5069 proposes the establishment of a tolerance 
for the head and stem Brassica subgroup, except cabbage, at 0.6 ppm; 
and cabbage at 4.0 ppm.
    8. FMC Corporation petition 8F5014 proposes the establishment of a 
tolerance for sweet corn grain at 0.05 ppm and corn forage at 3.0 ppm. 
The petition was amended by changing the commodity term ``sweet corn 
grain'' to read ``sweet corn kernel plus cob with husk removed.''

I. Background and Statutory Findings

    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).

II. Aggregate Risk Assessment and Determination of Safety

    Consistent with section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of 
bifenthrin and to make a determination on aggregate exposure, 
consistent with section 408(b)(2), for tolerances for residues of 
bifenthrin on cabbage at 4.0 ppm; the cucurbit vegetable crop group at 
0.4 ppm; edible-podded legume vegetable subgroup at 0.6 ppm; eggplant 
at 0.05 ppm; globe artichoke at 1.0 ppm; head and stem Brassica 
subgroup, except cabbage, at 0.6 ppm; rapeseed at 0.05 ppm; succulent 
shelled pea and bean subgroup at 0.05 ppm; sweet corn kernel plus cob 
with husk removed at 0.05 ppm; and corn forage at 3.0 ppm. EPA's 
assessment of the dietary 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.
    1. Genotoxicity. The following genotoxicity tests conducted with 
bifenthrin all yielded negative results including: gene mutation in 
Salmonella (Ames); chromosomal aberrations in Chinese hamster ovary and 
rat bone marrow cells; HGPRT locus mutation in mouse lymphoma cells; 
and unscheduled DNA synthesis in rat hepatocytes. Bifenthrin tested 
positive in a mouse lymphoma forward mutation assay, with and without 
metabolic activation.
     2. Developmental toxicity. In the rabbit developmental toxicity 
study, there were no developmental effects observed in the fetuses 
exposed to bifenthrin. The maternal no observed adverse effect level 
(NOAEL) was 2.67 milligrams (mg)/kilogram (kg)/day based on head and 
forelimb twitching at the lowest observed adverse effect level (LOAEL) 
of 4 mg/kg/day. In the rat developmental study, the maternal NOAEL was 
1 mg/kg/day, based on tremors at the LOAEL of 2 mg/kg/day. The 
developmental (pup) NOAEL was also 1 mg/kg/day, based upon increased 
incidence of hydroureter at the LOAEL of 2 mg/kg/day. There were 5 of 
23 (22 percent) litters affected with each litter having only one 
affected pup in the 2 mg/kg/day group, compared with zero in the 
control, 1 and 0.5 mg/kg/day groups. According to recent historical 
data (1992-1994) for this strain of rat, incidence of distended ureter 
averaged 11 percent with a maximum incidence of 90 percent.
    3. Reproductive toxicity. In the rat reproduction study, parental 
toxicity occurred as decreased body weight at 5.0 mg/kg/day with a 
NOAEL of 3.0 mg/kg/day. There were no developmental (pup) or 
reproductive effects up to 5.0 mg/kg/day (highest dose tested)(HDT).
     4. Chronic toxicity/carcinogenicity. In a 1-year chronic/
carcinogenicity study dogs were fed diets containing 0, 0.75, 1.5, 3, 
or 5 mg/kg/day. No mortality occurred during the study and there were 
no treatment-related effects on body weight, food consumption, organ 
weights, and gross or microscopic pathology. In addition, there were no 
treatment-related ophthalmological changes. Tremors were noted in all 
males and females at 5 mg/kg/day during weeks 15-29 and in 1 of 4 males 
and 2 of 4 females at 3 mg/kg/day during weeks 16-23. A significant 
increase in platelets was noted at 52 weeks in males fed 5 mg/kg/day . 
Serum sodium levels were significantly increased in males at 3 and 5 
mg/kg/day and serum chloride was increased in males fed 5 mg/kg/day. 
The LOAEL for this study is 3 mg/kg/day based on the increased 
incidence of tremors in both sexes. The NOAEL is 1.5 mg/kg/day.
    5. Chronic/carcinogenicity study. In this study mice were fed doses 
of 0, 50, 200, 500, or 600 ppm (0, 2.5, 10, 25, or 30 mg/kg/day) in the 
diet for 87 weeks (males) or 92 weeks (females). The chronic LOAEL was 
established at 10 mg/kg/day based on the incidence of tremors in both 
sexes. The chronic NOAEL is established at 2.5 mg/kg/day. Carcinogenic 
potential was evidenced by a statistically significant increased trend 
for hemangiopericytomas in the urinary bladders of males, a significant 
dose-related trend for combined hepatocellular adenomas and carcinomas 
in males, and a significantly higher incidence of combined lung 
adenomas and carcinomas in females.
    6. Chronic/carcinogenicity study. In this study rats were fed diets 
containing 0, 12, 50, 100, or 200 ppm (0, 0.6, 2.5,

[[Page 35053]]

5, or 10 mg/kg/day). The chronic LOAEL is 5 mg/kg/day based on the 
increased incidence of tremors in both sexes and possible increases in 
organ-to-body weight ratios in males, and the chronic NOAEL is 
established at 2.5 mg/kg/day. Under the conditions of this study, there 
was no evidence of carcinogenic potential.
     7. Animal metabolism. 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.

B. Toxicological Endpoints

    1. Acute dietary toxicity. The acute reference doses (RfD) for 
dietary exposure is established at 0.01 mg/kg/day. The acute RfD is 
based on a developmental toxicity study in the rat with a maternal 
NOAEL of 1.0 mg/kg of body weight/day and an uncertainty factor (UF) of 
100. The FQPA Safety Factor for the protection of infants and children 
was reduced to 1x. (See Unit II.E.iv. in the preamble of this document 
for discussion of pre- and post-natal sensitivity to bifenthrin.) The 
acute population adjusted dose (acute PAD) is determined by dividing 
the acute RFD by the FQPA factor: acute PAD = 0.01 / 1 = 0.01 mg/kg /
day. Since the FQPA Safety Factor is 1X, the acute RfD is identical to 
the acute PAD. This acute PAD applies to all population subgroups.
     2. Short- and intermediate-term residential dermal toxicity. For 
short- and intermediate- term dermal endpoints, EPA selected the 
maternal NOAEL of 1.0 mg/kg/day from the oral developmental toxicity 
study in rats (same study as for acute dietary exposure). The dermal 
absorption rate is 25% and a MOE of 100 was selected, which includes 
FQPA considerations.
    3. Chronic residential dermal exposure. For the chronic dermal 
endpoint, EPA selected the NOAEL of 1.5 mg/kg/day from the 1-year oral 
study in dogs (same study as for chronic dietary exposure). The dermal 
absorption rate is 25% and a MOE of 100 was selected, which includes 
FQPA considerations.
     4. Chronic dietary toxicity. EPA has established the chronic RfD 
for bifenthrin at 0.015 mg/kg/day. This RfD is based on a 1-year oral 
feeding study in dogs with a NOAEL of 1.5 mg/kg/day and an uncertainty 
factor (UF) of 100. The FQPA Safety Factor for the protection of 
infants and children was reduced to 1x. The chronic population adjusted 
dose (chronic PAD) is determined by dividing the chronic RfD by the 
FQPA factor. Since the FQPA safety factor is 1X, the chronic RfD is 
identical to the chronic PAD. This chronic PAD applies to all 
population subgroups.
    5. Carcinogenicity. Bifenthrin has been classified as a Group C 
Carcinogen (a possible human carcinogen). A cancer risk assessment 
using the RfD approach is required.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.442) for the residues of bifenthrin, in or on a variety of food 
commodities. Tolerances are established on plant commodities ranging 
from 0.05 ppm on field corn grain to 10 ppm on dried hops. Tolerances 
are also established on animal commodities including meat, meat 
byproducts and fat of cattle, goats, hogs, horses, poultry, sheep, and 
milk and eggs. Risk assessments were conducted by EPA to assess dietary 
exposures from bifenthrin as follows:
    The acute dietary (food only) risk assessment was conducted by 
Novigen Science, Inc. In this acute analysis, Monte Carlo analysis 
(Tier 3) was used. For those foods identified by EPA as single-serving 
commodities, 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 
considered to be blended or processed, mean field trial residues were 
calculated, substituting those samples for which residues were reported 
at or below the limit of detection (LOD) with one-half of the LOD. It 
was assumed that 100% crop treated for all pending registrations: 
citrus, snap beans, peas, lima beans, canola, sweet corn, cucurbits, 
eggplant, and Brassica vegetable. Secondary residues for meat and milk 
were derived from the total dietary burden and tissue- to- feed ratio, 
using the highest ratio for meat, and the average ratio for milk.
    This analysis evaluates individual food consumption as reported by 
respondents in the USDA Continuing Surveys of Food Intake by 
Individuals conducted in 1989 through 1992. The model accumulates 
exposure to the chemical for each commodity and expresses risk as a 
function of exposure to residues in food. This is a highly refined 
assessment since percent of crop treated was used for registered crops 
and anticipated residues for all crops.
    In conducting this DEEM analysis for chronic food risk assessment, 
Novigen used 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, substituting one-half of the LOD for 
those samples for which residues were reported below the LOD. It was 
assumed that 100% crop treated for all crops except hops at 43%, 
cottonseed-oil and cottonseed-meal at 4%. Secondary residues for meat 
and milk were derived from the total dietary burden and tissue- to- 
feed ratio, using the average ratio for meat and milk. The analysis 
evaluates individual food consumption as reported by respondents in the 
USDA Continuing Surveys of Food Intake by Individuals conducted in 1989 
through 1992.
    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 
these tolerances.
    Section 408(b)(2)(F) states that the Agency may use data on the 
actual percent of food treated (PCT) for assessing chronic dietary risk 
only if the Agency can make the following findings: 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; that the exposure estimate does not underestimate exposure for 
any significant subpopulation group; and 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 provide for the periodic evaluation of the estimate 
of percent of crop treated as required by the section 408(b)(2)(F), EPA 
may

[[Page 35054]]

require registrants to submit data on PCT.
    The Agency believes that the three conditions, discussed in section 
408 (b)(2)(F) in this unit concerning the Agency's responsibilities in 
assessing chronic dietary risk findings, have been met. The PCT 
estimates are derived from Federal and private market survey data, 
which are reliable and have a valid basis. A range of estimates are 
supplied and the upper end of this range is assumed for the exposure 
assessment. By using this upper end estimate of the PCT, the Agency is 
reasonably certain that the percentage of the food treated is not 
likely to be underestimated. The 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.
    i.  Acute exposure and risk (food). 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 percentages of the acute PAD 
utilized at the 99.9th percentile of exposure are 53% for the U.S. 
population, 63% for infants (<1 year), 58% for non-nursing infants (< 1 
year) and 96% for children (1-6 years old), the most highly exposed 
population subgroup. An acute dietary exposure (food plus water) of 
100% or less of the acute PAD is needed to protect the safety of all 
population subgroups.
    ii. Chronic exposure and risk (food). The most highly exposed 
population subgroup (children 1-6 years) will utilize 6.7% of the 
chronic PAD. The exposure for the U.S. population is 2.4% of the 
chronic PAD. A chronic dietary exposure (food plus water) of 100% or 
less of the chronic PAD is needed to protect the safety of all 
population subgroups.
    2. From drinking water. A Drinking Water Level of Comparison 
(DWLOC) is a theoretical upper limit on a pesticide's concentration in 
drinking water in light of total aggregate exposure to a pesticide in 
food, drinking water, and through residential uses. A DWLOC will vary 
depending on the toxic endpoint, drinking water consumption, and body 
weights. Different populations will have different DWLOCs. The Agency 
uses DWLOCs internally in the risk assessment process as a surrogate 
measure of potential exposure associated with pesticide exposure 
through drinking water. In the absence of monitoring data for 
pesticides, it is used as a point of comparison against conservative 
model estimates of a pesticide's concentration in water. DWLOC values 
are not regulatory standards for drinking water. They do have an 
indirect regulatory impact through aggregate exposure and risk 
assessments. The estimated acute and chronic drinking water 
concentrations were generated with the PRZMI/EXAMS model using the 
highest application rate of 0.5 pounds/acre, which is registered for 
use on cotton.
    i. Acute exposure and risk (water). For purposes of this acute risk 
assessment, the estimated acute maximum concentration for bifenthrin in 
surface and ground waters is 0.10 g (micrograms)/L (liter), 
which was used for comparison to the back- calculated DWLOCs for the 
acute endpoint. The DWLOCs for various population categories are 165 
g/L for the U.S. population, 200 g/L for females 13 
years and older, and 4 g/L for children 1 to 6 years. Acute 
exposure to bifenthrin in drinking water is below the calculated 
drinking water levels of concern.
    ii. Chronic exposure and risk (water). For purposes of chronic risk 
assessment, the estimated chronic maximum concentration for bifenthrin 
in surface and ground waters is 0.032 g/L, which was used for 
comparison to the back-calculated human health DWLOCs from the chronic 
(non-cancer) endpoint. These DWLOCs for various population categories 
are 530 g/L for the U.S. population, 450 g/L for 
females 13 years and older, and 140 g/L for children 1 to 6 
years. Chronic exposure to bifenthrin in drinking water is below the 
calculated drinking water levels of concern. iii. Short- and 
intermediate-term exposure and risk (water). For purposes of short- and 
intermediate-term risk assessment, the estimated chronic maximum 
concentration for bifenthrin in surface and ground waters is 0.032 
g/L, which was used for comparison to the back-calculated 
human health DWLOCs from the short- and intermediate-term endpoints. 
The DWLOCs for various population categories are 290 g/L for 
the U.S. population, 250 g/L for females 13 years and older, 
and 77 g/L for children 1 to 6 years. Short- and intermediate-
term exposure to bifenthrin in drinking water is below the calculated 
drinking water levels of concern.
    3. From non-dietary exposure. Bifenthrin is currently registered 
for use on the residential non-food sites outdoor lawn and garden, 
inside households and termiticide use. These registered uses constitute 
short- and/or intermediate-term, and chronic exposure.
    i. Chronic exposure and risk (residential). Although the registered 
termiticide use of bifenthrin constitutes a chronic exposure scenario, 
the exposure from this termiticide use is negligible considering the 
application technique of the termiticide use (buried underground) and 
the fact that vapor pressure of bifenthrin is extremely low (1.8 x 10 
-7 torr). .
    ii. Short- and intermediate-term exposure and risk (residential). 
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 (nondietary). The MOEs for residential exposures 
are 1600 for adults, 610 for children (1 to 6 years), and 600 for 
infants (<1 year). These MOE's are well above the acceptable short-term 
aggregate MOE of 100.
    4. Cumulative exposure to substances with common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    Bifenthrin is a member of a class of chemicals commonly referred to 
as ``Synthetic Pyrethroids.'' Other members of this class include 
cyfluthrin, cypermethrin, lambda- cyhalothrin, zeta-cypermethrin, 
deltamethrin, esfenvalerate,

[[Page 35055]]

fenpropathrin, tefluthrin and tralomethrin.
    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 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).
    5. Endocrine disrupter effects. EPA is required to develop a 
screening program to determine whether certain substances (including 
all pesticides and inerts) ``may have an effect in humans that is 
similar to an effect produced by a naturally occurring estrogen, or 
such other endocrine effect...'' The Agency is currently working with 
interested stakeholders, including other government agencies, public 
interest groups, industry and research scientists in developing a 
screening and testing program and a priority setting scheme to 
implement this program. Congress has allowed 3 years from the passage 
of FQPA (August 3, 1999) to implement this program. At that time, EPA 
may require further testing of this active ingredient and end use 
products for endocrine disrupter effects.

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

    1. Acute risk (food + water).  Using the Monte Carlo analysis, it 
is estimated that the acute exposure to bifenthrin from food for the 
U.S. population subgroup will utilize 53% of the acute PAD. Children 1 
to 6 years are the most highly exposed population subgroup. (See 
discussion in Unit II.E.) An acute dietary exposure (food plus water) 
of 100% or less of the acute PAD is needed to protect the safety of all 
population subgroups. Despite the potential for exposure to bifenthrin 
in drinking water, EPA does not expect the aggregate exposure to exceed 
100% of the acute PAD for adults, infants and children. The estimated 
maximum concentration of bifenthrin in surface and ground water for 
acute exposure is below the DWLOC.
    2. Chronic risk (food + water + residential). Using the exposure 
assumptions described in this unit, EPA has concluded that aggregate 
exposure to bifenthrin from food will utilize 2.4% of the chronic PAD 
for the U.S. population. The major identifiable subgroup with the 
highest aggregate exposure is children 1 to 6 years. [See discussion in 
Unit II.E. in the preamble of this document] EPA generally has no 
concern for exposures below 100% of the chronic PAD because the chronic 
PAD 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 
chronic PAD, the estimated maximum concentration of bifenthrin in 
surface and ground water for chronic exposure is very small compared to 
the DWLOC. Although the registered termiticide use of bifenthrin 
constitutes a chronic exposure scenario, the exposure from this 
termiticide use is negligible considering the application technique of 
the termiticide use (buried underground) and the fact that vapor 
pressure of bifenthrin is extremely low (1.8 x 10 -7 torr).
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account chronic dietary food and water 
(considered to be a background exposure level) plus indoor and outdoor 
residential exposure. In the case of bifenthrin, the registered 
residential use sites include outdoor lawn/gardens, inside households 
and termiticide. These uses constitute a short- and intermediate-term 
exposure scenario. The short- and intermediate-term aggregate risk 
assessment for bifenthrin includes inhalation, dermal, oral non-
dietary, chronic food, and water exposure routes. The acceptable MOEs 
for short- and intermediate-term exposures are all at 100. 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 (nondietary). The MOEs 
for food (excluding water) and residential exposures is 1200 for 
adults, 430 for children 1 to 6 years, and 500 for infants less than 1 
year. These MOEs are well above the acceptable short-term aggregate MOE 
of 100.
    Since residue values in drinking water are not available, the 
DWLOCs have to be back- calculated. The short- and intermediate-term 
DWLOCs are 290 g/L for adult males, 250 g/L for adult 
females, 77 g/L for children 1 to 6 years, and 77 g/L 
for infants (less than 1 year old). The estimated maximum concentration 
of bifenthrin in surface and ground water for chronic exposure 0.032 
g/L is very small compared to the DWLOCs.
    4. Aggregate cancer risk for U.S. population. Bifenthrin has been 
classified as a group C carcinogen, using the RfD approach. Based on 
the recommendation that the RfD approach be used, a quantitative (q*) 
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 PAD (RfD). For the 
U.S. population, only 2.4% of the chronic PAD (RfD) is occupied by 
chronic food exposure. As stated previously, based on a comparison of 
the calculated DWLOCs and the estimated exposure to bifenthrin in 
drinking water (0.032 g/L), EPA does not expect the aggregate exposure 
to exceed 100% of the chronic PAD (RfD) for adults.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
from aggregate exposure to bifenthrin residues.

E. Aggregate Risks and Determination of Safety for Infants and Children

    1. Safety factor for infants and children -- i. In general. In 
assessing the potential for additional sensitivity of infants and 
children to residues of bifenthrin, EPA considered data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat. The developmental toxicity studies are 
designed to evaluate adverse effects on the developing organism 
resulting from maternal pesticide exposure gestation. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for pre-and post-natal toxicity and the 
completeness of the database unless EPA determines that a different 
margin of safety will be safe for infants and children. Margins of 
safety are incorporated into EPA risk assessments either directly 
through use of a margin of exposure (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 uncertainty factor (usually

[[Page 35056]]

100 for combined inter- and intra-species variability) and not the 
additional tenfold MOE/uncertainty factor when EPA has a complete data 
base under existing guidelines and when the severity of the effect in 
infants or children or the potency or unusual toxic properties of a 
compound do not raise concerns regarding the adequacy of the standard 
MOE/safety factor.
    ii. Developmental toxicity studies. In the rabbit developmental 
study, there were no developmental effects observed in the fetuses 
exposed to bifenthrin. The maternal NOEL was 2.67 mg/kg/day based on 
head and forelimb twitching at the LOAEL of 4 mg/kg/day. In the rat 
developmental study, the maternal NOEL was 1 mg/kg/day, based on 
tremors at the LOAEL of 2 mg/kg/day. The developmental (pup) NOEL was 
also 1 mg/kg/day, based upon increased incidence of hydroureter at the 
LOAEL 2 mg/kg/day. There were 5 of 23 (22%) litters affected with each 
litter having only one affected pup in the 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%.
    iii. Reproductive toxicity study. In the rat reproduction study, 
parental toxicity occurred as decreased bwt at 5.0 mg/kg/day with a 
NOEL of 3.0 mg/kg/day. There were no developmental (pup) or 
reproductive effects up to 5.0 mg/kg/day (HDT).
    iv. Pre- and post-natal sensitivity -- a. Pre-natal. Since there 
was not a dose-related finding of hydroureter in the rat developmental 
study and in the presence of similar incidences in the recent 
historical control data, the marginal finding of hydroureter in rat 
fetuses at 2 mg/kg/day (in the presence of maternal toxicity) is not 
considered a significant developmental finding. Nor does it provide 
sufficient evidence of a special dietary risk (either acute or chronic) 
for infants and children which would require an additional safety 
factor.
    b. Post-natal. Based on the absence of pup toxicity up to dose 
levels which produced toxicity in the parental animals, there is no 
evidence of special post-natal sensitivity to infants and children in 
the rat reproduction study.
    v. Conclusion. There is a complete toxicity database for bifenthrin 
and exposure data is complete or is estimated based on data that 
reasonably accounts for potential exposures. Based on the completeness 
of the toxicity data and pre- and post-natal toxicity of bifenthrin, no 
additional safety factor is needed to protect infants and children.
    2. Acute risk. (Food + Water.) The percentages of the acute PAD 
utilized at the 99.9th percentile of exposure are 63% for infants (less 
than 1 year) and 96% for children (1 to 6 years), the most highly 
exposed population subgroup. An acute dietary exposure (food plus 
water) of 100% or less of the acute PAD is needed to protect the safety 
of all population subgroups. Despite the potential for exposure to 
bifenthrin in drinking water, EPA does not expect the aggregate 
exposure to exceed 100% of the acute PAD for infants and children. The 
estimated maximum concentration of bifenthrin in surface and ground 
water for acute exposure is below the DWLOC.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to bifenthrin from food 
will utilize 6.7% of the chronic PAD (RfD) for children (1 to 6 years). 
EPA generally has no concern for exposures below 100% of the RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. Despite the potential for exposure to bifenthrin in 
drinking water and from non-dietary, non-occupational exposure, EPA 
does not expect the aggregate exposure to exceed 100% of the RfD.
    4. Short- or intermediate-term risk. The MOEs for food (excluding 
water) and residential exposures is 430 for children (1 to 6 years), 
and 500 for infants (less than 1 year). These MOEs are well above the 
acceptable short-term aggregate MOE of 100. The short- and 
intermediate-term DWLOCs are 77 g/L for children (1 to 6 
years), and 77 g/L for infants (less than 1 year). The 
estimated maximum concentration of bifenthrin in surface and ground 
water for chronic exposure (g/L) is very small compared to the 
DWLOCs.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from aggregate exposure to bifenthrin residues.

III. Other Considerations

A. Metabolism In Plants and Animals

     The metabolism of bifenthrin in plants and animals is adequately 
understood. Studies conducted to delineate the metabolism of radio-
labeled bifenthrin in various crops and animals show similar results. 
The residue of concern is the parent compound only.

B. Analytical Enforcement Methodology

     Adequate enforcement methods are available for determination of 
the regulated bifenthrin residue in plants and animals. Residues of 
bifenthrin are recoverable under Protocols D and E of the FDA 
Multiresidue Methods.

C. Magnitude of Residues

     An adequate number of residue field trials reflecting the proposed 
use rates were submitted to EPA to demonstrate that tolerances for 
cabbage at 4.0 ppm; the cucurbit vegetable crop group at 0.4 ppm; 
edible-podded legume vegetable subgroup at 0.6 ppm; eggplant at 0.05 
ppm; globe artichoke at 1.0 ppm; head and stem Brassica subgroup, 
except cabbage, at 0.6 ppm; rapeseed at 0.05 ppm, succulent shelled pea 
and bean subgroup at 0.05 ppm; sweet corn at 0.05 ppm; and corn forage 
at 0.6 ppm will not be exceeded when bifenthrin products labeled for 
these uses are used as directed.

D. International Residue Limits

     There are no Codex Maximum Residue Levels (MRL's) for these 
commodities.

E. Rotational Crop Restrictions

     Crops with established U.S. tolerances may be rotated at any time. 
Leafy vegetable and root crops may be rotated 30 days following the 
final application. All other crops may be rotated seven months 
following the final application.

IV. Conclusion

    Therefore, the tolerance is established for residues of bifenthrin 
in cabbage at 4.0 part per million (ppm); the cucurbit vegetable crop 
group (Crop Group 9) at 0.4 ppm; edible- podded legume vegetable 
subgroup (Crop Subgroup 6A) at 0.6 ppm; eggplant at 0.05 ppm; globe 
artichoke at 1.0 ppm; head and stem Brassica subgroup (Crop Subgroup 
5A), except cabbage, at 0.6 ppm; rapeseed at 0.05 ppm, succulent 
shelled pea and bean subgroup (Crop Subgroup 6B) at 0.05 ppm; sweet 
corn kernel plus cob with husk removed at 0.05 ppm; and corn forage at 
3.0 ppm.

V. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation 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.

[[Page 35057]]

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 30, 1999, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given under the ``ADDRESSES'' section (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 
regulation. 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). 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 tolerance objection fee waivers, 
contact James Tompkins, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460. Office location, telephone number, and e-mail 
address: Rm. 239, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, (703) 305-5697, [email protected]. Requests for 
waiver of tolerance objection fees should be sent to James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460.
     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 CBI. Information so marked will not 
be disclosed except in accordance with procedures set forth in 40 CFR 
part 2. A copy of the information that does not contain CBI must be 
submitted for inclusion in the public record. Information not marked 
confidential may be disclosed publicly by EPA without prior notice.

VI. Public Record and Electronic Submissions

     EPA has established a record for this regulation under docket 
control number [OPP-300888] (including any comments and data submitted 
electronically). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
     Objections and hearing requests may be sent by e-mail directly to 
EPA at:
     [email protected].

     E-mailed objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption.
     The official record for this regulation, as well as the public 
version, as described in this unit will be kept in paper form. 
Accordingly, EPA will transfer any copies of objections and hearing 
requests received electronically into printed, paper form as they are 
received and will place the paper copies in the official record which 
will also include all comments submitted directly in writing. The 
official record is the paper record maintained at the Virginia address 
in ``ADDRESSES'' at the beginning of this document.

VII. Regulatory Assessment Requirements

A. Certain Acts and Executive Orders

    This final rule establishes a tolerance under section 408(d) of the 
FFDCA 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 specficed by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations as required by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    In addition, since tolerances and exemptions that are established 
on the basis of a petition under FFDCA section 408(d), such as the 
tolerance/exemption in this final rule, do not require the issuance of 
a proposed rule, the requirements of the Regulatory Flexibility Act 
(RFA) (5 U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency 
previously assessed whether establishing tolerances, exemptions from 
tolerances, raising tolerance levels or expanding exemptions might 
adversely impact small entities and concluded, as a generic matter, 
that there is no adverse economic impact. The factual basis for the 
Agency's generic certification for tolerance actions published on May 
4, 1981 (46 FR 24950), and was provided to the Chief Counsel for 
Advocacy of the Small Business Administration.

B. Executive Order 12875

    Under Executive Order 12875, entitled Enhancing the 
Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may 
not issue a regulation that is not required by statute and that creates 
a mandate upon a State, local or tribal government, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by those governments. If the mandate is unfunded, EPA 
must provide to OMB a description of the extent of EPA's prior 
consultation with representatives of affected State, local, and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulation. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local, and tribal 
governments ``to provide meaningful

[[Page 35058]]

and timely input in the development of regulatory proposals containing 
significant unfunded mandates.''
    Today's rule does not create an unfunded Federal mandate on State, 
local, or tribal governments. The rule does not impose any enforceable 
duties on these entities. Accordingly, the requirements of section 1(a) 
of Executive Order 12875 do not apply to this rule.

C. Executive Order 13084

    Under Executive Order 13084, entitled Consultation and Coordination 
with Indian Tribal Governments (63 FR 27655, May 19, 1998), EPA may not 
issue a regulation that is not required by statute, that significantly 
or uniquely affects the communities of Indian tribal governments, and 
that imposes substantial direct compliance costs on those communities, 
unless the Federal government provides the funds necessary to pay the 
direct compliance costs incurred by the tribal governments. If the 
mandate is unfunded, EPA must provide OMB, in a separately identified 
section of the preamble to the rule, a description of the extent of 
EPA's prior consultation with representatives of affected tribal 
governments, a summary of the nature of their concerns, and a statement 
supporting the need to issue the regulation. In addition, Executive 
Order 13084 requires EPA to develop an effective process permitting 
elected officials and other representatives of Indian tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory policies on matters that significantly or uniquely affect 
their communities.''
    Today's rule does not significantly or uniquely affect the 
communities of Indian tribal governments. This action does not involve 
or impose any requirements that affect Indian tribes. Accordingly, the 
requirements of section 3(b) of Executive Order 13084 do not apply to 
this rule.

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 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 the rule in the Federal Register. 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 
recordkeeping requirements.

    Dated: June 23, 1999.

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. 346a and 371.

    2. In Sec. 180.442, by amending paragraph (a) by revising the 
introductory text and the tolerance level for ``corn forage'' and by 
alphabetically adding the following entries to the table:


Sec. 180.442  Bifenthrin; tolerances for residues.

    (a) General. 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 or on the following food commodities:

 
------------------------------------------------------------------------
                 Commodity                        Parts per million
------------------------------------------------------------------------
Artichoke, globe..........................  1.0
Brassica, head and stem, subgroup,          0.6
 excluding cabbage.
Cabbage...................................  4.0
 
                    *    *    *    *    *    *    *
Corn, forage..............................  3.0
 
                    *    *    *    *    *    *    *
Corn, sweet, kernel plus cob with husk      0.05
 removed.
Eggplant..................................  0.05
 
                    *    *    *    *    *    *    *
Pea and bean, succulent shelled, subgroup.  0.05
 
                    *    *    *    *    *    *    *
Rapeseed..................................  0.05
 
                    *    *    *    *    *    *    *
Vegetable, cucurbit, crop group...........  0.4
Vegetable, legume, edible podded, subgroup  0.6
------------------------------------------------------------------------

* * * * *

[FR Doc. 99-16575 Filed 6-29-99; 8:45 am]
BILLING CODE 6560-50-F