[Federal Register Volume 65, Number 16 (Tuesday, January 25, 2000)]
[Rules and Regulations]
[Pages 3860-3866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-1667]



[[Page 3860]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300963; FRL-6485-2]
RIN 2070-AB78


Bifenthrin; Pesticide Tolerances for Emergency Exemptions

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Final rule.

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SUMMARY:  This regulation establishes time-limited tolerances for 
residues of bifenthrin (2-methyl [1,1'-biphenyl]-3-yl)methyl-3-(2-
chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate) in or on grapes and peanut nutmeats. 
This action is in response to EPA's granting of emergency exemptions 
under section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act authorizing use of the pesticide on grapes and peanuts. This 
regulation establishes maximum permissible levels for residues of 
bifenthrin in these food commodities. The tolerances will expire and is 
revoked on December 31, 2001.

DATES:  This regulation is effective January 25, 2000. Objections and 
requests for hearings, identified by docket control number OPP-300963, 
must be received by EPA on or before March 27, 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 VII. of the ``SUPPLEMENTARY 
INFORMATION.'' To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-300963 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Andrea Beard, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, Ariel Rios Building, 1200 Pennsylvania Avenue, NW., 
Washington, DC 20460; telephone number: (703) 308-9356; and e-mail 
address: <a href="/cdn-cgi/l/email-protection#d8babdb9aabcf6b9b6bcaabdb998bda8b9f6bfb7ae"><span class="__cf_email__" data-cfemail="1e7c7b7f6c7a307f707a6c7b7f5e7b6e7f30797168">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially 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 codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    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-300963. 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

    EPA, on its own initiative, in accordance with sections 408(l)(6) 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is 
establishing tolerances for residues of the insecticide bifenthrin (2-
methyl [1,1'-biphenyl]-3-yl)methyl-3-(2-chloro-3,3,3,-trifluoro-2-
chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate), in or on grapes at 0.2 part per 
million (ppm), and in/on peanut nutmeats at 0.05 ppm. These tolerances 
will expire and are revoked on December 31, 2001. EPA will publish a 
document in the Federal Register to remove the revoked tolerances from 
the Code of Federal Regulations.
    Section 408(l)(6) of the FFDCA requires EPA to establish a time-
limited tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
section 18 related tolerances to set binding precedents for the 
application of section 408 and the new safety standard to other 
tolerances and exemptions.
    Section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable 
certainty that no harm will result from aggregate exposure to the 
pesticide chemical residue, including all anticipated dietary exposures 
and all other exposures for which there is reliable information.'' This 
includes exposure through drinking water and in residential settings, 
but does not include occupational exposure. Section 408(b)(2)(C) 
requires EPA to give special consideration to exposure of infants and 
children to the pesticide chemical residue in establishing a tolerance 
and to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue. . . .''
    Section 18 of the Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) authorizes EPA to exempt any Federal or State agency from 
any provision of FIFRA, if EPA determines that ``emergency conditions 
exist which require such exemption.'' This provision was not amended by 
the Food Quality Protection Act (FQPA). EPA has

[[Page 3861]]

established regulations governing such emergency exemptions in 40 CFR 
part 166.

III. Emergency Exemptions for Bifenthrin on Grapes and Peanuts and 
FFDCA Tolerances

    1. Bifenthrin on grapes. The Applicant states that when the special 
local needs registration for carbofuran was canceled in 1997, the grape 
growers were left without adequate control for the black vine weevil, a 
seriously damaging pest in vineyards. Black vine weevil populations 
build up to damaging levels gradually, tending not to be pests in 
younger vineyards. Thus, this pest was generally not present at 
significant levels immediately following loss of carbofuran; however, 
the applicant states that this year, populations have been reaching 
damaging levels. The applicant stated that none of the available 
alternatives provide adequate control to avoid significant economic 
losses from this pest in grapes.
    2. Bifenthrin on peanuts. The Applicant states that although spider 
mite infestations have affected peanut growers for some years, the 
infestations have exceeded economically significant levels in recent 
years, and applications of available pesticides did not prevent these 
populations from rebounding quickly. In 1999, mite populations 
established earlier than normal, and the registered miticides were 
ineffective at providing adequate control, particularly with the hot 
dry weather conditions which are conducive to mite outbreaks. 
Additionally, it is believed that the mild winter contributed to a high 
overwintering survival rate, thus infestations were established 
earlier. With the infestations beginning so early, growers had to make 
multiple treatments with the alternatives, and were on the verge of 
using up their legal number of applications of these materials. 
However, spider mite outbreaks were still occurring at significantly 
damaging levels, and the Applicant stated that the use of bifenthrin 
was needed to avert significant economic losses from occurring. EPA has 
authorized under FIFRA section 18 the uses of bifenthrin on grapes for 
control of black vine weevil in Washington, and on peanuts for control 
of spider mites in Oklahoma. After having reviewed the submissions, EPA 
concurs that emergency conditions exist for these States.
    As part of its assessment of this emergency exemption, EPA assessed 
the potential risks presented by residues of bifenthrin in or on grapes 
and peanut nutmeats. In doing so, EPA considered the safety standard in 
FFDCA section 408(b)(2), and EPA decided that the necessary tolerances 
under FFDCA section 408(l)(6) would be consistent with the safety 
standard and with FIFRA section 18. Consistent with the need to move 
quickly on the emergency exemptions in order to address urgent non-
routine situations and to ensure that the resulting food is safe and 
lawful, EPA is issuing these tolerances without notice and opportunity 
for public comment as provided in section 408(l)(6). Although these 
tolerances will expire and are revoked on December 31, 2001, under 
FFDCA section 408(l)(5), residues of the pesticide not in excess of the 
amounts specified in the tolerances remaining in or on grapes and 
peanut nutmeats after that date will not be unlawful, provided the 
pesticide is applied in a manner that was lawful under FIFRA, and the 
residues do not exceed levels that were authorized by these tolerances 
at the time of that application. EPA will take action to revoke these 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these tolerances are being approved under emergency 
conditions, EPA has not made any decisions about whether bifenthrin 
meets EPA's registration requirements for use on grapes and peanuts or 
whether permanent tolerances for these uses would be appropriate. Under 
these circumstances, EPA does not believe that these tolerances serve 
as a basis for registration of bifenthrin by a State for special local 
needs under FIFRA section 24(c). Nor do these tolerances serve as the 
basis for any State other than Washington or Oklahoma to use this 
pesticide on these crops under section 18 of FIFRA without following 
all provisions of EPA's regulations implementing section 18 as 
identified in 40 CFR part 166. For additional information regarding the 
emergency exemptions for bifenthrin, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    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).
    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 time-limited tolerances for 
residues of bifenthrin (2-methyl [1,1'-biphenyl]-3-yl)methyl-3-(2-
chloro-3,3,3,-trifluoro-2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate) on grapes at 0.2 ppm, and on peanut 
nutmeats at 0.05 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 Unit II.A. of the Final Rule on Bifenthrin Pesticide 
Tolerances published in the Federal Register on June 30, 1999 (64 FR 
35051) (FRL-6089-9).

B. Toxicological Endpoint

    The toxicological endpoints for bifenthrin are discussed in Unit 
II.B. of the Final Rule on Bifenthrin Pesticide Tolerances published in 
the Federal Register on June 30, 1999.

C. Exposures and Risks

    1. From food and feed uses. Tolerances have been established (40 
CFR 180.442) for the residues of bifenthrin (2-methyl [1,1'-biphenyl]-
3-yl)methyl-3-(2-chloro-3,3,3,-trifluoro-2-chloro-3,3,3,-trifluoro-1-
propenyl)-2,2-dimethylcyclopropanecarboxylate), in or on a variety of 
raw agricultural 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 and risks 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

[[Page 3862]]

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% of the crop was treated for the 
following tolerances: canola, citrus, snap beans, peas, lima beans, 
sweet corn, cucurbits, eggplant, and Brassica vegetable. One hundred 
percent crop treated was also assumed for these section 18 uses for 
grapes and peanuts. 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 (CSFII) 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 (PCT) was used (except 
as indicated above) and anticipated residues for all crops.
    In conducting this Dietary Exposure Evaluation Model (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 CSFII conducted in 1989 through 
1992.
    i. Acute exposure and risk. Acute dietary risk assessments are 
performed for a food-use pesticide if a toxicological study has 
indicated the possibility of an effect of concern occurring as a result 
of a 1-day or single exposure. The percentages of the acute PAD (aPAD) 
utilized at the 99.9th percentile of exposure are 60% for the U.S. 
population, 75% for infants ( 1 year), and 99.7% 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 aPAD is 
needed to protect the safety of all population subgroups.
    ii. Chronic exposure and risk. Dietary exposure (food only) for the 
most highly exposed population subgroup (children 1 - 6 years old), 
will utilize 8.2% of the chronic PAD (cPAD). The exposure for the U.S. 
population is 3% of the cPAD. A chronic dietary exposure (food plus 
water) of 100% or less of the cPAD is needed to protect the safety or 
all population subgroups.
    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 
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 used PCT information as follows. It was assumed that 
100% crop was treated for all crops except hops at 43%, and cottonseed-
oil and cottonseed-meal at 4%.
    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 underestimated. 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. 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

[[Page 3863]]

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 EPA's Pesticide Root Zone Model/
Exposure Analysis Modeling Systems (PRZM/EXAMS) model using the highest 
application rate of 0.5 pounds/acre, which is registered for use on 
cotton.
    i. Acute exposure and risk. For the purposes of this acute risk 
assessment, the estimated acute maximum concentration for bifenthrin in 
surface and ground waters is 0.10 <greek-m>g/L, which was used for 
comparison to the back-calculated DWLOCs for the acute endpoint. The 
DWLOCs for various population categories are 140 <greek-m>g/L for the 
U.S. population, 180 <greek-m>g/L for females 13 years and older, and 
0.3 <greek-m>g/L for children 1 - 6 years old. Acute exposure to 
bifenthrin in drinking water is below the calculated drinking water 
levels of concern.
    ii. Chronic exposure and risk. For the purposes of the chronic risk 
assessment, the estimated chronic maximum concentration for bifenthrin 
in surface and ground waters is 0.032 <greek-m>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 <greek-m>g/L for the U.S. population, 450 <greek-m>g/L for 
females 13 years and older, and 140 <greek-m>g/L for children 1 - 6 
years old. 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 <greek-m>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 320 
<greek-m>g/L for the U.S. population, 270 <greek-m>g/L for females 13 
years and older, and 77 <greek-m>g/L for children 1 - 6 years old. 
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 following residential non-food sites: outdoor lawn and 
garden, inside households, and termiticide use. These registered uses 
constitute short- and/or intermediate and chronic exposure.
    i. Chronic exposure and risk. 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 
the vapor pressure of bifenthrin is extremely low.
    ii. Short- and intermediate-term exposure and risk. 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 1,600 for adults, 610 for children (1 - 6 years), and 600 for 
infants (<ls-thn-eq> 1 year). These MOEs are well above the acceptable 
short-term aggregate MOE of 100.
    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.'' Bifenthrin is a member of a class of 
chemicals commonly referred to as ``Synthetic Pyrethroids.'' Other 
members of the class include cyfluthrin, cypermethrin, lambda-
cyhalothrin, zeta-cypermethrin, deltamethrin, esfenvalerate, 
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 more 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).

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

    1. Acute risk (food plus 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 60% of the aPAD. Children 1 to 6 
years are the most highly exposed population subgroup, with 99.7% of 
the aPAD utilized. (See discussion in Unit II.E.) An acute dietary 
exposure (food plus water) of 100% or less of the aPAD 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 aPAD for adults, infants and 
children. The estimated maximum concentration of bifenthrin in surface 
and ground water for acute exposure is below all DWLOCs.
    2. Chronic risk (food plus water plus residential). Using the 
exposure assumptions described in this unit, EPA has concluded that 
aggregate exposure to bifenthrin from food will utilize 3% of the cPAD 
for the U.S. population. The major identifiable subgroup with the 
highest aggregate exposure is children 1 to 6 years, with 8.2% of the 
cPAD utilized. [See discussion in Unit II.E. in the preamble of this 
document]. EPA generally has no concern for exposures below 100% of the 
cPAD because the cPAD 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 cPAD, the estimated maximum concentration of bifenthrin in 
surface and ground water for chronic exposure is very small compared to 
the DWLOCs. 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.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate

[[Page 3864]]

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 (non-dietary). The MOEs for food (excluding water) 
and residential exposures is 1,100 for adults, 420 for children 1 to 6 
years, and 500 for infants  1 year. These MOEs are all 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 <greek-m>g/L for adult males, 250 <greek-m>g/L for adult 
females, 77 <greek-m>g/L for children 1 to 6 years, and 77 <greek-m>g/L 
for infants ( 1 year old). The estimated maximum concentration of 
bifenthrin in surface and ground water for chronic exposure 0.032 
<greek-m>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 Reference Dose (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 
cPAD RfD. For the U.S. population, only 3% of the cPAD 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 <greek-m>g/L), EPA does not expect the aggregate 
exposure to exceed 100% of the cPAD 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 during gestation. 
Reproduction studies provide information relating to effects from 
exposure to the pesticide on the reproductive capability of mating 
animals and data on systemic toxicity.
    FFDCA section 408 provides that EPA shall apply an additional 
tenfold margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal toxicity and 
the completeness of the data base unless EPA determines that a 
different margin of safety will be safe for infants and children. 
Margins of safety are incorporated into EPA risk assessments either 
directly through use of a 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 MOE and uncertainty factor (usually 100 for 
combined interspecies and intraspecies 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 NOAEL 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 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 2 mg/kg/day. There were 5 of 23 (22%) litters affected with each 
litter having only 1 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% 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 
NOAEL of 3.0 mg/kg/day. There were no developmental (pup) or 
reproductive effects up to 5.0 mg/kg/day (HDT).
    iv. Prenatal and postnatal sensitivity-- a.Prenatal. 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. Postnatal. Based on the absence of pup toxicity up to dose 
levels which produced toxicity in the parental animals, there is no 
evidence of special postnatal sensitivity to infants and children in 
the rat reproduction study.
    v. 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. Based on the 
completeness of the toxicity data and prenatal and postnatal toxicity 
of bifenthrin, no additional safety factor is needed to protect infants 
and children.
    2. Acute risk (food plus water.) The percentages of the aPAD 
utilized at the 99.9th percentile of exposure are 75% for infants ( 1 
year) and 99.7% 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 aPAD 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 aPAD for infants and children. The estimated maximum 
concentration of bifenthrin in surface and ground water for acute 
exposure is below the DWLOCs.
    3. Chronic risk. Using the exposure assumptions described in this 
unit, EPA has concluded that aggregate exposure to bifenthrin from food 
will utilize 8.2% of the cPAD for children (1 - 6 years old), the most 
highly exposed subgroup for infants and children. EPA generally has no 
concern for exposures below 100% of the cPAD because the cPAD 
represents the level at or below which daily aggregate dietary exposure 
over a lifetime will not pose appreciable risks

[[Page 3865]]

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 cPAD.
    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 ( 1 year). These MOEs are well above the acceptable 
short-term aggregate MOE of 100. The short- and intermediate-term 
DWLOCs are 77 <greek-m>g/L for children (1 to 6 years), and 77 
<greek-m>g/L for infants ( 1 year). The estimated maximum concentration 
of bifenthrin in surface and ground water for chronic exposure ( 0.032 
<greek-m>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.

V. 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

    Residues of bifenthrin are not expected to exceed 0.2 ppm in/on 
grapes, and 0.05 ppm in/on peanut nutmeats, as a result of these uses. 
Since the use on peanuts prohibits the feeding of peanut hay to 
livestock, the existing tolerances for livestock commodities are 
considered to be adequate.

D. International Residue Limits

    There are no Codex Maximum Residue Levels (MRLs) 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 7 months following 
the final application.

VI. 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-2-chloro-3,3,3,-trifluoro-1-propenyl)-2,2-
dimethylcyclopropanecarboxylate) in grapes at 0.2 ppm, and in peanut, 
nutmeats, at 0.05 ppm.

VII. 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-300963 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 March 27, 
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, 401 M St., SW., Washington, DC 20460. 
You may also deliver your request to the Office of the Hearing Clerk in 
Rm. M3708, 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 <a href="/cdn-cgi/l/email-protection#aedac1c3dec5c7c0dd80c4c7c3eecbdecf80c9c1d8"><span class="__cf_email__" data-cfemail="1c6873716c7775726f327675715c796c7d327b736a">[email protected]</span></a>, 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., 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, 401 M St., SW., 
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 VII.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 the docket control number OPP-300963, 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 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

[[Page 3866]]

your request via e-mail to: <a href="/cdn-cgi/l/email-protection#dbb4ababf6bfb4b8b0beaf9bbeabbaf5bcb4ad"><span class="__cf_email__" data-cfemail="701f00005d141f131b1504301500115e171f06">[email protected]</span></a>. 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).

VIII. Regulatory Assessment Requirements

    This final rule establishes time limited tolerances under FFDCA 
section 408. 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, 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 FIFRA 
section 18 petition under FFDCA section 408, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply. 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).

IX. 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: January 7, 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), 346(a) and 371.

    2. Section 180.442 is amended, by adding and alphabetically 
inserting the following entries to the table under paragraph (b) to 
read as follows:


Sec. 180.442  Bifenthrin; tolerances for residues.

* * * * *
    (b) * * *

------------------------------------------------------------------------
                                                     Parts   Expiration/
                    Commodity                         per     revocation
                                                    million      date
------------------------------------------------------------------------
 
                     *        *      *      *      *
Grapes...........................................   0.2         12/31/01
 
                     *        *      *      *      *
Peanuts, nutmeats................................   0.05        12/31/01
 
                     *        *      *      *      *
------------------------------------------------------------------------

    *      *      *      *      *
[FR Doc. 00-1667 Filed 1-24-00; 8:45 am]
BILLING CODE 6560-50-F


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