[Federal Register Volume 64, Number 245 (Wednesday, December 22, 1999)]
[Notices]
[Pages 71767-71774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33035]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-903; FRL-6396-2]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for Certain Pesticide Chemicals in or on Food

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the initial filing of pesticide 
petitions proposing the establishment of regulations for residues of 
certain

[[Page 71768]]

pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number PF-903, must be 
received on or before January 21, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-903 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Shaja R. Brothers, 
Registration Support Branch, Registration Division (7505C), Office of 
Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
Washington, DC 20460; telephone number: (703) 308-3194; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

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

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


    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 PF-903. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, 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 Highway, 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.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-903 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: ``[email protected],'' or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-903. Electronic comments may 
also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under ``FOR FURTHER INFORMATION 
CONTACT.''

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the

[[Page 71769]]

name, date, and Federal Register citation.

II. What Action is the Agency Taking?

     EPA has received pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions contain data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data supports granting of the petitions. Additional data 
may be needed before EPA rules on the petitions.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.

    Dated: December 10, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The petitioner summaries of the pesticide petitions are printed 
below as required by section 408(d)(3) of the FFDCA. The summaries of 
the petitions were prepared by the petitioners and represent the view 
of the petitioner. EPA is publishing the petition summaries verbatim 
without editing them in any way. The petition summaries announce the 
availability of a description of the analytical methods available to 
EPA for the detection and measurement of the pesticide chemical 
residues or an explanation of why no such method is needed.

1. Interregional Research Project Number 4 and BASF Corporation, 
Agricultural

 9E6002 and 7F4881

    EPA has received a pesticide petition (9E6002) from the 
Interregional Research Project Number 4 (IR-4), Center for Minor Crop 
Pest Management, Technology Center of New Jersey, Rutgers, the State 
University of New Jersey, 681 U.S. Highway #1 South, North Brunswick, 
NJ 08902-3390. EPA has also received a pesticide petition (7F4881) from 
BASF Corporation, Agricultural Products, P.O. Box 13528, Research 
Triangle Park, NC 27709. The petitions propose, pursuant to section 
408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 
346a(d), to amend 40 CFR part 180 by establishing a tolerances for 
residues of pyridaben 2-tert-butyl-5-(4-tert-butylbenzylthio)-4-
chloropyridazin-3(2H)-one in or on the raw agricultural commodities 
(RAC) cranberries (9E6002), and pistachio (7F4881) at 0.5 and 0.05 and 
parts per million (ppm). Registration for pyridaben on cranberries 
would be limited to areas along the eastern coast in the states of MA, 
NJ, ME, NY, CT, NH, VT, RI, and DE based on the geographical 
representation of the residue data submitted.
    EPA has determined that the petitions contain data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data supports granting of the 
petitions. Additional data may be needed before EPA rules on the 
petitions. This notice includes a summary of the petitions prepared by, 
BASF Corporation, the registrant, P.O. Box 13528, Research Triangle 
Park, NC 27709.

A. Residue Chemistry

    1. Plant metabolism. The nature of the residue in plants is 
adequately understood. The residue of concern is pyridaben per se as 
specified in 40 CFR 180.494.
    2. Analytical method. The proposed analytical method involves 
extraction, partition, clean-up and detection of residues by gas 
chromatography/electron capture detector (GC/ECD).
    3. Magnitude of residues. Three cranberry residue trials were 
conducted in two states. Residues of pyridaben were measured by GC/ECD. 
The method of detection had a limit of detection of 0.05 ppm. Residues 
ranged from 0.172 to 0.447. Pistachio use rates will be the same as 
almond which have already received a tolerance of 0.05 ppm.. Also, 
pending at EPA is a nut crop group tolerance petition including 6 
residue trials of pecans showing all residues are below 0.05 ppm.

B. Toxicological Profile

    1. Acute toxicity--i. Subpopulation females 13+ years old. The no 
observed adverse effect level (NOAEL) is 13 milligrams/kilograms (mg/
kg). In a developmental toxicity study, Sprague-Dawley rats (22/group) 
from Charles River, U.K., received NC-129 Pyridaben, 98.0% active 
ingredient (a.i.) via gavage at dose levels of 0, 2.5, 5.7, 13.0, or 
30.0 mg/kg/day from gestation day 6 through 15, inclusive. Natural 
mating was used. Maternal toxicity, observed at 13.0 and 30.0 mg/kg/
day, consisted of decreased body weight (bwt)/weight gain and food 
consumption during the dosing period. Based on these effects, the 
maternal toxicity lowest observed adverse effect level (LOAEL) is 13.0 
mg/kg/day and the maternal toxicity NOAEL is 4.7 mg/kg/day (82% of 5.7 
mg/kg/day based on concentration analysis). Developmental toxicity 
NOAEL is 13.0 mg/kg/day based on observed decreased fetal (bwt) and 
increased incomplete ossification in selected bones at 30.0 mg/kg/day 
LOAEL. With the 100 uncertainty factor (UF) (10x for interspecies 
extrapolation and 10x for intraspecies variability) the chronic 
population adjusted dose (cPAD) for females 13+ is 0.13 mg/kg/day.
    ii. General population including infants and children. NOAEL = 50 
mg/kg. In an acute neurotoxicity study, CD Rats (10/sex/group) were 
administered a single oral dose (gavage) of NC-129 in 1% aqueous 
carboxymethyl cellulose of 0 (vehicle), 50, 100, and 200 mg/kg (a.i. 
equivalents: 44.3, 79.6, and 190.0 mg/kg for males and 44.5, 99.7, and 
190.0 mg/kg bwt for females). The animals were observed for mortality 
and clinical signs of toxicity for 14 days post-dosing. During the 
first 5 days, compound-related decreases in bwt gain were noted in mid-
dose males (17%) and females (36%) and high-dose males (74%); the high-
dose females lost weight (4 g) during the first 4 days of the 
observation period. Food consumption was low in all treated groups on 
the day of dosing with severe effects seen in the high-dose males (73% 
lower than controls). Dose-dependent increases in clinical signs 
(piloerection, hypoactivity, tremors, and partially closed eyes) were 
seen in mid-dose males and high-dose males and females. These effects 
were reversible by observation day 4. Treatment-related findings in the 
functional observational battery consisted of lower body temperature 
and reduced motor activity among the high-dose males. No treatment-
related gross or microscopic neuropathologic findings were present. The 
NOAEL for systemic toxicity is 50 mg/kg for both sexes. The LOAEL of 
100 mg/kg/day is based on systemic toxicity including clinical signs 
and decreased food consumption and bwt gain. With the 100 UF the aPAD 
for the general population is calculated to be 0.5 mg/kg/day.
    2. Subchronic toxicity. The NOAEL is 100 mg/kg/day. In a 21-day 
dermal toxicity study, repeated doses of pyridaben were applied 
topically to approximately 10% of the body surface area of rats at 
doses of 0, 30, 100, 300, or 1,000 mg/kg/day for 21 days.

[[Page 71770]]

Increased squamous cell hyperplasia and/or surface accumulation of 
desquamated epithelial cells were noted sporadically in the 100, 300, 
and 1,000 mg/kg/day dose groups. These findings appear to be due to 
abrasions of the skin when the powdered substance was applied onto the 
skin, rather than a dose-related effect. No gross dermal irritation 
effects were noted. Based on the results of the study, the systemic 
dermal toxicity NOAEL is 100 mg/kg/day. The systemic dermal toxicity 
LOAEL is determined to be 300 mg/kg/day based on decreased bwt in the 
females. The dermal irritation NOAEL is 100 mg/kg/day. Note: In 
agreement, a dermal equivalent dose of 94 mg/kg/day is derived if the 
maternal oral NOAEL of 4.7 mg/kg/day (based on decreased bwt gain and 
food consumption) in the rat oral developmental toxicity study is 
adjusted by the proposed 5% dermal absorption rate.
    3. Chronic toxicity. EPA has established the cPAD for pyridaben at 
0.005 mg/kg/day. This cPAD is based on a 1 year feeding study in dogs 
with a NOAEL of 0.5 mg/kg/day and an uncertainty factor of 100 based on 
decreased bwt, emesis, and ptyalism.
    4. Animal metabolism. The nature of the residue in animals is 
adequately understood. The residue of concern is pyridaben and its 
metabolites PB-7 (2-tert-butyl-5-[4-(1-carboxy-1-
methylethyl)benzylthio]-4-chloropyridazin-3(2H)-one) and PB-9 (2-tert-
butyl-4-chloro-5-[4-(1,1-dimethyl-2-hydroxyethyl) benzylthio]-
chloropyridazin-3(2H)-one) as specified in 40 CFR 180.494.

C. Aggregate exposure

    1. Dietary exposure--i. Food. From the acute dietary risk 
assessment, the calculated exposure yields dietary percentage of the 
aPAD for females 13+ years old ranging from 29% for females 13+ years 
old--not pregnant, non-nursing, to 42% for females 13+ years old--
pregnant, not nursing. The calculated exposure yields dietary 
percentage of the aPAD for the remainder of the population ranging from 
9% for males 13-19 years old to 77% for nursing infants > 1 year old. 
This risk estimate should be viewed as highly conservative; refinement 
using anticipated residue values and percent crop-treated data in 
conjunction with a Monte Carlo analysis will result in a lower acute 
dietary exposure estimate. In conducting the chronic dietary risk 
assessment, the registrant has made somewhat conservative assumptions--
that 100% of cranberries will contain pyridaben residues and those 
residues will be at the level of the tolerance plus the ratio of 
organosoluble residues to pyridaben, and all commodities having 
published and pending pyridaben tolerances will contain pyridaben 
regulable residues, those residues will be at the anticipated residue 
level for the commodity, no percent crop treated data were used, and 
plant anticipated residues will be adjusted using the ratio of 
organosoluble residues to pyridaben all of which result in an 
overestimation of human dietary exposure. Thus, in making a safety 
determination for this tolerance, EPA is taking into account this 
conservative exposure estimate.
    ii. Drinking water. Based on information currently available to 
EPA, pyridaben is immobile and thus unlikely to leach to ground water. 
There is no established maximum contaminant level for residues of 
pyridaben in drinking water. No health advisory levels for pyridaben in 
drinking water have been established. EPA uses the Generic expected 
environmental concentration (GENEEC) and SCI-GROW screening models to 
estimate surface and ground water concentrations for first-tier 
exposure assessments. As screening models designed to estimate the 
concentrations found in surface and ground water for use in ecological 
risk assessment, they provide upper-bound values on the concentrations 
that might be found in ecologically sensitive environments because of 
the use of a pesticide. The models predict that as much as 2.3 part per 
billion (ppb) and 0.0003 ppb of pyridaben may be found in surface and 
ground water, respectively. The modeling data were compared to the 
results from modeling equations used to calculate the acute and chronic 
drinking water levels of concern (DWLOC) for pyridaben in surface and 
ground water.
    a. Acute exposure and risk. Acute DWLOCs have been calculated by 
EPA at the following amounts: U.S. population 14,000 g/L; adult male 
20+ years old 15,000 g/L; adult female 13+, pregnant, non-nursing 2,200 
g/L infant < 1g/L, nursing 1,100 g/L.
    b. Chronic exposure and risk. Chronic DWLOCs have been calculated 
by EPA at the following amounts: U.S. population 140 g/L; adult male, 
13-19 years old 160 g/L; adult female 13+, nursing 100 g/L; infant > 1, 
non-nursing 7 g/L.
    2. Non-dietary exposure. Pyridaben is currently not registered for 
use on residential non-food sites.

D. Cumulative Effects

    The registrant does not have, at this time, available data to 
determine whether pyridaben 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, 
pyridaben does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
the registrant has not assumed that pyridaben has a common mechanism of 
toxicity with other substances.

E. Safety Determination

    1. U.S. population--i. Acute risk. Using the published and pending 
tolerances, the dietary percentage of the aPAD range from 9% for males 
13-19 years old to 77% for nursing infants  1 year old, with 
the U.S. population at 18%. This risk estimate should be viewed as 
highly conservative; refinement using additional anticipated residue 
values and percent crop-treated data in conjunction with Monte Carlo 
analysis will result in a lower acute dietary exposure estimate. The 
acute dietary exposure does not exceed EPA's level of concern. 
Pyridaben is immobile and thus, unlikely to leach to ground water. The 
modeling data for pyridaben in drinking water indicate levels less than 
EPA's DWLOC for acute exposure. Since a refined acute risk for food 
only would not exceed EPA's levels of concern for acute dietary 
exposures and the monitoring and modeling levels in water are less than 
the acute DWLOC, the registrant does not expect aggregate acute 
exposure to pyridaben will pose an unacceptable risk to human health.
    ii. Chronic risk. Using the somewhat conservative anticipated 
residue contribution (ARC) exposure assumptions described in Unit 
III.B. of this preamble, EPA has concluded that aggregate exposure to 
pyridaben from food will utilize 20% of the cPAD for the U.S. 
population. The major identifiable subgroup with the highest aggregate 
exposure is discussed below. 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. The residues of pyridaben in 
drinking water do not exceed EPA's DWLOC. Pyridaben does not have any 
residential uses. The registrant does not expect the aggregate exposure 
to exceed 100% of the cPAD.
    iii. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account chronic dietary 
food and water (considered to be a background exposure level) plus 
indoor and outdoor

[[Page 71771]]

residential uses. Since there are no residential uses, a short-term or 
intermediate-term aggregate risk assessment is not required.
    iv. Aggregate cancer risk for U.S. population. Since pyridaben has 
been classified as a Group E carcinogen ``no evidence of 
carcinogenicity to humans,'' a cancer risk assessment is not required.
    v. 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 old from the 
passage of FQPA (August 3, 1999) to implement this program. At that 
time, EPA may require further testing of this a.i and end use products 
for endocrine disrupter effects.
    vi. Determination of safety. Based on these risk assessments, the 
registrant concludes that there is a reasonable certainty that no harm 
will result from aggregate exposure to pyridaben residues.
    2. Infants and children--i. Safety factor for infants and 
children--a. In general. In assessing the potential for additional 
sensitivity of infants and children to residues of pyridaben, data from 
developmental toxicity studies in the rat and rabbit and a 2-generation 
reproduction study in the rat were considered. 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 
prenatal and postnatal effects from exposure to pyridaben, 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 UF (usually 100 for 
combined interspecies and intraspecies variability) and not the 
additional tenfold MOE/UF 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--a. Rats. In a developmental 
toxicity study in rats, the maternal (systemic) NOAEL was 4.7 mg/kg/
day. The maternal LOAEL of 13 mg/kg/day was based on decreases in bwt, 
bwt gain, and food consumption during the dosing period (GD 6-15). The 
developmental (fetal) NOAEL was 13 mg/kg/day. The developmental LOAEL 
of 30 mg/kg/day was based on decreased fetal bwt and increased 
incomplete ossification in selected bones.
    b. Rabbits. In an oral developmental toxicity study in rabbits, the 
maternal (systemic) NOAEL was not established. The maternal LOAEL of 
1.5 mg/kg/day was based on decreases in bwt gain and food consumption. 
There was no developmental toxicity observed at any dose tested. 
Therefore, the developmental (fetal) NOAEL is 15 mg/kg/day at the 
highest dose tested (HDT).
    iii. Reproductive toxicity study--rats. In the 2-generation 
reproductive toxicity study in rats, the prenatal (systemic) NOAEL was 
2.3 mg/kg/day. The prenatal (systemic) LOAEL of 7 mg/kg/day was based 
on decreased bwt, decreased bwt gains, and decreased food efficiency. 
The reproductive (pup) NOAEL was 7 mg/kg/day and the LOAEL was 7 mg/kg/
day at the HDT.
    iv. Prenatal and postnatal sensitivity. The toxicological data base 
for evaluating prenatal and postnatal toxicity for pyridaben is 
complete with respect to current data requirements. There are no 
prenatal or postnatal toxicity concerns for infants and children based 
on the results of the rat and rabbit developmental toxicity studies as 
well as the 2-generation rat reproductive toxicity study. According to 
the above, reliable data support removing the additional 10x safety 
factor for protection of infants and children.
    v. Conclusion. There is a complete toxicity data base for pyridaben 
and exposure data are complete or are estimated based on data that 
reasonably accounts for potential exposures.
    a. Acute risk. Using the somewhat conservative exposure assumptions 
described above, the percentage of the aPAD that will be utilized by 
dietary exposure to residues of pyridaben for infants and children 
range from 16% for children 7-12 years old to 77% for nursing infants 
 1 year old. The acute DWLOC does not exceed EPA's level of 
concern. Taking into account the completeness and reliability of the 
toxicity data and this conservative exposure assessment, the registrant 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from acute aggregate exposure to pyridaben 
residues.
    b. Chronic risk. Using the somewhat conservative exposure 
assumptions described above, EPA has calculated that the percentage of 
the cPAD that will be utilized by dietary exposure to residues of 
pyridaben ranges from 27% for nursing infants less than 1 year old, up 
to 85% for non-nursing infants less than 1 year old. The chronic DWLOC 
does not exceed the level of concern. There are no residential uses for 
pyridaben. Taking into account the completeness and reliability of the 
toxicity data and this conservative exposure assessment, the registrant 
concludes that there is a reasonable certainty that no harm will result 
to infants and children from chronic aggregate exposure to pyridaben 
residues.
    c. Short-term or intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account chronic dietary 
food and water plus indoor and outdoor residential uses. Since the 
chronic food and chronic DWLOC do not exceed EPA's level of concern and 
there are currently no indoor or outdoor residential uses of pyridaben, 
the short-term and intermediate-term aggregate risk does not exceed 
EPA's level of concern.
    d. Determination of safety. Based on these risk assessments, the 
registrant concludes that there is a reasonable certainty that no harm 
will result to infants and children from aggregate exposure to 
pyridaben residues.

F. International Tolerances

    There are no CODEX, Canadian, or Mexican Maximum Residue Limits 
established for pyridaben on cranberries and pistachio.

2. Interregional Research Project Number 4

 9E6016, 9E6030, 9E6031, and 9E6034

    EPA has received pesticide petitions (9E6016, 9E6030, 9E6031, and 
9E6034) from the Interregional Project Number 4 (IR-4) Rutgers 
University, New Brunswick, NJ, 08903-0231 proposing,

[[Page 71772]]

pursuant to section 408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 
CFR part 180 by establishing a tolerance 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 the RAC as 
follows:
    1. PP 9E6016 proposes the establishment of a tolerance for grape at 
0.2 ppm.
    2. PP 9E6030 proposes the establishment of a tolerance for peppers 
at 0.5 ppm.
    3. PP 9E6031 proposes the establishment of a tolerance for head 
lettuce at 2.0 ppm.
    4. PP 9E6034 proposes the establishment of a tolerance for the 
caneberry subgroup at 1.0 ppm.
    EPA has determined that the petitions contain data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data supports granting of the 
petitions. Additional data may be needed before EPA rules on these 
petitions.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of bifenthrin in plants is 
adequately understood. Studies have been conducted to delineate the 
metabolism of radiolabelled bifenthrin in various crops all showing 
similar results. The residue of concern is the parent compound only.
    2. Analytical method. There is a practical analytical method for 
detecting and measuring levels of bifenthrin in or on food with a limit 
of detection that allows monitoring of food with residues at or above 
the levels set in these tolerances GC/ECD analytical method P-2132M.
    3. Magnitude of residues. Field residue trials meeting EPA study 
requirements have been conducted at the maximum label rate for these 
crops. Results from these trials demonstrate that the proposed 
bifenthrin tolerances of 0.2 ppm for grape, 0.5 ppm for peppers, 2.0 
ppm for head lettuce, and 1.0 ppm for the caneberry subgroup will not 
be exceeded when the product is applied following the proposed use 
directions.

B. Toxicological Profile

    1. Acute toxicity. For the purposes of assessing acute dietary 
risk, FMC has used the maternal NOAEL of 1.0 mg/kg/day from the oral 
developmental toxicity study in rats. The maternal LOAEL of this study 
of 2.0 mg/kg/day was based on tremors from day 7-17 of dosing. This 
acute dietary endpoint is used to determine acute dietary risks to all 
population subgroups.
    2. Genotoxicity. The following genotoxicity tests were all 
negative: gene mutation in Salmonella (Ames); chromosomal aberrations 
in Chinese hamster ovary (CHO) and rat bone marrow cells; hypoxanthine 
guanine phophoribosyl transferase (HGPRT) locus mutation in mouse 
lymphoma cells; and unscheduled DNA synthesis in rat hepatocytes.
    3. Reproductive and developmental toxicity. 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.
    4. Subchronic toxicity. The maternal NOAEL of 1.0 mg/kg/day from 
the oral developmental toxicity study in rats is also used for short-
term and intermediate-term MOE calculations (as well as acute, 
discussed in paragraph (1) above). The maternal LOAEL of this study of 
2.0 mg/kg/day was based on tremors from day 7-17 of dosing.
    5. Chronic toxicity--i. The chronic population adjusted dose (cPAD) 
has been established at 0.015 mg/kg/day. This cPAD is based on a 1 year 
oral feeding study in dogs with a NOAEL of 1.5 mg/kg/day, based on 
intermittent tremors observed at the LOAEL of 3.0 mg/kg/day; an 
uncertainty factor of 100 is used.
    ii. Bifenthrin is classified as a Group C chemical (possible human 
carcinogen) based upon urinary bladder tumors in mice; assignment of a 
Q* has not been recommended.
    6. Animal metabolism. The metabolism of bifenthrin in animals is 
adequately understood. Metabolism studies in rats with single doses 
demonstrated that about 90% of the parent compound and its hydroxylated 
metabolites are excreted.
    7. Metabolite toxicology. The Agency has previously determined that 
the metabolites of bifenthrin are not of toxicological concern and need 
not be included in the tolerance expression.
    8. Endocrine disruption. No special studies investigating potential 
estrogenic or other endocrine effects of bifenthrin have been 
conducted. However, no evidence of such effects were reported in the 
standard battery of required toxicology studies which have been 
completed and found acceptable. Based on these studies, there is no 
evidence to suggest that bifenthrin has an adverse effect on the 
endocrine system.

C. Aggregate Exposure

    1. Dietary exposure--i. Food. Tolerances have been established for 
the residues of bifenthrin, in or on a variety of RACs. Tolerances, in 
support of registrations, currently exist for residues of bifenthrin on 
hops; strawberries; corn grain, forage, and fodder; cottonseed; 
artichokes, the crop group cucurbit vegetables, the crop group legume 
vegetables - subgroup edible-podded legume vegetables and subgroup 
succulent shelled pea and bean, eggplant, the subgroup head and stem 
brassica, and livestock commodities of cattle, goats, hogs, horses, 
sheep, poultry, eggs, and milk. Pending tolerances for citrus, 
raspberries and sweet corn also exist. For the purposes of assessing 
the potential dietary exposure for the existing and pending tolerances, 
FMC has utilized available information on anticipated residues, 
monitoring data and percent crop treated.
    ii. Drinking water. Laboratory and field data have demonstrated 
that bifenthrin is immobile in soil and will not leach into ground 
water. Other data show that bifenthrin is virtually insoluble in water 
and extremely lipophilic. As a result, FMC concludes that residues 
reaching surface waters from field runoff will quickly adsorb to 
sediment particles and be partitioned from the water column. Further, a 
screening evaluation of leaching potential of a typical pyrethroid was 
conducted using EPA's Pesticide Root Zone Model (PRZM3). Based on this 
screening assessment, the potential concentrations of a pyrethroid in 
ground water at depths of 1 and 2 meters are essentially zero [< 0.001 
parts per billion (ppb)]. Surface water concentrations for pyrethroids 
were estimated using PRZM3 and Exposure Analysis Modeling System 
(EXAMS) using standard EPA cotton runoff and Mississippi pond 
scenarios. The maximum concentration predicted in the simulated pond 
was 0.052 ppb. Concentrations in actual drinking water would be much 
lower than the levels predicted in the hypothetical, small, stagnant 
farm pond model since drinking water derived from surface water would 
normally be treated before consumption. Based on these analyses, the 
contribution of water to the dietary risk estimate is negligible. 
Therefore, FMC concludes that together these data indicate that 
residues are not expected to occur in drinking water.
    2. Non-dietary exposure. Analyses were conducted which included an 
evaluation of potential non-dietary (residential) applicator, post-
application

[[Page 71773]]

and chronic dietary aggregate exposures associated with bifenthrin 
products used for residential flea infestation control and 
agricultural/commercial applications. The aggregate analysis 
conservatively assumes that a person is concurrently exposed to the 
same active ingredient via the use of consumer or professional flea 
infestation control products and to chronic level residues in the diet. 
In the case of potential non-dietary health risks, conservative point 
estimates of non-dietary exposures, expressed as total systemic 
absorbed dose (summed across inhalation and incidental ingestion 
routes) for each relevant product use category (i.e., lawn care) and 
receptor subpopulation (i.e., adults, children 1-6 years old and 
infants > 1 year old) are compared to the systemic absorbed dose NOAEL 
for bifenthrin to provide estimates of the MOEs. Based on the toxicity 
endpoints selected by EPA for bifenthrin, inhalation and incidental 
oral ingestion absorbed doses were combined and compared to the 
relevant systemic NOAEL for estimating MOEs. In the case of potential 
aggregate health risks, the above mentioned conservative point 
estimates of inhalation and incidental ingestion non-dietary exposure 
(expressed as systemic absorbed dose) are combined with estimates 
(arithmetic mean values) of chronic average dietary (oral) absorbed 
doses. These aggregate absorbed dose estimates are also provided for 
adults, children 1-6 years old and infants > 1 year old. The combined 
or aggregated absorbed dose estimates (summed across non-dietary and 
chronic dietary) are then compared with the systemic absorbed dose 
NOAEL to provide estimates of aggregate MOEs.
    The non-dietary and aggregate (non-dietary + chronic dietary) MOEs 
for bifenthrin indicate a substantial degree of safety. The total non-
dietary (inhalation + incidental ingestion) MOEs for post-application 
exposure for the lawn care product evaluated was estimated to be > 
194,000 for adults, 52,400 for children 1-6 years old and 56,700 for 
infants < 1 year old. The aggregate MOE (inhalation + incidental oral + 
chronic dietary, summed across all product use categories) was 
estimated to be 2,158 for adults, 579 for children 1-6 years old and 
966 for infants (< 1 year old). It can be concluded that the potential 
non-dietary and aggregate exposures for bifenthrin are associated with 
substantial margins of safety.

D. Cumulative Effects

    In consideration of potential cumulative effects of bifenthrin and 
other substances that may have a common mechanism of toxicity, to our 
knowledge there are currently no available data or other reliable 
information indicating that any toxic effects produced by bifenthrin 
would be cumulative with those of other chemical compounds; thus only 
the potential risks of bifenthrin have been considered in this 
assessment of its aggregate exposure. FMC intends to submit information 
for EPA to consider concerning potential cumulative effects of 
bifenthrin consistent with the schedule established by EPA pursuant to 
the Food Quality Protection Act (FQPA).

E. Safety Determination

    1. U.S. population--i. Chronic exposure and risk. Based on a 
complete and reliable toxicology data base, the acceptable cPAD is 
0.015 mg/kg/day, based on a NOAEL of 1.5 mg/kg/day from the chronic dog 
study and an uncertainty factor of 100. Available information on 
anticipated residues, monitoring data and percent crop treated was 
incorporated into an analysis to estimate the anticipaded residue 
contribution (ARC) for 26 population subgroups. The ARC is generally 
considered a more realistic estimate than an estimate based on 
tolerance level residues. The ARC are estimated to be 0.000444 mg/kg 
bwt/day and utilize 3.0% of the cPAD for the overall U. S. population. 
The ARC for children 7-12 years old and children 1-6 years old 
(subgroups most highly exposed) are estimated to be 0.000650 mg/kg bwt/
day and 0.001203 mg/kg bwt/day and utilizes 4.3% and 8.0% of the cPAD, 
respectively. Generally speaking, EPA has no cause for concern if the 
total dietary exposure from residues for uses for which there are 
published and proposed tolerances is less than 100% of the cPAD. 
Therefore, FMC concludes that the chronic dietary risk of bifenthrin, 
as estimated by the aggregate risk assessment, does not appear to be of 
concern.
    ii. Acute exposure and risk. Acute dietary exposure 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. For the purposes of 
assessing acute dietary risk for bifenthrin, the maternal NOAEL of 1.0 
mg/kg/day from the oral developmental toxicity study in rats was used. 
The maternal LOAEL of this study of 2.0 mg/kg/day was based on tremors 
from day 7-17 of dosing. This acute dietary endpoint was used to 
determine acute dietary risks to all population subgroups. Available 
information on anticipated residues, monitoring data and percent crop 
treated was incorporated into a Tier 3 analysis, using Monte Carlo 
modeling for commodities that may be consumed in a single serving. 
These assessments show that the MOEs are greater than the EPA standard 
of 100 for all subpopulations. The 99.9th percentile of 
exposure for the overall U. S. population was estimated to be 0.005932 
mg/kg/day (MOE of 168). The 99.9th percentile of exposure 
for all infants < 1 year old was estimated to be 0.007331 mg/kg/day 
(MOE of 136). The 99.9th percentile of exposure for nursing infants < 1 
year old was estimated to be 0.004599 mg/kg/day (MOE of 217). The 
99.9th percentile of exposure for non-nursing infants < 1 
year old was estimated to be 0.006974 mg/kg/day (MOE of 143). The 
99.9th percentile of exposure for children 1 to 6 years old 
was estimated to be 0.009983 mg/kg/day (MOE of 100). Therefore, FMC 
concludes that the acute dietary risk of bifenthrin, as estimated by 
the dietary risk assessment, does not appear to be of concern.
    2. Infants and children--i. General. In assessing the potential for 
additional sensitivity of infants and children to residues of 
bifenthrin, FMC considered data from developmental toxicity studies in 
the rat and rabbit, and a 2-generation reproductive study in the rat. 
The developmental toxicity studies are designed to evaluate adverse 
effects on the developing organism resulting from pesticide exposure 
during prenatal development to one or both parents. Reproduction 
studies provide information relating to effects from exposure to the 
pesticide on the reproductive capability of mating animals and data on 
systemic toxicity. FFDCA section 408 provides that EPA may apply an 
additional margin of safety for infants and children in the case of 
threshold effects to account for prenatal and postnatal natal toxicity 
and the completeness of the data base.
    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 5/23 (22%) litters affected (5/141 
fetuses since each litter only had one affected fetus) in the 2 mg/kg/
day group, compared with zero

[[Page 71774]]

in the control, 1, and 0.5 mg/kg/day groups. According to recent 
historical data 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.
    c. Conclusion. Based on the above, FMC concludes that reliable data 
support use of the standard 100-fold uncertainty factor, and that an 
additional uncertainty factor is not needed to protect the safety of 
infants and children. As stated above, aggregate exposure assessments 
utilized less than 10% of the cPAD for either the entire U. S. 
population or any of the 26 population subgroups including infants and 
children. Therefore, it may be concluded that there is reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to bifenthrin residues.

F. International Tolerances

    There are no Codex, Canadian, or Mexican residue limits for 
residues of bifenthrin in or on grape, peppers (bell and non-bell), 
lettuce, and caneberry.
[FR Doc. 99-33035 Filed 12-21-99; 8:45 am]
BILLING CODE 6560-50-F