[Federal Register Volume 67, Number 27 (Friday, February 8, 2002)]
[Notices]
[Pages 6024-6028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2986]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1065; FRL-6819-4]


Notice of Filing Pesticide Petitions to Establish a Tolerance 
fora Certain Pesticide Chemical 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 a 
certain pesticide chemical in or on various food commodities.

DATES: Comments, identified by docket control number PF-1065, must be 
received on or before March 11, 2002.

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-1065 in the subject line on the first page of your 
response.

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

[[Page 6025]]

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-1065. 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-1065 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, 1200 Pennsylvania Ave., NW., 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-1065. 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 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 a certain 
pesticide chemical 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 the 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 support 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: January 26, 2002.
  Peter Caulkins, Acting,
Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    The petitioner's 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 BASF Corporation, the registrant, 
and represents the view of BASF Corporation. EPA is publishing the 
petition summaries verbatim without editing them in any way. The 
petition summaries announces the availability of a description of the 
analytical methods available to EPA for the detection and measurement 
of the pesticide chemical

[[Page 6026]]

residues or an explanation of why no such method is needed.

Interregional Research Project 
Number 4

PP 0E6068 and 1E6226

    EPA has received pesticide petitions (0E6068 and 1E6226) from the 
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1 
South, North Brunswick, NJ 08902-3390 proposing, pursuant to section 
408(d) of the FFDCA, 21 U.S.C. 346a(d), to amend 40 CFR 180.494 by 
establishing tolerances for residues of pyridaben, (2-tert-butyl-5-(4-
tert-butylbenzylthio)-4-chloropyridazin-3(2H)-1) as specified in 40 CFR 
180.494 in or on the raw agricultural commodities:
    1. PP 0E6068 proposes the establishment of a tolerance in or on 
strawberry at 2.5 parts per million (ppm).
    2. PP 1E6226 proposes the establishment of a tolerance in or on 
hops at 10 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 support granting of the 
petitions. Additional data may be needed before EPA rules on the 
petitions.

A. Residue Chemistry

    1. Plant and animal 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. 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)-1) and PB-9 (2-tert-butyl-4-chloro-
5-[4-(1,1-dimethyl-2-hydroxyethyl) benzylthio]-chloropyridazin-3(2H)-1) 
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. Strawberry residue trials were conducted 
according to a split application program depending upon location for a 
total of 10 trials in 6 states. Residues of pyridaben were measured by 
GC/ECD. The method of detection (MOD) had a limit of detection (LOD) of 
0.05 ppm. Residues ranged from 0.19 to 2.26 ppm for 1 application 
program and 0.325 to 1.28 ppm for the second application program.
    Three hop residue trials were conducted, one in each of three 
states. Residues of pyridaben were measured by GC/ECD. The MOD had a 
LOD of 0.05 ppm. Residues ranged from 4.35 to 8.49 ppm.

B. Toxicological Profile

    1. Acute toxicity--i. Subpopulation females 13+ years old. No 
observe adverse effect level (NOAEL) = 13 milligrams/kilograms (mg/kg). 
In a developmental toxicity study, Sprague-Dawley rats (22/group) from 
Charles River, United Kingdom, received NC-129 (Pyridaben, 98.0% active 
ingredient 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/weight gain and food consumption during the 
dosing period. Based on these effects, the maternal toxicity lowest 
observe 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 body weight 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 acute reference dose (RfD) 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 active 
ingredient equivalents: 44.3, 79.6, and 190.0 mg/kg for males and 44.5, 
99.7, and 190.0 mg/kg body weight 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 body 
weight 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 effect 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 body weight 
gain. With the 100 UF (10X for interspecies extrapolation and 10X for 
intraspecies variability) the acute RfD for the general population is 
calculated to be 0.5 mg/kg/day.
    2. Short-term and intermediate-term toxicity. NOAEL = 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. 
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 body weight 
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 body weight/
weight gain and food consumption) in the four rat oral developmental 
toxicity study is adjusted by the proposed 5% dermal absorption rate).
    3. Chronic toxicity. EPA has established the RfD for pyridaben at 
0.005 mg/kg/day. This RfD is based on a 1-year feeding study in dogs 
with a NOAEL of 0.5 mg/kg/day and an UF of 100 based on decreased body 
weight, emesis, and ptyalism.
    4. Carcinogenicity. Because pyridaben has been classified by EPA as 
a Group E chemical (no evidence of carcinogenicity to humans), no 
additional analysis is necessary regarding carcinogenicity of this 
chemical.

C. Aggregate Exposure

    1. Dietary exposure-i. Food. From the acute dietary (food only) 
risk assessment, the calculated exposure yields dietary (food only) 
percentage of the acute RfD for females 13+ years old nursing is 14%. 
The highest calculated

[[Page 6027]]

exposure yields dietary (food only) percentage of the acute RfD for the 
remainder of the population is 19% for infants <1-year old. This risk 
estimate should be viewed as highly conservative as tolerance level 
residues and 100% crop use was used. 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 a Tier 2 chronic dietary risk assessment, EPA has 
made somewhat conservative assumptions in that 100% of crops treated 
with anticipated residues will contain pyridaben residues. The chronic 
dietary exposure evaluation model (DEEM) analysis indicates that the 
most highly exposed population subgroup is non-nursing infants which 
occupy up to 64% of the chronic population adjusted dose (PAD).
    ii. From 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 goal (MCLG) 
for residues of pyridaben in drinking water. No health advisory levels 
(HALs) for pyridaben in drinking water have been established. EPA uses 
the generic expected environmental concentration (GENEEC) and screening 
concentration in ground water (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 parts 
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 level of concern (DWLOC) for pyridaben in surface and 
ground water.
    a. Acute exposure and risk. Acute DWLOC have been calculated by EPA 
at the following amounts: U.S. population--14,000 g/Liter g/(L); adult 
male 20+ years old--15,000 g/L; adult female 13+, pregnant, non-
nursing--2,200 g/L; infant <1, nursing--1,100 g/L.
    b. Chronic exposure and risk. Chronic DWLOC 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. From non-dietary exposure. Pyridaben is currently not registered 
for use on residential non-food sites. Thus, a residential exposure 
assessment is not required. There is a potential for occupational 
exposure to pyridaben during, mixing, loading, and application 
activities. However, risks from these routes of exposure are considered 
negligible.

D. Cumulative Effects

    EPA 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, 
BASF Corporation 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 (food only) percentage of the acute RfD maximum 
is only 19% for nursing infants <1-year old. This risk estimate should 
be viewed as highly conservative; refinement using additional 
anticipated residues 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, BASF Corporation 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., EPA has concluded that aggregate exposure to pyridaben from 
food will utilize 20% of the RfD 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 RfD 
because the RfD represents the level at or below which daily aggregate 
dietary exposure over a lifetime will not pose appreciable risks to 
human health. The residues of pyridaben in drinking water do not exceed 
EPA's DWLOC. Pyridaben does not have any residential uses. BASF 
Corporation does not expect the aggregate exposure to exceed 100% of 
the RfD.
    iii. Short-term and intermediate-term risk. Aggregate exposure 
takes into account chronic dietary food and water (considered to be a 
background exposure level) plus indoor and outdoor 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 chemical (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 from the passage 
of the Food Quality Protection Act (FQPA) (Public Law 104-170) (August 
3, 1999) to implement this program. At that time, EPA may require 
further testing of this active ingredient and end use products for 
endocrine disrupter effects.
    vi. Determination of safety. Based on these risk assessments, BASF 
Corporation 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 
in assessing the potential for additional sensitivity of infants and 
children to residues of pyridaben. 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 prenatal and 
postnatal effects from exposure to

[[Page 6028]]

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 ten-
fold 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 ten-
fold margin of exposure/uncertainty factor 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 margin of exposure/safety factor MOE/(SF).
    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 body 
weight, body weight 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 body 
weight 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 body weight 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 parental (systemic) NOAEL was 
2.3 mg/kg/day. The parental (systemic) LOAEL of 7 mg/kg/day was based 
on decreased body weight, decreased body weight 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. Based on the 
above, BASF Corporation has concluded that reliable data support 
removing the additional 10X SF for protection of infants and children.
    v. Conclusion. There is a complete toxicity data base for pyridaben 
and exposure data are complete or estimated based on data that 
reasonably account for potential exposures.
    a. Acute risk. Using the somewhat conservative exposure assumptions 
described above, the percentage of the acute RfD that will be utilized 
by dietary (food) exposure to residues of pyridaben maximize to 19% 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, BASF 
Corporation 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 RfD that will be utilized by dietary (food) exposure to residues of 
pyridaben maximizes at 64% of the chronic PAD for the most highly 
exposed population subgroup, non-nursing infants. The chronic DWLOC 
does not exceed EPA's 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, BASF 
Corporation 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. Aggregate exposure takes 
into account chronic dietary food and water (considered to be a 
background exposure level) 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, BASF 
Corporation 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 levels 
established for pyridaben on hops or strawberry.
[FR Doc. 02-2986 Filed 2-7-02; 8:45 am]
BILLING CODE 6560-50-S