[Federal Register Volume 66, Number 53 (Monday, March 19, 2001)]
[Notices]
[Pages 15437-15443]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6711]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-1002; FRL-6771-2]


Notice of Filing Pesticide Petitions to Establish a Tolerance for 
a 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-1002, must be 
received on or before April 18, 2001.

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-1002 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Mary Waller, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9354; 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 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

[[Page 15438]]

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,'' ``Regulations and Proposed Rules,'' 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-1002. 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-1002 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-1002. 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 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 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: March 5, 2001.

  Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

Summary of Petitions

    The petitioner summary of the pesticide petitions is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petitions was prepared by the petitioner and represents the view of the 
petitioner. The petition summary announces 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.

[[Page 15439]]

Interregional Research/Bayer Corporation

PP 9E6045, 9E6046, 9E6048, 0E6103, 0E6117, 0E6153, 0E6158, 0E6212, 
7F4895, 0F6086, and 0F6091

    EPA has received pesticide petitions (PP 9E6045, 9E6046, 9E6048, 
0E6103, 0E6117, 0E6153, 0E6158, and 0E6212) from the Interregional 
Research Project Number 4 (IR-4), State Agricultural Experimentation, 
Rutgers University, 681 U.S. Highway #1 South, North Brunswick, NJ 
08902-3390. EPA has also received pesticide petitions (7F4895, 0F6086, 
and 0F6091) from Bayer Corporation, 8400 Hawthorn Road, P.O. Box 4913, 
Kansas City, MO 64120-0013. 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 tolerances for 
residues of tebuconazole, alpha-[2-(4-chlorophenyl)ethyl]alpha-(1,1-
dimethylethyl)-1H-1,2,4] in or on the raw agricultural commodities as 
follows:
     1. PP 9E6045. Proposes the establishment of tolerances in or on 
turnip, tops at 8.0 parts per million (ppm) and turnip, roots at 0.4 
ppm.
    2. PP 9E6046. Proposes the establishment of a tolerance in or on 
hop at 5.0 ppm.
    3. PP 9E6048. Proposes the establishment of a tolerance in or on 
vegetable, cucurbit, group at 0.1 ppm.
    4. PP 0E6103. Proposes the establishment of a tolerance in or on 
mango (postharvest) at 0.2 ppm.
    5. PP 0E6117. Proposes the establishment of a tolerance in or on 
plum (postharvest) at 1.0 ppm.
    6. PP 0E6153. Proposes the establishment of tolerances in or on 
sunflower, seed at 0.05 ppm, sunflower, refined oil at 0.2 ppm, and 
sunflower, meal at 0.2 ppm.
    7. PP 0E6158. Proposes the establishment of a tolerance in or on 
okra at 1.0 ppm.
    8. PP 0E6212. Proposes the establishment of a tolerance in or on 
lychee at 1.5 ppm.
    9. PP 7F4895. Proposes the establishment of tolerances for nut, 
tree, group at 0.05 ppm, almond, hulls at 5.0 ppm, pistachio at 0.05, 
wheat, forage at 3.0 ppm, wheat, hay at 6.0 ppm, and wheat, straw at 
1.4 ppm.
    10. PP 0F6086. Proposes the establishment of tolerances in or on 
bean, succulent at 0.1 ppm, bean, seed at 0.1 ppm, cotton, undelinted 
seed at 2.0 ppm, and cotton, gin byproducts at 16.0 ppm.
    11. PP 0F6091. Proposes the establishment of tolerances in or on 
asparagus at 0.01 ppm, coffee, green bean at 0.1 ppm, coffee, roasted 
bean at 0.2 ppm, garlic, bulb at 0.1 ppm, and onion, dry bulb at 0.1 
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 metabolism. The nature of the residue in plants and 
animals is adequately understood. The residue of concern is the parent 
compound only, as specified in 40 CFR 180.474.
    2. Analytical method. An enforcement method for plant commodities 
has been validated on various commodities. It has undergone successful 
EPA validation and has been submitted for inclusion in Pesticide 
Analytical Method II (PAM). The animal method has also been approved as 
an adequate enforcement method.
    3. Magnitude of residues--i. Wheat. Nineteen residue crop field 
trial studies were conducted to evaluate the quantity of tebuconazole 
residue in wheat following a foliar application of Folicur 3.6 F. These 
trials were conducted in EPA Regions II, IV, V, VI, VII, VIII, and X. 
Residues of tebuconazole were quantitated by gas chromatography using a 
thermionic specific detector. The limit of quantitation (LOQ) for green 
forage, hay, and straw was 0.1 ppm. The LOQ for grain was 0.05 ppm. The 
highest average field trial (HAFT) was 2.51 ppm for green forage, 5.31 
ppm for wheat hay, and 1.27 ppm for wheat straw. The residues of 
tebuconazole in wheat grain were less than the LOQ of 0.05 ppm. Data 
from a 5x processing study also showed residues of tebuconazole in 
wheat grain less than the LOQ of 0.05 ppm.
    ii. Pecans. Five residue crop field trial studies were conducted to 
evaluate the quantity of tebuconazole residue in pecan nutmeat 
following treatment of pecan trees with Folicur 3.6 F. These five 
trials were conducted in Regions II, IV, VI, and VIII as required in 
EPA's June 1994 guidance on number and location of trials. Residues of 
tebuconazole were quantitated using gas chromatography. Residues in all 
nutmeat samples were less than or equal to the LOQ of 0.05 ppm. 
Therefore, a tolerance of 0.05 ppm is being proposed.
    iii. Almonds. Six residue crop field trial studies were conducted 
in EPA's Region X to evaluate the quantity of tebuconazole residue in 
almond nutmeat and almond hulls following treatment with Elite 45 DF. 
Tebuconazole residues were quantitated by gas chromatography using a 
thermionic specific detector. The LOQ for tebuconazole was 0.05 ppm for 
almond nutmeat and 0.1 ppm for almond hulls. Residues in all nutmeat 
samples were less than or equal to the LOQ. The HAFT residue value for 
almond hulls was 4.13 ppm. Therefore, tolerances of 0.05 and 5.0 ppm 
are being proposed for almond nutmeat and hulls, respectively.
    iv. Turnips. Five field trials were conducted in order to provide 
information on the magnitude of tebuconazole residues on turnip tops 
and roots following foliar applications of Folicur 3.6 F. Trials were 
conducted in Georgia, New Jersey, Ohio, Tennessee, and Texas. Residue 
levels ranged from 0.75 ppm to 5.62 ppm for turnip tops and <0.05 ppm 
to 0.234 ppm for turnip roots. A tolerance of 8.0 ppm for turnip tops 
and 0.4 ppm for turnip roots is being proposed by IR-4.
    v. Hops. Three field trials were conducted in order to provide 
information on the magnitude of tebuconazole residues on hops following 
foliar applications of Folicur 3.6 F. One trial was conducted in Oregon 
and two trials in Washington. Residue levels ranged from 0.579 ppm to 
3.418 ppm. A tolerance of 5.0 ppm is being proposed by IR-4.
    vi. Cucurbits. Data from summer squash, cucumber and cantaloupe 
residue crop field trials were used to evaluate the quantity of 
tebuconazole residue in cucurbits. Data on summer squash were collected 
from California, Florida, Georgia, New York, and Ohio. Data on 
cucumbers were collected from Florida, Georgia, Michigan, North 
Carolina, Ohio, and Texas. Cantaloupe trials were conducted in 
California, Georgia, Ohio, and Texas. Residue levels from all cucurbits 
ranged from 0.02 to 0.076 ppm. A tolerance of 0.1 ppm is being proposed 
by IR-4.
    vii. Bean (succulent). Studies were conducted to evaluate the 
quantity of tebuconazole residue on fresh bean pods and dry bean seed 
following treatments with Folicur 3.6 F. Twelve field trials were 
conducted on fresh beans, and 14 field trials were conducted on dry 
beans. Tebuconazole residues were quantitated by gas chromatography 
using a thermionic specific detector. The LOQ for tebuconazole was 0.05 
ppm. The highest residue of tebuconazole was 0.06 ppm in fresh beans. 
The highest residue in dry beans was 0.08 ppm. Therefore, tolerances 
are

[[Page 15440]]

being proposed at 0.1 ppm for both succulent and seed beans.
    viii. Cotton. Studies were conducted to evaluate the quantity of 
tebuconazole residue in undelinted cotton seed and cotton gin 
byproducts (gin trash) following treatment of cotton plants with 
Folicur 3.6 F. Tebuconazole residues in undelinted cotton seed were 
quantitated by gas chromatography. The LOQ was 0.05 ppm in undelinted 
cotton seed and 0.2 ppm in gin trash. The highest measured residue in 
undelinted cotton seed was 1.89 ppm and 15.2 ppm in cotton gin trash at 
a 29-day PHI. Therefore, tolerances are being proposed at 2.0 ppm for 
undelinted cotton seed and 16.0 ppm for cotton gin trash.
    A cotton processing study was conducted with Folicur 3.6 F at 5 
times the maximum season proposed label use rate. Processing was 
performed using procedures which simulate commercial processing 
practices. The undelinted seed, meal, hull, and refined oil were 
evaluated for the residue of tebuconazole by gas chromatography. The 
LOQ in undelinted seed was 0.02 ppm. The LOQ in the processed products 
of meal, hull and refined oil was 0.04 ppm. Residue of tebuconazole in 
cotton undelinted seed was 0.04 ppm, while residue in the processed 
commodities were <0.04 ppm. Therefore, no tolerances are being 
requested for processed products.
    ix. Asparagus. Three field trials were conducted in Peru to 
evaluate the quantity of tebuconazole residue in or on asparagus spears 
following four foliar applications of Folicur 3.6 F to asparagus ferns. 
Tebuconazole residues were quantitated by gas chromatography using a 
nitrogen phosphorus detector. The LOQ for tebuconazole was 0.01 ppm. 
Since the residue of tebuconazole was <0.01 ppm in all treated 
asparagus samples, a tolerance on 0.01 ppm is being proposed.
    x. Coffee. Four field trials were conducted in Brazil and four 
field trials were conducted in Guatemala to evaluate the quantity of 
tebuconazole residue in or on dried green coffee beans following 
applications of Folicur 3.6 F to coffee trees. Tebuconazole residues 
were quantitated by gas chromatography. The LOQ was 0.01 ppm. The 
maximum residue value was 0.07 with the majority of the residue values 
being below the LOQ. Therefore, a tolerance of 0.1 ppm is being 
requested for green beans.
    A processing study was conducted on dried green coffee beans from a 
field trial in Guatemala. Tebuconazole residues in dried green coffee 
beans, roasted coffee beans, and instant coffee were quantitated by gas 
chromatography. The LOQ for tebuconazole was 0.01 in green coffee 
beans, 0.8 ppm in roasted coffee beans, and 0.04 ppm in instant coffee. 
The highest average residue found in this study was 0.04 ppm in dried 
green coffee beans, 0.08 ppm in roasted coffee and 0.03 ppm in instant 
coffee. The data show that there is no concentration of residues as a 
result of processing into instant coffee and a slight concentration 
from dry beans (0.04 ppm) to roasted beans (0.08) ppm. A 0.2 ppm 
tolerance is being proposed for roasted coffee beans.
    xi. Garlic. Three field trials were conducted in Mexico to evaluate 
the quantity of tebuconazole residue in or on garlic bulbs after a seed 
(clove) treatment of Folicur 3.6 F. Tebuconazole residues were 
quantitated by gas chromatography. The LOQ for tebuconazole was 0.10 
ppm. Since all average validated tebuconazole residues were at or below 
the LOQ, a tolerance of 0.1 ppm is being proposed.
    xii. Onion. Three field trials were conducted in Mexico to evaluate 
the quantity of tebuconazole residue in or on onion bulbs following 
foliar applications of Folicur 3.6 F. Tebuconazole residues were 
quantitated by gas chromatography. The LOQ for tebuconazole was 0.10 
ppm. Since the HAFT was below the LOQ, a tolerance of 0.1 ppm is being 
proposed.
    xiii. Mango. Three trials were conducted at a tropical fruit 
packing facility in order to provide information on the magnitude of 
tebuconazole residues on mango (post-harvest). Tebuconazole residues 
were quantitated by gas chromatography. All residue values were <0.05. 
A tolerance of 0.2 ppm is being proposed by IR-4.
    xiv. Plums. Two trials were conducted in California in a fruit 
packing facility in order to provide information on the magnitude of 
tebuconazole residues on plums (post-harvest). The highest tebuconazole 
residue detected in plums was 0.44 ppm. Therefore, a tolerance of 1.0 
ppm is being proposed by IR-4.
    xv. Sunflower. IR-4 received requests from Kansas and North Dakota 
for the use of tebuconazole on sunflowers. To support these requests, 
magnitude of residue data were collected from seven field trials 
located in EPA Region V. Three of the trials were conducted in Kansas; 
the remaining four trials were located in North Dakota. Since all 
residues in the 1X field trails are less than the LOQ of 0.04 ppm, a 
tolerance of 0.05 ppm is being proposed for sunflower seed. Based on a 
processing study on peanuts completed by Bayer Corporation, a 
processing study was deemed not necessary and tolerances of 0.2 ppm are 
being requested for sunflower oil and sunflower meal.
    xvi. Lychee. Three magnitude of residue field trials were conducted 
in Homestead, Florida. Residues from treated samples ranged from 0.4 
ppm to 0.98 ppm. Tebuconazole residues were quantitated by gas 
chromatography. A tolerance of 1.5 ppm is requested by IR-4 for 
tebuconazole residues in or on lychee.
    xvii. Okra. Magnitude of residue data were collected from six field 
trials located in EPA Region II (three trials), Region III (one trial), 
and Region VI (two trials). Residues ranged from 0.0863 ppm to 0.590 
ppm tebuconazole in the treated samples. Tebuconazole residues were 
quantitated by gas chromatography. A tolerance of 1.0 ppm is requested 
by IR-4 for tebuconazole residues in or on okra.

B. Toxicological Profile

    1. Acute toxicity. Tebuconazole exhibits moderate toxicity. The rat 
acute oral LD50 = 3,933 milligram/kilogram (mg/kg) (category 
III); the rabbit acute dermal LD50 >5,000 mg/kg (category 
IV); and the rat acute inhalation LC50 >0.371 milligram/
Liter (mg/L) (category II). Technical tebuconazole was slightly 
irritating to the eye (category III) and was not a skin irritant 
(category IV) in rabbits. Tebuconazole was not a dermal sensitizer.
    2. Genotoxicity. An Ames test with Salmonella sp., a mouse 
micronucleus assay, a sister chromatid exchange assay with Chinese 
hamster ovary cells, and an unscheduled DNA synthesis assay with rat 
hepatocytes provided no evidence of mutagenicity.
    3. Reproductive and developmental toxicity--i. In a developmental 
toxicity study, pregnant female rats were gavaged with technical 
tebuconazole at levels of 0, 30, 60, or 120 mg/kg/day between days 6 
and 15 of gestation. The maternal no observed adverse effect level 
(NOAEL) was 30 mg/kg/day and the maternal lowest observed adverse 
effect level (LOAEL) was 60 mg/kg/day based on increased absolute and 
relative liver weights. The developmental NOAEL was 30 mg/kg/day and 
the developmental LOAEL was 60 mg/kg/day based on delayed ossification 
of thoracic, cervical and sacral vertebrae, sternum and limbs plus an 
increase in supernumerary ribs.
    ii. In a developmental toxicity study, pregnant female rabbits were 
gavaged with technical tebuconazole at levels of 0, 10, 30, or 100 mg/
kg/day between days 6 and 18 of gestation. The maternal NOAEL was 30 
mg/kg/day and the maternal LOAEL was 100 mg/kg/day

[[Page 15441]]

based on minimal depression of body weight gains and food consumption. 
The developmental NOAEL was 30 mg/kg/day and the developmental LOAEL 
was 100 mg/kg/day based on increased postimplantation losses, 
malformations in eight fetuses out of five litters (including peromelia 
in five fetuses/four litters; palatoschisis in one fetus/one litter), 
hydrocephalus and delayed ossification.
    iii. In a developmental toxicity study, pregnant female mice were 
gavaged with technical tebuconazole at levels of 0, 10, 30, or 100 mg/
kg/day between days 6 and 15 of gestation (part 1 of study) or at 
levels of 0, 10, 20, 30, or 100 mg/kg/day between days 6 and 15 of 
gestation (part 2 of study). The maternal NOAEL was 10 mg/kg/day and 
the maternal LOAEL was 20 mg/kg/day. Maternal toxicity (hepatocellular 
vacuolation and elevations in AST, ALP and alkaline phosphatase) 
occurred at all dose levels but was minimal at 10 mg/kg/day. Reduction 
in mean corpuscular volume in parallel with reduced hematocrit occurred 
at doses greater than or equal to 20 mg/kg/day. The liver was the 
target organ. The developmental NOAEL was 10 mg/kg/day and the 
developmental LOAEL was 30 mg/kg/day based on an increase in the number 
of runts.
    iv. In a developmental toxicity study, pregnant female mice were 
administered dermal doses of technical tebuconazole applied at levels 
of 0, 100, 300, or 1,000 mg/kg/day between days 6 and 15 of gestation. 
Equivocal maternal toxicity was observed 1,000 mg/kg/day. The maternal 
NOAEL was nearly equal to 1,000 mg/kg/day. The developmental NOAEL was 
1,000 mg/kg/day.
    v. In a 2-generation reproduction study, rats were fed technical 
tebuconazole at levels of 0, 100, 300, or 1,000 ppm, (0, 5, 15, or 50 
mg/kg/day, males and females). The parental maternal NOAEL was 15 mg/
kg/day and the parental LOAEL was 50 mg/kg/day based on depressed body 
weights, increased spleen hemosiderosis and decreased liver and kidney 
weights. The reproductive NOAEL was 15 mg/kg/day and the reproductive 
LOAEL of 50 mg/kg/day based on decreased pup body weights from birth 
through 3-4 weeks.
    vi. In a developmental neurotoxicity study, pregnant female rats 
were fed a nominal concentration of 0, 100, 300 or 1,000 ppm of 
tebuconazole in the diet. The NOAEL for maternal toxicity in this study 
was 300 ppm (based on mortality, body weight and feed consumption 
reductions, and prolonged gestation in the 1,000 ppm dosage group). The 
1,000 ppm dose level was considered to be excessively toxic for the 
F1 offspring, based on mortality, marked reductions in pup 
body weight and body weight gain, reduction in pup absolute brain 
weight (at postpartum day (PD) 12 and adult), a developmental delay in 
vaginal patency, and decreased cerebellar thickness. The effects on 
brain weight and morphology are considered to represent incomplete 
compensation for the marked decrease in body weight gain during 
development. By approximately day 80 postpartum, the body weight had 
completely recovered in the females but was still reduced (89% of the 
control group value) in the males. The brain weights had shown an 
incomplete recovery (90% to 93% of the control group values) in both 
sexes. The NOAEL for the F1-generation rats was 300 ppm. 
Technical grade tebuconazole did not cause any specific neurobehavioral 
effects in the offspring when administered to the dams during gestation 
and lactation at dietary concentrations up to and including 1,000 ppm. 
The overall NOAEL in this study for the F1 offspring was 300 
ppm.
    4. Subchronic toxicity--i. In a 90-day oral feeding study, rats 
were administered technical tebuconazole at levels of 0, 100, 400, or 
1,600 ppm (0, 8, 34.8, or 171.7 mg/kg/day for males or 0, 10.8, 46.5, 
or 235.2 mg/kg/day for females). In males, the NOAEL was 34.8 mg/kg/day 
and the LOAEL was 171.7 mg/kg/day based on decreased body weight and 
decreased body weight gain, adrenal vacuolation and spleen 
hemosiderosis. In females, the NOAEL was 10.8 mg/kg/day and the LOAEL 
of 46.5 mg/kg/day was based on adrenal vacuolation.
    ii. In a 90-day oral feeding study, Beagle dogs were administered 
technical tebuconazole at levels of 0, 200, 1,000, or 5,000 ppm (0, 74, 
368, or 1,749 mg/kg/day for males or 0, 73, 352, or 1,725 mg/kg/day for 
females). In females, the NOAEL was 73 mg/kg/day and the LOAEL was 352 
mg/kg/day based on decreased body weight and decreased body weight 
gain, decreased food consumption and increased liver N-demethylase 
activity. At the highest dose tested (HDT), lens opacity was seen in 
all males and in one female and cataracts were seen in three females.
    iii. In a 21-day dermal toxicity study, rabbits were exposed 
dermally to technical tebuconazole 5 days a week at doses of 0, 50, 
250, or 1,000 mg/kg/day. No significant systemic effects were seen. The 
systemic NOAEL >1,000 mg/kg/day.
    iv. In a 21-day inhalation toxicity study, rats were exposed to 
technical tebuconazole (15 exposures - 6 hours/day for 3 weeks) at 
airborne concentrations of 0, 0.0012, 0.0106, or 0.1558 mg/L/day. The 
NOAEL was 0.0106 mg/L/day and the LOAEL was 0.1558 mg/L/day based on 
piloerection and induction of liver N-demethylase.
    5. Chronic toxicity--i. In a 2-year combined chronic feeding/
carcinogenicity study, rats were administered technical tebuconazole at 
levels of 0, 100, 300, or 1,000 ppm (0, 5.3, 15.9, or 55 mg/kg/day for 
males or 0, 7.4, 22.8, or 86.3 mg/kg/day for females). In males, the 
NOAEL was 5.3 mg/kg/day and the LOAEL was 15.9 mg/kg/day based on C-
cell hyperplasia in the thyroid gland. In females, the NOAEL was 7.4 
mg/kg/day and the LOAEL was 22.8 mg/kg/day based on body weight 
depression, decreased hemoglobin, hematocrit, mean corpuscular volume 
and mean corpuscular hemoglobin concentration and increased liver 
microsomal enzymes. No evidence of carcinogenicity was found at the 
levels tested.
    ii. In a 1-year chronic feeding study, Beagle dogs were 
administered technical tebuconazole at levels of 0, 40, 200, or 1,000 
(weeks 1-39) and 2,000 ppm (weeks 40-52) (0, 1, 5 or 25/50 mg/kg/day 
for males and females). The NOAEL was 1 mg/kg/day and the LOAEL was 5 
mg/kg/day based on ocular lesions (lenticular and corneal opacity) and 
hepatic toxicity (changes in the appearance of the liver and increased 
siderosis).
    iii. In a 1-year chronic feeding study, Beagle dogs were 
administered technical tebuconazole at levels of 0, 100, or 150 ppm (0, 
3.0, or 4.4 mg/kg/day for males or 0, 3.0 or 4.5 mg/kg/day for 
females). The NOAEL was 3.0 mg/kg/day and the LOAEL was 4.4 mg/kg/day 
based on adrenal affects in both sexes. In males there was hypertrophy 
of adrenal zona fasciculata cells amounting to 4/4 at 150 ppm and to 0/
4 at 100 ppm and in controls. Other adrenal findings in males included 
fatty changes in the zona glomerulosa (3/4) and lipid hyperplasia in 
the cortex (2/4) at 150 ppm vs. (1/4) for both effects at 100 ppm and 
control dogs. In females there was hypertrophy of zona fasciculata 
cells of the adrenal amounting to 4/4 at 150 ppm and to 0/4 at 100 ppm 
and 1/4 in controls. Fatty changes in the zona glomerulosa of the 
female adrenal amounted to 2/4 at 150 ppm and to 1/4 at 100 ppm and in 
controls.
    iv. In a 91-week carcinogenicity study, mice were administered 
technical tebuconazole at levels of 0, 500, or 1,500 ppm (0, 84.9, or 
279 mg/kg/day for males or 0, 103.1, or 365.5 mg/kg/day for females). 
Neoplastic histopathology

[[Page 15442]]

consisted of statistically significant increased incidences of 
hepatocellular neoplasms; adenomas (35.4%) and carcinomas (20.8%) at 
1,500 ppm in males and carcinomas (26.1%) at 1,500 ppm in females. 
Statistically significant decreased body weights and increased food 
consumption were reported that were consistent with decreased food 
efficiency at 500 and 1,500 ppm in males and at 1,500 ppm in females. 
Clinical chemistry values (dose-dependent increases in plasma GOT, GPT 
and alkaline phosphatase) for both sexes were consistent with 
hepatotoxic effects at both 500 and 1,500 ppm. Relative liver weight 
increases reached statistical significance at both 500 and 1,500 ppm in 
males and at 1,500 ppm in females. Non-neoplastic histopathology 
included dose-dependent increases in hepatic pancinar fine fatty 
vacuolation, statistically significant at 500 and 1,500 ppm in males 
and at 1,500 ppm in females. Other histopathology included significant 
oval cell proliferation in both sexes and dose-dependent ovarian 
atrophy that was statistically significant at 500 and 1,500 ppm. The 
Maximum Tolerated Dose (MTD) was achieved at or around 500 ppm.
    6. Animal metabolism. Rats were gavaged with 1 or 20 mg/kg radio-
labeled technical tebuconazole, 98.1% of the oral dose was absorbed. 
Within 72 hours of dosing, over 87% of the dose was excreted in urine 
and feces. At sacrifice (72 hours post dosing), total residue 
gastrointestinal (GI tract) amounted to 0.63% of the dose. A total of 
10 compounds were identified in the excreta. A large fraction of the 
identified metabolites corresponded to successive oxidations steps of a 
methyl group of the test material. At 20 mg/kg, changes in detoxication 
patterns may be occurring.
    7. Endocrine disruption. No special studies investigating potential 
estrogenic or endocrine effects of tebuconazole have been conducted. 
However, the standard battery of required studies has been completed. 
These studies include an evaluation of the potential effects on 
reproduction and development, and an evaluation of the pathology of the 
endocrine organs following repeated or long-term exposure. These 
studies are generally considered to be sufficient to detect any 
endocrine effects but no such effects were noted in any of the studies 
with either tebuconazole or its metabolites.

C. Aggregate Exposure

    1. Dietary exposure. An aggregate risk assessment was conducted for 
residues of tebuconazole. For purposes of assessing the potential acute 
and chronic dietary exposure, Bayer has estimated acute and chronic 
exposure for all registered crops; section 18 uses on filberts, garlic, 
sunflowers, wheat and barley; petitions and uses pending with the EPA 
on wheat, beans (succulent and dry), cotton, coffee, asparagus, garlic, 
onions and the tree nut crop group; and proposed IR-4 uses on the 
cucurbit vegetables crop group, turnips (roots and tops), hops, plums 
(post-harvest), mangoes (post-harvest), and sunflowers.
    Novigen Sciences, Inc.'s Dietary Exposure Evaluation Model (DEEM), 
which is licensed to Bayer, was used to estimate the chronic and acute 
dietary exposure. This software used the food consumption data for the 
1994-1996 USDA Continuing Surveys of Food Intake by Individuals (CSFII 
1994-1996). To assess acute dietary risk, EPA used an endpoint of 10 
mg/kg/day NOAEL from the developmental toxicity study in mice (64 FR 
1132, January 8, 1999) (FRL-6050-5). This endpoint was based on an 
increased incidence of runts observed at the LOAEL of 30 mg/kg/day. The 
population adjusted dose for acute dietary (aPAD) was determined by 
dividing the NOAEL by an uncertainty factor of 1,000 (10X for 
interspecies differences, 10X for intraspecies variability and 10X for 
FQPA safety factor): aPAD = 10/(1,000) = 0.01 mg/kg/day. To assess the 
chronic dietary risk, EPA (64 FR 1132) used the NOAEL of 3.0 mg/kg/day 
from a 1-year dog feeding study. This endpoint was due to 
histopathological changes in the adrenal gland. The population adjusted 
dose for chronic dietary cPAD was determined by dividing the NOAEL by 
an uncertainty factor of 100 (10X for interspecies differences and 10X 
for intraspecies variability): cPAD = 3/100 = 0.03 mg/kg bw/day. This 
cPAD applies to all population subgroups.
    Results from the acute and chronic dietary exposure analyses 
described below demonstrate a reasonable certainty that no harm to the 
overall U.S. population or any population subgroup will result from the 
use of tebuconazole on currently registered and pending uses.
    i. Food-- a. Acute. The acute dietary (food) risk assessment was 
conducted using a Monte Carlo analysis (Tier 3). The anticipated 
residue values used were determined from field trial data reflecting 
maximum application rates and minimum preharvest intervals. Field trial 
residue distributions were used in the Monte Carlo simulation for those 
foods identified as single-serving commodities. For those foods 
considered to be blended or processed, mean field trial residues were 
calculated. The dietary exposure assessment estimated percent of the 
aPAD and corresponding margins of exposure (MOE) for the overall U.S. 
population (all seasons) and subpopulations. For the overall U.S. 
population the %aPAD = 36.49%. The most highly exposed population 
subgroup, children (1-6 years), had an exposure equal to 70.20% of the 
aPAD. These exposure estimates are within EPA's criteria of 
acceptability at the 99.9th percentile.
    b. Chronic. In the analysis for the chronic dietary (food only) 
risk assessment the anticipated residue values used were determined 
from field trail data conducted at maximum application rates and 
minimum preharvest intervals. Mean anticipated residues values were 
calculated substituting half of the LOQ for those samples for which 
residues were reported below the LOQ. The chronic dietary analysis 
estimated the cPAD for the overall U. S. population (all seasons) and 
subpopulations. For the overall U.S. population the %cPAD = 0.1%. For 
the most highly exposed population subgroup, children (1 to 6 years), 
the exposure was estimated to be 0.3% of the cPAD.
    ii. Drinking water. EPA has determined (64 FR 1132) that there are 
no monitoring data for residues of tebuconazole in ground water. In 
addition, they have established no health advisory levels or Maximum 
Contaminant Levels for residues of tebuconazole in drinking water. EPA 
has determined that tebuconazole is persistent and relatively immobile 
in water. EPA has used the Screening Concentration in Ground Water 
(SCI-GROW) screening model to determine the Estimated Environmental 
Concentration (EEC) of 0.3 g/L of tebuconazole in ground water 
for both chronic and acute analysis.
    a. Acute. EPA has determined that the acute drinking water levels 
of concern (DWLOC) is 200 g/L for females (13+ years old) and 
14 g/L for infants/children. The EECs for acute analysis of 
water are 0.3 g/L (ground water) and 14 g/L (surface 
water). EPA does not expect the acute aggregate exposure to exceed 10% 
of the acute RfD. Therefore, EPA has concluded with reasonable 
certainty that no harm will result to the subpopulations of concern, 
females (13+ years old), or infants and children from aggregate 
exposure to residues of tebuconazole.
    b. Chronic. EPA has determined that the chronic DWLOC is 910 
g/L for the U.S. population, 720 g/L for females (13+ 
years, nursing), and 190 g/L for

[[Page 15443]]

infants/children. The EECs for chronic analysis of water are 0.3 
g/L (ground water) and 10 g/L (surface water). EPA 
does not expect the chronic aggregate exposure to exceed 100% of the 
chronic RfD. Therefore, EPA has concluded with reasonable certainty 
that no harm will result from chronic (non-cancer) aggregate exposure 
to tebuconazole residues.
    2. Non-dietary exposure. Tebuconazole is currently registered for 
use on the following residential non-food sites: the formulation of 
wood-based composite products, wood products for in-ground contact, 
plastics, exterior paints, glues and adhesives. EPA has determined (64 
FR 1132) that exposure via incidental ingestion (by children) and 
inhalation are not a concern for these products which are used 
outdoors. No paints or other end-use products containing tebuconazole 
are available for interior use. Therefore, EPA has determined that no 
risk is expected for residential nonfood sites.

D. Cumulative Effects

    Tebuconazole is a member of the triazole class of systemic 
fungicides which included other triazoles such as bitertanol, 
cyproconazole, diclobutrazole, difenoconazole, diniconazole, 
fenbuconazole, flusilazole, hexaconazole, myclobutanil, penconazole, 
propiconazole, tetraconazole, triadimefon, and triadimenol. At this 
time, the EPA has not made a determination that tebuconazole and other 
substances that may have a common mechanism of toxicity would have 
cumulative effects. Therefore, for these tolerance petitions, it is 
assumed that tebuconazole does not have a common mechanism of toxicity 
with other substances and only the potential risks of tebuconazole in 
its aggregate exposure are considered.

E. Safety Determination

    1. U.S. population. Based on the exposure assessments described 
above under Unit C. Aggregate Exposure and on the completeness and 
reliability of the toxicity data, it can be concluded that aggregate 
exposure estimates from all label and pending uses of tebuconazole are 
36.49% of the aPAD and 0.1% of the cPAD for dietary exposures. Since 
EPA found no concern from drinking water or non-dietary exposure (64 FR 
1132), it can be concluded with reasonable certainty that the potential 
risks to the overall U.S. population would not exceed the Agency's 
level of concern.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of tebuconazole, data 
from developmental toxicity studies in mice, rats, rabbits and a 2-
generation reproduction study in the rat are 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 
effects from exposure to the pesticide on the reproductive capability 
of mating animals and data on systemic toxicity.
    Using the conservative exposure assumptions described above under 
Unit C. Aggregate Exposure, it can be concluded that the aggregate 
dietary exposure estimates from the proposed uses of tebuconazole would 
not exceed 70.20% of the aPAD and 0.3% of the cPAD for the most 
sensitive population subgroup children (1-6 years). Since EPA found no 
concern from drinking water or non-dietary exposure (64 FR 1132), it 
can be concluded with reasonable certainty that the potential risks to 
infants and children would not exceed the Agency's level of concern.

F. International Tolerances

    There are no established Codex or Canadian Maximum Residue Levels 
(MRLs) for tebuconazole. A Mexican MRL has been established on barley 
for tebuconazole.

[FR Doc. 01-6711 Filed 3-16-01; 8:45 a.m.]
BILLING CODE 6560-50-S