[Federal Register Volume 67, Number 100 (Thursday, May 23, 2002)]
[Notices]
[Pages 36178-36184]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-12975]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-2002-0038; FRL-6835-9]


Notice of Filing Pesticide Petitions 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 pesticide chemicals in or on various food commodities.

DATES: Comments, identified by docket control number OPP-2002-0038, 
must be received on or before June 24, 2002.

[[Page 36179]]


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 OPP-2002-0038 in the subject line on the first page of 
your response.

FOR FURTHER INFORMATION CONTACT: By mail: Thomas C. Harris, 
Registration Division (7505C), Office of Pesticide Programs, 
Environmental Protection Agency , 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-9423; 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 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 OPP2002-0038. 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 OPP-2002-0038 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 OPP-2002-0038. 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 listed 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.

[[Page 36180]]

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 support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

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

    Dated: May 6, 2002.
Debra Edwards,
 Acting Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

     Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the Federal Food, Drug, and 
Cosmetic Act (FFDCA). The summaries of the petitions were prepared by 
Sankyo Company, Ltd., and represent the views of the Sankyo Company. 
EPA is publishing the petition summaries verbatim without editing them 
in any way. 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.

Sankyo Company, Ltd.

PP 0F6134 and 1F6317

    EPA has received pesticide petitions (0F6134 and 1F6317) from 
Sankyo Company, Ltd., c/o Rockwell Enterprises, Inc., 1720 Savannah 
Drive NE, Rio Rancho, NM 87124-5700 proposing, 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 milbemectin (a mixture of 
milbemycins containing greater than or equal to 70% milbemycin 
A4 [(6R, 25R)- 5-O-demethyl-28-deoxy-6, 28-epoxy-25-ethyl-
milbemycin B] and less than or equal to 30% milbemycin A3 
[(6R, 25R)-5-O-demethyl-28-deoxy-6, 28-epoxy-25-methyl-milbemycin B]) 
in or on the raw agricultural commodities citrus crop group at 0.02 
parts per million (ppm); citrus pulp, dried at 0.2 ppm; citrus oil at 
0.1 ppm; cotton, undelinted seed at 0.02 ppm (CA only); cotton gin by-
products at 0.08 ppm (CA only); pome fruit crop group at 0.02 ppm; 
apple pomace, wet at 0.15 ppm; stone fruit crop group at 0.03 ppm (CA 
only); strawberry at 0.04 ppm; tree nut crop group at 0.02 ppm; and 
almond hulls at 0.2 ppm. EPA has determined that the petition contains 
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 petition. Additional data may be needed before 
EPA rules on the petition.

A. Residue Chemistry

    1. Plant metabolism. The metabolism of milbemectin in apples, 
oranges and strawberries has been studied. The parent molecules 
(Milbemycin A3 and Milbemycin A4) are the only 
metabolites found at significant levels in plant metabolism studies or 
in field residue studies under conditions of use, and are the only 
expected metabolites of toxicological concern in plants. The photolytic 
metabolites of milbemectin (8,9Z-M.A3 and 8,9Z-
M.A4) were not found at toxicologically significant levels 
in these metabolism studies or in field residue studies limit of 
quantitation (LOQ) (Method LOQ = 0.01 ppm), but were included as part 
of the tolerance expression at the request of EPA.
    2. Analytical method. An adequate analytical method high 
performance liquid chromotography using ultra-violet detection (HPLC 
with UV fluorescence detection at 460 nm) is available for enforcement 
purposes. The parent compounds, milbemycin A3 and milbemycin 
A4, and their respective 8,9Z metabolites are converted to 
common moieties by derivatization before analysis. A successful 
Independent Laboratory Validation has been submitted.
    3. Magnitude of residues--i Cotton. A total of 3 individual trials 
were conducted in California during the 1999 and 2000 crop season. Due 
to the limited geographical distribution of the crop residue trials for 
this crop grouping, a geographical restriction of California only is 
being requested. Applications were made at 1X the maximum labeled rate 
of 2 applications of 0.0192 lb. active ingredient/acre (a.i./acre) per 
crop season. Analyzed samples of undelinted cotton seed were  0.01 ppm 
for both total M.A3 (M.A3 + 8,9Z-M.A3) 
and total M.A4 (M.A4 + 8,9Z-M.A4). 
Based on analysis of the findings, the expected maximum residue levels 
in undelinted cotton seed is 0.02 ppm (0.01 ppm total M.A3 
(M.A3 + 8,9Z-M.A3) + 0.01 ppm total M.A 
4 (M.A4 + 8,9Z-M.A4)). Analyzed 
samples of cotton gin by-products were  10 to 22.8 fg a.i./kg (0.023 
ppm) of total M.A3 (M.A3 + 8,9Z- M.A3) 
and  10 to 54.9 fg a.i./kg (0.055 ppm) of total M.A4 
(M.A4 + 8,9Z-M.A4). Based on analysis of the 
findings, the expected maximum residue levels in cotton gin by-products 
is 0.08 ppm total milbemectin (M.A3 + 8,9Z-M.A3) 
+ (M.A4 + 8,9Z-M.A4).
    ii. Strawberries. A total of 8 individual field trials were 
conducted over a period of two crop seasons (1997, 1998) in 6 states. 
Number, type and location of trials were in accordance with those 
specified by Guideline OPPTS 860.1500, Table 1. Applications were made 
at 1X (3 trials), 1.5X (1 trial) and 2X (4 trials) the maximum labeled 
rate of 4 applications of 0.019 lb. ai/acre, or 0.076 lb. ai/acre per 
crop season. After applying a correction factor of 0.5X to 0.75X where 
appropriate to the mean residue levels found in the samples, total 
residues of milbemectin (total M.A3 + total M.A4) 
in strawberries fell within a range of 0.012 ppm to 0.035 ppm. The 
method LOQ was 0.01 ppm each for total M.A3 (M.A3 
+ 8,9Z-M.A3) and total M.A4 (M.A4 + 
8,9Z-M.A4). The photolytic metabolites of milbemectin (8,9Z-
M.A3 and 8,9Z-M.A4) were not present in any 
samples where a separate analysis was conducted (LOQ = 0.01 ppm). Based 
on these findings, the expected maximum residue levels in strawberries 
is 0.04 ppm total milbemectin (M.A3 + 8,9Z-M.A3) 
+ (M.A4 + 8,9Z-M.A4).
    iii. Citrus Crop Group: The representative crops for this grouping 
as specified by 40 CFR 180.41 are sweet oranges, lemons and grapefruit.
    a. Oranges. A total of 12 individual field trials were conducted 
over a period of two crop seasons (1997, 1998) in the states of 
California, Florida and Texas. Number, type and location of trials were 
in accordance with those specified by Guideline OPPTS 860.1500, Table 
2. Applications were made at 1X (5 trials), 1.3X (3 trials) and 2X (4 
trials) the maximum labeled rate of 3 applications of 0.024 lb. ai/
acre, or 0.072 lb. ai/acre per crop season. All analyzed samples of the 
raw agricultural commodities (RAC) were less than the method LOQ of 
0.01 ppm each for total M.A3 (M.A3 + 8,9Z-
M.A3) and total M.A4 (M.A4 + 8,9Z-
M.A4). Based on these findings, the expected maximum residue 
levels in oranges is 0.02 ppm ((0.01 ppm total M.A3 
(M.A3 + 8,9Z-M.A3) + 0.01 ppm total 
M.A4 (M.A4 + 8,9Z-M.A4)).

[[Page 36181]]

    b. Grapefruit. A total of 6 individual field trials were conducted 
over a period of two crop seasons (1997, 1998) in the states of 
California, Florida and Texas. Number, type and location of trials were 
in accordance with those specified by Guideline OPPTS 860.1500, Table 
2. Applications were made at 1X (3 trials), 1.3X (2 trials) and 2X (1 
trial) the maximum labeled rate of 3 applications of 0.024 lb. ai/acre, 
or 0.072 lb. ai/acre per crop season. All analyzed samples of the RAC 
were less than the method LOQ of 0.01 ppm each for total 
M.A3 (M.A3 + 8,9Z-M.A3) and total 
M.A4 (M.A4 + 8,9Z-M.A4). Based on 
these findings, the expected maximum residue levels in grapefruit is 
0.02 ppm ((0.01 ppm total M.A3 (M.A3 + 8,9Z-
M.A3) + 0.01 ppm total M.A4 (M.A4 + 
8,9Z-M.A4)).
    c. Lemons A total of 5 individual field trials were conducted over 
a period of two crop seasons (1997, 1998) in the states of Arizona, 
California and Florida. Number, type and location of trials were in 
accordance with those specified by Guideline OPPTS 860.1500, Table 2. 
Applications were made at 1X (2 trials) and 2X (3 trials) the maximum 
labeled rate of 3 applications of 0.024 lb. ai/acre, or 0.072 lb. ai/
acre per crop season. After applying a correction factor of 0.5X where 
appropriate to residue levels found in the samples, all analyzed 
samples of the RAC were less than the method LOQ of 0.01 ppm each for 
total M.A3 (M.A3 + 8,9Z-M.A3) and 
total M.A4 (M.A4 + 8,9Z-M.A4). Based 
on these findings, the expected maximum residue levels in lemons is 
0.02 ppm ((0.01 ppm total M.A3 (M.A3 + 8,9Z-
M.A3) + 0.01 ppm total M.A4 (M.A4 + 
8,9Z-M.A4)).
    d. Processed oranges. The study was comprised of a single trial 
located in east central Florida. The test substance was applied to the 
treated plot once at 60 days prior to normal maturity at 0.120 lb. ai/
acre and an additional two times at 30 and 7 days prior to normal 
maturity at 0.240 lb. ai/acre, or 8.33X the maximum labeled rate. After 
processing, samples of orange juice, dried pulp and orange oil were 
analyzed for total M.A3 and total M.A4. Reported 
mean values for total milbemectin (total M.A3 + total 
M.A4) were as follows: RAC - 0.011 ppm, dry pulp - 0.107, 
juice - 0.01 ppm and oil - 0.0541 ppm. The method LOQ in each commodity 
was 0.01 ppm each for total M.A3 (M.A3 + 8,9Z-
M.A3) and total M.A4 (M.A4 + 8,9Z-
M.A4). The concentration factors were determined to be 9.7X 
for dry pulp and 4.9X for oil. Based on these findings, the expected 
maximum residue levels in dry citrus pulp is 0.20 ppm and in citrus oil 
is 0.10 ppm.
    iv. Pome Fruit Crop Group. The representative crops for this 
grouping as specified by 40 CFR 180.41 are apples and pears.
    a. Apples. A total of 12 validated individual field trials were 
conducted over a period of two crop seasons (1997, 1998) in the states 
of California, Colorado, Michigan, North Carolina, New York, 
Pennsylvania, and Washington. Number, type and location of trials were 
in accordance with those specified by Guideline OPPTS 860.1500, Table 
2. Applications were made at 1X (2 trials) and 2X (10 trials) the 
maximum labeled rate of 2 applications of 0.024 lb. ai/acre, or 0.048 
lb. ai/acre per crop season. After applying a correction factor of 0.5X 
where appropriate to residue levels found in the validated samples, all 
residues were less than or equal to the method LOQ of 0.01 ppm each for 
total M.A3 (M.A3 + 8,9Z-M.A3, and 
total M.A4 (M.A4 + 8,9Z-M.A4). Based 
on these findings, the expected maximum residue levels in apples is 
0.02 ppm ((0.01 ppm total M.A3 (M.A3 + 8,9Z-
M.A3) + 0.01 ppm total M.A4 (M.A4 + 8,9Z-
M.A4)).
    b. Pears. A total of 6 individual field trials were conducted over 
a period of two crop seasons (1997, 1998) in the states of California, 
New York, Oregon and Washington. Number, type and location of trials 
were in accordance with those specified by Guideline OPPTS 860.1500, 
Table 2. Applications were made at 1X (3 trials) and 2X (3 trials) the 
maximum labeled rate of 2 applications of 0.024 lb. ai/acre, or 0.048 
lb. ai/acre per crop season. After applying a correction factor of 0.5X 
where appropriate to residue levels found in the samples, all residues 
were less than or equal to the method LOQ of 0.01 ppm each for total 
M.A3 (M.A3 + 8,9Z- M.A3) and total 
M.A4 (M.A4 + 8,9Z-M.A4). Based on 
these findings, the expected maximum residue levels in pears is 0.02 
ppm ((0.01 ppm total M.A3 (M.A3 + 8,9Z-
M.A3) + 0.01 ppm total M.A4 (M.A4 + 
8,9Z-M.A4)).
    c. Processed apples. The study was comprised of a single trial 
located in eastern Washington. The test substance was applied to the 
treated plot twice at 28 and 7 days prior to normal maturity at 0.240 
lb. ai/acre, or 10X the maximum labeled rate. After processing, samples 
of apple juice and wet pomace were analyzed for total M.A3 
and total M.A4. Reported mean values for total milbemectin 
(total M.A3 + total M.A4) were as follows: RAC - 
0.168 ppm, juice -  0.01 ppm and wet pomace - 1.067 ppm. The method LOQ 
in each commodity was 0.01 ppm each for total M.A3 
(M.A3 + 8,9Z-M.A3) and total M.A4 
(M.A4 + 8,9Z-M.A4). The concentration factors 
were determined to be 6.4X for wet pomace and 0.06X for juice. Based on 
these findings, the expected maximum residue levels in wet apple pomace 
is 0.15 ppm. No residues in excess of the established tolerances in 
pome fruit juice, including apple juice, are expected.
    v. Stone Fruit Crop Group. The representative crops for this 
grouping as specified by 40 CFR 180.41 are cherries, peaches and plums. 
Due to the limited geographical distribution of the crop residue trials 
for this crop grouping, a geographical restriction of California only 
is being requested.
    a. Cherries. A total of 2 individual field trials were conducted 
during the 1999 crop season in the state of California. Applications 
were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. 
ai/acre per crop season. Analyzed samples of the RAC were  0.01 ppm for 
total M.A3 (M.A3 + 8,9Z-M.A3) and  
0.01 to 0.0117 ppm total M.A4 (M.A4 + 8,9Z-
M.A4). Based on analysis of the findings, the expected 
maximum residue levels in cherries is 0.03 ppm ((0.01 ppm total 
M.A3 (M.A3 + 8,9Z-M.A3) + 0.02 ppm 
total M.A4 (M.A4 + 8,9Z-M.A4)).
    b. Peaches. A total of 3 individual field trials were conducted 
during the 1999 crop season in the state of California. Applications 
were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. 
ai/acre per crop season. All analyzed samples of the RAC were  0.01 ppm 
for total M.A3 (M.A3 + 8,9Z-M.A3) and  
0.01 to 0.0145 ppm total M.A4 (M.A4 + 8,9Z-
M.A4). Based on analysis of the findings, the expected 
maximum residue levels in peaches is 0.03 ppm ((0.01 ppm total 
M.A3 (M.A3 + 8,9Z-M.A3) + 0.02 ppm 
total M.A4 (M.A4 + 8,9Z-M.A4)).
    c. Plums. A total of 5 individual field trials were conducted 
during the 1999 crop season in the state of California. Applications 
were made at 1X the maximum labeled rate of 2 applications of 0.024 lb. 
ai/acre per crop season. All analyzed samples of the RAC were  0.01 ppm 
for both total M.A3 (M.A3 + 8,9Z-M.A3) 
and total M.A4 (M.A4 + 8,9Z-M.A4). 
Based on analysis of the findings, the expected maximum residue levels 
in plums is 0.02 ppm (0.01 ppm total M.A3 ((M.A3 
+ 8,9Z-M.A3) + 0.01 ppm total M.A4 
(M.A4 + 8,9Z-M.A4)).
    d. Prunes. The study was comprised of a single trial located in 
California. Applications were made at 5X the maximum labeled rate as 2 
applications of 0.12 lb. ai/acre, 21 and 14 days respectively before 
crop harvest. After processing, samples of prunes were analyzed for 
total M.A3 and total M.A4. The mean residue 
levels in plums were

[[Page 36182]]

 0.01 ppm of total M.A3 (M.A3 + 8,9Z-
M.A3) and 0.0193 ppm total M.A4 (M.A4 
+ 8,9Z-M.A4). The mean residue levels in the prunes were  
0.01 ppm of total M.A3 (M.A3 + 8,9Z-
M.A3) and 0.0179 ppm total M.A4 (M.A4 
+ 8,9Z-M.A4). Based on analysis of the findings, no 
concentration of residues is expected in the processed commodity, 
prunes.
    vi. Tree Nut Crop Group. The representative crops for this grouping 
as specified by 40 CFR 180.41 are almonds and pecans.
    a. Almonds. A total of 5 individual field trials were conducted 
during the 1999 crop season in the state of California. Number, type 
and location of trials were in accordance with those specified by 
Guideline OPPTS 860.1500, Table 2. Applications were made at 1X the 
maximum labeled rate of 2 applications of 0.024 lb. ai/acre per crop 
season. Analyzed samples of the almond nut meat samples were  0.01 ppm 
for both total M.A3 (M.A3 + 8,9Z-M.A3) 
and total M.A4 (M.A4 + 8,9Z-M.A4). In 
almond hull samples the residue levels were  0.01 to 0.0388 ppm of 
total M.A3 (M.A3 + 8,9Z-M.A3) and  
0.01 to 0.0911 ppm total M.A4 (M.A4 + 8,9Z-
M.A4). Based on analysis of the findings, the expected 
maximum residue level in almonds is 0.02 ppm ((0.01 ppm total 
M.A3 (M.A3 + 8,9Z-M.A3) + 0.01 ppm 
total M.A4 (M.A4 + 8,9Z-M.A4)) and the 
expected maximum residue level in almond hulls is 0.2 ppm ((0.05 ppm 
total M.A3 (M.A3 + 8,9Z-M.A3) + 0.15 
ppm total M.A4 (M.A4 + 8,9Z-M.A4)).
    b. Pecans. A total of 5 individual field trials were conducted 
during the 1999 crop season in the states of Arkansas, Georgia and 
Texas. Number, type and location of trials were in accordance with 
those specified by Guideline OPPTS 860.1500, Table 2. Applications were 
made at 1X the maximum labeled rate of 2 applications of 0.024 lb. ai/
acre per crop season. Analyzed samples of the pecan meat samples were  
0.01 ppm for both total M.A3 (M.A3 + 8,9Z-
M.A3) and total M.A4 (M.A4 + 8,9Z-
M.A4). Based on analysis of the findings, the expected 
maximum residue levels in pecans is 0.02 ppm ((0.01 ppm total 
M.A3 (M.A3 + 8,9Z-M.A3) + 0.01 ppm 
total M.A4 (M.A4 + 8,9Z-M.A4)).
     A metabolism study in goats was conducted using 14C-labeled 
milbemycin A4. In this study it was determined that the 
primary route of elimination of milbemectin in the goat was the feces 
and urine. Only very low levels of total radioactive residues were 
found in meat or meat by-products, fat, and milk. Based on the total 
radioactive residue levels in meat, meat by- products and milk found in 
the goat metabolism study and analysis of the expected feeding levels 
from consumption of the feed commodities, the registrant has determined 
that finite residues in fed ruminants are not expected, therefore, no 
tolerances in meat or meat by-products, fat, and milk are required in 
accordance with 40 CFR 180.6.
     The feed commodities, dried citrus pulp, wet apple pomace and 
almond hulls, are not utilized as a poultry feed stuff. The feed 
commodity, cotton meal, is utilized as a poultry feed stuff at 20% of 
the diet. Since applications of milbemectin at 5X the labeled rate 
resulted in no detectable residues in cotton seed of total 
M.A3 or M.A4 at the LOQ of 0.01 ppm, no 
detectable residues are expected to occur in poultry tissues including 
meat, fat, meat by-products and eggs. Therefore, no tolerances are 
required under the provisions of 40CFR 180.6.

B. Toxicological Profile

    1. Acute toxicity. The acute oral LD50 in rats was 762 
mg/kg for males and 456 milligrams/kilogram (mg/kg) for females, the 
dermal LD50 of technical milbemectin is greater than 5,000 
mg/kg, and the 4-hour acute inhalation LC50 in rats is 1.9 
milligrams per liter (mg/L) in males and 2.8 mg/L in females. It is not 
a dermal irritant or sensitizer and is a mild eye irritant. In a 28-day 
dermal study in rabbits, the no observed effect level (NOEL) was 1,000 
mg/kg/day, the highest dose tested. No effects on mortality, general or 
specific toxic effects, gross pathology, clinical signs or other 
measured parameters at 1,000 milligrams/kilogram/day (mg/kg/day). The 
gross necropsy and histopathological evaluation revealed no apparent 
compound-related effects.
    2. Genotoxicty. The following genotoxicity tests were all negative: 
Ames gene mutation, CHL chromosome aberration, mouse lymphoma cell 
mutation and in vivo mouse bone marrow micronucleus.
    3. Reproductive and developmental toxicity. No reproductive or 
teratologic effects were observed in any study with milbemectin. 
Maternal NOEL's of 20 and 50 milligrams/kilogram/day (mg/kg/day) were 
observed in rat and rabbit teratogenicity studies but no teratogenic 
effects were observed at the highest doses tested, 60 and 1,000 mg/kg/
day respectively. In a rat reproduction study the NOEL for both parents 
and offspring was observed to be 200 ppm, equivalent to consumption up 
to 26.4 mg/kg/day for males and 27.0 mg/kg/day for females. There were 
no reproductive effects at the highest dose tested, 800 ppm.
    4. Subchronic toxicity. A NOEL of 3 mg/kg/day was derived from the 
dog 90-day feeding study. The NOEL derived from the rat 90-day study 
was 375 ppm for males. No NOEL was determined for females, however the 
NOEL from the chronic rat study for females was 150 ppm, equivalent to 
8.77 mg/kg/day. The NOEL derived from the dog subchronic study is 
therefore the lowest of those derived from the studies.
    5. Chronic toxicity. A NOEL of 3 mg/kg/day was derived from the dog 
12-month feeding study. The NOEL derived from the rat 24-month chronic 
and oncogenicity study was 150 ppm, equivalent to 6.81 mg/kg/day for 
males and 8.77 mg/kg/day for females. The NOEL derived from the 96-week 
mouse oncogenicity study was 200 ppm, equivalent to 18.9 mg/kg/day for 
males and 19.6 mg/kg/day for females. The NOEL derived from the dog 
chronic study is, therefore, the lowest of those derived from the 
chronic studies. Milbemectin did not produce an oncogenic effect in 
either the rat or mouse study.
    6. Neurotoxicity. The NOEL for acute neurotoxicity is 20 mg/kg with 
no neuropathological effects were noted at a dose levels of 100 mg/kg/
day in female and 500 mg/kg/day in males. No histopathological evidence 
of central or peripheral neuropathology was associated with a single 
oral gavage dose at 500 mg/kg/day (males) or 100 mg/kg/day (females). 
The NOEL for subchronic neurotoxicity is the highest dose tested, 750 
ppm (equivalent to 59.357 mg/kg/day for males and 72.416 mg/kg/day for 
females), based on a 13-week rat dietary neurotoxicity study. None of 
the observations noted during the functional observation battery (FOB) 
were considered to be related to exposure to the test substance. There 
were no statistically significant or otherwise notable differences 
between the mean motor activity counts of the control and treated rats 
during weeks 4, 8, and 13. There was no macroscopic or microscopic 
evidence central or peripheral neurotoxicity associated with 13 weeks 
of dietary administration to rats.
    7. Animal metabolism. In a rat metabolism study conducted in Japan, 
more than 98% of the applied dose was excreted within 7 days, mostly in 
the feces. Radioactivity in blood reached maximum levels within 3 
hours, with a half-life of 7-8 hours. In tissues, maximum levels were 
reached in 6 hours in the intestines, followed by the liver, fat and 
stomach. Residues in rats underwent extensive oxidation. Metabolites 
identified were hydroxy-, epoxy- and dehydrogenated

[[Page 36183]]

milbemectins, followed by a number of polar metabolites. No metabolite 
exceeded 5% of the dose. Excretion, tissue distribution and metabolic 
profile after multiple day dosing was essentially the same as the 
single dose suggesting that none of the residues accumulate in any 
tissue.
     In a more recent US study, no overt signs of toxicity were 
associated with 14C-M.A4 following oral administration to 
male and female rats at 2.5 and 25 mg/kg. No significant gender-related 
differences were noted in the excretion, adsorption or distribution of 
14C-M.A4. In analysis of tissues other than the 
gastroentestinal (GI) tract, the highest concentrations of total 
radioactive residue (TRR) was found in the liver for both genders at 
all time points. The lowest concentrations were found in the brain, 
eyes, uterus and testes of males and/or females. Excretion of TRR was 
rapid with most excreted within 24 hours post dose. Total recovery of 
radioactivity in feces through 168 hours post dose was from 84.8% to 
100% for the low dose, and 81.5% to 92.8% for the high dose. Biliary 
excretion played a significant role in elimination of 14C-
M.A4 in rats. Based on TRR in bile and urine, ca 47% of the 
dose was absorbed in both sexes at the low dose level, and 40% and 30% 
were absorbed in males and females respectively at the high dose. Based 
on pharmacokinetic parameters of TRR in plasma, 14C-M.A4 
reaches maximum concentrations at 2 to 3 hours post dose and is 
eliminated slowly in the high dose groups. The metabolic pathway of 
14C-M.A4 in rats consists mainly of primary metabolism by 
hydroxylation, with the major metabolite, 13-hydroxy-M.A4, 
found in all plasma, liver and kidney samples. The unchanged parent 
compound was detected in the high dose group in all liver samples, 
except the 24-hour liver samples, all analyzed kidney samples and in 
the early time points of the plasma samples. It was also found in the 
2-hour liver samples of the low dose group. A minor glucuronidation 
pathway was identified in the bile. Excretion, tissue distribution, and 
metabolic profiles were the same for single and multiple dosing 
suggesting that residues do not accumulate.
    8. Metabolite toxicology. There is no evidence that the metabolites 
of milbemectin as identified in either the plant, or animal metabolism 
studies are of any toxicological significance.
    9. Endocrine disruption. There is no evidence from the 
developmental/chronic studies that milbemectin induces any estrogenic 
or other endocrine effects.

C. Aggregate Exposure

    1. Dietary exposure. Milbemectin is not currently registered as a 
pesticide in the U.S. and no tolerances have been previously 
established for food or feed commodities. Analysis of dietary exposure 
for proposed tolerances was made using Novigen Sciences DEEM software 
Version 7.62 using the USDA Continuing Survey of Food Intakes by 
Individuals.
    i. Food. Tolerances are proposed for the combined residues of the 
miticide/ insecticide milbemectin (a mixture of milbemectins containing 
greater than or equal to 70% milbemycin A4 [(6R, 25R)-5-O-
demethyl-28-deoxy-6, 28-epoxy-25-ethyl-milbemycin B] and less than or 
equal to 30% milbemycin A3 [(6R, 25R)-5-O-demethyl-28-deoxy-
6, 28-epoxy-25-methyl- milbemycin B] and their 8,9-Z isomers (expressed 
as parts per million of the parent compound) in or on the following 
agricultural commodities: citrus crop group - 0.02 ppm, citrus pulp, 
dried - 0.20 ppm, citrus oil - 0.10 ppm, cotton, undelinted seed (CA 
only) - 0.02 ppm, cotton gin by-products (CA only) - 0.08 ppm, pome 
fruit crop group - 0.02 ppm, apple pomace, wet - 0.15 ppm, stone fruit 
crop group (CA only) - 0.03 ppm, strawberries - 0.04 ppm, tree nut crop 
group - 0.02 ppm and almond hulls - 0.20 ppm.
    a. Acute dietary risk analysis. An acute reference dose (aRfD) of 
0.20 mg/kg/day was used in a acute dietary risk analysis. The aRfD is 
based on oral no observed adverse effects levels (NOAEL's) of 20 mg/kg/
day in the acute neurotoxicity and teratology studies in rats, divided 
by an uncertainty factor of 100 (interspecies safety factor = 10, 
intraspecies safety factor = 10). There was no evidence from the 
developmental or chronic studies that milbemectin induces any 
estrogenic or other endocrine effects. Therefore, the Food Quality 
Protection Act (FQPA) additional 10X uncertainty factor was not used. 
In the Tier 1 analysis it was assumed that all residues would be equal 
to the pending tolerances on cotton seed of 0.02 ppm, strawberries of 
0.04 ppm, citrus, pome fruit, tree nuts of 0.02 ppm, and stone fruit of 
0.03 ppm. It was assumed that 100% of the nation's acreage would be 
treated. Based on the review of data from the reproduction and 
teratology studies, no additional FQPA safety factor was applied to 
infants, since no additional toxicity to or sensitivity of the fetal or 
nursing infant test animals was seen during exposure to the test 
material. Based on this tier 1 analysis, the acute dietary exposure of 
all infants and nursing infants (1 yr. old) would be only 0.58% at the 
99.9th percentile of the proposed aRfD. The percentage of 
the proposed aRfD for the U.S. population and all other subgroups are 
below this amount.
    b. Chronic dietary risk analysis. A reference dose(RfD) of 0.03 mg/
kg/day was used in a chronic dietary risk analysis. The RfD is based on 
a NOEL of 3 mg/kg/day derived from the dog 90-day and 12-month feeding 
studies, the lowest of those derived from the chronic feeding studies. 
In view of the fact that no special sensitivity in offspring were 
observed in any test and that no reproductive or teratogenic effects 
were observed, an uncertainty factor of 100 (interspecies safety factor 
= 10, intraspecies safety factor = 10) was used for milbemectin. In the 
Tier 1 analysis it was assumed that all residues would be equal to the 
pending tolerances on cotton seed of 0.02 ppm, strawberries of 0.04 
ppm, citrus, pome fruit, tree nuts of 0.02 ppm, and stone fruit of 0.03 
ppm. It was assumed that 100% of the nation's acreage would be treated. 
Based on the review of data from the reproduction and teratology 
studies, no additional FQPA safety factor was applied to infants, since 
no additional toxicity to or sensitivity of the fetal or nursing infant 
test animals was seen during exposure to the test material. Based on 
this tier 1 analysis, the dietary exposure of non-nursing infants would 
be only 0.4% of the proposed RfD. The percentage of the proposed RfD 
for the U.S. population and all other subgroups are below this amount.
    c. Carcinogenic risk analysis. Not applicable. Milbemectin did not 
produce an oncogenic effect in two animal feeding studies.
    ii. Drinking water. A screening level drinking water assessment for 
milbemectin was conducted using a maximum use scenario. Potential 
drinking water concentrations were estimated using models generated by 
GENEEC (surface water) and SCIGROW (ground water). Input parameters for 
the use models were those which maximized concentrations in water.
     Dietary exposures were modeled with DEEM version 7.62 using the 
USDA Continuing Survey of Food Intakes by Individuals. It was assumed 
that all residues would be equal to the pending tolerances on cotton 
seed of 0.02 ppm, strawberries of 0.04 ppm, citrus, pome fruit, tree 
nuts of 0.02 ppm, and stone fruit of 0.03 ppm. It was assumed that 100% 
of the nation's acreage would be treated. Both acute and chronic 
exposures were modeled. For the acute assessment, the 99.9th 
percentile of exposure was used. The most highly

[[Page 36184]]

exposed subpopulations representing children, adult males, and adult 
females were evaluated. There are no residential exposures to consider 
at this time.
    a. Acute exposure and risk. An aRfD of 0.20 mg/kg/day was used in 
an acute dietary risk analysis. The aRfD is based on oral NOAEL's of 20 
mg/kg/day in the acute neurotoxicity and teratology studies in rats, 
divided by an uncertainty factor of 100 (interspecies safety factor = 
10, intraspecies safety factor = 10). There was no evidence from the 
developmental or chronic studies that milbemectin induces any 
estrogenic or other endocrine effects. Therefore, the FQPA additional 
10X uncertainty factor was not used.
     The estimated screening level water concentrations of milbemectin 
in surface and ground water are 0.813 fg/L (peak EEC from GENEEC) and 
0.005 fg/L (from SCIGROW), respectively. The acute DWLOCs for 
milbemectin for the most susceptible populations were calculated to be 
6,990.83 fg/L, 5,985.45 fg/L and 1,987.55 fg/L for males, 13-19 years; 
females, 13+ years, nursing; and all infants, respectively.
     Since the screening level water concentrations were orders of 
magnitude less than the acute drinking water levels of concerns 
(DWLOC's), the Agency should have no concern about exposures from 
drinking water.
    b. Chronic exposure and risk. A RfD of 0.03 mg/kg/day was used in a 
chronic dietary risk analysis. The RfD is based on NOAEL of 3 mg/kg/day 
derived from the dog 90-day and 12-month feeding studies, the lowest of 
those derived from the chronic feeding studies. In view of the fact 
that no special sensitivity in offspring were observed in any test and 
that no reproductive or teratogenic effects were observed, an 
uncertainty factor of 100 (interspecies safety factor = 10, 
intraspecies safety factor = 10) was used for milbemectin. Based on the 
review of data from the reproduction and teratology studies, no 
additional FQPA safety factor was applied to infants, since no 
additional toxicity to or sensitivity of the fetal or nursing infant 
test animals was seen during exposure to the test material.
     The estimated screening level water concentrations of milbemectin 
in surface and ground water are 0.434 fg/L (56 day average EEC from 
GENEEC) and 0.005 fg/L (from SCIGROW), respectively. The chronic DWLOCs 
for milbemectin for the most susceptible populations were calculated to 
be 1,049.30 fg/L, 899.13 fg/L and 299.08 fg/L for males, 13-19 years; 
females, 13+ years, nursing; and non-nursing infants, respectively.
     Since the screening level water concentrations were orders of 
magnitude less than the chronic DWLOC's, the Agency should have no 
concern about exposures from drinking water.
    2. Non-dietary exposure. There are no current non-food uses for 
milbemectin registered under the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA), as amended. No non-dietary exposures are 
expected for the general public. Secondary exposure would not be 
expected since milbemectin is not expected to be taken up by plants 
from the soil. The low application rates and short soil half-life are 
not conductive to buildup in the environment.

D. Cumulative Effects

     At this time, the Agency has not reviewed available information 
concerning the potentially cumulative effects of milbemectin and other 
substances that may have a common mechanism of toxicity. For purposes 
of this petition only, the Agency is considering only the potential 
risks of milbemectin in its aggregate exposure.

E. Safety Determination

    1. U.S. population.. As pointed out above in dietary exposure-food, 
the acute dietary exposure of all infants and non-nursing infants (1 
yr. old) would be only 0.58% at the 99.9th percentile of the 
proposed aRfD and the chronic dietary exposure of non-nursing infants 
would be only 0.4% of the proposed RfD. The percentages of aRfD and 
chronic RfD for the U.S. population and all other subgroups are below 
these amounts.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of milbemectin, EPA 
considered data from developmental toxicity studies in the rat and 
rabbit and a 2-generation 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. No 
developmental or reproductive effects have been observed in any study 
with milbemectin. The calculation of safety margins with respect to 
these segments of the population were taken into consideration in the 
tolerance method validation (TMRC) estimates with respect to the risk 
associated with the percentage of the reference dose being consumed. It 
is concluded that there is a reasonable certainty of no harm to infants 
and children from aggregate exposure to milbemectin residues.

F. International Tolerances

     No Codex maximum residue levels have been established for residues 
of milbemectin. Milbemectin is not yet registered for use on any crop 
in Canada or Mexico. National maximum residue levels (MRL's) for 
milbemectin in Japan are as follows: Apple, Pear, Peach, Citrus, Melon, 
Watermelon, Cucumber, Eggplant, Adzuki-bean - 0.2 ppm, Strawberry, 
Cherry, Grape - 0.5 ppm, and Tea - 2 ppm. National MRL's for 
milbemectin in Taiwan are as follows: Small berry (Grape, Strawberry, 
Star fruit, etc.), Tree fruit (Pear, Apple, Cherry, Peach, Plum, etc.), 
Vegetables (Eggplant, Cucumber, Tomato, etc.), Melon (Watermelon, 
Muskmelon, etc.) - 0.2 ppm; Tea - 2 ppm. In general, where national 
MRL's differ from those proposed to EPA, they are associated with 
agricultural and regulatory practices that differ from those common in 
the U.S.
[FR Doc. 02-12975 Filed 5-22-02; 8:45 am]
BILLING CODE 6560-50-S