[Federal Register Volume 65, Number 157 (Monday, August 14, 2000)]
[Notices]
[Pages 49563-49571]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20539]



[[Page 49563]]

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ENVIRONMENTAL PROTECTION AGENCY

[PF-962; FRL-6739-2]


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

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  This notice announces the initial filing of a pesticide 
petition 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-962, must be 
received on or before September 13, 2000.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-962 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Hoyt Jamerson, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9368; 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 Potentially
             Categories                 NAICS       Affected Entities
------------------------------------------------------------------------
Industry                                    111  Crop production
                                            112  Animal production
                                            311  Food manufacturing
                                          32532  Pesticide manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' and then look up the entry for this document under the 
``Federal Register--Environmental Documents.'' You can also go directly 
to the Federal Register listings at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-962. 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-962 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 (7502C), 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-962. 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.

[[Page 49564]]

    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 a pesticide petition 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 Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains 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: August 4, 2000.

  James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it 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.

Monsanto Company

9E6003

    EPA has received a pesticide petition (9E6003) from the 
Interregional Research Project Number 4 (IR-4), 681 U.S. Highway #1, 
South, North Brunswick, New Jersey 08902-3390 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR 180.364. The proposed amendments to 40 
CFR 180.364, are listed in the section entitled ``Summary of Revisions 
to Sec. 180.364 Glyphosate; tolerances for residues Proposed by 
Monsanto''. The following summary also includes several revisions to 
Sec. 180.364 which were proposed by the registrant, Monsanto Company, 
in Federal Register notices of January 10, 2000, 65 FR 1370 (FRL-6394-
6) and July 25, 2000, 65 FR 45769 (FRL-6596-4). In the Federal Register 
notice of January 10, 2000, Monsanto Company proposed to amend 40 CFR 
part 180 by establishing tolerances for residues of glyphosate in or on 
the food commodities field corn forage at 3.0 ppm (PP 8F4973); alfalfa 
hay at 400 ppm and alfalfa forage at 175 ppm (PP 9F5906); and stover 
and straw of the cereal grains group at 100 ppm (PP 9F6007). Monsanto 
also proposed deletion of currently established tolerances on alfalfa 
at 200 ppm; fresh alfalfa at 0.2 ppm; field corn stover at 100 ppm; 
grain sorghum stover at 40 ppm; and wheat straw at 85 ppm. The 
registrant proposed these tolerances for deletion since they are either 
no longer needed or are superceded by the proposed crop group 
tolerances.
    In a second notice published in the Federal Register on July 25, 
2000, Monsanto proposed to amend 40 CFR part 180 by establishing 
tolerances for the grass forage, fodder, and hay group at 300 ppm and 
by revising the tolerance expression under Sec. 180.364(a)(1) to read 
as follows:
    ``(a) General. (1) Tolerances are established for residues of 
glyphosate (N-(phosphonomethyl)glycine) from the application of 
glyphosate, the isopropylamine salt of glyphosate, the ethanolamine 
salt of glyphosate, and the ammonium salt of glyphosate. * * *''
    Monsanto also proposed that the glyphosate commodity tolerances in 
Sec. 180.364(a)(2) and (a)(3) be transferred to Sec. 180.364(a)(1), 
that Sec. 180.364(a)(1) be redesignated as Sec. 180.364(a), and that 
Sec. 180.364(a)(2) and (a)(3) be deleted.

A Summary of the Revisions to Sec. 180.364 Proposed by Monsanto

    Revise Sec. 180.364 by redesignating paragraph (a)(1) as paragraph 
(a), which would read as follows:
    ``(a) General. Tolerances are established for residues of 
glyphosate (N-(phosphonomethyl)glycine) resulting from the application 
of glyphosate, the isopropylamine salt of glyphosate, the ethanolamine 
salt of glyphosate and the ammonium salt of glyphosate in or on the 
following food commodities:''
    Transfer the commodity tolerances from Sec. 180.364(a)(2) and 
Sec. 180.364(a)(3) to the table in Sec. 180.364(a) and delete 
Sec. 180.364(a)(2) and Sec. 180.364(a)(3).
    Revise the table under Sec. 180.364(a) by the establishment of new 
tolerances, increasing the tolerance for selected commodities 
(increase), the deletion of duplicate commodity tolerance entries and 
the deletion of commodity tolerances that are superceded by the 
proposed crop group tolerances, the conversion of commodity terms to 
comply with EPA's Food and Feed Vocabulary Data Base (http://www.epa.gov/pesticides/foodfeed/), and the transfer of commodity 
tolerances from Sec. 180.364(a)(2) and Sec. 180.364(a)(3) to the table 
in Sec. 180.364(a):

------------------------------------------------------------------------
     Existing Tolerances from
           180.364(a)(1)                      Proposed Changes
------------------------------------------------------------------------
Acerola at 0.2 ppm                  No change.
 
Alfalfa at 200.0 ppm                Delete. See tolerances for Alfalfa,
                                     hay and Alfalfa, forage.
 
Alfalfa, forage at 75.0 ppm         Increase tolerance for Alfalfa,
                                     forage to 175 ppm.
 
Alfalfa, fresh and hay at 0.2 ppm   Delete. See tolerances for Alfalfa,
                                     hay and Alfalfa, forage.
 
Alfalfa, hay at 200.0 ppm           Increase tolerance for Alfalfa, hay
                                     to 400 ppm.
 
Almonds, hulls at 1 ppm              Delete. Tolerance established for
                                     Almond hulls at 25 ppm.
 
Almond hulls at 25 ppm              Amend to read ``Almond, hulls'' at
                                     25 ppm.
                                    Add ``Animal feed, nongrass, group
                                     (except alfalfa)'' at 200 ppm.
 
Artichokes, Jerusalem at 0.2 ppm    Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.

[[Page 49565]]

 
                                    Add ``Aloe vera'' at 0.5 ppm.
                                    Add ``Ambarella'' at 0.2 ppm.
                                    Add ``Artichoke, globe'' at 0.2 ppm.
 
Asparagus at 0.5 ppm                No change.
 
Aspirated grain fractions at 200.0  Amend to read ``Aspirated grain
 ppm                                 fractions'' at 200 ppm.
 
Atemoya at 0.2 ppm                  No change.
 
Avocados at 0.2 ppm                 Amend to read ``Avocado'' at 0.2
                                     ppm.
 
Bahiagrass at 200.0 ppm             Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
                                    Add ``Bamboo, shoots'' at 0.2 ppm.
 
Bananas at 0.2 ppm                  Amend to read ``Banana'' at 0.2 ppm.
                                    Insert entry for ``Barley, bran'' at
                                     30 ppm from 180.364(a)(3).
                                    Insert entry for ``Barley, grain''
                                     at 20 ppm from 180.364(a)(3).
 
Beets at 0.2 ppm                    Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
                                    Insert entry for ``Beet, sugar,
                                     dried pulp'' at 25 ppm
                                     from180.364(a)(3).
                                    Insert entry for ``Beet, sugar,
                                     roots'' at 10 ppm from
                                     180.364(a)(3).
                                    Insert entry for ``Beet, sugar,
                                     tops'' at 10 ppm from
                                     180.364(a)(3).
 
Bermudagrass at 200.0 ppm           Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
                                    Add ``Berry group'' at 0.2 ppm.
 
Bluegrass at 200.0 ppm              Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
 
Breadfruit at 0.2 ppm               No change.
 
Bromegrass at 200.0 ppm             Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
                                    Add ``Betelnut'' at 1.0 ppm.
                                    Add ``Biriba'' at 0.2 ppm.
                                    Add ``Blimbe'' at 0.2 ppm.
                                    Add ``Borage, seed'' at 0.1 ppm.
                                    Add ``Cactus, fruit'' at 0.5 ppm.
                                    Add ``Cactus, pads'' at 0.5 ppm.
 
Canistel at 0.2 ppm                 No change.
                                    Insert entry for ``Canola, meal'' at
                                     15 ppm from 180.364(a)(3).
                                    Insert entry for ``Canola, seed'' at
                                     10 ppm from 180.364(a)(3).
 
Carambola at 0.2 ppm                Amend to read ``Starfruit'' at 0.2
                                     ppm.
 
Carrots at 0.2 ppm                  Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Cattle, kidney at 4.0 ppm           No change.
 
Cattle, liver at 0.5 ppm            No change.
 
Celeriac at 0.2 ppm                 Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
                                    Add ``Chaya'' at 1.0 ppm.
 
Cherimoya at 0.2 ppm                No change.
 
Chickory at 0.2 ppm.                Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Citrus, fruits at 0.5 ppm           Amend to read ``Fruit, citrus,
                                     group'' at 0.5 ppm.
 
Citrus pulp, dried at 1.5 ppm       Amend to read ``Citrus, dried pulp''
                                     at 1.5 ppm
 
Clover at 200.0 ppm                 Delete. Included in Animal feed,
                                     nongrass, group (except alfalfa) at
                                     200 ppm.
 
Cocoa beans at 0.2 ppm              Amend to read ``Cacao bean'' at 0.2
                                     ppm.
 
Coconut at 0.1 ppm                  No change.
 
Coffee beans at 1 ppm               Amend to read ``Coffee, bean'' at
                                     1.0 ppm.
 
Corn, field, forage at 1.0 ppm      Increase the tolerance for Corn,
                                     field, forage to 3.0 ppm.
 
Corn, field, grain at 1.0 ppm       No change.
 
Corn, field, stover at 100.0 ppm    Delete. Included in Grain, cereal,
                                     stover and straw, group at 100 ppm.
 
Cotton gin byproducts at 100.0 ppm  Amend to read ``Cotton, gin
                                     byproducts'' at 100 ppm.
 
Cottonseed at 15 ppm                Amend to read ``Cotton, undelinted
                                     seed'' at 15 ppm.
 
Cranberries at 0.2 ppm              Amend to read ``Cranberry'' at 0.2
                                     ppm.
                                    Add Crambe, seed at 0.1 ppm.
                                    Add Custard apple at 0.2 ppm.
 
Dates at 0.2 ppm                    Amend to read ``Date'' at 0.2 ppm.
                                    Add Dokudami at 2.0 ppm.
                                    Insert entry for ``Durian'' at 0.2
                                     ppm from 180.364(a)(2).
                                    Add ``Egg'' at 0.1 ppm.
                                    Add ``Epazote'' at 1.3 ppm.
                                    Add ``Feijoa'' at 0.2 ppm.
 
Fescue at 200.0 ppm                 Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
 

[[Page 49566]]

 
Figs at 0.2 ppm                     Amend to read ``Fig'' at 0.2 ppm.
 
Fish at 0.25 ppm                    No change.
                                    Add ``Flax, seed'' at 4.0 ppm.
                                    Add ``Flax, meal'' at 8.0 ppm.
 
Forage grasses at 0.2 ppm           Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
 
Forage legumes (except soybeans     Delete. Included in Vegetable,
 and peanuts) at 0.4 ppm             foliage of legume, group, (except
                                     soybean) at 0.2 ppm.
 
Fruits, small, and berries at 0.2   Delete. Included in Berry group at
 ppm                                 0.2. See also entries for
                                     cranberry, grape and strawberry in
                                     this table.
                                    Add ``Galangal, roots'' at 0.2 ppm.
 
Genip at 0.2 ppm                    Amend to read ``Marmaladebox'' at
                                     0.2 ppm.
                                    Add ``Ginger, white, flower'' at 0.2
                                     ppm.
                                    Add ``Gourd, buffalo, seed'' at 0.1
                                     ppm.
 
Goats, kidney at 4.0 ppm            Amend to read ``Goat, kidney'' at
                                     4.0 ppm.
 
Goats, liver at 0.5 ppm             Amend to read ``Goat, liver'' at 0.5
                                     ppm.
                                    Add ``Governor's Plum'' at 0.2 ppm.
                                    Add ``Gow Kee, leaves'' at 0.2 ppm.
                                    Insert entry for ``Grain crops
                                     (except wheat, corn, oats, grain
                                     sorghum, and barley)'' at 0.1 ppm
                                     from 180.364(a)(3) and amend to
                                     read ``Grain, Cereal Group (except
                                     barley, field corn, grain sorghum,
                                     oats and wheat)'' at 0.1 ppm.
                                    Add ``Grain, cereal, stover and
                                     straw, group'' at 100 ppm.
 
Grapes at 0.2 ppm                   Amend to read ``Grape'' at 0.2 ppm.
                                    Add ``Grass, forage, fodder and hay,
                                     group'' at 300 ppm.
 
Grasses, forage at 0.2(N) ppm       Delete. Included in ``Grass, forage,
                                     fodder and hay, group'' at 300 ppm.
 
Guavas at 0.2 ppm                   Amend to read ``Guava'' at 0.2 ppm.
                                    Add ``Herbs subgroup'' at 0.2 ppm.
 
Hogs, kidney at 4.0 ppm             Amend to read ``Hog, kidney'' at 4.0
                                     ppm.
 
Hogs, liver at 0.5 ppm              Amend to read ``Hog, liver'' at 0.5
                                     ppm.
                                    Add ``Hop, dried cones'' at 7.0 ppm.
 
Horseradish at 0.2 ppm              Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Horses, kidney at 4.0 ppm           Amend to read ``Horse, kidney'' at
                                     4.0 ppm.
 
Horses, liver at 0.5 ppm,           Amend to read ``Horse, liver'' at
                                     0.5 ppm.
                                    Add ``Ilama'' at 0.2 ppm.
                                    Add ``Imbe'' at 0.2 ppm.
                                    Add ``Imbu'' at 0.2 ppm.
 
Jaboticaba at 0.2 ppm               No change.
 
Jackfruit at 0.2 ppm.               No change.
                                    Add ``Jojoba, seed'' at 0.1 ppm.
                                    Add ``Juneberry'' at 0.2 ppm.
                                    Add ``Kava, roots'' at 0.2 ppm
                                    Add ``Kenaf, forage'' at 200 ppm.
 
Kiwifruit at 0.2 ppm.               No change.
 
Leafy vegetables at 0.2(N) ppm      Delete. Included in Vegetable,
                                     leafy, group at 0.2 ppm; Vegetable,
                                     Brassica leafy, group at 0.2
                                     ppm;Vegetable, leaves of root and
                                     tuber, group, except sugar beet
                                     tops, at 0.2 ppm.
                                    Add ``Lesquerella, seed'' at 0.1
                                     ppm.
                                    Add ``Leucaena, forage'' at 200 ppm.
                                    Add ``Lingonberry'' at 0.2 ppm.
 
Longan at 0.2 ppm                   No change.
 
Lychee at 0.2 ppm                   No change.
                                    Add ``Mamey apple'' at 0.2 ppm.
 
Mamey sapote at 0.2 ppm             No change.
 
Mangoes at 0.2 ppm.                 Amend to read ``Mango'' at 0.2 ppm.
                                    Insert entry for ``Mangosteen at 0.2
                                     ppm from180.364(a)(2).
                                    Add ``Meadowfoam, seed'' at 0.1 ppm.
                                    Add ``Mioga, flower'' at 0.2 ppm.
 
Molasses, sugarcane at 30.0 ppm     Amend to read ``Sugarcane,
                                     molasses'' at 30 ppm.
                                    Add ``Mustard, seed'' at 0.1 ppm.
                                    Add ``Nut, pine'' at 1.0 ppm.
 
Nuts at 0.2 ppm                     Delete. Included in Nut, tree, group
                                     at 1.0 ppm.
 
Oats, grain at 20.0 ppm             Amend to read ``Oat, grain'' at 20
                                     ppm.
 
Oil, palm at 0.1 ppm                Amend to read ``Palm, oil'' at 0.1
                                     ppm.
                                    Add ``Okra'' at 0.5 ppm.
 

[[Page 49567]]

 
Olives at 0.2 ppm                   Amend to read ``Olive'' at 0.2 ppm.
 
Olives, imported at 0.1 ppm         Delete. Included in entry for
                                     ``Olive'' at 0.2 ppm.
 
Orchardgrass at 200.0 ppm           Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
                                    Add ``Oregano, Mexican, leaves'' at
                                     2.0 ppm.
                                    Add ``Palm heart, leaves'' at 0.2
                                     ppm.
 
Papayas at 0.2 ppm                  Amend to read ``Papaya'' at 0.2 ppm.
                                    Add ``Papaya, mountain'' at 0.2 ppm.
 
Parsnips at 0.2 ppm                 Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Passion fruit at 0.2 ppm            Amend to read ``Passionfruit'' at
                                     0.2 ppm.
                                    Add ``Pawpaw'' at 0.2 ppm.
 
Peanut, forage at 0.5 ppm           No change.
 
Peanut, hay at 0.5 ppm              No change.
 
Peanuts at 0.1 ppm                  Amend to read ``Peanut'' at 0.1 ppm.
                                    Add ``Pepper leaf, fresh leaves'' at
                                     0.2 ppm.
 
Peppermint at 200 ppm               Amend to read ``Peppermint, tops''
                                     at 200 ppm.
                                    Add ``Perilla, tops'' at 1.8 ppm.
 
Persimmons at 0.2 ppm               Amend to read ``Persimmon'' at 0.2
                                     ppm.
 
Pineapple at 0.1 ppm                No change.
 
Pistachio nuts at 0.2 ppm           Amend to read ``Pistachio.''
                                     Increase tolerance to 1.0 ppm.
 
Pome fruits at 0.2 ppm              Amend to read ``Fruit, pome, group''
                                     at 0.2 ppm.
 
Pomegranates at 0.2 ppm             Amend to read ``Pomegranate'' at 0.2
                                     ppm.
 
Potatoes at 0.2 ppm                 Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Poultry, kidney at 0.5 ppm          Delete. Add ``Poultry, meat
                                     byproducts'' at 1.0 ppm.
                                    Add ``Poultry meat'' at 0.1 ppm.
 
Poultry, liver at 0.5 ppm           Delete. Incuded in Poultry, meat
                                     byproducts at 1.0 ppm..
                                    Add ``Pulasan'' at 0.2 ppm.
                                    Add ``Quinoa, grain'' at 5.0 ppm.
 
Radishes at 0.2 ppm                 Delete. Included in Vegetable, root
                                     and tuber group (except sugar beet)
                                     at 0.2 ppm.
                                    Insert entry for Rambutan at 0.2 ppm
                                     from 180.364(a)(2).
                                    Add ``Rapeseed, seed'' at 10 ppm.
                                    Add ``Rapeseed, meal'' at 15 ppm.
                                    Add ``Rose apple'' at 0.2 ppm.
 
Rutabagas at 0.2 ppm                Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Ryegrass at 200.0 ppm               Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
                                    Add ``Safflower, seed'' at 0.1 ppm.
                                    Add ``Salal'' at 0.2 ppm.
 
Salsify at 0.2 ppm                  Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Sapodilla at 0.2 ppm                No change.
 
Sapote, black at 0.2 ppm            No change.
 
Sapote, white at 0.2 ppm            No change.
 
Seed and pod vegetables at 0.2(N)   Delete. Included in Vegetable,
 ppm                                 legume, group (except soybean) at
                                     5.0 ppm. See also soybean at 20 ppm
                                     and okra at 0.5 ppm.
 
Seed and pod vegetables, forage at  Delete. Included in Vegetable,
 0.2(N) ppm                          foliage of legume, group (except
                                     soybean forage and hay) at 0.2 ppm.
                                     See also soybean, forage at 100
                                     ppm.
 
Seed and pod vegetables, hay at     Delete. Included in Vegetable,
 0.2(N) ppm.                         foliage of legume, group (except
                                     soybean forage and hay) at 0.2 ppm.
                                     See also soybean, hay at 200 ppm.
                                    Add ``Sesame, seed'' at 0.1 ppm.
 
Sheep, kidney at 4 ppm              Amend to read ``Sheep, kidney'' at
                                     4.0 ppm.
 
Sheep, liver at 0.5 ppm             No change.
 
Shellfish at 3 ppm                  Amend to read ``Shellfish'' at 3.0
                                     ppm..
 
Sorghum, grain at 15 ppm            Amend to read ``Sorghum, grain,
                                     grain'' at 15 ppm.
 
Sorghum, grain, stover at 40 ppm    Delete. Included in ``Grain, cereal,
                                     stover and straw, group'' at 100
                                     ppm.
 
Soursop at 0.2 ppm                  No change.
 
Soybean hulls at 100.0 ppm.         Amend to read ``Soybean, hulls'' at
                                     100 ppm.
 
Soybeans at 20.0 ppm                Amend to read ``Soybean'' at 20 ppm.
 
Soybeans, aspirated grain           Amend to read ``Soybean, aspirated
 fractions at 50.0 ppm               grain fractions'' at 50 ppm.
 
Soybeans, forage at 100.0 ppm       Amend to read ``Soybean, forage'' at
                                     100 ppm.
 

[[Page 49568]]

 
Soybeans, grain at 20.0             Delete. Duplicate entry. See soybean
                                     at 20 ppm.
 
Soybeans, hay at 200.0 ppm          Amend to read ``Soybean, hay'' at
                                     200 ppm.
                                    Add ``Spanish lime'' at 0.2 ppm.
 
Spearmint at 200 ppm                Amend to read ``Spearmint, tops'' at
                                     200 ppm.
                                    Add ``Spices subgroup'' at 7.0 ppm.
                                    Add ``Star apple'' at 0.2 ppm.
                                    Add ``Stevia, dried leaves'' at 1.0
                                     ppm.
                                    Add ``Strawberry'' at 0.2 ppm.
 
Stone fruit at 0.2 ppm              Amend to read ``Fruit, stone,
                                     group'' at 0.2 ppm.
 
Sugar apple at 0.2 ppm              No change.
 
Sugarcane at 2.0 ppm                No change.
 
Sunflower seed at 0.1 ppm           Amend to read ``Sunflower, seed'' at
                                     0.1 ppm.
                                    Add ``Surinam cherry'' at 0.2 ppm.
 
Sweet potatoes at 0.2 ppm           Delete. Included in the Vegetable,
                                     root and tuber, group (except sugar
                                     beet) at 0.2 ppm.
 
Tamarind at 0.2 ppm                 No change.
 
Tea, dried at 1.0 ppm.              Amend to read ``Tea, dried'' at 1.0
                                     ppm.
 
Tea, instant at 7.0 ppm             Amend to read ``Tea, instant'' at
                                     7.0 ppm.
 
                                    Add ``Teff, grain'' at 5.0 ppm.
 
                                    Add ``Ti, leaves'' at 0.2 ppm.
 
                                    Add ``Ti, roots'' at 0.2 ppm.
 
Timothy at 200.0 ppm                Delete. Included in Grass, forage,
                                     fodder and hay, group at 300 ppm.
 
Tree nut crop group at 1.0 ppm      Amend to read ``Nut, tree, group''
                                     at 1.0 ppm.
 
Turnips at 0.2 ppm                  Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) at 0.2 ppm.
                                    Add Ugli fruit at 0.5 ppm.
 
Vegetables, bulb at 0.2 ppm         Amend to read ``Vegetable, bulb,
                                     group'' at 0.2 ppm.
 
Vegetables, cucurbit at 0.5 ppm     Amend to read ``Vegetable, cucurbit,
                                     group'' at 0.5 ppm.
 
Vegetable, fruiting (except         Amend to read ``Vegetable, fruiting,
 cucurbits) group at 0.1 ppm         group'' at 0.1 ppm.
 
Vegetables, leafy, Brassica (cole)  Amend to read ``Vegetable, Brassica
 at 0.2 ppm                          leafy, group'' at 0.2 ppm.
                                    Add ``Vegetable, foliage of legume,
                                     group (except soybean forage and
                                     hay)'' at 0.2 ppm.
                                    Add ``Vegetable, leafy, group at 2.0
                                     ppm.
                                    Add ``Vegetable, leaves of root and
                                     tuber, group (except sugar beet
                                     tops)'' at 0.2 ppm.
                                    Insert entry ``Vegetable, legume,
                                     group (except soybeans) at 5.0 ppm
                                     from 180.364(a)(3).
                                    Add ``Vegetable, root and tuber,
                                     group (except sugar beets)'' at 0.2
                                     ppm.
                                    Add ``Wasabi , roots'' at 0.2 ppm.
                                    Add ``Water spinach, tops'' at 0.2
                                     ppm.
                                    Add ``Watercress, upland'' at 0.2
                                     ppm.
                                    Add ``Wax jambu'' at 0.2 ppm.
 
Wheat, grain at 5.0 ppm             Amend to read ``Wheat, grain'' at
                                     5.0 ppm.
 
Wheat milling fractions (excluding  Amend to read ``Wheat milling
 flour) at 20.0 ppm                  fractions (excluding flour)'' at 20
                                     ppm.
 
Wheat, straw at 85.0 ppm            Delete. Included in ``Grain, cereal,
                                     stover and straw, group at 100 ppm.
 
Wheatgrass at 200.0 ppm             Delete. Included in Grass, forage,
                                     fodder and hay group at 300 ppm.
                                    Add ``Yacon, tuber'' at 0.2 ppm.
 
Yams at 0.2 ppm                     Delete. Included in Vegetable, root
                                     and tuber, group (except sugar
                                     beet) group 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 qualitative nature of the residue in 
plants is adequately understood. Studies with a variety of plants 
including corn, cotton, soybeans, and wheat indicate that the uptake of 
glyphosate or its metabolite, aminomethylphosphonic acid (AMPA), from 
soil is limited. The material which is taken up is readily 
translocated. Foliarly applied glyphosate is absorbed and translocated 
throughout the trees or vines to the fruit of apples, coffee, dwarf 
citrus (calamondin), pears, and grapes. Metabolism via N-methylation 
yields N-methylated glycines and phosphonic acids. For the most part, 
the ratio of glyphosate to AMPA is 9 to 1 but can approach 1 to 1 in a 
few cases (e.g., soybeans and carrots). Much of the residue data for 
crops reflect a detectable residue of parent (0.05-0.15 ppm) along with 
residues below the level of detection (0.05 ppm) of AMPA. Only 
glyphosate parent is regulated in plant and animal commodities since 
the metabolite AMPA is not of toxicological concern.

[[Page 49569]]

    2. Analytical method. There is a practical analytical method for 
detecting and measuring levels of glyphosate in or on food with a 
limits of detection (0.05 ppm) that allows monitoring of food with 
residues at or above the levels set in these tolerances. These methods 
include gas liquid chromatography (GLC) (Method I in Pesticides 
Analytical Manual (PAM) II (the limit of detection is 0.05 ppm) and 
high performance liquid chromatography (HPLC) with fluorometric 
detection. The HPLC procedure has undergone successful Agency 
validation and was recommended for inclusion in PAM II. A gas 
chromatography/mass spectrometry (GC/MS) method for glyphosate in crops 
has also been validated by EPA's Analytical Chemistry Laboratory (ACL).

B. Toxicological Profile

    1. Acute toxicity. Results from an acute oral study in rats show a 
combined lethal dose (LD50) for glyphosate of is greater 
than 5,000 milligram/kilogram (mg/kg). An acute dermal study in rabbit 
resulted in a LD50 of greater than 5,000 mg/kg. The results 
of a primary eye irritation study in the rabbit showed severe 
irritation for glyphosate acid. However, glyphosate is normally 
formulated as one of several salts and eye irritation studies on the 
salts showed essentially no irritation. A primary dermal irritation 
study showed essentially no irritation. A primary dermal sensitization 
study showed no sensitization. Based on these data, Monsanto concludes 
that the acute toxicity and irritation potential of glyphosate is low.
    2. Genotoxicity. A number of mutagenicity studies were conducted 
and were all negative. These studies included: chromosomal aberration 
in vitro (no aberrations in Chinese hamster ovary cells were caused 
with or without S9 activation); deoxyribonucleic acid (DNA) repair in 
rat hepatocyte; in vivo bone marrow cytogenic test in rats; rec-assay 
with B. subtilis; reverse mutation test with S. typhimurium; Ames test 
with S. typhimurium; and dominant-lethal mutagenicity test in mice. 
Negative results were also obtained when glyphosate was tested in a 
dominant-lethal mutation assay.
    3. Reproductive and developmental toxicity. An oral developmental 
toxicity study with rats given doses of 0, 300, 1,000 and 3,500 mg/kg/
day with a maternal no observed adverse effect level (NOAEL) of 1,000 
mg/kg/day based on clinical signs of toxicity, body weight effects and 
mortality, and a fetal NOAEL of 1,000 mg/kg/day based on reduced body 
weights and delayed sternebrae maturation at the highest dose tested 
(HDT) of 3,500 mg/kg/day. An oral developmental toxicity study with 
rabbits given doses of 0,75, 175 and 350 mg/kg/day with a maternal 
NOAEL of 175 mg/kg/day based on clinical signs of toxicity and 
mortality, and a fetal NOAEL of 350 mg/kg/day with no developmental 
toxicity at the dose levels tested.
    A 3-generation reproduction study with rats fed dosage levels of 0, 
3, 10 and 30 mg/kg/day with a NOAEL for systemic and reproductive/
developmental parameters of 30 mg/kg/day based on no adverse effects 
noted at the dose levels tested. A 2-generation reproduction study with 
rats fed dosage levels of 0, 100, 500 and 1,500 mg/kg/day with a NOAEL 
for systemic and developmental parameters of 500 mg/kg/day based on 
body weight effects, clinical signs of toxicity in adult animals and 
decreased pup body weights, and a reproductive NOAEL of 1,500 mg/kg/
day.
    4. Subchronic toxicity. A 90-day feeding study in mice fed dosage 
levels of 0, 5,000, 10,000 and 50,000 with a NOAEL of 10,000 ppm based 
on body weight effects at the high dose. A 90-day feeding study in rats 
fed dosage levels of 0, 1,000, 5,000 and 20,000 ppm with a NOAEL of 
20,000 ppm based on no effects even at the HDT. A 90-day feeding study 
in dogs given glyphosate, via capsule, at doses of 0, 200, 600 and 
2,000 mg/kg/day with a NOAEL of 2,000 mg/kg/day based on no effects 
even at the HDT.
    5. Chronic toxicity. The reference dose (RfD) for glyphosate is 
calculated to be 2.0 mg/kg/bwt/day based on maternal effects in a 
developmental study with rabbits (NOAEL of 175 mg/kg/bwt/day) and using 
a hundred-fold safety factor.
    A mouse carcinogenicity study with mice fed dosage levels of 0, 
150, 750 and 4,500 mg/kg/day with a NOAEL of 750 mg/kg/day based on 
body weight effects and microscopic liver changes at the high dose. 
There was no carcinogenic effect at the HDT of 4,500 mg/kg/day.
    A 12-month oral study in dogs given glyphosate, via capsule, at 
doses of 0, 20, 100 and 500 mg/kg/day with a NOAEL of 500 mg/kg/day 
based on no adverse effects at any dose level.
    A 24-month chronic/feeding carcinogenicity study with rats fed 
dosage levels of 0, 89, 362 and 940 mg/kg/day (males) and 0, 113, 457 
and 1,183 mg/kg/day (females) with a systemic NOAEL of 362 mg/kg/day 
based on body weight effects in the female and eye effects in males. 
There was no carcinogenic response at any dose level.
    A 26-month chronic/feeding carcinogenicity study with rats fed 
dosage levels of 0, 3, 10 and 31 mg/kg/day (males) and 0, 3, 11 and 34 
mg/kg/day (females) with a systemic NOAEL of 31 mg/kg/day (males) and 
34 mg/kg/day (females) based on no carcinogenic or other adverse 
effects at any dose level.
    The EPA Carcinogenicity Peer Review Committee has classified 
glyphosate in Group E (evidence of non-carcinogenicity for humans), 
based upon lack of convincing carcinogenicity evidence in adequate 
studies in two animal species. There was no evidence of carcinogenicity 
in an 18-month feeding study in mice and a 2-year feeding study in rats 
at the dosage levels tested. The doses tested were adequate for 
identifying a cancer risk.
    6. Animal metabolism. The qualitative nature of the residue in 
animals is adequately understood. Studies with lactating goats and 
laying hens fed a mixture of glyphosate and AMPA indicate that the 
primary route of elimination was by excretion (urine and feces). These 
results are consistent with metabolism studies in rats, rabbits, and 
cows. The terminal residues in eggs, milk, and animal tissues are 
glyphosate and its metabolite AMPA; there was no evidence of further 
metabolism. The terminal residue to be regulated in livestock is 
glyphosate per se.
    7. Endocrine disruption. The toxicity studies required by EPA for 
the registration of pesticides measure numerous endpoints with 
sufficient sensitivity to detect potential endocrine-modulating 
activity. No effects have been identified in subchronic, chronic, or 
developmental toxicity studies to indicate any endocrine-modulating 
activity by glyphosate. In addition, negative results were obtained 
when glyphosate was tested in a dominant-lethal mutation assay. While 
this assay was designed as a genetic toxicity test, agents that can 
affect male reproduction function will also cause effects in this 
assay. More importantly, the multi-generation reproduction study in 
rodents is a complex study design which measures a broad range of 
endpoints in the reproductive system and in developing offspring that 
are sensitive to alterations by chemical agents. Glyphosate has been 
tested in two separate multi-generation studies and each time the 
results demonstrated that glyphosate is not a reproductive toxin.

C. Aggregate Exposure

    1. Dietary exposure. Tolerances have been established (40 CFR 
180.364) for the residues of (n-(phosphonomethyl)glycine resulting

[[Page 49570]]

from the application of the isopropylamine salt of glyphosate and/or 
the monoammonium salt of glyphosate, in or on a variety of plant and 
animal raw agricultual commodities (RACs) including kidney of cattle, 
goats, hogs, horses, and sheep at 4.0 ppm; liver of cattle, goats, 
hogs, horses, and sheep at 0.5 ppm; and liver and kidney of poultry at 
0.5 ppm based on animal feeding studies and worst-case livestock diets.
    i. Food. The chronic dietary exposure analysis was conducted using 
the RfD of 2.0 mg/kg/day based on the maternal NOAEL of 175 mg/kg/day 
from a developmental study and an uncertainty factor of 100 (applicable 
to all population groups). The Dietary Exposure Evaluation Model (DEEM) 
analysis assumed tolerance level residues and 100% of the crop treated.
    ii. Drinking water. Generic Expected Environmental Concentration 
(GENEEC) and Screening Concentration and Ground Water (SCI-GROW) models 
were run by EPA to produce maximum estimates of glyphosate 
concentrations in surface and ground water, respectively. The drinking 
water exposure for glyphosate from the ground water screening model, 
SCI-GROW, yields a peak and chronic Estimated Environmental 
Concentration (EEC) of 0.0011 parts per billion (ppb) in ground water. 
The GENEEC values represent upper-bound estimates of the concentrations 
that might be found in surface water due to glyphosate use. Thus, the 
GENEEC model predicts that glyphosate surface water concentrations 
range from a peak of 1.64 ppb to a     56-day average of 0.19 ppb. The 
model estimates are compared directly to drinking water level of 
comparison (DWLOC) (chronic). The DWLOC (chronic) is the theoretical 
concentration of glyphosate in drinking water so that the aggregate 
chronic exposure (food + water + residential) will occupy no more than 
100% of the RfD. This assessment does not take into account expected 
reductions in any glyphosate concentrations in water arising from water 
treatment of surface water prior to releasing it for drinking purposes. 
The Agency's default body weights and consumption values used to 
calculate DWLOCs are as follows: 70 kg/2L (adult male), 60 kg/2L 
(adult/female), and 10 kg/1L (child).
    2. Non-dietary exposure. Glyphosate is currently registered for use 
on the following residential non-food sites: Around ornamentals, shade 
trees, shrubs, walks, driveways, flower beds, and home lawns. Exposure 
(non-occupational) of the general population to glyphosate is expected 
based on the currently-registered uses; however, due to the low acute 
toxicity and lack of other toxicological concerns, Monsanto believes 
that the risk posed by non-occupational exposure to glyphosate is 
minimal. The proposed new uses are not expected to affect this route of 
exposure compared to presently approved uses.

D. Cumulative Effects

    Because the existing data base is insufficient to fully assess 
cumulative toxic effects that may be caused by glyphosate along with 
other chemical compound(s) that may share a common mechanism of 
toxicity, Monsanto believes that any consideration of such an analysis 
of toxicity is inappropriate at this time.

E. Safety Determination

    1. U.S. population--i. Acute risk. An acute dietary endpoint and 
dose was not identified in the toxicology data base. Adequate rat and 
rabbit developmental studies did not provide a dose or endpoint that 
could be used for acute dietary risk purposes. Additionally, there were 
no data requirements for acute or subchronic rat neurotoxicity studies 
since there was no evidence of neurotoxicity in any of the toxicology 
studies at very high doses.
    ii. Chronic risk. The theoretical maximum residue contribution for 
existing, published and pending tolerances for glyphosate is 1.5% of 
the RfD for the overall U.S. population. Even using conservative 
exposure assumptions, there is not enough exposure from the proposed 
new uses to calculate a significant contribution to the TMRC. 
Therefore, Monsanto concludes that aggregate exposure from the proposed 
new uses will not add to the RfD for the overall U.S. population. EPA 
generally has no concern for exposures below 100% of the RfD. The 
DWLOCs are 69,000 g/L for the U.S. population in 48 contiguous States, 
males (13+), non-Hispanic whites, and non-Hispanic blacks; and 19,000 
for non-nursing infants (less than 1 year old) and children (1-6 
years). Although the GENEEC and SCI-GROW models are known to produce 
worst-case estimates, the resulting average concentrations of 
glyphosate in the surface and ground water are more than 10,000-fold 
less than the DWLOC (chronic). Therefore, taking into account present 
uses and uses proposed in this action, Monsanto concludes with 
reasonable certainty that no harm will result from chronic aggregate 
exposure to glyphosate.
    iii. Aggregate cancer risk for U.S. population. Glyphosate has been 
classified as a Group E chemical, with no evidence of carcinogenicity 
for humans in two acceptable animal studies.
    2. Infants and children. In assessing the potential for additional 
sensitivity of infants and children to residues of glyphosate, data 
were considered from developmental toxicity studies in the rat and 
rabbit and multi-generation reproduction studies in rats. No birth 
defects were observed in the offspring of rats given glyphosate by 
gavage at dose levels of 0, 300, 1,000, and 3,500 mg/kg/day on days 6 
through 19 of gestation. The NOAEL for this study was 1,000 mg/kg/day 
based on maternal and developmental toxicity observed at the HDT, 3,500 
mg/kg/day. The high-dose in this study was 3.5 times higher than the 
limit dose that is currently required by the guidelines. No birth 
defects were observed in the offspring of rabbits given glyphosate by 
gavage at dose levels of 0, 75, 175, and 350 mg/kg/day on days 6 
through 27 of gestation. The NOAEL for this study is considered to be 
175 mg/kg/day based on maternal toxicity at the high-dose of 350 mg/kg/
day. Because no developmental toxicity was observed at any dose level, 
the developmental NOAEL is considered to be 350 mg/kg/day.
    Male and female rats were fed glyphosate at dose levels of 0, 3, 
10, and 30 mg/kg/day every day throughout the production of three 
successive generations. No adverse treatment-related effects on 
reproduction were observed. In a second reproduction study, male and 
female rats were fed glyphosate at dose levels of 0, 100, 500, and 
1,500 mg/kg/day every day throughout the production of two successive 
generations. Reduced body weights and soft stools occurred at 1,500 mg/
kg/day (3% of the diet); therefore, the systemic NOAEL is considered to 
be 500 mg/kg/day. Glyphosate did not affect the ability of rats to 
mate, conceive, carry or deliver normal offspring at any dose level.
    The TMRC for existing, published and pending tolerances (including 
the minor crops proposed for tolerances in this petition) for 
glyphosate utilize up to 3% of the RfD for non-nursing infants, the 
most highly-exposed subgroup. Although there is a low likelihood of 
potential exposure to glyphosate in drinking water and from non-
dietary, non-occupational exposure, EPA has previously concluded that 
the aggregate exposure is not expected to exceed 100% of the RfD. The 
safety determination is unaffected by the proposed change in the 
tolerance regulation. Therefore, based on the completeness and 
reliability of the toxicity data and the conservative

[[Page 49571]]

exposure assessment, Monsanto concludes that there is a reasonable 
certainty that no harm will result from aggregate exposure to residues 
of glyphosate, including all anticipated dietary exposure and all other 
non-occupational exposures.

F. International Tolerances

    Codex maximum residue levels have not been established for residues 
of glyphosate on the crops proposed for tolerances in this petition.

[FR Doc. 00-20539 Filed 8-11-00; 8:45 a.m.]
BILLING CODE 6560-50-S