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Notice

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

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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.

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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: jamerson.hoyt@epa.gov.

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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:

CategoriesNAICSExamples of Potentially Affected Entities
Industry111Crop production
112Animal production
311Food manufacturing
32532Pesticide 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: ``opp-docket@epa.gov,'' 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. Start Printed 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.

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List of Subjects

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Dated: August 4, 2000.

 James Jones,

Director, Registration Division, Office of Pesticide Programs.

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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 § 180.364 Glyphosate; tolerances for residues Proposed by Monsanto”. The following summary also includes several revisions to § 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 § 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 § 180.364(a)(2) and (a)(3) be transferred to § 180.364(a)(1), that § 180.364(a)(1) be redesignated as § 180.364(a), and that § 180.364(a)(2) and (a)(3) be deleted.

A Summary of the Revisions to § 180.364 Proposed by Monsanto

Revise § 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 § 180.364(a)(2) and § 180.364(a)(3) to the table in § 180.364(a) and delete § 180.364(a)(2) and § 180.364(a)(3).

Revise the table under § 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 § 180.364(a)(2) and § 180.364(a)(3) to the table in § 180.364(a):

Existing Tolerances from 180.364(a)(1)Proposed Changes
Acerola at 0.2 ppmNo change.
Alfalfa at 200.0 ppmDelete. See tolerances for Alfalfa, hay and Alfalfa, forage.
Alfalfa, forage at 75.0 ppmIncrease tolerance for Alfalfa, forage to 175 ppm.
Alfalfa, fresh and hay at 0.2 ppmDelete. See tolerances for Alfalfa, hay and Alfalfa, forage.
Alfalfa, hay at 200.0 ppmIncrease tolerance for Alfalfa, hay to 400 ppm.
Almonds, hulls at 1 ppmDelete. Tolerance established for Almond hulls at 25 ppm.
Almond hulls at 25 ppmAmend to read “Almond, hulls” at 25 ppm.
Add “Animal feed, nongrass, group (except alfalfa)” at 200 ppm.
Artichokes, Jerusalem at 0.2 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
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Add “Aloe vera” at 0.5 ppm.
Add “Ambarella” at 0.2 ppm.
Add “Artichoke, globe” at 0.2 ppm.
Asparagus at 0.5 ppmNo change.
Aspirated grain fractions at 200.0 ppmAmend to read “Aspirated grain fractions” at 200 ppm.
Atemoya at 0.2 ppmNo change.
Avocados at 0.2 ppmAmend to read “Avocado” at 0.2 ppm.
Bahiagrass at 200.0 ppmDelete. Included in Grass, forage, fodder and hay, group at 300 ppm.
Add “Bamboo, shoots” at 0.2 ppm.
Bananas at 0.2 ppmAmend 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 ppmDelete. 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 ppmDelete. Included in Grass, forage, fodder and hay, group at 300 ppm.
Add “Berry group” at 0.2 ppm.
Bluegrass at 200.0 ppmDelete. Included in Grass, forage, fodder and hay, group at 300 ppm.
Breadfruit at 0.2 ppmNo change.
Bromegrass at 200.0 ppmDelete. 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 ppmNo 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 ppmAmend to read “Starfruit” at 0.2 ppm.
Carrots at 0.2 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Cattle, kidney at 4.0 ppmNo change.
Cattle, liver at 0.5 ppmNo change.
Celeriac at 0.2 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Add “Chaya” at 1.0 ppm.
Cherimoya at 0.2 ppmNo 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 ppmAmend to read “Fruit, citrus, group” at 0.5 ppm.
Citrus pulp, dried at 1.5 ppmAmend to read “Citrus, dried pulp” at 1.5 ppm
Clover at 200.0 ppmDelete. Included in Animal feed, nongrass, group (except alfalfa) at 200 ppm.
Cocoa beans at 0.2 ppmAmend to read “Cacao bean” at 0.2 ppm.
Coconut at 0.1 ppmNo change.
Coffee beans at 1 ppmAmend to read “Coffee, bean” at 1.0 ppm.
Corn, field, forage at 1.0 ppmIncrease the tolerance for Corn, field, forage to 3.0 ppm.
Corn, field, grain at 1.0 ppmNo change.
Corn, field, stover at 100.0 ppmDelete. Included in Grain, cereal, stover and straw, group at 100 ppm.
Cotton gin byproducts at 100.0 ppmAmend to read “Cotton, gin byproducts” at 100 ppm.
Cottonseed at 15 ppmAmend to read “Cotton, undelinted seed” at 15 ppm.
Cranberries at 0.2 ppmAmend 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 ppmAmend 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 ppmDelete. Included in Grass, forage, fodder and hay, group at 300 ppm.
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Figs at 0.2 ppmAmend to read “Fig” at 0.2 ppm.
Fish at 0.25 ppmNo change.
Add “Flax, seed” at 4.0 ppm.
Add “Flax, meal” at 8.0 ppm.
Forage grasses at 0.2 ppmDelete. Included in Grass, forage, fodder and hay, group at 300 ppm.
Forage legumes (except soybeans and peanuts) at 0.4 ppmDelete. Included in Vegetable, foliage of legume, group, (except soybean) at 0.2 ppm.
Fruits, small, and berries at 0.2 ppmDelete. Included in Berry group at 0.2. See also entries for cranberry, grape and strawberry in this table.
Add “Galangal, roots” at 0.2 ppm.
Genip at 0.2 ppmAmend 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 ppmAmend to read “Goat, kidney” at 4.0 ppm.
Goats, liver at 0.5 ppmAmend 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 ppmAmend to read “Grape” at 0.2 ppm.
Add “Grass, forage, fodder and hay, group” at 300 ppm.
Grasses, forage at 0.2(N) ppmDelete. Included in “Grass, forage, fodder and hay, group” at 300 ppm.
Guavas at 0.2 ppmAmend to read “Guava” at 0.2 ppm.
Add “Herbs subgroup” at 0.2 ppm.
Hogs, kidney at 4.0 ppmAmend to read “Hog, kidney” at 4.0 ppm.
Hogs, liver at 0.5 ppmAmend to read “Hog, liver” at 0.5 ppm.
Add “Hop, dried cones” at 7.0 ppm.
Horseradish at 0.2 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Horses, kidney at 4.0 ppmAmend 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 ppmNo 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) ppmDelete. 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 ppmNo change.
Lychee at 0.2 ppmNo change.
Add “Mamey apple” at 0.2 ppm.
Mamey sapote at 0.2 ppmNo 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 ppmAmend 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 ppmDelete. Included in Nut, tree, group at 1.0 ppm.
Oats, grain at 20.0 ppmAmend to read “Oat, grain” at 20 ppm.
Oil, palm at 0.1 ppmAmend to read “Palm, oil” at 0.1 ppm.
Add “Okra” at 0.5 ppm.
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Olives at 0.2 ppmAmend to read “Olive” at 0.2 ppm.
Olives, imported at 0.1 ppmDelete. Included in entry for “Olive” at 0.2 ppm.
Orchardgrass at 200.0 ppmDelete. 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 ppmAmend to read “Papaya” at 0.2 ppm.
Add “Papaya, mountain” at 0.2 ppm.
Parsnips at 0.2 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Passion fruit at 0.2 ppmAmend to read “Passionfruit” at 0.2 ppm.
Add “Pawpaw” at 0.2 ppm.
Peanut, forage at 0.5 ppmNo change.
Peanut, hay at 0.5 ppmNo change.
Peanuts at 0.1 ppmAmend to read “Peanut” at 0.1 ppm.
Add “Pepper leaf, fresh leaves” at 0.2 ppm.
Peppermint at 200 ppmAmend to read “Peppermint, tops” at 200 ppm.
Add “Perilla, tops” at 1.8 ppm.
Persimmons at 0.2 ppmAmend to read “Persimmon” at 0.2 ppm.
Pineapple at 0.1 ppmNo change.
Pistachio nuts at 0.2 ppmAmend to read “Pistachio.” Increase tolerance to 1.0 ppm.
Pome fruits at 0.2 ppmAmend to read “Fruit, pome, group” at 0.2 ppm.
Pomegranates at 0.2 ppmAmend to read “Pomegranate” at 0.2 ppm.
Potatoes at 0.2 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Poultry, kidney at 0.5 ppmDelete. Add “Poultry, meat byproducts” at 1.0 ppm.
Add “Poultry meat” at 0.1 ppm.
Poultry, liver at 0.5 ppmDelete. 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 ppmDelete. 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 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Ryegrass at 200.0 ppmDelete. 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 ppmDelete. Included in Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Sapodilla at 0.2 ppmNo change.
Sapote, black at 0.2 ppmNo change.
Sapote, white at 0.2 ppmNo change.
Seed and pod vegetables at 0.2(N) ppmDelete. Included in Vegetable, 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 0.2(N) ppmDelete. Included in Vegetable, 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 0.2(N) ppm.Delete. Included in Vegetable, 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 ppmAmend to read “Sheep, kidney” at 4.0 ppm.
Sheep, liver at 0.5 ppmNo change.
Shellfish at 3 ppmAmend to read “Shellfish” at 3.0 ppm..
Sorghum, grain at 15 ppmAmend to read “Sorghum, grain, grain” at 15 ppm.
Sorghum, grain, stover at 40 ppmDelete. Included in “Grain, cereal, stover and straw, group” at 100 ppm.
Soursop at 0.2 ppmNo change.
Soybean hulls at 100.0 ppm.Amend to read “Soybean, hulls” at 100 ppm.
Soybeans at 20.0 ppmAmend to read “Soybean” at 20 ppm.
Soybeans, aspirated grain fractions at 50.0 ppmAmend to read “Soybean, aspirated grain fractions” at 50 ppm.
Soybeans, forage at 100.0 ppmAmend to read “Soybean, forage” at 100 ppm.
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Soybeans, grain at 20.0Delete. Duplicate entry. See soybean at 20 ppm.
Soybeans, hay at 200.0 ppmAmend to read “Soybean, hay” at 200 ppm.
Add “Spanish lime” at 0.2 ppm.
Spearmint at 200 ppmAmend 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 ppmAmend to read “Fruit, stone, group” at 0.2 ppm.
Sugar apple at 0.2 ppmNo change.
Sugarcane at 2.0 ppmNo change.
Sunflower seed at 0.1 ppmAmend to read “Sunflower, seed” at 0.1 ppm.
Add “Surinam cherry” at 0.2 ppm.
Sweet potatoes at 0.2 ppmDelete. Included in the Vegetable, root and tuber, group (except sugar beet) at 0.2 ppm.
Tamarind at 0.2 ppmNo change.
Tea, dried at 1.0 ppm.Amend to read “Tea, dried” at 1.0 ppm.
Tea, instant at 7.0 ppmAmend 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 ppmDelete. Included in Grass, forage, fodder and hay, group at 300 ppm.
Tree nut crop group at 1.0 ppmAmend to read “Nut, tree, group” at 1.0 ppm.
Turnips at 0.2 ppmDelete. 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 ppmAmend to read “Vegetable, bulb, group” at 0.2 ppm.
Vegetables, cucurbit at 0.5 ppmAmend to read “Vegetable, cucurbit, group” at 0.5 ppm.
Vegetable, fruiting (except cucurbits) group at 0.1 ppmAmend to read “Vegetable, fruiting, group” at 0.1 ppm.
Vegetables, leafy, Brassica (cole) at 0.2 ppmAmend to read “Vegetable, Brassica 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 ppmAmend to read “Wheat, grain” at 5.0 ppm.
Wheat milling fractions (excluding flour) at 20.0 ppmAmend to read “Wheat milling fractions (excluding flour)” at 20 ppm.
Wheat, straw at 85.0 ppmDelete. Included in “Grain, cereal, stover and straw, group at 100 ppm.
Wheatgrass at 200.0 ppmDelete. Included in Grass, forage, fodder and hay group at 300 ppm.
Add “Yacon, tuber” at 0.2 ppm.
Yams at 0.2 ppmDelete. 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. Start Printed 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 Start Printed Page 49570from 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 Start Printed Page 49571exposure 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.

End Supplemental Information

[FR Doc. 00-20539 Filed 8-11-00; 8:45 a.m.]

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