Notice of Filing Pesticide Petitions to Establish Tolerances for Certain Pesticide Chemicals 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 certain pesticide chemicals in or on various food commodities.

DATES:

Comments, identified by docket control number PF-941, must be received on or before June 22, 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-941 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Sheila Moats, EPA Biopesticides and Pollution Prevention Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-1259; e-mail address: moats.sheila@epa.gov.

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:

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-941. 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-941 in the subject line on the first page of your response.

1 . By mail. Submit your comments to: Public Information and Records Integrity Branch (PIRIB), Information Resources and Services Division (7502C), Office of Pesticide Programs (OPP), Environmental Protection Agency, Ariel Rios Bldg., 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-941. Electronic comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

Do not submit any information electronically that you consider to be CBI. You may claim information that you submit to EPA in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. In addition to one complete version of the comment that includes any information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public version of the official record. Information not marked confidential will be included in the public version of the official record without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified under FOR FURTHER INFORMATION CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Provide specific examples to illustrate your concerns.

6. Make sure to submit your comments by the deadline in this notice.

7. To ensure proper receipt by EPA, be sure to identify the docket control number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

II. What Action is the Agency Taking?

EPA has received pesticide petitions as follows proposing the establishment and/or amendment of regulations for residues of certain pesticide chemicals 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 petitions. Additional data may be needed before EPA rules on the petitions.

List of Subjects

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

Summaries of Petitions

The petitioner summaries of the pesticide petitions are printed below as required by section 408(d)(3) of the FFDCA. The summaries of the petitions were prepared by the petitioner and represents the view of the petitioner. The petition summaries announce 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.

1. Natural Plant Products S.A.

0F6073

Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended, Natural Plant Products S.A. has submitted the following summaries of information, data, and arguments in support of their pesticide petitions. The summaries were prepared by Natural Plant Products S.A. and EPA has not fully evaluated the merits of the pesticide petitions. The summaries may have been edited by EPA, if the terminology used was unclear, the summaries contained extraneous material, or the summaries unintentionally made the reader conclude that the findings reflected EPA's position and not the position of the petitioner.

A. Product Name and Proposed Use Practices

Geraniol will be incorporated into the end-use product Biomite as an active ingredient. Biomite is proposed for use as a foliar spray for the control of Tetranychid mites on a variety of agricultural and greenhouse crops. The product is used at the first appearance of spider mite activity on a particular crop, subsequent applications are made as required but not sooner than every 7 days. The application rates of 76 oz in 200 gallons to 20 oz in 50 gallons/per acre equate to 0.085—0.315 oz of Geraniol per acre.

B. Product Identity/Chemistry

Geraniol is a Monoterpene alcohol which is found in over 250 essential oils, and as a semiochemical in more than 14 species of insects encompassing 7 families from 5 orders. It is a colorless to pale yellow oily liquid with a sweet, rose odor. Geraniol is listed at 40 CFR 152.25(g) as a minimum risk pesticide active ingredient.

C. Mammalian Toxicological Profile

The toxicological profile of Geraniol is, acute oral two studies LD₅₀ 3.6 grams/kilograms (g/kg) and 4.8 g/kg in rats: acute dermal LD₅₀ greater than 5.0 g/kg. Chronic oral toxicity, 1,000 parts per million (ppm) fed to rats daily for 16 weeks produced no effects; 1,000 ppm fed to rats daily for 28 weeks produced no effects. Geraniol exhibited severe primary skin irritation in rabbits 100 milligrams (mg)/24 hr.; humans 16 mg/48 hr.; Guinea pigs 100 mg/24 hr. but was non-irritating to miniature pigs at 50 mg in the Draize test. Geraniol is a sensitizer although it exhibits relatively weak and variable responses. Geraniol when tested at doses up to 100 micrograms against Salmonella typhimurium TA 97 and TA 102 exhibited no mutagenicity. Geraniol was granted generally recognized as safe (GRAS) status by FEMA in 1965, and is approved as GRAS by the Food and Drug Administration (FDA) when used as a synthetic flavoring and adjuvant for direct addition to food for human consumption.

Waivers are being requested for genotoxicity, reproductive and developmental toxicity, sub-chronic toxicity and acute toxicity to non-target species based on Geraniol's ubiquity in nature, long history of use in the fragrance industry and as a flavoring in alcoholic and non-alcoholic beverages, ice cream, candies and baked good etc., favorable toxicological profile in chronic toxicological studies, and the inconsequential exposure resulting from the label-directed use rates.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Current dietary exposure to Geraniol occurs from its use as a flavoring agent and adjuvant in food and beverages (0.8 ppm—11 ppm). Considering the low dose of Geraniol required to achieve the desired effect and the levels of Geraniol found in processed food and beverages, it can be concluded that incremental dietary exposure from the proposed use on agricultural and greenhouse crops is insignificant.

ii. Drinking water. Geraniol residues in drinking water are expected to be minimal from the proposed uses due to the low application rate, insolubility in water, and the expected rapid biodegradation in the soil.

2. Non-dietary exposure. Geraniol is used to the approximate annual amount of 800,000 lbs as a fragrance component in the manufacture of detergents, soaps, creams, lotions, perfumes, and aromatherapy products. Geraniol is also a component of the floral blend used as a lure in Japanese beetle traps. In the seven currently registered Japanese beetle traps, the Geraniol is present at a loading of 2.84—10.70%. The contribution to non-dietary exposure of Geraniol through the use of Biomite is not expected to pose any risk.

E. Cumulative Exposure

It is not expected that Geraniol when used as proposed would result in residues that would remain in human food items at levels which would be of toxicological concern. Because of the low inherent toxicity, low agricultural use rates (compared with flavor and fragrance amounts) no cumulative effects with other substances that might have a common mechanism of toxicity are anticipated.

F. Safety Determination

1. U.S. population. The use of products containing Geraniol, which is of low toxicity and used in low concentrations is compatible with the Agency's objectives to register reduced risk pesticides. The application of a volatile Terpenoid alcohol at the label-directed rates is expected to result in negligible residues that are of no toxicological concern, and therefore exposure and risk to the general U.S. population from these proposed agricultural uses is not anticipated.

2. Infants and children. Geraniol is ubiquitous in foodstuffs beverages, in soaps, detergents, and creams and hence the proposed agricultural uses pose no threat to infants and children. In fact, as the Geraniol-containing biopesticide product replaces existing miticides with less favorable toxicological profiles risk to infants and children will be reduced.

G. Effects on the Immune and Endocrine Systems

Oral chronic toxicity studies and mutagenicity studies have been cited above. There is no literature available to suggest that immune or endocrine systems will be compromised by the use of Geraniol as an active ingredient in a biochemical pest control agent used at the label-directed rates.

H. Existing Tolerances

There are no known existing tolerances for the use of Geraniol as a pesticide.

I. International Tolerances

The Council of Europe listed Geraniol in 1970 giving it an allowable daily intake (ADI) of 5 milligrams/kilograms bodyweight/day.

2. Natural Plant Products S.A.

0F6145

A. Product Name and Proposed Use Practices

Citronellol will be incorporated into the end-use product Biomite as an active ingredient. Biomite is proposed for use as a foliar spray for the control of Tetranychid mites on a variety of agricultural and greenhouse crops. The product is used at the first appearance of spider mite activity on a particular crop, subsequent applications are made as required but not sooner than every 7 days. The application rates of 76 oz in 200 gallons to 20 oz in 50 gallons/per acre equate to 0.085—0.315 oz of Citronellol per acre.

B. Product Identity/Chemistry

Citronellol is a Monoterpene alcohol which is found in over 30 essential oils, and as a semiochemical in the spider mite Tetranychus urticae, the Formicine ant Lasius alienus and the bumble bee Pyrobombus pratorum. Citronellol also occurs in black currants, certain other fruits, wines, beer and black tea. It is a colorless to pale yellow oily liquid with a sweet, rose, leather, musty, floral odor. It is insoluble in water.

C. Mammalian Toxicological Profile

The toxicological profile of Citronellol is, acute oral LD₅₀ 3.45 g/kg in rats: acute dermal LD₅₀ 2.65 g/kg (rabbit). Citronellol exhibited severe primary skin irritation in rabbits and Guinea pigs (100 mg/24 hr) and moderate to humans (16 mg/48 hr). Citronellol when tested at doses up to 100 micrograms against Salmonella typhimurium TA 97 and TA 102 exhibited no mutagenicity. Citronellol has GRAS status at 21 CFR 172.515 when used as a synthetic flavoring and adjuvant for direct addition to foods for humans. Waivers are being requested for genotoxicity, reproductive and developmental toxicity, sub-chronic toxicity and acute toxicity to non-target species based on Citronellol's ubiquity in nature, long history of use in cosmetics, fragrance, detergent, and household cleaners, its natural occurrence in fruit and beverages, its wide use as a synthetic flavoring agent and adjuvant, and the inconsequential exposure resulting from the label-directed use rates.

D. Aggregate Exposure

1. Dietary exposure—i. Food. Current dietary exposure to Citronellol occurs from its natural occurrence in fruits and beverages, and its use as a flavoring agent and adjuvant in food and beverages. Considering the low dose of Citronellol required to achieve the desired effect and the levels of Citronellol found in natural and processed food and beverages, it can be concluded that incremental dietary exposure from the proposed use on agricultural and greenhouse crops is insignificant.

ii. Drinking water. Citronellol residues in drinking water are expected to be minimal from the proposed uses due to the low application rate, insolubility in water, and the expected rapid biodegradation in the soil.

2. Non-dietary exposure. Citronellol is widely used as a fragrance component in the manufacture of detergents, soaps, creams, lotions, perfumes, and aromatherapy products. Citronellol is also a component of Citronella oil used in candles, sprays, oils, lotions, and towelettes as a repellent for mosquitoes and other flying insects. Currently there are 31 active pesticide registrations containing Citronella oil. Citronellol is also contained in lemongrass oil, an active ingredient in two currently registered repellents. The contribution to non-dietary exposure of Citronellol through the use of Biomite is not expected to pose any risk.

E. Cumulative Exposure

It is not expected that Citronellol when used as proposed would result in residues that would remain in human food items at levels which would be of toxicological concern. Because of the low inherent toxicity, low agricultural use rates no cumulative effects with other substances that might have a common mechanism of toxicity are anticipated.

F. Safety Determination

1. U.S. population. The use of products containing Citronellol, which is of low toxicity and used in low concentrations is compatible with the Agency's objectives to register reduced risk pesticides. The application of a volatile Terpenoid alcohol at the label-directed rates is expected to result in negligible residues that are of no toxicological concern, and therefore, exposure and risk to the general U.S. population from these proposed agricultural uses, is not anticipated.

2. Infants and children. Citronellol is ubiquitous in foodstuffs and beverages, and in soaps, detergents and creams and hence the proposed agricultural uses pose no threat to infants and children. In fact, as the Citronellol-containing biopesticide product replaces existing miticides with less favorable toxicological profiles risk to infants and children will be reduced.

G. Effects on the Immune and Endocrine Systems

Mutagenicity studies have been cited above. There is no literature available to suggest that immune or endocrine systems will be compromised by the use of Citronellol as an active ingredient in a biochemical pest control agent used at the label-directed rates.

H. Existing Tolerances

There are no known existing tolerances for the use of Citronellol as a pesticide.

I. International Tolerances

The Council of Europe listed Citronellol in 1970 giving it an allowable daily intake (ADI) of 5 milligrams/kilograms bodyweight/day.