Notice of Filing a Pesticide Petition to Establish a Tolerance 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-927, must be received on or before May 5, 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-927 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:

By mail: Linda Hollis, Biopesticides and Pollution Prevention Division (7511C), Office of Pesticide Programs, Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (703) 308-8733; e-mail address: hollis.linda@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-927. 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-927 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-927. 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 a pesticide petition as follows proposing the establishment and/or amendment of regulations for residues of 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 supports 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

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. 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.

EPA has received a pesticide petition 0F6105 from BioTEPP, Inc, 177, 71 e Street East, Charlesbourg, Qc, Canada G1L 1H4, 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 part 180 to establish an exemption from the requirement of a tolerance for the microbial pesticide Mamestra configurata nucleopolyhedrosis virus.

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

BioTEPP, Inc. Petition Summary

0F6105

A. Product Name and Proposed Use Practices

Virosoft^BA3 is an insect specific viral insecticide for the control of the Bertha Armyworm on canola in the ecozone 3. It is to be applied either preventively directly on the ground at seeding or curatively on canopy upon appearance of adult moths. This product can be used in an integrated pest management program because of its high specificity which leaves the rest of the ecological system unaltered (including bees, natural predators, parasitoids, soil fauna, etc.).

B. Product Identity/Chemistry

1. Identity of the pesticide and corresponding residues. The active ingredient in Virosoft^BA3 is a wildtype baculovirus Mamestra configurata Nucleopolyhedrosis virus that has been selected from the same ecozone in which it will be produced and distributed. This group of insect viruses is known to be highly specific and able to infect only very closely related species. Their greatest advantage is their high host specificity; and the fact that they consist of the same molecular structures as all other living beings: nucleic acids and amino acids. Both facts account for the complete environmental safety of baculoviruses. There has been no literature which reports any adverse effects to humans or to any member of the ecosystem as these baculoviruses do no leave behind any threatening residues. Their ability to efficiently kill insect larvae and to increase in number in the environment, their long shelf life, ability to adapt to changes in their host species, and their complete environmental safety characterize baculoviruses as one of the most promising means in insect pest control for the future.

2. Magnitude of residue at the time of harvest and method used to determine the residue. Residues if any, are not expected to pose any threat to human health or to any member of the ecosystem due to the lack of toxicity associated with insect baculoviruses.

3. A statement of why an analytical method for detecting and measuring the levels of the pesticide residue are not needed. Because of their complete environmental safety for the environment, non-target species like bees or ants and for humans, it is considered that no analytical tests for detecting and measuring levels of baculovirus residue are necessary.

C. Mammalian Toxicological Profile

Both baculovirus types or genera (GVs and NPVs) have seen widespread development, testing, and use in biological pest control. During the past 40 years, extensive testing of the safety of baculoviruses for vertebrate species has been carried out. To date, at least 26 different baculoviruses have been tested in detail for pathogenicity. The data obtained from these studies proved baculoviruses to be harmless to and unable to replicate in microorganisms, non-invertebrate cell lines, vertebrates and plants. In 1973 a FAO document covered the use of viruses in pest management. Their view was that the use of baculoviruses had been sufficiently studied to allow its recommendation for insect pest control.

The long history of safe use as indigenous microbial pest control agent is an important element of its safety. Moreover, baculoviruses occur naturally in the environment for hundreds of thousands of years. They have been used extensively in many countries without any adverse effects on the existing fauna beside the target insect pest. Because the MCNPV/BIOTEPP in Virosoft^BA3 is an indigenous insect virus it constitutes an extension of the natural system that does not carry the risk associated with the introduction of foreign elements in the ecosystem.

In addition to the safe history of insect baculoviruses, invertebrate pathology disciplines as well as medical, veterinary and phytopathology sciences have failed to find incidences of NPVs and GVs infecting hosts outside of the arthropods. This gives rise to increasing confidence that new baculoviruses need to be subjected to only a reduced range of standardized tests required for registration.

The degree of exposure of vertebrates to naturally occurring baculoviruses is vast in scope and time and no adverse effects were ever observed on non-target animals or plants. Feces of birds, for example, contained 18% by weight of inclusion bodies when they fed on infected caterpillars with naturally occurring viruses. NPVs have undergone the most extensive safety test of all entomopathogenic viruses and no adverse effects were observed in many years of artificial applications and for many different baculoviruses on birds, wild mammals, fish, microorganisms and plants.

Virosoft^BA3 has been tested for its innocuity against mammalians and non-target arthropods and proven the lack of toxicological effects on non-target beneficial organisms or mammalians.

D. Aggregate Exposure

1. Dietary exposure— i. Food. Since Virosoft^BA3 is a naturally occurring baculovirus and that naturally occurring insect virus are present in the environment and consequently on our food, and because the amount of virus applied to one hectare (ha) of crop is equivalent to 100 insect larvae, the amount of virus expected to be present on food is not expected to be higher than in a natural system when insect control is maintained by a naturally occurring virus. As the lack of mammalian toxicity and of allergenic effects has been demonstrated over many years for baculoviruses and that the safety of Virosoft^BA3 has been demonstrated both in the field and in the laboratory (mammalians and non-target arthropods), aggregate exposure is considered to be insignificant as well as completely safe for human consumption.

ii. Drinking water. Because the amount of virus applied to one ha of crop is equivalent to 100 insect larvae, the amount of virus expected to be present in drinking water is not expected to be higher than in a natural system when insect control is maintained by a naturally occurring virus. As the lack of mammalian toxicity and of allergenic effects has been demonstrated over many years for baculoviruses and that the safety of Virosoft^BA3 has been demonstrated both in the field and in the laboratory (mammalians and non-target arthropods), aggregate exposure is considered to be insignificant as well as completely safe for human consumption.

2. Non-dietary exposure. Because the amount of virus applied to one ha of crop is equivalent to 100 insect larvae, the amount of virus expected to be present on food, water and non-dietary exposure is not expected to be higher than in a natural system when insect control is maintained by a naturally occurring virus. As the lack of mammalian toxicity and of allergenic effects has been demonstrated over many years for baculoviruses and that the safety of Virosoft^BA3 has been demonstrated both in the field and in the laboratory (mammalians and non-target arthropods), aggregate exposure is considered to be insignificant as well as completely safe for human consumption.

E. Cumulative Exposure

The unique high specificity of insect baculovirus coupled with the demonstrated absence of mammalian toxicity of Virosoft^BA3 excludes the expectation of cumulative exposure with other compounds.

F. Safety Determination

1. U.S. population. Both baculovirus types or genera (GVs and NPVs) have seen widespread development, testing, and use in biological pest control in the United States. There has been no human safety problems attributed to the use of baculoviruses. Our request for an exemption from the requirement of a tolerance is strongly supported by the safety characteristics of baculoviruses in terms of lack of mammalian toxicity/allergenicity and the environmental safety provided in this study and in numerous studies conducted in the United States and abroad.

2. Infants and children. Both baculovirus types or genera (GVs and NPVs) have seen widespread development, testing, and use in biological pest control in the United States. There have been no safety problems for infants and children that have been attributed to the use of baculoviruses. Our request for an exemption from the requirement of a tolerance is strongly supported by the safety characteristics of baculoviruses in terms of lack of mammalian toxicity/allergenicity and the environmental safety provided in this study and in numerous studies conducted in the United States and abroad.

G. Effects on the Immune and Endocrine Systems

There is no known information which suggests that Mamestra configurata NPV will have an effect on the immune and endocrine systems.

H. Existing Tolerances

There are no known tolerances, tolerance exemptions or exemptions from the requirement of a tolerance for Mamestra configurata NPV.

I. International Tolerances

There are no known international tolerances, international tolerance exemptions or international exemptions from the requirement of a tolerance for Mamestra configurata NPV.