[Federal Register Volume 65, Number 66 (Wednesday, April 5, 2000)]
[Notices]
[Pages 17869-17872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7890]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-927; FRL-6498-3]


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.

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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

[[Page 17870]]

number: (703) 308-8733; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                NAICS  codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

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

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

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations'' 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: ``[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-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.

[[Page 17871]]

List of Subjects

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

    Dated: March 22, 2000.
Kathleen D. Knox,
Acting Director, Biopesticides and Pollution Prevention 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. 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

    VirosoftBA3 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 VirosoftBA3 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 VirosoftBA3 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 VirosoftBA3 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

[[Page 17872]]

many years for baculoviruses and that the safety of 
VirosoftBA3 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 VirosoftBA3 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 VirosoftBA3 
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 VirosoftBA3 
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.
[FR Doc. 00-7890 Filed 4-4-00; 8:45 am]
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