Document ID: EPA-HQ-OPP-2008-0763-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2008-11-18T05:00Z

<EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER  

(7/1/2007)>

<EPA Biopesticides and Pollution Prevention Division contact: [Denise
Greenway 703-308-8263]>

 

<INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.>

<SUBMISSION: E-mail the completed template to: duggard.mari@epa.gov.>

<TEMPLATE:>

<[ Interregional Research Project Number 4 (IR-4), Rutgers University,
500 College Road East, Suite 201W, Princeton, NJ 08540 on behalf of the
USDA-ARS Appalachian Fruit Research Station, Kearneysville, WV, 2217
Wiltshire Road, Kearneysville, WV 25430]>

<[7E7231]>

<	EPA has received a pesticide petition ([7E7231]) from [[ Interregional
Research Project Number 4 (IR-4)], [500 College Road East, Suite 201W,
Princeton, NJ 08540] 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.>

<(Options (pick one)>

<	1. by establishing a tolerance for residues of NA-Remove>

<	2. to establish an exemption from the requirement of a tolerance for
Plum Pox Viral coat protein>

	

<	3. to establish an amendment/expansion of an existing tolerance
exemption for the NA-Remove>

<(Options (pick one)>

<	1. microbial pesticide  [insert name of active ingredient] NA-Remove>

<	2. biochemical pesticide [insert name of active ingredient] NA-Remove>

	

<	3. plant-pesticide [Plum Pox Viral coat protein] in or on [Fruit,
Stone, Group 12 and almond].>

<	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [[
Interregional Research Project Number 4 (IR-4), Rutgers University on
behalf of the USDA-ARS Appalachian Fruit Research Station,
Kearneysville, WV] has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This summary
was prepared by [[ Interregional Research Project Number 4 (IR-4),
Rutgers University] 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.>

<I. [[[ Interregional Research Project Number 4 (IR-4)on behalf of the
USDA-ARS Appalachian Fruit Research Station, Kearneysville, WV] 
Petition Summary>

<	[7E7231]>

<A. Product Name and Proposed Use Practices>

<	[ The Plum Pox Resistance Gene has been incorporated into the plum
variety C5 HoneySweet Plum to protect it from the disease known as plum
pox virus.  ]>

<B. Product Identity/Chemistry>

<	1. Identity of the pesticide and corresponding residues. [ The
pesticide and corresponding residues are identified as Plum pox Viral
coat protein]>

<	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [ There is no need for residue analysis because
there is a long history of mammalian consumption of the entire plant
virus particles in food, without causing any known deleterious human
health effects or any evidence of toxicity.  Virus infected plants are
part of the human diet and there have been no findings which indicate
that plant viruses are able to replicate in mammals or other
vertebrates, thereby eliminating the possibility of human infection. 
The portion of the genome coding for resistance to plum pox (viral coat
protein)  and subcomponents of the resistance gene expressed in the
plant are incapable of forming infectious particles. Non-occupational
exposure such as drinking water exposure is minimal to non-existent
since the gene is only expressed within plant tissues. The C5 plum pox
resistant plum does not represent a source of novel potential allergenic
or antinutrient proteins. Finally, it is highly unlikely that any
protein will be expressed. There are molecular methods of genetic
anaylsis using DNA blot techniques

]>

<	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [ There is no need
for residue analysis because there is a long history of mammalian
consumption of the entire plant virus particles in food, without causing
any known deleterious human health effects or any evidence of toxicity. 
Virus infected plants are part of the human diet and there have been no
findings which indicate that plant viruses are able to replicate in
mammals or other vertebrates, thereby eliminating the possibility of
human infection.  The portion of the genome coding for resistance to
plum pox (viral coat protein)  and subcomponents of the resistance gene
expressed in the plant are incapable of forming infectious particles.
Non-occupational exposure such as drinking water exposure is minimal to
non-existent since the gene is only expressed within plant tissues. The 
plum pox viral coat protein does not represent a source of novel
potential allergenic or antinutrient proteins. Finally, it is highly
unlikely that any protein will be expressed.]>

<C. Mammalian Toxicological Profile>

<	[ There is no need for mammalian toxicological testing  because there
is a long history of mammalian consumption of the entire plant virus
particles in food, without causing any known deleterious human health
effects or any evidence of toxicity.  Virus infected plants are part of
the human diet and there have been no findings which indicate that plant
viruses are able to replicate in mammals or other vertebrates, thereby
eliminating the possibility of human infection.  The portion of the
genome coding for resistance to plum pox (viral coat protein)  and
subcomponents of the resistance gene expressed in the plant are
incapable of forming infectious particles. Non-occupational exposure
such as drinking water exposure is minimal to non-existent since the
gene is only expressed within plant tissues. The C5 plum pox resistant
plum does not represent a source of novel potential allergenic or
antinutrient proteins. Finally, it is highly unlikely that any protein
will be so it does not present either a toxicological or an infectious
risk to mammals.>  

Researchers and other workers have worked with  C5 HoneySweet Plum at
the USDA-ARS  since 1992.

]

<D. Aggregate Exposure>

<	1. Dietary exposure. []>

<	i. Food. [ There is  a long history of mammalian consumption of the
entire plant virus particles in food, without causing any known
deleterious human health effects or any evidence of toxicity.  Virus
infected plants are part of the human diet and there have been no
findings which indicate that plant viruses are able to replicate in
mammals or other vertebrates, thereby eliminating the possibility of
human infection.  The portion of the genome coding for resistance to
plum pox (viral coat protein)  and subcomponents of the resistance gene
expressed in the plant are incapable of forming infectious particles.
Non-occupational exposure such as drinking water exposure is minimal to
non-existent since the gene is only expressed within plant tissues. The
C5 plum pox resistant plum does not represent a source of novel
potential allergenic or antinutrient proteins. Finally, it is highly
unlikely that any protein will be expressed 

]>

<	ii. Drinking water. [ Non-occupational exposure such as drinking water
exposure is minimal to non-existent since the gene is only expressed
within plant tissues.

]>

<	2. Non-dietary exposure. [ Non-occupational exposure such as drinking
water exposure is minimal to non-existent since the gene is only
expressed within plant tissues.

]>

<E. Cumulative Effects>

<	[ There are no other registered products containing the Plum Pox Viral
Coat Protein.]>

<F. Safety Determination>

<	1. U.S. population. [ There is  a long history of mammalian
consumption of the entire plant virus particles in food, without causing
any known deleterious human health effects or any evidence of toxicity. 
Virus infected plants are part of the human diet and there have been no
findings which indicate that plant viruses are able to replicate in
mammals or other vertebrates, thereby eliminating the possibility of
human infection.  The portion of the genome coding for resistance to
plum pox (viral coat protein)  and subcomponents of the resistance gene
expressed in the plant are incapable of forming infectious particles.
Non-occupational exposure such as drinking water exposure is minimal to
non-existent since the gene is only expressed within plant tissues. The
C5 plum pox resistant plum does not represent a source of novel
potential allergenic or antinutrient proteins. Finally, it is highly
unlikely that any protein will be expressed 

]>

<	2. Infants and children. [ Based on the lack of toxicity and natural
occurrence, there is reasonable certainty that no harm to infants,
children, or adults will result from aggregate exposure to Plum pox
Viral coat protein.  Exempting Plum Pox Viral coat protein from the
requirement of a tolerance should pose no significant risk to humans or
the environment.]>

<G. Effects on the Immune and Endocrine Systems>

<	[ The Plum pox Viral coat protein  was derived from a naturally
occurring organism, To date there is no evidence to suggest that the
Plum Pox Viral coat protein  functions in a manner similar to any known
hormone, or that it acts as an endocrine disrupter.]>

<H. Existing Tolerances>

<	[ The registrant is not aware of any existing tolerances or tolerance
exemptions for Plum pox Viral coat protein.]>

<I. International Tolerances>

<	[ There are no Codex maximum residue levels established for residues
of Plum pox Viral coat protein  containing products are presently not
registered for pest control outside of the United States.  

]>

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