crop-chem-docs/corpus/epa_ppls/100-1518.md

# NAVIVA LF

- EPA Reg No: **100-1518**
- Registrant: SYNGENTA CROP PROTECTION, LLC
- Signal word: Caution
- Active ingredients: Pasteuria spp. (Rotylenchulus reniformis nematode) - Pr3 (33.29%)
- Label accepted: 2012-06-13
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/085004-00008-20120613.pdf

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UNITt TATES ENVIRONMENTAL PROTECTIQ GENCY I (I
U S ENVIRONMENTAL PROTECTION AGENCY
Office of Pesticide Programs
Biopesticides and Pollution Prevention Division (751 IP)
1200 Pennsylvania Avenue NW
Washington D C 20460
NOTICE OF PESTICIDE
X Registration
Reregistration
(under FIFRA as amended)
EPA
Registration
Number
85004-8
Date of Issuance
JUN 1 3 2012
Term of
Issuance Unconditional
Name of Pesticide Product
NAVIVA LF
Name and Address of Registrant (include ZIP Code)
Pasteuna Bioscience, Incorporated
12085 Research Drive, Suite 185
Alachua, FL 32615
_ ^ i ^, j s^w,. )
Note Changes in labeling differing in substance from that accepted in connection with this registration must be
submitted to and accepted by the Biopesticides and Pollution Prevention Division prior to use of the label in,commerce In
any correspondence on this product always refer to the above EPA Registration Number *,-T ,
On the basis of information furnished by the registrant the above named pesticide is hereby registered/reregistered under
the Federal Insecticide Fungicide and Rodenticide Act (FIFRA or the Act) Registration is in no way to be construed as
an endorsement or recommendation of this product by the Environmental Protection Agency (EPA or the Agency) In
order to protect health and the environment the Administrator on his or her motion may at any time suspend or cancel
the registration of a pesticide in accordance with the Act The acceptance of any name in connection with the registration
of a product under this Act is not to be construed as giving the registrant a right to exclusive use of the name or to its use if
it has been covered by others
This registration does not eliminate the need for continual reassessment of the pesticide If EPA
determines at any time that additional data are required to maintain in effect an existing registration,
the Agency will require submission of such data under section 3(c)(2)(B) of FIFRA
This product is unconditionally registered in accordance with FIFRA section 3(c)(5) and is subject to
the following terms
1 Revise the EPA Registration Number to read as follows "EPA Reg No 85004-8 "
2 Submit two (2) copies of the final printed labeling before you release the product for shipment
Refer to the A-79 enclosure for further description of final printed labeling
Signature of Approving Official
Keith A Matthews, Director
Biopesticides and Pollution Prevention Division
Date
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SURNAME ^
DATE ^
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EPA Form 1 320-1 A (1 790) ^
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Printed on Recycled Paper OFFICIAL FILE COPY
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Pasteuna Bioscience, Inc
EPA Reg No 85004-8
3 Submit/cite all data, which are required to support NAVIVA Tech, within the time frames required
by the terms of EPA Registration Number 85004-4 These data must be determined by EPA to be
acceptable
4 Submit the following data on NAVIVA LF by the due dates specified below These data must be
determined by EPA to be acceptable
Study Type
Discussion of Formation
of Unintentional
Ingredients
(Guideline Number
885 1300)
Analysis of Samples
(Guideline Number
885 1400)
Required Data/Information
Provide information and/or additional data to address EPA s comments
regarding contaminant screens (specifically see page 10 of the March 2
2012 EPA Memorandum)
Submit an analysis of samples for four additional batches
Due Date
December 13
2012
June 13 2013
The March 2, 2012 EPA Memorandum and a stamped copy of the label are enclosed for your records
Sincerely,
Keith A Matthews, Director
Biopesticides and Pollution
Prevention Division (751 IP)
Enclosures (3)
NAVIVA LF Accepted Label
A 79 Enclosure
March 2 2012 EPA Memorandum

§/u
NAVIVA LFBiological control for use on specified food and non-food crops
against remform nematode
0 FOR ORGANIC PRODUCTION
Active Ingredient Pasteunaspp (Rotylenchulus remformis nematode) -Pr3* 332900%
Other Ingredients 66 7100%
Total 100 0000%
* Contains at least 1 3xl07 spores per g or 5 9x10 spores per pound
KEEP OUT OF REACH OF CHILDREN
CAUTION
See additional precautionary and first aid statements on the back panel
Net Contents 2 5, 5, 10 gallons
EPA Registration N° 85004-1
EPA Est Number
Manufactured for
®PASTEURIAbioscience12085 Research Dr , Suite 185
Alachua, FL32615
(386) 462-0008 LCCF PTFHwww pasteunabio com/ /»VrfV^l—i I L_Lx
JUN 1 3 2012Batch code
under the Federal Insecticide, Fungicide,
and Rodentiode Act, as amended, for
the pesticide registered under
FPAReg No fcooH- "&

r rProposed Label for NAVIVA LF
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION
Harmful if absorbed through skin or inhaled Avoid contact with skin, eyes, or clothing
Avoid breathing spray mist Wash thoroughly with soap and water after handling and before
eating, drinking, chewing gum, using tobacco, or using the toilet Remove and wash
contaminated clothing before reuse
FIRST AID
, Take off contaminated clothingIf on skin _ , , , , . _. , _ nn
• Rinse skin immediately with plenty of water for 15-20
, .. minutesclothing ' Call a poison control center or doctor for treatment advice
If
inhaled
Move person to fresh air
If person is not breathing, call 911 or an ambulance, then
give artificial respiration preferably mouth-to-mouth if
possible
Call a poison control center or doctor for treatment advice
HOT LINE NUMBER
Have the product container or label with you when calling a poison control
center or doctor, or going for treatment For emergency information
concerning this product call the National Pesticide Information Center (NPIC)
at 1-800-858-7378 seven days a week, 6 30 am to 4 30 pm Pacific Time
During other times, call your poison control center at 1-800-222-1222
PERSONAL PROTECTIVE EQUIPMENT (PPE)
Applicators and other handlers must wear
• Long-sleeved shut and long pants
• Waterproof gloves
• Shoes plus socks
Mixers/loaders and applicators must wear a dust/mist filtering respirator meeting NIOSH
standards of at least N-95 R-95, or P-95 Repeated exposure to high concentrations of
rmcrobial proteins can cause allergic sensitization
Follow the manufacturer's instructions for cleaning/maintaining PPE If no such instructions
are available, use detergent and hot water for washables Keep and wash PPE separately
from other laundry
Pasteuna Bioscience Inc 2 of 9 June 5 2012

r c 5(uProposed Label for NAVIVA LF
USER SAFETY RECOMMENDATIONS
Users should
* Remove clothmg/PPE immediately if pesticide gets inside Then wash thoroughly
and put on clean clothing
• Remove PPE immediately after handling this product Wash the outside of gloves
before removing As soon as possible wash thoroughly and change into clean
clothing
ENVIRONMENTAL HAZARDS
[Containers with capacities of 5 gallons or less ] For terrestrial uses, do not apply directly to
water, or to areas where surface water is present or to intertidal areas below the mean high
water mark
Do not contaminate water when disposing of equipment wash waters or nnsate
[Containers with capacities greater than 5 gallons ] Do not discharge effluent containing this
product into lakes, streams, ponds estuaries, oceans or other waters unless in accordance
with the requirements of a National Pollutant Discharge Elimination System (NPDES)
permit and the permitting authority has been notified in writing prior to discharge Do not
discharge effluent containing this product to sewer systems without previously notifying the
local sewage treatment plant authority For guidance contact your State Water Board or
Regional Office of EPA
For terrestrial uses do not apply directly to water or to areas where surface water is present
or to intertidal areas below the mean high water mark
Do not contaminate water when disposing of equipment wash waters or rmsate
DIRECTIONS FOR USE
It is a violation of Federal law to use this product m a manner inconsistent with its
labeling
Do not use this product until you have read the entire label Do not apply this product in a
way that will contact workers or other persons, either directly or through drift Only
protected handlers may be in the area during application For any requirement specific to
your State and Tribe, consult the State or Tribal agency responsible for pesticide regulation
Pasteuna Bioscience Inc 3 of 9 June 5 2012

uProposed Label for NAVIVA LF
AGRICULTURAL USE REQUIREMENTS
Use this product only in accordance with its labeling and with the Worker Protection Standard 40 CFR
Part 170 This Standard contains requirements for the protection of agricultural workers on farms
forests nursenes and greenhouses and handlers of agricultural pesticides It contains requirements
for training decontamination notification and emergency assistance It also contains specific
instructions and exceptions pertaining to the statements on this label about personal protective
equipment (PPE) and restricted entry interval The requirements in this box apply only to uses of this
product that are covered by the Worker Protection Standard
Do not enter or allow worker entry into treated areas during the restricted entry interval (REI) of 4
hours
PPE required for early entry to treated areas (that is permitted under the Worker Protection Standard
and that involves contact with anything that has been treated such as plants soil or water) is
» Coveralls
» Waterproof gloves
• Shoes plus socks
NON AGRICULTURAL USE REQUIREMENTS
The requirements in this box apply to uses that are NOT within the scope of the Worker Protection Standard
for agricultural pesticides (40 CFR Part 170) The WPS applies when this product is used to produce
agricultural plants on farms forests nurseries or greenhouses
Keep unprotected persons out of treated areas until sprays have dried
PRODUCT INFORMATION
This product contains a biological nematicide for the control of the following nematode on
specified food and non-food crops
Reniform Nematode Rotylenchulus remformis
USE RESTRICTIONS
Consult your extension agent or manufacturing representative before mixing this product
with fertilizer or seed
Pasteuna Bioscience Inc 4 of 9 JuneS 2012

r \\Proposed Label for NAVIVA LF
APPLICATION INSTRUCTIONS
Apply 013-64 fluid ounces (fl oz ) of NAVIVA LF per 100 square feet of the crop (see
Table 1 ) prior to planting and subsequently in 3 to 4 week intervals Use the higher
application rate on sites with high Remform nematode populations (greater than 50 Remform
nematodes per 0 4 cup [100 cm3] of soil) or areas with extensive nematode damage such as
stunted plants dying plants, or heavily stunted root systems compared to unaffected plants in
the same field For best control, a minimum of 3 sequential applications is required
Monthly applications throughout the year may help maintain Remform nematode
populations below economic threshold levels
Table 1 Amounts of NAVIVA LF applied to food and non-food crops
Food and Non-food Crops Scientific
Name
Amount of NAVIVA LF per
100 Square Feet of Crop Area
(fl oz)
Food Crop
Onion garlic
Beet
Broccoli collards mustard rape seed
kale brussel sprouts cauliflower
turnip kohlrabi cabbage
Peppers (all sweet hot bell etc )
Cucumber melons
Gourd pumpkin squash
Soybean
Cotton
Sunflower
Lettuce
Tomato
Mints
Beans
Peas
Beans
Alhum
Beta
Brassica
Brassica cont d
Brassica cont d
Capsicum
Cucumis
Cucurbita
Glycine
Gossypmm
Hehanthus
Lactuca
Lycopersicon
Mentha
Phaseolus
Pisum
Vigna
013-64
Non-Food Crop
Begonia
Spiderplants spiderflower spiderweed
Hibiscus sorrel
Impatiens jewelweeds
Asters
Tobacco flowering tobacco
Mangold
Zinnia
Begonia
Cleome
Hibiscus
Impatiens
Aster
Nicotiana
Tagetes
Zinnia
0 13-64
Pasteuna Bioscience Inc 5 of 9 JuneS 2012

Proposed Label for NAVIVA LF
NAVIVA LF may be diluted in water to attain proper distribution across the area to be
treated This product may be applied using standard calibrated ground spray-application
equipment and incorporated to a 4-mch depth prior to bed formation or applied via
chemigation through the irrigation system after bed formation (pre-plantmg) Agitation in
the mix tank is recommended for any application requiring dilution of the formulated
product with water prior to application When mixing fill the tank one-half full with water
add NAVIVA LF slowly to the tank with hydraulic or mechanical agitation, and continue to
fill with water For diluted product applications, apply product in the appropriate amount of
water to treat the root-zone of the crop without flushing the product beyond the root-zone of
the crop (this can vary with soil type and crop stage)
Apply enough water following all applications to move the Pasteuna spores into the plant
root-zone and to flush the irrigation lines of any remaining product After application of
NAVIVA LF and subsequent treatment with water, minimizing irrigation for several weeks
following treatment may improve Remform nematode control For areas under intense
irrigation repeat applications may be necessary to maintain Remform nematode populations
below an economic threshold
DAYS TO HARVEST
There are no restrictions on applying NAVIVA LF up to the time of harvest
CHEMIGATION
General Requirements
1) Apply this product only through sprinkler (including center pivot, lateral move, end
tow, side (wheel) roll, traveler, big gun solid set, or hand move) and drip (trickle)
irrigation systems Do not apply this product through any other type of irrigation
system
2) Crop injury or lack of effectiveness can result from non-uniform distribution of
treated water
3) If you have questions about calibration you should contact State Extension Service
specialists, equipment manufacturers, or other experts
4) Do not connect an irrigation system (including greenhouse systems) used for
pesticide application to a public water system unless the pesticide label-prescribed
safety devices for public water systems are in place
5) A person knowledgeable of the chemigation system and responsible for its operation,
or under the supervision of the responsible person, shall shut the system down and
make any necessary adjustments should the need arise
Requirements for Chemigation Systems Connected to Public Water Systems
1) Public water supply means a system for the provision to the public of piped water for
human consumption if such system has at least 15 service connections or regularly
serves an average of 25 individuals daily at least 60 days throughout the year
Pasteuna Bioscience Inc 6 of 9 June 5 2012

Proposed Label for NAVIVA LF
2) Chemigation systems connected to the public water systems must contain a
functional, reduced-pressure zone (RPZ), backflow preventer or the functional
equivalent in the water supply upstream from the point of pesticide introduction As
an option to the RPZ, the water from the public water system should be discharged
into a reservoir tank prior to pesticide introduction There shall be a complete
physical break (air gap) between the flow outlet end of the fill pipe and the top or the
overflow nm of the reservoir tank of at least twice the inside diameter of the fill pipe
3) The pesticide injection pipeline must contain a functional, automatic, quick-closing
check valve to prevent the flow of fluid back toward the injection pump
4) The pesticide injection pipeline must contain a functional, normally closed, solenoid-
operated valve located on the intake side of the injection pump and connected to the
system interlock to prevent fluid from being withdrawn from the supply tank when
the irrigation system is either automatically or manually shut down
5) The system must contain functional interlocking controls to automatically shut off
the pesticide injection pump when the water pump motor stops, or in cases where
there is no water pump, when the water pressure decreases to the point where
pesticide distribution is adversely affected
6) Systems must use a metering pump, such as a positive displacement injection pump
(e g , diaphragm pump), effectively designed and constructed of materials that are
compatible with pesticides and capable of being fitted with a system interlock
7) Do not apply when wind speed favors drift beyond the area intended for treatment
Requirements for Sprinkler Chemigation
1) The system must contain a functional check valve, vacuum relief valve, and low
pressure dram appropriately located on the irrigation pipeline to prevent water source
contamination from back flow
2) The pesticide injection pipeline must contain a functional, automatic quick-closing
check valve to prevent the flow of fluid back toward the injection pump
3) The pesticide injection pipeline must also contain a functional, normally closed,
solenoid-operated valve located on the intake side of the injection pump and
connected to the system interlock to prevent fluid from being withdrawn from the
supply tank when the irrigation system is either automatically or manually shut
down
4) The system must contain functional interlocking controls to automatically shut off
the pesticide injection pump when the water pump motor stops
5) The irrigation line or water pump must include a functional pressure switch, which
will stop the water pump motor when the water pressure decreases to the point where
pesticide distribution is adversely affected
6) Systems must use a metering pump, such as a positive displacement injection pump
(e g , diaphragm pump), effectively designed and constructed of materials that are
compatible with pesticides and capable of being fitted with a system interlock
7) Do not apply when wind speed favors drift beyond the area intended for treatment
Pasteuna Bioscience Inc 7 of 9 June 5 2012

CProposed Label for NAVIVA LF
Requirements for Drip Chemigation
1) The system must contain a functional check valve, vacuum relief valve and
low pressure dram appropriately located on the irrigation pipeline to prevent water
source contamination from back flow
2) The pesticide injection pipeline must contain a functional, automatic, quick-closing
check valve to prevent the flow of fluid back toward the injection pump
3) The pesticide injection pipeline must also contain a functional, normally closed,
solenoid-operated valve located on the intake side of the injection pump and
connected to the system interlock to prevent fluid from being withdrawn from the
supply tank when the irrigation system is either automatically or manually shut
down
4) The system must contain functional interlocking controls to automatically shut off
the pesticide injection pump when the water pump motor stops
5) The irrigation line or water pump must include a functional pressure switch, which
will stop the water pump motor when the water pressure decreases to the point where
pesticide distribution is adversely affected
6) Systems must use a metering pump, such as a positive displacement injection
pump (e g , diaphragm pump), effectively designed and constructed of
materials that are compatible with pesticides and capable of being fitted with
a system interlock
Pasteuna Bioscience Inc 8 of 9 June 5 2012

rProposed Label for NAVIVA LF
STORAGE and DISPOSAL
Do not contaminate water, food, or feed by storage and disposal
PESTICIDE STORAGE
Store in a cool dry place Reclose containers of unused portions of NAVIVA LF
PESTICIDE DISPOSAL
To avoid wastes use material in this container by application according to label directions
If wastes cannot be avoided, offer remaining product to waste disposal facility or pesticide
disposal program (often such programs are run by state or local governments or by industry)
CONTAINER HANDLING
[Plastic containers with capacities equal to or less than 5 gallons ] Nonrefillable container
Do not reuse or refill this container Triple rinse container (or equivalent) promptly after
emptying Triple rinse as follows Empty the remaining contents into application equipment
or a mix tank and dram for 10 seconds after the flow begins to drip Fill the container 1/4 full
with water and recap Shake for 10 seconds Pour nnsate into application equipment or a mix
tank, or store nnsate for later use or disposal Dram for 10 seconds after the flow begins to
drip Repeat this procedure two more times Then offer for recycling if available or puncture
and dispose of in a sanitary landfill, or by incineration Do not burn, unless allowed by state
and local ordinance If burned, stay out of smoke
[Plastic containers with capacities greater than 5 gallons ] Nonrefillable container Do not
reuse or refill this container Triple rinse container (or equivalent) promptly after emptying
Triple rinse as follows Empty the remaining contents into application equipment or a mix
tank Fill the container 1/4 full with water Replace and tighten closures Tip container on its
side and roll it back and forth, ensuring at least one complete revolution, for 30 seconds
Stand the container on its end and tip it back and forth several times Turn the container over
onto its other end and tip it back and forth several times Empty the nnsate into application
equipment or a mix tank, or store rmsate for later use or disposal Repeat this procedure two
more times Then offer for recycling if available or puncture and dispose of in a sanitary
landfill, or by incineration Do not burn, unless allowed by state and local ordinance If
burned, stay out of smoke
WARRANTY STATEMENT
Pasteuria Bioscience, Inc (PBI) warrants that this product conforms to its label description
and is suitable for its intended use if stored and used in accordance with the Directions for
Use To the extent consistent with applicable law, PBI makes no warranty, express or
implied, of merchantability, fitness or otherwise concerning the use of this product other
than as indicated on this label To the extent consistent with applicable law, user assumes all
risks of use, storage or handling not in accordance with accompanying directions
Pasteuria Bioscience, Inc 9 of 9 June 5 2012