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crop-chem-docs/corpus/epa_ppls/100-1519.md
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OLLAMA_URL get set at compose time.

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Co-Authored-By: Claude Opus 4.7 (1M context) <noreply@anthropic.com>
2026-05-24 12:32:41 -04:00

924 lines
52 KiB
Markdown

# SOYACYST LF
- EPA Reg No: **100-1519**
- Registrant: SYNGENTA CROP PROTECTION, LLC
- Signal word: Caution
- Active ingredients: Pasteuria nishizawae Pn1 (33.29%)
- Label accepted: 2012-05-17
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/085004-00009-20120517.pdf
---
UNITEf TATES ENVIRONMENTAL PROTECTION' ENCY
Ms. Susan Macintosh
Agent for Pasteuria Bioscience, Inc.
Macintosh & Associates, Inc.
1203 Hartford Avenue
Saint Paul, MN 55116
MAY 1 7 2012
Re: Pasteuria Bioscience, Inc.; Soyacyst LF
EPA Registration No. 85004-9
Non-Fast Track Amendment to Modify the Product Formulation & Certification of Limits and
Add Two Additional Manufacturing Facilities
Submission dated 02/10/2012
Decision No. 460925
Dear Ms. Macintosh:
The U.S. Environmental Protection Agency (EPA) reviewed your request to amend the subject product
registration, which included the following changes to the product label:
1)
2)
3)
Modification of the viability statement (in the Ingredient Statement) from "Contains at least
1 .3xl07 spores per g or 5.9xl09 spores per pound" to "Contains at least 2xl08 spores per g or
9.1xl010 spores per pound" (master label cover sheet and all sub-labels).
Modification of the EPA Registration Number from "85004-O" to "85004-9" (master label cover
sheet and all sub-labels).
Addition of the following EPA Establishment Numbers: 100-NC-002 (new), 071617-GA-001
(new), and 70815-GA-001 (old) (master label cover sheet and all sub-labels).
In conjunction with the label amendment, you also updated the confidential statement of formula (CSF)
on file for Soyacyst LF. There is now only one valid CSF, basic formulation dated May 16, 2012, for this
product registration. All previously accepted Soyacyst LF CSFs have been superseded by the
aforementioned CSF.
All the changes referred to above, submitted in connection with registration under section 3(c)(5) of the
Federal Insecticide, Fungicide, and Rodenticide Act, are acceptable provided that you comply with the
following terms:
1) By October 17, 2013, submit five-batch analyses from batches produced at the two new
manufacturing facilities, one from the registered establishment in North Carolina and one from
the registered establishment in Brunswick, Georgia.
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.
CONCURRENCES
SYMBOL ^
SURNAME ^
DATE ^
7SI1P
KlVoi cH
OS j ,1 I toil.
..ll\l?n.
J£*M]S>..!...-— ..|..W. .......
5|nlo-EPA Form 1320-1A (1/90) Printed on Recycled Paper OFFICIAL FILE COPY
* U.S. Government Printing Office: 2005 206-899 (mac)
(
Susan Macintosh
EPA Registration No. 85004-9
Your release for shipment of the product bearing the amended labeling constitutes acceptance of these
terms. If you have any questions regarding this letter, please contact Ms. Jeannine Kausch by telephone
(703-347-8920) or email (kausch.jeannine@epa.gov).
Copies of the associated science review and stamped label are enclosed for your records.
Sincerely,
i rv. rk If -V-CK-
Sheryl K. Reilly, Ph.D., Chief
Microbial Pesticides Branch
Biopesticides and Pollution
Prevention Division (751 IP)
Enclosures: (1) Soyacyst LF Accepted Label
(2) May 11, 2012 Memorandum
(3) A-79 Enclosure
( (
SOYACYST LF
Biological control for use on soybean against soybean cyst nematode
WITH THE ALTERNATE BRAND NAME;
SOYACYST ST
Biological control for use on soybean seed against soybean cyst nematode
MASTER LABEL
SUB-LABEL A: FOR AGRICULTURAL USE As FOLIAR TREATMENT AND SEED
TREATMENT
SUB-LABEL B: FOR AGRICULTURAL USE As FOLIAR TREATMENT
SUB-LABEL C: FOR SEED TREATMENT
X FOR ORGANIC PRODUCTION
Active Ingredient: Pasteurianishizawae-Pnl* 33.29%
Other Ingredients: 66.71%
Total: 100.00%
*Contains at least 2x10* spores per g or 9.1xl010 spores per pound.
EPA Registration N°: 85004-9
EPA Est. Number: 100-NC-002 or 071617-GA-001 or 70815-GA-001
Manufactured for:
®PASTEURIAbioscience12085 Research Dr., Suite 185
Alachua, FL 32615
(386)462-0008
www.pasteuriabio.com/ MAY 1 7 2012
Under the Federal Insecticide, Fungicide,
and Rodentfcide Act, as amended, for
the pesticide registered under
EPA Reg. No. 85o6f -^
IProposed Label for SOYACYST LF / ST
Sub-Label A
SOYACYST LF
Biological control for use on soybean against soybean cyst nematode
WITH THE ALTERNATE BRAND NAME:
SOYACYST ST
Biological control for use on soybean seed against soybean cyst nematode
SUB-LABEL A
FOR AGRICULTURAL USE AS FOLIAR APPLICATION
AND SEED TREATMENT
Pasteuria Bioscience, Inc. 2 of 2 8 May 16, 2012
(Proposed Label for SOYACYST LF / ST
Sub-Label A
SUB-LABEL A
SOYACYST LF
Biological control for use on soybean against soybean cyst nematode
WITH THE ALTERNATE BRAND NAME:
SOYACYST ST
Biological control for use on soybean seed against soybean cyst nematode
0 FOR ORGANIC PRODUCTION
Active Ingredient: Pasteuria nishizawae- Pnl* 33.29%
Other Ingredients: 66.71%
Total: 100.00%
* Contains at least 2xl08 spores per g or 9.1xl010 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°: 85004-9
EPA Est. Number: 100-NC-002 or 071617-GA-001 or 70815-GA-001
Manufactured for:
<T PASTEURIAbioscience12085 Research Dr., Suite 185
Alachua, FL32615
(386) 462-0008
www.pasteuriabio.com/
Pasteuria Bioscience, Inc. 3 of 28 May 16, 2012
Proposed Label for SOYACYST LF / ST
Sub-Label A
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION
Harmful if inhaled. Avoid breathing spray mist. Remove and wash contaminated clothing
before reuse.
FIRST AID
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 shirt and long pants
• 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
microbial 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.
Pasteuria Bioscience, Inc. 4 of 28 May 16, 2012
rProposed Label for SOYACYST LF / ST
Sub-Label A
USER SAFETY RECOMMENDATIONS
Users should:
• Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet.
• Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing.
• Remove PPE immediately after handling this product. 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 rinsate.
[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 rinsate.
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in 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 or
Tribe, consult the State or Tribal agency responsible for pesticide regulation.
Pasteuria B ioscience, Inc. 5 of 2 8 May 16, 2012
(Proposed Label for SOYACYST LF / ST
Sub-Label A
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, nurseries, 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 the 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.
EXCEPTION: If the product is soil injected or soil incorporated, the Worker Protection
Standard, under certain circumstances, allows workers to enter the treated area if there will be
no contact with anything that has been treated.
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:
• Water proof gloves
• Coveralls
• Shoes plus socks
NON- AGRICULTURAL USE REQUIREMENTS
The requirements in this box apply to uses of this product 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 treatment areas until seeds have dried or been packaged.
PRODUCT INFORMATION
This product contains a biological nematicide for the control of the following nematode:
Soybean Cyst Nematode Heterodera glycines
Pasteuria Bioscience, Inc. 6 of 28 May 16,2012
(Proposed Label for SOYACYST LF / ST
Sub-Label A
FOR USE As FOLIAR APPLICATION
APPLICATION INSTRUCTIONS
Soybean: Apply 1.3 to 64 fluid ounces (fl oz) of SOYACYST LF per 1000 square feet of
soybean prior to planting and subsequently in 3 to 4 week intervals. Use the higher
application rate on sites with high Soybean cyst nematode populations (greater than 50
Soybean cyst nematodes per 0.4 cup [100cm3] 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 Soybean cyst
nematode populations below economic threshold levels.
SOYACYST 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-inch depth prior to bed formation or applied via
chemigation through the irrigation system after bed formation (pre-planting). 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
SOYACYST 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 Pasteuria spores into the soybean
root-zone and to flush the irrigation lines of any remaining product. After application of
SOYACYST LF and subsequent treatment with water, minimizing irrigation for several
weeks following treatment may improve Soybean cyst nematode control. For areas under
intense irrigation, repeat applications may be necessary to maintain Soybean cyst nematode
populations below an economic threshold.
DAYS TO HARVEST
There are no restrictions on applying SOYACYST LF up to the time of harvest.
Pasteuria Bioscience, Inc. 7 of 28 May 16, 2012
( (Proposed Label for SOYACYST LF / ST
Sub-Label A
CHEMIGATION
Basic 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.
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 overflow rim 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.
Pasteuria Bioscience, Inc. 8 of 28 May 16, 2012
Proposed Label for SOYACYST LF / ST
Sub-Label A
Requirements for Sprinkler Chemigation:
1) The system must contain a functional check valve, vacuum relief valve, and low
pressure drain 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.
Requirements for Drip Chemigation:
1) The system must contain a functional check valve, vacuum relief valve and
low pressure drain 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.
Pasteuria Bioscience, Inc. 9 of 28 May 16, 2012
( (Proposed Label for SOYACYST LF / ST
Sub-Label A
FOR USE AS A SEED TREATMENT
Treatment of highly mechanically scarred or damaged seed, or seed known to be of low vigor
and poor quality, except for the purpose of curative control of existing disease pests, may
result in reduced germination and/or reduction of seed and seedling vigor. Treat a small
quantity of seed using equipment similar to that planned for treating the total seed lot.
Conduct germination tests on a small portion of seed before committing the total seed lot to a
selected seed treatment. Due to seed quality, crop or variety sensitivity, and seed storage
conditions beyond the control of manufacturer, no claims are made to guarantee the
germination of carry-over seed or propagating material for all crop seed.
FOR USE AS A PRE-PLANT SEED TREATMENT
Treat only those seeds needed for immediate use, minimizing the interval between treatment
and planting. Do not store excess treated seeds beyond planting time.
To achieve improved application coverage to the seed, dilute SOYACYST LF with water and
apply directly to dry seed or mix with inoculants and/or other registered seed treatment
coatings (e.g., colorants, polymers, etc.), insecticides and fungicides. Do not mix
SOYACYST LF with any product containing a label prohibition against such mixing. When
tank-mixing with any other registered seed treatment insecticide and/or fungicide, always read
and follow all use directions, restrictions, and precautions of both SOYACYST LF and the
tank mix partner(s). The resulting tank mix must be in accordance with the more restrictive
label limitations and precautions. Do not exceed label dosage rates. Please consult Pasteuria
Bioscience, Inc. for additional information (http ://www .pasteuriabio .com/) .
SOYBEAN
For control of soybean cyst nematode, apply 2 to 12 fluid ounces of SOYACYST LF per 100
Lbs (60-150 mL per 45.4 kg) of soybean seed.
FOR USE AS A COMMERICAL SEED TREATMENT
To achieve improved application coverage to the seed, dilute SOYACYST LF with water and
apply directly to dry seed or mix with inoculants and/or other registered seed treatment
coating (e.g., colorants, polymers, etc.), insecticides and fungicides. Do not mix SOYACYST
LF with any product containing a label prohibition against such mixing. When tank-mixing
with any other registered seed treatment insecticide and/or fungicide, always read and follow
all use directions, restrictions, and precautions of both SOYACYST LF and the tank mix
partner(s). The resulting tank mix must be in accordance with the more restrictive label
limitations and precautions. Do not exceed label dosage rates. Please consult Pasteuria
Bioscience, Inc. for additional information (http://www.pasteuriabio. com/).
SOYBEAN
For control of soybean cyst nematode, apply 2 to 12 fluid ounces of SOYACYST LF per 100
Lbs (60-150 mL per 45.4 kg) of soybean seed.
Pasteuria Bioscience, Inc. 10 of 28 May 16, 2012
(Proposed Label for SOYACYST LF / ST
Sub-Label A
STORAGE AND DISPOSAL
Do not contaminate water, food, or feed by storage and disposal.
PESTICIDE STORAGE
Store refrigerated (~4°C). Reclose container of unused portions of SOYACYST LF.
PESTICIDE DISPOSAL
To avoid wastes, use all material in this container by application according to label directions.
If wastes cannot be avoided, offer remaining product to a 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 drain for 10 seconds after the flow begins to drip. Fill the container 1/4 full
with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix
tank, or store rinsate for later use or disposal. Drain 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 rinsate into application
equipment or a mix tank, or store rinsate 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. (FBI) 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. 11 of 28 May 16, 2012
< (Proposed Label for Soyacyst LF
Sub-Label B
SOYACYST LF
Biological control for use on soybean against soybean cyst nematode
SUB-LABEL B
FOR AGRICULTURAL USE AS FOLIAR APPLICATION
Pasteuria Bioscience, Inc. 12 of 28 May 16, 2012
( (Proposed Label for Soyacyst LF
Sub-Label B
SUB-LABEL B
SOYACYST LF
Biological control for use on soybean against soybean cyst nematode
0 FOR ORGANIC PRODUCTION
Active Ingredient: Pasteuria nishizawae-Pnl* 33.29%
Other Ingredients: 66.71%
Total: 100.00%
* Contains at least 2xl08 spores per g or 9.1xl010 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°: 85004-9
EPA Est. Number: 100-NC-002 or 071617-GA-001 or 70815-GA-001
Manufactured for:
^PASTEURIAbioscience12085 Research Dr., Suite 185
Alachua,FL32615
(386) 462-0008
www.pasteuriabio.com/
Pasteuria Bioscience, Inc. 13 of 28 May 16, 2012
Proposed Label for Soyacyst LF
Sub-LabelB
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION
Harmful if inhaled. Avoid breathing spray mist. Remove and wash contaminated clothing
before reuse.
FIRST AID
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 shirt and long pants
• 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
microbial 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.
USER SAFETY RECOMMENDATIONS
Users should:
• Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet.
• Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing.
• Remove PPE immediately after handling this product. As soon as possible, wash
thoroughly and change into clean clothing.
Pasteuria Bioscience, Inc. 14 of 28 May 16,2012
(Proposed Label for Soyacyst LF
Sub-Label B
ENVIRONMENTAL HAZARDS
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 rinsate.
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in 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 or
Tribe, consult the State or Tribal agency responsible for pesticide regulation.
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, nurseries, 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 the 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.
EXCEPTION: If the product is soil injected or soil incorporated, the Worker Protection
Standard, under certain circumstances, allows workers to enter the treated area if there will be
no contact with anything that has been treated.
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:
• Water proof gloves
• Coveralls
• Shoes plus socks
Pasteuria Bioscience, Inc. 15 of 28 May 16, 2012
(Proposed Label for Soyacyst LF
Sub-Label B
PRODUCT INFORMATION
This product contains a biological nematicide for the control of the following nematode:
Soybean Cyst Nematode Heterodera glycines
APPLICATION INSTRUCTIONS
Soybean: Apply 1.3 to 64 fluid ounces (fl oz) of SOYACYST LF per 1000 square feet of
soybean prior to planting and subsequently in 3 to 4 week intervals. Use the higher
application rate on sites with high Soybean cyst nematode populations (greater than 50
Soybean cyst nematodes per 0.4 cup [100cm3] 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 Soybean cyst
nematode populations below economic threshold levels.
SOYACYST 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-inch depth prior to bed formation or applied via
chemigation through the irrigation system after bed formation (pre-planting). 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
SOYACYST 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 Pasteuria spores into the soybean
root-zone and to flush the irrigation lines of any remaining product. After application of
SOYACYST LF and subsequent treatment with water, minimizing irrigation for several
weeks following treatment may improve Soybean cyst nematode control. For areas under
intense irrigation, repeat applications may be necessary to maintain Soybean cyst nematode
populations below an economic threshold.
DAYS TO HARVEST
There are no restrictions on applying SOYACYST LF up to the time of harvest.
Pasteuria Bioscience, Inc. 16 of 28 May 16, 2012
Proposed Label for Soyacyst LF
Sub-Label B
CHEMIGATION
Basic 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.
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 overflow rim 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.
Pasteuria Bioscience, Inc. 17 of 28 May 16, 2012
rProposed Label for Soyacyst LF
Sub-Label B
Requirements for Sprinkler Chemigation:
1) The system must contain a functional check valve, vacuum relief valve, and low
pressure drain 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.
Requirements for Drip Chemigation:
1) The system must contain a functional check valve, vacuum relief valve and
low pressure drain 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.
Pasteuria Bioscience, Inc. 18 of 28 May 16, 2012
Proposed Label for Soyacyst LF
Sub-Label B
STORAGE AND DISPOSAL
Do not contaminate water, food, or feed by storage and disposal.
PESTICIDE STORAGE
Store refrigerated (~4°C). Reclose container of unused portions of SOYACYST LF.
PESTICIDE DISPOSAL
To avoid wastes, use all material in this container by application according to label directions.
If wastes cannot be avoided, offer remaining product to a 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 drain for 10 seconds after the flow begins to drip. Fill the container 1/4 full
with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix
tank, or store rinsate for later use or disposal. Drain 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 rinsate into application
equipment or a mix tank, or store rinsate 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.
Pasteuria Bioscience, Inc. 19 of 28 May 16,2012
(Proposed Label for Soyacyst LF
Sub-Label B
WARRANTY STATEMENT
Pasteuria Bioscience, Inc. (FBI) 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, FBI 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. 20 of 28 May 16, 2012
Proposed Label for Soyacyst ST
Sub-label C
SOYACYST LF
Biological control for use on soybean against soybean cyst nematode
WITH THE ALTERNATE BRAND NAME:
SOYACYST ST
Biological control for use on soybean seed against soybean cyst nematode
SUB-LABEL C
FOR SEED TREATMENT
Pasteuria Bioscience, Inc. 21 of 28 May 16, 2012
Proposed Label for Soyacyst ST
Sub-label C
SUB-LABEL C
SOYACYST LF
Biological control for use on soybean against soybean cyst nematode
WITH THE ALTERNATE BRAND NAME:
SOYACYST ST
Biological control for use on soybean seed against soybean cyst nematode
^ FOR ORGANIC PRODUCTION
Active Ingredient: Pasteuria nishizawae -Pnl* 33.29%
Other Ingredients: 66.71%
Total: 100.00%
* Contains at least 2xl08 spores per g or 9.1xl010 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 Number: 85004-9
EPA Est. Number: 100-NC-002 or 071617-GA-001 or 70815-GA-001
Manufactured for:
^PASTEURIAbioscience
12085 Research Dr., Suite 185 +1 (386) 462-0008
Alachua, FL 32615 www.pasteuriabio.com/
Pasteuria Bioscience, Inc. 22 of 28 May 16, 2012
y>Proposed Label for Soyacyst ST
Sub-label C
PRECAUTIONARY STATEMENTS
HAZARDS TO HUMANS AND DOMESTIC ANIMALS
CAUTION
Harmful if inhaled. Avoid breathing spray mist. Remove and wash contaminated clothing
before reuse.
FIRST AID
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 shirt and long pants
• 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
microbial 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.
Pasteuria Bioscience, Inc. 23 of 28 May 16,2012
(Proposed Label for Soyacyst ST
Sub-label C
USER SAFETY RECOMMENDATIONS
Users should:
• Wash hands before eating, drinking, chewing gum, using tobacco or using the toilet.
• Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and
put on clean clothing.
• Remove PPE immediately after handling this product. 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 rinsate.
[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 rinsate.
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in 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 or
Tribe, consult the State or Tribe agency responsible for pesticide regulation.
Pasteuria Bioscience, Inc. 24 of 28 May 16, 2012
(Proposed Label for Soyacyst ST
Sub-label C
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, nurseries, 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 the 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.
EXCEPTION: If the product is soil injected or soil incorporated, the Worker Protection
Standard, under certain circumstances, allows workers to enter the treated area if there will be
no contact with anything that has been treated.
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:
• Water proof gloves
• Coveralls
• Shoes plus socks
NON- AGRICULTURAL USE REQUIREMENTS
The requirements in this box apply to uses of this product 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 treatment areas until seeds have dried or been packaged.
PRODUCT INFORMATION
This product contains a biological nematicide for the control of the following nematode:
Soybean Cyst Nematode Heterodera glycines
Pasteuria Bioscience, Inc. 25 of 28 May 16, 2012
Proposed Label for Soyacyst ST
Sub-label C
FOR USE AS A SEED TREATMENT
Treatment of highly mechanically scarred or damaged seed, or seed known to be of low vigor
and poor quality, except for the purpose of curative control of existing disease pests, may
result in reduced germination and/or reduction of seed and seedling vigor. Treat a small
quantity of seed using equipment similar to that planned for treating the total seed lot.
Conduct germination tests on a small portion of seed before committing the total seed lot to a
selected seed treatment. Due to seed quality, crop or variety sensitivity, and seed storage
conditions beyond the control of manufacturer, no claims are made to guarantee the
germination of carry-over seed or propagating material for all crop seed.
FOR USE AS A PRE-PLANT SEED TREATMENT
Treat only those seeds needed for immediate use, minimizing the interval between treatment
and planting. Do not store excess treated seeds beyond planting time.
To achieve improved application coverage to the seed, dilute SOYACYST LF with water and
apply directly to dry seed or mix with inoculants and/or other registered seed treatment
coatings (e.g., colorants, polymers, etc.), insecticides and fungicides. Do not mix
SOYACYST LF with any product containing a label prohibition against such mixing. When
tank-mixing with any other registered seed treatment insecticide and/or fungicide, always read
and follow all use directions, restrictions, and precautions of both SOYACYST LF and the
tank mix partner(s). The resulting tank mix must be in accordance with the more restrictive
label limitations and precautions. Do not exceed label dosage rates. Please consult Pasteuria
Bioscience, Inc. for additional information (http://www.pasteuriabio.com/).
SOYBEAN
For control of soybean cyst nematode, apply 2 to 12 fluid ounces of SOYACYST LF per 100
Lbs (60-150 mL per 45.4 kg) of soybean seed.
FOR USE AS A COMMERICAL SEED TREATMENT
To achieve improved application coverage to the seed, dilute SOYACYST LF with water and
apply directly to dry seed or mix with inoculants and/or other registered seed treatment
coating (e.g., colorants, polymers, etc.), insecticides and fungicides. Do not mix SOYACYST
LF with any product containing a label prohibition against such mixing. When tank-mixing
with any other registered seed treatment insecticide and/or fungicide, always read and follow
all use directions, restrictions, and precautions of both SOYACYST LF and the tank mix
partner(s). The resulting tank mix must be in accordance with the more restrictive label
limitations and precautions. Do not exceed label dosage rates. Please consult Pasteuria
Bioscience, Inc. for additional information (http://www.pasteuriabio.com/).
Pasteuria Bioscience, Inc. 26 of 28 May 16, 2012
(Proposed Label for Soyacyst ST
Sub-label C
SOYBEAN
For control of soybean cyst nematode, apply 2 to 5 fluid ounces of SOYACYST LF per 100
Lbs (60-150 mL per 45.4 kg) of soybean seed.
STORAGE AND DISPOSAL
Do not contaminate water, food, or feed by storage and disposal.
PESTICIDE STORAGE
Store refrigerated (~4°C). Reclose container of unused portions of SOYACYST LF.
PESTICIDE DISPOSAL
To avoid wastes, use all material in this container by application according to label directions.
If wastes cannot be avoided, offer remaining product to a 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 drain for 10 seconds after the flow begins to drip. Fill the container 1/4 full
with water and recap. Shake for 10 seconds. Pour rinsate into application equipment or a mix
tank, or store rinsate for later use or disposal. Drain 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 rinsate into application
equipment or a mix tank, or store rinsate 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.
Pasteuria Bioscience, Inc. 27 of 28 May 16, 2012
Proposed Label for Soyacyst ST
Sub-label C
WARRANTY STATEMENT
Pasteuria Bioscience, Inc. (FBI) 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, FBI 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. 28 of 28 May 16, 2012