crop-chem-docs/corpus/epa_ppls/264-988.md

# VORTEX 

- EPA Reg No: **264-988**
- Registrant: BAYER CROPSCIENCE, LLC
- Signal word: Caution
- Active ingredients: Ipconazole (40.7%)
- Label accepted: 2008-11-12
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000264-00988-20081112.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
WASHINGTON, DC 20460 
Larry Hodges 
Product Registration Manager. 
Bayer CropScience 
2 T.W. Alexander Drive 
Research Triangle Park, NC 27709 
Subject: Vortex 
EPA Reg. No. 264-988 
November 12, 2008 
Your Submission Dated January 31, 2007 
OFFICE OF 
PREVENTION, PESTICIDES AND 
TOXIC SUBSTANCES 
Label Amendment to Add Food Uses (EPA Decision No. 376228) 
Dear Mr. Hodges: 
The amended label referred to above, submitted in connection with registration under the 
Federal Insecticide, Fungicide and Rodenticide Act as amended is acceptable, provided the 
following conditions met: 
1. Acute and Subchronic Neurotoxicity(870.6200) and Immunotoxicity (870.7800) studies 
as required for all food and non-food use pesticide registrations per the revised 40 CFR 
Part 158 are submitted by November 30,2010. 
2. For the soybean study reported in MRID 45542243 and 45542248, the petitioner must 
provide the sample analysis dates. In addition, evidence must be provided that the 
identity of residues did not change during the period between collection and final analysis 
by November 30,2010. . . 
3. For the wheat study reported in MRID 47048924, the petitioner must provide the sample 
storage conditions for all samples and extracts and provide all sample combustion and 
analysis dates. The petitioner must explain the discrepancy between their statement that 
all extractions were completed within 84 days of harvest and the reported extraction dates 
in Appendix IV ofthe submission, which indicated that extractions were not completed 
until 286 days after harvest. Evidence must be provided that the identity of residues did 
( 
not change during the period between collection and final analysis by November 30, 
2010. 
4. Additiorial storage stability data/information must be submitted for the extracts of certain 
barley and wheat commodities samples. For the barley and wheat crop field trial studies 
reported in MRIDs 47048925 and 47048930, the petitioner must submit the conditions of 
extract storage, and provide storage stability data to support the storage of extracts for 
durations up to 36 days (barley commodities) or 43 days (wheat commodities). If the

,~. 
EP A Reg. No. 264-988 
Vortex 
Page 2 of2 
petitioner can provide data demonstrating that the extracts of fortified untreated samples 
for concurrent method recovery analyses were stored for the same durations and under 
the same conditions as the extracts oftreated samples, these data will be considered 
adequate to support the extended extract storage conditions by November 30, 2010. 
5. The method, as written, does not meet the general requirement as a confirmatory method 
since only one MS/MS ion transition is documented. The method must be revised to 
include a second, confirmatory ion transition to provide unambiguous confinnation of 
analyte identity by November 30,2010. 
6. The radiotracer study for peanuts must be submitted into the Agency for database 
completeness by December 31, 2008. 
7. A new Chronic Exposure study on Daphnia magna to address this data gap must be 
submitted by November 30,2010. 
8. Submit a revised generic data matrix which correctly addresses all required generic data. 
Please contact us to discuss the revisions required for the subject matrix by December 31, 
2008. 
Also, bear in mind, in the Agency's risk assessment for 1 ,2,4-triazole and its metabolites 
triazole alanine, and triazole acetic acid, dated February 7,2006 (see docket number 2005-0497 
at http://www.regulations.gov), the Agency identified additional data that are needed for triazole~ 
derivative active ingredients which have the 1 ,2,4,-triazole ring. The Agency plans to issue a 
Data Call-In for all triazole-derivative active ingredients which will identify all data needs for 
these active ingredients listed in the February 7, 2006 risk assessment. The Data Call-In will not 
address data needs that are related to parent-only d~ta requirements. 
One copy of the label stamped "Accepted with Comments" is enclosed for your records. 
This label supersedes all labels previously accepted for this product. Please submit one copy of 
. '-/ the final printed label before the product is released for shipment. If you have any questions, 
please contact Tawanda Maignan by phone at (703) 308-8050 or via email at 
Maignan. tawanda@epa.gov. 
Enclosure 
Tony Kish 
Product Manager (22) 
Fungicide Branch 
Registration Division (7505P)

VORTEX® Seed Treatment Fungicide 
ACTIVE INGREDIENT: 
Ipconazole (CAS No. 125225-28-7) .................................................................................................................................. 40.70/0 
OTHER INGREDIENTS: ....................................................................................................................... : ................................ 59.30/0 
Contains 3.77 pounds active ipconazole per U.S. gallon 
EPA Reg. No. 264·988 EPA Est. 
IF SWALLOWED: 
KEEP OUT OF REACH OF CHILDREN 
CAUTION 
For MEDICAL And TRANSPORTATION Emergencies ONLY Call 24 Hours A Day 1·800·334·7577 
For PRODUCT USE Information Call1·866·99BAYER (1·866·992.2937) 
FIRST AID 
• Calla poison control center or doctor immediately for treatment advice. 
• Have person sip a glass of water if able to swallow. 
• Do not induct vomiting unless told to do so by a poison control center or doctor. 
• Do not give anything by mouth to an unconscious person. 
TOTAL 100.0% 
In case of emergency call toll free the Bayer CropScienceEmergency Response Telephone No. 1·800-334·7577. . 
Have a product container or label with you when calling a poison control center or doctor, or going for treatment. 
PRECAUTIONARY STATEMENTS 
CAUTION 
HAZARDS TO HUMANS AND DOMESTIC ANIMALS 
Harmful if swallowed. 
PERSONAL PROTECTIVE EQUIPMENT (PPE) 
Some materials that are chemical-resistant to this product are listed below. If you want more options, follow the instructions for category 
A on an EPA chemical resistance category selection chart. . 
Applicators and other handlers must wear: Long-sleeved shirt and long pants, socks, shoes, and chemical-resistant gloves, such as 
natural rubber. Follow manufacturer's instructions for cleaning/mairitainingPPE. If no such instructions for washables, use detergent 
and hot water. Keep and wash PPE separately from other laundry. 
USER SAFETY RECOMMENDATIONS 
Users should: Wash thoroughly with soap and water after handling. 
ENVIRONMENTAL HAZARDS 
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 apply when weather conditions favor drift from treated areas. Do not contaminate water when disposing of 
equipment washwater or rinsate. This fungicide may persist in soil, and long-term use in the same field may result in an accumulation of 
active ingredient. . 
DIRECTIONS FOR USE 
It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 
Not for use on agricuitural establishments in hopper-box, planter-box, slurry-box or other seed treatment applications at or immediately 
before planting. 
Page 1 of 4

STORAGE AND DISPOSAL 
Do not contaminate water, food or feed by storage, disposal or cleaning of equipment. 
PESTICIDE STORAGE 
Store in a cool dry location. Do not store in direct hoi sunlight: 
PESTICIDE DISPOSAL 
Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility. 
CONTAINER DISPOSAL 
28 ounces. 2.5 gallon, 15 gallon . 
Non-refillable container. Do not reuse or refill this container. Offer for recycling, if available. Offer for reconditioning, if appropriate. Triple 
rinse container (or equivalent) pror(lptly 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. 
Contact Bayer CropScience or your chemical supplier for container return instructions. If container is not returned in accordance with 
instructions, follow instructions for cleaning. Then puncture and dispose of in a sanitary landfill, or incineration, or, if allowed by state 
and local authorities, by burning. If burned, stay out of smoke. 
Federal law requires that bags containing treated seeds shall be labeled with the following information: . 
·"This seed has been treated with Ipconazole. Do not use for feed, food or oil purposes. Store away from feeds and foodstuffs." 
FAILURE TO FOLLOW DIRECTIONS ON THIS LABEL MAY RESULT IN CROP INJURY OR POOR DISEASE CONTROL. 
VORTEX is a systemic broad-spectrum fungicide seed dressing specifically for protection against soilborne and seedborne disease of 
crop plants. VORTEX is active against Rhizoctonia, Fusarium, and Phomopsis. In addition, VORTEX provides activity against weakly 
pathogenic fungi such as Mucor, Rhizopus, Aspergillus, Penicillium, Alternaria, and Cladosporium. VORTEX does not provide activity 
against Pylhium spp. or Phytophthora spp. To provide best seedling protection against a wide array of fungal pathogens, apply 
VORTEX as a tank mix with ALLEGIANCE-FL. Consult the ALLEGIANCE-FL label to assure registration on crop, or if not labeled, use 
another labeled seed treatment product that has activity against Pythium or Phytophthora. Consult the label for appropriate use rate and 
follow all use instructions for the products. Do not use with other seed treatment products unless previous experience assures 
compatibility. 
NOTE: This product is undyed. The purchaser of this product is responsible for ensuring that all seed treated with this product are 
adequately dyed with a suitable color to prevent its accidental use as food for man or feed for animals. Refer to 21 CFR, part 2.25. Any 
dye added to treated seed must be cleared for use under 40CFR, Part 153.155. 
VORTEX may be applied as a water-based slurry with other registered seed treatment insecticides and fungicides through standa.rd 
slurry or mist-type commercial seed treatment equipment. 
ROOT VEGETABLES 
Beet (garden), beet (sugar), burdock (edible), carrot, celeriac, chervil (turnip-rooted), chicory (roots), chufa, dandelion (roots), ginseng, 
parsley (turnip-rooted), parsnip, radish, radish (oriental), rutabaga, salsify, salsify (black), salsify (Spanish), skirret, turnip and yam bean. 
For protection against seed borne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.051 - 0.34 fl.oz .. 
of VORTEX per 100 Ibs of seed or propagating root or tuber material. 
LEAFY VEGETABLES (Except Brassica Vegetables) 
Amaranth (leafy, Chinese spinach, tampala), arugula, cardoon, celery (including Chinese), celtuce, chervil, chrysanthemum (edible­
leaved and garland), com salad; cress (garden and upland), dandelion, dock, endive, fennel (Florence, finochio), lettuce (head and 
leaf), orach, parsley, purslane (garden and winter), radicchio, rhubarb, spinach, spinach (New Zealand), spinach (vine), and Swiss 
chard. . 
For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.051 - 0.34 fl. oz. 
of VORTEX per 100 Ibs of seed. 
BRASSICA (COLE) LEAFY VEGETABLE GROUP 
Broccoli, broccoli (Chinese), broccoli (raab), Brussels sprouts, cabbage (including Chinese bok choy, Chinese napa, and Chinese 
mustard), cauliflower, cavalo broccolo, coliards, kale, kohlrabi, mizuna, mustard greens, mustard spinach, and rape greens. 
For protection against seedborne and soilborne fungi that cause seed decay, damping off, and seedling blight, apply 0.051 - 0.34 fl oz 
of VORTEX per 100 Ibs of seed. 
CUCURBIT VEGETABLES 
Chayote, Chinese waxgourd, citron melon, cucumber, gherkin, gourd edible (includes hyotan, cucuzza, hechima, Chinese okra), 
Momordica, all muskmelon, pumpkin, squash and watermelon. 
For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.051 - 0.34 fl oz 
of VORTEX per 100 Jbs of seed. Page 2 of 4

CEREAL GRAINS (Includes Forage And Silage) 
Corn (field corn, popcorn, and sweet corn) and sorghum. 
Corn (Field Corn and Popcorn): For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and 
seedling blight, apply 0.085 fl oz of VORTEX per 100 Ibs of seed. 
Sweet corn: For protection against seedborne and soilborne fungi which cause seed decay, damping-off and seedling blight, apply 
0.085 fI oz of VORTEX per 100 Ibs of seed. 
Sorghum: For protection against seedborne and soilborne fungi which cause seed decay, damping-off and seedling blight, apply 0.051 
- 0.17 fl oz of VORTEX per 100 Ibs of seed. . 
COrrON 
For protection against seed borne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.085 - 0.34 fl oz 
of VORTEX per 100 Ibs of seed. . 
SUNFLOWER 
For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.051 - 0.085 fl oz 
of VORTEX per 100 Ibs of seed. 
MUSTARD,RAPE,CANOLA 
For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and seedling blight, as well as for protection 
against Phoma lingam causing blackleg, apply 0.051 - 0.34 fl oz of VORTEX per 100 Ibs of seed. 
ORNAMENTAL FLOWERS 
/" . For protection against seedporne and soiiborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.051 - 0.34 fl oz 
of VORTEX per 100 Ibs of seed. 
CONIFERS 
For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.051 - 0.34 fl oz 
of VORTEX per 100 Ibs of seed. 
TURF GRASS 
For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.051 - 0.085 fl oz 
of VORTEX per 100 Ibs of seed. 
Peanut 
For protection against seedborne and soilborne fungi that cause seed decay, damping-off, and seedling blight, apply 0.085 fl oz of 
. VORTEX per 100 Ibs of seed. (For commercial application only.) Do not graze or feed livestock on treated areas or on hay grown 
from treated seed. 
Pag'e 3 of4

IMPORTANT: READ BEFORE USE 
Read the entire Directions for Use, Conditions, Disclaimer of Warranties and Limitations of Liability before using this product. If terms are 
not acceptable, return the unopened product container at once. 
By using this product, user or buyer accepts the following Conditions, disclaimer of Warranties and Limitations of Liability. 
Treatment of highly mechanically damaged seed, or seed of known low vigor and poor quality, may result in reduced germination and/or 
reduction of seed and seedling vigor. Treat and conduct germination tests on a small portion of seed before committing the total seed lot 
to a selected chemical treatment. Due to seed quality conditions beyond the control of Bayer CropScience, no claims are made to 
guarantee germination of carry-over seed. 
CONDITIONS: The directions for use of this product are believed to be adequate and must be followed carefully. However, it is 
impossible to eliminate all risks associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences 
may result because of such factors as weather conditions, presence of other materials, or the manner of use or application;. all of which 
are beyond the control of Bayer CropScience. All such risks shall be assumed by the user or buyer. 
DISCLAIMER OF WARRANTIES: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, BAYER CROPSCIENCE MAKES NO 
WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE OR 
OTHERWISE, THAT EXTEND BEYOND THE STATEMENTS MADE ON THIS LABEL. No agent of Bayer CropScience is authorized to 
make any warranties beyond those contained herein or to modify the warranties contained herein. TO THE EXTENT CONSISTENT 
WITH APPLICABLE LAW, BAYER CROPSCIENCE DISCLAIMS ANY LIABILITY WHATSOEVER FOR SPECIAL, INCIDENTAL OR 
CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT. 
LIMITATIONS OF LIABILITY: TO THE EXTENT CONSISTENT WITH APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER 
OR BUYER FOR ANY AND ALL LOSSES, INJURIES OR DAMAGES RESULTING FROM THE USE OR HANDLING OF THIS 
PRODUCT, WHETHER IN CONTRACT, WARRANTY, TORT, NEGLIGENCE,STRICT LIABILITY OR OTHERWISE, SHALL NOT 
EXCEED THE PURCHASE PRICE PAID, OR AT BAYER CROPSCIENCE'S ELECTION, THE REPLACEMENT OF PRODUCT. 
NOTICE TO BUYER 
Purchase of this material does not confer any rights' under patents governing this product or the use 'thereof in countries' outside of the 
United States. 
NET CONTENTS: 
VORTEX and ALLEGIANCE are registered trademarks of Bayer 
PRODUCED FOR 
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Bayer CropScience LP 
P.O. Box 12014, 2 T.W. Alexander Drive 
Research Triangle Park, North Carolina 27709 
1·866·99BAYER (1·866·992·2937) 
VORTEX Seed Treatment Fungicide. (PENDING 01/31/07) BASED ON MASTER Approved 08/01/06, Notification 08/25/06,Resub 
11/04/08 
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