crop-chem-docs/corpus/epa_ppls/264-971.md

# GAUCHO XT FLOWABLE

- EPA Reg No: **264-971**
- Registrant: BAYER CROPSCIENCE, LLC
- Signal word: Caution
- Active ingredients: Metalaxyl (0.82%); Tebuconazole (0.62%); Imidacloprid (12.7%)
- Label accepted: 2021-12-17
- Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000264-00971-20211217.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 
 WASHINGTON, DC 20460 
 
 
 
OFFICE OF CHEMICAL SAFETY 
AND POLLUTION PREVENTION 
 
December 17, 2021 
Christine Villegas 
Senior Regulatory Affairs Manager 
Bayer U.S.- Crop Science 
700 Chesterfield Pkwy W 
Chesterfield, MO 63017 
 
Subject: Registration Review Label Mitigation for METALAXYL 
 Product Name: GAUCHO XT FLOWABLE 
 EPA Registration Number: 264-971 
 Application Date: 06/28/2018 
Decision Number: 580524 
 
Dear Ms. Villegas: 
 
The Agency, in accordance with the Federal Insecticide, Fungicide and Rodenticide Act 
(FIFRA), as amended, has completed reviewing all the information submitted with your 
application to support the Registration Review of the above referenced product in connection 
with the Metalaxyl Interim Decision, and has concluded that your submission is acceptable. The 
label referred to above, submitted in connection with registration under FIFRA, as amended, is 
acceptable. 
 
Should you wish to add/retain a reference to the company’s website on your label, then please be 
aware that the website becomes labeling under the Federal Insecticide Fungicide and Rodenticide 
Act and is subject to review by the Agency. If the website is false or misleading, the product 
would be misbranded and unlawful to sell or distribute under FIFRA section 12(a)(1)(E). 40 
CFR 156.10(a)(5) list examples of statements EPA may consider false or misleading. In addition, 
regardless of whether a website is referenced on your product’s label, claims made on the 
website may not substantially differ from those claims approved through the registration process. 
Therefore, should the Agency find or if it is brought to our attention that a website contains false 
or misleading statements or claims substantially differing from the EPA approved registration, 
the website will be referred to the EPA’s Office of Enforcement and Compliance. 
 
A stamped copy of your labeling is enclosed for your records. This labeling supersedes 
all previously accepted labeling. You must submit one copy of the final printed labeling 
before you release the product for shipment with the new labeling. In accordance with 40 
CFR 152.130(c), you may distribute or sell this product under the previously approved 
labeling for 12 months from the date of this letter. After 12 months, you may only 
distribute or sell this product if it bears this new revised labeling or subsequently 
approved labeling. “To distribute or sell” is defined under FIFRA section 2(gg) and its 
implementing regulation at 40 CFR 152.3.

Page 2 of 2 
EPA Reg. No. 264-971 
Decision No. 580524 
 
If you have any questions about this letter, please contact Srijana Shrestha by phone at 202-566-
2329, or via email at shrestha.srijana@epa.gov. 
 
 Sincerely, 
 
 
 Linda Arrington, Branch Chief 
 Risk Management and Implementation Branch 4 
 Pesticide Re-Evaluation Division 
 Office of Pesticide Programs 
 
Enclosure: Stamped Label

1 
GAUCHO® XT FLOWABLE 
Contains Petroleum Distillate. 
ACTIVE INGREDIENTS: 
Imidacloprid: 1-[(6-Chloro-3-pyridinyl)methyl]-N-nitro-2-imidazolidinimine) ................................................................... 12.7%
Metalaxyl: N-(2,6-dimethylphenyl)-N-(methoxyacetyl)alanine methyl ester .................................................................. 0.82% 
Tebuconazole: Alpha-[2-(4-chlorophenyl)ethyl]-alpha-(1,1-dimethyl-ethyl)-1H-1,2,4-triazole-1-ethanol ....................... 0.62% 
OTHER INGREDIENTS: .............................................................................................................................................. 85.86%
TOTAL: 100.0% 
Contains 1.16 pounds of imidacloprid, 0.075 pounds of metalaxyl and 0.056 pounds of tebuconazole per gallon. 
EPA Reg. No. 264-971 EPA Est. 
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 Call 1-866-99BAYER (1-866-992-2937) 
Please refer to [back panel] [booklet] for additional precautionary statements and directions for use. [Note to 
reviewer: Location of additional precautionary statements and directions for use will vary between those listed, 
depending on container type/size.] 
FIRST AID 
IF SWALLOWED: x Immediately call a poison control center or doctor. 
x Do not induce vomiting unless told to do so by a poison control center or doctor. 
x Do not give any liquid to the person. 
x Do not give anything by mouth to an unconscious person. 
IF ON SKIN OR 
CLOTHING: 
x Take off contaminated clothing. 
x Rinse skin immediately with plenty of water for 15 – 20 minutes. 
x Call a poison control center or doctor for treatment advice. 
IF INHALED: x Move person to fresh air. 
x If person is not breathing, call 911 or an ambulance, then give artificial respiration, preferably 
mouth-to-mouth, if possible. 
x Call a poison control center or doctor for further treatment advice. 
In case of emergency call toll free the Bayer CropScience Emergency 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. 
NOTE TO PHYSICIAN: Contains petroleum distillate – vomiting may cause aspiration pneumonia. 
 
IMIDACLOPRID GROUP 4A INSECTICIDE 
METALAXYL GROUP 4 FUNGICIDE 
TEBUCONAZOLE GROUP 3 FUNGICIDE 
Dec 17, 2021
264-971

2 
 
PRECAUTIONARY STATEMENTS 
HAZARDS TO HUMANS AND DOMESTIC ANIMALS 
CAUTION 
Harmful if swallowed, absorbed through skin or inhaled. Avoid contact with eyes, skin or clothing. Avoid breathing vapor 
or spray mist. Wash thoroughly with soap and water after handling. Remove contaminated clothing and wash before 
reuse. 
PERSONAL PROTECTIVE EQUIPMENT (PPE) 
Some materials that are chemical-resistant to this product are listed below. 
Applicators and other handlers must wear: Long-sleeved shirt and long pants, socks and shoes and chemical-resistant gloves (such 
as barrier laminate, nitrile rubber •14 mills, and viton •14 mills). Follow manufacturer’s instructions for washables. Use detergent and 
hot water. Keep and wash PPE separately from other laundry. 
 
USER SAFETY RECOMMENDATIONS 
Users should: Wash hands before eating, drinking, chewing gum, using tobacco or using toilet. Users should remove 
clothing immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. Users should remove PPE 
immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash 
thoroughly and change clothing. 
 
ENVIRONMENTAL HAZARDS 
This product is highly toxic to birds and aquatic invertebrates. 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 washwaters. Cover or incorporate spilled treated seeds. 
Groundwater Advisory: Metalaxyl is known to leach through soil into groundwater under certain conditions as a result of 
agricultural use. Use of this chemical in areas where soils are permeable, particularly where the water table is shallow, 
may result in groundwater contamination.

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DIRECTIONS FOR USE 
It is a violation of Federal law to use this product in a manner inconsistent with its labeling. 
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 requirements specific to your State or Tribe, consult the agency 
responsible for pesticide regulation. 
This product is to be used in liquid or slurry treaters. Mix thoroughly before use or use entire container at one time. All 
tank mixes should be pre-tested to determine physical compatibility between formulations. Follow all cautions and 
limitations on labeling of all products used in mixtures. 
 
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 agriculture 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 only apply 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 24 hours. Exception if the seed is treated with the product and the treated seed is soil-
injected (drilled) 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 reentry 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, chemical-resistant gloves (such as barrier laminate, nitrile rubbe r 
•14 mills, and viton •14 mills), shoes plus socks, protective eyewear. 
 
USE RESTRICTIONS 
x Maximum usage when applying both metalaxyl- and mefenoxam-containing products to the same crop within the 
same season: Do not apply more than the maximum yearly total application rate for the active ingredient as stated 
on the label of the product containing the lowest yearly total on that crop. 
x 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 21CFR, Part 
2.25. Any dye or colorant added to treated seed must be cleared for use under 40CFR, Part 180.1001. 
 
RESISTANCE MANAGEMENT RECOMMENDATION 
For resistance management, please note that Gaucho XT Flowable contains a Group 3 (demethylation inhibitors) and a 
Group 4 (phenylamides) fungicide. Any fungal population may contain individuals naturally resistant to Gaucho XT 
Flowable and other Group 3 or 4 fungicides. A gradual or total loss of pest control may occur over time if these fungicides 
are used repeatedly in the same fields. Gaucho XT Flowable also contains a Group 4A (neonicotinoid) insecticide. Any 
insect population may contain individuals naturally resistant to Gaucho XT Flowable and other Group 4A insecticides. The 
resistant individuals may dominate the insect population if these insecticides are used repeatedly in the same fields. 
Appropriate resistance-management strategies should be followed. 
To delay fungicide and/or insecticide resistance, take one or more of the following steps: 
x Rotate the use of Gaucho XT Flowable or other Group 3 and 4 fungicides and Group 4A insecticides within a 
growing season sequence with different groups that control the same pathogens or pests. 
x Use tank mixtures with fungicide from a different group that are equally effective on the target pest when such use 
is permitted. Use at least the minimum application rate as labeled by the manufacturer. 
x Use tank mixtures with insecticides from a different group that are equally effective on the target pest when such 
use is permitted. Do not rely on the same mixture repeatedly for the same pest population. Consider any known 
cross-resistance issues (for the targeted pests) between the individual components of a mixture. In addition, 
consider the following recommendations provided by the Insecticide Resistance Action Committee (IRAC): 
o Individual insecticides selected for use in mixtures should be highly effective and be applied at the rates 
at which they are individually registered for use against the target species. 
o Mixtures with components having the same IRAC mode of action classification are not recommended for 
insect resistance management. 
o When using mixtures, consider any known cross-resistance issues between the individual components for 
the targeted pest(s). 
o Mixtures become less effective if resistance is already developing to one or both active ingredients, but 
they may still provide pest management benefits.

4 
 
o The insect resistance management benefits of an insecticide mixture are greatest if the two components 
have similar periods of residual insecticidal activity. Mixtures of insecticides with unequal periods of 
residual insecticide activity may offer an insect resistance management benefit only for the period where 
both insecticides are active. 
x Adopt an integrated disease management program for fungicide use and an integrated pest management 
program for insecticides use that includes scouting, uses historical information related to pesticide use, and crop 
rotation, and which considers host plant resistance, impact of environmental conditions on disease development, 
disease thresholds, as well as cultural, biological and other chemical control practices. 
x Where possible, make use of predictive disease models to effectively time fungicide applications. Note that using 
predictive models alone is not sufficient to manage resistance. 
x Monitor after application for unexpected target pest survival. If the level of survival suggests the presence of 
resistance, consult with your local university specialist or certified pest control advisor. 
x Contact your local extension specialist or certified crop advisor for any additional pesticide resistance-
management and/or IPM recommendations for specific crops and pathogens/pests. 
x For further information or to report suspected resistance contact Bayer CropScience LP at 1-866-99BAYER (1-
866-992-2937). You can also contact your pesticide distributor or university extension specialist to report 
resistance. 
 
SPECIFIC CROP USE DIRECTIONS 
Wheat, Oats 
Insect Control: Early season protection of seedlings against injury by Aphids (including Bird cherry-oat, English grain, 
Greenbug, and Russian wheat aphid) Wireworms and Hessian fly. 
Disease Control: Early season disease control of Pythium damping-off, Stinking smut, Flag smut, Loose smut, Early 
season Septoria disease complex, Early season Rhizoctonia root rot, Early season common root rot, Early season 
Fusarium foot rot, Early season suppression of powdery mildew, Early season suppression of wheat leaf rust and 
improves emergence of seed infected with Fusarium scab. Apply 3.4 to 4.5 fluid ounces per hundred weight of seed prior 
to planting as a slurry treatment. Ensure thorough coverage. Do not graze or feed livestock on treated areas for 45 days 
after planting. 
 
Barley 
Insect Control: Early season protection of seedlings against injury by Aphids (including Bird cherry-oat, English grain, 
Greenbug, and Russian wheat aphid) and Wireworms. 
Disease Control: Early season disease control of Pythium damping-off and Covered smut, Loose smut, Barley stripe 
(suppression), Early season Rhizoctonia root rot, Early season common root rot, Early season Fusarium foot rot, Early 
season suppression of powdery mildew, Early season suppression of barley leaf rust and improves emergence of seed 
infected with Fusarium scab. Apply 3.4 to 4.5 fluid ounces per hundred weight of seed prior to planting as a slurry 
treatment. Ensure thorough coverage. Do not graze or feed livestock on treated areas for 45 days after planting.

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ROTATIONAL CROPS 
Treated areas may be replanted with any crop specified on an imidacloprid label, or any crop for which a tolerance exists for t he active 
ingredient, as soon as practical following the last application. The following plant-back intervals are required for listed crops: 
 
ROTATIONAL PLANT-BACK INTERVALS* 
IMMEDIATE PLANT-BACK 30-DAY PLANT-BACK 
Artichoke Crambe Oats Soybean Cereals, including: 
Barley Cucurbits Okra Strawberry buckwheat 
Brassica (cole) leafy 
veg. 
Eggplant Pepinos Sugarbeet rice 
Borage Flax Peppe r Sunflowe r 
Bulb Veg Ground cherry Popcorn Tomatillo 
Canola Leaf petiole veg. Potato Tomato 
Cilantro Leafy veg. Rapeseed Triticale 
Corn, Field Legume veg. (succulent Rye Veg. Root and Tube r 
Corn, Sweet or dried, including 
soybean) 
Safflower Watercress 
Cotton Millet Sorghum Wheat 
Cranberry Mustard Seed 
 
* Cover crops for soil building or erosion control may be planted any time, but do not graze or harvest for food or feed. 
* For all other crops not listed on an Imidacloprid label, or for crops for which no tolerance for the active ingredient has been 
established, a 12-month plant-back interval is required. 
NOTIFICATION of the crop rotational restriction must be conveyed to the grower by appropriate seed tag labeling or bag printing on all 
seed units. 
 
SEED BAG TAG 
The Federal Seed Act requires that the container of seed treated with Gaucho XT Flowable must be labeled with the 
following statements: 
This seed has been treated with Gaucho XT Flowable, which contains 12.7% of Imidacloprid, 0.62% of Tebuconazole, 
and 0.82% of Metalaxyl. 
x Do not use treated seed for food, feed, or oil purposes. 
x Store treated seeds away from food and feedstuffs. 
x Do not allow children, pets, or livestock to have access to treated seed. 
x Wear long-sleeved shirt, long pants and chemical-resistant gloves when handling treated seed. 
x Treated seeds exposed on soil surface may be hazardous to wildlife. Cover or collect treated seeds spilled during 
loading. 
x Dispose of all excess treated seed. Leftover treated seed may be buried away from water sources in accordance 
with local requirements. 
x Do not contaminate water bodies when disposing of planting equipment wash waters. 
x Treated seed must be adequately covered with soil at planting. 
x Dispose of seed packaging or containers in accordance with local requirements. Do not use empty seed bags for 
any other purpose. 
x To reduce seed dust which can drift onto blooming crops or weeds, ensure that planting equipment is functioning 
properly in accordance with manufacturer’s recommendations. Surplus seed or empty seed containers should be 
stored or disposed according to local federal regulations. 
x Treated at manufacturer’s recommended rate.

6 
 
STORAGE AND DISPOSAL 
Do not contaminate water, food or feed by storage, disposal, or by cleaning of equipment. 
PESTICIDE STORAGE 
Store in a cool place. Do not store in direct sunlight. Protect from freezing temperatures. 
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 
 
Rigid, Non-refillable containers small enough to shake (i.e., with capacities equal to or less than 5 gallons) 
2.5 gal 
Non-refillable container. Do not reuse or refill this container. Offer for recycling, if available. 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. Dispose of rinsed empty container in a 
sanitary landfill or by incineration, or if allowed by state and local authorities, by burning. If burned stay out of smoke. 
 
Rigid Non-refillable containers that are too large to shake (i.e., with capacities greater than 5 gallons or 50 lbs) 
15 gal 
Non-refillable container. Do not reuse or refill this container. After emptying product from container, contact Bayer 
CropScience Customer Service Center (1-800-527-4781) with return authorization for container return instructions. 
Cleaning the container before final disposal is the responsibility of the person disposing of the container. Offer for 
recycling, if available. Dispose of rinsed empty container in a sanitary landfill or by incineration, or if allowed by state and 
local authorities, by burning. If burned stay out of smoke.

7 
 
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 a nd/or 
reduction of seed and seedling vigor. Treat and conduct germination tests on a small portion of seed before committing the tota l 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. 
 
 
NET CONTENTS: 
 
GAUCHO is a registered trademark of Bayer Group. 
 
 
PRODUCED FOR 
 
Bayer CropScience LP 
800 N. Lindbergh Blvd. 
St. Louis, MO 63167 
1-866-99BAYER (1-866-992-2937) 
 
GAUCHO
® XT Flowable (PENDING) 05/31/2018, 06/26/2018, 08/29/2019, 06/30/2021, 12/09/2021