crop-chem-docs/corpus/epa_ppls/100-1146.md

CGA-173506/CGA-329351 0.26 SE

• EPA Reg No: 100-1146
• Registrant: SYNGENTA CROP PROTECTION, LLC
• Signal word: Caution
• Active ingredients: Fludioxonil (0.72%); Metalaxyl-M (2.21%)
• Label accepted: 2019-07-19
• Source PDF: https://www3.epa.gov/pesticides/chem_search/ppls/000100-01146-20190719.pdf

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, DC 20460

Reg Review Label Acceptable v.20151230 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION July 19, 2019

Ricky Kyaw Regulatory Product Manager Syngenta Crop Protection, LLC P.O. Box 18300 Greensboro, NC 27419

Subject: Registration Review Label Mitigation for Fludioxonil and Mefenoxam Product Name: CGA-173506/CGA-329351 0.26 SE EPA Registration Number: 100-1146 Application Date: 7/31/2018; 2/1/2019 Decision Number: 552841; 552842

Dear Ricky Kyaw:

The Agency, in accordance with the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), as amended, has completed reviewing all of the information submitted with your application to support the Registration Review of the above referenced product in connection with the Fludioxonil and Mefenoxam Interim Decisions, 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 copy of your label stamped “Accepted” is enclosed. Products shipped after 12 months from the date of this amendment must bear the new revised label. Your release for shipment of the product bearing the amended label constitutes acceptance of these conditions. If these conditions are not complied with, the registration will be subject to cancellation in accordance with FIFRA section 6.

If you have any questions about this letter, please contact Darius Stanton by phone at 703-347- 0433, or via email at Stanton.Darius@epa.gov .

Page 2 of 2 EPA Reg. No. 100-1146 Decision No. 552841; 552842

Sincerely,

Linda Arrington, Branch Chief Risk Management and Implementation Branch 4 Pesticide Re-Evaluation Division Office of Pesticide Programs

Enclosure

(Master Label) MEFENOXAM GROUP 4 FUNGICIDE FLUDIOXONIL GROUP 12 FUNGICIDE CGA-173506/CGA-329351 0.26 SE Fungicide A seed treatment fungicide for protection against damage from listed seed-borne, soil- borne, and seedling diseases of soybeans and other specified legume crops. Active Ingredients: Mefenoxam* ............................................................................................................ 2.21% Fludioxonil** ............................................................................................................ 0.72% Other Ingredients: 97.07% Total: 100.00% *CAS Nos. 70630-17-0 and 69516-34-3 **CAS No. 131341-86-1 CGA-173506/CGA-329351 0.26 SE is a flowable concentrate for seed treatment containing 0.197 lb mefenoxam and 0.064 lb fludioxonil per gallon. KEEP OUT OF REACH OF CHILDREN. CAUTION [See additional precautionary statements and directions for use in booklet.] EPA Reg. No. 100-1146 EPA Est. XXXX SCP

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Net Contents Jul 19, 2019 100-1146

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FIRST AID 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 in eyes x Hold eye open and rinse slowly and gently with water for 15-20 minutes. x Remove contact lenses, if present, after the first 5 minutes, then continue rinsing. x Call a poison control center or doctor for treatment advice. If swallowed x Call a poison control center or doctor immediately for treatment advice. x Have person sip a glass of water if able to swallow. x Do not induce vomiting unless told to by a poison control center or doctor. x Do not give anything to an unconscious person. 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 treatment advice. Have the product container or label with you when calling a poison control center or doctor, or going for treatment. HOT LINE NUMBER For 24-Hour Medical Emergency Assistance (Human or Animal) or Chemical Emergency Assistance (Spill, Leak, Fire, or Accident), Call 1-800-888-8372

PRECAUTIONARY STATEMENTS

Hazards to Humans and Domestic Animals

CAUTION

Harmful if absorbed through skin. Avoid contact with eyes, skin, or clothing. Wash thoroughly with soap and water after handling and before eating, drinking, chewing gum, using tobacco or using the toilet. Remove and wash contaminated clothing before reuse.

PERSONAL PROTECTIVE EQUIPMENT (PPE)

Applicators and other handlers must wear: x Long-sleeved shirt and long pants

–3– x Chemical-resistant gloves made of barrier laminate, butyl rubber •14 mils, nitrile rubber •14 mils, neoprene rubber •14 mils, polyvinyl chloride (PVC) •14 mils or Viton®•14 mils x Shoes plus socks

Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this product. Do not reuse them. Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.

Engineering Controls

When handlers use closed systems, enclosed cabs, or aircraft in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4-6)], the handler PPE requirements may be reduced or modified as specified in the WPS.

User Safety Recommendations Users should: x Wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. x Remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing. x Remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.

Environmental Hazards

This pesticide is toxic to fish, aquatic invertebrates, oysters and shrimp. Do not contaminate water when disposing of equipment wash-water or rinsate.

Groundwater Advisory

Mefenoxam is known to leach through soil into groundwater under certain conditions as a result of label use. Fludioxonil has properties and characteristics associated with chemicals detected in groundwater. These chemicals may leach into groundwater if used in areas where soils are permeable, particularly where the water table is shallow.

–4–

CONDITIONS OF SALE AND LIMITATION OF WARRANTY AND LIABILITY

NOTICE: Read the entire Directions for Use and Conditions of Sale and Limitation of Warranty and Liability before buying or using this product. If the terms are not acceptable, return the product at once, unopened, and the purchase price will be refunded.

The Directions for Use of this product must be followed carefully. It is impossible to eliminate all risks inherently associated with the use of this product. Crop injury, ineffectiveness or other unintended consequences may result because of such factors as manner of use or application, weather or crop conditions, presence of other materials or other influencing factors in the use of the product, which are beyond the control of SYNGENTA CROP PROTECTION, LLC or Seller. To the extent permitted by applicable law, Buyer and User agree to hold SYNGENTA and Seller harmless for any claims relating to such factors.

SYNGENTA warrants that this product conforms to the chemical description on the label and is reasonably fit for the purposes stated in the Directions for Use, subject to the inherent risks referred to above, when used in accordance with directions under normal use conditions. To the extent permitted by applicable law: (1) this warranty does not extend to the use of the product contrary to label instructions, or under conditions not reasonably foreseeable to or beyond the control of Seller or SYNGENTA, and (2) Buyer and User assume the risk of any such use. TO THE EXTENT PERMITTED BY APPLICABLE LAW, SYNGENTA MAKES NO WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY OTHER EXPRESS OR IMPLIED WARRANTY EXCEPT AS WARRANTED BY THIS LABEL.

To the extent permitted by applicable law, in no event shall SYNGENTA be liable for any incidental, consequential or special damages resulting from the use or handling of this product. TO THE EXTENT PERMITTED BY APPLICABLE LAW, THE EXCLUSIVE REMEDY OF THE USER OR BUYER, AND THE EXCLUSIVE LIABILITY OF SYNGENTA AND SELLER FOR ANY AND ALL CLAIMS, LOSSES, INJURIES OR DAMAGES (INCLUDING CLAIMS BASED ON BREACH OF WARRANTY, CONTRACT, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHERWISE) RESULTING FROM THE USE OR HANDLING OF THIS PRODUCT, SHALL BE THE RETURN OF THE PURCHASE PRICE OF THE PRODUCT OR, AT THE ELECTION OF SYNGENTA OR SELLER, THE REPLACEMENT OF THE PRODUCT.

SYNGENTA and Seller offer this product, and Buyer and User accept it, subject to the foregoing Conditions of Sale and Limitation of Warranty and Liability, which may not be modified except by written agreement signed by a duly authorized representative of SYNGENTA.

–5–

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.

Use is permitted on-farm and in commercial seed treatment facilities. Do not use for at- plant applications (e.g. hopper box, planter box, etc.). This product is to be applied as a water-based slurry through standard slurry- or mist-type commercial seed treatment equipment.

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.

FAILURE TO FOLLOW THE DIRECTIONS FOR USE AND PRECAUTIONS ON THIS LABEL MAY RESULT IN CROP INJURY, POOR DISEASE CONTROL, AND/OR ILLEGAL RESIDUES.

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 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 48 hours. Exception: If the seed is treated with the product and the treated seed 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:

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x Coveralls over long-sleeved shirt and long pants x Chemical-resistant gloves made of barrier laminate, butyl rubber •14 mils, neoprene rubber •14 mils, nitrile rubber •14 mils, polyvinyl chloride (PVC) •14 mils, or Viton® •14 mils x Shoes plus socks

Treatment of highly mechanically scarred or damaged seed or seed known to be of low vigor and poor quality may result in reduced germination and/or reduction of seed and seedling vigor. Treat a quantity of seed using equipment similar to that planned for treating the total seed lot. Prior to treatment, conduct germination tests on a 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 Syngenta, no claims are made to guarantee the germination of carry-over seed or propagating material for all crop seed when treated with CGA-173506/CGA- 329351 0.26 SE.

PRODUCT INFORMATION

CGA-173506/CGA-329351 0.26 SE is a seed treatment fungicide that protects against damping-off and seed rots due to Pythium, Phytophthora, Fusarium, Rhizoctonia spp., and early season Phytophthora root rot. CGA-173506/CGA-329351 0.26 SE also suppresses seed-borne Sclerotinia and Phomopsis spp. CGA-173506/CGA-329351 0.26 SE contains the active ingredient mefenoxam found in Apron XL® that provides protection against Pythium and early season Phytophthora root rot. CGA-173506/CGA- 329351 0.26 SE also contains the active ingredient fludioxonil found in Maxim® 4FS that provides protection against the remaining diseases mentioned in this label.

RESISTANCE MANAGEMENT

MEFENOXAM GROUP 4 FUNGICIDE FLUDIOXONIL GROUP 12 FUNGICIDE

For resistance management, please note that CGA-173506/CGA-329351 0.26 SE contains both a Group 4/mefenoxam and Group 12/fludioxonil fungicide. Any fungal population may contain individuals naturally resistant to CGA-173506/CGA-329351 0.26 SE and other Group 4 or Group 12 fungicides. A gradual or total loss of pest control may occur over time if these fungicides are used repeatedly in the same fields. Appropriate resistance-management strategies should be followed.

Mefenoxam belongs to the phenylamide class of chemistry which interferes with fungal RNA synthesis. Fludioxonil belongs to the phenylpyrrole class of chemistry which interferes with osmotic signal transduction.

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To delay fungicide resistance, take one or more of the following steps:

x Rotate the use of CGA-173506/CGA-329351 0.26 SE or other Group 4 or Group 12 fungicides within a growing season sequence with different groups that control the same pathogens.

x Use tank mixtures with fungicides 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 Adopt an integrated disease management program for fungicide 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 application. Note that using predictive models alone is not sufficient to manage resistance.

x Monitor treated fungal populations for resistance development.

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.

x For further information or to report suspected resistance contact Syngenta at 1- 866-SYNGENT(A) (866-796-4368). You can also contact your pesticide distributor or university extension specialist to report resistance.

Syngenta encourages responsible product stewardship to ensure effective long term control of the fungal diseases on this label.

MIXING PROCEDURES

Important: Always re-circulate CGA-173506/CGA-329351 0.26 SE thoroughly before using.

Follow the manufacturer’s application instructions for the seed treatment equipment being used.

–8– Apply CGA-173506/CGA-329351 0.26 SE as a water-based slurry utilizing standard slurry seed treatment equipment which provides uniform seed coverage. Uneven or incomplete seed coverage may not give the desired level of disease control. Thoroughly mix the specified amount of CGA-173506/CGA-329351 0.26 SE into the required amount of water or liquid inoculant for the slurry treater and dilution rate to be used.

Certain crops require addition of inoculants when the seed is treated or planted. CGA- 173506/CGA-329351 0.26 SE is compatible with several liquid inoculant products. Consult the maker of the inoculant product and a Syngenta representative for directions before applying CGA-173506/CGA-329351 0.26 SE with inoculants.

The total application volume must be sufficient to provide desired level of coverage. Dilution is typically done with water or liquid inoculants. The minimum slurry volume to achieve adequate coverage is 4.0 fl oz/100 lb seed. More diluent may be required to obtain complete coverage.

Continuous agitation or mixing of the slurry mixture is necessary to prevent settling out of the solution. Clean out any unused product from the treater after treating or maintain constant agitation if the leftover slurry will be maintained overnight. CGA-173506/CGA- 329351 0.26 SE already contains an EPA-approved dye or colorant that imparts an unnatural color to the seed as stated in 40 CFR 153.155(c). Allow seed to dry before bagging.

SEED CONTAINER LABEL REQUIREMENTS

The Federal Seed Act requires that containers of treated seeds shall be labeled with the following statements:

x This seed has been treated with mefenoxam and fludioxonil fungicides.

x Do not use for feed, food, or oil purposes.

In addition, the U.S. Environmental Protection Agency requires the following statements on containers of seeds treated with CGA-173506/CGA-329351 0.26 SE:

x Ground Water Advisory: Mefenoxam is known to leach through soil into groundwater under certain conditions as a result of label use. Fludioxonil has properties and characteristics associated with chemicals detected in groundwater. These chemicals may leach into groundwater if used in areas where soils are permeable, particularly where the water table is shallow.

x Excess treated seed may be used for ethanol production only if: o (1) By-products are not used for livestock feed, and o (2) No measurable residues of pesticide remain in the ethanol by-products that are used in agronomic practice.

–9– x Do not allow children, pets, or livestock to have access to treated seed.

x Store away from feeds and foodstuffs.

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 and planting.

x Treated seed must be planted into the soil at a depth greater than 1 inch.

x Dispose of all excess treated seed by burying away from bodies of water.

x Do not contaminate water bodies when disposing of planting equipment washwaters.

x Dispose of seed packaging in accordance with local requirements.

x Do not use at a rate that will result in more than 0.004 lb fludioxonil per acre (2.0 grams ai/A) per year and 0.013 lb mefenoxam per acre (5.7 grams ai/A) per year as a seed treatment application.

CROP USE DIRECTIONS

When applied according to the CGA-173506/CGA-329351 0.26 SE RATE TABLE, CGA-173506/CGA-329351 0.26 SE provides protection against damping-off and seed borne rots due to Pythium, Phytophthora, Fusarium, Rhizoctonia species and early season Phytophthora root rot. CGA-173506/CGA-329351 0.26 SE also suppresses seed-borne Sclerotinia and Phomopsis species. Additional Apron XL, EPA Reg. No. 100-799, may be necessary for high levels of Phytophthora or Pythium. Refer to the table below to determine the appropriate use rate of Apron XL, if needed. Read and follow all label directions for Apron XL use.

Legume Vegetables (Succulent or Dried) Crop Group 6 & Foliage of Legume Vegetables Crop Group 7 Bean (Lupinus spp.) (grain lupin, sweet lupin, white lupin, white sweet lupin) Bean (Phaseolus spp.) (field bean, kidney bean, lima bean, navy bean, pinto bean, runner bean, snap bean, tepary bean, wax bean) Bean (Vigna spp.) (adzuki bean, asparagus bean, blackeyed pea, catjang, Chinese longbean, cowpea, Crowder pea, moth bean, mung bean, rice bean, southern pea, urd bean, yardlong bean) Broad bean (fava bean) Chickpea (garbanzo bean) Guar Jackbean

–10– Lablab bean (hyacinth bean) Lentil Pea (Pisum spp.) (dwarf pea, edible-pod pea, English pea, field pea, garden pea, green pea, snow pea, sugar snap pea) Pigeon pea Sword bean Soybean Soybean (immature seed)

CGA-173506/CGA-329351 0.26 SE RATE TABLE

Pathogens

Use Rate

fl oz/100 lb seed

g ai/100 kg CGA-173506/ CGA-329351 0.26 SE

Apron XL

CGA-173506/ CGA-329351 0.26 SE

Apron XL

Pythium, Fusarium, Rhizoctonia, seed-borne Sclerotinia and Phomopsis seed decay 5.0 – Fludioxonil 2.5

Mefenoxam 7.5 – Pythium (high pressure), Phytophthora, Fusarium, Rhizoctonia, seed-borne Sclerotinia and Phomopsis seed decay 5.0 0.32 Fludioxonil 2.5

Mefenoxam 7.5 Mefenoxam 7.5

–11– CGA-173506/CGA-329351 0.26 SE RATE TABLE (continued) Pathogens

Use Rate

fl oz/140,000 seeds*

Total mg ai/seed* g ai/100 kg

CGA-173506 /CGA-329351 0.26 SE

Apron XL CGA-173506 /CGA-329351 0.26 SE Apron XL CGA-173506 /CGA-329351 0.26 SE Apron XL

Pythium, Fusarium, Rhizoctonia, seed-borne Sclerotinia and Phomopsis seed decay

2.33 – 0.015 – Fludioxonil 2.5

Mefenoxam 7.5 –

Pythium (high pressure), Phytophthora, Fusarium, Rhizoctonia, seed-borne Sclerotinia and Phomopsis seed decay

2.33 0.15 0.015 0.011 Fludioxonil 2.5

Mefenoxam 7.5 Mefenoxam 7.5 *Rates expressed as fl oz/140,000 seeds and mg ai/seed are based on an average seed weight of 3,000 seeds/lb.

STORAGE AND DISPOSAL

Do not contaminate water, food, or feed by storage or disposal.

Pesticide Storage Store in a cool, dry place. Store in an area designated for pesticides and away from food or feed. Store in original containers only. Keep container closed when not in use. For minor spills, leaks, etc., follow all precautions indicated on this label and clean up immediately. Take special care to avoid contamination of equipment and facilities during cleanup procedures and disposal of wastes.

Pesticide Disposal Pesticide wastes are acutely hazardous. Improper disposal of excess pesticide, spray mixture or rinsate is a violation of Federal Law. If these wastes cannot be disposed of by use according to label instructions, contact your State Pesticide or Environmental Control Agency, or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance.

–12–

Container Handling [less than or equal to 5 gallons] Non-refillable 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 ¼ 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, or by other procedures approved by state and local authorities.

Container Handling [greater than 5 gallons – mini-bulk] Non-refillable 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 ¼ 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, or by other procedures approved by state and local authorities.

Container Handling [greater than 5 gallons - bulk] Refillable container. Refill this container with pesticide only. Do not reuse this container for any other purpose. Cleaning the container before final disposal is the responsibility of the person disposing of the container. Cleaning before refilling is the responsibility of the person refilling. To clean container before final disposal, empty the remaining contents from this container into application equipment or mix tank. Fill the container about 10 percent full with water. Agitate vigorously or recirculate water with the pump for 2 minutes. Pour or pump rinsate into application equipment or rinsate collection system. Repeat this rinsing procedure two more times. Then offer for recycling if available or puncture and dispose of in a sanitary landfill, or by incineration, or by other procedures approved by state and local authorities.

CONTAINER IS NOT SAFE FOR FOOD, FEED, OR DRINKING WATER.

Apron XL®, Maxim®, the ALLIANCE FRAME, the Syngenta Logo, and the PURPOSE ICON are trademarks of a Syngenta Group Company

©20XX Syngenta

Manufactured for: Syngenta Crop Protection, LLC P.O. Box 18300

–13– Greensboro, North Carolina 27419-8300

CGA-173506-329351 1146 MAS 0416 AMEND 0618 – sb – 6/25/2018 000100-01146.20180625.CGA-173506-329351.AMEND.JUN2018