U.S. ENVIRONMENTAL PROTECTION AGENCY EPA Reg. Number: Date of Issuance: Office of Pesticide Programs Biopesticides and Pollution Prevention Division (7511P) 70051-126 10/21/2019 1200 Pennsylvania Ave., N.W. Washington, D.C. 20460 NOTICE OF PESTICIDE: Term of Issuance: X Registration Reregistration Unconditional (under FIFRA, as amended) Name of Pesticide Product: LifeGard LC Name and Address of Registrant (include ZIP Code): Certis USA LLC 9145 Guilford Road, Suite 175 Columbia, MD 21046 Note: Changes in labeling differing in substance from that accepted in connection with this registration must be submitted to and accepted by the Biopesticides and Pollution Prevention Division prior to use of the label in commerce. In any correspondence on this product, always refer to the above EPA Registration Number. On the basis of information furnished by the registrant, the above named pesticide is hereby registered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA or the Act). Registration is in no way to be construed as an endorsement or recommendation of this product by the U.S. Environmental Protection Agency (EPA). In order to protect health and the environment, the Administrator, on his or her motion, may at any time suspend or cancel the registration of a pesticide in accordance with the Act. The acceptance of any name in connection with the registration of a product under the Act is not to be construed as giving the registrant a right to exclusive use of the name or to its use if it has been covered by others. This product is unconditionally registered in accordance with FIFRA section 3(c)(5) provided that you: 1. Submit and/or cite all data required for registration or registration review of your product when the EPA requires all registrants of similar products to submit such data. 2. Make the following labeling change before you release this product for shipment: Revise the EPA Registration Number to read, “EPA Reg. No. 70051-126.” Signature of Approving Official: Date: 10/21/2019 Seiichi Murasaki, Senior Regulatory Advisor Microbial Pesticides Branch Biopesticides and Pollution Prevention Division (7511P) Office of Pesticide Programs EPA Form 8570-6 Page 2 of 2 EPA Reg. No. 70051-126 OPP Decision No. 547037 3. Submit one (1) copy of the final printed labeling for the record before you release this product for shipment. Should you wish to add/retain a reference to your company’s website on your label, then please be aware that the website becomes labeling under FIFRA and is subject to review by the EPA. If the website is false or misleading, the product will be considered to be misbranded and sale or distribution of the product is unlawful under FIFRA section 12(a)(1)(E). 40 CFR § 156.10(a)(5) lists examples of statements the 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 EPA 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 Assurance. Your release for shipment of this product constitutes acceptance of these terms. If these terms are not complied with, this registration will be subject to cancellation in accordance with FIFRA section 6. A stamped copy of the labeling is enclosed for your records. Please also note that the record for this product currently contains the following acceptable Confidential Statements of Formula (CSFs): Basic CSF dated 03/07/2019 Alternate #1 CSF dated 03/07/2019 Any CSFs other than those listed above are superseded. If you have any questions, please contact Alex Boukedes by phone at (703) 347-0305 or via email at [email protected]. Enclosure: Stamped Label MASTER LABEL Revision Date: 2019-10-18 LifeGard® LC, EPA File Symbol 70051-REA Revises: 2019-09-30 draft LifeGard® LC BIOLOGICAL PLANT ACTIVATOR {Alternate Brand Names: None} To Reduce Occurrence and Severity of Plant Disease on Listed [Food] Crops [and] [Tobacco] Grown Outdoors or Grown Under Cover in Greenhouses, Shadehouses, or Other Cover (Hoophouse, High Tunnel, Low Tunnel, Polytunnel, Polyhouse, Grow Tunnel, Cold Frame, Cloche) FOR ORGANIC PRODUCTION CAN BE USED IN ORGANIC PRODUCTION ACTIVE INGREDIENT: Bacillus mycoides isolate J† .........................................................................................99.5% OTHER INGREDIENTS:.......................................................................................................0.5% TOTAL..............................................................................................................................100.0% † Contains a minimum of 1 billion (1×109) viable spores/mL of product. KEEP OUT OF REACH OF CHILDREN [See [side][back][inside][other] panel for [additional] [precautionary] [statements] [directions for use] [and] [storage and disposal].] [Refer to inside of label booklet for additional precautionary information and Directions for Use including Storage and Disposal.] MANUFACTURED BY: EPA Reg. No. 70051-REA Certis USA LLC EPA Est. No. 70051-CA-1 9145 Guilford Road, Suite 175 Columbia, MD 21046 Lot Number: Net Weight: Oct 21, 2019 70051-126 { } Symbolizes explanatory text to the reviewer Page 1 of 15 [ ] Indicates optional text MASTER LABEL Revision Date: 2019-10-18 LifeGard® LC, EPA File Symbol 70051-REA Revises: 2019-09-30 draft PRECAUTIONARY STATEMENTS Personal Protective Equipment (PPE): Applicators and other handlers must wear: x long-sleeved shirt x long pants x socks and shoes x a NIOSH-approved particulate respirator with any N, R, or P filter with NIOSH approval number prefix TC-84A; or a NIOSH-approved powered air purifying respirator with an HE filter with NIOSH approval number prefix TC-21C. (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 for washables, 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. IMPORTANT: When reduced PPE is worn because a closed system is being used, handlers must be provided all PPE specified above for "applicators and other handlers" and have such PPE immediately available for use in an emergency, such as a spill or equipment breakdown. User Safety Recommendations Users should: 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. As soon as possible, wash thoroughly and change into clean clothing. 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 contaminate water when disposing of equipment washwater or rinsate. DIRECTIONS FOR USE It is a violation of Federal law to use this product in a manner inconsistent with its labeling. These use directions must be in the possession of the user at the time of pesticide application. 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 State or Tribal agency responsible for pesticide regulation. { } Symbolizes explanatory text to the reviewer Page 2 of 15 [ ] Indicates optional text MASTER LABEL Revision Date: 2019-10-18 LifeGard® LC, EPA File Symbol 70051-REA Revises: 2019-09-30 draft 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 4 hours. For early entry into 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, wear: x Coveralls x Chemical-resistant gloves (made of any waterproof material) x Shoes plus socks BIOLOGICAL ACTIVITY LifeGard® LC contains a biological disease control agent (Bacillus mycoides isolate J, or BmJ) that reduces the occurrence and severity of plant disease by triggering the plant’s natural defense mechanisms against pathogens. BmJ itself has no direct effect on plant pathogens, but preventative applications (before infection or appearance of disease symptoms) can reduce the incidence and severity