UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES April 20, l993 PR NOTICE 93-7 OTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, AND REGISTRANTS OF AGRICULTURAL PESTICIDES Attention: Persons Responsible for Registration of Pesticide Products Subject: LABELING REVISIONS REQUIRED BY THE WORKER PROTECTION STANDARD (WPS) The Worker Protection Standard (WPS) for agricultural pesticides, issued in August, 1992, (40 CFR part 156, subpart K, and 40 CFR part 170) requires labeling changes for many pesticide end-use products. This Notice will help you to determine which of your products - if any - are affected by these new requirements, and will direct you to appropriate detailed guidance for making the required label revisions. I. APPLICABILITY OF THIS NOTICE In general, the labeling requirements of the WPS and this notice apply to end-use products registered under section 3 or 24(c) of FIFRA and bearing labeling which permits use in the production of agricultural plants on farms or in forests, nurseries, or greenhouses. Because there are some exceptions to this general rule, this notice includes specific criteria which must be applied to each registered product to determine whether it falls within the scope of this notice. This notice does not apply to manufacturing use products, or to unregistered pesticides used under an experimental use permit issued under FIFRA section 5 or under an exemption issued under FIFRA section 18. PR Notice 83-2, announcing the Farmworker Safety Label Improvement Program, is superseded by this notice. You must, however, retain any labeling language required by PR Notice 83-2 until it is replaced by new labeling complying with the require- ments of this Notice and 40 CFR part 156, subpart K. II. WHAT IS IN THIS PACKAGE The Agency has reviewed its records to identify all regis- trations accepted for any crop, forestry, nursery or ornamental uses, and therefore potentially affected by the WPS labeling requirements. If you hold no registrations accepted for any of these uses, EPA has sent you only this PR Notice, which contains the specific criteria to determine with certainty whether any of your products are within the scope of the WPS requirements. If you hold one or more registrations accepted for crop, forestry, nursery, or ornamental use you are being sent, in addition to this PR Notice, the following supplemental materials: Supplement 1: "Listing of Potential WPS Registrations". This lists all your registrations under section 3 or section 24(c) of FIFRA which EPA believes to have been accepted for crop, forestry, nursery, or ornamental uses, and which are likely to fall within the scope of the WPS. Supplement 2: "Procedures for Responding to PR Notice". This explains in detail the special procedures established for your response to this notice, and how EPA will act on your responses. Supplement 3: "Main Labeling Guidance". This contains step-by- step directions for determining exactly what language you must add to or remove from your current labeling to bring it into compliance with WPS requirements. Supplement 3a: "Addendum to Main Labeling Guidance". This contains a master copy of the Product Worksheet which will help you determine the necessary WPS labeling changes, examples of labels that meet the WPS requirements, special guidance on restricted- entry intervals for certain pesticides, and a list of active ingredients providing information you will need to complete certain sections of the Product Worksheet. III. REGISTRANT RESPONSIBILITIES It is your responsibility as a registrant to ensure your own compliance with the requirements of the WPS, and that of any supplementally registered distributors of your products. Currently registered products This notice requires all registrants to apply the criteria in section IV below to each of their products currently regis- tered under either section 3 or section 24(c) of FIFRA, to deter- mine whether it falls within the scope of this notice. You will have to review each product's uses as defined in its labeling. If any particular registration is NOT within the scope of the WPS requirements, no further action is required for that registration. If a registration IS within the scope of these requirements, you must apply for an amendment to your registration to bring its accepted labeling into compliance with the WPS requirements, consistent with the deadlines specified in the WPS itself and summarized below: - On or after April 21, 1993, products may be distributed or sold bearing the new WPS labeling. - After April 21, 1994, all products within the scope of this notice must bear the new WPS labeling when they are distributed or sold by the primary registrant or any supplementally registered distributor. - After October 23, 1995, all products within the scope of this notice must bear the new WPS labeling when they are distributed or sold by any person. BECAUSE OF THE LARGE NUMBER OF APPLICATIONS EXPECTED, AND BECAUSE THE WPS PROHIBITS YOUR SALE OR DISTRIBUTION OF ANY PESTICIDE PRODUCT WITHIN ITS SCOPE AFTER APRIL 21, 1994 WITHOUT APPROPRIATELY REVISED LABELING, THE AGENCY STRONGLY RECOMMENDS THAT YOU SUBMIT ALL APPLICATIONS FOR AMENDMENT IN RESPONSE TO THIS NOTICE AS EARLY AS POSSIBLE. Pending Applications Some currently pending registrations and new products first registered between now and April 21, 1994, will be subject to the WPS labeling requirements. You should evaluate any of your products for which an appli- cation is pending against the WPS scope criteria in section IV, and if any are within the scope of this Notice, you should submit revised proposed labeling consistent with the WPS as early as possible. This may permit the Agency to complete review of the application before the April 21, 1994, compliance date. A delay in your submission of revised proposed labeling is likely to delay Agency approval of your application. If you contemplate submitting an application for a new regis- tration within the scope of the WPS, you should submit proposed labeling in compliance with the WPS requirements. As the April 21, 1994, compliance date approaches the Agency may refuse to accept for review applications which do not include proposed labeling consistent with the WPS. Detailed instructions for bringing your labeling into compliance with the WPS are provided in the supplements to this notice. If you did not receive the supplements, and believe that one or more of your registrations is within the scope of this notice, please call the toll-free WPS Label Information Line at 1-800-777-2185 for assistance. IV. SCOPE CRITERIA: DETERMINING APPLICABILITY TO INDIVIDUAL PRODUCTS To determine which of your registrations fall within the scope of this notice, answer the questions below for each of them. Answer these questions for all your registrations, whether they were issued under section 3 or 24(c) of FIFRA, and whether or not they are included in the "Listing of Potential WPS Regis- trations" in Supplement 1. Note that some products outside the scope of this notice are still within the scope of the WPS (40 CFR part 156, subpart K, and 40 CFR part 170.) While no action with respect to such products is required at this time, EPA may issue future PR Notices that will apply to them. Begin here for each registration: A. Does the labeling contain directions for application to - Plants grown to produce food, feed, or fiber? - Turfgrass? - Ornamental plants, trees, or shrubs? - Plants grown to produce seedlings or transplants? - Plants grown to produce cut flowers or cut ferns? - Trees grown to produce timber? - Areas where any such plants are growing? - Areas where such plants will soon be grown (i.e., pre- plant or at-plant application)? - Areas from which such plants have just been harvested? If you answered "YES" to any of these questions, this product may be within the scope of this notice. Go on to question B. If you answered "NO" to all of these questions, this product is NOT within the scope of this notice. Begin again with question A for your next product. B. Does the labeling explicitly limit application ONLY to plants intended for aesthetic purposes or climate modifica- tion and growing in interior plantscapes, ornamental gardens or parks, or on golf courses or lawns and grounds? If you answered "YES", this product is NOT within the scope of this notice. Begin again with question A for your next product. If you answered "NO", this product may be within the scope of this notice. Go on to question C. C. Does the labeling explicitly limit uses ONLY to those NOT directly related to the production of food, feed, fiber, timber, turfgrass, or ornamentals, such as the following: - Use on pasture or rangeland; - Use on rights-of-way or other non-crop areas; - Use for structural pest control; or - Use for mosquito abatement, Mediterranean fruit fly eradication, or in other wide-area government-sponsored pest control programs? If you answered "YES" to this question, this product is NOT within the scope of this notice. Begin again with question A for your next product. If you answered "NO" to this question, this product may be within the scope of this notice. Go on to question D. D. Does the labeling contain directions only for one or more of the following: - Control of vertebrate pests; - Use as an attractant in traps; - Use on the portions of agricultural plants that have been harvested, including harvested timber; or - Application using a point-source pheromone dispenser of a size easily retrieved from the field, such as a "twist-tie"? If you answered "YES" to this question, this product is NOT within the scope of this notice. Begin again with question A for your next product. If you answered "NO" to this question, this product may be within the scope of this notice. Go on to question E. E. Is the product labeled PRIMARILY for use in production of plants in homes, home flower or vegetable gardens, home lawns, or home greenhouses? Answer "yes" to this question only if the current labeling meets ALL the following tests: 1. The labeling indicates that the product is intended for use in or around the home, home flower or vegetable garden, home lawn, or home greenhouse; AND 2. The labeling does NOT include any of the following directions or phrases: - Skull and crossbones symbol and word "Poison"; - A requirement for users to wear a respirator; - A requirement for users to wear chemical-resis- tant, waterproof, or liquid-proof suits or coveralls or "rainsuits"; - The phrase "for professional use"; - The phrase "for commercial use"; - Directions for use on farms, sod farms, forests, nurseries, or greenhouses except home greenhouses; - Directions for use including the word "crops" or the phrases "for crop production" or "for sod production"; - Application rates expressed per acre; - Dilution rates expressed per hundred gallons; - Directions for application by aerial, ground-boom, airblast, or other motor-driven vehicles or equipment; - Directions for use of a surfactant, buffer, or adjuvant; - Directions for tankmixing with fertilizer or with other pesticides; - Any reference to chemigation; - Directions for mechanical agitation; - Instructions or restrictions concerning livestock grazing; AND 3. The product is packaged in a container holding no more than 40 pounds if the product is a solid, or 2 gallons if it is a liquid, or 2 pounds if it is an aerosol. If all three tests (E. 1, 2, & 3) above are fully satisfied, this product is NOT within the scope of this notice. Begin again with question A for your next product. If any of these three tests is not fully satisfied, THIS PRODUCT IS WITHIN THE SCOPE OF THIS NOTICE. (If your product does not satisfy all these three tests but you believe it is nonetheless intended primarily for home use or is otherwise limited to use on plants grown for other than commercial or research purposes, call the WPS Label Information Line at 1-800-777-2185 for assistance.) Go on to question F. F. Does the product contain ethyl parathion, or is it a fumigant? If you answered "YES" to this question, THIS PRODUCT IS WITHIN THE SCOPE OF THIS NOTICE, but the required label changes are not addressed in Supplement 3: Main Labeling Guidance. Special labeling guidance for ethyl parathion products and fumigants is being distributed to affected registrants separately. DO NOT revise the labels of ethyl parathion products or fumigants until you have received the appropriate special guidance. If you hold a registration for an ethyl parathion product or a fumigant which is not flagged on the enclosed "Supplement 1: Listing of Potential WPS Registrations", you can obtain a copy of the special guidance by calling the WPS Label Information Line at 1-800- 777-2185. Go back to question A for your next product. If you answered "NO" to this question, start again with question A for your next product. When all your products have been assessed against the scope criteria, proceed to the next section. V. NEXT STEPS When you have applied the scope criteria in section IV to all your registrations, you are ready to proceed. - No further action is required for products which are not within the scope of this Notice. - For any product which is within the scope of this Notice you must decide how you will proceed. You have three possible choices, all described in detail in Supplement 2: "Procedures for Responding to PR Notice 93-7": - You may submit an application to amend the labeling to comply with the requirements of the WPS. - You may submit an application to amend the labeling to delete all uses or modify other statements that make the product subject to the WPS. If you choose this option you may not sell or distribute after April 21, 1994, any product whose label includes uses subject to the WPS unless that product is labeled in compliance with the amended Part 156, subpart K. - You may request cancellation of the product registration. If you choose this option you will not be permitted to sell or distribute existing stocks of product with non-complying labeling after April 21, 1994. Because of the large number of affected registrations and the early deadlines for compliance, the Agency has set up special procedures to improve efficiency. These procedures are described in Supplement 2 to this Notice. If you follow them exactly, your responses will be reviewed and acted upon more quickly by EPA. Registrants are advised, however, that even if the Agency has not acted on your response, it remains your responsibility to ensure that no product labeled for WPS uses is distributed or sold by you or any supplementally registered distributor of your product after April 21, 1994, unless its labeling complies with the requirements of amended 40 CFR part 156, subpart K. VI. FOR FURTHER INFORMATION AND ASSISTANCE The Agency has established a toll-free WPS Label Information Line to help registrants understand and implement the required labeling changes. If after reading this notice and any relevant supplements you are unsure whether a product falls within the scope of these requirements, or have questions about what you must do to bring your label into compliance, or need copies of application forms or of materials omitted from your package, you are encouraged to call the WPS Label Information Line (1-800-777-2185) for help. It is attended during normal business hours; at other times you may leave a message for a return call. Lawrence E. Culleen, Acting Director Registration Division Office of Pesticide Programs NOTE: OPP STAFF MAY OBTAIN COPIES OF THE SUPPLEMENTS FROM THE INFORMATION SERVICES CENTER, ROOM 234 CM2. ----------------------- CERIS-Net Posting Date: 05.20.94 DISCLAIMER: PR Notices are sent to CERIS/NPIRS by the U.S. EPA Documents Center in WordPerfect document format. CERIS/NPIRS converts files to ASCII text, with editing to facilitate file transfer, before posting on the CERIS-Net system. Occasionally, documents are sent in hard copy form and entered by CERIS staff as ASCII text. PR Notices are available by anonymous FTP from ceris.purdue.edu in the pub/info/prnotice directory. For access information, contact CERIS at 317/494-6616.