March 30, 1995 MEMORANDUM FROM: Jim Tompkins, Deputy Chief Fungicide-Herbicide Branch Registration Division (7505C) Office of Pesticide Programs TO: Interested Parties SUBJECT: Draft Notice for Comment on Labeling Revisions Required By The Worker Protection Standard (WPS) For Sale or Distribution of Certain Agricultural Pesticides After October 23, 1995 EPA is soliciting comments on a proposed policy to deal with the problem that retailers or other others to whom registrants sell their products may be caught with stocks on non-complying pesticides on 10/23/95. That policy is described in a draft document entitled, "Labeling Revisions Required By The Worker Protection Standard (WPS) For Sale or Distribution of Certain Agricultural Pesticides After October 23, 1995." Interested parties may submit written comments to: By mail, Jim Tompkins, Fungicide-Herbicide Branch, Registration Division (7505C), Office of Pesticide Programs, Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. In person bring comments to: Crystal Mall 2, Room 266A, 1921 Jefferson Davis Highway, Arlington, VA. addressed to Jim Tompkins, Fungicide-Herbicide Branch, Registration Division (7505C). ----------------------------------------------- PR NOTICE 95-X NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS, REGISTRANTS, DISTRIBUTORS, AND SELLERS OF AGRICULTURAL PESTICIDES Attention: Persons Responsible for Registration, Sale or Distribution of Pesticide Products Subject: LABELING REVISIONS REQUIRED BY THE WORKER PROTECTION STANDARD (WPS) FOR SALE OR DISTRIBUTION OF CERTAIN AGRICULTURAL PESTICIDES AFTER OCTOBER 23, 1995 On April 20, 1993, EPA issued a set of instructions, PR Notice 93-7, providing guidance to pesticide registrants on amending pesticide product labeling in compliance with the labeling requirements for the revised Worker Protection Standard (WPS) for agricultural pesticides (40 CFR part 156, subpart K) that was issued August 21, 1992. That guidance was supplemented by PR Notice 93-11, issued on August 13, 1993. No pesticide product within the scope of the WPS may be sold or distributed by anyone after October 23, 1995 unless its labeling complies with the new regulations as explained in the PR Notices listed above. This notice identifies an additional option that sellers of pesticides may choose to bring pesticide products for which they are not the registrant into compliance with the WPS and allow sale or distribution of such products after October 23, 1995. I. APPLICABILITY OF THIS NOTICE This notice applies to any person who holds and intends to sell or distribute stocks of pesticide products, of which they are not the registrant, within the scope of PR Notices 93-7 and 93-11. In general, WPS labeling requirements apply to end-use products registered under section 3 or 24(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and bearing labeling which permits use in the production of agricultural plants on farms, forests, nurseries, or greenhouses. There are several exceptions to this general rule, including an exception for products intended primarily for home use. See the attached scope criteria from PR Notices 93-7 and 93-11 if you need additional detail about determining whether any product is within scope. In most cases, however, you should be able to quickly identify a product that requires WPS labeling whenever OTHER, generally more recently produced, containers of the same product bear: * labeling with an Agricultural Use Requirements box that refers to the WPS, OR * stickers referring to replacement labeling that contains such an Agricultural Use Requirements box. All product within the scope of the earlier WPS PR Notices must have labeling containing such an Agricultural Use Requirements box when sold or distributed by anyone after October 23, 1995. When in doubt as to whether pesticide products you hold are within the scope of those notices, you are advised to check with the product's registrant for further information. For those products that are within scope of the WPS PR Notices but do not bear WPS amended labeling, ask the registrant for help with bringing the product into compliance through relabeling or use of stickers that refer to product-specific supplemental labeling. The option described in this notice is intended for products for which you are unable to obtain revised, product-specific labeling. NOTE: When the phrase "PRN-complying labeling" is used in this Notice, such complying labeling may be one of the following: * final labeling or interim product-specific replacement labeling that complies with the guidance in PR Notice 93-7 for adding WPS-related statements, * final labeling or interim product-specific replacement labeling that fully complies with the guidance in PR Notices 93-7 and 93-11 for removing the product from the scope of the PR Notices by deleting uses or by adding approved exclusionary statements, * final labeling or interim product-specific replacement labeling that EPA has stamped as accepted in response to an amendment request submitted by the registrant to comply with PR Notice 93-7. II. WHAT CAN BE DONE WITH STOCK WITH NON-PRN-COMPLYING LABELING? Persons who have under their ownership, custody or control existing stock of in-scope product that does not bear PRN-complying labeling may fully comply with the WPS by: * selling or distributing the product no later than October 23, 1995, or * working with the product's registrant to arrange relabeling of the product with final PRN-complying labeling or with interim PRN-complying labeling (as described in Supplement D of PR Notice 93-11) before selling or further distributing the product after October 23, 1995 (except for distribution necessary to relabel the product), or * modifying the labeling of the product using the guidance in this notice before any sale or distribution of such product after October 23, 1995. INTERIM GENERIC SUPPLEMENTAL LABELING OPTION EPA will allow any person to sell or distribute a non-PRN-complying pesticide product after October 23, 1995 provided the product labeling is first modified to comply with the requirements below. Acceptable interim generic labeling for PR Notice 93-7 compliance consists of: * a sticker or similar modification to an existing label, and * generic supplemental WPS labeling referenced by the sticker that meets the specifications and conditions of use listed below. Once a product has been correctly interim-generic-labeled, it may be sold or distributed by anyone without time limit. Sticker Specifications * Prominence -- must be legible and prominent on product package through use of contrasting colors or other graphic devices, and placement on the label of each product. * Location -- must be printed or affixed onto product package. If affixed, must be difficult to remove without residue or damage to underlying packaging or labeling and must not be located on the bottom or any other place that will not readily be noticed by users. If the product bears labeling on both outer packaging and immediate container, the sticker must be affixed to both. (Exception: Inner water soluble packages need not be modified under the interim generic labeling approach.) * Obscuring Existing Language -- the sticker must not obscure information on the existing label. * Required Text -- "The label for this pesticide has been modified by generic supplemental labeling received at sale. This product may only be used in compliance with that generic supplemental labeling. If you do not have the generic supplemental labeling for this product, contact the seller to obtain it before using this product. The Worker Protection Standard, 40 CFR Part 170, must be followed when this product is used." Generic Supplemental Labeling Specifications Samples of generic WPS supplemental labeling are attached to this notice. The fumigant generic supplemental labeling must be furnished to purchasers of agricultural fumigants; the non-fumigant generic supplemental labeling must be furnished to purchasers of all other agricultural pesticides, except ethyl parathion products. * Location -- need not be attached to container, but must accompany the product at each point of sale or distribution. * Format -- must be similar to that attached to this notice, with all text legible. * Content -- must be the same as that attached to this notice. Ethyl Parathion Products: Holders of stocks of non-PRN-complying ethyl parathion products may not employ the option of interim generic supplemental labeling described below and should contact the registrant of such products or, if necessary, EPA, for guidance. Use of Interim Generic Labeling Products may be stickered, or bear a label containing a facsimile of a sticker, provided: * The sticker or facsimile is applied before any sale or distribution after October 23, 1995, except for any distribution necessary to effect WPS relabeling. (See exception below for special provisions that apply to sale or distribution of product in intact pallet loads or in unopened shipping containers.) * The appropriate generic supplemental labeling accompanies the product at the time of any sale or distribution after October 23, 1995. III. WHERE MAY RELABELING OCCUR? DISTRIBUTION OR RETAIL SITES WPS-related stickering and provision of generic supplemental labeling may occur at any site (such as distribution or retail sites), by any person designated by the registrant and without registration of the site as a pesticide producing establishment. The registrant of the stocks of non-PRN-complying product, however, is fully responsible for ensuring that such labeling modifications are carried out correctly. Stickers and generic supplemental labeling should be requested from the registrant of the product. PURCHASER SITE Product may be sold or distributed in unopened shipping pallet loads or other unopened outer shipping containers without the ordinarily-required sticker affixed to the inner pesticide containers provided the seller or distributor: * ensures that the purchaser or other recipient is supplied at delivery (e.g. by attaching an envelope containing such supplies to the outside of the pallet load or other outer container) with sufficient quantity of stickers for each inner container (other than inner water-soluble packages). * ensures that the pallet load or other container prominently bears the following statement: "IMPORTANT NOTICE: It is a violation of Federal law to use any pesticide inside this outer container until the provided sticker has been applied to its container." * ensures that sufficient quantity of appropriate generic supplemental labeling for each inner container accompanies the product at the time of delivery to the purchaser. IV. FOR FURTHER INFORMATION AND ASSISTANCE If after reading this notice you have questions about what you must do to bring the labeling of any product you hold into compliance, you are encouraged to call the registrants of any such products for assistance. If further assistance is necessary, you may call EPA or any of its regional offices for assistance. The EPA headquarters number for assistance is ___________. Daniel M. Barolo, Director Office of Pesticide Programs ------------------------------------------------------ SCOPE CRITERIA: DETERMINING APPLICABILITY TO INDIVIDUAL PRODUCTS To determine whether pesticide products (that do not already bear labeling containing WPS requirements in an Agricultural Requirements box) fall within the scope of this notice, answer the questions below for each of them. _ Begin here for each product: 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 modification 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 the 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 the 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 the 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-resistant, 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 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", using those words; _ 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 the next product. If any of these three tests is not fully satisfied, THIS PRODUCT IS WITHIN THE SCOPE OF THIS NOTICE. (If the 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, check with the registrant. Start again with question A for the next product. ======================================================================= AGRICULTURAL PESTICIDE GENERIC SUPPLEMENTAL LABELING For compliance with the Worker Protection Standard (40 CFR part 170) IMPORTANT: This supplemental labeling does not apply (1) to soil or space fumigant products, (2) to products containing ethyl parathion, or (3) if elsewhere on the product labeling an Agricultural Use Requirements box requires compliance with the Worker Protection Standard (40 CFR Part 170). When this product is used on an agricultural establishment (farm, forest, nursery, or greenhouse) for the commercial or research production of agricultural plants, users must comply with the instructions in this supplemental labeling. Users who must comply with these instructions include owners/operators of the agricultural establishment and owners/operators of commercial businesses that are hired to apply pesticides on the agricultural establishment or to perform crop-advising tasks on such establishments. Failure to comply with the requirements on this supplemental labeling and with the Worker Protection Standard (40 CFR part 170) is a violation of Federal law, since it is illegal to use a pesticide product in a manner inconsistent with its labeling. -----------------------[text below is in box]-------------------------------- AGRICULTURAL USE REQUIREMENTS Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR 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 in this labeling about personal protective equipment, restricted-entry intervals, and notification to workers. The requirements in this box only apply to uses of this product that are covered by the Worker Protection Standard (WPS). 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. Entry-Restrictions: Do not enter or allow worker entry during the restricted-entry interval (REI). The restricted-entry interval for this product is: * the specific number of hours or days (if any) listed elsewhere on the product labeling as the reentry interval or entry restriction for the crop or site, if 12 hours or more; * 12 hours, if no specific number of hours or days is listed elsewhere on the product labeling as the reentry interval or entry restriction for the crop or site; The restricted-entry interval for this product must be at least 12 hours. Notification Instructions: Follow the rules in the WPS for notifying workers of the application. Exception: If the instructions about notification (if any) listed elsewhere on the product labeling require posting of treated areas (rather than offering a choice), you must notify workers of the application by warning them orally AND by posting signs at entrances to treated areas, following the rules in the WPS. Personal Protective Equipment (PPE) Requirements: * Handler PPE: Pesticide handlers must wear the PPE listed elsewhere in the product labeling for applicators. If specific PPE is required elsewhere on the product label for specific handling tasks (such as mixing or loading), it must be worn while performing such tasks. In any case, any handler using this product must wear no less than: long-sleeved shirt, long pants, shoes, socks, and chemical-resistant or waterproof gloves. * Early Entry PPE: 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 the same PPE as required elsewhere on this product label for applicators, except that any respirator requirement is waived. In any case, the minimum PPE required for any early entry worker exposed to this product is no less than: coveralls, shoes, socks, and chemical-resistant or waterproof gloves. Conflicting Instructions: If the requirements of the WPS conflict with instructions listed elsewhere on this product label, users must obey the more protective requirements. -----------------------------[end of box]---------------------------------- AGRICULTURAL FUMIGANT GENERIC SUPPLEMENTAL LABELING For compliance with the Worker Protection Standard (40 CFR part 170) IMPORTANT: This supplemental labeling applies ONLY to soil or space fumigant products used in the production of agricultural plants. It does not apply if elsewhere on the product labeling an Agricultural Use Requirements box requires compliance with the Worker Protection Standard (40 CFR Part 170). When this product is used on an agricultural establishment (farm, forest, nursery, or greenhouse) for the commercial or research production of agricultural plants, users must comply with the instructions in this supplemental labeling. Users who must comply with these instructions include owners/operators of the agricultural establishment and owners/operators of commercial businesses that are hired to apply pesticides on the agricultural establishment or to perform crop-advising tasks on such establishments. Failure to comply with the requirements on this supplemental labeling and with the Worker Protection Standard (40 CFR part 170) is a violation of Federal law, since it is illegal to use a pesticide product in a manner inconsistent with its labeling. --------------------------[text below is in box]--------------------------- AGRICULTURAL USE REQUIREMENTS Use this product only in accordance with its labeling and with the Worker Protection Standard, 40 CFR 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 in this labeling about personal protective equipment, restricted-entry intervals, and notification to workers. The requirements in this box only apply to uses of this product that are covered by the Worker Protection Standard (WPS). 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. Entry-Restrictions: Follow the applicable entry restrictions listed elsewhere on the product labeling. Notification Instructions: Follow the rules in the WPS for notifying workers of the application. Exception: If there are instructions listed elsewhere on the product labeling that requires the posting of specific signs at treated areas, you must notify workers of the application by warning them orally AND by posting the signs specified on the labeling. Personal Protective Equipment (PPE) Requirements: Follow the applicable PPE instructions (if any) listed elsewhere on the labeling. Conflicting Instructions: If the requirements of the WPS conflict with instructions listed elsewhere on this product label, users must obey the more protective requirements. -------------------------------[end of box]----------------------------------