PRN 95-5: Labeling Revisions Required By The Worker Protection Standard (WPS) For Sale Or Distribution Of Certain Agricultural Pesticides After October 23,1995
Attention: Persons Responsible for Registration, Sale or Distribution of Pesticide Products
Subject: Labeling Revisions Required by the Worker Protection Standard (WPS) For The Sale Or Distribution Of Certain Agricultural Pesticides After October 23, 1995
This notice provides guidance to people who sell or distribute pesticides on: 1) how to recognize pesticide products in their possession that do not comply with the Worker Protection Standard (WPS) requirements, 2) how to bring all applicable product labels into compliance with WPS requirements, so that such products may be legally sold and distributed after October 23, 1995, 3) required actions by registrants, wholesalers, and retailers in relabeling products, and 4) the deadline of October 23, 1996, by which all products within the scope of the WPS must bear final, printed WPS replacement labeling (not supplemental labeling as described in this notice).
- Applicability
- How to recognize product labels that need to be amended to comply with the WPS
- How to revise product labels to comply with the WPS
- How to revise product labels of Special Products to comply with the WPS
- Waiver of submission of amended and final printed labeling which complies with this notice
- Deadline for relabeling and final sale
- For further information and assistance
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Applicability of this Notice and Definitions
- Applicability
This notice applies to pesticide products that are within the scope of the WPS, do not bear full WPS labeling, and are being sold or distributed by any person, other than the registrant of the pesticide. Under this notice the registrant has the option to either relabel the product or authorize the person(s) holding the product for distribution or sale to relabel the pesticide. Both the registrant and the person(s) holding such pesticides are responsible for relabeling these products in accordance with the WPS and this PR notice. This notice does not apply to growers, custom applicators, or other persons holding product for their own use, unless they also distribute and sell pesticides or are registrants.
The WPS labeling regulations (40 CFR Part 156, subpart K) require that certain statements be placed on the labeling of all pesticide products within the scope of the WPS. These statements reference the WPS and certain practices intended to reduce or eliminate human exposure to pesticides. The WPS establishes a schedule for meeting these labeling requirements:
The schedule required that by April 21, 1994, all registrants of pesticides covered by the WPS amend product labeling in accordance with PR Notice 93-7 and 93-11. Most products sold or distributed by registrants since April 21, 1994, should have labeling that complies with the WPS. However, wholesalers and retailers may have stocks of product that do not have WPS complying labeling. These stocks may originate from sources such as:
The WPS provides that any person other than a registrant (e.g., pesticide retailers or wholesalers) who has under their ownership, custody or control existing stock of product that is within the scope of the WPS but does not bear WPS labeling may NOT legally sell or distribute the product after October 23, 1995. The primary purpose of this notice is to describe the process for relabeling to come into compliance the deadline. As described above, wholesalers and retailers may have stocks of product which do not have labeling which complies with the WPS.
- products shipped by registrants before the April 21, 1994 date;
- products distributed or sold by registrants under the "released for shipment" option allowed under PR Notice 93-11 (products could be sold or distributed after April 21, 1994 without the WPS label if the registrant agreed to either (a) recall and relabel or (b) relabel them at wholesaler sites through an "authorized agent" of the registrant by April, 1996); and
- "deleted use" products, for which the registrant has amended the registration to delete certain uses thereby putting the product outside the scope of the WPS (see Section IV.C).
- Definitions
The following definitions apply for the purposes of this notice:
Term Definition Registrant: Any person who has registered any pesticide pursuant to the provisions of the Federal Insecticide, Fungicide, Rodenticide Act (FIFRA). A supplemental distributor is considered an agent of the registrant. Wholesaler: Any person, other than a registrant, who distributes or sells pesticides to persons other than end-users. Retailer: Any person, other than a registrant, who distributes or sells pesticides to end-users. Distribute or Sell To distribute, sell, offer for sale, display, hold for distribution, hold for sale, hold for shipment, ship, deliver for shipment, release for shipment, or receive and (having so received) deliver or offer to deliver. These terms do not include the holding or application of registered pesticides or use dilutions thereof by any applicator who provides a service of controlling pests without delivering any unapplied pesticide to any person so served. Label The written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containers or wrappers. Labeling All labels and all other written, printed, or graphic matter -- a) accompanying the pesticide or device; or b) to which reference is made on the label or in literature accompanying the pesticide or device.
- Applicability
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How to recognize product labels that need to be amended to comply with the WPS
If a product has labeling required under the WPS, the labeling will have an Agricultural Use Requirements box and can be sold or distributed after October 23, 1995 without further action. The Agricultural Use Requirements box references the WPS and requires certain practices intended to reduce or eliminate worker and handler exposure from pesticides. The box includes restricted-entry intervals, personal protective equipment, and the notification requirement for pesticide-treated areas. An example of an Agricultural Use Requirements box is in Attachment 3.
If a product's labeling does not have an Agricultural Use Requirements box, you will need to determine whether it is within the scope of the WPS and, therefore, requires WPS labeling. In some cases you may be able to quickly identify a product that requires WPS labeling because other containers of the same product, that have been produced more recently, bear the following:
Labeling with an Agricultural Use Requirements box that refers to the WPS;
or
Stickers referring to supplemental replacement labeling which contains such an Agricultural Use Requirements box.
Products accompanied only by generic supplemental labeling as outlined in PR Notice 93-11 are not considered labeled in compliance with the WPS provisions after October 23, 1995. Products that do bear complying WPS labeling include those relabeled in accordance with Supplement D of PR Notice 93-11 (by using a sticker or similar modification to an existing label and full product-specific labeling referenced by the sticker). To determine whether any product is within the scope of the WPS, refer to Attachment 2 (Determining WPS Applicability to Individual Products) or call the registrant of the product. To get additional assistance, you may contact an industry-sponsored "WPS Task Force" at 1-800-713-2291, after October 15, 1995.
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How to revise product labels to comply with the WPS
- Required Actions
- Registrant
Conduct or authorize relabeling. Registrants are responsible for ensuring that relabeling of non-complying products takes place in accordance with the WPS and this PR Notice. They may choose to conduct relabeling by recalling the product and relabeling with final printed replacement labeling at a registered establishment or relabeling at the location of the product; or authorize a wholesaler or retailer to relabel in accordance with this PR notice.
Refer to Sections III.B. and IV. which provide options and required specifications for relabeling.
Provide written authorization for relabeling to retailers and wholesalers. The registrant must provide a written authorization to a wholesaler or retailer who agrees to relabel non-complying product. The authorization should outline the specific roles of the retailer, wholesaler, and registrant in relabeling. Registrants are fully responsible for ensuring that labeling modifications are carried out correctly by any person or company they authorize. Any limitations on who may be authorized to carry out relabeling under this PR Notice must be explicit in the authorization document. The authorization cannot change the responsibilities of any of the parts or terms of this PR notice. (Notice: Any relabeling of products with WPS labels must be in cooperation with all involved parties, and under the written authorization of the registrant.)
Provide product-specific WPS labeling. The registrant must provide labeling, to those they authorize to conduct relabeling, that complies with the WPS and this PR notice (including "STOP stickers," if supplemental labeling is used -- see Section III.B.2 and IV. for a description and specifications for "STOP stickers") for all products within the scope of the WPS. The next sections describe options and established requirements for labels, labeling, and "STOP stickers."
- Wholesaler
Wholesalers (any person, other than registrants, who distributes or sells pesticides to persons other than end-users) must take the following actions:
Registrant authorization for relabeling at wholesaler establishment. The registrant may authorize a wholesaler, retailer or other person(s) to perform relabeling. Any relabeling of products must be performed under the written authorization of the registrant. (See Section III.A.1 ) If the registrant will not perform relabeling or authorize you or another party to relabel, you should contact EPA's Registration Division (703-305-6250) for instructions on how to proceed with those products.
Refer to Sections III.B. and IV. which provide options and required specifications for relabeling.
Do not distribute products, except as permitted by this Notice. Products within the scope of the WPS that do not bear WPS labeling may not be legally distributed or sold after October 23, 1995. However this PR notice allows the wholesaler to ship non-complying product prior to relabeling, if (1) the wholesaler has notified and obtained agreement of the receiving person(s) to ensure that WPS relabeling will occur before the product is 'offered for sale' or distribution to the end user and (2) the registrant will either conduct or has authorized relabeling. For the purposes of this PR notice only, pesticides are considered "offered for sale" whenever they are available in areas accessible to customers, unless they are clearly identified as products which may not be sold until relabeled.
Industry-sponsored assistance. To get assistance in relabeling products to comply with the WPS, you may contact the industry-sponsored "WPS Task Force" at 1-800-713-2291, after October 15, 1995. This service will help identify which specific products are covered by the WPS and need WPS-complying labeling and distribute STOP stickers and required WPS supplemental labeling for registrants participating in the service. Other requests will be referred to other organizations.
- Retailer
Retailers (any person, other than registrants, who distributes or sells pesticides to end-users) must take the following actions:
Do not offer for sale after October 23, 1995, except as allowed by this Notice. Products may not be distributed or sold after October 23, 1995 unless they comply with the WPS. This PR notice allows products to be relabeled under certain specifications prior to being "offered for sale." For the purposes of this PR notice only, pesticides are considered "offered for sale" whenever they are available in areas accessible to customers, unless they are clearly identified as products which may not be sold until relabeled.
Registrant authorization for relabeling at retailer establishment. The registrant may authorize a wholesaler, retailer or other person(s) to perform such relabeling. Any relabeling of products must be performed under the written authorization of the registrant. (See Section III.A.1 ) If the registrant will not perform relabeling or authorize you or another party to relabel, you should contact EPA's Registration Division (703-305-6250) for instructions on how to proceed with those products.
Refer to Sections III.B. and IV. which provide options and required specifications for relabeling.
Industry-sponsored assistance. To get assistance in relabeling products to comply with the WPS, you may contact the industry-sponsored "WPS Task Force" at 1-800-713-2291, after October 15, 1995. This service will help identify which specific products are covered by the WPS and need WPS-complying labeling and distribute STOP stickers and required WPS supplemental labeling for registrants participating in the service. Other requests will be referred to other organizations.
- Registrant
- Options for Relabeling
The options described below apply to the majority of products covered by this PR Notice, i.e., stocks of registered products subject to the WPS which do not have required WPS labeling. Other products are described and addressed in Section IV. as "Special Products."
- Final printed WPS-complying replacement labeling
Products may be relabeled by replacing existing labeling with final printed WPS-complying replacement labeling supplied by the registrant of the product. Such labeling must be printed on or affixed to the product package. If affixed, it must be difficult to remove without residue or damage to the underlying packaging or labeling it is replacing. If final printed replacement labeling is used, it must meet the above standards as well as those required by the WPS.
Replacement labeling may also be designed to modify existing labeling by adding the required WPS labeling statements without replacing the entire existing labeling. If this option is chosen, the replacement labeling must be designed and affixed in such a way so as to not alter or obscure the other portions of the label text that remain unchanged. Under this option, an additional supplement containing WPS requirements can not be developed. Additionally, replacement labeling must be affixed in such a manner as to cover any existing labeling statements or requirements that are superseded by WPS requirements.
If the product bears existing labeling on the outer packaging and the immediate container, the replacement labeling must be affixed to both. NOTE: For inner water soluble packages, the outer package, but not the immediate container, will require replacement labeling.
- Supplemental product-specific labeling
Alternatively, products may be relabeled by using supplemental product-specific labeling that is provided with each product when it is offered for sale to the end user, provided that a "STOP sticker" is affixed to the label and the sticker meets the requirements as specified below. The supplemental product-specific labeling must be supplied by the registrant of the product.
Supplemental labeling can be presented in two formats:
Single-Product Supplement that contains labeling information for only the specific product the end-user is buying. This labeling must display the full text of current product labeling or partial text that includes complete WPS-complying labeling (as EPA-accepted or registrant-verified). See attachment 4 for an example; OR
Multi-Product Supplement that contains labeling information for all products for a specific registrant. WPS information required to appear on all product labels may appear in the brochure only once, along with product-specific WPS information presented for each product covered by the brochure. The generic (non product specific) information must be part of the brochure. This option is NOT available for fumigant products because of the specialized nature of the fumigant label. See attachment 5 for an example of a brochure.
Supplemental Product-Specific Labeling Specifications
Supplemental replacement labeling must meet the following specifications:
Title -- The supplemental labeling must prominently bear the words "SUPPLEMENTAL LABELING WITH WORKER PROTECTION REQUIREMENTS" at the top of the first page or be in a pouch prominently displaying the words "SUPPLEMENTAL LABELING WITH WORKER PROTECTION REQUIREMENTS," attached to the container.
Content -- Supplemental labeling can be presented in a single-product supplement or a multi-product brochure. Single-product supplements include labeling information for only the product the end-user is buying. These supplements will contain either the full text of current product labeling or the partial text that includes only the complete WPS product labeling information, a contact phone number for the registrant, and no other information unrelated to the products' labeling. See attachment 4 for an example of a single-product supplement.
Multi-product brochures must contain complete WPS product labeling information for all products that are within scope of the WPS for the registrant, a contact phone number for the registrant, and no other information unrelated to the products' labeling. If a brochure includes multiple products with similar names (e.g., Weed Killer 4EC, Weed Killer 10WP), the brochure must contain an advisory statement located near such a grouping reminding users to carefully match the WPS requirements in the brochure with the particular product they are using. See attachment 5 for an example of a multi-product brochure. This option is NOT available for fumigant products.
Supplemental distributors must develop separate brochures using their product names if these names differ from the registrant's product names. However, "buyout/transferred," "orphaned/ cancelled," and "dormant" products for which WPS label language has been approved by EPA (all described in Section IV) may be included in the same brochure if the following conditions are met. "Buyout/transferred" products can be included only if both registration numbers are listed in the reference table and the brochure cover specifies previous registrants' names represented on the "transferred" products' labels and that these products have been transferred to the existing registrant, (e.g., this brochure also contains products previously owned by companies B, C, and D but now owned by company A...). If "orphaned / cancelled" products are included, then the reference table should specify "cancelled: generic instructions" for each such product and should indicate the specific generic requirements for each particular pesticide's label (requirements will vary with different labels -- see attachment 6).
Optional information for both single-product supplements and multi-product brochures includes: complete registrant identification, including company logo; statements clearly connecting the brochure with the "STOP stickered" product; footnotes explaining chemical resistant categories for gloves, respirators, etc.; statements to clarify information given in the brochure; and statements concerning discarding, washing, or maintenance of personal protective equipment, user safety recommendations, Spanish language warnings, and Engineering Control Statements.
Highlighting -- If the registrant has chosen to use a multi-product brochure, instead of a single-product supplement, EPA strongly encourages that the wholesaler or retailer highlight or clearly identify in the brochure the specific product(s) being sold or distributed to the end user. This will assist the end-user in quickly identifying the requirements for the specific product before pesticide application.
Location -- EPA strongly encourages physically attaching the supplemental labeling to product containers to ensure end-users receive the supplemental labeling. (Note: It is a violation of the WPS and this notice to sell or distribute products with non-complying labels or "offer such products for sale", to the end-user without providing the appropriate supplemental labeling.) If the labeling is not attached, it must be located in close physical proximity (i.e., immediately adjacent or next to) and accompany the product when the product is offered for sale to the end-user. When products are "offered for sale" to the end user, the supplemental labeling must be placed in such a way that it is clear which labeling corresponds to which product. Therefore, single-product supplemental labeling for different products and multi-product brochures for different registrants should not be mixed.
Format -- The supplemental replacement labeling may be photocopied, provided all text is legible. Illegible photocopies and faxes are unacceptable. The User Safety Recommendations and Agricultural Use Requirements must each be located in a clearly separate box with lines or other graphic indicators to separate them from the surrounding text. Location and formatting of supplemental label information should be consistent with PR Notices 93-7 and 93-11 to the extent possible.
"STOP Sticker" Specifications
If supplemental product-specific labeling will be used (instead of final printed replacement labeling as defined in Section III.B.1) a "STOP sticker" must be applied only to those products that bear a label which has not been revised to comply with complete WPS requirements. If multiple products are contained on pallets or in shipping containers, these containers must be opened and a "STOP sticker" must be affixed to each individual product container and outside container before the product is offered for sale to the end-user. (The immediate containers of water soluble packages do not have to be stickered.)
"Stickering" of products must be carried out according to the following specifications:
Required Text -- "STOP! Use this product only in accordance with the Worker Protection Standard, 40 CFR Part 170, and the "SUPPLEMENTAL LABELING WITH WORKER PROTECTION REQUIREMENTS," which must be provided when the product is offered for sale. Otherwise, you are in violation of FIFRA. For more copies of the labeling, contact your dealer or call 1-800-713-2291.
Product labels that must not receive stickers -- "STOP stickers" must NOT be applied to product labels that already comply with WPS requirements or that do not require a WPS label. For instance, deleted-use products discussed in Chapter IV of this document must not receive a sticker or WPS labeling.
Timing -- The sticker must be affixed to the product container prior to the time the product is offered for sale to the end-user.
Prominence -- The sticker must be legible and prominent on the product package through use of contrasting colors or other graphic devices and must be placed on the label of each product container.
Location -- It must be printed on or affixed to the product container. If affixed, it must be difficult to remove without residue or damage to underlying packaging or labeling and it must not be located on the bottom of the package 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. However, inner water soluble packages need not be modified under this approach.
Obscuring Existing Language -- The sticker must not obscure any information on the existing label.
Highlighting Specific Products in Brochures. EPA strongly encourages that the retailer highlight or clearly identify in the brochure the specific product(s) being sold or distributed to the end user. This will assist the end-user in quickly identifying the requirements for the specific product before pesticide application.
- Final printed WPS-complying replacement labeling
- Where relabeling may occur
WPS-related relabeling under this PR Notice may occur at any site (such as wholesale or retail sites) without registration of the site as a pesticide-producing establishment. Under this PR Notice, relabeling of stocks of products with non-complying labels may only be carried out by persons acting under the authority of the registrant as an "authorized agent" of the registrant.
- Required Actions
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How to revise product labels of Special Products to comply with the WPS
- Orphaned or Cancelled Products
These products are those whose registrants are no longer in business or have been cancelled pursuant to FIFRA Section 4 or 6. Both have not been transferred to another registrant (for "transfers" of registrations or "buyouts" see IV.B.)
EPA will allow sale or distribution of a pesticide product which is an orphaned or cancelled product, after October 23, 1995, provided the product labeling is first modified to comply with the requirements below. Labels of orphan or cancelled products may be modified by using a "STOP sticker" and generic supplemental labeling that is provided when the product is being offered for sale to the end-user and meets certain requirements as specified below. WPS-related relabeling under this PR Notice, including generic supplemental labeling may occur at any site (except a registrant's site) by any retailer or wholesaler.
The required generic supplemental labeling is attached to this notice (see Attachment 6). 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.
NOTE: ETHYL PARATHION PRODUCTS: Holders of stocks on products without WPS-complying labels may not use the option of generic supplemental labeling described below and should contact the registrant of such products or, if necessary, EPA for guidance.
Supplemental generic labeling specifications
Title -- The supplemental labeling must prominently bear the words "SUPPLEMENTAL LABELING WITH GENERIC WORKER PROTECTION REQUIREMENTS" at the top of the first page or be in a pouch prominently displaying the words "SUPPLEMENTAL LABELING WITH GENERIC WORKER PROTECTION REQUIREMENTS" attached to the container.
Content -- As appropriate to the type of product, the generic supplemental labeling must contain the complete text of the labeling contained in Attachment 6 in this notice.
Location -- EPA strongly encourages physical attachment of the supplemental labeling to product containers to ensure end-users receive the supplemental labeling. (Note: It is a violation of the WPS and this notice to sell or distribute products with non-complying labels or offer such products for sale, to the end-user without providing the appropriate supplemental labeling.) If the labeling is not attached, it must be located in close physical proximity to (i.e., immediately adjacent or next to) and accompany the product when the product is offered for sale to the end-user. See specifically Section II.B. 2 "Supplemental Product-Specific Labeling Specification" -- "Content" and "Highlighting" for information about cancelled or orphaned products listed in multi-product brochures.
Format -- The generic supplemental labeling should be similar to that attached to this notice, with all text legible.
"STOP Sticker" Specifications for Generic Supplemental Labeling
"Stickering" of orphaned or cancelled products is only allowed according to the specifications in Section III.B.2.
- Buy-out or transferred products
These are stocks of products that have been transferred to another registrant who has responsibility for the product's registration. The existing stocks have the original company's name and registration number.
The new registrant may choose one of the following options to deal with these products:
Recall and relabel/repackage -- Recall the products and repackage/relabel them at a registered establishment with final printed replacement labeling, or
Product-specific relabeling -- Conduct or authorize relabeling of products with either final printed product-specific, WPS-complying replacement labeling or supplemental product-specific replacement labeling and a "STOP sticker" that meets certain requirements. Relabeling must occur in accordance with Section II.B. See specifically Section II.B. 2 "Supplemental Product-Specific Labeling Specification" -- "Content" for information about including "transferred" products in multi-product brochures. Note: Generic Supplemental Labeling may NOT be used for these products.
- Deleted-Use Products
These are products for which the registrant has amended the registration to delete certain uses thereby making the product outside the scope of the WPS. There may be existing stocks of such products that still have the previous label and are thus within the WPS scope.
The registrant should choose one of the following options to relabel these products:
Recall and repackage/relabel -- Recall the products and repackage/relabel them at a registered establishment with the current labeling that has been amended to delete WPS uses.
Product-specific relabeling -- Conduct or provide a written authorization for relabeling of products with the current labeling that has been amended to delete any WPS uses. Products can be relabeled by replacing existing labeling with the current final printed replacement labeling or marking/blocking out all WPS uses and references to WPS uses (e.g., use directions).
If final printed replacement labeling is used, the amended labeling must completely block the previous label. It must be securely affixed to the product package and be difficult to remove without residue or damage to the underlying packing or labeling. If the option to mark/block out all WPS references is chosen, all WPS uses and references to WPS uses must be completely blocked and no other portions of the label text that remain unchanged must be altered or obscured.
If the registrant is unwilling to recall, relabel, or authorize relabeling as described above, you should contact EPA's Registration Division (703-305-6250) for instructions on how to proceed with those products.
- Dormant Products
These are products where no quantity of the product has been produced and distributed after April 21, 1994 and for which registrants elected to defer labeling amendments. If there are products left in the channels of trade, they must not be sold or distributed after October 23, 1995. In this situation, the registrant has these options:
Product-specific relabeling -- Amend the product registration to include the WPS requirements and either (1) recall and relabel/repackage or (2) conduct or provide a written authorization for relabeling of products at the product's location in accordance with Section III. of this notice.
Relabeling with non-WPS label -- Amend the product registration to delete any WPS uses and either (1) recall and relabel/repackage or (2) conduct or provide a written authorization for relabeling of products at the product's location with the updated, non-WPS label (follow Section IV.C); OR
Generic labeling -- Voluntarily cancel the registration and follow all requirements in Section IV. A., for orphaned or cancelled products, which describes relabeling with supplemental generic replacement labeling;
- Orphaned or Cancelled Products
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Waiver of submission of amended and final printed labeling which complies with this notice
Normally, amendments to labels and labeling are accomplished either by submission of an application or a notification to EPA. However, because the labeling of products subject to this notice has already been amended and because submission of the generic supplemental labeling and STOP stickers would serve no purpose, EPA waives the requirement for submission of any labeling or supplemental labeling which has been amended in accordance with this PR Notice [40 CFR 152.44(b)(1)]. Similarly, EPA waives the requirement for submission of final, printed labeling of generic supplemental labeling or STOP stickers which comply with this PR Notice.
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Deadline for relabeling and final sale
By October 23, 1996, all products being distributed or sold must bear final printed, WPS-complying, replacement labeling that conforms to III.B.1. of this PR Notice. Supplemental product-specific replacement labeling will NOT be allowed after this date. Retailers or wholesalers of orphan or cancelled products may still use generic supplemental replacement labeling and "STOP stickers" in accordance of IV. A. of this PR Notice after October 23, 1996.
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For further information and assistance
Information and assistance is available from an industry-sponsored "WPS Task Force" at 1-800-713-2291 after October 15, 1995.
Daniel M. Barolo, Director
Office of Pesticide Programs