UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 December 30, 1991 PR NOTICE 91-7 NOTICE TO MANUFACTURERS PRODUCERS FORMULATORS AND REGISTRANTS OF PESTICIDES ATTENTION: Persons Responsible for the Federal Registration of Pesticides SUBJECT: False and Misleading Statements I. PURPOSE: This notice articulates EPA's current policy with respect to the use of label claims such as "professional strength", "extra strength", and other similar unquantified claims of heightened efficacy, and sets forth the actions registrants should take to remain consistent with the requirements of FIFRA. II. BACKGROUND: In the 1960s and early 1970s USDA and later EPA permitted certain pesticide labeling to bear claims such as "professional strength", "extra strength", "hospital strength", "extermination strength" and similar unquantified claims of heightened efficacy. In the late 1970s and early 1980s, EPA reevaluated this policy and determined for several reasons that such claims were unacceptable, and therefore, not permitted on new or amended labels, and should be removed from existing labels. The basis for the Agency's decision was that such label claims are false or misleading and therefore constitute misbranding under section 2(q)(1)(A) of FIFRA for the following reasons. First, terms such as "professional strength" or "extermination strength" misleadingly imply that these products contain higher percentages of active ingredients or more effective active ingredients than other products on the market. When EPA reviewed the list and percentages of ingredients in these products, however, the Agency found that products bearing such claims of heightened efficacy were generally no different from other products in either strength or percentage of active ingredient. Second, because such claims appear on EPA approved labeling, they could mislead consumers into believing that EPA has assessed such efficacy claims, or created efficacy classifications for these products when in fact EPA does neither. Finally, EPA is concerned that such claims may at times be confused with required statements for restricted use pesticides which permit sale to and use only by certified applicators. Because of the risks posed by restricted use pesticides, the Agency believes it is important that the distinction between restricted use and unrestricted pesticides remains clear to retailers, purchasers and applicators. Although EPA has not approved new labeling bearing these types of claims for many years, and has consistently taken the position that such claims are unacceptable, there are still products in the marketplace that contain them. While the reregistration process will ultimately ensure that these unacceptable claims are removed from pesticide labels, this will take a number of years to accomplish. Additionally, the Agency still receives label amendments and new registration applications that contain these types of misleading label claims. Accordingly, the Agency has issued this PR Notice to inform current and future registrants that such claims will no longer be permitted on pesticide labeling. III. Requirements To remain consistent with the requirements of FIFRA, claims such as "professional strength", "extra strength" and similar statements must be removed from pesticide labeling. If these claims are part of the product name, then a new name for the product must be proposed. All such modifications to product labeling wording must be submitted as proposed amendments on the EPA application form 8570-1. In the block headed "nature of the action" make the following notation: "Modification to product label in accordance with PR Notice 91-7." The amendment must be accompanied by five (5) copies of the proposed revised labeling. All applications must be sent to the Registration Division Product Manager to whom the product is assigned by March 30, 1992 (3 months from the date of the notice). Failure to submit an application for amendment and revised labeling may result in the Agency's issuance of a Notice of Intent to Cancel your product. Because the claims addressed by this Notice may take many forms, the Agency realizes that it may not be clear to some registrants whether this Notice applies to certain labeling claims. If you are unsure whether certain label statements on your product labeling are subject to this Notice, please contact your Product Manager. All products distributed or sold by registrants and supplemental distributors (i.e., supplemental registrants) after Dec. 30, 1992 (12 months from the date of this notice) must bear labeling which is consistent with this notice and complies with FIFRA. All products distributed or sold by persons other than the registrant or supplemental registrant after Dec. 30, 1994 (36 months from the date of this notice) must bear labeling which is consistent with this notice and complies with FIFRA. IV For Further Information You may call Dennis Edwards, Insecticide-Rodenticide Branch, RD at (703)305-6386 if you have any questions about this notice. Anne E. Lindsay, Director Registration Division ---------------------------- CERIS-Net Posting Date: 04.01.92 DISCLAIMER: Beginning 01.92, PR Notices have been sent to CERIS/NPIRS on diskette 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. See also, PR Notice 92-6a, Ammendment PR Notice 91-7