September 3, 1991 PR NOTICE 91-4 NOTICE TO MANUFACTURERS, FORMULATORS, PRODUCERS AND REGISTRANTS OF PESTICIDE PRODUCTS Attention: Persons Responsible for Registration of Pesticide Products Subject: Label Improvement Program (LIP) for Pesticides - For Products Containing DEET This Notice applies to registrants of any end-use pesticide product registered for human use under FIFRA containing the active ingredient DEET. Based on information currently available to the Environmental Protection Agency (the Agency) concerning the potential human health risks associated with the use of pesticide products containing DEET, the Agency believes that, in order to remain in compliance with the requirements of FIFRA, registrants of these products should revise the labeling for such products to include additional use directions and other statements described in this Notice. No end-use pesticide products labeled for human use should be released for shipment by a registrant or producer of that product after August 30, 1992, unless the product bears an amended label which complies with the LIP. If affected products do not incorporate these label changes, we may take action under Section 6 of FIFRA to suspend or cancel the registrations of those products. I. THE LABEL IMPROVEMENT PROGRAM On June 5, 1980, the Agency announced the establishment of a Label Improvement Program under which labels of products were to be upgraded, improved, or revised to meet current labeling standards. Notice of this program was issued in the Federal Register and provided to all registrants as PR Notice 80-1. This Notice is issued under that LIP. Pesticide labels are required to contain directions for use which are necessary for effecting the purpose for which the product is intended and are adequate to protect health. The label revisions specified by this Notice, if adhered to by the users, will decrease the likelihood of adverse health affects from possible misuse or overuse of DEET products. The Agency has received reports of adverse reactions from topical applications of the repellent N,N-diethyl-m-toluamide, commonly known as DEET. Most adverse reactions appear to involve accidental exposure, such as swallowing or spraying into the eye, although some skin reactions could be due to high rates of application and repeated applications at too frequent intervals. While most complaints involve transient skin or eye irritation, relatively rare cases of toxic encephalopathy in young children after frequent topical application or excessive exposure have been reported. The Agency is aware of less than 10 reports of neurological intoxication as a result of dermal application. DEET has not been confirmed as a causal agent in these cases, but the Agency is concerned that there may be individuals that are sensitive to DEET exposure. High rates of application or frequent application of DEET to repel ticks and other vector-borne pests may also contribute to such incidents. In all cases, The Agency believes that incremental costs will be outweighed by the benefits of having comprehensive and appropriate label use directions which encourage the proper and responsible use of DEET products. II. PESTICIDE PRODUCTS TO WHICH THIS NOTICE APPLIES The requirements of this Notice apply to any end-use pesticide product registered for use on humans containing DEET. III. LABEL STATEMENTS TO BE ADDED Based on the described health concerns, we believe the labeling for DEET products does not meet the statutory guidelines under FIFRA. Add the following statements to the Directions for Use for all end-use DEET products registered for human use. o At the beginning of directions for use add in bold print, "Read all directions before using this product." o Do not spray in enclosed areas. (For sprays or aerosols only) o Do not apply over cuts, wounds, or irritated skin. o Do not apply to eyes and mouth and do not apply to the hands of young children. Do not spray directly on face. o Use just enough repellent to cover exposed skin and/or clothing. Do not use under clothing. Avoid overexposure. Frequent reapplication and saturation is unnecessary for effectiveness. o After returning indoors, wash treated skin with soap and water. Wash treated clothing. o Use of this product may cause skin reactions in rare cases. If you suspect that you or your child is reacting to this product, wash treated skin and call your local poison control center. If you go to a doctor, take this repellent with you. IV. WHAT TO DO TO COMPLY If your product is subject to this Notice, take one of the following actions: 1. Revise your product labels in accordance with this Notice by adding all of the language identified in section III and not change your label in any other manner. If you choose this option, submit the following to the Agency: a. A letter indicating your intent to adopt the label language as specified no later than September 30, 1991. A single letter may be submitted listing all affected products. b. A copy of the final printed labeling as revised; and a certification, signed by an authorized representative of your company, that the labeling as revised is in compliance with the requirements of this Notice no later than August 31, 1992. 2. If you wish to modify the required LIP statements in any substantive manner or include other label changes, submit an application for amended registration, together with five copies of the proposed labeling no later than September 30, 1991. Please identify what requested changes you are making. Applications must be submitted to the appropriate Product Manager at EPA for all Federally registered products and acceptance must be obtained from EPA prior to distribution of the product with the amended label. V. COMPLIANCE DATES All subject products released for shipment after August 31, 1992, must bear the revised labeling. Products not in compliance as of this date will be deemed to be misbranded in violation of FIFRA sec. 12(a)(1)(E). The Agency may take enforcement action, issue Notices of Intent to Cancel the product's registration in accordance with FIFRA sec. 6, or both. Registrants are reminded that: A. A copy of the revised final printed label and, if appropriate, a certification statement must be submitted to the Agency prior to product distribution under the label. Revised labeling must be submitted by August 31, 1992. B. It is the responsibility of the registrant to ensure that his/her distributors (sub-registrants) comply with these requirements within the time frames given. VI. FOR FURTHER INFORMATION If you have questions regarding this Notice, contact Robert S. Brennis, Registration Division, Insecticide/Rodenticide Branch at (703)557-0688. Anne E. Lindsay, Director Registration Division (H7505C) ----------------------- CERIS-Net Posting Date: 05.07.96 DISCLAIMER: PR Notices are obtained by CERIS/NPIRS from the U.S. EPA gopher server in text format. This information is available by anonymous FTP from ceris.purdue.edu in the pub/info/prnotice directory.