United States Environmental Protection Agency Prevention, Pesticides And Toxic Substances (7508W) EPA-738-F-94-004 April 1994 R.E.D. FACTS Pesticide Reregistration Use Profile Regulatory History Periplanone B All pesticides sold or distributed in the United States must be registered by EPA, based on scientific studies showing that they can be used without posing unreasonable risks to people or the environment. Because of advances in scientific knowledge, the law requires that pesticides which were first registered years ago be reregistered to ensure that they meet today's more stringent standards. In evaluating pesticides for reregistration, EPA obtains and reviews a complete set of studies from pesticide producers, describing the human health and environmental effects of each pesticide. The Agency imposes any regulatory controls that are needed to effectively manage each pesticide's risks. EPA then reregisters pesticides that can be used without posing unreasonable risks to human health or the environment. When a pesticide is eligible for reregistration, EPA announces this and explains why in a Reregistration Eligibility Decision (RED) document. This fact sheet summarizes the information in the RED for Periplanone B. Periplanone B, a biochemical pesticide, is the specific sex-attractant pheromone of the American cockroach, Periplaneta americana. It currently is used as a lure or bait in conjunction with another pesticide (propoxur) in one registered pesticide product. Periplanone B has an extremely low use rate of less than one microgram per bait. It is impregnated into bait material that is pressed onto an open four-by-six inch tray. One of these bait packages is used per 100 square feet of area to be treated. Periplanone B was first registered as a pesticide in the U.S. in 1984. Currently, only one product is registered which contains this active ingredient, "Lure N Kill Roach and Ant Killer with Roach Sex Lure," which contains 0.001% Periplanone B and 10% propoxur. Because of its nature and extremely low usage rate, EPA applied a reduced set of data requirements for reregistration of Periplanone B. ------- Human Health Assessment Environmental Assessment Toxicity Acute mammalian toxicity studies on the currently registered end use product indicate that Periplanone B is of low acute toxicity. It is placed in Toxicity Category IV, indicating the lowest level of acute toxicity, for acute oral and primary eye irritation effects. It is slightly to moderately toxic in acute dermal, acute inhalation and primary dermal irritation studies, and has been placed in Toxicity Category III for these effects. It is not a skin sensitizer and does not cause mutagenic effects. Because the potential for human exposure to Periplanone B is negligible, all other toxicology data requirements are waived. Dietary Exposure The potential for dietary exposure to Periplanone B is considered negligible because of its application method—its labeling prohibits contamination of food—and because of the ultra-low amounts in the single registered product. Occupational and Residential Exposure Since use of Periplanone B results in little exposure and does not pose significant toxicological concerns, no exposure data are required. Human Risk Assessment The potential risks to humans from use of Periplanone B are considered negligible due to the pesticide's application method (low volume use in a bait product), low dietary and non-dietary exposure, and low level of toxicity. Environmental Fate No environmental fate data are required for biochemicals like Periplanone B, which cause no adverse effects in acute toxicology tests of fish, birds and aquatic invertebrates. Ecological Effects EPA waived all ecological effects data requirements for Periplanone B because this biochemical is used primarily indoors in very small quantities; is a synthetic duplicate of a natural sex pheromone; and rapidly and completely degrades to biologically inactive compounds when exposed to light and air. Ecological Effects Risk Assessment Both environmental exposure and ecological risk are expected to be negligible when Periplanone B is used according to label directions and precautions. ------- Additional Data The data base for Periplanone B is considered complete, and EPA is RedUJr0d n°t requiring any additional generic or product specific studies. Only a new Confidential Statement of Formula and revised labeling must be submitted for reregistration of the product containing this pesticide. Product Labeling Changes Required The single registered product containing Periplanone B must comply with EPA's current pesticide product labeling requirements. In addition: Application Rates - Product labeling must be revised to include a specific maximum application rate: "Use one baited tray per 100 square feet of surface to be treated or up to X trays per 100 square feet if infestation is widespread." Documentation of the rationale behind the maximum number of trays per 100 square feet must be submitted. Replacement Directions - Labels must read: "Replace insecticidal baits after 30 days to prevent cockroach infestation." Emphasize Non-Food Use - Use site labeling should say, "For use in homes, for use in non-food areas of schools, theaters, warehouses, motels, hotels, and commercial, industrial and institutional establishments. For use in non-food areas of restaurants and food-handling establishments." Directions for Use - Add the word "residential" before "kitchen." Regulatory Conclusion For More Information Use of the currently registered pesticide product containing Periplanone B in accordance with approved labeling will not pose unreasonable risks or adverse effects to humans or the environment. Therefore, all uses of this product are eligible for reregistration. This product will be reregistered once the required revised labeling is received and accepted by EPA, and when the other active ingredient in the product also is eligible for reregistration. EPA is requesting public comments on the Reregistration Eligibility Decision (RED) document for Periplanone B during a 60-day time period, as announced in a Notice of Availability published in the Federal Register. To obtain a copy of the RED document or to submit written comments, please contact the Pesticide Docket, Public Response and Program Resources Branch, Field Operations Division (7506C), Office of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone 703-305-5805. ------- Following the comment period, the Periplanone B RED document will be available from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650. For more information about EPA's pesticide reregistration program, the Periplanone B RED, or reregistration of individual products containing Periplanone B, please contact the Special Review and Reregistration Division (7508W), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000. For information about the health effects of pesticides, or for assistance in recognizing and managing pesticide poisoning symptoms, please contact the National Pesticides Telecommunications Network (NPTN). Call toll- free 1-800-858-7378, from 8:00 am to 6:00 pm Central Time, Monday through Friday. ------- |