CHAPTER 15 - OTHER TYPES OF REGISTRATIONS AND/OR APPROVALS THAT MAY BE NEEDED FROM FEDERAL OR STATE AGENCIES OTHER THAN EPA's PESTICIDE PROGRAMS A. GENERAL INFORMATION Although you may have obtained a Federal registration for your pesticide product, which allows you to distribute and sell your product in the U.S., there are state regulations that you may have to comply with before you can distribute and/or sell the product within that state. In addition, there may be other Federal, State, or local requirements that you must satisfy. The following listing is intended only to provide general information on some of these requirements, or to provide a point of contact. It should be noted that the listing is not all inclusive, nor is it complete. It is your responsibility to comply with all federal, state or local regulations. B. STATE REGULATION OF FEDERALLY REGISTERED PESTICIDES FIFRA Section 24(a) states that "A State may regulate the sale or use of any federally registered pesticide or device in the State, but only if and to the extent the regulation does not permit any sale or use prohibited by this Act". Even though you have obtained a Federal registration for your pesticide product which allows you to distribute and sell the product within the U.S., the various states in which you may wish to distribute and sell your product may have additional requirements for the regulation of pesticides within the state. The requirements vary from state to state, and may include additional data requirements, additional restrictions on pesticide use within their jurisdiction, and licensing requirements. You should contact each state in which you intend to market your product to determine what additional requirements may affect the sale, distribution or use of your product. WHO TO CONTACT: For additional information concerning state registration requirements for your Federally registered pesticide product, you should contact the pesticide regulatory authority in the state in which you intend to market your product. A listing of state regulatory authorities can be found in Chapter 18 of this manual. C. USE OF PESTICIDES IN MEAT AND POULTRY PLANTS Federally registered pesticides intended for use in federally inspected meat and poultry plants must be appropriately labeled and authorized by the U. S. Department of Agriculture (USDA). The Federal Meat Inspection Act, as amended by the Wholesome Meat Act of 1967, and the Poultry Products Inspection Act, as amended by the Wholesome Products Act of 1968, require the maintenance of safe and sanitary conditions in federally inspected meat and poultry plants. These Acts are enforced by the Animal and Plant Health Inspection Service through the Meat and Poultry Inspection Program (MPIP). The Inspection Program calls for the authorization of the use of substances and compounds in the plants, because use of such materials may result in adulteration or unwholesomeness of meat and poultry being processed. All chemicals produced in the U.S. for marketing to federally inspected meat and poultry plants must be evaluated by the USDA in order to provide assurance that the chemicals used in federally inspected plants are authorized for use and that their proper use will not result in adulteration or contamination of food products. 1. Labeling Requirements - Before directions for use in federally inspected meat and poultry plants can be accepted under the Federal Insecticide, Fungicide and Rodenticide Act, (FIFRA), you must obtain authorization from the USDA. Upon receipt of confirmation of USDA authorization, your product labeling can be amended to include the following statement: "Authorized by USDA for use in federally inspected meat and poultry plants." 2. Application for USDA Authorization - If you wish to have your product approved for use in a federally inspected meat or poultry plant, you must make an application to obtain authorization from the USDA. WHO TO CONTACT: For additional information on the use of pesticides in federally inspected meat and poultry plants, and where to obtain application forms for authorization from the USDA, contact: Product Assessment Division Compounds and Packaging Branch RP, FSIS, U.S. Department of Agriculture Building 306, BARC-East Beltsville, MD 20705 (301) 504-8566 D. USE OF PESTICIDES ON FOOD CONTACT SURFACES, FOR PAPER AND PAPERBOARD (FOOD USES), ON MEDICAL DEVICES, AS HUMAN AND ANIMAL DRUGS, AND IN CANE-SUGAR AND BEET SUGAR MILLS The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have several areas of mutual regulatory responsibility which may require review by one or both agencies. The following is a brief summary of these areas: 1. Sanitizers (pesticides used on food contact surfaces) Any pesticide product intended for sanitizing inanimate food contact surfaces must be approved by the FDA pursuant to 21 CFR 178.1010. Ingredients in these products are considered to be Indirect Food Additives. EPA will not register sanitizer products unless a food additive regulation has been issued for the active and inert ingredients or the ingredients are "generally recognized as safe" by FDA. Persons who wish to obtain FDA approval must submit a Food Additive Petition or similar request to: Division of Food and Color Additives (HFF-330) Food and Drug Administration 200 C Street, S.W. Washington, D.C. 20204 2. Microbiocides in paper and paperboard (food use) Other than EPA responsibilities under FFDCA and FIFRA, FDA evaluates the safety and efficacy of pesticides used in paper or other materials which are not themselves regulated as pesticides which come into contact with food. FDA must approve the ingredients of a pesticide as indirect food additives under 21 CFR Part 176 before EPA will approve a registration. Petitions or requests may be sent to the same address as in 1. above. 3. Antimicrobial pesticides used on medical devices An antimicrobial agent used on medical devices is considered by FDA to be an accessory to a medical device. Accordingly, FDA requires premarket notification under section 510(k) of the FFDCA for marketing of such agents. FDA reviews the safety and efficacy of these antimicrobial products. Approval by both FDA and EPA must be obtained before these products may be sold or distributed. Section 510(k) petitions may be submitted to: Division of Gastroenterology-Urology and General Use Devices Office of Device Evaluation Center for Devices and Radiological Health Food and Drug Administration (HFZ-332) 8757 Georgia Avenue Silver Spring, MD 20910 4. Human and Animal Drugs FDA and EPA have areas of mutual responsibility with respect to applications for drugs under FFDCA and for registration of pesticides under FIFRA. In 1971, FDA and EPA issued a Memorandum of Agreement stating which agency has primary or secondary responsibility on specific matters (See Federal Register Notice, 36 FR 24234). This agreement was updated in 1973 (38 FR 24233) and in 1979 (44 FR 63749). Briefly, EPA has primary jurisdiction for disinfectants and sanitizers, treatments of certain pests on animals, aquatic treatments solely for algae or bacterial slime, sanitizers for aquarium equipment, and sanitizers for inanimate surfaces or drinking water of animals which do not claim disease control. FDA has primary jurisdiction for new human or animal drugs, and products which are intended to: control parasites on humans, relieve the effect of insect bites, prevent diaper rash through treatment of diapers, treat athletes foot, treat certain animal diseases and pests, treat water for fish parasites or diseases, and treat drinking water to control animal parasites or diseases. Questions on these areas of jurisdiction may be referred to the EPA's Antimicrobial Program Branch. Refer to Chapter 18 of this manual. 5. Cane-sugar and beet-sugar mills Pesticides used for controlling microorganisms in cane-sugar and beet-sugar mills must be approved by the FDA under 21 CFR 173.320. Petitions may be directed to the following address: Division of Food and Color Additives (HFF-330) Food and Drug Administration 200 C Street, S.W. Washington, D.C. 20204 E. ANTIMICROBIAL FUEL ADDITIVES Any pesticide product intended for use in aviation fuel must have the approval of the Federal Aviation Administration (FAA) for use in aircraft engines. Persons who wish to obtain FAA approval must submit their request to: FAA Flight Standards Service Engineering and Manufacturing Division Federal Aviation Administration Washington, D.C. 20591 F. SHIPPING (TRANSPORTATION) OF PESTICIDES The U.S. Department of Transportation (DOT) and the Environmental Protection Agency (EPA) have several areas of mutual regulatory responsibility which may require review by one or both agencies. The Hazardous Material Transportation Uniform Safety Act, as amended in 1990, requires that pesticides being shipped are properly packaged, marked and labeled. If the pesticide to be shipped is considered a hazardous material, it will need to bear the proper DOT Hazard Warning Labels prominently on the product labeling. Also, depending upon the size of the shipment, trucks may need to be placarded. If you wish to transport pesticides which may present physical or chemical hazards, you must obtain shipping papers from DOT prior to such shipment. WHO TO CONTACT: For additional information on the transportation of pesticides, and how to obtain shipping papers, contact: Office of Hazardous Material Standards Department of Transportation ATTN: Ed Mazzullo Rm. 8100 400 7th St., SW Washington, DC 20590-0001 Phone: (202) 366-4488 G. NON-INDIGENOUS AND GENETICALLY ENGINEERED MICROBIAL PRODUCTS INCLUDING KILLED MICROBIALS 1. Toxic Substances Control Act (TSCA). Products of recombinant DNA technology are also regulated by EPA under TSCA by the Office of Pollution Prevention and Toxics (OPPT) during stages of production before the products become pesticides (such as during fermentation). A Pre-Manufacturing Notice (PMN) may be required for these products. PMNs are not required while the product is under research and development (such as under an EUP), and are also not required for nonindigenous or trans-conjugant organisms. For information on TSCA requirements related to microbial pesticide production contact: EPA Office of Pollution Prevention and Toxics Chemical Control Division Program Development Branch Kathleen Bailey (202) 260-5591 or David Giamporcaro (202) 260-6362 2. U.S. Department of Agriculture (USDA). Any organism (including plants) may be considered a potential plant pest. Such organisms may be regulated under either the Plant Pest Act and/or the Plant Quarantine Act. Such organisms may require a permit for import and/or introduction testing, and use. For information on USDA permit requirements contact: USDA Animal and Plant Health Inspection Service Sally McCammon (301) 436-8761 John Payne (301) 436-8378