Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Purpose To govern the use, sale, and labeling of pesticides Scope All pesticide manufacturers must submit data regarding the safety and efficacy of their pesticides Implementation of the program is by the EPA; but where a state has a federally approved pesticide program, the state is the primary enforcement authority

History & Antecedents of FIFRA FIFRA is almost exclusively a “federal” act in that states are given little authority to deal with the regulatory issues addressed by FIFRA Modified over time in an attempt to achieve the goal of protecting humans and the environment In its original iteration, FIFRA dealt more with form, such as the information on pesticide labels, than it did with the substance of protecting humans and the environment

Pesticides Pesticide Defined as any substance intended for “preventing, destroying, repelling or mitigating any pest” or any substance intended for use as a “plant regulator, defoliant or dessicant” Herbicides Chemical agents used against plants Insecticides Chemical agents used against insects Fungicides Chemicals used against fungi Rodenticides Chemical substances used against rodents Office of Pesticide Programs (OPP) The office the EPA uses to track registration of pesticides

Registration Criteria Unreasonable adverse effects A term defining the standard used in registering pesticides pursuant to FIFRA Defined as “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of the pesticide” Labeling The process of affixing warnings and information regarding pesticides to pesticide containers Enforcement

Evaluating Pesticides for Registration 4 conditions must be met before a pesticide can be registered The composition of the pesticide must be such as to warrant the proposed claim for it The labeling and other materials for the pesticide must comply with the provisions of FIFRA The pesticide will perform its intended function without unreasonable adverse effects on the environment When used in accordance with common practice, the pesticide will not generally cause unreasonable adverse effects on the environment

Registration of Pesticides Types of Registration Conditional Registrations Authorized by FIFRA under a section entitled “Registration Under Special Circumstances” that provides for conditional registration for pesticides identical or very similar to currently registered products new uses for existing pesticide registrations pesticides containing active ingredients not contained in any currently registered pesticide for which data needs to be obtained for registration Notice of Rebuttable Presumption Against Registration (RPAR) When a RPAR has been issued for a pesticide, conditional registration is not permitted

Registration of Pesticides (cont.) Reregistration “Me-too” pesticides Featherbedding Trade Secrets 2 Types of Registered Use General Use Registration Preferred over restricted use registration Restrictions, other than FIFRA restrictions and requirements, are not imposed on the sale and use of a pesticide Restricted Use Registration EPA restrictions imposed to mitigate identified potential harmful effects that are not severe enough to prevent registration but require mitigation in some manner Effects of Registration Cancellation of Registration

FIFRA Suspension Orders Generally Sought by the EPA administrator when it is believed that a pesticide presents an “imminent hazard” or an imminent risk The sale, distribution, and use of a pesticide is immediately suspended 2 Types Emergency Suspensions Infrequently used An order immediately suspending the sale, distribution, and use of a pesticide where the EPA administrator believes it poses an imminent risk/hazard No opportunity for a hearing Action is taken ex parte To overturn an emergency suspension order, a party must demonstrate that the order was arbitrary, capricious, an abuse of discretion, or “not issued in accordance with the procedures established by law” Ordinary Suspensions An order suspending the sale, distribution, and use of a pesticide because the EPA administrator believes it to be an imminent risk/hazard This differs from an emergency suspension in that with an ordinary suspension, the registrant has an opportunity to request an expedited pre-order hearing

How Much Risk is Needed for Purposes of a FIFRA Suspension Order? 5 Factors Used to Analyze Risk The seriousness of the threatened harm The immediacy of the threatened harm The probability that the threatened harm would result The benefits to the public of the continued use of the pesticides in question during the suspension process The nature and extent of the information before the administrator at the time the decision is made

Enforcement Written warning In lieu of a written warning, the EPA can issue a stop sale, use, or removal order or seek a seizure order from the federal court Civil penalties Range from upward of $1,000 per violation for private users or applicators to upward of $5,000 for violations by a registrant, wholesaler, retailer, or distributor Mitigating or aggravating factors used by the EPA to determine the amount of the fine requested, the effect of the fine on the viability of the business, and the seriousness of the violation Criminal penalties May be imposed for knowing about FIFRA violations Fines up to $1,000 for a user or applicator and fines up to $25,000 for a firm Jail sentences may be imposed for officers of a firm or private users or applicators