CHAPTER 14 - STATE REGULATORY AUTHORITY UNDER FIFRA A. STATE ISSUANCE OF EXPERIMENTAL USE PERMITS Section 5 of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) authorizes any State to issue an experimental use permit for a pesticide in accordance with a State plan approved by the Agency. 40 CFR Part 172, Subpart B - State Issuance of Experimental Use Permits, provides detailed information on state experimental use permits. In general, authorized states can issue experimental use permits for the purpose of gathering data necessary to support the State registration of a pesticide to meet special local needs under FIFRA Section 24(c) and for the purpose of experimentation. To date, Idaho, Florida and Vermont have received authorization from the Agency to issue state experimental use permits. WHO TO CONTACT: For additional information concerning state EUPs, you should contact the pesticide regulatory authority in the state in which you wish to obtain a state EUP. A listing of the state regulatory agencies can be found in Chapter 18. B. STATE REGISTRATION OF SPECIAL LOCAL NEEDS FIFRA Section 24(c) authorizes a State to provide registration for additional uses of federally registered pesticides formulated for distribution and use within that State to meet special local needs in accordance with the provisions of the Act. 40 CFR Part 162, Subpart D - Regulations Pertaining to State Registration of Pesticides to Meet Special Local Needs, provides detailed information on the scope and authority of the states to issue registration of pesticide products. Under FIFRA Section 24(c), states are authorized to register new end-use products or additional uses of federally registered pesticides if the following conditions exist: 1. a special local need for that product use, 2. the use, if a food or feed use, is covered by an appropriate tolerance or has been exempted from the requirement of a tolerance, 3. registration for the same use has not previously been denied, disapproved, suspended, or canceled by EPA, or voluntarily canceled by the registrant because of health or environmental concerns about an ingredient contained in the product, unless EPA has reversed the original action, 4. the registration is in accord with the purposes of FIFRA. 24(c)s which amendments federal registrations (new uses). States may register: 1. subject to the limitations set forth in 40 CFR Part 162, any new use of a federally registered pesticide product. 2. any use of a federally registered product for which registration of other uses of the product was denied, disapproved, suspended, or canceled by the EPA, provided that the proposed use was not considered by the EPA in reaching such a determination and only after the State consults with appropriate EPA personnel on its acceptability. 3. any use of a federally registered product for which registration of some or all uses has been voluntarily canceled by the registrant unless such voluntary cancellation follows the issuance of an EPA Notice of Intent to cancel for human health or environmental reasons. States may only grant 24(c) registrations for voluntarily canceled uses of products after consulting with appropriate EPA personnel. IMPORTANT NOTE: A State may not register an amendment to a federally registered manufacturing-use product. 24(c)s which are new products (not previously federally registered). States may register: 1. a product which is identical in composition to a federally registered product, but which has differences in packaging, or in the identity of the formulator, 2. a product which contains the same active and inert ingredients as a federally registered product, but in different percentages, 3. a product containing a new combination of active, or active and inert, ingredients only if each of the active ingredients in the new product is present because of the use of one or more federally registered products and if each of the inert ingredients in the new product is contained in a federally registered product, 4. a product containing an ingredient that (1) has had one or more of its formulations or uses denied, disapproved, suspended, or canceled by EPA because of human health or environmental concerns or (2) the registrant has voluntarily canceled a formulation or use following the issuance of an EPA Notice of Intent to Cancel because of health or environmental concerns, provided the 24(c) formulation and/or use was not considered in EPA's action and was not included in a Notice of Intent to Cancel and only after the State consults with appropriate EPA personnel regarding the acceptability of the 24(c) application. IMPORTANT NOTE: A State may not register a new manufacturing-use product. Requests for Special Local Need (SLN) registrations are generally made by pesticide companies to the specific state. Once a state approves the application, the state then forwards notification of the SLN registration to EPA for review. Provided the state has complied with the requirements of FIFRA section 24(c) and 40 CFR Part 162, the registration becomes effective immediately. The EPA has 90 days from receipt of the SLN notification from the state to disapprove the registration. Otherwise it becomes a Federal registration under FIFRA section 3 for the use only within the state. General Disapproval of State Registration EPA may disapprove any state registration on any reasonable grounds (excluding solely lack of essentiality), any state registration which, when compared to a federally registered product, does not have both a similar composition and use pattern. Grounds for disapproval may include, but are not limited to: 1. the 24(c) will probably create an unreasonable adverse effect upon man and/or the environment; 2. the refusal of the registering State to submit information supporting the registration, i.e., application form (within 10 working days), Labeling for the 24(c), Confidential Statement of Formula (new product only), final printed label (within 60 days), State revocation notice with date of revocation and reason(s) for revocation, and scientific studies supporting a "no unreasonable adverse effects" findings by the State (within 15 working days); 3. Failure of the information submitted by the State to support the State decision to issue the 24(c); Special Disapproval of State Registrations EPA may disapprove any SLN registration at any time (even beyond the 90 day period) if it is determined that the 24(c): (a) would constitute an imminent hazard; (b) may result in a residue on food or feed exceeding, or not covered by, a tolerance, exemption, or other clearance under the FFDCA. Once the SLN is registered under FIFRA, it is subject to any additional data requirements that may be required by the EPA either as the result of a Registration Standard or any other FIFRA Section 3(c)(2)(B) data call-in. FEE REQUIREMENTS FOR SLN'S The 1988 amendments to FIFRA requiring that annual maintenance fees be paid by registrants of pesticide products apply to registrations under Section 24(c) of FIFRA. You should refer to Chapter 8 for a discussion of registration maintenance fees. C. EMERGENCY EXEMPTIONS FIFRA section 18 authorizes the Administrator to exempt State and Federal agencies from any provision of FIFRA, if he determines that emergency conditions exist which require an exemption. The regulations in 40 CFR Part 166 establish procedures by which the Administrator may exempt a Federal or State agency from the provisions of FIFRA which regulate the manner in which a pesticide is made available for use or is used. There are four types of emergency exemptions which may be authorized: 1. Specific exemption. A specific exemption may be authorized in an emergency condition to avert a significant economic loss, or a significant risk to endangered species, threatened species, beneficial organisms, or the environment. EPA shall allow the use of a pesticide under a specific exemption for as long a period as is reasonably expected to be necessary but in no case for longer than 1 year. 2. Quarantine exemption. A quarantine exemption may be authorized in an emergency condition to control the introduction or spread of any pest new to or not theretofore known to be widely prevalent or distributed within and throughout the United States and its territories. EPA shall allow use of a pesticide under a quarantine exemption for as long a period as is deemed necessary but in no case for longer than 3 years. Quarantine exemptions may be renewed. Interim reports containing the information specified in 40 CFR 166.32(b) to the extent available shall be filed annually. 3. Public health exemption. A public health exemption may be authorized in an emergency condition to control a pest that will cause a significant risk to human health. EPA shall allow the use of a pesticide under a public health exemption for as long a period as is reasonably expected to be necessary but in no case for longer than 1 year. 4. Crisis exemption. A crisis exemption may be utilized in an emergency condition when the time from discovery of the emergency to the time when the pesticide use is needed is insufficient to allow for the authorization of a specific, quarantine, or public health exemption. The crisis provisions may not be utilized to authorize a pesticide use if any of the following has occurred: - EPA has informed the head of the Federal or State agency, the Governor, or their official designee, not to issue such an exemption; - The pesticide use has been suspended under section 6(c) of FIFRA; - The pesticide use has been canceled following a notice issued under section 6(b) of FIFRA; - The pesticide contains a new chemical; or - The application proposes the first food use of a pesticide. A crisis exemption may be authorized for: (a) only as long as is necessary to control the pest or conditions causing the emergency; (b) no longer than 15 days, unless an application requesting a specific, quarantine, or public health exemption for this use has been submitted to the Agency. The documents EMERGENCY EXEMPTIONS UNDER SECTION 18 OF THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT: I. Guidance for State and Federal Agencies, and II. Instructions for submission of emergency exemption applications can be obtained from the National Technical Information Service (NTIS) by calling (703) 487-4650. If you have any questions, or require any further information, please call the Communications Branch in OPP's Field Operations Division at (703) 305-5017. WHO TO CONTACT: Additional information concerning applications for a state special local need registration should be addressed to the state in which you wish to make an application for a SLN registration. A listing of the various state pesticide agencies can be found in Chapter 18 of this manual. D. REFERENCES CITED IN CHAPTER 14 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 162 - State registration of pesticide products Part 166 - Exemption of Federal and State agencies for use of pesticides under emergency conditions Part 172 - Experimental use permits 2. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988 Section 3 - Registration of pesticides Section 5 - Experimental use permits Section 18 - Exemption of Federal and State agencies Section 24 - Authority of states