Expanding the use pattern of a 3 label would be inappropriate if the added exposure would raise human or environmental risk concerns. 94 136w-3 28. EPA reviews the individual 24(c) registrations and broadly oversees the states' 24(c) registration programs. 11. A 24(c) registration must meet all the requirements of a 3 registration, and there must be data to support the use. No. EPA recommends that section 24(c) actions be granted for five years or less. FIFRA 24(c) SPECIAL LOCAL NEED LABEL (SLN) FOR DISTRIBUTION AND USE ONLY IN THE STATE OF CALIFORNIA For Aerial Application to Almonds; Citrus Fruit Crop Group 10-10; Stone Fruit, Crop Group 12-12 with Standing Water Quadris Top Fungicide EPA Reg. 1200 Pennsylvania Ave., N.W. This approach will respect the states' independence and responsibilities while allowing EPA to carry out its review function with minimal resources. The state should inform the EPA Regional Office of enforcement and follow up with appropriate enforcement action. 12. 21. However, use may continue unless the disapproval notice states otherwise. The Agencys experience with such studies is that it is quite unlikely a seed treatment will be considered a non-food use. To ensure the section 24(c) process is being implemented in accordance with applicable requirements, in addition to the Agencys initial review, EPA also evaluates section 24(c) registrations associated with a pesticide that is undergoing Registration Review for unreasonable adverse effects, appropriate tolerances and problematic use patterns. It is not intended, nor can it be relied upon, to create any rights enforceable by any party in litigation with the United States. Application for Section 18 Emergency Exemption, PDF (147 kb) Section 18 Emergency Exemption search. CA-200004 Reasons for disapproving these types of special local need registrations include, but are not limited to: Under 40 CFR 162.154(b), EPA may disapprove any special local needs registration at any time (even beyond the 90-day period) if it is determined that the registration: Once the special local needs use is registered under FIFRA, it is subject to any additional data requirements that may be required by EPA either as the result of a Reregistration Eligibility Decision Document, registration review, or other FIFRA section 3(c)(2)(B) data callin. The state would need to provide a clear explanation of the benefits and data to support the special local need. FIFRA Section 24(c) Special Local Need Label FOR DISTRIBUTION AND USE ONLY WITHIN THE STATE OF CALIFORNIA For Aerial Applications to Almond, Pistachio and Stone Fruit (Group 12) with Standing Water LUNA EXPERIENCE EPA Reg. Contact for More Information: 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. Refer to Chapter 19 for information on the source of these documents. Issue: When does a pest problem become regional or national in scope so that it should no longer qualify for 24(c) registration? The state should encourage the registrant to cancel the 24(c) with EPA either by filing a voluntary cancellation request or by not paying the annual pesticide registration maintenance fee. Response: There is no specific date before which residue data were generated that leads to automatic rejection of those data. 1 FIFRA 2 1-1So in original. 7 U.S.C. circumstances under which the EPA Administrator may disapprove or invalidate a special local needs registration. The Agency has already called in data for most chemicals under either the registration or registration review programs. Issue: What type of information does EPA need to keep a SLN for seed use non-food? Issue: How does a registrant or state notify EPA in order to voluntarily cancel a 24(c) registration? 31. 3. Following an evaluation of the statutory requirements, and after communicating with leaders from the Association of American Pesticide Control Officials, EPA has concluded that state registrations that limit or restrict use of pesticides registered by EPA are beyond the scope of FIFRA section 24(c), and that such registrations should be disapproved. Under the authority of 24(c) of FIFRA, states may register an additional use of a federally registered pesticide product, or a new end-use product, to meet special local needs. UNICORN DF Agriculture Safety Data Sheet; Filter. In general, authorized states can issue experimental use permits only 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. However, the product would continue to be registered with EPA unless the fees were not paid or other appropriate action under 6 occurred. SECTION 1. 8 above gives the EPA the ability monitor compliance and appropriateness of section 24(c) registrations issued within a state for a particular pesticide. However, EPA did receive numerous comments from stakeholders and EPA has provided feedback accordingly. Issue: How can states find out if EPA canceled the special local need; for instance, for failure to pay maintenance fees? A copy of the labeling approved by the state. Registrants should contact the appropriate state for information on obtaining a state registration. Refer to. If a state wishes to further restrict use of a pesticide, it may consider doing so under section 24(a) of FIFRA. Registrations for which the fee is not paid are subject to cancellation by order and without a hearing. (a) SHORTTITLE.This Act may be cited as the ''Federal Insec- States need a list of people they can call on for a given registration to ask about special requests (i.e., residue data requirements on seed crops, environmental fate questions, residue data comprehensiveness questions, labeling format, precautionary statements on a 24(c) registration). It can be a copy of a letter sent to the state or can be sent directly from the registrant. Given the statutory time period for EPA review under section 24(c), EPAs review of SLN was not intended to be and is not the equivalent of its review of new registration actions under section 3. If new data becomes available that resolves the Agency's health or environmental concerns, a 24(c) may be submitted. Response: Yes, a 24(c) registration should not be issued under any circumstance that would trigger further data requirements for a 3 registration to be issued. A copy of proposed labeling, including all claims made for the product as well as directions for its use to meet the special local need, consisting of: for a new product, a copy of the complete proposed labeling; or. Spin-Aid Agriculture Label; FIFRA SECTION 2ee FOR THE USE OF SPIN-AID HERBICIDE- AZ and CA. In either case the figures would allow an estimate of the dilution of residues due to growth of the plant. State contact information can be found at the. Issue: Can 24(c) be used to implement special programs such as groundwater, endangered species, worker protection, etc. Generally speaking, If the same 24(c) registration is issued in more than five (5) states, states should start to question if the pest problem is a "special local need" and not "interregional" or "national" in scope. Use of a product for which other uses of the same product, or uses of a product of similar composition, have had registration denied, disapproved, suspended or canceled by the Administrator. Response: Yes. Evidence must exist that the pest(s), use patterns, and climatic conditions for the proposed use under the 24(c) is the same or substantially similar to situations where resistance has been documented, e.g., similar pests, use patterns, and climatic conditions. The SLN permits distribution and use only in the registering state. In those cases where the application timing does not satisfy the first condition, there are two other possible means of meeting that condition: (A) The state in which the registration is sought provides assurance through some regulatory process that the seed crop will not be diverted to food or feed. A lock (LockA locked padlock) or https:// means youve safely connected to the .gov website. Registration for the same use has not previously been denied, disapproved, suspended, or canceled by the Administrator, or voluntarily canceled by the registrant subsequent to issuance of a notice of intent to cancel because of health or environmental concerns about an ingredient contained in the pesticide product. Response: For complicated or novel cases, the state should contact the appropriate EPA lead with specifics on the proposed 24(c) registration. State-Specific Registrations: Under Section 24 (c) of FIFRA, states can register a new pesticide product for any use, or a federally registered product for an additional use, as long as there is both a demonstrated "special local need," and a tolerance, exemption from a tolerance, or other clearance under the Federal Food, Drug, and Cosmetic Act. Is non-GLP data acceptable for a 24(c) registration? Secure .gov websites use HTTPS The additional use is covered by necessary tolerances or other clearances under the Federal Food, Drug, and Cosmetic Act (FFDCA). States may consider uses such as the following as candidates for special local needs: new method or timing of application, new crop/new site, new pest, changed rate, application in particular soil type, new product/different formulation, and products useful in managing pesticide resistance in a particular crop. EPA reviews the individual section 24(c) registrations and broadly oversees the states section 24(c) registration programs. Instead, and if a state desires to impose an additional restriction to a federally registered product, states may exercise their authority under FIFRA section 24(a) to regulate the sale or use of any federally registered pesticide in the state. 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. This guidance document clarifies the regulations implementing Section 24(c) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to assist FIFRA state lead agencies (SLAs) in submitting complete Section 24(c) notification submissions to EPA; and to facilitate EPA's review. All registrants with FIFRA Section 3 pesticide product registrations including those that were initially registered by a state through Section 24 (c) will receive an email to notify them of the updated $4,875 maintenance fee. As previously mentioned, EPA will continue to provide feedback and work with states on interpreting the section 24(c) regulations and exploring other authorities available under FIFRA. For this reason, EPA does not believe the use of such provisions on section 24(c) labeling is consistent with the purposes of FIFRA. FIFRA 2 TABLE OF CONTENTSContinued 136w-2 27. from states under section 24(c) of FIFRA. 10. A properly completed Notification of State Registration (EPA Form. A .gov website belongs to an official government organization in the United States. Share sensitive information only on official, secure websites. EPA reviews these registrations, and may disapprove the state registration if, among other things, the use is not covered by necessary tolerances, or the use has been previously denied, disapproved, suspended or canceled by the Administrator, or voluntarily canceled subsequent to a notice concerning health or environmental concerns. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 24 (c) authorizes the Department of Pesticide Regulation to register an additional use of a federally registered pesticide product or a new end use product to meet a special local need if certain conditions exist. If EPA finds problems, the Agency will discuss and resolve them with the appropriate state(s). If the same 24(c) registration is issued in fifteen (15) states, generally, further 24(c) registration will be denied and the Agency will contact the registrant involved to discuss the situation. For 24(c) products that are not substantially similar, EPA will ask for only a brief summary of the data, the state's conclusions and a certification that the product will not cause unreasonable adverse effects as defined in FIFRA for registration of pesticides. The key factors that EPA looks for in residue data are (1) evidence that the pesticide was applied according to label directions resulting in highest residues (maximum application rate, maximum number of applications, shortest interval between applications and shortest preharvest interval) and (2) recovery data showing the analytical method was capable of measuring the total residue of concern. EPA will also conduct general oversight by periodically reviewing its records of 24(c) registrations to assure that states and EPA have properly followed procedures and policies. A state may register any use of a federally registered product for which registration of other uses was denied, disapproved, suspended, or canceled if the new product is for a formulation or a use not included in the denial, disapproval, suspension, or cancellation, or if the federally registered use was voluntarily canceled without a prior notice of intent to cancel. EPA notifies the state, in writing, of the improper notification and that if the proper notification is not provided, the 24(c) registration will be considered invalid as issued. 7969-310 EPA SLN No. Response: No. If the state does not know who the appropriate Product Manager is, the state should contact the appropriate Branch Chief in the Registration Division who can indicate which PM to contact. An example would be use of a desiccant on carrots or radishes near the time of seed harvest. "based upon satisfactory information an appropriate federally registered pesticide is not sufficiently available" means a state can document that a federally registered product (a) is not available in the state for the desired site(s) to adequately control the target pest(s), or (b) cannot be applied without causing unacceptable risks to human health or the environment, or (c) is necessary to maintain an IPM, resistance management, or minor use pest control program, or (d) could be replaced by a formulation that poses less risk to man or the environment. EPA officials may decide to follow the guidance provided in this document, or to act at variance with such guidance, based on analysis of specific circumstances raised by a given 24(c) action. "existing or imminent pest problem" means a problem that already exists or is likely to exist. Issue: Whom should states call with questions about interpretations of 24(c) regulations? However, since 24(c) registrations are deemed by FIFRA to be 3 registrations after 90 days, EPA generally is not in a position to impose time limits on 24(c) registrations. How to Register a Pesticide Product A Guide for Applicants New to the Process, FIFRA authorizes states to issue Experimental Use Permits (EUPs), Special Local Needs (SLNs) registrations, and to apply for Emergency Exemptions under specific conditions. Federal Insecticide, Fungicide, and Rodenticide Act, as amended by the Food Quality Protection Act of August 3, 1996, Standard Operating Procedure 4001.7: 24(c) Review Process, Office of Pesticide Programs, EPA, February 9, 1996. sets forth the process and requirements for disapproving a state registration that involves products with composition or use patterns that are not similar to a currently registered product. This change is not intended to prevent any state from limiting or restricting access to or use of EPA-registered pesticides. (2) There is no likelihood of residues in crops grown from the harvested seed. EPA's role is to assure that each 24(c) registration meets the requirements of FIFRA since these registrations become federal registrations within 90 days unless EPA objects to them. Response: It is a misuse to use a 24(c) product in a state if it is not registered in that state. E-mail: [email protected], Get the latest updates from the California Department of Pesticide Regulation. The Agency has developed guidance and process measures that will enable the states to generate and EPA to review 24(c) registrations. If a state wishes to implement a special regulatory program related to that additional use, it may include localized restrictions and use directions on the 24(c) label. Entrust SC EPA Reg. For content questions, contact: For content questions, contact: Morgan Thai 1001 I Street, P.O. FIFRA Section 24(c) Special Local Need (SLN) Label Dow AgroSciences LLC 9330 Zionsville Road Indianapolis, IN 46268-1054 USA FOR DISTRIBUTION AND USE ONLY WITHIN THE STATE OF OREGON Stinger EPA Reg. FIFRA SECTION 2ee FOR THE USE OF SPIN-AID HERBICIDE- Texas. A state may register such a product: A state can issue a 24(c) registration for any use of a new end-use product containing an ingredient described in 40 CFR 162.152(a)(3)(i.e., registration for the same use has not previously been denied, disapproved, suspended, or canceled by the Agency, or voluntarily canceled subsequent to the issuance of a notice of intent to cancel that registration, unless the action is superseded by subsequent action of the Agency). If the state does not respond within 14 days, EPA may prepare a written response to the applicant (cc: registrant) stating that the Agency was not properly notified of the state registration, and therefore, without the requested information, EPA considers this registration to have been invalid as issued. 15. A properly completed copy of the Confidential Statement of Formula (CSF) Note: Only required if the product is not federally registered. FIFRA section 24(c)authorizes state lead agencies to register additional uses of federally registered pesticides (also called Special Local Needs (SLN) registrations or SLNs). ( 1) An application for registration submitted to a State under FIFRA section 24 (c). Under the authority of Section 24(c) of FIFRA, states may register an additional use of a federally registered pesticide product, or a new end use product to meet special local needs, if the following conditions exist: Special Local Need. Response: As stated in the response to issue 4, states may issue registrations under 24(c) to allow additional uses. Residue and efficacy data have been the primary supporting data for most 24(c) registrations in the past. Box 4015 Sacramento, CA 95812-4015 Phone: (916) 445-3054 E-mail: [email protected]. Public meetings (advisory groups and workshops), Active Ingredient Risk Assessment and Mitigation, Guide to Understanding Section 24(c) Special Local Electronic reporting under state registration of pesticide products for special local needs. An official website of the United States government. So long as the 24(c) registrant complies with FIFRA requirements for maintaining the registration (e.g., fee payment), EPA will not cancel the registration even if the state has done so, unless the registrant voluntarily cancels the product or EPA has a cause to issue a notice of intent to cancel. 22. Issue: Can a state issue a 24(c) registration citing more than one 3 registration? FIFRA Sec. If the state can demonstrate that the recommended 24(c) registration constitutes no added exposure or risks, or that the exposure or risks are reduced, a 24(c) may be appropriate. other uses of the same product, or of a product with a similar composition, have had registration denied, disapproved, suspended, or canceled by the Administrator. The name of the pesticide product, and if the application is for an amendment to a federally registered product, the EPA registration number of that product. This guidance is intended to empower the states in operating under authority of the 24(c) provision and to clarify EPA's position on important policy issues. Response: For clear enforcement issues, states should make referrals to the regional enforcement office. Issue: Could states be given a list of product managers by active ingredient? LIST OF ACTIVE FIFRA SECTION 24(c) SPECIAL LOCAL NEED LABELS License Number Product Name.
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