PDF FIFRA Sec. 24(c) Special Local Need Label - Amazon Web Services The state must notify the Agency within 10 days of the date of issuance of the registration. EPA will limit its review of individual 24(c) registrations to a minimal level that empowers states to meet the requirements of FIFRA and avoids any duplication of effort by EPA. Refer to. 26. this notice announces that EPA is seeking public comment on the following Information Collection Request (ICR): "FIFRA Section 24(c) Special Local Need Registrations" (EPA ICR No. A state may only grant 24(c) registrations for voluntarily canceled uses of products after consulting with appropriate EPA personnel (40 CFR 162.152(b)(1)(iii)). Response: As stated in the response to issue 4, states may issue registrations under 24(c) to allow additional uses. PDF FIFRA Section 24(c) Special Local Need (SLN) Label - US EPA A .gov website belongs to an official government organization in the United States. The provisions in FIFRA section 3(c)(1), (c)(2)(B), and (c)(2)(D) apply to the submission, compensation, and exemption of data required to conduct a registration review. PDF FIFRA Section 24 (c) Special Local Need (SLN) Label - Greenbook The complete formula of the product, if the application is for a new product registration. 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. If data/studies are submitted in support of a 24(c) application, the following applies: When full studies are submitted in support of a 24(c) application, they must comply with Pesticide Regulation Notice 11-3 format (PR Notice). (a) SHORTTITLE.This Act may be cited as the ''Federal Insec- In situations such as the chemical is under special review or the 3 label restricts the use to specific geographic areas because of groundwater concerns and the 24(c) would expand the use in a manner that could contaminate groundwater, a 24(c) should not be issued without consulting with EPA about the chemical/use pattern. Applications to crops grown for seed can be considered non-food uses if the following two conditions are met: (1) Subsequent to treatment, no parts of the crop will be diverted to use as human food or livestock feed. PDF A Guide for Pesticide Registrants - California 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). EPA will also conduct general oversight by periodically reviewing all records of section 24(c) registrations to ensure that states and EPA have properly followed procedures and policies. Issue: Should states set time limits for 24(c) registrations? Name and address of the applicant and any other person whose name will appear on the labeling or in the directions for use. 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. Issue: How does a registrant or state notify EPA in order to voluntarily cancel a 24(c) registration? 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. If EPA has a legitimate concern about carryover to subsequent crop, what kind of residue information is needed? The Agency believes that FIFRA and EPA regulations do not prevent the state from issuing a registration to a third-party applicant even if the registration does not have the support of the basic registrant. This would include product chemistry data identifying the amount of active and inert ingredients, making sure all ingredients are cleared for food use by EPA, acute toxicity data on which the toxicity category and precautionary labeling would be based, and any additional data as needed such as residue, efficacy and environmental fate. 32. 19. Data submitted with the first 24(c) registration may satisfy this requirement. Official websites use .gov PDF FIFRA Section 24(c) Special Local Need (SLN) Label This approach comports with the law and authority available to states under this provision of FIFRA. FIFRA section 24 (c) allows states to register "additional uses of federally registered pesticides" to meet special local needs within the state, but it does not provide for states to issue more restrictive registrations. 22. INTRODUCTION The Oregon Department of Agriculture (ODA), as defined in 40 CFR 162.151(j), is thedesignated lead agency responsible for registering pesticides to meet special localneeds under section 24(c) of the Federal Insecticide, Fungicide and Rodenticide Act(FIFRA) as Amended. With regard to seed treatments the use can be considered non-food only if a radiotracer study shows no uptake of radioactivity into the aerial portion of the crop (or into the underground portion of root crops). EPA did not provide a formal comment period on this issue because the statutory language of FIFRA section 24(c) is clear, and no alternative position was appropriate. a product that is identical in composition to a federally registered product but has differences in packaging, or in the identity of the formulator; or. EPA will make every effort to work out problems with states, but EPA retains the authority under 40 CFR 162.155to suspend a states authority to issue section 24(c) registrations, if necessary. The distributor product is the same as the 3 registration and is incorporated under the 3 registration. Need Registration, PDF, Policy and Criteria for Processing SLNs for ), (The above three factors can be used to estimate how much pesticide might move from seed to the growing crop.). The Agency may issue a Data Call-In notice under FIFRA section 3(c)(2)(B) at any time if the Agency believes that the data are needed to conduct the registration review. 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 believes the inclusion of such statements on product labeling may constitute misbranding pursuant to section 2(q)(1)(A) of FIFRA and 40 CFR 156.10(a)(5), because these statements may give growers the misleading impression that federal authorities have sanctioned such labeling and support the imposition of civil and/or criminal penalties against growers who choose to use a pesticide without first agreeing to waive their rights to bring civil actions for damages resulting from the use of the pesticide. The letter will direct that one copy of the amended labeling be submitted from the registrant, through the state, to the Agency. However, EPA has been turning down or requiring revisions of 24(c) registrations due to environmental and toxicological concerns. Issue: Can states issue 24(c) registrations that negate or void voluntary or mandatory restrictions on 3 labels? Response: The state should contact the appropriate Product Manager with specifics on the proposed 24(c) registration. 1. During the 2021 Triennial Code Adoption Cycle, California state agencies reviewed the most recent edition of national model codes and standards, and made amendments and additions to most parts of the California Building Standards Code, Title 24 of the California Code of Regulations (Title 24). If a state believes a use qualifies, it may contact the maintenance fee information line at 1-800-444-7255 for specific instructions. 1. Please note that this document is intended solely as guidance and does not represent final agency action. FIFRA Section 24(c) Special Local Need Label FOR DISTRIBUTION AND USE ONLY WITHIN THE STATE OF CALIFORNIA Ventura, Santa Barbara, San Luis Obispo, Los Angeles, Orange, San Bernardino, Riverside, San Diego, Imperial, Monterey, Santa Cruz, and San Benito Counties For control of Asian citrus psyllid (ACP) on citrus during bloom periods MOVENTO Sec. Search by name, CAS number, or DPR chemical code. Identification of pests; cooperation with In other words, the condition is met if the pesticide is applied to the seed crop at a point when it is no longer fit for consumption. 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 one year. Issue: Whom should states call with questions about interpretations of 24(c) regulations? 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. If a registrant decides not to support certain uses, EPA publishes those uses in the Federal Register to determine if anyone else wants to support them. ), (The above two factors can be used to estimate maximum likely residues on the harvested seeds. 40 CFR Part 152 Subpart E - eCFR :: Home A cover letter with a description of what special local need is being met by the issuance of the 24(c) and a clear explanation of how the definition of special local need is met. When submitting a 24(c) notification to the Agency, the state should include in the cover letter a description of what special local need is being met by the issuance of the 24(c) and a clear explanation of how the definition of special local need is met. 40 CFR Part 155 -- Registration Standards and Registration Review Washington, D.C. 20460-0001. More information on safety findings and information required for tolerance setting can be found in Chapter 11, Tolerance Petitions. Types of Products Types of Registrations Chapter 2: How to Obtain a New Product Registration Response: The term "seed use" could be interpreted to mean direct application of a pesticide to seeds before planting (seed treatments) or application in the field to crops grown for seed. Note: An Unreasonable Adverse Effects Determination Statement is only required if: When notified of any missing items or deficiencies, the state should work to respond and send in missing information as soon as possible. prec. Who can apply? EPA has informed the head of the federal or state agency, the Governor, or his/her 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. Finally, this guidance document is intended to empower the states to operate as independently as possible to reduce the resources EPA uses to review 24(c) applications and to assure the public that no unreasonable adverse effects will occur from 24(c) registrations. In late October, 2020, the Environmental Protection Agency ("EPA") announced that it had renewed the Federal Insecticide, Fungicide and Rodenticide Act ("FIFRA") registrations for three dicamba pesticides for growing seasons 2021 - 2025. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 25 (b) and California Code of Regulations Sections 6145-6168 exempt minimum risk pesticide products from registration, provided the product meets certain criteria. State contact information can be found at the. Special Local Need. If the state does not notify the Agency of the issuance of the registration within 10 days of its effective date, then the 90-day "clock" begins on the date that the Agency receives the application package [see40 CFR 162.154(c)]. 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. However, states may not issue 24(c) registrations to implement localized restrictions or use directions for uses already permitted by 3 labels. EPA will continue to make conforming changes to any documents which are contrary to the statutory language related to FIFRA 24(c). Issue: Can states issue 24(c) registrations for the purpose of avoiding buildup of pest resistance? This section provides background information on the states' and EPA's responsibilities under the law, how to submit 24(c) applications to EPA, and general policies. Phone: (916) 324-3538 31. Sacramento, CA 95812-4015 For antimicrobial and biopesticide chemicals, states may refer to the Antimicrobial Divisions Ombudsman (OPP_AD_Ombudsman@epa.gov) and the Biopesticides and Pollution Prevention Divisions Ombudsman (BPPDQuestions@epa.gov), respectively. It is not intended, nor can it be relied upon, to create any rights enforceable by any party in litigation with the United States. PDF HAWAII DEPARTMENT OF AGRICULTURE LIST OF ACTIVE FIFRA SECTION 24(c Studies that pass the PR Notice 11-3 screen will be entered into the Agency-maintained collection of documents. There is a possibility that the Agency may request additional residue data during review. 62719-73 EPA SLN No. Issue: How can a state find out what EPA's response to a 24(c) registration would be prior to actually submitting the registration? FIFRA section 24(c) allows states to register additional uses of federally registered pesticides to meet special local needs within the state, but it does not provide for states to issue more restrictive registrations. (2) There is no likelihood of residues in crops grown from the harvested seed. Issue: How should states review a 24(c) request on a product that does not have federal registration? ( a) FIFRA sections 12 (a) (1) (A) and (B) make it unlawful for any person to "offer for sale" any pesticide if it is unregistered, or if claims made for it as part of its distribution or sale differ substantially from any claim made for it as part of the statement required in connection with its registration under FIFRA section 3. 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. The use, if a food or feed use, is covered by an appropriate tolerance or has been exempted from the requirement of a tolerance. The Agency will then determine whether the studies to be provided are likely to be adequate. Treatment of Raw Agricultural Commodities for Export Only, PDF, Annual Pesticide Registration Maintenance Fees, Application for State Registration of a Pesticide to Meet a Special Local Need (EPA Form 8570-025), PDF, Pesticide Registration Manual: How to Obtain a Company Number and Register an Official Address. EPA will make every effort to work out problems with states, but as a last resort EPA has the authority to rescind a state's authority to issue 24(c) registrations if necessary. 5. PDF FIFRA 24(c) SPECIAL LOCAL NEED LABEL (SLN) FOR DISTRIBUTION AND USE Postal Service deliveries ONLY: Document Processing Desk (SLN) Calculate volatile organic compound emissions from agricultural applications of nonfumigant pesticides. JavaScript appears to be disabled on this computer. Questions may be directed toMick Yanchulis (yanchulis.michael@epa.gov) at(703) 347-0367. Response: The term "special local need" does not include situations such as interregional or nationwide pest problems. Federal Register :: FIFRA Section 24(c) Special Local Need 4. PDF Requirements to Obtain a Special Local Need (SLN) Pesticide Box 4015 This requirement applies to all registrations granted under FIFRA section 3 ( 7 U.S.C. Cucurbits and fruiting vegetables are probably not eligible for non-food uses since the fruit is still edible at the stage when the seeds have formed. What is a Section 24(c) special local need registration? 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. Important Note: The crisis exemption may not be used to authorize a pesticide use if any of the following have occurred: A crisis exemption may be authorized for: Section 408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA)requires the establishment of time-limited tolerances or exemptions from tolerance requirements for residues of those pesticides exempted from regulation under FIFRA section 18. b. This chapter provides detailed information relevant to state actions under FIFRA. Response: While EPA might assist the states in developing acceptable disclaimer language for third party 24(c) registrations, whether such disclaimers would be effective in court is a matter of individual state tort law and is, therefore, beyond the control of EPA. The avoidance of pest resistance can be described as a special local need if the state lead agency possesses satisfactory supporting information to document the need. No. 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 three years. 40 CFR 162.154(a) 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. Issue: Is offering growers a choice of products or a less hazardous formulation (to humans, non-target organisms, or other environmental component) an acceptable justification for a 24(c) registration? The 24(c) registration will not be valid as of the date EPA issues this letter. Section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes the U.S. Environmental Protection Agency (U.S. EPA) to allow an unregistered use of a pesticide for a limited time if U.S. EPA determines that an emergency condition exists. Background In most countries, pesticides must be approved for sale and use by a government agency. If a state wants to issue a 24(c) registration for an unsupported use, it must submit a letter, following the procedures given in the FR notice, describing the data to be submitted, if required, and providing a contact person. Refer to Section IV (General Policies), Question 1, for the definition of Special Local Need. 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. 136a) as well as those granted under FIFRA section 24 (c) ( 7 U.S.C. Interim reports containing the information specified in 40 CFR 166.32(b)to the extent available shall be filed annually. 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 in the State of Oregon Starane Ultra EPA Reg. This guidance document is not intended to replace the 24(c) regulations at 40 CFR part 162, rather to clarify the regulations and to provide additional guidance. Regulations in 40 CFR Part 166establish procedures by which the Administrator may exempt a federal or state agency from the registration requirements of FIFRA. Expanding the use pattern of a 3 label would be inappropriate if the added exposure would raise human or environmental risk concerns. Issue:May an applicant include on proposed section 24(c) labeling a provision that requires a grower, as a condition of lawful use of a product, to waive any right he or she may have to bring a civil action against the applicant? Response: When the state issues the 24(c) registration it is assumed to be valid and the product may be sold or distributed and used after that time. Response: General questions may be referred to the 24(c) Coordinator David Lieu (lieu.david@epa.gov), Acting Senior Regulatory Specialist, at (202) 566-2815. probable creation of unreasonable adverse effects on man or the environment by the registered use; refusal of the registering state to submit information supporting the registration, i.e., application form (within 10 working days), labeling for the section 24(c) registration, 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 finding by the state (within 15 working days); failure of the information submitted by the state to support the decision to issue the section 24(c) registration under the standards set forth in 40 CFR 162.153. may result in a residue on food or feed exceeding, or not covered by, a tolerance, exemption, or other clearance under the FFDCA. Search DPR's extensive database of pesticide use, endangered species, and groundwater protection area information. If it is determined that a disapproval is likely, EPA will issue a Notice of Intent to Disapprove the State Registration that will provide the reasons for disapproval. The 90-day "clock" will begin upon receipt of the resubmission. Archive; News. Examples of such cultural practices might be smaller crop spacing preventing adequate root formation or planting in a different season to encourage bolting versus head formation. If the answer is no, what sort of labeling statements may the applicant make with regard to the existence of private liability agreements or to disclaim liability generally? 25. Federal Register :: Pesticide Registration Maintenance Fee: Product Special local need means an existing or imminent pest problem within a state for which the state lead agency, based upon satisfactory supporting information, has determined that an appropriate federally registered pesticide product is not sufficiently available. FIFRA Sec. FIFRA Section 24(c) Archived August 23, 2022. A state may not register an amendment to a federally registered manufacturing-use product (40 CFR 162.152(b)(1)(iv)). E-mail: John.Inouye@cdpr.ca.gov, Get the latest updates from the California Department of Pesticide Regulation. 9. Response: Yes. Section 24(c) states that "A State may provide registration for additional uses of federally registered pesticides formulated for distribution and use within the state to meet special local needs . [6] States are strongly encouraged to ensure that this does not occur. Residue and efficacy data have been the primary supporting data for most 24(c) registrations in the past. 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: Under EPA's procedures, when an application package is incomplete, the Agency considers this to be an improper notification of state registration. Issue: Can EPA help the states develop a standard and effective liability disclaimer for third-party registrants? Generally, such a finding can be supported only if the following criteria are met: 8. The state should submit a complete 24(c) notification package for each registration to the following address: Electronic Submission (preferred option): Address for FedEx, UPS, DHL, Courier deliveries ONLY: Address for U.S. Response: Although any new data should follow GLP, non-GLP data are not automatically rejected. The table of contents does not correspond to the contents of the Act. A state or federal agency may issue a crisis exemption. FIFRA section 24(c) authorizes states to issue registrations for additional uses of pesticide products currently registered under section 3 to meet special local needs. In situations where a commodity is grown in a limited number of states, the Agency may seek consultation with the registrant involved if a 24(c) registration is issued by all most all the states growing the commodity. Instead, the state should utilize FIFRA section 24(a) for implementing special regulatory programs within their respective state to apply restrictions to uses on the 3 label.

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