What is a Section 24(c) special local need registration?
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 24(c) and Title 40, Code of Federal Regulations (40 CFR), section 162.152, authorize state pesticide regulators to register a new end-use product or an additional use of a federally registered pesticide product to address an existing or imminent pest situation. The pest situation must be a special local need within the state that cannot be mitigated by a currently registered product. To issue a special local need (SLN) registration, the following conditions must apply:
- If the pesticide is to be used on a food or feed commodity, the use is covered by the necessary tolerances or exemptions from tolerances.
- Registration for the same use has not previously been denied, disapproved, suspended, or cancelled by the U.S. Environmental Protection Agency (U.S. EPA), or voluntarily cancelled by the registrant.
- The pesticide product does not contain a new active ingredient unregistered by U.S. EPA.
- There is no federal registered product available to address the special local need.
An SLN may address a new pest, method or timing of application, different use rate, new crop/use site, or integrated pest management (IPM) practice in certain crops.
Who can apply?
The applicant could be the registrant of the product or a third-part such as a grower, grower association, of University Extension personnel.
How do I apply?
- A letter requesting the SLN registration. The letter should include the product name, active ingredient, and an explanation of why the SLN registration is needed.
- 2 letter of support for the SLN.
- One letter from grower associations, cooperative extension specialists, and/or other knowledgeable experts.
- One letter from the registrant of the product in support of the use.
- The region or counties in New Mexico where the SLN will apply.
- Estimates of the acreage to be treated, the number of growers who would use the SLN, and the anticipated time frame when it will be used.
- A copy of the draft SLN label.
- A copy of the federally registered FIFRA Section 3 label.
- Any additional pertinent information, such as results of research, residue chemistry, efficacy, phytotoxicity, any other data that may be identified during the review process to support the SLN use pattern an whether any other states have registered the SLN.
- A completed and signed U.S. EPA Form 8570-25, Application for/Notification of State Registration of a Pesticide to Meet a Special Local Need.
There is no charge to apply for a SLN, but the Section 3 product must be registered in New Mexico. Allow up to 30 days for NMDA to review the complete application package. After NMDA approval the U.S. EPA has 90 days to comment and/or disapprove the SLN. If the U.S. EPA disapproves the SLN, it cannot remain in effect and will be cancelled by NMDA.
What is a Section 18 emergency exemption from registration?
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 the U.S. EPA determines that an emergency condition exists. The regulation governing FIFRA Section 18, which are found in Title 4o, Code of Federal Regulation (40 CFR) part 166, define “emergency condition” as an urgent, non-routine situation that requires the use of a pesticide. It allows for the time-limited use of a pesticide product (not registered or not registered for that use) to control the emergency. Such uses are often referred to as “emergency exemptions” or “Section 18s”.
Section 18 emergency exemptions are used when there are no other federally registered pesticides available to control a serious pest problem and there would be significant economic loss without the use of the Section 18 pesticide. Pesticide applicators must have and follow the Section 18 use directions as well as the Section 3 registered label at the time of application.
There are four types of Section 18 emergency exemptions from registration:
- These form the majority of requests.
- Requested to avert a significant economic loss or a significant risk to endangered or threatened species, beneficial organisms, or the environment.
- Growers or agricultural research scientists identify a pest situation that registered pesticides cannot control.
- May be authorized for up to one year.
- Requested to control the introduction or spread of an invasive pest not previously found in the U.S.
- “Emergency” rests on the potential of an invasive species to cause a significant economic loss.
- May be authorized for up to three years.
Public Health Exemption
- Requested to control a pest that will cause a significant risk to human health.
- “Emergency” based upon the risk to human health from the pest to be controlled.
- May be authorized for up to one year.
- May only be issued when there is an immediate need for a specific, quarantine, or public health exemption in situations involving an unpredictable emergency situation 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 an exemption through normal means.
- NMDA must confer with and receive verbal authorization from U.S. EPA before issuance. U.S. EPA performs a preliminary review to ensure there are no concerns and whether the appropriate safety findings required by the Food Quality Protection Act (FQPA) can be made. If authorized by the U.S. EPA, a state or federal agency may issue a crisis exemption allowing the use for up to 15 days.
- An applicant may follow up the crisis exemption with a specific, quarantine, or public health emergency exemption request. This allows the use to continue until the U.S. EPA makes a decision on the corresponding exemption requested.
Who can apply?
Applicants must be someone other than the product registrant. Extension personnel, county agricultural commissioners, grower groups and others may apply. NMDA recommends that applicants contact the designated Section 18 staff person at NMDA before submitting an application to ensure all requirements are clearly understood.
How do I apply?
The applicant must submit the following information to NMDA. If NMDA approves the submission, it is then forwarded to U.S. EPA for review and approval.
- A letter requesting the Section 18 exemption. The letter should include the product name, active ingredient, and an explanation of why the Section 18 exemption is needed.
- A complete description of the emergency pest problem.
- Contact information for knowledgeable experts who can confirm the emergency.
- A detailed explanation of why currently registered pesticides or cultural practices are not adequate to address the situation.
- Product label instructions describing how to apply the product in order to control the pest problem.
- The economic history (typically three to five years’ worth of information) of the crop, including information on annual production, price of commodity, and cost of production before the pest problem occurred or became significant.
- Scientific data to support the Section 18.
- Efficacy, residue chemistry, and phytotoxicity data.
- If pest resistance is the basis for the exemption, field data to demonstrate resistance to currently registered products is required.
- A letter of authorization from the product registrant.
- A draft Section 18 label.
- A copy of the federally registered FIFRA Section 3 label (if applicable).