Water: Habitat Protection
Overview of EPA Authorities for Natural Resource Managers Developing Aquatic Invasive Species Rapid Response and Management Plans: FIFRA Section 24(c)-Special Local Need Registrations
- What is FIFRA Section 24(c)?
- When does FIFRA Section 24(c) apply to AIS rapid response or control actions?
- How do I apply for a FIFRA Section 24(c) Registration?
- FIFRA Section 24(c) Case Study: Controlling Old World Climbing Fern in Florida
What is FIFRA Section 24(c)?
FIFRA Section 24(c) authorizes states to register an additional use of a Federally-registered pesticide product or a new end use product to meet a special local need. (For EPA guidance on FIFRA Section 24(c) registrations, see www.epa.gov/opprd001/24c.)
When does FIFRA Section 24(c) apply to AIS rapid response or control actions?
AIS rapid response or control methods using pesticides must comply with FIFRA and the regulations promulgated thereunder. If a pesticide is already registered for the rapid response or control use under FIFRA, the action does not require additional permitting from EPA. There are several pesticides registered for use in aquatic environments, and natural resource managers may be able to rely on these pesticides to eradicate or control AIS. If the rapid response or control action requires the use of an unregistered pesticide or a pesticide registered for a different end use or use pattern and a state can demonstrate a special local need, FIFRA Section 24(c) authorizes a state to register an additional use of a Federally-registered pesticide product. Section 24(c) registrations are also referred to as state labels or special local need registrations and are considered Federal registrations authorizing distribution and use within the granting state only.
State registrations under Section 24(c) are subject to EPA's regulations at 40 CFR Part 162. A general summary follows.
States may register a new use or use pattern of a Federally-registered pesticide if all of the following conditions exist:
There is a special local need for the use within the state. A special local need is an existing or imminent pest problem within a state for which the state has determined that an appropriate Federally-registered pesticide is not sufficiently available.
If the pesticide use is a food or feed use, there must exist appropriate tolerances (maximum amount of pesticide residue allowed in or on a food or feed commodity) or exemptions from the requirement of a tolerance under Section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA). If these tolerances do not already exist, a Section 24(c) registration cannot be used, and a Section 18 emergency exemption may be more appropriate. Under FFDCA Section 408, EPA may establish a temporary tolerance or exemption from the tolerance requirement for a Section 18 emergency exemption.
Registration for the same use has not previously been denied, disapproved, suspended or canceled by EPA, or voluntarily canceled by the registrant subsequent to EPA issuing a notice of intent to cancel that registration because of health or environmental concerns, unless such denial, disapproval, suspension or cancellation has been superseded by a subsequent EPA action.
The registration is in accord with the purposes of FIFRA.
How do I apply for a FIFRA Section 24(c) Registration?
Each state designs its own review process and timeline for state pesticide registration. As part of its review process, each state is required to conduct an ecological risk assessment (ERA) to determine if the pesticide will cause unreasonable adverse effects on humans or the environment under the following circumstances:
- the pesticide's composition is not similar to any Federally-registered pesticide
- the use of the pesticide is not similar to any Federally-registered use of the same pesticide or a pesticide of similar composition
- EPA has denied, disapproved, suspended, or canceled registration of other uses of the same pesticide or uses of pesticides of similar composition
All products registered by a state must meet all appropriate packaging standards and might need to be classified as restricted use if their toxicity exceeds EPA specific hazard criteria. Depending on the length of time needed to conduct an ERA, Section 24(c) pesticide registrations requiring an ERA may be more useful for ongoing control of AIS rather than for carrying out AIS rapid response actions. If a state decides to issue a Section 24(c) registration, it must send EPA a notification package within 10 days of issuing a registration containing the following:
- an application for the Section 24(c) registration
- verification of a special local need
- if required, a determination of no unreasonable adverse effects on humans or the environment
- verification of efficacy for public health uses
- the original registered labeling and the Section 24(c) labeling of the pesticide; and
- notification of state pesticide registration describing:
- tolerances or clearances for food or feed use
- type of registration, i.e. new pesticide or changed use pattern
- history of previous Section 24(c) activity or registration for the pesticide
- list of threatened or endangered species within use area of pesticide
EPA has 90 days to verify that the special local need registration meets FIFRA requirements. If EPA subsequently disapproves the registration, sales and distribution must stop immediately.
FIFRA Section 24(c) Case Study: Controlling Old World Climbing Fern in Florida
Old World climbing fern Lygodium microphyllum is an aggressive perennial vine that has invaded cypress stands, pine flatwoods, wet prairies, sawgrass marshes, mangrove communities, and Everglade tree islands in Florida. The vine can reach 90 feet in length and form dense mats in tree canopies, on the ground, and over wetlands, killing native vegetation. The first reported occurrence of Old World climbing fern in Florida was a plant in cultivation at a Delray Beach nursery in 1958. In 1960, the vine was observed in the wild in Martin County. Old World climbing fern eventually became a severe threat to native Florida ecosystems, especially cypress-dominated wetlands, and in the 1990s, the South Florida Water Management District (SFWMD) began evaluating methods of controlling the vine, including herbicides, fire, flooding, physical removal by hand or machinery, and biological controls.
Aerial spraying of herbicides is one of the most effective means of controlling invasive plants in remote or otherwise inaccessible areas, but may involve the application of herbicide directly to water. Old World climbing fern had invaded many remote and inaccessible areas in Florida, and aerial spraying was desired to control the vine in those areas. At the time, the most effective product for controlling the vine registered for direct application to water was the glyphosate-based herbicide RodeoT, a broad spectrum herbicide that injures or kills many nontarget species. To avoid harming other vegetation in Old World climbing fern-infested areas, SFWMD sought alternatives to Rodeo. The District found that application of the herbicide Escort XPT, a metsulfuron methyl-based product, directly to water showed promise as an effective means to control the vine. The application of Escort XP directly to water was not a registered use for the product and was therefore not in compliance with FIFRA. To use Escort XP for vine control, the SFWMD pursued a Section 24(c) special local need registration for the herbicide.
Florida natural resource managers wishing to control invasive plants often informally consult weed management experts at the University of Florida Institute of Food and Agricultural Science (IFAS) to determine optimal control methods. The SFWMD contacted IFAS about the Old World climbing fern, and in April 2003, IFAS informally contacted the DuPont Corporation, the manufacturer of Escort XP, about using the herbicide to control Old World climbing fern in aquatic ecosystems. In Florida, pesticide manufacturers generally begin the Section 24(c) special local need registration process on behalf of natural resource managers who want to use one of their pesticide products for a new use or use pattern. Consequently, in May 2003, DuPont submitted a Section 24(c) special local need registration application to the Florida Department of Agriculture and Consumer Services (DACS), the lead state agency for pesticide registration. Section 24(c) special local need registration applications in Florida must include verification of the product's efficacy under Florida or Florida-like conditions, as well as the information described in the FIFRA Section 24(c) section of this document.
After DACS received the Section 24(c) special local need registration application, it reviewed the application to verify the special local need justification. In June 2003, DACS forwarded the application to the Florida Pesticide Registration Evaluation Committee (PREC), which is comprised of representatives from DACS and other state agencies. PREC reviewed the Section 24(c) special local need registration application to ensure that the proposed herbicide use would not have unreasonable adverse impacts on human health or the Florida environment and was in compliance with all applicable pesticide laws. PREC requested that DuPont make several revisions to the Escort XP Section 24(c) special local need label. After these revisions were made, the application was submitted to IFAS for independent external review of whether product label efficacy claims were justified. Three IFAS weed management experts offered individual opinions on the Escort XP efficacy claims. On the basis of these opinions, IFAS responded to DACS that it supported the Section 24(c) special local need registration of the herbicide but also requested additional changes to the product label.
In Florida, the Section 24(c) special local need registration application review process can take anywhere from a few months to over a year. In this case, the process was completed quickly. DACS accepted DuPont's Section 24(c) special local need registration with the revised label and submitted a notification package to EPA in August 2003. EPA also requested revisions to the Escort XP Section 24(c) special local need label, including the addition of a section prohibiting the use of the herbicide in areas where specific endangered or threatened species are present. In December 2003, DACS accepted the revised product label. The herbicide is now available for controlling Old World climbing fern populations in aquatic environments in Florida.