Water: Habitat Protection
Overview of EPA Authorities for Natural Resource Managers Developing Aquatic Invasive Species Rapid Response and Management Plans: FIFRA Section 18-Emergency Exemptions
- What is FIFRA Section 18?
- When does FIFRA Section 18 apply to AIS rapid response or control actions?
- How do I apply for a FIFRA Section 18 Emergency Exemption?
- Specific, Quarantine, or Public Health Emergency Exemptions
- Crisis Exemptions
- FIFRA Section 18 Case Study: Eradicating Northern Snakeheads in Crofton, Maryland Ponds
What is FIFRA Section 18?
FIFRA Section 18 authorizes EPA to allow states to use a pesticide for an unregistered use for a limited time if EPA determines that emergency conditions exist. (For more information about FIFRA Section 18 emergency exemptions, see www.epa.gov/opprd001/section18. For the text of Federal regulations regarding emergency exemptions, see 40 CFR Part 166 www.access.gpo.gov/nara/cfr/waisidx_04/40cfr166_04.html. )
When does FIFRA Section 18 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 an emergency situation exists, Federal or state agencies may be able to obtain approval to use an unregistered, i.e. nonlabeled, pesticide under FIFRA Section 18.
Emergency exemptions are subject to EPA´s regulations at 40 CFR Part 166. A general summary follows.
An emergency condition is an urgent, nonroutine situation that requires the use of a pesticide or pesticides and meets the following criteria:
- no effective registered pesticides are available
- no feasible alternative control practices are available
- the situation involves the introduction of a new pest, will cause significant economic loss, or will
- present significant risks to human health, endangered species, or the environment
Detection of an AIS can qualify as an emergency condition. Natural resource managers considering use of an unregistered pesticide or a pesticide registered for a different end use or use pattern to eradicate or control AIS should consult their lead state agency for pesticides about the possibility of developing a Section 18 emergency exemption application. Contact information for state pesticide regulatory agencies can be found at http://npic.orst.edu/state1.htm.
How do I apply for a FIFRA Section 18 Emergency Exemption?
Lead state agencies can develop applications for several categories of emergency exemptions:
- specific exemptions are issued to avert significant economic loss or a significant risk to endangered or
- threatened species, beneficial organisms, or the environment
- quarantine exemptions are issued to control the introduction or spread of a new or currently localized pest
- public health exemptions are issued to control a pest that poses a significant risk to human health
- crisis exemptions are issued in instances when the time between discovery of the emergency and the time when pesticide use is needed is insufficient to allow for the authorization of a specific, quarantine, or public health exemption
Quarantine exemptions are generally the most appropriate for AIS rapid response and control actions. Crisis exemptions may be appropriate when actions need to be taken extremely quickly (i.e. within a matter of days or weeks).
Specific, Quarantine, or Public Health Emergency Exemptions
EPA has developed regulations and guidance documents that describe the data necessary to apply for a Section 18 exemption. A specific, quarantine, or public health emergency exemption application must provide the following information:
- the type of exemption requested and the identity of contact persons
- a description of the pesticide and complete labeling for proposed exemption use
- a description of the proposed use
- alternative methods of control
- the effectiveness of the proposed use
- residue in food or feed use
- a discussion of risk information
- coordination with other affected Federal or state agencies
- notification of basic manufacturer or registrant
- compliance and enforcement program for any special requirements
- repeated uses
- progress toward registration, if applicable
- scientific and common name of the pest
- origin of the pest and the means of its introduction, if known
- anticipated impact of the pest
- impact of the pest if uncontrolled
- pertinent information about the potential economic impacts of the pest
EPA attempts to make decisions about the exemption within 50 days of receiving a completed application. During this period, EPA conducts dietary, occupational, and environmental risk assessments of the requested use. EPA also assesses the emergency situation and the progress toward permanent pesticide registration for the use in question, if applicable. Some emergency exemptions require public notification. If EPA determines that the risks posed by the proposed use of the pesticide are acceptable and that the criteria for an emergency condition have been met, EPA approves the emergency exemption request. If the proposed pesticide use may cause unreasonable adverse effects to health or the environment, or if the emergency exemption criteria are not met, EPA will deny the emergency exemption request. Section 18 emergency exemptions are typically utilized for pesticides that are already registered under FIFRA for other uses. Quarantine exemptions can be approved for up to 3 years, whereas other exemptions may only be approved for up to 1 year.
Crisis exemptions are used in dire situations when an emergency exists, the time period for pesticide application is critical, and there is insufficient time to request another type of exemption. A crisis exemption allows for the use of an unregistered pesticide for up to 15 days. If the Federal or state agency submits or has already submitted an application for a specific, quarantine, or public health exemption for the same use, use of the unregistered pesticide under the terms of a crisis exemption may be allowed to continue until EPA makes a decision on the exemption application.
A crisis exemption request may be issued by the head of a Federal or state agency, the Governor of a state, or their official designee. Whenever feasible, the Federal or state agency issuing the crisis exemption must notify EPA of this action at least 36 hours prior to using the crisis provisions. The notification provided to EPA must contain:
- the name of the active ingredient and Chemical Abstract Service (CAS) number
- the site or crop on which the pesticide is to be used
- the use pattern
- the approximate start and end date of application
- an estimate of the expected pesticide residue level for food crops
- a discussion of the emergency situation and any other pertinent information available at the time, including an explanation of why there was insufficient time to request another type of exemption
EPA reviews the notification package to ensure that all required information has been made available and that the use of the pesticide under the crisis exemption conditions will not pose an unreasonable risk to health or the environment. Notification must also be given to the registrant or the manufacturer of the pesticide. Crisis exemptions may not be utilized for pesticides that have been suspended under FIFRA Section 6(c), pesticides containing a new active ingredient, or the first food use of a pesticide. Neither are they issued to mitigate emergencies for which crisis exemptions or specific exemptions have been issued in previous years.
FIFRA Section 18 Case Study: Eradicating Northern Snakeheads in Crofton, Maryland Ponds
On May 18, 2002, a recreational angler caught an 18-inch fish in a small pond in Crofton, Maryland, which is located between Baltimore, MD and Washington, DC. He photographed the fish and released it back into the pond. A month later, the Maryland Department of Natural Resources (MD DNR) identified the fish as a species of snakehead. In the following two months, a second adult snakehead (26 inches long) and over 100 juveniles were caught in the same pond and identified as northern snakehead Channa argus. Northern snakeheads are large, predatory fish native to China. They can grow to 3 feet in length and primarily eat other fish, including fish up to one-third their length. They can breathe air and survive out of water if kept moist and cool. They cannot walk, as is commonly reported, but are easily shipped alive or transported by people. MD DNR conducted an investigation to determine the source of the snakeheads in the Crofton pond and learned that in 2000, a local resident had released two 12- to 14-inch northern snakeheads into the pond.
Immediately after the fish were positively identified and determined to be a risk to local ecosystems, the Secretary of the MD DNR (Secretary) assembled the Snakehead Scientific Advisory Panel (Panel) to develop strategies for eradicating and controlling the fish in the Crofton pond. On July 29, 2002, the Panel presented the Secretary with a list of risks the northern snakehead posed to natural resources. It recommended chemical eradication of the Crofton pond vegetation and fish populations, along with those of two small adjacent ponds, to prevent the spread of the fish to the Little Patuxent River. Chemical eradication of vegetation would remove potential refuges for the fish and facilitate application of the piscicide rotenone.
The herbicides glyphosate and diquat bromide were chosen to eliminate emergent and submerged pond vegetation. After removal of the vegetation, application of the piscicide rotenone would effectively eradicate the northern snakeheads in the ponds. These chemicals were chosen for their effectiveness and relatively rapid decomposition after application. The Panel recommendation to control vegetation in the entire pond area in one application exceeded the manufacturer's label restriction for a maximum 50 percent areal application and therefore did not meet Maryland Department of Environment (MD DE) standards. Because the proposed diquat bromide application differed from allowable use patterns and the available label for diquat bromide, the MD DNR worked with the Maryland Department of Agriculture (MD DA), the lead state agency for pesticide registration, to submit a FIFRA Section 18 emergency exemption application.
Quarantine exemptions are generally the most appropriate exemptions for AIS rapid response actions requiring Section 18 emergency exemptions. However, the potential for spread of the northern snakehead to other water bodies and the potentially devastating environmental impacts of such a spread led the MD DNR and MD DA to apply for a crisis exemption because those programs can be initiated immediately after the lead state authority declares a crisis situation. EPA reviews the crisis on an expedited basis, but use of the pesticide may begin once the lead state agency has invoked its authority to initiate a crisis program.
In the Crofton ponds case, effective interagency collaboration and communication resulted in the timely and successful preparation of a Section 18 emergency exemption application. The application was prepared by the MD DA Pesticide Coordinator with support from the MD DNR and the EPA Section 18 program. MD DA submitted the application package to EPA on August 1. The following day, EPA requested confirmation of the pesticide registration number (EPA's records showed that two pesticides with the same active ingredient were registered) and additional information regarding steps that would be taken to ensure that fish from the treated ponds would not be used for human consumption. On August 6, EPA granted a Section 18 crisis exemption for the proposed use of diquat bromide in the three Crofton ponds for up to 15 days.
State officials faced an additional obstacle to herbicide application in the Crofton ponds, however, because the ponds were on private property and the State lacked the statutory authority to access the property. Permission to access the property was eventually obtained from the owners, and the diquat bromide was applied before the end of the 15-day crisis exemption period. After the application of herbicides and a piscicide took place, over 1000 juvenile and six adult northern snakeheads were recovered. Approximately 800 pounds of native fish were also removed from the three ponds.
In late September and November 2002, state biologists used electro-shock monitoring in all three ponds and determined that no northern snakeheads remained in the ponds. Vegetation returned the following spring, and MD DNR stocked the ponds with native fish. Turtles, frogs, snakes, ducks, and beavers appear to have been unaffected by the pesticides.
In 2004 and 2005, northern snakeheads were found in several other water bodies in the region. These fish are believed to be the result of separate introductions rather than the spread of the species from the Crofton ponds.