One of the most poorly understood dimensions of wildlife contraception is the regulatory process. Depending upon the species in question, and the setting, one or more agencies, local, state and/or federal may be involved. A brief description of the process and regulations follows:

From 1993 through 2006, the regulation of PZP used with wild horses and zoo animals rested with the U. S. Food and Drug Administration (FDA). All projects in which the vaccine crossed state lines must be on record with the FDA. The authority to carry out projects has been conferred by two separate Investigational New Animal Drug documents (INADs) issued by the Center for Veterinary Medicine of the FDA to the Humane Society of the United States (HSUS). As each new project is identified, The HSUS reviewed the need for the project in the context of scientific, ethical, and moral issues and, if approved, issued permission to proceed. Notification of each project was accomplished by means of a form, filed with the FDA by the Science and Conservation Center, which specified how much vaccine was being shipped and what species were to be treated. The INAD also required that the data from each project be gathered in a systematic manner and filed, and to be made available to the FDA upon request. These files are maintained at the Science and Conservation Center. Additionally, the legal managers of wild horses (NPS or BLM) or the animal care committee of each zoo were required to provide permission to treat animals. This regulatory process was similar for any wildlife species not listed as a food animal by the FDA or as a game animal by a state fish and wildlife agency.

Deer:

The FDA classifies deer as food animals and has issued a separate INAD for this species. The first step in deer contraception was for the affected landowners and local legal authority (city, township, county, park board or some combination thereof, to agree to carry out a deer contraceptive project). The second step was a review by The HSUS to determine the scientific and ethical dimensions of the project (for example, do these particular deer really need more management?). The third step was the preparation of a proposal to the FDA for each specific project. The proposal was written jointly, by the local authorities and The HSUS. The proposal also had to be reviewed by the state fish and wildlife agency, regardless of whether the deer in question resided on public or private property. The principal exception to the state authority was deer residing on federal lands, and even in this case, the federal managers might have ceded the authority to the state is they so chose.

There were still two issues which resulted in considerable confusion. First, could a deer contraceptive project be carried out without FDA �approval�, and second, what constituted FDA �approval�? The FDA itself imposed no requirement for the non-commercial PZP vaccine to be �approved�, however, a state or local agency could require that there be some level of �approval� by the FDA prior to its use. The use of either a commercial drug for a purpose or a species other than that for which it was �approved� by the FDA, or the use of a non-commercial drug (as with PZP) both constituted an �experimental� use of the drug. In such cases, the investigator may have chosen to apply for an INAD to use the drug in deer, for example (as we have done with PZP). Attainment of the INAD for this purpose does not imply �approval� of the drug by FDA in the same sense that commercial drugs are approved for sale and use. Under the INAD the FDA reviews research proposals for scientific usefulness, as well as safety and environmental concerns. In turn, the INAD authorizes the interstate and international shipment of the vaccine for research purposes. The INAD is also an agreement that the investigators may pursue their contraceptive research , will collect certain data, follow certain procedures, and provide the FDA with all these data. An often heard objection to deer contraception is that �PZP is still experimental and unproven�. In its current form the vaccine will remain �experimental� under FDA rules only because we have no intention of marketing the vaccine in this form, but it is certainly a proven and safe fertility inhibitor in deer.

In addition to the regulations regarding the vaccine, the use of delivery equipment such as capture guns often requires additional levels of local authorization and/or training. For example, the use of capture gun equipment within an NPS unit, even to deliver contraceptive drugs, requires special NPS certification. This includes documentation of prior experience with the equipment, s certificate of completion of an NPS sponsored wildlife immobilization course or its equivalent, current CPR certification, passage of a qualifying test on the range, and a letter of certification from a superintendent of an NPS unit. In projects outside national parks, special training is usually required, and available through the Science and Conservation Center.
 

New Regulatory Developments

In 2006, the FDA and the Environmental Protection Agency (EPA) began work on a memorandum of understanding (MOU), that would shift regulatory responsibility for wildlife contraceptives to the EPA. An exception to this will be regulation of zoo animal contraception, which will remain under the FDA. At the present time, we have no idea how this will change or alter the procedures or levels of difficulties for registration of PZP and removal from the �experimental� designation, but it is our intention to pursue registration with EPA.

(see Kirkpatrick 2005; Kirkpatrick and Jochle 2005; )