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Regulatory Issues
The Environmental Protection
Agency ( EPA) is the new regulatory agency for wildlife (wild
horses, deer, etc.) although the US Food and Drug Administration
(FDA) will continue to regulate zoo animals. EPA regulations
will be posted as soon as they are known.
One of the most poorly understood
dimensions of wildlife contraception is the regulatory process.
Depending upon the species in question, one or more agencies,
local, state and federal may be involved. A brief description
of the process and regulations follows:
Wild Horses and Zoo Animals
All projects in which the vaccine crosses state lines must
be on record with the U. S. Food and Drug Administration (FDA).
The authority to carry out these projects is issued by two
separate Investigational New Animal Drug documents (INADs)
issued by the FDA to The Humane Society of the United States
(HSUS). As each new project is identified, The HSUS reviews
the need for the project in the context of scientific, ethical,
and moral issues and, if approved, issues permission to proceed.
Notification of each project is accomplished by means of a
form, filed with the FDA by the Science and Conservation Center,
which specifies how much vaccine is being shipped and what
species are to be treated. The INAD also requires that data
from each project be gathered in a systematic way and filed,
and to be made available to the FDA when the need arises.
These files are maintained at the Science and Conservation
Center. Additionally, the legal managers of the horses (NPS
or BLM) or the Animal Care Committee of each zoo must also
provide permission to treat animals. This regulatory process
is similar for any wildlife species not classified 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
is for the affected landowners and local legal authority (city,
township, county, park board or some combination thereof,
to agree to carry out a deer project). The second step is
a review by The HSUS, to determine the scientific and ethical
dimensions of the project (do these deer really need more
management?). The third step is the preparation of a proposal
to the FDA for each specific project. This proposal is written
jointly by both the local authorities and The HSUS. The proposal
must also be reviewed by the state fish and wildlife agency,
regardless of whether the deer in question reside on public
or private property. The principal exception to the state
authority is deer residing on federal lands, and even in this
case the federal managers may decide to seek state approval
if they so choose.
There are still two issues which cause considerable confusion.
First, may a deer contraceptive project be carried out without
FDA "approval", and second, what constitutes FDA
"approval". The FDA itself imposes no requirement
for the non-commercial PZP vaccine to be "approved",
however, a state or local agency may 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
constitute an experimental use of the drug. In such a case,
the investigator may choose to apply for an INAD to use the
drug in deer, for example (as we have done with PZP). Attainment
of an 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 immunocontraception
is that "it is still experimental and unproven".
In its current form the vaccine will remain "experimental"
only because we have no intention of marketing the vaccine
in this form, but it is certainly proven as a sound fertility
inhibitor in this species (Turner and Kirkpatrick 2002; Naugle
et al. 2002; Rutberg et al. 2004).
Delivery Equipment
In addition to the regulations regarding the vaccine, the
use of delivery equipment such as capture guns often requires
additional 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,
a 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 often required. This training
may be received from a number of qualified practitioners and
sources, including the SCC. (see Kirkpatrick and Turner 1995).
THE HSUS NO LONGER RUNS THE TRAINING PROGRAM.
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