Agriculture Reference
In-Depth Information
both types of enzymes are ubiquitous in nature.
40
Moreover, trypsin is
considered safe and used in food production in the United States and
elsewhere. Health risks might not necessarily be restricted to toxic or
allergenic effects, though. A human hormone could have detrimental
effects if it contaminates the food chain, and a vaccine, such as a virus
protein, might lead to desensitization in that those affected would per-
haps not develop a desired immune response when vaccinated.
41
Thus,
the hazards depend on the particular PMI involved.
Exposure, another key issue in risk assessment, will not only depend
on the amount of protein produced but also on the area of land used
for cultivation. Commercial production of PMPs could take place on 10
to 1,000 hectares, which is in the range of larger U.S. field trials with
first-generation GM crops. Beyond possible contamination in the open
environment, accidental exposure may also occur in processing or han-
dling the crops. Environmental exposure will also be different due to the
higher concentration of proteins/unit area. Environmental exposure and
spread could, however, be diminished by molecular, physical, and organi-
zational confinement measures, while worker exposure could be reduced
by other protective measures. Unintended secondary effects (see below)
might be of less concern in the case of small cultivation areas, especially
if confinement measures are effective.
Key Problem: Managing Confinement
Regulatory and industry experts are thus focusing on confinement. In
the United States and Canada, regulators have been working with indus-
try on a variety of physical and organizational confinement measures
40
B. Freese, Manufacturing Drugs and Chemicals in Crops: Biopharming Poses New
Threats to Consumers, Farmers, Food Companies, and the Environment (2002)
www.foe.org/camps/comm/safefood/biopharm/BIOPHARM REPORT.pdf.
41
D. D. Kirk & K. McIntosh, Social Acceptance of Plant Made Vaccines: Indications
from a Public Survey. 8
AgbioForum
228-234 (2005).
