|
Summary of US Government Regulation
The U.S. food regulatory system enjoys a high degree of public confidence as a
result of rigorous scientific reviews within a decision-making framework entirely
open to public participation. This approach to regulation provides full access
to documents on which decisions are based and is carried out completely in the
public eye as required by law.
Biotechnology products in the United States are regulated according to a system
put in place by the White House Office of Science and Technology Policy in 1986.
Deriving its mandate from existing laws to regulate the safety of food and agriculture,
it assigns lead responsibility for biotechnology products to the appropriate
regulatory agency, and sets out principles for coordinated and cooperative reviews
in areas where responsibilities or authorities adjoin or overlap.
Within the U.S. Department of Agriculture, the Animal and Plant Health Inspection
Service (APHIS) governs the field testing of agricultural biotechnology crops.
A petition for non-regulated status must be granted by USDA-APHIS prior to commercial
growth and sale of any genetically modified crop.
The Environmental Protection Agency (EPA) has regulatory authority for insect-protected
crops because they produce their own protection against pests. EPA regulates
environmental exposure to these crops to ensure there are no adverse effects
to the environment or any beneficial, nontargeted insects and other organisms.
Foods developed through biotechnology face the same regulatory requirements
the U.S. Food and Drug Administration uses to safeguard all foods in the marketplace
under the Federal Food Drug and Cosmetic Act. They are judged on their individual
safety and nutrition, not the methods used to produce them.
The FDA may require that genetic modifications that significantly alter the
nutritional value of a food using genetic material from outside the traditional
food supply or use known allergens be subject to strict pre-market testing and
regulatory oversight.
The FDA also requires that any genetically modified food product that significantly
alters a food's nutritional value or uses material from a known allergen be
clearly labeled. For example, any product that used a gene from a peanut, which
is a potential allergen, would be subject to testing and labeling requirements.
The FDA also has the authority to order unsafe products off the market. Legal
responsibility rests squarely with the food company to ensure the safety of
any product it places into commerce.
According to the FDA's own "Q&A" on biotechnology:
"We are confident that food derived from plants developed by new biotechnology
will be just as safe as those produced by traditional biotechnology."
| 
Printer Friendly