|FDA Approval of Genetically Engineered Foods is Necessary to Protect Consumers|
FDA should review and approve the safety of every genetically engineered ("GE") food
before it is marketed. The public deserves a fair, transparent, mandatory premarket approval
process, including an opportunity for meaningful public input. Only a mandatory premarket
approval process will safeguard the food supply and bolster public confidence in GE foods now
and as the technology matures.
Currently, FDA does not formally approve any GE crops as safe to eat. FDA has the
authority to approve new food additives, but says that the GE plants developed so far do not fall
within that authority. Instead, FDA adopted a voluntary process to review safety data provided
by seed companies to ensure compliance with existing laws. This consultation process, which
FDA states is "not a comprehensive scientific review of the data generated by the developer,"
culminates with FDA stating that it has "no further questions . . . at this time" regarding the food.
Although no human health problems with GE crops have been detected, this developer-driven
process is not the most effective way to protect human health and engender public confidence.
Recently, FDA proposed regulations that would require a mandatory notification before a
GE plant intended for food or feed is marketed, in part because FDA believes that the next
generation of GE crops is more likely to raise new food-safety concerns. Although that proposal
improves upon the current process by mandating a transparent agency review, it does not
materially change the agencys scientific review and will not result in an official safety
FDA should establish a new approval process, unrelated to the current food additive
process, for GE crops. FDA should promulgate regulations that establish testing and data
requirements based on advice from a National Academy of Sciences panel of scientists with a
charge to determine which scientific information is needed to assess food-safety concerns,
including the potential allergenicity, toxicity, and unintended effects of such crops. If new
legislation is needed so that FDA can implement an approval process, Congress should pass such
FDA also should approve in an open public process the safety of transgenic food animals.
FDA has stated that it will approve transgenic animals using the Food, Drug, and Cosmetic Acts
new animal drug provision (Section 512) since both the inserted gene and the protein it produces
can be considered animal drugs. Although that process may satisfy human health concerns, the
public will not be able to assess the adequacy of these closed-door reviews. There will be no
public access to the application or supporting scientific data and no opportunity for public input.
In addition, FDA has not made public any regulations or guidance documents that set forth what
safety data and testing will be required for a transgenic animal. Thus, it is currently impossible
to determine if the closed-door animal drug process will protect human health.
Although food safety is not the only issue in the controversy over GE foods, it is the issue
that most concerns consumers. Implementing a formal approval process is something that
everyone from environmental groups to industry should be able to support. Anything short
of this will not protect human health or restore public confidence in GE foods.
[This article appeared in the June 2001 issue of "AgBiotech Buzz", a publication of the Pew
Initiative on Food and Biotechnology.]