Agriculture Reference
In-Depth Information
pre-market review because inclusion of new genetic material would not
cause the food to be adulterated.
By this action, FDA created a large hole in its pre-market review
program that is extremely accommodating to GM foods, in keeping with
the Coordinated Framework. Although details are not available, crit-
ics believe that FDA applies this assumption in most instances, relies
mainly on information provided by GM food developers, and rarely calls
on them to do additional scientific studies.
36
The policy also states that
FDA expects companies to voluntarily consult with it prior to market-
ing new GM foods, especially with regard to genetic content that may
have toxic or allergenic characteristics, to minimize subsequent regula-
tory problems. A guidance for companies about the consultation process,
as well as a description of FDA's power to impose sanctions, are included
in the policy statement. In its 1992 Policy Statement, FDA claimed that
the voluntary consultation process was being followed by virtually all
companies.
37
It has not discussed the prevalence of consultations since
that time.
Friends of the Earth, a long-standing opponent of GM food, claims
that the consultation process is flawed because it does not require test-
ing, companies routinely ignore FDA requests for additional informa-
tion, and that at most, the agency merely reviews company-provided
summaries of data rather than the full content of the studies from which
the data were derived.
38
In addition, there is no transparency. The data
submitted by companies, on which the agency bases its determinations,
is usually claimed to be proprietary, kept confidential by FDA, and with-
held from the public. According to a notable agricultural policy expert,
“I know of not a single independent scientist in the U.S. that has gained
36
G. Mandel,
Gaps, Inexperience, Inconsistencies, and Overlaps: Crisis in the Regulation
of Genetically Modified Foods and Animals
, 45 WMLR 2167, 2219.
37
Statement of Policy: Foods Derived from New Plant Varieties, 57 Fed. Reg. 22984,
22991 (May 29, 1992).
38
Press Release, Friends of the Earth, GM Crop Safety Tests Flawed (Nov 16, 2004) (on
file with author).
