Government bureaucrats are playing with our food.
Food and Drug Administration
Special regulatory attention should be required for genetically
engineered food because it contains genetic material never before
seen in the diet, and releases life forms that never before existed
into the environment. Like a new drug, the effects of the genetic
changes are not entirely predictable, and may have unintended
consequences.
However, the rigorous review process for new drugs contrasts
sharply with the near total deregulation of genetically engineered
food. New drug applications submitted to the FDA first go through
several stages of required clinical trials, that include months or
years of experiments. A FDA physician, who also coordinates
considers input from other agency scientists, then reviews the
results in detail. Compare this process with the FDA's biotech
policy: "FDA has not found it necessary to conduct comprehensive
scientific reviews of foods derived from bioengineered plants…[but
instead] expects developers to consult with the agency on safety
and regulatory questions." (i)It is noteworthy that the agency has
never formalized its rules for genetically engineered food - they
remain as "guidelines" that do not have the force of law. Moreover,
the latest proposed FDA policy on genetically engineered food does
little to change the voluntary nature of biotech industry reporting
on the foods they intend to market. Under the pending proposal,
biotech companies would merely be required to notify the agency 120
days before bringing a new genetically engineered food to market.
Also, the FDA would still not require health or environmental
studies, leaving it to the industry to decide how many and what
kinds of tests to conduct.
In short, the FDA's consultation process for genetically
engineered foods has none of the scientific rigor seen in the drug
approval process, and is even weaker than FDA standards for other
food additives (such as artificial flavors or colors). As Dr.
Rebecca Goldburg (a senior scientist at Environmental Defense and a
member of USDA's advisory body on organic agriculture) noted:
Most
genetically engineered foods are essentially foods with added
substances, usually proteins. FDA's policy gives manufacturers who
use genetic engineering to add substances to food considerably more
discretion than manufacturers who use other technologies to add
substances to food…FDA's policy strongly favors food manufacturers
at the expense of consumer protection. ( ii )The FDA's proposed
guidelines also continue to leave genetically engineered foods
unlabeled, despite their own public opinion data, which notes that
when asked about labels for genetically engineered food, "Virtually
all participants said that bioengineered foods should be labeled as
such." ( none;">iii ) Furthermore, FDA guidelines are designed
to make it as difficult as possible for responsible food producers,
those that have rejected genetically engineered ingredients, to
label their products as "Non-GE" foods. According to the FDA, food
producers should not label products as "Non-GE" because, they say,
it could be "misleading." At the same time, the FDA somehow does
not find it misleading when genetically engineered food is
unlabeled - leaving consumers in the dark about what they are
buying.
Department of Agriculture
USDA biotech oversight is even less stringent than the FDA's. As
noted by the New York Times, and acknowledged by the agency, the
USDA has not denied a single one of over 5,000 applications for
genetically engineered crop field trials submitted by industry. (
iv ) The USDA claims that its review process, "evaluates
agricultural and environmental safety issues," ( v ) but scientists
outside the agency have pointed out that the agency virtually
abandoned its permit process in the mid-1990's, in favor of mere
notifications that do not require any risk assessment or specific
environmental review. In this system, "Ninety-nine percent of all
field trials can be undertaken without [USDA] review. Developers
need send only a brief notice to USDA along with a promise to
conduct the tests safely." ( vi )
Meanwhile, the USDA actively encourages and even partners with
industry in developing some of the worst genetically engineered
crop technologies. For example, the agency has spent over $200,000
of taxpayer's money to develop "terminator technology," a genetic
engineering technique intended to make it impossible for farmers to
save seed for replanting. Part of the USDA's mission is to support
American farmers - yet this technology is a direct assault on
farmers' long-held right to save seed. Despite worldwide outrage
about terminator, the USDA continues to pursue the technology with
its industry partners.
Environmental Protection Agency
Herbicide tolerant varieties make up about 70 percent of the
genetically engineered crop acreage in the United States. Yet, the
U.S. government agency charged with environmental protection does
not evaluate the environmental risks of these varieties. The EPA's
role in regulating these crops, such as Monsanto's Roundup Ready
brand soybeans, is limited to approving herbicide for use on the
new crop. ( vii ) In addition to allowing higher residue levels of
Monsanto's Roundup brand herbicide on foods ( viii ), the EPA has
approved the use of bromoxynal on cotton, despite a cancer risk
calculated at nearly twice the legal standard. ( ix )The EPA does
regulate the other main variety of biotech crop grown widely in the
United States, the so-called "Bt plant pesticides." However, the
agency's 1995 proposed policy showed that the EPA intended from the
outset to exempt the majority of Bt plants from insecticide or food
regulation. ( x ) Since allowing Bt crops on the market, the agency
has heard from three scientific panels on the issue of insect
resistance. The scientists warned the EPA that near perfect
compliance is required to forestall the development of insect
resistance. ( xi ) However, the EPA has made only minor adjustments
in resistance management recommendations - even though, as the
Associated Press reported on January 31, 2001, an EPA survey of
farmers showed that nearly 30 percent were not complying with
insect resistance management rules.
In September 2000, food testing by environmental watchdogs
showed the presence of StarLink corn in store-bought taco shells.
StarLink is a genetically engineered variety of Bt corn that the
EPA approved only for animal feed, due to scientists' concerns that
the corn could trigger dangerous allergies in some people. The
discovery of StarLink in the human food supply prompted the recall
of nearly 300 supermarket and restaurant foods. Aventis, the
biotech firm that developed StarLink, petitioned the agency to
retroactively approve the corn for human food, but pressure from
consumers and environmentalists forced the agency to withhold
approval, and StarLink was forced off the market.
To this day, the agency remains unwilling to impose effective
regulatory oversight, and another, possibly even more serious,
release of food not safe for human consumption is almost an
eventual certainty.
Notes
i 1998, US Food and Drug Administration, Center for Food Safety
and Applied Nutrition, "Guidance for Industry: Use of Antibiotic
Resistance Marker Genes in Transgenic Plants," appendix two,
September 4, 1998.
ii Statement of Rebecca Goldburg of the Environmental Defense
Fund, at the FDA Public Hearing on Genetically Engineered Foods,
November 30, 1999, Washington, DC
iii U. S. Food and Drug Administration, Center for Food Safety
and Applied Nutrition, Office of Scientific Analysis and Support
October 20, 2000, "Report on Consumer Focus Groups on
Biotechnology," at http://www.cfsan.fda.gov/~comm/biorpt.html.
iv Carol Kaesuk Yoon, "Reassessing the Risks of Genetically
Altered Crops," New York Times, November 3, 1999; Sally McCammon,
p. 15.
v McCammon, p.15.
vi The Gene Exchange, "USDA Retreats from Transgenic Crop
Oversight," Union of Concerned Scientists(UCS), Fall, 1997. Also,
Michael Hansen, "A Regulatory Patchwork - With Big holes," May/June
1999, The Environmental Forum, p. 51.
vii The Gene Exchange, "The Myth of EPA "Approval" of Roundup
Ready Soybeans," UCS, Winter, 1996.
viii Marc Lappe and Britt Bailey, Against the Grain, Common
Courage press, 1999.
ix The Gene Exchange, "EPA Gives Permanent Approval for
Bromoxynil on Cotton," Summer 1998.
x "Under the approach articulated in this policy statement,
[EPA] believes that most plant pesticides would not require
regulation under [the Federal Insecticide, Fungicide and
Rodenticide Act]...Similarly, under the [Food, Drug and Cosmetic
Act], the agency believes that most plant pesticides should be
exempt from the requirement of a tolerance." In Hansen, op cit,
p.51.
xi Philip Brasher, Associated Press,
"Farmers Unclear About Biotech Rules," January 31, 2001