|
|
|
Thank you for inviting me to testify today on
behalf of Consumers Union*, publisher of Consumer Reports, and its
Consumer Policy Institute. Consumer Reports in an article published
in September 1999 found genetically engineered ingredients in infant
formulas, soy burgers, tortilla chips, ovaltine and muffin mix. We
have closely followed Congressional and regulatory agency actions and
proposals to regulate genetically engineered food, and have testified
extensively at hearings since 1990.
We commend you for calling a hearing that asks
the question, "What can be done to enhance consumer confidence in
biotechnology?" This is a question that has not been enough in the
forefront of the thinking of regulatory bodies who are charged with
protecting the public interest.
One factor which significantly heightens
consumer anxiety about genetically engineered food is that they have
no control over whether they eat it or not. Consumers have no choice
about such food--it is being put in food products across the board
without their knowledge, and with no labeling.
Consumer confidence is also being eroded by
recent events and emerging scientific knowledge, which is showing
that the regulatory agencies in which the public has put its faith
are not watching out for consumers as expected. The first major blow
was the emergence of data indicating that BT engineered corn could be
harmful to the monarch butterfly--and the related realization that
this data came from independent academic research, and that the
regulatory agencies had not seriously evaluated this question before
approving the corn.
Now we have a major recall of a widely
distributed food product--Taco Bell taco shells. We have only the
highest praise for Kraft Foods in acting promptly, decisively and
comprehensively to address the problem once it was brought to their
attention. But it is not lost on consumers that the problem was
discovered not by the FDA or EPA, but by Friends of the Earth. Where
are our regulators in terms of assuring consumers safety? Are we now
in a situation where consumers must rely on Friends of the Earth to
see if products not approved for human consumption are showing up on
the grocery shelves?
The time has come for quick and decisive action
by the government before the erosion of consumer confidence becomes a
collapse. We need only look at events in the UK in the spring of
1999 to see how quickly a collapse of confidence in genetically
engineered food can occur. In my remarks I will address the specific
measures that need to be taken. However before I address those
concerns, I would like to urge this Committee to consider the need to
save this industry from itself, and its self-destructive focus on its
short term needs to get products out and turn a profit on them.
Biotech companies are forced into short-term thinking by Wall Street.
But someone is going to have to take a longer term view if this
technology is to fulfill its potential. Some of these steps will
inevitably slow the introduction of some products and slow market
penetration for others. But in the long run the steps consumers want
will create a foundation for a stable industry, that can take its
proper and appropriate place in our whole economy.
Pass Comprehensive Mandatory Labeling
Legislation
First and foremost, we urge the Senate to pass
S. 2080, the Genetically Engineered Food Right-to-Know Act, sponsored
by Senator Barbara Boxer (D-CA), requiring mandatory comprehensive
labeling of genetically engineered food. A companion bill, HR 3377,
sponsored by Rep. Dennis Kucinich (D-OH), must be passed in the
House.
There are many benefits to mandatory labeling.
The first, of course, is that it would enable consumers to decide for
themselves whether or not they will eat genetically engineered food.
Polls have repeatedly indicated that 70% to 90% of consumers want
mandatory labeling-about the same numbers as in the European Union,
Australia, New Zealand, Japan and Korea, all of which have instituted
such a policy. Industry worries that labeling will mean that
consumers won't buy engineered food, and some percentage will of
course avoid them. But labeling will also give consumers a measure
of control, and thus a greater sense of security, both of which are
essential to consumer confidence.
Mandatory labeling would also bring engineered
food in line with FDA policy on labeling in general. FDA requires
many types of purely informational, non-safety-related labeling,
designed only to facilitate consumer choice. This includes labeling
juice "from concentrate" or "not from concentrate," labeling food as
to ingredients, and labeling if it is frozen. All this labeling has
nothing to do with safety, but it is mandatory.
We have also long said, and this episode with
taco shells underlines, that mandatory labeling could help everyone
deal with any unexpected problems should they arise.
Had a mandatory labeling requirement been in
place, the contaminated taco shells might never have made it to the
market. If we had mandatory labeling, there would be much more
regular testing for presence of engineered varieties in commodities,
and tracking of unprocessed supplies with origins indicated. The
detection of the presence of this animal feed corn in a part of the
distribution chain where it didn't belong might have occurred long
before it got made into taco shells. Tracing back to determine where
the problem occurred might also have been easier.
In addition, if we had mandatory labeling, and
an unexpected allergic reaction did occur, there is a better chance
that the victim would be able to tie his or her reaction to the
product that caused it. As it is, we simply don't know if anyone has
developed an allergic reaction to the recalled taco shells.
Finally, mandatory labeling would bring us in
line with the policies of some of our major trading partners, and
would facilitate trade.
FDA got 50,000 comments this year on its
policies on genetically engineered food. I challenge FDA to show
that the vast majority of these didn't ask for mandatory labeling.
FDA claims that it doesn't have the authority to label, but
Representative David Bonior and 50 of his colleagues in the House
believe FDA does have the authority. If FDA continues to refuse to
act, then Congress must act. We therefore urge you to pass the Boxer
and Kucinich mandatory labeling bills.
Establish Mandatory Safety Review
As this Committee well knows, FDA consultations
on the safety of genetically engineered food are currently voluntary.
It would greatly enhance consumer confidence if FDA review were made
mandatory and ended in an approval, and applied to imported as well
as domestically grown foods.
FDA has promised that it would propose a rule
that would mandate notification to FDA before an engineered product
goes on the market. However even this minimal step has not been
forthcoming so far.
S. 2315, sponsored by Senator Patrick Moynihan
(D-NY), and a companion bill, HR 3883, the Genetically Engineered
Food Safety Act, sponsored by Rep Dennis Kucinich, would establish a
mandatory safety review and approval process at FDA. We urge you to
enact them.
Establish Strong Transparent Criteria for
Safety Approval
FDA has also promised to publish, for public
comment, the criteria by which it evaluates the safety of genetically
engineered food. However this has also not yet been forthcoming.
Several types of problems can occur in
genetically engineered food. There can be increased levels of
natural toxins. Known or unknown allergens can be introduced into
the food. There can be increases or decreases in levels of vitamins
and nutrients. And there can be unexpected effects.
These problems arise because while scientists
are very good at isolating the genes they want to introduce into a
plant, scientists are not precise in terms of where the gene gets
inserted. Furthermore, genes must be introduced with powerful
"promoter" genes and other regulatory elements (which act as "on-off"
switches and "volume control") as part of the package. This is done
in order to override the plant's natural defense mechanisms against
invading foreign DNA, known as gene silencing. Thus the results of
genetic engineering are actually fairly unpredictable.
We therefore need a thorough FDA or EPA review
to determine safety. These agencies should use a standard of
assuring "reasonable certainty of no harm" in assessing whether a new
engineered variety is safe-the same standard that is applied to food
additives.
They also need several benchmarks of safety.
FDA and EPA should
prohibit introduction of known allergens into
foods, such as the Brazil nut protein
which was introduced into a soy variety and determined to be
allergenic. In that case Pioneer Seeds commendably withdrew the
variety from development. However FDA has said only that it would
require labeling of such varieties. FDA should prohibit such gene
transfers.
In the case of a suspected allergen, such as is
present in the Starlink corn, regulators have a more difficult task.
We would first urge that FDA and EPA develop better protocols for
assessing allergenicity. This may require funding for public
research in this area. However for the foreseeable future, there
will be products like the Starlink whose allergenic potential cannot
be fully predicted. In those cases, FDA and EPA should take the
precautionary approach, which means that until science can tell us
that they are safe, they should be kept off the market.
FDA should also prohibit
introduction of antibiotic marker genes into plant
foods. These genes present a
possible risk of worsening the problem of antibiotic resistance of
diseases. The European Union has said it will not permit any
antibiotic marker genes after 2005. FDA should do the same.
No engineered crops used for food should be
allowed to be grown unless the crop is approved for human
consumption. We agree with Kraft Foods that approvals for animal
feed, only, of human food crops should not be allowed, precisely
because the kind of problem we just had. We urge EPA to withdraw its
approval for Starlink corn for the next growing season.
In the future there will be even more
problematic proposals for use of genetic engineering-using plants to
produce industrial chemicals and pharmaceutical products. Their
safety in food crops will pose even larger questions. Pollen and
wind are innocent of EPA and FDA regulation. We cannot expect that
they will abide by them.
Lastly fully validated test procedures should
be required for any genetically engineered variety that is put on the
market.
Thank you for considering our views. I would
like to append for the record, a copy of our comments submitted last
January to the FDA on their current regulatory policies, which
explain our concerns in more detail.
_____
* Consumers Union is a nonprofit
membership organization chartered in 1936 under the laws of the State
of New York to provide consumers with information, education and
counsel about goods, services, health, and personal finances; and to
initiate and cooperate with individual and group efforts to maintain
and enhance the quality of life for consumers. Consumers Union's
income is derived solely from the sale of Consumer Reports, its other
publications and from noncommercial contributions, grants and fees.
In addition to reports on Consumers Union's own product testing,
Consumer Reports, with approximately 4.5 million paid circulation,
regularly carries articles on health, product safety, marketplace
economics and legislative, judicial and regulatory actions which
affect consumer welfare. Consumers Union's publications carry no
advertising and receive no commercial support.
