Consumers Union

 

TESTIMONY BEFORE THE

SENATE COMMITTEE ON HEALTH, EDUCATION , LABOR AND PENSIONS

on

THE FUTURE OF FOOD: BIOTECHNOLOGY AND CONSUMER CONFIDENCE

by

MICHAEL K. HANSEN, PH.D.

Research Associate, Consumer

Policy Institute,

Consumers Union

September 26, 2000


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

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