Examination of witness (Questions 375
WEDNESDAY 8 JULY 1998
375. Mr Galvin, good morning and welcome
to the Sub-Committee. I start by thanking you very much for having
taken the trouble to come all the way from the United States to
give evidence and help us in our enquiry into genetic modification
in agriculture with particular reference to regulation. We have
just received from you written answers to some of the questions
that we put to your department relating to the practices in the
United States. Having had a quick glance at the document, it appears
to be a very full reply to our questions. I believe that initially
you had difficulty in answering these questions due to the fact
that other departments of state needed to be consulted. If that
is the case these answers have been provided with great speed.
We are extremely grateful that you have been able to do this.
Perhaps you would thank on our behalf all those involved. I understand
that you propose to begin by making a brief introductory statement.
If that is the case, I give you the floor straight away.
(Mr Galvin) My Lord Chairman and members of the
Sub-Committee, I appreciate this opportunity to present the views
of the US Department of Agriculture with respect to the regulation
of genetic modification in agriculture. As a former staff member
of the US Congress for nearly 17 years, I consider it a special
privilege to be here this morning. In advance of today's hearing
the Sub-Committee posed a number of questions to the US Department
of Agriculture. Those questions sought more information about
the details of the US system for regulating genetically modified
organisms as well as our views on the European Union's regulation
of those products. Because the US regulatory system involves three
separate federal agenciesthe Animal and Plant Health Inspection
Service, the Environmental Protection Agency and the Food and
Drug Administration - we consulted with those agencies in answering
the questions relating to the specifics of the US regulatory regime.
As has been indicated, I am providing those answers to the Sub-Committee
this morning. In addition, the Sub-Committee asked us to review
and comment upon a draft paper that has been prepared for the
Sub-Committee that analyses the US regulatory system. This is
a matter that also requires input from our three regulatory agencies.
They have asked for additional time to prepare a response. With
your permission, our reaction to that paper will be provided next
week. The Sub-Committee's effort to examine the regulation of
agricultural biotechnology is one that we welcome and are eager
to support. We fully recognise that the EU has the right to put
in place its own system for governing the approval and marketing
of genetically modified products. Our chief concern is that such
a system be characterised by certainty, timeliness and an adherence
to those science-based standards that are necessary to ensure
the protection of consumers and the environment. Similarly, we
are concerned that any policy developed for the labelling of these
products be practical and not constitute a barrier to trade. For
our part, we in the US Government have been engaged with EU officials
on a bilateral basis to share information and foster co-operation
in this area. We have also been active participants in the Trans-Atlantic
Business Dialogue (TABD) and are encouraged by progress made under
the TABD to improve the regulatory systems on both sides by exploring
common regulatory approaches, such as requiring similar data submissions.
In our view, there is much at stake in achieving an improved means
to regulate biotechnology worldwide. Clearly, the acreage devoted
to genetically modified varieties is increasing rapidly, as is
the number of varieties being offered to the marketplace, with
obvious implications for trade and commerce in general. More importantly,
these products if regulated properly offer significant benefits
in the form of reduced chemical use, improved yields, lower production
costs and enhanced qualities for consumers and other end users.
I appreciate the opportunity to be here and look forward to answering
376. Can you explain to the Sub-Committee
what you see as the fundamental difference between the EC approach
to biotechnology regulation and that undertaken in the US?
A. In general,
the key difference is that in the US our regulatory system is
well established. From the standpoint of the regulated community
it is viewed as offering a reasonable degree of certainty with
respect to requirements and procedures. By contrast, the EU regulatory
system is perceived as still evolving. Therefore, it is viewed
as uncertain and subject to changing procedures that perhaps are
not always driven by science-based requirements to ensure safety
of the regulated products. Currently, the issue of uncertainty
as it relates to product labelling and approval probably gives
rise to the greatest difference.
377. Do you think that in Europe we look
more at wider environmental issues than in the United States?
A. I do not believe
so. Frankly, I believe that there is great interest in both the
US and EU in looking at the environmental side of the equation
and trying to provide reassurance that these products are safe.
I do not perceive that there is a greater concern or awareness
in the EU than in the US. We are fortunate in the sense that in
the US we went through this whole procedure a decade ago. The
procedures are well accepted and well known by the regulated community
as well as by consumers groups that closely follow the process.
378. Is the situation in the US fairly stable?
There is no pressure to change the regulatory system in any way
to take into account considerations that hitherto have not been
taken into account?
A. More recently,
there was a request by some consumer groups for the labelling
of these products. There are some in the US who believe that we
should do more to regulate these products or label them, but they
tend to represent a minority. The overwhelming majority of the
public accepts the procedures that we have in place. Part of the
reason for that is that from the very start our process involved
a period of public comment and review. Even to this day as specific
products are reviewed and approved they are noted in our federal
register so that there is an awareness on the part of those following
this issue as to exactly what steps the federal agencies have
taken to approve these products.
379. You referred to labelling. In supermarkets
in the United Kingdom every genetically modified product is labelled.
Are you saying that in the US some products are not labelled as
A. That is correct.
380. Consumers are not aware that they are
eating genetically modified products?
A. Not in each
and every case, but they are aware that these products have been
approved and are available in the marketplace.
Lord Wade of Chorlton
381. You are critical in your paper of the
EC approval system. What changes would the US like to see take
A. The issue
comes down to certainty, timeliness and transparency in the process.
We view the EU system as still evolving. Frankly, we are confused
as to which authority is controlling this area. Is it Directive
90/220 EEC or the Novel Food Regulations, and so on? We do not
know exactly what procedures the various companies must follow
in getting products approved. That uncertainty is now complicated
by the new proposal on labelling because the practical aspects
of that policy are not clear to us. For example, it is not clear
what testing will be required or whether these commodities have
to be identity preserved all the way through the process to the
382. In the US, who assesses a product before
it is allowed into the marketplace? What issues are examined?
Are scientific committees consulted?
A. It is science-based.
The Department of Agriculture examines these products to determine
their likely impact on other plants or animal species. We review
products for safety to agriculture. The Environmental Protection
Agency looks at the impact of these products on the environment
generally, especially since the EPA also regulates pesticide use.
Many of these products are in some way related either to pesticide
use or have inherent qualities that allow them to combat certain
pests. The Food and Drug Administration, however, reviews these
products to make sure that in the end they are safe to any consumers
who may eat them.
383. Clearly, in the United States the public
has tremendous confidence in the system that the US Government
operates in terms of food. At the same time, it has turned out
to be very effective in that the public has been given warnings
about certain foods which have been quickly withdrawn from the
market. In Europe the experience is very different. There is considerable
concern about it. Very often, what governments say is the opposite
of what people believe. How would you tackle that on a European
basis? Would you like to see a more European-based committee or
group that considered all of these issues? You talk about certainty,
but how do you take the first steps in ensuring that there is
certainty and that consumers can have confidence that what the
body says is correct?
A. That takes
us back to the first steps that the US took when it put its policy
in place. We went to the public and offered a proposal for the
regulation of these products. That proposal was subject to public
comment and review. That transparency in the system has been ongoing
ever since, in the sense that we have scientific committees that
meet periodically to review issues that come up. We also issue
public notices on products that are approved. I believe that in
the view of those members of the public who follow this issue
there is a sense that we have not hidden anything and everything
is on the table for consideration. With all due respect, I suggest
that that is an important way of moving ahead and building public
confidence in this area. I have seen some of the polling data
both in the US and Europe with regard to consumer attitudes towards
biotechnology. From what I have seen, it appears that the difference
between the attitudes in the US and those in many European countries
are not that great. In general, it appears that about two-thirds
of the public endorse the idea of biotechnology, at least from
the survey data that I have seen. I am happy to share that with
the Sub-Committee this morning. For example, if you ask consumers
even in Europe how they rank the various threats to public health
at the very top is bacteriological contamination and biotechnology
ranks at about no.8, just ahead of food colouring.
384. In the paper that we received from
you a criticism was made of the Commission's use of review by
scientific committees, particularly in the case of corn. Do you
recall that and, if so, would you care to comment on it?
A. It does ring
a bell. We are not at all opposed to scientific review in the
case of these products. What we were concerned about in this specific
instance was the fact that this particular scientific review was
introduced very late in the process after the same products had
already been reviewed at the Member State level and then by the
Commission itself. Therefore, our concern was that it represented
a change in procedure very late in the game that added another
scientific review to the process.
385. You are also critical of the EC regulatory
system on the ground of politicisation. Can you explain what you
mean by that?
A. Perhaps the
best recent example of that is the situation that we face in France
where two of our corn products still await final approval. These
products were reviewed by France more than two years ago and then
sent to the Commission. The Commission approved those products
in April after that extensive review and re-review. They were
then sent back to France for final technical approval which should
have been almost a formality. Although these products have received
clearance by the Commission, France withheld that final step of
approval, even though French officials assured us that there were
no concerns about science or consumer safety; rather, there was
concern about public opinion. Therefore, France said that it would
be holding a so-called consensus conference. That took place about
three weeks ago. I believe that that will be the final step before
they decide whether or not to let these products go.
386. Is the problem in Europe that there
are consumer concerns which are different in various Member States
which make themselves felt through government action at different
stages in the process? This is not a problem that you have in
the United States, though I understand from what you say that
perhaps you had such a problem at one time. How can governments
avoid taking account of such public opinion?
A. I recognise
and appreciate the difficulty in Europe of trying to get the approval
of 15 different Member States. Frankly, that is not a situation
we face in the US. We do not have to go to any of our 50 states
to get approval for these products. In that respect we are very
fortunate. In terms of increasing public confidence in whatever
approval system is put in place, we would encourage those concerned
to take additional steps to increase the transparency of the process
or invite consumer and public comment on the procedure so that
the public has greater confidence in the system.
387. Could you deal in more detail with
your labelling philosophy? The FDA state that the "Food,
Drug and Cosmetic Act does not require disclosure in labelling
of information solely on the basis of consumer desire to know."
Do you consider that the consumer has the right to know? Perhaps
you can illustrate this to us? I am not familiar with the practical
example in the US of, say, how tomato paste is labelled if it
is a 100 per cent GM product. In the case of certain products
of which soya is a material ingredient, such as a pizza, does
that also involve particular labelling?
A. First, perhaps
I may explain the general policy that underlies the labelling
requirements in the US. Labelling policy falls under the Federal
Food, Drug and Cosmetic Act. Essentially, it requires that the
labelling of products should be truthful and not misleading and
it should include the common or usual name of the food. Perhaps
more importantly, it requires labelling only if the end product
is materially different in some respect. Our FDA has concluded
after a careful review that inherently there is nothing in these
genetically modified products that makes them materially different
from their conventional counterparts. Therefore, we do not as
a general matter of policy require that these products be labelled.
If however, in future there is a particular genetically modified
product that is materially different from its conventional counterpart,
it has to be labelled. Two specific examples: Our FDA has required
that oil derived from genetically engineered canola plants that
have high levels of laurate be labelled as "high laurate
canola oil", and that oil from soybean plants modified to
express high oleic acid content be labelled as "high oleic
soybean oil". Both of these products are significantly different
in composition and use than the conventional products. However,
in neither case was the product label required to state that the
oil was produced through genetic modification. Similar labelling
requirements were imposed on specific sunflower and safflower
varieties, even though those varieties were developed through
388. You do not label GM tomato paste?
A. It is just
tomato paste. That is because the FDA has reviewed the product
and concluded that the genetically modified version is not materially
different from the conventional product.
389. It is for the FDA to decide whether
or not labelling is required?
390. If, for example, an anti-freeze gene
from a flounder or other fish is inserted into a plant would labelling
A. That could
be an example, but I would have to address that question to our
391. If there were a modification that reduced
or increased fat content would that require labelling?
A. That sort
of information is disclosed on the so-called nutritional panel
on the side of the label. That covers fat and protein content
but there is no specific mention of the fact that the product
is genetically modified.
392. To return to the tomato paste, from
our observation it is a different product compared to standard
tomato paste. Although your FDA may say that it does not require
labelling, in practice do manufacturers of that product choose
to identify it as a different productas a GM paste?
A. Our companies
do not voluntarily disclose the fact that it is genetically modified.
They are free to do that. We would support that sort of voluntary
disclosure, but that is not something that the companies have
chosen to do. However, if it is a flavour savour tomato, for example,
they will sell that product with that sort of advertising so that
people know it is a special tomato which is more shelf stable
and so on. They do other things to advertise the fact that this
tomato has special characteristics.
393. It is identified as a different product,
not as a genetically modified product?
394. Is that because such labelling would
be detrimental to the sale of that product?
A. I do not know.
You would have to put that question to the manufacturers. For
whatever reason, they have not chosen to put that on the label.
It is likely that they would do so if they thought there was great
consumer concern in the US about whether or not the product had
been genetically modified.
395. Has there been any campaigning against
supermarkets who sell unlabelled genetically modified products?
A. There have
been some but it is only a distinct minority who are in favour
of this kind of labelling.
Lord Willoughby de Broke
396. Are there any consumer organisations
represented on the regulatory agencies - the FDA, EPA and Food
and Drug Administration - who monitor GM organisms?
A. No. The agencies
are wholly comprised of government officials. We have scientific
advisory committees. I do not have a list of their membership.
I would be happy to provide that information for the record. It
may be that some of the consumer groups have representatives on
those committees. But the consumer groups are free to comment
at various stages, even at the stage of developing regulations
or as public notice is given that various products are approved
or are about to be approved.
397. Is it your view that a labelling requirement
can constitute a barrier to trade?
A. It could depending
on how it is constructed. For example, on the basis of the new
labelling policy that has been issued by the EU it is not clear
to us at this point what level of testing may be required. If
the US sent a shipload of soybeans to Europe would each bin or
hold of the ship have to be sampled individually or would there
be one sample for the whole ship? It is not clear how intensive
that sampling has to be, or what sampling methods will be sanctioned.
Until all sorts of operational details are worked out we have
concerns that this policy may constitute a barrier to trade.
Lord Willoughby de Broke
398. This brings us to the question of segregation.
Our impression is that the US is opposed to segregation. Is that
correct, or do you accept that segregation should be decided by
consumer choice? Has the US Government made any attempt to prevent
segregation either at home or abroad?
A. What we are
opposed to in the US is mandatory segregation. We have not made
any attempt to discourage segregation to the extent that if a
seller wants voluntarily to segregate a commodity we are not opposed
to it. If a seller can find a certain market niche by advertising
a product as GMO-free or whatever he is free to do that. We would
support that as a voluntary measure. But in the case of mandatory
segregation the issue for us is whether or not the end product
is materially different. We have reviewed that issue very carefully
in the US and have concluded that these products are not materially
different from their conventional counterparts. We do not believe
therefore that segregation is necessary. We also believe that
on a broad scale segregation is impractical given the way that
major commodities are produced in the US. Typically, our farmers
harvest all their corn or soybeans together, put them in the same
bins and move them to the same terminal elevators. It would be
difficult and more costly if farmers segregated products according
to whether or not they were conventional or genetically modified.
However, increased segregation is occurring in the US but not
as a result of whether or not the products are genetically modified;
rather, it occurs because today farmers are more interested in
producing certain commodities with special characteristics. In
the case of corn, farmers are producing more higher oil, waxy
or white corn that meet specific end-user requirements. That corn
is then segregated and identity preserved in the marketplace.
But typically it also commands a premium in the marketplace because
it offers special characteristics. If a farmer is offered that
premium for producing a different product then he is happy to
segregate and give it the special handling and attention that
399. We were able to meet informally members
of the American Soybean Association who were over here earlier
this week. We learnt of some of the potential difficulties of
segregation that you describe. We also learnt of the likely prospect
of all sorts of different types of genetically modified soya that
may be produced in future which would make segregation essential.
Therefore, genetically modified products could be a vehicle for
the introduction of a great variety of crops and therefore segregation
would be required. Is that a likely pattern that you foresee?
A. Yes, I do.
But we view that as a more acceptable development because the
whole basis for segregation is different. The products would not
be segregated simply because they were genetically modified versus
conventional; they would be segregated because the end product
had some different characteristic that was preferred by the marketplace.
We prefer to see this develop in response to market and consumer
demand rather than because of any arbitrary decision by government
that these products should be segregated because they are genetically