Examination of witness (Questions 421
WEDNESDAY 8 JULY 1998
420. If the product became a problem why
would it be difficult to sue the manufacturer?
A. It would not
be difficult to sue, but I do not know how a court would rule
in such a case. I cannot prejudge the outcome of a lawsuit.
421. Just now you referred to various ways
in which you assess risk. As I understand it, the US Government
decided that there should not be special legislation to assess
the safety of the products of biotechnology. How adequate or useful
do you consider your pre-commercialisation risk assessment to
be? What can usefully be judged in the four and a half months
which the US took to assess Monsanto's pest- resistant corn or
the eight months to assess the herbicide-resistant soybeans? You
are probably aware that there has been great concern in Europe
about the resistance to antibiotics which is potentially involved
in one particular pest-resistant corn, although many believe that
the risk is minimal. Perhaps it would be useful to hear how the
US system assesses this risk for that BT maize or pest-resistant
corn. Undoubtedly, there was great public concern that in some
way immunity to antibiotics could enter the food chain?
A. The role of
pre-commercialisation testing and research is very important.
Typically, before the sponsors of these products approach the
US Government and ask for commercial approval they conduct at
least a couple of years' worth of field testing. That field testing
is done under standards prescribed by the federal agencies that
will ultimately review the product. You mentioned the number of
months that a product is before the different regulatory agencies.
As I understand it, that simply refers to the period of time during
which that final stage of the process occurs where the company
has completed its couple of years' field testing and is now providing
the data to USDA or EPA to get approval to move on to the commercial
phase of production. It is not as if those products are examined
for only four or six months. That is just the final stage of the
process prior to full-fledged commercialisation. In the case of
antibiotic markers, a lot of attention has been focused on that
issue. That issue was examined by the French during their consensus
conference three or four weeks ago. It has also received careful
scrutiny in the US. It looks as if most of the scientists who
have examined the issue are confident that the procedures are
safe. But I believe that the companies are aware of the sensitivities
in this matter and for that reason seem to be interested in other
alternatives as new products are submitted in the future.
422. You said that the final stage of field
testing was undertaken by the individual companies. Are those
field trials attended by independent scientists who verify the
results or is it done specifically by the company and you take
the results submitted by the company?
A. I cannot tell
you about the exact procedures. All I can say is that the test
protocols are laid down by our federal agencies at the start.
The companies have to follow those protocols. Whether or not the
federal agencies send out people to make sure that those protocols
are followed I am not able to say today.
423. Does the USDA or any other agency require
any follow-up monitoring after commercial release of particular
A. We generally
require monitoring, unless a product has been deregulated. Companies
are required to notify the federal government of any adverse findings
that may be discovered. To cite a specific example, our EPA has
required monitoring for Bt-based crops, primarily to monitor for
424. Does that requirement rest on the company
that provides the seed to the farmer?
A. The company
or anybody who may experience adverse findings. The company is
obligated to report that to the government.
425. Is that a statutory requirement? If
any ill-effect was subsequently discovered and not reported, the
person who should have notified it but did not would be pursued
A. It is more
a regulatory than statutory requirement.
426. The farmers and companies are told
what they should be monitoring?
A. That is my
understanding. I believe that that information is explained in
the detailed answers to the other questions that I have submitted.
427. Perhaps I can link the question of
risk assessment to one matter we discussed earlier; namely, the
possibility of an international convention. Is there not a need
for some internationally agreed worldwide standard for risk assessment;
otherwise, who will decide on the validity of the assessment?
Does every importing country have to accept the risk assessment
of every exporting country, or how should it be regulated?
A. I do not know
that there needs to be an international standard for everything,
but I believe that the burden on either the exporting country
or the importing country that challenges the product is to demonstrate
whether or not sound science has been used. I think of the other
current issue between the US and EU over hormones used in beef
production. The US believes that the science is very clear. We
have provided all the information to the WTO, for example. The
burden is on those who would challenge that decision to prove
that somehow the science is flawed. After examination it has been
proved that with respect to hormones in beef science is on our
side. The burden tends to shift depending on who is raising the
428. What crops or animals are now being
worked on as regards genetic modification? Will the present focus
of benefit to farmers continue? Are modifications at present benefiting
US consumers, and will that also continue?
A. If I may,
I would like to provide the Sub-Committee this morning with a
list of all the various products that have been approved and are
available to the marketplace today, as well as a list of products
that are likely to be available over the next six years. This
list is publicly available on the web page of an organisation
called the Biotechnology Industry Organization. Basically, it
is made up of all the companies that are active in this area.
If one goes through the list one sees that 40 or more products
are currently available to the marketplace today. Some of those
offer direct benefits to consumers. Looking at the products, they
include: tomatoes; carrots; sweep peppers; cherry tomatoes; and
high-oil soybeans. There is an enzyme that is used in approximately
60 per cent of all hard cheeses. In the case of tomatoes, there
is longer shelf life or improved taste. They offer direct benefits
to the consumer. But I argue that even in the case of some of
the other commodities like corn and soybeans, where it appears
that the benefits accrue only to the producers, the public as
a whole benefits to the extent that use of these products has
resulted in reduced pesticide and herbicide use. We all benefit
from that improved environmental stewardship. One does not necessarily
have to taste a sweeter tomato or something of that kind in order
to realise some of the benefits of this technology. Looking to
the future, some of the other products that the industry say will
be available six years from now include improved cotton varieties
with stronger fibres that reduce pollution from dyes; a number
of high-oil products, whether it be corn or soybeans; sweeter
tomatoes and strawberries; seedless melons; controlled ripening
in bananas and pineapples; firmer peppers; sweeter peppers and
peas. The list goes on and on. I would be happy to provide that
list to the Sub-Committee. (See Appendix to Supplementary Memorandum).
429. Does that include work on animals?
So far you have spoken only about plants.
A. The only mention
I see here of animals are some fish: salmon, trout and flounder.
Basically, they grow faster as farm-raised fish.
Lord Willoughby de Broke
430. What is the increased growth rate?
A. It is only
a paragraph which refers to fish being capable of growing to market
size in one to one and a half years as opposed to conventional
techniques that require three years.
431. The last question was aimed at discovering
who benefited morethe consumer or farmer. Quite a lot of
our evidence reveals that the view of people is that it is Monsanto
who benefits most rather than the consumer or farmer. There is
quite a strong feeling about the monopolistic role of Monsanto
in the development of GM technology. We heard about Monsanto dominating
the cotton business in China and buying up companies in this business.
Does Monsanto's monopolistic position in GM crop technology concern
A. It is interesting
and ironic that Monsanto is frequently put up as a kind of straw
man on this issue. From my experience, we deal with a number of
companies including European companies. Representatives of Novartis
and Agrevo come to see us on a regular basis with respect to GMO
commodities for which they seek approval in the US. Certainly,
European companies are very active in this area, as they should
be. It is a bit of a puzzle to me why Monsanto is always held
up as an example. That said, I agree with your observation that
there is concern about the level of consolidation that is occurring
in this industry. We see various companies either buy out each
other horizontally in the development of these products or move
to the next stage and buy out and consolidate the various seed
companies. There is concern about increased market concentration.
But today even with these acquisitions there is still a fair degree
of competition, in part because European and other companies are
very active in this area. Farmers are right to be concerned about
the direction in which things are moving and whether or not a
sufficient level of competition will be present in the industry
in 2010, 2020 and that sort of timeframe.
432. We heard from the American Soybean
Association about farmers' reduced freedom when growing modified
soybean crops and the amount of litigation that is threatened
if they do not conform to the standards set by Monsanto in this
area. Is your department aware of the reduction in the freedom
of farmers to produce crops as they want?
A. We are certainly
not there yet. Today, farmers still have plenty of choices in
the marketplace. Genetic modification technology offers the potential
dramatically to increase choice, so long as there are a number
of companies engaged in developing these products and offering
them to farmers. There is nothing inherent about genetic modification
that is spurring the concentration that we see occurring. If you
look at the history of hybrid corn development over the past 50
years, a concentration has occurred in that industry. One can
make the case that maybe hybrid corn is bad too. I do not think
that anyone is ready to reach that conclusion. There is nothing
inherent in this genetic technology that indicates that there
is a problem, but farmers have a legitimate concern about the
current rate of acquisitions and concentrations that occur. But
at least in the US farmers for the past 100 years have always
been concerned about monopolies and concentrations within agriculture,
whether it is in railroads, meat-packing or grain companies. They
are always worried about maintaining a level of competition with
respect to where they buy their inputs or sell their final product.
Lord Willoughby de Broke
433. I want to pursue the question of herbicides
and pesticides. With non-GM crops farmers have traditionally had
a wide range of companies from whom they buy their supplies. As
I understand it, nearly all the GM companies link their products
with their own herbicides. People are told that they must use
their herbicide with their seed; that's what the product's designed
for. I was not at the meeting with the American Soybean Association,
but I imagine that that is the sort of concern that it raises.
Is that a matter of concern to you?
A. I do not perceive
it as "must use". However, as a practical matter if
one is buying round-up ready soybeans one is buying that product
so one can use the round-up herbicide in conjunction with it.
It is not a question of "must use"; if one is buying
that particular seed one is buying it so one can use it in conjunction
with round-up ready. As the patent on round-up expires in a couple
of years I assume that it will be a generic herbicide. Others
can produce it and farmers can buy it from other companies.
434. That brings us to the end of our questions.
You have answered them very fully and clearly. We are extremely
grateful to you for having come to see us.
A. Thank you
for the opportunity. I view it as a special honour to be here