Chapter 22 Homework
1. What is the RAC? What was its role in regulating recombinant DNA research?
The RAC is the NIH Recombinant DNA Molecule Program Advisory Committee it is in
charge of overseeing new developments within the field of recombinant DNA biology and
modifying existing NIH rules on recombinant DNA research as they saw fit. This committee
was made of ethicists, scientists, and general public people. The RAC eventually helped to
diminish the fear surrounding genetically modified organisms because they relaxed their
guidelines considerably after seeing many positive experimental results.
2. What criteria are used by the FDA to determine if a recombinant protein is acceptable
as a food or food additive?
The FDA initially took the stance that special regulations of genetically engineered foods
was not necessary because there are already a battery of tests that non-engineered food
must pass before it makes it to the market. These criteria include toxicity, nutritional content,
allergenicity potential, and environmental aspects. The FDA believed that genetically modified
foods were not significantly different than the naturally grown foods and therefore should
not need more regulations. However, in cases where a food product is being produced by a
genetically engineered organism they have demanded that the product is proven to be
identical to the natural product.
4. Present an argument for or against the ban on production of L-tryptophan in a
genetically engineered bacterium for human consumption.
I do not think that the L-tryptophan should have been outright banned. It seems rash to
completely ban the use of the compound when one company begins to have problems with
one of their purification steps. As stated in the story all of the cases were traceable back to
a single company indicating that unless this was the only supplier to the entire area there
was specifically something wrong with their preparation. When people got sick from Taco
Bell’s tomatoes no one called for a ban on the production of tomatoes. It would have been
much more reasonable to simply halt production until more research could be done.
Or
The ban on L-tryptophan for human consumption, I believe, was taken as a safety measure
to protect consumers from its unwanted side effects which may have occurred. Since
studies have confirmed that EBT induced pathological changes in rats that caused EMS, Ltryptophan which is another derivative of tryptophan may have similar properties.
However, I suppose that in this case the minor change in the purification phase altered the
nature of the process and the product. Therefore, it would not be wise to ban or stop
possibilities because of a fault due to the lack in the safety tests that were not performed
after altering the purification process.
5. Discuss the positive and negative aspects of licensing recombinant bovine somatotropin.
The injection of bovine somatotropin into a dairy cow greatly improves the milk
production of a cow. Recombinant DNA technology is used to produce the compound in E.
coli. The compound has been studied extensively for safety. The cons of producing the
compound are that many fear that the fact that one cow could produce more milk would
limit the number of cows necessary to maintain production which would hurt the dairy
industry. However, opposition groups claimed that the “hormone laced milk” caused
cancer and was harmful to humans. Also it was argued that use of the compound would
increase the frequency of bacterial infection in the cows. Both of these claims were
disproved by studies of the compound. Despite these efforts the FDA approved the
compound for licensing but both Health Canada and the European Union refused to
approve the compound.
6. What are some of the criteria that regulatory agencies consider in approving transgenic
crops?
For the regulation of genetically modified plants each recombinant event is considered
individually. Some of the traits that are approved are the rate/method of reproduction, the
potential for the transfer of genetic material to other existing organisms, and sexual
compatibility with existing organism. Strategies for preventing insect resistance to
pesticides must also be considered. Plants the produce pharmaceutical compounds are
regulated more tightly and are treated as drugs.
Or
The natural bovine somatotropin is difficult and costly to accumulate, and therefore cannot be
used often. Licensing recombinant bovine somatotropin can help in the increase of milk yield
significantly. Also, the use of this technology doesn’t cause any adverse effects on human since
the bovine somatotropin is not active in humans. However, people fear that if this recombinant
DNA technology is licensed, small dairy farms have to face loss because fewer cows would be
required to produce the same amount of milk. Also, corporate business would dominate the
independent producers. There were arguments made which said that it would cause bacterial
infection of milk glands in dairy cattle. Also, in order to maintain the health of the treated cattle,
more antibiotics might have to be used which might trigger allergic responses in some people.
However, all these arguments were not proved. The risk of cancer was thought to be caused due
to increase in insulin-like growth factor-I in the milk of treated cows. This risk was also put aside
due to insufficient scientific evidence.
8. What are the essential requirements for patenting an invention?
In order to patent an invention, it must meet four requirements. The first requirement is
that the invention must be novel or new and like no other patented item. The second
requirement is that the patent must be for an invented item and not merely a discovered
item. The third requirement is that the invention must be useful in some way. The fourth
requirement for a patent is that the patent application should contain enough information for
a knowledgeable person in the field to be able to implement it.
10. What information must be present in a patent application?
A patent application must include six important sections. The first and most obvious
section is the title. Next is the abstract section which briefly describes the nature of the
invention. The next section is the background of the invention which gives all information
of the invention. A summary section is also included with figures to explain the results. A
section is also included for the description of methods for how the invention was made.
Lastly, a section is added with the applications of the invention.
13. Prepare arguments for both sides of the following debate: “Resolved: patenting of
genetically engineered multicellular organisms should be banned.”
For: Patenting of genetically engineered multicellular organisms should be banned because
of the secrecy involved and the loss of scientific values. These patents can cause
competition to lessen and result in higher costs. Large corporations grow while small
companies struggle. By having patents in place, scientists are less likely to work together
and get peer-reviews because they are worried someone will steal their idea before it is
patented. This means that every scientist is working for him or herself and not working
with others to create the best product possible. This could result in research and
innovation being inhibited due to individual work.
Against: Patenting of genetically engineered multicellular organisms should not be banned
because it helps companies to continuously create new products. It has been seen that
patent ownership does not prevent research and development in other companies. By
allowing patents to be created for these organisms, companies must continue to develop
and sell new ideas. This creates an environment where scientists are pushing themselves to
be better than the other scientists out there with brand new ideas never seen before.
Instead of using other scientist’s ideas already made, they are forced to come up with new
and improved ways to genetically engineer an organism.