Should FDA hold the proposal on Internationally Altered Genomic DNA in Animals?

Running head: MARKETS AND POLITICS
Market and Politics
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1MARKETS AND POLITICS
The New York Times
Should FDA hold the proposal on Internationally Altered Genomic DNA in
Animals?
By Katie Thomas | NY TIMES EDITOR May 19 at 3.22 PM
The FDA released the guidance for the Industry (GFI) #187 stating the alteration to rules and
regulations of Internationally Altered Genomic DNA in Animals. According to this new
guidance, animals whose genomes have been altered internationally by the use of modern
molecular technologies changes in the sequence of DNA and includes modern molecular
technologies, deletions or other advanced technologies that results in specific changes to the
genome of the animal (“Regulation of Intentionally Altered Genomic DNA in Animals.”, 2017).
The FDA claims that these alterations will help in the growth of the food and drug market.
Furthermore, FDA has proposed a healthier lifestyle to the consumer after the imposition of this
altered rule in the market.
The rule that is proposed highlights the regulation of the internationally gene alterations for the
security of the public from the possible Type 1 error in food and drug items that are produced
from the genetically modified animals after their DNA alterations (“BIO comments to FDA
Regarding the Regulation of Intentionally Altered Genomic DNA in Animals.”, 2017).The
intersection of the new genes into organisms is the new methods of the genetic engineering that
are proposed by the researchers for assisting the industrial benefits.

2MARKETS AND POLITICS
In the science industry, I believe the concept of genetic engineering has been a much-debated
topic and the current rule of FDA is basically proposed to make it safe for the customers. I surely
want to raise a question in this context stating that if the proposal is actually required and is it
actually harmful to the consumers. Though I think the concept of genetic engineering is highly
beneficial for the agricultural industry and passing of this proposal by FDA will result in huge
benefits on the agricultural industry, still there lie high chances of risks during the approval of a
new animal drug. The fundamental principles by the White House Office of Science and
Technology Policy of 1986 and FDA scope policy of 1992 also state the possible risks of the
product (“Department of Zoology”, 2017). For example, according to the new provision of the
federal food, drug, and cosmetic act, the generic modifications by the humans in the purpose to
bred animals’ results are affecting the function or the structure of the targeted animals. The
animals whose genomes have been intentional changes using the modern DNA technology and
the modern molecular techniques are unclear and subject to high risks (Funk & Kennedy, 2017).
Furthermore, I have found shreds of evidence that the new modern technology which is generally
used over the animals with the use of genome editing tools is unsafe as compared to the
traditional breeding methods. The alteration of a specific DNA is the new unsafe animal drug
when the change in the animal genome occurs since the changes directly affect the health of the
animals and are generally unsafe (Tosun & Hartung, 2018). On the other hand, animal breeders
are also negatively affected since they can be beneficial on these valuable breeding techniques
for combating the growing demand for animal protein.
The new FDA rule for the internationally altered genomes that is proposed to be treated as new
animal drugs should be revised further and FDA should hold the proposal and should not pass
the rule as of now.