Critical Analysis: FDA's Proposal on Altered Genomic DNA in Animals

This essay critically examines the FDA's proposal regarding the regulation of intentionally altered genomic DNA in animals. It discusses the potential benefits of genetic engineering in the agricultural industry, while also highlighting the risks associated with approving new animal drugs and the potential for Type 1 errors. The essay argues that the FDA should exercise caution and thoroughly investigate each genomic alteration before approval, emphasizing the importance of public knowledge dissemination to ensure food safety and consumer health. The author suggests the FDA should hold the proposal for further revision and prior clinical approval before implementation to prevent potential harm and maintain global food security. Desklib provides access to this and other solved assignments.

Running head: MARKETS AND POLITICS
Market and Politics
Name of the Student
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Author Note

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.

3MARKETS AND POLITICS
I praise FDA for taking required measures to stop the implementation of this new rule. Though
further efforts need to be made. Each and every genomic alteration in animals should be
approved on a prior basis and should be investigated beforehand by conducting some tests on
dead sample species in the laboratories. FDA should consider this new animal drug unsafe unless
it is being approved clinically. The FDA should further make sure that there is no guilt in the
Type 1 error in the process of alteration (“Why the FDA Has an Incentive to Delay the
Introduction of New Drugs: FDA Review.org.”, 2016). Researchers have found that many of the
safe and effective drugs that are beneficial for the consumers have been rejected by FDA due to
the delay in the process of approval and verification of this new animal drug.FDA is ensuring
that there lies no Type 1 errors and the new drug is safe and effective for use.
This rule should not be passed since there will be a hindrance to the security of the global food.
Food producers and consumers lack the relevant knowledge of the FDA rule guidance # 187 and
thus it is heavily affecting their health and the growth (Thomas, 2016). Dissemination of
knowledge is essential before the approval of the rule by FDA since little knowledge over the
topic of DNA alteration can result in wrong product selection which can further result in
affecting the health of the consumer.

4MARKETS AND POLITICS
References
BIO comments to FDA Regarding the Regulation of Intentionally Altered Genomic DNA in
Animals. (2017). Bio.org. Retrieved 24 April 2018, from
https://www.bio.org/sites/default/files/2017%20BIO%20comments%20FDA%20CVM
%20GFI%20%23187.pdf
Department of Zoology (2017). Comment on the Food and Drug Administration’s Draft Guidance
for Industry, Regulation of Intentionally Altered Genomic DNA in Animals, 82 Fed. Reg.
6561. University of Oxford.
Funk, C., & Kennedy, B. (2017). 3. Public opinion about genetically modified foods and trust in
scientists connected with these foods. Pew Research Center: Internet, Science & Tech.
Retrieved 24 April 2018, from http://www.pewinternet.org/2016/12/01/public-opinion-
about-genetically-modified-foods-and-trust-in-scientists-connected-with-these-foods/
Polcz, S., & Lewis, A. (2017). A Menagerie of Moral Hazards: Regulating Genetically Modified
Animals. Www-cdn.law.stanford.edu. Retrieved 24 April 2018, from https://www-
cdn.law.stanford.edu/wp-content/uploads/2017/12/GeneEditedAnimalsRegulation.JLME_.p
df
Regulation of Intentionally Altered Genomic DNA in Animals. (2017, January). Food and Drug
Administration, pp.3-30. Retrieved 24 April 2018, from
https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/
GuidanceforIndustry/UCM113903.pdf.

5MARKETS AND POLITICS
Thomas, K. (2016). F.D.A. Delays Rule on Generic Drug Labels. Nytimes.com. Retrieved 24 April
2018, from https://www.nytimes.com/2016/05/20/business/fda-delays-rule-on-generic-drug-
labels.html
Tosun, J., &Hartung, U. (2018). Decentralising competences in multi-level systems: insights from
the regulation of genetically modified organisms. West European Politics, 41(3), 803-823.
Why the FDA Has an Incentive to Delay the Introduction of New Drugs: FDAReview.org.
(2016). Fdareview.org. Retrieved 24 April 2018, from
http://www.fdareview.org/06_incentives.php