Posted: November 18th, 2022

Genetically Modified Animals

Genetically Modified Animals
Introduction
This is a GW Regulatory Studies Centre assessment report on the Assessment of the FDA regulation of animals with intentionally altered genomic DNA. Gene modification technologies involve the alteration of targeted or random DNA sequences including substitutions, deletions, and nucleotide insertions. The modifications introduce certain changes to the genome of the animals. The FDA regulations apply to the original animal whose DNA has been altered and the entire lineage that follows. Guidance by the FDA is mainly intended to clarify on the recommendations made for companies that develop and produce these animals. It also informs the public on whether it is safe to consume these products. This report addresses the existing problem in relation to the production, use, and disposal of animals using gene modification technologies.
Scope
The people who are likely to be negatively affected by the problem include the researchers, industrial producers of drugs and food products, as well as consumers of animals with intentionally altered genomic DNA. The researchers and producers are likely to be exposed to a negative public perception that their products are unsafe for human consumption. Previously, due to lack of proper market regulation, firms that produce these animals and their products have been very negligent in handling them. Their products have been poorly labeled, making it hard for the consumers to differentiate between genetically modified animals and the normal products (FDA, 2017). They have also been selling products whose quality has not been tested and approved for consumption in the market. This has created a lot of controversy among the consumers, with a good number of them raising concerns about the health implications of such products. Another issue that has arisen is the disposal of unused remainders of animals with intentionally altered genomic DNA. Disposing of the remains of genetically altered animals like any other waste materials exposes people to hazardous conditions (Lutter, & Lewis, 2017). This level of negligence has caught the attention of environmentalists who are concerned about the implications of genetically modified waste on the environment. Consumers, drugs manufacturers, and food producers who use products developed from animals with intentionally altered genomic DNA are the people likely to be heavily affected by the problem. There is very little information on safe production and use of the genetically modified animals (Food Science and Technology, 2012). Consumers are likely to buy products that can cause health complications. Drugs and food manufacturers will be exposed to negative publicity regarding the safety of their products, which will affect the overall sales and profits within the target market. The impact of poor regulation has a huge impact on the economic market, as well as the social life of the consumers. There is also very little regulation on the pricing of these products. Manufacturers have put them out into the market at their own defined prices and this has exposed the consumers to exploitation. It also creates a divide among the consumers as there are two different groups: The wealthy who can afford and the poor who can barely afford the products. The new regulations will help curb these concerns and bring stability to the market.
Scale
The use of animals with intentionally altered genomic DNA is an issue of global concern. Research by World Health Organization (WHO) in various countries has shown that there is a link between common diseases with the consumption of these animals (Food Science and Technology, 2012). Consumers of genetically modified products are usually not aware of their origin, which is a very risky position as their safety in relation to health worthiness cannot be ascertained. The WHO in their report indicated that many consumers both locally and internationally are not usually aware of the source of the products they consume. It would, therefore, be important for proper measures to be put in place to ensure that the health and safety of the consumers are guaranteed. If the issue was to remain unchecked, the long-term effects would be increased prevalence of diseases such as cancer, infertility, faulty insulin regulation, and changes in body organs and the gastrointestinal system. This contributes to a reduced life expectancy not only in the country but also internationally. Research shows that populations with poor nutrition standards are more exposed to health complications and their life expectancy is lower. In developing countries where the use of genetically modified products is poorly regulated, unethical companies and businessmen may take advantage of the situation and produce sub-standard products which can very harmful to the consumers. Lack of regulation at national level can expose national companies that produce and export food and drugs overseas to possible banning in selling their products on the basis of health concerns. Uncontrolled supply of genetically modified animals into the market will not only be risky for the national level but also across the globe. It will have negative social and economic impacts on the national economy.
Market Feasibility
It is imperative that the FDA addresses the issue of animals with intentionally altered genomic DNA. If proper regulations are not developed and implemented, they are likely to remain unsolved since the market lacks the power to solve the existing problems. The FDA needs to work closely with stakeholders in the market including the pharmaceutical companies, food companies, and consumer organizations to come up with the right solutions that are favorable and acceptable to all. Despite the fact that the use of these animals has elicited a lot of excitement, the market on its own remains, not the best-suited player to solve the problems. It is likely to be biased, which ultimately means that the issue remains unresolved. The proposed regulations by the FDA will ensure that the health and well-being of the consumers are protected. Continued use of these animals and disposal of the remains without regulations will see people being increasingly exposed to diseases and health hazards (Lutter, & Lewis, 2017). The new regulations will see an increase in transparency in the production, sale, and use of genetically modified animals. The move is likely to create public confidence in the products and hence expansion of the consumer market. Therefore, for the market to prevail, the newly proposed regulations must be strictly implemented.
Conclusion
The provisions provided for by the FDA in the new regulations are coherent with the direction that the issue of animals with modified genetic genomes ought to take. Technology has become of age, and it is time various markets crafted ways of accommodating these new developments. Therefore, the passing of this legislation will see increased control of the production, use, and disposal of animals with intentionally altered genomic DNA. This will impact how research in genetic modification is carried out. It is also going to have positive effects on how product identification is done. Specifically, it is likely to encompass the lineage of these animals and their use. Another important issue is that it is going to affect the molecular characterization of altered genomic DNA which describes the composition and components introduced in the animal. Through the new regulations, it will be possible to map the lineage of genetically modified animals and hence the genotype and phenotypes. Finally, the safety of the food will be guaranteed. Tests will be conducted on various products before being released out into the market. They will also be properly labeled to ensure that consumers are able to differentiate genetically modified products from the others.
References
FDA. (2017, Jan). Guidance No. 187 for Industry on Regulation of Genetically Engineered Animals (Draft Guidance). Food and Drug Administration. Retrieved Feb 1, 2018, from https://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf
Food Science and Technology. (2012). Genetically Modified and Non-Genetically Modified Food Supply Chains: Co-Existence and Traceability, 665-666.
Lutter, R., & Lewis, L. (2017). Public Interest Comment on The Food and Drug Administration’s Draft Guidance for Industry #187 “Regulation of Intentionally Altered Genomic DNA in Animals”: How to Regulate Genome Edited Animals? A Comment on FDA’s Proposed Guidance (ID No. FDA-2008-D-0394). Washington, DC: George Washington University. Retrieved Feb 1, 2018, from https://regulatorystudies.columbian.gwu.edu/sites/regulatorystudies.columbian.gwu.edu/files/downloads/Lutter%2BLewis_FDA-CRISPR-6-19-2017_0.pdf

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