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Recombinant DNA Technology and Gene Therapy Using Viruses
Published in Patricia G. Melloy, Viruses and Society, 2023
Recombinant DNA technology, also known as genetic engineering, is the idea that a gene or stretch of DNA from one biological source can be transferred to another source where it can be expressed in that new organism (Alberts et al. 2019; Kurreck and Stein 2016; Mukherjee 2016; Colavito 2007; Minkoff and Baker 2004). The transfer of genetic material into the new organism is a kind of genetic modification, resulting in a genetically modified organism (LabXChange 2022). The genetically modified organism (GMO) can also be called a transgenic organism, meaning that it is an organism containing a transgene or newly introduced gene (Pray 2008).
Answers
Published in Ken Addley, MCQs, MEQs and OSPEs in Occupational Medicine, 2023
Genetically modified organisms are not listed though their original wild species derivation may be listed. Group 1 is unlikely to cause human disease and a new agent should not be assumed to be in Group 1 initially. Group 3 causes severe disease but usually has available treatment and or vaccine. Advisory Committee on Dangerous Pathogens UK (ACDP) concerns itself with risks to humans.
Regulatory Challenges for Gene Delivery
Published in Yashwant Pathak, Gene Delivery, 2022
Vineet Mahajan, Shruti Saptarshi, Yashwant Pathak
Genome editing is a frontier technology that has revolutionized fields of medicine and plant/animal biotechnology. Human, animal, and plant genomes can now be specifically altered using editing tools such as TALENS, ZFNs CRISPER-Cas systems to develop new generation biopharmaceuticals and improved livestock or plant varieties.40 Regulatory bodies worldwide have already set up regulations for dealing with genetically modified organisms (GMOs). Inclusion or exemption of gene-edited organisms as GMOs is unclear. As a result, there are several inconsistencies in setting up regulatory frameworks for such products. Gene editing can be used to manipulate somatic as well as germline DNA.
Toxicity of the herbicides used on herbicide-tolerant crops, and societal consequences of their use in France
Published in Drug and Chemical Toxicology, 2022
Although these plants are genetic mutants selected through an artificial chemical mutagenesis and therefore true genetically modified organisms (GMOs) on a biological ground, an institutional trick is that they are not legally recognized as such (since a foreign and transgenic gene has not been inserted in their genome and also because the technological process used is leading to the same type of mutations than those arising through a ‘naturally’ acquired resistance). Consequently, these plants are excluded from the scope of the European directive on GMOs, which exempts them from any evaluation, traceability and labeling. Militant environmentalists are contesting this institutional position and point of view and are worrying about the environmental and possible health consequences of the use of herbicides of the IMI and SUL families. Trials are in progress and in this context the aims of the present review are first to address the question of the risks, potential toxicity and health consequences of the use of such mutant plants regularly sprayed with herbicides not only for the environment but also for the animals and humans consuming the products derived from these plants. And second to discuss the flaws of the official regulation during the marketing approval process of these mutant plants and the corresponding herbicides.
Bovine Liver Supplement Labeling Practices and Compliance With U.S. Regulations
Published in Journal of Dietary Supplements, 2022
Anthony J. Silva, MS, Olive J. Dahm, MS, Rosalee S. Hellberg
“Gluten-free” claims were identified in 21 products and were deemed compliant based on the information on the label, as no ingredients known to contain gluten were listed. However, further laboratory testing would be required to confirm the absence of gluten in these products. Numerous statements were observed on supplement labels that indicated the absence of genetically modified organisms (n = 22), hormones (n = 22), dairy or milk (n = 19), soy (n = 16), artificial colors or flavors (n = 15), wheat (n = 12), preservatives (n = 11), antibiotics (n = 9), and pesticides (n = 9). Statements related to the absence of dairy, soy, and wheat appeared to focus on avoidance due to dietary preferences and were therefore not considered to be nutrient content claims (21 CFR § 101.65). Label statements about substances that are nonnutritive or do not have a nutritive function, such as “no preservatives” or “no artificial colors,” are also not considered to be nutrient content claims and are not subject to the requirements of 21 CFR § 101.13 or 101.65.
Oxitec and MosquitoMate in the United States: lessons for the future of gene drive mosquito control
Published in Pathogens and Global Health, 2021
Cynthia E. Schairer, James Najera, Anthony A. James, Omar S. Akbari, Cinnamon S. Bloss
By spring of 2016, as reports of Zika emerging in Brazil created concerns for the US, hearings held by the House Energy and Commerce Committee drew attention to the FDA’s slow movement in reviewing Oxitec’s application [38]. In March of 2016, the FDA posted an environmental assessment of OX513A for public comment and received 2649 comments – a majority opposing the trial – after news outlets and activist organizations mobilized members of the public [58]. Despite this heated debate in the comments submitted to the FDA and assurances that the agency must review these comments [59], the agency’s procedures apparently do not require specific acknowledgment or direct response to public comments [25]. According to an analysis by Bloss et al, the most prevalent themes raised in these comments were ecological safety (51.2%), human health implications (67.3%), genetically modified organisms generally (65.1%), and mistrust of government (23.6%)” [58]. While the environmental assessment was certainly concerned with ecological safety and human health implications, opinions about the moral acceptability of ‘GMOs’ and government trustworthiness would have been outside of the scope of the FDA’s assessment.