GMO Regulation and Safety (PDF)

What is Genetically Modified Organisms ( GMO) ? A GMO, or genetically modified organism, is a living plant, animal or microorganism that has been subjected to biotechnology. GMO developers use biotechnology to alter that living organism's fundamental characteristics. Bi...

What is Genetically Modified Organisms ( GMO) ? A GMO, or genetically modified organism, is a living plant, animal or microorganism that has been subjected to biotechnology. GMO developers use biotechnology to alter that living organism's fundamental characteristics. Biotechnology includes techniques such as using synthetic genetic sequences to change the organism's genetic material (i.e., DNA or RNA), or forcing the combination of very unrelated organisms that would not normally reproduce in nature. When biotechnology is applied to a living organism, the result is a GMO. Some examples of GMOs include: Corn containing bacterial genes that cause the plant to produce an insecticide Fast-growing Atlantic salmon with genes from a Chinook salmon and an ocean pout Soybeans with edited genes which increase the amount of oleic acid Hens with an inserted lethality gene that can kill their male offspring before they hatch Laws that Regulate GMO's: 1. Executive Order No. 430 (1990) Issued by then-President Corazon Aquino, this order laid the groundwork for biotechnology regulation in the Philippines. The National Committee on Biosafety of the Philippines (NCBP) was created under the Department of Science and Technology (DOST). NCBP is responsible for crafting policies and guidelines to ensure the safe use of biotechnology. It emphasises risk assessment and management, particularly in agriculture and environmental sectors. 2. Executive Order No. 514 (2006) Issued by then-President Gloria Macapagal-Arroyo, this order updated the biosafety framework to align with international standards, specifically the Cartagena Protocol  on Biosafety. Enhanced the national biosafety framework to meet international standards. Established additional committees such as the Biosafety Clearing-House for transparency and information sharing. Strengthened the NCBP’s responsibilities in policy development and risk assessment. 3. Department of Agriculture Administrative Order No. 8 (2002) Developed by the Department of Agriculture to provide specific guidelines for GMOs in agriculture.Outlines procedures for the importation, testing, and release of GMOs for food, feed, or processing. Requires environmental and health impact studies. Mandates GMO product labelling to inform consumers. Sets up mechanisms to track GMOs post-release. 4. Joint Department Circular No. 1 Series of 2016 A collaborative effort by five government departments: Agriculture, Environment and Natural Resources, Health, Interior and Local Government, and Science and Technology. Detailed guidelines for GMO research, development, handling, and use. Emphasises transparency and public involvement in the approval process. Includes socio-economic considerations in the assessment process. Ensures stakeholders and community members can voice their opinions on GMOs. 5. Biosafety Guidelines on the Planned Release of Genetically Modified Organisms (2020) Issued by the NCBP to keep regulations current with scientific advancements and international standards. Details the process for field testing and commercial release of GMOs. Requires thorough scientific evaluations to assess risks to health and the environment. Includes provisions for stakeholder engagement. Stresses the importance of post-approval surveillance to mitigate unforeseen effects. How GMOs Are Regulated: In the United States, regulations regarding genetically modified organisms (GMOs) primarily fall under the jurisdiction of three federal agencies: 1. USDA (United States Department of Agriculture): USDA regulates GMOs that involve plants. This includes field trials, commercialization, and labeling requirements for genetically modified crops.  2. FDA (Food and Drug Administration): FDA regulates GMOs that are intended for human and animal consumption. They ensure the safety and proper labeling of genetically modified foods, including additives and substances derived from GMOs. 3. EPA (Environmental Protection Agency): EPA regulates GMOs that involve pesticides or plants modified to produce pesticides (e.g., Bt crops). They assess the environmental safety and impact of these GMOs. Key aspects of GMO regulation in the US include: Safety Assessments: Developers of GMOs are required to conduct safety assessments to demonstrate that the genetically modified product is safe for humans, animals, and the environment. Voluntary Consultation: FDA encourages developers of genetically engineered plants intended for food use to participate in a voluntary consultation process before marketing the product. Labeling: Labeling of GMO foods is required if they differ significantly in composition, nutritional value, or other attributes compared to their conventional counterparts. Field Trials: USDA oversees field trials to ensure compliance with regulations and to prevent potential environmental impacts. It's important to note that regulation and public perception of GMOs can vary globally, with different countries having their own regulatory frameworks and attitudes towards GMO technology. Issues Regarding GMO: Believed to be not safe for consumption. Philippine issue: golden rice A study from chemical food and toxicology about rats eating genetically modified foods all their life led them to having tumours in their body. Causes health concerns, environmental impact and agricultural innovations. Biotech companies are deregulated. Genetically modified foods are unrecognisable. Food Safety Concerns of GMO BT Corn in the Philippines: · Potential impact of Bt toxins on human health · Safety of consuming genetically modified Bt corn · Adherence to food safety standards for GMO products Long-Term Effects of GMO BT Corn in the Philippines: · Environmental impact on biodiversity and non-target organisms · Development of pest resistance and sustainable pest management practices · Importance of monitoring and research for mitigating long-term effects Use of GMO in Medical Fields: Pharmacy - Pharmaceutical products range from recombinant hepatitis B vaccine produced by GM baker’s yeast to injectable insulin (for diabetics) produced in GM Escherichia coli bacteria and to factor VIII (for haemophiliacs) and tissue plasminogen activator (tPA, for heart attack or stroke patients). Nursing - While GMOs themselves are not directly used in nursing practice, nurses play a vital role in educating the public about genetically engineered foods and their potential health implications. Nurses are encouraged to stay informed about GMOs due to the prevalence of genetically engineered foods in the market. Thus it is essential for nurses to understand the issues surrounding GMOs and their impact on human health to better serve their patients. Conclusion: Genetically modified organisms (GMOs) are a focal point in Science and Technology Studies (STS), as they intersect science, health, and politics. Scientifically, GMOs promise enhanced agricultural efficiency and resilience. Health debates pivot on safety, with numerous studies confirming their safety while public skepticism persists. Politically, GMOs incite regulatory and ethical discussions, often reflecting broader societal values and power dynamics. STS emphasizes the co-production of science and society, illustrating how GMOs are not just scientific constructs but are deeply entwined with cultural, economic, and political contexts.