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1. WHAT HAVE WE LEARNED LAST MEETING? 2021 Genetically Modified Organisms 1

2. GMO 2021 Genetically Modified Organisms 2

3. MA. JOY O. JOCOSOL EASTERN SAMAR STATE UNIVERSITY Chapter 3 Genetically Modified Organisms

4. TOPICS Regulatory Procedures Regulatory Processes Impacts on Food Quality and Food Quantity Impact on Health and Medicine Impacts on the Environment Impacts on the Economy 2021 Genetically Modified Organisms 4

5. OBJECTIVES At the end of this topic, we are expected to: Discuss the regulatory procedures in handling and manufacturing GMOs in the country; Enumerate the regulatory process in handling GMOs in the Philippines; Discuss the impacts of GMOs on Food Quality and Food Quantity, Health and Medicine, Environment and Economy. 2021 Genetically Modified Organisms 5

6. INTRODUCTION Genetically modified organisms (GMOs) can be defined as organisms (i.e. plants, animals or microorganisms) in which the genetic material (DNA) has been altered in a way that does not occur naturally by mating and/or natural recombination. The technology is often called “modern biotechnology” or “gene technology”, sometimes also “recombinant DNA technology” or “genetic engineering”. It allows selected individual genes to be transferred from one organism into another, also between nonrelated species. 2021 Genetically Modified Organisms 6

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10. The Philippine government has officially approved a more stringent set of regulations to manage the propagation and sale of biotechnology seeds in the country. This lesson will discuss the general regulatory procedures in adapting GMOs. 2021 Genetically Modified Organisms 10 1. Regulatory Procedures

11. Who are the stakeholders? Stakeholders are the individuals, organizations, communities, agencies and governments with a vested interest in the issue. Stakeholders in the debate over GMO foods include the global community, sovereign Tribal nations, municipalities, local communities, industry, biotechnology firms, organic and conventional farmers, farm workers, fishermen, religious groups, ecologists, engineers, toxicologists, risk analysts, doctors, politicians, parents, children, non-governmental organizations, and advocacy organizations. 2021 Genetically Modified Organisms 11 1. Regulatory Procedures

12. Philippines Policy Statement on Modern Biotechnology “We shall promote the safe and responsible use of modern biotechnology and its products as one of several means to achieve and sustain food security, equitable access to health services, sustainable and safe environment, and industry development” – Issued on July 16, 2001 by then President of the Philippines (Gloria Macapagal-Arroyo) 2021 Genetically Modified Organisms 12 1. Regulatory Procedures

13. Evolution of the Regulatory Structure • E.O. 430 (1990): Establishment of NCBP and Philippine Biosafety Guidelines – Established due to advocacy efforts of scientists from UPLB & IRRI – UPLB & IRRI formed committee to develop biosafety guidelines (14 members) – Drafted initial biosafety guidelines & recommended establishment of NCBP & national implementation – Draft submitted to NAST and NAST led the process • Public consultations (primarily science community) – E.O. 430 established (after further public consultations with other stakeholders) Evolution of the Regulatory Structure 2021 Genetically Modified Organisms 13 1. Regulatory Procedures

14. Evolution of the Regulatory Structure • NCBP Series No. 3 (1998): Guidelines on Planned Release of GMOs and PHES – Scope of E.O. 430 for contained & confined use only – NCBP developed these new guidelines in anticipation of field testing and release of GM corn – Subjected to public consultations • Stakeholders from academe, industry, NGOs, and gov’t – Pioneer Hi-Bred and Cargill (Monsanto) submitted first two applications for limited field tests of GM corn Evolution of the Regulatory Structure 2021 Genetically Modified Organisms 14 1. Regulatory Procedures

15. Evolution of the Regulatory Structure • DA A.O. No. 8 (2002): Rules for Importation and Release of GMOs – Prompted by near completion of field tests for GM corn – DA developed guidelines for commercialization and subjected it to public consultations – Considered procedures for risk assessments – Ensured socio-economic considerations included in decision-making – 2003: Bt corn approved for commercialization Evolution of the Regulatory Structure • E.O. 514 (2006): National Biosafety Framework of the Philippines – Formalized regulatory framework already in place and established “expanded” NCBP – Enhanced risk assessment procedures – Clarified roles of various agencies 2021 Genetically Modified Organisms 15 1. Regulatory Procedures

16. Evolution of the Regulatory Structure • DOST for contained use, DA-BPI for field tests • E.O. 514 & consequent AOs made Philippines biosafety regulations consistent with the Cartagena Protocol and Codex Alimentarius Guidelines Experience with Bt Corn and Bt Eggplant • Bt Corn Approval process (1996-2003) – First encounters with anti-biotech groups – Forced NCBP to explain biotech to public – Recognize the multi-dimensional nature of biotech (not just science-based risk assessment) 2021 Genetically Modified Organisms 16 1. Regulatory Procedures

17. Evolution of the Regulatory Structure • Bt Eggplant Supreme Court Decision (12/2015) – Halt field testing of GMOs and void A.O. No. 8 (2002) – Prompted Joint Dept. Circular No. 1 (2016) • Extensive public consultations with stakeholders – SC reversed decision 7/2016 Experience with Bt Corn and Bt Eggplant • Joint Department Circular No. 1 (2016): Updated DA A.O No. 8 (2002) – Made more “stringent” (i.e., environmental impact assessments, risk assessments, more public consultations) – Clarified roles of other government agencies (DA, DOST, DENR, DOH, DILG) – Addressed issues in first Bt Eggplant Supreme Court decision 2021 Genetically Modified Organisms 17 1. Regulatory Procedures

18. Here is the regulatory process in the Philippines: 1. Prepare a project proposal for submission to the Institutional Biosafety Committee (IBC) 2. Submit a proposal to the IBC, which conducts a risk assessment & endorses to NCBP 3. Apply to the NCBP for a permit to conduct contained testing 4. Apply to DA-BPI for a field testing permit after contained testing is complete and successful, conditional on the endorsement by the NCBP Regulatory Process 5. DA-BPI creates a STRP concurrent with public notification by the IBC, and the STRP evaluates potential adverse effects to humans and the environment 6. Risk assessment by STRP and the BPI-Core Biotechnology team (BPI-BCT) 7. Conduct single field test and then multilocation field tests (after receipt of field test permit and each field is evaluated ) 8. Obtain permit for release (propagation & commercialization) 2021 Genetically Modified Organisms 18 2. Regulatory Processes

19. Engineers design plants using genetically modified organisms, or GMOs, to be tougher, more nutritious, or taste better. However, people have concerns over their safety, and there is much debate about the pros and cons of using GMOs. 2021 Genetically Modified Organisms 19 3. Impacts on Food Quality and Food Quantity

20. As the world population continues to grow and more people need food, it becomes necessary to increase food production. This can either be though the clearing of new land for agriculture, or by increasing yield of the crops on the same amount or less land. The first generation of GMO technology has been directed at reducing the risks of various threats to crop yields such as insect attack and virus infection. Scientists have been adding genes to crop plants to give benefits to farmers. Four GM crops are cultivated in South Africa: insect-resistant cotton (since 1997), insect-resistant maize (since 1998), herbicidetolerant cotton (since 2000) and herbicidetolerant soybeans (since 2001). (Herbicides are chemical products used to destroy weeds, but not the crop plants.) 2021 Genetically Modified Organisms 20 3. Impacts on Food Quality and Food Quantity

21. Pros - Genetic modification can make crops more resistant to diseases as they grow. Manufacturers use genetic modification to give foods desirable traits. For example, they have designed two new varieties of apple that turn less brown when cut or bruised. The reasoning usually involves making crops more resistant to diseases as they grow. Manufacturers also engineer produce to be more nutritious or tolerant of herbicides. - Crop protection is the main rationale behind this type of genetic modification. Plants that are more resistant to diseases spread by insects or viruses result in higher yields for farmers and a more attractive product. - Genetically modification can also increase nutritional value or enhance flavor. All of these factors contribute to lower costs for the consumer. They can also ensure that more people have access to quality food. 2021 Genetically Modified Organisms 21 3. Impacts on Food Quality and Food Quantity

22. Cons - Because genetically engineering foods is a relatively new practice, little is known about the long-term effects and safety. - There are many purported downsides, but the evidence varies, and the main health issues associated with GMO foods are hotly debated. Research is ongoing. 2021 Genetically Modified Organisms 22 3. Impacts on Food Quality and Food Quantity

23. This section discusses the evidence for a range of drawbacks that people often associate with GMO foods. Allergic reactions Some people believe that GMO foods have more potential to trigger allergic reactions. This is because they may contain genes from an allergen — a food that prompts an allergic reaction. The World Health Organization (WHO) discourage genetic engineers from using DNA from allergens unless they can prove that the gene itself does not cause the problem. It is worth noting that there have been no reports of allergic effects of any GMO foods currently on the market. Cancer Some researchers believe that eating GMO foods can contribute to the development of cancer. They argue that because the disease is caused by mutations in DNA, it is dangerous to introduce new genes into the body. The American Cancer Society (ACS) have said that there is no evidence for this. However, they note that no evidence of harm is not the same as proof of safety and that reaching a conclusion will require more research. 2021 Genetically Modified Organisms 23 3. Impacts on Food Quality and Food Quantity

24. Antibacterial resistance There is concern that genetic modification, which can boost a crop’s resistance to disease or make it more tolerant to herbicides, could affect the ability of people to defend against illness. There is a small chance that the genes in food can transfer to cells the body or bacteria in the gut. Some GMO plants contain genes that make them resistant to certain antibiotics. This resistance could pass on to humans. There is growing concern globally that people are becoming increasingly resistant to antibiotics. There is a chance that GMO foods could be contributing to this crisis. The WHO have said that the risk of gene transfer is low. As a precaution, however, it has set guidelines for the manufacturers of GMO foods. Outcrossing Outcrossing refers to the risk of genes from certain GMO plants mixing with those of conventional crops. There have been reports of low levels of GMO crops approved as animal feed or for industrial use being found in food meant for human consumption 2021 Genetically Modified Organisms 24 3. Impacts on Food Quality and Food Quantity

25. GMOs have emerged as one of the mainstays of biomedical research since the 1980s. For example, GM animal models of human genetic diseases enabled researchers to test novel therapies and to explore the roles of candidate risk factors and modifiers of disease outcome. GM microbes, plants, and animals also revolutionized the production of complex pharmaceuticals by enabling the generation of safer and cheaper vaccines and therapeutics. 2021 Genetically Modified Organisms 25 4. Impact on Health and Medicine

26. GMOs in medicine GMOs can be applied in numerous aspects of medicine. GMOs are already being used to produce insulin, growth hormones and various antibodies used in cancer treatments. Other potential future applications include “gene therapy”. All techniques for this application are still under research and in trial phases and are not yet being used in clinics. Examples include treatments for diabetes, cystic fibrosis, cancer and HIV. Vaccine developments are using GM techniques to insert specific genes from disease-causing viruses and/or bacteria , into harmless viruses. These inserts potentially allow the body to develop immunity to the original, infectious virus or bacterium. In this way, we can develop an immune response in a way which is harmless to the body. Current HIV and TB GMO vaccines are being tested in trials in South Africa. The process known as “pharming” refers to using GM animals and plants to produce particular proteins as medicines. Such production techniques could dramatically reduce the cost of producing medicines. The gene for the desired protein, such as ones for vaccines, antibodies or other therapeutic proteins, is inserted into the animal or plant. For example, sheep and pigs can be modified to produce insulin, interferon and human blood clotting protein factor-8 in their milk. Research is also going into producing crops to produce vaccines. The CSIR is involved research to transform maize to carry antibodies to HIV. UCT has a plant-based vaccines research group working on Human Papillomavirus (HPV) and HIV plant-based vaccine. Despite the potential in this field, there are concerns of safety and contamination of food supplies, and production of such medicines may in future be limited to non-food crops. 2021 Genetically Modified Organisms 26 4. Impact on Health and Medicine

27. Although the global debate on GMOs has usually allied disparate groups concerned about food safety and the environment, environmental risks are perceived to differ from food safety risks in several ways. Experience built up through decades of environmental impact studies suggests that the impact of new biological elements in ecosystems may take years or decades to be understood. 2021 Genetically Modified Organisms 27 5. Impacts on the Environment

28. Environmental issues and GM crops GM crops are commercially available and planted on more than 40 million hectares across six continents. These plantings represent the largest-scale experience in the introduction of GMOs into ecosystems, and they have become the focus of environmental concerns. Activists, worried about GMOs being released into the biosphere, have destroyed test plots in at least four continents. This may show the depth of their commitment, but it also prevents anyone from learning from the data that should have been collected from those tests. The majority of the area under GM crops is planted with varieties resistant to herbicides. These herbicides are associated with a shift towards less mechanical tillage in large-scale arable crops, which reduces primary soil erosion. Early on, weed scientists appreciated and studied the environmental consequences of introducing GM crops, especially for weed control. 2021 Genetically Modified Organisms 28 5. Impacts on the Environment

29. A 1998 international technical meeting, organized by FAO on Benefits and Risks of Transgenic Herbicide-Resistant Crops, found that: 1. The repeated use of one herbicide causes a shift in the weed flora because there is very high selection pressure on weeds to evolve biotypes that are resistant to the herbicides associated with transgenic plants bred to be tolerant of those herbicides. 2. Gene flow occurs with the spread of genes through pollen and outcrossing from herbicide-resistant crops to related weed species. In the absence of the particular herbicide, the possession of this trait is unlikely to improve the strength of the weeds but, when the herbicide is applied, it would improve the weeds' strength and could reduce the economic benefits of herbicide resistance. 3. The risks of gene transfers are higher in areas of origin and diversification. Care needs to be taken to ensure that native germplasm, including weed and wild crop relatives, is not affected by the transfer of herbicide-resistant genes. 2021 Genetically Modified Organisms 29 5. Impacts on the Environment

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31. Environmental issues and GM fish In the fisheries sector, most GMOs show increased growth rates; therefore, concerns about environmental risk focus more on predation, competition and genetic pollution. GM fish may pose risks to the environment because of their increased rates of feeding on prey species; their wider environmental tolerances, which allow them to invade new territories and possibly to displace local native populations; and their potential for genetic mixing with, and thus the altering of, the composition of natural fish populations. Proponents of GM fish maintain that these fish will be very domesticated and will not survive well in nature. Alien species and genotypes that are used throughout the world, such as tilapia and domesticated salmon, present these same risks. The process of evaluating the risks of farming GMOs should be the same as for the farming of any aquatic species that is new to a local ecosystem. It should be based on an ecosystem approach that considers the spreading of impacts once a species is introduced. 2021 Genetically Modified Organisms 31 5. Impacts on the Environment

32. A key part of any assessment of the global further examines economic impacts on yields, key costs of production, direct farm income and effects, and impacts on the production base of the four main crops of soybeans, corn, cotton and canola. 2021 Genetically Modified Organisms 32 6. Impacts on the Economy

33. During the past 17 years, the adoption of crop biotechnology (by 17.3 million farmers in 2012) has delivered important economic benefits. The GM IR traits have mostly delivered higher incomes through improved yields in all countries. Many farmers, especially in developed countries, have also benefited from lower costs of production (less expenditure on insecticides). The gains from GM HT traits have come from a combination of effects. The GM HT technology-driven farm income gains have mostly arisen from reduced costs of production, though in South America, it facilitated the move away from conventional to low and/or no-tillage production systems and enabled many farmers to plant a second crop of soybeans after wheat in the same season.     Overall, there is a considerable body of evidence in peer reviewed literature that quantifies the positive economic impacts of crop biotechnology. The analysis in this paper therefore provides insights into the reasons why so many farmers around the world have adopted and continue to use the technology. Readers are encouraged to read the peer reviewed papers cited and the many others who have published on this subject (and listed in the references below) and to draw their own conclusions. 2021 Genetically Modified Organisms 33 6. Impacts on the Economy

34. THANK YOU 20XX Presentation title 34