1. Presentation 3 Regulatory Requirements of GM Technology: Social and Ethical Concerns of GM Foods Jebunnesa Chowdhury Assistant Professor Biotechnology

2. Humanitarian: Potential Benefits Improved farming Cheaper food More food Increased nutrition Reducing world hunger and improvin g world health Pest resistance Herbicide resistance Cold tolerance Drought tolerance Edible vaccines Environmental: reduced use of herbicides and chemicals in farming.

3. Potential Environmental Hazards Reduced effectiveness of pesticides as insects become resistant to engineered toxins. Loss of biodiversity Harm to other organisms Pollen from Bt corn was shown to cause high mortality rates in monarch butterfly larvae (9). BUT follow-up studies have shown that the exposure levels in the fields are negligible (10). 11

4. Gene Transfer to non-target species  Herbicide resistant plants and weeds could cross breed and create “superweeds”  To address this one could:  Create sterile male plants that don’t produce pollen  Engineer the plants so that pollen doesn’t contain the foreign genes  Create buffer zones of non-GM crops around GM crops. The buffer crops would not be harvested. Potential Environmental Hazards

5. Allergens  Genetic engineering could potential introduce or create allergens  For example, inserting genes from a nut into another plant could be dangerous for people who are allergic to nuts Unknown health risks  Biological processes involve a lot of INTERACTIONS  It is often difficult to identify every possible interaction. Potential Human Health Risks

6.  Elimination of competition  GM seeds are patented  Suicide seeds  Plants with sterile seeds that are infertile are created  Farmers are forced to buy seeds every year  However, some companies have reduced costs or donated GM seeds to impoverished nations. Economic Hazards

7. Creating a balance  So are GM foods a good or bad thing?  It depend on each individual case.  Consumers, the government and scientists should be responsible for weighing the benefits against the costs. Improved Nutrition Resistance to disease Reduced use of chemicals Environmental risks Health risks Economic risks

8. Two diametrically opposite trends of thought US-Canada No new risks associated with GM crops New regulations not considered necessary Safety assessments  ‘Product’ rather than ‘process’ based  In comparison and contrast to their ‘familiarity’ and ‘substantial’ equivalence to conventional crops Is GE inherently unsafe?

9. EU GE crops considered new and special Existing legislation not considered sufficient Safety assessment Process based Principle of ‘substantial equivalence’ beginning rather than the end Adoption of ‘Precautionary Principle’ as guide …Is GE inherently unsafe?

10.  NIH initially responsible for biotechnology regulation  Established safety protocols for biotech labs  1986 Coordinated Framework for Regulation of Biotechnology  primary blueprint for the regulation of biotechnology  Redistributed responsibility for biotechnology regulation to FDA, USDA and the EPA  1992 Statement of Scope  Speed up and simplify the process of bringing products, developed through biotech to consumers, food processors and farmers GMO Regulation in the US

11.  FDA Responsibility:  oversees the safety of all foods and animal feeds for consumption, including both GM and non-GM products  producers of new foods have an obligation under the HACCP to ensure that the foods they offer consumers are safe and in compliance with applicable legal requirements  Voluntary consultation with FDA prior to marketing GMO Regulation in the US

12.  Scientific evidence shows that bioengineered food ingredients are not materially different from the non-engineered versions  1992 Statement of Policy: Foods Derived from New Plant Varieties, said GM products are GRAS  Courts have concluded that the FDA's decision to accord bioengineered food a presumption of GRAS status was neither arbitrary nor capricious GMO Regulation in the US

13.  FDA  January 17, 2001- new proposal to expand the FDA's regulatory control by making pre-market consultation mandatory  Food producers must notify the FDA at least 120 days in advance of their intent to market GM product  Must show that the GM product is as safe as its conventional counterpart and no potential safety, labeling or adulteration issues  increase the transparency of the FDA's safety review process for GM foods GMO Regulation in the US

14.  USDA Responsibility:  conducted primarily under the Federal Plant Pest Act and Animal and Plant Health Inspection Service (APHIS)  Oversees field testing of GM seeds and plants  Places inspectors in biotechnology plants  Current USDA Secretary is “pro GMO”  Ann Veneman GMO Regulation in the US

15.  EPA Responsibility:  Authority over GMOs comes from Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)  Evaluates the pesticide properties of transgenic plants  Virus resistance  Insect protection  herbicide tolerance GMO Regulation in the US

16.  A GM food will be considered to be “substantially equivalent” to the natural product if after a comparison of several different characteristics, no difference is shown. Substantial Equivalence

17.  Unexpected substances may appear in GM foods  GM foods approved on the basis of substantial equivalence are not safe because not tested rigorously enough  Safety assessment based on “SE” not scientifically based Criticism:

18.  Labeling of GM products necessary only when the product is materially different from its non-GM equivalent  e.g. whether the use of biotechnology has changed the:  quality  safety  nutritional composition Labeling GM Foods (The US Position)

19.  Prefer traditional food practices  safer and closer to nature  Culture and tradition affect private attitudes toward regulation of foods  Have their source in the customs of the Middle Ages  Legacy of genetic testing on humans during the Nazi era  European resistance to GM products is a function of the public's distrust of the ability of their regulators to prevent such episodes as the mad cow disease crisis EU Consumers:

20.  1957 Treaty of Rome established EU  Silent on food safety  No central European Food Safety Authority similar to the FDA or USDA  Member States continue to possess discretion in their agri- food policies  EU has issued several important GMO directives GMO Regulation Internationally

21.  Directives 90/119 and 90/220 of 1990  regulates the unintentional and deliberate release of GM crops into the environment  1997 Council Regulation 258/97 on Novel Foods  novel foods and novel food ingredients are subject to a single safety assessment before they are placed on the market  Directive 1813/97  compulsory labeling of GM soya beans and maize marketed in the EU GMO Regulation Internationally

22.  EU has developed a complex codex of labeling regulations directly addressing GMOs as a separate category of agri-food products  Regulation 258/97 created additional labeling requirements for food products which have been found to be "no longer equivalent" to their traditional counterparts, as determined by scientific assessment” GMO Labeling Internationally

23.  January 2000, an international trade agreement for labeling GM foods established  130 countries, including the US, the world's largest producer of GM foods, signed  Exporters must be required to label all GM foods  Importing countries have the right to judge for themselves the potential risks and reject GM foods, if they so choose Labeling GM Foods (Internationally)

24.  Mandatory labeling of novel food products containing more than one percent engineered DNA or protein content  Mandatory pre-market testing  Refinement of the substantial equivalence concept  Development and implementation of GMO tracing technology  Creation of a content-based mandatory labeling requirements for products derived from GMO Labeling GM Foods (Internationally)

25.  Evolved out of German socio-legal tradition regarding good household management  “Vorsorgeprinzip” = foresight principle  Constructive partnership between individual, economy, and government to manage change so as to improve the lot of both society and the natural world Precautionary Principle

26. 1.Preventative anticipation 2.Safeguarding ecological spaces 3.Proportionality of response 4.Duty of Care 5.Promoting the cause of natural rights 6.Paying for past ecological debt Six Basic Concepts

27.  Where scientific information is insufficient, inconclusive, or uncertain and where there are indications that the possible effects of the environment, or human, animal or plant health may be potentially dangerous and inconsistent with the chosen level of protection," action may be taken in order to prevent such negative effects Precautionary Principle

28.  Feb 2000 - Commission produced the "Communication from the Commission on the Precautionary Principle”  outline the Commission's approach to using the precautionary principle;  establish Commission guidelines for applying it;  build a common understanding of how to assess, appraise, manage and communicate risks that science is not yet able to evaluate fully;  avoid unwarranted recourse to the precautionary principle, as a disguised form of protectionism. Precautionary Principle:

29.  GMO Generally  Definitions (magic words)  Safety Assessment Protocols:  Substantial Equivalence  Precautionary Principle  Regulation of GMOs in US:  Substantial Equivalence (SE)  Voluntary Consultation  Presumption of GRAS status  No labeling required if SE  Regulation of GMOs internationally  By EU Directive GMO Summary

30.  Alliance for Bio-Integrity v. Shalala 9/2000  Consumer group challenged FDA lack of mandatory labeling for GM foods  Alleged:  Violation of APA  FDA failure to provide EIS  FDA presumption that GM foods are GRAS is erroneous  GM foods w/o labeling are misbranded because fail to reveal “material facts” Recent Case

31. 1.www.enn.com 2.www.propanefl.com/ images/corn.jpg 3.www.columbia.edu/cu/ opg/images/dna.jpg 4.www.arctictravel.com/ GJOA/haven.html 5.www.foodsubs.com/ Fruitber.html 6.www2.utmb.edu/scccb/mouse/ images/microinjection.jpg 7.ss.jircas.affrc.go.jp/engpage/ jarq/32-4/hagio/fig4.htm 8.www.enn.comwww.enn.com 9.Transgenic pollen harms monarch larvae (Nature, Vol 399, No 6733, p 214, May 1999) 10.GM corn poses little threat to monarch (Nature Biotechnology, Vol 17, p 1154, Dec 1999) 11.www.vme.net/dvm/ARNHA/ monarch.html 12.http://www.csa.com/hottopics/gmfood/overview.htmlhttp://www.csa.com/hottopics/gmfood/overview.html 13.www.greenpeace.orgwww.greenpeace.org 14.www.biotechknowledge.monsanto.comwww.biotechknowledge.monsanto.com 15.http://www.inspection.gc.ca/english/ppc/biotech/labeti/response.shtml Sources

32. Relate to environmental, human and animal health consequences Both can have short and long term implications Biosafety risks involve the entire spectrum of biodiversity A universal ‘true for all’ approach may not be applicable Biosafety issues in transgenic crops Known Probability Unknown Probability Risks Rigorous Scientific Assessment Risk Mitigation Precautionary Principle

33. Biosafety concerns arise from: Horizontal gene transfer Genetic contamination Transfer of allergens and toxins from one life form to another and creation of new toxins and allergenic compounds..Biosafety issues in transgenic crops -

34. Main Concerns Development of aggressive weeds/ wild relatives by transfer of transgenic traits  Erosion of land races/wild relatives by genetic pollution in centres of origin/ diversity  Harm to the non-target organisms  Development of pest resistance by prolonged use  Monoculture and limitations to farmers’ choice in crop management  Hazard to human and animal health by transfer of toxins and allergens and by creation of new toxins and allergenic compounds..Biosafety issues in transgenic crops -

35. Assessment GE venturing into an unknown biological territory ASILOMAR Conference (1975): No research till safety guidelines in place Initially, focus on laboratory safety procedures Wider definition of biosafety with possibilities of commercialization of GM products The broad format of biosafety parameters essentially the same in all regulations..Biosafety issues in transgenic crops

36. Two main stages: 1. Laboratory/green house stage 2. Confined Trial Stage IMPORTANT Prevention of the spread of genetically engineered material outside lab/field..Biosafety issues in transgenic crops

37. Laboratory/green house stage Different biosafety levels as per the degree of risk involved Two methods of containment  Physical  Biological

38. A confined trial is a small scale release of a transgenic plant species for research purposes conducted under conditions that prevent spread of the organism and mitigate its impact on the surrounding environment Objective is to collect data to evaluate the crops’ performance Confined Trial Stage

39. Risk mitigation – the terms and conditions that are necessary to conduct the trial safely. Prevent Gene Flow Prevent entry of GMOs into food chain Prevent Persistence of GMOs in the field Focus on Risk Mitigation

40. Bio-pharmaceutical therapeutics Biosafety risk Survival, multiplication and dissemination of GMOs in contained/ open environment Interaction of GMOs with biological systems Routes of dissemination: physical; biological Risk depends upon Nature of organism involved Extent of use of LMOs End product LMO or not?

41. …Bio-pharmaceutical therapeutics Risk categorization of micro organisms: determining factors Capability to cause disease Hazard to laboratory workers Risk of spread to community Availability of effective treatment Health risks Toxigenicity Pathogenicity AllergenicityAntibiotic resistance

42. ..Bio-pharmaceutical therapeutics Environmental risks Outcrossing between GMOs and pathogens Negative effects on populations of non target organisms Risk assessment Access Expression Damage Risk management and communication Physical Biological

43. Expressed proteins generally not a part of regular food supply Food complex mixtures e.g. nutrients, anti- nutrients and natural toxins Directly enter human system Assume different forms Involve storage, processing, transportation GM foods: need for safety assessment

44. Guidelines by Codex Alimentarius Commission Assessment of possible allergenicity Assessment of possible toxicity Compositional analysis of key components Food processing Nutritional modification.. Safety assessment of GM foods comprise

45. ….GM foods: Allergenicity; Toxicity Allergy It is a hypersensitive reaction initiated by immunologic mechanisms caused by specific substances called allergens. Assessment Is the gene source allergenic? Expression level of introduced gene Unintended effect Digestibility and heat stability Toxicity New proteins as a result of intended modification Unintended new proteins as a result of the modification Natural constituents beyond their level of normal variation

46. ….GM foods: nutritional aspects; unintended effects Intended and unintended changes in nutrient levels Bioavailability of nutrients, stability and processing Presence and effect of anti-nutrients Impact of individual changes on overall nutritional profile Unintended effects Random integration of transgenes Insertional mutagenesis Disruption of gene functions Production of new proteins Changes in o PhenotypeMetabolites o EnzymesToxins o Genotype

47. Concluding Note…… Biosafety is integral to modern biotechnology The adoption of modern biotech products needs to be balanced with adequate biosafety safeguards Case by case scientific risk assessment and cost benefit analysis Greater acceptance of health care applications Need based adoption in GM crops and foods Participation of various stakeholders Dissemination of knowledge and information

48. Economic effects on non-GE producers are mixed and poorly understood  Purchasing decisions of GE producers affect non- GE producers  No quantitative estimate of economic impact on livestock producers  Landscape-level effects on pests  Costs of inadvertent gene flow  Benefits of segregated markets Economic Effects

49.  Stakeholder group needed to document emerging weed- resistance problems and develop cost-effect practices to increase longevity of HR technology  Infrastructure needed on the water quality effects of GE crops  Public and private research institutions improve monitoring and assessment capacity to ensure GE technologies contribute to sustainable agriculture  Increased support for the development of ‘public goods’ traits through collaborative approaches to genetic engineering technology Recommendations

50. Thank you. Report is available online at www.nap.eduwww.nap.edu.