Agenda Item 5	Conference Room Document 12 English only

FAO/WHO Regional Conference on Food Safety for Asia and Pacific

Seremban, Malaysia, 24-27 May 2004

Regulatory Procedure for Health Risk Assessment of GM Foods

(Philippines)

Food safety, as defined by FAO (2003) involves all hazards, whether chronic or acute, that may make food injurious to the health of the consumer. IT is NOT NEGOTIABLE. However, the US Congress has recognized that “zero” risk and “absolute safety” are impossible to achieve in a food system. Foods can easily be rendered unsafe by abuse in storage, preparation, or consumption; food allergies, food intolerances, food insensitivities, etc.

The Substantial Equivalence Concept

The substantial equivalence concept provides useful framework for safety assessment. In this analysis, each product is compared with its conventional counterpart and similarities and differences are then made the focus of the evaluation. The safety assessment of genetically modified foods requires an integrated and stepwise, case-by-case approach, which can be aided by a structured series of questions.A comparative approach focusing on the determination of similarities and differences between the genetically modified food and its conventional counterpart aids in the identification of potential safety and nutritional issues and is considered the most appropriate strategy for the safety and nutritional assessment of genetically modified foods.

Presently, no alternative strategies exist that would provide a better assurance of safety for genetically modified foods than the appropriate use of the concept of substantial equivalence. This concept was developed as a practical approach to the safety of genetically modified foods. It is a key step in the safety assessment process although it is not a safety assessment in itself; one must remember that it does not characterize a hazard, but it is used to structure the safety assessment of a genetically modified food relative to a conventional counterpart.

The concept of substantial equivalence involves methods to detect and evaluate the impact of unintended effects, such as the acquisition of new traits or loss of existing traits. Such is the case of genetically modified foods with intentional nutritional effect that may provide improved products for developed and developing countries. The change in nutrient levels in a particular crop plant may impact on overall dietary intake. In such cases, it is important to determine alterations in nutrient content and bioavailability, and their stability with time, processing and storage, as well as to monitor changes in dietary patterns as a result of the introduction of the genetically modified food and evaluate its potential effect on nutritional and health status of consumers. However, an assessment of the impact on the nutritional status of consumers is important for all significant dietary changes and not specific to the introduction of genetically modified foods.

Risk Assessment Process

The strategy of the risk assessment process that is applied to biotechnology-derived crops is based directly on the changes that have been made in the plant. The hazard identification process reveals that there are three principal issues that merit further risk assessment:

• The safety of the inserted DNA
• The safety of the newly introduced component
• The safety of the balance of the whole food

In the food safety evaluation of GM foods specific questions that must be answered should be:

• Is the transferred DNA safe to consume?
• If an antibiotic resistance marker is used, is it safe?
• Are the newly produced proteins safe to consume?
• Have potential allergens been introduced into the food?
• Are the composition and nutritional value changed?
• Are there changes in the content of important substances?
• In what forms will the food or food products isolated from it be consumed?
• Do the newly introduced substances survive processing, shipment, storage, and preparation?
• What is the expected human dietary exposure?

Discussions on the safety aspect of Genetically Modified foods have covered a broad range of aspects. According to WHO (2002), there are three main issues debated:

2.1 Allergenicity. As a precautionary principle, the transfer of genes from commonly allergenic foods is discouraged unless it can be demonstrated that the protein product of the transferred gene is not allergenic.

2.2 Gene transfer. Gene transfer from GM foods to cells of the body or to bacteria in the gastrointestinal tract would cause concern if the transferred genetic material adversely affects human health. This would be particularly relevant if antibiotic resistance genes, used in creating GM foods, were to be transferred. Important considerations for the assessment of the consequences of the transfer and expression of this gene in transformed cells would be the clinical and veterinary importance of the antibiotic in question, the levels of natural resistance and the availability of effective alternative therapies. Although the probability of transfer is low, the use of technology without antibiotic resistance genes has been encouraged by a recent FAO/WHO expert panel.

2.3 Outcrossing. The movement of genes from GM plants into conventional crops or related species in the wild (referred to as “outcrossing”) may have an indirect effect on food safety and food security.

3. Response of the Philippines regarding the safety of biotech foods

In 2001 President Gloria Macapagal Arroyo declared a national biotech policy, that is “…promote the safe and responsible use of modern biotechnology and its products as one of the means to achieve food security, equal access to health services, sustainable and safe environment and industry development.” With the above policy statement on modern biotechnology, coupled with the objective of the Department of Agriculture to accelerate agricultural development, enhance production, and diversify products for food security and global competitiveness, the need for a legal and strong framework on the importation and use of GMOs was emphasized.

3.1 Establishment of Administrative Order 8 and GMO Approval process

Finally, in 2002, the Department of Agriculture issued Administrative Order No. 8, which clearly addresses the risks of GM plant and plant products to human and animal health and the environment.

Under AO 8, no person shall be allowed to import or release into the environment any regulated article without a satisfactory risk assessment. The assessment of GM crops shall be:

• Science-based – identification and evaluation of risk based on scientific studies
• Transparent – basis for decision is open for public scrutiny
• Case by case – different GMOs pose different types and levels of risk and should be assessed accordingly
• By transformation event – unit of analysis in evaluating GMOs

The Bureau of Plant Industry is the central agency overseeing the approval process of importation, release and propagation of GM crops. As shown in Figure 2, the applicant submits his application for the approval of a regulated article to the BPI. After processing and evaluating the documents submitted to them, the BPI farms out the papers to the different concerned agencies involved in the risk assessment process. Each of the independent reviewers conducts their assessment. Inquiries and questions on the submitted scientific documents are channeled back to the applicant for clarification. Upon the conduct of the risk assessment, the reviewers shall then submit a report to the BPI, together with their decision whether they find the regulated article substantially equivalent to its conventional counterpart. The BPI thus collates the evaluations and the appropriate decision is given by the BPI. The functions of the following independent reviewers:

• Scientific and Technical Review Panel (STRP) – assess scientific quality of reports; assess feed safety and environmental safety of Bt Corn
• DA regulatory Agencies:
• Bureau of Agriculture and Fisheries Product Standards– assess food safety
• Fertilizer and Pesticide Authority – safety of pest-protected plants
• Bureau of Animal Industry – assess feed safety
• Bureau of Plant Industry - environmental safety

3.2 Food Safety Assessment – Bureau of Agriculture and Fisheries Product Standards

In line with its commitment to provide safe foods and under the provisions of AO 8, the Bureau of Agriculture and Fisheries product standards has come up with a specific framework in the Risk assessment of Foods derived from Modern Biotechnology. The process carried out was based on:

• Sound scientific evidence
• Pursued in accordance with recognized risk assessment guidelines
• Identify and characterize risks associated with the regulated article for direct use as food
• Evaluation shall be focused on the possible adverse effect of GM foods which exclude risk assessment attributed to discrete chemical entities such as additives, residues, chemical or microbiological contaminants
• Evaluation shall be carried out in a transparent manner
• Evaluation shall take into account the history of safe uses as food source from the importing country
• Evaluation of GM food shall consider the safety of its conventional counterpart

The food safety assessment of BAFPS focused on:

• Horizontal Gene transfer
• Safe use of Antibiotic Resistance Marker gene
• Nutritional composition
• Possible allergenicity
• Unintended effects

The agricultural industry relies on science and makes choices based on the consultation of the experts – the scientist and regulators to either: APPROVE or CHALLENGE each new product of biotechnology. A legal system, that is, AO 8, is crucial in ensuring food safety and positive environmental results. In the absence of knowledge and unavailability of information, the consuming public relies on trusted sources to validate what is “SAFE”.

4. Conclusion and Recommendations

Many future products developed through biotechnology will be intentionally designed not to be equivalent in composition or nutritional content with their conventional counterparts; products that are intended to directly provide consumer benefits through enhanced nutrition and health, address food security and/or nutritional adequacy in developing countries, and improve animal feed. New crop foods or food ingredients should be assessed on a case-by-case basis. Extending the paradigm used for assessing food safety should include foods that are designed to be not compositionally equivalent to their conventional counterparts. In addition, estimated dietary intake and effect on total nutrient intake are important additions to the safety assessment paradigm for non-equivalent foods.

Periodic review of legal instruments and subsequent identification of gaps, emerging needs and issues in the regulation of biotech products need to be done. Current regulatory framework does not address all problematic organisms and their products. The guidelines set by the National Committee on Biosafety of the Philippines (NCBP) guidelines only regulates research and development work on GMOs and Potentially Harmful Exotic Species. Similarly, DA AO 8 regulates only GM plants and selected plant products. Current problems on unregulated entry of some food ingredients derived from GMOs (i.e. unregulated entry of GM microbes, safety assessment of bioremediation/biocontrol agents are not required), as well as future entry of transgenic fish and farm animals need to be addressed.

ANNEX 1

ANNEX 2

References:

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Food and Agriculture Organization. 2003. Assuring Food Safety and Quality: Guidelines for strengthening national food control systems. Rome.

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