ISE01/19-20

• Foods produced from or using genetically modified organisms ("GMOs") are often referred to as genetically modified ("GM") foods. GMOs can be defined as plants, animals or microorganisms in which the genetic material (DNA) has been altered through modern biotechnology.^{1Legend symbol denoting See World Health Organization (2014).} Since the commercialization of GM crops in the mid-1990s, the cultivation of GM crops has been growing globally in view of their benefits such as improved resistance to insect damage and immunity to crop diseases, and increased crop yields.^{2Legend symbol denoting In 2018, 26 countries had cultivated GM crops, covering an area of 191.7 million hectares. It marked a drastic increase from 1.7 million hectares in 1996. See International Service for the Acquisition of Agri-biotech Applications (2019).} In 2018, the major producers of GM crops/foods were the United States ("US"), Brazil, Argentina and Canada, mainly producing GM corns and GM soya beans, following by other types such as papayas, sugar beets, sugarcane and apples. The global market value of GM crops was estimated at US$17.2 billion (HK$134.1 billion) in 2017. Apart from direct human consumption, GM crops/foods are used as animal feeds, or processed to become ingredients for other food items such as corn flour or corn syrup from corns for making snacks, and sugar from sugar beets for making various foods. Reportedly, about 70% to 80% of the processed foods in the US market contain GMOs as ingredients.^{3Legend symbol denoting See Bloomberg (2016).}
• As early as in the 1990s, major producers/exporters of GM crops/foods such as the US and Canada had established a food safety assessment mechanism, either voluntary or mandatory, to facilitate marketing of their products. In the Asia-Pacific region, Japan, Taiwan, South Korea, Australia, New Zealand, which are mainly importers of GM crops/foods, have since the late 1990s implemented their respective mandatory pre-market safety assessment mechanisms to evaluate the safety of GM crops/foods before placing them on the market. However, the assessment approach and process adopted by individual places may vary depending on the local social, economic and political circumstances.
• In Hong Kong, the Government has recently planned to introduce a mandatory pre-market safety assessment scheme ("PMSAS") for enhancing the food safety control over GM foods and will launch a public consultation on the proposed scheme in due course. In this connection, this issue of Essentials highlights the international guidelines on the food safety assessment of GM foods and provides an overview on the related food safety assessment framework in Taiwan (a key importer of GM foods in Asia) and the US (the world's largest producer of GM crops).

Principles and guidelines on the safety assessment of GM foods

• Over the past two decades, there have been ongoing debates on the potential safety risks of GM foods on human health. According to the World Health Organization ("WHO"),^{4Legend symbol denoting See World Health Organization (2014).} GM foods currently available on the international market have passed safety assessments of the relevant exporting or importing countries, and no effects on human health have been shown as a result of consumption of approved GM foods. However, WHO has recommended that the safety of individual new GM foods should be assessed according to the principles and guidelines developed by its Codex Alimentarius Commission ("Codex"),^{5Legend symbol denoting Codex was established under the Joint Food Standards Programme implemented by WHO and the Food and Agriculture Organization ("FAO") of the United Nations in 1963 with the purpose of, among others, promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations. Though the Codex guidelines and standards are voluntary in nature, Codex member countries are encouraged to make reference to them in developing their food safety assessment scheme to facilitate fair international food trading.} and post-market monitoring may be conducted where appropriate, for ensuring that they are safe for human consumption.
• According to the principles of risk analysis of GM foods adopted by Codex in 2003, the pre-market safety assessment of GM foods has to be conducted under the concept of "substantial equivalence",^{6Legend symbol denoting The concept of substantial equivalence has been endorsed by WHO, FAO and the Organisation for Economic Co-operation and Development.} a comparative approach which compares a GM food with an appropriate conventional counterpart on their agronomic, genetic and chemical aspects. The assessment helps identify issues regarding the composition, toxicity, allergenicity and nutritional value of the GM foods, taking into consideration both the intended and unintended effects of the genetic modifications. If the assessment demonstrates that the GM food is substantially equivalent to a conventional counterpart with a history of safe food use, the GM food is considered to be as safe as its conventional counterpart. However, if differences are identified, further safety assessment on the GM food/component is required.

Proposed pre-market safety assessment scheme for GM foods in Hong Kong

• Meanwhile, the Hong Kong Government has not assessed the food safety risks of GM foods before they are placed on the local market and has not ascertained the prevalence of such products. As an indication, a study conducted in 2012 by the Centre for Food Safety ("CFS") of the Food and Environmental Hygiene Department and the Consumer Council on GM food ingredients in corn and corn-based products found that 24% of the tested products contained GM food ingredients, of which 42% contained 5% or more GM ingredients.^{7Legend symbol denoting See消費者委員會(2013年).} The safety of GM foods sold in Hong Kong, like other foods, is monitored under the food surveillance programme administered by CFS. Under the programme, inspectors of CFS take food samples at import, wholesale and retail levels for microbiological, chemical and radiation testing for controlling and preventing food hazards.
• Indeed, the Government has considered introducing a mandatory PMSAS as early as in 2003 for ensuring the safety of GM foods sold in the local market, and supplementing it with a voluntary labelling scheme for food with a specified level of GM materials. Subsequently, the Government had implemented the voluntary labelling scheme in 2006,^{8Legend symbol denoting The Government introduced the voluntary labelling scheme for GM foods in July 2006. According to the related guidelines, the trade is encouraged to, among others, label a food item with 5% or more GM materials in their respective food ingredients as "genetically modified", and provide additional information on the label if the GM food concerned has undergone significant modifications in specific aspects. Nonetheless, a study conducted by CFS and the Consumer Council in 2012 indicated that the tested products meeting the labelling threshold had not been labelled as "genetically modified". See消費者委員會(2013年).} but the plan to introduce PMSAS had been held up due to other more pressing food safety priorities such as legislation on nutrition labelling. Over the years, there have been repeated calls to tighten food safety control on GM foods, and impose a mandatory labelling scheme for GM foods to enhance consumer protection.^{9Legend symbol denoting See Consumer Council (2011), South China Morning Post (2014), Minutes of Meeting of the Panel on Food Safety and Environmental Hygiene of the Legislative Council (2017) and消費者委員會(2013年).} Recently, the Government has reconsidered introducing a mandatory PMSAS to enhance the safety control over GM foods and provide the legal basis for preventing unauthorized GM foods from entering into the local market. Through the implementation of PMSAS, the Government can identify the types of GM foods sold in Hong Kong which will facilitate the consideration of introducing a mandatory labelling scheme for GM foods in the future.
• According to the Government's preliminary proposal, the developer of a GM food is required under PMSAS to submit an application together with the necessary supporting documentation to CFS for assessment and approval before the GM food concerned can be placed on the local market. CFS will determine whether the GM food developer has adequately addressed the food safety issues according to the Codex principles and guidelines. For GM foods that have already been approved for human consumption by other food safety regulatory authorities, the assessment procedures may be simplified provided that the approaches and principles adopted by the relevant regulatory authorities are similar to those of Codex. CFS will post a list of the approved GM foods on its website. Food traders such as importers, wholesalers and retailers have to ensure that a GM food item imported into Hong Kong or put on sales is on the approved list.
• The stakeholders have generally supported the Government's preliminary proposal to introduce PMSAS in an effort to ensure the food safety of GM foods. However, some stakeholders have expressed concerns on the impact of the scheme on food traders such as small to medium size retailers which may not be aware that they are selling GM foods, and the capacity of CFS in conducting safety assessment of GM foods.^{10Legend symbol denoting See Minutes of Meeting of the Panel on Food Safety and Environmental Hygiene of the Legislative Council (2017).} The Government has planned to conduct a public consultation on PMSAS in due course before the full launch of the scheme.

Food safety assessment of GM foods in selected overseas places

• As CFS may make reference to the approvals obtained from overseas regulatory authorities in assessing the applications from GM food developers under PMSAS, the food safety assessment frameworks for GM foods in Taiwan and the US are studied below to provide an overview on the regulatory approach and process from the perspective of an importer of GM foods and a major exporter respectively.

Taiwan

• Taiwan has been one of the major importers of GM crops in Asia. In 2018, Taiwan imported around 2.6 million metric tons of soya beans, of which 97% were GM soya beans. About 10% of the imported soya beans were for food use and the rest were for feeds and oil production.^{11Legend symbol denoting See校園午餐搞非基(2019年).} Nonetheless, the local consumers have been skeptical about the safety of GM foods and resisted to local cultivation of GM crops. Some have also called for tight regulatory control on imported GM foods.
• To ensure the safety of imported GM foods and address the concerns of the general public, the Ministry of Health and Welfare ("MOHW") of Taiwan has introduced a mandatory pre-market approval scheme and a mandatory labelling scheme for GM foods since 2003 and further tightened both schemes in the mid-2010s.^{12Legend symbol denoting In 2014, MOHW has expanded the coverage of the pre-market approval scheme for GM foods from covering only GM soya beans and GM corns to all GM foods. In 2015, MOHW has expanded the scope of the mandatory labelling scheme for GM foods to cover not only packaged foods but also food additives and unpackaged foods., 13Legend symbol denoting MOHW has also implemented a pre-market safety assessment scheme for regulating the safety of GM feeds since 2015.} Under the current pre-market approval scheme, only those GM foods that have passed a food safety assessment and registered with the Taiwan Food and Drug Administration ("TFDA") under MOHW^{14Legend symbol denoting TFDA is the regulatory authority for ensuring the safety and quality of foods, drugs, medical devices and cosmetics in Taiwan.} can be imported and placed on the market. Importers of registered GM foods are also required to establish a traceability system for tracking the origin and flow of the foods.
• TFDA has made reference to the Codex principles and guidelines in designing the framework and scope of the pre-market approval scheme. For example, the requirements on GM food information and related safety assessment data to be submitted by the food developers for evaluation are set according to the relevant Codex guidelines. The pre-market approval scheme features a three-phase assessment process:
  
  

  (a)	Phase I: evaluating information of the GM food concerned and related safety assessment data provided by the GM food developer;
  (b)	Phase II: further assessment of possible toxicity and/or allergenicity if Phase I assessment indicates the presence of possible toxin and/or allergen; and
  (c)	Phase III: conducting animal study on the whole food if assessments in Phases I and II indicate that the available data is insufficient for a thorough safety assessment.

• MOHW has established a dedicated expert group, the GM Food Advisory Group (基因改造食品審議小組), which comprises external experts in relevant fields such as food science, biotechnology and medicine, for conducting the food safety assessment of GM foods in accordance with the established guidelines. As at September 2019, 149 GM foods have been approved and registered with TFDA,^{15Legend symbol denoting See衛生福利部食品藥物管理署：《食品查驗登記管理 - 基因改造食品》(2019年).} markedly increased by 84% from 81 in April 2015.^{16Legend symbol denoting See潘子明(2015年).} This trend reflects that the food trade in Taiwan has generally accepted the mandatory pre-market approval scheme and complied with the arrangements to facilitate import of GM foods to Taiwan. The mandatory pre-market approval of GM foods together with the mandatory labelling requirement have been accepted by local consumers as the crucial measures for enhancing consumer protection and helping consumers make informed product choices.^{17Legend symbol denoting See農傳媒(2017年).}

The United States

• The US is the largest producer of GM crops in terms of the land areas used for GM crop cultivation, which accounted for 39% of the total land areas used for that purpose in the world in 2018. It has also produced the largest variety of GM crops including corns, soya beans, sugar beets, papayas, potatoes and apples.^{18Legend symbol denoting The average adoption rate of cultivating GM corns and GM soya beans reached 93% in 2018. See International Service for the Acquisition of Agri-biotech Applications (2019).} Moreover, the US was the largest exporter of corns (31% of the total market value) and second largest exporter of soya beans (38% of the total market value) in 2017.^{19Legend symbol denoting See The Observatory of Economic Complexity (2019).}
• The safety of GM foods, like most types of food,^{20Legend symbol denoting One exception is the food safety of meat and poultry which is regulated by the Food Safety and Inspection Service under the US Department of Agriculture ("USDA").} is primarily regulated by the US Food and Drug Administration ("FDA")^{21Legend symbol denoting Other authorities involved in the regulation of GM foods include: (a) the US Environmental Protection Agency which is responsible for ensuring that pesticidal substances produced by the GM crops do not pose unreasonable risks to human health or the environment; and (b) USDA which is responsible for regulating the introduction of GMOs that may pose a risk to plant health.} under the same food safety regulatory system. According to the policy statement regarding the regulation of GM foods issued by FDA in 1992, most foods derived from GM crops are "generally recognized as safe" as most GM proteins or other GM substances added to a food are likely to be similar to substances already in the food supply. As such, FDA does not require mandatory pre-market approval of GM foods unless the GM substances involved are significantly different in structure, function or composition from comparable substances found in existing foods.
• Nonetheless, FDA has put in place a voluntary consultation process since 1992 under which GM food developers are recommended to discuss the relevant regulatory issues with FDA and resolve any issues identified before placing a new GM food on the market. The process helps assure stakeholders, including food manufacturers and local consumers, of the safety of new GM foods. Under the consultation process, FDA will review, among others, the safety and nutritional assessment of the GM food concerned submitted by the GM food developer, including assessment of toxicity and allergenicity of the new material in the GM food, and whether the GM food is as nutritious as the traditionally bred counterparts. The information and food safety assessment to be reviewed under the process are in line with that recommended by Codex.
• The above consultation process is overseen by a dedicated team, the Biotechnology Evaluation Team, which comprises experts in relevant fields such as molecular biologist, chemist and toxicologist. FDA will notify the food developers to proceed to launch their GM foods if all safety and other relevant regulatory issues have adequately been addressed. A list of the completed consultations is posted on the website of FDA for stakeholders' reference.
• Notwithstanding the voluntary nature of the consultation process, GM food developers have routinely participated in the consultation process due to marketing consideration. Since FDA completed the first consultation in 1994, more than 150 GM crop varieties have been evaluated under the consultation process. FDA has assured that GM foods evaluated under the consultation process would not be marketed until all the safety issues have been resolved. Besides, evidence has indicated that foods from GM crops marketed to date are as safe as comparable non-GM foods.^{22Legend symbol denoting See United States Food and Drug Administration (2019).}

Concluding remarks

• GM foods have been growing in prevalence in different parts of the world over the past two decades. GM ingredients have been used for making many processed foods and may not be noticed by consumers. To control the safety of GM foods placed on the market, many economies have implemented a pre-market food safety assessment mechanism on GM foods making reference to the principles and guidelines laid down by Codex where appropriate. The experiences of Taiwan and the US reflect that the regulatory framework of GM foods may vary depending on local social, economic and political considerations. For example, strong consumer skepticism on GM foods has prompted the Taiwanese government to implement a stringent regulatory system on GM foods, including imposing mandatory pre-market approval and labelling of GM foods, to enhance consumer protection. In contrast, the wide acceptance of GM crop cultivation in the US has resulted in FDA adopting a voluntary consultation process for GM foods.
• Nonetheless, the pre-market food safety assessment mechanisms for GM foods in Taiwan and the US share the following common features: (a) establishing a dedicated expert team for evaluating the applications; (b) requiring GM food developers to submit supporting documentation on the safety and nutritional assessment of the GM foods concerned for evaluation; and (c) focusing on possible toxicity, allergenicity and nutritional change, and other common food safety issues in the assessment of the GM foods concerned.

Prepared by Ivy CHENG
Research Office
Information Services Division
Legislative Council Secretariat
30 October 2019