FDA DISCUSSION PAPER ON LABELLING OF GM FOODS_final draft.pdf
PURPOSE: To facilitate a national discussion on labeling of GM derived food and feed to build consensus towards a national position.
SCOPE: Food and feed derived from a GMO; including but not limited to raw and processed produce.
Food labeling refers to information displayed on food products (text, devices or pictures), for the purpose of facilitating consumer decisions during purchase and use of products; it is defined by legislation, and broadly categorized as mandatory or voluntary labeling. The general principle for labeling is to forestall false, misleading or deceptive presentation of prepackaged food, and also to prevent an erroneous impression regarding the character of the product in any respect (Codex, 2001).
Labeling information serves three main functions: i) product information: this comprises product names and descriptions, list of ingredients, net content/drained weight, product shelf-life, lot identification, grade/quality, details of manufacturer or distributor and country of origin. ii) health, safety and nutrition information: it includes instructions for safe handling, storage and use, nutrition information pertaining to composition per serving in nutritional information/facts table as well as for specific dietary uses. iii) promotional information: it advertises and markets a food using vignettes, promotion information and claims such as organic, natural, low fat, high source of fiber, fair trade, halal, kosher, quality management system certifications etc. (Codex, 2001 & CFIA, 2011).
Though labeling statements are ultimately driven by consumer welfare, over the years labeling standards have been initiated primarily by governments either proactively or in response to food industry initiatives that have the potential to mislead consumers. The balance between consumer needs and company labeling initiatives drives labeling standards to ensure that consumers are not exploited. In pursuance of this balance, government regulators have influenced the termination of some private labeling initiatives due to its potential to mislead the consumer (Fooducate, 2014).
The World Health Organisation (WHO), Food and Agriculture Organisation (FAO), and Organisation for Economic Co-operation and Development (OECD) considers genetically modified organisms for food, feed and processing (GMO-FFP) that have been approved in accordance with international guidelines for risk assessment of the same, are as safe as its conventional counterpart (OECD, 1993; WHO, 1991). After two-decades and a half long research commissioned by the EU, involving 130 research projects and 500 independent research groups; the report concluded that “biotechnology, and in particular GMOs, are not per se more risky than e.g. conventional plant breeding technologies” (EU, 2010). Such consensus among international organizations and the European Union on the safety of food and feed derived from GMOs as presented above suggests the discussion of labeling approved GM derived food, feed and ingredients is not a health and safety issue.
In spite of this consensus on the safety of approved GM foods, consumers continue to express concern about the safety of GMOs due to concerns expressed by several articles in peer reviewed journals, the most notable being the article by Séralini et al (2012) on long term toxicity of Roundup herbicide and a Roundup-tolerant genetically modified maize. This publication received worldwide media attention and was hailed as principal proof that GM foods are unsafe. It consequently influenced policy decisions in some African countries like Kenya where a ban on the importation and cultivation of GM foods was instituted (ACSH, 2015).
The Séralini et al. study was reviewed by European Food Safety Authority (EFSA) on request of the European Commission; they noted that the study’s inadequate design, analysis and reporting is of insufficient scientific quality for safety assessment, and concluded as follows “the Séralini et al. study as reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize NK603 and its related stacks” (EFSA, 2012). National competent authorities from France, Germany, Belgium, Australia and New Zealand reached the same conclusions as EFSA following their review of the Séralini et. al. study (ANES, 2012; HCB, 2012; VIB, 2012; BfR, 2012 and FSANZ, 2012). Following a thorough investigation of the study, the Journal of Food and Chemical Toxicology retracted the article on the inconclusiveness of the study results based on deficiencies in the study design (Wallace Hayes, 2014).
This discussion paper is aimed at highlighting the key issues to facilitate the consideration of a country position on labeling of GM foods.
LABELLING OF GM FOOD, FEED & INGREDIENTS
The call for labeling of GM derived food, feed and ingredient by environmental and civil society groups and some governments is based on a supposition that consumers have a fundamental right to know what their foods contain; to facilitate their decision to patronize or boycott such food based on one or several of the following; safety, health, nutrition, socioeconomic, ethical, religious, or environmental issues. These references also govern current labeling systems and strategies for foods and other consumer goods.
Globally there is currently no agreement, standards or guidelines on labeling of foods derived from GMOs. Following several years of discussion at the Codex Committee on Food Labeling no agreements was reached; individual countries have developed labeling regimes that meet their needs. In the development of labeling systems and requirements, several governments around the world have developed mandatory or voluntary labeling regulation on the basis of process-based or proof-based principle and the use of positive or negative labeling statements.
Mandatory labeling regulations require food products derived wholly or partially from GMOs to be labeled in accordance with guidelines; failure to comply with regulations attracts a penalty which is usually very hefty. On the other hand, voluntary regulations provide guidelines for labeling foods derived from GMOs, however, the decision to label is taken by the food product manufacturer or distributor.
For labeling regulations based on proof-based labeling principle, food products are labeled as GM in accordance with the guidelines when it contains detectable GM material, whilst for process-based regulations food products are labeled in accordance with GM labeling guidelines when the food or part of it was developed using modern biotechnology techniques.
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The proof-based systems rely on product testing and the process-based systems on identity preservation systems to authentic claims of applicants. Positive labeling highlights the GM content of food products, whilst negative labeling highlights the absence of GM content by employing symbols or statements such as “contains GMO” or “non-GM”.
Figure 1 below, shows information gathered by the FAO (n.d.) from 41 countries on the various strategies employed by their labeling regulations for foods derived from GMOs. One hundred and twenty-five countries were surveyed for their labeling requirements for labeling of foods derived from GMOs.
Fig. 1: GM Food Labeling Regulations Across 41 Countries Globally
MANDATORY OR VOLUNTARY REGULATIONS POSITIVE LABELING NEGATIVE LABELING POSITIVE AND NEGATIVE LABELING MANDATORY REGULATIONS POSITIVE LABELING (ALLOWS VOLUNTARY & NEGATIVE LABELING) NEGATIVE LABELING (ALLOWS VOLUNTARY & POSITIVE LABELING)
Globally, there are varied variations to how these labeling regulations in fig. 1 are implemented on two additional levels; threshold levels and coverage of guidelines. The thresholds levels relate to the unintentional and technically unavoidable presence of approved GMOs arising from cross pollination/fertilization, volunteer plants, add mixing in machinery during planting and harvesting – low level presence. The current levels vary widely from 0.9%, 1%, 5% to undefined levels. The application of labeling regulations for the following also vary from country to country:
• List of ingredients – from top 3 to all ingredients with threshold limits.
• Additives and flavorings
• Animal feed
• Meat and products derived from animals fed with GM feed.
• Foods sold at restaurants, caterers and unpacked food
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REVIEW OF SELECTED COUNTRY LABELING REGULATIONS
UNITED STATES OF AMERICA REGULATIONS
In the US, the FDA recommends food companies to voluntary consult the agency before it markets the GM food, except for situations where the food is significantly different or gene is sourced from a known allergenic plant. The FDA does not formally approve an application or conclude whether the GM food is safe or not, however, they issue a memorandum indicating the features of the food and how it may impact the safety concerns. In 2001 a proposed mandatory premarket approval, known as the Premarket Biotechnology Notice (PBN) was proposed but is yet to be enacted; with this system, a food company will notify the FDA 120 days prior to the commercial distribution of the food and supply all the requisite safety data irrespective of the GM content (Wong, 2003; Roberts, 2016). Until July 29, 2017, there was no obligation to label GM foods; companies were only obligated to label GM foods that were substantially different in respect of nutritional characteristics as per the 2002 voluntary labeling guidelines of the Food and Drugs Administration. There was therefore no labeling system that provided for standards, testing, certification and enforcement regarding GM foods in the US (Wong, 2003; Zainol et al, 2013).
In the absence of a US Federal Legislation for mandatory labeling, several States initiated mandatory legislation. In 2014, Vermont became the first US State to pass a law that mandates the labeling of foods derived from genetically modified crops; that comes into force on July 1, 2016 (Ford D. & Ferrigno L. (2014). Maine and Connecticut had also passed GM labeling laws but required other states to pass GM labeling laws before it could be enacted (Reuters, 2014). As more and more States push for mandatory labeling, plurality of the GM labeling strategies and requirements would create a compliance nightmare for the food industry as they will need to comply with the idiosyncratic labeling requirements of the different States; resulting in increased cost of compliance and consequently cost of products.
When the Vermont mandatory labeling law came into effect in July 1, 2016, a compromise Federal Legislation, the National Bioengineered Food Disclosure Notice, Public Law 114–216, was passed by Congress and accented to by the President on July 29, 2016 to avert the imminent chaos in the food industry. This standard requires mandatory disclosure on the label of a bioengineered food using any of the following; text, symbol, or electronic or digital link. It defines a bioengineered food, establishes exceptions from disclosure, and prevents individual states from directly or indirectly enacting laws in respect of bioengineered food disclosures. The USDA has up to two (2) years to write regulations, requirements and procedures for implementation of this federal legislation.
In 1997 the EU Novel Foods Regulation 258/97 required labeling of GM foods on the proof-based principle. This means that only final products with detectable genetic DNA fragments were required to be labeled. Thus when DNA fragments cannot be detected due to extensive processing, such a product did not require labeling. The new GM labeling regulations of 2004, is based on a process-oriented principle. Under this new regulation, food products that make use of GMOs at any point during their production; whether or not the DNA fragments are detectable, are required to be labeled under this
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regulation. The labeling is to provide information on the use of genetic modification irrespective of its effect on the final product composition. This process-oriented new system is stricter, labor and capital intensive than the proof-based system on the part of the regulatory system and processors due to traceability requirements along the food value chain (EU, 1997; GMO Compass, 2005).
The new EU regulation reduces the threshold value beyond which mandatory labeling is required from 1.0% to 0.9% only attributable to technically unavoidable presence. Operators must demonstrate that appropriate steps have been taken to avoid such presence to be exempt from labeling. Article 9 of Regulation (EU) 1169/2011 prescribes labeling phrases for GM component of a food or food ingredient:
- ‘genetically modified’ or ‘produced from genetically modified (name of the ingredient)’
- ‘contains genetically modified (name of organism)’ or ‘contains (name of ingredient) produced from genetically modified (name of organism)’
- ‘genetically modified’ or ‘produced from genetically modified (name of organism)’ In addition Regulation (EC) No 1830/2003 prescribes the following labeling phrases for pre-packaged and non-prepackaged foods:
- ‘This product contains genetically modified organisms’ or ‘This product contains genetically modified [name of organism(s)]’
The European regulations exempt the following categories
• Processing aids such as food enzymes produced using GMOs.
• Food products from animals fed with GM-feed or treated with GM medicinal products as these are produced with, but are not from a GMO. Milk, meat & eggs.
• Foods produced by fermentation using genetically modified microorganisms (GMMs) not present in the final product. CIAA (2007).
The Food Standards Australia New Zealand (FSANZ) is responsible for GM food labelling in Australia. It considers Australia and New Zealand to have a very rigorous and progressive labeling requirements for GM food labeling. They subject all foods derived from genetic modified crops to pre-market safety assessment and approval. GM food labeling is regulated using the Standard 1.5.2 Food Produced Using Gene Technology of the Australia New Zealand Food Standard Code (the Standard). The Standard requires the labeling of food and food ingredients that contains more than 1% of GM raw materials. For single-ingredient foods the phrase “genetically modified” should be placed on the principal display panel close to the name prescribed by law for the food, whilst for multi-ingredient foods, the GM ingredient should be declared in the list of ingredients. Foods whose status as to containing GM materials cannot be established by the manufacturer, are required to be labeled “may be genetically modified” or “may contain genetically modified [ingredient name]“. Exceptions to the labeling requirements are as follows:
i. When GM content is less than 1%; thus allowing for inadvertent mixing of GM and non-GM materials.
ii. Highly refined foods where the neither the DNA nor Protein is present.
iii. Foods that use GM processing aids in its manufacture but are not present in the final food.
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iv. Food prepared at the point of sale – e.g. restaurants. Foods that differ from its conventional counterparts in respect of the following require additional labeling: composition and nutritional values, anti-nutritional factors or natural toxicants, factors known to cause allergies, its intended use or factors that may raise ethical, cultural or religious concerns (Wong, 2003).
New biotechnology varieties for development of new food products are required to undergo premarket assessment by the Food Sanitation Committee of the Ministry of Health, Labour and Welfare (MHLW) in Japan. Food products that contain designated GM ingredients are required to be labeled; if it’s a top 3 ingredient and constitutes more than 5% of the total weight of the product. They publish a list of approved GM ingredients (the List); it is therefore illegal to sell or import food products with unapproved GM ingredients. Japan has zero tolerance for unapproved events in its food products, as such, continuous monitoring and testing is conducted for imports and processed foods at retail level. Non-conforming shipments are returned, destroyed or diverted for non-food use.
The labeling of food products are classified as:
i. Genetically modified – This is applicable to all prepackaged foods which are required to be labeled under the Food Sanitation Law and Japanese Agricultural Standard (JAS) Law.
ii. Not segregated from GM products – This is applicable to products that may contain GM materials because they have not been handled in accordance with identify preserved basis.
iii. Non-GM – This is applicable to products that have been identity preserved to ensure it does not contain any GM material.
Categories (i) & (ii) are mandatory whilst (iii) is voluntary.
There are exemptions to the labeling regulations:
i. Food products in which the recombinant DNA and the resulting protein have been degraded due to processing. However, though the recombinant DNA or its protein is not present in high oleic acid soybean oil obtained from GM soybean, it is labelled as GM.
ii. Food products containing less than 5% of GM materials due to unintentional inclusion or adventitious presence.
Under these regulations it is prohibited to label a food product that does not have a GM counterpart and foods derived from them cannot be termed as non-GM; as this will give the erroneous impression that there are GM varieties of that crop and what is being offered is not a GM variety. It is however, permitted for the use of the phrase “at present, there is no GM [name of crop] on the market” in close proximity to the name of the product as prescribed by law. (Wong, 2003; Umeda, 2014)
Hong Kong has mandatory pre-market approval for GM ingredients, and a voluntary labeling scheme. The labeling of food in Hong Kong is undertaken by Health, Welfare, and Food Bureau; part V of the Page 7 of 16 Public Health and Municipal Services Ordinance (Chapter 132) stipulates that all food (including GM foods) intended for sale in Hong Kong must be fit for human consumption. The Government of Hong Kong has issued guidelines for labeling of GM foods and encourages trade to use the voluntary labeling guidelines; providing reference for truthful positive and negative labels. The guidelines also cover standard terminologies and fundamental principles underlying the guidelines (Wong, 2003; CFS, 2006).
Positive vs. Negative Labeling
The use of positive labeling in GM food labeling is perceived as a tool for market limitation, as such labeling statements, are perceived as warnings to consumers who are skeptical of GMOs. It is argued to provide limited information, and fails to accurately define the consequences of consuming or patronizing GMO products from a safety or any other standpoint. Proponents further argue that positive labeling will promote GM foods that are transformed for improved nutrition or pharmaceutical attributes (Runge, 2001 & Hoffman, 2015).
For positive labeling to benefit the consumer, there is the need for a case by case labeling consideration that specifies attributes of the GM crop in question, otherwise even the benefits will be obscured by the limiting effect of consumer skepticism.
Since consumer choices for GM foods are based on either safety, health, nutrition, socioeconomic, ethical, religious, or environmental amongst other considerations, GM labeling statements should seek to directly address related consumer concerns; such a labeling statement that touches on all these concerns will be verbose, and take a lot of space on the label. Though current labeling statements provides a simplified scheme, it can contribute to the ignorance and misinformation of consumers as the effect of techniques used vary from one product to another, and consequently its impact on the issues under consideration. For instance GE crops that are drought resistant, salt tolerant, nutrient enriched or delayed ripening may not impact e.g. the environment in the same way as insect resistant and herbicide tolerant varieties for which there may be strong opposition.
GM food Labeling Policy and GM Crop Cultivation
Observations made during the review of labeling policies above corroborate other study reports of a correlation between GM food labeling policies and cultivation of GM crops. The US, Canada and Argentina who are major producers of GM crops globally have voluntary labeling regulations as opposed to mandatory labeling regulations in Europe, Japan and Australia, where little or no cultivation of GM crops takes place (Zepeda, 2002; Buttel, 2002 as cited by Wong, 2003). South Africa and Brazil are producers that have a mandatory labeling policy.
Consumer Choice: Mandatory & Voluntary Labeling Policies
Mandatory labeling is argued not to have placed products on the shelf, thus consumers do not get to make a choice. Rather it is said to have delivered processor and retailer choice, as GM food products never make it to the market on account of processor and retailer decisions. The current market situation in the EU, Japan and Australia where GM foods are not ubiquitous on the market despite the enforcement of mandatory labeling regulations (which intends to give consumers a choice), gives credence to the aforementioned assertion (Carter & Gruère, 2003a).
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For markets where anti-GMO advocacy and sentiments are very rife; it results in consumer skepticism, and the perception of positive GM food labeling statements as warnings. The perceived sales loss due to consumer skepticism, and the impact of environmental and consumer advocacy campaigns against labelled products strongly influence processors and retailer decisions to use non-GM certified materials to avoid GM food labeling.
The situation is reported to be further influenced by a relatively marginal price difference between nonGM and GM raw materials, and the fact that current traits of biotech crops are input traits which do not bring direct benefit to the consumers, but rather farmers and biotech companies. (Carter & Gruère, 2003a; GMO Compass, 2007a). Regulatory impact assessment carried out by Hong Kong in 2002 corroborated increased costs to trade for mandatory labeling framework; particularly for small to medium scale enterprises due to difficulties in securing contractual agreements with manufacturers in respect of GM status (Wong, 2003).
These observations suggest that mandatory labeling of GM foods may only deliver true consumer choice in markets where consumers are not extremely skeptical and/or are adequately informed through the provision of accurate information, such processors do not feel the threat of loss in using GM food ingredients. Such a case in point is Brazil, where a logo is used to identify foods derived from GMOs.
According to Carter & Gruère, 2003b only market forces are able to deliver true consumer choice; as the case is currently for Halal, Kosher, Fairtrade, Organic, Country-of-Origin, Ecolabels among others. Under a voluntary labeling scheme with guidelines for positive and negative labeling, consumers can demand for GM food and/or non-GM food to be labeled. In such an environment, sufficient demand by consumers for non-GM products will drive processors and retailers to respond to market demands.
RESOURCE REQUIREMENTS FOR MANDATORY & VOLUNTARY LABELLING SCHEME
The implementation of the mandatory labeling scheme is practically the most demanding implementation scheme of the three labeling options; as it requires continuous monitoring, documentation evaluation and/or testing of all foods that have GM variants. The following are required for the successful implementation of both mandatory & voluntary labeling schemes:
a. Principles for labeling i.e. process/proof based; mandatory/voluntary; positive/negative.
b. Exceptions – products exemptedc. Threshold levelsd. Traceabilitye. Penalties
2. Monitoring and sampling plans – where, what, when, how to sample? 3. List of authorized GMOs in Ghana.
4. Testing laboratories.
5. Validated test methods.
6. Import export monitoring systems.
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A country assessment will be required to ascertain the level of preparedness; following which timelines for addressing gaps are determined. Following this assessment, the timeline for enforcement of mandatory GM labeling in Ghana will be determined.
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CONSIDERATIONS TOWARDS A GHANAIAN POSITION ON LABELLING OF GM FOODS
Current Situation in Ghana
The Biosafety Act, 2011, Act 831 requires pre-approval of GM crops for environmental release and placement on the market. The National Biosafety Authority is responsible for this process, working with several regulatory institutions through its Technical Advisory Committee and other experts. The Food and Drugs Authority and the Ghana Standards Authority through their product registration and certification schemes respectively enforce mandatory food labeling legislations in Ghana. Current labeling legislations are the Ghana Standards Board (Food, Drugs and Other Goods) General Labelling Rules, 1992, LI 1541, and GS 46: 2004 Food Technology: Labelling of Pre-Packaged Foods. These legislations have no provisions on labeling of GM food. The lack of international consensus has stalled the process at Codex, and till date no Codex guidelines on labelling GM food. Ghana may therefore need to develop guidelines for GM food labeling following a decision on labelling of same.
Developing a Country Position
According to the OECD, the Bio-Economy holds the key to emerging challenges of increase demand for healthcare and for agricultural, forestry, and fishing products associated with increasing incomes in developing countries. Several countries including Ghana in line with OECD Bio-Economy to 2030 policy agenda have adopted a biotechnology policy within its National Science and Technology Policy and set sector specific goals. The European Council in response has created an Innovation Union that focuses on Building a Bioeconomy by 2020, to help it overcome its financial and economic turmoil that occurred prior to 2010.
In this respect the EU spent over EUR 200 Million through its Framework Programme on Research over a ten (10) year period to develop agricultural management techniques for coexistence, tools for detection in and analysis of food and feed, and methods of risk assessment of GMOs in response to consumer, farmers and policy maker’s needs (EU 2010).
To develop a country position, it’s important for us to place our discussions in the above context. Additionally, we must assess the impact of the decision on our current trade policy with our major trading partners and their policies on labeling of GM foods. Answers to the following cascade of questions will also serve as a guide to focus the discussion on national interest and socioeconomic impact:
1. Why do we want to label GM foods?
2. Which labeling scheme will be most practical for Ghana – mandatory, voluntary and/or no labeling?
3. How will the choice made in 2 (above) impact Ghana’s National Science and Technology Policy on the promotion of biotechnology for the development of a bio-economy for Ghana.
4. What remedial measures can we put in place if the choice made in 3 (above) hampers the achievement of the National goal of a Bio-Economy using biotechnology?
Cost of Labeling
The discussion on the cost of labeling goes beyond printing of labels which is negligible. The real cost of labeling lies in the proof of information declared on the label in respect of ingredient status as GM or non-GM. These include costs associated with monitoring, testing and enforcement programmes, development and maintenance of identity preservation, traceability and segregation systems, and compliance to regulations (verification of threshold levels). The cost of labeling is affected by the following factors: threshold level – low levels drive costs upward; capacity of industry to comply with regulations – low capacity drive costs upwards; and domestic production of GMOs – high local production drives costs upward. There is the need to undertake a regulatory impact assessment of the various labeling options to facilitate the decision making.
A national position for labeling is in the interest of consumers, farmers, policymakers, manufacturers, researchers and technology developers. The labeling of GM foods is an ongoing debate globally; progressive international consensus on safety of biotechnology and products of the same, particularly its use in agriculture notwithstanding, there are different national policies globally to serve idiosyncratic interests using the consumer right to know as the basis of their decision. It is important for Ghana to develop a national position and consequently a labeling scheme based on lessons drawn from the debate on the international front and establish its interest and priorities to arrive at a national position that will find its place in the international market place. To foster the development of Ghana’s Bioeconomy, it is essential that discussions focus on impact of proposals on indigenous research and technology companies, creating opportunity and protecting these enterprises to give them a competitive edge over large multinational companies locally and internationally. Prepared by Biosafety Unit Agro Product and Biosafety Department Food and Drugs Authority, Ghana ©2017
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Umeda S. (2014) Library of Congress [Online] Restrictions on Genetically Modified Organisms: Japan Available from: https://www.loc.gov/law/help/r
estrictions-on-gmos/japan.php Accessed on: May 12, 2016.
VIB (2012) [Online] VIB concludes that Séralini study is not substantiated Available from: http://www.vib.be/en/news/Page
s/VIB-concludes-that-Seralini- study-is-not-substantiated-.as px Accessed on: March 21, 2016.
Wallace Hayes A. (2014) Editor in Chief of Food and Chemical Toxicology answers questions on retraction. Food Chem. Toxicol. 65: 394-5 WHO (1991) World Health Organization [Online] Strategies for assessing the safety of foods produced by biotechnology. Available from: http://library.health.go.ug/do
wnload/file/fid/790 Accessed on: February 2, 2016.
Wong D. (2003) Genetically Modified Food Labelling [Online] Research and Library Services Division Legislative Council Secretariat. Available from: http://www.legco.gov.hk/yr02-0
3/english/sec/library/0203rp05 e.pdf Accessed on: May 16, 2016
Page 16 of 16
Zainol Z. A., Nordin R. and Akpoviri F. I. (2013) Mandatory labeling of genetically modified (GM) foods. Int Environ Agreements (2015) 15:199–216
To: Mr. Roderick Daddey-Adjei
Head, Agro Produce and Biosafety Department
Food and Drugs Authority
Dear Mr. Daddey-Adjei,
RE: DOCUMENTS RELATED TO GM FOOD LABELLING MEETING
I write on behalf of Food Sovereignty Ghana to submit our views regarding the labelling of GM food and feed in Ghana.
We are most grateful for the opportunity, and call for more public awareness and participation in such an important debate.
We are strongly for a mandatory labelling of GM foods and feeds, and sensitive to false narratives that tend to promote a regime of voluntary labelling of same.
We are however thankful and appreciative of the level of due diligence so far in the consultations process, and would greatly appreciate your reactions to your paper on Discussion Paper on the Labelling of GM Foods.
We have every intention to sustain the conversation and keep it going. Our eight-page response below is written as a brief with our allies in mind, rather than for mass distribution. At least, not yet, as we still remain hopeful for a constructive dialogue, for the good of our people.
Please, find below, our response: “FSG Calls for Mandatory Labelling of GMOs in Ghana”
Thank you very much for your kind attention,
For Life, the Environment, and Social Justice!Edwin Kweku Andoh Baffour
Communications Directorate, FSGContact: +233 207973808
E-mail : firstname.lastname@example.org
Communications Directorate, FSGContact: +233 207973808
E-mail : email@example.com
FSG Calls for Mandatory Labelling of GMOs in Ghana
Food Sovereignty Ghana (FSG) calls on the Ghana Food and Drugs Authority (FDA) to take all necessary measures to ensure the mandatory labelling of all genetically modified organisms (GMOs) in all food and feed in Ghana.
For the avoidance of any doubts, FSG equally insists on our earlier demand for a ban or an indefinite moratorium on all GMO produce in foods and feed until long-term epidemiological studies in human populations have been carried out to establish whether there are any health effects associated with GM food consumption. Ghana has nothing to lose in being careful not to rush with a technology that independent experts insist we do not even need, and which at the same time is capable of doing irreparable harm to human health and to the environment. 
Discussion Paper on the Labelling of GM Foods
Our call on the FDA for the mandatory labelling of GMOs in our food and feed is in response to a “Discussion Paper on the Labelling of GM Foods” prepared by Biosafety Unit, Agro Product and Biosafety Department Food and Drugs Authority, Ghana. The stated aim of the document is to “facilitate a national discussion on labelling of GM derived food and feed to build consensus towards a national position”. The paper is also accompanied with “Guidance Questions For Group Interactions On GM Food Labelling Policy Decision“. 
According to the FDA, labelling information “serves three main functions: (i) product information: this comprises product names and descriptions, list of ingredients, net content/drained weight, product shelf-life, lot identification, grade/quality, details of manufacturer or distributor and country of origin. (ii) health, safety and nutrition information: it includes instructions for safe handling, storage and use, nutrition information pertaining to composition per serving in nutritional information/facts table as well as for specific dietary uses. iii) promotional information: it advertises and markets a food using vignettes, promotion information and claims such as organic, natural, low fat, high source of fiber, fair trade, halal, kosher, quality management system certifications etc.”.
Mandatory Versus Voluntary Labelling?
According to the FDA paper, “Mandatory labeling regulations require food products derived wholly or partially from GMOs to be labeled in accordance with guidelines; failure to comply with regulations attracts a penalty which is usually very hefty. On the other hand, voluntary regulations provide guidelines for labeling foods derived from GMOs, however, the decision to label is taken by the food product manufacturer or distributor.”
The paper then launches into a discussion which largely favours voluntary labelling of GM food and feed, relegating treating it almost entirely as a sort of “promotional information” or advertisement platform. FSG is strongly opposed to this. We believe that a simple respect for the integrity of the product, and the fundamental respect for the consumer’s right to know, ought to have been enough basis for the justification of a mandatory labelling.
The arguments the paper advances to promote the voluntary labelling of GM food and feed suggest that (i) “the discussion of labeling approved GM derived food, feed and ingredients is not a health and safety issue.” and also that (ii) It may go against “Ghana’s National Science and Technology Policy on the promotion of biotechnology for the development of a bio-economy for Ghana.”
“Consensus on safety” of GMOs?
In a rather tortuous narrative aimed to rule out the necessity of mandatory labelling for GM foods and feeds in Ghana, the paper cites the World Health Organisation (WHO), Food and Agriculture Organisation (FAO), and Organisation for Economic Co-operation and Development (OECD) as “examples of international organisations that consider genetically modified organisms for food, feed and processing (GMO-FFP) that have been approved in accordance with international guidelines for risk assessment of the same, are as safe as its conventional counterpart.”
The paper thus argues that such “consensus among international organizations and the European Union on the safety of food and feed derived from GMOs as presented above suggests the discussion of labeling approved GM derived food, feed and ingredients is not a health and safety issue.”
The question the FDA needs to answer is which GMOs and in which country have they “been approved in accordance with international guidelines for risk assessment”? In the paper’s own review of selected country labelling regulations, it describes the United States of America regulations as:
“In the US, the FDA recommends food companies to voluntary consult the agency before it markets the GM food, except for situations where the food is significantly different or gene is sourced from a known allergenic plant. The FDA does not formally approve an application or conclude whether the GM food is safe or not, however, they issue a memorandum indicating the features of the food and how it may impact the safety concerns. In 2001 a proposed mandatory premarket approval, known as the Premarket Biotechnology Notice (PBN) was proposed but is yet to be enacted; with this system, a food company will notify the FDA 120 days prior to the commercial distribution of the food and supply all the requisite safety data irrespective of the GM content (Wong, 2003; Roberts, 2016). Until July 29, 2017, there was no obligation to label GM foods; companies were only obligated to label GM foods that were substantially different in respect of nutritional characteristics as per the 2002 voluntary labeling guidelines of the Food and Drugs Administration. There was therefore no labeling system that provided for standards, testing, certification and enforcement regarding GM foods in the US.”
Prof. David Schubert, professor and head, Cellular Neurobiology Laboratory, Salk Institute, commenting on a comprehensive peer-reviewed study of US government’s regulation of GMOs that he co-authored: “One thing that surprised us is that US regulators rely almost exclusively on information provided by the biotech crop developer, and those data are not published in journals or subjected to peer review… The picture that emerges from our study of US regulation of GM foods is a rubber-stamp ‘approval process’ designed to increase public confidence in, but not ensure the safety of, genetically engineered foods.” – David Schubert, professor and head, Cellular Neurobiology Laboratory, Salk Institute, commenting on a comprehensive peer-reviewed study of US government’s regulation of GMOs that he co-authored 
“It is often claimed that “trillions of GM meals” have been eaten in the US with no ill effects. However, no epidemiological studies in human populations have been carried out to establish whether there are any health effects associated with GM food consumption. As GM foods are not labelled in North America, a major producer and consumer of GM crops, it is scientifically impossible to trace, let alone study, patterns of consumption and their impacts. Therefore, claims that GM foods are safe for human health based on the experience of North American populations have no scientific basis”. 
Also, we find it interesting that the paper is talking about “international consensus” here when in another part of the very same paper, we read that there is no international consensus on labelling of GM foods, to such an extent that this “lack of international consensus has stalled the process at Codex, and till date no Codex guidelines on labelling GM food”!
“Consumer Concerns” or Scientific Objections?
“In spite of this consensus on the safety of approved GM foods,” the paper argues, “consumers continue to express concern about the safety of GMOs due to concerns expressed by several articles in peer-reviewed journals, the most notable being the article by Séralini et al (2012) on long term toxicity of Roundup herbicide and a Roundup-tolerant genetically modified maize. This publication received worldwide media attention and was hailed as principal proof that GM foods are unsafe. It consequently influenced policy decisions in some African countries like Kenya where a ban on the importation and cultivation of GM foods was instituted.”.
We find it revealing that the paper only dismissively refers to “concerns” by (ignorant?) “consumers” and fails to make any reference to important and independent peer-reviewed claims involving scientists, physicians, academics, and experts from disciplines relevant to the scientific, legal, social and safety assessment aspects of genetically modified organisms (GMOs), that strongly reject claims by GM seed developers and some scientists, commentators, and journalists that there is a “scientific consensus” on GMO safety.” 
Perhaps, the most perfidious aspect of this FDA paper is the spin put on the Séralini et al. study. Here, the paper literally hits below the belt. The account is not only incomplete, it also provides a skewed narrative to give the impression that the study is actually worthless!
The paper simply states:
“The Séralini et al. study was reviewed by European Food Safety Authority (EFSA) on request of the European Commission; they noted that the study’s inadequate design, analysis and reporting is of insufficient scientific quality for safety assessment, and concluded as follows “the Séralini et al. study as reported in the 2012 publication does not impact the ongoing re-evaluation of glyphosate, and does not see a need to reopen the existing safety evaluation of maize NK603 and its related stacks” (EFSA, 2012). National competent authorities from France, Germany, Belgium, Australia and New Zealand reached the same conclusions as EFSA following their review of the Séralini et. al. study (ANES, 2012; HCB, 2012; VIB, 2012; BfR, 2012 and FSANZ, 2012). Following a thorough investigation of the study, the Journal of Food and Chemical Toxicology retracted the article on the inconclusiveness of the study results based on deficiencies in the study design (Wallace Hayes, 2014).”
In the first place, paper fails to point out the important fact that the study was republished by another peer-reviewed journal: Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize | Environmental Sciences Europe |  The Editor-in-Chief of Food and Chemical Toxicology, A. Wallace Hayes’ own statement points clearly to the fact that he had not even read the report. As GMWatch puts it, in the article, “Did journal editor read the Séralini paper before retracting it?”, “Hayes not having read the paper is, of course, the charitable interpretation of his actions, because if he is familiar with the paper’s contents it might be hard not to conclude that he has deliberately misrepresented them”. 
Secondly, a trove of internal documents from Monsanto, recently unsealed in a lawsuit against the agricultural biotech giant, has revealed the firm’s role in the knotty tale of a paper from the lab of a scientist known for his stance against genetically modified organisms (GMOs). Unearthed emails: Monsanto connected to campaign to retract GMO paper 
As the recent “Monsanto Papers” scandal shows, we are compelled to ask whether this is not another case of industry ghostwriting, or the FDA dutifully doing its own version of the industry’s “cut and paste”? We are demanding answers because we know of such efforts by the industry elsewhere such as Secret Docs’ Show Monsanto’s Attempt to Influence Writers, Bribe Scientists 
Surely, the FDA cannot claim to be oblivious of the mind-blowing evidence that surfaced from the latest release of “Monsanto papers” – the internal documents of the agrochemical multinational made public in the context of a class action lawsuit against it in the United States. These documents clearly show that employees of the firm manoeuvred behind the scenes over several weeks to obtain the retraction of the controversial study by the French biologist. And that they achieved their aim.” 
It is simply not an accident that most criticisms of Séralini’s study wrongly assume it was a badly designed cancer study when it was not. The study was a chronic toxicity study – and peer-reviewed as a well-designed and well-conducted one.
The Séralini study is the only long-term study on the commercialized GM maize NK603 and the pesticide (Roundup) it is designed to be grown with. Séralini used the same strain of rat (Sprague-Dawley, SD) that Monsanto used in its 90-day studies on GM foods and its long-term studies on glyphosate, the chemical ingredient of Roundup, conducted for regulatory approval. The SD rat is about as prone to tumours as humans are. As with humans, the SD rat’s tendency to cancer increases with age. Compared with industry tests on GM foods, Séralini’s study analyzed the same number of rats but over a longer period (two years instead of 90 days), measured more effects more often, and was uniquely able to distinguish the effects of the GM food from the pesticide it is grown with.
If we argue that Séralini’s study does not prove that the GM food tested is dangerous, then we must also accept that industry studies on GM foods cannot prove they are safe. Séralini’s study showed that 90-day tests commonly done on GM foods are not long enough to see long-term effects like cancer, organ damage, and premature death. The first tumours only appeared 4-7 months into the study. Séralini’s study showed that industry and regulators are wrong to dismiss toxic effects seen in 90-day studies on GM foods as “not biologically meaningful”. Signs of toxicity found in Monsanto’s 90-day studies were found to develop into organ damage, cancer, and premature death in Séralini’s two-year study. Long-term tests on GM foods are not required by regulators anywhere in the world. GM foods have been found to have toxic effects on laboratory and farm animals in a number of studies. 
FSG’s position is as Prof. Séralini commented, “We are forced to conclude that the decision to withdraw our paper was based on unscientific double standards applied by the editor. These double standards can only be explained by pressure from the GMO and agrochemical industry to force acceptance of GMOs and Roundup. The most flagrant illustration is the appointment of Richard Goodman, a former Monsanto employee, onto the FCT editorial board, soon after the publication of the NK603 study. Worse, this pro-industry bias also affects regulatory authorities, such as EFSA (European Food Safety Authority), which gives favourable opinions on risky products based on mediocre studies commissioned by the companies wishing to commercialize the products, as well as systematically dismissing the findings of independent scientists which cast doubt on their safety.”
It is a bit too early for the FDA to declare that “labeling approved GM derived food, feed and ingredients is not a health and safety issue.” Is it not the same “pro-industry bias” that is also “affecting” the regulatory authority here in Ghana? The application of unscientific double standards to data on products that have entered our food supply puts public health at risk and throws into question the quality of scientific processes and independence of the FDA from corporate influence and bias. 
The Consumer’s Right To Know Versus Biotechnology Promotion
The paper also notes that, “The Food and Drugs Authority and the Ghana Standards Authority through their product registration and certification schemes respectively enforce mandatory food labeling legislations in Ghana. Current labeling legislations are the Ghana Standards Board (Food, Drugs and Other Goods) General Labelling Rules, 1992, LI 1541, and GS 46: 2004 Food Technology: Labelling of Pre-Packaged Foods. These legislations have no provisions on labeling of GM food. The lack of international consensus has stalled the process at Codex, and till date no Codex guidelines on labelling GM food. Ghana may therefore need to develop guidelines for GM food labeling following a decision on labelling of same.”
This is most interesting, given that in his ruling on our case, Food Sovereignty Ghana & 3 ors Vs National Biosafety Committee & 4 ors, the judge, His Lordship Sir Justice Denis Agyei, stated: “The law is that GMOs should be differentiated from organic or natural cause, and should be labelled to enable consumers know the products to take an informed decision».  Ruling On GMO Case: Food Sovereignty Ghana & 3 ors Vs National Biosafety Committee & 4 ors, Suit No. HRCM 43/15 29th Oct. 2015.
FSG is dismayed at the thought that the FDA appears to be abdicating from its primary responsibility to “ensure adequate and effective standards for food, drugs, cosmetics, household chemicals and medical devices” to dabble in the promotion of biotechnology. The section of the FDA paper dealing with Development of Bioeconomy, Competitive Edge for Indigenous Research & Technology Over Multinational Companies, states:
“To foster the development of Ghana’s Bioeconomy, it is essential that discussions focus on impact of proposals on indigenous research and technology companies, creating opportunity and protecting these enterprises to give them a competitive edge over large multinational companies locally and internationally.”
There is no reason why a Government policy should influence the favourable determination of the risks associated with the voluntary labelling of GMOs. As observed above, in North America, a major producer and consumer of GM crops, it is scientifically impossible to trace, let alone study, patterns of consumption and their impacts, as GM foods are not labelled. This is a situation Ghana must avoid at all costs. We need to be in a position to know what the long-term effect of GM consumption looks like, health-wise. This requires validation before the promotion of any government policy in the direction of promoting GM foods.
Besides, FSG sees the policy of promoting biotechnology in agriculture as misguided and short-sighted as there is overwhelming consensus of opinion by International Agencies & The IAASTD Report: the UN, FAO, WWI (World Watch Institute), the UNCTAD etc, pointing to the contrary that the solution to food and nutritional security is through agro-ecological sustainable models of agriculture, and confirm the findings of the IAASTD Report, (The International Assessment of Agricultural Knowledge, Science and Technology for Development, 2008).The IAASTD, to which Ghana is a signatory, is 4 year study commissioned by the UN and the World Bank, by over 400 scientists, and agriculture’s equivalent to the IPCC Report on Climate Change. It came to the conclusion that agricultural goals are not well served through the western innovation model. It delivers the message that simple solutions for complex problems – as they are being proposed with GMOs as the solutions to production problems of today and climate change impacts of tomorrow – are not credible (H Herren, Co-chair of the IAASTD53).The IAASTD makes it clear that the road map for agriculture for the next 50 years must be through localised solutions, combining scientific research with traditional knowledge in partnership with farmers and consumers. The Report calls for a systematic redirection of investment, funding, research and policy focus toward these alternative technologies, infrastructure like roads and food storage, and the needs of small-farmers. Food security will follow not only from producing more food, but how we produce and consume it (IAASTD, 2009c).
Why should Ghanaians sacrifice the right to know what is in their own food in the name of the promotion of biotechnology that we so clearly do not even need?
Furthermore, the WHO paper on GMO foods, “Frequently asked questions on genetically modified foods”, section 8 reads:
“Are GM foods safe? Different GM organisms include different genes inserted in different ways. This means that individual GM foods and their safety should be assessed on a case by case basis and that it is not possible to make general statements on the safety of all GM foods. GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health. In addition, no effects on human health have been shown as a result of consumption of such foods by the general population in the countries where they have been approved. Continuous application of safety assessments based on the Codex Alimentarius principles and, where appropriate, adequate post-market monitoring, should form the basis for ensuring the safety of GM foods.” 
Has the FDA any intention to ever conduct “post-market monitoring of GM foods” as recommended by the FAO as a good biosafety practice? Is so how is such “monitoring” going to be made if GM foods are not labelled?
The FDA’s General Labelling Rules, 1992, (L. I. 1514) stipulate that food labelling be informative and accurate. Labelling of packaged and prepackaged products is for purposes of health, food safety and need to know. The minimum labelling requirements are that labelling should be clear, concise and in English. There is a need to know if the food or feed contains GMOs. Traceability and culpability leads to responsibility, responsibility leads to safety.
We expect the FDA to support the food sovereignty movements challenging the imposition of GMOs into our food chain without any labelling, traceability, legal liability, nor responsibility. A biosafety regime must ensure that those who vouch for safety and benefit financially from harmful products are punished, and their victims compensated. A system without labelling, is a system without traceability. A system without traceability is a recipe for disaster. It implies a built-in protection for fraud, physical harm, and environmental degradation with impunity. This is what voluntary labelling implies. It makes no sense for the FDA to be seen to be supporting this.
A clear example of this impunity is the case of the release of unlabelled GM Salmon into the market in recent months. Approximately five tonnes of GM salmon has been sold in Canada at a market price of US$5.30 per pound, by the US-based AquaBounty Technologies, whose hybrid Atlantic salmon – which contains a gene from a Chinook salmon and a promoter sequence from the ocean pout, without informing consumers. 
In 2015, AquaBounty salmon was approved in the US by the Food and Drug Administration (FDA). Two months later, however, the FDA issued a ban on the import and sale of GM fish until clear labelling guidelines were established. The company did not disclose where the GM salmon fillets were sold or for what purpose. This is not something that should be tolerated in Ghana, even if according to the FAO, “GM foods currently available on the international market have passed safety assessments and are not likely to present risks for human health”. What about the “post-market monitoring of GM foods”?
So far as there is money to be gained without any legal consequences, the last thing a voluntary labelling can promote will be biosafety. Public awareness and participation in decision making regarding biosafety is the best biosafety practice. In that respect, a mandatory labelling of GMOs, is an important first step. The promotion of public safety, rather than biotechnology or “Ghana’s Bioeconomy”, ought to be the primary focus of the FDA. Our food laws must be fair and just rather than unwittingly promoting impunity in the pursuit of a misguided government policy.
A mandatory labelling of GM foods and feeds is absolutely indispensable.
 Ban All GM Foods In Ghana! | Food Sovereignty Ghana, May 20, 2014 http://foodsovereigntyghana.org/ban-all-gm-foods-in-ghana/
 FDA DISCUSSION PAPER ON LABELLING OF GM FOODS | Food and Drugs Administration – Ghana _final draft.pdf: http://foodsovereigntyghana.org/discussion-paper-on-labelling-of-gm-foods/
 GMO Seralini – USA: Food and Drug Administration (FDA) http://www.gmoseralini.org/fda/
 No scientific consensus on GMO safety http://www.ensser.org/increasing-public-information/no-scientific-consensus-on-gmo-safety/
 No scientific consensus on GMO safety http://www.ensser.org/increasing-public-information/no-scientific-consensus-on-gmo-safety/
 Republished study: long-term toxicity of a Roundup herbicide and a Roundup-tolerant genetically modified maize | Environmental Sciences Europe | Full Text https://enveurope.springeropen.com/articles/10.1186/s12302-014-0014-5.
 Did journal editor read the Séralini paper before retracting it? http://www.gmwatch.org/en/news/archive/2013/15215-did-journal-editor-read-the-seralini-paper-before-retracting-it
 Retraction Watch at Retraction Watch: http://retractionwatch.com/2017/08/10/unearthed-docs-monsanto-connected-campaign-retract-gmo-paper/
 Secret Docs’ Show Monsanto’s Attempt to Influence Writers, Bribe Scientists http://ow.ly/J3Qv30e94X9
 The Séralini affair – or the secret history of a torpedo http://gmwatch.org/en/news/latest-news/17908
 GMO Seralini – Ten things you need to know about the Séralini study: https://www.gmoseralini.org/ten-things-you-need-to-know-about-the-seralini-study/
 How EFSA dealt with French GM study: which lessons? EFSA and Séralini.pdf https://corporateeurope.org/sites/default/files/attachments/EFSA%20and%20S%C3%A9ralini.pdf
 Ruling On GMO Case: Food Sovereignty Ghana & 3 ors Vs National Biosafety Committee & 4 ors, Suit No. HRCM 43/15 29th Oct. 2015.
 WHO | Frequently asked questions on genetically modified foods http://www.who.int/foodsafety/areas_work/food-technology/faq-genetically-modified-food/en/
 GM salmon hits shelves in Canada – but people may not know they’re buying it | World news | The Guardian https://www.theguardian.com/world/2017/aug/09/genetically-modified-salmon-sales-canada-aqua-bounty