Wednesday 14 April 2021

Labelling of GM Foods: Consumers’ Legal Right vs. Technological Limitation

Labelling of GM Foods:

Consumers’ Legal Right vs. Technological Limitation

What should India do to address this techno-legal challenge?

When organic and sustainable certification is mandatory and desirable, similarly GMO certification should be considered.

By:

Vijay SARDANA

PGDM (IIM, Ahmedabad), LLB, M.Sc. (Food Tech) (CFTRI), 

B.Sc. (Dairy Tech), PGD in Arbitration, Intl. Trade Laws & Alt. Dispute Resolution,

IPR (WIPO), Justice (Harvard)

Advocate, Delhi High Court

Expert of Techno-legal Matters

Independent Director on Corporate Boards

India is importing a large number of food items and consumers are consuming them without knowing what they are eating. Consumers have a right to know how food is produced. Many consumers are now very sensitive hence there are many social movements towards the environment, animal welfare, GMO, vegan, organic production, responsible fishing,  water footprint, etc

“Right to Know” is Fundamental Right as well as Commercial Right

GM food labelling is one such interesting area for techno-legal analysis. Consumers have the right to know how food is produced and delivered to them because their actions can impact various dimensions of society, the environment. Consumers want to make an informed decision and do not want to be a party to any process and decisions that are not in line with their beliefs and ethics.

We should keep in mind it is a very complex issue because stakes are very high for all stakeholders. This issue has many interlinked dimensions. Approval of GM technology used in the food system in India will have serious implications on law, society, religion, ethics, environment, technology, politics and economy. It is a more complicated issue in a complex society like India where there are so many religious and emotional issues related to plant and animal life. In a society where plants and animals are worshipped, the identity preservation of the living objects matters.

Why is GM labelling crucial?

The way genetic technology is advancing, it is possible that genes of one species can be administered into another species. It is also possible to inject genes of animals and insects into fruits and vegetables to improve a particular trait. Example: genes from pig if introduced into tomatoes to improve the shelf-life and hardness of the tomato skin of the tomatoes to minimize transport damages., or fish genes into some other crop, etc. to improve keeping quality or vitamin content in the product. 

  • Now the issue is how the consumer will react?

  • Is animal genes in plant crops acceptable to vegan society?

  • Should devotees offer such products in temples, where devotees don’t even consume root vegetables like onions, potatoes and garlic?

  • What should be the labelling on such foods to ensure product integrity?

Law should facilitate an informed decision:

When the situation is complex, the simple and effective approach is to increase transparency in decision making at all levels. So that people make an informed choice. People may want to know what they are eating. When it comes to food, ultimately, it is the consumer who has to take a final call to eat or not to eat. 

 

Consumers have the right to know and WTO:

On July 5, 2011, More than 100 countries agreed on long-overdue guidance on the labelling of genetically modified (GM) food. The Codex Alimentarius Commission of the UN, made up of the world’s food safety regulatory agencies, has been labouring for two decades to come up with consensus guidance. In a striking reversal of their previous position during the annual Codex summit in Geneva, the US delegation dropped its opposition to the GM labelling guidance document, allowing it to move forward and become an official Codex text. The new Codex agreement means that any country wishing to adopt GM food labelling will no longer face the threat of a legal challenge from the World Trade Organization (WTO). This is because national measures based on Codex guidance or standards cannot be challenged as a barrier to trade. This will have immediate implications for consumers.

Labelling of GM foods

All food products, whether organic or non-organic, must comply with the labelling rules. These Consumer protection ACt and FSSAi Act must ensure that labels be:

  • truthful

  • not deceptive

  • not misleading

  • not an untrue impression of the foods:

    • merit

    • safety

    • quality

Besides, special labelling is required for all foods, including GM foods, where there are health and safety concerns such as:

  • the potential to cause allergic reactions

  • changes to the composition of the food

  • changes to the nutritional quality of the food

Such labelling is required to alert consumers or susceptible groups in the population.

Types of GM Labelling in various countries

The regulatory approaches on GM food labelling vary in different countries and areas. This can be broadly classified as voluntary or mandatory.

Voluntary labelling approach:

For the voluntary labelling approach, only GM food that is significantly different from its conventional counterpart, in terms of composition, nutritional value and allergenicity, needs to be labelled.

Mandatory labelling approach:

For the mandatory labelling approach, it can be further classified into two categories, i.e. "pan-labelling" or "labelling for designated products only". The "pan-labelling" category requires that any food products, which contain GM materials exceeding a threshold level or have any significantly different characteristics as a result of genetic modification, must be labelled. 

The "labelling for designated products only" category requires that only the designated products, which are genetically modified, need to be labelled.

Pros and Cons of Major Labelling Approaches

  1. Voluntary Labelling Approach

    1. Pros

      1. Appropriate labels on GM foods that are significantly different from their conventional counterparts help to alert consumers of their differences in terms of allergenicity, nutrition and toxicity. Therefore, this labelling approach addresses the basic concerns of most consumers and hence safeguards public health against any potential risks.

      2. This approach imposes fewer barriers and constitutes fewer trade implications. It is adopted by some GM crops producers and also our important trading partners.

      3. Many importing countries or buyers may protest against labelling requirements (e.g. pan-labelling of all GM foods) that are more stringent than the labelling of GM food with significantly different characteristics as an unnecessary barrier to international trade.

      4. This labelling approach would not significantly affect the cost of food production.

    2. Cons

      1. Consumers would not know whether the food contains any GM materials. This labelling approach hence limits their rights to "informed choices". 

      2. Many consumers would like to make their choices not only based on food safety grounds but also taking environmental, social or ethical issues into consideration.

2. Mandatory Labelling Approach

  1. "Pan-labelling"

  1. Pros

    1. Labelling of all GM foods enables consumers to know whether the food contains any GM materials at all and hence make informed choices.

    2. It helps to enhance surveillance and tracing on GM food.

  2. Cons

    1. Additional costs to the trade would be incurred.

    2. These costs would either be absorbed by the trade or passed on to the consumers and hence the extent of any price changes due to labelling GM food is uncertain. 

    3. Additional costs of labelling GM food may arise from traceability requirements.:

    4. Without labelling law, GM crops/foods and non-GM crops/foods are often mixed together during harvesting, storage or processing. It would be necessary to establish a system to segregate these crops along the food supply chain, especially when the trade would like to source for non-GM food products. Hence additional cost would be incurred to establish and maintain segregation systems. 

    5. The detection and identification of GM foods, which require sophisticated laboratory tests, might also incur additional cost.

3. "Labelling for designated products only"

  1. Pros

    1. Labelling for designated food products enables consumers to know whether the designated food items contain any GM materials and hence make informed choices.

    2. Moreover, this labelling requirement is possible to be enforced.

  2. Cons

    1. It might not address the need of consumers who would like to know whether the non-designated food items contain any GM materials or not.

    2. Additional costs might be added to the designated food items.

Challenge is GM Foods supply chains:

The requirement to label all GM foods is not easy to enforce because:

  • The Codex Committee on Methods of Analysis and Sampling under Codex Alimentarius Commission is still working towards the harmonisation of testing methods for GM food. Besides, not all GM food products are readily identifiable by end-product analysis.

  • Adventitious mixing of GM and non-GM crops may occur during processing and storage, hence the establishment of a threshold level may be necessary to determine whether the batch of the food product is GM or not. 

  • There is no international consensus on the threshold level for GM food labelling.

Issues to be considered in Setting-up a Labelling System:

Different labelling approaches have their merits and shortcomings. Issues to be considered in setting up a practical and balanced labelling system include:

1. Limitation of Detection Methods

Difficulties in the detection of GM materials include:-

  • At present, there is no international consensus on analytical methods for the detection of GM food.

  • Not all GM food products can be identified by end-product analysis.

  • Detection methods for highly processed foods e.g. soy lecithin are less sensitive and reliable when compared with raw or lightly processed foods, e.g. tofu (soy).

  • For highly refined food items such as oil and sugar, it is impossible to detect the presence of any GM materials.

  • There is no single test that can be used to detect all types of GM materials.

2. Present Practices of the Food Supply Chain

  • Since GM and non-GM crops are often mixed together during harvest, transportation, processing and storage, it is difficult to determine the GM status of the respective crops/foods.

  • A system to segregate GM and non-GM products at various stages of processing along the food supply chain need to be set up and maintained.

3. Costs of Compliance

  • The costs of compliance with GM food labelling requirements will either be absorbed by the trade or passed on to the consumers and hence the extent of any price changes due to labelling of GM food is uncertain in the short run.

4. International Practices

  • The Codex Alimentarius Commission, the authority for setting food-related standards under the United Nations, considers that governments of different places may make their own decisions on whether or not to label GMO food

International Practices on GM Food Labelling in various countries

100 plus countries in Codex meetings have agreed that GM labelling is important and should be done.

The Codex Alimentarius Commission (Codex) considers that governments of different places may make their own decisions on whether or not to label GMO food. The emphasises that labelling arrangements should be in conformity with the provisions promulgated by the Codex to avoid potential trade issues. At present, policies on GM food labelling vary in different countries and areas:

Canada and the United States

Labelling of GM foods is only required when the food is significantly different from its conventional counterpart in terms of composition, nutrition and allergenicity. However, the trade may label other GM foods voluntarily. In Canada, a set of guidelines for voluntary labelling of GM foods was issued in April 2004. While, in the United States, public consultation on draft guidelines for voluntary labelling has been finished but finalisation of the guidelines is still pending.

Member countries from the European Union: 

All GM foods have had to be labelled in countries of the European Union since 1998. This policy was amended by the European Commission in November 2003. The new requirement stipulates that all foods produced from Genetically Modified Organisms (GMOs) should be labelled, irrespective of whether the DNA or protein of GM origin is detectable in the final product. Moreover, conventional foods with the adventitious presence of GM materials of higher than 0.9% should also be labelled.

Australia and New Zealand

The Australian and New Zealand authorities decided that all food products produced or imported had to be labelled starting from 7 December 2001 when any of their ingredients contain more than 1% GM material. Additional labelling was also required for GM food ingredients with significantly altered characteristics. 

Highly refined foods, processing aids or food additives with the absence of GM materials, flavours in a concentration no more than 1g/kg in the final food, as well as foods prepared at point of sale are exempted from the GM food labelling requirement.

Japan

The Japanese authorities have required designated agricultural products and processed food items containing GM materials to be labelled. For the processed food items, those ingredients containing GM materials that are ranked within the top three constituents in terms of weight and the weight ratio of which account for five per cent or more of the total weight have to be labelled. Labelling is not required for oil and sauce, where the original GM materials can no longer be detected.

Republic of Korea

The Korean authority requires that all approved genetically modified agricultural products (including bean sprout originated from approved beans and other sprouts), which contain more than 3% GM materials have to be labelled. Besides, processed foods that contained these approved GM products as one of the top five ingredients were required to be labelled.

Taiwan

In Taiwan, mandatory labelling of designated foods has been implemented in three phases according to the degree of processing of the food products, and the last phase has come into effect from January 2005. Under the labelling requirement, foods containing ingredients of GM soya bean or corn which is more than 5% of the total weight of the finished product have to be labelled. Moreover, soya bean or corn, which is adventitiously or accidentally mixed with not more than 5% of GM varieties during harvest, storage, transportation or other reasonable causes, is regarded as "non-GM". Food products made of non-GM soya bean or corn may be labelled as "non-GMO" or "not-GM".

Mainland China 

The Ministry of Agriculture enacted a regulation "Implementation Regulations on Labelling of Agricultural Genetically Modified Organisms" which was effective on 20 March 2002. Under the regulation, five categories of GM crops including soya bean, corn, cotton, rapeseed and tomato, as well as some of their products are required to be labelled. On the other hand, the Ministry of Health enacted a regulation, "Measures for the Administration of Novel Foods", on GM food in December 2007. This regulation stipulated that all GM foods should be properly labelled.

Other places in Asia

Some other Asian countries such as Thailand and the Philippines have also set up regulations on GM food labelling.

What Indian policymakers should do?

GM food is an interesting area for techno-legal analysis. We should keep in mind it is a very complex issue because stakes are very high for all stakeholders. This issue has many interlinked dimensions. Approval of GM technology used in the food system in India will have serious implications on law, society, religion, ethics, environment, technology, politics and economy. It is a more complicated issue in a complex society like India where there are so many religious and emotional issues related to plant and animal life. In a society where plants and animals are worshipped, the identity preservation of the living objects matters.

Traceability from GM seed to retailing is a must:

Codex Alimentarius Commission (“Codex”) adopted guidelines allowing the labelling of genetically modified (“GM”) food products. Clearly, the GM Guidelines suggest that countries may implement one of the many different approaches regarding the labelling of GM food products, provided that they are consistent with already adopted Codex provisions.

In order to ensure the integrity of organic foods, there is an application of traceability systems, similar concepts should be mandatory for GM crops as well. Food safety laws around the world are moving towards making traceability and identity preservation mandatory. 

With the advancement of information technologies like blockchain, barcoding and QR codes, GPS, etc, it is easy to ensure traceability. Law should ensure labelling with suitable technology support to avoid any controversy and social and political implications. 

Simple & Cost-Effective Approach countries can adopt:

In the case of imported foods, the authorities of exporting country in the Country of Origin certificate must mention, whether the product contains GMO or not, as per the norms prescribed by the importing country government like exporters do when they export organic foods or products with sustainability certification to any country. Similarly, in this case, the exporter will follow the guidelines of the importing country, as it is happening in other products. This will reduce the requirement of testing in the country by Indian authorities. In a world where we emphasise democracy and the right to information, this is in line with the same principles.

In my view, it is useful to go for mandatory labelling to avoid any controversy in a complex society like India. Why policymakers avoid regulatory arbitrage in one form or the other. Let the consumer decide what they want to eat. The consumer should have the right to know. 

Consumers ‘ right to know should be respected. After all, it is their health, their beliefs, their own sentiments and their money which they are sending. They must know what they are eating and serving.


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Monday 29 March 2021

Proposed Pesticide Management Bill and Future of Agrochemicals

 “Legal Insights by Adv. Vijay SARDANA”


Proposed Pesticide Management Bill and Future of Agrochemicals


By:

Vijay SARDANA

PGDM (IIM, Ahmedabad), LLB, M.Sc. (Food Tech) (CFTRI), 

B.Sc. (Dairy Tech), PGD in Arbitration, Intl. Trade Laws & Alt. Dispute Resolution,

IPR (WIPO), Justice (Harvard)

Advocate, Delhi High Court

Expert of Techno-legal Matters

Independent Director on Corporate Boards


Indian Agriculture is passing through a turbulent phase due to internal and external factors. The world agriculture and food market is changing, technologies are changing, expectations of stakeholders are changing. The government of India is reviewing many of its agriculture-related policies including agri-input related policies and laws. In this article, the author will discuss the views related to agro-chemicals, also known as pesticides. 


Pesticide Management Bill and Future of Pesticides :

Before I discuss the dimensions of the new proposed law and subordinate legislation, it will be useful to have a detailed insight and information about the future of Agro-chemical use in India and global agriculture. The way the impact of climate change is predicted on food security, we should study the impact of this on various biological systems like seeds, insects behaviour etc. The role of agro-chemicals will remain crucial and may need a serious evaluation of various parameters to attract investments and technologies to address emerging issues.

The following points need serious consideration before we create a new regulatory system for agrochemicals in India.

  • We should Identify and evaluate the circumstances under which chemical pesticides may be required in future for pest management. 

  • It will be useful to determine what types of chemical products are the most appropriate for ecologically based pest management. 

  • It will also be useful to explore the most promising opportunities to increase the benefits of agrochemicals and at the same time reduce the health and environmental risks of pesticide use. 

  • What should be the role of the public sector and private sector in governance and supply of agro-chemicals like in research, product development, product testing and registration, implementation of pesticide use strategies, and public education about pesticides?

Pesticide Application and Food Security :

It is important to appreciate the use of agrochemicals in food security because it encompasses pesticide use in various stages of production systems i.e. processing, storage, and transportation of field crops, fruits, vegetables, ornamentals, fibre, fodder, forest products, livestock, and the products of aquaculture. 

In a wider sense, in modern world agriculture, the pests to be considered should also include weeds, pathogens, and vertebrate and invertebrate organisms that must normally be managed to protect crops, livestock, and urban ecosystems. Restricting the definition only to insects may create a lot of confusion and policy overlaps. 

Under the climate change situation to ensure food security, pesticide research must consider all aspects of pest control like identification of pest behaviour in the changing ecosystem, changing pest biochemistry and physiology, resistance management, impacts of pesticides on economic systems, and other relevant issues. The proposed law should encourage work and trials in these areas as well. 

A critical early challenge was to define the expected challenge and changes required. 

The policymakers should define the future of food security and agriculture in India or the next 10 and 20 years i.e. 2040 AD.  Beyond 15 to 20 years, it is difficult to predict technological innovations in a fast-changing world and their effects. For example, the invention of many pesticides and their spread and then identification of side effects and proposed restrictions for use is a classic example of how things change on the ground with emerging data and evidence. Similarly, we can see the changes in transgenic crops and their implication on climate and other ecological issues. A 20-year span is also sufficient to study the adverse unexpected effects of technology on the ground. Another example is the development and promotion of chlorinated hydrocarbons, widespread use beginning in the early 1950s culminated in regulatory restrictions in the early 1970s 

What is a pesticide?

The existing law is the Insecticide Act, the new proposed law is the Pesticide Management Bill. The term pesticide required a more precise definition and a more clear understanding. This will have a serious impact on the approval of the products, implementation of the proposed law and related subordinate regulations. Any inconsistency with biological definitions of pesticides will also become a serious loophole in the registration process. The definition of pesticide also has social aspects; public perceptions, safety considerations,  toxicity and colour related policy need detailed discussions before decisions.


Regulatory Challenges in Pesticide Registration:

According to the author, it is important to have a strict legal definition, but also including microbial pesticides, plant metabolites, and agents used in veterinary medicine to control insects, parasites and nematode pests in the livestock sector as well.

To identify circumstances in which chemical pesticides will continue to be needed in pest management will also need an assessment of the full range of agricultural pests and of the composition and deployment of chemical pesticides to control pests in various environments. It is also an impossible task to predict all scenarios because of the large volume of data and the number of analyses required to generate a credible understanding of all pesticides and their efficacy and uses. This can be ensured by making a clear and transparent registration process and also the re-evaluation process.

The potential effects of pesticides on productivity, the environment, and human health is a matter of social and political debate. The uses and potential effects of chemical pesticides and alternatives to improve pest management vary considerably among ecosystems. The proposed law should also have the potential to reduce overall risks by improving the adoption of Integrated Pest Management (IPM) approaches that optimise and minimizes the use of chemicals under diverse conditions of soils, crops, climates, and farm-management practices. 

Overall, chemical pesticides will continue to play a role in pest management for the foreseeable future, in part because the environmental compatibility of products is increasing — particularly with the growing proportion of reduced-risk pesticides being registered with the regulatory authorities. There is also a growing option of competition from safer alternatives. In many situations, the benefits of pesticide use are high relative to risks because there are no practical alternatives.

What should be the priority for Pesticide Management Regulations in India?

To determine the types of chemical products that are most appropriate for ecologically based pest management, the regulation should consider societal concerns, scientific advances, and regulatory pressures. The internal and external pressure will continue to drive some of the more hazardous products in the marketplace. With growing public pressure and scientific advances, synthetic organic insecticides traditionally associated with broad nontarget effects, potentially hazardous residues, and with exposure risks to applicators are expected to occupy a decreasing market share. Many products registered in the last few years have safer properties and smaller environmental impacts than older synthetic organic pesticides. This trend will put pressure on the regulatory changes that restricted the use of older chemicals and the technological changes will lead to competitive alternative products. 

Role of Innovations in Agrochemicals

The novel chemistry and new chemical products will have a very different genesis from traditional synthetic organic insecticides; the number and diversity of biological sources will increase, and products that originate in chemistry laboratories will be designed with particular target sites or modes of action in mind. Innovations in pesticide delivery systems (notably, in plants) promise to reduce adverse environmental impacts even further but are not expected to eliminate them. 

Innovative products may also have limitations

Many new products may also share many of the problems that have been presented by traditional synthetic organic insecticides. For example, there is no evidence that any of the new chemical and biotechnology products are completely free of the classic problems of resistance acquisition, nontarget effects, and residue exposure. 

New Tools of Pest Management in future

The role of Artificial intelligence in crop management, genetically engineered organisms, precision technology, drone-based monitoring, etc will reduce pest pressure and this may constitute a “new generation” of pest-management tools.

The experience says that genetically engineered crops that express a controlled chemical can exert a strong selection for resistance in pests. Similarly, genetically engineered crops that depend upon the concomitant use of a single chemical pesticide with a mode of action similar to that of the transgenically expressed trait could increase the development of pest resistance to the chemical. The serious debate on the adverse environmental impacts of many technologies is under serious considerations.

New Regulations may face bigger and complex challenges:

The multiple approaches and multiple modes of action to have effective mechanisms and to minimise side effects is vital, but the interplay between them may add new challenges for policymakers.

It is also fair to assume that the uses of transgenic crops will probably maintain or even increase. This will also emphasize the need for effective resistance management programs, novel genes that protect crops, chemicals with new modes of action and nonpesticide management techniques. 

Pesticides and their impact on Public health will remain a concern

There remains a need for new chemicals that are compatible with ecologically based pest management and also address the issues of applicator and worker safety. Pesticides in the human diet of the various vulnerable sections will remain a concern. The health of the applicator and worker safety will remain a concern for the regulators.

In conclusions:

The proposed Pesticide management Bill was drafted almost 15 years ago and still under discussion. It will be useful if we can have a fresh look at this proposed law and also address the issues which emerged in the last few years before getting approval from Parliament. This will help in making suitable subordinate legislation to address the needs of society will minimize controversies. 

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