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Lithuanian University of Health Sciences Faculty of Medicine

Yonatan Solomon

GMO legislation in The European Union and The United States.

A comparative research by Yonatan Solomon.

Medicine

Rita Raškevičienė, MD PhD Kaunas, Lithuania, 2016

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TABLE OF CONTENTS

01. TABLE OF CONTENTS 2

02. SUMMARY 3

03. ACKNOWLEDGMENTS 4

04. CONFLICTS OF INTEREST 4

05. CLEARANCE ISSUED BY THE ETHICS COMMITTEE 4

06. ABBREVIATIONS 5

07. INTRODUCTION 6

08. AIM AND OBJECTIVES 7

09. LITERATURE REVIEW 8

10. RESEARCH METHODOLOGY AND METHODS 12

11. RESULTS AND THEIR DISCUSSIONS 13

12. CONCLUSIONS 16

13. PRACTICAL RECOMMENDATIONS 16

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SUMMARY

Yonatan Solomon, Gene modified organisms (GMOs) legislation in the European Union (EU) and the United States (US).

Aim and objectives: The aim is to find the main difference in the legislation and opinion on GMOs in the EU and the US. In order to find the main difference in the legislation and opinion on GMOs in the EU and the US, following questions will be addressed:

1. Where do the legislations and policies on GMOs mainly differ?

2. What is the outcome of the EU and US regulatory regimes?

3. What is the public opinion on GMOs?

Methodology: The author is conducting a comparative research with the aim to find the main differences in the legislation and opinion on GMOs in the EU and the US. Public governmental documents, scientific publications and legal reports will be analyzed and compared.

Results: The EU has strict legislations regulating GMOs while the US lack a legislation specific to GMOs. All genetically modified (GM) food products in the EU must go through a process of authorization before introduced to the EU market, while in the US GM food products can get a premarket approval which exempts them from the process of authorization. All GM food products must be labeled in the EU, exemption to the rule is if the product does not exceed the threshold of 0.9 %. In the US there are no labeling requirements unless the product is materially different from conventional food products. The outcome of the EU and US regulatory regimes are that approval of new GM products and cultivation of GMOs are much higher than in the EU. The general public in the EU are more aware of GMOs than in the US. The majority of the people asked in the EU and the US supports labeling of GM foods.

Conclusion: GMOs are less regulated in the US due to lack of specific legislation to it. Premarket approval makes it easier to get GM foods approved in the US. The US nonmandatory labeling rule makes it harder for consumers to make an informed choice, which strongly favors the manufacturer. People in

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ACKNOWLEDGEMENTS

The author would like to give special thanks to Professor Rita Raškevičienė for good support and supervision and fellow student Mohammed Munir for good technical support.

CONFLICT OF INTERESTS

The author reports no conflict of interest.

ETHICS COMMITTEE CLEARANCE

This study did not require any sensitive data/records from patients or students. Thus, permission from bioethics committee was not required.

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ABBREVIATIONS

GMO - Genetically modified organism EU - European Union

US - United States

GM - Genetically modified GE- Genetic engineering

LMO- Living Modified Organisms DNA- Deoxyribonucleic acid

EFSA - European Food Safety Authority EC - European commission

TEFU - Treaty on the functioning of the European Union USDA - United States Department of Agriculture

APHIS - Animal and Plant Health Inspection Service PPA - Plant Protection Act

FDA - Food and Drug Administration

FFDCA - Federal Food, Drug and Cosmetic Act PHSA - Public Health Service Act

EPA - Environmental Policy Act PIP - Plant Incorporated Protectants

FIFRA - Federal Insecticide, Fungicide and Rodenticide Act TSCA - Toxic Substance Control Act

GRASS – Generally regarded as safe

NEPA - National Environmental Policy Act CATEX - Categorical Exclusion

EA - Environmental Assessment

FONSI - Finding of No Significant Impact EIS - Environmental Impact Statement

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INTRODUCTION

Food and feed originating from plants and animals have been bred and cultivated for thousands of years. The animals and plants with the most desirable characteristics were bred and cultivated to create a new generation with more desirable characteristics. These desirable characteristics appeared in a natural way through variation in the genetic makeup. In more recent times, modern biotechnology made it possible to modify living organism's genetic makeup by transferring selected genes from one organism to another. The technique is referred to as genetic engineering (GE) where deoxyribonucleic acid (DNA) is extracted from an organism with desirable trait. The gene of interest is then isolated from the DNA, this is called gene cloning. The cloned gene is mass produced in a host cell and modified in a way that it expresses the trait wished for in a host plant. The modified gene is then introduced into a plant cell by a process called transformation. The most common way of introducing modified genes into a plant cells are by using a gene gun or a bacteria mediated transformation. The plant is concidered transgenic when the introduced gene is stable, inherited and expressed. Finaly the transgenic crop is bred in a way that expressed the desirble trait of the modified gene, this is called backcross breeding.[1] These new plants are referred to as „‟genetically modified organisms‟‟ (GMOs). Some of the desirable properties of GMOs can be increased nutritional value, resistance to insects or herbicides etc. Food and feed that contains or consists of GMOs or are produced from GMOs are called „‟genetically modified (GM) food or feed. [2] GE alters the very building blocks of life by adjusting DNA. Many civilians and scholars are thus concerned over the potential risk of GMOs to human health and the environment. For this reason governments have set regulations in order to establish a legal framework that ensures that the development of GMOs takes place under safe conditions. In the EU the precautionary principle is applied in the regulation of GMOs as potential risks of GMOs are not completely known. [3] EU focuse more on potential risk than benefits and viseversa in the US where same regulation is applied to GM food as to conventional food.[4] When establishing rules and regulations for GMOs, the EU and the US evaluate similar types of scientific data. They often reach the same conclusion regarding the safety of GMOs as scientific studies represent a systematic method of establishing the safety. The main difference seems to lay in how the scientific data is interpreted. [5]

The aim with this thesis is to find the main difference in the legislation and opinion on GMOs in the EU and the US.

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AIM AND OBJECTIVES OF THE THESIS

This thesis aims to find the main difference in the legislation and opinion on GMOs in the EU and the US.

In order to find the main difference in the legislation and opinion on GMOs in the EU and the US, the author will answer the following questions:

1. Where do the legislations and policies on GMOs mainly differ?

2. What is the outcome of the EU and US regulatory regimes?

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LITERATURE REVIEW

GMOs are defined as an organism in which the genetic material has been altered not by the nature. [6] The EU regulates GMOs and GM food or feed in a strict manner where great measures are taken to prevent any unforeseen adverse effects on the environment and to protect human and animal health.[7] The EU is part of the Cartagena Protocol on Biosafety which is an international treaty governing the movement of living modified organisms (LMO). [8] The protocol aims to contribute to safer transfere, handling and use of LMO. Currently 170 nations world wide are parties to the protocol, the US being not one of them. [9] The US have a different approach to GMOs. As they have not yet been proven to be harmful to humans, animals or the environment, a more liberal approach have been taken to GMOs. In fact, the US lack a federal legislation specific to GMOs. They are instead regulated by the same legislation that governs food developed through conventional processes. The focus is on the product rather than the process of making it. [10]

Structure of the legal framework in the EU

This is the cornerstones of the legal framework of GMOs in the EU.

- Directive 2001/18/EC on the deliberate release of GMOs into the environment. [11] - Regulation (EC) 1829/2003 on genetically modified food and feed. [12]

- Directive (EU) 2015/412 amending Directive 2001/18/EC as regards the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory. [13]

- Regulation (EC) 1830/2003 concerning the traceability and labeling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms. [14]

- Directive 2009/41/EC on contained use of genetically modified micro-organisms. - Regulation (EC) 1946/2003 on transboundary movements of GMOs. [15]

On behalf of the member states, the legislations act as a legal framework ensuring the development of GMO‟s in safest possible way. Safety assessment are introduced to protect human and animal health and the environment and to create harmonized procedures for risk assessment and authorization of GMOs.[16] The legislations also makes sure that all GMO products on the market are traceable and clearly labeled in order to makes it easier for consumers to make a conscious choice.[17]

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Authorization of GMOs in the EU

All import and marketing of GMOs and GM food or feed are regulated at an EU level while cultivation is managed on a national level.[18] Before GMOs and GM food or feed are introduced to the European market a premarket approval must be conducted by the independent committee, European Food Safety Authority (EFSA). Within a period of two weeks a competent authority in the member state of the applicant notifies EFSA. EFSA has six months to assess the application. This is a centralized process in which EFSA conducts a scientific risk assessment. [19]

Risk assessment and risk management of GMOs in the EU

EFSA is the risk assessor, evaluating risks associated with the food chain. EFSA doesn‟t have scientific laboratories, nor does it generate new scientific research. It collects and analyses existing research and data and provides scientific advice to support decision-making by risk managers.

Risk managers are the European Commission (EC), Member State authorities and the European Parliament. They are responsible for making decisions or setting legislation about food safety. [20] One of the general principles of the Cartagena Protocol on Biosafety is that lack of scientific knowledge or consensus should not be interpreted as an absence of risk or an acceptable risk. [21] It also requires parties to the protocol to take necessary measures to prevent adverse effects and for managing and controlling risks identified by risk assessments. [22]

Labeling and traceability of GMOs in the EU

The European Union sets out a framework for guaranteeing the traceability of GMOs throughout the food chain at all stages of production. [23] Labeling requirements apply to foods delivered to the final consumers or mass caterers in the EU that either contain or consist of GMOs, or are produced from or contain ingredients produced from GMOs. Regulation No. 1829/2003 requires that the phrase “genetically modified” or “produced from genetically modified must appear clearly next to the ingredient list. [24] In the case of non packaged food, the same labeling must appear on the food display or next to it. Only traces of GMOs may be exempt from this obligation if they do not exceed the threshold of 0.9 % and if their presence is adventitious and technically unavoidable. This safety net will facilitate the monitoring of

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It also gives the consumers the freedom to choose. The right of consumers to information is recognized in article 169 of the Treaty on the functioning of the European Union (TFEU). Based on this article, the EU is obliged to promote this right in legislation affecting consumers. [25]

Public opinion of GMOs in the EU

The EC requested a report to evaluate the effectiveness of the legal framework on GMOs in EU. The report concluded that protection of human, animal‟s health through the use of science based risk assessment were sufficient and that there were no cases of animal or human health issues inflicted from GMOs to date. Both farmers and retailers were satisfied with the labeling rules and nongovernmental and consumer organizations were in favor of the rules which allow the general public to make an informed choice. [26]

Structure of the legal framework of GMOs in the US

There is no federal legislation specifically addressing GMOs in the United States. GMOs are regulated under the Coordinated Framework for Regulation of Biotechnology. Conventional food and GM food or feed are regulated the same, as the focus is on the final product rather than the process of making.[27] The coordinated framework for regulation of biotechnology sets the basic approach to the regulation of GMOs in the US. The coordinated framework was put together by an interagency group formed 1984 to address whether or not the regulation on conventional products was sufficient enough for GMOs. It was concluded that the existing laws supplemented with new regulations were adequate to address the needs. [28] GMOs are regulated by three agencies:

Animal and Plant Health Inspection Service (APHIS) under the Plant Protection Act (PPA). [29]

Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FFDCA) and the Public Health Service Act (PHSA). [30]

The environmental policy act (EPA) regulates pesticides [31] and microorganisms developed through genetic engineering. [32]

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Authorization of GMOs in the US

Regulation of GM foods in the US is enacted by multiple agencies. Although manufacturers submit different types of data to each agency, common principles unite the various regulatory processes. APHIS grants authorization to use GM plants through a notification process, a permitting process or a determination of non-regulated status.[33] EPA regulates pesticides and plant incorporated protectants (PIPs) under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA).[34] The Toxic Substances Control Act (TSCA) authorizes the EPA to regulate chemical substances that may present an unreasonable risk of injury to health or the environment.[35] The FDA treats food derived from GMOs as Generally Regarded as Safe (GRAS) in most cases. When regarded as GRAS premarket approval is not necessary, the product is thus exempted from the regulatory processes. [36]

Risk assessment and risk management of GMOs in the US

There are three levels of environmental review under the National Environmental Policy Act (NEPA). [37] [38]

1. Categorical exclusion determination (CATEX) - If a federal action does not have a significant impact on human environment it may be excluded from a detailed environmental analysis

2. Environmental Assessment/Finding of No Significant Impact (EA/FONSI) - If CATEX does not apply to a federal action, an Environmental Assessment (EA) have to be prepared to assess risk of a potential significant environmental effect.

3. Environmental Impact Statements (EIS) - In case of an increased impact risk, an EIS have to be prepared. EIS are more rigorously regulated than an EA.

Labeling and traceability of GMOs in the US

There is no law in the US requiring GMO food or feed to be labeled indicating that it contains GMOs. The US House of Representatives passed a debated measure blocking any mandatory labeling of GM foods or feed.[39] The FDA have stated that if a GM food product is not materially different from its conventional counterpart, there is no obligation to label or change the name of the product.[40]

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Public opinion on GMOs in the US

Several organizations such as the American Association for the Advancement of Science (AAAS) in the US have issued scientific studies regarding the safety of GMOs.[41] There have been no evidence reported indicating that GMOs might be more harmful than conventional products. Several legal academics have criticized the US regulations on GMOs. Many of them referring to the ethical impact of GMOs and how the current regulations on labeling and monitoring GM products hinder consumers from making a conscious choice. [42] In this recent poll executed in the US, 89% of the voters were in favor of mandatory labeling of food which have been GM or that contains ingredients that have been GM. [43]

RESEARCH METHODOLOGY AND METHODS

The author is conducting a comparative research with the aim of find the main differences in the legislations and opinion on GMOs in the EU and the US. The data for this report were gathered through public governmental documents, legal reports, journals and scientific publications. Once the regulatory framework for GMOs in the EU and the US were established, the key regulatory bodies and other agencies involved in the governance of GMOs were identified. To further understand the politics around GMO governance, existing policies that were relevant to the regulations were reviewed.

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RESULTS AND THEIR DISCUSSION

Legal framework of GMOs

Governments have set regulations in order to establish a legal framework that ensures the development of GMOs takes place under safe conditions. The US have a completely different take on GMOs where the same regulations are applied to GM and conventional foods as there is yet no scientific data proving GMOs to be harmful. The US does not have regulations specific to GMOs. [44] EU has a set of directives and regulations specific to GMOs. [45]

Process of authorization of GMOs

The same type of data is evaluated in the EU and the US when food GM food companies are seeking for approval of their products. Three separate agencies in the US evaluate the potential risks of GM foods, while a centralized approval process is established in the EU (see Fig 1). [46] Approval and labeling requirements are much stricter in the EU. In the US a lot of the products are exempted from the regulatory process of GMOs and labeling is not mandatory.

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Risk assessment and risk management of GMOs

The EU‟s legislation and policy on GMOs are based on the precautionary principle which is designed to prevent any adverse effects on the environment and the health and safety of humans and animals, in particular where scientific data do not permit a complete evaluation of the risk as with GMOs. In the case of an action being taken under the precautionary principle, the producer, manufacturer or importer may be required to prove the absence of danger. [47] In the US, a federal action that does not have a significant impact on human environment categorical exclusion (CATEX) may be applied which excluded the action from a detailed environmental analysis. [48] The US bases its regulations on the substantial equivalence principle. It states that if a new product contains similar quantities of basic components as a product already existing on the market, the products are considered substantially equivalent. This means that GM food products that are considered substantially equivalent as conventional food products do not need to go through the process of authorization before being introduced to the US market. [49]

Labeling and traceability of GMOs

The EU has enacted strict labeling regulations on GMOs. Labeling requirements apply to all foods delivered to the final consumers or mass caterers in the EU that either contain or consist of GMOs, or are produced from or contain ingredients produced from GMOs. [50] Exemption to the rules is if the product does not exceed the threshold of 0.9 % and if their presence is adventitious and technically unavoidable. [51] US labeling requirements are much more modest. There is no law in the US requiring GMO food or feed to be labeled indicating that it contains GMOs unless the product is materially different from its conventional counterpart.[52][53]

The outcome of the EU and US regulatory regimes

The outcomes are distinct. The US has a much higher rate of GM food approval as indicated in Figure 2. The cultivation of crops in the US in 2013 was over 70 million hectares, while all the EU states together grew less than 0.1 million hectares. [54] The EU‟s cautious approach to GMOs is a good way to go to protect consumers and the environment, but far from ideal in an economical point of view.

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Fig 2.

Public opinion on GMOs

According to a report requested by the EC on the effectiveness of the legal framework on GMOs farmers and retailers were satisfied with the labeling rules and nongovernmental and consumer organizations were in favor of the rules which allow the general public to make an informed choice. [55] In the US Several legal academics have criticized the US regulations on GMOs. Many of them referring to the ethical impact of GMOs [56] and how the current regulations on labeling and monitoring GM products hinder consumers from making conscious choices. In a recent poll in the US, 89% of the voters were in favor of mandatory labeling of food which has been GM or contains ingredients that have been GM. [57] While issues regarding the safety and environmental impact of GMOs and GM food or feed continue to surface in the US, to date their policy impact has been remarkably modest. In the EU the public opposition to GMOs has been relatively effective, it reflects the concerns expressed by skeptical consumers, farmers, and environmentalists. In general US citizens are more favorably inclined towards GMOs than are EU citizens, although a broad array of advocacy groups in both the EU and the US support labeling policies. [58]

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CONCLUSION

1. GMOs are less regulated in the US because they lack a specific legislation to it.

2. It is much easier to get GM food products approved in the US because of the possibility of a premarket approval.

3. The absence of a mandatory labeling rule in the US makes it harder for consumers to make an informed choice, which strongly favors the manufacturer.

4. The EU and the US assess the balance of potential risks and benefits of GMO use differently although same scientific data are evaluated.

5. The GM business in the US is more lucrative than in the EU.

6. The general public in the EU tend to be more aware of GMOs, although the majority of people in both EU and US are in favor of labeling GM foods.

Practical recommendations

I share the opinion of the public and many scholars that GM food products should be labeled in the US as in the EU, for the consumers to be able to make a conscious choice.[59] The US bases their regulations on the substantial equivalence principle which conciders GM foods to be equivalent to conventional food products. We can therefor not force producers of GM foods to label that their products contains GMOs. On top of that The US House of Representatives passed a bill in 2015 that blocks any mandatory labeling rule of GE foods. [60] To make mandatory labeling of GMOs in the US a reality, one would have to change the fundamental bases of the regulations and approch GMOs as they do in the EU. Taking part in the Cartagena Protocol on Biosafety would be a good start. In order to make a substantial change in labeling requirements, grassroots movements and scholars have to join forces and make the general public aware of GMOs. Only the can pressure be applied on the government, to make a change.

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2. GeneticallyModified Organisms - European Commission [Internet]. Ec.europa.eu. 2016 [cited 27 November 2015]. Available from: http://ec.europa.eu/food/plant/gmo/index_en.htm

3. EUR-Lex - l32042 - EN - EUR-Lex [Internet]. Eur-lex.europa.eu. 2016 [cited 27 November 2015]. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=URISERV%3Al32042

4. To amend the Federal Food, Drug, and Cosmetic Act to require that genetically engineered food and foods that contain genetically engineered ingredients be labeled accordingly [Internet]. 1st ed. U.S: U.S Congress; 2016 [cited 27 November 2015]. Available from:

https://www.gpo.gov/fdsys/pkg/BILLS-113s809is/pdf/BILLS-113s809is.pdf

5. Same Science, Different Policies: RegulatingGeneticallyModified Foods in the U.S. and Europe - Science in the News [Internet]. Science in the News. 2015 [cited 27 November 2015]. Available from: http://sitn.hms.harvard.edu/flash/2015/same-science-different-policies/

6. Glossaryofsummaries - EUR-Lex [Internet]. Eur-lex.europa.eu. 2016 [cited 27 November 2015]. Available from: http://eur-lex.europa.eu/summary/glossary/genetically_modified_organisms.html

7. EUR-Lex - 32003R1829 - EN [Internet]. Eur-lex.europa.eu. 2016 [cited 27 November 2015]. Available from: http://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32003R1829&from=EN

8. About the Protocol [Internet]. The Biosafety Clearing-House (BCH). 2016 [cited 12 May 2016]. Available from: https://bch.cbd.int/protocol/background/

9. Parties to the Protocol and signature and ratification of the Supplementary Protocol [Internet]. The Biosafety Clearing-House (BCH). 2016 [cited 12 May 2016]. Available from:

https://bch.cbd.int/protocol/parties/

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