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Legal Aspects of Implementing the Cartagena Protocol on Biosafety

Marie-Claire Cordonier Segger Frederic Perron-Welch Christine Frison

About the Book

This book, the first in a new series that focuses on treaty implemen­tation for sustainable development, examines key legal aspects of implementing the Cartagena Protocol on Biosafety to the UN Con­vention on Biological Diversity (CBD) at national and international levels. The volume provides a serious contribution to the current le­gal and political academic debates on biosafety by discussing key issues under the Cartagena Protocol on Biosafety that affect the further design of national and international law on biosafety, and analyzing recent progress in the development of domestic regulatory regimes for biosafety. It also examines the legal, political, economic, and practical challenges and solutions encountered in recent efforts to develop and implement domestic biosafety regulations, with a fo­cus on developing countries. In the year of the fifth UN Meeting of the Parties to the Cartagena Protocol on Biosafety, at the signature of a new Nagoya-Kuala Lumpur Protocol on Liability and Redress, this timely book examines recent developments in biosafety law and policy.

Key Features

  • Defines the key issues in sustainable development law on biosafety
  • Analyzes the key international mechanisms of the Cartagena Protocol
  • Examines the practical, legal, political and economic challenges and solutions encountered in the development and implementation of biosafety regulatory regimes in several countries from different regions of the world


Part I. Essentials of Biosafety and Sustainable Development Law: 1. Bio­safety, the Cartagena Protocol, and sustainable development Kathryn Gar- forth, Worku Damena Yifru and Mai Fujii; 2. Implementing sustainable development through national biosafety frameworks Christine Frison, Syl- vestre-Jose-Tidiane Manga and Marie-Claire Cordonier Segger; 3. Crafting national biosafety regulatory systems Gregory Jaffe; Part II. Sustainable Development Law and Policy on Biosafety: 4. Risk assessment and risk management Ryan Hill; 5. The decision-making procedures of the protocol Worku Damena Yifru, Mai Fujii and Kathryn Garforth; 6. Handling, trans­port, packaging and information Thomas Redick; 7. The question of public participation Christine Toczeck Skarlatakis and Julian Kinderlerer; 8. The biosafety clearing-house and sustainable development law Frederic Perron- Welch; 9. Use of the biosafety clearing house in practice Tomme Rosanne Young; 10. Socio-economics, biosafety and sustainable development Fred­eric Perron-Welch; 11. The compliance mechanism: development, adop­tion, content and first years of life Veit Koester; 12. Biosafety, liability and sustainable development Frederic Perron-Welch and Olivier Rukundo; Part III. National Implementation of Biosafety Regulatory Aspects: 13. Legisla­tive options for national implementation Tomme Rosanne Young; 14. Na­tional biosafety regulatory systems in Central and Eastern Europe David Duthie and Liina Eek; 15. Implementing the Cartagena Protocol in West Africa: national and regional activities Gregory Jaffe and Papa Meissa Di- eng; 16. Comparative analysis of the national biosafety regulatory systems in East Africa Gregory Jaffe; 17. The national biosafety regulatory systems in Asian and Near East countries Nizar Mohamed; 18. The regulatory and institutional biosafety systems in the Americas Jorge Cabrera Medaglia; 19. National experiences with legislative implementation of the protocol Tom- me Rosanne Young; 20. The Costa Rican legal framework on agricultural genetically modified organisms Jorge Cabrera Medaglia; 21. Innovations in biosafety law in New Zealand Frederic Perron-Welch; 22. Liability and redress in Canadian case law: Hoffman v. Monsanto Canada Inc. Kath­ryn Garforth and Paige Ainslie; 23. The use of GMOs in Chile and the protection of indigenous culture Konstantia Koutouki and Paula Honorato Marin; Part V. Global Policy Trends in Biosafety: 24. Sustainable develop­ment, biosafety and international law Frederic Perron-Welch, Marie-Claire Cordonier Segger, Christine Frison and Jorge Cabrera Medaglia; 25. Trade and investment implications of implementing the Cartagena Protocol Ma- rie-Claire Cordonier Segger and Markus Gehring; 26. The Cartagena Pro­tocol and the regulation of genetically modified food aid Martin Endicot.

В Польше узаконили ГМО

Президент Польши Бронислав Коморовский подписал закон, разрешающий регистрацию и оборот семян ГМО

Принятый парламентом закон «О семеноводстве» позволит привести в соответствие законодательство Польши с требованиями Европейского союза.

В новой редакции закона, посвященного урегулированию вопросов выращивания и введения в обращение посевных материалов (в т.ч. региональных и любительских сортов), два положения касаются генетически модифицированных организмов (ГМО): одно допускает регистрацию семян ГМО, второе легализует оборот таких семян на территории страны.

До сих пор в Польше были запрещены регистрация и оборот семян ГМО. Однако, как утверждают эксперты, это не гарантировало полного страхования сельского хозяйства страны от его использования, поскольку сельхозпроизводители могли закупить такие семена в соседних странах и бесконтрольно использовать их в своих угодьях.

Новый же закон дает основания для осуществления контроля за посевами, устанавливает наказание за нарушение нормативно-правовых актов, в частности, предусматривает возможность ликвидации такой культуры за счет сельскохозяйственного производителя-нарушителя.

Между тем, подписывая закон, глава государства обратился в Совет министров с просьбой о подготовке комплексного урегулирования вопроса ГМО в одном цельном законе, разработка и принятие которого должны сопровождаться широкими консультациями в экспертных кругах и общественными слушаниями.

По материалам интернет-ресурсов


The Aarhus Convention secretariat has developed a Clearinghouse mechanism (http://aarhusclearinghouse.unece.org/) for sharing information and good practices on the three pillars of the Convention, namely access to information, public participation in decision-making and access to justice in environmental matters including regarding GMOs.

The Clearinghouse provides useful links to information, news and resources on all three pillars as well as to a jurisprudence database regarding cases brought before the Courts making reference to the provisions of the Convention.

The Aarhus Convention secretariat is currently in the process of preparing an online tool for good practices on public participation covering inter alia GMO-related initiatives. Interested organisations, countries and other stakeholders are invited to check the Aarhus Convention page regularly for up-to-date information (http://www.unece.org/env/pp/welcome.html).

Call for precautionary approach to synthetic biology, 09 April 2014

Dear Friends and Colleagues


The 11th Conference of the Parties (COP) to the Convention on Biological Diversity (CBD) in 2012 adopted Decision XI/11 on “New and emerging issues relating to the conservation and sustainable use of biodiversity”, which included sections on synthetic biology.
The COP recognized“the development of technologies associated with synthetic life, cells or genomes, and the scientific uncertainties of their potential impact on the conservation and sustainable use of biological diversity”, and urged Parties and invited other Governments “to take a precautionary approach, in accordance with the preamble of the Convention and with Article 14, when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology…”
The COP also noted, “based on the precautionary approach, the need to consider the potential positive and negative impacts of components, organisms and products resulting from synthetic biology techniques on the conservation and sustainable use of biodiversity”.
It called for additional relevant information to be provided, synthesized and analysed, for the consideration of the CBD’s Subsidiary Body on Scientific, Technical and Technological Advice (SBSTTA). SBSTTA 18 will meet in June 2014 in Montreal, Canada and one of the key agenda items will be on synthetic biology.
The briefing below, produced by ETC Group, highlights the issues raised by synthetic biology, including new biosafety threats and the current lack of oversight or governance. ETC Group supports the precautionary approach and recommends that CBD Parties establish a moratorium on the environmental and commercial release of Synthetically Modified Organisms (SMOs) and assess their livelihood implications.
With best wishes,
Third World Network
131 Jalan Macalister
10400 Penang
Email: twnet@po.jaring.my
Website: http://www.biosafety-info.net/ and http://www.twn.my/



Key points:
* Synthetic Biology is a multibillion-dollar industry that aims to ‘programme’ living organisms to create ‘synthetically modified organisms’ (SMOs) for the production of foods, fuels and chemicals.[i]
* The release and use of SMOs introduce new direct and indirect risks to biodiversity and human health.
* SMO-derived products may threaten the livelihoods of millions of tropical farmers by displacing natural commodities, including coconut oil, cocoa butter, vanilla, saffron, stevia, rubber, patchouli and vetiver.
* Synthetic Biology provides the means to carry out ‘digital biopiracy’ that evades the Cartagena Protocol.
* SBSTTA 18 must relay clear advice on how to prevent harmful environmental and commercial releases of SMOs.
Box: Definition of Synthetic Biology
Synthetic biology is the applied design and synthesis of new biologically-based parts, devices, and systems at the organismal, cellular or sub cellular level as well as the de novo synthesis or re-design of existing, natural biological systems or genomes. The field is characterized by use of synthesized DNA and other synthetic genetic components and also by the use of engineering-based approaches to construction of living organisms. (ie. Synthetically Modified Organisms).
The synthetic biology industry is already partnering with the world’s largest grain, chemical and oil companies to release products into consumer and other markets. The industry forecasts sales of almost US$11 billion by 2016.

Synthetic Biology at SBSTTA 18:
Synthetic Biology will be discussed under the New and Emerging Issues agenda item (item x). Parties will issue advice on a programme of work based on consideration of two reviews prepared by the CBD Secretariat (see http://www.cbd.in/emerging). The CBD is the first multilateral body to address the topic of Synthetic Biology and has urged governments to take a precautionary approach.
Box/Pullquote: “Recognizing the development of technologies associated with synthetic life, cells or genomes, and the scientific uncertainties of their potential impact on the conservation and sustainable use of biological diversity, urges Parties and invites other Governments to take a precautionary approach, in accordance with the preamble of the Convention and with Article 14, when addressing threats of significant reduction or loss of biological diversity posed by organisms, components and products resulting from synthetic biology, in accordance with domestic legislation and other relevant international obligations;” CBD Decision XI/11(4)

Seven Issues Raised by Synthetic Biology:
1) New Biosafety Threats: Synthetic Biology creates highly novel, living artificial organisms that may persist and reproduce in nature. There exists no guidance on how to assess and manage SMOs for biosafety risks. Synthetic Biology companies now produce hundreds of thousands of different novel SMO strains per day raising serious questions about monitoring, recall and liability.
2) Threats to Livelihoods and Sustainable Use of Biodiversity: Companies are now bringing to market synthetic versions of natural plant compounds – including vanilla, stevia, coconut oil, cocoa butter, patchouli, rubber, vetiver and saffron. If these substances compete with botanical products grown by tropical farmers, they could destabilize markets, destroy rural livelihoods and impact sustainable use of biodiversity.
3) Agronomic Changes: The Synthetic Biology industry hopes to brew large quantities of commercial fuels, chemicals and other high-value compounds in vats of SMOs that require sugar as a feedstock. Sourcing enough sugar would drive extensive land-use changes and increased use of water, agrochemicals and fertilizer.
4) Digital Biopiracy: Synthetic Biology makes it possible to move genetic resources across borders as digital information. Agreements such as the Nagoya Protocol that govern ‘material transfer’ of genetic resources may become ineffective.
5) Bioweapons and Health Concerns: Synthetic Biology allows for the construction of viruses and bacteria that could be infectious or otherwise harmful to humans and/or animals – either purposefully or by mistake.
6) Lack of Oversight or Governance: Existing regulations to govern genetic engineering were framed before the emergence of Synthetic Biology techniques and are inadequate to provide safe and just oversight.
7) Danger of False Solutions: Speculative proposals to use Synthetic Biology techniques toward environmentally and socially beneficial goals (such as reviving extinct animals) should be assessed with a critical eye.

ETC Group supports the precautionary approach adopted by COP11 and recommends that Parties at COP12 establish a moratorium on the environmental and commercial release of Synthetically Modified Organisms (SMOs) and assess livelihood implications.
For further information see http://www.etcgroup.org/issues/synthetic-biology.
Contact etc@etcgroup.org +1 613 2412267
[i] The CBD Secretariat uses the term Synthetically Modified Organisms to refer to the products of Synthetic Biology in its Draft Document for Review entitled New and emerging issues relating to the conservation and sustainable use of biodiversity – potential positive and negative impacts of components, organisms and products resulting from synthetic biology techniques on the conservation and sustainable use of biodiversity.

Food science expert: Genetically modified crops are overregulated

CHAMPAIGN, lll. — It has been almost 20 years since the first genetically modified foods showed up in produce aisles throughout the United States and the rest of the world, but controversy continues to surround the products and their regulation.

Bruce Chassy

Bruce Chassy

Photo by L. Brian Stauffer

Bruce Chassy, a professor emeritus of food science and human nutrition at the University of Illinois at Urbana-Champaign, believes that after thousands of research studies and worldwide planting, «genetically modified foods pose no special risks to consumers or the environment» and are overregulated.

Chassy elaborated on this conclusion at the 2013 meeting of the American Association for the Advancement of Science in Boston on Feb. 17. During his talk, «Regulating the Safety of Foods and Feeds Derived From Genetically Modified Crops,» Chassy shared his view that the overregulation of GM crops actually hurts the environment, reduces global health and burdens the consumer.

Farmers have witnessed the advantages of GM crops firsthand through increases in their yields and profit, and decreases in their labor, energy consumption, pesticide use and greenhouse gas emissions, Chassy said.

Despite these benefits, various regulatory agencies require newly developed GM crops to be put to the test with rigorous safety evaluations that include molecular characterization, toxicological evaluation, allergenicity assessments, compositional analysis and feeding studies. This extensive testing takes five to 10 years and costs tens of millions of dollars, and Chassy argues that this process «wastes resources and diverts attention from real food safety issues.»

«With more than half of the world’s population now living in countries that have adopted GM crops, it might be appropriate to reduce the regulatory scrutiny of GM crops to a level that is commensurate with science-based risk assessment,» Chassy said.

During his talk, Chassy chronicled the scientific tests used in pre-market safety assessments of GM foods and elaborated on the evidence from thousands of research studies and expansive GM plantings that he says show these crops do not present risks to consumers or the environment. The overregulation of GM foods is a response not to scientific evidence, Chassy said, but to a global campaign that disseminates misinformation and fear about these food sources.

ГМО на подходе: Итоги электронной конференции (по данным FAO-BiotechNews-Ru, 18-01-2013)

Электронная конференция ФАО на тему «ГМО на подходе: Взгляд на следующие пять лет в секторе производства сельскохозяйственных культур, лесного хозяйства, животноводства, аквакультуры и агропромышленности в развивающихся странах» состоялась с 5 ноября по 2 декабря 2012 года. Уже доступен итоговый документ на 11 страницах под названием «Электронная конференция ФАО о ГМО в процессе разработки в развивающихся странах: Краткий обзор модератора», подготовленный Дж. Руане. Этот документ представляет собой краткое изложение основных вопросов, которые рассматривались участниками во время этой 4-недельной конференции, на основании 109 сообщений, которые были отправлены по этому поводу. В результате этой электронной конференции вырисовывается картина о ГМО в процессе разработки с огромным числом и разнообразием продуктов. Это означает, что в течение следующих пяти лет освобождение ГМО вероятно произойдет в развивающихся странах, причем будет продолжать доминировать сектор производства сельскохозяйственных культур, в котором уже на подходе — широкий спектр новых культур, основанных на комбинации признаков. Наблюдается также повышенный интерес к новым областям, как например, ГМ рыбы, насекомые и деревья. Смотрите: http://www.fao.org/docrep/017/ap998e/ap998e.pdf (90 KB) или пишите по адресу: biotech-admin@fao.org для получения копии документа. По ссылке http://www.fao.org/fileadmin/user_upload/biotech/docs/conf18msgs.pdf (0.9 MB) можете найти все письма по конференции.

Unapproved GM papaya found in Japan

Unapproved GM papaya found in Japan

  1. Summary

In December 2010, the Ministry of Agriculture, Forestry and Fisheries (MAFF), Japan, received information on potential distribution of unapproved GM papaya in one prefecture. Immediately after this, the MAFF started validation of an analytical method for detecting such GM papaya. After successful completion of the validation in February 2011, the MAFF started analysis of all papaya seeds and seedlings commercially available or stored throughout Japan. In April 2011, the MAFF confirmed the presence of the unapproved papaya.

  1. Analysis of papaya seeds and seedlings

Papaya seeds were sampled by technical officers belonging to the Food Safety and Consumer Affairs Division of the MAFF and National Center for Seeds and Seedlings. Seeds of all varieties in paper bags available in the market or stocked were collected from all the vendors. Seedlings were collected from all the vendors.

The analysis was conducted to detect the specific DNA sequence[1] [2] [3] unique to the suspected variety extracted from seeds or leaves by using the PCR technique.


Features of unapproved GM papaya seeds

The label attached to the paper bag states “Tainung No. 5”. Approximately one hundred grams of unapproved GM were contained in the paper bag.

Since 2005, all the papaya seeds labeled “Tainung No. 5” had been imported from a Taiwanese seed company named “Taiwan Agricultural Development Co., Ltd.”

From 2006 to 2008, approximately 5 kg of “Tainung No. 5” seeds were imported to Japan, equivalent to 25 million grains.

Since 2009, no “Tainung No. 5” seed has been imported.                       “Tainung No. 5”

Approximately 8,000 trees of “Tainung No. 5” were being cultivated.

  1. Measures taken
  1. All cultivated “Tainung No.5” trees were cut down.
  2. Monitoring for wildly growing papaya is being carried out around the area where “Tainung No.5” had been planted.
  3. All papaya seeds and seedlings imported to Japan are subject to GM testing in Plant Quarantine Station.

[1]  Same as the sequences of papaya DNA being studied in Taiwan

[2]  All of papaya seeds and seedlings other than “Tainung No. 5” were tested and confirmed not unapproved GM.

[3]  Original Tainung No.5 was bred in Taiwan as non-GM variety in 1987.