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-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 08:44
To: 'biotech-room1@mailserv.fao.org'
Subject: 20: Re: Experience of regulating GMOs in developing countries - India

I am Debasmita, doing my M.A. in sociology in the University of Hyderabad.

I just wanted to know about the Genetic Engineering Approval Committee's (GEAC) recent stance about granting permission to the GMOs in India.

Debasmita Patra,
University of Hyderabad
India
debasmitapatra (at) yahoo.com

-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 14:14
To: 'biotech-room1@mailserv.fao.org'
Subject: 21: A dynamic interdependent network

This is again Gert Willemse from South Africa. In my previous message (nr. 17, May 5), I referred to the need for two-way fertilization of regulatory framework development and evolution between developed and developing countries. To provide more clarity on this issue, it is necessary to view the current global situation in GMO regulation.

In the past, technological capacity for GMO development resided primarily in developed countries with regulatory or biosafety frameworks developing in tandem. Kele Lekoape (Message 12, May 2) alluded to the benefits of such parallel development, which was mostly not the case in developing countries. This situation is, at least in some developing countries, rapidly changing. Firstly, some developing countries, as part of a focused strategy, are developing capacity at national level in gene technologies and, secondly, developing countries are more frequently the site of field trials or bulking-up operations for GMOs developed elsewhere. Consequentially, technological capacity and regulatory framework development more frequently follow the same developmental path in developing countries as was historically the case in developed countries.

One important advantage the developing countries had was that they could rely substantially on the past experience and lessons from developed countries to guide the regulatory framework development. Currently, this is mostly still the case with capacity building initiatives modelling development of regulatory frameworks on the existing frameworks in developed countries.

Experiences and developments in developing countries with existing regulatory frameworks have, however, provided some important lessons that could, equally well, benefit, not only regulatory framework development in other developing countries, but also the review end evolution of existing frameworks in developed countries. A case in point is the example of stacked events, which I referred to in my previous message, where the notion that the stacked event should not be subject to regulation because the development was through a process of natural breeding and the risk assessment of parent stock suffices on the basis of substantial equivalence. This argument is, of course, contrary to the principle of regulating the product and not the process and bases the acceptable level of risk on the basis of assumption rather than scientific fact.

Similarly, the Mexican landrace debacle provides ample experience to influence, not only development of regulatory frameworks in countries of endemism or origin of biodiversity, but also revision of existing frameworks in countries of export to minimize risk of genetic pollution in such recipient countries.

In summary then, the global GMO regulatory scenario is evolving into a dynamic interdependent network that could only benefit from cross-fertilization of all experiences and lessons learnt.

Dr Gert Willemse
Private Bag X447
Pretoria 0001
South Africa
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk

-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 16:48
To: 'biotech-room1@mailserv.fao.org'
Subject: 22: The meaning of "regulatory framework"

This is Jessica Vapnek, a legal officer in the Development Law Service of FAO, at FAO headquarters in Rome.

I don't want to divert the "thread", but I can't resist asking whether, in our various postings, we have all been meaning the same thing when we've used the term "regulatory frameworks", or even "regulation", with reference to GMOs. The reason I ask is that I think to lawyers the term "regulatory framework" has a fairly specific meaning, but I have been finding it interesting that in many of the messages posted to the list, the term as it is being used does not *seem* to have the same meaning which we legal types assume it to mean. That is, when lawyers talk about the "regulatory framework for GMOs" or the "regulation of GMOs" in a particular country, we would be talking about what legislation there is which governs the subject matter, and then we would specify whether each piece of legislation in the universe of applicable legislation is binding or not binding (and we would also want to know who issued it). For example, one country might have two parliamentary-level acts that address the topic, plus a variety of implementing regulations (issued, say, by a relevant Minister), whereas another country might have no enacted legislation as such, but might have only policy statements, guidelines or other "soft law" instruments which are hortatory but not binding. To lawyers, these would be two examples of "regulatory frameworks for GMOs" at national level.

It may be that my question is off the thread, in which case maybe one or two of you non-lawyers out there could just write to me individually to satisfy my curiosity. It seems that many of you have been using the term "regulatory framework" to refer to the universe of specific rules that govern the use and release of GMOs at national level -- whether such rules are binding or not, and without any indication of who issued them. So does that mean that when you all think about these issues you don't focus on the legal status of the rules? Or have you only been referring to binding rules, wherever and by whomever issued?

I suppose the reason I've asked is that I obviously had the "lawyer's" understanding of the term when I signed up for the conference, and was therefore thinking that some of the conference submissions would illuminate the question of how GMOs are being "regulated" at national level -- i.e., how various governments and legislatures in developing and transition countries are choosing to address GMOs. For instance, are they regulating them through food legislation? Through phytosanitary legislation? Through both? Or through specific and targeted "GMO" legislation? Or, not through legislation at all? In several recent trips to FAO member countries, government representatives have expressed to me their interest in "regulating" GMOs (i.e., in preparing legislation), and since this is a new topic to me, I am interested in best practices, if there are any out there to be shared. (I know of the specific legislation in South Africa, for example.)

Jessica Vapnek
Legal Officer
United Nations Food and Agriculture Organization
Viale delle Terme di Caracalla
00153 Rome RM Italy
(+39-06) 5705-6605
(+39-06) 5705-4408 fax
Jessica.Vapnek (at) fao.org
www.fao.org/Legal

-----Original Message-----
From: Biotech-Mod1
Sent: 06 May 2003 16:56
To: 'biotech-room1@mailserv.fao.org'
Subject: 23: Re: A dynamic interdependent network

This is Kelebohile Lekoape, from the World Health Organization.

While I concur with Gert Willemse's notion (Message 21, May 6) of the regulatory evolution in some developing countries having similarities with the developed countries, it is important to point out that the majority do not have the resources, or perhaps the need, to establish similar frameworks. It is therefore imperative that capacity building initiatives are demand-driven. Developing countries should not feel obliged to follow in the footprints of the developed nations. Each country has a unique set of circumstances (level of development, capabilities, aspirations, cultures and traditions) that ought to influence its road map in the adoption and regulation of any technology.

Having forerunners certainly does mean there are lessons to be learnt from their experiences and, in my view, the most important is engaging the public at all levels, from drawing up a research policy to decision making of approvals. This bottom-up approach means consumers are not only a part of the process, they identify with it and assume responsibility for the end result, thus endorsing the credibility of a regulatory framework.

Kelebohile Lekoape
WHO,
Food Safety Department
Avenue Appia 20
1211 Geneva 27
Switzerland,
lekoapek (at) who.int