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Sent: 07 May 2003 10:59
Subject: 24: Regulating "process" versus "product"
This is Donald MacKenzie from AGBIOS in Canada.
In a previous contribution, Gert Willemse (Message 21, May 6) has used the example of stacked events to emphasize that regulatory systems should focus on the risks inherent in a product, rather than the process by which that product was made.
The implication was that countries which do not regulate stacked events to the same extent as the parental lines were doing so "contrary to the principle of regulating the product and not the process." For those countries, the line of reasoning may be summed up as "safe apart, safe together." Essentially, that bringing together two traits, which have been previously assessed and determined to be safe, by "traditional breeding" should not imply additional regulatory oversight. Although this example usually involves the cross-breeding of two independent transgenic lines, what about other examples?
To pose a hypothetical case, how does the crossing of insect-resistant maize (event MON 810) with glyphosate-herbicide tolerant maize (event GA21) differ from the same cross performed where imidazolinone-herbicide tolerant maize (EXP1910IT, produced by chemical mutagenesis) replaces GA21? What if the glyphosate-herbicide tolerant parental line had been produced by accelerated mutagenesis instead of recombinant-DNA technology?
In fact, all countries (except Canada, which regulates "novelty") have chosen to regulate "process" not "product". Even in countries employing a product-focused risk assessment process, the regulatory trigger is the process of genetic engineering. The situation is the same for the Cartagena Protocol on Biosafety. The development of biosafety regulations consistent with the philosophy of the Cartagena Protocol implies a trigger for regulatory oversight based on the process of genetic engineering rather than on the risks associated with the expression of any novel traits.
Certainly, focusing regulation on the process of recombinant-DNA technology and modern biotechnology goes a long way to addressing public fears, and is eminently more practical for regulators to manage from the compliance and enforcement perspective. For countries with "process-based" regulatory systems to invoke the "product risk" argument only for the special case of stacked events, is confusing at the least.
D.J. MacKenzie, Ph.D.
Exec VP/CFO, AGBIOS
106 St. John Street, P.O. Box 475
Merrickville, ON K0G1N0
Tel : +1.613.269.7966
Fax : +1.613.269.4367
E-Mail: djmackenzie (at) agbios.com
URL : www.agbios.com
URL : www.essentialbiosafety.info
Sent: 07 May 2003 11:23
Subject: 25: Codex food safety guidelines
This is from Héctor Villaverde, Consumers International, Chile.
I cannot agree with Kelebohile Lekoape (Message 23, May 6) that frameworks could be different, or more flexible.
One of the great advances in relation to regulatory frameworks is the Guidelines for food safety evaluation of GM foods, at Codex level, probably approved in the next session of the Codex Alimentarius Commission, guidelines that account with the support of all stakeholders, including consumer movement. This is a reference framework that, in my opinion, should be implemented in all countries of the world. The consumer movement has the opinion that all consumers should have the same degree of consumer protection. We battled for a lot of time to obtain such a reference framework, with the participation of all our worldwide membership, and now it is not realistic to think that our membership is willing to accept a regulatory framework less protective of consumer rights. Something similar could be said of environmental regulations raised by the Cartagena Protocol.
If a developing country wishes to export their GM food to the developed world, it must accomplish this with the regulatory framework of the importing country: In the case of the European Union, regulatory frameworks in food safety and environment risks, tracability and labelling; but also in the United States, the regulatory framework is increasingly less flexible. Therefore, the regulatory framework in a developing country does not have much degree of freedom in relation to the regulatory framework of the importing country, if that country wishes to export its products.
If their priority is not export, and their regulatory framework is weak or inexistent, its consumers could be exposed to potential risks, and this is inacceptable. We need to understand that this discussion on GM foods is global, and therefore need to have global solutions. The several cases of food contamination by GMOs intended for feed or pharmaceuticals highlight the importance of having a wide regulatory framework in place.
Food Programme Co-ordinator
Office for Latin America and the Caribbean
Las Hortensias 2371
Phone: (56-2) 335-1695
Fax: (56-2) 231-0773
Email: programalimentario (at) consint.cl
[The Joint FAO/WHO Codex Alimentarius Commission is an intergovernmental body set up to establish international standards on foods. The Codex Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology has just held its 4th and final scheduled session on 11-14 March 2003 in Yokohama, Japan. At the session, the Task Force advanced the "Draft Guideline for the Conduct of Food Safety Assessment on Foods Produced Using Recombinant-DNA Microorganisms" to the 26th session of the Codex Alimentarius Commission (CAC), to be held 30 June - 7 July 2003, Rome, Italy, for its adoption at Step 8. The Task Force previously agreed, at its 3rd session held on 4-8 March 2002 in Yokohama Japan, to advance the following texts to the 26th Session of the CAC for adoption at Step 8: "Draft Principles for the Risk Analysis of Foods derived from Modern Biotechnology", "Draft Guideline for the Conduct of Food Safety Assessment of Foods derived from Recombinant-DNA Plants" and "Proposed Draft Annex on the Assessment of Possible Allegenicity" (an Annex of the previous guideline). All these texts and reports/agendas of different sessions of the Task Force are available at www.codexalimentarius.net/reports.asp (or contact firstname.lastname@example.org for further information)...Moderator].
Sent: 07 May 2003 11:26
Subject: 26: Local control vs. one-size-fits-all
This is Justin Mog, from the University of Wisconsin-Madison, United States, again.
I just wanted to concur with the emphasis Kelebohile Lekoape (Message 23, May 6) has placed on GMO regulatory capacity-building initiatives being locally-controlled and demand-driven, rather than one-size-fits-all. Of course, nations which have yet to develop a regulatory framework for GMOs would do well to learn what they can from the experience of other countries; but this is no reason to expect them to follow the model of their predecessors (either in process or product).
My research on sustainable rural development and experience in the southern
Philippines has demonstrated the central importance of intimately involving
local people in the process of researching and developing both technologies
(like GMOs) and the policy measures necessary to regulate them. As
Kelebohile Lekoape has already noted, this is vital because:
1. it helps make them more effective and appropriate by tailoring them to local circumstances; and
2. it helps locals identify with, invest in, and take responsibility for them -- thereby increasing local credibility.
I would just add that such a participatory process will also better prepare a country to face unknown future challenges. With an issue as dynamic as the regulation of GMOs, what locals really need is help learning how to learn, innovate and adapt to the type of evolving concerns that GMOs raise. Simply "telling them how to do it" may solve some immediate crises, but it will be of little help in the long-run.
Justin Mog, PhD
Gaylord Nelson Institute for Environmental Studies
University of Wisconsin-Madison
315 N. Ingersoll St.
Madison, WI 53703-1611
E-mail: jmmog (at) wisc.edu
Sent: 07 May 2003 14:09
Subject: 27: Re: A dynamic interdependent network
Gert Willemse from South Africa again.
Having read Kelebohile Lekoape's response (No. 23, May 6) to my second message (No. 21, May 6) it seems that I have been interpreted as having proposed that developing countries should follow developed countries in the adoption and regulation of technologies. In actual fact, I am in total accord with the sentiments expressed by Kelebohile. Adoption of technologies (or their products) and regulation should always be driven by domestic demand and influenced by domestic circumstances, and no country (whether developed or developing) should be obliged to follow in the footsteps of any other. This was exactly the point I was making in suggesting that what informs the substantive content and structure of regulatory frameworks during development should not necessarily only be based on the experience of developed countries only, but that developing countries also have a significant contribution to make. Indeed, many developing countries may not have the resources or the need for either the technology or the products and consequently also no need for a domestic regulatory framework. Even in this instance, trade relations between such a country and another country that has adopted the technology may be positively influenced if the regulatory framework of the latter takes cognisance of the needs and requirements of the former.
As to the process of development and adoption of frameworks, again I am in agreement with Kelebohile, recognizing of course that this would again be determined by domestic demand and circumstances.
Perhaps a clearer distinction between process (framework development and evolution) and substance (framework nature and content) would serve to prevent confusion or misunderstanding. This returns also to the question posed by Jessica Vapnek (No. 22, May 6). I believe she is quite correct in that we may not all have the same understanding of what a regulatory framework constitutes. I can only give my own understanding of a regulatory framework and it may not necessarily be the correct one. In my understanding, a regulatory framework has two main components, namely a legislative component (any number of relevant domestic legislative instruments) and an institutional component (one or more institutional structures responsible for enforcement). It is my view that the effectiveness and credibility of regulatory frameworks in the long term depend on the effective and efficient functioning of the institutional component.
One should not, however, confuse policy and strategy instruments to be part of the regulatory frameworks. Although these instruments, together with regulatory frameworks, constitute the broader enabling environment, their functions are determinant of the direction and process of regulatory framework development and evolution, not necessarily of regulatory framework content and structure.
Dr Gert Willemse
Private Bag X447
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk
Sent: 07 May 2003 14:13
Subject: 28: Re: Experience of regulating GMOs in developing countries - India
This is from Professor C Kameswara Rao, Executive Secretary, Foundation for Biotechnology Awareness and Education, Bangalore, India.
In response to Message 14 (May 5) concerning the regulatory system in India:
The Genetic Engineering Approval Committee (GEAC), Government of India, is expected to accord approval for controlled trials or commercial release of genetically engineered products. Since most of the products have a direct or an indirect impact on the environment, the GEAC is attached to the Ministry of Forests and Environment, Government of India. The GEAC has so far taken a relatively cautious approach to granting approval of GE crops.
However, the policy of the Government of India and that of the general public is not anti-biotechnology. The Government established the Department of Biotechnology in 1985, one of the earliest such departments in the world. The Department of Biotechnology, the Indian Council of Agricultural Research, the Department of Science and Technology, the Council for Scientific and Industrial Research, the research and educational institutions of the Central Government and those of the States, are all actively engaged in research in biotechnology. It would take some years for any marketable products to come out of these efforts. While the policy of the Government is pro-technology, the climate of the regulatory processes in India is not conducive to promote biotechnology. Though the products of conventional agriculture through hybridisation and induced mutation can pose as serious risks as attributed to products of genetic engineering, stringent regulatory processes are applicable only to the latter.
Professor C Kameswara Rao,
Foundation for Biotechnology Awareness and Education,
e-mail krao (at) vsnl.com
Sent: 07 May 2003 15:30
Subject: 29: Using GMO registrants to informally regulate
This is Mark Kuhn, a graduate student in the field of biotechnology management at the University of Maryland in the United States. The following are some personal observations of mine.
I tend to agree that there is some truth to a common assertion that industry will only regulate itself when forced to. This probably applies to industry watching over itself with regard to GMOs, too. But portions of a report issued last month by the Pew Charitable Trusts' Initiative on Food & Biotechnology may illuminate a potential answer--at least a starting point--to solving the problem of how developing and transition nations that lack resources and expertise might regulate the global GM food trade, or other GMO-based products and services. That answer is industry self-policing. [This report, entitled "Post-Market Oversight of Biotech Foods: Is the System Prepared?" and co-authored by Michael Taylor and Jody Tick of Resources for the Future was released last month and is available from http://pewagbiotech.org/newsroom/releases/042403.php3 ...Moderator].
The Pew study, unintentionally no doubt, raises a possibility that one way of approaching global GM food regulation might be through GM crop registrants-companies that sponsor GM food products--much as the U.S. Environmental Protection Agency (EPA) presently does with plant-incorporated protectants (PIPs). The EPA considers it the responsibility of registrants to monitor the proper use of PIPs in the field. This includes registrants overseeing post-market use of GM crops by farmers. Thus, biotech companies selling GM food crops must keep an eye on those who grow them, including growers in foreign markets. Such an oversight system, regardless of its obvious imperfections, could provide regulatory penetration into developing counties' use of PIPs, or any other GM crop for that matter. In other words, relying on private-sector monitoring could accomplish some degree of GM food regulation in developing and transitions countries without a significant intrusion into those nations' governance or placing too great a burden on nations' government resources and bureaucracies. That is to say, oversight of a certain degree could be accomplished via the private sector through post-market monitoring by GM crop registrants, at least until a developing or transition nation's government matures enough to assume a greater oversight role of its own.
A similar model might be appropriate for other GMOs. For instance, an initial registrant-policing model may be appropriate for transgenic animals and microbes. The Pew report raises important questions about imposing testing and traceability requirements on registrants. Such tools, I believe, should be used to make registrant monitoring more effective. Indeed, such requirements might be unavoidable where nations lack governmental capacity to watch over the GM crop trade. I would also shorten the period of registrant recertification required by the EPA to once every two or three years instead of the current five years.
8404 Fenton St.,
mkuhn (at) cdpublications.com
Sent: 07 May 2003 16:26
Subject: 30: Re: Regulating "process" versus "product"
This is again Gert Willemse from South Africa.
In response to the message of Donald MacKenzie (No. 24, May 7), I would like to correct some misconceptions contained in his message. It is not correct that "all countries (except Canada...) have chosen to regulate "process" not "product"." In the case of South Africa, both process (genetic modification of organisms) and product (GMOs) are regulated. The genetic modification of organisms is also regulated whether achieved by means of recombinant DNA technology, chemical mutagenesis or any other means of genetic modification.
It is also incorrect that the philosophy of the Cartagena Protocol on Biosafety implies triggering of "regulatory oversight based on the process of genetic engineering rather than on the risks associated with the expression of any novel traits". Article 8(g) of the Convention on Biological Diversity, which forms the basis for the Cartagena Protocol negotiated in response to Article 19(3), is very clear on the measures to be taken to "regulate, manage or control the risks associated with the use and release of LMOs..." (=GMOs). Refer also to the scope of the Cartagena Protocol (Article 4) which specifies "transboundary movement...handling and use" of GMOs. The trigger for obligations under the Protocol is therefore not the process of genetic modification, but activities involving the product or GMO. [Multi-lingual versions of the texts of the Convention on Biological Diversity and of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity are available at http://www.biodiv.org/convention/articles.asp and http://www.biodiv.org/biosafety/protocol.asp respectively...Moderator].
Coming back to the stacked gene example, I would argue that the line of reasoning of "safe apart, safe together" is inherently flawed. It is based on the assumption that previously assessed novel traits in subsequent breeding would not have any further pleiotropic or other unforeseen effects. I reiterate that this assumption is no more than an assumption and is not based on any scientific fact. I concede that, from a regulatory viewpoint, no distinction should be made between a stacked event bred from parental lines where the genetic modification have been achieved by different means, and I am certainly not proposing that any regulatory framework should make exceptions to include/exclude any given ad hoc case. To do so would only lead to major confusion, as Donald MacKenzie has pointed out. It would be far less complex to set (depending on the individual country needs and circumstances) basic principles and parameters within which the flexibility of the regulatory framework would then ensure the required safety and efficiency. In this context, as I have earlier pointed out, it may be of benefit to address the needs and requirements of intended recipient countries in the approval process if transfer of GMOs is contemplated, in order to prevent unneccesary delays in the approval process of the recipient country. One principle that should not be negotiable is the right of the recipient country to decide its own criteria and level of biosafety.
Dr GT Willemse
Private Bag X447
Tel: +27 12 3103836
Fax: +27 12 3207026
bioconsult2002 (at) yahoo.co.uk
Sent: 07 May 2003 16:52
Subject: 31: The importance of having a regulatory framework
My name is Tamala Tonga Kambikambi. I am an agronomist and I lecture at the University of Zambia.
I guess most of you had heard about the saga of my country refusing to take the GMO food maize. I suppose that underscores the importance of having a regulatory framework because what really happened is that we did not know how to handle that product in the absence of appropriate legislation. We have hence moved on and are on the way to ensuring that we are ready for any such eventuality in future.
Jessica Vapnek (Message 22, May 7) brings in an important aspect. I totally agree that we need to know what type of regulatory framework we need to adopt i.e an Act of Parliament or a Policy statement. My belief is that both are important, especially for developing countries like ours. Why do I say so? I think that the Policy gives the direction which the country should be going. Given that a number of our countries rely on donors for support, that sort of gives them a guideline on what to do and also helps the nation to have a focused direction. I speak from experience in some other sectors where we went straight to enact Acts of Parliament without a Policy guideline. We have had donors coming in with their own 'agendas' for lack of a better term. So I seriously think a Policy should be the first step and we are in the process of putting one in place.
The Legislation is of course vital because it sets standards. What we are doing in our case is coming up with one specifically on Biotechnology and Biosafety because when we looked at the other existing legislation, we found that there were gaps and that even if we were to amend some to them, some gaps would not be covered. Hence, we felt that it is better to have a totally new piece of legislation to cover that. However, we shall have to relook at the other complimentary pieces like the Food and Drug Act, the Plant Varieties and Seeds Act and the Plant Quarantine and Phytosanitary Act, to mention but a few, and amend where possible to take into account issues of Biotechnology and Biosafety.
Before I end, I want to comment on Message 16 (by Justin Mog, May 7) where it said "herbicide-resistant crops only increase the incentive to use expensive (often) imported herbicides" and I think this was in reference to Bt cotton. [In Message 16, the comments about herbicide-resistant crops were made without referring to any specific crop...Moderator]. Cotton growers in our part of the world still use expensive, definitely imported, herbicides because if they do not, the result is zero yield. In Zambia, this is a crop grown solely by small scale farmers. They have to spray mostly by knapsack sprayer and the water to mix the chemical is normally drawn several km away from the field it is used in. To me, it therefore makes a lot of sense if the number of sprays can be reduced because of the inherent resistance the Bt cotton provides because this certainly reduces the labour burden of these poor and vulnerable farmers and I would like to believe that that saving can be used for other ventures.
Tamala Tonga Kambikambi
Crop Science Department,
School of Agricultural Sciences,
University of Zambia,
P.O. Box 32379, Lusaka.
tkambikambi (at) agric.unza.zm