TCS Daily


The Angel Is in the Details

By Henry I. Miller - April 25, 2007 12:00 AM

Twenty years ago, then-FDA Commissioner Frank Young and I began a Wall Street Journal op-ed thus: "Defining the terms 'biotechnology' and 'genetic engineering' isn't an easy task, since the terms don't represent natural groupings of processes or products. They connote something different to individual commentators, journalists, organizations, congressional staffers and members of the public. The terms are ambiguous, the source of much confusion and little advantage, and we would do well to return to more specific and descriptive terms."

These observations remain valid, sad to say. Many people who use the terms "biotechnology," "genetic engineering," and "genetically modified" don't know what they're talking about. Literally. Confusion about the terminology has led to the stigmatization of superior techniques by unscrupulous NGOs and some government officials, worthless conferences and reports, and poorly conceived experiments performed in the name of "biotechnology risk assessment."

Worst of all has been the unscientific, inconsistent and excessive regulation of the newest, most precise and predictable techniques. Although there is substantial and growing acreage of gene-spliced crops cultivated worldwide each year - 252 million acres in 2006 - more than 90 per cent of it is four large-scale commodity crops; largely because of the huge costs of meeting regulatory requirements, the application of the technology to fruits, vegetables and subsistence crops has been minimal, and disappointing.

Those who are ignorant of the history of plant breeding might be leery of messing with Mother Nature, but that does not alter the fact that we have been doing it for thousands of years. Currently, dozens of genetically improved varieties that are produced through hybridization, irradiation and other traditional methods of genetic improvement enter the marketplace and food supply each year without any governmental review or special labeling. A technique in use since the 1950s, induced-mutation breeding, involves exposing crop plants to ionizing radiation or toxic chemicals to induce random genetic mutations. These treatments most often kill the plants (or seeds) or cause detrimental genetic changes, but on rare occasions the result is a desirable mutation. For example, a mutation might produce a new trait in the plant that is agronomically useful, such as altered height, more seeds, larger fruit or enhanced resistance to pests.

One anti-biotech group even managed to bamboozle some seed companies that cater to home gardeners into signing on to something called the Safe Seed Pledge: "We pledge that we do not knowingly buy or sell genetically engineered seeds or plants." This is fascinating because, with the sole exception of wild berries and wild mushrooms, all the fruits, vegetables and grains in North American and European diets have been genetically modified or engineered by one technique or another. This even includes 'heirloom' varieties of fruits and vegetables. Often, this genetic modification has involved radical changes at the level of DNA, including the movement of genes or even entire chromosomes across natural breeding barriers.

Regulators have exploited the confusion over terminology to create unneeded and discriminatory rules, regulations and bureaucracies. During the past decade, delegates to the UN-based Convention on Biological Diversity have negotiated and implemented a regressive biosafety protocol to regulate the international movement of gene-spliced organisms. Its basis is the bogus "precautionary principle," which dictates that every new product or technology must be proven completely safe before it can be used -- a travesty that, by ignoring proven benefits of a new product or technology, flies in the face of sound regulatory practices.

Many other UN agencies have gotten in on the anti-biotech act. A technical working group of the UN Environment Program is considering whether to recommend a moratorium on the testing or commercialization of gene-spliced trees. Such a suggestion is absurdly anti-social and alarmingly anti-environmental: Plant biologists are engineering trees to grow more rapidly to combat deforestation; to require lower inputs; to resist pests, diseases and drought; to sequester more carbon; and to enhance output traits that afford greater efficiency for uses such as making paper and ethanol. The Codex Alimentarius Commission, the joint food standards program under the auspices of the WHO and the Food and Agriculture Organization, has singled out only food products made with recombinant DNA techniques for draconian and unscientific restrictions.

The regulation of gene-spliced plants makes no sense. Although the products of gene-splicing are no more a distinct and meaningful category than are organisms whose Latin names begin with the letter S, in defiance of the broad and long-standing scientific consensus that the technology is essentially a refinement of less precise and predictable genetic techniques, case-by-case reviews are performed on every gene-spliced plant variety that is to be field-tested anywhere in the world. (With very few exceptions, plants modified by conventional techniques are essentially exempt from regulation.)

An egregiously wasteful example of definitional dysfunction can be found in a massive document, "OECD Biotechnology Statistics - 2006 ," published by the Paris-based Organization for Economic Cooperation and Development. The OECD, whose thirty member countries account for most of the world's commerce, boasts that it "plays a prominent role in fostering good governance" and "helps governments to ensure the responsiveness of key economic areas with sectoral monitoring."

Not with this report.

The OECD's now-defunct Group of National Experts on Biotechnology made some valuable contributions to science-based public policy during the 1980s, but its attempts to survey biotechnology regulations and other developments in OECD countries were repeatedly stymied by inconsistent definitions - even when countries were asked to use a specific one. As discussed above, terms like "biotechnology" and "genetically modified" (or "GM") are not genuine, discrete, easily circumscribed categories, so it's not surprising that no one is quite sure what the terms define. Broad definitions encompass too much to be useful, and narrow ones that focus on the use of one technique or another are artificial, arbitrary and meaningless.

The OECD's 2006 report on "biotechnology statistics" illustrates that if we are ignorant of history, we are doomed to repeat it. The data were amassed with various responders once again using different, incompatible definitions of "biotechnology" - but this time the results were published anyway.

Offering responders a choice of using either a "single definition" or "list-based" definition in the same survey was virtually certain to elicit uninterpretable data. The first definition - "the application of science and technology to living organisms, as well as parts, products and models thereof, to alter living or nonliving materials for the production of knowledge, goods and services" - is absurdly expansive. It encompasses not only most biomedical R&D and commercial activity that involves laboratory animals or humans, but also virtually all of agriculture, baking that employs yeasts, and the production of fermented beverages and foods ranging from beer and yogurt to soy sauce. Such a broad definition is rather like surveying all structures that have doors, whether they are on dollhouses, jail cells or nuclear submarines: Even if the results of such a survey were based on reliable data, it is difficult to see how they would be useful.

The second definition, used (more or less) by most countries in the survey, is less expansive but equally vague, a Chinese restaurant menu-like (non-exhaustive) list of examples of various techniques and activities that could be considered "biotechnology": synthesis, manipulation or sequencing of DNA, RNA or protein; cell and tissue culture and engineering; vaccines and immune stimulants; embryo manipulation; fermentation; using plants for cleanup of toxic wastes; gene therapy; bioinformatics, including the construction of databases; and nanobiotechnology. These sub-categories - many of which could variously be interpreted as "old biotech" or even "non-biotech" - leave room for widely disparate interpretation. Consequently, the OECD survey report did contain widely disparate interpretations.

Huge disparities were evident not only between countries but in the reporting of data within single countries. For example, Finland, Korea, Spain, Sweden and the United States all offered two data sets, while New Zealand contributed no fewer than three. How can that be? Very simple: According to the report: "The definition of a biotechnology firm is partly linked to the method used in each country to sample firms. Three definitions are in common use. Two different methods are used in separate studies in Finland, Korea, New Zealand, Spain, Sweden and the United States." Consider the basis for the United States's reporting of different data sets: One agency used the "OECD definition"- presumably the list-based one - while another seems to have asked companies for information about biotechnology without defining it. Could this possibly yield comparable data?

And consider this gem from the survey report, about the data from the United States: "[T]he 2001 Department of Commerce survey estimates total biotechnology R&D of USD 16,834 million, while the 2003 R&D survey for the United States estimates total biotechnology R&D of USD 14,232 million . . ." Do the authors expect us to believe that between 2001 and 2003, total biotechnology R&D in the United States declined by 15 percent?

It's bad enough to compare apples and oranges, but the OECD survey compares apples, vaccine adjuvants and databases. The authors of the survey report seem to believe that acknowledging the difficulties in obtaining and reporting the survey data somehow validates them and redeems the project. Not so. I would draw an analogy to performing a laboratory experiment: The admission that you were unable to do the proper control experiments or that critical reagents were unavailable does not justify the publication of uninterpretable results.

In our two-decade-old article, Frank Young and I quoted a 1986 report on biotechnology from the US General Accounting Office (as the agency was then known), which concluded: "Because of the inconsistent interpretation of the term 'biotechnology',...[i]t may be useful, for the purpose of discussing possible regulatory approaches, to avoid the term "biotechnology" and instead use more specific terms..." That is still good advice, and not only with respect to regulatory issues. Greater clarity and discipline in terminology might promote greater perspicacity in how we view and formulate policy toward biotechnology. That would certainly better inform the public, educate the bureaucrats, vex the fear-mongering activists and force regulation to be more appropriately focused.

Henry I. Miller, a physician, is a fellow at the Hoover Institution. He headed the FDA's Office of Biotechnology from 1989-1993 and is the author, most recently, of "The Frankenfood Myth."


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7 Comments

The Devil is in the shallowness
I do not know how long we should be subjected to such baseless propoganda like this one under the title "The angel is in the details". I read these same claims and blames over and over again against those who promote safe use of biotechnology.

One of the international instruments under such a constant attack is the Cartagena Protocol on Biosafety. The Protocol has now been ratified by 140 countries. Any attempt to undermine the instrument is an act of contempt directed to these 140 sovereign nations, including the European Commission.

The Biosafety Protocol is a very progressive multilateral environmental agreement, which provides a framework that is flexible enough to take into account the concerns of all stakeholders.

The requirements in the Protocol especially those procedural requirements that are intended to apply to transboundary movements of living modified organisms (usually known as GMOs) need not necessarily be followed by all Parties all the time. Parties are allowed to use their domestic regulatory frameworks in place of the decision procedure of the Protocol; they are allowed to exempt GMOs from the Protocol procedure; they are free to enter into bilateral, regional or multilateral agreements or arrangements regarding matters covered by the Protocol and may apply the rules of these agreements and arrangements; they can have transactions with non-Parties, etc. as long as they meet the minimum conditions specified.

The Protocol is objective or outcome oriented. The goal is not to put in place rigid procedural rules. The goal is to ensure safety in the transboundary movements, handling and use of GMOs. As long as this goal is maintained, any other means that a Party may opt to apply or pursue to attain it, is not excluded by the protocol. The basic requirement that no one Party is allowed to set aside is the requirement to conduct the transfer or release of GMOs in consistent with the objective of the Protocol. The Objective is perhaps more critical than the procedures specified in the Protocol.

Given this flexibility, therefore, the Biosafety Protocol and more specifically its procedures that apply to transboundary movement of GMOs hardly affect the progress of biotechnology or disrupt trade in GMOs, as some groups are claiming.

The Protocol procedures for example, provide for timelines- when to respond to notifications, etc. These requirements have nothing to do with environmental protection or values. They are intended to facilitate trade by ensuring predictability in decision-taking. By putting in place these deadlines or timelines the Protocol is trying its part to be supportive of trade and the trade rules.

Yes human beings have been manipulating nature for millenia. However, they have been doing so in a naturl way. Genetic enginnering techniques where a foreign gene from other species could be inserted into the gene of another species to produce a desired trait is unnatuarl. No one is in a position to predict its long term consequences on the ecosystems and on agro-biodiversity. Is there any one who can explain to us with certanity as to what happened to the millions of bees and their colonies that are perishing at the moment in the US?

If you don't know what your talking about. . .
. . .you should keep your mouth shut.

Farmers have been passing genes between plant and animal species for generations. What do you think 'corn' is? Or for that matter, a 'mule'?

Whats more, 'natural' in no way implies 'safe.' It is 'natural' to have half or more of a generation die before they reach reproductive age. It is 'natural' for a hundred different diseases to constitute death sentences for the victims. And the 'natural' way to know whether something is safe to eat is to wait for some people to be starving to death, and see what happens when they eat it.

The perfect regulatory target...
For some time I have been concerned that the FDA was hurting for a real opportunity to expand its portfolio beyond drugs and back into food.

With drugs there is some real urgency for the FDA to ultimately be reasonable and let people start buying the medicine. The FDA has, almost single-handedly, caused the cost of R&D in the medical products industry to push prices up to where everyone now needs insurance coverage and the barriers to entry for new pharmaceutical companies crush competition.

The problem with medicine is that people die. If the FDA neglectfully holds an efficacious product off the market then patients suffer. If the FDA fails to administer its clinical trial policies and procedures appropriately then patients may be harmed.

With genetically engineered foods, however, virtually no American will lose his life for lack of food no matter long it takes to approve a new biological model. Further, there is no possibility that anyone will be made sick as a result of eating these new foods once they are approved for distribution. Because everyone already knows they are completely safe. It's perfect!

The FDA gets to grow. The government gets to create an entire new bureaucracy. Finally work for smooth lawyers who failed high school biology. Or for smooth lawyers who know this is all politics and morality theatre.

It is an emotional issue. And that makes it terrific for politics. People want to believe there is some immeasurable risk, here. And that their leaders are protecting them. So the government gets full credit, more lawyers (bless their hearts) find jobs, everyone gets a warm feeling and nothing bad ever happens. But food gets more expensive...like drugs!

If there is any way this foolishness can be spread to include all food then just imagine! Food is one of the things we absolutely must have. We've been missing an immense business opportunity. Food should be much more expensive. We successfully fixed the (nearly) free drinking water deal by scaring everyone into bottled water.

Clothing is also entirely too cheap. We need to do this same thing to all natural fibers. They touch our skin after all. Can't be too safe.

And synthetic fibers? That should really scare people to death if we can think up something good and make a movie about it.

If global warming doesn't have legs (for example, that hole in the ozone business seems to have failed completely) then our "scare everyone in the world to death" industry will be looking for fresh material.

Building materials. Wood. Genetically engineered lumber. Very bad. Maybe. A sea urchin gene dropped into the genome of a pine tree? We can't just let that sort of thing happen to our homes without lots of testing. Wouldn't be prudent. Wood is too cheap. Money to be made.

We already fixed the crude oil...

Water! (Oh yeah. We already did that.)

Whoever you are...
You talk like a lawyer.

Failed high school Biology, didn't you?

devilish
The author talks about the stigmatizing of " unscrupulous NGOs and some government officials". This is normal and to be expected because it is their 'raison d'etre', to expand their empires and control people. They overstate phoney needs or problems, and idiocies like the precautionary principal, and sorneyns exley, this then gives them reason to expand or create more government control. then the idiots scratch their heads when famous scientist go to places like singapore for biotech, and companies do their IPOs in other stock exchanges instead of NY. More examples of American shooting itself in the foot. There's plenty of people, the fifth columnists that want to see the States flop.

devilish
The author talks about the stigmatizing of " unscrupulous NGOs and some government officials". This is normal and to be expected because it is their 'raison d'etre', to expand their empires and control people. They overstate phoney needs or problems, and idiocies like the precautionary principal, and sorneyns exley, this then gives them reason to expand or create more government control. then the idiots scratch their heads when famous scientist go to places like singapore for biotech, and companies do their IPOs in other stock exchanges instead of NY. More examples of American shooting itself in the foot. There's plenty of people, the fifth columnists that want to see the States flop.

Off the subject...
I just heard that the Carbon Credits market is doing $100 billion worth of transactions today. However, when the underlying "carbon savings" events are examined it is impossible to determine just who is doing what to earn those dollars. Apparently a carbon credit is a vanilla piece of paper without supporting documents.

This might be some dirty producer in the Ukraine purchasing a smoke-stack scrubber with the money. And that might be OK. Or it could be some kid in Jakarta planting a palm tree in the jungle...Or it might be absolutely nothing at all. Some sort of Trust account that should someday fund a study. If that entity is established in a jurisdiction that cannot be fully audited then those dollars simply disappear. For certain. This is a global endeavor.

We do have a lot of money to throw around uselessly and for political gain, don't we?

But we cannot simply go kill the mosquitoes? Fine, America. Great.

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