Experts, Regulation, and Food

A few weeks ago I wrote a post on the Bassetti Foundation website called The Innovation Principle.

The post was a review of a letter sent by some of Europe’s largest corporations to the European Commission. The letter claims that regulation in the EU risks damaging development and the economy, they want a series of things to be taken into account within the regulation process.

It is easy to read and short and I recommend a look, it is free to download through the link above, but I would like to take one of their suggestions and apply it to food regulation, as part of my food series.

The letter calls for the “Full inclusion of relevant expertise”, and this sounds perfectly reasonable. But what does it actually mean in practical terms?

If we take the example of GM food development that I raised last week, it means finding experts in the field and putting them on committees to determine if proposals are safe. Now this means that you have to look to industry, because most of the experts work within the industry.

Now I believe that in all likelihood an expert working for a nuclear energy company will tell you that nuclear energy production is 100% safe, a nanotechnology researcher will paint a glowing picture of how the future is bright thanks to nano developments, and a GM food expert will do the same.

In the USA, the Federal Drug Administration is responsible for regulating the safety of GM crops that are eaten by humans or animals. According to a policy established in 1992, FDA considers most GM crops as “substantially equivalent” to non-GM crops. In such cases, GM crops are designated as “Generally Recognized as Safe” under the Federal Food, Drug, and Cosmetic Act (FFDCA) and do not require pre-market approval.

But here the waters start to murk and merge. As I said, experts in the field working or having worked for industries working with technology are likely to be positive about their products. And the FDA seems to contain several of these experts, and some of them may have helped to make the distinction above.

According to this IVN article, over the last decade at least 7 high ranking FDA officials have also held high positions in Monsanto, the largest producer of GM seeds in the world. This is generally accepted as true, and in fact Monsanto have several employees present or past that have held high ranking positions in other capacities in the US Government. This is known as the revolving door in the USA, and it is worthy of exploration.

Monsanto and US Government Employees

Monsanto and US Government Employees (click to enlarge)

The website states that “At the forefront of this controversy is Michael R. Taylor, currently the deputy commissioner of the Office of Foods. He was also the deputy commissioner for Policy within the FDA in the mid ’90s. However, between that position and his current FDA position, Mr. Taylor was employed by Monsanto as Vice President of Public Policy.

Other Monsanto alumni include Arthur Hayes, commissioner of the FDA from 1981 to 1983, and consultant to Searle’s public relations firm, which later merged with Monsanto. Michael A. Friedman, former acting commissioner of the FDA, later went on to become senior Vice President for Clinical Affairs at Searle, which is now a pharmaceutical division of Monsanto (Oh Donald Rumsfeld ex Secretary of Defense was also on the Board of Directors).  Virginia Weldon became a member of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, after retiring as Vice President for Public Policy at Monsanto”.

Another controversy surrounded the appointment of Margaret Miller. The following is taken from Red Ice Creations website:

“In order for the FDA to determine if Monsanto’s rBGH growth hormones were safe or not, Monsanto was required to submit a scientific report on that topic. Margaret Miller, one of Monsanto’s researchers put the report together. Shortly before the report submission, Miller left Monsanto and was hired by the FDA. Her first job for the FDA was to determine whether or not to approve the report she wrote for Monsanto. In short, Monsanto approved its own report. Assisting Miller was another former Monsanto researcher, Susan Sechen”.

Obviously I am not in a position to determine whether these allegations are true, but a look at this article that appeared originally in the Observer newspaper might lead one to believe that there is a fine line being walked here.

The article states that “Monsanto received copies of the position papers of the EC Director General for Agriculture and Fisheries prior to a February 1998 meeting that approved milk from cows treated with BST.

Notes jotted down by a Canadian government researcher during a November 1997 phone call from Monsanto’s regulatory chief indicate that the company ‘received the [documents] package from Dr Nick Weber’, a researcher with the US Food and Drug Administration (FDA).
Sources noted that Weber’s supervisor at the US FDA is Dr Margaret Mitchell who, before joining the agency, directed a Monsanto laboratory working on the hormone.”

Oh and the hormone treatment made the cows sick, but you can read Robert Cohen’s reported testimony before the FDA on the subject of rBGH including the disclosure that, while at the FDA and in response to increasing sickness in cows treated with the hormones, Margaret Miller increased the amount of antibiotics that farmers can legally give cows by 100 times. Once again I cannot verify the transcription but it is widely reported on the web and was apparently shown on C-Span Congress TV live.

I am not suggesting that there is any collusion here, and as Monsanto argue people move jobs, taking jobs that suit their qualifications. A look at these people’s profiles show that they have many different positions, many of which we would say were undoubtedly working for public good. But some suggest that some of their positions might lead to conflicts of interests. But if you need experts where are you going to get them from? Here though I might simply suggest that you don’t need so many experts.

Within my life’s work of trying to promote responsible innovation I have come to the conclusion that a broader public involvement within decision-making process must be a good for society. Closed sessions full of experts deciding what is or is not safe for us may be efficient in terms of getting things done, but the public’s voice is not heard, and maybe that voice could lead to more responsible choices, or at very least some reflexivity in the decision-making process.

On a closing note, arguments are currently raging in the US about the labelling of GM foods, as currently there is no need to label it, something pushed for by many organizations. There is a counter movement that is arguing that as the FDA state that there is no fundamental difference, GM products that do not contain additives should be allowed to be labelled as “natural”, in the way organic vegetables are. This Common Dreams article presents a critical view of current practices that although strongly worded offers an insight into how a section of US society thinks about the issue.

The question remains however, who do we want to regulate our food and the technology used in its production?

What actually is GM Food?

Last week I gave some statistics about GM food production both in the USA and worldwide, and this week I wanted to consider what genetic modification actually is. It appears to me that confusion reigns when addressing issues surrounding GM, so I would like to try and clarify a few issues.

GM exists in plants but also in animals as the salmon link showed last week (not currently approved for consumption), but we tend to associate it mainly with crops, so what does it entail?

In relation to the biggest crops that I mentioned last week, soybean, cotton and corn, there are 2 distinctly different approaches. The first is herbicide tolerance (HT) and the second insect resistance (Bt). In other cases nutritional changes have been made, but the major cash crops are based around the following approaches.

Herbicide-tolerant (HT) crops are developed to survive application of specific herbicides that previously would have destroyed the crop along with the targeted weeds. So you can plant your seeds and spray a herbicide that kills everything apart from your desired crop.

Herbicides target key enzymes in the plant metabolic pathway, which disrupt plant food production and eventually kill it. Genetic modification creates a degree of tolerance to the broad-spectrum herbicides – in particular glyphosate and glufosinate – which will control most other green plants.

Industrial Herbicide Techniques

Industrial Herbicide spreading Techniques

1. Glyphosate-tolerant crops
Glyphosate herbicide kills plants by blocking the EPSPS enzyme, an enzyme involved in the biosynthesis of aromatic amino acids, vitamins and many secondary plant metabolites.  There are several ways by which crops can be modified to be glyphosate-tolerant. One strategy is to incorporate a soil bacterium gene that produces a glyphosate-tolerant form of EPSPS. Another way is to incorporate a different soil bacterium gene that produces a glyphosate degrading enzyme.

2. Glufosinate-tolerant crops
Glufosinate herbicides contain the active ingredient phosphinothricin, which kills plants by blocking the enzyme responsible for nitrogen metabolism and for detoxifying ammonia, a by-product of plant metabolism. Crops modified to tolerate glufosinate contain a bacterial gene that produces an enzyme that detoxifies phosphonothricin and prevents it from doing damage.

The developers argue that use of this type of seeds cuts fuel usage and tilling as there are fewer weeds, (tilling leads to top soil loss as it is blown in the wind). They also argue that GM production has led to less herbicide use, and this seems to currently be the case.

Unfortunately one effect of this mass usage seems to be the development of ‘superweeds’, that are becoming resistant to theses herbicides. Farmers have had to address this problem by using more and different types of herbicide, with the journal Nature recently reporting a Pennsylvania State University research article that claims that pesticide use will increase dramatically in the very near future as a result, questioning the sustainability of the process. Something similar to the present antibiotics resistance problem that we are seeing in the human population. It should also be noted that the use of broad spectrum herbicides has grown as GM usage has grown, as its ease of application using the new seeds has made it more widespread, even though it only needs to be applied once.

Insect-resistant crops containing the gene from the soil bacterium Bt (Bacillus thuringiensis) have been available for corn and cotton since 1996. These bacteria produce a protein that is toxic to specific insects. Instead of the insecticide being sprayed, the plants produce the bacteria so the insects eat the plant and die.

There are risks associated with this approach as well as the advantage that farm workers are not exposed to spraying insecticides.

Invasiveness – Genetic modifications, through traditional breeding or by genetic engineering can potentially change the organism to become invasive. Few introduced organisms become invasive, yet it’s a concern for the users.

Resistance to Bt – The biggest potential risk to using Bt-crops is resistance. Farmers have taken many steps to help prevent resistance but as in the previous case it is a potentially serious problem.

Cross-contamination of genes, genes from GM crops can potentially introduce the new genes to native species.

Now I am no scientist as we all know but I presume that the human must consume the bacteria too, although scientists assure me that the bacteria is not harmful to humans or other mammals.

Much of the recent dramatic growth in GM usage can be attributed to the development of plants that offer both of these systems.

Next week I will take a look at the regulation of GM foods.

The FDA Shuts Down Home Genetic Testing Company 23andMe

On Monday the US Government FDA forced the main home testing company 23andMe to stop selling its saliva genetics home testing kit. As this is their only product this means that they effectively shut down their operation.

Looking at Genes

Looking at Genes

The problem seems to be that the company is offering testing for gene mutations that may lead to rises in probability of contracting diseases. This is considered a medical test by the FDA, and so they require trials and results in order to see how well the tests work before they license them. 23AndMe have been unable or unwilling to provide such results, so cannot market their device unless they take away all of the medical arguments.

This is the technical reason, but there are serious ethical issues surrounding home genetic testing. The following are just a few of my own ideas:

Without serious research doubt must remain about the quality of the results. The samples are not second tested, and the quality of testing cannot be of the same level as other medical hight cost exams. There have been problems reported due to the small number of people involved in the test groups, as statistics require masses of data that are not yet available.

Are customers qualified to interpret the results? What does a statistical rise in probability actually mean to a person that has never studied statistics or probability? And the results are delivered without any counseling, so if there is bad news the customer is left to process the information alone.

Here just a few examples might demonstrate the difficulty. If I have a 1% chance of contracting problem A, but I have a gene variant that means that I am 70% more likely to contract it, I might be distraught. The reality is that I now have a 1.7% chance, very little difference, but I might try to change my lifestyle, treat my kids differently, get paranoid, have preemptive surgery, who knows how an individual will react without medical advice?

If on the other hand I am negative for a mutation for something I might adopt an equally problematic stance. I don’t have the gene mutation that leads to skin cancer so I can stop worrying and have another hour on the sun bed. Social factors are really the big ones in many cases.

And what about testing your children? How will parents react knowing that their child might be susceptible to certain problems later in life?

Oh and if I discover that I have something hideous, should I tell my brothers? They might carry it and pass it on to their children. How personal is this type of medicine? It is familial, not individual.

The 23andMe problem is a prime example of money ruling. They have operated for 6 years, without regulation and blatantly challenging the FDA and medical profession that they see as holding up progress. As far as I can see this is about as far away from the responsible innovation that I have spent my recent life trying to promote as I would like to see anyone go. I would add though that it is a systemic problem here in the USA, not a personal divisive choice, and it is very different to the European approach underscored by the precautionary principal (with all its critics).

For further reading you will find several of my articles linked through this post on the same subject from last year.

The National Post has a good article too that includes both sides of the argument.