The Biotech Industry is Poorly Regulated. Fr. Seán McDonagh, SSC (June 14th 2009)

In the introduction to the booklet of the Pontifical Academy of Sciences’ Study Week on “Transgenic Plants for Food Security in the Context of Development” the convenor, Dr. Igno Potrykus claims that “GMO-overregulation  makes the use of GMOs for the public sector inaccessible for cost and time reasons.”  One of the aims of the Study Week was to “free the technology from the unhealthy constraints of ‘extreme regulation.’ ”  A paper on this theme entitled, “Gene-splicing is Over-Regulated, but Science Shows a Better Way” was given by Henry Miller. [1] In his abstract he writes that “excessive and unscientific, poorly conceived regulation has been the most significant obstacle” to more general acceptance by farmers of GM technology. [2]


Dr. Henry J Miller worked for the Food and Drug Administration (FDA) from 1979 to 1994. He served as Special Assistant to the FDA Commissioner, with responsibility for biotechnology issues from 1984 to 1989. Today he is a senior research fellow at the Hoover Institution which promotes both the free market and limited government. The Hoover Institute’s home page states that, “he was the medical reviewer for the first genetically engineered drugs evaluated by the FDA and was instrumental in the rapid licensing of human insulin and human growth hormones.” [3] Miller  has played a  crucial role in the licensing of GMOs in the United States and by extension in almost every other country.


Many scientists disagree with Miller’s claims.  Dr. Don Lotter in his article “The Genetic Engineering of Food and the Failure of Science: Part 1: The Development of a Flawed Enterprise” insists that “in the early stages of the development of crop transgenics in the 1980s, thorough scrutiny of this truly radical technology would likely, in this author’s opinion, have led to restrictions on cultivation and marketing of transgenic products and may have resulted in non-approval altogether.”[4] The reason this did not happen was the “early influence of the biotechnology industry, better termed dominion, over the highest levels of the federal regulatory agencies, which led to a ‘hands-off’ policy regarding regulation of transgenic foods.” [5]


During the Presidency of Ronald Reagan and George H.W. Bush in the 1980s, Lotter claims that, “Monsanto created a ‘support for biotechnology’ at the highest U.S. policy levels right up to the White House.” [6] One strand in this strategy was to “develop a ‘revolving door’ policy between the highest executive-related positions at Monsanto and the top positions of the federal regularly agencies.” [7] This tactic continued under the Presidency of Bill Clinton and George W Bush.


The most important element in facilitating the acceptance of GM crops was to have them treated in a similar way to non-genetically engineered crops. This is called the doctrine of ‘substantial equivalence’.  There was serious resistance from scientists from within the FDA to both the doctrine of ‘substantial equivalence’ and the ‘light touch’ approach to regulating GM food.  Lotter refers to a 2004 paper by Freese and Schubert which showed that “there were internal FDA memos documenting and overwhelming consensus among the agency’s scientists that transgenic crops can have unpredictable, hard-to detect side-effect – allergens, toxins, nutritional effects, new diseases.” [8] These reservations were brushed aside.


There was an even more ludicrous element to the regulatory process. It was essentially voluntary. “Companies that wish to release a genetically engineered food onto the market decided whether or not to consult with the federal agencies, and decided what data to submit. The FDA does not test the products for safety (Mellon and Rissler, 2003). The regulators rely almost exclusively on information provided by the biotech crop developer, and the data is not published in journals or subjected to peer review (Friends of the Earth 2004).”[9]


In all of the above there is a huge conflict of interests.  The company which was submitting data for approval was likely to make billions of dollars from their new product.  Lotter refers to a 2005 Monsanto marketing document which projected that “full adoption of GM crops globally would result in income gains of US$210 billion per year for the next decade, with the largest potential gains occurring in developing countries at the rate of 2.1 percent gross national product per year.” [10] Public and private money is being used to push GM crops on poor countries.  According to Lotter’s research the US Agency for International Development (USAID) is “mandated to partner with US biotechnology corporations to promote the companies’ crops in developing countries.” Well endowed agencies such as the Rockefeller and Gates Foundations are promoting GM crops in Africa, even though numerous studies state that GM crops have little role to play in combating hunger.




[1] . Henry Miller, Hoover Institution, accessed on February 7th 2009.

[2] Introductory booklet for the Study Week of the Pontifical Academy of Sciences, page 11.

[3] Henry Miller, op.cit., accessed February 7th 2009.

[4] Don Lotter, “Genetic Engineering of Food and the Failure of Science – Part 1: The Development of a Flawed Enterprise”,  International Journal of  Sociology of Agriculture and Food, Vol 16, No 1, page 33.

[5] . Ibid page 33.

[6] Ibid page 36.

[7] Ibid page 36.

[8] Ibid page 36.

[9] Ibid page 36.

[10] Ibid page 35.


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