US Food Standard: Reasonable Certainty of No Harm

There seems to be some confusion among people I have interacted with recently as to whether the standard for food safety in the United States is one of “relative safety,” i.e. one that permits foods, food additives or foods with pesticide chemical residues to be marketed as long as their benefits have been deemed to exceed their risks, or one that focuses on “safety” (without regard to benefits or regulatory costs) and requires a “reasonable certainty of no harm” for all products in the American food supply.

So I asked a representative from the US Environmental Protection Agency (EPA) during the public engagement session on how the products of agricultural biotechnology are regulated in the US (held at UC Davis on March 30 in response to a White House request for a review of the US “Coordinated Framework” for regulating GMOs):

What is the US standard? “Relative safety” or  “safety”?

His answer (not a direct quote): According to the US federal Food, Drug, and Cosmetic Act (the Act), the primary food safety statute in the United States, the standard for food safety is “reasonable certainty of no harm,” not relative safety.

And this standard applies to all foods in the US, whether GE, organic and/or produced using industrialized agriculture.

In researching this topic, however, I can see how it could be seen as confusing.

For one thing, the 1906 federal Food, Drug and Cosmetic act (345 pages long and amended multiple times, starting in 1958) doesn’t provide much of a definition of “safety.” This is how “safety” is defined in it: The term ‘‘safe,’’ as used in paragraph (s) of this section and in sections 409, 512, and 721, has reference to the health of man or animal.

That’s it.

It also appears, according to an article in the Ecology Law Quarterly by Daryl M. Freedman, that the US Food and Drug Administration (FDA) and various US courts do not necessarily adhere well to this standard of “reasonable certainly of no harm” (at least not back in the 1970s!).

But I think Freedman’s article is still amazingly relevant to not only regulation of GMOs but to other food-related issues being debated today as well.

For example, the author quotes members of Congress from back in the times various amendments to the Act were being considered, shedding light on the concerns expressed by congressional members about regulatory costs, the limits of science, etc.

Despite these concerns, however, Congress still supported the strict standard of safety: “reasonable certainly of no harm.”

For anyone interested in the safety of the American food supply and how we regulate foods, produced using new biotechnologies or otherwise, I highly recommend this article…because we should know where we have come from so that we can more wisely decide where we should be heading.
This entry was posted in Biotechnology and tagged , , , , , . Bookmark the permalink.

2 Responses to US Food Standard: Reasonable Certainty of No Harm

  1. Thanks for the link to the law review article “Reasonable Certainty of No Harm: Reviving the Safety Standard for Food Additives, Color Additives, and Animal Drugs,” by Daryl M. Freedman. I have been reading some law review articles lately, and stumbled onto one from 1989: “Federal Regulation of Genetically Engineered Food Additives and Pesticides,” by Warren Ausubel, Berkeley Technology Law Journal, Vol. 4, Issue 2; January 1989 (33 pages). It is interesting to see from a historical perspective how the author tries to predict variations possible outcomes that may occur with the Coordinated Framework (before the official 1992 policy by the FDA was announced).
    I have also been doing a lot of research on glyphosate – after the IARC classified it as a Group 2A probable carcinogen. (Just the other day, Hugh Grant, the CEO of Monsanto, asserted that glyphosate is not cancerous). In the 1989 article, Ausubel conveys great optimism when he says: “Biotechnology techniques may prove to be very helpful in the development of products which could be used to eliminate the current reliance on carcinogenic pesticides and additives.” If I am correct, I recall reading several statements from Monsanto about such predictions during that time as well.
    It’s unfortunate that when the U.S. agencies do a risk assessment of another new GMO glyphosate tolerant brand, they fail to consider the cumulative effects that additional similar brands will have on the environment – or on human health. As Rebecca Bratspies states in the Vermont Law Review, “A regulatory system that cannot, or will not, analyze the cumulative effects of glyphosate-resistant crops on the development of glyphosate-resistant weeds in deciding whether to approve commercialization of these crops defies logic,” (“Is Anyone Regulating? The Curious State of GMO Governance in the United States,” Vermont Law Review, Vol. 37; 2013). This observation was echoed by Rebecca K. Stewart in “Weeds, Seeds & Deeds Redux: Natural and Legal Evolution in the U.S. Seed Wars,” (Stanford Technology Law Review, Vol. 18:79; 2014) when she stated: “As things currently stand, there are no regulatory mechanisms in place to review the cumulative environmental impacts of glyphosate use before glyphosate resistant crops enter the U.S. marketplace.”
    In 2013 you wrote a blog post, “Should Monsanto be the Target?” where you raised a very good point. If I understand it correctly, the goals of certain activists may be better served if they focus more on targeting our regulatory agencies, and perhaps consider putting less focus on trying to ‘stop’ Monsanto. As long as the three agencies allow these biotech giants to have their way, those corporations will take full advantage of the situation; after all, they are legally bound to do what is in the best interests of their shareholders, which is to make a profit. Don’t get me wrong – I despise Monsanto for many reasons, but I do question the (lack of) effectiveness of focusing entirely on one corporation to try to bring about change.

    • Belinda says:

      And don’t get me wrong…I am very disappointed in Monsanto, other biotech companies and plant molecular biologists, most of whom have conflicts of interest when it comes to determining how best to regulate the products of their labs prior to those products being served on children’s dinner plates or released into the greater environment. There are risks associated with the “traditional” methods of genetic engineering, there are “imprecise” aspects of these technologies that scientists in biotech companies and academic research labs aren’t telling the public about–and those scientists should know better.
      But the regulatory system sits at the interface between labs and grocery stores when it comes to our food in the United States. And the FDA, EPA and USDA are all we have got to protect our food and environment from developers who may well have good intentions but also have those conflicts of interest that appear to be preventing them from being abjectly honest about the risks associated with the process(es) of genetic engineering. One of the big jobs of a good democracy, in my opinion, is to keep the capitalists–whose mandate, after all, is not the “public good” but the “bottom line”–in check. Our U.S. democracy has let us down in this regard over the last two decades of “regulating” the agricultural products of genetic engineering.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s