Why We Want The FDA To Revisit GRAS For GMOs.

Potential Rationale for revising FDA’s current GRAS policy governing regulation

of Genetically Engineered Foods

May 31, 2014

· In 1991, then Vice President Dan Quayle’s Council on Competitiveness called for regulation of Genetically Engineered products based on their performance, not the processes by which they are produced.

· These directives resulted in a system in which the USDA, EPA and FDA regulate GE crops and foods under existing laws, with the responsibility for regulation resulting in USDA’s oversight over plants, EPA over pesticides and FDA over foods.

· The Federal Food, Drug, and Cosmetic Act (FFDCA) grants FDA authority to ensure the safety of all domestic and imported foods.

· FFDCA requires pre-market safety testing of any food additive (defined as a substance intentionally added to food) unless a decision is made that the additive is Generally Recognized as Safe (GRAS). GRAS substances do not require testing of any kind.

· A 1992 Statement of Policy promulgated by FDA argues that genes added to common food substances via genetic engineering are GRAS because the new food is largely the same as its conventional counterpart. (Policy referred to as “Substantial equivalency.”)

· Consequently, the FDA does not require pre-market testing, nor does it impose any obligations on the biotechnology industry.

· The FDA’s own internal files attest that none of these GE foods has been backed by technical evidence of safety as the FFDCA requires.

· The preponderant majority of experts on the FDA’s Biotechnology Task Force has concluded that GE foods pose unusual risks and cannot be presumed safe.

· Federal law requires that material facts about food be disclosed through labeling. However, the FDA claims that the fact a food was produced via genetic engineering is not material because such foods have not been significantly altered and do not pose uncommon risk.

· We as healthcare providers have serious reservations that genetically engineered foods are neither studied nor safe and therefore strongly believe these should not be considered by FDA as GRAS.

· Therefore, we petition that genetically engineered foods be removed from the GRAS list, and be thoroughly studied, and labeled.


Showing 4 reactions

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  • Daniel Osman
    I understand that we may want people to sign-in in order to have all their information in order to make the signing of the petition simple but given that it does not appear unless the person is signed in, they may run into the same confusion I did when I read this post originally and could not figure out where there was a place to sign the petition or even if there was a place to sign the petition. It would help if we could have a link as part of the above post directly to where a person can sign the petition.
  • Daniel Osman
    Uh oh again. Now I see that the link I saw before titled “Ask FDA to revisit GMOs as GRAS” only appears if I am logged into the website. Is that what we want?
  • Daniel Osman
    Oops. Now I see on the right hand side of www.labelgmos.org webpage a link titled “Ask FDA to revisit GMOs as GRAS” – and that link takes the user to a citizen petition.
  • Daniel Osman
    What is the best approach for we citizens to help make positive progress with this petition?
    Is this petition going to be a resolution that we will attempt to get agreed to by legislators?
    Is there a citizen petition?
    Is this petition only for healthcare providers?
    Should we convert this text to a letter and sent it to the top of FDA?