GMO Regulation: Find Out Why the U.S. Finally Joined the International Fray

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“Genetically engineered or genetically modified organisms (‘GMO’s, or ‘GM foods’) are defined as those in which ‘the genetic material (‘DNA’) has been altered in such a way that does not occur naturally.’ This methodology is then used ‘to create GM plants – which are then used to grow GM food crops.’”[1]

On July 29th, President Obama signed bill S.764 into law, creating the National Bioengineered Food Disclosure Standard, which was added as an amendment to the Agricultural Marketing Act of 1946 (U.S. Act).[2]Under this legislation, food producers are required to provide information about “bioengineered” food. [3] The law grants the Secretary of Agriculture (Secretary) a large amount of discretion in setting the standards for labeling and determining what exactly constitutes a bioengineered food.[4] Additionally, the U.S. Act defines food as that which “is intended for human consumption.”[5] Interestingly, the U.S. Act specifically excludes “food served in a restaurant, similar retail food establishment, and very small food manufacturers.”[6]

However, the food producing companies which are subject to the U.S. Act have been given flexibility in how to present information required by the Secretary to the consumer. This flexibility reflects a bipartisan compromise reached by Congress that allowed the bill to pass the House and the Senate.[7] The producer may elect to place a Quick Response Code (QR Code) on their packages, allowing consumers to scan the code with their phones for information prior to purchasing.[8] Alternatively, producers can place a phone number or a website on the package for consumers to utilize to obtain information.[9] This legislation effectively overturned Vermont’s recently passed labeling law, just before it was scheduled to go into effect, which required GM food to be labeled.[10] White House spokesperson Katie Hill described this new federal measure as “provid[ing] new opportunities for consumers to have access to information about their food.”[11]

Narendra Modi
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These “new opportunities and recent GMO regulation may be a new trend in the U.S., but the international community has been addressing biosafety concerns related to GMOs for over a decade. On January 29, 2000, the Cartagena Protocol on Biosafety (Protocol) was adopted, and it became effective on September 11, 2003.<[12] The stated objective of the Protocol is to:

[C]ontribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.[13]

Thus far, 166 parties have signed the Protocol, and the U.S. is not one of those parties.[14] Unlike the U.S. Act, the. Protocol explicitly provides a definition of “modern biotechnology,” removing the discretion the U.S. chose to implement in its Act.[15] The Protocol departs significantly from the U.S. Act in two major respects.

First, the Protocol places a strong emphasis on biodiversity. The Protocol prevents parties from making policy decisions in response to a lack of scientific information on the effect GMOs have on biodiversity.[16] The Protocol also requires parties to address the “sustainable use of biological diversity” when conducting risk assessments pursuant to the Protocol.[17]

Second, the Protocol focuses heavily on the movement of GMOs.[18] The Protocol addresses “intentional transboundary movement from one Party to another Party” or “export” as well as “intentional transboundary moment into one Party from another Party” or “import.”[19] This “transboundary movement” of GMOs applies to transfers between parties and non-parties as well.[20] A method for calculating damages associated with liability for this movement was proposed in the adoption of the 2010 Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (Supplementary Protocol).[21] To date the Supplementary Protocol has been ratified by 36 countries and “will enter into force on the ninetieth day after the date of deposit of the 40th instrument of ratification, acceptance, approval or accession.”[22]

Despite these focuses which differ from the U.S. Act, the Protocol still addresses labeling requirements. Packages must clearly identify that products “may contain” GMOs and also provide “a contact point for further information.”[23] Unlike the broad U.S. labeling requirements, the Protocol specifically provides a list of required information producers must provide, such as “any requirements for the safe handling, storage, transport and use.”[24] Importantly, these requirements do not apply to GMOs used within the country, only to GMOs that move transnationally.[25]

Thus, while the Protocol and Supplemental Protocol do a more comprehensive job of addressing ecological and transnational economic concerns, the U.S. Act is far more successful at controlling GMOs on a regional level. If the U.S. were to ratify the Protocol, producers would be subjected to far stricter regulations. However, given the difficulty and length of time taken to pass the U.S. Act in the first place, such a ratification does not seem likely.

[1] Ramona Bashshur, FDA and Regulation of GMOs, American Bar Association HealtheSource (Feb. 2013), [] (internal citations omitted).

[2] National Bioengineered Food Disclosure Standard of 2016, Pub. L. No. 114—216, 130 Stat. 834.

[3]Id. at § 291(1).

[4]Seeid. at § 293(b)(1) (“In general.--A food may bear a disclosure that the food is bioengineered only in accordance with regulations promulgated by the Secretary in accordance with this subtitle.”).

[5]Id. at § 291(2).

[6]Id. at § 293(b)(G)(i)—(ii).

[7] Michal Addady, President Obama Signed This GMO Labeling Bill, Fortune (July 31, 2016, 9:49 PM), [].

[8] Dan Charles, Congress Just Passed a GMO Labeling Bill. Nobody’s Super Happy About It, NPR (July 14, 2016, 5:34 PM), [].

[9] Peggy Lowe, Senators Reach Deal on National GMO Labeling Bill, NPR (June 23, 2016, 6:39 PM), [].


[11] Paul Blake, Obama Signs Bill Mandating GMO Labeling, ABC News (July 29, 2016, 6:10 PM), [].

[12]EXCOP 1 Decision EM-I/3: Adoption of the Cartagena Protocol and Interim Arrangements, Convention on Biological Diversity, id=7174 [] (last visited Sept. 15, 2016).

[13]Protocol on Biosafety, art. 1, Jan. 29, 2000, 2226 U.N.T.S. 208 [hereinafter Cartagena Protocol]; Protocol text in English.

[14]Parties to the Protocol and Signature and Ratification of the Supplementary Protocol, Convention on Biological Diversity, [] (last visited Sept. 16, 2016) [hereinafter Parties to the Protocol].

[15]SeeCartagenaProtocol, supra note 13, at art. 3(i). (“‘Modern biotechnology’ means the application of: a. In vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or b. Fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection.”).

[16]Id. at art. 10(6).

[17]Id. at art. 15(1).

[18]Id. at art 2.

[19]Id. at art. 3(c) & (e).

[20]Id. at art. 3(k).

[21]The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, Convention on Biological Diversity, [] (last visited Sept. 15, 2016).

[22] Parties to the Protocol, supra note 14.

[23]CartagenaProtocol, supra note 13, art. 18(2)(a).

[24]Id. at art. 18(2)(c) (“Living modified organisms that are intended for intentional introduction into the environment of the Party of import and any other living modified organisms within the scope of the Protocol, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter.”).

[25]Id. at art. 3(j).

Posted by Amanda L. Aragon on Sat. October 1, 2016 11:14 AM
Categories: Food and agriculture, GMO

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