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What it does 

The FDA closely monitors food labeling; however, no uniform standards previously exist for labeling food that is considered bioengineered. Public Law 114–216 (S 764) establishes a definition of bioengineered food and requires the Secretary of Agriculture (“Secretary”) to promulgate regulations for labeling such foods. This legislation would void and preempt state labeling laws in favor of a national, uniform label. Specifically, the bill amends the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.) by adding new sections that address:  

  • Definitions - ‘Bioengineering’ refers to a food:
    • “That contains genetic material that has been modified using in vitro recombinant deoxyribonucleic acid (DNA) techniques”; and
    • “for which the modification could not otherwise be obtained through conventional breeding or found in nature”; 
  • Application: Bioengineered disclosure labels will only be required for food that is subject to labeling requirements under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), Federal Meat Inspection Act (21 U.S.C. 601et seq.), Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 103 et seq.);
  • Mandatory Standard - Within two years of enactment, the Secretary must establish a mandatory national bioengineered food disclosure standard, including requirements and procedures to carry out the standard. Regulations must include:
    • Prohibiting a food derived from an animal to be deemed bioengineered solely because its feed contains a bioengineered substance;
    • Determining the quantity of a bioengineered substance in food necessary for it to be considered bioengineered; and
    • Requiring that the form of disclosure labeling be a text, symbol, electronic or digital link (i.e. QR code), with the disclosure option selected by the food manufacturer.
  • Study- Within one year of enactment, the Secretary must identify potential technological challenges consumers may face in trying to access the disclosure information through electronic or digital means. The process shall include an opportunity for public comments and consideration of certain factors, such as the availability of wireless networks and obstacles for rural retailers. If the Secretary concludes that consumers would have insufficient access to disclosure information while shopping, the Secretary shall provide additional options.
  • Disclosure- Associated on-package language is limited to stating only technological phrases such as “scan here for more food information.” The label must be displayed in a conspicuous and consistent manner, taking a consumer directly to a site page overviewing the disclosure that excludes marketing information and does not capture and maintain any personally identifiable data.
  • Existing Law- Restricts continuation or establishment of state law that is not identical to the mandatory national bioengineered food disclosure standard.  The Secretary is also directed to consider establishing consistency between the standard and the Organic Food Production Act of 1990 (7 U.S.C. 6501et seq.) (only foods certified as such may claim to be “not bioengineered”).
  • Enforcement- Prohibits knowingly failing to adhere to the mandatory national bioengineered food disclosure standard and also establishes standards for recordkeeping and audit performance.
Relevant Science 

Bioengineered foods are a class of genetically modified organisms (GMOs). GMOs are developed using lab-based techniques, often referred to as “recombinant DNA techniques” that specifically alter genetic material, a substance composed of DNA, in order to introduce non-natural, desirable characteristics or delete less desirable ones.

The genetic material of an organism can be edited to either:

  1. Insert a gene from another organism; or
  2. Delete a piece of DNA from the original organism’s genome.

The introduction of foreign or non-natural genetic material can provide many advantages, such as increased production, increased resistance to pests and disease (and reduced need for pesticides), enhanced crop nutrient content, and enhanced crop viability in harsh soil and weather conditions. GMOs do not refer to living organisms that have been modified through selective breeding, a technique that has historically been used in agriculture to select for plants with high yields or sweet fruits.

Relevant Experts 
Background 

FDA regulation prohibits mandatory labeling about a food’s production method if there is no “material difference” in the product due solely to the production process. The FDA has not found that, as a class, GMO foods differ materially in nutritional value, organoleptic properties (those components that stimulate the sensory organs, such as texture or aroma), or functional characteristics. Therefore, the FDA does not consider a food made by genetic engineering to be materially different, requiring mandatory labeling.

Endorsements & Opposition 

Both the purpose of GMO labels and the methods of this disclosure continue to be debated.

Endorsements:

  • S. 764 has broad support from food producers, industry trade groups, and GMO labeling advocates.
  • On mandatory disclosure labels for bioengineered food, the Grocery Manufacturers Association a trade group representing the food industry, states in a letter of support: “We thank Senators Roberts and Stabenow for their hard work and leadership to find the solution that can give consumers more information about genetically engineered ingredients and prevent different state labeling laws...America’s food industry fully supports the disclosure provisions in this legislation. GMA members are committed to making available the product information that consumers want. We are pleased to see that the legislation enables transparency, clarity and consistency in disclosure and reflects the wide variety of ways that consumers will get this information about the foods they buy.”

Opposition:

  • The Consumers Union, the advocacy branch for Consumer Reports, writes in a letter of opposition: “First, S. 764 undermines GE labeling occurring in the marketplace.  Labels marking products with GE ingredients are already appearing on store shelves across the country, in compliance with duly enacted state labeling requirements…the bill’s definition of “bioengineered” specifies that the bill applies to food “that contains genetic material that has been modified” through in vitro rDNA techniques. This would likely leave out many highly processed foods from GE sources without detectable genetic material, such as refined sugars, high-fructose corn syrup, oils, or proteins from GE plants.”
  • On the methods of disclosure, the Consumers Union letter continues, “S. 764 allows companies to employ methods of disclosure that are difficult to use, and are not available to all consumers. In particular, scanning a QR code may not be feasible for numerous consumers who are unfamiliar with the technology or who lack a smartphone, as three out of four older Americans and about half of rural residents do.”
Status 

Bill S. 764 was introduced to the Senate on March 17th, 2015 and referred to the Committee on Commerce, Science, and Transportation on July 23rd, 2015. On July 28th, 2015, the bill passed the Senate and was sent to the House; on September 18th, 2015, the bill passed the House. Next, on July 7th, 2016 the Senate amended the House version of S. 764 with a 63-30 (Yea-Nay) vote. The House then concurred to the Senate version with a 306-117 (Yea-Nay) vote. Finally, on July 29th, 2016, the bill was signed by the President and became public law.

Sponsors 

Senator Roger F. Wicker (R-MS) is the sponsor of S. 764 and Senator Dan Sullivan (R-AK) is an original cosponsor. 

Primary Author 
Bryan McMahon
Editor(s) 
Amy Hafez, PhD Candidate & Aubrey Incorvaia, MPP
Recommended Citation 

Duke SciPol, “Compromise Bioengineered Food Labeling Legislation (Public Law 114-216)” available at http://scipol.duke.edu/content/compromise-bioengineered-food-labeling-legislation-public-law-114-216 (07/29/2016).