Genetically Engineered Salmon Labeling Act (HR 4713, 114th Congress)

The Policy

What it does

Requires genetically modified salmon to be labeled accordingly and calls for independent scientific review of FDA activities relating to AquAdvantage Salmon.

Synopsis

Genetically modified food is a subject of constant study and debate. This bill requires labeling of genetically engineered salmon and the independent scientific review of the Food and Drug Administration’s (FDA) approval related activities.  Specifically, HR 4713:  

  • Defines genetically engineered salmon as those animals “modified by recombinant DNA (rDNA) techniques, including the entire lineage of salmon that contain the rDNA modification;”
  • Requires salmon modified using rDNA to be labelled as “Genetically Engineered” or “GE” prior to the existing acceptable market name to ensure that U.S. consumers can make informed decisions; and
  • Mandates that the Secretary of Health and Human Services ensures independent scientific review of an FDA environmental review supporting approval of AquAdvantage Salmon’s 2015 animal drug approval.  The bill’s stated purpose for third-party review is to:
    • Discern the impacts of genetically engineered salmon on wild salmon stocks, and
    • Inspect the FDA’s approval of genetically modified salmon for human consumption.

Context

<p><a href="http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryIn... regulation</a> 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, GM animals 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 modification to be a materially different, requiring mandatory labeling.</p>

The Science

Science Synopsis

Genetically modified organisms (GMOs) are developed using complex lab-based measures that specifically alter genetic material in order to introduce non-natural, desirable traits or delete less desirable ones. The genome of an organism can be edited to either:

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

The introduction of foreign genetic material can provide many advantages, such as

  • Increased yields, increased resistance to pests and disease (and reduced need for pesticides), enhanced crop nutrient content, and enhanced crop viability in harsher 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.

Extracting or isolating DNA from a ‘donor organism’ and modifying the DNA in the lab to either delete or introduce new genes is known as recombinant DNA technology. This newly engineered DNA can then be inserted into the host organism to produce genetic combinations not naturally found in nature. 

Atlantic salmon have been genetically engineered using recombinant DNA to increase their growth rate, allowing the fish to reach full size much quicker than its non-GMO counterparts. AquAdvantage salmon, produced by by AquBounty technologies, is the first genetically modified animal cleared for public consumption by the FDA. 

Relevant Experts

Alison Van Eenennaam, PhD

The recent NAS report [The National Academies of Sciences - Genetically Engineered Crops: Experiences and Prospects] that a process-based regulatory approach is becoming less and less technically defensible as the old approaches to genetic engineering become less novel and as emerging processes — such as genome editing and synthetic biology — fail to fit current regulatory categories of genetic engineering. They recommended a tiered regulatory approach focused on any intended and unintended novel characteristics of the end product resulting from the breeding method (i.e. phenotype) that may or may not present potential hazards, rather than the process or breeding method by which that genetic change was achieved.”

Relevant publications:


The Debate

Endorsements & Opposition

At present, there have not been publicly reported endorsements or opposition specifically to this bill.

The broad debate surrounding genetically modified organisms and labeling requirements, however, continues to be highly contested.

  • Some argue that GMOs are safe for consumption and can offer public health, agricultural, and economic benefits. Studies to-date have found no evidence of negative effects on human health associated with the consumption of GM foods. The US National Academy of Sciences, the UK’s Royal Society of Medicine, the European Union, and the WHO studied and declared GM crops are safe for human consumption; the FDA also conducted a scientific review of the safety and effectiveness of genetically modified salmon. In November, 2015, the FDA approved the “Farm-raised Atlantic Salmon of Panama” for public consumption; however, regulatory debates surrounding the labeling of this GM salmon have since kept it off the market.
  • Others advance several concerns surrounding GM foods. If released into the wild, GMOs may outcompete and eliminate their wild plant and animal counterparts. Additionally, some worry that inserting foreign DNA into an organism (as accomplished using the rDNA technique) could potentially increase the risks to humans consuming GMOs, like increased allergic reactions or transferred antibiotic resistance; however, a recent review of GMO foods by the National Academy of Sciences found no evidence of such increased risks associated with GMO foods over their non GMO counterparts.
  • Regarding labels, those against the requirement to clearly label GMOs claim that the public unnecessarily fears such foods due to a lack of knowledge and understanding. Anti-labelers further argue that mandatory GMO labeling imposes an additional undue burden since GMO foods are less likely to be bought than their non-GMO counterparts.
  • Proponents of GM food labels argue the public has a right to know which foods are genetically modified, so that consumers may make informed decisions about the consumption of GM foods.