On July 29 2016 President Obama signed into law S764, which mandates the establishment of federal disclosure standards applicable to "bioengineered" foods.(1) The enactment of S764 moves the United States one step closer to a coherent disclosure regime for certain foods that have been genetically engineered (GE) or that contain components of genetic engineering.
Approximately 64 countries in the world have some form of GE foods labelling requirement.(2) These requirements exist notwithstanding the clear scientific consensus that there are no food safety or environmental concerns associated with cultivating and consuming the GE foods currently planted and sold for consumption.(3) Notwithstanding this clear scientific consensus on the safety of GE foods, there are still many proponents of GE food labelling laws who insist that consumers have a "right to know" whether foods are genetically engineered or contain GE components.(4)
To address these insistent calls for GE food labelling, in 2015 the House of Representatives passed HR1599, the Safe and Accurate Food Labelling Act 2015. In the pertinent part, HR1599 included provisions that:
- mandated that the Food and Drug Administration (FDA) continue its voluntary consultation process for GE foods;
- explicitly stated that the fact that a food is genetically engineered is not material to a determination as to whether there is a difference in safety between a GE food and a conventional counterpart;
- allowed the FDA to require labelling of GE food if there is a material difference in the functional, nutritional or compositional characteristics of the GE food and if the disclosure of such differences is necessary to protect public health and safety;
- made it unlawful to sell in interstate commerce a food derived from a GE plant unless the FDA has determined that the food is safe for humans or animals;
- required the US Department of Agriculture (USDA) to publish on its website a registry of GE plants that have been evaluated by the USDA and the FDA;
- required that within one year of enactment the USDA issue "interim final regulations" to carry out the procedures required under the act; and
- pre-empted, as of the date of enactment, state and local requirements applicable to GE foods that are not identical to the actions of the USDA and the FDA.
HR1599 also required the USDA to establish a national GE food certification programme and national standards for the voluntary labelling of GE and non-GE foods.
However, HR1599 was not passed by the Senate, and on March 16 2016 the Senate failed, on a procedural vote, to move a companion voluntary labelling law. Notwithstanding the failure to progress the bill, Senators Pat Roberts and Debbie Stabenow (chairman and ranking member of the Senate Committee on Agriculture, Nutrition and Forestry) continued to work on a compromise approach, which they announced on June 23 2016. The compromise bill, S764, mandates that the USDA promulgate regulations establishing a mandatory disclosure regime for "bioengineered" foods. The Senate passed S764 on July 7 2016 by a vote of 63 to 30, and on July 14 2016 the House of Representatives passed S764 by a vote of 306 to 117.(5) Given the intense controversy over the labelling of GE foods, passage of S764 stands as a signature achievement of the 114th Congress.
S764 represents a compromise law that mandates disclosure of information regarding GE foods and food components, but allows substantial discretion in how this disclosure is accomplished. Within two years of enactment, the USDA must promulgate regulations establishing a mandatory disclosure standard for bioengineered food. Once the USDA promulgates these regulations, any disclosure that a food is bioengineered must be in accordance with USDA regulations. The regulations must require that disclosure be either in the form of text, symbol or an electronic or digital link, with the option to be selected by the food manufacturer. The regulations must prohibit food from animals consuming GE feed from being considered to be bioengineered, and must exclude food served in restaurants and produced by "very small food manufacturers".(6) S764 mandates that any bioengineered food that completes the federal pre-market review not be treated as less safe or safer than a non-bioengineered conventional counterpart. This is consistent with the position of the US regulatory agencies that GE foods present no unique risks when compared to conventional counterparts.(7)
An important aspect of S764 is the scope of foods that are subject to the disclosure requirements. S764 mandates disclosures related to bioengineered foods which, as defined by the statute, could constitute a narrow category of products. S764 provides that it "shall apply to any claim in a disclosure that a food bears that indicates that the food is a bioengineered food". A 'bioengineered food' is defined as a food "that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques" and "for which the modification could not otherwise be obtained through conventional breeding or found in nature". Taken literally, this may constitute a limited scope for bioengineered foods. By restricting the definition to food that "contains genetic material" and that has been modified in ways that "could not otherwise be obtained through conventional breeding or found in nature", S764 essentially limits the regulatory scope to foods that have not been processed to the extent that genetic material has been removed,(8) and for which the genetic modification could not be accomplished with sexually compatible organisms. Examples of the latter are the GE plants that express pesticidal proteins derived from the bacteria Bacillus thuringiensis. However, many plants that in the future may be developed using new gene-editing techniques such as CRISPR, TALENs, zinc finger nucleases and RNAi could conceivably be found in nature and could be developed through conventional breeding. Thus, the scope of gene-edited plants that do not fall under the definition of 'bioengineering' could be large.(9)
The USDA Office of General Counsel, in a letter to Stabenow, opined that:
"Section 291(1) of the Senate bill provides authority to include food in the national disclosure program, including products of certain gene editing techniques. This would include novel gene editing techniques such as CRISPR when they are used to produce plants or seeds with traits that could not be created with conventional breeding techniques."(10)
It remains to be seen how the USDA will describe the scope of covered foods in the implementing regulations, but the plain language of the statute appears to leave a potentially large universe of gene-edited constructs outside of its scope. Existing gene-editing techniques such as CRISPR, TALENs, zinc finger nucleases, and RNAi can certainly be used to produce gene-edited foods with alterations that could be found in nature and also be created through conventional breeding. In technical comments that the FDA submitted to the Senate Agriculture, Nutrition and Forestry Committee, it noted that "[i]t may be difficult to demonstrate that a particular modification could not be obtained through conventional breeding".(11) Thus, it may be anticipated that the issue of regulatory and definitional scope will almost certainly receive substantial attention in the rulemaking process for the implementing regulations.
S764 also imposes broad pre-emption of state and local government GE labelling requirements. S764 contains two express pre-emption provisions. The first provision, Section 293(e) of the statute, prohibits states or localities from establishing or continuing in effect any requirement relating to the labelling or disclosure of whether a food is bioengineered or was developed or produced using bioengineering for food products that are subject to the federal standard, unless the requirement is identical to the federal mandatory disclosure requirement. This provision is likely best read as not being effective before the promulgation of the USDA's implementing regulations. The second pre-emption provision, Section 295, is much more broad. Section 295 prohibits a state or local government from establishing or continuing in effect "as to any food or seed in interstate commerce" any requirement relating to whether a food or seed is genetically engineered or "was developed or produced using genetic engineering". This prohibition is not conditioned on consistency with federal regulations or any other limitation. Rather, it unequivocally prohibits a state or local government from establishing or continuing in effect a labelling or disclosure requirement applicable to genetically engineered food. Thus, upon the enactment of S764, the Vermont GE foods labelling law that went into effect on July 1 (Act 120) was immediately pre-empted.(12)
The enactment of a statute that mandates a national bioengineered food disclosure standard applicable to bioengineered foods and that pre-empts inconsistent state and local labelling requirements is a significant accomplishment. Notwithstanding this achievement, the debate over the role of GE foods and challenges to the use of bioengineering techniques can be expected to continue. This debate will now move to the rulemaking process, where many of the actual details of the national standards will be established by the USDA.(13) It will be incumbent on concerned companies and individuals to participate in this rulemaking (and, perhaps, in litigation that may follow) to ensure that their interests are represented in the implementation of the new US national bioengineered food disclosure standard.
For further information on this topic please contact Keith A Matthews at Sidley Austin LLP by telephone (+1 202 736 8000) or email ([email protected]).The Sidley Austin LLP website can be accessed at www.sidley.com.
(1) See www.whitehouse.gov/the-press-office/2016/07/29/statement-press-secretary-hr-2607-hr-3700-hr-3931-hr-3953-hr-4010-hr.
(2) These include Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Cameroon, China, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, El Salvador, Estonia, Ethiopia, Finland, France, Germany, Greece, Hungary, Iceland, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lithuania, Luxembourg, Malaysia, Mali, Malta, Mauritius, the Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Romania, Russia, Saudi Arabia, Senegal, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, the United Kingdom and Vietnam.
(3) Nicolia, A et al, "An Overview of the Last 10 Years of Genetically Engineered Crop Safety Research", 34 Crit Rev Biotechnology 77 (2014). See also www.aaas.org/sites/default/files/AAAS_GM_statement.pdf, which identifies a number of leading scientific bodies that declared that the GE foods produced to date bear no greater risk than conventionally produced foods. These include the American Association for the Advancement of Science, the American Medical Association, the US National Academy of Sciences, the British Royal Society and the World Health Organisation. Similarly, regulatory bodies worldwide, including the FDA, the Environmental Protection Agency, the European Food Safety Authority and other regulatory agencies around the world strictly scrutinise GE food products before approving them for consumption (www.cfr.org/agricultural-policy/regulation-gmos-europe-united-states-case-study-contemporary-european-regulatory-politics/p8688).
(4) See, eg, www.justlabelit.org/right-to-know-center/right-to-know/; www.vtrighttoknowgmos.org/.
(5) See www.congress.gov/bill/114th-congress/senate-bill/764/text.
(7) For example, see the FDA's response to a petition requesting that it impose mandatory labelling of GE food products. In denying the petition, the FDA noted that:
"The petition does not provide evidence sufficient to show that foods derived from genetically engineered plants, as a class, differ from foods derived from non-GE plant varieties in any meaningful or uniform way, or that as a class, such foods present any different or greater safety concern than foods developed by traditional plant breeding." (Letter from Leslie Kux, associate commissioner for policy, FDA, to Andrew Kimbrell, executive director, Centre for Food Safety (November 19 2015).
(8) For example, as the FDA noted, oils, starches and purified proteins derived from genetically engineered substances would not be covered by this definition. See www.centerforfoodsafety.org/files/fda-to-senate-ag-on-draft-legislation_29928.pdf. This, of course, is distinct from the labelling requirements in the European Union, which require labelling for foods that contain "derived" products (ie, foods that contain ingredients derived from a genetically engineered source that would not be identifiable by analysis, such as vegetable oils).
(9) See, for example, recent determinations by the USDA that GE plants developed using gene-editing techniques are not subject to regulation under the Plant Protection Act; Letter from Michael J Firko, APHIS deputy administrator, BRS, to Dr Yinong Yang, Pennsylvania State University, re Request for Confirmation That Transgene-Free, CRISPR-Edited Mushroom is not a Regulated Article (April 13 2016); and Letter from Michael J Firko, APHIS Deputy Administrator, BRS, to Dr Daria H Schmidt, DuPont Pioneer, re Confirmation of Regulatory Status of Waxy Corn Developed by CRISPR-Cas Technology (April 18 2016).
(10) See https://www.congress.gov/crec/2016/07/12/CREC-2016-07-12-pt1-PgS4994.pdf (emphasis added).
(11) See www.centerforfoodsafety.org/files/fda-to-senate-ag-on-draft-legislation_29928.pdf (emphasis in original).
(12) The USDA Office of General Counsel in a letter to Representative Michael Conaway, chairman of the House Agriculture Committee, opined that the pre-emption provisions of S764 are "triggered upon... enactment" (http://agriculture.house.gov/uploadedfiles/ogc_conaway_response_letter_070816.pdf). On August 2 2016 the Vermont attorney general acknowledged the pre-emption of Act 120, and announced that Vermont will no longer enforce that GE food labelling law (http://ago.vermont.gov/focus/news/attorney-general-will-not-enforce-ge-food-labeling-law-will-advocate-for-clear-on-package-labels.php).
(13) The USDA has already established a working group to establish the timeline for the rulemaking (https://www.ams.usda.gov/rules-regulations/gmo).