On July 14, 2016, the House of Representatives passed S. 764, “An Act to reauthorize and amend the National Sea Grant College Program Act, and for other purposes” by a vote of 306 to 117. S. 764 mandates that the United States Department of Agriculture (USDA) promulgate regulations establishing a mandatory disclosure regime for bioengineered foods. The Senate had previously passed S. 764 on July 7 by a vote of 63 to 30 after announcing a bipartisan compromise on June 23. Passage of S.764 marks a milestone and significant achievement by the U.S. Congress that will finally result in a coherent nationwide disclosure scheme for genetically engineered (GE) foods.
The issue of whether to require some form of labeling on GE foods has simmered for some time (see Food Manufacturing, May 24, 2016). A major concern has been whether the United States would end up with a patchwork of differing and inconsistent state and local GE food labeling requirements. Passage of S.764 ensures that will not happen. Following are five things you need to know about how this legislation will impact food labeling and marketing in the United States:
1. S. 764 Mandates Disclosure of Certain GE Components in Foods
In contrast to H.R. 1599 (the Safe and Accurate Food Labeling Act of 2015) which passed the House of Representatives in 2015 and authorized a voluntary GE foods labeling scheme, S. 764 requires mandatory disclosure of bioengineered foods. Any disclosure that a food is bioengineered could only be in accordance with regulations that are to be promulgated by USDA. 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. Similar to H.R. 1599, S. 764 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. S. 764 also contains strong preemption provisions that prohibit any state or local government from establishing or continuing in effect any requirement relating to labeling of whether a food is genetically engineered or was developed or produced using bioengineering. Significantly, S. 764 preempts requirements applicable to “genetically engineered” foods, whereas the mandatory disclosure regulations to be promulgated by USDA will apply to “bioengineered” foods. Thus, the preemption provisions sweep more broadly than does the disclosure mandate.
2. Disclosure Requirements Would Be Implemented by USDA not FDA
H.R. 1599 established significant implementation roles for both FDA and USDA. S. 764, in contrast, places the bulk of authority for development and implementation of the disclosure standard with USDA. This approach is notable because while most FDA-regulated food products come within the scope of S. 764, only USDA-regulated meat, poultry or egg products that predominantly contain ingredients other than meat, poultry or eggs, such as frozen pepperoni pizza, are included in S. 764’s scope. Thus, disclosure is not mandated for meat, poultry or egg products that lack a substantial proportion of ingredients subject to FDA jurisdiction (e.g., certain varieties of frozen chicken entrees). As FDA noted in its comments to the Senate Agriculture Committee, USDA will have authority with respect to “food labeling that is otherwise under FDA’s sole regulatory jurisdiction.” In some ways, this incongruous approach is similar to USDA’s regulation of “organic” labeling, which applies to food products that are otherwise regulated by FDA. FDA also stated in its comments that it has not sought responsibility for a mandatory bioengineering disclosure program because of its long-held position that bioengineering in foods does not present safety concerns and therefore is not a material fact requiring disclosure. In fact, FDA reiterated this position as recently as November 2015 when it issued a final guidance permitting voluntary labeling for bioengineered and non-bioengineered foods. S. 764 mandates that bioengineered foods meet the requirements of USDA’s implementing regulations. It remains to be seen, however, whether FDA’s guidance will remain in effect with respect to voluntary labeling of foods that do not fall within the scope of bioengineered foods.
3. S. 764’s Disclosure Mandate Applies to Bioengineered Foods, a Potentially Restrictive Definition
Section 292 of S. 764 provides that it “shall apply to any claim in a disclosure that a food bears that indicates that the food is a bioengineered food.” Section 291(1) defines “bioengineering,” with respect to a food, 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.” This may be interpreted as an extraordinarily restrictive definition of bioengineering. 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,” S. 764 essentially limits regulatory scope to foods that are minimally processed (i.e., not processed to the extent that genetic material has been removed) and derive from or contain transgenic organisms. For example, plants engineered to express Cry endotoxins derived from the bacteria Bacillus thuringiensis (B.t.) likely could not be developed through conventional breeding, nor or they likely to be found in nature. Many plants that may be developed using new gene editing techniques such as CRISPR, TALENs, zinc finger nucleases and RNAi certainly could conceivably be found in nature and developed through conventional breeding. Interestingly, in a letter to Senator Debbie Stabenow, Ranking Member of the Senate Committee on Agriculture, Nutrition and Forestry, the USDA General Counsel 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.” This statement merely restates the bill language and does not address what would be expected to be the much more common situation of CRISPR (also TALENs, ZFN and RNAi) being used to produce gene edited foods with traits that could also be created through conventional breeding, just not as efficiently. It should also be noted that FDA, in its technical comments to the Senate Agriculture Committee, noted these same points. The issue of regulatory and definitional scope will almost certainly receive substantial attention in the rulemaking promulgating the implementing regulations.
4. S. 764 Imposes Broad Preemption of Labeling Requirements Applicable to Genetically Engineered Food
S. 764 preempts all state and local labeling requirements applicable to GE foods that are not identical to those set forth in the regulations to be promulgated by USDA. S. 764 contains two express preemption provisions. The first provision, section 293(e), prohibits states or localities from establishing or continuing in effect any requirement relating to the labeling 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.” The language of this provision could lead one to believe that states or localities are authorized to adopt non-identical requirements for foods that are not subject to the federal standard, such as foods served in a restaurants.
The second preemption provision, section 295, sweeps much more broadly. 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.” Together, these preemption provisions prohibit state or local governments from establishing non-identical labeling requirements for bioengineered food products that are subject to the federal standard as well as any requirements for bioengineered or GE food products that either the statute or USDA’s implementing regulations exempt from the standard (e.g., restaurant foods). Thus, state labeling requirements applicable to GE foods, such as Vermont’s “GMO” foods labeling law, or similar laws passed in other states that have not gone into effect, are preempted.
Note that in a letter to Representative Michael Conaway, Chairman of the House Agriculture Committee, the USDA General Counsel opined that the preemption provisions of S. 764 are “triggered upon . . . enactment.” Should the bill become law, the Vermont GMO labeling requirements could be immediately preempted. Note also that foods exempted from the federal standard are shielded from state or local bioengineered or GE food labeling mandates. S. 764 exempts from disclosure meat, eggs and poultry products regulated by USDA that do not also contain a substantial proportion of ingredients subject to FDA jurisdiction, foods under a concentration level to be established by regulation, food from animals raised on GE feed, food served in restaurants, and foods produced by very small manufacturers. Given the preemptive effect of the federal requirements, USDA’s interpretation of which food products are or are not covered, such as dietary supplements which were exempted from Vermont’s GMO labeling law, will be of significant interest. There are other questions as well including whether the preemptive provisions affect state or local measures aimed at preventing food manufacturers from using terms like “natural” for bioengineered foods, among other things.
5. USDA Must Conduct a Study to Determine the Adequacy of Digital Disclosures
Section 293(c) of S. 764 requires USDA to conduct a study regarding electronic or digital disclosures to determine whether there may be “potential technological challenges” that could affect whether consumers will have adequate access to bioengineered food disclosures provided by such methods. The study must examine how consumer access may be affected by a range of factors, including availability of wireless internet or cellular networks, other issues specific to small and rural retailers and related costs and benefits. Should USDA conclude that electronic or digital disclosure methods would not provide consumers with sufficient access to bioengineering disclosures while shopping, USDA must work with industry to provide “additional and comparable options to access the bioengineering disclosure.” Despite this, consumer groups have objected to the digital disclosure option on the basis that it discriminates against low-income and elderly consumers who may lack smartphones and those living in areas with poor internet connectivity. According to press reports, the Center for Food Safety is considering a lawsuit challenging the bill as discriminatory if President Obama signs it into law.
Passage of a statute that mandates national standards for disclosure of information relating to GE foods and preempts inconsistent state and local labeling requirements is a significant accomplishment of the 114th Congress. Notwithstanding this achievement, the debate over the role of GE foods and challenges to modern science-based agriculture can be expected to continue. Many of the actual details of the national standards are to be established by USDA in implementing regulations. Concerned companies and individuals will need to be diligent in participating in this rulemaking and, perhaps, in litigation that will follow, to assure that the proponents of bioengineering are well represented in the implementation of these statutory mandates.