July 3, 2018
Agricultural Marketing Service
Room 3071-S, Ag Stop 0201
1400 Independence Avenue, SW
Washington, DC 20250-0273
Re: National Bioengineered Food Disclosure Standard (Doc. No. AMS-TM-17-0050)
Dear Mr. Summers,
The Academy of Nutrition and Dietetics (the "Academy") appreciates the opportunity to comment on the Agricultural Marketing Service (AMS) of the United States Department of Agriculture's (USDA's) May 4, 2018 proposed rule implementing the National Bioengineered (BE) Food Disclosure Standard (NBFDS) (Doc. No. AMS-TM-17-0050) (the "Proposed Rule"). Representing over 104,000 registered dietitian nutritionists (RDNs),1 nutrition and dietetic technicians, registered (NDTRs), and advanced-degree nutritionists, the Academy is the largest association of food and nutrition professionals and is committed to a world where all people thrive through the transformative power of food and nutrition. Our members work in a variety of clinical and community settings across the continuum of care and work with industry and consumers to develop and effectively utilize product labels that influence individuals' food choices.
A. National Academies of Science, Engineering, and Medicine Report
The National Academies of Sciences, Engineering, and Medicine (the "National Academies") conducted a "study examining a range of questions and opinions about the economic, agronomic, health, safety, or other impacts of genetically engineered2 (GE) crops and food . . . to provide an independent, objective examination of what has been learned since the introduction of GE crops, based on current evidence (the 'National Academies Report')."3 The Academy of Nutrition and Dietetics' Positions Committee, Evidence Based Practice Committee, and our GMO Task Force followed a systematic process to identify a reputable and complete scientific report on genetically modified organisms (GMOs), and the Academy Board of Directors accepted their recommendation to support the National Academies Report as the most reputable and complete scientific report available to guide policy decisions. Thus, we are pleased to associate the Academy's comments with the recommendations and findings in the National Academies Report and we greatly appreciate the significant effort they undertook to identify a modern framework for the regulation of GE crops and a review of our country's experiences and prospects with them.
B. Academy's Labeling Principles
The Academy reiterates its ongoing commitment to working with government, industry, consumer, and scientific organizations in the hope of creating a balanced and effective regulatory structure. In 2014, the Academy adopted the following nine principles for labeling to guide development of our regulatory comments and policy stances. Recognizing that the BE food disclosure is a marketing claim without the health and safety purposes of the Food and Drug Administration's product labels and health claims for which our labeling principles were developed, our labeling principles with specific relevance to AMS's proposed rule are bolded below and appear (slightly edited) as headers for the applicable sections of our comments.
- Label claims should be clear and understandable to consumers; consumers' nutrition literacy is key to promoting understanding.
- The label must be truthful and not misleading.
- Content on the label should help consumers make informed decisions to build a healthy diet.
- Labels should help to provide understanding about the nutrient density and overall healthfulness of overall food rather than a focus on particular nutrients.
- Label content should have consistent type and format so products can be read and consumers can make product comparisons.
- Labeling should enhance consistency among the various government nutrition recommendations.
- All claims should include labeling of accurate quantitative information about the dietary substance, including percent of Daily Value in a single serving of the products, when known, or the daily dietary intake necessary to achieve the claimed effect.
- Consumer research is imperative before making changes to the label.
- The label is only a source of information, and thus sustained support for educational programs and individual counseling by registered dietitian nutritionists is essential.
C. Label Claims Should Be Clear and Understandable to Consumers
- Seek Consensus and Buy-In
The Academy notes one of the fundamental difficulties in creating a regulatory regime around the novel concept of "bioengineered foods" in the Proposed Rule is that the definitions seem appropriate and appear internally consistent until they no longer do, whether because of the mounting numbers of exceptions, exemptions, and variances or because of advances in scientific understanding. In creating the NBFDS, it is critical that its definitions are recognized by stakeholders as both consistent and grounded in science, such that there are clear legal and scientific reasons for exemptions beyond arbitrary policy and political reasons. Without consensus as to the definitions and the associated buy-in from all relevant groups recognizing their validity and usefulness, we are concerned that the public may neither trust nor have confidence in the BE food disclosure as an objective, accurate, consistent, or non-biased statement of fact.
- Text Disclosure and the Exclusive Use of "Bioengineered Food"
Consumers are confused by the Proposed Rule's mandate that the NBFDS will exclusively use the new term "bioengineered" in its disclosures, prohibiting use of the more familiar terms "genetically modified" and "genetically engineered." The highly-nuanced proposed definition for a "bioengineered food" rejects the plain meaning and broad applicability inherent in the term GMO by narrowing the class of products that must be labeled to food that "contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques' and 'could not otherwise be obtained through conventional breeding or found in nature.'" The USDA's refusal to regulate a mushroom with a modified genome as a GMO represents a similar narrowing of the class of traditionally regulated GE products, in this base because CRISPR technology modified the mushroom's genome using precision editing rather than the introduction of foreign genes.
The Academy emphatically recommends that AMS does not equate a government agency's determination that a particular category of GMOs may sidestep regulatory processes as effectively determining that this category of GMOs is exempt from the BE labeling requirements. The factors triggering premarket regulatory review and BE labeling are different, their purposes are different, and they address different priorities. The National Academies Report found that "[p]olicy regarding GE crops has scientific, legal, and social dimensions, and not all issues can be answered by science alone. Indeed, conclusions about GE crops often depend on how stakeholders and decision-makers set priorities among and weigh different considerations and values."4 The Report subsequently recommended that "[i]n addition to issues of product safety, socioeconomic issues that go beyond product safety are technology-governance issues that should be addressed by policy-makers, the private sector, and the public in a way that considers competing interests of various stakeholders and inherent tradeoffs."5 The Academy wholeheartedly agrees with the National Academies and seeks clarification to resolve ambiguity in the definition regarding its applicability to new and forthcoming GE technologies, including gene-editing, synthetic biology and RNAi. The Academy respectfully recommends that all genetically engineered foods from all forms of genetic engineering carry the NBFDS.
The Academy seeks clarification of AMS's rationale for prohibiting use of the commonly-understood, familiar terms "genetically modified" and "genetically engineered" to instead mandate use of "bioengineered," a term with which virtually no layman was familiar. We seek information about the specific efforts AMS intends to undertake to educate consumers about this new term, its definition, and the ways (if any) AMS understands a "bioengineered food" to be different than a "genetically-engineered food."
- Treatment of Technologies
Continued use of process-based definitions are likely to exempt many GMOs from needing to be labeled as such and to additionally exempt them from existing premarket safety reviews on the rationale that the modification could (over time) conceivably be replicated in nature or conceptually be produced through conventional breeding. The National Academies Report cautioned that "[b]y focusing only on particular forms of genetic engineering, such process-based regulatory approaches may be underregulating plants developed with other breeding processes that can pose equal or greater hazards, increase exposure, or create greater uncertainty about risk."6 The National Academies Report further highlighted reports from the National Research Council that "have consistently upheld the view that the process by which a food is made or a crop is bred is a poor indicator of risk. All technologies for improving plant genetics have the potential to change foods in ways that raise safety issues."7
AMS proposes to use the process for establishing and amending the food lists to assess whether the foods resulting from new or evolving technologies "may or may not meet the definition of BE food" and would be commercially available. The Academy agrees with the National Academies that "[t]he array of emerging genetic-engineering technologies, including genome editing and synthetic biology, makes it clear that any attempt by regulators to define the scope of a regulatory system through the definition of specified technologies will be rapidly outmoded by new approaches. Many of the emerging technologies will not be covered under existing rules."8 Notably, we seek to underscore that it would not be a positive development for new technologies to operate outside of a regulatory framework as existing rules atrophy from a lack of regulatory flexibility and the unwillingness of agencies to embrace the opportunity to start building a framework anew.
AMS can enhance the clarity of the NBFDS and consumers' understanding of it by engaging regularly with the public about relevant issues, using consumer-friendly plain language, staying current with newly-introduced technologies, and updating the list of bioengineered foods on a continuous, rolling basis rather than an annual update. In addition, the Academy concurs with the National Academies recommendation that "[r]egulating authorities should be particularly proactive in communicating information to the public about how emerging genetic-engineering technologies (including genome editing and synthetic biology) or their products might be regulated and about how new regulatory methodologies (such as the use of -omics technologies) might be used. They should also be proactive in seeking input from the public on these issues."9
D. The Label Must Be Truthful and Not Misleading
Section 201(n) of the United States Federal Food, Drug, and Cosmetic Act (FDCA) prohibits food labels from being "false or misleading," which is defined as a failure "to reveal facts that are material in light of representations made or suggested in the labeling, or material with respect to consequences that may result from the use of the food to which the labeling relates under the conditions of use prescribed in the labeling, or under such conditions of use as are customary or usual." The Proposed Rule states that "the purpose of the NBFDS is to provide a mandatory uniform disclosure standard for BE food to provide uniform information to consumers," but as detailed below, the NBFDS lacks uniformity across food types, lacks uniformity in the manner of disclosure, is riddled with exemptions that swallow the rule, and includes a loophole allowing meat-, egg-, and poultry-based food products comprised of 49 percent bioengineered food to avoid being labeled as containing any BE food at all.
- Exemptions for Meat, Poultry, and Egg Products
The Academy is troubled that the Proposed Rule would exempt from BE disclosure "foods subject to the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.) [unless either (1)] the most predominant ingredient of the food would independently be subject to the labeling requirements under the FDCA; or if the most predominant ingredient of the food is broth, stock, water, or a similar solution and the second-most predominant ingredient of the food would [not] independently be subject to the labeling requirements under the FDCA." We recognize that statutory language creates the loophole by which numerous meat, egg, and poultry food products will avoid being labeled a bioengineered food even if 49 percent of the product is composed of bioengineered ingredients, but the effect of the loophole is a hugely inconsistent double standard that will mislead consumers to believe they purchased a product that did not contain any bioengineered foods when in fact nearly one-half of it could well be.
Although the passage below from the National Academies Report details the flaws of a voluntary GE-labeling system, its critique is similarly applicable to a weak but putatively mandatory GE-labeling system so rife with exemptions and large loopholes that the absence of a GE-label on a product cannot reasonably be understood to correlate with the absence of any amount of GE-foods in the product:
For example, if non-GE labeling is voluntary, many products would have no label information about GE content. Consumers would not know whether the product contained GE ingredients and so would be deprived of the ability to make an informed choice about each product. Mandatory labeling provides the opportunity for consumers to make their own personal risk-benefit decisions (regardless of the regulatory determination of safety) and to express a preference for a method of production. A voluntary non-GE label places the burden on consumers who want to avoid GE foods to search for non-GE products and provides no information to consumers who may not be actively searching for the information but who might be informed by the label.10
The Academy does not support a double standard exempting egg, meat, and poultry products from BE labeling, and reiterates that regulations designating various foods as bioengineered or not should be recognized by stakeholders as both internally consistent and grounded in science, such that there are clear legal and scientific reasons for exemptions beyond arbitrary policy and political reasons.
- Definition of "Bioengineering" and "Bioengineered Food"
The Academy supports Position 2, "that the scope of the definition of 'bioengineering' includes all foods produced from bioengineering, such as highly refined products." The process of refining bioengineered food into processed food product does not magically erase its history or its present reality as bioengineered food. Moreover, the Academy rejects the assertion proffered for Position 1 that all genetic materials must have been removed during refining because common testing fails to detect it. The history of science is replete with examples of discoveries made possible with the introduction of more sophisticated devices and tests able to observe and identify what once was not believed to exist. Indeed, we note researchers have already detected DNA in many highly-processed or refined foods.11,12,13
We agree with the Proposed Rule that, "[w]hether genetic material is detectable may depend on the characteristics of the refinement process, as well as the sample and the testing method applied." The Academy strongly supports improving and standardizing detection methods, and we urge AMS to include meaningful testing specifications (e.g., test method validation according to Codex Alimentarius guidelines, lab accreditation standards in the Proposed Rule, and sampling plan requirements that ensure sufficient validity and rigor of the process). In short, we support reputable testing and we strongly reject the underlying premise of Position 1 that the absence of detection equals the detection of absence. In so doing, we agree with the Sixth Circuit's holding in the analogous Int'l Dairy Foods Ass'n v. Boggs, 622 F.3d 628, 637 (6th Cir. 2010) case, "the failure to discover rbST in conventional milk is not necessarily because the artificial hormone is absent in such milk, but rather because scientists have been unable to perfect a test to detect it."
- Additional Considerations
The Academy does not believe regulated entities should be permitted to use a "may" disclosure for foods on the non-highly adopted BE foods list even if their records provide certainty that the foods are bioengineered. Use of a "may" disclosure would be misleading when the regulated entity has knowledge of its contents, and misleading statements are impermissible on a product label.
E. Label Content Should Have Consistent Type and Format So Products Can Be Read and Consumers Can Make Product Comparisons
- Location of Disclosure
The Academy supports proposed § 66.100(c), which we agree "would require the disclosure to be of sufficient size and clarity to appear prominently and conspicuously on the label, making it likely to be read and understood by the consumer under ordinary shopping conditions." We also support proposed § 66.100(d) that would provide that the BE food disclosure be placed in one of several appropriate places on the package.
- QR Codes
The Academy has long been concerned that QR Codes are not the ideal solution to identified labeling concerns. We remain concerned with the possibility that multiple forms of food disclosures such as digital links, symbols, and text may be used in the NBFDS, thereby eliminating any hope of uniformity and complicating future educational initiatives.
Given the informative but inauspicious results of the Deloitte Study referenced in Section G(1) below, we are reminded that "[t]he amended Act also requires the Secretary, after consultation with food retailers and manufacturers, to provide additional and comparable options to access the bioengineering disclosure, should the Secretary determine that consumers, while shopping, would not have sufficient access to the bioengineering disclosure through electronic or digital disclosure methods. 7 U.S.C. 1639b(c)(4)."
It is premature to consider use of a QR code as consumers lack sufficient access to meet the requirements of the statute given the significant concerns outlined in the Deloitte Study and the ongoing need to address the technology improvements and educational initiatives necessary to make QR codes a viable option to a greater proportion of consumers.
In addition to the need for consumer research regarding the design and perception of the symbols noted in Section G, below, the Academy has additional concerns with the symbol designs. The Academy questions whether the symbols sufficiently convey any useful information to consumers and questions whether the information is conveyed in an unbiased manner. The use of the letters BE on the symbol (without more information) provides consumers with no instantly recognizable or useful information. Instead, the symbol merely includes an unknown and unused abbreviation of a largely unknown and unused term without proposing either educational initiatives or conducting sufficient consumer research instead of simply using or incorporating one of two far more familiar terms that the Proposed Rule deems impermissible to communicate the very idea that the symbol fails to do.
F. Labeling Should Enhance Consistency among the Various Government Food Recommendations
The Academy applauds AMS for looking to definitions of terms used at other agencies when defining its own, such as the Environmental Protection Agency's definition of "conventional breeding" in 40 CFR 174.3. Recognizing the value of consistency and interagency cooperation, we encourage AMS to consider incorporating elements of the EPA's definition into that proposed for AMS, with an additional clarification that AMS's definition of "conventional breeding" should specifically include marker-assisted selection, which the National Academies notes "do not become part of the plant's genome."14
The Academy also encourages consistency where possible with other nations' GE-labeling standards to facilitate international manufacturing and trade, in addition to conforming with existing industry standards when possible. Thus, the Academy supports Alternative 1-B (for § 66.5(c)) to "establish that food, in which an ingredient contains a BE substance that is inadvertent or technically unavoidable and accounts for no more than nine-tenths percent (0.9%) of the specific ingredient by weight, would not be subject to disclosure as a result of that one ingredient."
G. Consumer Research Is Imperative Before Making Changes to the Label
- Deloitte "Study of Electronic or Digital Link Disclosure"
Deloitte conducted the "Study of Electronic or Digital Link Disclosure" mandated by the statute, revealing that at present, there are too many technological, educational, and functional hurdles to assure that consumers have sufficient access to an electronic or digital disclosure method. The Academy appreciates the study and its honest recognition of the technological challenges and additional contributing factors that are likely to challenge consumers in accessing the digital link disclosure. In addition to noting the need for rural broadband, in-store scanners, and landlines with customer access, the study identified three steps the government should do to improve access:
- Education for consumers and retailers around electronic and digital disclosure links and bioengineered foods will improve access and understanding.
- Offline options, such as those that provide the bioengineering disclosure through phone or text message, will increase access for consumers who lack smartphones or broadband access.
- Developing or endorsing user-friendly scanner apps will ease the consumer experience.15
The Academy recognizes the value of technology in conveying information to consumers and the public at large, and works to advance its effective use. However, the Deloitte Study notes that only 62% of consumers who were already interested in digital disclosures believes they could access it, which indicates both substantial technological assistance and infrastructure investment would be required before the Secretary could reasonably determine consumers had sufficient access.
We seek clarification regarding Deloitte's methodological decision to limit its focus to individuals who had already expressed an interest "in accessing information on the bioengineered status of their food." Specifically, we encourage clarification whether that self-selected pool of responses likely provided an overly optimistic set of data compared to that which would be received from the broader public from whom the statute sought comment.
2. Specific Consumer Research Needed
The National Academies Report found that "[t]ransparency and public participation have been shown by research to be critically important for appropriate, sound, and credible governance of all aspects of the development, deployment, and use of GE crops."16 The Academy is grateful for the opportunity to suggest important consumer research be undertaken to better understand both the current environment of consumer understanding and engagement and to identify whether the types of tools, rules, and educational initiatives being considered are likely to accomplish their goals. Below are several specific consumer research items the Academy supports examining further:
- Given the possibility that only a restricted subset of GMOs will be required to be labeled as "bioengineered," AMS should study whether designation of only some GMOs as bioengineered leads consumers to deem GMO products and non-GMO products without the BE food disclosure as any more or less healthy, safe, or environmentally friendly than those with it.
- AMS has a responsibility to determine current consumer understandings of the terms "bioengineered," "BE," "genetically engineered," "genetically modified," and "GMO," and we encourage specifically asking respondents whether they ascribe different meanings to them.We note that regulatory classifications or legal definitions do not necessarily reflect consumers' understandings and we urge AMS not to adopt definitions for terms used in this Proposed Rule that differ materially from those offered by consumers.
- If it has not already done so, AMS should conduct significant research on consumers' perception of the various symbols offered for public comment and possible adoption.Specifically, the Academy is concerned that the colors, pastoral imagery, and evocation of a smiling sun unintentionally "conveys [positive] information about the health, safety, or environmental attributes of BE food compared to non-BE counterparts."We understand the need for AMS to appear and remain neutral as it develops and implements the NBFDS, which we are concerned has become more difficult for AMS given that the chosen symbols have a stylistic favorability toward the BE disclosure rather than merely offering unbiased information about the nature and provenance of the labeled food. We are reminded of Judge Koh's cautionary holding in Kane v. Chobani, Inc., 973 F. Supp. 2d 1120, 1136-37 (N.D. Cal. 2014), that it is well known that "consumers will pay more for labels that they think add value, and consumers are also misled to believe that some labels are meaningful, and that deludes consumer demand and it deludes moving the marketplace forward."
H. The Label Is Only a Source of Information, and Thus Sustained Support for Educational Programs Is Essential
To effectively implement the NBFDS, AMS and USDA have the responsibility of coordinating the education of consumers on the use of, and any changes in the common and technical meanings of, terms, because there will not likely be a readily available definition on packages. Consumer education—and particularly funding therefor—has long been the missing piece of federal labeling initiatives. The Academy would be happy to discuss education and dissemination strategies with AMS and is committed to working with Congress to secure sufficient funding for AMS's food labeling education initiatives.
AMS should educate consumers about the meaning of bioengineered foods, the applicability of the term to new and forthcoming GE technologies, including gene-editing, synthetic biology and RNAi, and the ways (if any) AMS understands a "bioengineered food" to be different than a "genetically-engineered food." In addition, and as noted above, the Deloitte Study revealed the need for "education for consumers and retailers around electronic and digital disclosure links and bioengineered foods [that] will improve access and understanding."17
The Academy appreciates the opportunity to offer comment on this Proposed Rule and offers its support to AMS as it implements the new BE food disclosure standard.Please contact either Jeanne Blankenship at 312/899-1730 or by email firstname.lastname@example.org Pepin Tuma at 202/775-8277, ext. 6001 or by email email@example.com any questions or requests for additional information.
Jeanne Blankenship, MS, RDN
Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics
Pepin Andrew Tuma, Esq.
Government & Regulatory Affairs
Academy of Nutrition and Dietetics
1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.
2 The Academy's comments refer interchangeably to genetically engineered foods and genetically modified foods. They use the term "bioengineered foods" for GE or GMO foods as they apply to provisions of the Proposed Rule and with reference to their role in the NBFDS.
3 National Academies of Sciences, Engineering, and Medicine. 2016. Genetically Engineered Crops: Experiences and Prospects. Washington, DC: The National Academies Press. doi: 10.17226/23395. ("NASEM GE.")
4 NASEM GE at 502
5 NASEM GE at 502
6 NASEM GE at 508
7 NASEM GE at 501
8 NASEM GE at 509
9 NASEM GE at 506
10 NASEM GE at 305-306
11 Arun, Ö Ö, Yılmaz, F., & Muratoğlu, K. (2013). PCR detection of genetically modified maize and soy in mildly and highly processed foods. Food Control,32 (2), 525-531. doi:10.1016/j.foodcont.2013.01.023.
12 Jinxia, A., Qingzhang, L., Xuejun, G., Yanbo, Y., Lu, L., & Minghui, Z. (2011). A multiplex nested PCR assay for the simultaneous detection of genetically modified soybean, maize and rice in highly processed products. Food Control,22 (10), 1617-1623. doi:10.1016/j.foodcont.2011.03.018
13 Costa, J., Mafra, I., Amaral, J. S., & Oliveira, M. (2010). Monitoring genetically modified soybean along the industrial soybean oil extraction and refining processes by polymerase chain reaction techniques. Food Research International,43 (1), 301-306. doi:10.1016/j.foodres.2009.10.003
14 NASEM GE at 58.
15 Study of Electronic or Digital Link Disclosure: A Third-Party Evaluation of Challenges Impacting Access to Bioengineered Food Disclosure. July 2017. Page 5. Accessed July 1, 2018. Available at https://www.ams.usda.gov/sites/default/files/media/USDADeloitteStudyofElectronicorDigitalDisclosure20170801.pdf.
16 NASEM GE at 506.
17 Study of Electronic or Digital Link Disclosure: A Third-Party Evaluation of Challenges Impacting Access to Bioengineered Food Disclosure. July 2017. Page 5. Accessed July 1, 2018. Available at https://www.ams.usda.gov/sites/default/files/media/USDADeloitteStudyofElectronicorDigitalDisclosure20170801.pdf.