Navigating the “Maize” of Biotech Regulation in the Food Industry

Regulatory Approval for Biotech Food Ingredients in the U.S.

The use of science to improve agricultural production and select traits to improve in particular crops is not new. Genetic modification has been occurring both in nature and by human intervention for over 30,000 years.¹ Today, when we talk about genetic modification of crops it is not the painstaking, slow, and somewhat uncertain process that Gregory Mendel undertook with his pea plants.² What most call genetic modification actually refers to genetic engineering, a process that involves taking genetic material from one organism and transferring it to another, allowing scientists to insert genes from unrelated organisms to enhance or improve crops.³ Two common examples are adding a gene that makes a crop resistant to an herbicide (allowing producers to use previously damaging herbicides to address weed issues) or increasing/adding a nutrient to a particular staple crop (addressing issues of malnutrition). First discovered in the 1970s, this technology raised concerns on impacts to humans and the environment, and fostered excitement related to possibilities for improving nutrition and the food system.

It was not until the 1990s that the United States government approved the first genetically engineered food crop for production and human consumption (the short-lived Flavr Savr tomato). With the approval of genetically engineered corn a few years later, the race was on as companies competed to develop the next “must have” crop technology. Agricultural producers in the U.S. have adopted genetic engineering at high rates in certain crops. However, issues such as the speed of the approval process, cost of development, differences in international regulatory requirements, and challenges in consumer acceptance have caused uncertainty and concern for the entire supply chain.

Estimates are that at least 75% of food in our grocery stores contains genetically engineered ingredients. This is primarily in processed foods, as most of the crops approved by the FDA for human or animal consumption are not ones we eat directly. Approved crops produced in the US include varieties of corn, soybeans, cotton (cottonseed oil), potatoes, papaya, squash, canola, alfalfa, apples and sugarbeets.⁴ The use of genetically engineered crops in the U.S. is widespread. In 2018, 92% of all corn planted in the U.S. was a genetically engineered variety, and as were 94% of all cotton and soybeans.⁵

Through an agreement referred to as the Coordinated Framework, the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) each play a role in the regulation of biotechnology (the all-encompassing word that includes genetic modification occurring naturally or in a lab, genetic engineering, and other technologies).⁶ For purposes of this article, we focus on the role of the FDA, the agency responsible for ensuring the safety of foods derived from biotechnology that are intended for human or animal consumption.⁷ The FDA’s regulatory approach assumes that genetically engineered crops are generally safe and “substantially equivalent” to non-engineered crops, unless the engineering process causes the crop to change its properties. That is, if the genetically engineered corn has the same nutritional value and other properties as the non-engineered variety, then the engineered variety is generally accepted as safe and no approval or special labeling is required.⁸ However, if the gene inserted into the corn plant causes a change that could be potentially harmful (such as an unexpected allergen) or that significantly alters the structure, function or quality of the natural plant, then the inserted gene is considered a food additive and pre-market approval is required.⁹ While the FDA offers a consultation process for genetically engineered plant developers, it is not required. ¹⁰

The FDA does not currently require that foods containing genetically engineered ingredients be labeled accordingly, and in fact the FDA set limitations in how a company can label or market a product as being “GMO” or “GE” free.¹¹ The rationale is that genetically engineered crops and ingredients derived from those crops are substantially similar to traditionally bred crops and safe for consumption, so there is no need to provide this information. Drawing a distinction between foods containing ingredients derived from biotechnology and those that did not might confuse consumers and lead consumers to think negatively of genetically engineered ingredients. If you look in your pantry though, you might notice that many products have a statement on the label indicating the food, or some of its ingredients, were “produced with genetic engineering”. While some companies are disclosing this information voluntarily, all companies will be providing information in a yet-to-be-determined way under a federal law enacted in July 2016.¹² While final regulations are overdue and have not been released as of October 2018, the expectation is that USDA will release the final rule by the end of 2018 with requirements going into effect in 2020. As a result, the U.S. will join more than 60 countries across the world in requiring foods derived from genetic engineering to have a label informing consumers of this fact.¹³ For companies, whether now required to label the existence of genetically engineered ingredients or voluntarily marketing the absence of such ingredients, there is a need for documentation and careful review of labeling, marketing, and supply chain agreements. For all levels of the supply chain, maintaining this information in an easily accessible and reliable way is important not just to prove compliance with existing regulations, but also in order to manage risks such as those related to litigation or supplier errors. Consumers are increasingly focused on transparency within the food system, and litigation is one tool they are turning to in order to get it.

The Rise of the Consumer

Why did the federal government, after 20 years of consumer demand for more transparency related to genetically engineered foods, finally “give” and pass mandatory labeling legislation? Individual states were moving this direction, leading food companies to push for a unified national standard rather than a patchwork of state legislation.¹⁴ Overall, recent years have seen increased public interest in food production and nutrition, and consumers are demanding more information than ever about where their food comes from. While scientists generally agree that genetically engineered food products are safe to eat, skepticism remains among many consumers regarding the long-term health and environmental effects.¹⁵ Consumers argue this information is required in order to make informed choices.

Consumers are also taking the fight for transparency to the courtroom. Litigation related to the food label and marketing claims rose dramatically in the past decade, with federal filings jumping from 19 in 2008¹⁶ to over 400 active cases in 2016.¹⁷ In particular, litigation often nvolves use of the word “natural” on a product label when the food is made with genetically engineered ingredients, as well as other claims related to health and nutrition.¹⁸ The FDA has not established a formal definition of the word “natural”, a particular challenge (and opportunity) for food companies striving to meet consumer demand for wholesome, nutritious foods.¹⁹ In 2016, the FDA requested public comment on use of the word “natural” on food labels, but no further action has been taken.²⁰ Because of consumer demand for food products seen as healthy and natural, many companies continue to use the term, but others have decided the risk of litigation outweighs any potential benefit. Confusion over use of “natural” led to Vermont banning use of the term on food products containing genetically engineered ingredients, however, the law was pre-empted by the 2016 federal law and it is uncertain if the forthcoming federal regulations will include a similar ban. ²¹

Food label litigation remains a major concern for food companies, and with the new labeling law on the horizon, it is unlikely to ebb. While companies may argue that they are complying with federal labeling requirements, it is becoming evident that compliance alone does not remove the risk of litigation. The focus instead turns to how products are being marketed, and a battle of consumer perception and choice, transparency, science, and health and safety fears.

Consumer demand is also causing some food companies to make changes to food ingredients. Cheerios announced it would go “GMO” free, while Dannon and Hershey have made plans to source ingredients not derived from genetic engineering.²² For Hershey, this means switching to primarily sugar cane, as almost all sugar beets produced in the U.S. are genetically engineered. Dairies that supply milk to Dannon must transition to use only non-engineered feed. Whether a marketing tool, effort to improve sustainability, or direct response to consumer demand, these are significant changes.

On the Horizon

Issues such as changing climate conditions, loss of arable land, and increasing populations lead many to believe that biotechnology is necessary to ensure a safe and adequate supply of food. Whether or not that is true, it is certain that science continues to move forward. What is less clear is how these emerging food technologies will be regulated and received by consumers. Cellular meat and CRISPR are just two examples, but they highlight regulatory challenges and uncertainties in today’s marketplace.

Cellular Agriculture

Cellular meat, lab grown meat, cell-based meat…whatever you call it, this technology has the potential to disrupt the meat and poultry industries. Using stem cells collected from animals, scientists are able to grow these cells into muscle, fat, and other tissues to create a meat product that replicates the constitution and composition of traditionally produced meat and poultry.²³ This simplistic description does not do the science justice, but it is hailed as a potential answer to environmental, antibiotic-resistance, and other health concerns related to livestock production. While much is still to be done before widely available, debate over how to regulate this type of product and what to call it has begun in earnest. FDA and USDA are both vying for primary regulatory oversight, as USDA is the traditional regulatory body for livestock and meat production and FDA the primary regulator for new food ingredients or products.²⁴ It remains to be seen if one agency will serve as the primary regulatory authority or if some sort of joint oversight can be established, but the two entities are starting to work together to discuss food safety, labeling, and oversight of cell-cultured meat.²⁵

Who will regulate this technology though is not the only concern, as what to call it is also in dispute. Whether these products can even be called “meat” is an issue, as some argue that cell-based meat products are not truly meat but instead are imitation products. The U.S. Cattlemen’s Association filed a petition with USDA arguing that placement of cell-based products next to traditional products in the meat case could confuse customers, particularly if there is not some sort of labeling claim to distinguish the cell-based products.²⁶ There is a split in the industry on this, and an answer will likely not come until some regulatory and oversight issues are resolved.

A product like cell-based meat does not fit neatly into our current biotechnology regulatory scheme. It does not involve genetic engineering as described above, and likely would not require a label based on the forthcoming regulations. Assuming that the products develop as described, cell-based food items could be considered “substantively equivalent” under FDA’s labeling standards for biotechnology, meaning no pre-approval or labeling would be required.

Yet even outside the uncertain regulatory structure, significant questions exist regarding whether consumers will even accept such a product and what information should be provided, even voluntarily. If no labeling is required, should a company opt to provide this information? Is there risk in not including a label, and then facing consumer backlash for lack of transparency? While some argue that no labeling should be required and it is better to not give consumers a choice, the history of the past 20 years related to genetically engineered foods indicates this might not be the best strategy if the goal is consumer acceptance and trust. Companies need to determine how to proceed with the marketing of highly technical and innovative products such as this into the public realm, knowing that consumers are wary, uncertain, and demanding more transparency about what they eat.

Another new technology in the food sector is CRISPR (clustered regularly interspaced short palindromic repeats). Like genetic engineering, CRISPR involves working with the genes of an organism but is a form of gene editing seen as more precise and faster than previous genetic engineering technology. CRISPR allows scientists to edit genes within a plant by providing a way to “snip and tweak DNA at precise locations,” such as the exact gene that codes for the enzyme that causes a mushroom to quickly brown.²⁷ Instead of adding genes, scientists generally look to remove or edit “problem” genes that already exist. This form of technology, while involving changes to the genetic makeup of a plant, is not seen as falling under the same regulatory process as genetic engineering, at least for the moment. For example, a researcher used CRISPR technology to disable a gene in a mushroom that produced a particular enzyme, meaning the mushroom would not brown as quickly.²⁸ When the researcher asked about the regulatory process to bring the mushroom to market, the USDA indicated the CRISPR mushroom was not subject to USDA oversight for production because no new genes were added to the plant. In addition, FDA review is only voluntary, assuming that the mushroom meets the “substantially equivalent” standard. There is potential that products like this mushroom could come to market without any oversight or labeling.

The FDA takes a different approach to the use of CRISPR technology in animals, with much more stringent regulation than plants. The FDA views the editing of an animal’s genetic code to improve health, structure, or function as creating a new animal drug that requires review and approval under that regulatory structure.²⁹ While plants genetically edited through the use of CRISPR technology could potentially be marketed without approval or oversight, the same process used on animals takes a much different regulatory path.

International Markets Take a Different Approach

While the U.S. is seen as a friendly market for the adoption and use of biotechnology, the same is not true for much of the rest of the world. Many countries have developed regulatory structures that focus on the process from which a product or ingredient was derived, not just the end result. ³⁰ The European Union (EU) and Russia, for example, have strict limits, or in some cases outright bans, on the production of genetically-engineered crops.³¹ The limitation applies widely in the EU, as it established a broad definition of genetically modified organism. The limits extend to any time “the genetic material has been altered in a way that does not occur naturally by mating and/or natural recombination”, with few exceptions.³²

Most recently, the EU determined that CRISPR technology falls under the GMO regulations, limiting its development and use. Thus, CRISPR-derived organisms will be subject to the same “assessment of risks to health and the environment…as well as elaborate labeling, tracking and monitoring” as genetically-engineered crops.³³ This raises concerns related to food trade and exports, and as new technologies enter the market ensuring compliance with international regulations poses a hurdle and can limit markets.

It is also worth noting that biotechnology is now being incorporated into U.S. trade agreements. The new North American Free Trade Agreement (known as the USMCA), is an example of what some say is a U.S. attempt to reduce some international resistance to biotechnology in food and agricultural production.³⁴ As both Canada and Mexico are already developers and adopters of agricultural biotechnology, this may not have much impact. However, inclusion of this in the agreement indicates a way the U.S. might try to reduce limitations on biotech crops, arguing that these restrictions are illegal trade barriers.³⁵

Compliance and Risk Management in the Food Industry

New technologies, consumer demand, and regulatory uncertainties highlight some of the limitations of our current regulatory structure, even with updates made in recent years attempting to clarify roles and increase public understanding of the process.³⁶ This also demonstrates the challenges of a multi-agency system, where USDA, EPA, and FDA all play various roles. Some might argue that the major flaw in our regulatory system is its lack of transparency and failure to provide information that would allow informed decisions. The speed at which science progresses also proves challenging. Ensuring that safeguards are in place to protect health and safety is necessary, but doing so in a way that does not also stifle innovation can be difficult.

For those in the food supply chain, additional challenges exist. Not only do they need to ensure compliance with labeling and other regulatory requirements, concerns about marketing and consumer backlash need to be considered as well. How to market a product, how much information to provide, and how to reduce the risk of litigation based on labeling or marketing are just some of the questions that should be asked regularly. For any sort of voluntary claim, whether related to biotechnology or not, recordkeeping needs to be thorough and reviewed regularly, particularly any time there is a change in suppliers or ingredients. Competing in a global market adds another level of concern when it comes to complying with labeling requirements, as well as meeting consumer demand in those markets. It remains to be seen if the new federal labeling regulations will address consumer concerns or cause more confusion or will be drafted in a way that encompasses future technological developments. It is likely the regulations will lead to additional litigation against the government and potentially food manufacturers. As regulations change and new technologies emerge, effective risk management in the food supply chain requires working together to provide greater transparency and education to consumers, not just ensuring compliance at each individual level of production.

Endnotes

1. Gabriel Rangel, From Corgis to Corn: A Brief Look at the Long History of GMO Technology, Harvard Univ. Science in the News, (Aug. 2015), http://sitn.hms.harvard.edu/flash/2015/from-corgis-to-corn-a-brief-look-at-the-long-history-of-gmo-technology/.

2. Amanda Montañez, A Visual Guide to Genetic Modification, Scientific American, (Mar. 3, 2016), https://blogs.scientificamerican.com/sa-visual/a-visual-guide-to-genetic-modification/.

3. Agricultural Biotechnology Glossary, USDA, https://www.usda.gov/topics/biotechnology/biotechnology-glossary; see also Rangel, supra note 1.

4. Which Genetically Engineered Crops are Approved in the U.S.?, Genetic Literacy Project, https://gmo.geneticliteracyproject.org/FAQ/which-genetically-engineered-crops-are-approved-in-the-us/.

5. Adoption of Genetically Engineered Crops in the U.S., USDA, https://www.ers.usda.gov/webdocs/DataFiles/47649/alltables.xls?v=0.

6. Biotechnology Glossary, supra note 3.

7. Coordinated Framework, USDA, https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/sa_regulations/ct_agency_framework_roles.

8. FDA, How FDA Regulates Food from Genetically Engineered Plants, https://www.fda.gov/Food/IngredientsPackagingLabeling/GEPlants/ucm461831.htm.

9. Id.

10. Id.

11. Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants, FDA, https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm059098.htm.

12. National Bioengineered Food Disclosure Law, 7 U.S.C. § 1639b (2018).

13. How Are GMOs Labeled Around the World, Genetic Literacy Project, https://gmo.geneticliteracyproject.org/FAQ/how-are-gmos-labeled-around-the-world.

14. Vermont Passes First in the U.S. GMO Labeling Law, ISU Ctr. for Agric. Law & Taxation, (May 12, 2014), https://www.calt.iastate.edu/article/vermont-passes-first-us-gmo-labeling-law; Congress Passes GMO Food Labeling Bill, NBC News (July 14, 2016), https://www.nbcnews.com/health/health-news/congress-passes-gmo-food-labeling-bill-n609571.

15. Genetically Engineered Crops: Experiences and Prospects, Nat’l Acad. of Sciences, (May 2016), https://nas-sites.org/ge-crops.

16. Nicole Negowetti, Food Labeling Litigation: Exposing Gaps in the FDA’s Resources and Regulatory Authority, Governance Studies at the Brookings Institute (June 2014), https://www.brookings.edu/wp-content/uploads/2016/06/Negowetti_Food-Labeling-Litigation.pdf

17. The Food Court: Trends in Food and Beverage Class Action Litigation, U.S. Chamber Inst. for Legal Reform (Feb. 2017), http://www.instituteforlegalreform.com/uploads/sites/1/TheFoodCourtPaper_Pages.pdf.

18. Id.

19. Id.

20. “Natural” on Food Labeling, FDA, https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/ucm456090.htm.

21. ISU Center for Ag Law & Taxation, supra note 14.

22. Aaron Smith, General Mills: Original Cheerios are GMO free, CNNBusiness (Jan. 3, 2014), https://money.cnn.com/2014/01/03/news/companies/cheerios-gmo/index.html; Press Release, Dannon, Dannon Announces Breakthrough Sweeping Commitment for Sustainable Agriculture, More Natural Ingredients and Greater Transparency (Apr. 27, 2016), http://www.dannon.com/the-dannon-pledge-on-sustainable-agriculture-naturality-and-transparency; Dan Charles, As Big Candy Ditches GMOs, Sugar Beet Farmers Hit A Sour Patch, NPR The Salt (May 12, 2016), https://www.npr.org/sections/thesalt/2016/05/12/477793556/as-big-candy-ditches-gmos-sugar-beet-farmers-hit-sour-patch.

23. FDA Tackles Cell-Cultured Foods, Food & Drug Law Institute, https://www.fdli.org/2018/07/fda-tackles-cell-cultured-foods.

24. Jacqui Fatka, “Fake meat” Regulatory Pathway Should Include FDA and USDA, Feedstuffs (Aug. 23, 2018), https://www.feedstuffs.com/news/fake-meat-regulatory-pathway-should-include-fda-and-usda

25. Joint Public Meeting on the Use of Cell Culture Technology To Develop Products Derived From Livestock and Poultry, 83 Fed. Reg. 46476 (Sept. 13, 2018).

26. Leanna Garfield, There’s a Growing Battle Between Fake Meat Startups and Big Beef, and Neither Side is Backing Down, Bus. Insider, (June 10, 2018), https://www.businessinsider.com/beef-companies-file-petition-against-lab-grown-meat-startups-2018-2.

27. Kenneth Chang, These Foods Aren’t Genetically Modified, but They Are ‘Edited’, N.Y. Times (Jan 9, 2017), https://www.nytimes.com/2017/01/09/science/genetically-edited-foods-crispr.html; Melody M. Bomgardner, CRISPR: A New Toolbox for Better Crops, 95 Chem. & Eng’g News 30-34 (June 2017), https://cen.acs.org/articles/95/i24/CRISPR-new-toolbox-better-crops.html; Dan Charles, Will Genetically ‘Edited’ Food be Regulated? The Case of the Mushroom, NPR The Salt (Apr. 15, 2016), https://www.npr.org/sections/thesalt/2016/04/15/474358416/will-genetically-edited-food-be-regulated-the-case-of-the-mushroom. See also Deepa Jaganathan, Karthikeyan Ramasamy, Gothandapani Sellamuthu, Shilpha Jayabalan and Gayatri Venkataraman, CRISPR for Crop Improvement: An Update Review, 9 Frontiers in Plant Science 1 (July 2018); 13 SciTech Lawyer No. 1 (Fall 2016) (focusing on gene editing technologies and providing wide range of background on the gene editing process and related concerns).

28. Charles, supra, note 27.

29. Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry. 82 Fed. Reg. 6561 (Jan. 19, 2017).

30. How Are GMOs Labeled Around the World?, Genetic Literacy Project, https://gmo.geneticliteracyproject.org/FAQ/how-are-gmos-labeled-around-the-world/.

31. Where are GMOs Grown and Banned?, Genetic Literacy Project, https://gmo.geneticliteracyproject.org/FAQ/where-are-gmos-grown-and-banned.

32. Press Release, Court of Justice of the European Union, Organisms Obtained by Mutagenesis are GMOS and are, in Principle, Subject to the Obligations Laid Down by the GMO Directive, (July 25, 2018), https://curia.europa.eu/jcms/upload/docs/application/pdf/2018-07/cp180111en.pdf.

33. Kai Kupferschmidt, EU Verdict on CRISPR Crops Dismays Scientists, 361 Science 435 (Aug. 3, 2018); Ewen Callaway, EU Law Deals Blow to CRISPR Crops, 560 Nature 16 (Aug. 2018).

34. Catherine Boudreau, New NAFTA Furthers U.S. Push to Set Global Rules on Ag Biotech, PoliticoPro (Oct. 15, 2018), https://subscriber.politicopro.com/agriculture/article/2018/10/new-nafta-furthers-us-push-to-set-global-rules-on-ag-biotech-843545.

35. Id.

36. Update to the Coordinated Framework for the Regulation of Biotechnology, EPA, https://www.epa.gov/regulation-biotechnology-under-tsca-and-fifra/update-coordinated-framework-regulation-biotechnology.