Mayhew-Hite Report        Proposal for Negotiated Rulemaking in the FDA

Disclaimer: The following article has been reviewed by the Mayhew-Hite Editor. Articles published in the Mayhew-Hite Report do not undergo the same rigorous accuracy check or editing process as articles published in the print edition of the Ohio State Journal on Dispute Resolution. 

Valerie Jama

I. Introduction

Genetically-modified organisms, commonly known as GMOs, have become a composite of both confusion and contention for many Americans. The question of whether the Food and Drug Administration (FDA) should label foods that contain, or that are free-of, GMOs still looms. Much of the public is concerned with these products’ risks to human health and the environment, with around only twenty-seven percent of the population trusting food label claims from 2001-2006.[i] Part of the concern is the unnatural process of producing GMOs, which involves breaching the species barrier by changing genes of plants and other organisms from one to another through mutation, cross-pollination, or chromosome doubling.[ii] In addition, the administrative agencies that regulate GMOs follow federal guidelines that were drafted before biotechnology-produced food became common, and these regulations focus chiefly on the final product.[iii] Many states have proposed labeling laws, but most failed at the ballot or are contingent on other states’ participation.[iv] As a result, consumers have begun to demand natural foods from food producers by boycotting or severely questioning the presence of GMOs in products. And yet, the FDA has refused to define natural, which has led to the “perfect storm” among all interested parties.[v] To subside the storm, the FDA should act. Class-action litigation for food labeling disputes has continued for over six years, with most occurring in the now-proclaimed “food court,” in the United States District Court for the Northern District of California. For one company, it cost up to two million dollars just in pre-trial negotiations.[vi] With more than ninety percent of corn and soy genetically produced in the U.S. today, litigation is unlikely to slow down anytime soon unless a proper statute is introduced.[vii]

To create an effective and consensus-driven law, the FDA should promulgate a rule regulating the specific labeling requirements for GMOs. This is because Congress is split on the issue of whether GMOs should be labeled and whether these crops are natural. Some food-conscious individuals and organizers are lobbying for state-level labeling laws while others aim for a uniform, federal law that regulates and defines GMOs and whether they are natural.[viii] The U.S. House of Representatives passed House Resolution 1599 in July 2015, which preempts state authority to label and regulate GMOs, but the Senate has said they will not consider the bill.[ix] This bill included a voluntary labeling system so that companies can claim natural on their label even with GMOs present.[x] In December of 2015, Congress further acted on the GMO issue by not including a rider in the Federal Omnibus spending bill that would have blocked state GMO labeling laws from going into effect.[xi] Thus, Congress will likely be working through this issue for some time to come. Instead of the long, arduous process of passing a bill through Congress, rulemaking is a sensible alternative since the FDA already has authority for such a labeling law under the Federal Food, Drug and Cosmetic Act (FDCA).[xii]

Current rulemaking in administrative agencies can take years to go through the notice and comment procedure; therefore, the FDA should consider negotiated rulemaking, commonly referred to as “reg-neg.” Part A of Section II will detail what reg-neg involves, evaluating the costs and benefits when applied to a potential rulemaking process for the FDA. Then, Part B of Section II will detail the FDA’s rulemaking history under the authority of the FDCA, and how reg-neg can be introduced into the agency’s procedures. Last, Section III will propose a reg-neg regime and encourage the FDA to act now since both the issue of food labeling and consumers’ “right to know” the ingredients in food are becoming a greater source of economic and social pressure. The FDA should use the mediation process of negotiated rulemaking to develop a rule that satisfies all stakeholders’—including farmers, food producers and manufacturers, and consumers—interests in GMO labeling, or the amount of litigation from stakeholders and public skepticism toward GMOs will continue, costing the food industry more than necessary. Even if reg-neg does not lead to a complete agreement for the FDA’s proposed rule, the conversations that result from such a process are useful for the conventional procedure of rulemaking; thus, the FDA would benefit from reg-neg regardless of the result.[xiii]

II. FDA and Agency rulemaking History

While the FDA has not promulgated rules out of stakeholder negotiation, many agencies have incorporated this form of rulemaking. This note will explore the benefits of using this rulemaking process to move the GMO debate further, as other agencies have already done. There are both costs and benefits of negotiated rulemaking, but it will likely aid the tribulations caused by special interest groups and resulting power inequalities, such as Monsanto versus the sustainable farmer.[xiv] When given the opportunity to convene and hear other perspectives on the issue, a more accurate, compliable, and fair rule will likely result.

A. Negotiated Rulemaking is a Viable Alternative for Contentious FDA Rulemaking

Dispute resolution is a common tool courts use to reduce litigation costs, time and energy. Agencies have been slower to incorporate forms of alternative dispute resolution, especially in the rulemaking process.[xv] Reg-neg first started as an experimental tool, which was enacted by statute eight years later.[xvi] President Clinton, who created the regulatory framework that Federal agencies still follow today, even called on agencies to use reg-neg in Executive Order 12866.[xvii] This section will detail the era of reg-neg, how it ended, and how agencies can bring it back.

1. Negotiated Rulemaking History

Like many forms of rulemaking, reg-neg became a viable solution for the current ossification problem among agencies, which includes a slow-down of new regulations and a rise in time and resources required to develop new rules.[xviii] Rulemaking is adversarial in nature, which leads to much expense and delay as parties take extreme positions in preparation for expected litigation.[xix] Thus, Congress proposed the Negotiated Rulemaking Act (NRA) of 1990 as a reform effort.[xx] Consequently, President Clinton’s Executive Order, which is still chiefly followed today, directs agencies to include negotiated rulemaking when appropriate.[xxi]

The NRA of 1990 brought along a dispute resolution scheme that agency procedure has not seen before. Basically, an agency could bring neutral advisors, or conveners, as third parties who assembled a committee of stakeholders and individuals with affected interests.[xxii] Negotiation in this way includes three principles: “to focus on the respective interests of the parties, seek options that allow mutual gain, and define objective criteria.”[xxiii]

The first step in reg-neg includes the stakeholders determining whether the proposed rulemaking has criteria that would be within the scope of the NRA. This criteria includes: whether the negotiation process can ensure a limited number of interests, adequately represent all interests in a balanced committee, prevent the delay of issuing a rule, and guarantee the agency has resources needed for negotiating committee.[xxiv] Also, parties of the committee should have a relative amount of power and be “sufficiently diverse” in its composition.[xxv] Once a consensus is reached under the negotiation process, the committee submits a report to the agency, who would then publish the draft rule with notice and opportunity for comment, which is the formal procedure under the Administrative Procedure Act (APA).[xxvi] Consensus is defined in the statute as “unanimous concurrence among the interests represented on a negotiated rulemaking committee.”[xxvii] Because the unanimity requirement may take time to accomplish, considering a possible delay in rulemaking this way is essential to make reg-neg work.

In the 1980’s, many agencies began implementing reg-neg, such as the Environmental Protection Agency (EPA), Federal Aviation Administration (FAA) and the Occupational Safety and Health Administration (OSHA), as well as a few states such as Massachusetts, New York and California.[xxviii] An agency typically decides to use reg-neg if it affects many constituencies, the subject matter is complex or controversial, the issues are generally known, and the agency lacks complete information on the matter and thus the rule would not have reached the same heights.[xxix] Meeting all four of these components, the FDA would benefit from reg-neg because it affects farmers, food companies and consumers; creating a natural definition is controversial yet well-known to the public; and, the agency lacks expertise for the very scientific nature of a rule that encompasses food labeling and production.

2. The Decline of Reg-Neg

Starting in the 2000’s, agencies stopped using reg-neg as often because its gatekeeper, the Administrative Conference of the U.S. (ACUS), was defunded.[xxx] Lack of support from the Office of Information and Regulatory Affairs (OIRA) also led to a decline in reg-neg, since it is the agency that must approve any rule before it gets published in the Federal Register.[xxxi] In addition, many professionals in the legal sphere have criticized the mediation effects of reg-neg. For instance, agencies may uphold what is in the public interest by moving forward with the parties’ proposed rule, which in turn leads to results out of the agency’s legal authority.[xxxii] Basically, an agency acts outside its scope when it does not comply with a statute that dictates their authority; oftentimes, these issues end up in court, and if the agency was “arbitrary and capricious,” or acted unreasonably outside of its authority, the court will revoke its actions.[xxxiii] As a result, in the effort to be collaborative, the rule may not be upheld in court.[xxxiv] And, the purpose of the NRA was not carried through, because the negotiations become a source of litigation.[xxxv] One critic found rules developed through negotiation were challenged more in court than those from formal rulemaking.[xxxvi]

Phil Harter and other reg-neg proponents see value in the process, however, providing opportunity for an agency such as the FDA to still embrace such negotiation. Some recognized benefits from reg-neg include greater overall satisfaction with the result and a fair process that increases public trust in agencies; in addition, reg-neg prevents needless litigation that results from interests not being properly served.[xxxvii] Harter finds that it knocks off time from the typical rulemaking schedule compared to “traditional intermediaries that represent the interest in an adversarial proceeding.”[xxxviii]

The benefits to implementing a reg-neg program appear to greatly outweigh the costs the FDA would endure, and the public would finally have some answers to the hotly contested issue of natural foods from the appropriate regulatory body.

3. What the FDA can Expect from Implementing Reg-Neg

A surprising fact about food labeling rules is that the FDA’s twin agencies—the U.S. Department of Agriculture (USDA) and the EPA—have accomplished more on answering what is natural. Of course, their answers are for different purposes: the USDA looks at natural field testing procedures for crops and the EPA deals with pesticides.[xxxix] The Food Safety and Inspection Services (FSIS) is the regulatory body in the USDA that deals with food labeling. While there is no final rule on natural labeling from the USDA, FSIS put forth a Food Standards and Labeling Book with two factors required for a food to be called natural: (1) it cannot contain any artificial coloring or flavoring; and (2) it cannot be more than minimally processed.[xl] With this guidance comes uncertainty and confusion for food producers, who want to comply with the regulations to gain the health-conscious as customers but may not use “natural” as a label because of the fear of litigation. As plaintiff’s attorneys in the frequent class-action litigation suits describe it, “no matter what the product contains, the lack of a formal definition permits an argument that the product does not fit the consumers’ conceptions of natural.”[xli] But, the USDA has made at least some steps in the process of defining natural.

Another source of progress for the USDA is the agency’s organic certification program, or National Organic Program (NOP), which includes mediation agreements.[xlii] The goal of the program is for the organic “accredited certifying agencies” (ACA’s) to help farmers reach a settlement that will bring the food operator into compliance with the USDA organic regulations, or assist their exit from organic production.[xliii] With this more peaceful resolution process, operators can more easily navigate the new regulations of organic labeling and production.[xliv] As such, a natural label would work in a similar way, especially regarding the potential for labeling GMOs in food. The FDA should follow the USDA’s progress with a scheme that brings consensus building in a manner comparable with the NOP mediation system.

The EPA has also used negotiation as part of rulemaking for pesticide regulations, emissions, and farm work standards.[xlv] For instance, the EPA promulgated a rule for permits under the Resource Conservation and Recovery Act using reg-neg, and all parties agreed that several elements would not have existed in the rule had it been promulgated through regular rulemaking procedures.[xlvi] The proposed rule included a default provision—the deal clincher for industry stakeholders—for granting temporary approval of a class and an expanded public comment and participation period.[xlvii] The parties conceded to this default provision because the industry representatives were able to educate the other parties on the advantages.[xlviii] This way, everyone had a chance to agree on the final report instead of consenting at the beginning for the third-party facilitator to make the decisions in an arbitration setting.[xlix] Reg-neg is seen as a “valuable complement to the conventional process” because it often yields superior rules that reflect the affected groups’ preferences.[l] And, when the agency has already set criteria for complex scientific standards, reg-neg can limit the time spent by the agency on promulgating a similar rule.[li] Thus, the FDA would benefit from following the USDA and EPA’s footsteps in applying reg-neg to GMO label rulemaking.

B. The FDA and its Big-Food Industry Influence

Since Holk v. Snapple Beverage Corp., there have been numerous state class-action cases dealing with whether GMOs are natural products.[lii] However, the FDA will not hear these cases in an adjudicatory setting or create regulation that would preempt states from deciding on this issue.[liii] Thus state courts—especially in California—have opined about whether the allegations against food products have merit.[liv] For reasons such as big industry economic clout and the plaintiff’s failures to certify a class, the defendant food companies have prevailed for the most part in terms of settlement.[lv] No issue has been resolved because each settlement or ruling has not set precedent for future cases. These class-action cases will continuously return to court unless a more cost-effective option, such as reg-neg, can provide results.

1. THE FDCA and Trends Behind FDA Rules

First, it is important to understand how the FDA functions in rulemaking to fathom its reasoning behind agency actions and propose an alternative. The FDCA was enacted in 1938 to respond to the increased public fear of dangerous food and drug products in the marketplace.[lvi] The FDA from then on had the regulatory power to enforce proper labeling techniques for claims about health, such as “low fat,” and claims about the make-up of a product.[lvii] However, the FDA has remained inactive on the natural claim, citing “resource limitations and other agency priorities” which indeed is common in traditional rulemaking procedure.[lviii] This argument is contradictory with the other areas that the agency focuses on:

Open meetings, public hearings, and advisory committees are all quite time and resource-intensive, and yet the agency [FDA] has demonstrated that it believes these types of regulatory innovations are worthwhile. What they all lack, however, is the face-to-face negotiations and dynamic participation in the process that negotiated rulemaking fosters, which in turn increase participant satisfaction with the regulatory process.[lix]

The pressure from industry groups to focus resources on a natural label perhaps will finally convince the FDA that it is an important issue worth investing in reg-neg for. For instance, certain industry groups, such as the American Feed Industry Association (AFIA), have begun to demand negotiation on FDA proposed rules.[lx]

Additionally, the FDA has been identified as an agency that could use reg-neg. In 2007, one of the major amendments in the Food and Drug Administration Amendments Act (FDAAA) was to expand the Clinical Trial Registry Data Bank.[lxi] The Senate bill of the FDAAA proposed a negotiated rulemaking scheme as a solution for regulating tracking clinical trials.[lxii] The negotiated rulemaking committee would have brought together representatives from the FDA, other relevant federal agencies, patient advocacy and provider groups, the pharmaceutical industry, contract clinical research organizations, the International Committee of Medical Journal Editors, and other interested parties, who would all work together to arrive at an agreeable rule to govern the clinical trials database content.[lxiii] But, the Secretary of Health and Human Services (HHS) removed the reg-neg portion of the amendment from the final bill.[lxiv] While the mediation method was not incorporated, the attempt will provide useful for the reconvention of such a process, as the Senate initiated a conversation on how reg-neg would work for the FDA.

There are several theories that examine why the FDA has chosen not to implement reg-neg. One suggests it is because the agency’s regulations are not being challenged as frequently; plus, the agency already has many procedures for encouraging public participation in rulemaking; and their success in court.[lxv] However, there already is anticipated consideration of implementing reg-neg in the FDA code; the provision states: “[There shall be] [a] statement concerning the feasibility of convening associations, corporations, consumers, and other interested parties to engage in negotiated rulemaking to develop a proposed rule consistent with the Negotiated Rulemaking Act.”[lxvi] If FDA-regulated industries have requested new procedures, it may be time to try reg-neg in order to remain legitimate to the stakeholders. Otherwise, without much rulemaking input from the FDA, stakeholders will continue to label their products in ways not intended by the FDA due to lack of rules to govern the proper procedures, or the final rule that the FDA promulgates will result in litigation. The FDA has experimented with “public boards of inquiry,” where a party waives its opportunity for a full hearing for the chance to follow up with a submitted comment instead, in front of a public advisory committee. These public boards, consisting of three members, are known as a science court, where complex technical issues are reviewed. The science court would engage the public by being consisted of non-FDA employees, but because it is very costly, one has not convened since 1979.[lxvii]

2. The Current Extent of Dispute Resolution in the FDA is Not Enough

A few other attempts at alternative regulation should be noted to demonstrate that reg-neg is the correct outlet for the FDA. The FDA occasionally solicits public input with open meetings where the agency encourages dialogue between stakeholders and identifies priorities for health concerns; however, this does not seem to bring all stakeholders to a consensus as reg-neg is designed to do. For instance, in U.S. v. Nova Scotia Food Production Corp., a fish production company challenged regulation on the hot-process for smoking fish, alleging the FDA failed to disclose scientific data to the regulated fish industry.[lxviii] The court held for the company, and the FDA had to re-write the regulation.[lxix] A more simple procedure would have been for the respective fish industry to give its input before a final rule is promulgated, in the form of negotiated rulemaking. Now, as will be shown below, reg-neg can reach a sound, effective result that the public and FDA’s regulated industries both agree on for GMO labeling, eliminating the amount of litigation the FDA has recently dealt with.

3. What’s Next: Since the Natural Dispute Has Led to More Social Pressure

2016 will likely be a big year in food labeling lobbying and legislation, but since less than a majority of Congress can agree on a certain definition for GMOs, the FDA should take this opportunity to conduct reg-neg for rulemaking. At least sixty percent of people believe a natural label means packaged and processed foods have no genetically modified organisms, no artificial ingredients or colors, no chemicals and no pesticides, per the study by Consumer Reports.[lxx] These consumers, in addition to the rest of society, deserve to know what the now-common term GMO truly means regardless of whether they are harmful or not.

Similar to food allergens, putting genetically-engineered products into one’s body may not be agreeable due to that person’s internal composition; indeed, there may be worse unintended effects from GMOs: some possibilities include introducing a new allergen into foods, changing a food’s composition drastically or increasing the amount of natural toxin proteins.[lxxi] For instance, some cannot tolerate “fake sugars” such as sorbitol, which is why an ingredient label will list those products.[lxxii] The same reasoning should apply to GMO labeling.

In November of 2015, the FDA decided to give notice for proposed rulemaking, and solicited comments about a potential natural food label.[lxxiii] “Plates of the Union,” a campaign among different food policy non-profit groups, gathered followers to ask the next president to act on improving the food system; these followers likely submitted comments.[lxxiv] However, while an agency must read the comments it solicits, the detachment between the advocates and the agency officials makes accountability an issue in normal rulemaking procedures. And, the comment process is just the beginning; realistically, a potential rule on this issue would not take effect for several years.[lxxv]

The agency has already issued guidance on voluntary labeling of GMOs.[lxxvi] For instance, it states “these tomatoes are genetically engineered to improve texture” and “this product contains cornmeal that was produced using biotechnology” as two options; in addition, a label that mentions the food is superior because it is not bioengineered would be misleading in the FDA’s eyes.[lxxvii] Since groups from both ends of the debate are demanding the FDA to define “natural,” reg-neg should be the avenue the FDA takes to understand both sides of this contentious issue.

III. Contemporary Proposal for FDA Decisionmaking

A renewed dialogue within the FDA on the reg-neg process is due, with Congress working on the prospective bill for GMO labeling. It is essential that the agency that would regulate the labeling law becomes acquainted with its intricacies from those who deal with it firsthand: food companies, farmers and consumers.[lxxviii] The resulting labeling law will call for agency action, which includes creating an interpretive rule so the law is easier to comply with for all relevant parties. The best means for incorporating many perspectives in a promulgated rule is for the agency to utilize reg-neg.

A. What Reg-Neg Should Look Like

If the FDA adopts a reg-neg scheme, questions about the need of GMO labeling will be answered. Indeed, GMOs are a complex and controversial matter, and groups on both sides of the aisle have strong and varying opinions. However, there is a lack of science behind the effects—if there are any—of eating GMOs.[lxxix] Thus, the agency cannot simply rely on public comments or agency expertise here for an accurate rule. By having stakeholders such as major biotech industry and food production businesses participate in the process, they will thus understand and comply well with the rule.  First I discuss building on the current process and how reg-neg can improve and speed up the rulemaking process. Then, I suggest re-funding ACUS to oversee such a reg-neg process, and finally, I will conclude with an overall picture of how the practice of negotiation will benefit the FDA and the public.

1. How to Incorporate Reg-neg into the FDA Rulemaking Scheme

The FDA says genetic engineering is safe for consumers, but many consumers are still becoming more conscious about buying natural products. The FDA needs to hear these concerns directly, in a mediation setting. A beginner’s step to the reg-neg procedure is to negotiate consensus standards, which tend to be based on those developed by private organizations for mandatory regulation.[lxxx] Thus, representatives affected by the standard—food industry groups, consumer advocates and farmers to name a few—should convene to negotiate a structured standard.[lxxxi] These meetings do not always go congenially at first, even though the reg-neg process is said to be “nonadversarial.”[lxxxii] However, it leads to negotiations ripe for decision, which means a concrete issue is ready to be determined.[lxxxiii] An important piece of the discussion should be the timeline for implementing the rule, so the FDA has a clear idea of how to move forward. The parties must come to realize that implementing a rule that is a “win-win situation” will benefit them in the long-run because if not, another forum—the FDA or a court—will generate limitations to a zero-sum, or winner take all, solution.[lxxxiv] At the very least, agreeing on the fundamental principles for the potential rule will likely ensure the stakeholders’ values will be implemented in the final rule.

An alternative for beginning GMO labeling discussions is with “sequential negotiation,” which is more traditional rulemaking with a formal discussion; as such, stakeholders meet with agency representatives alone to sway the decisionmaker to their side. Thus, the parties do not meet all together and instead negotiate as supplicants, in which the FDA still has sovereign power on the proposed rule.[lxxxv] While this is clearly not reg-neg, it is still a better solution than not engaging stakeholders at all. Therefore, this could be the beginning step the FDA uses as platform to eventually move to a full reg-neg process.

The EPA provides a great example of how reg-neg works with truly adversarial parties, when the agency incorporated reg-neg into the rulemaking process to deal with an energy issue called the National Coal Policy Project.[lxxxvi] The reg-neg process began when a manager for the Dow Chemical Company decided to inquire about negotiation with environmental groups, with assistance from a neutral third party as the chairman.[lxxxvii] After five government agencies, four foundations and eighty corporations funded this process, the parties reached an agreement on 200 separate action items, some of which became the basis for a proposed rule for the Federal Energy Regulatory Commission (FERC).[lxxxviii] This process involved personnel to conduct research, draft initial documents for the parties to review and compile scientific data.[lxxxix] But, the end result proved that the work involved with reg-neg paid off.

As such, the FDA should similarly play an active role in the reg-neg for the process to be successful, which may be difficult considering the multitude of issue items the agency must also deal with. But, it is vital that the parties receive guidance on what is acceptable in the FDA’s eyes, and to understand the boundaries for discussion.[xc]

2. ACUS: Should it Make a Needed Return?

The need for an independent, nonpartisan body was filled by ACUS in 1964; as a sign of success, it was reauthorized every four years until 1995, when it was defunded.[xci] As Thomas Susman, a former staff member of ACUS, stated:

[T]here is no single office or organization in either the executive or legislative branch of government, besides the Administrative Conference, whose sole objective is improving the quality of government procedure. There is no other place in the federal government that better understands the costs, delays, and burdens that are imposed by inadequate, inefficient, or duplicative government processes.[xcii]

In addition, ACUS was a catalyst for improving agency procedures through alternative dispute mechanisms, such as reg-neg.[xciii] Therefore, it could make a big difference in facilitating proper reg-neg procedures for when agencies like the FDA start the process for the first time. It would be worth the investment for Congress to consider reauthorizing funding for ACUS after eleven years. However, if it would not be feasible to reinstate ACUS funding, this is where a convenor will step in to aid the process.

To help facilitate reg-neg, the convenor can be from within the agency or a third party. There are benefits that come along with utilizing a convenor from inside the agency; these include: the person already has accessibility and knowledge about the FDA’s values and priorities, they are least likely to reveal information to outside parties, and they are the least expensive alternative.[xciv] However, other stakeholders could see this as a partial means for achieving a reg-neg rule. Therefore, the FDA should consider bringing in an independent convenor for an objective perspective on the issues, despite the potential for it being costly, if the benefits would outweigh these costs.[xcv]

B. The Ideal Negotiated Rulemaking Procedure for the FDA

To ensure the FDA acts on enacting a rule for natural food labels, big names should become involved in the regulation negotiations. Already, Campbell’s Soup has come forth as supporting a national labeling law, citing the fact that ninety-two percent of consumers want to know what products contain GMOs: “Our purpose calls for us to acknowledge that consumers appreciate what goes into our food, and why—so they can feel good about the choices they make, for themselves and their loved ones.”[xcvi]

This well-known company has set the bar for further pressure on the FDA to commence negotiated-rulemaking. Not all parties must agree that GMOs are bad for human consumption to label products; oppositely, Campbell’s does not believe GMOs are per se unhealthy. And as the CEO of Campbell’s, Denise Morrison, serves on the Grocery Manufacturer’s Association (GMA) board, she could potentially convince other large food companies to join suit in the labeling initiative.[xcvii] This may be an uphill battle with strong opposition coming from large companies such as McDonald’s and Monsanto, but it is worth a shot to get all voices heard.

And, according to the advocacy group, “Just Label It,” companies that are pro-GMO labeling include organizations such as the Center for Food Safety, the California Certified Organic Farmers, Ben & Jerry’s, Whole Foods and many organic food producers across the country.[xcviii] Chipotle, the burrito conglomerate, also supports food labeling that includes “non-GMO” in the definition of natural.[xcix] It is likely that many partners of Just Label It would want to participate in reg-neg to speak on their strong issues with GMOs. Thus, there are big names on either side of the political stratosphere. While the food industry needs to take part in reg-neg for the FDA, other parties should also be present. Farmers can provide a perspective from the production side and consumers from the other end of the food chain. A convenor is needed to ensure these sides listen and negotiate fairly among themselves.

Last, a proper reg-neg experience should also include expert opinions, since labeling foods as “natural” is a complex process. Consensus building processes like reg-neg allow for the agencies’ lack of expertise in the area because of the outside perspectives it brings forward. Experts from the food science sector seem to be a good fit for such a task. So long as the convenor and other negotiation participants frame the questions for the experts to answer in a way that is understandable to everyone, the expert can allow for interpretation of the many implications of defining natural a certain way.[c] The combination of scientific analysis with the stakeholder’s policy concerns will create a balanced negotiating scheme.

C. Consensus Building Will Provide the FDA a Foundation for Future Reg-neg

While the hope is for the FDA to achieve a valid rule to promulgate, it is important for the negotiation rulemaking group to remember that a consensus does not or cannot always emerge. The initial goal for the FDA’s reg-neg should be mutual gains, which includes creating value, distributing value to the parties’ respective organizations, and following through on the agreement.[ci] According to the Consensus Building Institute, negotiations should be more than a “win-win” approach; indeed, it is important for the host of the negotiations, in this case the FDA, to have a Best Alternative to a Negotiated Agreement (BATNA).[cii] A good way of incorporating this in negotiation is to not just state a position, but to explain the interest behind the position. For example, “I won’t pay more than ninety thousand” is a position, while the interest behind the position could include fears and assumptions about the payment.[ciii] In addition to these common negotiation items to consider, the parties involved should also bring forth multiple options for a more diverse conversation. Representatives of the GMA may not want a natural label to encompass GMOs, for example, but they should be prepared to compromise with their least-harmful alternatives. Once a consensus is reached, the parties should also include specific follow-up procedures for any confusion that arises when the FDA begins the rulemaking process.[civ]

The result of such a reg-neg practice will be valuable to the FDA regardless of whether the agency can take it as-is and promulgate a rule from it. It is the understanding and acknowledging common problems that first result in new dispute resolution practices, which moves the ball forward for future success on the issue. “The consensus building process is one in which participants…come to reason in ways they may not have anticipated…[and] it should create a situation in which they have no choice but to try to understand.”[cv] Applied in the FDA rulemaking realm, reg-neg could have a great eye-opening effect on the “natural” labeling issue for the agency. The goal is that, eventually, the parties’ self-interested bargaining will combine with agreement to result in productive negotiations for a sound proposed rule.[cvi]

IV. Conclusion

The FDA will soon face a rulemaking procedure, for determining what natural means for food labeling and production purposes.  As mentioned throughout this note, reg-neg is the best means for constructing such a complex, time-intensive, and high stakes rule. This note detailed the history of the FDA, an agency that has had little legal contention with its rulemaking procedures. However, this is also an agency that has been slow to respond to the Natural and GMO labeling initiatives; indeed, it has been since September of 2016 that the FDA mentioned it will soon work on the public comments solicited for the proposed rule.[cvii] It received about 5,000 comments from consumers, many stating they are against the FDA labeling GMOs as natural. One comment stated, “Natural should be limited to those ingredients that have been created by God.”[cviii] The agency will need to answer the comments soon, because now that the Presidential Election has occurred, a new executive office will likely halt any progress.

Reg-neg is not currently a well-known dispute resolution device for agencies, but should be. It is an effective means for building a consensus among different groups who have strong beliefs in how the food system should work and be regulated. While the beginning stages of reg-neg may be slow and less-than fulfilling, if the FDA begins the process now, then it will build a strong foundation for when the FDA will need to answer the question of what natural food is. The food policy climate is very different than it was fifteen years ago, with an influx of litigation and growing contention about the food that citizens put into their bodies. Thus, this notes’ contemporary proposal pushes the FDA, policymakers, negotiators, and lawyers who work alongside the agency to begin a dialogue on the costs and benefits that reg-neg can and should provide for a rule defining natural food.

[i] Food Safety, § 7.02 (2015).
[ii] See Toby Bradshaw, Genetically Engineered Food: The Science Behind the Controversy (2006),
[iii] Id. (arguing the GMO process of production is a source of greater risk in human consumption and is largely the public’s concern.)
[iv] Id. (Vermont passed a labeling law effective July 1, 2016.)
[v] Erik Benny, ANNUAL REVIEW OF ADMINISTRATIVE LAW: ADMINISTRATIVE LAW ESSAY: “Natural” Modifications: The FDA’s Need to Promulgate an Official Definition of “Natural” that Includes Genetically Modified Organisms, 80 Geo. Wash. L. Rev. 1504, 1507.
[vi] Paul M. Barrett, California’s Food Court: Where Lawyers Never Go Hungry, Bloomberg Business (Aug. 23, 2013),
[vii] David Johnson & Siobhan O’Connor, These Charts Show Every Genetically Modified Food People Already Eat in the U.S., TIME (April 30, 2015),
[viii] Id.
[ix] H.R. 1599, 114th Cong. (1st Sess. 2015).
[x] Center for Food Safety, Congress Keeps Anti-GMO Labeling Rider out of Spending Bill, Ecowatch (Jan. 11, 2016),
[xi] A rider is an additional part added to a legislative bill, which doesn’t specifically deal with the legislation in question as a common diversion tactic. See Merriam-Webster, Rider (2014),
[xii] 21 U.S.C § 301 (1938).
[xiii] Cornelius M. Kerwin, Rulemaking: How Government Agencies Write Law and Make Policy 197­–202 (CQ Press, 3d ed. 2003).
[xiv] Monsanto is a power player in the biotechnology business, which began with selling Roundup herbicide and now sells GMO seeds and licenses genetic traits. Sustainable and organic farmers and consumers do not believe these seeds are good for the health of people or the planet. See The Parable of the Sower, The Economist (2009),
[xv] Jerry L. Mashaw, et. al., Administrative Law: The American Public Law System, Cases and Materials 783 (7th ed. 2014).
[xvi] William Funk, Bargaining Toward the New Millennium: Regulatory Negotiation and the Subversion of the Public Interest, 46 Duke L.J. 1351 (1997).
[xvii] Id. at 1354.
[xviii] Benny, supra note 5.
[xix] This combative nature of rulemaking emerged because of its design, which separates interested parties from each other, where limited exchange through written comment of a legislative hearing brings little support from major constituencies. See Kerwin, supra note 13.
[xx] Id.
[xxi] Jeffrey S. Lubbers, Achieving Policymaking Consensus: The (Unfortunate) Waning of Negotiated Rulemaking, 49 S. Tex. L. Rev. 987, 991 (2008).
[xxii] 5 U.S.C. §§ 551-559 (2006).
[xxiii] Robert E. Burns, The Evolving Role of Dispute Resolution in Administrative Procedures, 5 Admin. L. and Prac. 27 (1990).
[xxiv] 5 U.S.C. § 561 (1992).
[xxv] Phil J. Harter, Negotiating Regulations: A Cure for Malaise, 71 Geo. L.J. 1 (1982).
[xxvi] See 5 U.S.C § 563 (1992).
[xxvii] 5 U.S.C. § 562(2) (1992).
[xxviii] The FAA created the Aviation Rulemaking Advisory Committee (ARAC) with consensual decision-making. See Kerwin, supra note 13; See also USDA, What is Negotiated Rulemaking? (2011), (discussing how an agency can properly utilize Negotiated Rulemaking).
[xxix] Harter, supra note 25.
[xxx] Philip J. Harter, Assessing the Assessors: The Actual Performance of Negotiated Rulemaking (1999),
[xxxi] Id.
[xxxii] Lubbers, supra note 21.
[xxxiii] Mashaw, supra note 15.
[xxxiv] Id.
[xxxv] The NRA’s purpose should be to reduce judicial challenges to regulations by encouraging the parties to narrow their differences in advance of the formal rulemaking proceeding, which was not the result in this case. See USA Grp. Loan Servs. v. Riley, 82 F.3d 708, 715 (7th Cir. 1996).
[xxxvi] Kerwin, supra note 13.
[xxxvii] Laura I. Langbein & Cornelius M. Kerwin, Regulatory Negotiation Versus Conventional Rulemaking: Claims, Counterclaims, and Empirical Evidence, 10 J. of Public Admin. Research and Theory 599, 611 (2000).
[xxxviii] Harter, supra note 30.
[xxxix] Mo. Farm Law § 7.31 (2006).
[xl] Allyson Weaver, “Natural” Foods: Inherently Confusing, 39 Iowa J. Corp. L. 657, 673.
[xli] Benny, supra note 5.
[xlii] Gene Summerlin, Mediation of NOP Disputes, Husch Blackwell LLP (March 12, 2015),
[xliii] Mediation, 7 CFR § 205.663, (“Mediation shall be requested in writing to the applicable certifying agent. If the certifying agent rejects the request for mediation, the certifying agent shall provide written notification to the applicant for certification or certified operation.”)
[xliv] Id.
[xlv] Daniel J. Fiorino, Regulatory Negotiation as a Policy Process, 48 Pub. Admin. Rev. 764 (1988).
[xlvi] Id.
[xlvii] Id.
[xlviii] Id. at 766.
[xlix] Arbitration is known to be less fair and less negotiable. See id. at 768.
[l] Id. at 771.
[li] Id.
[lii] Holk v. Snapple Bev. Corp., 574 F.3d 329 (2009).
[liii] Benny, supra note 5.
[liv] Id. at 1526.
[lv] Id.
[lvi] Federal Food, Drug and Cosmetic Act, 21 U.S.C. §§ 301-399 (1938).
[lvii] Benny, supra note 5.
[lviii] Id.
[lix] Julie Kobick, Negotiated Rulemaking: The Next Step in Regulatory Innovation at the Food and Drug Administration?, 65 Food & Drug L.J. 425, 443 (2010).
[lx] Id.
[lxi] Id.
[lxii] Food and Drug Administration Revitalization Act, § 1082, 110th Cong. (2007).
[lxiii] Kobick, supra note 59, at 425.
[lxiv] Id.
[lxv] Id. at 442.
[lxvi] Food for Human Consumption, 21 C.F.R. § 101.12 (2015).”
[lxvii] Kobick, supra note 59, at 425.
[lxviii] See U.S. v. Nova Scotia Food Prod. Corp., 568 F.2d 240, 243 (1977).
[lxix] Id.
[lxx] Hadley Malcolm, More Shoppers Buying “Natural” Food, Yet Most Don’t Know What it Means, USA Today (Jan. 27, 2016),
[lxxi] Stephanie Amaru, A Natural Compromise: A Moderate Solution to the GMO & “Natural” Labeling Disputes, 69 Food & Drug L.J. 575, 576 (2014).
[lxxii] Don Amerman, Negative Effects of Artificial Sweeteners, Livestrong, (“[Indeed], saccharin and stevia are not yet approved for use by pregnant or lactating women.”)
[lxxiii] Sarah L. Brew & Courtney A. Lawrence, FDA Takes A Step Forward on ‘Natural’ Food Labeling, Law 360 (2015),
[lxxiv] Chellie Pingree & Anna Lappe, The Food Movement is Small? Not From Where We Sit, It Isn’t, The Washington Post (Feb. 4, 2016),
[lxxv] Brew & Lawrence, supra note 75.
[lxxvi] The Grocery Manufacturer’s Association does not want a GMO label to exist while Consumer Reports does, to name two prominent companies. Id.
[lxxvii] FDA, Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants (Nov. 2015),
[lxxviii] Chris Clayton, Biotech Label Bill Delayed (Feb. 24, 2016),
[lxxix] Gene Logsdon, Factual Science and Maybe Science, The Contrary Farmer (March 23, 2016, 9:17 AM), (commenting that media reports on GMOs are not scientifically-based.)
[lxxx] Harter, supra note 25.
[lxxxi] Id.
[lxxxii] Id. at 42.
[lxxxiii] Mashaw, supra note 15.
[lxxxiv] Harter, supra note 25.
[lxxxv] See Melvin Aron Eisenberg, Private Ordering Through Negotiation: Dispute-Settlement and Rulemaking, 89 Harv. L. Rev. 637 (1976).
[lxxxvi] Harter, supra note 25.
[lxxxvii] Id. at 39.
[lxxxviii] Id. at 40.
[lxxxix] For more details on the reg-neg process and choosing the proper negotiators, see Harter, supra note 25, at 66.
[xc] Id. at 59.
[xci] Toni M. Fine, A Legislative Analysis of the Demise of the Administrative Conference of the United States, 30 Ariz. St. L.J. 19, 114 (1998).
[xcii] Id. at 117.
[xciii] Id. at 189.
[xciv] Lawrence Susskind, The Consensus Building Handbook 232 (1st ed. 1999).
[xcv] Id.
[xcvi] Sally Painter, Why Campbell’s Stand for GMO Labeling Is So Important (Feb. 19, 2016),
[xcvii] Id. (explains the GMA, with members such as Pepsi, Coca Cola and Nestle, largely opposes mandatory GMO labeling for economic reasons. However, it is also inefficient for them to fight the labeling advocates, costing the GMA $5.8 million. And, General Mills recently came out with a statement supporting a national labeling law for non-GMO products. See On GMOs, General Mills (2016),
[xcviii] Just Label It, Partner Center (2015),
[xcix] Food with Integrity: G-M-Over It, Chipotle,
[c] Susskind supra note 94, at 253.
[ci] Consensus Building Institute, CBI’s Mutual Gains Approach to Negotiation,
[cii] Id.
[ciii] Id.
[civ] Id.
[cv] Susskind supra note 94, at 272.
[cvi] Id. at 274.
[cvii] FDA, “Natural” on Food Labeling (Nov. 14, 2016),
[cviii] Alan Levinovitz, What is ‘Natural’ Food? A Riddle Wrapped in Notions of Good and Evil, NPR (May 8, 2016),