Summary¹

Federal guidance on nutrition and diet is intended to reflect the state of the science and deliver the most reliable recommendations possible according to the best available evidence. This guidance, updated and presented every 5 years in the Dietary Guidelines for Americans (DGA), serves as the basis for all federal nutrition policies and nutrition assistance programs, as well as nutrition education programs. Despite the use of the guidelines over the past 30 years, recent challenges prompted Congress to question the process by which food and nutrition guidance is developed.

The DGA is a report that provides nutritional and dietary information to the public for the purpose of promoting health and preventing disease. To help Americans make healthy food choices, the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) are mandated by Congress in the National Nutritional Monitoring and Related Research Act of 1990 to jointly review and author the guidelines through a multistep process to reflect “the preponderance of the scientific and medical knowledge which is current at the time the report is prepared.” The process to create the guidelines is not simple, and it changes as the science evolves. The process begins with an assessment of relevant scientific data by a federal advisory committee selected and convened by USDA and HHS. This panel of nationally recognized experts, known as the Dietary Guidelines Advisory Committee (DGAC), indepen-

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¹ This summary does not include references. Citations for the findings presented in the summary appear in subsequent chapters of the report.

dently evaluates the scientific evidence and makes recommendations to the departments about how the DGA could be revised. The conclusions of the DGAC are submitted to the secretaries of USDA and HHS in the form of a scientific report and are only advisory; they do not constitute draft policy. The DGAC report serves as the scientific basis for the next edition of the DGA.

When the 2015 DGAC released its report, some of the content received criticism from different stakeholders leading to questions about the advisory committee’s composition and membership selection processes. Further questions were raised about the breadth of the DGAC’s scope, the processes used to evaluate the evidence, and the completeness of the advisory committee’s work.

CHARGE TO THE NATIONAL ACADEMIES OF SCIENCES, ENGINEERING, AND MEDICINE

In response to concerns raised about the 2015–2020 DGA, Congress mandated that the National Academies of Sciences, Engineering, and Medicine (the National Academies) evaluate the entire process used to develop the DGA. Specifically, the Consolidated Appropriations Act, 2016, calls for a review of the following:

1. How the advisory committee selection process can be improved to provide more transparency, eliminate bias, and include committee members with a range of viewpoints;
2. How the Nutrition Evidence Library (NEL) is compiled and utilized, including whether NEL reviews and other systematic reviews and data analysis are conducted according to rigorous and objective scientific standards;
3. How systematic reviews are conducted on long-standing DGA recommendations, including whether scientific studies are included from scientists with a range of viewpoints; and
4. How the DGA can better prevent chronic disease, ensure nutritional sufficiency for all Americans, and accommodate a range of individual factors, including age, gender, and metabolic health.

The National Academies appointed 14 members to the Committee to Review the Process to Update the Dietary Guidelines for Americans. Specifically, the task is to assess the process used to develop the guidelines, and not evaluate the substance or use of the guidelines (see Chapter 1 for the full statement of task). The committee was asked to respond to the first part of the task: “How the advisory committee selection process can be improved to provide more transparency, eliminate bias, and

include committee members with a range of viewpoints,” in a first short report for the purpose of informing the 2020 cycle, which is scheduled to begin in early 2017. As part of an overall, comprehensive review of the process to update the DGA, additional findings and recommendations about the selection process may be made as part of this committee’s next report.

MODELS FOR COMPOSING AN ADVISORY COMMITTEE

The DGAC is established in pursuit of fulfilling the National Nutrition Monitoring and Related Research Act and governed by the Federal Advisory Committee Act (FACA), which directs the establishment, operation, oversight, and termination of advisory committees within the executive branch of the federal government. To comply with FACA, a number of administrative processes must be followed to institute each DGAC, including filing a charter and developing a plan to fairly balance membership.² Other administrative tasks used by USDA and HHS include updating bylaws, updating the charge, and preparing a database for public comments. Once the federal advisory committee is established, steps used by USDA and HHS for selecting members include soliciting candidates, reviewing nomination packages and creating a slate of potential members, approving the slate, and finally, formal appointment.

This National Academies committee sought to ground its work in as much evidence as possible but found few objective measures to assess the effectiveness of a selection process. An exploratory search of other advisory committees’ selection processes—including those that are and are not governed by FACA—identified a number of differing noteworthy models. This search revealed a lack of standardization for how experts are nominated, screened, vetted, and appointed to a committee. No set of best practices to promote transparency and engage a broad set of viewpoints and expertise could be identified. Although there are certain similarities in the selection processes used by federal advisory committees, wide variations exist in how the selection of advisory committees is operationalized. Additionally, some advisory committees make use of stakeholder representatives with varying levels of involvement, while others only engage stakeholder groups through public comments. Identified differences alluded to each advisory committee’s unique origins and goals.

One important difference identified among advisory committees is the approaches used to address biases and conflicts of interest. For the purpose of selecting members to the DGAC, it is important to interpret

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² The administrative lead department switches between USDA and HHS every 5 years. The department with the lead is responsible for following the appropriate processes.

conflicts of interest broadly by including not only financial sources, but also nonfinancial conflicts of interest (e.g., statements in publications, history of unpaid advisory roles, organizational affiliations). Defined this broadly, it might not always be possible to entirely eliminate biases and conflicts of interest on a panel of experts. The ultimate goal of limiting and managing conflicts of interest is to develop a trustworthy process and create reliable guidelines, independent from undue influences. Significant conflicts ought to be avoided, but some situations may exist where the requisite expertise cannot be found in individuals without some conflicts of interest. In these instances, it is necessary to identify, disclose, and manage the influences in question.

OPPORTUNITIES TO BUILD TRUST

The goal of this review is to provide recommendations to develop a trustworthy process for creating the DGA. One critical but early step that can be taken to ensure the DGA is reliable is to optimize the integrity of the selection process. This National Academies committee identified a set of values to enhance the integrity of the selection process:

1. Enhance transparency. To the extent practicable, each step ought to be described in as much detail as possible and be made available to the public for its understanding. This transparency can help reassure the public that no undue influences or untoward actions are being taken.
2. Promote diversity of expertise and experience. A broad range of expertise and experience must be considered to create a balanced committee. Expertise has to align with the topic areas to be reviewed. Diversity with respect to nontechnical skills (e.g., ability to form consensus or develop compromise) also needs to be considered. Building on the first characteristic of transparency, involvement from a broad range of perspectives, including public involvement, is also critical to fostering diversity.
3. Support a deliberative process. A deliberative process should be used that considers information from a wide variety of sources. Decision makers ought to freely exchange information with one another toward the goal of coming to agreement or consensus. To the extent possible, the public should be engaged as well.
4. Manage biases and conflicts of interest. The biases of individual members should be balanced among a broad representation of perspectives. Actual and/or perceived conflicts of interest—both financial and nonfinancial—should be eliminated to the extent possible or their effects be minimized.

5. Adopt state-of-the-art processes and methods. As practicable, selection processes and actions ought to be based on the best available evidence for the broader purpose of managing bias and conflict of interest. They should be revised and improved on as new evidence arises.

This National Academies committee compared these values of an “ideal” selection process to the current DGAC selection process. The committee found that, overall, the DGAC selection process is thoughtful and works within the bounds of the relevant laws to serve USDA and HHS, as well as the American public. However, the lack of transparency in the current process could lead to the perception that the membership of the DGAC is inequitable, which affects its integrity and trustworthiness. Specifically, the step currently used to “conduct a review of nominations and propose a slate of candidates” was found to be largely subjective and could be improved. The other steps were generally more direct and were not deemed to inhibit trust. Recommendations and suggestions are offered specifically in response to this step to enhance transparency and inclusiveness, and minimize undue influences (see Figure S-1).

Review of Candidates

“Conduct a review of nominations and propose a slate of candidates,” step 3 of the current process, is inherently the most subjective step in the DGAC selection process. Concern has been expressed that the departments are not fairly considering all qualified candidates and not including members with a broad spectrum of perspectives. Unfortunately, there are limited objective measures to judge a nominee’s qualifications and the overall balance of a committee.

A more transparent process to review candidates is needed, as the mandate from Congress indicates that some subsets of the public do not trust the DGA. Based on lessons learned from an evaluation of other advisory committees, this National Academies committee concludes that the initial screening of nominees should be separated from the appointment authority. A neutral, unbiased arbiter should evaluate candidates’ nomination packages and qualifications, identify other candidates as necessary, interview promising candidates, provide an initial cursory review of biases and conflicts of interest, and submit a slate of primary and alternate nominees for consideration by the secretaries of USDA and HHS. With its experience in the field, USDA and HHS could still be responsible for balancing the final advisory committee and appointing members.

The third party would need to be an organization without a political, economic, or ideological identity. It would need a strong record of hav-

ing both the theoretical knowledge and practical expertise in the assembly of impartial committees. Since the third party would not be making final selections, it would not necessarily need to be expert in nutrition or dietary guidance, just skilled in evaluating individuals’ expertise and experience. It could be a private, nonprofit, or government organization, but should not be part of either sponsoring agency.

This National Academies committee’s opinion is that political bias—both the perception and reality—would be reduced by a third party since USDA and HHS would not be involved in narrowing the field of candidates. If the secretaries of USDA and HHS are selecting final nominees from a short list of equally well-qualified, nonconflicted candidates, there is a greater potential that the final DGAC will be neutral. This in fact has the potential to reduce bias but even stronger potential to improve perception. Having the secretaries continue to select the final membership would also remove the need for the external organization to have specific expertise related to the DGA, likely resulting in a broader pool of candidates.

There is no absolute guarantee that a third party will reduce bias; there is no evidence to say that a third party would not come up with the same exact committee of experts as assembled by the current process. Additionally, the secretaries of USDA and HHS would remain the appointing authorities. However, to the many critics of the process, a third party would ensure that USDA and HHS were more at an arm’s length from the selection of DGAC members. This committee believes that at the very least, this would improve public perception of a more objective process. Another drawback is that this approach would likely have budgetary implications despite some savings in staff time, as well as lengthen the selection process. However, selection of a third party could begin before the charter is filed so as to leave the DGAC with as much time as possible to conduct its work.

Membership Criteria and Composition

Critical components in the selection process are the criteria against which they are evaluated and approaches to balancing the advisory committee’s overall composition. In the current process, candidates are assessed “based upon their qualifications, level of expertise and knowledge, and ability to contribute to the work to be performed,” as well as diversity of “geographic areas, academic institutions, gender, race, ethnicity, and disability.” Conflicts of interest and background checks are considered prior to appointment to the advisory committee.

Other factors are likely considered during the balancing process, but they are not explicitly stated. These include willingness to serve; minimal financial and nonfinancial conflicts of interest; biases that can be balanced

with those of other members; and prior experience working on advisory committees or panels. Skills need to be reviewed for the group as a whole, as well as individuals. All criteria used in making a final selection ought to be clearly stated. The organization selecting candidates will need to review the collective expertise, experience, and perspectives before making final appointments. Through this deliberative process, the public can be assured that the advisory committee is objective and has the requisite expertise to complete its task.

The composition of the advisory committee ought to be dictated to a great degree by the content areas under review, while also representing a wide variety of perspectives. Ideally, any group of experts with a similar composition could be appointed and derive the same findings. The 2015 DGAC membership balance plan listed but was not limited to a set of 17 specialty areas to be represented. Experts may have experience in one or more of the areas, so a one-to-one match between category of expertise and DGAC members is not required.

In considering the specific areas of expertise needed, the complicated question arose of which should be developed first: the specific questions to be answered by the DGAC or the areas of expertise needed to address the charge? The current process relies on the DGAC to develop priority topics for review rather than for an a priori process to identify which updates and reviews are most critically needed, thus influencing the expertise needed on the DGAC. This National Academies committee discussed the potential value of focusing on specific areas that need revision or updating in the DGA. This situation would allow for concentration of expertise in key priority areas rather than comprehensive expertise needed for review of the complete DGA. This issue was recognized because of the need to focus on recommendations for pregnant women and children from birth to 24 months in the 2020–2025 DGA. However, to meet the short timeline for its first report, this National Academies committee was not able to formulate a specific recommendation on this approach or more broadly about the DGAC composition. This issue will be addressed upon a full examination of the DGAC’s charge and the overall DGA process.

Additional Public Comment Periods

Prior DGACs were criticized primarily for their lack of balance and not necessarily the qualifications of specific individuals. The one formal opportunity for public input during the selection process was in response to a call for nominations.

A reasonable amount of time for feedback is critical to a transparent selection process. The public should have an additional opportunity to comment after the initial solicitation of nominations (see step 7

of Figure S-1). The additional time and resources required for another public comment period was determined to have the significant benefit of increasing transparency during the selection process. Some advisory committees invite the public to comment on all individuals nominated for the activity, while others request comments on a provisional panel before they are officially appointed. Considering the size of the candidate pool (150 to 200 candidates were considered in each of the past three cycles) and the need to focus on the overall composition, an opportunity should be made for the public to provide input on a provisional panel; appointments would be finalized upon consideration of public comments. This would allow the departments to address any concerns raised and encourage transparency.

Candid information from the public about proposed members is critical for a deliberative process. However, full transparency in the form of publicly accessible deliberations or posting of public comments about every nominee is not practical given the sensitivity around why someone is or is not considered a strong candidate for DGAC membership. Such a process would likely lead to ad hominem attacks presented in public comments or explanations by USDA or HHS that could result in candidates being maligned in the public press and their reputations damaged, discouraging people from willingly volunteering their time to serve on the DGAC, reducing the pool of qualified candidates.

Biases and Conflicts of Interest

Biases and conflicts of interest may unduly influence the deliberations and outcomes of an advisory committee. The perception of biases and conflicts of interest can also undermine the public’s trust in the process. It is therefore critical that these biases and influences be discussed prior to appointment. But given the breadth of this National Academies committee’s definitions of biases and conflicts of interest to include nonfinancial conflicts, the committee does not believe these influences can be eliminated entirely. As such, those who have had relationships with industry or issue-specific advocates in the recent past could participate fairly on a panel if the nature of the relationship was incidental to the work of the panel. However, strict policies must be made publicly available explaining how such conflicts will be identified and managed.

To identify conflicts, the federal Office of Government Ethics Form 450, which is currently used for the DGAC, was found to cover financial conflicts of interest adequately. However, since the Office of Government Ethics only reviews financial conflicts, no explicit, formal steps were identified for candidates to disclose nonfinancial conflicts or biases. To enhance transparency, a form should be developed and used for the disclosure of relevant nonfinancial conflicts of interest and biases. Ethics officers not involved in the development of the DGA should independently judge the presence of conflicts. A detailed description of how biases and conflicts of interest would be identified should be made publicly available as part of a policy concerning bias and conflict of interest.

Potential biases and conflicts of interest ought to be disclosed at varying levels to three audiences: the appropriate ethics officers; other members of the specific activity, in this case, DGAC members; and to the public to the extent possible. Any potential biases or conflicts should be shared with ethics officers. Disclosure should also be made revealing sources of conflicts to all other DGAC members so they can better understand the basis for each other’s positions. Finally, an abstraction of conflicts of interest deemed to be significant ought to be shared with the public, including sources of funding, consultancies, and other relationships as appropriate.

Management of biases and conflicts of interest are as important as their identification. Many tools exist to manage conflicts of interest. For example, exemptions could be made in instances where the potential conflict is deemed too remote or inconsequential to significantly influence an individual’s judgment, or waivers could be granted that would allow for varying ranges of participation. Changes to the advisory committee’s structure could also be adopted to minimize the effect of any undue influence during its work. Individuals could also choose to resign from a disqualifying activity or divest property. These and other approaches are often used to mitigate the effect of activities deemed to be actual or perceived conflicts. A certification describing management plans put in place should be issued with the advisory committee’s final report.

3. Certifying that a federal ethics officer independently reviewed and judged the advisory committee’s biases and conflicts of interest; and by
4. Documenting how conflicts of interest were managed in the Dietary Guidelines Advisory Committee report.

A CONTINUOUSLY LEARNING SELECTION PROCESS

USDA and HHS will need to dynamically improve the DGAC selection process to drive toward positive change and contribute to enhanced trustworthiness of the DGA. Sustained, optimal performance of a process is the product of systematic quality improvement activities. Development of systemic quality improvement will allow future DGAC selection processes to be grounded in evidence. However, development of a true system for quality improvement takes time and commitment. This National Academies committee recognizes that both development of a system for quality improvement and changes to the DGAC selection process will not be immediate. Actions could be taken in the short term and are suggested at three levels: the selection process as a whole, the structure of the advisory committee, and advisory committee functions. Improvements should be made as evidence about the selection process evolves and becomes available. A full discussion of a continuously learning process will be presented in this National Academies committee’s second report.

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