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The Dietary Guidelines Advisory Committee Process

A BRIEF HISTORY

In 1977, the U.S. Senate Select Committee on Nutrition and Human Needs recommended a set of dietary goals for Americans, calling for the public to expend as much or more energy (kcals) as it consumes, and suggesting nutrient- and food-based targets. When those goals were publicly released, industry and the scientific community questioned whether the recommendations could be supported by available science. To provide the public with authoritative guidance on diet and health, the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) (then called the U.S. Department of Health, Education, and Welfare) convened scientists from within the departments and released a set of principles in the 1980 report Nutrition and Your Health: Dietary Guidelines for Americans, the first edition of the dietary guidelines. Like the 1977 report, the 1980 report suggested a causal relationship between the guidelines and health that also sparked questions about whether sufficient science was available to make these recommendations. To address those concerns, a 1983 congressional report directed that a scientific advisory committee of external experts be convened to review the evidence and suggest updates to the 1980 report. Those recommended revisions informed the development of the second edition of the Dietary Guidelines for Americans (DGA; 1985). Congress indicated that advisory committees should continue to be reestablished to review relevant scientific data and make recommendations on appropriate changes to the secretaries of USDA

and HHS.¹ As a result, an advisory committee has been an explicit part of the Dietary Guidelines process for more than 30 years, more commonly known as the Dietary Guidelines Advisory Committee (DGAC) (HHS/USDA, 2013).

The role of diet in preventing chronic disease was questioned after conflicting reports were released on the effectiveness of dietary recommendations on the public’s health. These reports made clear that a universal standard of scientific evidence regarding nutrition is needed (GAO, 1984). Three landmark publications—The Surgeon General’s Report on Nutrition and Health (HHS, 1988), Diet and Health: Implications for Reducing Chronic Disease Risk (NRC, 1989), and How Should the Recommended Dietary Allowances Be Revised? (IOM, 1994)—set the stage for a public conversation about the role of diet in reducing risk of chronic disease, food components related to health benefits, and evaluation of risk from both nutritional deficiency and excess as contemporary public health concerns. As an outcome, federal nutrition policy began to evolve, incorporating the concept of the whole diet and the role of food-based dietary patterns into guidance for the public about diet and health.

ESTABLISHMENT OF A FEDERAL ADVISORY COMMITTEE

The DGAC is established pursuant to the National Nutrition Monitoring Act and governed by the Federal Advisory Committee Act (FACA), which directs the establishment, operation, oversight, and termination of advisory committees to the executive branch of the federal government.² One key goal of the act is to ensure advice is objective and accessible to the public.³ The act is generally not prescriptive, but rather it provides executive branch agencies and/or departments (hereafter referred to as agencies when referencing FACA) with the flexibility to develop their own processes. Agencies have discretion over the particular processes they put in place where the act is silent. Agencies are also required to develop administrative guidelines that describe how they will implement FACA at their agency; while the content of these guidelines is at the agency’s discretion, they must be consistent with FACA. To comply with FACA, a number of administrative processes must be followed to establish the DGAC, which is installed at the discretion of the secretaries of USDA and HHS, including filing of a charter and developing a plan to fairly balance membership (see Box 2-1).

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¹ U.S. House of Representatives Conference Committee. 100th Cong., 1st sess., H. Rep. 498, 1987.

² Federal Advisory Committee Act, 1972, Public Law 92-463. 92nd Cong., 86 Stat. 770.

³ Advice must come from groups that include at least one nonfederal member.

Federal advisory committees can be composed of members from one or more of the following categories: special government employees, regular government employees, representative members, and ex officio members (see descriptions in Box 2-2).

While USDA and HHS develop the guidelines jointly, the administrative lead for a particular edition of the guidelines is responsible for following the appropriate processes (e.g., USDA is the lead for the 2020–2025 report). A memorandum of understanding is put in place between the two departments to provide a framework for this collaborative relationship. The following sections describe the relevant FACA processes and HHS and USDA’s interpretation of the law in the development of the 2015–2020 edition of the DGA. The process includes filing the charter and submitting the membership balance plan. Other administrative tasks USDA and HHS complete include updating bylaws, updating the charge, and preparing a database for public comments (USDA/HHS, 2016a).

Charter

To establish a federal advisory committee to advise an agency or federal official in the executive branch of government, FACA requires a charter be filed with the agency head; standing committees of the Senate and House having legislative jurisdiction of the agency; the Library of Congress; and the committee management secretariat. The charter outlines the mission and scope for advisory committees and includes the following: (1) Committee’s official designation; (2) Authority; (3) Objectives and scope of activities; (4) Description of duties; (5) Agency or official to whom the committee reports; (6) Support; (7) Estimated annual operating costs and staff years; (8) Designated federal officer; (9) Estimated number and frequency of meetings; (10) Duration; (11) Termination; (12) Member-

ship and designation; (13) Subcommittees; (14) Recordkeeping; and (15) Filing date (GSA, 2011b).⁴

The DGAC is a discretionary committee, which means that it is established by either the secretary of USDA and HHS; the agency with administrative lead switches with every edition of the DGA. The decision to establish or terminate the DGAC lies with the respective secretary. The main objective listed in the charter of the 2015 DGAC was “to provide independent, science-based advice and recommendations for development of the Dietary Guidelines for Americans, 2015” (Secretary of Health and Human Services, 2013). The committee’s report is described as the basis for the policy document, although the committee’s work is advisory only. The charter instructs the committee to take new scientific evidence and current resource documents into consideration of its scientific recommendations. Notably, the DGAC is directed to state its rationale in the presentation of its conclusions.

As part of the process, USDA and HHS each appoint co-executive secretaries from their respective agencies to support the work of the advisory committee and ensure it stays within its charge. For the 2015 advisory committee, a total of four co-executive secretaries, two from USDA and two from HHS, were appointed.⁵ One of the officials from the lead agency serves as the designated federal officer to oversee management and support services and submit FACA reporting requirements.

The “membership and designation” field states not only the expected number of committee members but also the categories of expertise to be represented. The 2015 advisory committee was proposed to consist of 13 to 17 members, led by a chair, and potential for a vice chair and/or cochairs. In the end, 15 members were appointed by the secretaries of HHS and USDA, led by a chair and vice chair. One member stepped down from the committee after 3 months and was not replaced, leaving a total of 14 members. Members were appointed for the duration of the project. All members of the 2015 DGAC were classified as special government employees (see Box 2-2), meaning that all members were chosen to represent themselves and use their own judgment on behalf of the federal government, and were not representing a group or entity. In accordance with FACA, the advisory committee is limited to 2 years to complete its work.

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⁴ The authority, designated federal officer, membership and designation, subcommittees, and recordkeeping sections “are not explicitly required (at this time) but improve the overall charter and provide valuable additional information for interested parties” (GSA, 2011b).

⁵ The USDA undersecretaries of food, nutrition, and consumer services and research, education, and economics appoint one representative from the Center for Nutrition Policy and Promotion and one from the Agricultural Research Service. The two representatives from the Health and Human Services Office of Disease Prevention and Health Promotion are appointed by the assistant secretary for health.

Expertise sought for the 2015 DGAC as listed in the charter included but was not limited to cardiovascular disease; type 2 diabetes; overweight and obesity; osteoporosis; cancer; pediatrics; gerontology; maternal/gestational nutrition; epidemiology; general medicine; energy balance, which includes physical activity; nutrient bioavailability; nutrition biochemistry and physiology; food processing science, safety, and technology; public health; nutrition education and behavior change; and/or nutrition-related systematic review methodology (Secretary of Health and Human Services, 2013). These categories of expertise are developed by the departments and are revised with each charter.

Advisory committee members do not receive payment for their service with the exception of per diem and reimbursed travel expenses. Estimated annual operating costs to support the 2015 advisory committee were $400,000. A total of 4.4 full-time equivalents were projected to support the DGAC. Additional costs borne by the departments for administrative support and staff time were not included in these estimates (USDA/HHS, 2016a).

The charter clearly provides the advisory committee’s authority to establish subcommittees and working groups. These groups may only provide recommendations to the parent committee and may not report directly to a federal official. The 2015 advisory committee split itself into three initial working groups. Upon developing its direction, the DGAC broke into five topic-specific subcommittees and four working/writing groups.⁶ Under the 2015 charter, the DGAC was authorized to identify and use nonmember consultants who did not vote on the final report. Two subcommittees of the 2015 DGAC engaged with three consultants who were expert in the respective subcommittees’ work. Consultants were trained and cleared through a formal federal process similar to the one the DGAC members underwent (HHS/USDA, 2015, part C).

Membership Balance Plan

As part of its compliance with FACA, agencies must ensure the membership of a federal advisory committee is “fairly balanced in terms of the points of view represented and the functions to be performed by the advisory committee.”⁷ Discretionary committee agencies are required to develop a membership balance plan that describes how the agency will

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⁶ The five subcommittees were (1) food and nutrient intakes and health: current status and trends; (2) dietary patterns, foods and nutrients, and health outcomes; (3) diet and physical activity behavior change; (4) food and physical activity environments; and (5) food sustainability and safety. Working/writing groups were sodium, added sugars, saturated fats, and food and physical activity environments.

⁷ Federal Advisory Committee Act, 1972, Public Law 92-463, 86 Stat 770, § 5(b)(2).

attain fairly balanced membership.⁸ The membership balance plan is provided to the committee management secretariat as part of the required consultation process for establishing, renewing, or reestablishing a discretionary advisory committee. A membership balance plan can include elements such as points of view, other balance factors an agency identifies as important to achieve a balanced group, and the candidate identification process (GSA, 2011a). Although not required, a membership balance plan is also recommended for nondiscretionary advisory committees.

The points of view section in the 2015 DGAC restates the categories of expertise identified in the charter and underscores the point that members represent themselves and personal viewpoints, not those of a specific group. The plan lists other factors aimed to support balance including diversity across geographic areas, academic institutions, gender, race, ethnicity, and disability.

The membership balance plan for the 2015 DGAC describes a general candidate identification process, beginning with a notice in the Federal Register. Various offices within HHS and USDA review the nominees and identify qualified candidates, as well as those with the experience to potentially serve in leadership positions.⁹ For the 2015 advisory committee, a list of primaries and alternates was developed and primaries were submitted through the formal nomination request to the secretaries of HHS and USDA (USDA/HHS, 2016a).

Bylaws

Federal advisory committees may operate in accordance with bylaws (also referred to as operating procedures). In addition to the committee’s purpose, authority, membership selection, and appointment processes, the bylaws can delineate procedures for meetings, receipt of public comments, voting, role of board officials, expenses and reimbursement, and additional information. However, there currently is no standard template for the content of bylaws for federal advisory committees.

Bylaws were proposed by USDA and HHS and agreed upon by each DGAC. The bylaws governing the 2015 DGAC affirm that its operations are in accordance with FACA. Details are described, such as that meeting agendas will be approved by the designated federal officer and announced in the Federal Register; a quorum—defined as at least two-

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⁸ 41 C.F.R. § 102-3.60.

⁹ Specifically, the HHS Office of Disease Prevention and Health Promotion; the USDA Food, Nutrition, and Consumer Services’ Center for Nutrition Policy and Promotion; and the USDA Research, Education, and Economics’ Agricultural Research Service review and evaluate nominations.

thirds of the committee’s members—must be present for meetings to be held; meetings related to substance will be open to the public (some meetings are administrative in nature, such as training on ethics and compliance with federal advisory committee rules); and that no closed meetings are planned. As one way to enhance transparency, written public comments to the advisory committee are all shared with the public through an online public comments database. Documentation of advisory committee deliberations are made publicly available. The bylaws state that decisions of the advisory committee are generally to be made through consensus but allow for formal voting if needed and outline processes to do so. Roles of the committee’s chair and the co-executive secretaries are described. The document also details allowable expenses. Finally, it identifies the lead department’s committee management officer as an additional source of guidance to ensure the advisory committee meets its objectives and to oversee the advisory committee’s work (USDA/HHS, 2016a).

Charge

The DGAC is charged by HHS and USDA with reviewing the latest scientific evidence to inform revisions to the current guidance. DGACs are constituted for 2 year periods to complete their tasks and submit their findings to the secretaries of HHS and USDA in the form of scientific reports, which include technical recommendations and rationale but do not translate recommendations into policy.

In the case of the 2015 advisory committee, the charge was to review the 2010 guidelines and identify where new evidence would likely exist that may update existing guidance or suggest areas for new recommendations. The charge emphasizes systematic reviews and analyses of evidence published since the last advisory committee’s deliberations. The 2015 advisory committee was also directed to place its primary emphasis on topics of public health importance for Americans ages 2 years and older (HHS/USDA, 2015, part C).

The charge can change between editions as needed. For example, the guidelines have historically focused on adults and children 2 years of age and older. However, the USDA-HHS Dietary Guidance Development Project for Pregnancy and Birth to 24 Months has initiated a project to develop advice for expanding the DGA beginning with the 2020–2025 edition (Raiten et al., 2014). Per the Agricultural Act of 2014, the guidelines will include pregnant women and children under the age of 2 years.

Public Comments Database

To promote transparency and public participation, the departments created an electronic database at www.dietaryguidelines.gov. This database is accessible to the public, as well as members of the advisory committee, and allows people to submit and access comments submitted for the committee’s consideration. The comments are processed and organized by federal staff.

CURRENT ADVISORY COMMITTEE SELECTION PROCESS

The selection process is designed by HHS and USDA to vet the proposed slate within the departments, while also complying with FACA. Steps involved with the selection process include soliciting candidates, reviewing nomination packages and creating a slate of potential members, approving the nomination request package, and finally, formal appointment (see Figure 2-1). The nomination process begins while the aforementioned administrative tasks to establish the advisory committee are completed. The entire nomination process for the 2015 advisory committee took 7 months.

The co-executive secretaries initiate the process to form a federal advisory committee, which begins with announcing the intent to establish the advisory committee, solicitation of nominations, and formation of the charter. Nominees are solicited through a number of media, including the Federal Register, federal online mailing lists, and stakeholder communications. The Federal Register announcement of intent to establish the DGAC and solicitation of nominations lists the workplan (e.g., timing and number of meetings), general selection criteria, and categories of expertise sought. It also lists the information required to submit a nomination, including

1. a nomination letter and the qualifications of the nominee, as well as confirmation from the nominee that he or she would be willing to serve if asked;
2. nominee’s contact information; and
3. curriculum vitae or resume, limited to no more than 10 pages.

The call for nominations for the 2015 DGAC lasted 45 days, resulting in 185 nominations (USDA/HHS, 2016b).

Initial reviews are conducted by the four co-executive secretaries who convene repeatedly to narrow the candidate pool to those who meet the requirements stated in the balance plan and charter. Remaining nominees are assessed for their abilities to contribute to the committee, both with respect to their specific areas of expertise as well as the breadth of their

experiences. Additionally, individuals’ abilities to collaborate and work well with others, as well as skills related to communication and leadership, are considered. Members are selected to represent themselves and their own best judgment, not those of an employer or group. The candidates that collectively (1) reflect the requirements in the charter and membership balance plan and (2) address the advisory committee’s charge are formed into a slate to be reviewed by the respective USDA and HHS offices. Feedback from the assistant secretary for health and the USDA undersecretaries of food, nutrition, and consumer services and research, education, and economics are passed back to the co-executive secretaries, and revisions are made as needed. Further vetting and consideration,

including background checks, are conducted by the lead agency. The final slate is included with other materials, such as biographical sketches and decision memoranda, to form a nominations request package. The package is routed to the secretaries for their approval.

Advisory committee members are then notified of their appointments. However, substantive work cannot commence until members are sworn in during the first public meeting. In accordance with FACA, the members and first meeting details are published in the Federal Register at least 15 days prior to the meeting (USDA/HHS, 2016a).

The lead agency finalizes appointments as special government employees by ensuring that personnel actions and ethics requirements are met. This includes a disclosure of financial conflicts of interest (through Office of Government Ethics Form 450), reviewed by the lead agency. Members are finally required to undergo administrative training prior to their first meeting to review FACA, the charter and charge, and expectations of a special government employee.

DIETARY GUIDELINES ADVISORY COMMITTEE OPERATING PROCESS

Over their 30 year history, the DGACs have improved their processes for evaluating science. This evolution reflects updates in nutrition science and innovations in methods for developing public health guidance (USDA, 2016). For example, the Dietary Reference Intakes (DRIs) provide the infrastructure for the guidelines by establishing intake values and safe upper levels of nutrient consumption (IOM, 2003). A complete set of DRIs—recommended nutrient intakes—was not available for inclusion in the DGA until the 2005 edition (IOM, 2004). The stated philosophy of the DGA is that the recommendations should promote health with the ultimate goal of improving diets and decreasing risk of chronic disease by reducing inadequate or excessive intakes of food, nutrients, and calories. This goal is important to keep in mind as specific DRIs may be updated prior to or during the 2020–2025 DGA. As updates occur, these developments in nutrition science will need to be taken into consideration by the DGAC. Similarly, the Nutrition Evidence Library (NEL) was created to bring tailored systematic reviews into the process. The 2010–2015 edition was the first DGA to use the NEL.

To provide background for the selection of members, the following section briefly describes how the DGAC operated in 2015 and how advisory committee members functioned. A more detailed description of the technical processes for evaluating the science will be provided in this National Academies committee’s second report.

The charge to the advisory committee is to “examine the previous edi-

tion of the DGA and determine topics for which new scientific evidence is likely to be available that may inform revisions to the current guidance or suggest new guidance” (USDA/HHS, 2016a). To address its charge, the advisory committee breaks into topic-specific subcommittees, each of which is led by a chair; DGAC members are all expected to serve on multiple subcommittees. These subcommittees identify topics for consideration and develop research questions within each topic. Consultants can also be identified and invited by the DGAC to partake in subcommittee deliberations. While consultants receive training and are cleared through the federal process like the DGAC members, they are not members of the full committee (USDA/HHS, 2016c).

Next, the advisory committee determines the best approach to answer each question identified by the subcommittees, many of which may require a combination of methods to address. The 2010 and 2015 DGACs considered four types of evidence: (1) original systematic reviews commissioned by the DGAC with support from USDA’s NEL, (2) systematic reviews or reports existing in the literature, (3) data analyses (e.g., intakes of foods and nutrients), and (4) food pattern modeling analyses. Other sources of information for the advisory committee to consider come from expert speakers and public comments. Through their discussions, the subcommittees assess the evidence and draft conclusions for consideration by the full DGAC (USDA/HHS, 2016c). The advisory committee works together to produce conclusions and draft the final report. Historically the DGA has been developed by consensus, but that decision is made by each DGAC itself.

CONCLUSION

In the development of the DGA, USDA and HHS convene a scientific advisory committee to evaluate the evidence and suggest updates to the previous edition. The DGAC has become a critical piece of the process to update the guidelines. This chapter described the process designed by the departments for selecting the advisory committee and its operating procedures, and the criteria the process must include to be in compliance with FACA.

REFERENCES

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GSA. 2016. GSA order: GSA Federal Advisory Committee Management Program. ADM 5420.40E. Washington, DC. https://www.gsa.gov/portal/getMediaData?mediaId=139662 (accessed October 5, 2017).

HHS (U.S. Department of Health and Human Services). 1988. The Surgeon General’s report on nutrition and health. DHHS publication PHS 88-50210. Washington, DC: U.S. Government Printing Office.

HHS/USDA (U.S. Department of Health and Human Services/U.S. Department of Agriculture). 2013 (unpublished). History of dietary guidance development in the United States and the Dietary Guidelines for Americans.

HHS/USDA. 2015. Scientific Report of the 2015 Dietary Guidelines Advisory Committee. Washington, DC: USDA, Agricultural Research Service.

IOM (Institute of Medicine). 1994. How should the Recommended Dietary Allowances be revised? Washington, DC: National Academy Press.

IOM. 2003. Dietary Reference Intakes: Applications in dietary planning. Washington, DC: The National Academies Press.

IOM. 2004. Dietary Reference Intakes: Water, potassium, sodium, chloride, and sulfate. Washington, DC: The National Academies Press.

NRC (National Research Council). 1989. Diet and health: Implications for reducing chronic disease risk. Washington, DC: National Academy Press.

OGE (U.S. Office of Government Ethics). 2016. Advisory committee members. https://www.oge.gov/Web/oge.nsf/Resources/Advisory+Committee+Members (accessed October 5, 2017).

Raiten, D. J., R. Raghavan, A. Porter, J. E. Obbagy, and J. M. Spahn. 2014. Executive summary: Evaluating the evidence base to support the inclusion of infants and children from birth to 24 mo of age in the Dietary Guidelines for Americans—“the B-24 project.” American Journal of Clinical Nutrition 99(3):663s-691s.

Secretary of Health and Human Services. 2013. Charter: 2015 v. Washington, DC. https://health.gov/dietaryguidelines/dgac2015-charter-final.pdf (accessed October 5, 2017).

USDA (U.S. Department of Agriculture). 2016 (unpublished). Understanding the committee’s charge: A discussion with the sponsor. Presentation to the Committee to Review the Process to Update the Dietary Guidelines for Americans.

USDA/HHS (U.S. Department of Agriculture/U.S. Department of Health and Human Services). 2016a (unpublished). Dietary Guidelines for Americans: Process brief, sections 1–3. Prepared for the Committee to Review the Process to Update the Dietary Guidelines for Americans.

USDA/HHS. 2016b (unpublished). HMD follow-up questions for USDA. Response to Committee to Review the Process to Update the Dietary Guidelines for Americans.

USDA/HHS. 2016c (unpublished). Dietary Guidelines for Americans: Process brief, sections 4–5. Prepared for the Committee to Review the Process to Update the Dietary Guidelines for Americans.