[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]




 
  HEARING TO REVIEW THE DEVELOPMENT OF THE 2015 DIETARY GUIDELINES FOR
                               AMERICANS

=======================================================================

                                HEARING

                               BEFORE THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             FIRST SESSION

                               __________

                            OCTOBER 7, 2015

                               __________

                           Serial No. 114-29
                           
                           
                           
                           
 [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
 


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                        COMMITTEE ON AGRICULTURE

                  K. MICHAEL CONAWAY, Texas, Chairman

RANDY NEUGEBAUER, Texas,             COLLIN C. PETERSON, Minnesota, 
    Vice Chairman                    Ranking Minority Member
BOB GOODLATTE, Virginia              DAVID SCOTT, Georgia
FRANK D. LUCAS, Oklahoma             JIM COSTA, California
STEVE KING, Iowa                     TIMOTHY J. WALZ, Minnesota
MIKE ROGERS, Alabama                 MARCIA L. FUDGE, Ohio
GLENN THOMPSON, Pennsylvania         JAMES P. McGOVERN, Massachusetts
BOB GIBBS, Ohio                      SUZAN K. DelBENE, Washington
AUSTIN SCOTT, Georgia                FILEMON VELA, Texas
ERIC A. ``RICK'' CRAWFORD, Arkansas  MICHELLE LUJAN GRISHAM, New Mexico
SCOTT DesJARLAIS, Tennessee          ANN M. KUSTER, New Hampshire
CHRISTOPHER P. GIBSON, New York      RICHARD M. NOLAN, Minnesota
VICKY HARTZLER, Missouri             CHERI BUSTOS, Illinois
DAN BENISHEK, Michigan               SEAN PATRICK MALONEY, New York
JEFF DENHAM, California              ANN KIRKPATRICK, Arizona
DOUG LaMALFA, California             PETE AGUILAR, California
RODNEY DAVIS, Illinois               STACEY E. PLASKETT, Virgin Islands
TED S. YOHO, Florida                 ALMA S. ADAMS, North Carolina
JACKIE WALORSKI, Indiana             GWEN GRAHAM, Florida
RICK W. ALLEN, Georgia               BRAD ASHFORD, Nebraska
MIKE BOST, Illinois
DAVID ROUZER, North Carolina
RALPH LEE ABRAHAM, Louisiana
JOHN R. MOOLENAAR, Michigan
DAN NEWHOUSE, Washington
TRENT KELLY, Mississippi

                                 ______

                    Scott C. Graves, Staff Director

                Robert L. Larew, Minority Staff Director

                                  (ii)
                                  
                                  
                                  
                                  
                                  
                             C O N T E N T S

                              ----------                              
                                                                   Page
Conaway, Hon. K. Michael, a Representative in Congress from 
  Texas, opening statement.......................................     1
    Prepared statement...........................................     3
Hartzler, Hon. Vicky, a Representative in Congress from Missouri, 
  submitted report...............................................    61
Lujan Grisham, Hon. Michelle, a Representative in Congress from 
  New Mexico, submitted statements...............................    70
McGovern, Hon. James P., a Representative in Congress from 
  Massachusetts, submitted article...............................    70
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, opening statement...................................     4
    Submitted article............................................    55

                               Witnesses

Burwell, Hon. Sylvia M., Secretary, U.S. Department of Health and 
  Human Services, Washington, D.C................................     5
    Prepared statement...........................................     6
    Submitted joint questions....................................   127
    Submitted questions..........................................   139
Vilsack, Hon. Thomas ``Tom'' J., Secretary, U.S. Department of 
  Agriculture, Washington, D.C...................................     8
    Prepared statement...........................................     9
    Submitted joint questions....................................   127
    Submitted questions..........................................   139

                           Submitted Material

Archer, Ph.D., M.S., Edward, NIH/NIDDK Research Fellow, Nutrition 
  Obesity Research Center, University of Alabama at Birmingham, 
  submitted statement............................................    73
Campagna, Shannon, Director, Federal Government Affairs, Mars, 
  Incorporated, submitted letter.................................   102
Schoenfeld, M.S., R.D., Pamela, Executive Director; Adele Hite, 
  M.P.H., R.D., Public Policy Advisor, Healthy Nation Coalition, 
  submitted letter...............................................   106
Teicholz, Nina, Author, The Big Fat Surprise: Why Butter, Meat 
  and Cheese Belong in a Healthy Diet, submitted statement.......   110
Wilcox, Kristin Pearson, Vice President of Government Relations, 
  International Bottled Water Association, submitted letter......   117
Grain Chain,* submitted letter...................................   119
      
---------------------------------------------------------------------------
    * American Bakers Association; American Institute of Baking 
International Grain Foods Foundation; Independent Bakers Association; 
National Association of Wheat Growers; National Pasta Association; 
North American Millers' Association; Retail Bakers of America; USA Rice 
Federation; Wheat Foods Council.


  HEARING TO REVIEW THE DEVELOPMENT OF THE 2015 DIETARY GUIDELINES FOR



                               AMERICANS

                              ----------                              


                       WEDNESDAY, OCTOBER 7, 2015

                          House of Representatives,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Committee met, pursuant to call, at 8:59 a.m., in Room 
1300 of the Longworth House Office Building, Hon. K. Michael 
Conaway [Chairman of the Committee] presiding.
    Members present: Representatives Conaway, Neugebauer, 
Lucas, King, Rogers, Thompson, Gibbs, Austin Scott of Georgia, 
Crawford, DesJarlais, Gibson, Hartzler, Benishek, LaMalfa, 
Davis, Yoho, Allen, Rouzer, Abraham, Moolenaar, Newhouse, 
Kelly, Peterson, David Scott of Georgia, Costa, Walz, Fudge, 
McGovern, DelBene, Kuster, Nolan, Maloney, Kirkpatrick, 
Aguilar, Plaskett, Adams, Graham, and Ashford.
    Staff present: Anne DeCesaro, Callie McAdams, Haley Graves, 
John Goldberg, Mary Nowak, Mollie Wilken, Scott C. Graves, 
Stephanie Addison, Faisal Siddiqui, Lisa Shelton, Liz 
Friedlander, Mary Knigge, Mike Stranz, and Nicole Scott.

OPENING STATEMENT OF HON. K. MICHAEL CONAWAY, A REPRESENTATIVE 
                     IN CONGRESS FROM TEXAS

    The Chairman. Well, good morning. Let us go ahead and get 
started. Mr. Kelly, would you open us with a prayer, please?
    Mr. Kelly. Dear Heavenly Father, we just ask that you bless 
this Committee. We ask that you bless this government. We ask 
that you bless all those who lead this great nation. Dear Lord, 
we just ask that everything we do honor and please you. In 
Jesus's name I pray, amen.
    The Chairman. Thank you, Trent. This hearing of the 
Committee of Agriculture regarding the review of the 
development of the 2015 Dietary Guidelines for Americans, will 
come to order. I want to thank our witnesses for being here 
this morning. It is no small feat to get the Secretaries of two 
of the most important agencies of government to come sit at the 
same table at the same time, and so I thank you, Secretary 
Vilsack, Secretary Burwell, for making this happen. We 
certainly appreciate it.
    We are joined today by the Secretary of Agriculture and the 
Secretary of Health and Human Services to discuss development 
of an important document: The 2015 Dietary Guidelines for 
Americans. It is not this Committee's intention to legislate 
specific recommendations or guidelines, however we will demand 
that the guidelines be developed in a transparent and objective 
manner. The DGA is not only a recommendation to the American 
people on how to make healthy food purchasing decisions to live 
a healthy lifestyle, but it also forms the basis of Federal 
nutrition policy, education, outreach efforts used by 
consumers, industry, nutrition educators, and health care 
professionals.
    It is essential that the guidance that comes out of this 
process can be trusted by the American people. To achieve this, 
it must be based on sound, consistent, and irrefutable science. 
The DGA is Congressionally mandated under the National 
Nutrition Monitoring and Related Research Act of 1990. 
According to the Act, the DGA shall contain nutritional and 
dietary information and guidelines for the general public, 
shall be ``based on the preponderance of the scientific and 
medical knowledge current at the time the report is prepared'', 
and ``shall be promoted by each Federal agency in carrying out 
any Federal food, nutrition, or health program''. Ensuring a 
sound development process is important because it is extremely 
difficult to reverse or change public policy once implemented 
without causing consumer confusion. At a time when consumers 
are already subjected to conflicting, and often contradictory, 
nutrition and health information, staying within the scope of 
the intent of the law by providing the public with science-
based realistic and achievable information is more likely to 
improve public health outcomes.
    The process of the 2015 DGA began in 2012, when Secretary 
Vilsack and Secretary Burwell's predecessor, Secretary 
Sebelius, created, and then appointed, the 15 members to the 
Dietary Guidelines Advisory Committee. Though this committee is 
not specifically authorized, it was chartered under the Federal 
Advisory Committee Act, which requires that the advice rendered 
by the Committee be ``objective and accessible to the public'' 
by formalizing the process for ``establishing, operating, 
overseeing, and terminating'' the committees. This makes the 
committee solely responsible to USDA and HHS, who are then 
responsible for continually reviewing the committee's 
performance and process compliance, which include activities as 
detailed as approving all of the meeting agendas. It is 
therefore the responsibility of USDA and HHS to maintain 
control over the scope and methods used by DGAC.
    I personally weighed in with both of you, as have many of 
my colleagues, about our concerns with the process of 
developing the guidelines. I raised concerns about the 
committee's report shortly after its release, and called on you 
to extend the public comment period, which you did, and I 
appreciate that very much. USDA and HHS received over 29,000 
public comments to the committee's report, many of which were 
developed by nutritionists and other experts in the study of 
human health. Included in their submitted comments, available 
for public viewing on DGA's website, were scientific studies 
and other evidence that observers assert had been ignored by 
the committee. As a result, I repeatedly requested that each 
and every comment be considered by USDA and HHS before the 
final guidelines are published.
    In May the Ranking Member and I sought, in writing, details 
on your plan to review the more than 29,000 comments, and to 
make sure that they were viewed properly. You response to us on 
that plan, though, was less than sufficient, so I look forward 
to hearing more today on this matter.
    Uncertainty in the process leads to concern about whether 
the committee's recommendations will maintain the scientific 
integrity necessary to be actionable by Americans. It is my 
hope that as USDA and HHS review of the 2015 recommendations, 
that in that review they are mindful of the process failures 
that lie squarely between each of the recommendations. It is 
imperative to hear assurances from each of you that Americans 
were ultimately presented with the best and most reliable 
information for making healthy food and beverage choices.
    Again, thank you, Secretary Vilsack and Secretary Burwell 
for being with us today, and I look forward to our 
conversation.
    [The prepared statement of Mr. Conaway follows:]

  Prepared Statement of Hon. K. Michael Conaway, a Representative in 
                          Congress from Texas
    I want to welcome our distinguished witnesses to today's hearing 
and thank them for taking the time to be with us. We are joined by both 
the Secretary of Agriculture and the Secretary of Health and Human 
Services to discuss the development of an important document: The 2015 
Dietary Guidelines for Americans (DGA).
    It is not this Committee's intention to legislate specific 
recommendations or guidelines; however we will demand that the 
guidelines be developed in a transparent and objective manner.
    The DGA is not only a recommendation to the American people on how 
to make healthy food purchasing decisions in order to live a healthy 
lifestyle, but it also forms the basis of Federal nutrition policy, 
education, and outreach efforts used by consumers, industry, nutrition 
educators, and health professionals. It is essential that the guidance 
that comes out of this process can be trusted by the American people. 
To achieve this, it must be based on sound, consistent, and irrefutable 
science.
    The DGA is Congressionally mandated under the National Nutrition 
Monitoring and Related Research Act of 1990. According to the Act, the 
DGA shall contain nutritional and dietary information and guidelines 
for the general public; shall be ``based on the preponderance of the 
scientific and medical knowledge current at the time the report is 
prepared''; and ``shall be promoted by each Federal agency in carrying 
out any Federal food, nutrition, or health program.''
    Ensuring a sound development process is important because it is 
extremely difficult to reverse or change public policy, once 
implemented, without causing consumer confusion. At a time when 
consumers are already subjected to conflicting and often contradictory 
nutrition and health information, staying within scope of the intent of 
the law by providing the public with science-based, realistic and 
achievable information is more likely to contribute to improved public 
health outcomes.
    The process for the 2015 DGA began in 2012, when Secretary Vilsack 
and Secretary Burwell's predecessor, Secretary Sebelius, created and 
then appointed fifteen members to the Dietary Guidelines Advisory 
Committee (DGAC). Though the DGAC is not specifically authorized, all 
advisory committees must be charted under the Federal Advisory 
Committee Act which requires that the advice rendered by the committee 
be ``objective and accessible to the public'' by formalizing the 
process for ``establishing, operating, overseeing, and terminating'' 
the committees. This makes the DGAC solely accountable to USDA and HHS, 
who are then responsible for continually reviewing the DGAC's 
performance and process compliance, which included activities as 
detailed as approving all DGAC meeting agendas. It was therefore the 
responsibility of USDA and HHS to maintain control over the scope and 
methods used by DGAC.
    I have personally weighed in with you both, as have many of my 
colleagues, about my concerns with the process of developing the 
Dietary Guidelines. I raised concerns about the DGAC report shortly 
after its release and called on you to extend the public comment 
period, which you did.
    As we are all aware of by now, USDA and HHS received over 29,000 
public comments to the DGAC report, many of which were developed by 
nutritionists and other experts in the study of human health. Included 
in their submitted comments, available for public viewing on the DGA's 
website, were scientific studies and other evidence that observers 
assert had been ignored by the DGAC. As a result, I repeatedly 
requested that each and every comment be considered by USDA and HHS 
before the final Dietary Guidelines are published.
    In May, the Ranking Member and I sought, in writing, details on 
your plan to review the more than 29,000 public comments because public 
comments do matter. Your response to us on that plan was less than 
sufficient so I look forward to hearing more from you today.
    Uncertainty in the process leads to concern about whether the DGAC 
recommendations will maintain the scientific integrity necessary to be 
actionable by Americans. It is my hope that as USDA and HHS review the 
2015 DGAC recommendations, they are mindful of the process failures 
that lie squarely behind each of DGAC's recommendations. It is 
imperative to hear assurances from USDA and HHS that Americans will 
ultimately be presented with the best and most reliable information for 
making healthy food and beverage choices.
    Again, thank you Secretary Vilsack and Secretary Burwell for being 
here today, I look forward to our conversation.

    The Chairman. Are there any opening comments from the 
Ranking Member?

OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE 
                   IN CONGRESS FROM MINNESOTA

    Mr. Peterson. Thank you, Mr. Chairman, and I welcome both 
Secretary Burwell and Secretary Vilsack to the Committee, and I 
look forward to your testimony. Given that USDA and HHS are 
still reviewing comments, we are probably getting ahead of 
ourselves here, but I do hope that today's testimony can shed 
more light on the process to establish new guidelines, and what 
they will actually mean for our constituents. There has been a 
strong reaction to the Dietary Guidelines Advisory Committee 
report. I have heard concerns about future sodium targets, 
difficulties of small schools meeting the guidelines, and what 
this could mean for cranberries and sugar. But these are mostly 
coming from those who are directly impacted, industries, 
schools, and the medical community. We are not really hearing 
from the public.
    I don't think the general public is paying much attention. 
For those who are, I think they are very skeptical of the whole 
process. For example, we were once told that butter and eggs 
were bad for you. Now I guess they are okay. According to the 
Washington Post this morning, they were wrong on milk as well, 
and I don't know how much government subsidized powder we 
bought because of it. So people may be losing confidence in 
these guidelines. Given the public skepticism, maybe we should 
reconsider why we are doing this. Is it because it is something 
that we have always done? We may wish, at first look, to expand 
on a provision in the 2008 Farm Bill that would help us 
understand more about what people are actually eating, and then 
go from there.
    I am a little concerned that we have lost sight of what we 
are doing, and we seem to be more focused on ideology and 
marketing food products than providing clear nutrition advice 
to the general public. But I do hope we can have a productive 
hearing and achieve a good outcome. I know you are going to do 
the best that you can breaking through all this noise, and I 
thank the Secretaries for appearing before us today, and I 
yield back.
    The Chairman. I thank the gentleman. I would like to inform 
my colleagues that Ms. Burwell has a hard stop at 11:30. She 
has an international flight to catch. And so, with that, I 
don't know who wants to go first. Secretary Burwell?
    Secretary Burwell. I would be happy to, yes.
    The Chairman. Okay.

STATEMENT OF HON. SYLVIA M. BURWELL, SECRETARY, U.S. DEPARTMENT 
                 OF HEALTH AND HUMAN SERVICES,
                        WASHINGTON, D.C.

    Secretary Burwell. Good morning. Thank you, Mr. Chairman, 
and Ranking Member Peterson, as well as Members of the 
Committee, for the opportunity to discuss the Dietary 
Guidelines. I want to begin by thanking the Committee for your 
interest in the Dietary Guidelines, and for your work to 
support Americans, and a healthy agriculture sector.
    One of the most important responsibilities that our 
government is entrusted with is protecting the American public, 
and that includes empowering them with the tools they need to 
make educated health decisions. Since 1980, families across the 
nation have looked to the Departments of Health and Human 
Services and Agriculture for science-based Dietary Guidelines 
to serve as a framework for nutritious eating and healthy 
lives. Our guidelines also help lay a foundation for preventing 
diet-related health conditions, like obesity, diabetes, and 
heart disease.
    As is required by the National Nutrition Monitoring and 
Related Research Act, the Departments update these regulations 
and guidelines every 5 years. The key elements that make up a 
healthy lifestyle remain consistent, fruits and vegetables, 
grains and lean proteins, and limited amounts of saturated 
fats, added sugars, and sodium. We anticipate these will 
continue to be the building blocks of the 2015 guidelines, 
updated to reflect the latest research in science, as well as 
our current understanding of the connections between food and 
health. As part of our effort to rely on the best science 
available, we have appointed an independent Advisory Committee 
of nutrition and medical experts and practitioners to inform 
each addition. The 2015 Advisory Committee evaluated research, 
and considered comments from the public to develop 
recommendations included in its finished report.
    It is important to note that the Advisory Committee report 
is one input into the Dietary Guidelines. The guidelines 
themselves are written and reviewed by experts at both of our 
Departments. In addition to the recommendations of the Advisory 
Committee, our Department's experts perform their own extensive 
review and consideration of public comments. In fact, as was 
mentioned, we received 29,000 written comments during the 75 
day public comment period. As a result, the 2015 Dietary 
Guidelines will be informed by a review of thousands of 
scientific papers, and decades of nutrition and medical 
research, as well as input from the public.
    We know that the guidelines are of critical importance to 
many Americans. They contribute to a culture of wellness, and 
empower individuals to better manage their own health, help 
keep their families healthy, reduce the onset of disease, and 
reduce the amount of money that we spend on healthcare. They 
also provide guidance to public and private programs, and 
support efforts to help our nation reach its highest standard 
of health. At HHS, the Dietary Guidelines provide a roadmap for 
the nutrition advice, and services that we deliver, such as 
chronic disease prevention efforts, food assistance programs, 
and educational initiatives.
    HHS and USDA are working together to finalize the 2015 
Dietary Guidelines, which are expected to be completed in 
December of this year. Without a finished product, I am unable 
to comment on the final content of the forthcoming edition at 
this time. I expect, however, that the new guidelines will 
continue to emphasize the importance of healthy eating habits 
and individual food choices. I want to thank you again for your 
interest in this topic, as well as the feedback that we have 
received. I know many of you have specific questions and 
concerns, and I want to assure you that we are taking your 
concerns into consideration. And we are working hard to answer 
your questions as thoroughly as we can as we are in the process 
of doing the guidelines. I look forward to continuing to work 
together, and look forward to your questions today. Thank you.
    [The prepared statement of Ms. Burwell follows:]

     Prepared Statement of Hon. Sylvia M. Burwell, Secretary, U.S. 
       Department of Health and Human Services, Washington, D.C.
    Chairman Conaway, Ranking Member Peterson, and Members of the 
Committee, thank you for the opportunity to discuss the Dietary 
Guidelines for Americans (Dietary Guidelines).
    I want to begin by thanking Members of this Committee for your 
interest in the Dietary Guidelines and, more broadly, for your work to 
support Americans and a healthy agricultural sector. The Dietary 
Guidelines are a critical science-based initiative drafted by experts 
at the Departments of Agriculture and Health and Human Services that 
gives Americans advice on building healthy eating patterns that can 
help prevent chronic diseases and promote the health and well-being of 
our nation. I want to emphasize that the focus of the Dietary 
Guidelines is on preventing diet-related health conditions, such as 
obesity, diabetes, and heart disease, rather than treating these and 
other diseases. The Dietary Guidelines are one part of a larger effort 
to help lower disease rates in the United States and give every 
American the tools they need to live healthy and productive lives.
History
    The Dietary Guidelines are required under the 1990 National 
Nutrition Monitoring and Related Research Act, which directs the 
Departments of Health and Human Services (HHS) and Agriculture (USDA) 
to publish a report entitled ``Dietary Guidelines for Americans'' at 
least every 5 years. By law, each edition of the Dietary Guidelines 
includes ``nutritional and dietary information and guidelines for the 
general public . . . .'' The law also states that the Dietary 
Guidelines should ``be promoted by each Federal agency in carrying out 
any Federal food, nutrition, or health program.'' In our development of 
these Guidelines, we follow this statute to guide the scope of our 
work.
    Historically, the Key Recommendations of the Dietary Guidelines 
have not changed substantially from one edition to the next. Elements 
of healthy eating patterns continue to include fruits, vegetables, 
grains, dairy, and protein-rich foods such as lean meats and seafood, 
and limit components like saturated fats, added sugars, and sodium. The 
guidelines provide a science-based framework for policy makers, 
nutrition educators, and healthcare providers to include nutrition as 
part of an overall prevention strategy for lowering rate of disease. 
The guidelines also help Americans make healthy food choices, enjoy 
food, and celebrate personal culture through food, all of which are 
important to Americans.
Development
    HHS and USDA strive to develop Dietary Guidelines recommendations 
that are based on the strongest available scientific evidence and 
represent our current understanding of the connections between food and 
health. One of the ways that we achieve this goal is by appointing a 
Dietary Guidelines Advisory Committee (Advisory Committee). The 
Advisory Committee is an independent group of experts and practitioners 
in the fields of nutrition and medicine that is voluntary and solely 
advisory, and although their work informs the government's work, they 
are not directly involved in the Departments' development of the 
Dietary Guidelines. It develops a scientific report and recommendations 
to inform each edition of the Dietary Guidelines. The use of an 
Advisory Committee is a best practice to ensure that the Federal 
Government is obtaining sound, external scientific advice to inform 
policy decisions. Advisory Committees have been used to inform the 
development of the Dietary Guidelines since the 1985 edition.
    The 2015 Advisory Committee used state-of-the-art standards to 
develop its scientific recommendations to the Federal Government, which 
were delivered to HHS and USDA in its Advisory Report in February 2015. 
In addition to drawing on the expertise of the Committee members, the 
Advisory Committee also received both written and oral public comments 
over the course of its work. These comments helped ensure that the 
Committee discussed topics and issues of interest to the public and 
received evidence to consider in the scientific process.
    The work of the Advisory Committee informs HHS and USDA's 
development of the Dietary Guidelines; however, the Advisory Report is 
only one component that the Departments consider when developing each 
edition of the guidelines. The Guidelines themselves are written and 
reviewed by the experts at our Departments and ultimately by Secretary 
Vilsack and me. In addition to the Advisory Committee's report, HHS and 
USDA consider public comments on the Advisory Report and look to 
Federal agencies with expertise in nutrition to review both the 
Advisory Report and the draft policy before Secretary Vilsack and I 
approve it.
    We recognize that the Advisory Report addressed many issues about 
which nutrition and agricultural stakeholders care deeply. We received 
over 29,000 written comments during the 75 day public comment period on 
the Advisory Report, as well as 73 oral comments during a March 2015 
public meeting. This demonstrates public interest and concern about 
information in the Dietary Guidelines. In response to the high level of 
interest and Congressional requests, HHS and USDA extended the public 
comment period by 30 days to accommodate a high volume of public 
comment submissions and ensure we were able to take the public's input 
into account. These comments have been fully reviewed by staff within 
our Departments and are being considered in the development of the 2015 
Dietary Guidelines. While all public comments are reviewed, in order to 
ensure the Dietary Guidelines are based on sound science, the 
Departments focus heavily on public comments that include scientific 
justification.
    As a result, the 2015 Dietary Guidelines will be informed by a 
review of thousands of scientific papers and decades of nutrition and 
medical research, as well as significant input from the public. The 
Guidelines will translate this science into succinct, food-based 
guidance that Americans can rely on for choosing a healthy diet.
Impact
    The 2015 edition of the Dietary Guidelines will build on this 
strong scientific foundation to continue to provide guidance to help 
encourage more healthy food choices across our nation. As Members of 
this Committee know, this issue is of critical importance. We must 
strive, together, to prevent nutrition-related disease and improve the 
health of American families and communities.
    The Dietary Guidelines are one of numerous important Federal policy 
initiatives that aim to help Americans reach their highest standard of 
health. For more than 25 years, over \1/2\ of our adult population has 
been overweight or obese. Today, about \1/2\ of all American adults 
have one or more preventable chronic diseases, which are attributable 
to several causes, including poor-quality diet and physical activity 
behaviors. All sectors of society play an integral part in contributing 
to a culture in the United States that champions wellness and empowers 
all people to achieve their highest standard of health. The Dietary 
Guidelines provide the framework for not only the Federal Government 
but also for other sectors of influence, including other policymakers, 
health professionals, etc. who can apply the Guidelines in a multitude 
of ways with the potential to lower nutrition-related disease rates.
    At HHS, the Dietary Guidelines for Americans provide a roadmap for 
the nutrition advice and services that we deliver to the public through 
chronic disease prevention efforts, food assistance programs, and 
educational initiatives. Examples include the Older Americans Act 
Nutrition Services Programs and Head Start. The Guidelines are also 
used to inform national disease prevention and health promotion 
objectives related to nutrition and weight status, primarily through 
Healthy People 2020. CDC's prevention campaigns, NIH's lifestyle 
guidance, and FDA's Nutrition Facts Label regulations consider the 
nutrition information in the Dietary Guidelines. As in the past, the 
2015 edition of the Dietary Guidelines will help focus our resources on 
efforts that have the greatest positive impact on health outcomes.
Dietary Guidelines for Americans, 2015
    HHS and USDA are working together to finalize the 2015 Dietary 
Guidelines, which are expected to be completed in December of this 
year. We will conduct several layers of scientific review prior to 
preparing a draft for final approval, which has not yet occurred. As 
such, I am unable to comment on the final content of the forthcoming 
edition of the Dietary Guidelines at this time. However, I expect the 
new Dietary Guidelines will continue to focus on food-based 
recommendations that emphasize the importance of consuming a total 
``healthy eating pattern'' over time while recognizing the importance 
of individual choices.
Closing
    Again, thank you, Chairman Conaway, Ranking Member Peterson, and 
Members of the Committee for this opportunity to discuss the Dietary 
Guidelines and for your interest in this important topic. I am looking 
forward to continuing our partnership so that together we can ensure 
that every American has access to the building blocks of healthy and 
productive lives. I am happy to answer your questions.

    The Chairman. Thank you, Secretary. Secretary Vilsack?

 STATEMENT OF HON. THOMAS ``TOM'' J. VILSACK, SECRETARY, U.S. 
          DEPARTMENT OF AGRICULTURE, WASHINGTON, D.C.

    Secretary Vilsack. Thank you, Mr. Chairman, Ranking Member 
Peterson, and all of the Members of this Committee, I want to 
thank the Chairman for the opportunity to be here today, and I 
want to thank my colleague, Sylvia Burwell, for the 
extraordinary work that she and her team have done, in concert 
with the Department of Agriculture, in getting us to this point 
today.
    I will tell you that I struggle with the Dietary 
Guidelines, because it is important for people to understand 
precisely what they are and what they are not. These guidelines 
are a set of recommendations based on a series of well-informed 
opinions that create a framework that is designed to encourage 
and to educate Americans about what they can do to increase 
their chances of preventing chronic diseases. This is not about 
treating disease. This is about trying to prevent chronic 
diseases.
    As a result, the guidelines that we formulate are, and 
should be, restricted, by law, to nutritional and dietary 
information. The Advisory Committee report, which Secretary 
Burwell mentioned, is not the guidelines, and sometimes there 
is confusion about that. The report informs our work, but 
certainly does not, and should not, dictate it. Only HHS and 
USDA can, and should, write the guidelines, based on a variety 
of inputs. This has been an open and transparent process. 
Questions were posed by and to the Advisory Committee. A number 
of studies, indeed thousands of studies, and tens of thousands 
of pages of documents, were reviewed. Those reviews went 
through a very strict and gold standard process for determining 
what is the strongest, best, and most available science. 
Multiple public meetings took place. Information was posted on 
the web, and we indeed received 29,000 comments as a result of 
the extended comment period, of which 8,000 comments are 
probably considered unique.
    I recognize that our process here is to determine the best 
available science, and, based on that, and the preponderance of 
that, we formulate the guidelines. I believe I have the same 
goal that Secretary Burwell has, which is to finish our work on 
time, before the end of the year, so that we can use these 
guidelines, as directed by Congress. So I too look forward to 
your comments and questions, and this hearing is an important 
opportunity for us to educate folks about what these guidelines 
are and what they are not.
    [The prepared statement of Mr. Vilsack follows:]

 Prepared Statement of Hon. Thomas ``Tom'' J. Vilsack, Secretary, U.S. 
              Department of Agriculture, Washington, D.C.
    Chairman Conaway, Ranking Member Peterson, and Members of the 
Committee, thank you for the opportunity to discuss the Dietary 
Guidelines for Americans with you. I know it is important to all of us 
that the Department of Health and Human Services (HHS) and Department 
of Agriculture (USDA) deliver on our Congressional mandate.
    The Dietary Guidelines are focused on promoting health and 
preventing disease by providing food-based recommendations on diet and 
nutrition. The Guidelines form the cornerstone for all Federal 
nutrition programs. Over the years, they have also become an important 
resource for policy makers, nutrition educators, health professionals, 
and industry. What unites us all is the shared appreciation for the 
importance of nutrition in helping to prevent chronic diseases such as 
cardiovascular disease, high blood pressure, type 2 diabetes, diet-
related cancers, and obesity--and the knowledge that too many Americans 
suffer from these preventable diet-related diseases.
    It is important to note that the Dietary Guidelines are intended to 
prevent these diet-related conditions, not to treat them. The 
recommendations apply to individuals 2 years of age and older who are 
healthy or at increased risk of chronic disease, not those with medical 
conditions or special dietary needs. Dietary recommendations for 
specific populations that suffer from various conditions are likely to 
differ from those recommended by the Dietary Guidelines.
    HHS and USDA currently are working together to develop the eighth 
edition of the Dietary Guidelines, which is scheduled to be released by 
the end of this calendar year.
Background
    HHS and USDA have jointly published the Dietary Guidelines every 5 
years since 1980, even before it was required by statute. The 1990 
National Nutrition Monitoring and Related Research Act now directs HHS 
and USDA to publish the Dietary Guidelines at least every 5 years. The 
Congressional mandate states that the Dietary Guidelines ``shall 
contain nutritional and dietary information and guidelines for the 
general public, and shall be promoted by each Federal agency in 
carrying out any Federal food, nutrition, or health program.'' The law 
also requires that each edition of the Dietary Guidelines ``shall be 
based on the preponderance of the scientific and medical knowledge 
which is current at the time the report is prepared.''
    Since the 1985 edition of the Dietary Guidelines, the Secretaries 
of HHS and USDA have appointed an external, independent group of 
experts and practitioners in the fields of nutrition and medicine to 
provide independent, science-based advice and recommendations to the 
Departments as we develop the Dietary Guidelines. Each Dietary 
Guidelines Advisory Committee is compliant with the Federal Advisory 
Committee Act, serves in a voluntary and advisory role only, and 
submits a report of scientific recommendations to the Federal 
Government. The Advisory Committee does not develop the Dietary 
Guidelines; that is the role of HHS and USDA, and the recommendations 
we receive from the Advisory Committee inform our work.
External Scientific Evidence Review Prior to HHS-USDA Dietary 
        Guidelines Development
    The 2015 Advisory Committee was charged with reviewing the 2010 
Dietary Guidelines and reviewing the current state of scientific 
evidence on nutrition and health to develop food-based recommendations 
of public health importance for Americans ages 2 years and older. Their 
recommendations were outlined in the Scientific Report of the Dietary 
Guidelines Advisory Committee, submitted to HHS and USDA in February 
2015.
    The Advisory Committee conducted comprehensive and rigorous 
systematic reviews of scientific evidence on food, nutrition, and 
health using state-of-the-art standards to develop its Scientific 
Advisory Report. The Committee formulated and addressed more than 80 
scientific questions using: (1) original systematic reviews conducted 
through USDA's Nutrition Evidence Library (NEL); (2) existing high-
quality systematic reviews, meta-analyses, and reports from the 
scientific community; (3) data analyses; and (4) food pattern modeling 
analyses. These four approaches contribute to a comprehensive body of 
scientific evidence upon which the Federal Government can develop 
policy.
    It is worth noting that systematic reviews were used to examine the 
majority of the scientific evidence in diet and health. Considered the 
gold standard and standard practice for more than 25 years in the 
medical field, systematic reviews are relied upon to inform the 
development of national guidelines for use by research and health 
professionals. The NEL, developed in consultation with leaders in the 
systematic review community such as the highly respected Cochrane 
Collaboration, involves a structured, protocol-driven approach to 
identify, evaluate, summarize, and synthesize peer-reviewed scientific 
literature as a means to answer the scientific questions specifically 
focused on diet and public health. Use of the NEL involves thorough 
searches of all peer-reviewed scientific literature contained in 
multiple electronic databases, and putting the results through pre-
determined inclusion/exclusion criteria to focus on those that answer 
the scientific questions. Because the Dietary Guidelines focus on 
disease prevention, and not treatment, these reviews excluded studies 
that involved treating disease, such as those in which patients with an 
existing condition followed a therapeutic diet. Of approximately 4,000 
manuscripts screened for inclusion, the 2015 Advisory Committee 
reviewed nearly 300 studies that met the criteria for the systematic 
review questions.
    In addition, the Advisory Committee used existing systematic 
reviews from the NEL and external national and international scientific 
organizations to prevent duplication of efforts and to conserve Federal 
resources and time. All existing systematic reviews were screened by 
Federal staff and underwent assessment to ensure the proper quality and 
objectivity.
Public Participation in the Process
    Public participation in the Dietary Guidelines scientific review 
process has been important and extremely valuable. HHS and USDA issued 
a public call for nominations of candidates for 2015 Dietary Guidelines 
Advisory Committee members in the fall of 2012. Following a careful and 
diligent process, members were appointed to the Advisory Committee by 
Secretary Sebelius and me. The Advisory Committee proceeded to hold 
seven public meetings spanning 19 months, which included an opportunity 
for the public to provide oral testimony. After each public meeting, 
the Committee's slides and videos were posted for public access on 
DietaryGuidelines.gov, along with a list of all the scientific studies 
discussed during the meetings and the inclusion-exclusion criteria the 
Committee used. Throughout this time, the public was encouraged to 
submit comments to the Advisory Committee on DietaryGuidelines.gov. 
These comments ensured that the Committee considered all relevant 
topics in preparation of the Scientific Advisory Report.
    Once the Advisory Committee submitted its Scientific Advisory 
Report to Secretary Burwell and me in February 2015, the report was 
posted on DietaryGuidelines.gov for public review and comment. HHS and 
USDA extended the public comment period from 45 days to 75 days; for 
comparison, the public comment period to review the 2010 Advisory 
Report was 30 days. In addition, the public was invited to provide oral 
testimony to the Federal Government on the Scientific Advisory Report 
in March 2015.
    Public comments serve as a vital resource to our Departments in 
drafting the Dietary Guidelines. In addition to the March public 
meeting for oral testimony, we received more than 29,000 written 
comments during the 75 day public comment period. Staff from both 
Departments have reviewed all comments submitted and posted them online 
at DietaryGuidelines.gov. To ensure the Dietary Guidelines are based on 
the totality of sound science, the Departments' focus is primarily on 
public comments with scientific justification.
HHS-USDA Development of the 2015 Dietary Guidelines for Americans
    In addition to the Advisory Committee's report and public comments, 
HHS and USDA look to Federal agencies with expertise in nutrition to 
review both the Scientific Advisory Report and the draft of the Dietary 
Guidelines for Americans. This ensures that the Dietary Guidelines are 
grounded in the current scientific knowledge and are compliant with 
existing Federal policies before Secretary Burwell and I review and 
approve it for release and implementation across Federal nutrition 
programs.
    As a result of this multi-faceted process, the 2015 Dietary 
Guidelines for Americans will be informed by thousands of scientific 
papers, decades of nutrition and medical research, public comments, and 
reviews by Federal experts. We will conduct several layers of review 
prior to preparing a draft for final approval, which has not yet 
occurred. However, I can assure you that the 2015 Dietary Guidelines 
for Americans will be grounded in the preponderance of the best 
available scientific evidence, represent our current understanding of 
the connections between food and health, and integrate the science into 
succinct, food-based guidance that Americans can rely on for choosing a 
healthy diet.
    The Dietary Guidelines has been referred to as the nutrition 
backbone of our nation. We take this responsibility very seriously. 
Again, thank you, Chairman Conaway, Ranking Member Peterson, and 
Members of the Committee for this opportunity to discuss the Dietary 
Guidelines for Americans.

    The Chairman. Well, thank you. I got ahead of myself. Let 
me mention that the Chairman requests that other Members submit 
their opening statements for the record. And I rudely failed to 
introduce Secretary Tom Vilsack, who is the Secretary of the 
Department of Agriculture, and the Honorable Sylvia Burwell, 
who is Secretary of Department of Health and Human Services. 
Two folks who needed no introduction, and I didn't introduce 
you, I apologize for that. The chair would remind Members that 
they will be recognized for questioning in order of seniority 
for the Members who were here at the start of the hearing. 
After that, Members will be recognized in order of arrival, and 
I appreciate the Members' understanding. And I recognize myself 
for 5 minutes.
    Ms. Burwell, you said in your comments that the guidelines 
don't change substantially from one set to the next, but yet 
the Advisory Committee reports have gone from 57 pages in 1995 
to 571 pages for this one. So I am not sure we have gotten ten 
times better information today than we did at that point in 
time.
    As I mentioned in my opening statement, the oversight we 
are conducting today is on the development of the guidelines in 
sight of concern for the integrity of the process, and its 
resulting recommendations. The Federal Advisory Committee Act 
defines how Advisory Committees operate. The law puts special 
emphasis on open meetings, chartering, public involvement and 
reporting. According to statute, a Federal Advisory Committee 
shall, among other things, require the membership of the 
Advisory Committee to be fairly balanced in terms of the points 
of view represented and the functions to be performed, contain 
appropriate provisions to assure that the advice and 
recommendations of the Advisory Committee will not be 
inappropriately influenced by the appointing authority, or by 
special interests, but will instead be the result of Advisory 
Committee's independent judgment.
    Despite these statutory safeguards, serious questions have 
been raised about the oversight of the overall DGAC process 
while it was ongoing. This has tended to fuel concerns that 
members of the commission may have been appointed in order to 
achieve certain policy outcomes outside the legitimate purview 
of the Advisory Committee. I refer specifically to an op-ed 
published on October 1, 2015 by former Deputy Secretary 
Kathleen Merrigan, who currently serves as the Executive 
Director of the Sustainability Institute at George Washington 
University. I note that Secretary Merrigan was serving as USDA 
Deputy Secretary during the time the DGAC was chartered and 
appointed. The suggestion of including sustainability and tax 
issues by the DGAC has been a topic of intense discussion for 
some time. I recognize that you both jointly published a blog 
yesterday acknowledging that sustainability is out of the scope 
of this exercise, and I hope to get some comments from you 
about tax issues as well. I am likewise sure you recognize that 
the inclusion of these issues in this process could have 
resulted in misguided recommendations, which would have ill 
effects on consumer habits and agricultural production.
    The counter to potential bias in the process is the public 
comment period. The 75 day period was the public's first real 
opportunity to review the 571 page document. In your written 
statement, Secretary Burwell, you mentioned that USDA and HHS 
staff have already fully reviewed all the comments. You also 
mentioned that you focused most heavily on those with 
scientific justification. Help us understand, then, what is 
going on right now. What have you done with the studies, such 
as those evaluating low carbohydrate consumption patterns, 
since the review has been taking place?
    Secretary Burwell. I think there were a number issues 
raised, and I apologize, I could not hear your final question.
    The Chairman. What have you been doing? Have you been 
studying the comments, and the report itself. Can you talk to 
us about how you have been evaluating other information, like 
low carbohydrate consumption patterns, as a part of that 
review?
    Secretary Burwell. With regard to one issue that you 
touched on earlier that I want to go ahead and address, you 
asked which was the tax issue, and the question of tax policy. 
I think, like our comments yesterday in the blog that Secretary 
Vilsack and I put out about the issue of sustainability, while 
we haven't received recommendations from our staff speaking to 
the specifics of what are in the Dietary Guidelines, that is a 
question of scope, like the sustainability question, and that 
is not an issue that we would address, on the tax issue, when I 
address that.
    With regard to the process that we are now going through, 
and how, whether it is the carbohydrate issue, or any of the 
specific issues, what is happening is we received the report of 
the committee. Our staffs are reviewing that. At the same time, 
we are reviewing all of the public comments that we have 
received. In addition to that, we are bringing in the experts 
from all of our Departments to make sure that they weigh in as 
we do the consideration. And, for us, that includes the Food 
and Drug Administration, the NIH, the Centers for Disease 
Control, the Office of the Assistant Secretary for Health, and 
many others. So that is the process that we are using now, to 
review what we received, and to put together the guidelines.
    The Chairman. Could the guidelines have things in them that 
weren't necessarily directly reported in the recommendations 
from the committee? Your own wisdom, your own thoughts, would 
be reflected in the guidelines as well?
    Secretary Burwell. In terms of the expert advice of our 
staffs that exist, with regard to the question of studies and 
pieces of work, it is important to reflect what Secretary 
Vilsack said, which is there has been a systemic literature 
review with regard to the studies, and that is part of keeping 
integrity to the process. With regard to our experts who are 
constantly involved in those issues, yes, they will be a part 
of that process.
    The Chairman. Thank you. Ranking Member?
    Mr. Peterson. Thank you, Mr. Chairman. I think you both 
know that sodium not only provides a benefit in making products 
shelf stable, it also improves taste, and is an important food 
safety component in cheese. Studies have shown that there is 
insufficient evidence to conclude that lowering sodium intake 
below 2,300 milligrams per day decreases risk of cardiovascular 
disease, and the Dietary Guidelines Advisory Committee agreed. 
So why has the committee continued to support further sodium 
reduction, and is this something that you will be able to 
address in your guidelines?
    Secretary Vilsack. Well, let me take a stab at that. First 
of all, again, we are going to probably respond to a number of 
questions by pointing out these guidelines have not been 
formulated yet, and we can't comment on the specifics of what 
the guidelines will be because we haven't had an opportunity to 
prepare them and to review them.
    Having said that, the Advisory Committee, basically, they 
go through a process, as Secretary Burwell indicated, of 
reviewing a variety of studies. There, no doubt, were studies 
that linked pre-hypertension, hypertension, to sodium 
consumption. They probably looked at the National Academy of 
Medicine studies, in terms of sodium, and they probably 
concluded that there was evidence relating to sodium 
consumption and these chronic diseases, which is why they have 
recommended what they have recommended.
    The reality of this situation is that science changes, and 
we learn more information, and that is why it is important to 
have a process that we have in place to review what the 
Advisory Committee recommends, then to have public input, to 
get public comments, to have our own staff review studies, 
based on information they have accumulated during the course of 
the 5 year period since the last Dietary Guidelines, and also 
to refer back to the last set of guidelines, which is a 
foundation for this set of guidelines. So, Congressman, I can't 
comment specifically on why the Advisory Committee did what 
they did because they sort of operate independent. We don't 
inject ourselves into that process. But we do basically take 
their input into consideration, along with many, many other 
studies, many, many other opinions, to try to formulate the 
best set of guidelines and framework for the country.
    Mr. Peterson. Thank you, Secretary. I don't know if you 
both have seen the Washington Post story today? Secretary 
Vilsack, I guess you have seen it.
    Secretary Vilsack. I have seen it, and several people were 
mentioned in there. I have read books by those folks in 
preparation for this. This is what has caused my concern about 
what these guidelines are and what they are not.
    Mr. Peterson. Well, my concern is that we have had these 
guidelines that have pushed people away from eggs, and butter, 
and milk, and so forth, and then they come back and say, well, 
we were wrong. And so my question is, for both of you, what are 
we going to do to make sure that doesn't happen in the future? 
First of all, do you agree with this, and second of all, how 
are we going to keep this from happening? Why are we going off 
on these tangents if we have a process that is so heavily 
vetted?
    Secretary Burwell. I would say a couple of things. First, 
the consistency over time for most issues has been there, and 
it is right to point out that, with regard to the issue 
specifically of dietary cholesterol, there has been a change 
over time.
    I can think of a couple things, to answer your question. 
First, for the most part, things are consistent over time. 
Second, we need to make sure we use the most scientific 
evidence we can. And there has been an evolution and change, 
and that does get reflected in what the Advisory Committee has 
given us. They no longer will do recommendations based on 
expert opinion. Instead, they will only do recommendations 
based on the science, and that is a change that will occur.
    The other thing that is an important thing to reflect is 
that, in some cases, science does change. And in the case of 
our understanding of blood cholesterol versus dietary 
cholesterol, there has been an evolution in understanding of 
the difference of those, and what they cause. And we want to be 
prepared to make sure we review in a rigorous way changes that 
happen. There is not one simple answer to the problem that you 
raise, but a number of pieces of how we can work to get to a 
place where we have the most consistent science-based advice.
    Secretary Vilsack. And let me just simply add that Congress 
has directed us to take a look at the preponderance of that 
available science, which suggests, which is a term that I am 
familiar with in the practice of law, it suggests that there 
may be studies on both sides of an issue. And it is important 
and necessary for folks to sort of weigh the studies. And one 
of the challenges of this is to distinguish between one single 
quality study that is absolutely solid versus a bulk of studies 
over time that may have a slightly different view.
    And this is the challenge here, and it is a reflection of 
the fact that all of this is evolving. You are not going to 
ever have something that just basically is going to be a fact 
about this, because science evolves. We learn more, we 
understand more. And I would hope that we would be flexible 
enough to appreciate that, and to take that into consideration.
    Mr. Peterson. Well, I thank both of you for your 
observations, and you have made some points, but I just want 
you to understand, for my constituents, most of them don't 
believe this stuff anymore. You have lost your credibility with 
a lot of people, and they are just flat out ignoring this 
stuff. And so that is why I say I wonder why we are doing this. 
From what I am hearing from my constituents,
    Secretary Vilsack. Congressman----
    Mr. Peterson.--what it is worth.
    Secretary Vilsack.--can I respond to that for just a 
second? Here is the challenge, though. We take these 
guidelines, we incorporate them in our website, 
choosemyplate.gov. We have had over 290,000,000 hits on 
choosemyplate.gov. It may very well be that there are folks who 
are concerned about this, but I still think there is merit in 
it, as long as people understand what they are and what they 
are not. They are not a hard and fast set of rules, they are a 
guideline, a set of guidelines, a framework. And they are not 
about treating disease, they are about preventing it.
    The Chairman. Thank you. Mr. Neugebauer, for 5 minutes.
    Mr. Neugebauer. Thank you, Mr. Chairman. I want to go back 
to something that the Chairman was asking, and I want to make 
sure that we are all on the same page here. So, taxes are off 
the table, as far as consideration in the guidelines, is that 
correct?
    Secretary Burwell. With regard to the question of whether 
there be a tax recommendation in our Dietary Guidelines, we do 
not believe that that is something that is in the scope of the 
work that we are doing.
    Mr. Neugebauer. Secretary Vilsack?
    Secretary Vilsack. Well, that is not within the scope. It 
is not dietary, it is not nutrition, and it doesn't belong in 
this context. There are probably many other ways in which that 
conversation should be taken and should be had. As is the case 
with sustainability, it doesn't belong here, it belongs 
elsewhere. And I am happy to have that conversation with folks 
if they are interested.
    Mr. Neugebauer. So both of you agree, then, sustainability 
and taxes are off the table, as far as these recommendations 
are concerned?
    Secretary Burwell. Both are important issues that we 
believe should have conversations, but not in the context of 
this document.
    Mr. Neugebauer. Thank you. HHS and USDA have always stated 
that they have looked to appoint members to the DGAC so it 
consists of nationally recognized experts in the fields of 
nutrition and health. As you know, the DGAC is subject to the 
Federal Advisory Committee Act, which is widely used throughout 
the Federal Government. This Act is designed to ensure that the 
various Advisory Committees formed over the years are objective 
and accessible to the public. The Act has formalized a process 
of establishing and operating and terminating these advisory 
bodies. For the 2015 guidelines, the HHS and the USDA began to 
solicit nominations for the DGAC in 2012. Once selected and 
appointed, the DGAC was composed of academics, including 
professors, epidemiologists, and even a physician-scientist.
    In a departure from prior Dietary Guidelines' Advisory 
Committees, nutritionists and food scientists were not selected 
to serve on this DGAC. Understandably, questions regarding the 
inherent bias are being raised by the fact that no food 
industry scientists were included in the DGAC committee. 
Additionally, after the DGAC had officially disbanded, the 
former Advisory Committee members decided to hold a public 
event, acting in their capacity as DGAC members, which they 
were not, according to the committee's charter and Federal 
Advisory Committee Act.
    Based on the charter, it is the DGAC's responsibility to 
review the science and make recommendations to your 
Departments, which is then developed for final recommendations 
for the public. It is, however, not the responsibility of the 
DGAC to educate the general public on the report that still 
needed to be considered by the HHS and USDA claiming the 
nutritional recommendations were based on Dietary Guidelines.
    Secretary Burwell, what instructions were given the 
Advisory Committee members regarding the FACA and the Advisory 
Committee's disbandment?
    Secretary Burwell. With regard to the specifics of the 
disbandment, I can get back to you, Congressman, with regard to 
the direction that was given as to review the science with 
regard to the issues that were in front of them with regard to 
the Dietary Guidelines, and present a report about that. So, 
with regard to the question of disbandment, I don't know what, 
if any, specific direction was given, but the point that you 
have made, which is this is about an Advisory Committee 
producing a document, an independent group of people producing 
a document, that then is an element in the basis of what our 
decisions will be on the Dietary Guidelines, is what their role 
is.
    Mr. Neugebauer. Well, was their role to then go out and 
start doing a road show on their recommendation? Is that a part 
of the scope of that committee?
    Secretary Burwell. With regard to what we followed, at 
least at the Department, and what I know about is the fact 
that, once we received the committee's recommendations, and 
those became public, that there was a public comment period. 
That was the part that we have both been focused on, and the 
29,000 comments that have come in from the public. As well as, 
when we heard from you all that you asked for an extension of 
the public comment, Secretary Vilsack and I very quickly agreed 
that that was something we thought was an important thing to 
do. That is the----
    Mr. Neugebauer. Well----
    Secretary Burwell.--part of the process, in terms of 
public----
    Mr. Neugebauer.--the question here is that; first, did they 
follow the guidelines, and second, what steps were taken to 
make sure that the committee followed the law? And then, from 
an ethical standpoint, once you have served in your capacity on 
that Advisory Committee, and made your recommendations, what is 
your responsibility, moving forward? And one of the things we 
don't want is that this turn into some kind of a profitable 
situation on their behalf because of their participation on 
that Advisory Committee.
    Secretary Burwell. With regard to--these are voluntary, 
non-paid. They all have to file financial disclosures on an 
annual basis as they go through this process, and so those are 
all things we want to protect against. With regard to the 
specific question of a press briefing, or some kind of 
briefing, I apologize, I am not familiar with that. As I said, 
we have focused on the public comments and the steps and 
process that we are following.
    The Chairman. The gentleman's time has expired. Mr. Scott, 
for 5 minutes.
    Mr. David Scott of Georgia. Thank you very much, Mr. 
Chairman. I am very concerned that you are not using the most 
relevant, basic, and the best science-related information in 
formulating these guidelines. You certainly did not use some of 
the most recent peer-reviewed and published nutrition and diet-
related science. It was not even considered by the Advisory 
Committee, and not even included in the evidence-based library 
to be considered by the Advisory Committee when they were 
finalizing the report. That is a fact.
    And, Mr. Vilsack, you said you were using the best 
information. Your quote was we have the best informed opinions. 
But if you are not using the most recent peer review, that 
information that is there, and your committee has not even 
agreed to put it into the final report. So maybe you all can 
give me some level of confidence that your staffs and you will 
take into consideration the strong scientific evidence with the 
final policy document, even though it was not included in the 
evidence-based library throughout the working group process?
    Secretary Vilsack. Congressman, can you be specific about 
which study you are talking about?
    Mr. David Scott of Georgia. I am talking about the 
scientific study that came out that gave evidence that certain 
things were very important. Let me just give you one example. 
Let us look at the whole issue of the involvement of sugar, and 
how it is not even included. Why, for example, that low calorie 
sweeteners are not being recommended, when the study pointed 
out that low calorie sweeteners could be used to lower weight, 
to be able to help what is called atopocity, and it is not even 
being used. What is wrong with low calorie sweeteners that can 
be used, and it is not even in the report?
    Secretary Vilsack. Congressman, let me try to respond to 
the question as best I can. First of all, when you have a 
process that is every 5 years, you, obviously, are going to 
have to have, at some point in time, a cutoff of what 
information you consider, because, theoretically, the minute 
before we publish the guidelines, somebody could publish a 
study, and you would be criticizing us for not taking the 
latest science into consideration. So there has to be a cutoff 
time in terms of consideration. Having said that, over 4,000 
studies were reviewed, 300 manuscripts were reviewed, and they 
went through a gold standard process for evaluating the 
appropriateness and efficiency of those studies. That it is 
unfair to the committee, and unfair to the process, to suggest 
that we are not looking at the science. We are. Number one.
    Number two, as far as sugars are concerned, look, here is 
the problem. Our children, 15 to 17 percent of what they 
consume is sugar. And so, obviously, we are looking for ways in 
which we can reduce that. And what they were recommending and 
suggesting is that if you are going to have sugared drinks, if 
you are going to have sugar in your diet, you ought to at least 
look for the most nutritionally dense foods that you possibly 
can consume for that sugar, that you don't basically use empty 
calories to obtain it. So you could have something like 
chocolate milk versus a low cal drink. You would get more 
nutrition bang for your sugar buck, if you will, out of that 
process. And that is what they were suggesting.
    Mr. David Scott of Georgia. But you are familiar with that 
report? The Added Sugars Working Group said that moderate, and 
generally consistent, evidence from studies conducted in adults 
and children supports replacing sugar-containing sweeteners 
with low calorie sweeteners to reduce calorie intake, body 
weight, and atopocity.
    So the issue simply is for both of you to be able to 
explain why the DGAC, the Dietary Guidelines for America, would 
then recommend that consumers not--that is the whole point. You 
have used this evidence, it is pointed to where it could be 
helpful, but then the committee recommends that the consumers 
not use low calorie sweeteners as a tool in the toolbox to 
reduce added sugars. All I am simply saying is that if this 
report is going to have value for the welfare of the American 
people, and you all say you are using the most relevant basic 
information, then this clearly contradicts that.
    Secretary Burwell. There are two different things. One is 
what the Advisory Committee has in its report, and the other is 
what we do in the guidelines. And the specifics of that, as we 
have said, are not something we received as recommendations. My 
understanding of what is in the committee report, with regard 
to the question of substitution of the drinks, is that not 
enough evidence exists one way or another to make a 
recommendation, and that that is where the committee left the 
issue of the specific of the substitution.
    The Chairman. The gentleman's time has expired. Mike 
Rogers, 5 minutes.
    Mr. Rogers. Thank you, Mr. Chairman. I thank you all for 
being here. You have both made reference to the fact that you 
take these comment periods seriously, and that you consider 
these comments in your guideline making process. And I take you 
at your word. One particular area of concern to me, though, and 
producers in my district, is in the Dietary Guidelines Advisory 
Committee recommendations regarding red meat. The current DGAC 
report seemingly recommends that Americans consume less red 
meat. Will your agencies be reviewing studies submitted during 
the comment period that address the recommendations for red 
meat, both pro and con, and can you tell me more about that?
    Secretary Vilsack. In terms of the issue of red meat, it is 
fairly clear that there is a recognition that lean meat is, and 
should be, part of a healthy diet. The challenge is to 
understand that, as Americans, if we look at the obesity 
epidemic that we are confronting in this country, that some of 
us are consuming more calories than we should. And so the 
recommendation is in relationship to the overall consumption of 
calories. And one way to reduce the overall consumption of 
calories is, obviously, to eat less of certain things. And in 
that category would be red meat, but that is by no means the 
only thing in that category. So I want to be clear here----
    Mr. Rogers. What I don't understand. I am sorry, Mr. 
Vilsack, but why would you include in that category red meat? I 
mean, why wouldn't you just say anything that takes you over a 
caloric level that is unacceptable, you shouldn't eat? Why 
would there be a category of things not to eat?
    Secretary Vilsack. Because of the importance of having 
balance, in terms of what you consume, in terms of what a 
healthy diet consists of. Again, remember what this is. It is a 
set of guidelines which is designed to give you the best chance 
of reducing cardiovascular, cancer, and chronic diseases.
    Mr. Rogers. But wouldn't red meat be part of a----
    Secretary Vilsack. It is.
    Mr. Rogers.--list of things that you should eat, as long as 
you eat lean?
    Secretary Vilsack. It is. That is what I am saying. It is.
    Mr. Rogers. I am sorry, I thought you said that you would 
put it in a list of things not to eat.
    Secretary Vilsack. No. Sir----
    Mr. Rogers. Okay.
    Secretary Vilsack.--what I said was, if you are concerned 
about over-consumption of food generally, then obviously you 
are going to suggest that people should eat less of something 
that they are eating a lot of. That is the key.
    Mr. Rogers. I agree.
    Secretary Vilsack. To suggest that we are not going to have 
a guideline, it is fair to say, regardless of the fact the 
guidelines aren't fixed yet, that lean mean is going to be part 
of a healthy diet. There is no question about that, as far as--
--
    Secretary Burwell. Yes. The Advisory Committee's 
recommendation on this is exactly the same as 2010. So I 
think----
    Mr. Rogers. Yes.
    Secretary Burwell.--the Secretary's comments hold.
    Mr. Rogers. Okay.
    Secretary Burwell. The Secretary's comments are also 
reflected--I have Fiesta plates, those are what my mother had. 
Those are the plates, those colorful plates, and my mother used 
those. The plates that I have from my mother, and the ones I 
received for my wedding, they are a different size, reflecting 
the issue that we, as a nation, I just think that is a visible 
thing that people see. My mom's plates, they are smaller, the 
ones I have from her. The ones that I received--and this gets 
to the issue of the totality that we need to work on at the 
same time that we think about the nutritional content. So we 
have too much, and we have to get the right nutritional 
content.
    And what everybody wants is an opportunity to be able to 
have guidelines to do that. And that is what the 
choosemyplate.gov hits are about, and everything is about. 
Being a mother of an 8 and a 6 year old, and your time in the 
grocery story, having worked for the largest grocer in the 
country, Wal-Mart. The average time for a working mom or dad 
is, like, 20 minutes. And so your ability to get in there, get 
it done, and try and do it in a way that is healthy for your 
children, you need ease in decision-making. This is step one. 
It is just the guidelines. How it gets translated into other 
things are the next steps. That is what the Secretary's comment 
about what this is, and what this isn't, and why we want 
something that is useful for working families who are just 
trying to get this right for themselves and their children.
    Mr. Rogers. Great. Thank you both. I yield back.
    The Chairman. The gentleman yields back. Mr. Walz, for 5 
minutes.
    Mr. Walz. Thank you, Mr. Chairman. And I want to thank both 
of you for being here, for the work you do. And, Secretary 
Burwell, I appreciate that last comment, too, as a father of a 
young son, and someone who, as I often tell my colleagues, I 
supervised the high school lunchroom for 20 years, so you see 
that side of things, and how those school lunches impact. You 
brought up great points here, and this is an important hearing. 
And articulating what this is and what this isn't is really 
important. Because, at the heart of this, with so much 
information out there, and Americans are going to try and find 
it, from their uncle's e-mail to them to Dr. Oz and others, 
they are looking for the gold standard on what makes a 
difference in their own lives as they search for this.
    And all we have to do is look at the cost of obesity in the 
United States, estimated at between $150 and $200 billion per 
year. This is an important subject. We need to help people find 
the information. They are busy, there is lots of it. And that 
is why the questions that are coming up from colleagues about 
the integrity of your suggestions, as many of us saw, and still 
do believe, as the gold standard on how this gets done, and 
valid concerns about the decisions we make here. And, in full 
disclosure, I have the ninth largest agricultural district in 
America. We produce lots of pork, lots of milk, lots of 
turkeys, and all those things. When we make those decisions, 
they have an economic impact. So the concern is valid, it is 
warranted, but we have a responsibility to move headlong into 
this to help the American public get it. So, for me, and more a 
statement on this, we are concerned on process, and hearing 
that. It is important to hear both of you articulate that, and 
it is important for the American public to know that they can 
trust these as guidelines for them, and they are going to make 
decisions for their own family based on them.
    So maybe what I would do is just ask you, what you are 
hearing on this process, do you feel like the concerns you are 
hearing from Members on the totality of the evidence and 
things, are you comfortable that those are being included when 
you make your guidelines? You are hearing about Members talking 
about things that aren't included, specific commodities that 
aren't in that? Are you comfortable? And maybe, Secretary 
Burwell, start with you.
    Secretary Burwell. Yes, that we are including these 
comments. And whether that is the blog that we issued 
yesterday, we had a number of questions about that 
sustainability issue, or the tax issue that we tried to address 
here today, that we are, across the board, hearing and 
listening. And you can be assured that the questions that you 
all are asking us are the questions that we will be asking our 
teams as the recommendations come forward. It was mentioned 
cranberries, and the issue of something that has high nutrient 
value, and the question of how that interrelates with added 
sugar, and how we think about those issues. Your questions 
become our questions as part of this process.
    And we do believe--I mean, the comments that came in, as 
the Secretary mentioned, there were a number of repeat--8,000 
were probably singular. There were 19,000 comments on 
sustainability: 97 percent of those comments, so we are clear 
and transparent, were positive, and that we should include 
sustainability as part of the Dietary Guidelines. And I say 
that to make the point that we want to hear. We are going to 
ask the questions, and then, based on what the Dietary 
Guidelines are, and the scientific evidence, that is how we 
will go about making the decisions.
    Secretary Vilsack. I would only add that the debate that we 
are having here, and the debate that is taking place outside of 
this room, is a reflection of people's interest in where their 
food comes from, how it is produced, who is producing it, who 
is benefiting from it. And that is a healthy debate----
    Mr. Walz. Yes.
    Secretary Vilsack.--for us to have, in the right context.
    Mr. Walz. Yes.
    Secretary Vilsack. It is a healthy debate for us to have in 
the context of developing a farm bill. It is a healthy debate 
for us to have in the context of conservation, in the local and 
regional food system effort. All of those are avenues and 
vehicles for having that conversation, and we are having that 
conversation, and we should have that conversation. This, 
however, is about dietary and nutrition, and that is what we 
are going to focus on as we develop these guidelines.
    Mr. Walz. Well, I very much appreciate that point of view. 
I am not going to miss this opportunity, with my last 40 
seconds, Mr. Chairman. Mr. Secretary, again, off topic, but I 
am going to use it. The effect of sequestration on ARC and PLC. 
I am going to ask, if my folks are out there, if you could help 
me.
    Secretary Vilsack. It will be a 6.8 percent reduction----
    Mr. Walz. Okay.
    Secretary Vilsack.--across the board, regardless of when 
they came into the FSA office, or when they basically----
    Mr. Walz. So what they are hearing is true, there will be a 
reduction----
    Secretary Vilsack. Yes.
    Mr. Walz.--to them?
    Secretary Vilsack. Unless something happens with the 
sequester.
    Mr. Walz. Very good. I yield back. Thank you.
    The Chairman. The gentleman yields back. Mr. Gibbs, for 5 
minutes.
    Mr. Gibbs. Thank you, Mr. Chairman. I have to tell you, 
hearing the Ranking Member's, Mr. Peterson's, comments that I 
agree with about everything he said. Why are we doing all this, 
if it is really necessary. And I make the comment that there is 
a lot of information out there to consumers. You have the 
medical associations, the cancer, heart. There are all kinds 
out there. I am encouraged to hear you say that the process--to 
make sure that the tax, sustainability issues aren't part of 
this, because they shouldn't be.
    I guess my only demand, demand, would be that you use 
common sense, and say, moderation, people out there can make a 
lot of decisions on their own. There is a lot of information 
out there, and these guidelines should just be common sense 
things, that if you have a weight problem, you need to lower 
your calorie intake. So that is just my comment. I wonder if 
you know how much--I won't even bother to ask how much all this 
process costs, but I can just imagine.
    But, Secretary Vilsack, what I want to ask you, these 
guidelines are supposed to be guidelines. And how does that 
have an affect on the school lunch program? Because we have 
seen the school lunch program be turned on its head, and there 
have been all kinds of reports of certain school districts that 
want to get out of the program, and there are guidelines--part 
of that effect of determining what is happening in the school 
lunch program?
    Secretary Vilsack. Well, the school lunch program is, 
obviously, focused on compliance with the Healthy Hunger Free 
Kids Act, which passed Congress in 2010. And in that, Congress 
directed us to do a better job, in terms of the quality and 
nutritional value of those meals. More fruits and vegetables, 
more whole grains, more low fat dairy, and less fat, sugar, and 
sodium, and we are compliant with that. And, in fact, 95 
percent of school districts have been certified as following 
the standards. Surveys of children, surveys of school 
administrators, surveys of parents, and surveys of the public 
all indicate strong support for what we are doing. And we are 
helping school districts that are struggling through a series 
of programs--for success, where we are seeing struggling 
schools linked up with succeeding schools, and we are finding a 
good success for that program as well.
    So the Dietary Guidelines help to inform, as they do with 
some of the other nutrition programs, as they do with the 
Department of Defense, in developing what they are going to 
serve our military. These Dietary Guidelines help to inform the 
process.
    Mr. Gibbs. Okay. Because I am just really concerned what is 
happening in the school lunch program. I am hearing issues out 
there that kids aren't eating, their food is going to waste. 
There are things, when I was a kid, that I wouldn't eat that I 
eat--I love to eat today, so there are different behaviors----
    Secretary Vilsack. I can say a couple things about that. 
Number one, there are several studies, University of 
Connecticut, Harvard Public Health School, that suggest that 
food waste is not as significant as it has been reported, and, 
in fact, is no greater than it was prior to the new guidelines. 
Number two, it is a matter of time. There is some research to 
suggest that if kids are given more time to eat there is less 
food waste. And the timing of the meal, in terms of whether it 
is before or after recess, may also impact that.
    And then, finally, I had an interesting conversation with 
the President of Tufts yesterday, they did away with food trays 
at Tufts, and what they have found is that that has reduced 
significantly the amount of food waste, because kids came in 
with a tray, and they feel like they have to fill up the tray, 
as opposed to a plate. And they fill up the plate, they get 
satisfied, they don't go back for seconds, there is less food 
waste. So there is a lot of opportunity here for us, as a 
nation, to reduce food waste, but I don't think it is a 
reflection, or an indication, of the new school----
    Mr. Gibbs. When USDA's working on the school lunch program 
and stuff, is there much discussion about physical activity? 
That is probably--maybe more so than what they are--I--
especially in kids.
    Secretary Vilsack. Well, we have over 6,000 schools that 
have now been certified under the U.S. Healthier School 
Challenge, which is an effort on our part to encourage both 
calories in and calories out. And we reward and acknowledge 
school districts that are doing a good job of balancing 
nutrition and exercise. We also have an interesting 
relationship with the Dairy Association, and the NFL, on their 
Fuel Up to Play 60----
    Mr. Gibbs. Okay.
    Secretary Vilsack.--program. So there is an----
    Mr. Gibbs. Okay.
    Secretary Vilsack.--emphasis on exercise.
    Mr. Gibbs. Secretary, your comment about sustainability, 
and all the comments you had, I guess my only comment would be 
something that gets a little weighted by certain agendas, by 
certain organizations, we saw this in the waters of the United 
States. We saw a lot of comments that came in, and obviously 
that was orchestrated, and there are agendas out there, just so 
you are aware of that, and some of those comments are sometimes 
subject to how credible they really are. I yield back.
    The Chairman. The gentleman yields back. Ms. Fudge, 5 
minutes.
    Ms. Fudge. Thank you very much, Mr. Chairman, and I thank 
you both for being here this morning. On August 24 the Center 
for Nutrition Policy and Promotion issued a Federal Register 
Notice asking for input as to how to better inform the public 
about the 2015 Dietary Guidelines. I think that is a great 
idea, because so many Americans really do not understand, and 
are confused, about the guidelines, and the dietary patterns. 
So tell me how you are planning your messaging around the 
guidelines, and if you have any just straightforward 
suggestions as to how Americans can improve their eating 
habits?
    Secretary Vilsack. Well, we take the guidelines and 
incorporate it into our choosemyplate.gov initiative, which 
Secretary Burwell referred to it earlier. It is an opportunity 
for us to visually give people an idea of what a healthy plate 
looks like. The choosemyplate.gov website, which I mentioned 
before, is also part of our effort to try to do outreach. We 
also have a super tracker program that if you are struggling 
with weight--I have it on my iPhone--it basically gives you 
daily updates on--and suggestions on how you might be able to 
control your weight, tips on substituting foods and so forth so 
that you have a healthier, balanced diet. So there are a series 
of ways in which we incorporate the information from the 
guidelines in our educational materials, which we then 
disseminate through a variety of mechanisms, social media, and 
legacy media.
    Ms. Fudge. Thank you. How many American households do you 
believe are at risk for food insecurity, and how can the 2015 
DGA address the critical needs of our most vulnerable 
populations?
    Secretary Vilsack. Well, I can tell you our focus has been, 
obviously, on children, and there are 15.8 million children who 
live in food insecure homes. That number is down, which is good 
news. We, obviously, still have work to do. There are a variety 
of ways in which we can provide help and assistance. Some of 
the obvious ways are the SNAP program, and expansion of summer 
feeding, weekend feeding programs during the school year. There 
is an opportunity for us to also work with day care facilities 
and child care facilities to ensure that youngsters in those 
facilities get decent snacks.
    And we mentioned the school lunch program. Unfortunately, a 
lot of kids today get \1/2\ or at least \1/3\, and in some 
cases all of the calories they consume in schools. So, to the 
extent that we can do a good job of not only providing school 
meals, school breakfast and school lunch, but also after school 
snacks through our snack program, these are all a variety of 
ways in which we can try to provide help.
    The last thing I would say is that we are also trying to 
find creative ways for SNAP families to extend their SNAP 
dollar by giving them tips on how they might be able to use 
fruits and vegetables effectively in recipes. We are also 
making access to farmers' markets more available. Over 6,200 
farmers' markets today, that is a dramatic increase in the 
number, now have the EBT cards that allow SNAP beneficiaries to 
access farmer's markets.
    Ms. Fudge. Which, by the way, works very, very effectively. 
I have it in my district, so I thank you for that.
    Last, tell me how important it is to maintain the 5 year 
cycle for the Dietary Guidelines, so that Americans really do 
get the benefit of the current science for diet and health.
    Secretary Burwell. I think we think that the 5 year review 
is a very important part of doing many of the things that we 
are being asked to do, which is make sure that we have the most 
up to date science, and make sure that we are listening to the 
public, because it is a formalized process that we do hear from 
the public, and there are those opportunities. While it is in 
statute, and that is a big part of why we do it, I think we 
would agree that it is important to have points in time where 
you do the work, and settle, and do the analysis, and the 
listening. And so I think we think that updating it on a 
regular basis, on a 5 year cycle, is important.
    Secretary Vilsack. I agree.
    Ms. Fudge. Thank you very much, Mr. Chairman. I yield back.
    The Chairman. The gentlelady yields back. Mr. Scott, 5 
minutes, Austin Scott.
    Mr. Austin Scott of Georgia. Thank you, Mr. Chairman. Madam 
Secretary, Mr. Secretary, thank you for being here. As we talk 
about the reports, the credibility of the report is arguably 
the most important thing. It doesn't matter how much time and 
money went into it, if we have a credibility gap, we have a 
problem. There were certainly some questions about the fact 
that Ms. Mylett was from the private sector now. I have read 
her resume: 30 years at one of the major institutions, 
certainly qualified in every way, shape, and form from her 
academic career to be there. But there are questions about the 
fact that she is now a member of the private sector, chairing 
the committee.
    Historically, we have not allowed industry representatives 
on the panel. And I recognize that she doesn't represent, for 
example, the cattle industry or the corn industry, because we 
would believe that there would be the assumption--whether true 
or not, there would be the assumption that there would be bias 
in the opinions of people who represented a certain industry on 
the panel. When I see issues like tax on sodas and other things 
being recommended, it seems to me that ideology is taking 
precedence over science, and that creates a tremendous 
credibility gap as well.
    And I would just ask, as we go forward, how do we make sure 
that we don't have that credibility gap in the report? Because 
the CDC and the others do use this information to send out 
recommendations to the American public. And if the Nutrition 
Evidence Library is not being used, how do we guarantee the 
credibility of the report?
    Secretary Burwell. Do you want to speak to the nutrition 
library----
    Secretary Vilsack. Yes, go ahead.
    Secretary Burwell.--and I will speak with regard to the 
credibility, that is a very important element of the trust of 
what we have in front of us, and that is why we are having the 
conversation. In the places where we can provide clarity, we 
do, as well as providing clarity--and that is a little bit of--
some of our follow-up questions about, there is a scientific 
approach to what documents are included, how they are included. 
That is the standard of scientific research. The gold standard 
is used. I have checked even with our economists, had them come 
in and look at it.
    Mr. Austin Scott of Georgia. Can I----
    Secretary Burwell. So clearing----
    Mr. Austin Scott of Georgia.--ask you a question there? If 
the standard is scientific research, how do recommendations for 
tax on sodas get into the report?
    Secretary Burwell. It is important to reflect that in the 
Advisory Committee's report that there wasn't a recommendation. 
It was an articulation that some used policy, and so I don't 
think there were recommendations. They did not make 
recommendations. But with regard to the issue that has been 
raised, when we get to the Dietary Guidelines, how we take what 
we are given, that is one input, and use it will be an 
important part of establishing a process that people believe 
in.
    Mr. Austin Scott of Georgia. I am down to a minute, so I 
would like to hear what Secretary Vilsack has to say, but I 
would suggest that, when you see those things in the report, 
and whether it is a jump to conclusion or not, there is a 
belief, then, that the people on the committee entered with a 
bias in some way, shape, or form, and we are searching for the 
science to back up what they already believe to be true, 
instead of using the best available science. Whether it is true 
or not, we can debate that there is a credibility gap from 
those things working their way into the report.
    Secretary Vilsack. Congressman, I would like just simply 
to, again, emphasize there is a fundamental difference between 
the Advisory Committee's report and the guidelines. And there 
is confusion out there. For some reason, people seem to think 
that the report equals the guidelines. It does not. It is one 
aspect of information that will be taken into consideration, 
relative to the dietary and nutrition guidelines that we have 
to put together, number one.
    Number two, the Nutrition Evidence Library was used, and 
there is an extensive process that is involved in accumulating 
information and putting it through a filter, if you will, of--
--
    Mr. Austin Scott of Georgia. Secretary Vilsack, I am down 
to 30 seconds, but it was used for 30 percent, at least the 
reports, that a tremendous number of things were not taken from 
that library. This is a text I received from a dad yesterday, 
and he is saying that their school can't sell candy bars, which 
they used to do to help pay for a kids' trip, and that they are 
being told from our local school system that that comes from 
the Federal Government----
    Secretary Vilsack. That is not----
    Mr. Austin Scott of Georgia.--that they can't sell candy 
bars to raise money. Is that----
    Secretary Vilsack. That is not true. Folks can sell outside 
of school, which is what these candy deals are. Outside of 
school, there is no prohibition. There are exceptions and 
waivers that can be granted. Oftentimes it is not the Federal 
law that is in place. It can be a state law that is that, or it 
could be----
    Mr. Austin Scott of Georgia. I don't think we would have 
that in----
    Secretary Vilsack. Well, that may be the case. Well, then 
folks are mistaken about that.
    Mr. Austin Scott of Georgia. Thank you, sir, for clearing 
that up.
    The Chairman. The gentleman's time has expired. Mr. 
McGovern, 5 minutes.
    Mr. McGovern. Thank you, and, Secretary Vilsack and 
Secretary Burwell, thank you for being with us today, and thank 
you both for your respective agencies' work on the Dietary 
Guidelines Advisory Committee's report. I know that this is no 
simple undertaking, and I appreciate the fact that it takes and 
requires months and months of scientific analysis and 
consideration of thousands of stakeholder comments, and 
thoughtful collaboration among committee members and agency 
staff. And I want to say that I appreciate the process that the 
Advisory Committee went through. It is a solid process, one 
that was open, and included, as you mentioned, many 
opportunities for the public to weigh in.
    And it is also important, to kind of put all this in 
perspective here, my colleagues understand, that, in this 
country today, one in three school-age children and adolescents 
is overweight or has obesity. And more than one in three 
American adults suffers from cardiovascular disease and 
diabetes. Clearly we can do better. When I look at what we are 
all talking about here today, this is an attempt for us to get 
it better. And if people aren't interested in the well-being of 
our citizenry, and all they are interested in is the bottom 
line, they should be very supportive of what you are talking 
about here today, because, at the end of the day, healthier 
people mean lower healthcare costs. So we all benefit here.
    You mentioned earlier the HHS blog yesterday, where the 
issues of sustainability were taken off the table for inclusion 
in the final guidelines. And I get that is the case, and I 
respect your decision, but this is an important issue, and you 
both have acknowledged that. Sustainability, somehow, in this 
Congress is a dirty word. I don't quite get it, but it is 
important, and we ought to be talking about sustainability when 
we are talking about issues of diet and food security. And I do 
think that it is important that at least we start this 
conversation about this issue in the context of Dietary 
Guidelines.
    I also appreciate that both your testimonies do a good job 
of emphasizing the importance of nutrition on disease 
prevention, and putting these recommendations into context. In 
Congress we ought to be focusing more on prevention as a way to 
reduce healthcare costs and improve overall well-being and 
economic productivity. We should be highlighting what the 
science says on good nutrition for our kids and for our 
families.
    I have an op-ed here today that was in today's Hill 
newspaper, penned by the Presidents of the American Academy of 
Pediatrics and the American Medical Association. It is 
entitled, Physician's Perspective, Keep Politics Out of Dietary 
Guidelines, and I would like to insert that in the record. In 
it they talk about the importance of Dietary Guidelines, and 
the soundness of science used to inform them. The issue was 
raised that sometimes science changes. Everything changes. We 
know more today than we knew yesterday. Our research techniques 
have improved over the last 10, 20, 30 years. So when we learn 
the latest science, then we need to make the necessary 
adjustments.
    [The information referred to is located on p. 70.]
    But, as you know, some of the biggest critics of these 
guidelines are from industries that produce the least healthy 
foods, and from special interests with questionable 
credentials. I was reading about some billionaire from Texas 
who is a former Enron executive who is funding some initiatives 
to try to raise questions about what you are doing. I don't 
know what Enron knows about Dietary Guidelines, but, 
nonetheless, there are powerful special interests out there 
trying to raise issues of credibility, trying to question 
science.
    And so I just would conclude by saying I encourage you to 
keep, first and foremost, the health and well-being of our kids 
and our citizenry in the forefront as you move forward. And 
maybe, in my last minute, can you explain to me if we all 
improved our diets, what would be the impact on the rates and 
costs of diabetes, and heart disease, and obesity? Secretary 
Burwell?
    Secretary Burwell. When I examined both Medicaid and 
Medicare costs over the 10 year period, and as a trustee, as 
one goes out over periods of time, both heart disease, 
something that we know about how to do--and diabetes are two 
very, very large cost drivers for us as a nation. And they are 
cost drivers because those are both conditions that continue 
over an extended period of time, and especially as we have a 
population that lives longer, which is a good thing.
    But the idea that these are costs that are controllable--
and I would also say that in my engagement with the private-
sector, and CEOs of companies--and I am sure you all hear this 
in your districts. They talk about wellness a lot. And the 
reason they are so deeply focused on this issue, and want to 
engage with us as a Department on the issue, is because they 
are putting initiatives in place because they are starting to 
see. And I was just actually with NAM this week, the National 
Association of Manufacturers, and had one of the CEOs who says 
she has done it now for almost 10 years, and she has the 
analytics to show it. Those are analytics companies can make 
decisions on. We want to see those to see if they are worthy 
enough for us to make decisions on the taxpayers' money.
    So it is across the board in both the public-sector 
spending and the private-sector spending on these health 
issues, and diabetes and heart disease are two of the leading 
costs that we have, both publicly and privately.
    The Chairman. The gentleman's time has expired. I would ask 
my colleagues' indulgence, Secretary Burwell has a hard stop at 
11:30, and, given the apparent interest everyone has in getting 
these, I would ask for colleagues' unanimous consent to go to 4 
minutes for questioning so that we give a chance for everybody 
to get here to make that happen. So, without objection, we will 
go to 4 minutes from this point forward. So, Mr. Crawford, for 
4 minutes.
    Mr. Crawford. Thank you, Mr. Chairman. Kind of keeping on 
that subject, a lot of attention has been paid to the Dietary 
Guidelines, and the fact that they are guidelines, they are not 
rules. Am I correct in that?
    Secretary Burwell. Yes. They are guidelines----
    Mr. Crawford. Okay.
    Secretary Burwell.--that then are used as a basis for 
programmatic and policy decisions.
    Mr. Crawford. Okay. So they actually are used pretty hard 
and fast on rulemaking, then, correct?
    Secretary Burwell. It depends on which program. So, for 
instance, school lunch programs in our area--the Administration 
for Community Living----
    Mr. Crawford. Yes.
    Secretary Burwell.--in terms of Meals on Wheels and those 
types of programs, they are used, and they are applied in 
different settings in different ways.
    Mr. Crawford. We have heard a lot of talk about the school 
lunch program, and it seems that--and I know that my colleague 
mentioned he had gotten a text just in the last few minutes, 
and I have gotten phone call, after phone call, after phone 
call once the new school lunch program was implemented fully in 
2012, but there has been very little attention paid to how we 
roll this out and apply it rigidly to the SNAP program.
    And so it seems like using the argument that, well, we can 
be proactive, and we can sort of help to regulate the kind of 
food that people eat that we can control, the Secretary 
mentioned Department of Defense, and meals that our soldiers, 
sailors, airmen, Marines receive. We mentioned the school 
nutrition program, meals that our students receive, but we are 
not talking about actively engaging in how we do a better job 
in administering the SNAP program with respect to the sugary 
drinks that are often purchased, and all the other things that 
are bad, according to these guidelines. So why aren't we doing 
a better job of actually going in and proactively engaging in 
rules that help us do a better job on dietary structure, as it 
applies to the SNAP program?
    Secretary Vilsack. Well, first of all, we are trying to 
address through a variety of mechanisms. The farm bill provided 
for the Food Nutrition and Security Initiative, which is 
designed to provide assistance and help for SNAP families to 
purchase more fruits and vegetables and alike. The expansion of 
access to farmers' markets is also giving them that 
opportunity. We are looking at a--we had a data-based, 
research-based program at Holyoke, Massachusetts for 2 years to 
determine what would actually provide direction for SNAP 
families, in terms of purchasing nutritious food, making 
nutritious choices. What we found was that incentives work.
    Also, there is a fairly serious technology challenge, in 
terms of trying to prohibit people from using SNAP for certain 
products.
    Mr. Crawford. Okay, let me stop you right there, Mr. 
Secretary, because I know that our travel card will deny a 
purchase. If you try to fill up your car on official business 
with your travel card, and then put a Snickers on there, it 
will decline that purchase.
    Secretary Vilsack. Well----
    Mr. Crawford. So I know the technology exists that we can 
do a better job in administering what the SNAP card can be used 
for.
    Secretary Vilsack. There are 300,000 different products 
that are sold in grocery stores across the United States.
    Mr. Crawford. Right. We ought to identify the ones that 
aren't allowed.
    Secretary Vilsack. Well, here is the problem. You want to 
do sugared drinks? Does that include apple juice, 100 percent 
apple juice? Do you want to permit that?
    Mr. Crawford. But that is my question, why are we not 
addressing that----
    Secretary Vilsack. Well, I am asking, do you want to 
exclude that? Because----
    Mr. Crawford. No, I am asking you because we are not 
marking up a bill here. I am trying to get feedback from you on 
why the Dietary Guidelines are not more rigidly utilized in 
the----
    Secretary Vilsack. They----
    Mr. Crawford.--SNAP program, they are in the school 
nutrition program.
    Secretary Vilsack. They are used in the SNAP program, in 
terms of providing guidance and direction to SNAP families in 
terms of how they can extend their SNAP dollar, where they can 
buy fruits and vegetables, how they might be able to use 
recipes.
    Mr. Crawford. And you mentioned incentives. What kind of 
incentives are being used to incentivize people to make those 
smarter choices?
    Secretary Vilsack. Well, the Food Insecurity Initiative is 
providing resources to a number of groups that are providing 
cash incentives. So when a person goes to a farmers' market, 
and they buy $5 worth of tomatoes, they actually will be able 
to buy $10 because of the additional incentive. So they get 
more bang for their buck. It is also an opportunity for 
associations involved to provide sales, to provide promotions, 
to provide recipes. There are a whole series of programs. We 
will be happy to provide you a list of all the grants that have 
been made under that initiative, and what actually is being 
done. I think that might be helpful to you.
    Mr. Crawford. Thank you, I appreciate it. I yield back.
    The Chairman. The gentleman's time--Mr. Aguilar, 5 
minutes--4 minutes, excuse me.
    Mr. Aguilar. Thank you, Mr. Chairman, and thank you both to 
the Secretaries for being here. I wanted to expand a little bit 
on that discussion. I participated, and I mentioned it to my 
colleagues before, in the SNAP challenge earlier this year. And 
the biggest piece that struck me was there was an end in sight, 
when I went through this challenge, but it was the budgetary 
constraints on healthy eating. And, Mr. Secretary, you were 
just talking about those programs, and the success that you are 
seeing there, and I hope that we can continue to grow those 
programs.
    And I understand that, within the Dietary Guidelines, both 
USDA and HHS also plan to release marketing materials. And, Mr. 
Secretary, you talked about choosemyplate.gov as an example, 
showing folks how to live on a low budget and a balanced diet. 
In the Advisory Committee report it is mentioned that the best 
food patterns of healthy living include the healthy U.S. style 
pattern, the healthy Mediterranean style pattern, and the 
healthy vegetarian pattern. Do you know approximately how much 
it would cost to afford each of these lifestyles per week, and 
could you expand a little bit on the programs that educate low-
income families on healthy purchases like the food insecurity 
program?
    Secretary Vilsack. Well, the guidelines help to inform a 
series of meal patterns, and it goes from the high end to the 
low end. And the Thrifty Food Plan basically is the plan--I 
don't know the specific dollar amount. Obviously, it depends on 
the choices that people make, Congressman. But we need to sort 
of dispel the myth that healthy eating necessarily has to be 
more expensive. And here is why people think that. If you take 
a portion of potato chips and a portion of broccoli, in the 
past, the way we judge the value of that was by looking at 100 
calories' worth of potato chips, and 100 calories' worth of 
broccoli. Well, 100 calories' worth of potato chips would be 
about three potato chips. One hundred calories' worth of 
broccoli would probably fill \1/2\ this room. Obviously that is 
going to be more expensive. But what we ought to be doing is 
looking at portion sizes, because people eat more than three 
potato chips, and they don't eat \1/2\ a room full of broccoli.
    When you look at portion sizes, fruits and vegetables 
become affordable, number one. Number two, if you look at 
recipes, the use of canned and frozen vegetables and fruits 
also is an opportunity--there are ways in which we can stretch 
dollars, and so part of our education initiative is to provide 
people with the recipes and the information that will allow 
them to use fruits and vegetables more effectively, to 
understand that it doesn't necessarily have to be more 
expensive.
    And then also the incentive programs that we have, where we 
work with foundations to encourage farmers' market purchases by 
incenting those, the food and nutrition incentives that allow 
grocery stores to offer additional bonus points, if you will, 
for SNAP families to purchase fruits and vegetables. I mean, 
there are a wide variety of things. And we are also working 
with food banks to make sure that the areas of opportunity that 
they have to help struggling families also includes more 
healthy choices. So there are a wide variety of steps and ways 
in which we are attempting to make a difference.
    Mr. Aguilar. I would love to see how we can stretch to 
become healthier. But, I would say, it was incredibly tough, 
Mr. Secretary, my wife and I, $66, on the SNAP challenge, to 
include healthy portions and to manage our portions. I ate 
peanut butter and jelly every day for at least one meal because 
we were trying to have a couple salads for the week.
    Secretary Vilsack. The SNAP program, as everyone knows, is 
a Supplemental Nutrition Assistance Program. It is not 
designed, and not engineered, and not funded to be the be-all 
and end-all for a family----
    Mr. Aguilar. But for countless Americans it is.
    Secretary Vilsack. Well, I understand that, but that is why 
we work with food banks, that is why we work with foundations, 
that is why we work with shelters, that is why we work with 
other avenues. That is why we have the school lunch and school 
breakfast programs that are expanding. That is why we have 
after school efforts, why we have a summer feeding program, to 
try to supplement and to----
    Mr. Aguilar. And I look forward to working with you to 
carry out the mission of those programs----
    The Chairman. The gentleman's time has expired. Mr. 
DesJarlais, 4 minutes.
    Mr. DesJarlais. Thank you. Thank you both for being here. 
Secretary Burwell, I can count on one finger the number of 
times that a sitting secretary has reached out to all the 
Members of a Committee prior to the hearing to ask if they had 
any concerns, and so thank you for that. I appreciate you doing 
that. I know that is time consuming, but very thoughtful.
    Historically, the Dietary Guidelines for Americans policy 
document, which you say will be released in December, have not 
made suggestions about specific ingredients of commodities, yet 
that hasn't prevented the Advisory Committee from taking a look 
at aggregate consumption by the U.S. population, and potential 
health risks of ingredients such as low calorie sweetener 
aspartame. Aspartame is one of the most widely studied food 
additives in the history of the FDA, and its approval came 
after more than a decade of review through an affirmative food 
additive petition. FDA has asserted, and re-asserted, the 
safety of aspartame, yet DGAC used a dubious process to call 
into question its safety, citing extremely weak science against 
the backdrop of decades of research that shows otherwise. And 
now we are calling for more research, in spite of the fact that 
FDA spent over a decade studying this ingredient's safety, and 
concluded there is no increased risk of cancer from aspartame 
consumption.
    During your inter-agency review of the guidelines, are you 
consulting with the FDA on recommendations after they spent 
years reviewing the science?
    Secretary Burwell. Yes, FDA is a part of the process at 
HHS. And, with regard to the issue of the safety of aspartame--
and there are basically five products that FDA has said in 
given contents are fine and safe. And so, yes, FDA is a part of 
the HHS process.
    Mr. DesJarlais. How did the inter-agencies review 
ultimately impact the final recommendations?
    Secretary Burwell. The inter-agency review is an extremely 
important part of the process. Both the Secretary and I have 
indicated that the input of the Advisory Committee is something 
that we are reviewing, but our own experts across our 
Departments, not just FDA for us, but CDC and NIH as well. The 
whole Department is a part of this process. It comes together, 
reviews everything together, and that is what forms the 
recommendations that we will receive from our Departments 
collectively together.
    Mr. DesJarlais. Okay. Additionally, DGAC recommends 
replacing sugared beverages with water or low fat milk only. 
However, for the guidelines to be effective to most Americans, 
we need to be able to meet them in the middle and offer 
guidelines that are realistic, not idealistic. In your final 
recommendations, how do you intend to balance dietary ideals 
that are realistic and achievable for most Americans?
    Secretary Burwell. With regard to that question, getting 
ahead of where the recommendations are from our staff, I 
wouldn't be able to comment on the specifics. But we do look 
for a balanced approach and an evidence-based approach. With 
regard to where we have the evidence about issues of--when we 
say balanced, it is also about this issue the Secretary raised 
of nutritional value. And so, when you are trying to have a set 
number of calories, and you have to get in certain numbers of 
nutrition, how you can get that puzzle to fit together is an 
important part of what we will think about as we put together 
the final guideline.
    Mr. DesJarlais. Okay. Thank you, Secretary. Secretary 
Vilsack, at the December meeting, before the final Advisory 
Committee recommendations were voted upon, the committee got in 
a discussion about the definitions of red versus lean versus 
processed meat. At the end of the discussion they decided to 
remove lean meat from the healthy dietary pattern, even though 
the scientific data in their own report was not changed, and 
the same, as the 2010 Dietary Guidelines, which recognized lean 
meat as a nutrient-dense food, and nutrient-dense foods were 
encouraged to increase.
    It is important for the Dietary Guidelines to have a strong 
scientific background, peer reviewed and published research to 
give Americans clear advice on their diets and health. Can you 
please give me the assurances that you have both taken into 
account to ensure strong scientific evidence is the foundation 
for the 2015 guidelines?
    Secretary Vilsack. I can, and I can also suggest--it is my 
understanding, and maybe I am wrong about this, that the report 
basically is fairly consistent with the recommendation that was 
made in the 2010 guidelines with reference to lean meat. I 
would be surprised if our final conclusion is not to include 
that as part of a healthy diet.
    Mr. DesJarlais. Thank you, sir.
    The Chairman. Mr. Costa, 5 minutes.
    Mr. Costa. Four minutes, I got it. Thank both Secretaries 
for your efforts in reaching out. I do appreciate that, and to 
the degree that we collaborate on a greater basis, we all do a 
better job.
    A lot of discussion this morning has been talking about the 
process in these guidelines, and I do appreciate your 
emphasizing that they are guidelines, as a part of a total work 
product. And I guess I would like to get your take, both of 
you, on how we measure success. Clearly we all believe, or I 
hope it is not in debate, that part of healthy Americans is a 
healthy diet, and it is part of preventative health care. As 
our mothers told us a long time ago, an ounce of prevention is 
worth a pound of cure. So how do we measure success in terms of 
the incredible changes that have been taking place in 
American's dietary habits over decades, and this effort to use 
these guidelines as a means to provide better diets so that we 
have healthier lifestyles? Have you thought about that in this 
process?
    Secretary Burwell. So----
    Mr. Costa. I mean, we are asking you the questions. How can 
we make this process better?
    Secretary Burwell. When we think about success, first, the 
guidelines themselves being a quality product. We need to start 
with that, and that is a lot of the conversation that we are 
having today, about an evidence-based and quality product. The 
second thing is how the guidelines get used in an appropriate 
fashion, in terms of people understanding what they are and----
    Mr. Costa. Do you think we are making progress along those 
lines?
    Secretary Burwell. I think it----
    Mr. Costa. There is a lot of advertising out there that 
tries to, especially among young people, skew their eating 
habits.
    Secretary Burwell. Yes, and so that comes to the third, 
which is the knowledge has to be activated so that people are 
acting and behaving. And those are all places where we believe 
that we, as a nation, can improve. And we can improve it both 
at a population health level, and then we improve it in the 
ways that we use it in the programs. And whether that is the 
programs at USDA, or the programs at HHS, in terms of applying 
them. And CDC, and its work in population health, is another 
place that I believe we can make progress.
    Mr. Costa. Secretary Vilsack, you have been at this for 7 
years.
    Secretary Vilsack. Congressman----
    Mr. Costa. How do you measure success?
    Secretary Vilsack. I would only add to what Secretary 
Burwell said, is that one way, potentially, of looking at this 
is to take a look at the healthy eating index that we have, 
which is a 100 point system. And currently today the average 
American is about 57. We have seen improvement over the last 
couple of years. That is good, but obviously--I don't know what 
your mother said about 57 out of 100, but my mother wasn't 
satisfied with that.
    Mr. Costa. No.
    Secretary Vilsack. So it is important for us----
    Mr. Costa. Not good.
    Secretary Vilsack.--to continue. That is one index. That is 
one way of measuring. Another way is to measure whether or not 
we are making headway on obesity. I am pleased by the fact 
that, at least among young children, we are beginning to see 
some indication of a plateauing, and potentially maybe even a 
slight decline in obesity rates. That is good news. But we 
still have work to do.
    And in terms of improving the process, I would say that 
this debate is healthy because it allows people to understand 
what these recommendations are, and what they aren't. And there 
is a misunderstanding between a prevention orientation, which 
is what these guidelines are, versus a treatment orientation, a 
lot of the criticisms often are because you aren't dealing with 
certain diets that would be helpful in dealing with obesity. 
And so maybe there is a way which we could potentially expand, 
or create an avenue, for that kind of treatment discussion to 
take place.
    Mr. Costa. Okay. I have other questions regarding GMO 
labeling, and biotech traits as it relates to that, and I will 
submit that for the record, because there is no time. I guess, 
just a final comment, and it is getting back to good habits. 
When I grew up, it was a few years ago, but 8 ounces was 
considered a regular thing, and a 12 ounces was really 
considered big. And then I remember we were all floored by 16 
ounces. Today, you see 24 ounces. It is a large part of the 
problem, just sizes and amounts as it relates to obesity, and 
how we combat against obesity. That is a comment.
    The Chairman. The gentleman's time has expired. Mrs. 
Hartzler, 4 minutes.
    Mrs. Hartzler. Thank you, Mr. Chairman. Thank you, 
Secretaries. I really appreciate the work that you are doing, 
as a former family consumer sciences teacher who taught 
nutrition for many years. It is very, very important, and very 
important to be science-based. I am very encouraged to hear 
that you are going to make sure that it is that, and doesn't 
include sustainability, tax policies, other issues.
    I wanted to focus on the Nutrition Evidence Library. We 
have heard much about it, with even the USDA officials 
describing it as the gold standard. But I have heard concerns 
that the Nutrition Evidence Library has ignored a large 
credible and growing body of peer-reviewed science on low carb 
diets, as it contradicts the evidence from previous guidelines. 
So can you elaborate on how scientific studies are added to the 
Nutrition Evidence Library, and what can be done to ensure that 
cutting edge research in nutrition science is considered?
    Secretary Vilsack. Well, there are four approaches as it 
relates to the library. There are original systematic reviews, 
there are existing reports, there are new reports that are 
funneled in from a variety of different locations. There is a 
review of what the typical diet of an American might be. Food 
pattern modeling is also included. So there is a broad array of 
things that are included in this effort.
    The issue of low carb diets raises the point that I just 
made with Representative Costa. I think that is ultimately in 
the context of how do you treat a particular condition, 
obesity, for example? It may very well be that a low carb diet, 
or a high protein diet, might be a way in which a physician 
would prescribe for an obese individual to deal with obesity. 
That is not what these guidelines are about. These guidelines 
are about preventing that circumstance to begin with.
    There isn't an avenue within the guidelines today for that 
treatment discussion, and that is why there is a lot of 
confusion about all of this, and why there is a lot of angst 
about it, because some people are looking at the guidelines as 
treating all health issues, and we are looking at what the law 
requires us to do, and that is----
    Mrs. Hartzler. Sure.
    Secretary Vilsack.--focus on dietary and nutritional 
guidelines relative to prevention.
    Mrs. Hartzler. Now, some people point out that 52 percent 
of U.S. adults are pre-diabetic, and they allege that a low 
carb diet helps prevent people becoming pre-diabetic, so it is 
actually----
    Secretary Vilsack. So in that----
    Mrs. Hartzler.--would be helpful to include that.
    Secretary Vilsack. So in that circumstance you have 
competing studies, which is why it is important to understand 
this is really about well-informed opinion. I wish there were 
scientific facts, but the reality is stuff changes, right? 
Stuff changes. And the key here is taking a look at the 
preponderance, the greater weight of the evidence, and trying 
to make a judgment based on the greater weight of the evidence. 
If you have one study on one side, and you have 15 studies on 
another side, the preponderance of the evidence may be on this 
side, with the 15 studies.
    And that is a challenge, and that is why we do this every 5 
years, to give an opportunity for that quality study to be 
further enhanced so that, 5 years from now, maybe there are 15 
studies on this side, and 15 studies on this side.
    Mrs. Hartzler. In the guidelines----
    Secretary Vilsack. It is an evolving process.
    Mrs. Hartzler. In the guidelines, are there any disclaimers 
mentioned in there that say for certain populations, this might 
not be true, or for certain populations this might be helpful? 
Do you include that, or do you just pick one and say, this is 
it?
    Secretary Vilsack. It isn't so much that. It is a caveat 
that these are recommendations focused on prevention. They are 
guidelines. They are not saying, ``You shall do this.'' They 
are recommendations and suggestions that you should do this. 
And that, sort of an indirect way----
    Mrs. Hartzler. Yes.
    Secretary Vilsack. We obviously haven't crafted the 
guidelines yet, so I don't know whether or not they will be 
caveats as----
    Mrs. Hartzler. Yes, is there any population--I mean, there 
has to be differences, perhaps, for different populations----
    Secretary Vilsack. Well, there are----
    Mrs. Hartzler.--the guidelines may not be one size fits 
all, or do you present it as everybody--this is for----
    Secretary Vilsack. It is a general guideline. It is a 
general set of recommendations. It is--I mean, in theory, you 
could have 317 million different guidelines----
    Mrs. Hartzler. Yes.
    Secretary Vilsack.--because we are all slightly different, 
in slightly different circumstances. So you have to create kind 
of a wide berth here, but within that wide berth, this is what 
we are recommending. If you are interested in a healthy diet, 
if you are interested in reducing the risk of diabetes and 
cardiovascular, this is a course that you might want to 
consider. Obviously, people are going to make choices and 
decisions based on what is best for them.
    The Chairman. The gentlelady's time has expired. Ms. 
Plaskett, for 4 minutes.
    Ms. Plaskett. Yes, thank you, Mr. Chairman, and good 
morning to you both. Thank you so much for your time today. I 
was just looking at the volume of comments that you had 
received, the 29,000 comments after the report came out. Can 
you explain how you are going to, and will you be able to, meet 
the timeframe that you have for an evaluation of all of those 
responses to be able to issue that report, the guidelines?
    Secretary Burwell. Yes. Our staffs have gone through all of 
the comments. One of the things that is helpful, in a sense, is 
that a large percentage of them actually were form letters. So, 
as the Secretary reflected, only about 8,000 were individual. 
Not only, but that is less than 29,000----
    Ms. Plaskett. Yes.
    Secretary Burwell.--in terms of our ability to get through. 
And the Secretary and I are both working very hard with our 
teams to meet the deadline of this year.
    Ms. Plaskett. Okay, great. And I guess my other question is 
related to moderate alcohol intake. And, looking at the 
guidelines that were issued in 2010, I noted in the 2015 
Committee Statement that it confirmed the conclusions from 
2010. Do we think that that is going to remain the same, or 
what is considered moderation? Will that change as well?
    Secretary Burwell. So, as you appropriately reflect, the 
Advisory Committee has the identical recommendations from the 
2010 report. While we are not going to comment on specifics, it 
is important----
    Ms. Plaskett. Yes.
    Secretary Burwell.--to reflect that there was no change.
    Ms. Plaskett. Okay.
    Secretary Vilsack. After this hearing, I may be consulting 
that guideline.
    Secretary Burwell. The FDA would say he meets age 
requirements.
    Ms. Plaskett. And that is two for males, right?
    Secretary Vilsack. Good enough.
    Ms. Plaskett. Well, I just want to thank you all for the 
tremendous work you have done. This is really important to the 
American people. I am just echoing my colleagues' discussions 
about proportion sizes, and the need for healthy diets, 
particularly in communities in which there may be a dearth of 
fresh foods that are available to them as well.
    And also, let us not forget, in terms of obesity, the thing 
we haven't talked about, which is not just your diet, but 
exercise as well, which is something that Americans have been 
woefully lacking for our young people for some time now. So 
thanks very much. I yield the balance of my----
    The Chairman. The gentlelady yields back, and I don't think 
the Secretary--after 5 o'clock, did you? Mr. Rouzer, 4 minutes.
    Ms. Plaskett. It will be 5 o'clock somewhere.
    Mr. Rouzer. Thank you, Mr. Chairman, Secretary Vilsack, 
Secretary Burwell. Thank you both for being here today. I 
appreciate it very much, because this is an incredibly 
important issue, and I am looking at this from a very macro 
perspective. We have close to a $20 trillion debt. Medicare and 
Medicaid, which you referenced a little earlier, is such a huge 
component of that debt because the vast majority of our budget 
is mandatory spending. Medicare and Medicaid are a huge 
component of mandatory spending.
    And so you consider the obesity issue that we are facing, 
and you mentioned obesity and heart disease as two major 
components that drive the cost of Medicare and Medicaid. All 
that gets back to what we consume. And back to my time, when I 
was in K through 12, versus the schools that I go in today, 
when I look at the student population, I do not recall, at 
least, when I was growing up, the number of overweight kids 
that are in school that you have today.
    And I visit all kinds of schools all across my district, 
and I would say \1/3\ of them are clearly overweight. And some 
of them are really young, I mean exceptionally young. And some 
of them I know their parents, I knew their grandparents, and 
obesity was not an issue in the family until this generation. 
And so that leads me to think that clearly something has 
changed in our society over the last 20 years, in particular, 
and I look at it from the perspective of that you have 
different movements out there influencing public policy. In the 
Dietary Guideline Advisory Committee, there is the statement in 
there that says common characteristics of dietary patterns 
associated with positive health outcomes include lower 
consumption of red meats.
    It was mentioned earlier about caloric diet, trying to 
maintain a certain number of calories. Well, not all calories 
are the same. I would suggest, just from a common sense 
perspective, 2,000 calories of beef versus 2,000 calories of 
donuts are very different. Your body reacts to it very 
different. Your body takes the carbohydrate and turns it into 
sugar, and that often goes straight to the belly. Whereas 
consumption of protein, same calorie amount, the body treats it 
very differently. In fact, if you go and have a blood test 
done, they measure protein level in your blood, which suggests 
that obviously protein is a key component to a healthy 
lifestyle.
    So my main point that I want to drive home this morning is 
that it is very, very important to understand that there is a 
difference, not all calories are the same. And, from a public 
policy standpoint, perhaps maybe we have gotten too smart for 
our own good. I recognize science has improved dramatically, 
but mankind has survived for many a thousand a year on red 
meat, whole milk. In fact, I remember growing up when there was 
a report that came out that said apple juice was bad for you, 
and then they came out and said, actually, no, we are wrong. 
Eggs, bacon. I remember growing up where they said, ``May 
contribute to high cholesterol and heart disease.''
    I want to make sure that we get back to common sense, and 
that we do what is right for future generations, because--not 
only for the health standpoint, but that translates directly in 
terms of the public policy decisions we have to make as it 
relates to our budget.
    Finishing it up here, I want to ask both of you----
    The Chairman. You can't ask anything at this point. We are 
going to have to keep going. Ms.----
    Mr. Rouzer. No problem.
    The Chairman.--DelBene, 4 minutes.
    Ms. DelBene. Thank you, Mr. Chairman, and thank you both 
for being here and for your time today. First I wanted to ask 
you about dairy. As you know, it has been a distinct food group 
in the past, and, according to the report, dairy products 
contribute many essential nutrients, Vitamin D, calcium, 
magnesium, iron, Vitamin A, riboflavin. And yet, since 2010, 
one percent flavored milks haven't been allowed in schools, and 
we also know that dairy consumption has dropped in girls ages 4 
to 8. And so I just had a couple questions: how do we continue 
to make sure students have access to appealing and nutritious 
dairy products, and do you expect that dairy would remain its 
own food group, going forward?
    Secretary Vilsack. Well, I don't want to assume what we are 
going to do, in terms of the guidance, but I will tell you that 
one of the things that we have done is to work yogurt into the 
school lunch program. And we are also taking a look at the 
issue of milk, relative to school meals. So that is in the 
process, not in the context of the guidelines, but in the 
context of our efforts to try to encourage healthier choices at 
schools.
    Ms. DelBene. Yes.
    Secretary Vilsack. I don't think there is any question that 
dairy is an important component. It is going to be recognized, 
and should be recognized.
    Ms. DelBene. And, kind of on a different note, given that 
we have regional, cultural, socioeconomic diversity throughout 
the country, how will the Dietary Guidelines meet the 
challenges of being relevant, accessible, achievable for all 
Americans, knowing that, folks have different backgrounds, 
cultural backgrounds, that may impact the types of foods that 
they are eating?
    Secretary Burwell. I think that many of the programs that 
the Secretary has spoken about, in terms of how you put those 
out, it is about having information that is simple enough that 
you can use it in your own cultural context, and then it is 
about a number of the programs, in terms of how the information 
moves. Not just the guidelines themselves, but then the 
programmatic piece that follows on. So it is the step beyond 
the guidelines. Having guidelines that are clear and simple 
enough that can be applied across context is the first step, 
but then it is how those guidelines are then implemented.
    Secretary Vilsack. Right. Our work at USDA with Native 
American populations, is a good example of where we are trying 
to work to reflect the traditions and culture of Native 
Americans and Indians to make sure that their dietary choices 
are a wide enough range that they can meet their cultural and 
traditional needs.
    So there is a greater sensitivity, and that is the 
challenge for us in the future, which is to understand those 
differences, and to try to figure out creative ways from 
recipes, and from direction and instruction, to reflect those 
differences without necessarily getting to a circumstance where 
we have to move away from the purpose of these guidelines, 
which is a--sort of a general recommendation.
    Ms. DelBene. Thanks. I guess it is also, then, important to 
understand what the messaging might be, going forward, and how 
different folks will understand and be able to learn about the 
guidelines as well.
    Secretary Vilsack. Well, there will be an extensive effort 
at both Departments, but certainly at USDA we will be using all 
of the tools that we currently have, which have been pretty 
effective. The choosemyplate.gov has been one of the more 
effective efforts on the part of USDA. We are going to refresh 
that, obviously, the choosemyplate.gov, the super tracker, the 
SNAP education and nutrition information that we provide to 
SNAP families, the work that we will continue to do on menus 
with school lunch personnel. There are a variety of ways in 
which we can incorporate and assist folks in trying to follow 
these recommendations.
    Ms. DelBene. Thank you both again for being here, and I 
yield back, Mr. Chairman.
    The Chairman. The gentlelady yields back time. I need to 
apologize, Mr. Rouzer. I was brusque and rude. I should have 
simply said your time has expired. So, David, please accept my 
apologies.
    Mr. Rouzer. No problem, Mr. Chairman.
    The Chairman. Mr. Kelly, 4 minutes.
    Mr. Kelly. Thank you, Mr. Chairman. Thank you, witnesses. 
The Dietary Guidelines for Americans have been published every 
5 years since 1980. We are concerned that the public at large 
has lost faith in the process to develop the Dietary 
Guidelines, which will ultimately decrease the adherence to 
them, with potentially costly effects on public health. In the 
military, in my service, we often say you can have an SOP, 
standard operating procedure, but if your units and your 
soldiers don't know them and use them, you don't have an SOP. 
It is the same thing with guidelines.
    Before coming to Congress I was a prosecutor, and I 
understand that two people can look at a problem and come to a 
different solution. And, Secretary Vilsack, during your process 
you talked many times about the preponderance of evidence, but 
as a prosecutor, I didn't get by with that standard, because 
the things that I was doing were so important that I had to 
prove beyond a reasonable doubt my case.
    Because for different things and different priorities, the 
importance of them, sometimes we have to use a different 
standard of evidence, and I would say maybe a preponderance of 
the evidence for scientific evidence is not the right standard. 
Maybe it is clear and convincing evidence. Or maybe it is 
beyond a reasonable doubt that, when we have science, that we 
hold them to a standard that makes sure that the end result is 
something that we have a good belief that it will be viable, 
and it will be the right answer. Although we won't always be 
correct, if we raise the standard, maybe we will be correct 
more often.
    Secretary Vilsack. Congressman----
    Mr. Kelly. Further--if I can finish--there have always been 
disagreements about this, and there always will be, about what 
the science is. I just say, sometimes we may want to look at 
the standards. But over 1,350 percent increase in public 
comments, it raises some concern with me that people don't have 
faith in the system.
    So, to both of you, I just ask you, what can we do? Because 
it doesn't matter how good the standards are, and it does not 
matter if we are doing the right things, if the public doesn't 
have trust that it is the right thing, we have to build that 
trust. And, Secretary Vilsack or Secretary Burwell, what would 
you do to make sure that our public believes that the standards 
of the guidelines that we are putting forward are the true and 
correct ones? Thank you.
    Secretary Vilsack. Congressman, first of all, the 
preponderance of the evidence standard is a Congressional 
mandate, so we have to follow the Congressional mandate. So if 
you all believe that it should be a higher standard, that is 
obviously your call, and whatever your call is, we will follow 
it. Second, despite the fact that we had 29,000 comments, we 
have also had 290,000,000 hits on our choosemyplate.gov 
website, which would suggest to me that people are following 
these guidelines, they are interested in these guidelines, and 
they haven't necessarily lost confidence in them. So that is 
another data point that I think is important to take into 
consideration.
    And I see this as a positive thing. Maybe I am looking at 
this wrong, but the more public input that you have, the better 
the decision-making can be. And we are obviously going to take 
all this information into consideration, as we should, and 
there are a variety of input focuses on all of this, and 
hopefully we are going to come up with the best guidelines that 
continue to have the faith and confidence in the American----
    Secretary Burwell. And I would just add, even as we 
implement the statute in preponderance, that, as you 
appropriately indicate, there are different levels of evidence, 
and it is related to your colleague's earlier comment about 
aren't there different populations that are affected in 
different ways? And the evidence that we look at, and whether 
that is on the issue of sodium, and what that recommendation 
will be, and what we did last time, it does look at different 
places, where there is more evidence or less evidence. And that 
is something that is important to do, and we do follow statute. 
But we hear your point----
    Mr. Kelly. Thank you.
    Secretary Burwell.--and the scientific review actually--
when we get our----
    Mr. Kelly. If I can just--I have 10 seconds. If I can have 
one further point? I just think it is just important, that the 
citizens want to know that we are not using science to justify 
ideology, that it is the other way around. Thank you, and I 
yield back, Mr. Chairman.
    The Chairman. The gentleman's time has expired. Mr. Davis, 
4 minutes.
    Mr. Davis. Thank you, Mr. Chairman. Thank you, Secretary 
Burwell. It was great to speak with you last week, and thanks 
for being here and talking about this very important subject. 
Secretary Vilsack, I know you are probably going to be 
surprised by this, but I am not going to ask you about the 
school lunch today. It has been discussed already, so I will 
skip over that. But I do have some concerns.
    My most serious concern today is what I see as a lack of 
evidence to show that the recommended dietary patterns proposed 
by the DGA have been based on any evidence on children. 
According to the citations in some previous advisory reports 
for recommendations, the recommended diet has been tested 
almost exclusively on middle-aged men, and women, whose 
nutritional needs, obviously, are very different from young 
people and growing children.
    In particular, I am concerned because young children need 
certain vitamins and minerals, obviously, in order to grow and 
develop. We are talking about where, in previous reports, the 
expert report states that the recommended dietary patterns do 
not meet sufficiency goals for potassium, Vitamin D, Vitamin E, 
choline, and that Vitamin A sufficiency may be marginal. These 
are essential basic nutrients for growth and health in 
children, and as a dad of a freshman in high school, and a 
coach, these are things that concern me on a regular basis too.
    At the same time, the DGAC appear to be deficient in their 
role in developing nutritional guidance to meet the basic 
nutritional sufficiency for children to grow and be healthy. 
They were expanding their review of what has been referred to 
as the dining out topic. Specifically, the fast food category 
was broadened to capture other types of dining out venues, 
including, like, quick serve, casual, formal restaurants, and 
grocery store take-out.
    And, given today's busy lifestyle, and really, when you 
look at restaurants, they have offered a lot more healthy 
choice than what we saw just a decade ago. And, with that, I am 
kind of disappointed, and others are disappointed, that 
restaurants seem to be singled out, even though they are doing 
their best to offer healthier options to customers, and that 
concerns me. And I just find it difficult to understand that 
location in which we would eat, without any other 
consideration, automatically impacts the quality or nutritional 
value of the food served. And I certainly understand that some 
restaurants may serve better food than others, but that is the 
consumer that can make that final decision on that too.
    So, Secretary Burwell, wouldn't you agree that the nutrient 
content of food is more important than where the food is 
purchased, and that, rather than directing people away from 
dining out, maybe we should focus on helping to educate them on 
their nutritional choices?
    Secretary Burwell. So, with regard to the issue of 
children, and the amount of research and evidence that we have 
in that space, even as we are preparing to complete where we 
are now, the conversation--my team actually brought up the 
issue of children yesterday, as we look to making sure we have 
appropriate evidence for a number of the things that you are 
talking about for the next set. Because, what you are 
appropriately reflecting is the research doesn't exist because 
it is on older, so we need to get started on that now. So with 
regard to the issue of, do we need to understand this better, 
we don't have the facts yet. We don't have a science base, but 
if we start now, we will for the next.
    With regard to the question----
    Mr. Davis. Great.
    Secretary Burwell.--the dining out----
    Mr. Davis. And I appreciate that.
    Secretary Burwell.--the dining out question, right now 30 
percent of your calories, for Americans, are consumed outside 
the home. And with regard to how we think about making sure 
that----
    Mr. Davis. What percentage?
    Secretary Burwell. Thirty percent. So when that is 
happening, what we need to focus on, with regard to this issue, 
is making sure people have appropriate information. That is 
what we want to do, is make sure that people have appropriate 
information to make the choices. As you reflect, it is up to 
people to make their own choices in that context. And that is 
where we touch on that issue. And, again, always separating the 
Advisory Committee's work with the work that we are doing.
    Mr. Davis. Well, thank you again both. My time has expired.
    The Chairman. The gentleman's time has expired. Mr. 
Benishek, 4 minutes.
    Mr. Benishek. Thank you, Mr. Chairman. Thank you both for 
being here today. I want to follow up on a few of the thoughts 
that Representative Hartzler had. As a physician, I have been 
involved in peer-reviewed science in my training, and in my 
career, and I am a little bit concerned about some of the 
things you guys have said here. You brought up the fact that 
the AMA brought out that 52 percent of Americans are pre-
diabetic, or diabetic, and yet, the dietary recommendations, as 
I understand it, are not really appropriate for that. There are 
too much carbohydrates. These people have a carbohydrate 
intolerance, and there are more carbohydrates in the diet that 
you are recommending than is really appropriate for that. And 
you mentioned that this would be a treatment, but this is 
really not a treatment. This is a preventative problem, and I 
think that you have to address that more.
    Those are my comments, but one of the questions that I had 
is, how are the studies taken, how do you determine what 
studies to base your science on? I have evidence that this 
evidence library included some trials, while excluding several 
other larger trials, some of which were funded by the NIH. I 
don't know why all the studies aren't included in the data. How 
does that not lead me to believe that there is a pre-determined 
result that has been looked for?
    Secretary Vilsack. Well, the process starts with a series 
of questions that are formulated, and then information is 
accumulated, and it goes through a process of evaluation.
    Mr. Benishek. Is the NIH involved in this process?
    Secretary Vilsack. Well, it is involved in the sense that 
the NIH helps to fund studies that----
    Mr. Benishek. I know, but I mean they are not involved as 
inter-agency review of how the studies are picked?
    Secretary Burwell. I think there are two different 
processes. There are three. One is the library of materials 
that people use, and that is housed at USDA. I think the second 
is----
    Mr. Benishek. So is stuff excluded from that library? Who 
makes the choice of what goes in the library?
    Secretary Vilsack. Well, there is a process that the folks 
at the National----
    Mr. Benishek. That is what I am asking. Is the NIH involved 
in that process? I mean, I am just surprised that NIH funded 
studies, some of which were larger than the studies that you 
rely on for your data, contradictory studies, funded by the 
NIH, are not included in the data. So I am just kind of 
wondering why.
    Secretary Vilsack. If you can give me specific----
    Mr. Benishek. Well, yes, I can do that.
    Secretary Vilsack. Yes, I will be able to provide you a 
specific answer as to why that particular study, or series of 
studies, were not included, or perhaps they were, and we are 
having a----
    Mr. Benishek. Well, my understanding is they are not. That 
is----
    Secretary Vilsack. Well----
    Mr. Benishek.--why I am concerned, because that is leading 
to my question, and some of your comments suggested that 
diabetes, and pre-diabetes, and obesity are major problems in 
this country. And, because of the cut down on the fat portion 
of the diet, we are recommending more carbohydrates. Well, this 
is a--that is exactly the problem that pre-diabetics and 
diabetics have, is not being able to respond to carbohydrates. 
So, I mean, for the majority of the people, 52 percent of the 
people being pre-diabetic, this is the wrong diet to recommend.
    So when you say it is a general diet, well, that is great, 
but then shouldn't it be the caveats that Mrs. Hartzler 
mentioned? This is pretty serious stuff here, somebody else 
mentioned, when we were kids, people aren't as fat back when we 
were kids, and we are eating more fat. And, frankly, it is not 
an exercise thing, as far as I can see, because I am 
experienced with it. If you eat a lot, you can exercise it all 
off. You have to get it right.
    The Chairman. The gentleman's time has expired.
    Mr. Benishek. I am sorry. I did go on, but----
    Secretary Vilsack. Mr. Chairman, if I could just have 30 
seconds. I would say that the NEL website will provide you the 
information as to why certain studies weren't selected, but if 
you get us specific information, Congressman, we will be happy 
to provide you specific answers to specific studies.
    The Chairman. All right. Mr. Allen, for 4 minutes.
    Mr. Allen. Yes, and I will just follow up on that question, 
as far as the NEL was concerned, and as far as the Dietary 
Guidelines Advisory Committee did not use the NEL for more than 
70 percent of their research questions, why was the NEL not 
used in these guidelines?
    Secretary Burwell. For certain issues, like food pattern 
analysis, that they needed to do to understand what we actually 
are eating, an issue that has been brought up a number of times 
in this hearing, that is not information that would be 
available there, and they need to turn to other sources for 
that information to understand what is it actually Americans 
are eating? The sources for that are different. I think there 
were some other issues.
    The reason it is not all there is if the question--if that 
is not where the source of information can come from, there are 
certain data analytics, and there are also places where 
systemic reviews have already been done on the issues, and 
while they do their own systemic review, they at least consider 
the other systemic reviews. And so I don't think those are 
counted in that percentage. But, Secretary, since that is 
housed at----
    Secretary Vilsack. Well, the only other thing I would say 
is that the review process goes through a series of mechanisms 
to try to provide an understanding of what the best science is, 
the best available science is, and the least biased science is. 
And it is a series of things, the Cochran Collaboration, the 
Academy of Nutrition and Dietetics, the Aging for Healthcare 
Research and Quality, the Data Quality--all consistent with the 
Data Quality Act. So that is the other parameter that we have 
to work under, is that the Congress has given us direction, 
under the Data Quality Act, as to how this is to be managed.
    Mr. Allen. Well, the NEL is basically science-based. There 
is very little ideology there. They go by exact science. And I 
didn't quite understand why you--still don't understand why you 
are not using them as a--more of a resource in these 
guidelines.
    Secretary Vilsack. They are used----
    Secretary Burwell. Extensively.
    Mr. Allen. Extensively.
    Secretary Burwell. It is only when a question can't be 
answered--one of the issues is certain of the data analytics 
around what everyone is eating right now are different sources, 
is my understanding of why the Advisory Committee didn't use 
it. That is the kind of----
    Mr. Allen. So they didn't have the information on more than 
70 percent of the research?
    Secretary Burwell. I think there are a number of other 
places that the Advisory Committee has to turn to other things, 
and they do that.
    Mr. Allen. Regarding sodium, obviously, there are some of 
us that retain fluid, and there are others who do not retain 
fluid. Sodium, back in my athletic career, I took salt pills, 
and I had a hard time retaining fluid. Of course, now it is the 
opposite, I am on a low sodium diet. All this stuff is very 
personal. It depends strictly on your DNA, and that sort of 
thing. In my opinion, it is very dangerous to set forth 
guidelines when everybody has a different DNA, and at different 
ages you have different requirements. And, of course, we 
already talked about it doesn't apply necessarily as much to 
children.
    And the mistrust here is that this one size fits all thing. 
Because, folks are getting a lot of bad information in our SNAP 
program. They are really not getting good information, and then 
the consequences are this epidemic of diabetes that we have, 
particularly in Georgia, with folks who do not know how their 
diet works, and how it fits. Is there any way to get this more 
locally based, rather than Washington top down?
    Secretary Burwell. We want to get it to the place where it 
is useful, and I think that is a big part of the conversation. 
With regard to the issues like sodium, we do take care to not 
put something--a standard that--it is the standard for 
everyone, not the standard for individuals. And then, this is 
about how one implements, in terms of--if it is the standard--
but if you have a certain disease condition, then we need to 
figure out how we, in a public health setting, and other 
settings, can provide the right information for you. Because 
the IOM has said 2,300 milligrams of salt, but perhaps right 
now, for you, in your current state, that is not actually 
accurate.
    Mr. Allen. Yes. I am less than 1,000. And I yield back, Mr. 
Chairman.
    The Chairman. The gentleman's time has expired.
    Secretary Burwell. So we have to make sure, even though we 
set at 2,300, that we can have a forum in which we can 
communicate, so you know where to turn, together with your 
physician.
    The Chairman. Mr. Moolenaar, for 4 minutes.
    Mr. Moolenaar. Thank you, Mr. Chairman, and Secretary 
Vilsack, and Secretary Burwell. Thank you for being with us, 
and my apologies for my voice. It still hasn't gotten better 
since yesterday. I wanted to mention just a couple of themes 
that I have heard, especially you, Secretary Vilsack, stating 
today is that you don't want to assume what we will do with the 
guidelines. You don't want to pre-determine what the outcome 
will be. Is that a fair assessment?
    Secretary Vilsack. The process hasn't been completed yet.
    Mr. Moolenaar. Okay. And then one of the other themes I 
heard you say was that the more public input you have, the 
better decisions we will have. Is that a fair statement?
    Secretary Vilsack. Yes.
    Mr. Moolenaar. Okay. Well, one of the concerns I have about 
the process that you are currently following, my understanding 
is you have the Dietary Guidelines that are based on the expert 
report from the Advisory Committee, and then that is translated 
by you and your staff into--or your Department into actual 
guidelines. Is that----
    Secretary Vilsack. That is one aspect of it, Congressman. 
It is not the only thing that we rely on or look at. It is one 
piece of a large puzzle.
    Mr. Moolenaar. Okay. Well, the concern is, and I know that 
we have had a comment period to date, and it seems that right 
now the process only allows for the American people to comment 
after the committee releases its report, but does not allow for 
public comment after USDA and HHS release the final Dietary 
Guidelines. And I appreciate that you did extend the 60 day 
public comment period by an additional 15 days following the 
release of the report this spring, but, as you can tell from 
the hearing today, there is still considerable criticism of the 
report.
    And there is a provision in the Fiscal Year 2016 
agricultural appropriations legislation that, if enacted, 
requires a 90 day comment period after the Dietary Guidelines 
are formally released. And this process seems more in line with 
the Administrative Procedures Act, which long pre-dates the 
current process you are using for the Dietary Guidelines. And 
considering the fact that more than 29,000 comments were 
submitted on this report, while only 2,000 were received on the 
2010 report, it really shows that there is a great deal of 
interest in this by the public, and it seems to me that the 
public should have a final opportunity to comment on this 
report before it is finalized. And I guess my question is would 
you agree to give the American people another comment period, 
given the fact that the 2015 committee report generated the 
most comments in the history of the guidelines?
    Secretary Vilsack. Well, first of all, I would point out 
that there were a number of places where the public could have 
input in this process before even the public comment period. As 
the dietary advisory group was meeting, there were a series of 
public meetings, opportunities for people to have input, and 
the like. There has also been continued opportunity to have 
input in the process. The challenge I have, Congressman, is 
when does the process--you have to have a finality to it. You 
have to have a stopping point to it, and--in order for us to be 
able to factor into the various other decisions we have to make 
that are in some places based on the guidelines. So I am 
concerned about how long you extend this process.
    Mr. Moolenaar. Well, yes, but----
    Secretary Vilsack. And the last thing I would say is the 
public does have a way of commenting on this, and that is that 
they could decide not to follow them. They could decide to be 
critical of them once they are proposed. So, I mean, there is 
an ongoing debate and conversation about this.
    Mr. Moolenaar. I guess----
    Secretary Vilsack. It never ends.
    Mr. Moolenaar.--my concern is, right from the start you 
made the comment, and I appreciated it, that you didn't want to 
pre-judge what the guidelines will be. It is not a complete 
process. You are taking in feedback now. But the reality is 
that once you publish those guidelines, those are the 
guidelines, and there is no avenue for the public to have input 
on that. And I think that is----
    Secretary Vilsack. Well, I would disagree with that, in the 
sense that there have already been several places where they 
have had input, and they can continue to have input. They 
continue to respond to the 2010 guidelines, which are part of 
the foundation and the information that we take into 
consideration. So it is an ongoing education process. I don't 
think it ever stops. Now, there may not be a formalized period 
of time, but it never stops.
    Mr. Moolenaar. Well----
    The Chairman. The gentleman's time has expired.
    Mr. Moolenaar. Thank you, Mr. Chairman.
    The Chairman. Mr. King, 4 minutes.
    Mr. King. Thank you, Mr. Chairman. Thanks to the witnesses 
for testifying today. A few questions still come to mind, after 
all this discussion that we have had here. And the first one 
that I have is that when I look at data on the students that 
are overweight or obese, have we had any evidence that of which 
direction their weight has gone? I ask first Ms. Burwell. Do we 
have any indication on whether this program is reducing the 
obesity of our children in school, or whether it might be 
working against us?
    Secretary Burwell. So with regard to the specifics of 
programs in schools, I would----
    Mr. King. The lunch program, yes.
    Secretary Burwell.--defer to my colleague, Secretary 
Vilsack, in terms of those programs. What we do know is that in 
younger children we are starting to see overarching across the 
board, not just from a programmatic school base, but we are 
starting to see the numbers go in the right direction. With 
regard to the specifics of school programs, I would defer----
    Mr. King. Well----
    Secretary Burwell.--to Secretary Vilsack.
    Mr. King. And I was actually prepared to redirect that 
question after your response, so thanks for pointing that out. 
I would say this information, Mr. Secretary, according to the 
Centers for Disease Control, we saw the obesity rate of high 
school students by nine percent in the 4 years prior to the 
Healthy and Hunger Free Kids Act's implementation, and, in the 
4 years after, that the obesity rate increased by 16 percent. 
Have you seen any data like that from the Centers for Disease 
Control, and does that cause you to wonder what the result of 
that might be?
    Secretary Vilsack. Congressman, I would be happy to take a 
look at that information to better understand it, but there is 
no question in my mind this is not a situation where we are 
going to see fundamental change in a year. It is going to be a 
generational process. And I am convinced that, from a 
generational process, we are going to see progress. And 
Secretary Burwell's correct, that we have begun to see 
progress, particularly among younger children.
    Mr. King. Let me just ask you another one. This data says 
the opposite. It says the obesity rate of high school students 
had reduced by--we just picked the 4 years since it has been 
implemented and went to the 4 years prior, so it was the 
longest period of time that we could have that would have 
balance, 4 years before, 4 years after. In the 4 years before, 
obesity rates went down nine percent, according to CDC, and the 
4 years after obesity rates for high school students went up 16 
percent, according to the CDC.
    Now, I don't know how to explain that, because what I am 
getting back from my constituents, and across this country, is 
more and more complaints about not enough food for these kids. 
And I would ask, Mr. Secretary, we are all very well aware of 
those complaints, especially as this was implemented in the 
fall of 2014. Now we are well into the school year of 2015. Are 
those complaints going up or down, in comparison to the year 
earlier?
    Secretary Vilsack. They have gone down. In fact, some 
school districts that left the program have come back into the 
program.
    Mr. King. Well, I am glad to hear that, and how is that 
program doing in Rhode Island that was spawned by the waste, 
and do you have any measure on the waste of the food that has 
been--the program in Rhode Island that I am referring to is 
aptly named--it is at North Smithfield, Rhode Island, where 
they are feeding 3,000 pigs with the waste from the school, 
essentially an industry that is created. And I still get a lot 
of complaints on hungry kids.
    Secretary Vilsack. So----
    Mr. King. I am concerned. Is there any question, and then 
is there evidence that our students, K through 12, are getting 
overweight because of school lunch program, or are they eating 
that food somewhere else that is making them overweight? Was 
there ever any evidence that indicated it came from the school 
lunch?
    Secretary Vilsack. Congressman, in terms of food waste, 
there is the Rudd study at the University of Connecticut. There 
is the Harvard Public Health school study. There is a study at 
Berkeley, University of California Berkeley, suggesting that 
kids are eating more fruits and vegetables, no more food waste, 
and, in fact, are eating more of their entrees than before. So 
I don't think there is documentary evidence. There may be 
anecdotal evidence from school to school, and we are, 
obviously, focused on the food waste issue. I am sorry, the--
your second question?
    Mr. King. Were they ever getting overweight on school 
lunch? Was there ever any evidence prior to 2010?
    Secretary Vilsack. Well, that is sort of an interesting 
question. It could be answered yes and no. Yes, because it was 
part of the overall caloric intake that a young person was 
taking, and if they were taking more calories than they should, 
then everything that they ate in that particular day, in a 
sense, contributed. But if you are asking whether or not the 
number of calories consumed in a school meal, if we fit it 
within the standard, it shouldn't contribute to obesity.
    Mr. King. Either before after----
    Secretary Vilsack. Especially----
    Mr. King.--2010?
    Secretary Vilsack. Especially if we are reducing the fat, 
sodium, and sugar, as we are.
    Mr. King. I am out of time, I regret. Thank you, 
Secretaries.
    The Chairman. The gentleman's time has expired.
    Secretary Vilsack. Thank you, Mr. Chairman.
    The Chairman. Mr. Newhouse, for 4 minutes.
    Mr. Newhouse. Thank you, Mr. Chairman, and thank you, Mr. 
Secretary, and Madam Secretary, for being here with us this 
morning. I appreciate your time. I have a couple observations, 
but also some requests, and a question or two, and I will try 
to get through in 4 minutes. I have spoken with a lot of 
impacted constituents, and also through my own review. It seems 
clear that this Dietary Guidelines Advisory Committee went 
outside the scope of their mandate in developing the 
recommendations for the report, including policy 
recommendations from taxes to local restaurant zoning, to food 
labeling, and sustainability policy. According to the 
underlying statute, that was the sole product of this committee 
back in 1990, each such report shall contain nutritional and 
dietary information and guidelines for the general public.
    Secretary Vilsack, back in March, the Wall Street Journal 
reported you saying, ``I read the actual law, and what I read 
was that our job ultimately is to formulate dietary and 
nutrition guidelines, and I emphasize dietary and nutrition 
because that is what the law says. It is my responsibility to 
follow the law.'' Sustainable diets are an appropriate debate 
to have, you said, however there are forums and places for that 
to take place. And I was pleased to hear your comments, but 
what concerns me is the lack of evidence to suggest that 
neither of the agencies exercised any effort to instruct the 
Advisory Committee on their scope, or mandate.
    When you, Secretary Vilsack, and Secretary Burwell, your 
predecessor established the committee, you did so under the 
Federal Advisory Committee Act. This Act is designed to ensure 
that advice by the various Advisory Committees formed over the 
years is objective, and accessible to the public. The Act has 
formalized a process for establishing, operating, overseeing, 
and terminating these advisory bodies across government. The 
DGAC members are not full time employees, and rely very heavily 
on agency staff to carry out their duties.
    To be clear, when I review portions of the report, such as 
the Advisory Committee's conflict statements on encouraging 
lower meat consumption, but then higher meat consumption for 
the Mediterranean diet, or when I can see the Advisory 
Committee's recommendations on added sugars versus natural 
sugar, or use a lower scientific threshold than groups like the 
Institute of Medicine have used to reach their conclusions, I 
worry greatly about the process, and the guidance and oversight 
that they have been given.
    So it would be helpful for you to provide the Committee 
evidence in writing to confirm that your agencies did, in fact, 
make attempts to oversee the Advisory Committee once it became 
clear they were delving to areas of public policy. In response 
I would like to see evidence that your agencies provided 
instructions to the committee during their assembly to ensure 
they were staying focused on the right guidance, and not 
straying into policy matters outside their scope or mandate. 
And, likewise, I would like to receive documented evidence of 
the instructions agencies provided to the committee on the 
public law to help them understand their report must be based 
on the preponderance of scientific and medical knowledge that 
is current at the time of publication.
    And, finally, I would like to welcome your comments on any 
advice you could give future secretaries as to future Advisory 
Committees, and how they could stay focused on their charter, 
and produce a recommendation that really stays coloring with in 
the lines. So I would appreciate a response. Thank you.
    Secretary Vilsack. We will certainly provide a response to 
your questions, Congressman, as we are bound to do, and would 
be happy to do that in writing.
    My advice to future secretaries will be to continue the 
process of educating people about what these recommendations 
are and what they are not, and the distinction between the 
report and the guidelines. There seems to--again, I have said 
this several times today, there seems to be a misunderstanding 
upon some folks that the report equals the guidelines, and that 
is not the case. The report is one aspect of our consideration, 
one aspect of the data, or the information, that is used to 
formulate these guidelines.
    And, to me, this debate has been helpful, I hope, in 
getting a better understanding of precisely what the 
recommendations are. And the discussion we have had today is 
also healthy, as it relates to what is the purpose of these 
guidelines? Is it focused on prevention, or is it focused on 
treatment, or should it be focused on both? I think that is a 
healthy discussion.
    The Chairman. The gentleman's time has expired. Mr. 
Thompson, 4 minutes.
    Mr. Thompson. Thank you, Mr. Chairman. Thank you, both 
Secretaries. I really, really appreciate you being here. My 
first question actually is very specific. It is an area I care 
a lot about. So my question is, why do Americans, especially 
children over the age of 4, continue to fall short of the 
Dietary Guidelines' recommended servings of milk, and its nine 
essential nutrients and vitamins, and what can we do to remove 
policies that are hindering milk consumption, or promote 
policies that could enhance milk consumption?
    Secretary Vilsack. We can, basically we are taking a look 
at those issues right now, Congressman, and that is the goal 
here, is that, as we learn more, as we understand more, as we 
re-learn lessons of long ago, that is obviously going to change 
the direction and focus. That is the whole purpose, and the 
whole reason why we do this every 5 years, is it is an evolving 
process.
    Mr. Thompson. Yes.
    Secretary Vilsack. And as our information evolves, our 
policies will evolve. And we are taking a look at the issue of 
milk, and taking a look at ways in which milk can be introduced 
into diets in a variety of different ways, dairy products.
    Mr. Thompson. And we worked together on that, and I 
appreciate those efforts. I want to know, how much of a factor 
do you think that it is that we publish these guidelines once 
every 5 years, and as you said, 5 minutes before you are ready 
to publish it, there is new evidence that probably is contrary 
to what you are publishing. And I am assuming, correct me if I 
am wrong, that the rate of research within nutrition is 
significant. Which is a really good thing, so the fact is, as 
soon as you publish these guidelines, to some extent they are 
inaccurate, and the longer they are there until the next 5 
years, the more inaccurate they are. But when you publish them, 
doesn't that influence the markets?
    I would argue--I would think, I am not going to argue, but 
I would think that when it comes to milk, the fact that at one 
point the guidelines discouraged milk took all the flavor out 
of it, because somehow fat was bad for you. And I know the 
science today shows contrary to that. But you take the fat, you 
take the taste out, and that somehow these guidelines that we 
do every 5 years, that are never really totally accurate, and 
increasingly more inaccurate towards the end of the 5 years, 
increases the impacts on the ag commodity markets.
    My question for you, given the fact that these were under--
I may be wrong--President Carter, so it would be late 1970s 
when it was originated, are Americans healthier or less healthy 
since the guidelines have been published, and therefore, are 
these, in some way, haven't these guidelines somewhat failed? 
We are talking about increasing obesity. The Pentagon is more 
concerned than ever about having access to kids that would be 
able to serve in the military. Have these guidelines really 
been successful, given disease, and chronic illnesses, and 
conditions? And that is not to be a criticism, because my 
second question is, then, how do we use these in a way that 
they could be successful? Because they don't seem like they are 
accomplishing the objective, as you two have very well 
articulated today.
    Secretary Burwell. So we do want to--and I think the issue 
of obesity is one that has a number of different elements. And 
the physical activity guidelines, which are something that 
Congress mandated----
    Mr. Thompson. As a former rehabilitation guy, I am all in 
on that. I agree, yes.
    Secretary Burwell. So that is another piece that I think 
that we need to focus on, and we need to make sure that these 
things are being used. I think you are right to reflect. The 
question is, what is the critical path issue, and what is the 
counterfactual? That is the other thing that we all can't 
answer. We are on the wrong trajectory, but would the----
    Mr. Thompson. Yes.
    Secretary Burwell.--trajectory have been worse, and then 
second----
    Mr. Thompson. Sure. Well----
    Secretary Burwell.--what is the----
    Mr. Thompson.--let me make a suggestion, and get a response 
in the few seconds I have left. It seems like once every 5 
years this doesn't work because it changes. And, in fact, it 
can negatively impact ag commodities, which is irresponsible, 
to tell people not to eat certain things when the next round of 
research says that you want to eat more of it. Shouldn't we do 
something, in this day and age, with technology that would just 
share the best research with folks? A place where people can go 
to get the best possible information in terms of eating, and 
knowing that that changes all the time? Once every 5 years, I 
don't think this is effective. Sorry, Chairman.
    Secretary Vilsack. Honestly, this discussion suggests that 
there is some extraordinarily bright line on science, that over 
here there is the real science, and then over here, there is 
not the real--the science is evolving. It is----
    Mr. Thompson. That is my point.
    Secretary Vilsack. And so----
    Mr. Thompson. That is what science does.
    Secretary Vilsack. It does. So you have to have general 
guidelines that provide some parameters.
    Mr. Thompson. Well, do we have static guidelines once every 
5 years, or do we have----
    Secretary Vilsack. Well, you could theoretically go through 
this process every year, but I don't know that that would be 
particularly helpful.
    Mr. Thompson. No.
    Secretary Vilsack. I think a 5 year period is good. 
Obviously, it gets better informed. And this issue of obesity 
is far more complex than just simply saying, because we have 
these guidelines, that somehow we have become an obese nation. 
It has to do with the fact that an average kid spends 7 hours 
in front of a screen every day. I mean, that is part of it, 
right? It is portion size, that is part of it. It is a variety 
of factors. I suppose if every American followed the guidelines 
it might be a different situation. But we don't.
    The Chairman. The gentleman's time has expired.
    Secretary Vilsack. Doesn't mean we shouldn't have them.
    Mr. Thompson. Yes.
    The Chairman. Mr. LaMalfa, for 4 minutes.
    Mr. LaMalfa. Thank you, Mr. Chairman, and both Secretaries, 
thank you for being here today. Ms. Burwell, let me follow up 
on what Mr. Thompson was saying on that as well, we have been 
hearing, ever since I was a kid, eggs are bad, so my 
grandparents had a lot of powdered eggs, because of their age, 
and factors like that. And it turns out eggs are okay later. 
Then you hear beef, red meat, and then we have high protein 
diets are supposed to help you lose weight. Somebody I was 
talking to just over the weekend, a constituent, they lost 
weight, but they are staying away from fruit, because fruit has 
sugar in it. Well, I mean, how are people supposed to really 
know when the ideals are changing all the time, the guidelines?
    So, I guess following up on the 5 year thought, is it good 
to have a hard and fast 5 year timeline of changing the Dietary 
Guidelines, or should it be less frequent, more frequent, or 
does it need to be even more--kind of change what you know to 
change, and have the--and leave the rest alone? What do you 
think of that?
    Secretary Burwell. I think that the Congress, in making a 
choice on 5 years, probably made a good choice. And the reason 
for that is, while we heard from some of your colleagues about 
extending the period--I think that this took 18 months for the 
Advisory Committee to do its work, then you had an additional 
75 days of the period of comment for us to receive comments on 
that, and then you have the period for us to review and get it 
out. And so when you add that up, and you think about that 
timetable, if you tried to shrink that, the question is, would 
you have relevant----
    Mr. LaMalfa. Well, I guess what I am looking at is maybe 
you have most of the guidelines are going to be consistent for 
a long time. When you have school books, for example, it seems 
like they throw out the whole school book. You are buying a new 
one where maybe most of that math lesson is fine, so maybe you 
are just changing the elements in there, since it is 
electronic, and not doing something every 5 years.
    So let me follow that up with should there be a legislative 
change that we should produce that would help this process?
    Secretary Burwell. I don't know that there should, and 
actually, we are like the school books, in that most of this is 
consistent. You reflected on, in terms of where there are 
changes, the things that there are key recommendations on have 
been relatively consistent over the period since the 1980s, in 
terms of the importance of fruits and vegetables, the 
importance of a balanced approach that provides nutrition that 
is fewer calories than the nation currently consumes.
    In several select areas, it is fair to appropriately 
reflect the science has changed, but the dominant picture is a 
very similar picture over the periods of time. And so I also 
think it is important to distinguish between the Dietary 
Guidelines and what is happening in our popular culture with 
regard to different diets that are proposed by different people 
in different ways. Distinguishing that is also an important 
element, and this gets to what are the guidelines, and what are 
they not?
    Mr. LaMalfa. Certainly, there is a lot of overlap, a lot of 
different messages being sent. The Dietary Guidelines, though, 
they can be seen by people as confusing, or difficult to 
follow. Do you think the 2015 Guidelines will be more 
straightforward, giving people a little more straightforward 
ideas of how to follow this pattern for what they need? Is the 
2015 going to be an improvement over that?
    Secretary Burwell. We will, obviously, work to make things 
as simple as we can. But the real way that people interact with 
these things is actually in their implementation in programs. 
And whether that is the topic we have talked about in school 
lunch, or another topic we haven't touched as much on, which is 
the labeling issues. And that is how most people interact with 
what the Dietary Guidelines are, in terms of how they get their 
advice about what they are going to eat, and that sort of 
thing.
    Mr. LaMalfa. Well, let me ask, then, since most of the 
efforts say to follow or be consistent with the guidelines, 
what does follow the DGA mean to you, Madam Secretary?
    Secretary Burwell. What it means to me is that there are 
these guidelines, and when we apply those from a perspective of 
the Federal Government to certain of our programs, that they 
are the basis that we think about promoting the programs. And 
whether that is our Meals on Wheels program, or, as we think 
about our Million Hearts initiative at CDC to try and reduce by 
a million the number of people with heart attacks, that an 
important element of that is understanding what the Dietary 
Guidelines say.
    Mr. LaMalfa. Thank you. You have had a very difficult job 
the last year or so, so thanks for coming.
    The Chairman. The gentleman's time has----
    Secretary Burwell. Thank you.
    The Chairman.--expired. And before we adjourn, David Scott, 
any comments you have from the Ranking Member?
    Mr. David Scott of Georgia. Yes. Well, thank you very much, 
Mr. Chairman. First thing I want to say is how much we 
appreciate both of you Cabinet officials coming before us at 
the same time. That is a rarity, and we really appreciate it.
    Agriculture is indeed our most important industry. It is 
the food we eat, it is the water we drink. It is our survival. 
And you do get the feeling from this Committee of how important 
this is. And I hope that what we have discussed today, that you 
all will take back in the manner and the spirit in which we 
have given it, because this is the single most important 
industry in the world, our agriculture. My hope is that you 
will take back and understand--even go back and review a bit.
    Secretary Vilsack, you hit the nail on the head when you 
stated that they sit there before the screen. That is exactly 
right. When you and I were coming along, folks would say, Daddy 
or Mama, can I go out to the playground? That is a phrase we 
don't even hear now. I am going upstairs, or I am going 
downstairs, I am going in the room, and get on the Internet, 
sit before that screen hour after hour. And that is why it is 
so important now that we use our science to make up for that.
    And that is why I hope that you will take my suggestions to 
go back, and look, and make sure we are using the strong 
scientific evidence. And if there are things like the low 
calorie sweeteners, where the study has already shown that it 
will lower obesity, go back and review, and explain why you 
don't use that. Or maybe you go back and you look at, and you 
say, you know what, I think we can use this and make a 
difference. And that is why, Mr. Chairman, this has been an 
extraordinary and very important hearing, and I thank you for 
calling it.
    The Chairman. Well, I thank the gentleman. I also want to 
thank our witnesses. This is a big deal, to get both of you at 
the table at the same time. I appreciate that. The emphasis 
today was on the process, and restoring trust.
    And, Ms. Burwell, your testimony said that the guidelines 
don't change much from issue to issue. Is that a bias that, if 
I am a scientist, and I have a body of work that comes to 
certain conclusions, and I am going to be hard bent to change 
my conclusion against new evidence? That is going to be an 
issue that is there. Hopefully the next time you will be asked 
are the guidelines themselves contributing to the problem? For 
example, the emphasis on carbohydrates over the last 20 years, 
and the impact that has had on these issues that we are talking 
about, whether it is obesity, or diabetes, or other things. Do 
we have anybody who is going to live these guidelines for 5 
years so we could see what it did to them? I know you guys try 
to gather that information, because the guidelines are 
important. They are voluntary for me. I am going to go have 
lunch here in a little bit, and I will decide for myself. They 
are not voluntary, though, when they get woven into school 
lunch programs, and SNAP, and everything else. They become the 
law of the land in many instances, so it is important that we 
get these right.
    And I appreciate both of your comments this morning about 
limiting the criticisms about sustainability and taxes. You 
laid those to rest. Thank you so very much for that, for the 
emphasis on staying within the scope that was supposed to be 
there. I appreciate that. And I really also appreciate your 
work on trying to clarify that these are guidelines, and that 
the report was one thing. You have work to be done between now 
and December to make that happen. The idea that perhaps a 
proposed rule might have some value. I understand time and that 
getting it finished is an important process as well. I 
appreciate that both of you came today, and the comments that 
were made from my colleagues.
    Under the rules of the Committee, the record of today's 
hearing will remain open for 10 calendar days to receive 
additional material and supplementary written responses from 
the witnesses to any questions posed by a Member. This hearing 
of the Committee on Agriculture is adjourned.
    [Whereupon, at 11:25 a.m., the Committee was adjourned.]
    [Material submitted for inclusion in the record follows:]
   Submitted Article by Hon. Collin C. Peterson, a Representative in 
                        Congress from Minnesota
The Washington Post
Wonkblog
For decades, the government steered millions away from whole milk. Was 
        that wrong?
By Peter Whoriskey October 6 

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          The United States Government once considered butter and 
        margarine as one of seven food groups to consume daily. Look 
        back at other advice that unfortunately is no longer a part of 
        the USDA's Dietary Guidelines. (Jayne W. Orenstein/The 
        Washington Post)
          Video hyperlink: http://wapo.st/1VEwNVl.

    U.S. Dietary Guidelines have long recommended that people steer 
clear of whole milk, and for decades, Americans have obeyed. Whole milk 
sales shrunk. It was banned from school lunch programs. Purchases of 
low-fat dairy climbed.
    ``Replace whole milk and full-fat milk products with fat-free or 
low-fat choices,'' says the Dietary Guidelines for Americans, the 
Federal Government's influential advice book, citing the role of dairy 
fat in heart disease.
    Whether this massive shift in eating habits has made anyone 
healthier is an open question among scientists, however. In fact, 
research published in recent years indicates that the opposite might be 
true: millions might have been better off had they stuck with whole 
milk.
    Scientists who tallied diet and health records for several thousand 
patients over 10 years found, for example, that contrary to the 
government advice, people who consumed more milk fat had lower 
incidence of heart disease.
    By warning people against full-fat dairy foods, the United States 
is ``losing a huge opportunity for the prevention of disease,'' said 
Marcia Otto, an assistant professor of epidemiology at the University 
of Texas and the lead author of large studies published in 2012 and 
2013, which were funded by government and academic institutions, not 
the industry. ``What we have learned over the last decade is that 
certain foods that are high in fat seem to be beneficial.''
Over Decades, Consumers Spurned Whole Milk
    For decades, public health authorities have advised Americans to 
switch away from whole milk, and they have obeyed. The chart shows 
sales of milk in millions of pounds.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          Source: USDA/The Washington Post.*
---------------------------------------------------------------------------
    * Editor's note: this is an interactive graphic that was embed in 
the article. To access the interactive functionality go to http://
www.washingtonpost.com/news/wonkblog/wp/2015/10/06/for-decades-the-
government-steered-millions-away-from-whole-milk-was-that-wrong/.

    This year, as the ``Dietary Guidelines for Americans'' undergoes 
one of its periodic updates, the Federal bureaucrats writing them must 
confront what may be the most controversial and weighty question in all 
of nutrition: does the consumption of so-called saturated fats--the 
ones characteristic of meat and dairy products--contribute to heart 
disease?
    It is, without doubt, an important question. Heart disease is the 
leading cause of mortality in the United States, and the Federal 
Government has long blamed saturated fats.

          [Whole milk is okay. Butter and eggs too. What's next--bacon? 
        (https://www.washingtonpost.com/news/speaking-of-science/wp/
        2015/10/07/whole-milk-is-okay-butter-and-eggs-too-whats-next-
        bacon/)].

    But the idea that spurning saturated fat will, by itself, make 
people healthier has never been fully proven, and in recent years 
repeated clinical trials and large-scale observational studies have 
produced evidence to the contrary.
    After all the decades of research, it is possible that the key 
lesson on fats is two-fold. Cutting saturated fats from diets, and 
replacing them with carbohydrates, as is often done, likely will not 
reduce heart disease risk. But cutting saturated fats and replacing 
them with unsaturated fats--the type of fats characteristic of fish, 
nuts and vegetable oils--might.
    This shift in understanding has led to accusations that the Dietary 
Guidelines harmed those people who for years avoided fats--as 
instructed--and loaded up excessively on the carbohydrates in foods 
such as breads, cookies and cakes that were marketed as ``low fat.''
    It also has raised questions about the scientific foundations of 
the government's diet advice: To what extent did the Federal 
Government, and the diet scientists they relied upon, go wrong? When 
the evidence is incomplete on a dietary question, should the government 
refrain from making recommendations?
    The dietary science has drawn the skepticism of some on Capitol 
Hill. On Wednesday, a House Committee will air concerns regarding the 
evidence for the guidelines with Agriculture Secretary Tom Vilsack and 
Health and Human Services Secretary Sylvia Burwell.

          [Read: Could 95 percent of the world's people be wrong about 
        salt? (http://www.washingtonpost.com/news/wonkblog/wp/2015/05/
        26/could-95-percent-of-the-worlds-people-be-wrong-about-salt/
        )].

    The Dietary Guidelines have stepped back slightly from their 
blanket advice to reduce saturated fats, adding the caveat that 
saturated fats ought to be replaced with unsaturated fats. But Dariush 
Mozaffarian, a cardiologist, epidemiologist, and dean of the Friedman 
School of Nutrition Science & Policy at Tufts University said that in 
his view the Dietary Guidelines have yet to retreat far enough from the 
idea that saturated fat is a dietary evil, and their suspicion of whole 
milk is a good example. Judging a particular food solely on how much 
fat it contains, he said, can too easily blind people to its other 
benefits.
    ``If we are going to make recommendations to the public about what 
to eat, we should be pretty darn sure they're right and won't cause 
harm,'' Mozaffarian said. ``There's no evidence that the reduction of 
saturated fats should be a priority.''
    Some, including representatives of the American Heart Association, 
disagree. In their view, the evidence for the dangers of saturated fats 
arises from these two ideas: Consuming saturated fats raises levels of 
so-called ``bad'' cholesterol in the blood, and higher levels of 
``bad'' cholesterol, in turn, raise risks of heart disease.

          [Related--USDA: We will not steer people away from meat to 
        protect the environment (https://www.washingtonpost.com/news/
        wonkblog/wp/2015/10/06/usda-we-will-not-steer-people-away-from-
        meat-to-protect-the-environment/)].

    In support of their position, they point to the trials of statin 
drugs, which show that the drugs lower ``bad'' cholesterol levels and 
lower risks of heart disease.
    There is a ``mountain of evidence'' explaining how consumption of 
saturated fats raises the risk of heart disease, said Penny Kris-
Etherton, a Nutrition Professor at Penn State University and a former 
member of the Dietary Guidelines Advisory Committee.
How We Die
    Heart disease is the leading cause of death in the U.S. and health 
authorities have long blamed its prevalence, at least in part, on our 
consumption of fatty foods.
The Case Against Saturated Fats Begins
    Over the long tortured course of fat research, it certainly seemed 
at times that there was strong evidence in the case against saturated 
fats.
    The history of the fat warning is usually traced to the work of 
Ancel Keys, a scientist at the University of Minnesota, whose study of 
heart disease in the 1950s startled the medical world.
    Keys examined fat consumption and rates of heart disease in various 
countries. In places where people eat lots of fat, he found high levels 
of heart disease. One of his famous charts, from 1953, showed that in 
the United States, where close to 40 percent of the diet came from fat, 
people suffered a disproportionate number of heart disease deaths. 
People in Japan and Italy, by contrast, consumed less fat and died of 
heart disease less often.
Degenerative Heart Disease
1948-49, Men

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          Fig. 2. Mortality from degenerative heart disease (Categories 
        93 and 94 in the Revision of 1938, categories 420 and 422 in 
        the Revision of 1948, International List. National vital 
        statistics from official sources. Fat calories as percentage of 
        total calories calculated from national food balance data for 
        1949 supplied by the Nutrition Division, Food and Agriculture 
        Organization of the United Nations.
          In 1953, scientist Ancel Keys linked national fat consumption 
        to heart disease.
          From the Keys, A., Atherosclerosis: A problem in newer public 
        health. 1953. Journal of Mount Sinai Hospital 20: 118-39.

    In 1953, scientist Ancel Keys linked national fat consumption to 
heart disease.
    To Keys, the data offered proof that Americans could improve their 
health by reducing the fats in their diets.
    ``It is now abundantly clear that degenerative heart disease is not 
an inevitable consequence of aging,'' he wrote in the 1953 medical 
journal article.
    More evidence was coming. In the 1960s, several clinical trials--
from Oslo, Los Angeles, Finland, London and Minnesota--put his 
suspicion to the test. Three of the five suggested that he was right.
    The Oslo study, for example, studied 412 men who'd previously had a 
heart attack. Half were given a special diet that was low in saturated 
fat; the other half was allowed to eat their usual diet, which was 
richer in saturated and trans fats. The special diet seemed to work: 
After 5 years, 64 subjects on the special diet had a relapse of heart 
disease, while of those eating their regular diet, 90 people did.
    Public health authorities, including those in the United States, 
were soon recommending that people reduce their consumption of 
saturated fats--meat, eggs and dairy--as a means of lowering heart 
disease risks.
    The idea became a part of U.S. official advice in 1977, when the 
U.S. Dietary Goals, a forerunner of the Dietary Guidelines, embraced 
the position.
How a Hypothesis Became Dogma
    But even as a Senate committee was developing the Dietary Goals, 
some experts were lamenting that the case against saturated fats, 
though thinly supported, was being presented as if it were a sure 
thing.
    ``The vibrant certainty of scientists claiming to be authorities on 
these matters is disturbing,'' George V. Mann, a biochemist at 
Vanderbilt's medical school wrote in the New England Journal of 
Medicine.
    Ambitious scientists and food companies, he said, had ``transformed 
[a] fragile hypothesis into treatment dogma.''
    Indeed, the subsequent 40 years of science have proven that, if 
nothing else, the warning against saturated fats was simplistic.
    By itself, cutting saturated fats appears to do little to reduce 
heart disease. Several evidence reviews--essentially summing up years 
of research--have found no link.
    ``There is no significant evidence for concluding that dietary 
saturated fat is associated with an increased risk of coronary heart 
disease,'' said one published in 2010 in the American Journal of 
Clinical Nutrition.
    ``Current evidence does not clearly support'' guidelines linking 
saturated fat and heart disease, according to a review of experiments 
and observational studies published in the Annals of Internal Medicine.
    ``Saturated fats are not associated'' with mortality, heart 
disease, strokes or type 2 diabetes, a major review in the British 
Medical Journal reported in July.
    One of the most noted experiments on fats was the Women's Health 
Initiative, which involved more than 48,000 older women. Some had 
counseling to eat less fat and more vegetables and fruits; others 
continued, more or less, with their normal diets. Subjects in the diet 
group cut their saturated fat intake from 13 percent of their diet to 
ten percent, as well as their consumption of other fats. Their levels 
of ``bad'' cholesterol dropped. Yet when it came to heart disease, 
researchers found no significant difference between the two groups.
    To many critics, the trouble with the fat warning was not merely 
academic.
    The ``campaign to reduce fat in the diet has had some pretty 
disastrous consequences,'' Walter Willett, dean of the nutrition 
department at the Harvard School of Public Health has said. ``With more 
fat-free products than ever, Americans got fatter.''
    Best-sellers such as ``Good Calories, Bad Calories'' by Gary Taubes 
and ``Big Fat Surprise'' by Nina Teicholz went further in their 
critique of the government position.
    ``There's a large body of scientific literature to show that a 
high-carb diet, as recommended by the Dietary Guidelines for Americans, 
provokes a number of heart-disease risk factors,'' said Teicholz, whose 
critique of the guidelines appears in a recent issue of the British 
Medical Journal.
The Case Weakens
    For the bureaucrats writing the forthcoming Dietary Guidelines, the 
shifting evidence against saturated fats may be a lesson, experts said: 
there were weaknesses in each of the three lines of evidence used.
    First, there were those studies by Keys showing that a country's 
fat consumption was linked to its rate of heart disease. After Keys' 
paper appeared, scientists began adding other countries to his graph, 
and when they did, the pattern suggesting a link between fat 
consumption and heart disease became less distinct.
    More importantly, by the very nature of his research, Keys' data 
could only show that saturated fat consumption was associated with 
heart disease, not that consuming saturated fat caused heart disease. 
That's because his study was ``observational''--that is, it was based 
on merely observing subjects rather than randomly assigning them to 
high-fat and low-fat diets. It was possible, in other words, that some 
unaccounted factor caused the varying rates of heart disease.
    The second line of evidence in the case against saturated fats came 
from those controlled experiments in the 1960s--in Oslo, Finland and 
Los Angeles. These suggested that subjects who consumed less saturated 
fat suffered less from heart disease.
    As further scientific review showed, none of the experiments was 
perfectly designed to assess the danger of saturated fats, and the 
results in some cases were modest. Moreover, the diets showing a 
benefit were not just low in saturated fats, they were also high in 
unsaturated fats--the ones common in fish, nuts and vegetable oil.
    Indeed, these trials, along with more recent studies, have led many 
scientists to conclude that merely cutting back on saturated fats 
provides no benefit, but replacing them with unsaturated fats does. By 
contrast, cutting back on saturated fats and eating breads and cookies 
instead won't help.
    ``We have strong evidence that replacing saturated fats with 
carbohydrates has no effect on cardiovascular disease,'' said Alice 
Lichtenstein, a Tufts University nutritionist who served this year on 
the Dietary Guidelines advisory panel.
No More ``Blanket Recommendations''
    Even so, the advisory panel has continued to tout the benefits of 
limiting saturated fat to ten percent of the diet, and of swapping 
whole milk for fat-free.
    In doing so, the panel is relying on the third piece of the 
argument against saturated fats, which is that two-step chain of logic: 
that saturated fats raise the levels of ``bad'' cholesterol in the 
blood, and that higher levels of ``bad'' cholesterol in turn raise the 
risks of heart disease.
    Scientists generally agree on the premises of that argument. The 
trouble, according to critics, is that connecting the two and drawing 
the conclusion that saturated fats lead to heart disease is a vast 
oversimplification, for a handful of reasons.
    First, while consumption of saturated fats tends to raise levels of 
``bad'' cholesterol in the blood, they also tend to raise the levels of 
``good'' cholesterol levels, too, and that may have compensating 
effects.
    Second, saturated fatty acids come in chains of carbon of varying 
lengths, and each one differs in its effects on heart disease risks. 
Some molecules appear to raise the amount of ``bad'' cholesterol in the 
bloodstream, while other longer chains appear to have no appreciable 
effect.
    And it gets even more complicated. It turns out that ``bad'' 
cholesterol comes in two forms. One consists of particles that are 
smaller and denser and these appear to be strongly linked to heart 
disease; the other type of ``bad'' cholesterol consists of lighter, 
fluffier particles that appear to have lesser effects on heart disease. 
Saturated fats do raise the levels of ``bad'' cholesterol, but seem to 
produce mainly the lighter, fluffier and less dangerous particles.
    As a result of such complexity, as well as the ways in which food 
sources vary in their health effects, ``blanket recommendations to 
reduce total saturated fats may not be appropriate,'' according to the 
most recent Annual Review of Nutrition, an academic publication that 
provides summaries of the latest research.
So What About Whole Milk?
    While nutrition advice is often presented in terms of 
``macronutrients''--fats, proteins, carbohydrates--foods may be more 
than the sum of their scientific parts.

    Milk is a good example.

    Repeated research on milk, not funded by the industry but by public 
institutions, has provided evidence that the fats in milk are, for some 
reason, different.
    In 2013, New Zealand researchers led by Jocelyne R. Benatar 
collected the results of nine randomized controlled trials on dairy 
products. In tallying the tests on 702 subjects, researchers could 
detect no significant connection between consuming more dairy fat and 
levels of ``bad'' cholesterol. (Four of the nine studies included in 
the tally were funded by the industry. Those results were consistent 
with those of the trials funded by government entities.)
    The same year, Otto and Mozaffarian, then both at the Harvard 
School of Public Health, conducted another study on the effects of 
milk. Their study sought to address a key weakness in the previous 
research.
    One of the flaws of nutrition studies is that they rely on people 
to accurately recall what they've eaten over the course of a year. 
Those recollections are vulnerable to inaccuracy, especially for dairy 
fats which can be found in small amounts in many different foods. This 
inaccuracy may be one of the reasons studies have yielded contrary 
results on the link between milk and heart disease.
    To improve estimates, Otto and Mozaffarian used a blood sample for 
each of more than 2,800 U.S. adults. Using the blood sample, they could 
detect how much dairy fats each had consumed. And over the 8 year 
follow up period, those who had consumed the most dairy fat were far 
less likely to develop heart disease compared to those who had consumed 
the least.
    The advocates of whole milk allow that it has more calories than 
its low fat cousins, and for some, that might be reason to avoid it. 
But the traditional case against whole milk--based on the risk of heart 
disease--has frayed enough now that many argue the Dietary Guidelines 
should yield to the new findings.
    ``There is no scientific basis for current dietary advice regarding 
dairy,'' Benatar said. ``Fears [about whole milk] are not supported by 
evidence. The message that it is okay to have whole fat food, including 
whole fat milk, is slowly seeping into consciousness. But there is 
always a lag between evidence and changes in attitude.''

          Peter Whoriskey is a staff writer for The Washington Post 
        handling investigations of financial and economic topics. You 
        can email him at [email protected]
                                 ______
                                 
 Submitted Report by Hon. Vicky Hartzler, a Representative in Congress 
                             from Missouri
Scientific Integrity in Policymaking
A White Paper authored by Joanne L. Slavin, Ph.D., R.D.
Executive Summary
    A scientific white paper was commissioned by a coalition of food 
and agriculture trade associations to examine the use of scientific 
research in U.S. food and nutrition policymaking efforts, including the 
Dietary Guidelines for Americans (DGA). The white paper, authored by 
Joanne Slavin, Ph.D., R.D., was published in Nutrition Journal 
(Attachment). Following is an executive summary of the white paper's 
main findings and recommendations.
Rationale
    The current Administration, Federal agencies and regulators are 
increasingly looking to policy and systems-change interventions to 
improve public health in America. The process by which Federal agencies 
and policymakers consult scientific research in developing proposed 
regulations and policies varies and greatly impacts the nature of the 
ultimate recommendations. Because of the profound effect that many of 
these policies have on consumers, the food environment, Federal 
nutrition assistance programs and subsequent policy and regulatory 
recommendations, it is imperative that only the strongest, best 
available evidence is used to inform and set policy.
White Paper Objectives

  1.  Describe the current U.S. food and nutrition policy environment.

  2.  Examine how science is used in Federal food and nutrition 
            policymaking efforts, using the Dietary Guidelines for 
            Americans (DGA) as an example.

  3.  Describe strong versus weak science as well as what types of 
            studies are most appropriate for use in policymaking.

  4.  Discuss the potential effects and consequences of making policy 
            recommendations in the absence of scientific consensus or 
            agreement.

  5.  Make recommendations to support the present and ongoing 
            development of science-based policy likely to positively 
            impact public health.
Barriers to Setting Evidence-Based Policy

   Scientific studies are used by all agencies to set nutrition 
        policy. Yet, consistent guidelines for how to identify, 
        evaluate, and translate research into policy recommendations do 
        not exist. This can lead to national dietary guidance based on 
        research studies with varying degrees of methodological 
        strength and applicability.

   Nutrition is a constantly evolving science and much of our 
        available knowledge and thus dietary recommendations are based 
        on observational data or research that is of a weaker quality. 
        It is critical that study methodology is carefully considered 
        and applied to our interpretation of nutrition science. 
        Limitations of such data are often underappreciated by 
        nutrition scientists and policymakers.

   The DGA serve as the cornerstone for all Federal nutrition 
        education and program activities, including but not limited to 
        nutrition labeling campaigns, Healthy People objectives, and 
        nutrition assistance programs including the Supplemental 
        Nutrition Assistance Program (SNAP) and the National School 
        Lunch Program (NSLP). The Dietary Guidelines Advisory Committee 
        (DGAC) is the review committee responsible for formulating and 
        publishing recommendations that lead to the development of the 
        DGA policy document.

     The nutrition and health topics investigated, as well 
            as the evidence review, interpretation, and grading 
            processes are at the discretion of DGAC members.

     Final DGAC recommendations will be provided to the 
            Secretaries of the Department of Health and Human Services 
            and USDA by the end of 2014/early 2015. The content of the 
            ultimate DGA policy document is at the discretion of both 
            agencies.

   It is extremely difficult to reverse or change public 
        policy, once enacted, without causing consumer confusion. 
        Inaccurate and conflicting dietary guidance messages are 
        detrimental to consumer understanding of nutrition and the 
        ability to build healthy diets. At a time when consumers are 
        already subjected to an overabundance of nutrition and health 
        information, providing the public with science-based, realistic 
        and achievable information is more likely to contribute to 
        improved public health outcomes.
Recommendations

   It is imperative that food and nutrition policies reflect, 
        and do not get ahead of the strongest available scientific 
        evidence. It is unlikely we will ever have RCT data available 
        to answer most nutrition questions, but we should rely on our 
        strongest designs. We must demand stronger scientific standards 
        from appointed committee members who serve on authoritative IOM 
        and DGAC panels.

   A universal system that grades evidence quality would help 
        achieve consistency in science interpretation and use across 
        all nutrition policies and regulations. Grading schemes should 
        be vetted and approved by authoritative bodies, so that 
        findings and recommendations are supported across a wide array 
        of credible groups.

   Food and nutrition policy must be a cooperative effort of 
        scientists from universities, the government, commodity groups 
        and food companies. Dietary guidance that is produced in such a 
        collaborative system will more likely be translatable and 
        realistic for the general public.

   When policy recommendations are developed by committees, 
        such as the DGAC, those committees should be comprised of a 
        balanced and well-rounded set of perspectives and expertise. A 
        scientific nutrition committee should not only include experts 
        in nutrition, biochemistry, physiology, epidemiology and 
        statistics, but also food science, food production and 
        processing, food policy and behavior. This would ensure that 
        the ultimate recommendations adequately reflect our entire food 
        system and food environment.

   Policies should reflect what is practical and likely to have 
        the greatest impact on the general population. Simple, flexible 
        and straightforward messages that are rooted in the best 
        available evidence are likely to be most effective.

          Joanne Slavin is a Professor in the Department of Food 
        Science and Nutrition at the University of Minnesota, St. Paul. 
        She is a Science Communicator for the Institute of Food 
        Technologists and served as a member of the 2010 Dietary 
        Guidelines Advisory Committee (DGAC).
                               attachment
Slavin Nutrition Journal (2015) 14:15 *
---------------------------------------------------------------------------
    * Correspondence: [email protected], Department of Food Science and 
Nutrition, University of Minnesota, 1334, Eckles Avenue, St. Paul, 
Minneapolis, MN 55108, USA.
    2015 Slavin.; licensee BioMed Central. This is an Open Access 
article distributed under the terms of the Creative Commons Attribution 
License (http://creativecommons.org/licenses/by/4.0), which permits 
unrestricted use, distribution, and reproduction in any medium, 
provided the original work is properly credited. The Creative Commons 
Public Domain Dedication waiver (http://creativecommons.org/
publicdomain/zero/1.0/) applies to the data made available in this 
article, unless otherwise stated.
---------------------------------------------------------------------------
The Challenges of Nutrition Policymaking
DOI 10.1186/s12937-015-0001-8
Review, Open Access
Joanne L. Slavin
Abstract
    In my over 3 decades of work in the field of food and nutrition, I 
have participated in many efforts that seek new policy initiatives in 
the hopes that these programs can curb rates of obesity and chronic 
disease and help consumers make healthier dietary choices. Because of 
the profound effect that many of these policies have on consumers, the 
food environment, Federal nutrition assistance programs and subsequent 
policy and regulatory recommendations, it is imperative that only the 
strongest, best available evidence is used to set policy. This review 
evaluates methods by which current nutrition policies use scientific 
research as well as provides recommendations for how best to ensure 
future nutrition policies are truly science-based and likely to have a 
meaningful impact on public health. Specifically, this review will:

   Describe the current food and nutrition policy environment 
        in the U.S.

   Examine how science is used in Federal food and nutrition 
        policymaking efforts, using the Dietary Guidelines for 
        Americans (DGA) as an example.

   Describe strong versus weak science as well as what types of 
        studies are most appropriate for use in policymaking.

   Discuss the potential effects and consequences of making 
        policy recommendations in the absence of scientific consensus 
        or agreement.

   Make recommendations to support the present and ongoing 
        development of science-based policy likely to positively impact 
        public health.

    Keywords: Dietary guidance, Nutrition policy, Evidence based 
review, Sodium, Added sugars
Introduction
    The U.S. food and nutrition policy and regulatory environment is 
highly active. The current Administration, Federal agencies and 
regulators are increasingly looking to policy and systems-change 
interventions to improve public health in America. For example, within 
the last 5 years, Federal and state/local governments have instituted 
significant changes to the school food environment [1], proposed state 
and local initiatives to tax and/or ban certain foods and beverages 
[2], and published proposed rules to significantly change nutrition 
labeling regulations [3]. Additionally, the 2015 Dietary Guidelines 
Advisory Committee (DGAC) [4] is presently meeting and will issue the 
2015 DGAC report in the coming year.
    The process by which Federal agencies and policymakers consult 
scientific research in developing proposed regulations and policies 
varies, and greatly impacts the nature of the ultimate recommendations. 
An investigation into this process would yield important understanding 
about how science is used to set policy and what impact this process is 
likely to have on consumers.
Review
How Science Is Used in Policymaking
    Science is used by all agencies to set nutrition policy. Yet, 
guidelines for how to identify, evaluate, and translate scientific 
research into policy recommendations vary among agencies. Policymakers 
generally rely on published research and consensus reports by 
scientific authorities and government bodies; however the manner in 
which research findings and report conclusions are interpreted and 
applied can differ from one initiative to the next. Government agencies 
have outlined their approach for evaluation of scientific studies to be 
used in decision-making. For example, NIH uses the AHRQ system [5] and 
FDA has an accepted system of systematic review for health claims [6]. 
Because there is not a universally accepted evidence-grading scheme, 
conclusions are based on research studies with varying degrees of 
methodological strength and applicability. The fact that nutrition 
research produces constantly evolving scientific findings further 
complicates the development of objective, evidence-based policy 
recommendations.
    One example of a U.S. scientific authority with significant 
influence is the Institute of Medicine (IOM). The IOM is one of the 
premier authoritative bodies that conducts health-related research and 
promulgates health and nutrition recommendations for policymaking 
purposes. IOM reports are frequently commissioned by government 
agencies for topics where policy and/or regulatory interest exists but 
research gaps remain. Some recent examples include sodium [7] and 
front-of-package labeling [8]. Once IOM recommendations are published, 
they are often used as scientific basis for proposed regulations and 
nutrition guidance. IOM recommendations aim to reflect our most current 
scientific understanding and usually precede the actual setting of 
policy to ensure any action is evidence-based. However, the IOM is 
challenged to keep pace with advances in our understanding of 
nutrition.
    For example, the IOM completes the Dietary Reference Intake (DRI) 
reports, which are considered the most reliable sources of nutrient 
recommendations--they inform the very basis of our current nutrition 
understanding. The DRIs are summarized in the 2006 volume [9] and are 
an update to the Dietary Recommended Allowances (RDA) that have been 
published since 1941. While DRI reports for certain nutrients have been 
updated recently (vitamin D and calcium were updated in 2011), other 
DRI reports have not been updated since 1997-1998. This means that the 
body of research that has been completed for a number of nutrients 
within the last 15+ years is not accounted for in our current IOM DRI 
report conclusions.
    Researchers and policymakers also rely heavily on the National 
Health and Nutrition Examination Survey (NHANES), an ongoing group of 
studies designed to assess the health and nutritional status of adults 
and children in the United States. These studies are based on self-
reporting; they consist of 24 hour dietary recalls completed through 
individual surveys. NHANES also collects biological data and 
anthropometrical data with mobile units. NHANES information is a 
valuable resource on changes in nutrient intake and health status of a 
cross-sectional group of U.S. consumers.
    Critics suggest the data are flawed because of biases that 
accompany self-reporting measures [10]. As one might expect, survey 
respondents have a tendency to under-report their caloric intake or 
over-report the amount of more nutritious foods they consume and under-
report the amount of less nutritious foods they consume. Archer, et al. 
[11] reported that 67% of women and 59% of men who participated in 
NHANES provided caloric intake responses that were not physiologically 
plausible. They calculated physiologically credible energy intake 
values as the ratio of reported energy intake to estimated basal 
metabolic rate and subtracted estimated total energy expenditure to 
create disparity values. The greatest mean disparity values were ^716 
kcal/day and ^856 kcal/day for obese men and women, respectively. The 
limitations of our nutritional data are generally not acknowledged in 
scientific reports or consensus statements. And yet, NHANES is cited by 
virtually every government agency involved in health and nutrition as 
an accurate representation of Americans' eating habits.
    These examples raise important questions about the data that U.S. 
nutrition policymakers have available to them. How confident can we be 
that Federal dietary guidance is evidence-based when our foundational 
measures are outdated and significantly limited? What controls can be 
put in place to ensure that policies and regulations are likely to have 
demonstrated, positive public health impact?
The Dietary Guidelines Advisory Committee
    Another highly influential scientific authority is the Dietary 
Guidelines Advisory Committee (DGAC), the appointed review committee 
responsible for formulating and publishing (in the form of a 
comprehensive report) an evidence-based review that provides scientific 
support for the Dietary Guidelines for Americans (DGA) policy document. 
The DGA are statutorily mandated (Section 301 of Public Law 101-445 (7 
U.S.C. 5341, the National Nutrition Monitoring and Related Research Act 
of 1990, Title III)) and are a collaborative effort between the 
Department of Health and Human Services (HHS) and Department of 
Agriculture (USDA); the DGA have been published every 5 years since 
1980. The DGA aim to provide ``sound advice for making food and 
physical activity choices that promote good health, a healthy weight, 
and help prevent disease for Americans ages 2 years and over, including 
Americans at increased risk of chronic disease'' [12]. DGA 
recommendations serve as the cornerstone for all Federal nutrition 
education and program activities, including but not limited to 
nutrition labeling campaigns by the Food and Drug Administration (FDA) 
and USDA Food Safety and Inspection Service (FSIS), the Office of 
Disease Prevention and Health Promotion (ODPHP) Healthy People 
objectives, and USDA Food and Nutrition Service nutrition assistance 
programs including the Supplemental Nutrition Assistance Program (SNAP) 
and the National School Lunch Program (NSLP). As a result, DGA reach 
and impact are extensive.
    The 2015 DGA process is underway, with the current DGAC holding 
meetings to share their evidence review process and findings with the 
general public. According to the 2015 DGAC charter, the Committee's 
official responsibilities are to ``examine the current Dietary 
Guidelines for Americans, take into consideration new scientific 
evidence and current resource documents, and then develop a report to 
be submitted to the Secretaries that outlines its science-based 
recommendations and rationale which will serve as a basis for 
developing the eighth edition of Dietary Guidelines for Americans'' 
[12].
    The DGAC is governed by Federal Advisory Committee Act (FACA) 
guidelines and an official charter and charge [13]. While the freedom 
exists to explore food and nutrition topics that the DGAC deems 
important and scientifically relevant, the charge explicitly states 
that ``DGAC responsibilities include providing authorship for this 
report; however, responsibilities do not include translating the 
recommendations into policy or into communication and outreach 
documents or programs'' [13]. In other words, DGAC recommendations 
should be scientific in nature and not indicative of policy direction.
The DGAC Evidence Review Process
    The DGAC process to identify, review, and evaluate available 
nutrition research for a variety of topics is complex and time-
intensive. Typically, DGAC members are divided into subcommittees to 
address specific research areas based on topic importance and DGAC 
member expertise. In 2010, the DGAC consisted of thirteen scientists 
with expertise in nutrition, physical activity, food behavior and 
nutrition through the lifecycle. There were eight subcommittees 
focusing on the following dietary issues: (1) alcohol; (2) 
carbohydrate; (3) energy balance and weight maintenance; (4) fatty 
acids and cholesterol; (5) food safety and technology; (6) nutrient 
adequacy; (7) protein; and, (8) sodium, potassium and water. As a 
member of the 2010 DGAC, the author of this paper served as chair of 
the carbohydrate and protein subcommittees and also as a member of the 
energy balance and the nutrient adequacy subcommittees.
    The 2015 DGAC is organized somewhat differently, with fourteen 
scientists serving on five subcommittees: (1) Food and Nutrient 
Intakes, and Health: (2) Current Status and Trends; 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. There are separate working 
groups for sodium, added sugar, saturated fat and physical activity. 
The 2015 Committee is also using expert consultants to inform its 
evidence reviews.
    One of the first steps in the DGAC evidence review process is to 
develop research questions regarding the relationship between diet and 
health outcomes, including disease risk or health benefits (e.g., what 
is the relationship between dietary fiber intake and specific health 
outcomes). These questions should reflect the research gaps identified 
by the previous DGAC, as well as areas of nutrition where there is new, 
influential evidence since the previous edition of the DGA. Once the 
research questions have been agreed upon, the DGAC, in concert with 
USDA Nutrition Evidence Library (NEL) staff, gathers the relevant 
available studies.
    The research studies are then closely examined and evaluated based 
on strength of study design as well as relevance of outcomes. In past 
years, the DGAC used the NEL evidence-based review process [14], a 
strict hierarchy of evidence and rigorous grading process. For each 
question addressed in the 2010 evidence-based report, the DGAC 
developed precise search criteria, inclusion and exclusion criteria for 
all of the studies, including the range of dates searched, and made 
this information available on the USDA DGA portal [14]. Such detailed 
process and transparency in the NEL evidence-based approach minimizes 
bias and therefore adds credibility to the findings. However, the 
scientific review method ultimately used by the DGAC is at the 
Committee's discretion--for example, at the time of this paper's 
completion, the 2015 DGAC has decided to use the NEL process to answer 
some research questions, but not others. This permitted subjectivity 
and variability increases the potential for less rigorous studies to be 
used to inform DGAC recommendations.
    Once the DGAC has determined which studies to examine for each 
research question, evidence conclusion statements are written. Within 
the NEL system, the conclusions drawn can be deemed as strong, 
moderate, limited, or lacking data to support them. There may also be 
strong evidence of no relationship. For example, strong evidence was 
found of no relationship between glycemic index and disease outcomes in 
the 2010 DGAC review [15]. Agreeing on the strength of the relationship 
is always difficult, as for each question, different types of studies 
with a variety of outcomes have been published. A closer examination of 
study methodology will help further illustrate this point.
    The DGAC process is transparent and open to input from scientists 
and consumers. The 2015 DGAC will hold seven public meetings with 
public comments accepted throughout the process. Although the final 
DGAC report is not released, the committee regularly updates their 
progress on reviewing scientific questions at the public meetings.
Research Methodology: What Makes a Strong vs. Weak Study
    The evidence-based medicine (EBM) hierarchy ranks research design 
in the following order of strength (from highest to lowest): systematic 
reviews of randomized-controlled trials (RCT), RCT, prospective cohort 
studies, case control studies, cross-sectional studies, case series/
case reports and editorials/expert opinions. RCT are the strongest 
study designs for determining cause and effect between a dietary 
exposure and a health outcome [16]. Following RCT are prospective 
cohort studies, where a group or cohort of subjects is studied over 
time. Food frequency instruments are often used to collect dietary 
information before any diagnosis of disease, making these studies more 
reliable than cross-sectional studies where diet and outcome measures 
are assessed simultaneously. Historically, in the case of DGAC reviews, 
no case-control studies, animal research, or in vitro studies have been 
considered due to their relative weakness and because their findings 
cannot prove cause and effect in humans. Typically cross-sectional 
studies are only included in DGAC reviews if no stronger prospective 
studies are available.
    Following this reasoning, food and nutrition policies would be best 
served if only the strongest types of evidence--perhaps RCT alone--
informed their development. However, this is an unrealistic ideal as 
not all diet and health outcome relationships can be practically or 
ethically evaluated using RCT. For example, it is difficult to carry 
out blind food treatments in dietary studies (subjects know they are 
consuming an apple versus apple juice). However, such trials can work 
with nutrients, as nutrients can be added to food or drinks without the 
knowledge of the participants or investigators (the double-blind 
mechanism).
    Further, all RCT data are not created equal. RCT generally use 
biomarkers as outcome measures rather than disease incidence due to the 
length of time it takes healthy people to manifest disease symptoms. 
Biomarker data can be extrapolated to infer relationships regarding 
population health without adequately accounting for weaknesses in the 
relationship between the biomarker and the disease state. Ultimately, 
this can result in a strong study methodology being misapplied and used 
to make assumptions that are not actually supported by the research. 
For example, RCT are clear that sodium intake or excretion is directly 
related to blood pressure, yet prospective cohort studies show that too 
low sodium intakes actually increase risk of cardiovascular disease 
(CVD). Thus, at low levels of sodium consumption, blood pressure does 
not account for all of the CVD risks. Biomarker data fail to tell the 
complete story.
    In reality, many dietary recommendations are supported by evidence 
primarily from observational data, particularly those from prospective, 
cohort studies. Nutrition scientists and policymakers often under-
appreciate limitations of such data. Some of the limitations of 
observational evidence for diet-disease relationships include imprecise 
exposure measures, collinearity among dietary exposures, displacement/
substitution effects, healthy/unhealthy consumer bias, and residual 
confounding. Maki, et al. [16] recommend greater caution in making 
dietary recommendations for which RCT evidence of clinical event 
reduction after dietary intervention is not available.
    For these reasons and because nutrition science is complex and 
changeable, it is critical that study methodology is carefully 
considered and applied to our interpretation of nutrition science. 
Ideally, observational data would be validated by stronger research 
methods before being used to inform policy. While observational 
research may be valuable to our understanding of nutrition and health, 
its limitations must be acknowledged. Consider the 2015 DGAC 
investigation into sustainable dietary patterns. This field of research 
is arguably in its infancy--in fact, there is no scientific consensus 
for even a definition of sustainability [17]. Any sustainability-
related recommendations in the 2015 DGAC report should be preliminary 
at best, recognizing the need for additional, rigorous research to 
validate initial findings. Without these underlying studies in place, 
it would be premature for HHS and USDA to use sustainability 
recommendations to inform nutrition guidance in the 2015 DGA policy 
document.
Consequences of Non-Evidence-Based Policy
    We don't have to travel very far back in time to witness examples 
of dietary guidance recommendations that were made prematurely and are 
now challenged as more research is introduced. Our understanding of 
fats has evolved considerably, with dietary recommendations now 
emphasizing healthy consumption of monounsaturated and polyunsaturated 
fats, proving that healthier dietary patterns include, rather than 
exclude, foods higher in fat content.
    More recently, it could be argued that the 2010 DGA sodium intake 
recommendation was made in the absence of scientific consensus. The 
policy document recommends that individuals over 51 years old, African 
Americans or those with hypertension, diabetes, or chronic kidney 
disease reduce their daily sodium intake to 1,500 milligrams. This 
applies to about \1/2\ the U.S. population, including children and the 
majority of adults.
    Since then, the IOM published its Sodium Intake in Populations: 
Assessment of Evidence report. Findings stated that recent studies 
``support current efforts to reduce excessive sodium intake in order to 
lower risk of heart disease and stroke. However, the evidence on health 
outcomes is not consistent with efforts that encourage lowering of 
dietary sodium in the general population to 1,500 mg/day. Further 
research may shed more light on the association between lower--1,500 to 
2,300 mg--levels of sodium and health outcomes'' [7].
    The 2010 DGA recommendations are now inconsistent with our most 
recent scientific understanding of sodium and health. As noted, this 
conflict could have been avoided if the DGA policy document had 
withheld such extreme guidance until more rigorous studies were 
fielded, reviewed, and published. Recent papers in the New England 
Journal of Medicine cast further doubt on our low sodium 
recommendations for the general public [18].
    The sodium example is important because of the aforementioned 
impact of DGA recommendations on other food and nutrition policies. The 
Final Rule for the Nutrition Standards in the National School Lunch and 
School Breakfast Programs [1] states that schools must ``reduce the 
sodium content of meals gradually over a 10 year period through two 
intermediate sodium targets of 2 and 4 years post implementation''. Now 
that schools have begun to implement the new regulations, these severe 
sodium reductions are proving difficult, costly, and may reduce student 
participation rates [19]. These consequences are especially concerning 
considering the underlying recommendation may not accurately reflect 
the current evidence base.
    Inaccurate and conflicting dietary guidance messages are also 
detrimental to consumers' understanding of nutrition and their ability 
to build healthy diets. At a time when consumers are already subjected 
to an over-abundance of nutrition and health information, government 
agencies should be held accountable for developing policies and 
regulations that are rooted in strong science, and are realistic and 
achievable for the majority of the population. In the case of sodium, 
not only is there insufficient evidence to link highly restrictive 
sodium intakes to improved health outcomes, but encouraging the general 
public to reduce intakes from the estimated current average of 3,400 
mg/day to 1,500 mg/day is self-defeating and unachievable [20].
    Another example can be seen in the use of the 2010 DGAC review to 
support the FDA proposal to mandate added sugars labeling on the 
Nutrition Facts panel [3]. Added sugars have become the current 
nutrition ``watch out'', believed by some to uniquely contribute to 
obesity and other adverse health outcomes. However, the majority of 
scientific evidence shows that all sugars (added or intrinsic) provide 
4 kcalories/gram just like any other digestible carbohydrate and are no 
more likely to cause weight gain or negative health outcomes than other 
calorie sources [21]. In fact, even the proposed rule acknowledges this 
fact:

          ``U.S. consensus reports have determined that inadequate 
        evidence exists to support the direct contribution of added 
        sugars to obesity or heart disease. Specifically, although it 
        is recognized that sugar-sweetened beverages increase adiposity 
        (body fat) in children (Ref. 30), neither the 2010 DGA nor the 
        IOM macronutrient report concluded that added sugars 
        consumption from all dietary sources, in itself, increases 
        obesity. In fact, the 2010 DGA states that added sugars do not 
        contribute to weight gain more than any other source of calo-
        ries . . .'' [3].

    FDA states that the basis for this proposed labeling requirement is 
the 2010 DGA recommendation to reduce intakes of added sugars to assist 
consumers in maintaining healthy dietary practices. The DGA rationale 
is that lower intakes of added sugars will result in decreased calorie 
intakes and increased nutrient density of individual diets, not reduced 
risk of adverse health outcomes. Specifically, the 2010 DGAC energy 
balance subcommittee investigated sugar-sweetened beverage intakes and 
found that ``strong evidence shows that children who consume more 
sugar-sweetened beverages have greater adiposity (body fat) compared to 
those with a lower intake'' [15]. However, a closer look at the 
evidence review shows that only 12 of the 19 studies (which included 
crosssectional studies) found a positive association between sugar-
sweetened beverage intakes and adiposity in all or a subsample of 
population studies. It is difficult to see how the subcommittee 
concluded this to be ``strong'' evidence.
    Furthermore, it is unclear why FDA proposed mandatory added sugars 
labeling in the absence of consumer research to demonstrate whether the 
change will in fact influence consumer understanding and purchasing 
behavior. The proposed rules even preceded the agency's own study. 
Existing consumer research suggests that consumers already find aspects 
of the current nutrition label confusing [22]. In addition, public 
misunderstanding about added sugars abounds. Some consumers believe 
added sugars do cause unique adverse health outcomes compared to other 
sugars and even contain more calories that intrinsic sugars [22]. Even 
if the intention behind the proposed rule is to steer consumers away 
from purchasing non-nutrient dense foods and beverages that contain 
added sugars, current available research suggests they will do this for 
the wrong reasons. This proposal stands to perpetuate misleading 
beliefs about nutrition and lead to more consumer confusion.
    It is extremely difficult to reverse or change public policy, once 
enacted, without causing consumer confusion. There are few mechanisms 
available to regulators and policymakers to make adjustments that 
reflect new science and understanding. Furthermore, nutrition policy 
recommendations, once adopted, appear frequently in the media and 
online. Reversing consumer misunderstanding about nutrition is an 
incredibly difficult task; providing the public with accurate, 
realistic and achievable information first would go a long way in 
improving our understanding of nutrition and health, and ultimately 
contributing to improved public health outcomes.
Conclusions
    It is imperative that food and nutrition policies reflect, and do 
not get ahead of the strongest available scientific evidence. It is 
unlikely we will ever have RCT data available to answer most nutrition 
questions, but we should rely on our strongest designs, including 
prospective cohort studies. We should not accept cross-sectional 
studies as influential drivers of policy development. We must demand 
stronger scientific standards from our appointed committee members who 
serve on advisory IOM and DGAC panels.
    A transparent system that grades evidence quality would help 
achieve consistency in science interpretation and use across nutrition 
policies and regulations. Grading schemes should be vetted and 
discussed by experts across the wide expertise needed in dietary 
guidance, including nutritionists, dietitians, food scientists, 
physicians, applied economists, and food processors so that findings 
and recommendations could be supported across a wide array of credible 
groups. This would also help ensure that the dietary guidance messages 
consumers are receiving are factual and consistent.
    When policy recommendations are developed by committees, such as 
the DGAC, those committees should be comprised of a balanced and well-
rounded set of perspectives and expertise. Ideally a scientific 
nutrition committee would not only include experts in nutrition, 
biochemistry, physiology, epidemiology and statistics, but also food 
science, food production and processing, food policy and behavior. This 
combination of skills would ensure that the ultimate recommendations 
adequately reflect our entire food system and food environment.
    Scientists who understand how we ``learn'' about nutrition must be 
included, even if they have worked on research supported by commodity 
groups or food companies. The IOM process considers bias of individual 
committee members and whether they have taken such strong public stands 
on issues that it is not possible for them to move to another position 
based on the deliberations of the committee. Any linkages to the food 
industry are criticized, yet there seems to be little concern about 
committee members who are closely linked to professional groups, such 
as American Heart Association or other advocacy groups. Improvements to 
our food system and public health can only be realized if we work 
together, respecting the strengths of all parties. Nutrition advice 
that is produced in such a collaborative system will more likely be 
translatable and realistic for the general public.
    Policies should reflect what is practical and likely to have the 
most impact on the general population. Simple, flexible and 
straightforward messages that are rooted in the best available evidence 
are likely to be most effective. For example, the majority of Americans 
are unlikely to be interested in or able to prioritize building 
sustainable diets, shop at farmers markets, or avoid processed foods, 
which provide nutrition and convenience for individuals with less 
access to full-service grocery stores and fresh produce.
    I would finally suggest that the U.S. Government consider 
elongating the DGA publication schedule. The DRI reports and nutrition 
labeling regulations are not updated every 5 years; instead they are 
reexamined when there is a sufficient level of new research to warrant 
a change. Without new science to review, the DGAC may choose to focus 
on fads and trends instead of updating the scientific data for the core 
areas of dietary guidance. As every DGAC wants to be bold and set new 
direction, nutrition science would support that first we must do no 
harm with our dietary guidance. Moderation and variety must be kept 
front and center, as well as an appreciation that a teenage active boy 
may need two or three times more calories than an elderly man or young 
child. A suggestion that all Americans should reduce sodium intakes is 
not sound and is potentially dangerous. Targeting certain foods and 
beverages, including chocolate milk, processed meats, added sugars, and 
even the noble potato as villains in the nutrition wars is not a 
science-based strategy and may need to be countered on the political 
front if appointed scientific review committees continue to take this 
approach.
    As described by Schneeman [6], science is necessary for developing 
effective food regulation and policy, but it is not sufficient. The 
interface between nutrition and public health must include food science 
and agriculture. Food technology can help all consumers, including 
those of lower socioeconomic status, have access to safe, nutritious 
foods that science has found to be linked to improved health outcomes.

 
 
 
Abbreviations
 
    HHS: Department of Health and Human Services; USDA: Department of
 Agriculture; DGAC: Dietary Guidelines Advisory Committee; DGA: Dietary
 Guidelines for Americans; DRI: Dietary reference intakes; EBM: Evidence-
 based medicine; FACA: Federal Advisory Committee Act; FDA: Food and
 Drug Administration; IOM: Institute of Medicine; LDL: Low-density
 lipoprotein; NHANES: National Health and Nutrition Examination Survey;
 NSLP: National School Lunch Program; ODPHP: Office of Disease
 Prevention and Health Promotion; RCT: Randomized-controlled trials;
 SNAP: Supplemental Nutrition Assistance Program; FSIS: USDA Food Safety
 and Inspection Service; NEL: USDA Nutrition Evidence Library.
 
Competing Interests
 
    In the past 5 years Dr. Slavin has received research grants from
 Minnesota Beef Council, Minnesota Cultivated Wild Rice Council,
 Novartis Consumer Health, USA Rice, Nestle Nutrition, Tate and Lyle,
 General Mills, Inc., USA Pears and American Pulse Association. In the
 past 5 years Dr. Slavin has received speaking fees from food companies
 and commodity groups with interests in processed foods, dairy products,
 meat, pulses, fruits, vegetables, fiber, grains, and carbohydrates. Dr.
 Slavin has participated in scientific panels and advisory boards that
 are funded by food companies, ingredient companies, commodity groups,
 scientific societies, and trade groups. She holds a third interest in
 the Slavin Sisters LLC, a 119 acre farm in Southern Wisconsin.
 
Author information
 
    Joanne Slavin, Ph.D., R.D., is a Professor in the Department of Food
 Science and Nutrition, University of Minnesota, St. Paul. She is a
 Science Communicator for the Institute of Food Technologists and served
 as a member of the 2010 Dietary Guidelines Advisory Committee (DGAC).
 
Acknowledgements
 
    The author thanks Sarah Levy, M.P.H., R.D., for her support in the
 development of this paper, which includes assistance with outline
 development and revision of drafts. Ms. Levy is a Vice President with
 FoodMinds LLC, a food and nutrition affairs company that represents a
 range of food, nutrition, and wellness organizations. During this
 paper's development, she worked for FleishmanHillard, a global
 communications agency that represents the Corn Refiners Association.
    This paper was funded by an unrestricted grant from the following
 organizations: Corn Refiners Association, Grocery Manufacturers
 Association, International Dairy Foods Association, American Beverage
 Association, National Confectioners Association, and American Meat
 Institute.
    Received: 13 September 2014 Accepted: 20 January 2015.
    Published online: 07 February 2015.
 
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                                 ______
                                 
   Submitted Article by Hon. James P. McGovern, a Representative in 
                      Congress from Massachusetts
The Hill
October 07, 2015, 06:30 a.m.
Physician Perspective: Keep Politics Out of Dietary Guidelines
By Sandra G. Hassink, M.D., F.A.A.P. and Steven J. Stack, M.D.

    The process by which the Federal Government provides the best 
available dietary advice to millions of Americans is under attack on 
Capitol Hill. As physicians and leaders of professional medical 
organizations, we are compelled to speak out.
    Physicians routinely provide patients with guidance on how to stay 
healthy. We rely on the best available scientific evidence to make 
these recommendations, and fortunately, we have had the Dietary 
Guidelines for Americans to turn to. Unfortunately, that could all 
change; there are unprecedented attacks taking place in Congress right 
now that threaten the scientific integrity of the guidelines.
    Every 5 years, the guidelines are updated and published as 
America's authority for nutrition advice. Important legislation, the 
Healthy, Hunger-Free Kids Act of 2010, called for school meals to 
conform to these guidelines, which makes sense: since children 
typically consume up to \1/2\ of their daily calories in school, we 
have an obligation to ensure those meals are healthy and nutritious.
    At a time when nearly one in three school-age children and 
adolescents is overweight or has obesity and more than one in three 
American adults suffer from cardiovascular disease and diabetes, 
science, not politics, should drive the Federal Government's efforts to 
revise the guidelines. And indeed, the guidelines themselves are 
informed by an expert committee made up of scientists, doctors and 
nutritionists who are nominated by their peers and selected by the 
Federal Government after a rigorous vetting process. They evaluate the 
evidence and provide independent advice to the U.S. Government in the 
form of Dietary Guidelines.
    This process takes years, and is intentionally removed from the 
political process. And yet, it is currently under threat on Capitol 
Hill: Language pending in multiple spending bills would hinder the 
Federal Government's ability to provide the best available advice to 
millions of children and adults on healthy diets and lifestyles. If 
enacted, efforts to reduce consumption of added sugars in order to 
lower the risk of cardiovascular disease, type 2 diabetes and dental 
caries would be stymied. Interventions to reduce screen time and 
increase physical activity in children and adults would be disrupted.
    What's more, the language would limit dietary information or 
guidelines that can be included in the 2015 Dietary Guidelines for 
Americans only to those with a ``strong'' evidence rating, which means 
it is completely free from study design concerns or disagreements 
between findings. As any nutrition scientist or dietician will tell 
you, nutrition research is exceptionally difficult to perform. Meals 
are so complex and varied that establishing an individual's true 
pattern requires meticulous diet tracking; population-level data is 
easier to obtain but less specific. In addition, there is an unlimited 
amount of factors that influence health, including physical activity, 
chemical exposure, and co-morbid health issues. A ``strong'' rating is 
only given if virtually every study on a topic agrees. As this rarely 
happens in science, the Dietary Guidelines for Americans have 
historically relied on both strong and moderate evidence to make key 
recommendations.
    Our patients deserve nutrition guidance that is free of political 
interference. The 2015 Dietary Guidelines for Americans will play a 
crucial role in the lives of millions of children and adults. Nutrition 
and physical activity are integral to a healthy population, and it's 
essential that doctors are able to continue to advise our patients 
based on what the evidence recommends. Congress should support, not 
derail, what the science shows and keep the politics out of the 
guidelines.

          Hassink, is president of the American Academy of Pediatrics. 
        Stack is president of the American Medical Association.
                                 ______
                                 
 Submitted Statements by Hon. Michelle Lujan Grisham, a Representative 
                      in Congress from New Mexico
 statement of academy of nutrition and dietetics; american academy of 
      pediatrics; american college of cardiology; american dental 
               association; american medical association
    As the science leaders of the Academy of Nutrition and Dietetics, 
American Academy of Pediatrics, American College of Cardiology, 
American Dental Association and the American Medical Association, we 
are writing to clear up possible misunderstandings regarding scientific 
evidence and the 2015 Dietary Guidelines for Americans.
    We are concerned that the proposed language in the House's 
Departments of Agriculture, Rural Development, Food and Drug 
Administration and Related Agencies (section 734) and Departments of 
Labor, Health and Human Services and Education and Related Agencies, 
(section 232) Fiscal Year 2016 Appropriations Bills is an overreach 
regarding the intention of evidence-based science.

          (1) Each revision to any nutritional or dietary information 
        or guideline contained in the 2010 edition of the Dietary 
        Guidelines for Americans and any new nutritional or dietary 
        information or guideline to be included in the eighth edition 
        of the Dietary Guidelines for Americans--

                  (A) shall be based on scientific evidence that has 
                been rated ``Grade I: Strong'' by the grading rubric 
                developed by the Nutrition Evidence Library of the 
                Department of Agriculture;

    The Academy of Nutrition and Dietetics' Evidence Analysis Library 
was established in 2004. The Nutrition Evidence Library was launched in 
July 2008 by the Department of Agriculture's Center for Nutrition 
Policy and Promotion and mirrors the Academy's EAL but specializes in 
systematic reviews to inform Federal nutrition-related policies and 
programs. The NEL conducts systematic reviews on food and nutrition-
related topics by using a rigorous, transparent and reproducible 
methodology to support Federal nutrition policies and programs.

    This process includes developing a specific research question on 
diet and health, developing a corresponding search plan for literature 
review designed to answer the research question, extracting data from 
existing literature as directed by the search plan, developing a 
conclusion statement to answer the question and grading the strength of 
evidence supporting the conclusion. A conclusion can be graded Strong, 
Moderate, Limited or Grade Not Assignable.

    The strong rating is reserved for bodies of evidence completely 
free from study design concerns or disagreements between findings. The 
nature of science and statistics is such that a small number of 
contrary findings is expected and a preponderance of evidence can 
overcome limitations of individual studies. Therefore, recommendations 
with a moderate rating, which indicates a sizable body of well-designed 
research with which the committee had no more than minor doubts, are 
more than sufficient to inform the Dietary Guidelines for Americans.

    The exclusion of recommendations with a moderate rating would 
strike several uncontested truths from the record available to USDA, 
including the relationships between sugar and cavities and between a 
sedentary lifestyle and obesity. Additionally, the current language 
would bar USDA and HHS from supporting two recommendations derived from 
emerging science that are vital to the health of Americans: the use of 
school-based nutrition and exercise programs to prevent obesity and the 
reduction of added sugar intake to prevent heart disease. Obesity and 
heart disease are deadly and costly burdens to the nation and Americans 
deserve access to the knowledge of every effective tool to combat them.
    Nutrition focused systematic reviews, unlike pharmaceutical 
research, use a plethora of methodology, not just randomize clinical 
trials. The reason for a paucity of randomized clinical trials in 
nutrition literature is multifactorial but basically people must eat to 
survive and thus pure control groups are difficult. Fortunately, many 
new research methods are becoming acceptable to study key research 
questions relating to the health of the public. Unfortunately, many of 
these have yet to be utilized to fill the current large gaps in human 
nutrition research. Currently, the published food and nutrition 
research, which has been funded by the government, foundation and 
industry is a mixture of clinical trials, observational trials and 
cohort and case studies the latter of which do not receive as high of a 
grade value as randomized clinical trials. Thus, if the United States 
is to continue to guide the American population on healthy eating 
choices to prevent disease and have optimal health we must accept 
conclusion statements that are less than Grade 1 while futuristically 
funding rigorously designed food and nutrition studies in a variety of 
populations to fill the prevalent nutrition research gaps.
    The DGAC's scientific conclusions and HHS/USDA's final development 
of the Dietary Guidelines use more than one question or source of 
evidence, such as NEL systematic reviews. The DGAC considered seven 
questions examining the relationship between dietary patterns and 
health outcomes, including cancer, type 2 diabetes and cardiovascular 
disease. The DGAC also reviewed evidence using a process known as food 
pattern modeling to describe the combination of foods and drinks a 
person should consume to meet nutrient needs and the impact on chronic 
disease. The final Dietary Guidelines consider all this information.
    Nutrition is an evolving science and a lack of evidence or limited 
evidence for one specific question does not mean that there is not 
strong evidence to support guidance. DGA recommendations have 
historically been made drawing upon both ``Strong'' and ``Moderate'' 
strength evidence. The Dietary Guidelines are developed based on the 
preponderance of the strongest available evidence. Limited or Moderate 
evidence for one health outcome could greatly limit the ability to 
provide guidance on dietary patterns when the evidence may be Strong 
for other health outcomes. Using the cutoff of ``Strong'' will 
significantly limit the ability to develop recommendations across the 
Dietary Guidelines.
    The 2010 Dietary Guidelines for Americans were based on the 
strongest evidence available, not just the evidence that was identified 
as Grade 1: Strong. Making a change for 2015 would create an 
inconsistency between recommendations in the 2010 DGAs, some of which 
are supported by ``Moderate'' evidence.
    We ask that the House's Departments of Agriculture, Rural 
Development, Food and Drug Administration and Related Agencies (section 
734) and Departments of Labor, Health and Human Services and Education 
and Related Agencies, (section 232) Fiscal Year 2016 Appropriations 
Bills not be included in the final spending package for Fiscal Year 
2016.
    We would be glad to discuss this request further. Please feel free 
to connect Alison Steiber, Ph.D., R.D.N., Chief Science Officer for the 
Academy of Nutrition and Dietetics, with your questions. 
([email protected]).
    Thank you for your consideration.
            Respectfully,

Academy of Nutrition and Dietetics;
American Academy of Pediatrics;
American College of Cardiology;
American Dental Association;
American Medical Association.
 statement of academy of nutrition and dietetics; american society for 
                               nutrition
    As the food and nutrition leaders representing the of the Academy 
of Nutrition and Dietetics and the American Society for Nutrition, we 
ask for your support of the 2015 Dietary Guidelines process to continue 
without interference by Congress. We are concerned that the proposed 
language in the House's Departments of Agriculture, Rural Development, 
Food and Drug Administration and Related Agencies (section 734) and 
Departments of Labor, Health and Human Services and Education and 
Related Agencies,(section 232) Fiscal Year 2016 Appropriations Bills 
will halt the progress of this important nutrition policy that could 
improve public health.

    The Dietary Guidelines for Americans are founded in evidence-based 
science and should be insulated as much as possible from political 
influences. The Nutrition Evidence Library (NEL) was launched in July 
2008 by the Department of Agriculture's Center for Nutrition Policy and 
Promotion. The NEL was built as an outgrowth from the Academy of 
Nutrition and Dietetics' Evidence Analysis Library (EAL), developed in 
2004. The NEL mirrors the Academy's EAL but specializes in systematic 
reviews to inform Federal nutrition-related policies and programs. The 
NEL conducts systematic reviews on food and nutrition-related topics by 
using a rigorous, transparent and reproducible methodology to support 
Federal nutrition policies and programs. This process includes:

   Developing specific research questions on diet and health.

   Developing corresponding search plans for literature review 
        designed to answer the research questions.

   Extracting data from existing literature as directed by the 
        search plans.

   Developing conclusion statements to answer each question and 
        grading the strength of evidence supporting the conclusion.

    A conclusion can be graded Strong, Moderate, Limited or Grade Not 
Assignable. The Strong rating is reserved for bodies of evidence 
completely free from study design concerns or disagreements between 
findings, which is rare. Science and statistics expect a small number 
of contrary findings and it is the ``preponderance of evidence'' that 
can overcome limitations of individual studies. As a result, 
recommendations with a Moderate rating, which indicates a sizable body 
of well-designed research with which the Dietary Guidelines Advisory 
Committee (DGAC) had no more than minor doubts, are more than 
sufficient to develop the Dietary Guidelines for Americans. The 
exclusion of recommendations with a Moderate rating would eliminate 
several uncontested truths from the record available to USDA and HHS 
and interfere with helping Americans consume a healthy diet.

    Nutrition-focused systematic reviews draw on several types of 
methodologies, not just randomized clinical trials. The reason for this 
lack of randomized clinical trials in nutrition is multi-faceted, but, 
most important, people must eat to survive and pure control groups are 
ethically difficult. Large clinical trials are also very costly and 
take many years to complete. Fortunately, new research methods are 
becoming acceptable to study key research questions relating to the 
health of the population, which will hopefully enhance nutrition 
related research. Currently, the published food and nutrition research, 
which has been funded by government, foundations and industry, is a 
mixture of randomized controlled trials and observational studies which 
include prospective cohort and case-control studies. The NEL and the 
DGAC utilized only randomized controlled trials and prospective cohorts 
and did not consider results from case-control studies due to the 
potential for bias or weaker designs such as case reports or ecological 
studies. If we are to continue to guide the American population on 
healthy eating choices to prevent disease and have optimal health, we 
must accept recommendations that are rated less than Strong. The DGAC's 
scientific conclusions and HHS/USDA's final development of the Dietary 
Guidelines use more than one question or source of evidence, such as 
NEL systematic reviews. The DGAC also conducted de novo data analysis 
using data from our national nutrition surveillance system (the 
National Health and Nutrition Examination Survey, NHANES) and reviewed 
evidence using a process known as food pattern modeling, which is used 
to describe the combination of foods and drinks a person should consume 
to meet nutrient needs without exceeding calorie intake to maximize 
health benefits and reduce risk of diet-related chronic disease. The 
final Dietary Guidelines for Americans will consider all this 
information.
    Nutrition, like all sciences, evolves with new research and 
information. A lack of evidence or limited evidence for one specific 
question does not mean that there is not strong evidence to support 
guidance. The Dietary Guidelines will continue to be developed on the 
preponderance of the strongest available evidence available at the 
time. Limited or Moderate evidence for one health outcome could greatly 
limit the ability to provide guidance on dietary patterns when the 
evidence may be Strong for other health outcomes. Using the cutoff of 
``Strong'' will significantly limit the ability to develop 
recommendations across the Dietary Guidelines and could therefore 
undermine advances in improving public health.
    We ask that the House's Departments of Agriculture, Rural 
Development, Food and Drug Administration and Related Agencies (section 
734) and Departments of Labor, Health and Human Services and Education 
and Related Agencies, (section 232) Fiscal Year 2016 Appropriations 
Bills not be included in the final spending package for Fiscal Year 
2016 based on their current language regarding the Dietary Guidelines 
for Americans.
    We would be glad to discuss this request further. Please feel free 
to connect Alison Steiber Ph.D., R.D.N., Chief Science Officer of the 
Academy of Nutrition and Dietetics, at [email protected] or Mary 
Pat Raimondi, Vice President at [email protected] with your 
questions.
    Thank you for your consideration.
            Respectfully,

Academy of Nutrition and Dietetics;
American Society for Nutrition.
                                 ______
                                 
 Submitted Statement by Edward Archer, Ph.D., M.S., NIH/NIDDK Research 
  Fellow, Nutrition Obesity Research Center, University of Alabama at
                               Birmingham
    Thank you Chairman Conaway, Ranking Member Peterson, and Members of 
the Committee for the opportunity to submit this statement for the 
record to the Committee on Agriculture, United States House of 
Representatives. My name is Dr. Edward Archer and I am currently an 
NIH/NIDDK Research Fellow at the Nutrition Obesity Research Center, 
University of Alabama at Birmingham. I hold multiple graduate degrees 
including a Doctorate and two Masters of Science degrees with extensive 
training in physiology, psychology, nutrition, exercise science, and 
epidemiology. I have conducted extensive research, lectured, and 
published scientific papers in peer-reviewed journals regarding 
obesity, nutrition, and physical activity, particularly as they relate 
to the Dietary Guidelines published jointly by the United States 
Department of Health and Human Services (HHS) and the United States 
Department of Agriculture (USDA). My curriculum vitae is attached.\1\
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    \1\ Exhibit A.*
    * Editor's note: this document is retained in Committee file.
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    I am submitting this Statement for the Record because my research 
and a recent scientific paper of mine published in the July 2015 issue 
of Mayo Clinical Proceedings directly address the subject matter of 
this hearing, namely, the biased, unscientific methods used by USDA and 
HHS to collect the dietary data that have informed dietary and 
nutritional guidelines over the past 40 years. My paper, entitled The 
Inadmissibility of What We Eat in America and NHANES Dietary Data in 
Nutrition and Obesity Research and the Scientific Formulation of 
National Dietary Guidelines,\2\ outlines the lack of valid scientific 
evidence for and consequent confusion in Federal dietary guidance.
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    \2\ Exhibit B (Edward Archer, Ph.D.; Gregory Pavela, Ph.D.; and, 
Carl J. Lavie, M.D., The Inadmissibility of What We Eat in America and 
NHANES Dietary Data in Nutrition and Obesity Research and the 
Scientific Formulation of National Dietary Guidelines, Mayo Clin. 
Proc., 90(7): 911-926 (July 2015), also available at http://dx.doi.org/
10.1016/j.mayocp.2015.04.009 (last accessed Oct. 19, 2015).
---------------------------------------------------------------------------
    As this paper explains, ``[t]he Scientific Report of the 2015 
Dietary Guidelines Advisory Committee was primarily informed by memory-
based dietary assessment methods (M-BMs) (e.g., interviews and 
surveys). The reliance on M-BMs to inform dietary policy continues 
despite decades of unequivocal evidence that M-BM data bear little 
relation to actual energy and nutrient consumption. Data from M-BMs are 
defended as valid and valuable despite no empirical support and no 
examination of the foundational assumptions regarding the validity of 
human memory and retrospective recall in dietary assessment. We assert 
that uncritical faith in the validity and value of M-BMs has wasted 
substantial resources and constitutes the greatest impediment to 
scientific progress in obesity and nutrition research.'' \3\
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    \3\ Id. at 911 (emphasis added).
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    The evidence is conclusive in this regard: ``M-BMs are 
fundamentally and fatally flawed owing to well-established scientific 
facts and analytic truths.'' \4\ This is so for the following reasons:
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    \4\ Id.

   M-BM produce data that are ``physiologically implausible'' 
        and often ``incompatible with life.'' \5\
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    \5\ Id. at 914 (emphasis added). ``Incompatible with life'' means 
the survey respondent could notsurvive on the amount of food and 
beverages he or she reported consuming.

   ``[T]he assumption that human memory can provide accurate or 
        precise reproductions of past ingestive behavior is 
        indisputably false.'' \6\
---------------------------------------------------------------------------
    \6\ Id. at 911 (emphasis added).

   ``[T]he subjective (i.e., not publicly accessible) mental 
        phenomena (i.e., memories) from which M-BM data are derived 
        cannot be independently observed, quantified, or falsified; as 
        such, these data are pseudoscientific and inadmissible in 
        scientific research.'' \7\
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    \7\ Id. (emphasis added).

   ``Given the overwhelming evidence in support of our 
        position, we conclude that M-BM data cannot be used to inform 
        national Dietary Guidelines and that the continued funding of 
        M-BMs constitutes an unscientific and major misuse of research 
        resources.'' \8\
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    \8\ Id. (emphasis added).

    The results of the research reported in my paper demonstrate that 
the dietary data collected by the USDA and HHS via the National Health 
and Nutrition Examination Survey (NHANES) and analyzed by the 2015 
Dietary Guidelines Advisory Committee (DGAC) were derived from fatally 
flawed, unscientific methods. As such, the USDA and HHS data are 
meaningless numbers, not scientific evidence.
    This finding is critical because, as Chairman Conaway correctly 
stated, dietary guidance should be ``based on sound, consistent and 
irrefutable science.'' \9\ I assert that because the NHANES dietary 
data are ``incompatible with life'' \10\ and are therefore not 
representative of what Americans actually eat, it is clear that these 
data are unequivocally not ``sound, consistent and irrefutable 
science.'' \11\
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    \9\ Chairman K. Michael Conaway, U.S. House of Rep. Comm. on 
Agric., Full Committee--Public Hearing: 2015 Dietary Guidelines for 
Americans (Oct. 7, 2015), Videotape at 00.01.05-00.01.08 (emphasis 
added) (``Hearing Videotape''), available at https://www.youtube.com/
watch?v=x6DNns4oFao&feature=youtu.be (last accessed Oct. 19, 2015).
    \10\ Ex. B at 914 (emphasis added).
    \11\ See supra note 9.
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    Importantly, the testimony and written statements of The Honorable 
Tom Vilsack, Secretary, United States Department of Agriculture, and 
The Honorable Sylvia Burwell, Secretary, United States Department of 
Health and Human Services, do not bear up under scientific review. For 
example, Secretary Burwell's testimony that food pattern analyses 
allowed the DGAC to understand ``what is it actually Americans are 
eating . . .'' \12\ is patently false. All food pattern analyses in the 
DGAC report were based on dietary data that are ``incompatible with 
life.'' \13\ Food pattern analyses based on physiologically implausible 
data cannot be representative of ``what is it actually Americans are 
eating.'' \14\
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    \12\ Hon. Sylvia Burwell, Sec'y, U.S. Dep't of Health & Human 
Servs., Hearing Videotape at01.52.34-01.52.36 (emphasis added).
    \13\ Ex. B at 914 (emphasis added).
    \14\ See supra note 12.
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    Secretary Vilsack testified ``we should take a look at the Healthy 
Eating Index.'' \15\ The Healthy Eating Index estimates are derived 
from the physiologically implausible NHANES dietary data. It should be 
obvious that a valid Healthy Eating Index cannot be created from 
dietary data that are ``incompatible with life.'' \16\
---------------------------------------------------------------------------
    \15\ Hon. Tom Vilsack, Sec'y, U.S. Dep't of Agric., Hearing 
Videotape at 01.21.32-01.21.34(emphasis added).
    \16\ Ex. B at 914 (emphasis added).
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    Secretary Vilsack also testified the DGAC review process produces 
the ``strongest, best . . . available science'' \17\ and the ``best 
science . . . best available science . . . and least biased science'' 
\18\ and wrote ``the 2015 Dietary Guidelines for Americans will be 
grounded in the preponderance of the best available scientific 
evidence.'' \19\ These statements are patently false. Data from 
scientific papers demonstrating the implausible nature of both M-BM and 
the NHANES dietary data \20\ were excluded from the 2015 DGAC's report, 
and have been excluded from all previous DGAC reports. The decades-long 
exclusion of contrary data is in violation of the Data Quality Act,\21\ 
and is indicative of the bias and scientific misconduct (i.e., omission 
of data) of the DGAC.
---------------------------------------------------------------------------
    \17\ See supra note 15 at 00.12.26-00.12.30 (emphasis added).
    \18\ Id. at 01.53.12-01.53.17 (emphasis added).
    \19\ Statement by Thomas J. Vilsack, Sec'y of Agric., U.S. House of 
Rep. Committee on Agric.(Oct. 7, 2015) at 5.
    \20\ See, e.g., Exhibit C (Archer E., Hand G.A., Blair S.N., 
Validity of U.S. Nutritional Surveillance: National Health and 
Nutrition Examination Survey Caloric Energy Intake Data, 1971-2010, 
PLoS One (2013), at 8(10):e76632), available at http://
journals.plos.org/plosone/article?id=10.1371/journal.pone.0076632 (last 
accessed Oct. 19, 2015).
    \21\ Pub. L. No. 106-554, H.R. 5658 (Treasury and Gen. Gov't 
Appropriation Act for Fiscal Year 2001,  515 Appendix C, 114 Stat. 
2763A-153 (2000) (effective Oct. 1, 2002).
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            Sincerely,
            
            [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            
Edward Archer, Ph.D., M.S.
                              exhibit a *
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    * The document referred to is retained in Committee file.
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                               exhibit b
The Inadmissibility of What We Eat in America and NHANES Dietary Data 
        in Nutrition and Obesity Research and the Scientific 
        Formulation of National Dietary Guidelines
Mayo Clinic Proceedings
Article in PressDSpecial Article
          Mayo Clin Proc. n XXX 2015;nn(n):1-16 n http://dx.doi.org/
        10.1016/j.mayocp.2015.04.009  
        www.mayoclinicproceedings.org  2015 Mayo Foundation for 
        Medical Education and Research.*
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    * From the Office of Energetics, Nutrition Obesity Research Center, 
University of Alabama at Birmingham, Birmingham (E.A., G.P.); and 
Department of Cardiovascular Diseases, John Ochsner Heart and Vascular 
Institute, Ochsner Clinical School the University of Queensland School 
of Medicine, New Orleans, LA (C.J.L.).

Edward Archer, Ph.D.; Gregory Pavela, Ph.D.; and Carl J. Lavie, M.D.
Abstract
    The Scientific Report of the 2015 Dietary Guidelines Advisory 
Committee was primarily informed by memory-based dietary assessment 
methods (M-BMs) (e.g., interviews and surveys). The reliance on M-BMs 
to inform dietary policy continues despite decades of unequivocal 
evidence that M-BM data bear little relation to actual energy and 
nutrient consumption. Data from M-BMs are defended as valid and 
valuable despite no empirical support and no examination of the 
foundational assumptions regarding the validity of human memory and 
retrospective recall in dietary assessment. We assert that uncritical 
faith in the validity and value of M-BMs has wasted substantial 
resources and constitutes the greatest impediment to scientific 
progress in obesity and nutrition research. Herein, we present evidence 
that M-BMs are fundamentally and fatally flawed owing to well-
established scientific facts and analytic truths. First, the assumption 
that human memory can provide accurate or precise reproductions of past 
ingestive behavior is indisputably false. Second, M-BMs require 
participants to submit to protocols that mimic procedures known to 
induce false recall. Third, the subjective (i.e., not publicly 
accessible) mental phenomena (i.e., memories) from which M-BM data are 
derived cannot be independently observed, quantified, or falsified; as 
such, these data are pseudoscientific and inadmissible in scientific 
research. Fourth, the failure to objectively measure physical activity 
in analyses renders inferences regarding diet-health relationships 
equivocal. Given the overwhelming evidence in support of our position, 
we conclude that M-BM data cannot be used to inform national Dietary 
Guidelines and that the continued funding of M-BMs constitutes an 
unscientific and major misuse of research resources.

          2015 Mayo Foundation for Medical Education and Research 
         Mayo Clin Proc. 2015;nn(n):1-16.

          When the facts change, I change my mind.
          What do you do, sir?
                    John Maynard Keynes 1, p. 19
Success, Failure, and Confusion in Nutrition Research
    During the past century, our nation's food supply and the 
nutritional status of Americans have improved to a level unparalleled 
in human history.\2\-\3\ Although this reality may be 
contrary to the popular belief that our modern diet is inherently 
inadequate, the data are clear. In the early 20th century, nutritional 
diseases such as pellagra, beriberi, rickets, and goiter were 
substantial public health challenges. In the United States alone, 
pellagra (a disease of niacin deficiency) claimed more than 100,000 
lives and severely affected more than three million people.\4\ Yet in 
2013, the Centers for Disease Control and Prevention's Second National 
Report on Biochemical Indicators of Diet and Nutrition reported that 
nearly ``80% of Americans (aged %6 y) were not at risk of deficiencies 
in any of the 7 vitamins'' 4, p. 938 examined via biomarkers 
(i.e., vitamins A, B6, B12, C, D, E, and folate; 
emphasis added).\2\ In addition, approximately 90% of women of 
childbearing age (12-49 years) were not at risk for iron deficiency, 
and folate levels have increased by approximately 50% since the 
previous national report.2, 5 As such, most of the U.S. 
population is not at risk for nutritional deficiencies, and neither do 
they have nutritional deficienciesand associated diseases.
    Given these important improvements in diet-related health and 
recent work demonstrating that nongenetic evolution is the predominant 
driver of the diseases of excess (e.g., obesity and type 2 diabetes 
mellitus),\6\-\8\ it can be posited that diet is no longer a 
major risk factor for disease for most Americans. If accurate, this 
hypothesis suggests that the billions of research dollars targeted for 
diet and nutrition-related health research are 
misdirected.\9\-\10\ Nevertheless, despite the important 
dietary milestones of the past century and the substantial increases in 
Federal funding during the past 2 decades,\9\-\10\ research 
into human nutrition has been increasingly 
criticized.\11\-\13\ The genesis of these criticisms is the 
appalling track record of highly publicized nutrition claims derived 
from epidemiologic studies (e.g., see the studies by Stampfer, et 
al.\14\ and Rimm, et al.\15\) that consistently failed to be supported 
when tested using objective study designs. 11, 16 Young and 
Karr examined \17\ more than 50 nutritional claims from observational 
studies for a variety of dietary patterns and nutrient supplementation 
and found that ``100% of the observational claims failed to replicate'' 
p. 117 and that five claims were statistically significant 
``in the opposite direction.'' p. 117 These outcomes and 
others \18\-\21\ suggest that as often as not, when 
epidemiologic nutrition claims are tested against objective research 
methods, the results are either inconclusive or indicative of a 
contrary outcome.
A Failed Research Paradigm
    Epidemiologic studies suggest that almost any nutrient can be 
associated with a myriad of outcomes,11, 22 as observed in 
Schoenfeld and Ioannidis' article, ``Is Everything We Eat Associated 
With Cancer?'' 22, p. 117 With persistent cycles of specious 
nutrition claims in the media, it is not surprising that the public is 
confused and incredulous.\23\ Insofar as the provision of clear and 
consistent Dietary Guidelines for the consuming public is a goal of 
nutrition epidemiology, it has failed in decisively answering the 
simple question, ``What should we eat?'' \24\ Nowhere is this fact more 
evident than the shifting sands of opinion on the relative risks of 
fat, salt, cholesterol, and sugar.\25\-\30\ Five decades of 
controversy surrounding basic Dietary Guidelines and nutrition 
recommendations is a public acknowledgement of a failed research 
paradigm. The striking incongruence between the improvements in the 
nutritional status of the U.S. population2, 5 and the 
current state of confusion, controversy, and clinical failure of 
epidemiologic nutrition research could not be clearer and necessitates 
an examination of the validity and value of epidemiologic nutrition 
research.
Purpose of this Review
    Memory-based dietary assessment methods (M-BMs) (e.g., interviews, 
questionnaires, and surveys \31\-\32\) are the dominant data 
collection protocols in national nutrition surveillance \33\ and 
government-funded epidemiologic nutrition \34\ and obesity \33\ 
research. Importantly, M-BM data are used to inform national 
nutritional policy and Dietary Guidelines.\30\ The recent Scientific 
Report of the 2015 Dietary Guidelines Advisory Committee (DGAC) stated 
explicitly that most of the DGAC data analyses used the M-BMs of the 
National Health and Nutrition Examination Survey (NHANES) dietary 
component, What We Eat in America (WWEIA).\30\ Although decades of 
unequivocal evidence demonstrate that the indirect, proxy estimates 
derived from M-BMs bear little relation to actual energy or nutrient 
consumption,13, 33, 35-45 the underlying assumptions 
regarding the validity of human memory and recall in dietary assessment 
have not been questioned. To the contrary, M-BM data are vigorously 
defended as valid and inherently valuable despite no empirical support 
for those assertions.\46\ Although the relationship between two 
different constructs may be expected to be weak, the trivial 
relationships between the proxy estimates (i.e., self-reported energy 
intake [EI] and nutrient intake) and their referents (i.e., actual EI 
and nutrient intake) are unacceptable. We assert that the explanatory 
and predictive failure of epidemiologic nutrition research is explained 
by its reliance on M-BMs, and, as such, the uncritical faith in the 
validity and value of M-BMs has wasted significant resources and 
constitutes the single greatest impediment to actual scientific 
progress in the fields of obesity and nutrition research.
    The purpose of this review is to survey the explanatory and 
predictive failure of nutrition epidemiology in 
general,11, 17 with a focus on the WWEIA-NHANES data,\33\ 
and argue that these failures are due to the reliance on M-BMs. First, 
we present evidence that the anecdotally derived proxy data produced by 
M-BMs bear little relation to actual EI or nutrient 
consumption.13, 33, \35\-\45\ Second, we provide 
interdisciplinary evidence that human memory is an amalgam of 
constructive and reconstructive processes \47\-\52\ (e.g., 
imagination \53\) that render the archival model of human memory \54\ 
and the naive assumption that recall provides literal, accurate, or 
precise reproductions of past events indisputably 
false.50, 52, \55\-\58\ Third, M-BMs require 
respondents to undergo protocols \59\ and perform behaviors \31\ that 
mimic procedures known to induce false 
recall.50, 52, 53, 60, 61 Fourth, the subjective (i.e., 
private, not publicly accessible) mental phenomena (i.e., memories) 
from which M-BM data are derived are not subject to independent 
observation, quantification, falsification, or verification; as such, 
M-BM data are pseudoscientific and inadmissible in scientific 
research.\62\-\66\ Fifth, the failure to accurately and 
objectively measure and control for physical activity (PA), 
cardiorespiratory fitness (CRF), and other obvious confounders annuls 
inferences regarding diet-health relationships.
The M-BMs of Nutrition Epidemiology
Self-Reported Dietary Intake
    The primary methods of data collection for nutrition epidemiologic 
research (e.g., the WWEIA-NHANES) are M-BMs (e.g., 24 hour dietary 
recalls [24HRs] and food frequency questionnaires [FFQs] 
\31\-\33\). For clarity, these methods do not directly or 
objectively measure EI or nutrient intake, and neither do they directly 
or objectively measure food and beverage consumption. The actual data 
derived from M-BMs are the a priori numeric values from nutrient 
databases that are assigned by researchers to the participants' reports 
of their memories of past eating and drinking behaviors. In other 
words, nutrition researchers designate numeric values to whatever the 
respondents are willing or able to recall about what they think (or 
would like the researcher to think \67\) he or she consumed during the 
study period. Given the indirect, pseudoquantitative (i.e., number-
generating \68\) nature of M-BMs and the fact that the respondents' 
reports of their memories are subject to intentional and unintentional 
distorting factors (e.g., perceptual, encoding, and retrieval errors; 
\69\ social desirability; \42\ false memories; \55\ and omissions 
48, 49, 70), it is not surprising that most conclusions 
drawn from these number-generating protocols have not been supported 
when subjected to rigorous objective examination.11, 17
The Implausibility of M-BMs in Dietary Assessment
          It is the natural tendency of the ignorant to believe what is 
        not true. In order to overcome that tendency it is not 
        sufficient to exhibit the true; it is also necessary to expose 
        and denounce the false.
                         H.L. Mencken 71, p. 124

    Research into M-BMs reports a wide range of EIs that are not 
physiologically plausible (i.e., incompatible with survival) and that 
do not accurately quantify the foods and nutrients 
consumed.11, 33, 35, 38-40, 42 Recently, we used multiple 
methods to ascertain the validity and plausibility of the NHANES and 
WWEIA-NHANES EI data from 1971 to 2010 \33\ and found that they had 
such severe systematic biases as to render them fatally flawed. Given 
that ``[a] cross the 39 year history of the NHANES, [self-reported 
energy intake] data on the majority of respondents (67.3% of women and 
58.7% of men) were not physiologically plausible'' \33\ (Figure), we 
concluded that these data are not valid for any inferences regarding EI 
and the etiology of the obesity epidemic. A recent editorial in the 
British Medical Journal concurred and stated that the NHANES dietary 
data are ``incompatible with life.'' 11, p. 7
    In a previous report,\33\ we used two objective, physiologically 
based methods to determine misreporting: (1) Goldberg cutoff values 
44, 45, 72 (i.e., reported EI [rEI] divided by basal 
metabolic rate [BMR]) and (2) the disparity between the Institute of 
Medicine total energy expenditure (TEE) equations \73\ and rEI via 
NHANES MBMs. The two methods were in close agreement, demonstrating 
significant misreporting. The cutoff values we used (i.e., rEI/BMR 
<1.35 and >2.40) were more generous than the rEI/BMR cutoff value of 
1.50 suggested by Goldberg et al.\45\ when using a single 24HR, and the 
BMR is ``predicted from the Schofield equations'' with a sample size of 
300 or greater.45, p. 577 Given the reduced sensitivity of 
the cutoff values, we captured far fewer under-reporters. As reported, 
when using the proposed cutoff value of 1.50, under-reporting increased 
to more than 70% for the entire NHANES sample and to approximately 77% 
and 85% for obese men and women, respectively. We also reported the 
large and significant disparity between rEI and the Institute of 
Medicine TEE: ^467 and ^554 kcal/d (>17% and 30%) for obese men and 
women, respectively. In addition to under-reporting, there was 
significant overreporting in all of the subpopulations (e.g., normal, 
overweight, and obese men and women). One important caveat with the use 
of cutoff values is that the term plausible reporter is not synonymous 
with accurate reporter. Participants with high levels of PA may 
substantially underreport yet still be considered plausible reporters.
Figure

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          Percentage of implausible reporters by body mass index (BMI) 
        for U.S. women aged 20 to 74 years in the National Health and 
        Nutrition Examination Survey (NHANES) (1971-2010). 
        Physiologically implausible values were determined via the 
        following equation: (reported energy intake/basal metabolic 
        rate) 1.35. Implausible values may be considered 
        ``incompatible with life.'' 11, p. 7

    Given these results, we ask four questions, (1) What is the value 
of WWEIA-NHANES M-BM data if 70% to 80% of obese women's self-reported 
EI is physiologically implausible and, therefore, incompatible with 
life (Figure)? (2) Given the extant objective data on the nutrition-
related health status of Americans,\2\ why does the DGAC rely on the 
subjective M-BM data? \30\ (3) What is the ``unrealized potential'' 
46, p. 447 and ``utility'' 74, p. 5 of these data 
when implausible overreporting and implausible underreporting are 
demonstrated in all of the subgroups? (4) Can statistical alchemy 
transform these implausible data into valid estimates of dietary 
consumption, or will it continue to spawn searches for machinations 
that generate numbers with improved correlations (i.e., post hoc data 
manipulation) while ignoring the lack of validity?
The Pervasiveness of Implausible Results
    The conclusions drawn by our study \33\ and the recent British 
Medical Journal editorial \11\ are, in fact, supported by many decades 
of evidence demonstrating that M-BMs have severe, intractable 
systematic biases that render the data implausible and, therefore, 
invalid.11, 13, 37, 44, 75, 76 Research with ``. . . 
motivated . . . well-educated, non-smoking-Caucasians'' 
35, p. 957 (i.e., respondents less likely to misreport) 
demonstrated that compared with doubly labeled water, a biomarker for 
TEE, self-reported dietary intake was significantly 
misestimated.35, 38 Men underreported EI 12% to 14% using 
the average of two 24HRs and 31% to 36% using FFQs. Women underreported 
by 16% to 20% using the average of two 24HRs and by 34%to 38% using 
FFQs. Contrary to the oft-repeated statement that additional self-
reports improve precision and accuracy, the second administration of 
the 24HR ``showed greater underreporting.'' 38, p. 12 These 
results are in agreement with our analyses of the NHANES in which the 
mean estimates for the second 24HR in every NHANES wave from 2001 to 
2010 exhibited significantly greater levels of underreporting than the 
first. We agree with the authors of the Observing Protein and Energy 
Nutrition study when they wrote, ``[w]e measure energy so poorly . . 
.'' 38, p. 12 and ``[t]he
24HR . . . may be particularly problematic in the obese.'' 35,p956 
These words echo statements on underreporting from 60 years ago.\77\
    Recently, some of the strongest proponents of M-BMs have provided 
additional data that clearly demonstrate the futility of the continued 
use of these methods.\36\ In the paper by Freedman, et al.,\36\ the 
pooled, squared average correlation between true EI and self-reported 
EI were similar to our results using NHANES data, ranging from 0.04 to 
0.10. This suggests that the measurement noise (i.e., error) is more 
than nine times greater than the signal (i.e., valid information) 
derived from M-BMs. Nevertheless, an important finding from the 
Observing Protein and Energy Nutrition study that Freedman, et al.\36\ 
overlook in their analyses is that despite the fact that the second 
administration of the 24HR ``showed greater underreporting,'' 
38, p. 12 the correlations between true and reported EI 
increased. This demonstrates an increase in precision with a 
concomitant reduction in the accuracy of the estimate. These results 
clearly support our position that M-BM data ``offer an inadequate basis 
for scientific conclusions'' 13, p. 1413 and, more 
importantly, that statistical machinations, however sophisticated, 
cannot overcome the systematic recall bias that renders all inferences 
suspect.41, 78
    The phenomenon of misreporting is not limited to U.S. epidemiologic 
studies or specific populations.\45\ The European Prospective 
Investigation Into Cancer and Nutrition study is one of the largest 
epidemiologic studies in the world and found strong evidence of 
systemic underreporting across all study sites, with approximately 10% 
to 14% of survey respondents being ``extreme underreporters,'' 
79, p. 1329 and ``. . . most centres were below the expected 
reference value.'' 79, p. 1330 These results are consistent 
with research from the early 1990s that found that more than 65% of the 
mean rEI values were physiologically implausible in 37 studies across 
ten countries.\45\ The misreporting value of more than 65% is 
strikingly similar to our NHANES results using similar methods.\33\ In 
2015, a multinational report demonstrated that misreporting ``in five 
populations of the African Diaspora'' 80, p. 464 was 
substantial, with the South African cohort exhibiting an astounding 
52.1% underreporting of dietary EI.\80\ With respect to age, Forrestal 
\81\ found in children and adolescents that misreporting ``. . . 
appeared to be more common than it is among adults.'' p. 112 
The ubiquitous nature of misreporting and the consistency of research 
results over many decades and across multiple populations, cohorts, and 
countries provide strong support that M-BM measures of EI are fatally 
flawed, and, therefore, diet-health inferences from studies that use M-
BMs are essentially meaningless.
Examinations of Dietary Patterns via M-BMs
    It is well-established that specific macronutrients, foods, 
beverages, and food groups (e.g., protein, fat, carbohydrate, alcohol, 
sugar, and vegetables) are subject to differential misreporting that 
significantly affects subsequent estimates of 
EI.38, 78, 82-88 Because EI is the foundation of dietary 
consumption and all nutrients must be consumed within the quantity of 
food and beverages needed to meet minimum energy requirements,\89\ it 
is a logical and analytic truth that dietary patterns (i.e., 
macronutrient and micronutrient consumption; e.g., protein, 
carbohydrate, fat, vitamins, and minerals) are differentially and 
unpredictably misreported when total rEI is physiologically 
implausible. For example, both macronutrient and micronutrient 
composition are significantly altered in underreporters, with reported 
fat and carbohydrate consumption often lower and reported protein, 
fruit, and vegetable intakes higher.42, 82, 86 In other 
words, participants qualitatively and quantitatively misreport owing to 
both unintentional (e.g., forgetting and false memories) and 
intentional (e.g., health-related perceptions) factors. This 
nonuniformity of misreporting leads to macronutrient- and 
micronutrient-specific errors,\86\ -\87\ which alter 
nutrient to EI ratios in an unpredictable and nonquantifiable manner. 
This simple fact renders energy adjustments fallacious 
41, 78 and demonstrates that the assumption that M-BM data 
can be used to examine patterns of diet or dietary composition is not 
logically valid.
The Validity of Human Memory and Recall as Instruments for the 
        Generation of Scientific Data
Overview
    The use of M-BMs requires faith in the belief that human 
perception, memory, and recall are accurate and reliable instruments 
for the generation of scientific data. Nevertheless, more than 80 years 
of research demonstrates that this belief is patently 
false.50, 58, 70, 90 The discrepancy between objective 
reality and human memory is well established,48, 91 and the 
limitations of recall are widely acknowledged in disciplines outside of 
nutrition and obesity.47-49, 69, 70, 92 In fact, the 
scientific study and analysis of memory would be impossible if it were 
not for the inherent fallibility of memory.\49\ Bartlett \93\ presented 
the first empirical evidence that the human memory is not a literal, 
accurate, or precise reproduction of past events. During the ensuing 80 
years, research has clearly demonstrated that the encoding of memories 
69, 91 and subsequent recall depend on constructive and 
reconstructive processes (e.g., imagination) 48, 69, 53 that 
are susceptible to errors, distortions, omissions, complete 
fabrications, false reports, and 
illusions.50, 58, 69, 70, 90
    Given the breadth of this research, reported memories, such as 
those presented in 24HRs and FFQs, can be most accurately defined as 
mere attributions based on mental experiences that are strongly 
influenced by the respondents' idiosyncratic qualities (i.e., 
education), previous memories and information, knowledge and beliefs, 
motives, goals, habitual behavior, and the social context in which the 
memories are encoded or reported.47, 49, 58 Perhaps the most 
salient example of the fallibility of memory and recall (and misplaced 
confidence) is that false reporting (i.e., inaccurate eyewitness 
testimony) was a key factor in approximately 75% of the first 100 cases 
of individuals exonerated by DNA evidence after conviction for crimes 
that they did not commit.\57\ The following subsections provide a 
survey of the evidence to support the contention that data can be only 
as valid as the accuracy of the instrument used in its collection and 
that human memory and recall are not valid instruments for the 
generation of data to be used in the scientific formulation of 
nutrition guidelines.
The Social Sciences
    Numerous studies, dating back more than 50 years, have reported 
that there is little or no correlation between self-reported behavior 
and actual behavior.\94\-\95\ Bernard, et al.\58\ reviewed 
the validity of self-reported data in ``The Problem of Informant 
Accuracy.'' Surveying multiple research domains, including health care, 
child care, communications, nutrition, criminal justice, economics, 
anthropology, and psychology, Bernard, et al.\58\ concluded that 
``[t]he results of all of these studies leads to one overwhelming 
conclusion: on average, about \1/2\ of what informants report is 
probably incorrect in some way.'' p. 503 Bernard, et al.\58\ 
also provide a prescient commentary: ``In sum, despite the evidence, 
the basic fact of informant inaccuracy seems not to have penetrated 
either graduate training or professional social science research. 
Informant inaccuracy remains both a fugitive problem and a well-kept 
open secret.'' p. 504 Given the substantial funding of M-BMs 
each year,\9\ -\10\ it seems that this 30 year old 
commentary also applies to nutrition and obesity research.
    Furthermore, when events or behaviors are commonplace (e.g., food 
and beverage consumption), previous experiences (e.g., previous 
memories and mental schema 69, 96 of past meals) will 
determine what is encoded in memory and not the actual perception of 
behavior. For example, Freeman, et al.\97\ demonstrated a 52% error 
rate in recalling social interactions, with reports of social 
interactions shaped by typical past experiences. They explain their 
results by suggesting that when events are repeatedly experienced, each 
specific event will be minimally processed and the ``actual memory of 
such elements will be poor,'' and ``attempts at recall result in a 
constructive process that taps into the general structure rather than 
the specific memory.'' 97, p. 315
    Importantly, Bernard, et al.\58\ lamented two common problems with 
social scientific data: (1) the lack of an explicit formal theory of 
human behavior and (2) objective evidence from which to test the 
plausibility of self-reported data. Nevertheless, nutrition 
epidemiologists have both a formal theory (i.e., human metabolism and 
the basic energy requirements of human life) and voluminous objective 
data \44\-\45\ by which to test the validity of M-BMs.\33\ 
Despite the availability of formal theory and overwhelming evidence 
that self-reported EI data are not accurate, ``plausible,'' \33\ or 
even ``compatible with life,'' 11, p.7 self-reported EI 
continues to be assumed a valid-measure of actual energy and nutrient 
consumption that can be used to inform public nutrition and dietary 
policy.\30\
    A detailed review of the social research literature is beyond the 
scope of this paper, and we direct our readers to Bernard, et al.'s 
review.\58\ Nevertheless, one more notable example is warranted. 
Immediately on leaving a restaurant, Kronenfeld, et al.\98\ had 
participants report on the attire of the waitstaff and the restaurants' 
choice of music.\58\ Participants demonstrated much greater agreement 
on what the waiters were wearing compared with the waitresses' attire. 
The interesting finding was that these restaurants had an all-female 
waitstaff (i.e., there were no waiters in the restaurants). 
Participants also provided much greater detail on the music from 
restaurants that were not playing music than from restaurants that 
were.58, 98 These results raise the question: What is the 
possibility that self-reported food and beverage consumption in a 
restaurant setting will be a literal, accurate, or reliable 
representation of actual ingestive behavior?
Cognitive Neuroscience
    The domain of cognitive neuroscience supports the hypothesis that 
human memory is an amalgam of dynamic constructive and reconstructive 
processes.47-53, 55-57, 69, 70 For example, encoding is not 
a process that begins de novo with each perception. Encoding is the 
result of the limited amount of information available to perception at 
any given moment being ``patched together to form memories with varying 
degrees of accuracy'' 49, p. 149 (e.g., the process of 
associative grouping via semantic relatedness 50, 92, 99) 
and subject to ``the distorting influences of present knowledge, 
beliefs, and . . . previous experience.'' 49, p. 149 As 
such, the general knowledge and availability of mental schemas from 
previous eating occasions intrude on the encoding of current 
consumption to produce false and fuzzy (i.e., gist) 
memories.51, 100 Memory and recall are subject to a myriad 
of unintentional ``sins,'' \70\ including but not limited to 
distortions, misattribution, suggestibility, simple forgetting, 
falsehoods, and omissions.49, 90-91 Because selective and 
elaborative processes operate on the perceptions that are encoded and 
recalled, ``memory does not [and cannot] operate like a video 
recording.'' 57, p. 119
    Recently, the process of reconsolidation (i.e., the reconstruction 
and re-encoding of memories after recall) has been demonstrated in 
rodents, and the evidence in humans is 
supportive.\101\-\102\ Reconsolidation involves the same 
neural processes as the encoding of the original memory.\91\ Therefore, 
each time a memory is recalled, it is irretrievably changed such that 
the original memory no longer exists and a new memory of unquantifiable 
error replaces it.\101\-\102\ This fact has implications for 
the current state-of-the-art 24HR instrument the U.S. Department of 
Agriculture (USDA) Automated Multiple-Pass Method.\31\ With each pass 
of the multipass procedure, the process of reconsolidation alters the 
original memory so that by the end of the data collection period, the 
result will be an amalgam of multiple new memories and reports with 
unquantifiable error. As such, neither the researchers nor the 
participants know the validity or reliability of the reported food and 
beverage consumption.
False Reporting: An Inherent Design Feature of M-BMs
False Reporting and FFQs
    False reports are the recollection of an event, or details of an 
event, that did not actually occur.\69\ False memories and recalls may 
be produced in multiple contexts (e.g., during 
research,55, 103 psychotherapy, and criminal investigatory 
interviews \60\). Although research has demonstrated that false 
memories of ingestive behavior and subsequent false reporting of foods 
occur in laboratory settings,55, 61, 103 there is a larger 
literature base outside of nutrition. The Deese-Roediger and McDermott 
(DRM) paradigm is commonly used in research settings to elicit false 
reports.\104\-\105\ In this protocol, a list of semantically 
related words (e.g., breakfast, bacon, sausage, orange juice, and 
cereal) are presented or read to participants. After a delay (minutes 
to days), participants are asked to report the words they remember. The 
mere presentation of lists of semantically related words induces 
extremely high levels (i.e., >75%) of the false reporting of related 
but nonpresented words (i.e., critical lures; 49, 99, 105 
e.g., the word egg in the previous example). The DRM paradigm is so 
effective at inducing false reports that memory distortions occur even 
in the small percentage of individuals with highly superior 
memories.\50\ With the DRM paradigm, respondents are often more 
confident in their false reports than in the presented words.\92\
    Researchers familiar with FFQs will recognize that, by design, FFQs 
mimic the DRM protocol in that lists of semantically related words 
(i.e., foods and beverages) are presented and respondents are expected 
to provide a response. Given that FFQs mimic the procedures designed to 
produce false recall, it is not surprising that FFQs with longer lists 
of semantically related words elicit more responses.\106\ Given the 
vast literature demonstrating misreporting with FFQs 
35, 38, 42, 107 and the parallel literature on the extremely 
high level of false reports using the DRM 
paradigm,92, 100, 104-105 it is not a question of whether 
FFQs induce false reporting but to what extent. As stated previously, 
neither the researchers nor the participants know the validity or 
reliability of the reported food and beverage consumption, and neither 
can they quantify the error induced via false reporting. As we discuss 
in a later section, the inability of current nutrition epidemiologic 
research designs to independently falsify or confirm M-BM data renders 
the error due to false reports unquantifiable and, therefore, 
inadmissible as scientific data.
False Reporting and the WWEIA-NHANES 24HR
    Recent research has examined the effects of creating ``false 
memories for food preferences and choices.'' 55, 61, p. 134 
We refer our readers to a review by Bernstein and Loftus.\55\ Their 
work has established that it is relatively simple to ``implant false 
beliefs and memories regarding a variety of early childhood food-
related experiences.'' 55, p. 138 We assert that false 
memories and reports are induced via the NHANES interview protocol 
itself, as has been demonstrated in other interviewing contexts.\60\ 
The factors that potentially induce false memories and reporting are 
well established. For example, the development of a rapport between an 
authority figure and respondents followed by the use of guided imagery, 
silence in responding, repetition, props, suggestive or repeated 
questioning, and encouragement to reminisce, imagine, or elaborate on 
past behaviors have all been shown to increase false 
recall.55, 69, 91, 92, 100, 105 All of these factors are 
explicitly described in the training manual for the research personnel 
who conduct the NHANES 24HR.\59\ The use of rapport, silence, imagery, 
props, repeated questioning, eye contact, and ``expectant looks,'' 
p. 4-12 to ``motivate the respondent to answer more 
fully'',p. 4-4 are explicit and noteworthy in the training 
manual.\59\ For example, the following directive is an exemplar of the 
potentially false memorye inducing protocol: ``If you sit quietly--but 
expectantly--your respondent will usually think of something. Silence 
and waiting are frequently your best probes for a `don't know' reply. 
Always try at least once to obtain a reply to a `don't know' response, 
before accepting it as the final answer.'' 59, p. 4-13 The 
use of rapport combined with repeated questioning, silence, eye 
contact, and expectant looks is especially coercive when applied by an 
authority figure in a research context. In addition, NHANES personnel 
are directed to ask respondents to ``imagine,'' and ``think'' about 
their food intake and to ``encourage'' and ensure that the respondents 
are ``convinced of the importance of the survey.'' 
59, p. 4-3 Throughout the manual there are examples of 
guided imagery and suggestive questioning, such as directing 
participants to begin ``thinking about where you were, who you were 
with, or what you were doing, like working, eating out, or watching 
television,'' 59, p. 6-2 and directives such as, ``Your own 
state of mind your conviction that the interview is important will 
strongly influence the respondent's cooperation. Your belief that the 
information you obtain will be significant and useful will help 
motivate the respondent to answer fully . . .'' p. 4-4 
Although the NHANES training manual states that ``[t]his methodology is 
designed to maximize respondents' opportunities for remembering and 
reporting foods they have eaten,'' p. 6-2 the scientific 
literature on false memories and recall strongly supports the 
contention that the NHANESM-BM generates significant false reporting. 
Given that imagination and coercive techniques (e.g., the use of 
silence \59\) are known to increase the probability of illusory (i.e., 
false) recollections,53, 60 it may be that most 24HR data 
are false reports. If true, the NHANES 24HR is a mere exercise in 
number generation, and, therefore, by design, it does not provide proxy 
estimates of energy or nutrient consumption. This premise provides an 
empirically supported explanation why most M-BM data are implausible 
and have trivial relationships with reality (i.e., actual EI and 
nutrient intake.) Nevertheless, without objective corroboration it is 
impossible to quantify what percentage of the recalled foods and 
beverages are completely false, grossly inaccurate, or somewhat 
congruent with actual consumption. Regardless, it is clear that people 
consistently ``remember [and report] events that never happened.'' 
105 ,p. 803
The Inadmissibility of M-BM Data
Criteria for Scientific Research: Observable, Measurable, and 
        Falsifiable
    Although the terms science and research are used interchangeably, 
they are not synonymous. Science is more than mere data collection; it 
is an attempt to discover order, a potentially self-correcting, 
explanatory, and predictive process that demonstrates lawful relations 
(e.g., diets high in vitamin C prevent scurvy). In contrast, research 
is simply the process of collecting information, and many forms of 
research do not meet the rigor necessary for the results to be 
scientific. There is a long history of efforts to formally demarcate 
scientific from nonscientific and pseudoscientific data, the most 
famous of which may be Popper's falsifiability 
criterion.\64\-\66\ For example, in U.S. jurisprudence, the 
Daubert standard \108\-\109\ provides the rules of evidence 
for the admissibility of expert testimony. The criterion of 
falsifiability is central to expert scientific testimony and was used 
by Judge William Overton in ruling in McLean v. Arkansas Board of 
Education. This case determined that creation science was not a science 
because it was not falsifiable and, therefore, could not be taught as 
science in Arkansas public schools.\110\ As we detail in later 
sections, we assert that M-BM data are akin to creation science in that 
they fail to meet the basic requirements of scientific research.
    Although philosophers continue to debate demarcation criteria, 
practicing scientists must set forth principles from which to judge the 
admissibility of data in scientific research. We extend Popper's 
criterion and proffer the following widely accepted principles of 
scientific inquiry. First, for results to be scientific, the study's 
protocols must produce outcomes that are subject to replication. To 
accomplish this goal, the data must be (1) independently observable 
(i.e., accessible by others), (2) measureable, (3) falsifiable, (4) 
valid, and (5) reliable. These nonmetaphysical criteria were first 
suggested by Roger Bacon in the 13th century and later were elaborated 
on by the ``father of empiricism,'' Sir Francis Bacon, in the late 16th 
century.\111\ They were again reiterated by Sir Isaac Newton in the 
17th century \112\ and have been subsequently clarified and 
defined.62-66, 68 The skepticism and empirical rigor 
inherent in these criteria are of such importance to science that The 
Royal Society of London, the oldest scientific society in the modern 
world, succinctly summarized them in its motto, Nullius in Verba. This 
phrase, derived from Horace's Epistles,\113\ is translated as ``on the 
word of no one'' or ``take no one's word for it'' and suggests that 
scientific knowledge should be based not on authority, rhetoric, or 
mere words but on objective evidence.
    The first three criteria (i.e., independently observable, 
measureable, and falsifiable) define the phenomena that are in the 
domain of science (i.e., able to be examined via the scientific 
method), and the final two criteria (i.e., validity and reliability) 
refer to the concordance between a measurement and its referent as well 
as the error associated with the measurement protocols used to collect 
the data. Together, the five basic tenets distinguish scientific 
research from mere data collection and pseudoscience. For example, if 
someone is eating an apple, his or her behavior can be independently 
observed, measured, and verified or refuted. Yet, if he or she reports 
eating an apple at some point in the past (e.g., as with an FFQ or 
24HR), neither the past behavior nor the neural correlates of the 
memory of that behavior are independently observable or quantifiable, 
and without additional information, his or her statement cannot be 
falsified or confirmed. It is a rather obvious fact that the respondent 
is the only person who has access to the raw data of M-BMs (i.e., his 
or her memories of consumption). As such, researchers cannot examine 
the validity of the memory and base M-BM research results on their 
faith in the verbal report (i.e., the belief that the participant is 
telling the truth). Nevertheless, faith and belief are basic tenets of 
religion, not science. The unwavering credulity of nutrition 
epidemiologists with respect to verbal reports is literally in direct 
opposition to Nullius in Verba (i.e., take no one's word for it) and 
skeptical, rigorous science. The confluence of these simple facts and 
the well-documented failure of self-reported EI to accurately 
correspond to reality,33, 35 demonstrate that the memory and 
subsequent recall of ingestive behavior are not within the realm of the 
scientific investigation of nutrition and obesity. As the philosopher 
Karl Popper stated, ``all the statements of empirical science must be 
capable of being finally decided, with respect to their truth and 
falsity,'' 65, p. 17 and it is wholly impossible to verify 
or refute something that cannot be directly or indirectly independently 
observed and measured (e.g., memories).
The Pseudoscience of Nutrition Epidemiology
    The term pseudoscience describes data or results that are presented 
as scientific but lack plausibility because they cannot be reliably, 
accurately, and independently observed, quantified, and confirmed or 
refuted.\62\-\66\ When M-BMs are examined from the 
perspective of the basic tenets of science, the reason for the 
explanatory and predictive failure of epidemiologic nutrition research 
becomes obvious. First and foremost, scientific conclusions cannot 
result from nonempirical (i.e., unobserved) or subjective (i.e., 
private, not publically accessible) data that are not subject to 
independent observation, quantification, and falsification. When a 
person provides a dietary report, the data collected are not actual 
food or beverage consumption but rather an error-prone and highly 
edited anecdote regarding memories of food and beverage consumption. As 
such, M-BMs do not meet the basic requirements of the scientific method 
and, by definition, are pseudoscientific when presented as actual 
estimates of energy or nutrient consumption. Two famous physicists of 
the 20th century, Wolfgang Pauli and Arthur Schuster, summed up the 
problem with pseudoscientific data eloquently when they stated, 
respectively, that a pseudoscientific conclusion ``is not only not 
right, it is not even wrong . . .'' 114,p. 186 and ``[w]e 
all prefer being right to being wrong, but it is better to be wrong 
than to be neither right nor wrong .'' 115, p. 117
    It is difficult to determine the empirical consequences of M-BMs 
because the primary data (i.e., memories: private information to which 
the respondents have privileged access) do not meet the basic tenets of 
scientific methods (e.g., independent observation of data, 
falsifiability, and accuracy). If neither the researchers nor the 
participants are able to quantify what percentage of the recalled foods 
and beverages are completely false reports, grossly inaccurate, or 
reports that are somewhat congruent with actual consumption, it is 
impossible to know the validity and the error associated with each 
report. As Dhurandhar, et al.\75\ recently suggested, the use of M-BM-
based data is a context in which ``. . . something is not better than 
nothing.'' p. 1 Given the forgoing, M-BM-derived data are 
inadmissible and constitute a substantial ongoing threat to nutrition 
and obesity research and national Dietary Guidelines because the 
greatest obstacle to scientific progress is not ignorance but the 
illusion of knowledge created by pseudoscientific data that are neither 
right nor wrong.
    Nevertheless, performing rigorous science is a skill that can be 
learned, but only if mentors understand and practice rigorous science. 
Given the ubiquitous use of M-BMs over many decades, it seems that 
nutritional epidemiologists have eschewed the inherent rigor and 
skepticism of Nullius in Verba (i.e., take no one's word for it) and 
literally replaced it with Totius in Verba (i.e., take everyone's word 
for it). As a result, skeptical rigorous science is not practiced or 
taught in nutrition and obesity epidemiologic research.\24\
National Nutrition Surveillance: M-BM Data and USDA Food Availability 
        Economic Data
    If the two major components of U.S. national nutritional 
surveillance are valid (i.e., NHANES M-BM data and USDA Food 
Availability economic data), estimates from these surveillance tools 
should track together and independently provide population-level 
approximations of trends in food consumption or use. Nevertheless, 
history demonstrates that this is not the case. Trends in estimates of 
macronutrient consumption from population-level epidemiologic surveys 
(i.e., M-BMs) exhibited statistically significant trends that were in 
opposition to those of USDA economic data for fat, carbohydrates, 
protein, and energy (i.e., kilocalories per day) from the 1960s to the 
late 1980s.\116\ It should be apparent that U.S. residents could not be 
simultaneously consuming more and less fat, protein, carbohydrates, and 
energy over time. The contradictory patterns and striking lack of 
correspondence between the two primary U.S. nutrition surveillance 
tools suggest that one or more likely both protocols are invalid. As 
with the severe misreporting demonstrated across the 
globe,45, 80 these contradictory patterns are not limited to 
the United States; many countries exhibit considerable disparity 
between national surveillance via M-BMs and economic/food supply 
data.\117\-\120\ This fact is further evidence that M-BMs 
are fatally flawed and diet-health inferences from M-BM-derived data 
are meaningless.
PA and CRF: Essential Elements in Nutrition, Obesity, and Health 
        Research
    The lack of explanatory and predictive power of epidemiologic 
nutrition research may also be explained by the limited acknowledgement 
of nonnutritional determinants of health and disease, such as 
nongenetic evolution,\6\-\8\ PA,\121\-\122\ 
CRF,\123\ and other components of nutrient partitioning and energy 
balance.\124\-\130\ For example, more than 50 years ago the 
Food and Agriculture Organization of the United Nations and the World 
Health Organization determined that human food energy requirements 
should be estimated using TEE and that PA and basal energy expenditure 
were the primary determinants.\131\-\132\ Yet, most 
nutrition research does not measure any form of energy expenditure or 
objectively quantify PA. Currently, there is only one manuscript of 
which we are aware that uses the NHANES objectively measured PA data to 
directly assess nutrition-related outcomes \133\ and no nutrition-
related publications that include the NHANES treadmill CRF data in 
analyses. The lack of publications may be due to the fact that only two 
waves in the more than 40 year history of the NHANES include objective 
measures of PA, and despite the widespread acknowledgment of the 
necessity of daily PA for health and well-being, it is routinely 
discounted by governmental public health funding agencies. For example, 
PA, CRF, and exercise are not even listed on the National Institutes of 
Health's spreadsheet of categorical spending of nearly 250 
classifications through 2016.\9\ This is unfortunate given that 80% of 
Americans are not at risk for most nutritional deficiencies,\2\ but 95% 
of Americans are at risk for PA deficiency (i.e., inactivity or high 
sedentary behavior) and do not meet the Federal recommendations of 30 
minutes per day of moderate to vigorous PA.\134\
    Given that PA and CRF are major determinants of health 
122-123, 133, 135-137 and that PA is the only major 
modifiable determinant of TEE and nutrient-energy partitioning (i.e., 
the metabolic fate of the foods we consume),6, 124-130, 133 
it is clear that PA and CRF must be objectively measured and controlled 
for in analyses if the health effects of any dietary intervention are 
to be examined accurately. Yet, because PA questionnaires are 
susceptible to many of the same systematic biases 
75, 138-139 and inadmissibility issues as M-BMs, the failure 
to objectively-measure PA and control for it in analyses renders health 
inferences from previous nutrition epidemiologic studies moot. 
Fortunately, for the science of health and disease, there are objective 
tools for the measurement of PA (e.g., pedometers and accelerometry-
based PA monitors),\140\ and despite limitations,\141\ these should be 
used in place of surveys and questionnaires to quantify PA in future 
examinations of health and disease.
Summary and Future Directions
          A wise man proportions his belief to the evidence.
                           David Hume 142, p. 87

    This critical review provides empirical and analytic evidence to 
support the position that (1) M-BM estimates of EI and nutrient intake 
have trivial relationships with actual EI and nutrient intake; (2) the 
assumption that human memory and recall provide literal, accurate, or 
precise reproductions of past ingestive behavior is indisputably false; 
(3) M-BMs require participants to submit to protocols that mimic 
procedures known to induce false recall; (4) the subjective (i.e., 
private, not publically accessible) mental phenomena (i.e., memories) 
from which M-BM data are derived are not subject to independent 
observation, quantification, or falsification; therefore, these data 
are pseudoscientific and inadmissible in scientific research; and (5) 
the failure to objectively measure and control for PA and CRF in 
analyses renders inferences regarding most diet-health relationships 
moot.
    Given the overwhelming evidence in support of our hypotheses, we 
conclude that M-BM data cannot be used to informational Dietary 
Guidelines and that continued funding of M-BMs constitutes an 
unscientific and major misuse of research resources. In addition, given 
that there are objective data on the nutrition-related health status of 
Americans,\2\ we find the DGAC's reliance on M-BMs to be without 
scientific support or merit. We think that skepticism and rigor are 
essential requirements in scientific investigations, and we fault the 
overly credulous nature of nutrition epidemiology for the obvious and 
well-demonstrated failures of the scientific community to properly 
inform previous Federal Dietary Guidelines (e.g., cholesterol 
consumption).30, 143 We think that our nation's Dietary 
Guidelines should not be based on the pseudoscientific and highly 
edited anecdotes of M-BMs, and although others may disagree, we ask 
that they do as we have done and provide empirical evidence rather than 
rhetoric to support their positions. Without valid evidence, the 
dogmatic defense of illusory knowledge and the status quo in nutrition 
and obesity research (e.g., see previous commentaries and guidelines 
30, 46, 74) is an impediment to scientific progress and 
empirically supported public nutrition and obesity policy.
    We began this critical review with evidence that our nation's food 
supply and the nutritional status of Americans have improved to a level 
unparalleled in human history.2-3, 5 Given this reality and 
recent work on the intergenerational transmission of obesity and type 2 
diabetes mellitus,\6\-\8\ we posit that the American diet is 
no longer a significant risk factor for disease for most individuals. 
This hypothesis is supported by multiple lines of evidence, such as a 
40% decline in the age-adjusted mortality rate from 1969 to 2010,\144\ 
a progressive decades long reduction in age-adjusted cardiovascular 
disease incidence and mortality,\145\-\146\ and a 1.5% per 
annum reduction in age-adjusted mortality rates from all major cancers 
as well as significant reductions in lung cancer incidence in men and 
women between 2001 and 2010.\147\ Given the forgoing and the evidence 
presented herein demonstrating the pseudoscientific nature of M-BMs, we 
assert that research efforts and funding of M-BMs and diet-health 
research are misdirected and argue that those resources would be better 
targeted to the most prevalent disease of deficiency of the 21st 
century: inactivity (i.e., a lack of PA and exercise and high levels of 
sedentary behavior).121, 134
Conclusion
    In this critical review, we argued that the essence of science is 
the ability to discern fact from fiction, and we presented evidence 
from multiple fields to support the position that the data generated by 
nutrition epidemiologic surveys and questionnaires are not falsifiable. 
As such, these data are pseudoscientific and inadmissible in scientific 
research. Therefore, these protocols and the resultant data should not 
be used to inform national Dietary Guidelines or public health policy, 
and the continued funding of these methods constitutes an unscientific 
and major misuse of research resources.

 
 
 
Acknowledgments
 
    The content is solely the responsibility of the authors and does not
 necessarily represent the official views of the National Institutes of
 Health.
    Abbreviations and Acronyms: BMR = basal metabolic rate; CRF =
 cardiorespiratory fitness; DRM = Deese-Roediger and McDermott; DGAC =
 Dietary Guidelines Advisory Committee; EI = energy intake; FFQ = food
 frequency questionnaire; M-BM = memory-based dietary assessment method;
 NHANES = National Health and Nutrition Examination Survey; PA =
 physical activity; rEI = reported energy intake; TEE = total energy
 expenditure; USDA = U.S. Department of Agriculture; WWEIA = What We Eat
 in America; 24HR = 24 hour dietary recall
    Grant Support: This work was supported by grant T32DK062710 (E.A.,
 G.P.) from the National Institute of Diabetes and Digestive and Kidney
 Diseases of the National Institutes of Health.
    Potential Competing Interests: Dr. Archer has received honoraria
 from the International Life Sciences Institute and The Coca Cola
 Company. Dr. Lavie reports receiving consulting fees and speaking fees
 from The Coca-Cola Company and writing a book on the obesity paradox
 with potential royalties.
    Correspondence: Address to Edward Archer, Ph.D., Office of
 Energetics, Nutrition Obesity Research Center, University of Alabama at
 Birmingham, Birmingham, AL 35222 ([email protected]).
 
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                               exhibit c
Validity of U.S. Nutritional Surveillance: National Health and 
        Nutrition Examination Survey Caloric Energy Intake Data, 1971-
        2010
PLoS ONE
          PLoS ONEDwww.plosone.orgDOctober 2013DVolume 8DIssue 
        10De76632

Edward Archer 1 *, Gregory A. Hand,\1\ Steven N. Blair 
1, 2
---------------------------------------------------------------------------
    \1\ Department of Exercise Science, Arnold School of Public Health, 
University of South Carolina, Columbia, South Carolina, United States 
of America.
    \2\ Department of Epidemiology and Biostatistics, University of 
South Carolina, Columbia, South Carolina, United States of America.
    * E-mail: [email protected]
---------------------------------------------------------------------------
Abstract
    Importance: Methodological limitations compromise the validity of 
U.S. nutritional surveillance data and the empirical foundation for 
formulating dietary guidelines and public health policies.
    Objectives: Evaluate the validity of the National Health and 
Nutrition Examination Survey (NHANES) caloric intake data throughout 
its history, and examine trends in the validity of caloric intake 
estimates as the NHANES dietary measurement protocols evolved.
    Design: Validity of data from 28,993 men and 34,369 women, aged 20 
to 74 years from NHANES I (1971-1974) through NHANES 2009-2010 was 
assessed by: calculating physiologically credible energy intake values 
as the ratio of reported energy intake (rEI) to estimated basal 
metabolic rate (BMR), and subtracting estimated total energy 
expenditure (TEE) from NHANES rEI to create `disparity values'.
    Main Outcome Measures: (1) Physiologically credible values 
expressed as the ratio rEI/BMR and (2) disparity values (rEI-TEE).
    Results: The historical rEI/BMR values for men and women were 1.31 
and 1.19, (95% CI: 1.30-1.32 and 1.18-1.20), respectively. The 
historical disparity values for men and women were ^281 and ^365 
kilocalorie-per-day, (95% CI: ^299, ^264 and ^378, ^351), respectively. 
These results are indicative of significant under-reporting. The 
greatest mean disparity values were ^716 kcal/day and ^856 kcal/day for 
obese (i.e., $30 kg/m2) men and women, respectively.
    Conclusions: Across the 39 year history of the NHANES, EI data on 
the majority of respondents (67.3% of women and 58.7% of men) were not 
physiologically plausible. Improvements in measurement protocols after 
NHANES II led to small decreases in underreporting, artifactual 
increases in rEI, but only trivial increases in validity in subsequent 
surveys. The confluence of these results and other methodological 
limitations suggest that the ability to estimate population trends in 
caloric intake and generate empirically supported public policy 
relevant to diet-health relationships from U.S. nutritional 
surveillance is extremely limited.

 
 
 
    Citation: Archer E., Hand G.A., Blair S.N. (2013) Validity of U.S.
 Nutritional Surveillance: National Health and Nutrition Examination
 Survey Caloric Energy Intake Data, 1971-2010. PLoS ONE 8(10): e76632.
 doi:10.1371/journal.pone.0076632.
    Editor: Darcy Johannsen, Pennington Biomed Research Center, United
 States of America Received May 9, 2013; Accepted August 25, 2013;
 Published October 9, 2013.
    Copyright: 2013 Archer, et al. This is an open-access article
 distributed under the terms of the Creative Commons Attribution
 License, which permits unrestricted use, distribution, and reproduction
 in any medium, provided the original author and source are credited.
    Funding: This study was funded via an unrestricted research grant
 from The Coca-Cola Company. The sponsor of the study had no role in the
 study design, data collection, data analysis, data interpretation, or
 writing of the report.
    Competing Interests: Dr. Gregory Hand has received consultancy fees
 from the National Institutes of Health (NIH) and grants from the NIH,
 and The Coca-Cola Company. Dr. James Hebert is supported by an
 Established Investigator Award in Cancer Prevention and Control from
 the Cancer Training Branch of the National Cancer Institute (K05
 CA136975). Dr. Steven Blair receives book royalties (<$5,000/year) from
 Human Kinetics; honoraria for service on the Scientific/Medical
 Advisory Boards for Clarity, Technogym, Santech, and Jenny Craig; and
 honoraria for lectures and consultations from scientific, educational,
 and lay groups which are donated to the University of South Carolina or
 not-for-profit organizations. Dr. Blair is a consultant on research
 projects with the University of Texas-Southwestern Medical School and
 the University of Miami. During the past 5 year period Dr. Blair has
 received research grants from The Coca-Cola Company, the National
 Institutes of Health, and Department of Defense. Funding for the study
 was provided by an unrestricted research grant from The Coca-Cola
 Company. The sponsor of the study had no role in the study design, data
 collection, data analysis, data interpretation, or writing of the
 report, and does not alter the authors' adherence to all the PLoS ONE
 policies on sharing data and materials.
 

Introduction
    The rise in the population prevalence of obesity has focused 
attention on U.S. nutritional surveillance research and the analysis of 
trends in caloric energy intake (EI). Because these efforts provide the 
scientific foundation for many public health policies and food-based 
guidelines, poor validity in dietary measurement protocols can have 
significant long-term implications for our nation's health.
    In the U.S., population-level estimates of EI are derived from data 
collected as part of the National Health and Nutrition Examination 
Survey (NHANES), a complex, cross-sectional sample of the U.S. 
population. The primary method used in NHANES to approximate EI is the 
24 hour dietary recall interview (24HR) [1]. The data collected are 
based on the subject's self-reported, retrospective perceptions of food 
and beverage consumption in the recent past. To calculate EI estimates, 
these subjective data are translated into nutrient food codes and then 
assigned numeric energy (i.e., caloric) values from food and nutrient 
databases. Prior to 2001-2002, the NHANES relied upon databases of 
varying quality and composition for the post-hoc conversion of food and 
beverage consumption (24HR) data into energy values [2-5]. After 2001-
2002, the NHANES and the U.S. Department of Agriculture's (USDA) 
Continuing Survey of Food Intakes by Individuals were integrated into 
the ``What We Eat in America'' program [6], and the translation process 
was standardized via use of successive versions of the USDA's National 
Nutrient Database for Standard Reference (NNBS) [7].
Misreporting
    Given the indirect, pseudo-quantitative nature of the method (i.e., 
assigning numeric values to subjective data without objective 
corroboration), nutrition surveys frequently report a range of energy 
intakes that are not representative of the respondents' habitual 
intakes [8], and estimates of EI that are physiologically implausible 
(i.e., incompatible with survival) have been demonstrated to be 
widespread [9-11]. For example, in a group of ``highly educated'' 
participants, Subar, et al. (2003) demonstrated that when total energy 
expenditure (TEE) via doubly labeled water (DLW) was compared to 
reported energy intake (rEI), the raw correlations between TEE and rEI 
were 0.39 for men and 0.24 for women. Men and women underreported 
energy intake by 12-14% and 16-20%, respectively. The level of 
underreporting increased significantly after correcting for the weight 
gain of the sample over the study period [9], and underreporting was 
greater for fat than for protein, thereby providing additional support 
for the well-documented occurrence of the selective misreporting of 
specific macronutrients (e.g., fat and sugars) [12-15]. These results 
are consistent with earlier work, in which the correlations between 
DLW-derived TEE and seven 24HR and the average of two 7 day dietary 
recalls were 0.33 and 0.30, respectively [16].
    Because the NHANES collected dietary data over the period in which 
the population prevalence of obesity was increasing, these data have 
been used (despite the widely acknowledged issues [17]) to examine the 
association of trends in EI with increments in mean population body 
mass index (BMI) and rates of obesity (e.g., [18-20]). Given that 
implausible rEI values and the misreporting of total dietary intake 
render the relationships between dietary factors, BMI and other indices 
of health ambiguous [21], and diminish the usefulness of nutrition data 
as a tool to inform public health policy, this report examines the 
validity of U.S. nutrition surveillance EI data from NHANES I (1971-
1974) through NHANES 2010 (nine survey periods) using two protocols: 
the ratio of reported energy intake (rEI) to basal metabolic rate (rEI/
BMR) [22,23] and the disparity between rEI and estimated total energy 
expenditure (TEE) from the Institute of Medicine's (IOM) predictive 
equations [24].

   Table 1. rEI/BMR values for all men and women from NHANES I through
                            NHANES 2009-2010.
 Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 =
   plausible U.S. Men & Women (20-74 years); NHANES I-NHANES 2009-2010
------------------------------------------------------------------------
                                           95% Confidence     rEI Value
 NHANES           Estimate    Standard        Interval       Plausible Y
 Survey    Sex     rEI/RMR      Error   --------------------  = Yes N =
  Year            (mean) *                 Lower     Upper        No
------------------------------------------------------------------------
NHANES I  Men          1.30       0.012      1.28      1.32           N
           (n =
           4,65
           2)
          Women        1.10       0.010      1.08      1.12           N
           (n =
           7,70
           9)
NHANES    Men          1.28       0.010      1.26      1.30           N
 II        (n =
           5,23
           6)
          Women        1.08       0.008      1.06      1.09           N
           (n =
           6,00
           6)
NHANES    Men        b 1.36       0.011      1.34      1.39           Y
 III       (n =
           6,12
           2)
          Women      a 1.22       0.009      1.20      1.24           N
           (n =
           7,12
           7)
NHANES    Men          1.31       0.018      1.27      1.34           N
 I999-00   (n =
           1,60
           0)
          Women      a 1.23       0.016      1.19      1.26           N
           (n =
           1,88
           6)
NHANES    Men          1.31       0.015      1.28      1.34           N
 2001-20   (n =
 02        1,78
           2)
          Women      a 1.24       0.011      1.22      1.26           N
           (n =
           2,02
           9)
NHANES    Men          1.32       0.013      1.30      1.35           Y
 2003-20   (n =
 04        1,67
           1)
          Women      a 1.23       0.018      1.20      1.27           N
           (n =
           1,83
           8)
NHANES    Men        c 1.34       0.013      1.31      1.36           Y
 2005-20   (n =
 06        1,74
           9)
          Women      a 1.21       0.014      1.18      1.24           N
           (n =
           1,99
           8)
NHANES    Men          1.27       0.017      1.24      1.30           N
 2007-08   (n =
           2,15
           4)
          Women      a 1.19       0.020      1.15      1.23           N
           (n =
           2,30
           6)
NHANES    Men          1.29       0.013      1.26      1.31           N
 2009-20   (n =
 10        2,31
           9)
          Women      a 1.20       0.007      1.18      1.21           N
           (n =
           2,53
           2)
         ---------------------------------------------------------------
  All     Men          1.31       0.005      1.30      1.32           N
   Surve   (n =
   ys      27,2
           85)
          Women        1.19       0.005      1.18      1.20           N
           (n =
           33,4
           31)
------------------------------------------------------------------------
* All estimates are weighted means.
a Significantly different from NHANES I at p50.001 (Women).
b Significantly different from NHANES I at p50.001 (Men).
c Significantly different from NHANES I at p50.05 (Men).
Note: rEI was from NHANES 24HR data and BMR was calculated using the
  Schofield predictive equations. [26] Values <1.35 are considered
  implausible and indicative of underreporting. TEE = estimated total
  energy expenditure; IOM = Institute of Medicine; rEI = reported energy
  intake; BMR = Basal Metabolic Rate calculated via Schofield predictive
  equation.
Values <1.35 are not physiologically credible.
doi:10.1371/journal.pone.0076632.t001.

Methods
Population
    Data were obtained from the National Health and Nutrition 
Examination Surveys for the years 1971-2010 [1]. The NHANES is a 
complex multi-stage, cluster sample of the civilian, non-
institutionalized U.S. population conducted by the Centers for Disease 
Control and Prevention (CDC). The National Center for Health Statistics 
ethics review board approved protocols and written informed consent was 
obtained from all NHANES participants.
Inclusion Criteria
    The study sample was limited to adults aged $20 and 574 years at 
the time of the NHANES in which they participated, and had a body mass 
index (BMI) $18 kg/m2, and with complete data on age, sex, 
height, weight, and dietary energy intake.
Dietary Data
    Estimates of EI were obtained from a single 24HR from each of the 
nine NHANES study periods [1]. Energy content of the self-reported food 
consumption was determined by NHANES using nutrient databases based on 
previous versions of the USDA National Nutrient Database for Standard 
Reference (NNDS) [7].

         Table 2. rEI/BMR index for all women by BMI categories from NHANES I through NHANES 2009-2010.
   Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 = plausible U.S. Women (20-74 years);
                                            NHANES I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
                                                                                   95% Confidence     rEI Value
                                                          Estimate    Standard        Interval       Plausible Y
    NHANES Survey Year              BMI Category           rEI/BMR      Error   --------------------  = Yes N =
                                                          (mean) *                 Lower     Upper        No
----------------------------------------------------------------------------------------------------------------
NHANES I                    Normal (n = 4,222)                 1.20       0.013      1.18      1.23           N
                            Overweight (n = 2,028)             1.00       0.012      0.98      1.02           N
                            Obese (n = 1,459)                  0.88       0.014      0.86      0.91           N
NHANES II                   Normal (n = 3,171)                 1.18       0.010      1.16      1.20           N
                            Overweight (n = 1,671)             0.98       0.012      0.96      1.01           N
                            Obese (n = 1,164)                  0.89       0.012      0.87      0.91           N
NHANES III                  Normal (n = 2,661)                 1.32       0.014      1.30      1.35           Y
                            Overweight (n = 2,150)             1.18       0.019      1.14      1.22           N
                            Obese (n = 2,316)                  1.07       0.015      1.04      1.10           N
NHANES 1999-2000            Normal (n = 555)                   1.36       0.020      1.32      1.40           Y
                            Overweight (n = 572)               1.19       0.033      1.12      1.25           N
                            Obese (n = 759)                    1.12       0.030      1.06      1.18           N
NHANES 2001-2002            Normal (n = 630)                   1.38       0.018      1.35      1.42           Y
                            Overweight (n = 639)               1.26       0.028      1.21      1.32           N
                            Obese (n = 760)                    1.08       0.012      1.05      1.10           N
NHANES 2003-2004            Normal (n = 550)                   1.35       0.031      1.29      1.41           Y
                            Overweight (n = 546)               1.19       0.027      1.14      1.25           N
                            Obese (n = 742)                    1.15       0.026      1.10      1.20           N
NHANES 2005-2006            Normal (n = 615)                   1.34       0.026      1.29      1.39           Y
                            Overweight (n = 558)               1.19       0.028      1.13      1.24           N
                            Obese (n = 825)                    1.10       0.024      1.05      1.15           N
NHANES 2007-2008            Normal (n = 634)                   1.30       0.038      1.23      1.38           Y
                            Overweight (n = 694)               1.17       0.026      1.12      1.22           N
                            Obese (n = 978)                    1.10       0.020      1.06      1.14           N
NHANES 2009-2010            Normal (n = 690)                   1.31       0.022      1.26      1.35           Y
                            Overweight (n = 745)               1.23       0.024      1.18      1.28           N
                            Obese (n = 1,097)                  1.08       0.006      1.06      1.09           N
----------------------------------------------------------------------------------------------------------------
* All estimates are weighted means.
Note: rEI was from NHANES 24HR data and BMR was calculated using the Schofield predictive equations. [26] Values
  <1.35 are considered implausible and indicative of underreporting. TEE = estimated total energy expenditure;
  IOM = Institute of Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield
  predictive equation.
doi:10.1371/journal.pone.0076632.t002.


          Table 3. rEI/BMR index for all men by BMI categories from NHANES I through NHANES 2009-2010.
Reported Energy Intake (rEI)/Basal Metabolic Rate (BMR) rEI/BMR >1.35 = plausible U.S. Men (20-74 years); NHANES
                                               I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
                                                                                   95% Confidence     rEI Value
                                                          Estimate    Standard        Interval       Plausible Y
    NHANES Survey Year              BMI Category           rEI/BMR      Error   --------------------  = Yes N =
                                                          (mean) *                 Lower     Upper        No
----------------------------------------------------------------------------------------------------------------
NHANES I                    Normal (n = 2,115)                 1.41       0.016      1.38      1.44           Y
                            Overweight (n = 1,945)             1.24       0.017      1.21      1.28           N
                            Obese (n = 592)                    1.08       0.025      1.04      1.13           N
NHANES II                   Normal (n = 2,431)                 1.37       0.009      1.35      1.39           Y
                            Overweight (n = 2,111)             1.25       0.015      1.22      1.28           N
                            Obese (n = 694)                    1.08       0.018      1.05      1.12           N
NHANES III                  Normal (n = 2,275)                 1.47       0.018      1.43      1.50           Y
                            Overweight (n = 2,482)             1.35       0.015      1.32      1.38           Y
                            Obese (n = 1,365)                  1.20       0.018      1.17      1.24           N
NHANES 1999-2000            Normal (n = 476 )                  1.42       0.020      1.38      1.46           Y
                            Overweight (n = 655)               1.33       0.022      1.28      1.37           Y
                            Obese (n = 469)                    1.16       0.036      1.09      1.23           N
NHANES 2001-2002            Normal (n = 493)                   1.43       0.038      1.35      1.50           Y
                            Overweight (n = 774)               1.32       0.017      1.29      1.36           Y
                            Obese (n = 515)                    1.18       0.027      1.13      1.24           N
NHANES 2003-2004            Normal (n = 465)                   1.46       0.029      1.41      1.52           Y
                            Overweight (n = 659)               1.35       0.025      1.30      1.40           Y
                            Obese (n = 547)                    1.18       0.035      1.11      1.24           N
NHANES 2005-2006            Normal (n = 413)                   1.51       0.030      1.45      1.57           Y
                            Overweight (n = 735)               1.33       0.023      1.29      1.38           Y
                            Obese (n = 601)                    1.22       0.014      1.19      1.25           N
NHANES 2007-2008            Normal (n = 539)                   1.40       0.038      1.32      1.47           Y
                            Overweight (n = 835)               1.29       0.017      1.26      1.32           N
                            Obese (n = 790)                    1.15       0.019      1.12      1.19           N
NHANES 2009-2010            Normal (n = 563)                   1.38       0.027      1.33      1.44           Y
                            Overweight (n = 872)               1.35       0.021      1.31      1.39           Y
                            Obese (n = 884)                    1.16       0.016      1.13      1.19           N
----------------------------------------------------------------------------------------------------------------
* All estimates are weighted means.
Note: rEI was from NHANES 24HR data and BMR was calculated using the Schofield predictive equations. [26] Values
  <1.35 are considered implausible and indicative ofunderreporting. TEE = estimated total energy expenditure;
  IOM = Institute of Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate calculated via
  Schofieldpredictive equation.
doi:10.1371/journal.pone.0076632.t003.

Determination of Physiologically Credible rEI Values
    The ratio of rEI to BMR (rEI/BMR) <1.35 [22,23,25] was used to 
determine EI values that were implausible. BMR was estimated via the 
Schofield predictive equations [26]. The <1.35 cut-off for implausible 
EI values was used because ``it is highly unlikely that any normal, 
healthy free-living person could habitually exist at a PAL [i.e., TEE/
BMR] of less than 1.35'' [22].
    It is important to note that the <1.35 cut-off does not assess all 
forms of misreporting (e.g., over-reporting). To avoid the confounding 
effects of potential over-reporting, all rEI/BMR values >2.40 [27] were 
excluded from analyses of underreporting. One form of misreporting that 
neither cut-off addresses is the underreporting of EI from a high 
caloric intake associated with elevated levels of physical activity.
Disparity of the rEI and Estimated Total Energy Expenditure (TEE)
    In 2002, the IOM used datasets derived from studies using DLW to 
create factorial equations to estimate energy requirements for the U.S. 
population. IOM TEE values were subtracted from the NHANES rEI to 
calculate disparity values. Negative values indicate underreporting.
IOM Equations for Predicting TEE Normal Weight (NW) Adults only ($19 
        Years)
          Equation 1 Men: TEE= 864^(9.72age [y])+PA*(14.2weight 
        [kg]+503height[m]) (R202).
          Equation 2 Women: TEE = 387^(7.31age [y]+PA*(10.8weight 
        [kg]+660.7height[m]) (R156).
          * Physical activity (PA) values were 1.12 and 1.14 for NW men 
        and women, respectively. The use of these values assumes 
        physical activity level (PAL) of $1.4 and <1.6, which is 
        indicative of a ``low active'' population [24].
Figure 1
Percent of Plausible Reporters
(rEI/BMR >1.35)
U.S. Men & Women (20-74 yrs)

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          Percent of plausible reporters (i.e., rEI/BMR >1.35) by sex 
        from NHANES I to NHANES 2009-2010; U.S. Men and women (20-74 
        years).
IOM Equations for Predicting TEE Overweight (OW)/Obese (OB) Adults Only 
        ($19 Years)
          Equation 3 Men: TEE= 1,086^(10.1age [y])+PA*(13.76weight 
        [kg]+416height [m]).
          Equation 4 Women: TEE= 448^(7.95age [y])+PA*(11.46weight 
        [kg]+619height [m]).
          * PA values were 1.12 and 1.16 for OW/OB men and women, 
        respectively. The use of these values assumes a physical 
        activity level (PAL) of $1.4 and <1.6, which is indicative of a 
        ``low active'' population [24].
          Note: age (years); weight (kg); height (m; meters); BMI= body 
        mass index, (kg/m2), IOM= Institute of Medicine; TEE 
        = total energy expenditure.
Anthropometry [1]
    Body mass was measured to R0.1 kg. Height was measured to R0.1 cm. 
BMI was calculated as weight (kg)/height (m)2. The sample 
was divided into three standard BMI categories: BMI $18 kg/
m2 and <25 kg/m2 were normal weight (NW), BMI 
between 25 kg/m2 and 29.9 kg/m2 were overweight 
(OW), and $30 kg/m2 were obese (OB).
Statistical Analyses
    Data processing and statistical analyses were performed using 
SAS', V 9.2 and SPSS' V.19 in 2012-2013. Analyses 
accounted for the NHANES' complex survey design via the incorporation 
of stratification, clustering and post-stratification weighting to 
maintain a nationally representative sample for each survey period. All 
analyses included adjusted means, and a <0.05 (2-tailed) was used to 
identify statistical significance.
Results
Examination of Underreporting via rEI/BMR
    Table 1 depicts the rEI/BMR values for men and women from NHANES I 
through NHANES 2009-2010. rEI was from NHANES 24HR data and BMR was 
calculated using the Schofield predictive equations [26]. Values <1.35 
are considered implausible and indicative of underreporting.

   Table 4. Disparity of rEI and TEE for men and women (20-74 years).
 Disparity between rEI and IOM TEE U.S. Men & Women (20-74 years) NHANES
                           I-NHANES 2009-2010
------------------------------------------------------------------------
                                           95% Confidence     Validity:
 NHANES           Estimate                  Interval (CI)       95% CI
 Survey    Sex    rEI minus   Standard  --------------------   includes
  Year           TEE (mean)     Error                         zero (Y =
                      *                    Lower     Upper   Yes, N= No)
------------------------------------------------------------------------
NHANES I  Men        ^290.8        20.3    ^330.7    ^250.9           N
           (n =
           4,65
           2)
          Women      ^479.7        14.5    ^508.1    ^451.3           N
           (n =
           7,70
           9)
NHANES    Men        ^323.2        17.8    ^358.1    ^288.3           N
 II        (n =
           5,23
           6)
          Women      ^505.8        11.6    ^528.4    ^483.1           N
           (n =
           6,00
           6)
NHANES    Men      b ^183.3        19.1    ^220.8    ^145.7           N
 III       (n =
           6,12
           2)
          Women    a ^325.3        13.5    ^351.7    ^298.8           N
           (n =
           7,12
           7)
NHANES    Men        ^285.3        37.7    ^359.3    ^211.4           N
 1999-20   (n =
 00        1,60
           0)
          Women    a ^328.7        27.3    ^382.3    ^275.1           N
           (n =
           1,88
           6)
NHANES    Men        ^270.3        26.8    ^322.9    ^217.7           N
 2001-20   (n =
 02        1,78
           2)
          Women    a ^306.0        15.5    ^336.3    ^275.6           N
           (n =
           2,02
           9)
NHANES    Men        ^255.6        24.7    ^304.0    ^207.3           N
 2003-20   (n =
 04        1,67
           1)
          Women    a ^308.2        27.2    ^361.5    ^254.8           N
           (n =
           1,83
           8)
NHANES    Men        ^232.2        25.3    ^281.8    ^182.6           N
 2005-20   (n =
 06        1,74
           9)
          Women    a ^347.5        20.8    ^388.4    ^306.6           N
           (n =
           1,99
           8)
NHANES    Men        ^355.0        32.1    ^417.9    ^292.0           N
 2007-08   (n =
           2,15
           4)
          Women    d ^379.4        28.5    ^435.3    ^323.5           N
           (n =
           2,30
           6)
NHANES    Men        ^330.9        22.7    ^375.4    ^286.4           N
 2009-20   (n =
 10        2,31
           9)
          Women    a ^366.9         9.8    ^386.1    ^347.7           N
           (n =
           2,53
           2)
         ---------------------------------------------------------------
  All     Men        ^281.4         9.1    ^299.3    ^263.5           N
   Surve   (n =
   ys      27,2
           85)
          Women      ^364.6         7.0    ^378.3    ^351.0           N
           (n =
           33,4
           31)
------------------------------------------------------------------------
* All estimates are weighted means.
a Significantly different from NHANES I at p50.001 (Women).
b Significantly different from NHANES I at p50.001 (Men).
c Significantly different from NHANES I at p50.05 (Men).
d Significantly different from NHANES I at p50.05 (Women).
Note: TEE = estimated total energy expenditure; IOM = Institute of
  Medicine; rEI = reported energy intake; BMR = Basal Metabolic Rate
  calculated via Schofield predictiveequation.
These values were calculated by subtracting the IOM TEE from the NHANES
  rEI. Negative values indicate the kilocalorie-per-day (kcal/day) value
  of underreporting.
doi:10.1371/journal.pone.0076632.t004

    As Table 1 depicts, the 95% confidence intervals (CI) suggest that 
all mean rEI values for women and six of nine mean rEI values for men 
were apparently implausible.
    Table 2 depicts the rEI/BMR index for all women by BMI categories 
from NHANES I through NHANES 2009-2010.
    As Table 2 depicts, the 95% CI suggest that in 20 of the 27 
measurement categories (i.e., three BMI categories and nine surveys) 
the rEI values were not in the physiologically plausible range. The 
overall mean for rEI/BMR values for the total sample of women (n= 
33,431) across all NHANES was 1.19 (95% CI: 1.18, 1.20) and therefore 
not physiologically plausible.
    Table 3 depicts the rEI/BMR index for all men by BMI categories 
from NHANES I through NHANES 2009-2010.
    As shown in Table 3, the 95% CI suggest that in 12 of 27 
measurement categories (i.e., three BMI categories and nine surveys), 
the rEI values were not in the physiologically plausible range. The 
overall mean value for rEI/BMR for the total sample of men (n = 27,285) 
across all NHANES was 1.31 (95% CI: 1.30, 1.32), and therefore not in 
the physiologically plausiblerange.
Percent of Plausible Reporters
    Figure 1 depicts the percent of plausible reporters (i.e., rEI/BMR 
>1.35) by sex from NHANES I to NHANES 2009-2010.
    As Figure 1 depicts, across the entire study period (i.e., 1971-
2010) the majority of respondents did not report plausible rEI values 
in any survey. When stratified by sex and BMI categories, plausible 
reporting in OB women ranged from a low of 12% in NHANES I and II to a 
high of 31% in NHANES 2003-2004. At no point in the history of the 
NHANES did more than 43% of OW and OB women report plausible values. 
Plausible reporting in NW women ranged from a low of 32% in NHANES II 
to 52% in NHANES 2001-2002. Plausible rEI values in OB men ranged from 
a low of 23% in NHANES II to a high of 35% in NHANES 2005-2006. At no 
point in the history of NHANES did more than 49% of OW and OB men 
report plausible rEI values.
Disparity between NHANES rEI and IOM TEE
    Table 4 depicts the disparity of rEI and TEE for men and women (20-
74 years). These values were calculated by subtracting the IOM TEE from 
the NHANES rEI. Negative values indicate the kilocalorie-per-day (kcal/
day) value of underreporting.

              Table 5. Disparity between rEI and the TEE for women (20-74 years) by BMI categories.
     Disparity between rEI and IOM TEE; U.S. Women by BMI categories (20-74 years) NHANES I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
                                                                                   95% Confidence     Validity:
                                                          Estimate                  Interval (CI)       95% CI
    NHANES Survey Year              BMI Category          rEI minus   Standard  --------------------   includes
                                                         TEE (mean)     Error                         zero (Y =
                                                              *                    Lower     Upper   Yes, N= No)
----------------------------------------------------------------------------------------------------------------
NHANES I                    Normal (n = 4,222)               ^316.0        17.7    ^350.8    ^281.2           N
                            Overweight (n = 2,028)           ^595.3        17.7    ^629.9    ^560.6           N
                            Obese (n = 1,459)                ^856.0        23.5    ^902.0    ^809.9           N
NHANES II                   Normal (n = 3,171)               ^351.6        13.7    ^378.5    ^324.8           N
                            Overweight (n = 1,671)           ^617.6        17.1    ^651.1    ^584.1           N
                            Obese (n = 1,164)                ^850.6        19.5    ^888.9    ^812.3           N
NHANES III                  Normal (n = 2,661)               ^158.6        17.7    ^193.3    ^123.9           N
                            Overweight (n = 2,150)           ^357.1        26.5    ^409.1    ^305.2           N
                            Obese (n = 2,316)                ^594.2        22.6    ^638.5    ^549.9           N
NHANES 1999-2000            Normal (n = 555)                 ^106.0        27.2    ^159.3     ^52.6           N
                            Overweight (n = 572)             ^359.6        48.8    ^455.3    ^264.0           N
                            Obese (n = 759)                  ^530.1        50.2    ^628.5    ^431.6           N
NHANES 2001-2002            Normal (n = 630)                  ^74.0        21.7    ^116.6     ^31.4           N
                            Overweight (n = 639)             ^239.6        38.7    ^315.5    ^163.7           N
                            Obese (n = 760)                  ^591.1        20.5    ^631.4    ^550.9           N
NHANES 2003-2004            Normal (n = 550)                 ^116.3        39.2    ^193.2     ^39.4           N
                            Overweight (n = 546)             ^339.0        37.7    ^413.0    ^265.0           N
                            Obese (n = 742)                  ^477.1        42.2    ^560.0    ^394.2           N
NHANES 2005-2006            Normal (n = 615)                 ^131.1        34.1    ^198.0     ^64.3           N
                            Overweight (n = 558)             ^342.8        38.0    ^417.4    ^268.3           N
                            Obese (n = 825)                  ^567.3        38.7    ^643.2    ^491.3           N
NHANES 2007-2008            Normal (n = 634)                 ^173.2        52.1    ^275.4     ^71.0           N
                            Overweight (n = 694)             ^374.1        35.8    ^444.4    ^303.7           N
                            Obese (n = 978)                  ^567.3        33.2    ^632.5    ^502.1           N
NHANES 2009-2010            Normal (n = 690)                 ^173.0        27.8    ^227.5    ^118.4           N
                            Overweight (n = 745)             ^288.9        34.0    ^355.7    ^222.2           N
                            Obese (n = 1,097)                ^590.5        14.0    ^617.8    ^563.1           N
----------------------------------------------------------------------------------------------------------------
Note: BMI = body mass index; TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI =
  reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation.
These values were calculated by subtracting the IOM TEE from the NHANES rEI for each respondent. Negative values
  indicate the kcal/day value of underreporting.
doi:10.1371/journal.pone.0076632.t005

    As Table 4 depicts, in no survey group (i.e., men & women in nine 
surveys) does the 95% CI for the disparity between rEI and TEE include 
zero. This suggests that that underreporting of EI occurred in both men 
and women, and across all surveys. The overall mean value for the 
disparity of rEI and IOM TEE for the total sample of women (n= 33,431) 
across all NHANES was ^365 kcal/day (95% CI: ^378, ^351), or 18% of 
TEE, and for the total sample of men (n= 27,285) was ^281 kcal/day (95% 
CI: ^299, ^264), or 10% of TEE.
    When stratified by sex and BMI categories (see Tables 5 & 6), the 
disparities between rEI and TEE in OB women ranged from 2,856 kcal/day 
(95% CI: ^902, ^810), an underreporting of 41% of TEE, to 2477 kcal/
day (95% CI: ^560, ^394), an underreporting of 20% of TEE. The 
disparities between rEI and TEE in OB men ranged from ^717 kcal/day 
(95% CI: ^790, ^643) in NHANES II to ^464 kcal/day (95% CI: ^527, ^401) 
underreporting of 25% and 15%, respectively.
Trends in Underreporting
    After the removal of over-reporters, both protocols, that is rEI/
BMR (Figure 1) and the disparity between rEI and IOM TEE (Table 4) 
exhibited significant decreases in underreporting from NHANES II and 
NHANES III (p<0.001). There were significant negative linear trends for 
both men and women in changes in underreporting total caloric intake 
from NHANES I to NHANES 2009-2010 (rEI/BMR: p<0.001, and disparity: p 
=0.028).
Trends in Over-Reporting
    Across the study period, approximately 4.9% of men and 2.9% of 
women reported rEI/BMR values suggestive of over-reporting (i.e., rEI/
BMR >2.4) with no significant trends. The greatest increase in the 
percentage of over-reporters between survey periods occurred from 
NHANES II to NHANES III, with men increasing from 4.1% to 6.4%, and 
women from 1.7% to 3.4% (both p<0.001). The greatest absolute 
percentage of over-reporters was in NHANES III, with 6.4% of men over-
reporting and NHANES 2003-2004, with 3.9% of women over-reporting.

             Table 6. Disparity between rEI and the TEE for all men (20-74 years) by BMI categories.
      Disparity between rEI and IOM TEE; U.S. Men by BMI categories (20-74 years) NHANES I-NHANES 2009-2010
----------------------------------------------------------------------------------------------------------------
                                                                                   95% Confidence     Validity:
                                                          Estimate                  Interval (CI)       95% CI
    NHANES Survey Year              BMI Category          rEI minus   Standard  --------------------   includes
                                                         TEE (mean)     Error                         zero (Y =
                                                              *                    Lower     Upper   Yes, N= No)
----------------------------------------------------------------------------------------------------------------
NHANES I                    Normal (n = 2,115)                ^96.3        26.8    ^149.0     ^43.6           N
                            Overweight (n = 1,945)           ^374.7        30.8    ^435.1    ^314.2           N
                            Obese (n = 592)                  ^702.1        49.7    ^799.7    ^604.5           N
NHANES II                   Normal (n = 2,431)               ^178.7        15.9    ^209.9    ^147.6           N
                            Overweight (n = 2,111)           ^367.6        27.0    ^420.5    ^314.6           N
                            Obese (n = 694)                  ^716.5        37.3    ^789.8    ^643.3           N
NHANES III                  Normal (n = 2,275)                 ^8.8        31.1     ^69.8      52.2           Y
                            Overweight (n = 2,482)           ^191.5        27.9    ^246.3    ^136.7           N
                            Obese (n = 1365)                 ^494.4        38.0    ^569.0    ^419.9           N
NHANES 1999-2000            Normal (n = 476)                  ^87.2        34.8    ^155.6     ^18.8           N
                            Overweight (n = 655)             ^221.8        41.5    ^303.3    ^140.2           N
                            Obese (n 469)                    ^590.9        76.8    ^741.6    ^440.2           N
NHANES 2001-2002            Normal (n = 493)                  ^64.1        63.1    ^188.0      59.9           Y
                            Overweight (n = 774)             ^229.2        29.5    ^287.1    ^171.3           N
                            Obese (n = 515)                  ^527.5        55.3    ^636.1    ^418.9           N
NHANES 2003-2004            Normal (n = 465)                   ^6.8        47.3     ^99.6      86.0           Y
                            Overweight (n = 659)             ^175.4        46.9    ^267.4     ^83.4           N
                            Obese (n = 547)                  ^549.8        72.0    ^691.1    ^408.5           N
NHANES 2005-2006            Normal (n = 413)                   70.4        53.0     ^33.7     174.5           Y
                            Overweight (n = 735)             ^222.4        39.7    ^300.3    ^144.4           N
                            Obese (n = 601)                  ^464.2        32.1    ^527.2    ^401.2           N
NHANES 2007-2008            Normal (n = 539)                 ^117.9        64.8    ^245.2       9.3           Y
                            Overweight (n = 835)             ^286.7        31.3    ^348.1    ^225.2           N
                            Obese (n = 790)                  ^608.0        42.2    ^690.8    ^525.2           N
NHANES 2009-2010            Normal (n = 563)                 ^154.4        43.5    ^239.8     ^69.1           N
                            Overweight (n = 872)             ^178.9        42.1    ^261.5     ^96.4           N
                            Obese (n = 884)                  ^590.9        32.9    ^655.4    ^526.4           N
----------------------------------------------------------------------------------------------------------------
Note: BMI = body mass index; TEE = estimated total energy expenditure; IOM = Institute of Medicine; rEI =
  reported energy intake; BMR = Basal Metabolic Rate calculated via Schofield predictive equation.
These values were calculated by subtracting the estimated IOM TEE from the NHANES rEI for each respondent.
  Negative numbers indicate the kcal/day value of underreporting.
doi:10.1371/journal.pone.0076632.t006.

Discussion
Validity of NHANES EI Data
    Our results suggest that across the 39 year history of U.S. 
nutrition surveillance research, rEI data on the majority of 
respondents (67.3% of women and 58.7% of men) were not physiologically 
plausible. The historical average rEI/BMR values for all men and women 
were 1.31 and 1.19 respectively (Table 1). These values are indicative 
of substantial underreporting. The expected average values for healthy, 
free living men and women are 1.55, with a range of >1.35 to <2.40 
[23, 27]. In no survey did at least 50% of the respondents report 
plausible EI values (Figure 1). These data are consistent with previous 
research demonstrating that the misreporting of EI in nutrition surveys 
is widespread [9, 11, 28-34]. Goldberg, et al. (1991) demonstrated that 
in 37 studies across ten countries, >65% of the mean rEI/BMR values 
were below the study-specific plausibility cut-off [23]. In addition to 
the extensive underreporting in our sample, 4.9% of men and 2.9% of 
women reported rEI/BMR values suggestive of over-reporting (i.e., rEI/
BMR >2.40).
Disparity between NHANES rEI and IOM Derived TEE
    Throughout the study period (i.e., 1971-2010) the disparity between 
rEI and TEE values were large and variable across BMI and sex 
categories suggesting substantial systematic biases in underreporting 
(Tables 4, 5, 6). The overall mean disparity values for men and women 
were ^281 kcal/day and 2365 kcal/day, respectively. The greatest mean 
disparity values were ^717 kcal/day (25% of TDEE) and ^856 kcal/day 
(41% of TEE) in OB men and women, respectively.
Trends in the Validity and Inferences from NHANES rEI Data
    As depicted in Tables 1 and 2, and Figure 1, there were large 
decreases in underreporting between NHANES II and NHANES III. This is 
clearly evidenced by the increase in rEI/BMR index (Table 1), the large 
and significant increase in the percent of plausible reporters (Figure 
1), and the reduction in the disparity between NHANES rEI and NAS/IOM 
EER (Table 4). This decrement in underreporting between NHANES II and 
subsequent surveys across all sex and BMI categories is likely the 
result of improvements in survey protocols for NHANES III, such as the 
inclusion of more days of dietary recall (i.e., weekends), automated 
multi-pass methodology, and increased staff training and quality 
control (see [35]), The extent of these improvements is notable; for 
example, the percentage of OB women reporting implausible values 
decreased from 88% in NHANES II to 74% in NHANES III.
    These changes in measurement protocols led to an apparent increase 
in mean rEI values that has been reported as an actual increase in 
population-level EI despite caveats that the ``Interpretation of trends 
in energy and nutrient intakes is difficult when methodologic changes 
occur between surveys'' [36]. Nevertheless, Briefel and Johnson state 
(without caveat) in their abstract, ``During the 30 year period, mean 
energy intake increased among adults . . .'' [37]. The data presented 
in the present report refute this inference. When the NHANES dietary 
measurement protocols were altered after NHANES II, the improved method 
captured a higher percentage of actual intakes. The apparent increase 
in mean rEI was merely an artifact of improved measurement protocols 
and not indicative of a true increase in caloric consumption. Despite 
this fact, the apparent increase has been regularly published and 
uncritically accepted as a true upward trend in caloric consumption 
(e.g., [37, 38]) and the cause of the obesity epidemic (e.g., [39, 
40]).
Changes in Underreporting and Public PolicyRecommendations
    In addition to the ubiquity of misreporting, there is strong 
evidence that the reporting of `socially undesirable' (e.g., high fat 
and/or high sugar) foods has changed as the prevalence of obesity has 
increased [12-15]. Additionally, research has demonstrated that 
interventions emphasizing the importance of `healthy' behaviors may 
lead to increased misreporting as participants alter their reports to 
reflect the adoption of the `healthier' behaviors independent of actual 
behavior change [17, 41]. It appears that lifestyle interventions 
``teach'' participants the socially desirable or acceptable responses 
[17, 42]. As such, the ubiquity of public health messages to `eat less 
and exercise more' may induce greater levels of misreporting and may 
explain the recent downward bias in both self-reported EI [20] and body 
weight [17, 43], especially given that social desirability bias is 
often expressed in the underreporting of calorically dense foods [44].
    Selective misreporting of specific macronutrients has important 
ramifications for epidemiological research and nutrition surveillance. 
Heitmann and Lissner (2005) demonstrated that the selective 
misreporting of dietary fat by groups at an increased risk of chronic 
non-communicable diseases may result in an overestimated association 
between fat consumption and disease [45]. If the potentially negative 
effects of high-fat diets are overestimated due to selective 
misreporting, current recommendations for fat intake may be overly 
conservative [45].
Additional Systematic Biases of Nutrition Surveillance Data
    In addition to known sources of systematic reporting error, there 
are numerous sources of systematic bias in nutrition surveillance 
research protocols that are not addressed via our data. Another 
potentially large source of error is the translation of food and 
beverage consumption data (e.g., 24HR) into nutrient energy values via 
nutrient composition databases. The accuracy of this translation relies 
on a number of assumptions that are rarely justified. As cited earlier, 
research on misreporting shows that reports do not accurately reflect 
the quantity or number of foods consumed, and are not representative of 
usual intakes [12-15, 46-50]. Given that the basic methodological 
assumptions are violated, it is not surprising that research has 
demonstrated that food data to nutrient energy conversions are 
``riddled with potential pitfalls at all stages'' that ``hamper the 
interpretability of the results'' [51-53], and represent a major source 
of systematic error in national nutrition surveillance efforts [2].
    Throughout its history, the NHANES has relied upon databases of 
varying quality and composition for the post-hoc conversion of food and 
beverage consumption (i.e., 24HR) data into energy values [2-5, 53]. 
This makes the analysis of trends extremely complex because the 
nutrient energy (i.e., caloric) values in the databases varied 
considerably over time [54, 55]. Additionally, research has 
demonstrated that the energy content of restaurant food (and especially 
fast-food outlets) vary significantly when compared to the industry 
values used in the NNDS [56], and an internal quality review of NHANES 
2003-2004 data led to 400 substantive changes in nutrient and energy 
values. [57]. The result of these limitations are discussed in detail 
elsewhere, see [4, 5, 58].
    As with the improvements in the NHANES survey protocols, the 
progressive alterations to the nutrient database combined with changes 
in the types of foods that are available for consumption led to 
artifactual differences in nutrient and energy consumption estimates 
that frustrate efforts to examine trends in caloric consumption [58]. 
To account for these changes, researchers must maintain the real 
differences in the composition of foods while correcting for 
artifactual differences attributable to improvements in the quality of 
nutrient data [58]. Given the lack of comprehensive crossover studies 
and metrics for adjustment as the food and nutrient databases evolved, 
papers examining trends in caloric consumption must be treated with 
skepticism [51,58].
Commercially Prepared Foods and Meals Away From Home
    One of the most prominent systematic errors from 24HR data-to-
nutrient energy conversions is due to the increased reliance on the 
food service industry and the substantial rise in meals eaten `away 
from home' [59-61]. As stated previously, the vast majority of foods 
and beverages in the NNDS have not been evaluated empirically and 
research has demonstrated that the energy and macro/micro nutrient 
content of commercially prepared foods varies significantly compared to 
the industry values used in the NNDS [56]. When foods or commodities 
are not in the database, substitutions are necessitated. For these 
interpolations to be accurate, the analogues must be similar in 
composition to the consumed food or beverage. This is extremely 
difficult to perform in practice because no two foods or commodities 
are identical, and local vs. imported foods/commodities differ 
significantly. For example, in survey data collection, knowledge of the 
specific preparation and cut of beef are essential since the energy 
content of generic beef substitutions may differ dramatically (e.g., 
166 kcals per 100 grams in round steak to 257 kcals in top sirloin 
[62]) [63,64]. Given these realities, USDA estimates of caloric 
consumption may be increasingly inaccurate as the number of food and 
beverages supplied by the commercial sector expands rapidly.
    Recent research has attempted to quantify the changes in consumer 
packaged foods and beverages, and their impact on the American diet 
[65]. Nevertheless, these efforts suffer from the same limitations as 
all food data-to-nutrient energy value conversions via nutrient 
composition databases. Additionally, the translation of ``as-
purchased'' foods and beverages (using information from the commercial 
sector) to ``as-consumed'' energy and macro/micronutrient content for 
national surveillance relies on the accurate quantification of food 
preparation and waste [65]. Unfortunately, these data are limited and 
highly variable [52, 66]. In a report from the USDA's Economic Research 
Service, Muth, et al. (2011) state that the current data are incomplete 
and overstate actual consumption because the level of ``documentation 
of food losses . . . ranged from little to none for estimates at the 
retail and customer levels.'' [67]. These results clearly demonstrate 
the conceptual and methodological complexity of translating food and 
beverage purchases into nutrient energy and macro/micronutrient intake 
in the context of a rapidly evolving food supply.
Methods of Adjustment for Systematic Biases
    There are various methods that attempt to improve estimates of 
caloric consumption derived from self-reported dietary intake [32, 68-
72]. While these methods may improve the shape of the distribution of 
the estimates, none can address the significant systematic biases 
described in this report. For example, the National Research Council 
and the Iowa State University methods provide significantly improved 
estimates of the shape of the distribution, but do not substantially 
improve estimates of mean energy intake (10-15% underestimation) or 
protein consumption (6-7% underestimation) [70]. 291.
Strengths and Limitations
    A strength of the present study was the use of the established rEI/
BMR method for the determination of physiologically implausible EI 
values. We used a liberal cutoff (i.e., <1.35) that is below the study-
specific theoretical cutoff for our smallest subgroup (i.e., n >400). 
The use of the more conservative cutoff of rEI/BMR <1.50 recommended by 
Goldberg, et al., (1991) [22] increased underreporting by 10% in women 
and 7% in men across all surveys. A second strength was the use of a 
rEI/BMR >2.4 for the elimination of potential over-reporters to correct 
the limitations of previous research [29].
    Finally, the use of the IOM factorial equations for estimating TEE 
for specific subgroups (i.e., OW & OB respondents) in the calculation 
of disparity values is a significant strength. The results of this 
additional protocol demonstrated significant underreporting in all 
surveys, and that the disparity values closely paralleled the 
implausible values in 15 of the 18 sub-groups (i.e., men & women in 
nine surveys). The close agreement between these two dissimilar 
protocols increases confidence in our results and conclusions.
    A potential limitation to our analysis was the use of the Schofield 
predictive equation for estimating BMR. The Schofield predictive 
equations may overestimate BMR in some populations [73, 74]. If the 
Schofield equation overestimated BMR, a greater percentage of survey 
respondents would be classified as underreporters. To address this 
potential limitation, we performed the analyses using the Mifflin 
equation [75], which has been validated in OW and OB populations such 
as the U.S. [74]. The results of those analyses were similar to those 
obtained using the Schofield equation, with substantial underreporting 
(>50%) in all surveys, significant trends in changes in underreporting, 
and a small increase in over-reporting. To remain consistent with past 
research on implausible rEI and underreporting [29, 33], we chose to 
present the results from the Schofield predictive equations.
Conclusions
    Throughout its history, NHANES dietary measurement protocols have 
failed to provide accurate estimates of the habitual caloric 
consumption of the U.S. population. Furthermore, successive changes to 
the nutrient databases used for the 24HR data-to-energy conversations 
and improvements in measurement protocols make it exceedingly difficult 
to discern temporal patterns in caloric intake that can be related to 
changes in population rates of obesity. As such, there are no valid 
population-level data to support speculations regarding trends in 
caloric consumption and the etiology of the obesity epidemic. Because 
under-reporting and physiologically implausible rEI values are a 
predominant feature of U.S. nutritional surveillance, the ability to 
generate empirically supported public policy and Dietary Guidelines 
relevant to the obesity epidemic based on these data is extremely 
limited.

 
 
 
Acknowledgments
 
    The data used in this study are available at: http://www.cdc.gov/
 nchs/nhanes/nhanes_questionnaires.htm.
 
Author Contributions
 
    Conceived and designed the experiments: E.A., S.N.B. Performed the
 experiments: E.A. Analyzed the data: E.A., G.A.H., S.N.B. Wrote the
 paper: E.A.
 
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                                 ______
                                 
  Submitted Letter by Shannon Campagna, Director, Federal Government 
                      Affairs, Mars, Incorporated
October 6, 2015

  Hon. K. Michael Conaway,
  Chairman,
  House Agriculture Committee,
  Washington, D.C.;

  Hon. Collin C. Peterson,
  Ranking Minority Member,
  House Agriculture Committee,
  Washington, D.C.

    Dear Chairman Conaway and Ranking Member Peterson:

    Mars, Incorporated (Mars) is pleased to submit these comments to 
the House Agriculture Committee in advance of its hearing titled, 
``Public Hearing: 2015 Dietary Guidelines for Americans'' scheduled for 
Wednesday, October 7. Mars shares its recommendations to improve the 
scientific review process of the Dietary Guidelines for Americans (DGAs 
or policy document).
    Mars, Incorporated is a private, family-owned business with more 
than a century of history and some of the best-loved brands in the 
world including M&M'S', PEDIGREE', 
DOUBLEMINT' and UNCLE BEN'S'. Headquartered in 
McLean, VA, Mars has more than $33 billion in sales from six diverse 
business segments: Petcare, Chocolate, Wrigley, Food, Drinks, and 
Symbioscience. More than 75,000 Associates across 73 countries are 
united by the company's Five Principles: Quality, Efficiency, 
Responsibility, Mutuality, and Freedom and strive every day to create 
relationships with stakeholders that deliver growth we are proud of as 
a company.
Recommendations to Improve the Scientific Review Process
    Mars believes that the scientific review process of the DGAs can be 
improved to ensure its integrity. For example, Mars understands that 
the U.S. Department of Health and Human Services (HHS) and the U.S. 
Department of Agriculture (USDA) can only address issues in the DGAs if 
scientific studies have been properly submitted to the National 
Evidence Library (NEL) and have been reviewed and rated by the Dietary 
Guidelines Advisory Committee (DGAC). Mars' concern, however, is that 
if the DGAC elects not to conduct a systematic review of the scientific 
studies for a variety of reasons that do not pertain to the quality of 
the studies, HHS and USDA cannot use their discretion to address the 
issue in the policy document.
    For example, during the most recent DGAC scientific review process, 
over 50 scientific studies and literature on the oral health benefits 
of chewing sugar-free gum were submitted properly and in a timely 
manner to the NEL. The scientific studies covered over 40 years of 
research showing that chewing sugar-free gum stimulates salivary flow, 
which neutralizes plaque acids and enhances remineralization of the 
tooth enamel, as well as reduces dental caries.
    The 2015 DGAC, however, decided for reasons unclear to us not to 
conduct a scientific review of this evidence, which means that these 
studies were never rated as strong, moderate, or weak. Because these 
studies were never rated, HHS confirmed that neither Department has the 
discretion to include guidelines on the oral health benefits of chewing 
sugar-free gum, even if the preponderance of evidence exists. As such, 
stakeholders must wait until the 2020 DGAs to address the issue. 
Therefore, we recommend that if the DGAC decides not to conduct a 
scientific review of studies on a specific topic, then it must provide 
a justification for its decision. This would be especially helpful when 
past DGACs have provided recommendations on that topic and there are 
properly submitted studies and literature looking to update those 
recommendations. By taking this approach, USDA and HHS would then have 
greater discretion to decide whether the agencies should address the 
topic in the policy document along with stakeholder input and other 
considerations.
    For example, in the 2005 scientific report, the DGAC concluded that 
there is a relationship between the intake of sugars and starches and 
the formation of dental caries. The report also focused on how to best 
optimize oral hygiene practices and recommended drinking fluoridated 
water and/or using other fluoride containing dental hygiene products to 
help reduce the risk of dental caries.\1\ The 2010 DGAC affirmed these 
recommendations in its scientific report, but the 2015 DGAC did not 
reaffirm these conclusions or make additional recommendations on oral 
health measures despite receiving over 50 studies on the oral health 
benefits of chewing sugar-free gum.\2\
---------------------------------------------------------------------------
    \1\ 2005 Dietary Guidelines Advisory Committee, ``The Report of the 
Dietary Guidelines Advisory Committee on Dietary Guidelines for 
Americans, 2005,'' at Part A: Executive Summary, page 6, (2005), 
available at http://www.health.gov/dietaryguidelines/dga2005/report/ 
(last accessed September 29, 2015).
    \2\ 2010 Dietary Guidelines Advisory Committee, ``Report of the 
Dietary Guidelines Advisory Committee on the Dietary Guidelines for 
Americans, 2010,'' at Part D: Carbohydrates, page 286, (2010), 
available at http://www.cnpp.usda.gov/sites/default/files/
dietary_guidelines_for_americans/2010DGACReport-camera-ready-Jan11-
11.pdf (last accessed September 29, 2015).
---------------------------------------------------------------------------
    Mars also recommends that if a DGAC fails to conduct a scientific 
review, HHS and USDA should have the discretion to address the issue in 
the policy document if either Department has previously made a decision 
on that issue in a formal rulemaking or through another significant 
proceeding. As it relates to the oral health benefits of chewing sugar-
free gum, USDA previously recognized that chewing sugar-free gum after 
meals reduces dental caries through the Smart Snacks rulemaking, which 
was based on the exact same studies submitted to the NEL for the 2015 
DGAC scientific review process. In the final rule allowing sugar-free 
gum products to be sold in schools, USDA stated that ``[c]linical 
studies have shown that chewing sugarless gum for 20 minutes following 
meals can help prevent tooth decay.'' \3\ Therefore, if an issue has 
already been reviewed through a formal rulemaking or another 
significant proceeding within HHS or USDA, this could be considered to 
be evidence, similar to a DGAC's scientific recommendation. Otherwise, 
it would appear that the DGAC has absolute authority to foreclose 
opportunities for USDA and HHS to address topics in the DGAs, even when 
there is a preponderance of scientific evidence that the agency has 
already examined. This raises concerns as USDA and HHS are 
authoritative bodies, as opposed to the DGAC.
---------------------------------------------------------------------------
    \3\ National School Lunch Program and School Breakfast Program: 
Nutrition Standards for All Foods Sold in School as Required by the 
Healthy, Hunger-Free Kids Act of 2010, 78 Fed. Reg. 125 (June 28, 2013) 
(to be codified at 21 CFR pts. 210 and 220).
---------------------------------------------------------------------------
    Last, Mars notes that during the 2015 scientific review process the 
DGAC considered studies that were not submitted properly to the NEL. By 
doing so, the DGAC has set a disruptive precedent that must be 
addressed. Currently, studies properly submitted to the NEL do not have 
to be reviewed, which means that they can be automatically disqualified 
from consideration by HHS and USDA. Studies not submitted to the NEL, 
however, can be used to support the DGAC's recommendations and thus 
give authority for HHS and USDA to address the issue in the policy 
document. We are not necessarily arguing that studies cannot supplement 
the DGAC's findings, but we do have concerns that such studies may take 
priority over those properly submitted to the NEL.
Conclusion
    Once again, Mars recognizes the significant effort undertaken by 
the DGAC, as well as USDA and HHS, to update the DGAs to reflect the 
latest nutritional science. Specifically, Mars supports the DGAC's 
recommendations on limiting intake of added sugars and sodium.
    We also thank the Committee for considering our concerns with the 
current scientific review process. For the Committee's review, we have 
attached a letter signed by 13 Members of Congress expressing similar 
concerns about the DGAC's failure to conduct a scientific review of the 
studies on the oral health benefits of chewing sugar-free gum.
    If you would like to discuss our positions, please do not hesitate 
to contact Shannon Campagna at [Redacted] or [Redacted].
            Sincerely,

Shannon Campagna,
Mars, Incorporated.
                               attachment
May 13, 2015

  Hon. Thomas ``Tom'' J. Vilsack,
  Secretary,
  U.S. Department of Agriculture,
  Washington, D.C.;

  Hon. Sylvia Mathews Burwell
  Secretary,
  U.S. Department of Health and Human Services,
  Washington, D.C.

    Dear Secretaries Vilsack and Burwell:

    We are concerned that the 2015 Scientific Report of the Dietary 
Guidelines Advisory Committee (DGAC) did not meaningfully address oral 
health despite the fact that both the 2005 and 2010 editions of the 
Dietary Guidelines for Americans (DGAs) recognized oral health as a 
public health priority.
    The absence of oral health as a public health priority in the 
Scientific Report of the 2015 Dietary Guidelines Advisory Committee is 
a step backward in the Federal Government's long-standing effort to 
address the chronic, yet preventable disease of tooth decay. Fifteen 
years ago, in the first Surgeon General's report on oral health, the 
Surgeon General called for a ``national effort to improve oral health 
among all Americans.'' The report found that ``oral health is integral 
to general health,'' and stated that ``you cannot be healthy without 
oral health.''
    In recognizing oral health as a public health priority, both the 
2005 and 2010 DGAs concluded that there is a relationship between the 
intake of sugars and starches and the formation of dental cavities. 
Both DGAs also focused on how to best optimize oral hygiene practices 
and recommended drinking fluoridated water and/or using other fluoride-
containing dental hygiene products to help reduce the risk of dental 
cavities. The 2015 Scientific Report, however, did not make such 
recommendations. Therefore, we request that the 2015 Policy Document 
reaffirm the oral health conclusions from the 2005 and 2010 DGAs.
    We also strongly encourage the U.S. Department of Health and Human 
Services (HHS) and the U.S. Department of Agriculture (USDA) to 
identify additional scientifically-proven ways to optimize hygiene 
practices, including the chewing of sugar-free gum after eating meals. 
Over 40 years of research has shown that chewing sugar-free gum 
stimulates salivary flow, which neutralizes plaque acids and enhances 
remineralization of the tooth enamel, as well as reduces dental 
cavities.
    This research, which includes over 50 scientific studies and 
literature, was submitted properly and in a timely manner to USDA's 
National Evidence Library; however, the 2015 DGAC decided for reasons 
unclear to us not to conduct a systematic review of this evidence. 
Therefore, we request HHS and USDA conduct a systematic review of the 
submitted evidence or affirm USDA's science-based regulatory finding in 
the Smart Snacks rule that chewing sugar-free gum after meals reduces 
dental cavities. In that rule, and based on USDA's review of the same 
studies submitted to the 2015 DGAC, USDA recognized that ``[c]linical 
studies have shown that chewing sugarless gum for 20 minutes following 
meals can help prevent tooth decay'' in allowing sugar-free gum 
products to be sold in schools.
    As a global leader, the United States should continue to make great 
strides in addressing tooth decay, which remains the most prevalent 
chronic disease in both children and adults, yet it is largely 
preventable. We ask that HHS and USDA continue to make oral health a 
public priority in the 2015 Dietary Guidelines for Americans because 
oral health is essential to improving general health.
            Sincerely,
            
            [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            

 
 
 
Hon. Doug Collins,                   Hon. Sanford D. Bishop, Jr.,
Member of Congress;                  Member of Congress;
 

                                     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
                                     

 
 
 
Hon. Brenda L. Lawrence,             Hon. Steve Chabot,
Member of Congress;                  Member of Congress;
 

                                     
                                     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

 
 
 
Hon. Joseph J. Heck,                 Hon. Donald M. Payne, Jr.,
Member of Congress;                  Member of Congress;
 

                                     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
                                     

 
 
 
Hon. Joyce Beatty,                   Hon. Brian Babin,
Member of Congress;                  Member of Congress;
 

                                     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
                                     

 
 
 
Hon. Ryan A. Costello,               Hon. Dina Titus,
Member of Congress;                  Member of Congress;
 

                                     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
                                     

 
 
 
Hon. Lynn Jenkins,                   Hon. Paul Cook,
Member of Congress;                  Member of Congress;
 

                                     [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
                                     

 
 
 
Hon. Diane Black,
Member of Congress.
 

                                 ______
                                 
Submitted Letter by Pamela Schoenfeld, M.S., R.D., Executive Director; 
    Adele Hite, M.P.H., R.D., Public Policy Advisor, Healthy Nation 
                               Coalition

 
 
 
House Committee on Agriculture       U.S. Senate Committee on
                                      Agriculture, Nutrition, and
                                      Forestry,
Washington, D.C.;                    Washington, D.C.
 

    Why the USDA/HHS Dietary Guidelines for Americans (DGA) development 
process must be overhauled:
    The DGA:

  1.  Exceed the language of their authorizing statute.

  2.  Do not achieve the stated goals of prevention of chronic disease 
            and promotion of healthyweight.

  3.  Are inappropriate for large sectors of the American population--
            especially children.

  4.  Do not ensure that Americans meet essential nutrition needs.

  5.  Are out-of-step with our multicultural nation and diverse dietary 
            practices.

  6.  Do not reflect the most up-to-date and comprehensive research 
            findings.

  7.  Act to limit or restrict the availability of certain categories 
            of foods.

  8.  Are not held to rigorous scientific standards.

  9.  May be contributing in part to our nation's health problems.

  10. Should be replaced by guidance, for use by the general public, 
            focused on essential nutrition.
1. The DGA exceed the language of their authorizing statute.
    According to Secretary Vilsack: ``I struggle with the Dietary 
Guidelines because I think it is important to understand precisely what 
they are and are not. These guidelines are a set of recommendations 
based on a series of well-informed opinions that create a framework 
that is designed to encourage and educate Americans about what they can 
do to increase their chance of prevention of chronic disease. This is 
not about treating disease, this is about trying to prevent chronic 
disease.'' \1\
---------------------------------------------------------------------------
    \1\ Quote found at 00:12:18 of October, 7, 2015 Full Committee on 
Agriculture hearing (http://www.c-span.org/video/?328598-1/secretaries-
tom-vilsack-sylvia-burwell-testimony-nutritional-guidelines); this is 
the source for all quotation time marks used herein.
---------------------------------------------------------------------------
    Vilsack continues ``We're looking at what the law requires us to 
do, and that is focus on dietary and nutritional guidelines relative to 
prevention.'' \2\
---------------------------------------------------------------------------
    \2\ 01:25:00.
---------------------------------------------------------------------------
    As posted on the Department of Health and Human Services website 
(http://health.gov/dietaryguidelines/purpose.as):

          These recommendations aim to:

     Promote health.

     Prevent chronic disease.

     Help people reach and maintain a healthy weight.

    Yet, there exists no language in the legislation that specifies 
that the DGA should be designed for the prevention of chronic disease. 
The key part of the legislative mandate is below:

          7 U.S. Code  5341--Establishment of dietary guidelines

                  (1) In general

                          At least every 5 years the Secretaries shall 
                        publish a report entitled ``Dietary Guidelines 
                        for Americans.'' Each such report shall contain 
                        nutritional and dietary information and 
                        guidelines for the general public, and shall be 
                        promoted by each Federal agency in carrying out 
                        any Federal food, nutrition, or health program.

                  (2) Basis of guidelines

                          The information and guidelines contained in 
                        each report required under paragraph (1) shall 
                        be based on the preponderance of the scientific 
                        and medical knowledge which is current at the 
                        time the report is prepared.

    Note that the report is to contain guidelines for the ``general 
public.''
    The ``general public'' is a demographically diverse population with 
an equally diverse set of nutritional needs. Attempting to design 
guidelines for the prevention of chronic disease has led to a narrow 
and limited focus and has shifted our priority away from ensuring the 
intake of adequate levels of essential nutrients demonstrated to be 
required for human health, reproduction, and growth. In the past, USDA 
dietary guidance emphasized the inclusion of a wide variety of animal 
and plant foods with the goal of meeting essential nutritional 
requirements.\3\
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    \3\ For examples of historical USDA dietary guidance please see: 
http://www.nal.usda.gov/fnic/history/8549v.gif (WWII era); http://
www.nal.usda.gov/fnic/history/0007v.gif (post-war era); and others at: 
https://nutritionhistory.nal.usda.gov/.
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2. The DGA do not achieve the above stated goals of prevention of 
        chronic disease and promotion of healthy weight.
    While there are no goals specifically mandated in the legislation, 
the increases in the prevalence of obesity, diabetes, and related 
diseases such as non-alcoholic fatty liver, demonstrate that the DGA 
have not had the desired impact on the health of Americans.
    These increases should not come as a surprise: the food patterns in 
the DGA have ``not been specifically tested for health benefits.'' \4\ 
Although we might surmise that the ``goal'' of the DGA from their 
inception was to reduce incidence of chronic disease, this has never 
been shown to be the case.
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    \4\ 2010 Dietary Guidelines for Americans, p. 50
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3. The DGA are inappropriate for large sectors of the American 
        population--especially children.
    The following exchange from the hearing illustrates this critical 
point:
    Rep. Rodney Davis raised his ``most serious concern today is what I 
see as a lack of evidence to show that the recommended dietary patterns 
proposed by the DGA have been based on any evidence on children. 
According to citations in some previous advisory reports for 
recommendations, the recommended diet has been tested almost 
exclusively on middle age men and women whose nutritional needs 
obviously are very different from young people and growing children. In 
particular, I am concerned because young children need certain vitamins 
and minerals obviously in order to grow and develop.'' Of note is the 
fact that the recommended diet has not been tested at all; the studies 
used to support the guidelines have been conducted in adults, generally 
males.\5\
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    \5\ 01:44:30.
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    Secretary Burwell addressed [her] concern: ``My team brought up the 
issue of children yesterday as we look to making sure we have 
appropriate evidence for a number of the things that you are talking 
about for the next set [of guidelines in 2010]. Because I think what 
you are appropriately reflecting is the research doesn't exist because 
it is on older [adults]. So we need to get started on that now. So with 
regard to the issue of do we need to understand this better. We don't 
have the facts yet. We don't have a science base. If we start now we 
will for the next'' [emphasis added].\6\
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    \6\ 01:47:10.
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    It is clear that applying guidelines to children where ``research 
doesn't exist'' is irresponsible at best. We should be very careful not 
to draw conclusions or make recommendations when we cannot even meet 
the required preponderance of evidence standard. The DGA as they stand 
now must not be applied to children (inclusive of birth to 18 years of 
age). In the interim, guidelines to ensure essential nutritional needs 
for children are met, including vitamins and minerals, should be 
developed in their place. We already have a strong evidence base to use 
in their development, which are the Dietary Reference Intakes published 
by the Institute of Medicine (http://iom.nationalacademies.org/
Activities/Nutrition/SummaryDRIs/DRI-Tables.aspx).
4. The DGA do not ensure that Americans meet essential nutrition needs.
    This is an extension of the previous concern.
    In the 2015 DGAC report, the Committee characterized the following 
as shortfall nutrients: ``vitamin A, vitamin D, vitamin E, vitamin C, 
folate, calcium, magnesium, fiber, and potassium. For adolescent and 
premenopausal females iron also is a shortfall nutrient. Of the 
shortfall nutrients, calcium, vitamin D, fiber, and potassium also are 
classified as nutrients of public health concern because their 
underconsumption has been linked in the scientific literature to 
adverse health outcomes. Iron is included as a shortfall nutrient of 
public health concern for adolescent females and adult females who are 
premenopausal due to the increased risk of iron-deficiency in these 
groups.'' \7\
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    \7\ Scientific Report of the 2015 DGAC: Executive Summary. Part A. 
p 2., herein cited as ``Report.''
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    Zinc, while not cited by the Committee as a shortfall nutrient, is 
an important mineral that may be underconsumed when animal proteins, 
especially red meat, are limited. This is of particular concern for 
young children, who have high physiologic requirements for iron and 
zinc to support rapid growth and brain development. The recommended 
``healthy vegetarian pattern'' is devoid of red meat and is thus 
inappropriate to indiscriminately recommend for children.
    The recommendations of previous and the current DGA have actually 
served to increase the risk for below-adequate intake of several of the 
above-listed nutrients. We provide scientific support on the reasons 
for this in the attached commentary previously submitted to the USDA/
HHS through their website during the allotted period.\8\
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    \8\ See point number 3 on page 9 of the attached commentary,* where 
we address nutrient shortfalls. Your attention to the entire attached 
letter (written by the undersigned on behalf of the Weston A. Price 
Foundation) would be very much appreciated as we have outlined several 
others scientifically supported concerns we have with the 2015 DGAC 
Report as well as the process utilized for the development of the DGA.
    * Editor's note: The document referred to is retained in Committee 
file.
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    Of significance, as recent as 2000, the DGA continued to include 
beef, turkey dark meat, and liver and other organ meats and dark meat 
as good sources of iron.\9\ Previous DGA editions also included pork 
and lamb. No mention of organ or dark meat is made in either the 
current 2010 DGA or the 2015 DGAC Report. In addition, USDA-sponsored 
family and consumer literature published by the University of Arkansas 
Division of Agriculture in 2010 do recommend liver a source of iron for 
infants and toddlers: and for young children.\10\ We highly recommend 
that liver and other organ meats be re-evaluated as a nutrient dense 
food for inclusion in the DGA recommendations.
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    \9\ https://nutritionhistory.nal.usda.gov/download/CAT40000623/PDF
    \10\ https://nutritionhistory.nal.usda.gov/download/1759104/PDF; 
https://nutritionhistory.
nal.usda.gov/download/1759103/PDF.
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5. The DGA are out-of-step with our multicultural nation and diverse 
        dietary practices.
    Unfortunately, the DGAC Report does not consider this diversity 
when deciding on the three recommended dietary patterns: the Healthy 
U.S.-style Pattern, the Healthy Mediterranean-style Pattern, and the 
Healthy Vegetarian Pattern (Report: Part D. Ch 1. Line 2827). We ask 
that the USDA and HHS be required to consider the foodways of our 
immigrant and native populations when making population-wide 
recommendations. This is especially necessary given the DGAC's 
recognition of a need for future research to ``[e]xpand WWEIA (What We 
Eat in America) participation to include more respondents from race/
ethnic minorities and non-U.S. born residents; while acknowledging that 
`[v]ery little is known about the dietary habits of many of the 
cultural subgroups in the United States. This knowledge is essential to 
moving forward any nutrition programs for first and second generation 
immigrants.' '' \11\
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    \11\ Report: Part D. Ch. 1, Line 2838.
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    Secretary Burwell discussed keeping the DGA information ``simple 
enough'' that it can be used ``in your own cultural context''; \12\ 
Secretary Vilsack highlighted the USDA programs that are ``working with 
Native Americans to reflect [their] traditions and culture.'' \13\ We 
commend these ideas and efforts and urge they be emphasized in the 
upcoming edition.
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    \12\ 01:37:40.
    \13\ 01:38:10.
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6. The DGA do not reflect the most up-to-date and comprehensive 
        research findings.
    To illustrate the lack of sound scientific methodology that has 
permeated the DGA processes from its inception please consider the 
following:
    The 2015 DGAC reversed the long-standing opinions of previous DGACs 
and recommendation of previous DGA that dietary cholesterol should be 
limited to less than 300 mg per day, stating: ``The 2015 DGAC will not 
bring forward this recommendation because available evidence shows no 
appreciable relationship between consumption of dietary cholesterol and 
serum cholesterol, consistent with the conclusions of the AHA/ACC 
report (2, 35). Cholesterol is not a nutrient of concern for over-
consumption.'' \14\ The same evidence was available to the 2010 DGAC 
which continued to recommend cholesterol limits; these limits were 
carried forward into the 2010 DGA.
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    \14\ Report: Part D. Ch. 1, Line 642.
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    Graded evidence is not provided by the 2015 DGAC to support this 
revision. This is unfortunate considering the language of H.R. 3049: 
``Each revision to any nutritional or dietary information or guideline 
contained in the 2010 edition of the Dietary Guidelines for Americans 
and any new nutritional or dietary information or guideline to be 
included in the eighth edition of the Dietary Guidelines for 
Americans--(A) shall be based on scientific evidence that has been 
rated ``Grade I: Strong'' by the grading rubric developed by the 
Nutrition Evidence Library of the Department of Agriculture.''
    We strongly encourage your committees to reconsider the language of 
the proposed bill. We respectfully offer that any standing guideline be 
carried forward only if it can be supported by Grade I: Strong evidence 
per the NEL process, subject to an independent scientific review.\15\
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    \15\ Other examples of weak scientific methodology are detailed in 
the attached commentary * to the USDA/HHS; point number 1, page 2, 
provides a key example.
    * Editor's note: The document referred to is retained in Committee 
file.
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7. The DGA act to limit or restrict the availability of certain 
        categories of foods.
    A key example here is the removal of whole (3.5% fat) milk from the 
National School Lunch Program (NSLP). Preventive public health measures 
must provide an expected benefit to the individual upon whom the 
intervention is imposed, with minimal risk of harm, as ascertained by 
strict standards of evidence. For example, whole milk has been removed 
from the NSLP. However, there is limited evidence of benefit from 
restricting whole milk, and there has been no recognition of potential 
harm from alternative choices, such as inadequate nutrition (if 
students refuse to drink milk at all rather than drink reduced-fat 
milk) or excess intake of sugar (if students choose sweetened milk when 
full-fat milk is unavailable). Parents may feel it is better for their 
children to have whole milk rather than no milk or sweetened milk. That 
choice should not be made by government officials without strong 
evidence of the singular benefits of reduced-fat milk and the specific 
harms of whole milk.
    A recent Washington Post article (http://www.washingtonpost.com/
news/wonkblog/wp/2015/10/06/for-decades-the-government-steered-
millions-away-from-whole-milk-was-that-wrong/) presented more up-to-
date scientific findings that whole milk has a place in a nutritionally 
balanced diet. Not mentioned in the article is additional research 
showing that whole milk consumption is associated with a lower risk for 
overweight/obesity in children.\16\
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    \16\ Berkey et al., 2005 Arch. Pediatr. Adolesc. Med. 159(6); 
Scharf et al., 2013 Arch. Dis. Child. doi :10.1136/archdischild-2012-
302941.
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8. The DGA are not held to rigorous scientific standards.
    Notwithstanding Secretary Vilsack's current view that a ``gold 
standard process'' \17\ is being adhered to, the current process lacks 
rigor. For future DGA, scientific standards should be raised to 
``beyond a reasonable doubt'' that a recommendation will provide 
benefit and will not cause harm.
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    \17\ 00:13:40.
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    For the development of 2020 DGA, we concur with Rep. Trent Kelly 
who suggested that the preponderance of evidence standard is not the 
right standard to use: ``Maybe it is clear and convincing evidence or 
maybe it's beyond a reasonable doubt that when we have science that we 
hold them to a standard that makes sure that the end result is 
something that we have a good belief that it will be viable and it will 
be the right answer'' [emphasis added].\18\ The right answer may not be 
a single answer for all individuals; it should however ensure that we 
provide the best fundamental information so that the majority of 
Americans can meet their basic nutritional needs. Secretary Vilsack is 
in agreement with Rep. Trent and provides an opportune solution: ``We 
have to follow the Congressional mandate. So if you all believe that it 
should be a higher standard, that is your call and whatever your call 
is, we will follow it.'' \19\
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    \18\ 01:41:04.
    \19\ 01:42:09.
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9. The DGA may be contributing in part to our nation's health problems.
    During the hearing, statistics were cited on the rising prevalence 
of obesity and diabetes. We cannot afford to wait another 5 years; our 
survival as a great nation depends on getting this right. According to 
Rep. David Scott, ``Agriculture is indeed our most important industry. 
It's the food we eat. It's the water we drink. It's our survival. And I 
think that you got the feeling from this Committee how important this 
is.'' \20\ We wholeheartedly concur with the Rep. Scott and other 
Members of the Committee and ask that the entire DGA process and 
resulting guidelines be given an immediate and thorough review by 
Congress and by an independent scientific panel selected by Congress 
and under their direction.
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    \20\ 02:22:30.
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10. The DGA should be replaced by guidance, for use by the general 
        public, focused on essential nutrition.
    The DGA should, first and foremost, provide general dietary 
guidance on selecting from a variety of foods that supply adequate 
essential nutrients. This could look like previous editions produced by 
the USDA (examples cited above in point 1), perhaps with multicultural 
versions to meet our diverse population's dietary preferences. To 
ensure scientific rigor, the DRIs should be utilized. Any and all 
guidance for the prevention of chronic disease must be limited to that 
designated as Grade 1: Strong evidence by the USDA Nutrition Evidence 
Library and directed only at relevant demographic group(s).
    In conclusion, any measurement of the success of the DGA must not 
be in regard to how well the American public applies and adheres to 
them as Secretary Vilsack states.\21\ Success must be measured by 
nutrition and health outcomes including the following:
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    \21\ 01:24:20.

   Are Americans, especially children, meeting all of their 
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        nutrient needs?

   Are we seeing meaningful declines in the prevalence of 
        obesity, diabetes, fatty liver, and other diseases that are 
        afflicting our children?

     From the questions asked of Secretaries Burwell and Vilsack, we 
know that a number of policymakers share our concerns. We commend the 
language in the House's Departments of Agriculture, Rural Development, 
Food and Drug Administration and Related Agencies (section 734) and 
Departments of Labor, Health and Human Services and Education and 
Related Agencies, (section 230) Fiscal Year 2016 Appropriations Bills 
that indicates a call for the highest standards of evidence, and we 
suggest that these standards be applied to all national nutrition 
guidance.
            Respectfully submitted by,

Pamela Schoenfeld, M.S., R.D.,
Executive Director,
Adele Hite, M.P.H., R.D.,
Public Policy Advisor,
The Healthy Nation Coalition.
www.forahealthynation.org
                                 ______
                                 
Submitted Statement by Nina Teicholz, Author, The Big Fat Surprise: Why 
            Butter, Meat and Cheese Belong in a Healthy Diet
    I want to thank Chairman Michael Conaway (R-TX) and Ranking Member 
Collin Peterson (D-MN) for holding this important hearing on the U.S. 
Dietary Guidelines for Americans. My name is Nina Teicholz and I am an 
investigative journalist who spent 10 years researching the science, 
politics and history of U.S. nutrition policy and particularly how we 
came to believe that dietary fat is bad for health. This work 
culminated in my best-selling book, The Big Fat Surprise: Why Butter, 
Meat and Cheese Belong in an Healthy Diet, which was named a ``Best 
Book'' of 2014 by the Economist, Wall Street Journal, Forbes, Mother 
Jones, Library Journal, and Kirkus Reviews, and received strong review 
in both the BMJ and American Journal of Clinical Nutrition. In the 
spring of 2015, I received a grant from the Laura and John Arnold 
Foundation to undertake a comprehensive scientific analysis of the 
Dietary Guidelines, resulting in a report (``Critical Review'') that is 
available to the public at www.forbetterdietaryguidelines.com. Based on 
that work, I wrote a comprehensive peer-reviewed, fact-checked 
investigation of the guidelines that was published by the British 
Medical Journal (BMJ), available to read here: http://www.bmj.com/
content/351/bmj.h4962. My testimony today is based on this body of 
work.
    In general, I found that expert report underpinning the next set of 
U.S. Dietary Guidelines for Americans fails to reflect much relevant 
scientific literature in its reviews of crucial topics and therefore 
risks giving a misleading picture. The omissions seem to suggest a 
reluctance by the committee behind the report to consider any evidence 
that contradicts the last 35 years of nutritional advice.
    My analysis for the BMJ found that the committee's report used weak 
scientific standards, reversing recent efforts by the government to 
strengthen the scientific review process. This backsliding seems to 
have made the report vulnerable to internal bias as well as outside 
agendas.
    The 2015 report states that the committee abandoned established 
methods for most of its analyses. Since its inception, the guideline 
process has suffered from a lack of rigorous methods for reviewing the 
science on nutrition and disease, but a major effort was undertaken in 
2010 to implement systematic reviews of studies to bring scientific 
rigor and transparency to the review process. The U.S. Department of 
Agriculture set up the Nutrition Evidence Library (NEL) to help conduct 
systematic reviews using a standardized process for identifying, 
selecting, and evaluating relevant studies.\3\
    However, my BMJ analysis found that on questions requiring reviews 
of the scientific literature, the committee did not use the NEL for 63% 
of them. The questions include some of the most controversial issues in 
nutrition today.\4\ Instead, the committee relied on systematic reviews 
by external professional associations, almost exclusively the American 
Heart Association (AHA) and the American College of Cardiology (ACC), 
or conducted ad hoc examinations of the scientific literature without 
well defined systematic criteria for how studies or outside review 
papers were identified, selected, or evaluated.
    Use of external reviews by professional associations is problematic 
because these groups conduct literature reviews according to different 
standards and are supported by food and drug companies. The ACC reports 
receiving 38 percent of its revenue from industry in 2012, and the AHA 
reported 20 percent of revenue from industry in 2014. Potential 
conflicts of interest include, for instance, decades of support from 
vegetable oil manufacturers, whose products the AHA has long promoted 
for cardiovascular health. This reliance on industry backed groups 
clearly undermines the credibility of the government report.
Saturated Fats
    On saturated fats, for example, the committee did not ask the NEL 
to conduct a formal review of the literature from the past 5 years, 
even though this topic clearly merited re-examination. When the 
committee started its work in 2012, there had been several prominent 
papers, including a meta-analysis \5\ that failed to confirm an 
association between saturated fats and heart disease, and two major 
reviews (one systematic) \6\-\7\ that did not consistently 
show an causal effect of saturated-fat reduction on cardiovascular 
mortality.
    Restrictions on saturated fats have been a foundation of nutrition 
policy since the first guidelines in 1980 and have had a dominant role 
in determining which foods, such as low fat dairy and lean meats, are 
considered ``healthy.'' Instead of requesting a new NEL review for the 
recent literature on this crucial topic, however, the 2015 committee 
recommended extending the current cap on saturated fats, at 10% of 
calories, based on a review by the AHA and ACC,\8\ a 2010 NEL review, 
and the 2015 committee's ad hoc selection of seven review papers (see 
table A on thebmj.com).\9\
    The NEL systematic review on saturated fats from 2010 \10\ covers 
only the literature published from 2004 to 2009, the period which the 
2010 committee had been asked to review. Fewer than 12 small trials are 
cited, and none supports the hypothesis that saturated fats cause heart 
disease (see table B on thebmj.com).
    More significantly, the 2010 review omits a large controlled 
clinical trial, the Women's Health Initiative, which included nearly 
49,000 people and achieved a significantly lower intake of saturated 
fat in the intervention group yet, compared with controls, observed no 
benefits for this group in incidence of fatal and non-fatal coronary 
heart disease events and total cardiovascular disease, including 
stroke.\11\
    Papers on saturated fats published since 2010 were covered by the 
committee's ad hoc review, which did not use a systematic method to 
select or evaluate studies. One of the meta-analyses it cited was 
arguably inappropriately included because it considered polyunsaturated 
vegetable oils rather than saturated fats.\12\ Another analysis cited 
in great detail had already been covered by the 2010 NEL review, so 
including it again amounted to double counting.\13\ Three meta-analyses 
concluded that saturated fats did not increase cardiovascular 
mortality,\14\-\16\ but the committee downplays these 
findings. And two other included meta-analyses had mixed results: 
saturated fats generally looked more atherogenic than polyunsaturated 
fats but less atherogenic than carbohydrates or monounsaturated 
fat.\17\-\18\ Despite this conflicting evidence, however, 
the committee's report concludes that the evidence linking consumption 
of saturated fats to cardiovascular disease is ``strong.''
    Perhaps more important are the studies that have never been 
systematically reviewed by any of the Dietary Guideline committees.\19\ 
These include the large, government funded randomized controlled trials 
on saturated fats and heart disease from the 1960s and 1970s. Taken 
together, these trials followed more than 25,000 people, some for up to 
12 years. They are some of the most ambitious, well controlled 
nutrition studies ever undertaken.\20\-\25\ These studies 
showed mixed health outcomes for saturated fats, but early critical 
reviews, including one by the National Academy of Sciences, which 
cautioned against the inconclusive state of the evidence on saturated 
fats and heart disease, were dismissed by the USDA when it launched the 
first Dietary Guidelines in 1980.\26\ Subsequent guideline committees 
have never gone back to systematically review these early trials but 
instead relied on other government reports.
Low Carbohydrate Diets
    Another important topic that was insufficiently reviewed is the 
efficacy of low carbohydrate diets. Again, the 2015 committee did not 
request a NEL systematic review of the literature from the past 5 
years. The report says that this was because, after conducting 
``exploratory searches'' of the literature since 2000, the committee 
could find ``only limited evidence [on] low-carbohydrate diets and 
health, particularly evidence derived from U.S. based populations.'' 
\27\
    The report provides no documentation of these ``exploratory 
searches,'' yet many studies of carbohydrate restriction have been 
published in peer review journals since 2000, nearly all of which were 
in U.S. populations. These include nine pilot studies, 11 case studies, 
19 observational studies, and at least 74 randomised controlled trials, 
32 of which lasted 6 months or longer (see table C on thebmj.com). A 
meta-analysis and a critical review have concluded that low 
carbohydrate diets are better than other nutritional approaches for 
controlling type 2 diabetes,\28\-\29\ and two meta-analyses 
have concluded that a moderate to strict low carbohydrate diet is 
highly effective for achieving weight loss and improving most heart 
disease risk factors in the short term (6 months).\30\-\31\ 
Weight loss benefits on different diets tended to converge over the 
long term (12 months), according to various reviews, but a recent meta-
analysis found that if carbohydrates are kept ``very low,'' weight loss 
is greater than with a low fat diet maintained for a year.\32\ Given 
the growing toll taken by these conditions and the failure of existing 
strategies to make meaningful progress in fighting obesity and diabetes 
to date, one might expect the guideline committee to welcome any new, 
promising dietary strategies. It is thus surprising that the studies 
listed above were considered insufficient to warrant a review.
New Strategies
    The committee's approach to the evidence on saturated fats and low 
carbohydrate diets reflects an apparent failure to address any evidence 
that contradicts what has been official nutritional advice for the past 
35 years. The foundation of that advice has been to recommend eating 
less fat and fewer animal products (meat, dairy, eggs) while shifting 
calorie intake towards more plant foods (fruits, vegetables, grains, 
and vegetable oils) for good health. And in the past decades, this 
advice has remained virtually unchanged.\33\
    Because the guidelines have obviously not led to better health, 
however, there has been a need to find new strategies to tackle 
nutrition related diseases. The committee's most significant shift, 
which began in 2010, however, has been to redouble its efforts towards 
emphasizing a plant based diet. This can be seen in a number of ways in 
the 2015 report, none of which is supported by strong evidence.
    New proposals by the 2015 report include not only deleting meat 
from the list of foods recommended as part of its healthy diets, but 
also actively counseling reductions in ``red and processed meats.'' 
\34\ This advice has been the subject of much debate, which guideline 
supporters have successfully characterized as a conflict between the 
self interested meat industry versus virtuous efforts to safeguard 
health (and the environment).\35\-\36\ Yet framed this way, 
the debate fails to address the question fundamental to nutrition: 
would reducing meat lead to better health? Consulting the NEL for a 
review on this topic turns up a surprising fact: a systematic review on 
health and red meat has not been done. Although several analyses look 
at ``animal protein products,'' these reviews include eggs, fish, and 
dairy and therefore do not isolate the health effects of red meat, or 
meat of any kind.\37\
    Importantly, some of the report's findings also contradict the 
dietary committee's advice on red meat. For example, to support the 
idea that red meat harms health, the committee repeatedly cites one 
large randomized trial conducted in Spain. However, this trial did not 
intend to lower consumption of red and processed meats in the 
experimental group, compared with the control group, so cannot be said 
to support the committee's advice.\38\ Also, the sole diagram on red 
meat in the committee's report, which plots the data from observational 
studies, shows a roughly equal number of health benefits associated 
with the diets higher in red meat as with diets lower in red meat.\39\
Recommended Diets
    Another clear move towards a plant based approach in the report is 
the introduction of the ``healthy vegetarian diet'' as one of three 
recommended diets (the others are: ``healthy Mediterranean-style'' and 
``healthy U.S.-style'').\2\ A NEL review of a healthy vegetarian diet 
does exist, but it concludes that the evidence for this diet's disease 
fighting powers is only ``limited,'' which is the lowest rank for 
available data.\40\ Moreover, although the NEL conducted eight reviews 
on fruits and vegetables, none found strong (grade 1) evidence to 
support the assertion that these foods can provide health benefits.\41\
    In general, the quality of the evidence supporting the report's 
three recommended diets is limited (table D on the bmj.com). The 
committee could find only ``limited'' to ``not assignable'' evidence to 
show that its diets protect against osteoporosis, congenital 
abnormalities, or neurological or psychological illnesses.\27\ The NEL 
review found only ``limited'' or ``insufficient'' evidence that the 
diets could combat diabetes.\42\ In a highly unorthodox move, the 
guideline committee overruled the NEL's systematic reviews on this 
topic and decided to upgrade the rank to ``moderate,'' based on its 
opinion that one review paper on observational data, which showed 
positive results, was particularly strong.
    And are the recommended diets better than other diets in helping 
people lose weight? On this question, the report ranked the evidence as 
moderate, yet to support this claim, it presents only a single clinical 
trial in 180 people with metabolic syndrome, which found the 
Mediterranean diet produced more weight loss than a low fat diet.\43\ 
One randomized controlled trial listed by the review did not actually 
test weight loss, only the ability to adhere to the diet,\44\ which, 
although important, is relevant only if the diet works. Three trials 
\45\-\47\ and an AHA/ACC review \48\ concluded that compared 
with other diets, those recommended by the Dietary Guidelines offered 
at best a marginal advantage in fighting obesity (less than a pound 
over trial periods lasting up to 7 years).
    The report also gave a strong rating to the evidence that its 
recommended diets can fight heart disease.\27\ Again, several studies 
are presented, but none unambiguously supports this claim. Eight trials 
reviewed by the NEL to support its strong grade include one trial that 
should not have been included because it lacked a comparable control 
group; \49\ three that showed no beneficial effects on cardiovascular 
health other than improved blood pressure (and studied hypertensive 
populations) \50\-\52\; another, also in hypertensive 
people, showing that the recommended diet had poorer cardiovascular 
outcomes than other options that were higher in monounsaturated fat or 
protein; \53\ one showing mixed results on cardiovascular risk factors 
(although low density lipoprotein cholesterol fell, so did ``good'' 
high density lipoprotein cholesterol); \54\ and the largest one, which 
concluded that the diet was ineffective for reducing cardiovascular 
risk.\11\ The committee also cites an AHA/ACC review, but this paper 
examines trials already covered by the NEL review, so including them 
again amounts to double counting.\8\ The committee reviewed other, more 
recent studies but not using any systematic or predefined methods.
    In conclusion, the recommended diets are supported by a minuscule 
quantity of rigorous evidence that only marginally supports claims that 
these diets can promote better health than alternatives. Furthermore, 
the NEL reviews of the recommended diets discount or omit important 
data. There have been at a minimum, three National Institutes of Health 
funded trials on some 50,000 people showing that a diet low in fat and 
saturated fat is ineffective for fighting heart disease, obesity, 
diabetes, or 
cancer.\46\, \11\, \55\-\59\ Two of 
these trials are omitted from the NEL review. The third trial is 
included, but its results are ignored. This oversight is particularly 
striking because this trial, the Women's Health Initiative (WHI), was 
the largest nutrition trial in history.\55\-\56\ Nearly 
49,000 women followed a diet low in fat and high in fruits, vegetables, 
and grains for an average of 7 years, at the end of which investigators 
found no significant advantage of this diet for weight loss, diabetes, 
heart disease, or cancer of any 
kind.\11\, \56\-\59\ Critics dismiss this trial 
for various reasons, including the fact that fat consumption did not 
differ enough significantly between the intervention and control 
groups, but the percentage of calories from both fat and saturated fat 
were more than 25% lower in the intervention group than in the control 
group (26.7% v. 36.2% for total fat and 8.8% v. 12.1% for saturated 
fats).\57\ The WHI findings have been confirmed by other sizeable 
studies and are therefore hard to dismiss. When the omitted findings 
from these three clinical trials are factored into the review, the 
overwhelming preponderance of rigorous evidence does not support any of 
the dietary committee's health claims for its recommended diets.
    My Critical Review makes additional points about the recommended 
diets. One is that although the committee states that these diets offer 
``multiple ways'' for people to eat a healthy diet, they are, in fact, 
all still virtually the same. In other words, the committee is still 
recommending a ``one-size-fits-all'' diet. This is problematic, given 
that there is clearly great variation in the nutrition needs of various 
populations, depending on age, gender, genetic background and state of 
metabolic disease state. (see Critical Review, pages 31-32). Moreover, 
the recommended diets are nearly identical to previous DGA dietary 
advice (pages 29-30), so in effect, ``Dietary Patterns'' are simply a 
new name on the same diet that has been recommended for more than a 
decade.
    Moreover, this diet is modeled, in the tables of the report, to be 
low in fat (32-34% of calories as fat), even though the report 
concludes that a diet low in fat worsens important heart disease risk 
factors. In effect, this low-fat advice may potentially worsen heart-
attack risk.
    Another serious problem with the recommended diets is that, 
according to the committee, they are not nutritionally sufficient. The 
committee states that the nutrients ``for which adequacy goals are not 
met'' in most of the recommended diets are ``potassium, vitamin D, 
vitamin E, and choline.'' [1] Vitamin A sufficiency is 
reported as borderline,[2] and without consumption of 
fortified grains, primarily refined-grain breakfast cereals, the diets 
are also deficient in iron and folate.[3] Thus, although the 
committee recommends consuming primarily whole grains, the reality is 
that the recommended diets remain just as high in refined grains as in 
the past, due to the need for nutrients from fortification. Indeed, the 
recommended diets contain an equal amount of refined grains as whole 
grains.
---------------------------------------------------------------------------
    \[1]\ DGAC report, (Part D, Ch. 1, p. 22, lines 827-828 (http://
www.health.gov/dietaryguidelines/2015-scientific-report/06-chapter-1/
d1-2.asp)) (Appendix E-3.1, Text and Figure 4 (http://www.health.gov/
dietaryguidelines/2015-scientific-report/15-appendix-E3/e3-1.asp)).
    \[2]\ 2015 DGAC report, Part D, Ch. 1, Figure D1.1, p. 131.
    \[3]\ Appendix E-3.2, Table 3, (http://health.gov/
dietaryguidelines/2015-scientific-report/15-appendix-e3/e3-2.asp) see 
``grains'' for the contributions of these foods to nutritional 
sufficiency.
---------------------------------------------------------------------------
    The committee does not address the issue of how its recommended 
diets might become nutritionally sufficient. However, it does note that 
for a number of nutrients for which the American population is 
currently ``under-consumed,'' including calcium, iron, and Vitamin D, 
the best and most bioavailable sources of these nutrients are animal 
foods. For example, red meat is ``an excellent source'' of heme iron, 
and the greatest amount of calcium, in its most bioavailable form, is 
in hard cheeses, yet these foods are limited in the recommended diets 
due to the overall cap on saturated fat. The evidence suggests that 
easing or eliminating the limit on saturated fat would eliminate these 
nutritional deficiencies. A more complete discussion of these issues 
can be found in my Critical Review.
    A final area examined by The BMJ where the report offers advice 
that contradicts its data is on sodium. The committee says that it 
``concurs'' with a recent report by the Institute of Medicine, which 
states that the evidence is ``inconsistent and insufficient to conclude 
that lowering sodium intakes below 2,300 mg/day will have any effect on 
cardiovascular risk or overall mortality.'' \9\ Yet the report 
recommends that sodium intake ``should be less than 2,300 mg/day'' and 
encourages the choice of low salt options without reservation.
Questions About Bias
    The overall lack of sound science and proper methods in the 2015 
report could be seen as a reluctance to depart from existing dietary 
recommendations. Many experts, institutions, and industries have an 
interest in keeping the status quo advice, and these interests create a 
bias in its favor. Abandoning the NEL review methods, as the 2015 
committee has done, opens the door not only for bias but also for 
influence from outside agendas and commercial interests, and all of 
these can be observed in the report.
    For example, a bias towards the longstanding view that saturated 
fats are harmful can be seen in the report's designation of them, 
together with sugar, as a new category it calls ``empty calories.'' \2\ 
The report repeatedly mentions the need to reduce ``sugar and solid 
fats,'' because, ``both provide calories, but few or no nutrients.'' 
\2\ Yet this pairing is unsupported by nutrition science. Unlike sugar, 
saturated fats are mostly consumed as an inherent part of foods such as 
eggs, meat, and dairy, which together contain nearly all of the 
vitamins and minerals needed for good health.
    Not following the NEL methods has also allowed outside agendas to 
enter into the report, most clearly in the form of the new 
consideration for environmental sustainability. Although, as the report 
states, the environmental effects of food and drink production are 
considerable, they are outside the committee's formal mandate to 
provide the Federal Government with the ``current scientific evidence 
on topics related to diet, nutrition, and health.'' \2\ In a new 
development for 2015, the USDA hired a food policy analyst focused on 
environmental issues to oversee the guideline committee's work, 
reflecting a new agenda in the process.\60\
    Much has been written about how industries try to influence 
nutrition policy, so it is surprising that unlike authors in most major 
medical journals, guideline committee members are not required to list 
their potential conflicts of interest. A cursory investigation shows 
several such possible conflicts: one member has received research 
funding from the California Walnut Commission \61\ and the Tree Nut 
Council,\62\ as well as vegetable oil giants Bunge and 
Unilever.\63\-\64\ Another has received more than $10,000 
from Lluminari, which produces health related multimedia content for 
General Mills, PepsiCo, Stonyfield Farm, Newman's Own, and ``other 
companies.'' \65\ And for the first time, the committee chair comes not 
from a university but from industry: Barbara Millen is President of 
Millennium Prevention, a company based in Westwood, MA, that sells web-
based platforms and mobile applications for self health monitoring. 
While there is no evidence that these potential conflicts of interest 
influenced the committee members, the report recommends a high 
consumption of vegetable oils and nuts as well as use of self 
monitoring technologies in programs for weight management.
    Still, it's important to note that in a field where public research 
dollars are scarce, nearly all nutrition scientists accept funding from 
industry. Of far greater influence is likely to be bias in favor of an 
institutionalized hypothesis as well as a ``white hat'' bias to distort 
information for what is perceived as righteous ends.\66\
    The report is highly confident that its findings are supported by 
good science, stating that ``The evidence base has never been stronger 
to guide solutions.'' \2\ Millen told The BMJ, ``You don't simply 
answer these questions on the basis of the NEL. Where we didn't feel we 
needed to, we didn't do them. On topics where there were existing 
comprehensive guidelines, we didn't do them. We used those resources 
and that time to cover other questions. The notion that every question 
that we posed should have a NEL is flawed.'' She said she would ``go to 
the mat'' to defend the committee's approach. ``That's why you have an 
expert committee . . . to bring expertise,'' including ``our own 
original analyses.''
    ``These folks know how to do this work. People who criticize this 
are coming from the point of view that they don't like the answer. They 
don't like the fact that randomised controlled trials testing these 
dietary patterns are successful. I think you have to read the report. 
NEL helped us to do the searches to update the literature. That is 
stated. If it doesn't satisfy you, that is all I can say. It's well 
stated and been reviewed by dozens of people.''
    On saturated fats, especially, she said, ``We thought we nailed 
it.'' Millen said that her committee's work had not been entirely 
without methodology but had ``worked with the NEL and USDA assistance 
to identify the research literature.'' She said that ''it was clear 
that polyunsaturated fats reduced heart disease risk and mortality,'' 
yet that the ``evidence is not as clear on whether replacement of 
saturated fat with monounsaturated fats or carbohydrates reduces 
cardiovascular disease risk, and likely depends on the type and 
source.''
    On diets low in carbohydrates, she said that there was ``not 
substantial evidence'' to consider. ``Many popular diets don't have 
evidence. But can you achieve healthiness, the answer is yes.''
    Regarding the committee's conflicts of interest, she said that 
members were vetted by counsel to the Federal Government. She would not 
reveal details of her company's activities. Critics of the report, she 
said, ``are coming from the point of view that they don't like the 
answer.''
    The argument by the USDA has been that the Guidelines have not been 
successful because people do not adequately follow them. However, 
government data contradicts this explanation: from 1970 to 2005, 
Americans increased consumption of vegetables by 23% (with one of the 
biggest percentile increases being in leafy greens), fruit by 13%, 
grains by 41% and vegetable oils by 91%. At that same time, Americans 
have decreased consumption of animal fats by 16%, red meat by 17%, 
(beef by 22%), whole milk by 73%, butter by 14%, and eggs by 17%. (67) 
These numbers suggest that Americans have successfully followed the 
Guidelines, yet clearly better health has not been the result.
    After 35 years of pursuing the same flawed nutrition policy, the 
time has come for an objective scientific review of the proposed 
Dietary Guidelines. Congress initiated the guidelines 35 years ago and 
Congress should require an objective scientific review of the 
guidelines by the National Academy of Sciences, and the Administration 
should embrace this transparent, objective analysis of one of the 
fundamental tenets of national nutrition policy.

 
 
 
Notes
 
         Competing interests: I have received modest honorariums
       for presenting my research findings presented in the book to a
       variety of groups related to the medical, restaurant, financial,
       meat, and dairy industries. I am also a board member of a
       nonprofit organization, the Nutrition Coalition, dedicated to
       ensuring that nutrition policy is based on rigorous science.
 
         This article was fully funded with a grant from the
       Laura and John Arnold Foundation. The analysis was conducted
       independently, and the report reflects the views of the author
       and not necessarily those of the foundation. The article was
       submitted in June and provisionally accepted for publication in
       July of 2015.
 
         Provenance and peer review: Commissioned; externally
       peer reviewed and fact checked.
 
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                                 ______
                                 
     Submitted Letter by Kristin Pearson Wilcox, Vice President of 
     Government Relations, International Bottled Water Association
October 7, 2015

 
 
 
Hon. K. Michael Conaway,             Hon. Collin C. Peterson,
Chairman,                            Ranking Minority Member,
House Committee on Agriculture,      House Committee on Agriculture,
Washington D.C.;                     Washington D.C.
 

    Dear Chairman Conaway and Ranking Member Peterson:

    On behalf of the members of the International Bottled Water 
Association (IBWA), thank you for holding the hearing today on the 
importance of basing the 2015 Dietary Guidelines for Americans (DGA) on 
sound science.
    IBWA is the primary, authoritative source of information on bottled 
water. This includes all types of water, such as spring, mineral, 
sparkling, artesian and purified bottled water. Our membership includes 
over 700 United States and international bottlers, suppliers and 
distributors that are small, medium and large-sized companies. IBWA and 
the bottled water industry are committed to making safe and healthy 
products. In addition to U.S. Food and Drug Administration (FDA) and 
state regulations, IBWA member bottlers must adhere to the IBWA Bottled 
Water Code of Practice. In some cases, the FDA and IBWA standards for 
bottled water are more stringent than the U.S. Environmental Protection 
Agency (EPA) regulations for tap water.
    We appreciate your attention today to the nutritional health of our 
citizens. Every American is affected by the nutritional recommendations 
made in the Dietary Guidelines. It is essential for them to be based on 
consistent, and sound nutritional science. We want to provide you with 
our insights on the nutritional importance of water, and its role in 
health, as you examine the Administration's efforts to finalize the 
2015 Dietary Guidelines. We believe the science supports having the 
final guidelines stress the importance of water consumption, including 
bottled water consumption.
    Making healthy hydration an equally important part of the wellness 
equation, along with a well-balanced diet and daily physical activity 
for all Americans, should be a clear focus of the 2015 DGAs. Bottled 
water presents a healthy option for consumers when making a beverage 
choice. Having no calories and no sugar, it is often the best choice as 
a beverage on the go. This simplicity gives bottled water an advantage 
over other packaged beverages when consumers are trying to make a 
healthy beverage selection.
    Scientific studies clearly demonstrate the importance of water 
consumption, and science and health professionals are speaking up on 
behalf of water. For example, on September 10, 2014, fourteen 
researchers, scientists, nutritionists, clinicians, and public health 
professionals wrote a letter to the Dietary Guidelines Advisory 
Committee (DGAC) asking them to strengthen the language for drinking 
water in the 2015 Dietary Guidelines and adding a water graphic to the 
MyPlate nutrition guide. We think the science is clear, and researchers 
and clinicians are saying Americans should drink more water. And, 
consumers are listening.
    Americans' consumption of bottled water increased by 7.3 percent to 
11 billion gallons in 2014 and bottled water sales were up 6.4 percent 
to $13 billion (wholesale) over the previous year. Americans upped 
their annual bottled water consumption by almost 11 gallons per person 
during the period 2004 to 2015. It went from 23.2 gallons per person in 
2004 to 34 gallons in 2014, according to Beverage Marketing Corporation 
(BMC). BMC reported that over the past 5 years alone, bottled water has 
increased its ``share of stomach'' of the overall beverage market from 
14.4 percent in 2009, to 17.8 percent in 2014.
    We hope that the revised DGA's will take this growth, and the 
advice of nutrition experts, into account in the final 2015 DGA 
document. Numerous peer-reviewed scientific studies indicate that water 
consumption can aid in weight management and that there is a need to 
promote the consumption of water. IBWA submitted a full list of the 
scientific research supporting the importance of water consumption to 
the DGAC.
    This impressive list of academic endorsements of the importance of 
water consumption is supported by the government's own data. The U.S. 
Department of Agriculture's (USDA) National Health and Nutrition 
Examination Survey (NHANES) IV data show that older adults are not 
consuming enough water. Neither are children. Water accounted for only 
29% of children's total fluid intake; the majority coming from soda, 
sports drinks and teas. Of children 4-8 years, 75% failed to satisfy 
the Daily Recommended Intake (DRI) for water. Dr. Adam Drewnoski, of 
the Center for Public Health Nutrition at the University of Washington, 
who conducted this study of NHANES data, concluded, ``Increasing total 
water consumption can be achieved through various means, though 
promotion and encouragement of non-caloric beverages is likely to be 
the most successful avenue for increasing water consumption.''
    IBWA and its members believe the Dietary Guidelines should 
encourage the consumption of water of all kinds: bottled, filtered, and 
tap. It is our hope that the 2015 Dietary Guidelines will reinforce 
those healthy behaviors that are already changing for the better. As 
noted, people are forming new habits like drinking more water--both 
bottled and tap. Besides growing in consumption nationally, bottled 
water is already outselling carbonated soft drinks in supermarkets here 
in Washington, D.C. and in 17 other major markets, including New York, 
Los Angeles, Miami, and Philadelphia. And according to BMC, bottled 
water will become the number one beverage product in the United States 
by 2020.
    The message to drink more water is resonating around the world. For 
example, the Mediterranean Diet Pyramid includes drinking water as an 
essential component of a healthy diet. The DGAC has discussed the 
merits of the Mediterranean Diet during its deliberation of the 2015 
Guidelines. The Japanese Food Guide also includes water at the top of 
its pyramid. Again, they all recognize water as an important element of 
a well-balanced lifestyle. Other countries, such as France, Spain, 
Germany, and Austria, include water in their dietary guideline visual 
depictions. We believe the U.S. should join these countries and include 
water in its Dietary Guidelines and on the MyPlate visual.
    The DGAs do not need to pit healthy foods and beverages against 
each other. No one supports healthy beverage choices, such as milk, 
more than our industry and we recognize the nutrient value of milk and 
100% fruit juice. We are, however, suggesting that science supports 
having water, along with milk and dairy, on the MyPlate nutrition 
guide. According to a recent W.K. Kellogg Foundation poll, 90 percent 
of the people polled say they support making water a preferred beverage 
in the new 2015 Dietary Guidelines for Americans. IBWA commissioned a 
study by the Artemis Strategy Group on the different MyPlate visuals. 
One of the visuals included the original USDA/HHS MyPlate, which has a 
dairy cup next to a plate. Another visual had a cup of dairy and cup of 
water next to one another alongside the plate. Among the 76% of those 
surveyed who reported that they are very or somewhat likely to consume 
dairy when viewing the original MyPlate, 49% of them said they that 
they would drink both water and dairy when they saw a MyPlate visual 
including water and dairy.
    The 2015 Dietary Guidelines and MyPlate will serve as a platform 
for Americans to begin or continue living a healthy lifestyle. We hope 
that both will include messaging and visuals to encourage the adoption 
of healthy hydration habits. Americans should be healthier and drink 
more water. If we want Americans to drink more water, there should be a 
consistent ``think water'' encouragement in the Dietary Guidelines' 
final recommendations. Delivery of this message to American families is 
critical.
    We are concerned about two messages in the DGAC recommendations. In 
particular, its steps into providing economic rather than nutritional 
advice when the DGAC stresses that consumers should drink ``free'' 
water. We think the final Guidelines should encourage consumers to 
drink ``accessible'' water.
    We are also concerned about the DGAC's straying into a discussion 
of environmental sustainability. We want to make sure that you are 
aware of bottled water's small impact on the environment, and on our 
small water use, as you deliberate on what beverages to promote. 
Bottled water has the smallest environmental footprint among all 
packaged beverages.
    Statistics show that the bottled water industry is a sustainability 
leader. From an environmental standpoint, when people choose bottled 
water instead of any other canned or bottled beverage, they are 
choosing less packaging, less energy consumption, and less use of 
natural resources. According to a 2014 Antea Group Study, bottled water 
facilities have the lowest water use ratio and energy use ratio when 
compared to other beverage products, including sugar-sweetened 
beverages. These ratios represent the average amount of water and 
energy used within the facility to produce 1 liter of bottled water. 
The Antea study found that it only takes 1.32 liters of water to 
produce 1 liter of bottled water and that includes the liter that is 
consumed.
    PET plastic bottled water containers are the single most recycled 
item in nationwide curbside collection programs. And large 3 and 5 
gallon bottled water containers are washed, sanitized and reused 
between 30-50 times before being recycled. Data derived from EPA 
figures demonstrate that plastic water bottles make up less than \1/3\ 
of 1 percent of the entire U.S. waste stream.
    Bottled water producers, like the American farmers this Committee 
works to uplift and protect, care about the quality of the water and 
land that produce the food and beverage products that Americans and 
people around the world consume.
    We pledge to remain good stewards of water resources. And we stand 
ready to partner with you and the Administration to help ensure good 
nutritional health for all Americans.
    Thank you for this opportunity to comment on this important issue.
            Sincerely,
            [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            
Kristin Pearson Wilcox
Vice President of Government Relations.
                                 ______
                                 
                   Submitted Letter by Grain Chain *
---------------------------------------------------------------------------
    * American Bakers Association; American Institute of Baking 
International Grain Foods Foundation; Independent Bakers Association; 
National Association of Wheat Growers; National Pasta Association; 
North American Millers' Association; Retail Bakers of America; USA Rice 
Federation; Wheat Foods Council.
---------------------------------------------------------------------------
October 19, 2015

  Hon. K. Michael Conaway,
  Chairman,
  House Agriculture Committee
  Washington, D.C.

  RE: Grain Chain Comments for Hearing Record: House Agriculture 
            Committee Hearing on 2015 Dietary Guidelines for Americans 
            (October 7, 2015)

    Dear Chairman Conaway:

    As the organizations comprising the Grain Chain, a grains industry 
coalition from farm to table, we are pleased to provide written 
comments for the public hearing record on the House Agriculture 
Committee's recent hearing to review the 2015 Dietary Guidelines for 
Americans.
    We commend the Chairman and the Committee on analysis of the 
dietary guideline review process and for emphasizing that as the 2015 
recommendations are finalized by HHS and USDA, there needs to be a base 
of strong scientific evidence and within scope.
    The Grain Chain comments provide detailed justification for the 
following specific recommendations:

  1.  Retain the DGAC 2010 recommendation for six servings of grains 
            with balance between whole and enriched (refined);

  2.  Use the term ``enriched grains'' when referring to refined 
            grains, since more than 95% of the refined grains in the 
            U.S. are enriched and fortified;

  3.  Reject the DGAC 2015 recommendation to limit added sugar to no 
            more than 10% of total calories;

  4.  Reject the DGAC 2015 recommendation to restrict dietary sodium to 
            less than 2300 mg per day;

  5.  Acknowledge the emerging evidence of the beneficial effects of 
            whole grains on maintaining a healthy microbiome;

  6.  Note the negative health implications of fad diets.

    In the following sections we provide the scientific rationale for 
each of our recommendations.
1. Retain the DGAC 2010 Recommendation for Six Servings of Grains with 
        Balance Between Whole and Enriched (Refined)
The Crucial Role of Enriched Grains in the Diet
    The Grain Chain fully endorses the 2015 Dietary Guidelines Advisory 
Committee's decision to ``bring forward'' the recommendation of the 
2010 Dietary Guidelines for Americans which called for \1/2\ of all 
grain intake to come from whole grains. This would allow Americans to 
reap the multiple, established health benefits of whole grains, leaving 
the other \1/2\ of daily grain intake for enriched grain products, 
which have their own unique benefits. Furthermore, because at least 95% 
of the refined grains in the U.S. are enriched and fortified and 
labeled as such, it is more appropriate to use the term ``enriched 
grains'' as opposed to ``refined grains,'' especially when speaking to 
staple grain products [see below, section on ``Clarification of 
Terminology'']. Since Americans have yet to achieve the current Dietary 
Guidelines recommendation for whole grain intake, the recommendation's 
goal is still valid and vital in the setting of a calorically 
appropriate diet. As well, the science does not show that there are 
benefits to higher daily intake of whole grains beyond ``making \1/2\ 
your grains whole grains,'' reinforcing that all grains have a place in 
a balanced eating pattern.
    As a category, grain foods contribute vital, and often 
underconsumed, nutrients to the American diet, including 43.7% of all 
fiber.\1\ Approximately \2/3\ of the grain contribution to total fiber 
intake comes from enriched grains.\2\ The contributions of both whole 
and enriched grains to total fiber intake are important because more 
than 90% of adults and children fall short of dietary fiber 
recommendations.\2\ Enriched grains also are the largest contributor of 
folate in the American diet.\3\ Although the current dietary fiber 
shortfall could theoretically be made up by consuming more fruits and 
vegetables, which together contribute 43.8% of total dietary fiber 
intake,\1\ a reduction in enriched grain intake could have unintended 
health consequences (e.g., nutrient shortfalls from reduced intake of 
enriched grain products--see section 2, below). Furthermore, a number 
of scientific reports have demonstrated the distinctive benefits of 
cereal fiber compared to fiber from fruits and vegetables. For example:

   A 2007 meta-analysis including nine cohort studies 
        demonstrated a 33% reduction in type 2 diabetes incidence 
        associated with cereal fiber intake, but no association with 
        either fruit or vegetable fiber intake.\4\

   A 2014 analysis of data from 17 prospective studies found an 
        inverse linear relationship between cereal fiber intake and 
        reduction in type 2 diabetes risk but no such associations with 
        fruit or vegetable fiber intake.\5\

   A 2014 publication using data on survivors of myocardial 
        infarction among participants in the Nurses' Health Study and 
        Health Professionals Follow-up Study showed a 27% reduced risk 
        in all-cause and CVD mortality associated with cereal fiber 
        intake, but no association with fiber from either fruit or 
        legumes.\6\

    These articles are not presented to diminish the established 
benefits of fruits and vegetables, but rather to highlight the findings 
that when compared head-to-head, a considerable body of evidence (i.e., 
28 separate cohorts examined in these three studies) indicates that 
cereal fiber may be more important for reducing all-cause and some 
cause-specific mortality. Fiber from enriched grains makes up 
approximately \2/3\ of total cereal fiber in the American diet.
    While whole grains have a well-established link to reduced obesity 
risk, the 2015 DGAC has overstated the evidence against refined 
(enriched) grains. For example:

   A systematic review of the literature showed little 
        relationship between refined (enriched) grain intake and body 
        mass index.\7\

   A 2012 special review for Nutrition Reviews concluded that 
        the published data on the relationship between refined 
        (enriched) grain intake and body weight are mixed, with no 
        clear and consistent trends.\8\

   Refined (enriched) grain intake was not associated with any 
        measure of body fat distribution in older adults.\9\

   Among adolescent girls and boys in the NHANES III study, 
        both refined (enriched) grain intake and whole grain intake 
        were inversely associated with central adiposity, measured by 
        waist circumference.\10\

    With respect to facilitating weight loss, both refined (enriched) 
grains and whole grains may be equally effective:

   A 2014 report showed that when consuming a hypocaloric diet, 
        enriched-grain foods and whole-grain foods were equally 
        effective in facilitating weight loss and reducing abdominal 
        adipose tissue in men and women with increased waist 
        circumference.\11\

   A 2008 publication demonstrated that whole- and enriched-
        grain diets produced equal weight loss and improvements in 
        several CVD risk markers in men and women with the Metabolic 
        Syndrome.\12\
Refined (Enriched) Grain Intake and Chronic Disease: Weak Scientific 
        Evidence
    The 2015 DGAC concluded that higher consumption of refined 
(enriched) grains is linked to higher risk of several chronic diseases. 
This conclusion is not consistent with a large body of scientific 
evidence and again, reflects the disconnect in how staple grain 
products are classified. We have shared some examples of these 
inconsistencies but ultimately request a continued recommendation for 
balanced intake between enriched and whole grains.
    Some examples:

   The 2015 DGAC report cited a 2014 meta-analysis in the 
        Journal of Human Nutrition and Dietetics that indicated a 
        positive relationship between refined (enriched) grain intake 
        and risk of type 2 diabetes.\13\ However, refined grains were 
        not analyzed separately, but only as part of a dietary pattern. 
        Surprisingly, the 2015 DGAC report did not cite a 2013 meta-
        analysis published in the European Journal of Epidemiology that 
        showed no relationship between refined (enriched) grain intake 
        and diabetes risk.\14\ The impact factor for the Journal of 
        Human Nutrition and Dietetics is 2.07, while the impact factor 
        for the European Journal of Epidemiology is 5.15. It is 
        important to note that the article not cited by the committee 
        found no association between diabetes risk and refined grain 
        intake, even up to seven servings per day. This information is 
        extremely relevant because Figure D1.28 in the DGAC report (p. 
        144) shows that refined (enriched) grain intake ranged between 
        three and 6.5 servings per day, depending on sex and age group, 
        between 2001 and 2010 (based on NHANES data). Furthermore, the 
        reduced diabetes risk associated with whole grain intake was 
        maximized at three servings per day, which is completely 
        consistent with the current recommendations of 3 servings per 
        day of whole grains. If total grain intake is to stay at six 
        servings per day, there is no reason to advocate that all 
        servings should come from whole grains.

   A report from the Framingham Heart Study showed that the 
        lowest level of visceral abdominal fat was observed in persons 
        who consumed approximately two servings per day of refined 
        (enriched) grains and approximately three servings per day of 
        whole grains. There was no benefit of reducing refined 
        (enriched) grain intake to less than one serving per day.\15\

   A 2012 review concluded, ``The totality of evidence shows 
        that consumption of up to 50% of all grain foods as refined-
        grain foods (without high levels of added fat, sugar, or 
        sodium) is not associated with any increased disease risk.'' 
        \16\

   Among 28,926 participants in the Women's Health Study, 
        refined (enriched) grain intake was not associated with 
        hypertension, but whole grain intake was inversely associated 
        with hypertension risk. The lack of an association with refined 
        (enriched) grain intake was observed even at intakes of six or 
        more servings per day.\17\
All Grain-Based Foods Can Be Part of a Healthy Diet
    Recent data analyses presented at the 2015 Experimental Biology 
meeting in Boston that was supported by the Grain Foods Foundation 
revealed how many grain-based foods can cost-effectively fit into a 
healthy diet.18-20 The results of these three separate 
analyses are described below:

   The 2015 DGAC relied on food pattern modeling analyses 
        performed by the 2005 and 2010 DGACs to answer questions 
        related to the impact of reducing refined/enriched grain 
        consumption, and overall grain consumption, on nutrient intake. 
        We would like to bring to your attention recent modeling 
        research, supported by the Grain Foods Foundation, and 
        presented at the 2015 Experimental Biology meeting.\18\ The 
        modeling analysis was conducted within a 2,000 kcal/d USDA 
        ideal food pattern where the ideal USDA grain food composite 
        was replaced with ten different grain food patterns based on 
        data from What We Eat In America 2005-2010. All patterns were 
        compared to the USDA ideal and USDA typical food patterns. All 
        ten models examined provided less energy in comparison to the 
        USDA typical food pattern. Several grain patterns, including 
        refined grains, contributed nutrient and energy intakes similar 
        to USDA recommendations. In fact, a pattern that included three 
        servings of refined grains, two high-fiber grain servings and 
        one serving of whole grains resulted in less sodium intake and 
        greater intake of folate and fiber than a dietary pattern that 
        included six servings of whole grains.

   A cluster analysis using data from What We Eat in America 
        2005-2010 found that there were no significant differences 
        observed comparing those in the ``no grains'' cluster to those 
        in several different grain patterns, including many non-whole 
        grain-based foods, for body mass index or fasting blood 
        concentrations of glucose, insulin, total cholesterol, LDL-
        cholesterol and triglycerides.\19\ Thus, inclusion of several 
        grain foods patterns in the diet is associated with several 
        health- and nutrition-related outcomes in adults.

   A cost-of-nutrients analysis used NHANES 2003-2004 data and 
        the USDA Center for Nutrition Policy and Promotion prices 
        database to show that certain grain-based foods are a 
        ``nutrition bargain'' for American consumers.20 The rolls/buns 
        category and the rice category were particularly cost 
        effective, each ranking in the top five most cost effective 
        food categories for 13-14 of the nutrients/substances 
        evaluated, including dietary fiber, protein, folate, iron, 
        magnesium, calcium, niacin and thiamin.
2. Clarification of Terminology: Use the Term ``Enriched Grains'' When 
        Referring to Refined Grains
    We would like to clarify some important points on grains 
terminology.
    Although the 2015 DGAC acknowledged the enrichment and 
fortification of grains, its repeated recommendations to reduce 
consumption of ``refined'' grains to improve health undermines the 
established benefits of enriched grain products.
    Furthermore, rather than ``refined,'' ``enriched'' is a more 
appropriate term to describe the grain products that the average 
American sees in the grocery aisle. These staple foods contain some 
fiber and are enriched with important nutrients, like thiamin, niacin, 
riboflavin and iron. They are fortified with folic acid, which is 
essential for women of childbearing age to help prevent neural tube 
birth defects. The rate of neural tube defects in the United States has 
decreased by 35 percent since the fortification of enriched grains 
began in 1998.\21\
    Enriched grains, as mandated by the U.S. Government since 1941, 
have the three major B vitamins and iron replaced in equal or larger 
amounts to those in whole grain products as defined by the standards of 
identity. These essential B vitamins help maintain a healthy nervous 
system, increase energy production, and may play a role in lowering 
cholesterol. Due to this enrichment policy, serious diseases, including 
pellagra and beriberi, have been eradicated from the U.S. population. 
The reduction in neural tube defects has reduced health care costs 
associated with spina bifida and anencephaly, resulting in annual 
savings in total direct costs of approximately $508 million for the 
NTD-affected births that were prevented with folic acid 
fortification.\21\
    Enriched, fortified grain foods are the primary source of folic 
acid in Americans' diets. This is particularly important for women of 
child-bearing age, the majority of which do not take folic acid 
supplements. Furthermore, folic acid is better absorbed by the body 
than natural folate, almost twice as efficiently.\22\ The U.S. also has 
a growing Hispanic population, and adequate consumption of folate-rich 
foods is critical for this group since statistically, Hispanic women 
are 1.5 to 3 times more likely to have a baby with an NTD.\23\
    A Centers for Disease Control and Prevention (CDC) proclamation in 
2011 named the fortification of folic acid to enriched grains as one of 
the top ten health achievements in the first decade of this 
century.\24\ This fortification policy has also almost totally 
eradicated folate-deficiency anemia in older adults in the U.S.\25\
3. Reject the DGAC 2015 Recommendation To Limit Added Sugar To No More 
        Than 10% of Total Calories
    The 2015 DGAC recommends limiting added sugars to a maximum of 10% 
of total daily caloric intake. This recommendation was based on the 
food pattern modeling analysis conducted by the 2015 DGAC and on the 
scientific evidence review on added sugars and chronic disease risk 
conducted by the Committee. The DGAC rated the evidence as ``strong.'' 
But the two major meta-analyses that the 2015 DGAC relied heavily upon 
reported rather small associations between sugar intake and body 
weight.26-27 Moreover, the committee did not include several 
published reports that showed no significant relationships between 
sugar intake and a number of health outcomes.28-34
    The association with obesity, for example, has been shown to be 
primarily due to caloric excess rather than sugar 
itself.31-32 Furthermore, data on adults from the 1999-2006 
National Health and Nutrition Examination Surveys (NHANES) demonstrated 
that sugar consumption was not positively associated with body weight 
or indicators of the metabolic syndrome.\33\ Similarly, among children 
ages 6-18 participating in the 2003-2006 National Health and Nutrition 
Examination Survey, intake of added sugars was not associated with body 
weight, BMI z-score or any measure of adiposity.\30\ In fact, added 
sugar consumption explained less than 0.25% of the variance in BMI z-
scores of the children in this study, indicating that more than 99.75% 
of the variation in BMI z-scores of these children was due to factors 
other than sugar. It is difficult to justify specific recommendations 
for sugar consumption when this macronutrient's contribution to body 
weight and blood biomarkers for cardiovascular health is so small. 
Sugars have no specific role as a determinant of body weight other than 
being one of many sources of energy.\34\
    We would also like to point out that the benefits of whole-grain 
consumption are independent of sugar consumption, and can be documented 
even with relatively high sugar intakes:

   In children ages 2-5, 6-12, and 13-18, whole-grain intake 
        was found to be associated with higher diet quality (assessed 
        by the Healthy Eating Index that reflects recommendations of 
        the Dietary Guidelines for Americans), despite the fact that 
        total sugar intake did not differ across quartiles of whole-
        grain intake. Highest diet quality was observed in children 
        consuming more than three servings of whole grains per day. 
        Sugar intake in these groups accounted for 19-23% of total 
        calories.\28\

   In adults ages 51 and older participating in the National 
        Health and Nutrition Examination Survey, 1999-2004, whole-grain 
        intake was associated with a significantly higher Healthy 
        Eating Index score, despite no differences in total sugar 
        intake across quartiles of whole-grain intake.\29\
4. Reject the DGAC 2015 Recommendation To Restrict Dietary Sodium to 
        Less Than 2,300 mg Per Day
    The recommendation of the 2015 DGAC for dietary sodium intake to 
below 2,300 mg may not be compatible with minimizing risk for mortality 
or cardiovascular disease as stated in the 2013 Institute of Medicine 
(IOM) report on ``Sodium Intake in Populations: Assessment of 
Evidence'' and in other peer reviewed journals.35-41 
Evidence linking sodium intake to mortality outcomes is scant and 
inconsistent.36-41 Several publications in 2014 and 2015 
have demonstrated an increased mortality risk associated with low 
sodium intake.38-41 Because sodium reduction has 
physiological effects that may adversely affect health outcome, it is 
premature to recommend sodium levels lower than 2300 mg until more 
definitive data can justify such broad population-wide advice.
5. Acknowledge the Emerging Evidence of the Beneficial Effects of Whole 
        Grains on Maintaining a Healthy Microbiome
    In recent years there has been heightened interest in the role of 
the gastrointestinal system in overall health, but after conducting an 
exploratory search the 2015 DGAC concluded that there was insufficient 
evidence to address the role of diet in the microbiome.
    While we agree that this is an emerging area of study, we would 
also like to emphasize that published research indicates that grains, 
especially those with high amounts of resistant starches, are important 
for maintaining a healthy composition of gut bacteria. Whole grain 
cereals, among other plant foods, are associated with the up-regulation 
of various bacteria that are beneficial to gut health.\42\ Resistant 
starches found in whole grains have a prebiotic action that helps 
create a healthy composition of gut bacteria which may reduce risk of 
some cancers, inflammatory conditions and cardiovascular 
disease.43-50 Despite the relatively small number of 
studies, the data that have been published call attention to a very 
prominent role for grain-based foods in creating a healthy microbiome. 
We think that this should be at least acknowledged in the 2015 Dietary 
Guidelines, especially as an area for future study.
6. Note the Negative Health Implications of Fad Diets
    Fad diets are temporary interventions that may carry long-term 
health consequences for the American public.
    Contrary to the nature of fad diets, the Dietary Guidelines for 
Americans are focused on setting the stage for a long-term, healthful 
eating pattern for all Americans, one that is based on a common sense 
approach built on balance, variety and moderation. As a Grain Chain, we 
believe that healthy weight maintenance/loss relies on the simple 
equation of balancing calories in (consumed) with calories out 
(expended), not eliminating specific foods or relying primarily on one 
food group.
    While there are countless fad diet plans available to the average 
American, we would like to briefly address the evidence countering 
three plans which often receive attention in the popular press: low-
carbohydrate/Atkins, grain- and wheat-free (such as the plans detailed 
in the books Wheat Belly and Grain Brain) and gluten-free.
    Low-carbohydrate/Atkins: Two meta-analyses published in 2014 showed 
no difference between low-fat and low-carbohydrate diets for weight 
loss or cardiovascular risk factors; researchers concluded that weight 
loss is determined by calorie deficit regardless of calorie type and 
asserted most cardiovascular improvements can be attributed to the 
weight loss.51-52 More importantly, in a sample of nearly 
44,000 Swedish women followed for an average of 15.7 years, study 
organizers found ``low carbohydrate, high-protein diets used on a 
regular basis and without consideration of the nature of carbohydrates 
or the source of proteins are associated with increased risk of 
cardiovascular disease.'' \53\ Carbohydrate consumption is also 
associated with better body weights. According to a study published in 
the Journal of the Academy of Nutrition and Dietetics, those who 
consume a medium-to-high percentage of carbohydrates in their diets 
have a reduced risk of obesity. The study also showed that people 
following a low-carbohydrate diet actually had a higher risk of being 
overweight or obese.\54\
    Grain- and wheat-free: Carbohydrates are the preferred fuel source 
for the human brain; beyond this necessary role, grain consumption has 
been shown to have positive effects on brain function, specifically:

   As part of an overall healthful eating pattern, specifically 
        one that follows the principles of the Mediterranean diet, 
        consuming whole grain foods has been shown to positively impact 
        cognitive function.55-60

   Consumption of dietary fiber and B vitamins found in grain 
        foods is associated with better cognitive 
        health.61-63

   Folic acid fortification of enriched grain foods has been 
        shown to be a cost effective method of improving cognitive 
        health and brain development in utero.64-68

    Gluten-free: Gluten-free dieting has gained popularity in the 
general population out of proportion to the prevalence of gluten-
related disorders such celiac disease (CD), non-celiac gluten 
sensitivity (NCGS), and wheat allergy; supporting this are findings 
from a 2013 survey by Mintel indicating that 65% of American adults say 
they eat gluten-free products because they think they are more 
healthful, and 27% eat gluten-free products to lose weight.
    Despite these claims for gluten-free eating, no published 
experimental evidence supports a weight loss claim for a gluten-free 
diet or suggests that the general population would be better off by 
avoiding gluten.\69\ Furthermore, no published studies have found that 
a gluten-free diet produces weight loss in patients without CD or NCGS. 
This may be because gluten-free foods are not necessarily low-calorie 
and often times contain more calories than their gluten-containing 
counterparts. Moreover, a gluten-free diet may also result in lower 
intake of whole grains and dietary fiber and some evidence suggests 
that following a gluten-free diet reduces concentrations of beneficial 
gut bacteria; on the other hand, a gluten-rich diet may boost the 
numbers of beneficial gut bacteria.
    We appreciate the opportunity to provide comments to the public 
hearing record. Should the Committee have questions or seek additional 
information, please contact Lee Sanders, American Bakers Association 
Senior Vice President for Government Relations and Public Affairs at 
[Redacted] or at [Redacted].
            Sincerely,

American Bakers Association (ABA);
American Institute of Baking International;
Grain Foods Foundation (GFF);
Independent Bakers Association;
National Association of Wheat Growers (NAWG);
National Pasta Association (NPA);
North American Millers' Association;
Retail Bakers of America;
USA Rice Federation;
Wheat Foods Council (WFC).

 
 
 
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Descriptions of Grain Industry Organizations
 
    American Bakers Association (ABA) is the Washington, D.C.-based
 voice of the wholesale baking industry. Since 1897, ABA has represented
 the interests of bakers before the U.S. Congress, Federal agencies, and
 international regulatory authorities. ABA advocates on behalf of more
 than 700 baking facilities and baking company suppliers. ABA members
 produce bread, rolls, crackers, bagels, sweet goods, tortillas and many
 other wholesome, nutritious baked products for America's families. The
 baking industry generates more than $103 billion in economic activity
 annually and employs 633,000 highly skilled people. [Redacted]
    American Institute of Baking International (AIB) is a corporation
 founded by the North American wholesale and retail baking industries in
 1919 as a technology transfer center for bakers and food processors.
 The original mission of the organization was to ``put science to work
 for the baker,'' which is still central to all of the programs,
 products, and services provided by AIB to baking and general food
 production industries worldwide. [Redacted]
    Grain Foods Foundation (GFF), a joint venture of members of the
 milling, baking and allied industries formed in 2004, is dedicated to
 advancing the public's understanding of the beneficial role grain-based
 foods play in the human diet. Directed by a board of trustees, funding
 for the Foundation is provided through voluntary donations from private
 grain-based food companies and is supplemented by industry
 associations. [Redacted]
    Independent Bakers Association (IBA) The Independent Bakers
 Association is a Washington, D.C. based national trade association of
 over 400 mostly family owned wholesale bakeries and allied industry
 trades. The Association was founded in 1968 to protect the interests of
 independent wholesale bakers. [Redacted]
    National Association of Wheat Growers (NAWG) is a federation of 21
 state wheat grower associations that works to represent the needs and
 interests of wheat producers before Congress and Federal agencies.
 Based in Washington, D.C., NAWG is grower-governed and grower-funded,
 and works in areas as diverse as Federal farm policy, trade,
 environmental regulation, research and climate change. [Redacted]
    National Pasta Association (NPA) Founded in 1904, NPA is an
 organization of pasta and pasta-related product manufacturers, millers
 and suppliers to the U.S. pasta industry serving as a cohesive industry
 advocate, a promoter of pasta and a center of knowledge for its
 members, the government and the public. [Redacted] and [Redacted]
    North American Millers' Association (NAMA) is the trade association
 of the wheat, corn, oat, and rye milling industries. Member companies
 operate mills in 38 states and Canada, representing more than 90
 percent of total industry production capacity. [Redacted]
    Retail Bakers of America (RBA) was founded in 1918. Its purpose is
 to assist retail bakers in furthering the health of the nation by
 making available delicious bakery foods; to foster a better
 relationship between the public and the baking industry; to promote and
 encourage the production of high quality, wholesome, healthful bakery
 foods; and to represent the baking industry, especially its retail
 branch, to the government. [Redacted]
    USA Rice Federation is the global advocate for all segments of the
 U.S. rice industry with a mission to promote and protect the interests
 of producers, millers, merchants and allied businesses. Over 20 billion
 pounds of long, medium, and short grain, and organic and specialty rice
 is grown and harvested each year by farmers in Arkansas, California,
 Louisiana, Texas, Mississippi and Missouri. [Redacted]
    Wheat Foods Council (WFC) is a nonprofit organization formed in 1972
 to help increase public awareness of grains, complex carbohydrates, and
 fiber as essential components of a healthful diet. The Council is
 supported voluntarily by wheat producers, millers, bakers and related
 industries. [Redacted]
 

                                 ______
                                 
                          Submitted Questions
Joint Response from Hon. Sylvia M. Burwell, Secretary, U.S. Department 
        of Health and Human Services; Hon. Thomas ``Tom'' J. Vilsack, 
        Secretary, U.S. Department of Agriculture
Question Submitted by Hon. Randy Neugebauer, a Representative in 
        Congress from Texas
    Question. Secretary Burwell, what instructions were given to the 
Advisory Committee members regarding the FACA and the Advisory 
Committee's disbandment?
    Answer. HHS and USDA are strongly committed to an open and 
transparent process around their Federal Advisory Committees. The two 
Departments conducted an administrative webinar with the 2015 Dietary 
Guidelines Advisory Committee (DGAC) in January 2015 a few weeks before 
its Advisory Report was submitted to HHS and USDA. At this webinar, the 
Committee was reminded that it would formally disband upon submittal of 
its Advisory Report to the Secretaries as specified in its charter; the 
transition from being a Special Government Employee (SGE) as a Federal 
advisory committee member to being a former SGE/member after 
disbandment was described. Included in this discussion was a specific 
instruction that after disbandment each former member cannot speak on 
behalf of the U.S. Government or the DGAC (while in no way limiting 
their ability to speak as individual citizens on their own behalf). 
This instruction is an important point that each individual should 
convey in any situation that he/she chooses to engage in regarding the 
Committee's works, such as media interviews or professional 
presentations. After disbandment, each former DGAC member only 
represents themselves. When former Committee members held a public 
event regarding the Advisory Report, they were no longer SGEs and were 
not speaking on behalf of the Committee or the Federal government. They 
were private citizens voicing their opinions. As such, the Federal 
government has not assisted or provided support for former members for 
public speaking events.
Questions Submitted by Hon. Eric A. ``Rick'' Crawford, a Representative 
        in Congress from Arkansas
    Question 1. In light of the controversial nature of many of the 
comments and recommendations of the 2015 Dietary Guidelines Advisory 
Committee (DGAC), and in light of the fact that the final Guidelines 
are prepared with very limited transparency, will the Departments of 
Health and Human Services, and Agriculture consider publishing the 
draft Guidelines in the Federal Register, and allowing for a 60-90 day 
public comment period before producing your final Guidelines?
    Answer. We understand that an open and transparent Dietary 
Guidelines process is a priority and share your interest. We place a 
high value upon public input and have prioritized it throughout the 
development of the Dietary Guidelines. The Dietary Guidelines Advisory 
Committee (DGAC) deliberated on the scientific evidence through seven 
public meetings, spanning June 2013 to December 2014. The public 
attended the meetings, provided oral comments during one of the 
meetings, and was invited to submit written comments to the DGAC 
throughout the 19 months of its deliberations. All of the scientific 
studies they reviewed were posted on DietaryGuidelines.gov after each 
public meeting, during which the studies' topics were discussed and 
deliberated, providing transparency of the evidence being examined and 
allowing the public to provide sufficient comment on that and anything 
else the DGAC covered. A new public comment period opened when the 2015 
Advisory Report was published in February 2015. During this period, HHS 
and USDA also held a public meeting for oral testimony from the public. 
The public comment period also was extended from the scheduled 45 days 
to 75 days. For context, the public comment period for the 2010 
Advisory Report was 30 days. In addition, HHS and USDA provided several 
briefings on the Dietary Guidelines to House Agriculture Committee and 
Appropriations Subcommittee staff in 2015. We have and will continue to 
conduct our business with the utmost integrity and transparency, in 
accordance with all legal requirements.

    Question 2. I recognize this would be a slightly extraordinary step 
in the process, but don't you agree that the American public's 
acceptance of the scientific validity of the data supporting the final 
Guidelines outweighs an arbitrary deadline for their publication?
    Answer. The National Nutrition Monitoring and Related Research Act 
of 1990 (NNMRRA) requires HHS and USDA to publish the Dietary 
Guidelines for Americans at least every 5 years. The public was invited 
to participate in the process through meeting participation and public 
comment throughout the 19 months of the DGAC's scientific review, and 
during the 75 day period for public comment on the published Advisory 
Report. Throughout this time and up to the present, all science 
informing the Advisory Report has been listed for the public on 
DietaryGuidelines.gov. Every comment received from Federal agencies and 
the public is reviewed by HHS and USDA. Although all public comments 
are valued, to ensure the scientific foundation of the 2015 Dietary 
Guidelines for Americans, emphasis is placed on those comments with 
scientific justification. As required by the NNMRRA, the 2015 Dietary 
Guidelines will be based on the preponderance of the scientific and 
medical knowledge which is current at the time the report is prepared.

    Question 3. On several occasions during the House Agriculture 
Committee hearing you noted that the final Dietary Guidelines will be 
based on `the preponderance of scientific evidence'. In light of the 
fact that the Dietary Guidelines Advisory Committee acknowledged it 
employed the USDA's Nutrition Evidence Library (NEL) for less than 25% 
of its final recommendations--and based many of its findings on 
limited-grade evidence (nearly the lowest of the NEL's grading scale)--
how are the Agencies interpreting the term ``preponderance''?
    Answer. The 2010 and 2015 Dietary Guidelines Advisory Committees 
(DGAC) both utilized four science-based sources of evidence to answer 
their research questions: (1) Original systematic reviews conducted by 
USDA's Nutrition Evidence Library (NEL); (2) High-quality existing 
reports, comprised primarily of systematic reviews; (3) Data analyses 
of the typical American diet; and (4) Food pattern modeling to ensure 
Americans meet their food and nutrient needs. For each research 
question, the DGAC determined which method was appropriate, given the 
nature of the question. For example, questions regarding current 
intakes of different foods and nutrients in the United States were 
answered using data analyses, as this information is not available 
through a systematic review of scientific studies. Food pattern 
modeling was used to answer questions about how Americans can meet the 
Daily Reference Intakes (DRIs).
    The NEL is a systematic review methodology designed specifically to 
analyze food, nutrition and public health science. For context, the 
medical field has used systematic reviews as the gold standard and 
standard practice for more than 25 years to inform the development of 
national guidelines for health professionals. Use of systematic reviews 
in nutrition, became common practice more recently. At the time that 
the NEL was created by USDA for use in informing the 2010 Dietary 
Guidelines for Americans, it was among the first to apply the 
systematic review methodology in the field of nutrition--thus, there 
were very few existing nutrition-focused systematic reviews that the 
2010 DGAC could draw from. Since that time, systematic reviews in the 
nutrition field have become common practice. Therefore, as stated in 
their Advisory Report on DietaryGuidelines.gov, ``unlike the 2010 DGAC, 
the 2015 Committee was able to use existing sources of evidence to 
answer an additional 45 percent of the questions . . .'' and that 
``[t]his was done to prevent duplication of effort and promote time and 
resource management.'' The 2015 DGAC answered 70 percent of its 
research questions using NEL systematic reviews or existing reviews and 
reports. The Committee used existing systematic reviews when available 
and complemented them with original reviews of evidence newly published 
since the existing review was conducted. Existing systematic reviews 
underwent quality assessment to ensure they were just as rigorous and 
were held to the same high standards as the NEL systematic reviews. The 
remaining questions were answered using data analyses and food pattern 
modeling, consistent with the 2010 DGAC's scientific review.
    The Committee considers all evidence at the time of the systematic 
review that (1) addresses the question they seek to answer and (2) 
meets the pre-determined inclusion criteria. The quality of each 
included study is evaluated using the NEL Bias Assessment Tool. The 
DGAC then looks at the entire body of evidence as a whole to draw a 
conclusion statement and uses predefined criteria to evaluate and grade 
the strength of the evidence. The grade communicates to decision makers 
and stakeholders the strength of the evidence supporting a specific 
conclusion statement. The grade for the body of evidence and conclusion 
statement is based on five elements outlined in the NEL grading rubric: 
quality, quantity, consistency, impact and generalizability.
Questions Submitted by Hon. Jackie Walorski, a Representative in 
        Congress from Indiana
    Question 1. In testimony before the House Agriculture 
Appropriations Subcommittee last month, Angie Tagtow of USDA's Center 
for Nutrition Policy and Promotion described the Nutrition Evidence 
Library as ``the gold standard for informing recommendations'' and 
stated in her written testimony:

          The NEL provides a rigorous and transparent system to review 
        the scientific literature and uses the preponderance of science 
        to inform nutrition policy and programs. The NEL also ensures 
        compliance with the Consolidated Appropriations Act of 2001, or 
        Data Quality Act, which mandates that Federal agencies ensure 
        the quality, objectivity, utility, and integrity of the 
        information used to form Federal guidance.

    I applaud the NEL's development, which was first developed by 2005 
Advisory Committee out of need to ensure a transparent process for 
reviewing and ranking the overwhelming amount of science that needs to 
be considered. Then the 2010 Advisory Committee was able to use it and 
relied heavily on it for the majority of their recommendations.
    Now the 2015 Dietary Guidelines Advisory Committee's report states 
that it did not use the Nutrition Evidence Library for more than 70 
percent of its analyses. Instead, the report states that it used the 
following approaches:

   Outside systematic reviews used for 45 percent of research 
        questions; and

   Original data analyses and food pattern modeling analyses 
        used for 30 percent of research questions.

    One example of the concern with systemic reviews is caffeine. 
Secretary Vilsack, you mentioned in your written testimony the 
``Cochrane Collaboration'' approach as being a well-respected and it 
is. But in the example of caffeine, as stated on page 381 of the 
report, it was a ``modification'' of that method that was used. So 
while DGAC correctly acknowledge that new scientific evidence existed 
since the last report, making it the first Advisory Committee on 
caffeine's positive health benefits, it did not use the gold-standard 
NEL. Instead they used a systematic review of the data that allowed 
them to make claims that straight black coffee was the only acceptable 
approach to consuming caffeine, as opposed to energy drinks or other 
alternatives.
    For comparison, the 2010 Advisory Committee used the NEL for nearly 
three out of every four of their recommendations. Why did the 2015 DGAC 
circumvent the NEL process for more than 70% of their recommendations? 
Do the existing reports that were used follow the same scientific rigor 
and approach as the NEL?
    Under FACA, this is your Advisory Committee so I ask, how was the 
decision made that the NEL should not be used for a particular research 
question? Was it ad hoc, or were there established criteria?
    Answer. Thank you for raising this issue. The 2010 and 2015 Dietary 
Guidelines Advisory Committees (DGAC) both utilized four science-based 
sources of evidence to answer their research questions: (1) Original 
systematic reviews conducted by USDA's Nutrition Evidence Library 
(NEL); (2) High-quality existing reports, comprised primarily of 
systematic reviews; (3) Data analyses of the typical American diet; and 
(4) Food pattern modeling to ensure Americans meet their food and 
nutrient needs. For each research question, the DGAC determined which 
method was appropriate, given the nature of the question. For example, 
questions regarding current intakes of different foods and nutrients in 
the United States were answered using data analyses, as this 
information is not available through a systematic review of scientific 
studies. Food pattern modeling was used to answer questions about how 
Americans can meet the Dietary Reference Intakes (DRIs).
    The NEL is a systematic review methodology designed specifically to 
analyze food, nutrition and public health science. For context, the 
medical field has used systematic reviews as the gold standard and 
standard practice for more than 25 years to inform the development of 
national guidelines for health professionals. Use of systematic reviews 
in nutrition became common practice more recently. At the time that the 
NEL was created by USDA for use in informing the 2010 Dietary 
Guidelines for Americans, it was among the first to apply the 
systematic review methodology in the field of nutrition--thus, there 
were very few existing nutrition-focused systematic reviews that the 
2010 DGAC could draw from. Since that time, systematic reviews in the 
nutrition field have become common practice. Therefore, as stated in 
the Scientific Report of the 2015 Dietary Guidelines Advisory Committee 
(Advisory Report) on DietaryGuidelines.gov, ``unlike the 2010 DGAC, the 
2015 Committee was able to use existing sources of evidence to answer 
an additional 45 percent of the questions . . .'' and that ``[t]his was 
done to prevent duplication of effort and promote time and resource 
management.'' The 2015 DGAC answered 70 percent of its research 
questions using NEL systematic reviews or existing reviews and reports. 
The Committee used existing systematic reviews when available and 
complemented them with original reviews of evidence newly published 
since the existing review was conducted. Existing systematic reviews 
underwent quality assessment to ensure they were just as rigorous and 
were held to the same high standards as the NEL systematic reviews. The 
remaining 30 percent of the questions that could not be answered using 
the systematic review methodology were answered using data analyses and 
food pattern modeling, consistent with the 2010 Advisory Committee's 
scientific review.

    Question 2. In a letter dated October 2, 2015 from Secretaries 
Vilsack and Burwell to U.S. Senator Johnny Isakson you stated that ``in 
regard to caffeine and energy drinks, the (Advisory) Committee noted 
that these drinks are highly variable in caffeine content'' and that 
``until safety has been demonstrated, limited or no consumption of 
high-caffeine drinks or other caffeine-containing products is advised 
for children and adolescents.'' This statement also holds true for 
coffee (i.e., home brewed vs. coffee house, where the range could be 
50-400mg of caffeine).
    According to the American Beverage Association, mainstream energy 
drinks--which represent more than 95% of the entire American energy 
drink market--contain the same, or less, caffeine than coffee. Further, 
there is no chemical difference between the caffeine in coffee and the 
caffeine in energy drinks, tea, or soda and all leading and credible 
health authorities from around the world have acknowledged that 
caffeine metabolism is a function of body weight and composition (body 
fat, etc.) rather than age.
    Last, it is worth noting the conclusion reached by the European 
Food Safety Authority, which was published in its extensive report, 
Scientific Opinion on the Safety of Caffeine: ``The single doses of 
caffeine considered to be of no concern for adults (3mg/kg bw per day) 
may also be applied to children, because the rate at which children and 
adolescents process caffeine is at least that of adults, and the 
studies available on the acute effects of caffeine on anxiety and 
behavior in children and adolescents support this level.''
    Given this body of evidence, how do you rationalize the 
recommendations made by the Advisory Committee to focus on only one 
class of products when it comes to limiting caffeine intake? If there 
is to be any recommendations consistent with the evidence, shouldn't it 
be about caffeine intake generally, regardless of the class of 
products?
    Answer. The 2015 Dietary Guidelines Advisory Committee (DGAC) 
developed its report to provide advice and recommendations to the 
government on the current state of scientific evidence on nutrition and 
health for the general public. The DGAC identified the area of caffeine 
consumption as a public health concern. It included the safety of 
caffeinated drinks for children and adolescents in its review of the 
evidence because of case reports of adverse events associated with 
consumption of high-caffeine drinks and in light of recommendations of 
caution from the American Academy of Pediatrics and the American 
Medical Association. The Committee also noted that the limited evidence 
in regard to high-caffeine energy drinks and health outcomes shows 
mixed results. Much of the available evidence on caffeine focuses on 
coffee intake. The Committee stated that moderate coffee consumption 
(three to five 8 oz. cups/day, or providing up to 400 mg/day of 
caffeine) can be incorporated into healthy eating patterns.
    HHS and USDA are considering the information in the Committee's 
report as well as public and Federal agency comments in the development 
of the 2015 Dietary Guidelines for Americans. We look forward to 
working on this issue with you moving forward.
Question Submitted by Hon. David Rouzer, a Representative in Congress 
        from North Carolina
    Question. Can the House Committee on Agriculture be assured that 
you will both work to ensure that the final Dietary Guidelines state 
that protein is critical to a balanced diet and that the inclusion of 
lean meats are essential to a ``balanced diet?''
    Answer. We understand this is a priority for you and share your 
interest. The Scientific Report of the 2015 Dietary Guidelines Advisory 
Committee (Advisory Report) states that ``lean meats can be a part of a 
healthy dietary pattern.'' While we cannot comment on the content of 
the 2015 Dietary Guidelines for Americans, which is still under 
development, we can highlight that the amount of ``meat, poultry, and 
eggs'' recommended in the Advisory Report is the same as the amount 
recommended in the 2010 Dietary Guidelines for Americans--26 oz. per 
week for a 2,000 calorie diet. The Advisory Report recommends reducing 
the amount of red and processed meat consumed compared to current 
consumption, not compared to the 2010 Guidelines.
Questions Submitted by Hon. John R. Moolenaar, a Representative in 
        Congress from Michigan
    Question 1. I have personally met with a wide variety of 
constituents on the topic of school nutrition in my District in 
Michigan, including a local school food service director. On multiple 
occasions, my constituents expressed concerns regarding sodium limits 
in the National School Lunch and School Breakfast Programs, and the 
dramatic effect the implementation of the target levels has had on 
consumption and food waste.
    As you are aware, the sodium limits were placed on a time line, 
with key targets to reach by designated years. A primary concern I have 
is the implementation of any further reductions to sodium to reach the 
target two and final target levels. In your findings, is there sound 
scientific evidence that the target two levels of sodium limits were 
necessary?
    If target two levels are implemented, what effect do you believe 
this will have on other foods, such as cheeses and others that are 
served in school meal programs?
    Answer. USDA remains committed to applying the most up-to-date, 
evidence-based guidelines to all nutritional parameters set forth in 
Child Nutrition Programs regulations. As required by both the FY 2012 
Agriculture Appropriations Act and the Consolidated and Further 
Continuing Appropriations Act, 2015, USDA continues to evaluate the 
science as it relates to sodium intake and human health. The 2015 
Dietary Guidelines Advisory Committee (DGAC) reviewed and analyzed the 
most recent scientific literature evaluating the relationship between 
sodium intake and blood pressure among children and their findings can 
be found in their Advisory Report, which was submitted to HHS and USDA 
in February 2015. The DGAC used an extensive systematic review process 
to critique relevant literature on this topic, and the Advisory Report 
affirmed that sodium reduction to the levels reflected in the targets 
is beneficial to children.
    USDA is providing significant technical assistance to help school 
food operators lower the sodium content of school meals. Consistent 
with the Congressional directive, prior to requiring school compliance 
with the second (school year 2017-18) and final (school year 2022-23) 
sodium targets, USDA's Food and Nutrition Service (FNS) will review the 
2015 Dietary Guidelines for Americans, once released. Because the 
sodium goals apply to the average meal offered over the course of the 
school week, menu planners have and will retain under target 2 the 
flexibility to incorporate some higher sodium items, such as cheese, 
into some of the meals. To help menu planners offer a variety of 
nutritious and flavorful foods, while lowering the sodium content of 
meals, USDA recently unveiled What's Shaking? Creative Ways to Boost 
Flavor with Less Sodium. This is a national collaborative sodium 
reduction initiative to foster creative ways to boost flavor and 
maximize taste in an effort to lower the sodium content of school 
meals. The website, http://healthymeals.nal.usda.gov/menu-planning/
sodium-reduction is dedicated to helping schools find the resources 
they need to increase awareness of the need for dietary sodium 
reduction, and move in the right direction.

    Question 2. I am concerned about the selective nature taken by the 
Dietary Guidelines Advisory Committee (DGAC) with respect to existing 
data. For example, when it comes to energy drinks, the Committee noted 
that the evidence was of a limited grade. At the same time, the DGAC 
chose to completely disregard an extensive and authoritative body of 
evidence developed by the European Food Safety Authority (EFSA), and in 
particular its most recent Scientific Opinion on the Safety of 
Caffeine. Is there any reason why the DGAC appeared to disregard the 
EFSA's work? What are your thoughts on the information from EFSA that 
was disregarded by the DGAC?
    Also, as you develop the final guidelines, what threshold of 
evidence will be used to determine whether to issue a recommendation, 
and will limited grade evidence be permitted in the classification of 
preponderance of scientific evidence`?
    Answer. The European Food Safety Authority (EFSA) published its 
Scientific Opinion on the Safety of Caffeine in May of 2015. The 2015 
Dietary Guidelines Advisory Committee (DGAC) released its Scientific 
Report in February of 2015. As such, the DGAC had disbanded prior to 
the release of the EFSA report. It should be noted that the 2015 DGAC 
did use the EFSA Scientific Opinion on the Re-evaluation of Aspartame 
as a Food Additive for their question on aspartame and health. This 
report was published within the timeframe of the DGAC's work. As 
mandated in the National Nutrition Monitoring and Related Research Act 
of 1990, the 2015 Dietary Guidelines for Americans will be based on the 
preponderance of the scientific and medical knowledge which is current 
at the time it is prepared. While we cannot comment on the content of 
the 2015 Dietary Guidelines for Americans, which are still under 
development, the recommendations will be made based on the strongest 
available evidence. The 2010 Dietary Guidelines included statements 
supported by different grades of evidence. As described in the 2010 
Dietary Guidelines, ``[w]hen appropriate, specific statements in 
Dietary Guidelines for Americans, 2010 indicate the strength of the 
evidence (e.g., strong, moderate, or limited) related to the topic as 
summarized by the 2010 DGAC. The strength of evidence is provided so 
that users are informed about how much evidence is available and how 
consistent the evidence is for a particular statement or 
recommendation. This information is useful for educators when 
developing programs and tools. Statements supported by strong or 
moderate evidence can and should be emphasized in educational materials 
over those with limited evidence.'' When only limited evidence is 
available on a topic, it may still be appropriate for discussion in the 
Dietary Guidelines, such as when the evidence for that topic reinforces 
recommendations on related topics that have a stronger evidence base, 
to clarify that it is not possible to make a recommendation, or to 
identify an area of emerging research.

    Question 3. According to the Charter for the 2015 Dietary 
Guidelines Advisory Committee (DGAC), Committee members were selected 
based upon their knowledge in the fields of human nutrition and chronic 
disease. However, it appears the DGAC made many recommendations far 
outside of the scope of its Charter and far beyond issues of human 
nutrition and chronic disease.
    For example, matters involving ingredient safety (i.e., caffeine 
and aspartame) and risk assessment rest squarely within the scope of 
the Food and Drug Administration (FDA), not the Dietary Guidelines. 
Despite this, the DGAC chose to offer recommendations on what is and is 
not safe.
    During your testimony you noted that the FDA, along with the 
National Institutes of Health and the Centers for Disease Control and 
Prevention, are providing technical expertise as you finalize the 
Guidelines.
    Is it the intention of both Departments to make new assertions 
about ingredient safety in the Dietary Guidelines that have not been 
previously made by the FDA? If yes, will matters of such importance be 
subject to the appropriate rulemaking by the relevant agency in charge?
    Answer. No, the Departments will not make new assertions about 
ingredient safety in the Dietary Guidelines. The purpose of the Dietary 
Guidelines does not include rulemaking. The charge of the 2015 DGAC 
included identifying areas it felt were of public health concern. The 
DGAC chose to address the relationship of caffeine consumption and of 
aspartame consumption to health because they are of high public health 
concern, are commonly consumed in food and beverages, and evidence had 
been recently updated in the scientific literature. Dealing with these 
issues was within the scope of the DGAC's charge to provide the 
Government with advice and recommendations on the current state of 
scientific evidence on nutrition and health. We appreciate your 
feedback on this topic.
Questions Submitted by Hon. Dan Newhouse, a Representative in Congress 
        from Washington
    Question 1. I understand the HHS and USDA are planning to note that 
moderate alcohol consumption is an important part in a healthy diet 
pattern, which I appreciate. What are your Departments doing to provide 
recommendations on how best to inform consumers about what that looks 
like?
    Answer. Thank you for raising this important issue. HHS and USDA 
are working together to finalize the 2015 Dietary Guidelines, which are 
expected to be completed in December of this year. We are unable to 
comment on the final content of the forthcoming edition of the Dietary 
Guidelines at this time, as they are still under development. However, 
to clarify, the Dietary Guidelines Advisory Committee (DGAC) found that 
moderate alcohol consumption can be a component of a healthy eating 
pattern but did not include alcohol in its three examples of healthy, 
nutrient dense food patterns (Healthy U.S.-style, Healthy Vegetarian, 
and Healthy Mediterranean-style). The DGAC stated, ``it is not 
recommended that anyone begin drinking or drink more frequently on the 
basis of potential health benefits.''

    Question 2. The 2010 Dietary Guideline's section on sodium seems to 
suggest that all alcoholic beverages are the same, and there is such a 
thing as a standard drink. It does nothing to differentiate different 
benefits or risks derived from wine, beer, distilled spirits, hard 
ciders, and so on, or that alcohol levels can vary significantly even 
internally in each of these categories. Many scientific studies claim 
different health effects depending on the type of alcohol consumed, and 
the Tax and Trade Bureau guidance from May 2013 refutes the idea of a 
``standard drink'' as a tool to inform consumers. Can you tell me if 
there are any plans in the 2015 Dietary Guidelines to clarify or 
establish different nutritional benefits or drawbacks related to 
different alcohol types?
    Answer. As noted above, HHS and USDA are working together to 
finalize the 2015 Dietary Guidelines for Americans, which is expected 
to be completed in December of this year. We are unable to comment on 
the final content of the forthcoming edition of the Dietary Guidelines 
at this time, as they are still under development. HHS and USDA are 
cognizant of the variability of alcohol content in different alcoholic 
beverages and the value in better articulating this variability in 
dietary guidance. Several industry associations and individuals have 
provided both oral and written comments on this issue, which we will 
take into consideration as we develop the Dietary Guidelines.

    Question 3. The Dietary Guidelines Advisory Committee claimed that 
Americans are eating more meat than recommended; however, the DGAC also 
holds up the so-called Mediterranean Diet as a healthy dietary pattern. 
When compared to the Mediterranean Diet, Americans are consuming less 
than recommended. How do you account for this discrepancy?
    Answer. There are numerous studies based on different variations of 
a Mediterranean Diet, and, as such, there is not ``one'' Mediterranean 
Diet. Therefore, there is not a single, consistent recommendation on 
meat for comparison. The DGAC used current research to inform the 
development of its Healthy Mediterranean-Style Eating Pattern. As shown 
in the Advisory Report, the quantitative amount of meat, poultry, and 
eggs the DGAC recommended in the Healthy U.S.-Style Eating Pattern and 
the Healthy Mediterranean-Style Eating Pattern are identical--26 oz. 
per week for a 2,000 calorie diet.

    Question 4. The Dietary Guidelines Advisory Committee recommends 
that Americans continue to eat the same quantity of lean meat as the 
2010 Dietary Guidelines recommend, but the current DGAC report also 
recommends that Americans consume less processed meat. What is the 
recommendation for lean, processed meat?
    Answer. The Scientific Report of the 2015 Dietary Guidelines 
Advisory Committee (Advisory Report) states that ``lean meats can be a 
part of a healthy dietary pattern.'' While we cannot comment on the 
content of the 2015 Dietary Guidelines for Americans, which are still 
under development, we can highlight that the amount of ``meat, poultry, 
and eggs'' recommended in the Advisory Report is the same as the amount 
recommended in the 2010 Dietary Guidelines--26 oz. per week for a 2,000 
calorie diet. The 2010 Dietary Guidelines for Americans and the 2015 
Advisory Report do not make a quantitative recommendation specifically 
for lean processed meat.

    Question 5. In testimony before the House Appropriations 
Agriculture Subcommittee, Angie Tagtow of USDA's Center for Nutrition 
Policy and Promotion stated, ``the Nutrition Evidence Library (NEL) 
provides a rigorous and transparent system to review the scientific 
literature and uses the preponderance of science to inform nutrition 
policy and programs.'' That being said, the 2015 Dietary Guidelines 
Advisory Committee only used the NEL in 27 percent of their nutritional 
recommendations, while the 2010 one used NEL for more than 70 percent. 
What justification can you provide for the departure from such an 
important resource? Did USDA or HHS provide any guidance to the Dietary 
Guidelines Advisory Committee on what resources were available or which 
should be used?
    Answer. The 2010 and 2015 DGACs both utilized four science-based 
sources of evidence to answer their research questions: (1) Original 
systematic reviews conducted by USDA's Nutrition Evidence Library 
(NEL); (2) High-quality existing reports, comprised primarily of 
systematic reviews; (3) Data analyses of the typical American diet; and 
(4) Food pattern modeling to ensure Americans meet their food and 
nutrient needs. For each research question, the DGAC determined which 
method was appropriate, given the nature of the question. For example, 
questions regarding current intakes of different foods and nutrients in 
the United States were answered using data analyses, as this 
information is not available through a systematic review of scientific 
studies. Food pattern modeling was used to answer questions about how 
Americans can meet the Dietary Reference Intakes (DRIs).
    The NEL is a systematic review methodology designed specifically to 
analyze food, nutrition and public health science. For context, the 
medical field has used systematic reviews as the gold standard and 
standard practice for more than 25 years to inform the development of 
national guidelines for health professionals. Use of systematic reviews 
in nutrition became common practice more recently. At the time that the 
NEL was created by USDA for use in informing the 2010 Dietary 
Guidelines for Americans, it was among the first to apply the 
systematic review methodology in the field of nutrition--thus, there 
were very few existing nutrition-focused systematic reviews that the 
2010 DGAC could draw from. Since that time, systematic reviews in the 
nutrition field have become common practice. Therefore, as stated in 
their Advisory Report on DietaryGuidelines.gov, ``unlike the 2010 DGAC, 
the 2015 Committee was able to use existing sources of evidence to 
answer an additional 45 percent of the questions . . .'' and that 
``[t]his was done to prevent duplication of effort and promote time and 
resource management.'' The 2015 DGAC answered 70 percent of its 
research questions using NEL systematic reviews or existing reviews and 
reports. The Committee used existing systematic reviews when available 
and complemented them with original reviews of evidence newly published 
since the existing review was conducted. Existing systematic reviews 
underwent quality assessment to ensure they were just as rigorous and 
were held to the same high standards as the NEL systematic reviews. The 
remaining 30 percent of the questions that could not be answered using 
the systematic review methodology were answered using data analyses and 
food pattern modeling, consistent with the 2010 DGAC's scientific 
review.

    Question 6. FDA recently announced that it is proposing additional 
revisions to the Nutrition Facts Panel. The supplemental proposal would 
require the declaration of daily reference value and percent daily 
value for added sugars. The additional declarations for added sugars 
are based on new information and findings from the 2015 Dietary 
Guidelines Advisory Committee's (DGAC) technical report. This is a 
great departure from the past because FDA has a long history of relying 
on the Institute of Medicine (IOM) to develop Dietary Reference 
Intakes. The 2015 DGAC recommendation of less than 10% of total 
calories from added sugar as noted in the supplemental proposal is 
based on, ``modeling of dietary patterns, current added sugars 
consumption data, and a published meta-analysis on sugars intake and 
body weight.'' I am concerned that a balanced, scientifically rigorous 
process such as that used by the IOM was not used to develop the 
recommendation. Why is FDA applying the DGAC recommendations to develop 
nutrition labeling regulations instead of the most recent IOM 
recommendations? Do you believe this is appropriate, given your 
testimony on the scope and nature of the DGAC recommendations, and how 
they differ from the actual guidelines?
    Answer. The Food and Drug Administration (FDA or the Agency) 
considered the scientific evidence underpinning the recommendations 
provided in the 2015 Dietary Guidelines Advisory Committee (DGAC) 
technical report in setting a proposed Dietary Reference Value (DRV) 
for added sugars. The 2015 DGAC report evaluated more recent scientific 
evidence than the evidence that had been evaluated by the Institute of 
Medicine (IOM) when it issued its 2002 report. FDA will consider all of 
the public comments received by the Agency as it proceeds with this 
rulemaking process and will keep your office updated as we progress.

    Question 7. I am interested in the recommendations related to 
coffee. According to the Dietary Guidelines Advisory Committee, three 
to five cups of coffee per day are not associated with long-term health 
risks. It was also noted that this amount of coffee correlated with 
reduced risk for heart disease and type 2 diabetes. Can you share what 
scientific evidence or process the DGAC used to suggest this change?
    Answer. The 2015 DGAC examined the relationship between usual 
caffeine consumption and health. Specifically, they asked the question, 
What is the relationship between usual coffee/caffeine consumption and 
health? Furthermore, they examined the relationship between coffee/
caffeine consumption and its impact on total mortality, cardiovascular 
disease, type 2 diabetes, cancers, Parkinson's disease, cognitive 
function, and pregnancy. Below is the list of scientific evidence 
examined by the Advisory Committee to answer the questions related to 
coffee/caffeine consumption.
    It is important to note that while the DGAC was interested in usual 
caffeine intake, most of the available research was conducted with 
coffee as the source of caffeine. After reviewing the evidence, the 
Committee stated that moderate coffee consumption can be incorporated 
into a healthy lifestyle. However, the DGAC noted that caloric 
additions from cream, milk, and added sugars should be minimized. 
Furthermore, the Advisory Committee stated that individuals who do not 
consume caffeinated coffee should not start to consume it for potential 
health benefits alone. The Advisory Committee recommendations are not 
binding on the Departments, but are intended to inform the Departments' 
work.

    For additional details on this body of evidence, visit: Appendix E-
2.39a Evidence Portfolio available at http://health.gov/
dietaryguidelines/2015-scientific-report/14-appendix-E2/e2-39a.asp. 
(Attachment 1)

    Question 8. I think it would be helpful for you to provide the 
Committee evidence in writing to confirm that your agencies did, in 
fact, make attempts to oversee the Advisory Committee once it became 
clear they were delving to areas of public policy. In response I would 
like to see evidence that your agencies provided instructions to the 
committee during their assembly to ensure they were staying focused on 
the right guidance, and not straying into policy matters outside their 
scope or mandate. And, likewise, I would like to receive documented 
evidence of the instructions agencies provided to the committee on the 
public law to help them understand their report must be based on the 
preponderance of scientific and medical knowledge that is current at 
the time of publication.
    Answer. Thank you for raising this issue. Shortly after the 2015 
DGAC was appointed by the Secretaries of HHS and USDA in May 2013 and 
before its first meeting held on June 13-14, 2013, HHS and USDA 
conducted two administrative webinars with the Committee members to 
provide orientation and training. (Note that meetings of the full 
Committee that are solely administrative in nature are not required by 
the Federal Advisory Committee Act (FACA) to be open to the public.) 
Topics included the charge to the Advisory Committee, the National 
Nutrition Monitoring and Related Research Act, the charter and bylaws 
of the Advisory Committee, and FACA, which included a presentation by 
an HHS attorney in the Office of the General Counsel.
    Below are some of the materials you requested.

  1.  FACA Pamphlet--http://www.gsa.gov/portal/content/101010 
            (Attachment 2)

  2.  Ethics Rules for SGEs--https://ethics.od.nih.gov/topics/SGE-
            Training-Oct-04.pdf (Attachment 3)

  3.  Charge--http://health.gov/dietaryguidelines/2015-BINDER/meeting1/
            chargeCommittee.aspx (Attachment 4)

  4.  Charter--http://health.gov/dietaryguidelines/2015/committee-
            resources.asp (http://health.gov/dietaryguidelines/
            dgac2015-charter-final.pdf) (Attachment 5)

    At the first public meeting (June 13-14, 2013), the charge was 
reviewed by USDA Under Secretary Concannon and subsequently the 
objectives and purpose of the Advisory Committee were presented by the 
Designated Federal Officer (DFO). The agenda, meeting summary, and 
videocast of this first meeting are available at http://health.gov/
dietaryguidelines/2015-BINDER/meeting1/index.aspx. In addition, at that 
public meeting, the DGAC members were divided into three work groups, 
which met separately in the afternoon of the first day of this meeting; 
at those work group meetings, the first item on the agenda was a 
discussion led by federal staff on the charge and guiding principles 
for their work.
    Throughout the DGAC's work, the DFO or his representative was 
present on all work-group/subcommittee calls or meetings, and at all 
public Committee meetings to ensure FACA was being followed; this 
includes following the charge as approved by the charter. The DGAC's 
charge was read at each public Committee meeting and during 
Subcommittee meetings.

    Question 9. And, finally, I would like to welcome your comments on 
any advice you could give future secretaries as to future Advisory 
Committees, and how they could stay focused on their charter, and 
produce a recommendation that really stays coloring with in the lines. 
So I would appreciate a response. Thank you.
    Answer. We would advise future secretaries to continue the process 
of distinguishing what the Dietary Guidelines for Americans are and 
what they are not. There is a misunderstanding that the DGAC's report 
is the Dietary Guidelines for Americans or a draft of the Guidelines--
it is not. The Guidelines are recommendations for the general public, 
intended to prevent diet-related conditions, not to treat disease.
    Diabetes and other chronic, diet-related diseases cost Americans 
billions of dollars annually and contribute to rising health care costs 
across the health system. However, we know that diet plays a critical 
role in disease prevention and in both individual and public health--a 
good diet can help prevent diabetes, high blood pressure, and 
cardiovascular disease. The Dietary Guidelines are a critical tool to 
help Americans make healthy choices in their daily lives to prevent 
these diseases and enjoy a healthy diet. They are used to inform the 
development of federal food, nutrition, and health policies and 
programs.
Questions Submitted by Hon. Suzan K. DelBene, a Representative in 
        Congress from Washington
    Question 1. Ensuring that the Federal Government is providing women 
with latest, science-based nutrition advice based on the latest science 
to benefit both their body and their children is of utmost importance. 
One area where there is substantial confusion today is regarding 
seafood consumption during pregnancy. It was encouraging when FDA 
issued updated draft seafood advice in June 2014 that attempted to 
clarify that confusion. According to the Federal Register notice 
(http://www.gpo.gov/fdsys/pkg/FR-2014-06-11/pdf/2014-13584.pdf), this 
draft advice was based on data from the Food and Agriculture 
Organization of the United Nations (FAO), the World Health Organization 
(WHO) and the FDA's net effects report entitled: ``A Quantitative 
Assessment of the Net Effects on Fetal Neurodevelopment from Eating 
Commercial Fish (As Measured by IQ and also by Early Age Verbal 
Development in Children).'' Will FDA be issuing final seafood advice 
that follows the draft advice with changes to make it consistent with 
the FAO, WHO and FDA's latest science?
    Answer. Thank you for raising this issue. The final seafood 
consumption advice is undergoing review. In developing it, HHS has 
taken and will continue to take steps to ensure that it is reflective 
of the latest nutrition science.
    By way of background, in June 2014, FDA and the Environmental 
Protection Agency (EPA) jointly issued a draft update to the seafood 
advice they last issued in 2004. The joint advice in the draft update 
is consistent with the current recommendation in the Dietary Guidelines 
for Americans 2010, in that it advises pregnant women, women who may 
become pregnant, and nursing women to eat at least 8, and up to 12, 
ounces per week of a variety of fish lower in mercury in order to 
optimize the developmental benefits that fish could provide.
    The FDA Risk Communication Advisory Committee held a public meeting 
on the advice provided in the draft update in November 2014, and the 
comment period for the draft updated advice closed in March 2015.
    FDA and EPA have studied the public comments, are making the 
appropriate modifications to the advice, and then will publish the 
final advice. As with the 2014 draft version of the advice, the purpose 
is to provide useful and science-based information to pregnant and 
breastfeeding women and to caregivers of young children. We will keep 
your office updated as we progress on this issue.

    Question 2. I was interested to learn about the information related 
to coffee consumption. The report indicated that consumption of coffee 
within the moderate range (three to five cups per day) is not 
associated with increased long-term health risks and is associated with 
reduced risk of type 2 diabetes and cardiovascular disease in adults. 
Can you share some of the other diseases prevention or risks also 
associated with moderate coffee intake?
    Answer. The 2015 Dietary Guidelines Advisory Committtee (DGAC) 
addressed this issue in the question, ``What is the relationship 
between usual coffee/caffeine consumption and health?'' In reviewing 
chronic disease health outcomes, evidence was available primarily on 
coffee consumption and total mortality, cardiovascular disease (CVD), 
type 2 diabetes, and cancer. The Committee identified research on 
coffee consumption and CVD, stroke, heart failure, hypertension, and 
several intermediate outcomes including blood pressure, blood lipids, 
and blood glucose; the specific findings are detailed in its Advisory 
Report. The DGAC examined several types of cancer in regard to coffee 
consumption, including lung, liver, breast, prostate, ovarian, 
endometrium, bladder, pancreas, upper digestive and respiratory tract, 
esophagus, stomach, colon, and rectum. Regular coffee consumption is 
associated with reduced risk of cancer of the liver and endometrium.
Questions Submitted by Hon. James P. McGovern, a Representative in 
        Congress from Massachusetts
    Question 1. According to the National Consumers League, a typical 
serving of coffee, soda or an energy drink all contain about the same 
amount of caffeine. The Dietary Guidelines Advisory Committee report 
recommends the establishment of a guideline for caffeine but also 
recommends that coffee be classified as a `normal' caffeine drink and 
energy drinks as `high' caffeine drinks. If each of these products are 
essentially the same, how can you support such a distinction? Can you 
elaborate on the scientific rational for this distinction?
    Answer. The Dietary Guidelines Advisory Committee (DGAC) did not 
recommend that HHS and USDA classify coffee as a ``normal'' caffeine 
drink or energy drinks as ``high'' caffeine drinks. Instead, the 
references the Committee made to ``coffee'' and ``high-caffeine energy 
drinks'' were to the evidence it reviewed related to intake of these 
products and health outcomes. For example, the literature that the 
Committee reviewed demonstrated the highly variable amount of caffeine 
in energy drinks and shots; a table in the article by Reissig, et al. 
(reference 122 in Part D, Chapter 5: Food Sustainability and Safety) 
shows that many energy drinks are in the same caffeine concentration 
range as coffee although many have serving sizes twice that of an 8 oz. 
coffee serving. The table also lists ``higher caffeine energy drinks'' 
as well as ``high concentration energy drinks'' also known as energy 
shots. Much of the available evidence on caffeine focuses on coffee 
intake. The Committee stated that moderate coffee consumption (three to 
five 8 oz. cups/day, or providing up to 400 mg/day of caffeine) can be 
incorporated into healthy eating patterns. The Committee also noted 
there is not currently enough available evidence to support a 
recommendation for the general population regarding energy drinks.

    Question 2. As you may know, cranberries are the state fruit of 
Massachusetts, one of three fruits native to North America, and a 
perennial crop grown commercially in five states. They are power packed 
with unique compounds that have documented health benefits, but not 
blessed by Mother Nature with natural sweetness like other juices and 
dried fruit products.
    Cranberry growers are concerned that if required to include a % 
Daily Value (%DV) in a modified Nutrition Facts Panel for added sugar 
in addition to total sugars as currently proposed, consumers will be 
misled to believe that cranberry products, for which sugar is added for 
palatability, are less nutritious than other fruit products containing 
the same or higher levels of intrinsic or natural sugar. They are also 
concerned that these consumers will be misled about how much total 
sugar is contained in cranberry products.
    While the Dietary Guidelines for Americans are updated every 5 
years, modifications to the Nutrition Facts Panel happen less 
frequently. Therefore, it is critical that we get the labels right. How 
can FDA ensure that consumers will not be misled about the 
healthfulness of cranberry products under the proposed FDA Nutrition 
Facts Panel labeling regulation? Specifically, has FDA considered how 
consumers will react when comparing products with natural sugars that 
contain equal or more total sugars and calories than cranberry products 
with a declared %DV? If not, is additional information needed?
    Answer. FDA is reviewing its own consumer research and other 
research that has been submitted to the Agency, along with the science 
regarding an added sugars declaration and Percent Daily Value (%DV). 
FDA will also consider all of the comments submitted regarding the 
healthfulness of foods containing added sugars, including cranberry 
products, as it proceeds with this rulemaking process.

    Question 2a. Has FDA considered the potential economic impact to 
agriculture producers of perennial crops like cranberries in which 
producers cannot rotate into other fruit, vegetable or row crops to 
offset potential losses and broader agribusinesses? If not, why was 
this not considered?
    Answer. FDA's estimate of the total cost of the proposed Nutrition 
Facts Label and Serving Size rules is an aggregate measure of costs, 
and captures relabeling costs associated with adding the added sugars 
declaration and percent daily value to the Nutrition Facts Panel, and 
reformulation costs associated with product reformulation aimed at 
reducing added sugars content in products (e.g., substituting a high-
intensity, low-calorie sweetener for sugar). FDA did not explicitly 
consider the potential economic impact to agriculture producers of 
perennial crops like cranberries because the industry may reformulate 
products to include less added sugars (by using other sweeteners, for 
example, or using other juice blends).

    Question 2b. It is my understanding that FDA has based the proposed 
added sugar labeling requirements on the findings of the 2015 Dietary 
Guidelines Committee Report which is currently still under review by 
HHS and USDA. Is it correct that the Committee's findings do not agree 
with the Institute of Medicine's (IOM) current recommendations for 
upper limits on added sugar and that added sugar consumption is 
declining to levels nearly 50% below the upper limit as recommend by 
the IOM?
    Answer. FDA considered the scientific evidence underpinning the 
recommendations provided in the 2015 DGAC technical report in setting a 
proposed Dietary Reference Value (DRV) for added sugars. The 2015 DGAC 
report evaluated more recent scientific evidence than the evidence that 
had been evaluated by the Institute of Medicine (IOM) when it issued 
its 2002 report. In 2002, the IOM provided a suggested maximum intake 
level of 25 percent or less of calories for added sugars based on data 
that demonstrated decreased intakes of some micronutrients among 
American subpopulations whose intake of added sugars exceeded this 
level. This suggested maximum intake level, however, is not considered 
an upper level of intake, which are set by the IOM for many other 
nutrients. The 2015 DGAC recommended that ten percent or less of 
calories should come from added sugars. The current average U.S. intake 
of added sugars is approximately 13.4 percent of total calories, with 
some subpopulations such as adolescents and young adults consuming 
greater amounts. Added sugars intake has decreased for both males and 
females across all age groups between 2001-2004 and 2007-2010, but 
intakes still exceed the amount that can be consumed while meeting food 
group and nutrient needs within the calorie levels. FDA will consider 
the scientific evidence and all of the public comments received by the 
Agency as it proceeds with this rulemaking process.
Questions Submitted by Hon. Ann Kirkpatrick, a Representative in 
        Congress from Arizona
    Question 1. The Dietary Guidelines are aimed at general populations 
based on age and gender. But, obesity on tribal land is especially 
severe. How do the Dietary Guidelines help my tribal constituents eat 
healthier? And will these guidelines be achievable for people of all 
cultures and socioeconomic levels?
    Answer. HHS and USDA are working together to finalize the 2015 
Dietary Guidelines for Americans, which are expected to be completed in 
December of this year. We are unable to comment on the final content of 
the forthcoming edition of the Dietary Guidelines at this time, as they 
are still under development. However, the review of the evidence 
conducted by the Dietary Guidelines Advisory Committee (DGAC) included 
obesity as an outcome on several research questions when applicable, 
and thus there is evidence on obesity available in the Advisory Report 
that the Departments are taking under consideration when updating the 
Dietary Guidelines.
    HHS and USDA recognize that many factors influence the diet and 
physical activity choices individuals make. The United States is a 
diverse nation, with people from many backgrounds, cultures, and 
traditions with varied personal preferences. In addition, significant 
health and food access disparities exist, with many U.S. households 
having insufficient resources to acquire adequate food to meet their 
needs. All of these factors can have a profound impact on choices. The 
Dietary Guidelines are meant to provide a sound, healthy diet for the 
general population, including those at increased risk for obesity and 
obesity-related chronic diseases. It is not a rigid prescription, but 
rather, an adaptable framework in which individuals can meet their 
personal, cultural, and traditional food preferences and stay within 
their budget, including those within tribes in the State of Washington.

    Question 2. A typical serving of coffee, soda or an energy drink 
all contain about the same amount of caffeine. The Dietary Guidelines 
Advisory Committee recommends that you establish a guideline for 
caffeine, for the first time, but then recommends that you classify 
coffee as a `normal' caffeine drink and energy drinks--and only energy 
drinks--as a `high' caffeine drink. What is the scientific 
justification for this distinction?
    Answer. The DGAC did not recommend that HHS and USDA classify 
coffee as a ``normal'' caffeine drink or energy drinks as ``high'' 
caffeine drinks. Instead, the references the Committee made to 
``coffee'' and ``high-caffeine energy drinks'' were to the evidence it 
reviewed related to intake of these products and health outcomes. For 
example, the literature that the Committee reviewed demonstrated the 
highly variable amount of caffeine in energy drinks and shots; a table 
in the article by Reissig, et al. (reference 122 in Part D, Chapter 5: 
Food Sustainability and Safety) shows that many energy drinks are in 
the same caffeine concentration range as coffee, although many have 
serving sizes twice that of an 8 oz. coffee serving. The table also 
lists ``higher caffeine energy drinks'' as well as ``high concentration 
energy drinks,'' also known as energy shots. Much of the available 
evidence on caffeine focuses on coffee intake. The Committee stated 
that moderate coffee consumption (three to five 8 oz. cups/day, or 
providing up to 400 mg/day of caffeine) can be incorporated into 
healthy eating patterns. The Committee also noted that the limited 
evidence in regard to high-caffeine energy drinks and health outcomes 
shows mixed results.
Response from Hon. Sylvia M. Burwell, Secretary, U.S. Department of 
        Health and Human Services
Question Submitted by Hon. John R. Moolenaar, a Representative in 
        Congress from Michigan
    Question. In an 18 month process, spanning June 2013-December 2014, 
the DGAC waited until September 2014 to form its Added Sugars Working 
Group. This gave the Committee a mere 90 days to collect, review, 
synthesize and formulate conclusions on the extensive body of 
literature on sugars.
    Considering the complexity and recent controversy around sugars 
intake, why wasn't the review of the scientific evidence on sugars 
initiated at the very beginning of the process?
    Do you believe 90 days was a sufficient amount of time allocated 
for stakeholders to review and provide comment on the scientific 
evidence used, and conclusions made, by this DGAC regarding sugars 
intake?
    Answer. The work of the 2015 Dietary Guidelines Advisory Committee 
(DGAC) on the topic of added sugars spanned its entire 19 months of 
work, during which time the public was invited to submit comments to 
the Advisory Committee. The process chosen by the Advisory Committee to 
address the topic was comprehensive and consistent with the methodology 
it applied across its Advisory Report. The Committee began its 
discussion on added sugars at its first public meeting in June 2013 
when it began developing the questions it wanted to examine. The 
Science Review Subcommittee, which served as an executive subcommittee 
to provide guidance to the full Committee to support its reviews of the 
evidence, decided to form the Added Sugars Working Group in June 2014 
based on extensive discussion that had already occurred within various 
topic-specific subcommittees and at public meetings. These discussions 
made it clear that an Added Sugars Working Group would be the most 
efficient and consistent way to comprehensively address the topic. The 
Added Sugars Working Group had its first meeting on July 16, 2014, not 
in September 2014. After the Advisory Report was released in February 
2015, a public comment period ending May 8, 2015 provided additional 
time for the public to review this issue and submit comments to HHS and 
USDA.
Response from Hon. Thomas ``Tom'' J. Vilsack, Secretary, U.S. 
        Department of Agriculture
Questions Submitted by Hon. Collin C. Peterson, a Representative in 
        Congress from Minnesota
    Question 1. In an 18 month process, spanning June 2013-December 
2014, the DGAC waited until September 2014 to form its Added Sugars 
Working Group. This gave the Committee a mere 90 days to collect, 
review, synthesize and formulate conclusions on the extensive body of 
literature on sugars.
    Considering all of the complexity and recent controversy around 
sugars intake, why wasn't this review of the scientific evidence on 
sugars initiated at the very beginning of this process?
    Were fewer than 90 days a sufficient amount of time for 
stakeholders to review and provide comment on the scientific evidence 
used, and conclusions made, by this DGAC regarding sugars intake?
    Answer. The work of the 2015 Dietary Guidelines Advisory Committee 
(DGAC) on the topic of added sugars spanned its entire 19 months of 
work, during which time the public was invited to submit comments to 
the Advisory Committee. The process chosen by the Advisory Committee to 
address the topic was comprehensive and consistent with the methodology 
it applied across its Advisory Report. The Committee began its 
discussion on added sugars at its first public meeting in June 2013 
when it began developing the questions it wanted to examine. The 
Science Review Subcommittee, which served as an executive subcommittee 
to provide guidance to the full Committee to support its reviews of the 
evidence, decided to form the Added Sugars Working Group in June 2014 
based on extensive discussion that had already occurred within various 
topic-specific subcommittees and at public meetings. These discussions 
made it clear that an Added Sugars Working Group would be the most 
efficient and consistent way to comprehensively address the topic. The 
Added Sugars Working Group had its first meeting on July 16, 2014 not 
in September 2014. After the Advisory Report was released in February 
2015, a public comment period ending May 8, 2015 provided additional 
time for the public to review this issue and submit comments to HHS and 
USDA.

    Question 2. The following chart was published on the National 
Consumers League website during March 2015, National Nutrition Month, 
along with an article entitled ``What's the Buzz on Caffeine?''.
Caffiene Equivalence
70-90 mg of Caffeine
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

          http://www.nclnet.org/whats_the_buzz_on_caffeine.

    If a typical serving of coffee, soda or an energy drink all contain 
about the same amount of caffeine, do you think final dietary guidance 
to consumers should be based upon recommendations that classify coffee 
as `normal' caffeine, energy drinks--and only energy drinks--as `high' 
caffeine and did not take tea or other common caffeine sources into 
account whatsoever as far as contribution to daily caffeine intake of 
Americans is concerned?
    Answer. The DGAC did not recommend that HHS and USDA classify 
coffee as a ``normal'' caffeine drink or energy drinks as ``high'' 
caffeine drinks. Instead, the references the Committee made to 
``coffee'' and ``high-caffeine energy drinks'' were to the evidence it 
reviewed related to intake of these products and health outcomes. For 
example, the literature that the Committee reviewed demonstrated the 
highly variable amount of caffeine in energy drinks and shots; a table 
in the article by Reissig, et al. (reference 122 in Part D, Chapter 5: 
Food Sustainability and Safety) shows that many energy drinks are in 
the same caffeine concentration range as coffee although many have 
serving sizes twice that of an 8 oz. coffee serving. The table also 
lists ``higher caffeine energy drinks'' as well as ``high concentration 
energy drinks'' also known as energy shots. Much of the available 
evidence on caffeine focuses on coffee intake. The Committee stated 
that moderate coffee consumption (three to five 8 oz. cups/day, or 
providing up to 400 mg/day of caffeine) can be incorporated into 
healthy eating patterns. The Committee also noted that the limited 
evidence in regard to high-caffeine energy drinks and health outcomes 
shows mixed results.
Question Submitted by Hon. Vicky Hartzler, a Representative in Congress 
        from Missouri
    Question. Has the USDA considered moving the Nutrition Evidence 
Library from CNPP to ARS to allow for more open access of the nutrition 
science data for all government agencies?
    Answer. The Nutrition Evidence Library (NEL) is unique in its 
special focus on systematic reviews specifically in nutrition to help 
inform Federal nutrition policies and programs--it requires the 
expertise of the professionals at CNPP. Since its inception, the NEL 
has been fully available and accessible to the public on NEL.gov, and 
all government agencies have had access not only to its contents, but 
also to its staff at CNPP. For example, USDA's Food and Nutrition 
Service (FNS) utilized the NEL for a series of systematic reviews in 
order to answer targeted nutrition education-related questions to 
inform guidance, policy, and program development related to FNS-
administered nutrition education programs.
                              attachment 1
Appendix E-2.39a: Evidence Portfolio
Part D. Chapter 5: Food Sustainability and Safety
Usual Caffeine Consumption and Health

 
 
-------------------------------------------------------------------------
    Systematic Review Question: Total Mortality
      What is the relationship between usual caffeine consumption and
   total mortality?
    Conclusion Statement: Strong and consistent evidence shows that
 consumption of coffee within the moderate range (3 to 5 cups/d or up to
 400 mg/d caffeine) is not associated with increased risk of major
 chronic diseases, such as cardiovascular disease (CVD) and cancer and
 premature death in healthy adults.
    DGAC Grade: Strong
------------------------------------------------------------------------

Key Findings

   Coffee consumption was associated with reduced risk of total 
        mortality (3-4% lower mortality with 1 cup/day), especially 
        cardiovascular mortality.

   Decaffeinated coffee consumption was associated with a lower 
        risk of death (5 studies only).

   The limited number of studies on decaffeinated coffee 
        indicates that protective association of coffee consumption may 
        not be due to caffeine alone.
Description of the Evidence
    Two systematic reviews and/or meta-analyses (SR/MAs) of 20 and 23 
prospective cohort studies (Je, 2013 and Malerba, 2013, respectively). 
Je, et al. examined total mortality and Malerba, et al., examined 
total, CVD, and cancer mortality. Evidence suggests a significant 
inverse relationship between coffee consumption of 1-4 cups/day with 
total mortality, especially cardiovascular disease mortality. This 
evidence is based on three meta-analyses of more than 20 prospective 
cohort studies (Je, 2013; Malerba, 2013; Crippa, 2014). In general, 
results were similar for men and women. The risk reduction associated 
with each cup of coffee per day was between 3-4 percent. In addition, 
Je (2013) found a significant inverse association between coffee 
consumption and cardiovascular disease mortality. This association was 
stronger in women (16% lower risk) than in men (8% lower risk). 
However, no association was found for cancer mortality. Crippa, et al., 
found that the lowest risk was observed for 4 cups/d for all-cause 
mortality (16%, 95% CI = 13-18) and 3 cups/d for CVD mortality (21%, 
95% CI = 16-26),

 
 
-------------------------------------------------------------------------
    Systematic Review Question: Cardiovascular Disease
      What is the relationship between usual caffeine consumption and
   cardiovascular disease?
    Conclusion Statement: Consistent observational evidence indicates
 that moderate coffee consumption is associated with reduced risk of
 type 2 diabetes and cardiovascular disease in healthy adults. In
 addition, consistent observational evidence indicates that regular
 consumption of coffee is associated with reduced risk of cancer of the
 liver and endometrium, and slightly inverse or null associations are
 observed for other cancer sites.
    DGAC Grade: Moderate
------------------------------------------------------------------------

Key Findings
CVD
   Non-linear association between coffee intake and risk of CVD

   Moderate coffee consumption was inversely associated with 
        CVD risk

     Lowest risk at 3-5 cups/d

   Heavy consumption was not associated with higher CVD risk
Stroke

   Non-linear association between coffee intake and risk of 
        stroke

   Moderate coffee consumption was inversely associated with 
        stroke

     Lowest risk at 3-4 cups/d

   Higher intakes were not associated with higher stroke risk
CHD
   Moderate coffee consumption was associated with lower CHD 
        risk

   Higher intakes were not associated with higher CHD risk
Heart Failure

   Moderate (1-5 cups/d) coffee consumption was inversely 
        associated with risk of heart failure

   The largest inverse association observed for 4 cups/d
Blood Pressure & Hypertension
   No effect of coffee on long-term BP or risk of HTN

   For habitual coffee consumption, consumption of >3 cups/d 
        was not associated with increased risk of HTN compared with <1 
        cup/d

     There was a slightly elevated risk of HTN for light to 
            moderate consumption (1-3 cups/d)

   In hypertensive individuals, caffeine intake produces an 
        acute increase in BP for %3 h, but there is no evidence of an 
        association between long-term coffee consumption and increased 
        BP

   Regular caffeine intake (median 410 mg/d) increases BP in 
        short-term RCTs, although when ingested through coffee, BP 
        effect of caffeine was smaller but significant
Atrial Fibrillation

   Caffeine was not associated with increased risk of atrial 
        fibrillation

   Low-dose caffeine exposure (<350 mg) may have a protective 
        effect
Blood Lipids

   Caffeinated, but not decaffeinated coffee, had significant 
        effect on serum lipids.

      The effects were mostly found in unfiltered coffee.

     Coffee consumption increased TC, LDL-C, and TG

     Positive dose-response relation between coffee intake 
            and TC, LDL-C, and TG
Description of the Evidence
    Twelve SR/MAs examined CVD (Ding, 2014; Caldiera, 2013; Cai, 2013; 
Kim, 2012; Mostofsky, 2012; Steffen, 2012; Zhang, 2011; Mesas, 2011; 
Larrson, 2011; Wu, 2009; Soffi, 2007; Noordjiz, 2005). Some SR/MAs 
covered only RCTs (Cai, 2013). Others included only prospective cohort 
studies (Larsson, 2011; Zhang, 2011; Kim, 2012; Mostofsky, 2012; Wu, 
2009). Other SR/MAs covered RCTs and cohort studies (Steffen, 2012); 
controlled trials (randomized and non-randomized) and cohort studies 
(Mesas, 2011); prospective studies and case-control (Soffi, 2007); 
prospective cohort studies, case-cohort, and nested case-control 
studies (Ding, 2014); and RCT, prospective or retrospective cohorts and 
case-control studies (Caldiera, 2013). The number of studies included 
in the SR/MAs ranged from 5-36.
    A large and current body of evidence directly addressed the 
relationship between normal coffee consumption and risk of 
cardiovascular disease (CVD). The evidence included 12 systematic 
reviews with meta-analyses, all of which had high quality ratings 
(AMSTAR scores 8/11-11/11). CVD incidence and mortality, as well as 
coronary heart disease (CHD), stroke, heart failure, and hypertension 
were assessed by meta-analyses that consisted primarily of prospective 
cohort studies; intermediate outcomes such as blood pressure, blood 
lipids, and blood glucose were assessed by meta-analyses of randomized 
controlled trials.
    CVD risk was assessed by a current meta-analysis of 36 prospective 
cohort studies on long-term coffee consumption (Ding, 2014). This 
analysis showed a non-linear association, such that the lowest risk of 
CVD was seen with moderate coffee consumption (3-5 cups/day), but 
higher intakes (>5 cups/day) were neither protective nor harmful. 
Overall, moderate consumption of caffeinated, but not decaffeinated, 
coffee was associated with a 12 percent lower risk of CVD.
    Results from the assessment of CHD risk in three meta-analyses 
(Ding, 2014; Wu, 2009; Sofi, 2007) were inconsistent. Ding (2014) found 
10 percent lower CHD risk with moderate coffee consumption (3-5 cups/
day) in a meta-analysis of 30 prospective cohort studies, whereas Wu 
(2009) and Sofi (2007) in meta-analyses of 21 and 10 prospective cohort 
studies, respectively, found no association between coffee consumption 
and CHD risk. However, in sub-group analysis, Wu (2009) found that 
habitual moderate coffee consumption (1-4 cups/day) was associated with 
an 18 percent lower risk among women. Overall, the meta-analyses of 
Sofi (2007) and Wu (2009) were conducted with smaller bodies of 
evidence and Ding (2014) assessed several more recent studies. One 
reason for the inconsistent associations may be that coffee brewing 
methods have changed over time and the filter method has become more 
widely used, replacing unfiltered forms of coffee such as boiled coffee 
that were more widely consumed by participants in earlier studies.
    Risk of stroke was assessed in two systematic reviews with meta-
analyses of prospective cohort studies (Larsson, 2011; Kim, 2012) with 
consistent findings. Kim (2012) found that coffee intake of 4 or more 
cups/day had a protective effect on risk of stroke. Larsson (2011) 
documented a non-linear association such that coffee consumption 
ranging from 1 to 6 cups/day was associated with an 8 percent-13 
percent lower risk of stroke, and higher intakes were not associated 
with decreased or increased risk. The inverse associations were limited 
to ischemic stroke and no association was seen with hemorrhagic stroke.
    Regarding blood pressure, three meta-analyses evaluated the effect 
of coffee and caffeine on systolic and diastolic blood pressure using 
controlled trials (Steffen, 2012; Mesas, 2011; Noordzij, 2005). The 
most recent meta-analysis of 10 randomized controlled trials by 
Steffen, et al. (2012) showed no effect of coffee on either systolic or 
diastolic blood pressure. Similarly, in another meta-analysis of 11 
coffee trials and 5 caffeine trials, caffeine doses of <410 mg/day had 
no effect on systolic and diastolic blood pressure while doses of 410 
or more mg/day resulted in a net increase (Noordzij, 2005). A third 
meta-analysis showed that among individuals with hypertension, 200-300 
mg of caffeine (equivalent to 2-3 cups filtered coffee) resulted in an 
acute increase of systolic and diastolic blood pressure (Mesas, 2011). 
Additionally, two meta-analyses quantified the effect of coffee on 
incidence of hypertension (Steffen, 2012; Zhang, 2011) and found no 
association between habitual coffee consumption and risk of 
hypertension. However, Zhang, et al. (2011) documented a slightly 
elevated risk for light to moderate consumption (1-3 cups/day) of 
coffee compared to less than 1 cup/day. Regarding blood lipids, in a 
quantitative analysis of short-term randomized controlled trials, Cai, 
et al. (2012) revealed that coffee consumption contributed 
significantly to an increase in total cholesterol, LDL-cholesterol, and 
triglycerides, and that unfiltered coffee had a greater effect than 
filtered coffee. Interestingly, caffeinated, but not decaffeinated 
(more likely to be filtered), coffee had this effect on serum lipids.
    In a meta-analysis of observational study data, including 
prospective, retrospective, and case-control studies, higher amounts of 
coffee or caffeine had no association with risk of atrial fibrillation, 
but low doses of caffeine (<350 mg/day) appeared to have a protective 
effect (Caldeira, 2013). In contrast, coffee consumption of 1-5 cups/
day was found to be inversely associated with risk of heart failure in 
a meta-analysis of 5 prospective studies (Mostofsky, 2012). A non-
linear association was documented and the lowest risk was observed for 
4 cups/day (Mostofsky, 2012).

 
 
-------------------------------------------------------------------------
    Systematic Review Question: Type 2 Diabetes
      What is the relationship between usual caffeine consumption and
   type 2 diabetes?
    Conclusion Statement: Consistent observational evidence indicates
 that moderate coffee consumption is associated with reduced risk of
 type 2 diabetes and cardiovascular disease in healthy adults. In
 addition, consistent observational evidence indicates that regular
 consumption of coffee is associated with reduced risk of cancer of the
 liver and endometrium, and slightly inverse or null associations are
 observed for other cancer sites.
    DGAC Grade: Moderate
------------------------------------------------------------------------

Key Findings
   Coffee consumption was inversely associated with T2D risk in 
        a dose-response manner.

   Both caffeinated and decaffeinated coffee were associated 
        with lower T2D risk.

   Increased coffee consumption by 1 cup/d was associated with 
        7% lower T2D risk.

   Similar associations were seen in men and women.

   A smaller number of studies on decaffeinated coffee indicate 
        that protective association of coffee consumption is unlikely 
        to be due to caffeine alone.

   In T2D individuals, ingestion of caffeine (200-500 mg) 
        significantly increased blood glucose, serum insulin, and 
        lowered insulin sensitivity in those with T2D in short-term 
        RCTs.
Description of the Evidence
    Five SR/MAs examined T2D (Ding, 2014; Jiang, 2014; Whitehead, 2013; 
Huxley, 2009; van Dam, 2005). One SR/MA covered controlled trials 
(Whitehead, 2013) and two others covered only prospective cohort 
studies (Jiang, 2014; Huxley, 2009). Other SR/MAs covered both 
prospective cohort and nested case-control studies (Ding, 2014) or 
prospective cohort and cross-sectional studies (van Dam, 2005). The 
number of studies included in the SR/MAs ranged from 9-31.
    Coffee consumption has consistently been associated with a reduced 
risk of type 2 diabetes. In four meta-analyses of prospective cohort 
studies (Ding, 2014; Jiang, 2014; Huxley, 2009; van Dam, 2005) and 
cross-sectional studies (van Dam, 2005), coffee consumption was 
inversely associated with risk of type 2 diabetes in a dose-response 
manner. Risk for type 2 diabetes was 33 percent lower for those 
consuming 6 cups/day in the analysis by Ding, et al. (2014) while the 
risk was 37 percent lower for those consuming 10 cups/day in the 
analysis by Jiang, et al. (2014). Using a sub-set of the prospective 
cohorts in the Ding, et al. (2014) and Jiang, et al. (2014) meta-
analyses, Huxley (2009) documented that each cup of coffee was 
associated with a 7 percent lower risk of type 2 diabetes. Similarly, 
van Dam (2005) noted that consumption of %6 or %7 cups/day was 
associated with a 35 percent lower risk of type 2 diabetes. Three meta-
analyses (Ding, 2014; Jiang, 2014; Huxley, 2009) found protective 
associations for decaffeinated coffee. Moderate decaffeinated coffee 
consumption (3-4 cups/day) was associated with a 36 percent lower risk 
of type 2 diabetes (Huxley, 2009). Each cup of decaffeinated coffee was 
associated with a 6 percent lower risk (Ding, 2014) while every 2 cups 
were associated with a 11 percent lower risk (Jiang, 2014). Both 
reports also documented a dose-response association between caffeine 
and type 2 diabetes risk such that every 140 mg/day was associated with 
an 8 percent lower risk in the Ding, et al. (2014) meta-analysis while 
every 200 mg/day was associated with a 14 percent lower risk in the 
analysis by Jiang, et al. (2014). However, it remains unclear if this 
inverse association is independent of coffee consumption as Ding et al 
(2014) indicated that none of the studies included in the caffeine 
dose-response analysis adjusted for total coffee.
    Only one systematic review of 9 randomized controlled trials 
examined the effects of caffeine on blood glucose and insulin 
concentrations among those with type 2 diabetes (Whitehead & White 
2013). Ingestion of 200-500 mg of caffeine acutely increased blood 
glucose concentrations by 16-28 percent of the area under the curve and 
insulin secretions by 19-48 percent of the area under the curve when 
taken prior to a glucose load. At the same time, these trials also 
noted a decrease in insulin sensitivity by 14-37 percent. Although it 
is not clear if the acute effects of caffeine on blood glucose and 
insulin persist in the long term, evidence from prospective cohorts 
indicate that caffeine may have no adverse effect on the risk of type 2 
diabetes.

 
 
-------------------------------------------------------------------------
    Systematic Review Question: Cancer
      What is the relationship between usual caffeine consumption and
   cancer?
    Conclusion Statement: Consistent observational evidence indicates
 that moderate coffee consumption is associated with reduced risk of
 type 2 diabetes and cardiovascular disease in healthy adults. In
 addition, consistent observational evidence indicates that regular
 consumption of coffee is associated with reduced risk of cancer of the
 liver and endometrium, and slightly inverse or null associations are
 observed for other cancer sites.
    DGAC Grade: Moderate
------------------------------------------------------------------------

Key Findings
Total Cancer
   Total Cancer Coffee drinkers had a modestly lower total 
        cancer incidence compared to nondrinkers or those with the 
        lowest intakes.
Lung Cancer
   Coffee consumption was associated with higher risk of lung 
        cancer, but the association was mainly explained by smoking. An 
        association was not founder among nonsmokers.
Liver Cancer
   Significant inverse association between coffee consumption 
        and liver cancer risk seen in both case-control and cohort 
        studies (after adjustment for existing liver disease).

   Risk of hepatocelluar carcinoma was reduced by 40% for any 
        coffee consumption versus no coffee consumption.
Breast Cancer
   No association between caffeine, coffee, or decaffeinated 
        coffee and breast cancer risk.

     An inverse association was seen in postmenopausal 
            women and a strong inverse association seen in BRCA1 
            mutation carriers.

   Borderline lower risk for highest versus lowest coffee 
        consumption.

     For all studies together, an increase of 2 cups of 
            coffee per day was associated with a 2% marginally lower 
            breast cancer risk.
Prostate Cancer
   Regular coffee consumption associated with modestly lower 
        risk of prostate cancer.

   Significant inverse association documented for cohort 
        studies. For case-control studies, a 2 cup increment was 
        associated with a higher risk of prostate cancer.

   Dose-response meta-analysis of coffee consumption showed 
        inverse association with prostate cancer mortality, but not 
        incidence.
Ovarian Cancer
   No association between coffee consumption and ovarian cancer 
        risk in high versus low or dose-response meta-analysis.
Endometrial Cancer
   Increased coffee intake was associated with a reduced risk 
        of endometrial cancer in both cohort and case-control studies.

   A reduction of 20% in endometrial cancer risk among coffee 
        drinkers; >20% and >30% reduction in risk among low to mod and 
        heavy drinkers, respectively.
Bladder Cancer
   Data from case-control studies suggest that consumption of 
        coffee is associated with an increased risk for bladder cancer, 
        but no significant association was seen in prospective cohort 
        studies.
Pancreatic Cancer
   Meta-analysis of prospective cohort studies showed that 
        coffee drinking was inversely associated with pancreatic cancer 
        risk (in sub-group analyses, there was a reduced risk in men 
        but not women).

   A positive association was found between coffee intake and 
        pancreatic cancer in case-control studies that did not adjust 
        for smoking. An inverse association was found in prospective 
        cohort studies.
Upper Digestive & Respiratory Cancer
   Coffee drinking was inversely related to oral/pharyngeal 
        cancer risk while there was no relation with laryngeal cancer, 
        ESCC, and EAC.
Gastro-esophageal Cancer
   Coffee consumption was inversely, but non-significantly, 
        associated with risk of esophageal cancer.

   No association between coffee consumption and gastric cancer 
        risk in cohort or case-control studies.
Colorectal Cancer
   Case-control studies suggest coffee consumption decreases 
        risk of colorectal and colon cancer, especially in women; the 
        association was inverse, but marginally non-significant, for 
        cohort studies for colorectal and colon cancer.

   Prospective cohort studies showed no association between 
        coffee consumption on colorectal cancer risk (a suggestive 
        inverse association was slightly stronger in studies that 
        adjusted for smoking and alcohol).
Description of the Evidence
    A large number of SR/MAs addressed cancer, including total cancer 
(Yu, 2011), lung cancer (Tang, 2010), liver cancer (Sang, 2013; Bravi, 
2013), breast cancer (Jiang, 2013; Li, 2013; Tang 2009), prostate 
cancer (Cao, 2014; Zhong, 2013; Discacciati, 2013; Park, 2010), ovarian 
cancer (Braem, 2012), endometrial cancer (Je, 2012; Bravi, 2009), 
bladder cancer (Zhou, 2012), pancreatic cancer (Turati, 2011; Dong, 
2011), upper digestive and respiratory tract cancer (Turati, 2011), 
esophageal cancer (Zheng, 2013), gastric cancer (Botelho, 2006), and 
colorectal cancer (Li, 2012; Galeone, 2010; Je, 2009). The majority of 
the studies included cohort and cross-sectional studies, although some 
covered only prospective cohort studies or case-control studies. The 
number of studies included in the SR/MAs ranged from 3-54.
    Several systematic reviews and meta-analyses examined the 
association between coffee consumption and risk of cancer. Types of 
cancer examined by the Committee included total cancer, cancers of the 
lung, liver, breast, prostate, ovaries, endometrium, bladder, pancreas, 
upper digestive and respiratory tract, esophagus, stomach, colon, and 
rectum.
    In a quantitative summary of 40 prospective cohort studies with an 
average follow-up of 14.3 years, Yu (2011) found a 13 percent lower 
risk of total cancer among coffee drinkers compared to non-drinkers or 
those with lowest intakes. Risk estimates were similar for men and 
women. In sub-group analyses, the authors noted that coffee drinking 
was associated with a reduced risk of bladder, breast, buccal and 
pharyngeal, colorectal, endometrial, esophageal, hepatocellular, 
leukemic, pancreatic, and prostate cancers.
    Tang, et al. (2010) evaluated 5 prospective cohorts and 8 case-
control studies and found that overall those with the highest levels of 
coffee consumption had a 27 percent higher risk for lung cancer 
compared to never drinkers or those with least consumption. An increase 
in coffee consumption of 2 cups/day was associated with a 14 percent 
higher risk of developing lung cancer. However, because smoking is an 
important confounder, when analyses were stratified by smoking status, 
coffee consumption was marginally protective in non-smokers and was not 
associated with lung cancer among smokers. When estimates from 2 
studies that examined decaffeinated coffee were summarized, there was a 
protective association with lung cancer. No association was seen with 
lung cancer when only case-control studies were considered.
    Results from two meta-analyses indicate the coffee consumption is 
associated with a 50 percent lower risk of liver cancer (Sang, 2013) 
and a 40 percent lower risk of hepatocellular carcinoma (Bravi, 2013) 
when considering both cohort and case-control studies. Associations 
were significant in men but not in women (Sang, 2013).
    Three meta-analyses of observational studies found no association 
between coffee consumption (Jiang, 2013; Li, 2013; Tang, 2013), 
caffeine consumption (Jiang, 2013), or decaffeinated coffee consumption 
(Jiang, 2013) and risk of breast cancer. In all 3 reports, each 2 cup/
day of coffee was marginally associated with a 2 percent lower risk of 
breast cancer. However, in sub-group analyses, coffee consumption was 
protective against breast cancer risk in postmenopausal women (Jiang, 
2013), BRCA1 mutation carriers (Jiang, 2013), and women with estrogen 
receptor negative status (Li, 2013).
    The association between coffee consumption and risk of prostate 
cancer was mixed. Cao (2014) and Zhong (2013) found that regular or 
high coffee consumption, compared to non- or lowest levels of 
consumption, was associated with a 12 percent-17 percent lower risk of 
prostate cancer in prospective cohort studies. Further, each 2 cups of 
coffee per day was associated with a 7% lower risk of prostate cancer. 
However, no associations were seen with case-control data alone or when 
these studies were examined together with prospective cohort studies. 
Using a combination of both prospective cohort and case-control data, 
Discacciati (2013) found that each 3 cups/day of coffee was associated 
with a 3% lower risk of localized prostate cancer and an 11% lower risk 
of mortality from prostate cancer. On the other hand, after summarizing 
data from 12 prospective cohort and case-control studies, Park (2010) 
found a 16% higher risk of prostate cancer. However, in sub-group 
analyses by study design, the higher risk was observed in case-control 
but not in cohort studies.
    Consumption of coffee was not associated with risk of ovarian 
cancer in a meta-analysis of 7 prospective cohort studies with over 
640,000 participants (Braem, 2012).
    Two meta-analyses confirmed an inverse association between coffee 
consumption and risk of endometrial cancer (Je, 2012; Bravi, 2009). In 
the most recent and updated meta-analysis of prospective cohort and 
case-control studies, compared to those in the lowest category of 
coffee consumption, those with the highest intakes of coffee had a 29% 
lower risk of endometrial cancer (Je, 2012). Each cup of coffee per day 
was associated with an 8% lower risk of endometrial cancer. Similar 
results were found in the meta-analysis by Bravi (2009) that included a 
sub-set of the studies in Je (2012) and documented a 20% lower risk of 
endometrial cancer overall, and a 7% decrease for each cup of coffee 
per day. However, the association was significant only in case-control 
studies but not in cohort studies, most likely due to lower statistical 
power.
    A recent meta-analysis of 23 case-control studies by Zhou (2012) 
found coffee was a risk factor for bladder cancer. There was a smoking-
adjusted increased risk of bladder cancer for those in the highest 
(45%), second highest, (21%), and third highest (8%) groups of coffee 
consumption, compared to those in the lowest group. No association was, 
however, seen in cohort studies.
    Two meta-analyses of coffee consumption and pancreatic cancer risk 
provided mixed results (Turati, 2011; Dong, 2011). Using both 
prospective cohort and case-control studies, Turati (2011) found that 
coffee consumption was not associated with risk of pancreatic cancer. 
However, an increased risk was seen in case-control studies that did 
not adjust for smoking. Using a sub-set of prospective cohorts included 
in the Turati (2011) meta-analysis, Dong (2011) found that coffee 
drinking was inversely associated with pancreatic cancer risk but did 
not separate studies based on their adjustment for smoking status. Sub-
group analyses revealed a protective association in men, but not in 
women.
    Turati (2011) quantified the association between coffee consumption 
and various upper digestive and respiratory tract cancers using data 
from observational studies. Coffee consumption was associated with a 
36% lower risk of oral and pharyngeal cancer but not with risk of 
laryngeal cancer, esophageal squamous cell carcinoma, or esophageal 
adenocarcinoma. In a meta-analysis of prospective cohort and case-
control studies, Zheng (2013) noted that coffee was inversely, but non-
significantly, associated with risk of esophageal cancer. Regarding 
gastric cancer, no association between coffee consumption and risk was 
seen in a meta-analysis of observational studies by Botelho (2006).
    Three meta-analyses on the association between coffee consumption 
and colorectal cancer risk (Li, 2012; Galeone, 2012; Je, 2009) have 
yielded mixed findings. Results from case-control studies suggested 
coffee consumption was associated with lower risk of colorectal (15% 
lower) and colon cancer (21% lower), especially in women. However, this 
inverse association was non-significant for cohort studies. Using all 
but one of the case-control studies, Galeone (2012) arrived at similar 
conclusions as the Li (2012) analysis although associations were in 
general stronger. Galeone (2012) also provided suggestive evidence for 
a dose-response relationship between coffee and colorectal cancer such 
that each cup of coffee was associated with a 6% lower risk of 
colorectal cancer, 5% lower risk of colon cancer, and 3% lower risk of 
rectal cancer. Using several prospective cohort studies as in the Li 
(2012) meta-analysis, Je (2009) found no significant association of 
coffee consumption with risk of colorectal cancer. Interestingly, no 
differences were seen by sex but the suggestive inverse associations 
were slightly stronger in studies that adjusted for smoking and 
alcohol.

 
 
-------------------------------------------------------------------------
    Systematic Review Question: Cognitive Function
      What is the relationship between usual caffeine consumption and
   cognitive function?
    Conclusion Statement: Limited evidence indicates that caffeine
 consumption is associated with a modestly lower risk of cognitive
 decline or impairment and lower risk of Alzheimer's disease.
    DGAC Grade: Limited
------------------------------------------------------------------------

Key Findings:
   There was a trend toward a protective effect of caffeine 
        from different sourcesand cognitive impairment/dementia.
Description of the Evidence
    Two systematic reviews (Arab, 2013; Santos, 2010) and one meta-
analysis (Santos, 2010) examined the effects of caffeine from various 
sources, including coffee, tea, chocolate, on cognitive outcomes. Arab 
(2013) systematically reviewed six longitudinal cohort studies 
evaluating the effect of caffeine or caffeine-rich beverages on 
cognitive decline. Most studies in this review used the Mini Mental 
State Examination Score as a global measure of cognitive decline. The 
review concluded that estimates of cognitive decline were lower among 
consumers, although there was no clear dose-response relationship. 
Studies also showed stronger effects among women than men. In a 
metaanalysis of nine cohort and two case-control studies, caffeine 
intake from various sources was associated with a 16% lower risk of 
various measures of cognitive impairment/decline. Specifically, data 
from four studies indicate that caffeine is associated with a 38% lower 
risk of Alzheimer's disease.

 
 
-------------------------------------------------------------------------
    Systematic Review Question: Parkinson's Disease
      What is the relationship between usual caffeine consumption and
   Parkinson's disease?
    Conclusion Statement: Consistent evidence indicates an inverse
 association between caffeine intake and risk of Parkinson's disease.
    DGAC Grade: Moderate
------------------------------------------------------------------------

Key Findings
   There was a non-linear inverse association between coffee 
        and Parkinson's disease risk with maximum protection at 3 
        cups/d (adjusted for smoking).

   For caffeine consumption, a linear inverse association was 
        found (adjusted for smoking); every 300 mg/day was associated 
        with a 24% lower risk of Parkinson's disease.
Description of the Evidence
    Evidence from two systematic reviews (Ishihara, 2005; Costa, 2010) 
and one quantitative meta-analysis (Qi, 2013) confirmed an inverse 
association between coffee, caffeine, and risk of Parkinson's disease. 
Qi (2013) evaluated six case-control studies and seven prospective 
articles and documented a non-linear relationship between coffee and 
risk of Parkinson's disease, overall. The lowest risk was observed at 
3 cups/day (smoking-adjusted risk reduction was 28%). For caffeine, a 
linear dose-response was found and every 200 mg/day increment in 
caffeine intake was associated with a 17% lower risk of Parkinson's 
disease. Using a combination of cohort, case-control, and cross-
sectional data, Costa (2010) summarized that the risk of Parkinson's 
disease was 25% lower among those consuming the highest versus lowest 
amounts of caffeine. Like Qi (2013), Costa documented a linear dose-
response with caffeine intake such that every 300 mg/day was associated 
with a 24% lower risk of Parkinson's disease. In both reports, 
associations were weaker among women than in men.

 
 
-------------------------------------------------------------------------
    Systematic Review Question: Pregnancy outcomes
      What is the relationship between usual caffeine consumption and
   pregnancy outcomes?
    Conclusion Statement: Consistent evidence from observational studies
 indicates that caffeine intake in pregnant women is not associated with
 risk of preterm delivery. Higher caffeine intake (especially >=300 mg/
 day ) is associated with a small increased risk of miscarriage,
 stillbirth, low birth weight, and small for gestational age (SGA)
 births. However, these data should be interpreted cautiously due to
 potential recall bias in the case-control studies and confounding by
 smoking and pregnancy signal symptoms.
    DGAC Grade: Moderate
------------------------------------------------------------------------

Key Findings
   No important association between caffeine intake during 
        pregnancy and risk of pre-term birth were observed in either 
        cohort or case-control studies.

   Consumption of caffeine from various sources was associated 
        with a significantly increased risk of spontaneous abortion and 
        low birth weight. Control for confounders such as maternal age, 
        smoking, and ethanol use was not possible.
Description of the Evidence
    Two SR/MAs assessed observational studies on the association of 
caffeine intake with adverse pregnancy outcomes (Greenwood, 2014; 
Maslova, 2010). The pregnancy outcomes included miscarriage, pre-term 
birth, stillbirth, small for gestational age (SGA), and low birth-
weight. The most recent SR/MA by Greenwood, et al., quantified the 
association between caffeine intake and adverse pregnancy outcomes from 
60 publications from 53 separate cohort (26) and case-control (27) 
studies. The evidence covered a variety of countries with caffeine 
intake categories that ranged from non-consumers to those consuming 
>1,000mg/day. They found that an increment of 100 mg caffeine was 
associated with a 14% increased risk of miscarriage, 19% increased risk 
of stillbirth, 10% increased risk of SGA, and 7% increased risk of low 
birth weight. There was no significant increase in risk of preterm 
delivery. The magnitude of these associations was relatively small 
within the range of caffeine intakes of the majority women in the study 
populations, and the associations became more pronounced at higher 
range (>=300 mg/day). The authors also note the substantial 
heterogeneity observed in the meta-analyses shows that interpretation 
of the results should be cautious. In addition, the results from 
prospective cohort studies and case-control studies were mixed 
together. Since coffee consumption is positively correlated with 
smoking, residual confounding by smoking may have biased the results 
toward a positive direction.
    The other SR/MAs did not cover all of the above pregnancy outcomes, 
but for those adverse outcomes covered, the results were in agreement 
with Greenwood, et al., Maslova (2010) reviewed 22 studies (15 cohort 
and 7 case-control studies) and found no significant association 
between caffeine intake and risk of pre-term birth in either 
casecontrol or cohort studies. For all of the observational studies 
assessed across the three SR/MAs, most studies did not adequately 
adjust for the pregnancy signal phenomenon, i.e., that nausea, 
vomiting, and other adverse symptoms are associated with a healthy 
pregnancy that results in a live birth, whereas pregnancy signal 
symptoms occur less frequently when the result is miscarriage. Coffee 
consumption decreases with increasing pregnancy signal symptoms, 
typically during the early weeks of pregnancy, and this confounds the 
association (Peck, et al. 2010). Greenwood, et al., state that this 
potential bias is the most prominent argument against a causal role for 
caffeine in adverse pregnancy outcomes. Only one randomized controlled 
trial of caffeine/coffee reduction during pregnancy has been conducted 
to date (Bech, 2007). The study found that a reduction of 200 mg of 
caffeine intake per day did not significantly influence birth weight or 
length of gestation. The trial did not examine other outcomes.
Research Recommendations
  1.  Evaluate the effects of coffee on health outcomes in vulnerable 
            populations, such as women who are pregnant (premature 
            birth, low birth weight, spontaneous abortion).

  2.  Examine the effects of coffee on sleep patterns, quality of life, 
            and dependency and addiction.

  3.  Evaluate the prospective association between coffee/caffeine 
            consumption and cancer at different sites.

  4.  Examine prospectively the effects of coffee/caffeine on cognitive 
            decline, neurodegenerative diseases, and depression.

  5.  Understand the mechanisms underlying the protective effects of 
            coffee on diabetes and CVD.

  6.  Understand the association between coffee and health outcomes in 
            individuals with existing CVD, diabetes, cancer, 
            neurodegenerative diseases, or depressive symptoms.
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    49. Santos C., Costa J., Santos J., Vaz-Carneiro A., Lunet N.
 Caffeine intake and dementia: systematic review and meta-analysis. J.
 Alzheimers Dis. 2010; 20 Suppl. 1:S187-204. PMID: 20182026. http://
 www.ncbi.nlm.nih.gov/pubmed/20182026.
    50. Greenwood D.C., Thatcher N.J., Ye J., Garrard L., Keogh G., King
 L.G., et al. Caffeine intake during pregnancy and adverse birth
 outcomes: a systematic review and dose-response meta-analysis. Eur. J.
 Epidemiol. 2014; 29(10):725-34. PMID: 25179792. http://
 www.ncbi.nlm.nih.gov/pubmed/25179792.
    51. Maslova E., Bhattacharya S., Lin S.W., Michels K.B. Caffeine
 consumption during pregnancy and risk of preterm birth: a meta-
 analysis. Am. J. Clin. Nutr. 2010; 92(5):1120-32. PMID: 20844077. http:/
 /www.ncbi.nlm.nih.gov/pubmed/20844077.
 

Analytical Framework
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

Inclusion Criteria
    PubMed was searched for original research articles published in 
English in peer-reviewed journals. Studies published since January 2000 
with subjects who were healthy or at elevated chronic disease risk from 
countries with high or very high human development were considered. 
Study design was limited to systematic reviews or systematic reviews 
with meta-analyses. All other study designs were excluded. Studies were 
required to specify level of caffeine and included caffeine from any 
source. Both short- and long-term health outcomes were included. 
Studies that examined low-calorie diets and other treatment diets were 
excluded. Finally, studies were required to include a description of 
the dietary pattern along with sustainability or food security 
outcomes.
Search Results
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

                              attachment 2
The Federal Advisory Committee Act (FACA) Brochure
An Overview
U.S. General Services Administration,
Office of Governmentwide Policy,
Committee Management Secretariat,
Washington, D.C. 20417

    Advisory committees have played an important role in shaping 
programs and policies of the Federal Government from the earliest days 
of the Republic. Since President George Washington sought the advice of 
such a committee during the Whiskey Rebellion of 1794, the 
contributions made by these groups have been impressive and diverse.
    Today, an average of 1,000 advisory committees with more than 
60,000 members advise the President and the Executive Branch on such 
issues as the disposal of high-level nuclear waste, the depletion of 
atmospheric ozone, the national fight against Acquired Immune 
Deficiency Syndrome (AIDS), efforts to rid the nation of illegal drugs, 
to improve schools, highways, and housing, and on other major programs.
    Through enactment of the Federal Advisory Committee Act (FACA) of 
1972 (Public Law 92-463), the U.S. Congress formally recognized the 
merits of seeking the advice and assistance of our nation's citizens. 
At the same time, the Congress also sought to assure that advisory 
committees:

   Provide advice that is relevant, objective, and open to the 
        public;

   Act promptly to complete their work; and

   Comply with reasonable cost controls and record keeping 
        requirements.
Role of Federal Advisory Committees
    With the expertise from advisory committee members, federal 
officials and the nation have access to information and advice on a 
broad range of issues affecting federal policies and programs. The 
public, in return, is afforded an opportunity to provide input into a 
process that may form the basis for government decisions.
Federal Agency Responsibility
    Each Federal agency that sponsors advisory committees must adhere 
to the requirements established by the FACA, as well as regulations 
promulgated by the U.S. General Services Administration's (GSA) 
Committee Management Secretariat. GSA has had the responsibility for 
overseeing the FACA since 1977.
GSA's Role Under the FACA
    With approximately 1,000 advisory committees in existence at any 
given time, special attention is required to assure compliance with the 
FACA, the Freedom of Information Act, and related regulations, as well 
as to encourage effective and efficient use of committee resources.
    While Executive Branch departments and agencies are responsible for 
continually reviewing committee performance and compliance in these 
areas, the General Services Administration was designated by the 
President in 1977 to monitor committee activities government-wide. As 
part of this responsibility, GSA:

   Conducts annual reviews of advisory committee activities and 
        accomplishments;

   Responds to requests from agencies on establishing new 
        committees or the renewal of existing groups; and

   Maintains a FACA database on the internet from which 
        advisory committee information may be obtained.

    Together, GSA and the Federal community work to eliminate the 
overlap or duplication of advisory bodies, terminate unnecessary or 
inactive committees, and develop committee management regulations, 
guidelines, and training in response to requirements of the Executive 
Branch and Congress.
Complying with FACA
    Any advisory group, with limited exceptions, that is established or 
utilized by a federal agency and that has at least one member who is 
not a Federal employee, must comply with the FACA. To find out if a 
group comes under the FACA, contact the sponsoring agency's Committee 
Management Officer. The GSA Committee Management Secretariat is an 
additional resource (see the last section ``For More Information . . 
.'').
Requirements for Establishing and Managing Advisory Committees
    Under the Federal Advisory Committee Act, advisory committees can 
be created only when they are essential to the performance of a duty or 
responsibility conveyed upon the Executive Branch by law or 
Presidential Directive. Before committees can be set up, high-level 
officials within the sponsoring agency must review and approve the 
request. Once a committee is approved, a charter is prepared outlining 
the committee's mission and specific duties and forwarded to GSA's 
Committee Management Secretariat for final review. Following a required 
public notification period, and the filing of the charter with 
Congress, the committee may begin operation.
Committee Management Officer and Designated Federal Officer
    The Federal Advisory Committee Act also provides that each agency 
sponsoring a federal advisory committee must appoint a Committee 
Management Officer to oversee the administration of the Act's 
requirements.
    In addition, a Designated Federal Officer must be assigned to each 
committee to:

   Ensure compliance with FACA, and any other applicable laws 
        and regulations;

   Call, attend, and adjourn committee meetings;

   Approve agendas;

   Maintain required records on costs and membership;

   Ensure efficient operations;

   Maintain records for availability to the public; and

   Provide copies of committee reports to the Committee 
        Management Officer for forwarding to the Library of Congress.
Expiration of a Committee's Charter
    Unless the renewal of a committee charter is justified under the 
FACA, the charter automatically expires after a 2 year period (or as 
otherwise provided by law).
Advisory Committee Members
    Federal advisory committee members are drawn from nearly every 
occupational and industry group and geographical section of the United 
States and its territories. The FACA requires that committee 
memberships be ``fairly balanced in terms of the points of view 
represented and the functions to be performed.''
    As a result, members of specific committees often have both the 
expertise and professional skills that parallel the program 
responsibilities of their sponsoring agencies. In balancing committee 
memberships, agencies are expected to consider a cross-section of those 
directly affected, interested, and qualified, as appropriate to the 
nature and function of the advisory committee.
Appointing Committee Members
    Agency officials, Members of Congress, the general public, or 
professional societies or current and former committee members may 
nominate potential candidates for membership on a committee.
    Selection of committee members is made based on the FACA's 
requirements and the potential member's background and qualifications. 
Final selection is made by the president or heads of departments or 
agencies.
    Prior to accepting an appointment with a Federal advisory 
committee, each prospective member should clarify his/her role, 
obligations, duties, allowable expenses, compensation limitations, and 
any ethics requirements with their committee's Designated Federal 
Officer and/or Committee Management Officer, as appropriate.
Federal Ethics and Conflict of Interest Laws
    Agency officials must provide prospective advisory committee 
members with information regarding any applicable standards of 
conduct--including those imposed by federal conflict of interest 
statutes. In some instances, members may be subject to special 
limitations during the course of their service on an advisory 
committee. For some members, these restrictions also may apply (for 
limited periods) after their committee assignments have ended.
    Some agencies may impose additional administrative requirements as 
well. To avoid potential conflicts, each advisory committee member 
should assure that he or she receives adequate information from the 
sponsoring agency and completes any required appointment papers and 
disclosure forms prior to service on a committee.
    Oral briefings and other explanatory material may be obtained 
through the sponsoring agency's Committee Management Officer, 
Designated Agency Ethics Official, or from the Office of Government 
Ethics, which has government-wide jurisdiction on federal ethics 
issues.
Limits on Membership Terms
    Each agency may set limits (unless provided by law or Presidential 
Directive) on the lengths of terms for serving on advisory committees 
to allow for new membership.
Open Access to Committee Meetings and Operations
    Under the provisions of the Federal Advisory Committee Act, Federal 
agencies sponsoring advisory committees must:

   Arrange meetings that are reasonably accessible and at 
        convenient locations and times;

   Publish adequate advance notice of meetings in the Federal 
        Register;

   Open advisory committee meetings to the public (with some 
        exceptions--see the section on ``Government in the Sunshine 
        Act'' below);

   Make available for public inspection, subject to the Freedom 
        of Information Act, papers and records, including detailed 
        minutes of each meeting; and

   Maintain records of expenditures.
Government in the Sunshine Act
    Advisory committee meetings may be closed or partially closed to 
the public based upon provisions of the Government in the Sunshine Act 
of 1976 (Public Law 94-409). Examples of meetings that may be closed 
under the FACA are:

   Those including discussions of classified information;

   Reviews of proprietary data submitted in support of Federal 
        grant applications; and

   Deliberations involving considerations of personnel privacy.
For More Information . . .
    For more information on the requirements of the Federal Advisory 
Committee Act, contact the General Services Administration's Committee 
Management Secretariat at [email protected] or via the internet at:

          http://www.gsa.gov/faca; or
          http://www.gsa.gov/committeemanagement

    Examples of materials available on the Committee Management 
Secretariat website are:

   Federal Advisory Committee Act (http://www.gsa.gov/portal/
        content/100916)

   GSA Final Rule on Federal Advisory Committee Management 
        (http://www.gsa.gov/portal/content/104034)

   Guidance documents

   Access to the Federal Advisory Committee Act database 
        (http://www.facadatabase.gov/)

   Information on the Federal Advisory Committee Act Training 
        course (http://www.gsa.gov/portal/content/162635).

    Other materials, such as samples of nominating letters and 
committee reports, are available from each sponsoring agency.

          (Accessed December 10, 2015.)
                              attachment 3
Office of the General Counsel Ethics Division
Revised October 2004 (Previous Editions Obsolete)
Ethics Rules for Advisory Committee Members and Other Individuals 
        Appointed as Special Government Employees (SGEs)
Introduction
    This summary has been prepared primarily for individuals appointed 
to serve as ``special Government employees'' (SGEs) on Department of 
Health and Human Services (HHS) advisory committees or Presidential 
boards, councils, or commissions that are attached to HHS for purposes 
of administration. The information also will be useful to other SGEs 
without advisory committee responsibilities, such as ``experts or 
consultants'' or ``personal services contractors.''
    New appointees, especially those that provide temporary, 
intermittent services only a few days a year, often are surprised by, 
or even resentful of, the complexity of the rules governing Federal 
employees. The ethics rules do not appear to many people to be logical, 
intuitive, or even, fair. Ignoring these rules, however, can result in 
serious consequences or embarrassment, both personally and for the 
Department. Criminal conflict of interest violations are ``strict 
liability'' offenses, and even an inadvertent, ``technical'' violation 
will require the initiation of an Inspector General investigation and 
possible referral to the Department of Justice. Moreover, the entire 
matter in which a violator participates may be considered so 
compromised that the Department may have to nullify, cancel, or retract 
any agency action that is perceived as tainted by the conflict. 
Therefore, if you have questions on any of the topics covered in this 
guidance, you should consult with the Designated Federal Official 
responsible for your committee or the Deputy Ethics Counselor assigned 
to your operating or staff division.
Definition of a Special Government Employee (SGE)
    A ``special Government employee'' is an officer or employee in the 
Executive Branch of the Federal Government who is appointed to perform 
temporary duties, with or without compensation, for a period not to 
exceed 130 days during any period of 365 consecutive days. 18 U.S.C.  
202(a). This status is important because the ethics rules for SGEs are 
somewhat less restrictive than the rules for other Federal employees 
and officials. Some members of advisory committees are appointed for a 
multi-year term. During each year of their term of appointment, 
committee members generally will not be expected to perform work for 
HHS in excess of 130 days during any period of 365 consecutive days. 
Thus, most committee members will be considered ``SGEs.''
    In addition, individuals who provide advice as an ``expert or 
consultant'' or render assistance under a ``personal services 
contract'' for a period that is not expected to exceed 130 days do so 
as the functional equivalent of an employee and thus are treated as 
SGEs for ethics purposes. Only ``true'' independent contractors are 
excluded from the definition. Although several factors are evaluated to 
determine independent contractor status, this category, for the most 
part, comprises individuals who produce a defined ``end product'' or 
``deliverable'' without detailed supervision by a Federal employee.
Financial Disclosure Reporting Requirements
    HHS advisory committee members appointed as SGEs are required under 
the Ethics in Government Act, as amended by the Ethics Reform Act of 
1989, and 5 CFR Part 2634, to file a financial disclosure report when 
first appointed and annually thereafter on the anniversary date of 
their appointment. Committee members also may be required to update the 
information on the report before each meeting throughout their term of 
appointment. (Certain committee members are permitted to utilize an 
alternative reporting system, e.g., FDA Form 3410, that focuses solely 
on each filer's assets and associational interests that are directly 
implicated by the subjects on the meeting agenda.) The information 
reported is used to determine the matters for which a committee member 
must be disqualified under the criminal financial conflict of interest 
statute, 18 U.S.C.  208(a), and the matters for which a committee 
member may be granted a waiver under 18 U.S.C.  208(b).
    Complete reporting is essential to protect the committee member 
from inadvertently violating any of the criminal conflict of interest 
statutes, and to assure the public that the advice provided by an HHS 
advisory committee is free from any real, or perceived, conflicts of 
interest. The information reported by committee members is confidential 
and may not be released except under the limited circumstances 
described in the Privacy Act notice provided with the report or by 
order of a Federal court. (SGEs who serve more than 60 days in any 
period of 365 consecutive days and who are compensated at certain pay 
levels may be required to file a publicly available financial 
disclosure report.)
Criminal Conflict of Interest Statutes
    The following criminal conflict of interest statutes apply to SGEs:
    18 U.S.C  201. Section 201, commonly known as the ``bribery and 
illegal gratuities'' statute, prohibits Federal employees, including 
SGEs, from seeking, accepting, or agreeing to receive anything of value 
in return for being influenced in the performance of an official act.
    18 U.S.C.  203. Section 203 prohibits an SGE from receiving 
compensation for representational services rendered by the employee or 
another person before HHS or another Federal agency or other specified 
entity (such as a court or commission) in any particular matter 
involving a specific party (i) in which the SGE has participated 
personally and substantially as a government employee, or (ii) which is 
pending in the government agency in which the SGE is serving if the SGE 
has served for more than 60 days during the immediately preceding 365 
days.
    Exempted from this rule are representations required in the proper 
discharge of official duties. Also exempted are representations 
determined by the head of the agency to be required in the performance 
of work under a grant, contract or other agreement with or for the 
benefit of the government.
    A particular matter involving specific parties is a matter that is 
focused upon the interests of identified persons in a specific 
proceeding or an isolatable transaction or related set of transactions. 
Examples include, but are not limited to, reviews of grant proposals or 
contract applications, or similar funding decisions; recommendations or 
approvals of scientific studies, projects, clinical trials, new drug 
applications; and other actions that involve deliberation, decision, or 
action affecting the legal rights of identified parties.
    In contrast, a particular matter of general applicability is a 
matter that is focused on the interests of a discrete and identifiable 
class of persons or entities, but does not involve specific parties. 
Examples include recommendations or consideration of legislative 
proposals, regulatory initiatives, or policy development that affect an 
industry, group of manufacturers, or health care providers.
    Pay close attention to which type of particular matter is involved 
in your assignment because the ethics rules may differ depending upon 
whether a ``specific party matter'' or a ``general policy matter'' is 
involved. The terms ``matter'' or ``particular matter,'' without more 
description, are deemed to encompass both types.
    Representational services include communications (written or oral) 
and appearances made on behalf of someone else, generally with the 
intent to influence or persuade the government. An inquiry as to the 
status of a pending matter is not necessarily a representation, 
although depending upon the context of the inquiry, it could give rise 
to the appearance of a prohibited representation.
    To avoid appearance problems, during the period in which a 
committee is in session, committee members are advised not to contact 
Department staff concerning any matters pending before the agency, or 
as to which the agency has an interest. Such matters would include, for 
example, applications for Federal funding, progress reports regarding 
Cooperative Research and Development Agreements (CRADAS) or clinical 
trials, and pending drug investigations or applications.
    18 U.S.C.  205. Section 205 prohibits an SGE from representing a 
party, with or without compensation, before HHS or another Federal 
agency or other specified entity (such as a court or commission) in any 
particular matter involving a specific party in which the United States 
is a party or has a direct and substantial interest: (i) that the SGE 
participated in personally and substantially as a government employee; 
or (ii) which is pending in the agency in which the SGE is serving, if 
the SGE has served for more than 60 days during the immediately 
preceding 365 days.
    18 U.S.C.  207. Section 207, the ``post-employment'' statute, 
imposes a lifetime ban on a former SGE from representing another person 
or entity to HHS or another Federal agency or other specified entity 
(such as a court or commission) in any particular matter involving a 
specific party in which the former SGE participated personally and 
substantially while serving in the government. In addition, for two 
years after terminating Federal employment, an SGE may not make such 
representational communications to the government regarding specific 
party matters that were pending under his or her official 
responsibility during the last year of government service. Moreover, 
``senior employees,'' those paid at an annual rate equivalent to level 
ES-5 in the Senior Executive Service, are subject to a one-year 
``cooling-off'' period which precludes any contacts with their former 
agency on any matter for which official action is sought, even if the 
former employee had no involvement with the matter while in government 
service. For SGEs, this one-year ``cooling-off'' period does not apply 
if the SGE served less than 60 days in the one-year period prior to 
termination of senior employee status.
    18 U.S.C.  208. Section 208(a), the main conflict of interest 
statute, prohibits an SGE from participating personally and 
substantially in any particular matter that could affect the financial 
interests of the SGE, the SGE's spouse, minor child, general partner, 
an organization in which the SGE serves as an officer, director, 
trustee, general partner, or employee, or an organization with which 
the SGE is negotiating or with which the SGE has an arrangement for 
prospective employment.
    Under this statute, for example, an SGE would be prohibited from 
reviewing a grant application submitted by a researcher from the same 
university in which the SGE is employed, or a contract proposal from an 
association for which the SGE serves as a member of the board of 
directors. In these instances, the SGE would be required to recuse from 
participation in the reviews.
    Section 208 might also prohibit the SGE from participating in 
setting standards for grantees or contractors in general, to the extent 
that the SGE's university (or any organization with which the SGE is 
affiliated as an officer or board member) would be affected by those 
standards. (Under this scenario, however, a waiver could be issued to 
permit the SGE to participate in such general policy matters. Also, a 
regulatory waiver might apply to this situation. See discussion below.)
    A waiver for advisory committee members may be granted under 18 
U.S.C.  208(b)(3). Section 208(b)(3) authorizes issuance of a waiver 
to an SGE who serves on a committee subject to the Federal Advisory 
Committee Act if the official responsible for the individual's 
appointment certifies in writing that the need for the individual's 
services outweighs the potential for a conflict of interest created by 
the particular financial interest involved. The waiver granted is 
considered a ``general'' waiver, in that it allows participation in 
matters that affect all institutions, or types of institutions, 
similarly. Even with a general waiver, however, SGEs must disqualify 
themselves from participation in all matters that specifically and 
uniquely affect their financial interests.
    The Designated Federal Official responsible for a committee will 
explain the procedures for disqualification. SGEs who do not serve on 
advisory committees are subject to more exacting waiver requirements in 
18 U.S.C.  208(b)(1), and a Deputy Ethics Counselor should be 
consulted.
    In addition, under regulations issued by the Office of Government 
Ethics, a regulatory (i.e., automatic) waiver of the disqualification 
requirement of 18 U.S.C.  208 is available under certain 
circumstances, including instances involving the following classes of 
financial interests:

   interests held in broadly diversified investment funds;

   publicly traded securities of $15,000 or less;

   publicly traded securities of $25,000 or less if the matter 
        is a general policy matter and the total value of all 
        investments in the affected industry sector is no more than 
        $50,000;

   employment in one campus of a multi-campus state university 
        if the matter affects only another campus and the employee does 
        not have multi-campus responsibilities.

    In addition, there is an automatic exemption which allows SGEs 
serving on Federal advisory committees to participate in particular 
matters of general applicability where the otherwise disqualifying 
financial interest arises solely from the committee member's non-
Federal employment or prospective employment, provided that the matter 
will not have a special or distinct effect on the employee or employer 
other than as part of a class. This exemption is unavailable if the 
employee (or those persons whose interests are imputed to the employee) 
owns stock, stock options, or has some other financial interest in the 
employer other than his or her employment interest.
    18 U.S.C  219. Section 219 prohibits an SGE from acting as an 
``agent of a foreign principal'' as defined under the Foreign Agents 
Registration Act (FARA) or a ``lobbyist'' on behalf of a foreign entity 
that is required to register under the Lobbying Disclosure Act of 1995 
(LDA).
    The ban on participating in foreign agent activities covered by 
FARA prohibits representation of foreign governments or foreign 
political parties before the United States Government, as well as a 
number of other activities conducted within the United States on behalf 
of such entities: (1) political activities; (2) public relations 
counseling; (3) publicity agent activities; (4) information services; 
(5) political consulting; and (6) solicitation or disbursement of 
contributions, loans, money, or other things of value; where such 
services are rendered with the intent to influence the American public 
or the government, with reference to formulating the domestic or 
foreign policies of the United States, or with reference to the 
political or public interests, policies or relations of a government of 
a foreign country or a foreign political party.
    There are certain FARA exceptions related to trade or commerce, 
legal representation, humanitarian fundraising, and religious, 
scholastic, or scientific pursuits. The head of an agency may authorize 
the employment of an agent for a foreign entity as a special government 
employee upon a certification that such action is in the national 
interest. The LDA ban prohibits certain lobbying of covered legislative 
and executive branch officials on behalf of foreign corporations, 
associations, or other organizations.
Standards of Ethical Conduct
    In addition to criminal statutes, the conduct of SGEs is governed 
by a series of ethics rules that apply 24 hours per day and even on 
days during which the SGE provides no Federal services. The following 
are some of the major Standards of Ethical Conduct regulations (5 CFR 
Part 2635) that pertain to HHS SGE advisory committee members during 
the term of their appointment:
I. Teaching, Speaking and Writing in a Personal Capacity (i.e., Other 
        Than as a Government Employee)
    Generally, during their term of appointment, committee members may 
continue to receive fees, honoraria, and other compensation for 
teaching, speaking and writing undertaken in their personal or non-
governmental capacities. However, there are some limitations:

          (A) An SGE is prohibited from receiving compensation for 
        teaching, speaking, and writing that ``relates to the 
        employee's official duties.'' 5 CFR  2635.807. The 
        ``relatedness'' test is met for an SGE if:

                  (1) the activity is undertaken as an official 
                government duty;

                  (2) the circumstances indicate that the invitation to 
                engage in the activity was extended to the SGE 
                primarily because of the employee's position in the 
                government rather than the employee's expertise in the 
                particular subject matter;

                  (3) the invitation to engage in the activity or the 
                offer of compensation for the activity was extended to 
                the employee, directly or indirectly, by a person who 
                has interests that may be affected substantially by the 
                performance or nonperformance of the employee's 
                official duties; or

                  (4) the information conveyed through the activity 
                draws substantially on ideas or official data that are 
                confidential or not publicly-available.

          (B) Additionally, if a committee member serves for 60 days or 
        less during a one-year period, the SGE may not accept 
        compensation for teaching, speaking, and writing if the subject 
        matter of the teaching, speaking or writing concerns a 
        particular matter involving specific parties in which the SGE 
        participated or is participating personally and substantially 
        as a government employee.
          For example, an AIDS researcher has been appointed to a 4 
        year term as a member of an advisory committee established for 
        the purpose of surveying and recommending modification of 
        procedures that deter the development of treatments for HIV 
        infection and HIV-related diseases. The committee member is not 
        expected to serve more than 60 days each year during her 4 year 
        term of appointment.
          The committee member may accept compensation for an article 
        or speech about the deterrent effect of certain procedures 
        required for clinical investigations and trial designs even 
        though such issues are being discussed by the advisory 
        committee. Clinical procedures in general are not a particular 
        matter involving specific parties. The committee member could 
        not accept compensation for an article or speech which recounts 
        committee deliberations that took place in a closed meeting, or 
        which relies upon other, non-public information. In addition, 
        the committee member could not accept compensation for an 
        article or speech about specific collaborations in the HIV drug 
        development process which were discussed by the committee, 
        since the collaborations are considered a particular matter 
        involving specific parties.
          (C) If a committee member serves for more than 60 days, the 
        SGE is additionally prohibited from receiving compensation for 
        teaching, speaking, and writing if the subject of the activity 
        deals in significant part with any matter to which the SGE is 
        presently assigned or was assigned during the previous one-year 
        period.

    Exceptions:

  1.  This rule does not preclude a committee member from receiving 
            compensation for teaching, speaking, or writing on a 
            subject within the committee member's discipline or 
            inherent area of expertise based on the SGE's educational 
            background or experience. The outside activity must not be 
            about or distinctly related to the work the SGE is 
            providing to the government.

  2.  These restrictions also do not apply to teaching a course 
            requiring multiple presentations that is part of the 
            regularly established curriculum of an institution of 
            higher education, an elementary or secondary school, or a 
            program of education or training sponsored and funded by 
            the Federal, State, or local government.
II. Gifts
    Any gift given to a committee member because of the member's 
service on an HHS advisory committee would raise concerns. The 
Designated Federal Official responsible for the committee should be 
consulted should this situation arise. Gifts given to an SGE because of 
the SGE's position or achievements in the private (non-government) 
sector generally are not problematic.
III. Charitable Fundraising
    A committee member may engage in charitable fundraising in a 
personal capacity as long as the committee member does not personally 
solicit funds or other support from any person or entity known to the 
committee member to be a person or entity whose interests may be 
substantially affected by the performance or nonperformance of the 
committee member's Federal duties. 5 CFR  2635.808. If specific 
questions concerning particular fundraising events or activities should 
arise, the Designated Federal Official responsible for the committee 
should be consulted.
IV. Expert Witness
    A committee member cannot serve as an expert witness, in a 
proceeding before a United States court or agency in which the United 
States is a party or has a direct and substantial interest, except on 
behalf of the United States, if the committee member participated, 
while a Federal employee, in the particular proceeding, unless 
authorized by the HHS Designated Agency Ethics Official (DAEO), who can 
be reached at (202) 690-7258.
    In addition, a committee member who was appointed by the President, 
serves on a commission established by statute, or has served or is 
expected to serve for more than 60 days in a period of 365 consecutive 
days, cannot serve, other than on behalf of the United States, as an 
expert witness, with or without compensation, in any proceeding before 
a United States court or agency in which the committee members's 
employing agency is a party or has a direct and substantial interest 
unless authorized by the DAEO. 5 CFR  2635.805.
V. Impartiality
    Although committee members are prohibited under 18 U.S.C.  208(a) 
from participating in matters in which they have a financial interest, 
there may be other circumstances in which a committee member's 
participation in a particular matter involving specific parties would 
raise a question regarding the member's impartiality in the matter. For 
example, a committee member asked to review a grant application 
submitted by the SGE's mentor, or someone with whom the SGE has a close 
personal or professional relationship, would raise a concern about the 
committee member's impartiality in the review. In such circumstances, 
the committee member should discuss the relationship with the 
Designated Federal Official responsible for the committee and a 
determination will be made as to whether the member should be 
disqualified from participation in the specific party matter, or should 
be granted an ``authorization'' to permit the member to participate in 
such matter. 5 CFR  2635.502.
VI. Misuse of Position
    Committee members are subject to a number of prohibitions intended 
to address the use, or appearance of use, of ``public office for 
private gain.'' 5 CFR Part 2635, Subpart G. These prohibitions include:

  (A)  Using their HHS titles or referring to their government 
            positions for their own private gain, the private gain of 
            friends, relatives, or anyone with whom they are affiliated 
            in a non-governmental capacity (including nonprofit 
            organizations which they serve as officers, members, 
            employees, or in any other business relationship), or for 
            the endorsement of any product, service, or enterprise.

  (B)  Using their HHS titles or government positions to coerce or 
            induce another person to provide any benefit to themselves 
            or another person.

  (C)  Using non-public government information in a financial 
            transaction to further their private interests or those of 
            another, or disclosing confidential or non-public 
            information without authorization.

  (D)  Using government property for unauthorized purposes.
Employment by, or Gifts from, Foreign Governments
    The Constitution prohibits a committee member's employment by a 
foreign government, including political subdivisions of a foreign 
government. For SGEs, this provision has particular relevance to 
positions with foreign universities that are government-operated, as 
opposed to private institutions. United States Constitution, art. I  
9, cl. 8. There are also statutory provisions restricting acceptance of 
gifts from foreign governments. 5 U.S.C.  7342. Committee members 
should consult with the Designated Federal Official responsible for 
their committee for details about these restrictions. Employment or 
consultation with a foreign entity for the purpose of providing foreign 
agent representation or lobbying is barred by a criminal statute; see 
the discussion above concerning 18 U.S.C.  219. All SGEs are required 
to complete HHS Form 697, Foreign Activities Questionnaire, for the 
purpose of determining whether a committee member's foreign connections 
are incompatible with Federal service.
Lobbying Activities
    In their official capacities or as a group, committee members are 
prohibited from engaging in any activity which directly or indirectly 
encourages or directs any person or organization to lobby one or more 
members of Congress. 18 U.S.C.  1913. When authorized, committee 
members may appear before any individual or group for the purpose of 
informing or educating the public about a particular policy or 
legislative proposal. Committee members also may communicate to Members 
of Congress at the request of any Representative or Senator. 
Communications to Members of Congress initiated by committee members, 
in their official capacity as members of the committee, should be 
coordinated through the Office of the Assistant Secretary for 
Legislation.
    As private citizens, committee members may express their personal 
views (but not the views of the committee as a whole or the opinions of 
HHS) to anyone. In doing so, committee members may state their 
affiliation with the committee, may factually state the committee's 
official position on the matter (to the extent that non-public 
information is not used), but may not take new positions and represent 
those views as the committee's position on the matter. Moreover, in 
expressing their private views, as with all other personal (non-
governmental) activities, committee members are not permitted to use 
government computers, copiers, telephones, letterhead, staff resources, 
or other appropriated funds. All personal activities must occur ``off 
duty time.''
    Committee members are prohibited in their personal capacities from 
making representations on behalf of others, to the government, on 
particular matters involving specific parties in which they were 
involved as Federal employees. (See discussion above under 18 U.S.C.  
203 and 205.)
Political Activities
    The Hatch Act (5 U.S.C.  7321-7326) prescribes the restrictions 
on certain political activities of Federal employees (see the 
explanatory chart on the following page). Unlike the criminal conflict 
of interest statutes and the ethics rules which are fully applicable to 
an SGE throughout the SGE's entire term of appointment, the Hatch Act 
restrictions apply only during the period of any day in which the SGE 
actually is performing government business. For example, if an SGE 
attends an advisory committee meeting from 8:00 a.m.-1:00 p.m., the SGE 
could attend a political fund raiser at 3:00 p.m. and even solicit 
political contributions from the attendees.

    A series of criminal political statutes (18 U.S.C.  595, 600-603, 
606-607, 610) applies to SGEs even on non-duty hours. These sections, 
which focus on patronage crimes and election offenses, prohibit 
coercive ``political shakedowns,'' intimidation regarding political 
activities, campaign fundraising on Federal property, and the use of 
public office or authority for the purpose of affecting the outcome of 
an election.

                Hatch Act Political Activity Restrictions
------------------------------------------------------------------------
                                        Prohibited Activities (while on
       Permissible Activities                        duty)
------------------------------------------------------------------------
 May be candidates for         May not use their
 public office in nonpartisan          official authority to interfere
 elections                             with an election.
 May register and vote as      May not collect political
 they choose.                          contributions, unless both
 May assist in voter           individuals are members of the
 registration drives.                  same Federal labor organization
 May express opinions about    and the one solicited is not a
 candidates and issues.                subordinate employee.
 May contribute money to
 political organizations.
 May attend and be active at   May not knowingly solicit
 political rallies and meetings.       or discourage the political
 May attend political fund     activity of any person who has
 raising functions.                    business before the agency.
 May join and be an active     May not engage in
 member of a political party or        political activity while on duty.
 club.                                 May not engage in
 May sign nominating           political activity in any
 petitions.                            government office.
 May campaign for or against   May not engage in
 referendum questions,                 political activity while wearing
 constitutional amendments,            an official uniform.
 municipal ordinances.
 May campaign for or against   May not engage in
 candidates in partisan elections.     political activity while using a
                                       government vehicle.
 May distribute campaign       May not solicit political
 literature in partisan elections.     contributions from the general
                                       public.
 May hold office in            May not actively
 political clubs or parties (except    participate as a candidate for
 Treasurer).                           public office in a partisan
                                       election.
------------------------------------------------------------------------

                              attachment 4
Initial Meeting Materials
Charge to the 2015 Dietary Guidelines Advisory Committee
    The Dietary Guidelines for Americans provide science-based advice 
on how nutrition and physical activity can help promote health and 
reduce the risk for major chronic diseases. The Guidelines form the 
basis of Federal nutrition policy, standards, programs, and education 
for the general public. The Dietary Guidelines are published jointly by 
the U.S. Department of Health and Human Services and the U.S. 
Department of Agriculture every 5 years.
    The Dietary Guidelines Advisory Committee (DGAC), whose duties are 
time-limited and solely advisory in nature, will:

   Examine the Dietary Guidelines for Americans, 2010 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.

   Place its primary focus on the systematic review and 
        analysis of the evidence published since the last DGAC 
        deliberations.

   Place its primary emphasis on the development of food-based 
        recommendations that are of public health importance for 
        Americans ages 2 years and older.

   Prepare and submit to the Secretary of Health and Human 
        Services and the Secretary of Agriculture a report of technical 
        recommendations, with rationales, to inform the development of 
        the 2015 Dietary Guidelines for Americans. DGAC 
        responsibilities include providing authorship for this report; 
        however, responsibilities do not include translating the 
        recommendations into policy or into communication and outreach 
        documents or programs.

   Disband upon the submittal of the Committee's 
        recommendations via the Report of the Dietary Guidelines 
        Advisory Committee on the Dietary Guidelines for Americans, 
        2015 to the Secretaries.

   Complete all work within the required 2 year charter time 
        frame.

          (Accessed December 10, 2015.)
                              attachment 5
Charter
2015 Dietary Guidelines Advisory Committee Authority
    The 2015 Dietary Guidelines Advisory Committee (the Committee or 
2015 DGAC) is authorized under 42 U.S.C. 217a, Section 222 of the 
Public Health Service Act, as amended. The Committee is governed by 
provisions of the Federal Advisory Committee Act (FACA), Public Law 92-
463, as amended (5 U.S.C., App.), which sets forth standards for the 
formation and use of advisory committees.
Objectives and Scope of Activities
    Under Section 301 of Public Law 101-445 (7 U.S.C. 5341, the 
National Nutrition Monitoring and Related Research Act of 1990, Title 
III) the Secretaries of Health and Human Services (HHS) and Agriculture 
(USDA) are directed to jointly issue at least every 5 years a report 
entitled Dietary Guidelines for Americans. The law instructs that this 
publication shall contain nutritional and dietary information and 
guidelines for the general public, shall be based on the preponderance 
of scientific and medical knowledge current at the time of publication, 
and shall be promoted by each Federal agency in carrying out any 
Federal food, nutrition, or health program. The Dietary Guidelines for 
Americans was issued voluntarily by HHS and USDA in 1980, 1985, and 
1990; the 1995 edition was the first statutorily mandated report, 
followed by subsequent editions at the appropriate intervals.
    The 2015 DGAC is established to provide independent, science-based 
advice and recommendations for development of the Dietary Guidelines 
for Americans, 2015, which forms the basis of Federal nutrition 
programs, nutrition standards, and nutrition education for the general 
public. A variety of services and tools will be made available to the 
Committee to support development of recommendations that promote health 
and reduce chronic disease risk for Americans. The USDA Nutrition 
Evidence Library will assist the Committee in conducting and creating a 
transparent database of systematic reviews reflecting the most current 
research available on a wide range of food and nutrition-related topics 
to inform its recommendations.
Description of Duties
    The work of the Committee will be solely advisory in nature and 
time-limited. The Committee will examine the current Dietary Guidelines 
for Americans, take into consideration new scientific evidence and 
current resource documents, and then develop a report to be submitted 
to the Secretaries that outlines its science-based recommendations and 
rationale which will serve as a basis for developing the eighth edition 
of Dietary Guidelines for Americans.
Agencies or Officials to Whom the Committee Reports
    The HHS Assistant Secretary for Health and USDA Under Secretaries 
of the Food, Nutrition, and Consumer Services (FNCS) and Research, 
Education and Economics (REE) will provide guidance and oversight for 
the Committee's function and activities.
Support
    Management and support services for the 2015 DGAC primarily will be 
provided by the Office of Disease Prevention and Health Promotion 
(ODPHP) within the Department of Health and Human Services. The ODPHP 
is a program office within Office of the Assistant Secretary for Health 
(OASH), which is a staff division in HHS Office of the Secretary. 
Responsibility for administrative services will be shared with staffs 
of the USDA FNCS and REE. USDA administrative leadership and Nutrition 
Evidence Library support will come from the Center for Nutrition Policy 
and Promotion within FNCS. REE agencies will provide administrative and 
data analysis support.
Estimated Annual Operating Costs and Staff Years
    The estimated annual HHS cost for operating the DGAC, including 
travel and per diem expenses for members, but excluding staff support 
is $400,000. It is estimated that the annual person-years of HHS staff 
support required is 4.4 FTEs, at an estimated cost of $430,000.
Designated Federal Officer
    The HHS Assistant Secretary for Health will appoint two Co-
Executive Secretaries from HHS, one of whom will serve as the 
Designated Federal Officer (DFO). USDA Under Secretaries of FNCS and 
REE will appoint two Co-Executive Secretaries from USDA, one from the 
Center for Nutrition Policy and Promotion, who will serve as the lead 
for USDA, and the other from the Agricultural Research Service.
    Since HHS has responsibility for providing management support for 
the 2015 DGAC, the HHS Co-Executive Secretaries will, in collaboration 
with the USDA Co-Executive Secretaries, schedule and approve all 
meetings of the 2015 DGAC, and make logistical arrangements that are 
necessary for public meetings of the 2015 DGAC, including meetings of 
any established subgroups. The DFO, in collaboration with the USDA Co-
Executive Secretaries, will prepare and approve all meeting agendas; 
development of the meeting agenda also can include consultation with 
the Committee Chair.
    The DFO or other official to whom the authority has been delegated 
will be present at all meetings of the full Committee and any subgroups 
that have been established to assist the Committee. The DFO has 
authority to adjourn meetings, when it is determined to be in the 
public interest, and may also chair the committee meetings when 
directed to do so by the Assistant Secretary for Health and/or other 
authorized official.
Estimated Number and Frequency of Meetings
    It is estimated that the 2015 DGAC will meet approximately five 
times during the projected period for its operation. More meetings will 
be held if it is necessary to accomplish the mission of the Committee 
and funds are available to support additional meetings. It is required 
that \2/3\ of the appointed members be present for the Committee to 
meet to conduct business. Meetings will be open to the public, except 
as determined otherwise by the Secretaries of HHS and USDA or other 
official to whom this authority has been delegated, in accordance with 
guidelines under Government in the Sunshine Act at 5 U.S.C. 552b(c) and 
the FACA. Notice of all meetings will be provided to the public. 
Meetings will be conducted and records of the proceedings will be kept, 
as required by applicable laws and Departmental policies.
Duration
    The 2015 DGAC is established to accomplish a single, time-limited 
task. It is expected that the Committee will complete the mission for 
which it was established within two years from the date this charter is 
filed.
Termination
    Unless renewed by appropriate action prior to its expiration, the 
2015 DGAC will terminate after delivery of its final report to the 
Secretaries of HHS and USDA or 2 years from the date this charter is 
filed, whichever comes first.
Membership and Designation
    The 2015 DGAC will consist of not more than 17 members, with the 
minimum number being 13; one or more members will be selected to serve 
as the Chair, Vice Chair, and/or Co-Chairs. Individuals will be 
selected to serve as members of the Committee who are familiar with 
current scientific knowledge in the field of human nutrition and 
chronic disease. Expertise will be sought in specific specialty areas 
that may include but are 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.
    Members will be invited to serve for the duration of the Committee. 
Individuals who are appointed to serve as members of the Committee will 
be jointly agreed upon by the Secretaries of HHS and USDA. All 
appointed members of the 2015 DGAC will be classified as special 
government employees (SGEs).
    Pursuant to an advance written agreement, the appointed members 
will receive no compensation for the advisory service they render 
during their tenure on the 2015 DGAC. However, as authorized by law and 
in accordance with Federal travel regulations, members of the 2015 DGAC 
will receive per diem and reimbursement for travel expenses incurred 
while performing duties and/or conducting business related to the 
Committee.
Subcommittees/Working Groups
    To accomplish its mission, and with approval of the official to 
whom authority has been given, the 2015 DGAC may establish 
subcommittees and/or working groups that are composed of members of the 
parent committee and non-member special consultants and/or individuals 
with demonstrated expertise in the specialty areas designated for the 
Committee membership.
    The established subgroups will provide advice and/or make 
recommendations to the parent committee. All reports and 
recommendations developed by an established subgroup of the 2015 DGAC 
must be submitted to the parent committee for the appropriate action to 
be taken. An established subgroup may not report its findings to any 
Federal official unless there is specific statutory authority for such 
reporting.
    The Department Committee Management Officer will be notified if any 
subgroup is established for the 2015 DGAC, and will be provided 
information regarding the name of the subgroup, function, membership, 
and estimated frequency of meetings.
Recordkeeping
    Records of the Committee and any established subgroup will be 
handled in accordance with General Records Schedule 26, Item 2 or other 
approved agency records disposition schedule. These records will be 
made available to the public for inspection and copying, subject to the 
Freedom of Information Act, 5 U.S.C. 552.
    Filing Date: February 19, 2013
Approved

 
 
 
January 9, 2013                      //s//
Date                                 Kathleen Sebelius