CDC —Trans Fats - a

09/09/2014

HHS Information Quality Web Site
Information Requests for Corrections and HHS' Responses

September 9, 2014

 

Centers for Disease Control and Prevention (CDC)
CDC/ATSDR, Attn: MASO, MS-E11
1600 Clifton Road, N.E.
Atlanta, GA 30333
Sent via E-mail: InfoQuality@cdc.gov

RE: Request for Correction of Information Disseminated to the Public that Improperly Attributed a Study to the Centers for Disease Control and Prevention (CDC)

 

Dear Sir or Madam:

 

I am hereby submitting[1] this request for correction of information pursuant to the Information Quality Act,[2] as implemented through the Office of Management and Budget (OMB),[3] United States Department of Health and Human Services,[4] and the Centers for Disease Control and Prevention.[5]

Information that is disseminated must meet the requirement of “objectivity.”[6] According to the HHS Guidelines, “‘objectivity’ involves a focus on ensuring that information is accurate, reliable and unbiased and that information products are presented in an accurate, clear, complete and unbiased manner.”[7]  The information identified fails to meet this requirement.

 

Location of Inaccurate Information

 

The inaccurate information can be found in the report “Winnable Battles Progress Report: 2010-2015.”[8]

 

CDC is Improperly Attributing Data and a Study as its Own 

 

In the report "Winnable Battles Progress Report: 2010-2015,"[9] the CDC claims “CDC has concluded that 10,000–20,000 heart attacks and 3,000–7,000 coronary heart disease deaths each year in the U.S. could be prevented by removing artificial trans fat from processed foods.”  This language is giving the impression that the CDC came up with this data; the CDC has also claimed through emails to me that the study containing this data is from a CDC study.[10]  The alleged CDC study is “Eliminating the Use of Partially Hydrogenated Oil in Food Production and Preparation” [11] that was written by CDC employees and published in the Journal of the American Medical Association (JAMA).  The study though includes the following express disclaimer, “The findings and conclusions in this report are those of the authors and do not necessarily reflect the official position of the US Centers for Disease Control and Prevention.”

 

In other locations on the CDC web site, the CDC cites to the study without giving this misimpression that the data and study come from the CDC.  On the agency’s trans fat web page,[12]  the CDC states “Further reducing trans fat consumption by avoiding artificial trans fat could prevent 10,000-20,000 heart attacks and 3,000-7,000 coronary heart disease deaths each year in the U.S.” There is a footnote after this claim citing to the study.  The CDC cites the study again when using these estimates in the publication “Trans Fat: The Basics.”[13]  In these instances, the CDC is properly recognizing that the study is not a CDC study by using citations to the external source. The citation does not direct readers to a location on the CDC web site but merely provides the JAMA study citation; it appears that the study is not located on the CDC web site, further demonstrating that it is not a CDC study. 

 

The CDC took an affirmative step to clarify that the study should not be attributed to the CDC.  As I was told via email on June 23, 2014 by Karen Hunter, a CDC senior press officer, “You are correct it [the disclaimer] is on all CDC studies[14] that are published in non-CDC scientific journals, such as JAMA.”[15]

 

Under the CDC’s Information Quality Act Guidelines, “covered information” includes:

 

Scientific research papers, books, journal articles, reports, and similar materials, unless they have disclaimers to distinguish the research from CDC views and positions. [Emphasis added].[16]

 

Under this language, the study would not be “covered information” under the Guidelines.  It also suggests that because of the disclaimer it is not a CDC study.  Any interpretation to the contrary would allow the CDC to exempt any documents from the IQA that it wants to simply by including a disclaimer but simultaneously asserting when it so chooses that a document is still a CDC publication contrary to the plain language of the disclaimer.  Further, the very reason why the CDC did not include as “covered information” any studies that have disclaimers is because the documents are not CDC information.

 

The Study is a Highly Influential Scientific Assessment if it is a CDC Study

If the CDC determines that the study is in fact a CDC study, it would be required to meet the IQA requirements.  The only way for the agency to determine that the study is a CDC study is to arbitrarily ignore the definition of “covered information” and specifically the exception covering studies containing disclaimers.

 

As “covered information,” the study must meet the requirements under the IQA.  The study has not been classified as either influential scientific information or a highly influential scientific assessment.[17]

 

This study is a highly influential scientific assessment requiring the most rigorous form of peer review, pursuant to OMB’s “Final Information Quality Bulletin for Peer Review.”[18]

 

According to the Bulletin:  

A scientific assessment is considered “highly influential” if the agency or the OIRA Administrator determines that the dissemination could have a potential impact of more than $500 million in any one year on either the public or private sector or that the dissemination is novel, controversial, or precedent-setting, or has significant interagency interest. One of the ways information can exert economic impact is through the costs or benefits of a regulation based on the disseminated information.[19]

 

The study and the data from the study that is being disseminated are:

 

·         Novel (There is no comparable government report)

·         Controversial (The findings are making serious health claims about an ingredient that has been used for many years); and  

·         Precedent-Setting (The study will be used to inform policy as seen with FDA’s “Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information”[20] and could influence actions taken by other nations).   

The study and its data have already garnered interagency interest, specifically with the FDA.  The study is central to the FDA justifying its potential revocation of Generally Recognized as Safe (GRAS) status for partially hydrogenated oils (PHOs).  According to the FDA, the costs and the benefits greatly exceed the $500 million in any one year threshold:

 

We estimate the 20-year net present value of costs to be between $12 and $14 billion, where the upper and lower estimates are calculated at 3 and 7 percent discount rates. Using the same method, we estimate benefits between $117 and $242 billion.[21] 

 

The FDA is also widely disseminating the data from the study and indicating that the data comes from a CDC study.

 

The Impact of Improperly Attributing the Data and Study to the CDC and not Deeming the Study to be a Highly Influential Scientific Assessment (Including the Impact on the Requester)

 

The FDA is incorrectly claiming the data is from a CDC study thereby improperly giving the data much greater legitimacy due to the imprimatur of the government.  This characterization of the data as coming from the CDC impacts public perception and even the perception of the FDA.  If it was properly clarified that the study was not a CDC study, it is highly unlikely that the FDA would be using it as a major justification for its Tentative Determination that, by the agency’s own estimates, will result in billions of dollars in costs and benefits, which will impact me along with all Americans.

 

An ingredient in food that is available to me and to the public would effectively be banned if the FDA decides to revoke GRAS status for PHOs.  Some companies may not be able to transition away from PHOs, or if they do, it will come at great cost and altered product quality.  This great cost to companies would also be incurred by employees (through lost jobs) and consumers (through higher prices).   

 

If the study is deemed to be a CDC study and not considered a highly influential scientific assessment, the findings from the study will be in question.  The FDA’s Tentative Determination is based in large part on a study that has not undergone the proper peer review required by OMB Guidelines.  The FDA could move forward with a final action soon, but without proper peer review of this study that it is heavily relying upon, its actions arguably would be arbitrary and capricious.  According to OMB, “Peer review is one of the important procedures used to ensure that the quality of published information meets the standards of the scientific and technical community.”[22]  This critical procedure would be ignored.

 

Recommended Corrections

The CDC should edit or remove the “Winnable Battles” report and clarify that the study is not a CDC study.  This information should also be communicated to the FDA in a prompt manner before any action is taken on its Tentative Determination.

 

If the CDC determines that the study is a CDC study, then it needs to be classified as a highly influential scientific assessment and undergo the proper peer review process.

I appreciate your consideration of this request.  The impact of the data and study is significant. If the FDA relies on the study because it improperly believes it is a CDC study, major public policy will be developed based on a critical misunderstanding.  If it is deemed to be a CDC study, the FDA would be relying on a study that has not gone through proper peer review.  In either case, the public will be severely harmed.

 

Sincerely,

 

 

Daren Bakst

Research Fellow in Agricultural Policy

Thomas A. Roe Institute for Economic Policy Studies

The Heritage Foundation
Phone: (202) 608-6163
Email: daren.bakst@heritage.org

 

 


[1] This request is made on my own behalf.  All views expressed are solely my own.

[2] Section 515(a) of the Treasury and General Government Appropriations Act for Fiscal Year 2001, P.L.

106-554.

[3] Office of Management and Budget, Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information Disseminated by Federal Agencies,” 67 Fed. Reg. 8452 (Feb. 22, 2002). (“OMB Guidelines”) at http://www.whitehouse.gov/system/files/omb/assets/omb/fedreg/reproducible2.pdf (accessed September 5, 2014).

[4] U.S. Department of Health and Human Services, “HHS Guidelines for Ensuring and Maximizing the Quality, Objectivity, Utility, and Integrity of Information,” http://aspe.hhs.gov/infoquality/Guidelines/index.shtml

(accessed September 5, 2014).

[5] U.S. Department of Health and Human Services, “Guidelines for Ensuring the Quality of Information Disseminated to the Public, Centers for Disease Control and Prevention and Agency for Toxic Substances and Disease Registry,” December 13, 2006,  http://aspe.hhs.gov/infoquality/Guidelines/cdcinfo2.shtml  (accessed September 5, 2014).

[6] See the statutory language and the various Guidelines.

[7] U.S. Department of Health and Human Services, HHS Guidelines.”

[8] Centers for Disease Control and Prevention, “Winnable Battles Progress Report, 2010-2015,” Office of the Director, November 21, 2013, http://www.cdc.gov/winnablebattles/targets/pdf/winnablebattlesprogressreport.pdf (accessed September 5, 2014).

[9] CDC, “Winnable Battles Progress Report.”

[10] I tried to get clarification from the agency’s General Counsel’s office on whether CDC deems the study to be a CDC study.  I had been in communication with Karen Hunter, a CDC senior press officer, who explained that the study was deemed to be a CDC study.  However, through my exchange with Ms. Hunter, I was never able to get this clarification from the General Counsel’s office.    

[11] William H. Dietz and Kelley S. Scanlon, “Eliminating the Use of Partially Hydrogenated Oil in Food Production and Preparation,” Journal of the American Medical Association. Vol. 308, No. 2 (July 2012), pp. 143-144, http://jama.jamanetwork.com/article.aspx?articleid=1216486 (accessed September 5, 2014).

[12] Centers for Disease Control and Prevention, “Nutrition for Everyone,” January 8, 2014, http://www.cdc.gov/nutrition/everyone/basics/fat/transfat.html (accessed September 5, 2014).

[13] Centers for Disease Control and Prevention, “Trans Fat: The Facts,” Division of Nutrition, Physical Activity, and Obesity, http://www.cdc.gov/nutrition/downloads/trans_fat_final.pdf (accessed September 5, 2014).

[14] The email does state “CDC studies,” but as discussed, the disclaimers are efforts to expressly clarify that the studies are not CDC studies.

[15] Email from Karen Hunter of the CDC to Daren Bakst, June 23, 2014.  The email is available upon request.

[16] CDC, “Guidelines for Ensuring the Quality of Information.”

[17] Centers for Disease Control and Prevention, “CDC/ATSDR Peer Review Agenda,” August 21, 2014,   http://www.cdc.gov/od/science/quality/support/peer-review.htm (accessed September 5, 2014).

[18] Joshua B. Bolton, Director, Office of Management and Budget, memorandum to Heads of Departments and Agencies, December 16, 2004, http://www.whitehouse.gov/system/files/omb/memoranda/fy2005/m05-03.pdf (accessed September 5, 2014).

[19] Ibid.

[20] Tentative Determination Regarding Partially Hydrogenated Oils; Request for Comments and for Scientific Data and Information, 78 Fed. Reg. 67169 (November 8, 2013) at https://www.federalregister.gov/articles/2013/11/08/2013-26854/tentative-determination-regarding-partially-hydrogenated-oils-request-for-comments-and-for (accessed September 5, 2014).

[21] Ibid.

[22] Joshua Bolton, memorandum to Heads of Departments and Agencies, p.3.