Governments



U.S. GOVERNMENT AGENCIES AND RELATED ORGANIZATIONS DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH CENTERS FOR DISEASE CONTROL FOOD AND DRUG ADMINISTRATION CENTER FOR FOOD SAFETY AND APPLIED NUTRITION CENTER FOR VETERINARY MEDICINE UNITED STATES DEPARTMENT OF AGRICULTURE AGRICULTURAL RESEARCH SERVICE FOOD SAFETY AND INSPECTION SERVICE UNITED STATES ANIMAL HEALTH ASSOCIATION NATIONAL JOHNE'S WORKING GROUP ENVIRONMENTAL PROTECTION AGENCY


FDA: Center for Food Safety and
Applied Nutrition (CFSAN)

Overview


Governed by Food and Drug Administration (FDA)
Mission Statement "CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled."  (From CFSAN website)
 
DirectorJoseph A. Levitt
 
Web Pagehttp://www.cfsan.fda.gov/
 
Overview

Center for Food Safety & Applied Nutrition (CFSAN) is one of six centers within the Food and Drug Administration (FDA). Its major responsibility is ensuring that food is safe, nutritious and wholesome.

CFSAN is headed by Joseph A. Levitt, Director. With respect to ensuring that milk/dairy products are safe for the American consumer, two subordinate agencies falling under the jurisdiction of CFSAN are:

  • Milk Safety Branch of the Office of Field Programs
  • Division of Programs and Enforcement Policy of the Office of Plant and Dairy Foods and Beverages
Paper TrailSee PARA's Paper TrailNew window link indicator for communications between PARA and various agencies of the U.S. Government.
 

Before proceeding further, we would encourage you to read the Important Developments Page prior to reading the rest of this webpage. This will give you some background which may be helpful in evaluating the action or inaction taken by CFSAN, and to assess PARA's Concerns in light of significant developments that have taken place around the world.



About CFSAN


The Center for Food Safety and Applied Nutrition (CFSAN) is  responsible for the safety of milk in the United States.  Additionally, CFSAN is responsible for the safety of all milk-derived dairy products. This includes infant-formula, cheese, cream, yogurt, ice-cream, chocolate, butter, etc. One-third of cheese for sale in the United States is made from unpasteurized milk. Given that between 20% and 40% of dairy herds in the United States contain BJD-infected cattle, it is certain that raw unpasteurized milk from cattle infected with MAP goes into the making of such unpasteurized cheeses.

With respect to MAP in milk, CFSAN has taken no action to protect the public from exposure to MAP in milk.  CFSAN has conducted no research, taken no action, and issued no policy statement in relation to the presence of MAP in dairy products other than milk, and whether or not these bacteria are viable.

Since 1997, PARA has urged FDA/CFSAN to exert the precautionary principle with regard to MAP in milk.  In the ensuing years, much has happened worldwide both politically and scientifically, yet CFSAN still refuses to take action. 


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PARA's Concerns


Since 1997, PARA has repeatedly petitioned the responsible US Federal Agencies (including FDA and CFSAN)  to - "TEST THE RETAIL SUPERMARKET FOOD FOR THE PRESENCE OF LIVE MAP."  Further, PARA has repeatedly urged the FDA and other responsible agencies to exert the Precautionary Principle to ensure the protection of the public health. To date, all of our petitions have fallen upon deaf ears at CFSAN and other agencies.

We would encourage you to visit PARA's Paper Trail to read all of the letters that have transpired between PARA and the U.S. Government (including FDA/CFSAN) for background information.   PARA's detailed position is clearly stated in its letter to CFSAN dated September 25, 2000. 

Since PARA's inception, in addition to the "Paper Trail,"  there have been other significant events that have taken place which call into question CFSAN's actions and positions.  Those events include

  • Contradictory Statements Made by CFSAN
  • Evidence of Potential Conflicts of Interest at CFSAN
  • Food Safety Policy at CFSAN Apparently Based on Politics, not Science
  • MAP in Milk Given Low Priority at CFSAN
     

PARA's Concern:  Contradictory Statements

Made by CFSAN

Initially CFSAN was very eager to deny responsibility for the safety of dairy products in relation to MAP

In June 1997, in a telephone conversation with Mr. Joseph Smucker (Team Leader, Milk Safety Team, CFSAN), PARA was referred to the USDA Animal and Plant Health Inspection Service (APHIS), and was assured that this issue was not the responsibility of CFSAN.

Yet, in February 1998, in a letter to USDA-APHISNew window link indicator, Mr. Smucker (Team Leader, Milk Safety Team, CFSAN) stated the following position:

"USAHA requested that FDA '...review scientific data on the thermal tolerance of M. paratuberculosis and report to the Johne's Committee of the USAHA an opinion whether current pasteurization standards are sufficient to insure complete killing of M. paratuberculosis in raw milk. '

"We are pleased to provide this response to that resolution. After a review of the available literature on this subject, it is the position of FDA that the latest research shows conclusively that commercial pasteurization does indeed eliminate this hazard."


PARA would like to address the following question to Mr. Smucker: 

Why was CFSAN responsible for the safety of dairy foods in February 1998, but in 1997 you denied that CFSAN had that responsibility?



PARA's Concern:  Evidence of Potential Conflicts

 of Interest at CFSAN

Another of PARA's concerns is that CFSAN's Milk Safety Policy appears to be influenced by the dairy industry. 

In July 1998,  Kurt Gutknecht, editor of the farm publication Wisconsin Agriculturist, while preparing an article on milk safety ("A Needling Question:  Does pasteurization really kill M. paratuberculosis") called Joseph M. Smucker of the CFSAN  to question him about the FDA position regarding safety of commercial pasteurization.

Mr. Smucker refused to talk to him. Despite being the Team Leader of the Milk Safety Team, Smucker asserted that he did "not have the expertise nor the clearance from the FDA to speak to you on this subject."  Gutknecht was surprised at Mr. Smucker's reluctance to talk to him.

Calls to the FDA Press Office were returned only after Gutknecht contacted John Adams,  chairman of the National Johne's Working Group and Milk Safety Officer for the National Milk Producers Federation, a registered political lobbying organization which represents the interests of the dairy industry in Washington, D.C.   It was after Mr. Adam's intervention that the FDA Press Office finally returned the calls. 

An FDA spokesperson later acknowledged to the reporter that it was "very unusual" for an official of the FDA not to respond directly to press inquiries. 

No FDA official concerned with milk safety ever responded to the reporter's inquiries. 

Previously, in the letter of February 1998, Mr. Smucker had no hesitation about openly stating, "It is the position of FDA that the latest research shows conclusively that commercial pasteurization does indeed eliminate this hazard."


Therefore, PARA would like to ask the following:

  • Did Mr. Smucker have the clearance from the FDA to make that position statement of the FDA in that February 1998 letter?
     
  • Did Mr. Smucker have the expertise to formulate policy on the presence of MAP in dairy foods?  If not, who did? 
     
  • What is the involvement of the dairy industry in the formulation of food safety policy in relation to dairy products?



PARA's Concern:  Food Safety Policy at CFSAN Apparently Based on Politics, Not Science

PARA is also concerned that whatever policies CFSAN is making in relation to MAP in dairy supplies are based on a single, limited, laboratory simulation of HTST milk pasteurization. Simulations are, by definition, approximations of reality, and even with the best intent to get as close to reality as possible, can only come close. Simulations are not capable of answering the real question

 

Are the MAP bacteria present in retail supplies of dairy products (milk, cheese, cream, yogurt, ice-cream, etc) alive, viable and capable of multiplying?

 

Instead of testing the retail dairy supply for the presence of viable MAP, CFSAN has chosen to base national dairy safety policy on a simulation study that has been extensively criticized by other researchers who work in this area. For a detailed list of these criticisms, see the dedicated USDA Agricultural Research Service page. To quote from a CFSAN policy statementNew window link indicator.

 

"The ARS researchers ..... set out to accurately duplicate the commercial pasteurization process in their research facilities. The equipment used in the ARS study was an actual lab-scale HTST unit which duplicated commercial pasteurization conditions in the lab as opposed to merely simulating the time and temperature of commercial heat treatment conditions. This latest research, in our view, demonstrates conclusively that commercial pasteurization does indeed eliminate this particular hazard."

 

As can be seen in PARA's webpage "MAP in Dairy Products,"  the USDA-ARS research has been extensively criticized by other scientists who conduct research in the area.  The USDA-ARS researchers failed badly to "accurately duplicate the commercial pasteurization process in their research facilities". Their treatment of the bacteria was nothing like the treatment the bacteria would receive in the real world. The ARS researchers deprived the bacteria of nutrition, froze them to a temperature (-80oC) sufficient to kill some of them and injure all of them, blasted them with sound waves twice, as well as pasteurizing them.

However, regardless of the validity or invalidity of the ARS research results, there are other important points that must be raised:

Whether or not live MAP are present in retail supplies of milk and derived dairy products is a question that many researchers have tried to answer. The overwhelming majority of laboratory simulation studies found that the bacterium was able to survive pasteurization.

Moreover, in May of 2002, researchers at Queens University, Belfast, published a very important study confirming that MAP survives pasteurization standards used in the UK, pasteurization standards which equal or exceed those used in the U.S.  That study is entitled "Incidence of Mycobacterium paratuberculosis in Bulk Raw and Commercially Pasteurized Cows' Milk from Approved Dairy Processing Establishments in the United Kingdom"  (Grant, I.R.; Ball, H J.; Rowe, M.T.  Applied and Environmental Biology, May 2002, p. 2428-2435, Vol. 68. No. 5).14  

Therefore, the debate should be over!  MAP does survive pasteurization. 

Instead of taking measures to ensure that the dairy products we give our children are free from MAP, CFSAN has chosen to fund more "simulation" studies.  
 



PARA's Concern: MAP in Milk Given

Low Priority at CFSAN

Another disturbing concern of PARA is the fact that CFSAN has openly admitted that this issue is a low priority for their agency.  

In a 12/13/99 letter to PARA, Terry C. Troxell, Ph.D. of CFSAN states: 

"Finally, from a resource point of view, there are a number of priority issues before the agency involving the reduction of known human pathogens in the food supply.  This does not diminish the importance of your request but only places it in the context of other food safety challenges before the agency."  [Underline added for emphasis]

In other words, this issue is given low priority at CFSAN!   This statement is an affront to every person affected by Crohn's disease.

Indeed, we find it unconscionable that CFSAN is putting higher priority on a mere handful of deaths a year from bacteria causing acute disease rather than the millions who endure a lifetime of repeated surgeries and vicious suffering due to the dread and chronic disease known as Crohn's disease.

Perhaps policy-makers at CFSAN should view Crohn's "in the context" of what suffering the patients go through? Perhaps policy-makers at CFSAN should view Crohn's "in the context" of the $3.2 billion spent in this nation annually on Crohn's treatments - treatments which only attempt to maintain patients' lives, but do little to reduce the misery, and do nothing to cure this disease.

Apparently policy-makers at CFSAN are crossing their fingers behind their backs hoping that this issue won't explode in their faces.  While they are crossing their fingers...

Retail testing of supermarket milk in the U.S. for the presence of MAP has been undertaken...not by CFSAN...but by thehighly regarded  Marshfield Clinic in Marshfield, Wisconsin.  



Marshfield Clinic Retail Milk Study


The Marshfield Clinic Retail Milk Study is testing retail supermarket milk, taken from the shelves of supermarkets, for the presence of MAP. This study is being conducted by Dr. Jay L. E. Ellingson, Director of Marshfield Laboratories Food Safety Services.  In its July/August 2002 newsletter published by the Marshfield Clinic, Dr. Ellingson states: 

 "Mycobacterium paratuberculosis is considered a suspect zoonotic agent because it causes Johne's disease in cattle, and some studies in the UK say it causes Crohn's disease in humans.  The question is whether people get Crohn's disease by ingesting food product derived from infected cattle." 

This is the first and only retail supermarket milk testing program for the presence of MAP ever undertaken in the United States.  Results of the study will be published in the summer of 2003.  

With over 20 years of agricultural safety and health research experience, Marshfield Clinic's National Farm Medicine Center specializes in research, education, outreach, consulting and testing programs that deal with critical health issues in agriculture, where food safety begins.  For more information about Marshfield Clinic, visit their website at:  www.marshfieldclinic.org.



CFSAN Continues to Evade the Issue


In August 2002 CFSAN was contacted by PARA numerous times for  clarification of their position about the safety of retail milk supplies in the United States, in light of the United Kingdom findings by the Queen's University researchers in 2002.  (See MAP in Dairy Products.)   Not surprisingly, no one at FDA's CFSAN would speak with us, and instead referred us to FDA's Risk Assessment Department, to their attorney.

After PARA's repeated attempts to reach Attorney John Sheehan at the Risk Assement Department of CFSAN's Office of Plant and Dairy Foods and Beverages (OFDFB), a telephonic interview was finally conducted by PARA's Steve Merkel on August 26, 2002.  CFSAN insisted on having multiple participants present at this interview:    Attorney John Sheehan (OFDFB's Risk Assessment Department),  Kimberly Rawlings (FDA Press Office), and Dr. Johnny Braddy (CFSAN).  

In this interview CFSAN's answers were vague and evasive.  A few excerpts are pasted below: 

Question What is the FDA's position on the Grant study?

Answer:  We don't offer critiques on individual researcher's work.

* * * * *

Question Previous studies have all been done using simulations of one sort of another using spiked milk rather than naturally occurring infected milk.  This is the first study that has used naturally occurring MAP.  Would that have any influence on your opinion on the studies in general?

Answer:  No.

* * * * *

The final question and answer in the interview summarizes FDA's position about protecting the public: 

Question What is FDA's position on using the precautionary principle - if it might be a pathogen, let's do something about it.

Answer:  That's not something we typically do.  FDA takes action on the basis of science and we don't take action on the basis of speculation.  We are a science-based agency and all of our actions must be grounded in science.


It should be noted that Mr. Sheehan is absolutely incorrect in his statement that "FDA takes action on the basis of science and we don't take action on the basis of speculation," when it comes to human pathogens.  One example is their treatment of the BSE (Mad Cow Disease) issue as it relates to blood donors.   There is still no conclusive proof that BSE causes the human disease known as Creutzfeld-Jakob Disease (CJD), yet FDA has banned any blood donations from people who have recently visited the UK.   FDA is exerting the Precautionary Principle on this issue, despite the fact that proof is not 100% conclusive.

CFSAN/FDA cannot have it both ways!   Either they base policy on science or they don't.   PARA contends that FDA is totally inconsistent in this area, and the BSE/CJD policy  is a prime example of this agency's being influenced by politics over science!

The bottom line remains the same:  FDA will not exert the precautionary principle



Summary


CFSAN's Mission Statement is:

"CFSAN, in conjunction with the Agency's field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled...and any unsafe or unlawful products are removed from the marketplace."

PARA contends that CFSAN has failed to live up to its own Mission Statement.


 

   
   

Action you can take


Please visit PARA's "How to Help" section to learn how you can get involved in creating awareness about this vital issue. 


Source: http://www.crohns.org/governments/cfsan.htm   
Contact PARA: http://www.crohns.org/contact.htm
Paratuberculosis Awareness & Research Association, 1999-2003.