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

Overview

"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)

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 Trail

See PARA's Paper Trail 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.

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.

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-APHIS,
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.

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

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
statement.

"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.

Low
Priority at CFSAN

"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 Studyis 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.