The following letter was submitted to the Subcommittee on Livestock and Horticulture on 5/14/01. It was later ascertained by PARA that the Proposed NMPF Plan for Johne's Management was not specifically on the agenda of the hearing held on Tuesday, May 22, 2001. However, PARA is pleased to report that the following letter and its attachments have been made a part of the formal congressional record of said hearing.

May 14, 2001

The Honorable Richard W. Pombo, Chairman
Subcommittee on Livestock and Horticulture
House Committee on Agriculture
1301 Longworth HOB
Washington, DC 20515

Re: Proposed National Voluntary Johne's Management, Testing, Research and Indemnity Program for Dairy Cattle

Dear Chairman Pombo:

We are writing this letter out of concern that Congress has not been sufficiently informed about many issues surrounding the above proposed plan by the NMPF. As reflected in the NMPF Plan, they are requesting funding for their Johne's eradication program. Johne's disease is a chronic wasting disease in cattle caused by MAP (Mycobacterium avium subspecies paratuberculosis.) Unfortunately, the NMPF plan has failed to inform Congress that MAP is also associated with Crohn's disease, a serious inflammatory bowel disease. There are circumstances surrounding this urgent and grave issue which must be brought to your Committee's attention prior to the hearing that is to take place on Tuesday, May 22, 2001. We will attempt to explain the overall situation in this letter and its attachments. However, given the complexity of the issues involved and the serious implications for human health, I would respectfully request the opportunity to address the Committee at Tuesday's hearing. I have a vested interest in the outcome of this hearing...my son has suffered from Crohn's disease for nine long years.

What is Crohn's disease? Crohn's is a devastating and often debilitating inflammatory bowel disease. Lifelong, chronic and progressive in nature, Crohn's most commonly strikes the young, usually between the ages of 15 and 25, and is not infrequently seen in younger children also. (See Attachment 1 entitled "What is Crohn's Disease?") Crohn's affects AT LEAST 500,000 Americans, and many experts believe that number to be in the millions. Since PARA's formation in mid 1997, at least 100,000 new cases of Crohn's disease have been diagnosed. Most of those victims are young people between the ages of 15 and 25...many are small children.

Just as Johne's is known as "the hidden disease," the same can be said of Crohn's due to the fact that people are reluctant to discuss it's socially embarrassing symptoms, and for that reason, many postpone treatment until such time that the disease has progressed to a critical stage. Sadly, most of its victims suffer in silence as the disease leaves in its wake a path of destruction in terms of physical and emotional damage.

Who is PARA and why we are concerned. Incorporated in mid-1997, the Paratuberculosis Awareness and Research Association, or PARA, is a nonprofit organization comprised of lay persons with Crohn's disease, their families and friends. PARA was formed because we became aware of scientific evidence suggesting that MAP may be causing Crohn's disease. At its inception, PARA began contacting a handful of highly regarded researchers and physicians who, despite little or no available funding, were valiantly, sometimes at their own expense, continuing to pursue the truth about MAP and Crohn's disease. (Today many of these researchers sit on PARA's Medical and Scientific Advisory Boards.) Most impressively, these researchers were amassing a rapidly growing body of evidence evidence suggesting a causal link between MAP and Crohn's disease. In the past four years the entire story has become increasingly clear and the evidence has become increasingly more compelling. (See Attachment 2 entitled "Scientific Facts About MAP and Crohn's Disease").

Is MAP in our food supply? It is an undisputed scientific fact that live MAP is excreted in the milk of infected cattle. Terrifyingly enough, nine out of ten scientific studies published in peer-reviewed journals have determined that MAP may be capable of surviving U.S. pasteurization standards. And, scientists have levied significant criticism at the one study that disagrees with the other nine studies, citing a misinterpretation of data by the scientists that conducted the study. It should be noted and emphasized that the FDA is relying upon that single, highly controversial study, to conclude, quote, "it is the position of FDA that the latest research shows conclusively that commercial pasteurization does indeed eliminate this hazard," referring to MAP. Despite PARA's urgings, the FDA refuses to change their position. In effect, they have ignored the overwhelming body of scientific evidence. Congress should ask why!

U.S. Agencies have passed the buck. For four long years PARA has been attempting to get various agencies of the U.S. Government to act on behalf of the American public with respect to our concerns about the MAP/Crohn's disease issue. "PARA's Paper Trail" (found at http://members.aol.com/ParaTBweb ) is a compilation of more than 50 letters/replies that PARA has sent to/received from various agencies of the U.S. Government (USDA, FDA, USAHA, CDC, NIH and others). What has transpired over the course of the past four years is a "passing of the buck" from one agency to the other. At best, the issue has been given mere lip service by the agencies responsible for human health.

As evidenced by "PARA's Paper Trail" of letters, we have been extremely careful to preserve these documents for posterity sake so that the formal record clearly demonstrates that every responsible agency of the U.S. Government has historically been sufficiently apprised of this situation. Undoubtedly, there will be accountability issues raised in the future as to why the individuals within those agencies have been remiss in their responsibility to the American public. In the opinion of PARA, the failure of these federal agencies to take swift action to ensure the protection of U.S. citizens is nothing short of a national disgrace!

The U.S. dairy industry now appears to see the "handwriting on the wall". Relying on the counsel of well experienced and renowned veterinarians and scientists, the U.S. dairy industry has, for some time, been well aware of the mounting scientific evidence that implicates MAP as the cause of human Crohn's disease as well as the fact that, in the majority of scientific studies, scientists have concluded that MAP is capable of surviving U.S. pasteurization standards. In light of this knowledge, one is not surprised that the National Milk Producers Federation (NMPF) has suddenly done an "about face" and has rushed to develop a plan to test herds and to kill every cow in this nation infected with MAP. Moreover, it comes as no surprise either that, after many, many years of letting the MAP infection run rampant in U.S. herds, the NMPF has suddenly prepared and submitted its plans to request "indemnity from the U.S. Government in the amount of $1.3 billion" so that these MAP infected cattle are killed and sent to rendering (not for human consumption). Interestingly, this proposed "indemnity plan" looks much the same as those historical indemnity plans developed and implemented to kill all U.S. cattle infected with Tuberculosis and Brucellosis both known human as well as animal pathogens. Certainly, these sudden actions on the part of the U.S. dairy industry (i.e. developing a "MAP Indemnity Plan," etc.) should be soberly and duly noted, as they would appear to only further support the potentially grave and critically urgent situation that this nation may likely soon find itself in with regard to possible contamination of our retail food with MAP.

Questions that need to be asked. PARA has prepared a sampling of important questions that should be asked of the NMPF concerning this matter (see Attachment 3). Several of those questions include - Why now? Why not ten years ago when Johne's was a relatively small animal disease? Very likely the reason it's finally being addressed is because of the Crohn's disease/MAP association. Yet, conspicuously absent in that request for funding is any mention of the human health implications. Why has this information been deliberately withheld from Congress?

It is not surprising that they are attempting to downplay it for the public. They are very concerned about the mounting evidence implicating MAP may cause at least some, if not most, cases of Crohn's disease, and there is a public relations nightmare looming overhead for them. They've been forced, much in part due to PARA's persistence, to finally come to terms with the reality that they must finally deal with this problem.

How could a problem of this magnitude have been ignored for so long? At first it was likely due to complacency on the part of industry, who had gambled that the problem would go away. The "don't ask/don't tell" policies of reporting Johne's disease have created a situation where the dairy industry is now faced with an epidemic of catastrophic proportions.

Consider, if it is proven that MAP is causing Crohn's disease, how badly would the dairy industry be damaged if mothers were to find out that the milk they give their babies contains bacteria that have been implicated in a devastating disease? Similarly, if it is proven that MAP is causing Crohn's disease, how badly would the beef industry be hurt if it were proven that Happy Meal hamburgers contain a human pathogen?

Finally consider, if it is proven that MAP is causing Crohn's disease, how angry consumers would likely become if they come to believe that the beef and dairy industries had good scientific reason to be concerned about the potential safety of their products, and yet they had failed to take any precautionary measures, and further, that they had failed to support research to determine whether viable MAP enter the human food chain through dairy and beef products.

We would like to point out that during the congressional hearings last year concerning the Firestone tire issue, the pivotal question was not: "Why are the tires bad?" Rather, the question was: "WHEN did you know there was a risk to consumers?"

Just as the U.S. agencies cannot claim ignorance on these matters, the dairy and beef industries can never claim that they were not sufficiently warned about the potential impending crisis. The consequences for these industries could be catastrophic if it is proven that the industries had good reason to suspect a potential problem with their products, and yet, although it was within their power to exercise the precautionary principle to protect the children of this nation, the industries, nevertheless, chose not to do so. Yet, that is the stance they have clearly taken. Congress should ask why.

Other nations are acting. Smaller and less able nations have acted and/or are in the process of determining action to ensure the protection of the public health relative to live MAP in food supplies. The lessons learned by the UK Government's BSE crisis have not been forgotten. They realize that mounting PR campaigns to assure the public that there is no food safety problem is simply not enough. Sadly, to date, federal agencies in the U.S. responsible for food safety have not taken the "conservative approach" and have not acted to exercise the precautionary principle in the U.S. to ensure the protection of the public health relative to the potential threat posed by MAP.

Politics vs. Human Health. There are many facets of the MAP/Crohn's disease issue human health, animal health and, of course, economics and politics. Unfortunately, politics and economics have perpetuated this crisis.. The smoke screen that industry and regulatory agencies have put forth is, "There is no proof that MAP causes Crohn's disease." PARA's response to that is: Other diseases have not had to be "conclusively proven" before action has been taken. In fact, many diseases are not and never will be "conclusively proven." There is now and has been for many years sufficient scientific evidence to prompt swift action by our regulatory agencies and industry leaders.

Additionally, there are clearly policy inconsistencies that exist when it comes to formulating policy on this issue. As example, there is the issue of BSE and CJD. Nations have formed policy to protect the public health on the assumption that "BSE is the probable cause of CJD." This is not proven; yet, extreme measures have been undertaken to ensure public health. Conversely, there is more than sufficient information to warrant the precautionary principle in protecting the public from exposure to MAP. Yet, still nothing is being done. Congress should ask why.

Conclusion. Before PARA's grassroots involvement four years ago, there was no public awareness about this issue. Because of the internet, PARA has been able to communicate our concerns globally. That increased awareness is having an impact...at least the elephant is now out of the closet. Slowly but surely media attention is bringing light to this subject which had heretofore been unreported. This increased awareness will be meaningful only if it results in significant being taken...immediately.

There is a political game being played out at this very moment...tragically, the bargaining chips in this game are the lives of Crohn's disease patients. Who is protecting the interests of Crohn's disease patients? Sadly, it appears there are only a very few of us. Meanwhile, millions of people in this nation suffer horrendously - those who have been diagnosed, those who are yet to be diagnosed, and those who love them. Many of the undiagnosed are children who are literally ticking time bombs. Tragically, one day their mothers will be present when the doctor gives the diagnosis, "Your child has Crohn's disease." They probably won't know what that really means, not at first. But as the days go by, the months, and then the years, they will too live the nightmare we have lived. As with any chronic, lifelong illness, the toll it takes is immeasurable and can only be understood by those who live it every single day of our lives.

Mr. Chairman, we would like the opportunity to address the Agriculture Committee because we feel that Crohn's disease patients should have a voice in these proceedings. Undoubtedly much time will be devoted to the economics surrounding an indemnification program, the logistics of implementing it, as well as various and sundry extraneous issues relating to such a program. However, all of those "program issues" pale in comparison to the health of the children of this nation.

It is time for the priorities on this issue to be reversed - human health should take precedence over politics and economics. We of PARA are convinced that this can only happen if Congress intervenes immediately on behalf of the American public. Please help us!

Thank you for your consideration of this matter.

Sincerely,

Karen Meyer

Co-Executive Director

/km

Enclosures:

Attachment 1 - "What is Crohn's Disease?

Attachment 2 - "Scientific Facts About MAP and Crohn's Disease

Attachment 3 - "Questions to Ask National Milk Producers Federation (NMPF)"

(For additional information on this issue, please visit PARA's website at - http://www.crohns.org )