September 25, 2000
Terry C. Troxell, Ph.D., Director
Office of Plant, Dairy Foods and Beverages - CFSAN
200 C Street, SW, HFS - 300
Washington, D.C. 20204
Dear Dr. Troxell:
On December 13, 1999, you responded to PARA's letter of September 28, 1999, which was addressed to Dr. Joseph A. Levitt, Director, Center for Food Safety and Applied Nutrition (CFSAN) and copied to: Donna E. Shalala - DHHS, Jane E. Henney - FDA, Joseph Smucker - CFSAN, Morris Potter - FSI/CFSAN, Stephen Sundlof - CVM, and R.L. Rissler - APHIS.
We are responding to your December 13, 1999, letter at this time because important new evidence has been documented, evidence which validates PARA's long-standing position to "TEST THE RETAIL SUPERMARKET FOOD FOR LIVE MAP" (Mycobacterium avium, subspecies paratuberculosis).
More specifically, as you are aware, in August 1998, the United Kingdom's (UK's) Ministry of Agriculture and Fisheries (MAFF) undertook a nationwide study to investigate the microbiological quality of raw and pasteurized cows' milk in the UK. Complete study results from the UK effort have not been fully compiled as of this date, however, due to the critical and urgent nature of the results, the UK did believe it necessary to publish formal "interim results" of this study - interim results which have become a matter of public record, and which provide sufficient and very grave basis for concern about the ability of MAP to survive pasteurization.
Attachment A to this correspondence is a copy of the published Interim Report issued by the MAFF Advisory Committee on the Microbiological Safety of Food, entitled "National Study on the Microbiological Quality and Heat Processing of Cows' Milk." Quoting from Paragraph 6 of the UK document: "Viable M. paratuberculosis has been found in about 5% of the raw milk samples and about 3% of the pasteurized milk samples for which confirmed results are available. These results are confirmed for 192 of 1000 samples." We look forward with great anticipation to publication of the final results of the MAFF study, which we are told may happen as early as the autumn of 2000.
Based on the published MAFF Interim Report, it would certainly appear that it no longer can be disputed that significant percentages of MAP may indeed survive pasteurization and that viable MAP is in the retail supermarket milk of the UK. In fact, Great Britain's Sunday Times recently reported that, "As much as TEN PERCENT of milk sold in Britain may be contaminated with a form of tuberculosis bacterium [MAP], which can survive the pasteurisation process."
In this connection, the potential implications of the UK findings for the US producers/public are alarming indeed, especially when considered in conjunction with the following facts:
For the past three and a half years, PARA as a whole and PARA Board of Directors members Karen Meyer and Cheryl Miller, have repeatedly petitioned the responsible US Federal Agencies to - "TEST THE RETAIL SUPERMARKET FOOD FOR THE PRESENCE OF LIVE MAP." Further, PARA/Members of PARA's Board of Directors have 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 to cognizant federal agencies have fallen upon deaf ears. While the responsible agencies in the US have chosen to do nothing, smaller and less financially able nations have valiantly stepped to the plate, forging ahead to make progress in eradicating MAP infection from cattle and beef herds and determining whether viable MAP is contaminating their food supplies!
Consider, as example, the UK - a relatively small nation with only about one-fifth the population of the US and less than fifteen percent (15%) of the Gross Domestic Product of the US. Nevertheless, subsequent to respected UK researcher, Professor John Hermon-Taylor's, published findings in 1996 (Reference: J. Hermon-Taylor et al, Sept 1996 Applied and Environmental Microbiology, p 3446-3452, IS900 PCR To Detect Mycobacterium paratuberculosis in Retail Supplies of Whole Pasteurized Cow's Milk in England and Wales) indicating that he had cultured live MAP from UK milk, the leaders of this small nation had adequate concern and care about the safety of its retail food products for consumers, that it had as of two long years ago, managed to scrape together adequate funding and put together a top-notch, highly qualified scientific research team to have taken at least this first critical step to "Test the Retail Milk in the UK for contamination with live MAP." Certainly, such action on the part of the UK is admirable.
Conversely, now let us consider the US - a behemoth among nations and with more than ample resources [current Gross Domestic Product approaching $8,512 trillion]. Yet, the leaders/cognizant federal agencies have, for years on end done nothing - although they were repeatedly made aware of PARA's/respected scientists concerns. In fact, when highly regarded US scientist, Dr. Michael T. Collins, et al, of the University of Wisconsin published (M.T. Collins, et al, March 1998, Applied and Environmental Microbiology:64(3):999-1005, Thermal Tolerance of Mycobacterium paratuberculosis) findings that MAP was able to survive current US pasteurization standards, it was ignored. All in all, six studies came in from the US and around the world indicating that MAP may survive current US pasteurization standards/practices and all of them the FDA tossed to the side, ignored!
Why did this happen? This happened because the FDA, instead of listening to independent, highly regarded and experienced scientists with proven track records in working with this most difficult mycobacterium - scientists who repeatedly proved the same facts in multiple studies which demonstrated the potential of MAP to survive US pasteurization methods, chose instead, to rely upon one small USDA study - a study lead by a researcher selected by USDA/ARS - a researcher who, as far as PARA has been able to determine (and we invite your correction if we are wrong) - is not a Veterinarian, nor a specialist in food safety research - a researcher who is not, in fact, even a microbiologist! Rather, it is our understanding (and again, we invite your correction if we are wrong) this USDA/ARS researcher's educational background/experience is in the field of Immunology - at best, dubious qualification for working with this most difficult to culture mycobacterium! Nevertheless, this is the researcher whose singular findings that MAP did not survive HTST pasteurization is what the FDA chose to rely upon to ensure the protection of the US public health!
Moreover, it was grossly ignored that even this USDA/ARS study did find that MAP survived batch (standard holder method) pasteurization - the most common pasteurization technique used by local dairies in cities throughout this nation! Apparently, the FDA considers it acceptable for live MAP to contaminate milk supplies throughout this nation, as long as it is the milk supplies are from local dairies!
The fact that the US has not taken significant and adequate steps to properly fund qualified researchers with proven track records in culturing/working with this most difficult mycobacterium to study and determine the presence of live MAP in US retail food supplies, is nothing short of shameful - indeed, it is a national disgrace! Furthermore, it casts serious doubt upon whether US Federal Agencies cognizant of Food Safety issues have adequately fulfilled their very serious responsibilities to the citizens of this great nation!
PARA urgently petitions all cognizant US Federal Agencies - End this disgrace now! Do what is right and long overdue the American public! Act immediately upon this new and highly significant evidence from the UK - immediately fund significant research/qualified researchers to address these justifiable and grave concerns about the potential presence of live MAP in US retail food supplies!
Our above comments relate primarily to new and critical evidence from the UK. We have provided additional comments in Appendix 1 to this letter. These additional comments specifically address the points covered in your letter of December 13, 1999, since there are some points that require clarification and/or rebuttal and/or adequate response.
We request your response to our concerns and questions within thirty (30) days of the date of this letter. The US can no longer pretend that this problem does not exist. Other countries are acting swiftly on this matter. The day is quickly approaching when responsible US agencies/leaders will answer to the American public, individually and collectively, for their action...or lack of action on these critical concerns. We urge you to consider - on what leg will you stand when that day comes?
For questions or comments relative to this correspondence, please contact Cheryl Miller, Co-Executive Director, PARA, Inc., directly at E-mail address: cmiller@crohns.org, or written comments may be sent directly to PARA Headquarters in Temple Terrace, Florida.
Very Truly Yours,
Cheryl Miller
Co-Executive Director for PARA's Board of Directors
/cm
Enclosures:
Appendix 1 -- Additional Comments/Detailed Response to CFSAN
December 13, 1999 Letter
Attachment A - MAFF Interim Report
Copies Furnished By Certified Mail to:
Joseph A. Levitt - Director, CFSAN
Donna E. Shalala - Secretary, DHHS
Morris E. Potter - Director, FSI (Food Safety Initiative)
Jane E. Henney, M.D. - Commissioner, FDA
Joseph Smucker - Chief of Milk Safety Branch, CFSAN
Stephen Sundlof - Director, CVM (Center for Veterinary Medicine)
R.L. Rissler - APHIS (Animal Plant Health Inspection Service)
Appendix 1
Additional Comments/Detailed Response to CFSAN December 13, 1999 Letter
Our comments below specifically address the points covered in your letter of December 13, 1999, since there are some points that require clarification and/or rebuttal and/or adequate response. For the ease of the reader, we have provided comments in specific format with "Troxell/CFSAN Statement" verbatim from the December 13, 1999, letter and "PARA Response" immediately following:
Troxell/CFSAN Statement: "You are correct that FDA has the responsibility for assuring the safety of foods within the scope of its regulatory responsibility. These are responsibilities that the agency takes very seriously."
PARA's Response: The above CFSAN statement is conveniently general and "verbally comforting." But, comforting general statements such as these do nothing to answer specific PARA concerns, nor to potentially end the suffering of millions whose lives are daily devastated by the dread disease known as Crohn's disease.
PARA would ask what specific steps (including internal and external funding of scientific studies/qualified researchers with proven track records) has the FDA taken to ensure the protection of US citizens from the known pathogen, MAP - a mycobacterium proven to cause an intestinal wasting disease (a disease that is pathologically and clinically similar to human Crohn's disease) in a wide variety of species, including primates, and which the FDA is well aware is shed directly into the milk of cattle infected with the MAP pathogen, and which the majority of scientific studies to date have concluded is capable of surviving pasteurization, including HTST pasteurization and/or batch (standard holder method) pasteurization?
Troxell/CFSAN Statement: "If there is a causal association between M. paratuberculosis and disease in humans, we agree that there is cause for concern due to the widespread nature of the organism in the environment...However, FDA concurs with the conclusions of the National Institutes of Health (NIH) workshop in that further research needs to be conducted in order to determine if there is a causal relationship between M. paratuberculosis and disease in humans."
PARA's Response: It is PARA's opinion that there already exists adequate evidence, published in peer-reviewed scientific journals - evidence which severally and/or collectively suggests a causal relationship between MAP and human Crohn's disease - to warrant swift and urgent action being taken by CFSAN and other agencies of the US Government which are charged with ensuring the protection of the public health. Much of this evidence (in excess of fifty [50] scientific studies) is directly linked from PARA's website.
We petition you - it is time (and past time, in fact) to exercise the Precautionary Principle in the form of warning the US public about the multitude of scientific studies performed by respected scientists, and published in peer-reviewed scientific journals, which suggest MAP as a cause of Crohn's disease. Further, it is time (and again past time) to tell the US public that MAP - this known pathogen of primates - is shed directly into the milk of infected cattle and that the majority of scientific studies of pasteurization have found that MAP may survive pasteurization.
You must do this! Babies are born every day in this nation. Parents, believing the very expensive "Got Milk?" and "Milk Mustache" commercials generated by the dairy industry, are feeling good about feeding their young offspring lots of "nutritious" milk - yet, you know about the scientific studies that link MAP to human Crohn's disease. And, you know that MAP is shed into the milk of infected daily cattle, and you know that 40% of our large herds are infected with MAP, and you know that the majority of the scientific studies performed found that MAP survives one or more types of pasteurization. With such knowledge comes responsibility. You have, and in PARA's opinion, have had for some time, the responsibility to make these facts known to the American people and to take precautionary measures to ensure the protection of the public health!
Furthermore, you state that FDA "...concurs with the conclusions of the National Institutes of Health (NIH) workshop in that further research needs to be conducted in order to determine if there is a causal relationship between M. paratuberculosis and disease in humans." Thank you for concurring, but PARA would like to know what your Agency is DOING to answer this critical and urgent question - the answer to which may mean the end of horrendous suffering for millions? More specifically, what specific and significant support and funding has your Agency provided to pursue urgent research to conclusively prove a relationship between MAP and Crohn's?
Troxell/CFSAN Statement: "The primary question before the agency is the determination of the relationship between M. paratuberculosis and Crohn's disease. The Department of Health and Human Services (HHS) has a working group of medical experts who are finalizing a position on the issue. The position should become available in the next several months and likely will not differ significantly from the conclusion of the NIH workshop, which is that further research is needed to answer the question before us."
PARA's Response: We wonder why it is necessary to waste more precious time as Crohn's patients continue suffering, and why it is necessary to waste more taxpayer money for the HHS to form a "working group" to develop a position statement that you know "...likely will not differ significantly from the conclusion of the NIH workshop" or that of the EU Commission (report released March 2000).
Why not just adopt the NIH statement? NIH is the premier medical research institution in the world - and they did very clearly instruct you in their conclusions as follows: "Further study of MAP as a food and/or waterborne pathogen should be conducted. Viable MAP should be sought in commercial milk and other dairy products as well as in meat. Conclusive studies of the effectiveness of pasteurization using commercial equipment and process rather than laboratory simulations should be performed. In order to conduct the above, standard methods for the concentration, detection, and in vitro culture of MAP should be developed and used by participating researchers. Federal agencies with regulatory authority over the food supply should consider conducting such research in cooperation with relevant food production industries and academic researchers."
Nevertheless, since it has likely already occurred, we are extremely interested in learning about the conclusions that the HHS working group has made. Your letter states that the position should become available in the next several months. Since your letter was written over nine months ago, certainly FDA must have a position by now. Please provide this statement to the PARA as soon as possible.
Troxell/CFSAN Statement: "FDA fully supports the efforts of NIH in developing the data necessary to answer this fundamental question."
PARA's Response: We would be interested in knowing whether this is verbal or financial support. Are you currently involved in jointly and/or severally funding such studies?
Verbal support does not help to "develop the data necessary to answer this fundamental question." Specifically, what steps has FDA taken to answer this fundamental question? Please furnish PARA with the particular details surrounding this "support," including, but not limited to, timetables, financial investment, etc. Failure of FDA to take such action can only be construed as lack of concern and evidence that your "support" equates to little more than "lip service."
Troxell/CFSAN Statement: "...FDA/CFSAN has met with the U.S. Department of Agriculture/Agriculture Research Service (USDA/ARS) to discuss the impact of M. paratuberculosis as an animal health issue that has particular relevance to the occurrence of the organism in the food and water supply. FDA and USDA/ARS are developing a research program to identify factors that influence the incidence of M. paratuberculosis in raw milk at the farm level. The data that will be generated will be used in the development of any necessary risk-based policies and guidance to the industry, as well as to provide tools to ensure that on-farm and milk processing practices are conducted in a manner that minimizes risk."
PARA's Response: This sounds great! However, history has clearly proven that ARS is not equal to the task of the scientific study of M. paratuberculosis [see next PARA response for details]. Therefore, PARA would strongly encourage the Agencies - do not employ potentially unqualified and inexperienced USDA/ARS researchers - instead, contract out any such studies to properly qualified and independent academic researchers with proven track records in working with this very difficult to culture/detect bacterium, MAP.
You are well aware of the difficulty of working with this particular mycobacterium and, therefore, the need for the most highly qualified researchers - researchers with proven track records to ensure the adequacy of the design of the scientific studies and resultant findings. We would further remind you that you are responsible for this knowledge and sooner or later, you will be held accountable for your decisions in this regard.
Troxell/CFSAN Statement: "The agency acknowledges that prior research on the effectiveness of pasteurization has produced conflicting results. We have previously noted that there were problems with some of the prior studies that suggest that pasteurization is insufficient to completely eliminate M. paratuberculosis in milk. We also recognize that there are some criticisms being make of the work of Stabel et al that suggest that pasteurization is sufficient to eliminate M. paratuberculosis in milk. We note that there has been no such criticism of the work done by Keswani and Frank at the University of Georgia which confirms the work of Stabel, et al. We are enclosing with this letter, a copy of the University of Georgia study that corroborates the work done by USDA/ARS."
PARA's Response: Again, PARA encourages you - do not use USDA/ARS researchers. Instead, contract out any such studies to properly qualified and independent academic researchers with proven track records in working with this very difficult to culture/detect bacterium, MAP.
You are correct in that significant criticism has been leveled - and very justifiably so and from the most highly regarded researchers - at the work of ARS researcher Stabel, et al. Indeed, it appears the ARS chose and placed a possibly unqualified researcher over this very critical project and working with this most difficult of mycobacterium.
In summary, it appears that, instead of a highly experienced and well qualified researcher with a proven track record, ARS placed in charge of this critical project a researcher who lacked the necessary education, training and background to be adequate to the task of working with this most difficult organism! Therefore, the judgment of USDA/ARS cannot be relied upon to select adequate researchers. Any research conducted and paid for MUST be performed outside of the USDA/ARS or other groups influenced by animal agriculture. Indeed, it is a well known fact that the dairy industry provided funding for the USDA/ARS study - interestingly, this study "found" that MAP did not survive HTST pasteurization. High quality, credible research must be free of any potential conflict of interest.
Of equal interest, however, is the fact that it is routinely ignored that even the USDA/ARS study found that MAP did survive batch (standard holder method) pasteurization. It appears that the USDA/ARS finds this acceptable. Apparently, they also find acceptable, if it is conclusively proven that MAP is causing Crohn's disease, that innocent people are contracting the dread disease known as Crohn's disease from batch (standard holder method) pasteurized milk?
Competitively awarded independent, academic research (designed and conducted by fully qualified researchers with proven track records in culturing/detecting MAP) which has been contracted outside the influence of "special interest groups" that is peer-reviewed and published in scientific journals is the only way that results can be relied upon. The millions suffering from life-destroying Crohn's disease certainly deserve no less!
Finally, we take vigorous exception to your conclusion that the work of "...Keswani and Frank at the University of Georgia confirms the work of Stabel, et al....corroborates the work done by USDA/ARS." In fact, PARA's elite panel of scientific experts disagree with the conclusion that the Georgia study supports the Stabel/USDA/ARS data. PARA requests audience for our Council of expert advisors to provide "second opinion" on this erroneous conclusion! Indeed, a review of the "thermal tolerance" of MAP (measured in D-values) tells a story quite opposite the "FDA conclusion" you state above!
Troxell/CFSAN Statement: "Finally, FDA is supporting research to answer any remaining questions surrounding the adequacy of commercial pasteurization to eliminate the organism in milk...In preparation for this study, the agency is involved in developing the study protocol and upgrading the pasteurization equipment to exactly duplicate the commercial process used in the industry."
PARA's Response: First, again, PARA strongly encourages the cognizant officials ensure that any study efforts relative to MAP be competitively contracted out to independent academic researchers with proven track records in working with MAP.
Second, it is the opinion of PARA that it is an unconscionable and frivolous waste of taxpayer money to perform more "pasteurization simulations," especially when testing the readily available and pre-pasteurized milk on grocery shelves - the very actual milk that consumers will purchase to feed their families - is easily obtainable for study, and which study of will provide the only definitive results to determine what actually happens in the REAL world.
Moreover, all of the above information concerning "simulations and argument over studies about simulations" appear to be a moot point in light of the findings evidenced in the enclosed Interim Report which states unequivocally that MAP survives pasteurization - and pasteurization at standards generally higher than those currently employed in the US. An adequate and reliable MAP detection methodology has been developed and successfully used by UK researcher, Irene Grant. PARA encourages you to contract out testing of the retail milk in the US to qualified academic researchers with proven track records in MAP culture/detection to employ the methods used by Irene Grant of the UK, and/or Michael Collins, University of Wisconsin, in the culture/detection of live MAP in retail milk.
Until retail milk testing in the US is completed, we will never know for sure whether, and at what level, the milk that we give our children is contaminated with live MAP!
Troxell/CFSAN Statement: "The lack of a rapid and efficient analytical test severely limits the agency's ability to conduct the survey of the food supply that you are requesting. The agency is considering research into the development of more efficient detection methodology for this organism."
PARA's Response: We would like to know what FDA has specifically done, to date, to invest in improved MAP detection or infection diagnosis technology. It would certainly seem the prudent and responsible thing to do. Or are you still "considering research" into it? We would submit that "the agency's ability to conduct the survey of the food supply" is severely limited because of a lack of ACTION and significant INVESTMENT to improve its technology.
But, if FDA is serious about improving its technology, PARA would recommend and suggest that CFSAN consult with Dr. Michael T. Collins and/or Dr. Irene Grant who have successfully cultured LIVE MAP. Undoubtedly, both of these researchers would be able to provide valuable information. Further, Grant could provide expertise, so that the US may adopt the techniques which have proven successful in the UK this past year. For the FDA to do less than this sends a clear message to the American public that FDA is not interested in answering the important question - "Is live MAP contaminating our food supply?"
Troxell/CFSAN Statement: "Secondly, we are uncertain if such a survey will produce meaningful results. From a statistical standpoint it would be very difficult to draw any conclusions from a limited sampling of the food supply."
PARA's Response: We disagree with your "uncertainty that such a survey will produce meaningful results." From a statistical standpoint, PARA would recommend that the study be designed and conducted by experienced independent academic researchers trained and capable of producing a statistically valid study result. Statically valid results have been documented in many studies more complex than one involving testing the retail milk supply!
As far as meaningful, it will be meaningful indeed to the American public, meaningful indeed to the mothers in this nation to learn whether or not the food products they give their children is free from live MAP. The technology does exist to provide "great assurance of food safety" on this issue. Dr. Michael Collins, Dr. Irene Grant, and Professor John-Hermon Taylor, as well as others, have demonstrated that. Sadly, it appears that what is lacking is the will on the part of FDA to properly and adequately implement it.
Troxell/CFSAN Statement: "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."
PARA's Response: This statement is an affront to every person affected by Crohn's disease. What you are in effect saying is that this matter does not warrant any special attention. We vigorously disagree.
Indeed, we find it unconscionable that CFSAN is putting a higher priority on few deaths - a mere handful of deaths - a year from bacteria causing acute disease (such as E. coli 0157), 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.
And, speaking of "context," perhaps PARA can place Crohn's in the proper "context" for you. Perhaps you should think of Crohn's in the "context" of what suffering the patients go through? Perhaps you should think of Crohn's in the "context" of the combined forty-two years of vicious suffering and those years represent the suffering of only three "average Crohn's victims" to date (the oldest of which is in his early thirties)? But, in case, you still don't grasp the "context," perhaps you should consider Crohn's in the "context" of twenty-two hospitalizations and five major surgeries in the past three years - and those statistics just represent three of PARA's Board of Directors or their children. But, maybe you will only understand the "context" if we try to bring it a little closer to home for you? Perhaps you should think of Crohn's in the context of YOUR child spending a straight forty-three (43) days in the hospital, and then you must picture yourself sitting there day and night in agony, not knowing if she will live or die? Or, perhaps you might prefer to 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. If you do not have the "context" Crohn's must be placed in yet, please let us know. There are plenty of Crohn's stories more horrific than our own that we will be more than willing to share with you!
In summary, this is a food safety issue which affects millions worldwide, with at least 30,000 new cases being diagnosed every year in the US alone. Most of its victims are young, with more and more small children being stricken down every day! Based upon the available scientific studies, it appears that it may be more than coincidence that the incidence of M. paratuberculosis in cattle and the incidence of Crohn's disease in people are both rising. Moreover, as M. paratuberculosis continues to spread in food producing animals, we will not know the true consequences of today's governmental inaction to prevent contamination of foods with M. paratuberculosis for 15-20 years. If MAP is conclusively proven to cause Crohn's in humans, those persons infected in the intervening years will ask why something was not done to prevent this catastrophe, especially in light of the currently available evidence.
Indeed, PARA has researched the issue. The truth is that we can have answers in a reasonably short period of time on whether the US food supply is contaminated with live MAP. Implementation of a study of the retail milk supply modeled after the MAFF study headed by Dr. Irene Grant would by best rough estimates only cost $75,000 to $250,000 here in the US - a very small price to pay to answer this important question. To put this proposed "national expenditure" into "context" for you, the child of one of our Board of Directors members had surgery due to Crohn's this spring. This one child - this ONE Crohn's victim's hospital costs (excluding physicians and surgeons fees) EXCEEDED $100,000.
It is unconscionable for FDA to fail to perform such testing. The victims of Crohn's disease pay dearly every day of their lives in terms of human suffering. And unless and until the agencies of government act responsibly to ensure the protection of our citizens, the toll in human suffering will continue to mount, although this may have been preventable.
Troxell/CFSAN Statement: "We will continue to work with the NIH and others to develop the data necessary to answer the fundamental question of the relationship between M. paratuberculosis and Crohn's disease. When more clarity comes to this issue, the agency will be better positioned to direct appropriate resources to further address the impact of M. paratuberculosis in the food supply."
PARA's Response: We submit that until the agencies of government begin acting to ensure the protection of the public health, and immediately undertake the necessary research to "answer the fundamental question of the relationship between M. paratuberculosis and Crohn's disease," the lack of answers will serve as a smokescreen and a reason to avoid dealing with this problem. How can there be clarity in the presence of such an abundance of smoke?
As we have previously stated, in excess of fifty (50) scientific studies - published in peer-reviewed scientific journals - jointly and/or severally, suggest that MAP may cause Crohn's disease. We believe that these scientific studies provide adequate "clarity" to this issue! Every day the evidence mounts from scientists around the world...and it becomes increasingly compelling. Right now, the US is behind smaller and less able nations, as they strive to determine the truth! It is past time for our leaders to take aggressive lead in this matter and take immediate steps to ensure the protection of the public health!
Attachment A
ACM/458 - Tabled Paper
Advisory Committee on the Microbiological Safety of Food
http://members.aol.com/ParaTBweb/letters/fda/troxell_acmsf.htm