Appendix V

FOOD SAFETY CONCERNS

Concerns about Mycobacterium avium subspecies paratuberculosis (MAP) and the scientific studies that suggest a connection to Crohn's disease in humans raise extremely grave concerns about food safety in the U.S.

What are the chances that live MAP is in our food?

As a bit of history, in 1993 -- seven long years ago -- the first scientific study was published indicating that MAP may survive pasteurization standards used in the U.S.

This study was ignored by federal agencies responsible for food safety in this nation. Much later, in 1998, when University of Wisconsin researchers published their findings that MAP was able to survive current U.S. pasteurization standards, it was again ignored by our U.S. Federal Agencies cognizant of food safety. All in all, during the period 1993 through 1998 -- five long years -- six studies came in from the U.S. and around the world which suggested that MAP may survive current U.S. pasteurization standards/practices and all of them the were tossed aside, ignored by cognizant U.S. Federal Agencies such as USDA/FDA.

While our U.S. Federal Agencies ignored these significant findings, smaller and less able nations stepped to the forefront in this issue. Indeed, the United Kingdom, a relatively small nation with only about one-fifth the population of the U.S. and less than 15% of the Gross Domestic Product of the U.S., took action and 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.

During this same timeframe, Ireland also stepped to the plate taking dramatic steps to remove MAP from the food chain. A summary of the 11 August 1998 Press Release From Food Safety Authority of Ireland set forth the following:

1. Irish regulators require that animals diagnosed with Johne's disease are removed from the food chain
2. From the time an animal is diagnosed with JD until it is culled, milk will not be used (pasteurized or raw) for humans or calves
3. On no farm where there have been cattle diagnosed with JD (and there might be subclinically affected animals that are not yet "diagnosable" by currently available methods) the milk will not be used without pasteurizing it.

What is the situation today?

Findings from the U.K. study have been published stating that live MAP was found in retail milk in the U.K. It should be noted that U.K. pasteurization standards are equal to or exceed those used in the U.S.

Studies which have found that MAP may be capable of surviving pasteurization

1. 1993: Chiodini, R. J. and J. Hermon-Taylor. 1993. The thermal resistance of Mycobacterium paratuberculosis in raw milk under conditions simulating pasteurization. J.Vet. Diagn. Invest. 5:629-631.
2. 1996: I.R. Grant, et al. 1996. Inactivation of Mycobacterium paratuberculosis in cows' milk at pasteurization temperatures. Appl. Environ. Microbiol. 62:631-636.
3. 1996: Meylan, M. etal. 1996. Survival of Mycobacterium paratuberculosis and preservation of immunoglobulin G in bovine colostrum under experimental conditions simulating pasteurization. American Journal of Veterinary Research 1996;57(11):1580-1585.
4. 1996: D. Millar, et al. 1996. IS900 PCR to detect Mycobacterium paratuberculosis in retail supplies of whole pasteurized cows' milk in England and Wales. Applied and Environmental Microbiology 3446-52. September, 1996.
5. 1996: Hope AF, Tulk PA, and RJ Condron. Pasteurization of Mycobacterium paratuberculosis in whole milk. Proceedings of the Fifth International Colloquium on Paratuberculosis, p377-382
6. 1998: Sung N. and Collins MT. Thermal tolerance of Mycobacterium paratuberculosis. Applied and Environmental Microbiology 64(3), 999-1005
7. 2000: I. Grant. Findings in the U.K. of live MAP in retail Milk
8. 2001: Title: "Mycobacterium paratuberculosis"; Authors: International Dairy Federation Task Force on Mycobacterium paratuberculosis. Source: Bulletin of the International Dairy Federation Number 362/2001; (Part 5.4, Germany -- Study finding that MAP may survive pasteurization)

Studies which have found that MAP does not survive pasteurization

There are two published studies -- a USDA study and one from the University of Georgia that suggest that MAP may not survive pasteurization. Both of these studies have had significant criticisms levied at them from the scientific community. Methodology of the USDA study has been criticized, and the Georgia study has been criticized for a misinterpretation of data generated in the study.

Conclusions

Considering the available scientific evidence, it appears that there is a very high likelihood of live MAP in retail milk in the U.S. Nevertheless, some argue that the data remains incomplete.

The Centers for Disease Control issued the following statement relative to incomplete data: "Consumer health takes precedence over market concerns, and when data are incomplete, a conservative response is warranted until the risk can be accurately assessed."

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.

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. 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.