Hypothetical Liability Resulting From MAP Adulteration of Milk-based Products

by The Crohn’s Infection Site Administrator

This opinion piece was originally published in the June 2016 edition of the International Association for Paratuberculosis newsletter. A modified version is reproduced here with permission. The International Association for Paratuberculosis is a non-profit organization devoted to the advancement of knowledge and scientific achievement towards the eradication of paratuberculosis in domestic livestock and other species affected by Mycobacterium paratuberculosis. For more information, visit their website at www.paratuberculosis.net. The views and opinions expressed in the following article are those of the author in his personal capacity.

 

by Gilles R. G. Monif, M.D.

If and when research eventually proves that Mycobacterium avium paratuberculosis (MAP) is not just associated with Johne’s disease, but is the cause of Crohn’s disease, the issue of liability will become of paramount interest  to those whose lives have been radically transformed (1,2).

Liability arising from the potential MAP contamination of milk and milk-based products is projected to reside with the United States government. In its attempt to insulate agribusiness from added cost, a policy of not identifying MAP status in an animal’s health certificate was implemented. This failure to act allowed infected animals to be shipped across state and national borders (3). The USDA compounded the problem by licensing diagnostic tests that identified animals at risk for Johne’s disease rather than the serological status of the animals (4). The net result has been the widespread dissemination of MAP among milk producing animals and the secondary shedding of MAP into the bulk tank milk or from the fecal contamination of previous unadulterated milk (5,6).

In matters concerning food safety, The Rio Declaration on Food Safety’s precautionary principle places the obligation to act to protect the public welfare squarely on the federal government (6). Principle 15 of the Rio Declaration states that “the precautionary approach shall be widely applied by States according to their capacities. Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” The precautionary principle is embedded in food safety (7).  Given the responsibility of oversight and governance, the cost of added steps to protect the public health by reducing the amount of MAP entering the human food chain resides with the federal government which allowed the widespread dissemination of MAP.

MAP receptors line the entire small bowel (8). The scale of MAP’s penetration into milk based products makes it, more probable than not, that the majority of individuals within industrialized nations has been or will be infected by MAP. The presence of MAP DNA in the blood of health of healthy subjects incorporated into clinical studies supports the postulate that MAP infection is widespread in the general population (9-11). If this assumption is correct, the number of Crohn’s disease afflicted individuals is comparatively small in contrast to the number of individuals theoretically infected by MAP. This discrepancy has been advanced in support of the argument that, in the presence of both acquired and inherent immunity, human MAP infection is of limited health consequences.

The Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Protection Inspection Act (21m U.S.C. 451 et seq.) and the Federal Food, Drug, and Cosmetic Act (21 U.S.C 321 et seq.) are instruments of administrative law. They identify a food as being adulterated if it bears or contains any poisonous or deleterious substance which may render it injurious to health and is not neutralized by its subsequent processing. Products that are adulterated under these laws cannot enter into commerce for food consumption.

The economic importance of milk derived protein, coupled with the adverse economic fallout of attempting to remove MAP from food sources and governmental reluctance to do anything contrary to the interests of influential third parties, makes the current Crohn’s disease epidemic involving an estimated one million U.S. residents another instance in which the public health has been subordinated to economics.

Human MAP disease occurs primarily in individuals with congenital or acquired immunodeficiency. At birth, newborn infants lack a critical component of their immune system. They obtain their acquired immunity as a consequence of microbial colonization of the gastrointestinal tract. At birth, a baby’s immune system mirrors that of germ-free animals. In both germ-free animals and newborns, the imposition of a viral and mycobacterial infection results in exaggerated pathological consequences.

In summary, the Hruska Postulate states that the widespread presence of MAP in the nation’s food supply is responsible for Crohn’s disease in individuals who, having been infected by MAP in the early neonatal period, loss immunological tolerance to MAP’s antigen array and respond by elaborating a pro-inflammatory response when re-exposed to them.(2).

The definitive experiment to substantiate the Hruska Postulate can never be ethically or morally done. This fact has allowed FDA to sin by silence and behind its internally engendered requirement for “conclusiveness” before labelling anything a hazard to the public health. In so doing, FDA overtly mocks the international principle of the precautionary approach as stated in the Rio Declaration on Food Safety and Phytosanitary Measures of the World Health Organization.

The manufacturers of infant formula are the likely to be in the moral and fiscal cross hairs. Since 2005, MAP has been identified as being in infant formula. In 2008, the American Academy of Microbiologists concluded that “the association of MAP and CD (Crohn’s disease) is no longer in question. The critical issue today is not whether MAP is associated with CD, but whether MAP causes CD or is only incidentally present”. Once the potential adulteration of infant formula by MAP had been documented and its significance evidence based inferred, the manufacturers should have been under obligation to institute measures consistent with the precautionary principles regarding food safety embedded in The Rio Declaration and Article 5.7 of The World Trade Organization Agreement on Sanitary and Phytosanitary Measures (7,12).  The manufacturers of infant formula had the options of 1) making certain that the milk powder used for their infant formula was MAP-free 2) developing a non-milk based formula to be used for the first few weeks of a baby’s life or 3) advocating that women initially breast feed their infants. Action on their part was even more imperative, given that virtually every study done to date has shown that breast feeding confers relative protection against the future development of Crohn’s disease and that the American Academy of Pediatrics had and has strongly advocated for breast feeding.

Whether MAP infection in the early neonatal period results in loss of immunological tolerance to MAP or not is circumstantial to the issue of liability. Given the knowledge that their product can be adulterated by a documented pathogenic mycobacterium and that the preponderance of evidence pointed to an association between this microbe and human disease, the manufacturers of infant formula failed to implement the precautionary principle embedded in food safety. They sinned by silence by NOT putting a warning on their product labels as to the possibility of product adulteration. Women were denied the opportunity to make an informed decision as to whether or not they want their babies to be potentially exposed to MAP at a time when their immune system is incomplete. Possible surrogates may have acted contrary to evidence based facts (13).

Without a government upholding the precautionary principle, there can be no assurance of safety in what you eat. Crohn’s disease may be a prime example of what is termed negligent entrustment on the part of government agencies. Criminal negligence is said to occur when an accused actually foresees the potential adverse consequences to the planned actions and goes ahead, exposing an unknown victim to risk of suffering injury or loss.

 

References

  1. Nacy C, Buckley M, 2008.Mycobacterium avium paratuberculosis: Infrequent human pathogen or public health threat? Report from the American Academy of Microbiology 2008. p. 1-37.
  2. Monif GRG, 2015.The Hruska Postulate of Crohn’s disease.  85, 878-881.
  3. Momotani E, 2012.Epidemiological situation and control strategies for paratuberculosis in Japan. Jpn J Vet Res. 60: 19s-29s.
  4. Monif GRG, Williams JE, 2013.The significance of a negative MAP ELISA test or Mycobacterium avium subspecies Intern J Appl Res Vet Med, 11: 1117-22.
  5. USDA-APHIS.Johne’s Disease in U.S. Dairies 1991-2007.
  6. Pinedo PJ, Williams JE, Monif GRG, Rae DO, Buergelt CD, 2008.Mycobacterium paratuberculosis shedding into milk; association of ELISA reactivity with DNA detection in milk. Intern J Appl Res Vet, 6:137-44.
  7. United Nations Environmental Program, 1992.Rio Declaration on Environment and Development.
  8. Schleig PM, Buergelt CD, Davis JK, Williams E, Monif GRG, Davidson MK, 2005.Attachment of Mycobacterium avium subspecies paratuberculosis to bovine intestinal organ cultures; method development and strain differences. Vet Microbiol, 108: 271-9.
  9. Naser SA, Ghobrial G, Romero C, Valentine JF, 2004.Culture of Mycobacterium avium subspecies paratuberculosis (MAP) from the blood of Crohn’s disease patients. Lancet 364: 1039-44.
  10. Naser SA, Collins MT, Crawford JT, Valentine JF, 2009.Culture of Mycobacterium avium subspecies paratuberculosis (MAP) from the blood of patients with Crohn’s disease: A follow-up blind multi-center investigation. The Open Inflam J. 2:22-24.
  11. Juste RA, Elguezabal N, Pavon A, Garrido JM, Sevilla I, Cabtiada JL, Tejada A, GarciaCampos F, Casado R, Ochotorena I, Izeta A, 2009.Association ofMycobacterium avium subspecies paratuberculosis DNA in blood and cellular and humeral immune response in inflammatory bowel disease patents and controls. Intern J Infect Dis, 13:247-254
  12. The WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement.https://www.wto.org/english/tratop_e/sps_e/spsagr_e.htm
  13. Jung C.:Overselling Breast Feeding. 2015; New York Times, Sunday edition Review Section: first page.

 

Gilles R. G. Monif, M.D. is a former assistant dean at a United States medical school, a special consultant in infectious diseases to the American College of Obstetricians and Gynecologists, an Editor of the leading source book on Infection diseases in Obstetrics and Gynecology and has published over one hundred per reviewed articles dealing with infectious diseases.

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