Regulation

PATHOGENS BURDEN OF PROOF

In order to be legally recalled, the following must be proven to classify a pathogen as an Adulterant:

  1. The serotyped bacteria must be pathogenic, meaning it is poisonous or deleterious to humans, dogs or cats. See CDC, WHO data and Definitions.
  2. The pathogenic bacteria must be found in a quantity capable of causing illness. See data on Infective Doses of pathogens and FDA dog studies.
  3. The Serotype and Quantification data must indicate that exposure to the product is a public health risk – identify if there are reports of illness or death, as well as information found in number 1 and 2.
  4. The government agency or laboratory that positively identified a pathogen in a product must be able to prove that they followed official laboratory protocol and procedure, ensuring that the product was not contaminated by the lab itself or otherwise was not affected in the chain of custody.
  5. Regulators must prove that the manufacturer was unwilling or unable to comply with attempts to prevent issues in the future.  A HACCP plan is considered a stop gap method and is legally required.  WHAT you do and HOW you do it is not specified.

Zero Tolerance Policy

FDA

USDA

Policy

Law

Enforcement