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Updated: 2005-11-29

Sec. 527.300 Pathogens in Dairy Products (CPG 7106.08)

BACKGROUND:

Over the past few years there has been an upsurge of incidents involving dairy products contaminated with pathogenic microorganisms. The most significant outbreaks have been Yersiniosis in Tennessee, Arkansas, and Mississippi in 1982; Listeriosis in Massachusetts in 1983 and in California in 1985; and Salmonellosisin Illinois in 1985. These incidents appear to be occurring with greater frequency and involving larger numbers of affected people. A number of deaths have been associated with these outbreaks.

This Compliance Policy Guide provides guidance for initiating legal action in cases involving products found to be improperly pasteurized, contaminated with pathogenic microorganisms, or prepared and packed under insanitary conditions.

REGULATORY ACTION GUIDANCE:

  1. The following represents criteria for direct reference seizure to the Division of Compliance Management and Operations (HFC-210) and for direct citation by district offices:
    1. Analysis of the dairy product demonstrates that one or more units is positive for Salmonella, Campylobacter jejuni, Campylobacter coli, Yersinia enterocolitica or Listeria monocytogenes and is confirmed;

      or
    2. Analysis of the product demonstrates that one or more of the subs has phosphatase values of 2.0 or more micrograms phenol per ml after subtraction of microbial phosphatase;


      3. or

    3. Analysis of the product is positive for staphylococcal enterotoxin and is confirmed.

    2. SPECIMEN CHARGE:

    Pathogens or staphylococcal enterotoxin:

    Article adulterated (when introduced into and while in interstate commerce) or (while being held for sale after shipment in interstate commerce) within the meaning of 21 U.S.C. 342(a)(1), in that it contains (a pathogenic microorganism, namely (list the microorganism)), or (an added poisonous and deleterious substance, namely staphylococcal enterotoxin) which may render it injurious to health.

    Phosphatase:

    Article adulterated (when introduced into and while in interstate commerce) or (while held for sale after shipment in interstate commerce) within the meaning of 21 U.S.C. 342(a)(4), in that it has been prepared, packed or held under unsanitary conditions whereby it may have been rendered injurious to health.

  2. The following represents criteria for recommending legal action to CFSAN/Office of *Compliance*/Division of Enforcement (HFS-605):
    1. All Dairy Products
      Analysis of the product demonstrates that one or more of the subs has phosphatase values between 1.0 and 2.0 micrograms phenol per ml after subtraction of microbial phosphatase.


    2. Cheese and Cheese Products Only
      1. Analysis of the cheese or cheese product demonstrates that one or more units have enteropathogenic E. coli levels greater than 1 X 103 per gram of product;

        or
      2. Analysis of the cheese or cheese product demonstrates that one or more units have E. coli levels greater than 1 X 104 per gram of product and a recent inspection demonstrates the existence of significant insanitary conditions.

NOTES:

  1. Direct reference seizures must be based upon the procedures in BAM, 7th Ed.
  2. A copy of direct reference seizure should be sent to HFS-605.
  3. Use direct reference citation authority only when prosecution is anticipated and evidence to support a prosecution is included with the adulteration charge. Evidence necessary to support a prosecution is specified in existing regulatory procedures issuances.
  4. Products produced in a IMS listed plant which demonstrate any of the above criteria should first be referred to the appropriate State regulatory agency for follow-up. This would also include a non-IMS product manufactured in an IMS-listed plant. If the State fails to take appropriate action the District should proceed to initiate FDA legal action.
  5. For milk products in liquid form (e.g., whole milk, lowfat milk), only those products that are labeled as being pasteurized are to be analyzed for phosphatase. Heat dried dairy products (e.g., nonfat dry milk, casein) are not expected to contain phosphatase and therefore should not be analyzed for phosphatase.
  6. Criteria for E. coli are applicable only to cheese and cheese products because other dairy products would not be expected to contain significant levels of E. coli.

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 7/1/83, 8/1/86, 3/95, 8/96, 5/2005