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:
- 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:
- 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
- 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;
or
- Analysis of the product is positive for staphylococcal enterotoxin
and is confirmed.
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.
- The following represents criteria for recommending legal action to CFSAN/Office
of *Compliance*/Division of Enforcement (HFS-605):
- 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.
- Cheese and Cheese Products Only
- 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
- 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:
- Direct reference seizures must be based upon the procedures in BAM, 7th
Ed.
- A copy of direct reference seizure should be sent to HFS-605.
- 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.
- 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.
- 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.
- 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