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For Business and Industry:
Notice 32-05 - Verification of Establishment's Reassessment of HACCP Plans to Address Mechanically Tenderized Beef
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Q. Does FSIS test the mechanically tenderized products for E. coli O157:H7?
A. FSIS does not test the mechanically tenderized beef for E. coli O157:H7 at this time. Such raw products are non-intact beef products, however, and thus would be adulterated if contaminated with E. coli O157:H7. In Q&A #1 in attachment 1 to Directive 10,101.1, states that FSIS intends to sample non-intact beef products other than ground beef in the future.
Q. An establishment has a CCP for cooler storage temperature of their meat that is mechanically tenderized. Is that enough to meet the requirements of Notice 32-05?
A. The requirement in the Federal Register
notice is that establishments that produce mechanically tenderized
beef products consider as part of their next HACCP plan reassessment
for these products the fact that there has been three relatively recent
E. coli O157:H7 outbreaks associated with consumption of
such products (70 FR 30331). The establishment needs to consider whether,
in light of this information, its hazard analysis and HACCP plan adequately
address the hazard presented by these products.
Q. Why does a plant that produces cooked mechanically tenderized beef have to reassess for E. coli O157:H7 according to FSIS Notice 32-05?
A. As explained in the Federal Register notice that announced the need for this reassessment, establishments producing cooked mechanically tenderized beef products may need to consider whether their cooking procedures are adequate to destroy E. coli O157:H7, should it be present. Information on a study concerning the effects of cooking on O157:H7 in blade tenderized steaks is included in the Federal Register notice (70 FR 30333-30334).
Q. An establishment
has already reassessed its HACCP plan in 2005. Does it have to conduct
reassessment again to meet the requirements of FSIS Notice 32-05?
A. According to the Federal Register notice, an establishment that has already conducted its 2005 reassessment for mechanically tenderized beef products but has not yet considered the significance of the three outbreaks during its hazard analysis should do so as part of its 2006 annual HACCP plan reassessment (70 FR 30331). Establishments that produce mechanically tenderized beef products that have already taken these three outbreaks into account in a HACCP plan reassessment for these products are not required to consider these outbreaks in their next annual HACCP plan reassessment.
Note: Establishments are not required to maintain a record of all reassessments done to the plan (9CFR 417.4(a)(3). However if the reassessment revealed that HACCP plan needs to be modified, there may be changes such as an updated HACCP plan or flow diagram. In addition, the same verification methodology that applies to the annual reassessment would also apply to the reassessment in the Federal Notice. FSIS has simply identified a specific hazard to be addressed for the 2006 annual requirement.
Q. If an establishment had reassessed its annual HACCP plan and made minor changes, would this be considered as the annual reassessment required by Notice 32-05?
A. Whether the HACCP plan reassessment for
mechanically tenderized beef products meets the requirements of the
Federal Register notice would depend on whether the reassessment took
into account the fact that there have been three relatively recent
E. coli O157:H7 outbreaks associated with consumption of
mechanically tenderized beef.
Q. Does a process using vacuum tumbling marination (which does not involve actual needle penetration) need to be reassessed as per FSIS Notice 32-05?
A. The reassessment requirement applies to HACCP plans for mechanically tenderized beef products, including products that are injected with marinade (or "enhanced" products). Vacuum tumbled products are considered to be marinated or "enhanced"; and the action of the vacuum tumbling could cause microorganisms to be drawn into the product. The reassessment requirement would apply to HACCP plans for these vacuum tumbled products.
Q. Does Notice 32-05 apply to reassessment of the common "cube" machines found in most establishments?
A. The reassessment requirement would apply to HACCP plans for products produced by "cube" machines, such as "cubed steaks", because these machines mechanically tenderize the meat.
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Last Modified: February 13, 2006 |
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