Implementing E coli
0157:H7 Policy in a HACCP Environment
National Advisory Committee on Meat and Poultry
May 16-17, 2000 Public Meeting
Issue Paper on Current Thinking
The purpose of the briefing is to provide the National Advisory
Committee on Meat and Poultry Inspection (NACMPI) with the Agency's current
thinking for implementing its policy on E. coli O157:H7 announced on
January 19,1999 (64 FR 2803), Attachment
1, and to receive input from the Committee on the Agency's current
thinking on measures to control E. coli O157:H7.
FSIS held a public meeting on March 8, 1999, to discuss the policy. On
February 29, 2000, FSIS held another public meeting at which recent
developments regarding beef products contaminated with E. coli
O157:H7 were discussed. A copy of the Federal Register Notice
announcing the meeting is included as Attachment
FSIS has carefully considered the information made available at the
March 8, 1999, and February 29, 2000, public meetings and the responses of
various constituents. In addition, FSIS notes that as of January 2000, all
meat and poultry establishments were required to have implemented Hazard
Analysis and Critical Control Point (HACCP) systems. This milestone
provides the context for moving forward to update FSIS policy regarding E.
FSIS is not changing its policy, articulated in January 1999, that raw
ground beef and other non-intact raw beef products will be
considered adulterated if they are found to contain E. coli O157:H7.
Raw, non-intact beef products present a significant public health risk
because they are consumed after preparation (e.g., cooking hamburger to a
rare or medium rare state) that may not destroy E. coli O157:H7
organisms that have been introduced below the product's surface by chopping
or grinding. Based on available data, FSIS believes that E. coli
O157:H7 may be a food safety hazard reasonably likely to occur in beef
Exposure to E. coli O157:H7 has been linked with serious,
life-threatening human illnesses (hemorrhagic colitis and hemolytic uremic
syndrome). See Tables 1-3. In addition,
positive results obtained by the FSIS regulatory testing program for E.
coli O157:H7 in ground beef continue to result in recalls (See Table
The Agency believes that with the exception of beef products that are
intact cuts of muscle that are to be distributed for consumption as intact
cuts, an E. coli O157:H7-contaminated beef product must not be
distributed until it has been processed into a ready-to-eat product, or
irradiated. A ready-to-eat product is one that may be consumed safely
without any further cooking or other preparation. Otherwise, such
non-intact beef products (e.g., beef injected with solutions; mechanically
tenderized by needling, cubing, Frenching or pounding devices, or
reconstructed into formed entrees) must be deemed adulterated. Furthermore,
manufacturing trimmings (i.e., pieces of meat remaining after steaks,
roasts, and other intact cuts are removed) must be treated as if they will
be further processed into non-intact products such as ground beef.
FSIS is open to excluding certain non-intact products from this policy
at some future time if scientific data are provided to the Agency that
demonstrate that cooking such non-intact products using normal cooking
practices results in a product that does not present a food safety hazard
from the pathogen, if it is present. We intend to consult with the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF) about the
type of data that would be appropriate and necessary to make such a
showing. In the meantime, FSIS current thinking on policy follows:
- Based on available data presented at the recent public meeting, and
preliminary results from its risk assessment on E. coli O157:H7 in
ground beef, FSIS believes that E. coli O157:H7 may be a food safety
hazard that is reasonably likely to occur in beef production. The Agency
will provide public notification and supporting data for this view in a Federal
Register notice in the near future.
- Following publication of this notice, FSIS would expect all
establishments engaged in beef production and processing to reassess their
HACCP plans to determine whether additional critical control points,
monitoring procedures, critical limits, verification procedures, corrective
actions and records should be included. FSIS expects that if establishments
add new features to their HACCP plans, they will promptly validate the
controls they are adding.
- FSIS intends to re-design its testing program for E. coli
O157:H7 so that it can operate as a HACCP verification activity under 9CFR
417.8. Currently, FSIS testing for the pathogen focuses exclusively on
ground beef, and the Agency tests for the pathogen from the grinding plant
forward, into distribution channels. Under the revised program, the testing
may apply to any stage of beef production. If an establishment produces
carcasses, trimmings, or primal cuts, it could be subjected to FSIS
verification sampling and testing.
- FSIS would revise Directive 10, 010.1 to reflect the Agency's revised
testing program. Current FSIS thinking is to provide for reduced Agency
sampling in establishments that have included controls for the pathogen in
their HACCP plans that provide inspection program personnel with access to
records of plant test results and corrective actions, and whose records
evidence that the establishment's HACCP system is working to prevent E.
coli O157-H7-contaminated product from entering commerce.
- FSIS will develop guidance material for slaughter plants about best
practices for controlling or reducing E. coli O157:H7 prevalence and
also will update its guidance for establishments that produce raw, ground
beef to reflect best current thinking on this matter. FSIS will also
develop materials to help producers.
FSIS expects that this series of steps to implement its policy could be
accomplished over a 4-month period.
- What are the Committee's views on the Agency's current thinking on
measures to control E. coli O157:H7 in a HACCP environment, and what
additional measures should FSIS take to address E. coli O157:H7?
Philip Derfler, Deputy Administrator
Office of Policy, Program Development and Evaluation
Table 1: Severe Foodborne Illness Caused by
E. coli O157:H7
Table 2: Foodborne Infections: Healthy People
2000 Objectives, Illnesses Caused by E. coli O157:H7
Table 3: Healthy People 2010 Objectives,
Illnesses Caused by E. coli O157:H7
Table 4: Number of Recalls for FY 1999 by
1: January 19, 1999, Federal Register notice on Beef Products
Contaminated with E. coli O157:H7.
2: Federal Register Notice for February 29, 2000, public meeting
Attachment 3: (PDF 9 pp) FSIS
Directive 10,010.1 (including questions and answers)