January 15, 1999 8:30 a.m. PST

Information from Rosemary Mucklow, NMA Executive Director

One week before regulatory HACCP implementation in approximately 4,000 federal-inspected establishments, Tom Billy, FSIS Administrator, has announced a huge expansion of the interpretation of adulteration on beef products contaminated with E. coli O157:H7.

In a Notice on display today, and to be printed in next Tuesday’s Federal Register, the action is summarized as follows:

"In 1994, the Food Safety & Inspection Service (FSIS) notified the public that raw ground beef products contaminated with the pathogen E, coli O157:H7 are adulterated under the Federal Meat Inspection Act unless the ground beef is further processed to destroy this pathogen. FSIS is publishing this notice to provide the public with information about its policy regarding beef products contaminated with E. coli O157:H7 and to afford the public an opportunity to submit comments and recommendations relevant to the Agency’s policy, and any regulatory require-ments that may be appropriate to prevent the distribution of beef produfdts adulterated with this pathogen."

In the Notice, FSIS argues that, given the low infectious dose of E. coli O157:H7 associated with foodborne disease outbreaks and the very severe consequences of infection, that the public health risk is not limited to raw ground beef products. It proceeds to distinguish between "intact" and "non intact" cuts, defining the former as steaks, roasts, briskets, stew beef, beef cubes for stew, and thin-sliced strips of beef for stir frying. It defines non intact cuts as beef injected with solutions, mechanically tenderized by needling, cubing, Frenching, or pounding devices, or reconstructed into formed entrees. In addition, it includes beef products in which pathogens may be introduced below the surface by a comminution process such as chopping, grinding, flaking, or mincing. It argues that intact cuts that are to be further processed into non-intact cuts prior to distribution for consumption must be treated as non-intact cuts, because of the potential for introduction of pathogens. Further, it states: "Although manufacturing trimmings may be intact, they are generally further processed into non-intact products." The agency cites its belief that, other than intact cuts of beef, all other products must not be distributed until they have been processed into a ready-to-eat product, i.e. a food product that may be consumed safely without any further cooking or other preparation. Otherwise, the agency postulates a policy that non-intact products and intact cuts of muscle that are to be further processed into non-intact cuts of muscle and further processed into non-intact products prior to distribution for consumption must be deemed adulterated.

FSIS states it is not, at this time, expanding its sampling/testing program to include non-intact beef products, but will reconsider this based on comments. It notes that it is participating in a risk assessment regarding E. coli O157:H7. It states it is reviewing its regulations to determine what changes it should make to increase consumer protection against products contaminated with E. coli O157:H7.

Characterizing this as a "clarification" is grossly misleading. Quite frankly, this is a sweeping expansion of FSIS policy interpretation of adulteration. The development of this policy has been done secretly by the agency until it was announced today, and is counter to the stated policy of openness in the development of public policy. NMA will attend the industry briefing at one o’clock today and keep its members informed as events unfold.



Notes by Rosemary Mucklow, NMA Executive Director

January 15, 1999 Teleconference Briefing by FSIS on Adulterant Issue

Tom Billy, FSIS Administrator, opened the industry briefing at 10 a.m. PST (one o’clock Washington time), announcing that two Notices are on display and being published next week in the Federal Register. The first is the clarification of the policy considering beef with E. coli O157:H7 an adulterant; the second is an updated version of the guidance for beef grinders first published by FSIS in March 1998. Billy said that they had worked with the Microbiological Criteria Committee, the Centers for Disease Control and others in the industry. In response to a later question, the "others" were described as a trade association that raised concerns that smaller firms in the industry were receiving product for grinding that had been found unacceptable by large firms and some companies that shared data with FSIS on risk assessment.

Mr. Billy proceeded to describe the "intact" and "non intact" products and to point out that it is not the agency’s intent to modify its sampling program, but it will consider it in the context of risk assessment.

The Q&As were the most stimulating, and suggest a conclusion that the rules are highly uncertain, a thoroughly disquieting and unsatisfactory situation for the commercial meat industry. The following summarizes some of the most important points that surfaced:

1. The "clarification," or as NMA perceives it, the substantial expansion of the 1994 requirement, as published, has no effective date -- it is now!

2. FSIS has promised to provide information on illnesses that may have resulted from the ingestion of non-intact products (such as marinated, injected or tenderized steaks).

3. FSIS has not conducted an Economic Impact Analysis and does not feel that it needs to do so.

4. It is timely, since the large plants that are doing an annual reassessment of HACCP plans, and those coming into HACCP on January 25 should evaluate this hazard and take account of the risks.

5. Responses to questions about parameters of lots, sub-lotting combos in a trailer load, and whether each sub-lot stands/falls based on a test were answered vaguely, such as: It would turn on the information from the source operation, how that plant handled raw materials, and how the source plant operates.

This being an essential question for most people, it was raised in several different ways, and the FSIS officials said they would work to develop and publish within a few days Q&As that spoke to the issue. This is unsatisfactory to the industry for whom there is no lag time for effectiveness.

6. It was pointed out that with 4,000 plants coming under HACCP on January 25, this is a very confusing action.

7. Billy said that he is hoping for clearance of the irradiation proposed rule soon.

8. The expanded interpretation is likely to discourage testing. FSIS believes that it will encourage more testing "when the dust settles" and people should submit comments.

9. When pressed further about the situation now (see 5. above), where a grinder who subdivides a trailer load of combos, and one sub-lot tests positive, what is the linkage to the other combos from the same source? Glavin responded: A Processor who is using methods to protect its customer should continue to do so.