Food Safety Magazine, April/May 2011

(1) the scientific or technical support for the HACCP system and ( 2) the initial practical in-plant demonstration proving the HACCP system can perform as expected.” A letter from Alfred Almanza, FSIS Administrator, to the meat trade in March 2010 clearly suggested that, along with meeting these criteria for CCPs, plants will also be expected to meet the same criteria for prerequisite programs when such programs are used in Hazard Analysis logic to justify why an identified hazard is not significant, thereby not requiring a CCP to control it, and also when food safety warning labels are used to address a significant hazard.

quired element of validation)? ( 2) Is it necessary to re-do each laboratory validation study each time a new pathogen of concern is identified (relating to the first required element of validation)?

Where Are the Answers?

According to a www.meatpoultry.com
report from the North American Meat
Processors annual meeting in Scottsdale,
best prevent illnesses and deaths from
dangerous E. coli in beef, our policies
need to evolve to address a broader
range of these pathogens, beyond E. coli
O157:H7.” Hence, it appears likely that
FSIS will take regulatory action to con-
trol contamination with non-O157
STECs on/in meat products in the near
future. Therefore, if/when such regula-
tion occurs, will the past 16 years’ worth

“What happens when the ‘next’ pathogen of
concern is identified as a public health threat?”
What Can We Expect?

Discussion during public meetings suggested that the FSIS intends to focus more emphasis on explaining expectations regarding the second element of validation in the Guidance rather than on the first element. It is our contention that, perhaps, both elements require clarification—especially if scientists are to conduct applied research and publish results in peer-reviewed journals such that those results are meaningful in the context of which hazards need validation— now and in the future—and which pathogens are to be considered.

For example, we know that FSIS will require validation of intervention system effectiveness for Escherichia coli O157:H7 on beef in each facility, both by way of scientific support and via in-plant data, substantiating that the system works in practice. We also know that a plethora of scientific studies have been conducted over the past 16 years addressing this topic, that those studies were subsequently published in peer-reviewed journals and that they documented under laboratory-controlled conditions the effectiveness of a multitude of potential plant systems, using both quantitative counts of indicator organisms as well as inoculated E. coli O157:H7. What we don’t know are the answers to the two following questions: (1) How should a company document that the laboratory-controlled results translate into similar results when implemented in a meat production plant under equal application parameters (relating to the second re-

AZ on October 29, 2010, 2 these questions may already require an answer. Dr. Dan Engeljohn, FSIS Assistant Administrator, was quoted as saying, “FSIS plans to move forward on non-O157 [Shigella toxin-producing E. coli] STECs . . . The agency is working to develop reliable test methodologies for the six STECs of primary concern—four of six have been developed so far.” Dr. Engeljohn’s comment came shortly after a September 2 New York Times story was published, addressing a recall of ground beef found to have caused illness from contamination with E. coli O26.3 The story quoted a written statement by Dr. Elisabeth Hagen, appointed only a month earlier as USDA Undersecretary for Food Safety, as saying that, “In order to

CSU* identification

FSL E1-102

FSL E1-123

FSL A1-002

FSL E1-106

Pathogen strain

E. coli O103:HN

E. coli O103:N

E. coli O111

E. coli O111:NM FSL E1-109

E. coli O121

E. coli O121:H19

FSL E1-112

FSL E1-118

FSL E1-092

E. coli O145:H28

E. coli O145:NM

E. coli O26:H11

FSL E1-115

E. coli O26:H11

Table 1: Non-O157 STEC Inoculation Strains

of scientific publications that have specifically dealt with E. coli O157:H7 serve to also validate intervention effectiveness against the top-six non-O157 STECs? Is an entire new round of laboratory validation studies needed to fill this void? What happens when the ‘next’ pathogen of concern is identified as a public health threat? How does a company validate that plant intervention systems installed to address E. coli O157:H7, in reality, address that organism plus any new pathogenic public health threats?

These questions cannot be answered until FSIS determines what will constitute appropriate validation. Nonetheless, some beef industry companies are anticipating a need to (a) produce scientific