OLSSON, FRANK AND WEEDA, P.C.

May 16, 2000

FROM: Olsson, Frank and Weeda, P.C.

RE: FSIS Listeria Public Meeting

At this well-attended meeting: (1) a representative of the Centers for Disease Control (CDC) described the public health impact of L.m; (2) a representative of the Food and Drug Administration (FDA) reported on the status of the interagency risk assessment; (3) FSIS representatives summarized the agency's activities to date; (4) industry representatives discussed their recent survey of how establishments are addressing Listeria; (5) representatives of the Center for Science in the Public Interest (CSPI) summarized their petition to require that establishments conduct both environmental and finished product testing; and (6) FSIS representatives summarized the agency's "current thinking" on how FSIS intends to move forward in addressing this pathogen. Much of the material presented at the meeting is summarized in the FSIS Listeria monocytogenes "White Paper" available on the FSIS web site.

The CDC representative discussed the public health impact of L.m, identifying the nature of the pathogen (ubiquitous in the environment), the susceptible groups (pregnant women, elderly, immuno-compromised), its incubation period (11-70 days, median of three weeks), and how L.m is detected and classified in the laboratory (serotyping and pulsed-field gel electrophoresis (PFGE)). Although the total number of listeriosis cases per year is small, the hospitalization and mortality rates are the highest of any food-borne pathogen.

Since the 1986 L.m outbreak with soft cheeses in the Los Angles area, CDC has tracked listeriosis, most recently through its FoodNet Surveillance program. Since 1986, the incidence of listeriosis has declined from approximately 8 cases per million population to 4.7 cases in 1998. The incidence of the total number of cases has not changed in any significant degree after 1993. However, the incidence of perinatal (age < 1 year) has significantly decreased in that period.

As an example of its investigation methods, the CDC representative discussed a 1998 multi-state outbreak. Beginning with the increase in reported listeriosis cases in four states in 1998, CDC identified the L.m subtypes through PFGE and interviewed all patients about their consumption of specific foods. The PFGE identified 20 patients with the same strain and 89% with consumption of hot dogs. Of the patients remembering the brand, 11 of the 20 ate brands made by one company. That particular company's establishment had data showing that after construction in the summer of 1998, there were higher levels of indicator organisms. Moreover, the dates of illnesses corresponded to the onset of the outbreak. After the company recalled products, the illnesses subsided.

CDC will continue to monitor listeriosis and investigate other possible outbreaks. In addition, it will conduct a case-control study of sporadic infections and attempt to determine the infectious dose of L.m and identify virulence markers. Finally, it will work with the meat and poultry industry to assist in plant sanitation measures and develop post-packaging pasteurization methods.

A FDA representative reported on the status of the interagency Listeria Risk Assessment. The purpose of this risk assessment is to determine the factors that most contribute to the risk of listeriosis. Although the draft is still under review, the assessment has generally identified four factors which elevate the risk: (1) the food supports the growth of L.m; (2) the food has an extended shelf life; (3) there is a high incidence of initial contamination post lethality; and (4) the product is distributed with less than an optimal cold chain. Although the risk assessment focuses primarily on ready-to-eat products, it does include some "raw" products, such as ground beef. The draft report will be published by July 14 with a 45 day comment period.

Laboratory Changes -- FSIS laboratories have increased the number of Listeria samples conducted each year, from 3,546 in 1998 to 7,368 in 1999. The agency also revised its laboratory technique to shorten the time it takes to perform a L.m analysis and began using the PFGE analysis. Finally, it revised its sampling program to require collection of intact samples only.

Education -- FSIS has been increasing its education efforts to target the groups most at risk from listeriosis (elderly, pregnant women, and immuno-compromised). This included a video news release, a news article, and a brochure. In addition, FSIS is contacting organizations that service the at-risk groups and the medical community to get the information out. However, this out-reach program to other groups has had only limited success to date.

During the question and answer period following this presentation, one consumer organization representative questioned the effectiveness of any education program without changes to product labels, such as not labeling products as ready-to-eat, and including behavior-changing statements in the other materials, such as "seniors should not eat these products."

Regulatory -- There have been several FSIS regulatory actions within the past year:

• Federal Register Notice requiring establishments to reassess their HACCP plans;
• Issued Guidance to Industry on preventing L.m contamination;
• Developed guidelines on environmental and chill water brine sampling;
• Held a technical conference on the Sanitation Performance Standards; and
• Issued a direct final rule approving inhibitor substances -- sodium diacetate, sodium lactate, and potassium lactate.

Enforcement -- There has been a substantial increase in the number of recalls attributed to L.m. Most of these recalls follow a positive FSIS sample for product that had been shipped. Prior to late 1998, an establishment was only required to hold a two-hour lot following an agency sample. Now, with an entire lot from clean-up to clean-up affected, it has become more difficult to hold the product pending results. In addition, a positive finding, regardless of whether product has been shipped, will trigger additional agency scrutiny in terms of additional L.m testing and a HACCP reassessment.

Agency Survey of Reassessment -- FSIS has just finished a limited survey of 30 establishments to determine compliance with the 1999 requirement of reassessing HACCP plans. All 30 of the large and small establishments sampled had reassessed their HACCP plans. Approximately three-fourths of the establishments modified their HACCP plans. Some establishments added product or environmental testing, but not usually both. According to the survey, approximately two-thirds of the establishments are conducting some form of environmental testing on at least a weekly basis and approximately one-third conducted product sampling. If an establishment did not make any changes to its HACCP plan, the decision generally was based on previous test results or existing microbiological controls. Establishments also viewed L.m as a sanitation issue with about two-thirds of the establishments reviewing their SSOP programs.

In February and March, a coalition of trade associations conducted a survey of establishments manufacturing ready-to-eat items to determine the actions industry has taken in response to the 1999 FSIS requirement that establishments reassess their HACCP programs for risks posed by L.m. According to the survey, virtually all the establishments responding (representing an estimated 80% of the total production of these products) did conduct the reassessment. Moreover, many establishments are conducting some form of testing (with all large establishments conducting environmental and 88% conducting product testing as well, and with 92% of small plants conducting environmental and 64% conducting finished product). Most had these programs in place prior to the reassessment, but many did refine the programs as part of the reassessment.

In conjunction with reporting on the survey, the trade associations discussed their own "white paper" on L.m. According to this paper, the purpose of all L.m activities should be to reduce the risk of Listeriosis. In this regard, FSIS should focus its resources where needed. This would mean modifying the agency's zero tolerance and not testing products where there is no reasonable risk of growth, such as products with growth inhibitors, frozen products, or testing products cooked in the package. In addition, FSIS should focus its testing on establishments which are not conducting any testing -- this could be achieved by amending the FSIS Directive on L.m testing. Finally, FSIS should provide incentives for an establishment taking a pro-active role in addressing this pathogen. The industry speaker summed up with a call for co-operation not compliance.

Earlier this year, CSPI submitted a petition to FSIS requesting that the agency mandate all establishments producing ready-to-eat products to conduct both environmental and finished product L.m testing. CSPI apparently recognizes that a positive environmental finding should not require an automatic enforcement response. Instead, the focus should be on how the establishment responds to the positive finding.

CSPI requests that the regulations require the testing information generated under the mandatory program to be shared with FSIS and that FSIS suspend inspection at any facility that repeatedly fails to take effective preventive actions following environmental positives or has repeated positive product samples.

FSIS will take several short term, intermediate and long term actions.

FSIS will address L.m by revising its Directive on Microbiological testing of ready-to-eat products. The agency will make four basic changes.

First, it will change the products subject to the sampling program to include all ready-to-eat products. Although all products will be subject, the priority will be to test any of the following: products packaged after cooking; products sliced or peeled after cooking; products where ingredients are added after cooking; high volume products; and products previously found to contain L.m.

Second, it will make analytical changes. FSIS will test the entire contents of a multi-component product rather than simply extracting the meat/poultry component. Also, it will test every sample for both L.m. and Salmonella rather than only one of these pathogens.

Third, it will respond to positive findings with a more clearly specified policy.

Fourth, it will reduce sampling at establishments that conduct their own programs to control L.m. To be eligible the establishment must conduct its own end product testing at some frequency, or conduct environmental testing under its SSOP or HACCP plan, with positive findings ultimately triggering end product testing. Under either of the above, the establishment must take appropriate corrective and preventive action when a positive is found.

1. FSIS will publish a proposed regulation within 120 days to mandate that establishments conduct environmental testing for Listeria species (presumably including product contact surfaces) as part of the establishment's SSOP. To minimize costs for establishments, the mandated frequency would be based on production volume.

2. FSIS will publish proposed performance standards for all ready-to-eat products not covered by such a standard.

3. FSIS will publish proposed regulations to require that establishments validate the accuracy of their handling instructions or shelf life. At the meeting, the FSIS officials did not provide specifics on what validation would be adequate.

4. FSIS will develop industry guidance, especially for the small and very small establishments.

5. FSIS will conduct in-depth verifications to assess the adequacy of establishment programs for addressing L.m.

6. FSIS will work with AMS and other agencies to change the instructional labeling of ready-to-eat products purchased for the commodity food programs.

7. FSIS will continue working on the Listeria risk assessment and conduct further consumer educational activities.

We will continue to monitor this issue for you. Meanwhile, if you have any questions or desire further information, please do not hesitate to contact us.

OFW:drj