FSIS Docket Clerk
Docket #99-025N
Room 102, Cotton Annex
300 12th Street, SW
Washington, DC 20250-3700
Re: [Docket No. 99-025N] Listeria monocytogenes Contamination of Ready-to-Eat Products;
64 Federal Register 28351; May 26, 1999
Dear Ms. Moore:
NFPA is the voice of the $460 billion food processing industry on scientific and public policy issues involving food safety, nutrition, technical and regulatory matters and consumer affairs. NFPA’s three laboratory centers, its scientists and professional staff represent food industry interests on government and regulatory affairs and provide research, technical services, education, communications and crisis management support for the Association’s U.S. and international members, who produce processed and packaged foods, drinks and juices.
On May 26, 1999, FSIS published a document in the Federal Register (64 FR 28351) to convey the Agency’s position that, for “ready-to-eat” (RTE) livestock and poultry products, if Listeria monocytogenes (L. monocytogenes) is a food safety hazard “reasonably likely to occur” manufacturers must reassess their Hazard Analysis and Critical Control Points (HACCP) plans. Moreover, the Agency indicated that, given current knowledge, L. monocytogenes contamination should be considered reasonably likely to occur and that it would not be adequate to deal with the hazard in SSOPs, thus implying the Agency expected that HACCP plans would be revised to add a CCP to address post-processing contamination by L. monocytogenes. Factors to be considered in the reassessment were listed and guidance was provided in a separate document. FSIS invited comments on the document and guidance.
- The processed food industry is committed to food safety. It has recognized the importance of controlling L. monocytogenes in RTE foods for many years.
- It is appropriate that manufacturers of RTE products reassess their HACCP plans to assure that they adequately address the hazard of L. monocytogenes. The Agency must recognize, however, that because of the unique nature of the
organism, an adequate control program for L. monocytogenes will involve much more than HACCP alone. - Not all ready-to-eat foods appear to present the same level of public health risk. Given the limitations on resources, both within industry and the government, it seems prudent and practical to focus on products in which the organism can grow.
- Controls, remedial actions and enforcement policies can (and should) differ for low-risk products without having a negative impact on public health.
- L. monocytogenes contamination of RTE products results primarily from recontamination from the environment. It is not possible to identify one, or even a few, key controls that can effectively serve as CCPs for post-processing contamination at this time, although the use of new technologies could result in new, effective CCPs. FSIS should not abandon the sound science underlying the HACCP system by forcing establishments to designate a single point or step in a processing line as a CCP. Such actions will only be partially effective.
- NFPA believes that to verify control of L. monocytogenes in the plant environment, establishments should implement an environmental monitoring program for an indicator organism such as Listeria species. It cannot, however, replace an effective sanitation program. NFPA is concerned that the Agency has overly emphasized the environmental testing program such that the main focus of a control program (sanitation) is not clearly communicated.
- While environmental testing for Listeria species is an excellent tool for identifying potential sources of L. monocytogenes in the processing and packaging area, lack of correlation between environmental findings and safety of products limits the utility of environmental testing as a monitoring function within a HACCP system.
- USDA should expedite the use of new technologies, including ingredients and processes (e.g., sodium lactate, diacetate, irradiation and other technologies as they become available) by eliminating bureaucratic delays and duplicative approval processes. FSIS must also provide the necessary incentives to use such developments through adjustments in Agency testing programs, establishment of appropriate performance standards, or other appropriate vehicles.
- NFPA is concerned that the Agency’s continued reliance on testing of finished product, especially for those plants with “limited resources” undercuts the importance of sanitation in the control of L. monocytogenes and is counterproductive to efforts to promote a system that relies on prevention.
- While we recognize the importance of process validation, it does not appear that inadequate process delivery is a major contributor to Listeria contamination of RTE food products.
- NFPA advocates the creation of a “non-RTE” product category for products with fully cooked meat and poultry and other components that are not ready to eat.
- NFPA supports development of labeling features that clearly indicate to consumers the need to cook the product prior to consumption.
- NFPA strongly opposes the inclusion of safe handling instructions as specified for raw products [9 CFR 317.2 (l) and 381.125] on NRTE products containing RTE meat or poultry.
- NFPA encourages industry to develop data to support the lethality of cooking instructions.
- A regulatory approach that encourages the industry to have environmental control and testing programs without penalizing establishments for finding the organism in the environment is essential to reducing the risk from L. monocytogenes. A focus on those products in which the organism can grow is also critical to place the resources where the true risks lie.
FDA and FSIS are currently undertaking a risk assessment for L. monocytogenes in foods that is expected to provide a risk ranking of products. This risk assessment is expected to be completed this fall. In addressing the risk of listeriosis from various meat and poultry products it is reasonable to assume that products in which the organism can grow will be given a higher risk ranking than those in which it cannot. Given the lack of evidence that many RTE products, especially those that are frozen, present a risk to public health, there is no basis for the Agency to rush towards requiring industry to make extensive and expensive changes to in-plant controls for L. monocytogenes for these products until the risk assessment provides the risk rankings for products.
Certainly the heat-treatment given to fully cooked products should be adequate to inactivate L. monocytogenes, and this should be a CCP in a HACCP plan. However, L. monocytogenes contamination of RTE products results primarily from recontamination from the environment. L. monocytogenes is widespread in the environment and in many raw components of meat and poultry food products. Because of its pervasiveness, there is a constant re-introduction of the organism into the plant environment. Extensive efforts to control L. monocytogenes can reduce the frequency and level of contamination, but it has not been possible, given currently available technology, to eradicate it from the processing environment nor to totally eliminate the potential for contamination of finished products. The Agency must recognize this limitation in its approach to assessing an establishment’s control programs and support industry in the development of new control strategies and technologies (see below). Because L. monocytogenes recontamination can come from multiple sources, control through HACCP CCPs is usually impractical – prerequisite programs (Sperber, W.H., K.E. Stevenson, D.T. Bernard, K.E. Deilbel, L.J. Moberg, L.R. Hontz, and V.N. Scott. 1998. Dairy, Food and Environmental Sanitation 18: 418-423) are the foundation for L. monocytogenes control, with GMPs, sanitation, and training targeted toward specific control of this organism. It is not possible to identify one, or even a few, key controls that can effectively serve as CCPs for post-processing contamination at this time, although the use of new technologies discussed below could result in new, effective CCPs. FSIS should not abandon the sound science underlying the HACCP system by forcing establishments to designate a single point or step in a processing line as a CCP, as such an action can only be partially effective.
To address the potential for contamination of RTE foods with L. monocytogenes, establishments should have a well-developed sanitation and preventive maintenance program designed to prevent colonization of any specific location in the facility. In addition, such a program should address routes of re-introduction into the plant. By preventing colonization, gross recontamination of product can be avoided. By addressing the potential points of reintroduction, the sporadic contamination of product can be minimized. NFPA has developed specific guidance to address the control of post-processing contamination (Tompkin, R.B., V.N. Scott, D.T. Bernard, W.H. Sveum and K.S. Gombas, 1999. Dairy, Food and Environmental Sanitation, in press). The many controls advocated in this guidance document would be unmanageable as a component of a HACCP system. For many of these controls, it is not possible to define appropriate monitoring and critical limits that delineate “safe” product from product that is potentially unsafe. Occasional deviation from many of the controls described would not create a food safety hazard. The importance of such prerequisite programs in HACCP is recognized by the National Advisory Committee on Microbiological Criteria for Foods (Int. J. Food Microbiol. 14: 185-246. 1991).
While environmental testing for Listeria species is an excellent tool for identifying potential sources of L. monocytogenes in the processing and packaging area, lack of correlation between environmental findings and safety of products limits the utility of environmental testing as a monitoring function within a HACCP system. In addition, results are not available in “real time” and it is difficult to set meaningful “critical limits” that are relevant to product safety. We believe that the Agency incorrectly implies in its “Listeria Guidelines for Industry” that such testing could be part of an establishment’s HACCP plan.
Industry supports the consideration of finished product characteristics such as water activity, pH and other barriers to pathogen growth, such as freezing, when evaluating the public health risk of a product during a hazard analysis. The implementation of control measures may, and often should, be different between product that does not support the growth of L. monocytogenes and product that is susceptible to growth. Moreover, since the use of additives that minimize the growth of L. monocytogenes can significantly reduce the risk of listeriosis, FSIS should provide incentives for industry to develop products that contain such additives and expedite their approval, as noted above. An appropriate incentive would be for FSIS to consider these product characteristics when allocating resources and to reduce testing and evaluation of such products accordingly.
Since the potential for recontamination during the packaging process will always exist, alternative post packaging processes need to be developed. Irradiation of packaged product seems to offer the most promise. FSIS, working with FDA, should accelerate the broad approval of this potentially valuable tool and should help educate consumers to its usefulness, benefits and safety. The implementation of new controls such as in-package pasteurization (by heat, irradiation or other processes) and the use of inhibitors of L. monocytogenes growth could result in the use of additional CCPs in a HACCP plan.
NFPA, as a recognized authority in the processing of foods, has long recognized the importance of validation of processing parameters as adequate to meet a level of performance determined to be adequate to protect public health. NFPA appreciates that the Agency has provided guidance that can be used as a safe harbor for many of the processed products now being produced. NFPA also notes, however, that inadequate processing of livestock or poultry products does not appear to have been the cause of any of the recent problems that have resulted in recalls due to the finding of L. monocytogenes in foods. Thus, while we agree with FSIS on the importance of this topic, it does not appear that inadequate process delivery is a major contributor to Listeria contamination of RTE food products. NFPA recommends a measured approach to Agency emphasis on process validation, as this area will be unfamiliar to many in the industry who have traditionally followed Agency guidelines assuming that product produced under such guidelines would be safe.
In addition, NFPA has repeatedly cautioned the Agency that there are many items, which have been successfully and safely produced for many years that have never been studied scientifically to determine what factors contribute to their safety. Many of these products are manufactured by small and very small processors who lack the resources to commission research that may be needed to respond to Agency questions. Thus, a stringent approach to validating processes would place in jeopardy many of these products, as well as more common products produced by larger firms.
While being strong supporters of process validation, NFPA urges a cautious approach to Agency expectations for processing and stabilization validation. NFPA is committed to working with the Agency to develop useful and practical guidance on processing and cooling validation procedures, as well as an expansion of the generic information which may be used as safe harbors.
NFPA advocates the creation of a “non-RTE” product category for products with fully cooked meat and poultry and other components that are not ready to eat.
NFPA applauds Agency intent to recognize a distinct category for products that are composed of both ready-to-eat (RTE) meat or poultry and other not-ready-to-eat (NRTE) ingredients. We suggest that this category of NRTE products should be defined as any product with a fully cooked or otherwise RTE meat or poultry component and “raw, uncooked, blanched, or otherwise not fully cooked non-meat or poultry components.” We fully support the position taken by FSIS in the preamble to the Agency’s safe handling instructions that such products need not bear the safe handling instructions specified for raw products, as we strongly believe that these instructions may be misleading with respect to this category of product.
NFPA strongly recommends that the guidance provided to inspectors for the purpose of verification of HACCP plan reassessment must include explicit information to assure that inspectors can accurately distinguish between RTE and NRTE foods. Clearly, the focus of the recent Federal Register notice was RTE products. No precipitous action should be taken on products that are NRTE. In regard to that guidance, we suggest that the FSIS inspector should be advised to inquire about the establishment’s HACCP categorization; if the category is
“heat-treated but not fully cooked – not shelf stable,” no further action by the inspector should be necessary.
These products do not represent a significant risk to consumers.
As an initial matter, we call upon the Agency to recognize that there is no scientific basis for considering these products as representing a significant public health risk. In fact, whether considered by the Agency to be RTE or NRTE in the past, these products in their current packages have been consumed by the billions without any significant public health concerns. In deed, we are not aware of a single public health incident involving L. monocytogenes that has been linked to any frozen, fully cooked meat or poultry product, including those which are combined with raw, uncooked or lightly processed components. We know of no public health emergency for the Agency to dictate that industry must rush to incorporate a host of new labeling features at this time. Specifically, we see no basis for imposing unwarranted labeling expectations that will be interpreted by inspectors as “requirements.” In the absence of notice and comment rulemaking, such defacto requirements are inappropriate.
In the absence of an identified risk to public health, the Agency should consider the major economic impact involved and allow ample time for industry to make the recommended changes. Label changes are expensive. In fact, one company has indicated that limited changes with black lettering would cost the company $1000 per SKU and the addition of white lettering or a banner would cost $5000 per SKU. Based on the number of SKUs affected, the cost for this company would range from $250,000 -$500,000. It should be kept in mind that for most of these products such a change would involve packages as opposed to paper labels. Thus the expenses involved are much higher than for many other types of labeling changes. Another member company has estimated that their relabeling costs would be approximately $4,000 each for over 175 SKUs and between $6,000 and $10,000 each for more than 40 additional SKUs for larger packages that involve full color and affect the vignette. Total costs for this company would be approximately $1,000,000. A third member firm with over 500 SKUs estimates that its costs for relabeling will exceed $1,500,000.
Since some firms may have as much as a 6-month inventory of packaging, Agency consideration must be given to allowing the use of existing supplies, especially given the lack of public health concerns. For these and other reasons, we believe the most appropriate policy for the Agency would be to allow for a period of time of at least 6-months and preferably one year in order to make any changes that may ultimately be determined to be necessary. NFPA has previously urged the Agency to adopt a uniform labeling date for label changes that do not involve issues of public health. We believe this issue would be appropriate for such consideration.
NFPA supports development of labeling features which clearly indicate to consumers the need to cook the product prior to consumption.
NFPA concurs with the Agency that it is important to alert consumers to the fact that for safety reasons, NRTE products must be cooked according to labeled instructions. However, we believe that it is the totality of labeling information that provides effective information to the consumer rather than individual specific labeling components. We believe that consumers have been, and will continue to be, adequately alerted to the special needs by: 1) prominent display on the PDP of a statement that conveys the need to cook the product along with a referral to the location of the cooking instructions, in the manner of special handling requirements found in 318.17(k) for refrigerated or frozen foods; 2) information provided alongside the cooking instructions on the information panel along the lines of “FOR PROPER FOOD SAFETY AND QUALITY, FOLLOW THESE COOKING INSTRUCTIONS;” and 3) cooking instructions which can be validated as providing listericidal treatment of the product.
We believe that much of this information in one form or another is already in place for many frozen meat and poultry products. NFPA urges that the industry should have wide latitude and flexibility for label statements so long as the end result is that the consumer is alerted to the need to follow the cooking instructions provided on the package.
We believe that a label statement that mentions food safety is appropriate for this category of products. We feel confident that a statement along the lines noted above, adjacent to the cooking instructions, would definitively inform the consumer that for safety the cooking instructions must be followed.
NFPA does not believe that modification of the product name is essential to convey this information, nor do we think that a “flag” or “burst” would always be necessary to fully alert consumers. NFPA members are preparing for discussion with FSIS “mock labels” containing language in a format that we believe adequately conveys the need to properly cook such products.
NFPA and other industry groups have initiated a good faith effort to work with the Agency on various types of consensus labeling statements that will accomplish our mutual desire to assure that consumers are informed about the nature of these products. We believe the Agency should allow time for this effort to work on these low risk NRTE combination products without unnecessary disruption to the industry.
NFPA strongly opposes the inclusion of safe handling instructions on NRTE products containing RTE meat or poultry.
NFPA objects to any requirement for these products to bear safe handling instructions as specified for raw products [9 CFR 317.2 (l) and 381.125]. The messages are simply not appropriate and would result only in confusing the consumer. The position espoused by the Agency in the preamble to the safe handling instructions regulation was correct at that time and it is still correct.
There should be no special requirements for documentation of lethality of fully cooked meat or poultry components of these products.
In most cases, establishments which produce frozen entrees and dinners, etc. receive fully cooked (RTE) meat/poultry components from FSIS-inspected establishments. Even if prepared on site, the fully cooked meat/poultry components are required to be produced under the provisions of HACCP and must meet FSIS requirements for lethality. There should be no need for a receiving establishment to maintain special documentation on file that the RTE meat/poultry has received a lethality treatment validated for safety or that it has been handled in a manner to prevent cross contamination.
NFPA encourages industry to develop data to support the lethality of cooking instructions.
While NFPA supports the desirability for firms to document the lethality of their cooking instructions, data on the low level of pathogens in NRTE components simply are not widely available at this time. It must be recognized that the expected levels of L. monocytogenes in these products will be low, since the meat or poultry component is fully cooked and other ingredients may have been given a treatment that substantially reduces the level of contamination. It would not be appropriate to require such products to have cooking instructions that meet the published lethality performance standards or the safe harbor temperatures, although if the cooking instructions do achieve this level of lethality, there should be no question about the adequacy of the cooking instructions.
Industry will be addressing methods for validating the cooking instructions and for determining appropriate levels of inactivation and heat resistance (D-values) of L. monocytogenes for various products. However, there is no reason to believe that current instructions are inadequate to ensure product safety. Thus, in the absence of a clear public health risk, we believe that the Agency must allow a substantial amount of time for the development of these data.
NFPA objects to any agency expectation that all products should carry cross contamination and leftover handling instructions.
Refrigeration of leftovers and cross contamination warnings are not of special importance to the NRTE products under discussion. Rather they represent common sense food handling messages that are neither unique nor product specific. We believe such universally applicable messages are most appropriate for use in consumer education materials, such as the “Fight BAC” campaign. We believe it is inappropriate to mandate the inclusion of this type of information in the limited space available on food product labels. Nevertheless, when appropriate, many products which are clearly intended as multi-serve portions already bear instructions about prompt refrigeration of leftovers. We see no problem with this.
We also believe that the currently required statement, “KEEP FROZEN” adequately conveys the need to keep product frozen until it is ready to be cooked. Nevertheless, we have no problem with firms which elect to include “DO NOT THAW” alongside the required special handling statement.
Labeling for ready-to-eat foods
These products are not required to bear safe handling instructions. Nevertheless, if a manufacturer desires to include safe handling instructions on such products (for example, in order to promote uniformity of labeling on a product line which includes both RTE and NRTE products) it should be permitted to do so. We believe that providing more stringent than necessary cooking instructions for this purpose would promote uniform handling rather than cause confusion among consumers. The cooking instructions should be listericidal.
CONCLUSION
In conclusion, NFPA reiterates its position that L. monocytogenes control is more complex than simply indicating that the hazard must be addressed in a HACCP plan. The Agency must recognize that, because of the unique nature of the organism, control strategies for L. monocytogenes must involve several components, including stringent industry control and monitoring programs, education of the at-risk consumers (and/or their care-givers), and targeted regulatory monitoring programs, along with a tolerance for low levels of the organism in foods in which the organism cannot grow. A regulatory approach that encourages the industry to have environmental control and monitoring programs without penalizing establishments for finding the organism in the environment is essential to reducing the risk from L. monocytogenes. It is critical that the Agency focus its attention on those products in which the organism can grow in order that its limited resources can be most effectively applied to true food safety risks.
NFPA appreciates this opportunity to comment on this important rulemaking activity.
Sincerely,
Rhona Applebaum
Executive Vice President, Scientific and Regulatory Affairs