Docket Clerk
USDA-FSIS, Room 102
Cotton Annex, 300 12th Street, SW
Washington, DC 20250-3700
Re: USDA-FSIS Docket No. 97-013P Performance Standards for the Production of Processed Meat and Poultry Products
The Association of Food and Drug Officials (AFDO) Board of Directors (hereinafter referred to as the Board) is pleased to have the opportunity to comment on the U.S. Department of Agriculture, Food Safety and Inspection Service’s (FSIS) proposed rule, Performance Standards for the Production of Processed Meat and Poultry Products, Docket No. 97-013P, Federal Register, Vol. 66, No. 39, February 27, 2001.
The Board applauds the efforts of FSIS to develop microbiological performance standards for ready-to-eat (RTE) meat and poultry products and believes that this is an appropriate direction for FSIS to focus its attention. In the preamble of the proposed rule, FSIS presents significant documentation to justify selecting Salmonella, as the reference organism for most RTE meat and poultry products and the Board believes that this is an appropriate choice. The Salmonella performance standard, coupled with the E. coli O157:H7 performance standard for fermented RTE products that contain any amount of beef, should substantially improve the margin of safety for consumers. However, the Board does believe that FSIS should develop criteria that identify the level, number and frequency of violations of the performance standards that will trigger enforcement actions.
FSIS requests comment on whether the regulations should enumerate lethality performance standards for other pathogens and toxins that can pose hazards to specific products or within specific processing contexts. Based on the documentation presented or referenced in the preamble, the Board believes that substantial completed research fully justifies FSIS’s selection of Salmonella and E. coli O157:H7 as the reference organisms, and, with the exception of fermented RTE products that do not contain beef, that no other performance standards, based on current science, should be necessary. Additionally, the fact that meat and poultry establishments must also reduce other pathogens and their toxins or toxic metabolites to prevent product adulteration provides additional support to the position that performance standards are necessary for most products. The requirement that the presence of certain viable pathogens, even in the absence of reference pathogens, would render a RTE product as adulterated appropriately places the responsibility for assurance of product safety at the producer level.
FSIS is fully justified in proposing the E. coli O157:H7 performance standard for fermented RTE products that contain any amount of beef, based on confirmed cases of foodborne illness that have been caused by such products. FSIS states that it is not proposing the E. coli O157:H7 performance standard for fermented RTE products that do not contain beef. The Board feels that if compliance with the proposed Salmonella performance standard provides a reasonable level of assurance that a product would not be adulterated with E. coli O157:H7, no additional performance standard would be necessary for these products. However, the Board believes that the fact that E. coli O157:H7 has been found to colonize the ceca of chickens and has been isolated from retail poultry in the United States may be justification enough to propose an additional performance standard for fermented RTE products that do not contain beef. The Board believes that FSIS should reconsider proposing an additional performance standard for such products. Since there have been no documented illnesses or outbreaks from chicken due to E. coli O157:H7, perhaps another organism, such as Campylobacter, would be an appropriate reference organism for the development of an additional performance standard for fermented RTE products that do not contain beef.
The Board believes that the proposed stabilization performance standards to control the multiplication of toxigenic microorganisms such as Clostridium botulinum and Clostridium perfringens in RTE and partially heat-treated products are proper and sensible. In particular, the no (zero) multiplication of C. botulinum, as proposed, is a matter of necessity if there is to be continued assurance, as consumers have come to expect, that C. botulinum will not be a microorganism of concern in RTE products.
FSIS asks for comments about the proposed testing frequencies for Listeria spp. on food contact surfaces. The Board does not believe that enough data is currently available to properly assess the suitability and efficacy of the proposed testing frequencies. If FSIS eventually implements this environmental testing program, time will certainly demonstrate the effectiveness of these frequencies in preventing product adulteration. Environmental testing of food contact surfaces for Listeria spp. may be an appropriate protocol for controlling Listeria monocytogenes in finished RTE products. Certainly, if environmental testing is implemented, it is proper that a finding of Listeria spp. on food contact surfaces should lead to more specific requirements regarding product sampling and testing. Simply put, an environmental sample that is positive for Listeria spp. does not necessarily equal a finished product sample that is positive for Listeria monocytogenes. Therefore, it would appear that environmental testing for Listeria spp., coupled with finished product testing for Listeria monocytogenes when environmental samples are positive, would be a more effective food safety protocol. Additionally, the testing for Listeria spp. on food contact surfaces should provide some level of assurance to producers of the efficacy of the establishment’s Sanitation Standard Operating Procedures in controlling Listeria monocytogenes.
Utilization of “Use by” dates on packages of RTE products could provide significant benefit to consumers with respect to control of Listeria monocytogenes. However, for “Use by” dates to provide any benefit, procedures must be established to assure that such dates have not been arbitrarily determined, but that they were developed utilizing appropriate scientific and food safety engineering methodologies. The Board is also concerned that the use of “Use by” dates may not take into consideration that temperature abuse or mishandling could have occurred during any point throughout the channels of commerce or in the hands of the consumer. If that is the case, “Use by” dates could provide a false sense of security to consumers. The Board also believes that any required dating practices that are implemented should be uniform throughout the food industry and for all food products to eliminate any confusion that consumers may experience. In other words, “Use by” dates cannot be used in conjunction with “Sell by” dates, dates of manufacture, or other dating systems if they are to have any effective meaning to consumers.
The Board believes that refrigeration statements on shelf stable RTE products that require refrigeration after opening are imperative. The mere appearance of these products often seems to imply that they may be shelf stable, even after opening. Therefore, extra measures must be taken to provide consumers with necessary information about the safe storage of such products after opening. The Board is previously on record with the U.S. Food and Drug Administration (FDA) relative to FDA’s document entitled Guidance on Labeling of Foods That Need Refrigeration by Consumers. On January 30, 1998, the Board commented that there should be a single set of nationally uniform guidelines to address labeling of foods needing refrigeration, and that these guidelines should convey a consistent and uniform message to the consumer. Additionally, the Board stated in those comments that it supported labeling designations contained in the National Food Processors Association document entitled Labeling Recommendations for Refrigerated Foods. The Board still believes that whatever labeling guidelines are decided upon, they need to be a single set of nationally uniform guidelines that convey a consistent and uniform message to the consumer.
Existing requirements for thermally processed, commercially sterile meat and poultry products are time-tested and broadly accepted requirements. Although the proposed general performance standard would represent regulatory reform, the Board agrees with the expressed reservations concerning the replacement of the existing regulations with performance standards. The complexity of the canning process and the virulence of C. botulinum toxin are certainly more than adequate justification for maintaining the existing prescriptive regulations. The Board believes that these prescriptive regulations represent a situation where regulatory reform is absolutely unnecessary.
Based on the information provided, the elimination of the Trichina treatment requirements would appear to be premature, since there are no published studies comparing the lethalities of Salmonella and E. coli O157:H7 to the destruction of Trichina in dried, salt cured, or fermented products. FSIS should develop a greater level of certainty with regards to the Salmonella and E. coli performance standards and their efficacy relative to the destruction of Trichina before eliminating the Trichina treatment requirements. The Board recommends that FSIS reconsider the proposed elimination of the Trichina treatment requirements until there is sufficient science-based rationale available to justify such a move.
The AFDO Board appreciates the opportunity to provide comments on this proposed rule and encourages FSIS to give serious consideration to revising appropriate portions of the proposed rule to incorporate these suggestions.
Sincerely,
Doug Saunders
President
