"The interim final rule on the control of Listeria monocytogenes (Lm) in Ready-to-Eat (RTE) Meat and Poultry Products, like all USDA Food Safety & Inspection Service (FSIS) regulations, is based on sound science and has as its number one goal the protection of public health.

"The interim final rule, published in June, 2003, is far stronger and requires significantly more from industry than the proposed rule published on Feb. 27, 2001. The requirements of the interim final rule have spurred the industry to greatly increase testing and incorporate new technologies to control or eliminate Lm.

"The results have been remarkable. The number of Lm recalls fell from 40 in 2002 to 14 in 2003 and there has not been a large Lm recall in more than two years. According to the Centers for Disease Control and Prevention, no outbreaks of Lm related to meat and poultry products were documented in 2003. The CDC data are consistent with the results of FSIS regulatory testing for Lm, which showed a 25 percent reduction in the percentage of positive samples collected in 2003 compared to 2002.

"The 2001 proposed rule, which was based on the limited information available at the time, followed the two largest recalls in FSIS history – both for Lm – 35 million pounds in 1998 and 33 million pounds in 1999. The proposed rule:

• Treated all plants that produced ready to eat products the same, despite the fact that not all products carry the same level of risk;
• Did not require that plants treat Lm as a hazard likely to occur and address preventative measures in their HACCP plans;
• Contained minimum levels of food contact surface testing for Listeria species; and
• Did not specifically mandate that plants share their testing data results with FSIS.

"In contrast, the interim final rule was based on an extensive Lm risk assessment of RTE meat and poultry products carried out by FSIS, as well as a risk ranking conducted by the FDA and FSIS. The risk assessment found that the minimal food contact surface testing in the proposed rule would not be as effective as a combination of interventions. This finding guided the development and implementation of the interim final rule. The results of the risk assessment were presented at a public meeting in early 2003 and were posted on the FSIS web site. The interim final rule is unique in that, for the first time, the agency provided for an extended comment period set at 18 months so that the effectiveness of the regulations could be studied. The comment period will continue until January 31, 2005.

"The interim final rule requires that establishments producing RTE products must consider Lm a hazard likely to occur and address it through a written program such as their HACCP plan. Establishments must verify the effectiveness of their action through in-plant testing and must share their testing data with FSIS. The requirements for testing by plants are determined by the relative risk of what is being produced and the interventions in place to control or eliminate Lm. Those establishments producing the highest risk products relying on sanitation alone to control Lm receive the greatest level of scrutiny by FSIS.

"FSIS has significantly enhanced its scrutiny of establishments producing RTE products through the interim final rule, while providing incentives for industry to implement new preventive measures. An internal assessment of the interim final rule, prepared by a 28-member team and released December 1, 2004, found that plants have made significant improvements to address Lm, such as adding antimicrobial ingredients to their product formulations to inhibit Lm growth and installing a post-processing treatment step to eliminate the pathogen. In addition, the report found that plants have either initiated or greatly increased their testing for Listeria or Listeria-like organisms on plant surfaces that come in contact with products after cooking. These testing data are available to FSIS inspection personnel as a result of the interim final rule and are used to determine the effectiveness of sanitation and other control measures.

"The interim final rule has made RTE products safer and improved health protection for American consumers. FSIS will continue to review public comments and the rule's implementation to make it even stronger."