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FSIS Strengthens Regulations to Reduce Listeria monocytogenes In Ready-To-Eat Meat and Poultry Products

WASHINGTON, June 4, 2003--The U.S. Department of Agriculture's Food Safety and Inspection Service today announced an interim final rule requiring federal establishments producing certain ready-to-eat (RTE) meat and poultry products to take steps to further reduce the incidence of Listeria monocytogenes.

The rule requires all establishments that produce RTE products that are exposed to the environment after cooking to develop written programs to control Listeria monocytogenes and to verify the effectiveness of those programs through testing.  Establishments must share testing data and plant generated information relevant to their controls with FSIS. The rule also encourages all establishments to employ additional and more effective Listeria monocytogenes control measures.

This rule follows a number of actions the Department has already taken over the last few months on Listeria.  In October 2002, Agriculture Secretary Ann M. Veneman asked FSIS to develop a plan to strengthen controls for Listeria monocytogenes, including a revised testing protocol and a focus on those establishments that produce the highest risk products.  This rule is an important step in that process.

“While the Centers for Disease Control and Prevention reported a 35 percent drop in the incidence of listeriosis from 1996-2002, it remains a very serious food safety concern, especially for the very young, the elderly and individuals with compromised immune systems," said Under Secretary for Food Safety Dr. Elsa Murano.  “This rule encourages plants to incorporate technologies that can kill the bacteria or prevent its growth after cooking and packaging.  Furthermore, FSIS will verify through testing that plant controls are working as intended, focusing its resources to attain the greatest benefit to public health."

Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, RTE product is adulterated if it contains Listeria monocytogenes or if it comes into direct contact with a food contact surface that is contaminated with the pathogen.  Listeria monocytogenes can contaminate and grow in RTE products if they are not formulated or produced in a manner to destroy or suppress the growth of the organism.

“This rule will help us protect public health because it establishes a proactive mechanism to detect and prevent Listeria monocytogenes,” said FSIS Administrator Dr. Garry L. McKee.

The rule was developed after considering information from a variety of sources, including numerous public comments, a risk ranking conducted by the Food and Drug Administration (FDA) and FSIS, and a risk assessment on ready-to-eat meat and poultry products carried out by FSIS. 

"The risk assessment demonstrated that a combination of interventions appear to be much more effective than any single intervention in reducing contamination," said Dr. Murano.

Under the rule, establishments producing RTE products must address Listeria monocytogenes through a written program such as their Hazard Analysis and Critical Control Point (HACCP) systems, Sanitation Standard Operating Procedures (Sanitation SOPs) or other prerequisite programs.  Establishments must also verify the effectiveness of these actions through testing and share the results with FSIS.  To ensure that establishments effectively control this pathogen, FSIS will continue to conduct its own random testing to verify each establishment’s control program. 

Establishments must choose one of three alternatives to control for Listeria monocytogenes.  However, FSIS will conduct the greatest number of verification activities in those establishments that rely solely on sanitation practices.  

The alternatives that establishments must choose from are:

• Alternative 1 – Employ both a post-lethality treatment and a growth inhibitor for Listeria monocytogenes on RTE products.  Establishments opting for this alternative will be subject to FSIS verification activity that focuses on the post-lethality treatment’s effectiveness.  Sanitation is important but is built into the degree of lethality necessary for safety.

• Alternative 2 – Employ either a post-lethality treatment or a growth inhibitor for the pathogen on RTE products. Establishments opting for this alternative will be subject to more frequent FSIS verification activity than those in Alternative 1.

• Alternative 3 – Employ sanitation measures only.  Establishments opting for this alternative will be targeted with the most frequent level of FSIS verification activity.  Within this alternative, FSIS will place increased scrutiny on operations that produce hotdogs and deli meats.  In a 2001 risk ranking, FSIS and FDA identified these products as being high-risk products for listeriosis. 

In addition, the rule requires establishments to furnish information on the production volume and related information on products affected by the regulations.  This information is critical for FSIS to design a more risk-based verification-testing program.  In particular, FSIS will increase verification in operations that produce large volumes of product due to the potential impact on public health that the pathogen poses if present.

The rule also enables establishments to make claims on their RTE product labels that describe the processes used to eliminate or reduce Listeria monocytogenes, or suppress its growth.   FSIS believes this will be one way for consumers to be able to identify products with enhanced safety specific to this pathogen.

This rule becomes effective 120 days after publication in the Federal Register on June 6.  FSIS will accept comments to the rule for 18 months after publication for the purpose of reviewing and evaluating the effectiveness of these approaches.

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NOTE: Access news releases and other information at the FSIS web site at http://www.fsis.usda.gov.

For Further Information, Contact:
FSIS Congressional and Public Affairs Staff
Phone: (202) 720-9113
Fax: (202) 690-0460

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