"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
- 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