Alliance for Listeriosis Prevention - Questions and Answers

These questions and answers relate to the Petition to Establish a Regulatory Limit for Listeria monocytogenes in Foods That Do Not Support Its Growth.

Note: A helpful resource for information and questions about Listeriosis generally can be found on the Web site of the Centers for Disease Control and Prevention.

Q:

What is a "regulatory limit"?

A:

A regulatory limit establishes limits on levels of unavoidable deleterious substances. Regulatory limits are binding on the Food and Drug Administration and the U.S. Department of Agriculture, the courts and regulated industry. Foods that comply with the regulatory limit are deemed in compliance with the Federal Food Drug and Cosmetic Act. From a public policy perspective, requesting a limit for an “unavoidable” microorganism (including Listeria monocytogenes,. which is ubiquitous) is more appropriate than requesting a tolerance.

Q:

Isn’t maintaining a “zero tolerance” safer than establishing a regulatory limit for Listeria monocytogenes. in some foods?

A:

No. Numerous countries have established a standard for Listeria monocytogenes. contamination of foods that do not support the growth of the microorganism. The incidence of listeriosis in the United States is not lower than other industrialized countries that have applied policies that permit 100 cfu/g in certain foods. In fact, a regulatory limit will have public health benefits, including the application of risk management practices associated with a regulatory limit; enhanced allocation of finite resources; encouragement of sampling programs; enhanced availability of concentration data and fostering of the development of products that do not support the growth of Listeria monocytogenes.. In short, providing a regulatory limit is a risk-based approach that will allow regulatory resources to focus on foods with the potential for having high numbers of Listeria monocytogenes..

Q:

Why was 100 cfu/g chosen for the regulatory limit?

A:

Although there is no scientific consensus regarding the minimum infectious dose for Listeria monocytogenes., there is agreement that levels that substantially exceed 100 cfu/g are needed to present a high likelihood of illness even in those most susceptible to listeriosis, such as immunocompromised individuals. Risk assessments have demonstrated that foods with 100 cfu/g or lower provide a negligible contribution to the number of cases of listeriosis. In fact, many scientific experts indicate that the 100 cfu/g regulatory limit is conservative, and could safely be set substantially higher.


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