# Presentation: 463016

## Draft Compliance Policy Guide

**Robert L. Buchanan**
**HHS Food and Drug Administration**
**Center for Food Safety and Applied Nutrition**

## Draft Guidance Documents 

**Draft Compliance Policy Guide for FDA Staff Sec. 555.320 *****Listeria monocytogenes***
**Federal Register Announcement of Public Meeting**

## Background

**After initial improvements, the incidence of foodborne listeriosis cases has ceased declining over the past 4 years, suggesting that new focused approaches should be considered**
**The FDA received an industry petition that stated that a “numbers-based approach” would encourage reformulation and testing by industry**
**Critically important that FDA is viewed nationally and internationally as a “science-driven,” risk-based food safety agency**
**Increasingly important that our food safety requirements are harmonized to the degree appropriate with international standards**
**Risk assessments, scientific evaluations and extensive research have identified the key factors that influence the risk of foodborne listeriosis **

## Goal

**Within our legal framework, the goal is to:**
_**Enhance public health**_
**Focus our efforts where there is the greatest risks**
**Base our actions on science and risk**
**Encourage industry to develop innovations that enhance the safety of their products such as**
**Product reformulation **
**Post-packaging treatments**
**Effective testing programs **
**Harmonize, where appropriate, our guidelines with those accepted internationally**

## Draft Compliance Policy Guide

**“****This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance.”**

## Draft Compliance Policy Guide

**Scope:  Ready-to-Eat Foods**
**Foods consumed without further cooking by consumer **
**Foods that reasonably appear to be suitable for consumption without cooking**
**Foods may be considered RTE if consumers are likely to use the product without cooking, despite cooking instructions provided on the label **

## Draft Compliance Policy Guide

**The CPG establishes two levels for foods to be considered adulterated under 402(a)(1) based on their ability to support growth of *****L. monocytogenes***** over the course of the food’s shelf-life**
**RTE foods that support growth: <0.04 CFU/g (absence in 25 g) **
**Current requirement**
**RTE foods that do not support growth:  ≤100 CFU/g**

## Draft Compliance Policy Guide

**The draft CPG:**
**Establishes general criteria for distinguishing between foods that do and do not support growth of *****L. monocytogenes***
**a****W**** ****≤**** 0.92**
**pH ****≤ 4.4**
**Frozen until consumed**
**Provides option for other validated controls (e.g., antimicrobials, pH/aw combinations) that prevent growth over the course of a RTE food’s entire shelf-life **

## Draft Compliance Policy Guide

**Would appreciate comments related to the our “draft guidance to industry” on how to validate that a food does not support growth of *****L. monocytogenes*****  and documentation needed by our inspectors**
**Duration of the test period (e.g., 1.3X shelf-life)?**
**Temperature for determining ability to support growth (e.g., 4****o, 8oC)?**
**Differences in *****L. monocytogenes***** levels still considered as not indicative of growth (e.g., 1-log, 0.5-log)?**

## Draft Compliance Policy Guide

**The draft CPG:**
**Provides guidance on the standard methods to be used by FDA laboratories for analyzing samples**
**Food that support growth: Bacteriological Analytical Manual Online, Chapter 10 - "*****Listeria monocytogenes*****," "Detection and Enumeration of *****Listeria monocytogenes***** in Foods" as the method for detecting and confirming presence of *****L. monocytogenes***** (available at**** **_**[http://www.cfsan.fda.gov/~ebam/bam-10.html](http://www.cfsan.fda.gov/~ebam/bam-10.html)**_**)**
**Food that do not support growth:  Use ISO 11290-2:1998(E) "Microbiology of food and animal feeding stuffs - Horizontal method for the detection and enumeration of *****Listeria monocytogenes***** - Part 2: Enumeration method"  **
**Confirmation:  BAM method**

## Microbiological Testing

**ISO 11290-2:1998(E) - Enumeration method**
**Direct Plating **
**Lower limit of sensitivity is appropriate for 100 CFU/g**
**Simplifies testing for foods that do not support growth**

## Draft Compliance Policy Guide

**The draft CPG:**
**Is to be applied on a case-by-case basis**
**Does not establish an acceptable level of *****L. monocytogenes***** in food**
**FDA does not expect to see a decrease in the general level of control of *****L. monocytogenes***** now achieved in RTE foods that do not support growth **
**Does not excuse CGMP violations or preclude an action under 402(a)(4)**

## Anticipated Impact

**It is expected that the draft CPG will:**
**Encourage industry to reformulate RTE foods and implement other control measures**
**Allow FDA to focus more of its resources on the highest risk foods**
**Allow FDA to harmonize its programs with the international guidance being developed by Codex Alimentarius**

## Comments on CPG

**Submit comments to:**
**Docket No. FDA–2008–D–0058**
**	****Draft Compliance Policy Guide Sec. 555.320 *****Listeria monocytogenes*****; Notice**
**	****of Public Meeting**