Draft Compliance Policy Guide Sec. 555.320-Listeria monocytogenes, 7293 [08-547]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 73, Number 26 (Thursday, February 7, 2008)]
[Notices]
[Page 7293]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 08-547]



[[Page 7293]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0058]


Draft Compliance Policy Guide Sec. 555.320--Listeria 
monocytogenes; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the draft Compliance Policy Guide (CPG) Sec. 555.320 
Listeria monocytogenes (the draft CPG). The draft CPG provides guidance 
for FDA staff on the agency's enforcement policy for Listeria 
monocytogenes in ready-to-eat (RTE) foods that support growth of the 
organism and RTE foods that do not support growth of the organism.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by April 7, 2008.

ADDRESSES:  Submit written comments on the draft CPG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic comments 
to https://www.regulations.gov.
    Submit written requests for single copies of the draft CPG to the 
Division of Compliance Policy (HFC-230), Office of Enforcement, Food 
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send 
two self-addressed adhesive labels to assist that office in processing 
your request, or fax your request to 240-632-6861. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the draft 
CPG.

FOR FURTHER INFORMATION CONTACT:  Mary Losikoff, Center for Food Safety 
and Applied Nutrition (HFS-325), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 301-436-1412.

SUPPLEMENTARY INFORMATION:

I. Background

    L. monocytogenes is a pathogenic bacterium that is widespread in 
the environment and thus may be introduced into a food processing 
facility. L. monocytogenes can contaminate foods and cause a mild 
illness (called listerial gastroenteritis) or a severe, sometimes life-
threatening, disease (called invasive listeriosis). Foods that have 
been implicated in outbreaks or sporadic cases of invasive listeriosis 
have been foods that are RTE.
    The draft CPG is intended to provide clear policy and regulatory 
guidance for FDA staff regarding L. monocytogenes in certain foods. In 
particular, the draft CPG sets forth an enforcement policy concerning 
L. monocytogenes in RTE foods that support the growth of L. 
monocytogenes and RTE foods that do not support the growth of L. 
monocytogenes. The draft CPG describes the characteristics of RTE foods 
that do and do not support the growth of L. monocytogenes and 
identifies examples of foods that fall into each category.
    For RTE foods that support the growth of L. monocytogenes, FDA's 
current thinking is that it may regard the food to be adulterated 
within the meaning of section 402(a)(1) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 342(a)(1)) (the act) when L. monocytogenes is 
present in the food, based on an analytical method that can detect 1.0 
colony forming units (CFUs) of L. monocytogenes per 25 grams (g) of 
food (i.e., 0.04 CFU/g). For RTE foods that do not support growth of L. 
monocytogenes, FDA's current thinking is that it may regard the food to 
be adulterated within the meaning of section 402(a)(1) of the act when 
L. monocytogenes is present at or above 100 CFUs/g of food.
    Further discussion of FDA's current thinking on L. monocytogenes in 
RTE foods, including the scientific support informing FDA's current 
thinking, can be found in the Notice of Public Meeting regarding the 
draft CPG, published elsewhere in this issue of the Federal Register, 
and in the references cited therein.
    The draft CPG is being issued as a Level 1 draft guidance 
consistent with FDA's good guidance practices regulation (21 CFR 
10.115). The draft CPG, when final, will represent the agency's current 
thinking on L. monocytogenes in RTE foods. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternate approach may be used if such approach satisfies 
the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the draft CPG. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. The draft CPG and received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through the FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the draft CPG from 
the Office of Regulatory Affairs home page. It may be accessed at 
https://www.fda.gov/ora under ``Compliance Reference.''

    Dated: January 23, 2008.
Margaret O'K. Glavin,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 08-547 Filed 2-6-08; 8:45 am]
BILLING CODE 4160-01-S