Federal Register / Vol. 73, No. 26 / Thursday, February 7, 2008 / Notices 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-toeat (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draft guidance by April 7, 2008.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 http:// 

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 selfaddressed 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 http:// 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0494] 

Draft Guidance for Industry: Control of 

Listeria monocytogenes in 

Refrigerated or Frozen Ready-To-Eat 

Foods; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Guidance for Industry: Control 

of Listeria monocytogenes in 

Refrigerated or Frozen Ready-To-Eat 

Foods’’ (the draft Listeria guidance). 

This draft guidance, when finalized, 

will complement FDA’s current good 

manufacturing practices (CGMP) 

regulations by providing specific 

guidance on the control of L. 

monocytogenes in the processing of 

refrigerated or frozen ready-to-eat foods 

(RF-RTE foods). The draft Listeria 

guidance and the CGMP regulations are 

intended to assist processors in 

controlling L. monocytogenes in the 

food processing environment during the 

manufacture of RF-RTE foods. 

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 


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