[Federal Register: May 3, 2005 (Volume 70, Number 84)]
[Notices]               
[Page 22888-22889]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03my05-66]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0065]

 
Risk Assessment of the Public Health Impact From Foodborne 
Listeria Monocytogenes in Smoked Finfish; and Evaluation of Food Code 
Provisions That Address Preventive Controls for Listeria Monocytogenes 
in Retail and Foodservice Establishments; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to July 5, 
2005, the comment period for the notice that appeared in the Federal 
Register of March 4, 2005 (70 FR 10650). In the notice, FDA requested 
comments and scientific data and information to assist the agency in 
its plans to conduct a risk assessment for Listeria monocytogenes in 
smoked finfish and to evaluate the provisions of the 2001 Food Code 
that address preventive controls for L. monocytogenes in retail and 
foodservice establishments. The agency is taking this action in 
response to a request for an extension to allow interested persons 
additional time to submit comments and scientific data and information.

DATES: Submit written and electronic comments and scientific data and 
information by July 5, 2005.

ADDRESSES: Submit written comments and scientific data and information 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments, data, and information to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov.gov/dockets/ecomments
.


FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food 
Safety and Applied Nutrition (HFS-06), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1903.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 4, 2005 (70 FR 10650), FDA 
published a notice with a 60-day comment period to request comments and 
scientific data and information to assist the agency in its plans to 
conduct a risk assessment for L. monocytogenes in smoked finfish 
(smoked finfish risk assessment) and to evaluate the provisions of the 
2001 Food Code that address preventive controls for L. monocytogenes in 
retail and foodservice establishments.
    For the smoked finfish risk assessment, the agency specifically 
requested information on the following topics:
    1. L. monocytogenes levels in raw fish, smoked fish, and finished 
product,
    2. Effect of mitigation measures (e.g., ozonation, acidified sodium 
chlorite) to reduce L. monocytogenes levels in raw and finished 
product,
    3. Potential for transfer of L. monocytogenes to food from 
contaminated food contact and noncontact surfaces during manufacturing 
and/or processing (e.g., equipment, workers, floor drains, etc.),
    4. Potential for transfer of L. monocytogenes from the slicer to 
cold-smoked fish,
    5. Impact of adding inhibitors (e.g., bacteriocins and 
bacteriocins-producing bacterial strains or sodium lactate) to smoked 
finfish to reduce or prevent L. monocytogenes growth,
    6. Impact of frozen versus refrigerated storage conditions on 
levels of L. monocytogenes,
    7. Impact of time and temperature on levels of L. monocytogenes for 
commercial and home storage conditions of finished product, and
    8. Effect of training regarding sanitation and hygienic practices 
on reducing the levels of L. monocytogenes in smoked finfish.
    For evaluating the Food Code provisions for preventive controls for 
L. monocytogenes in retail and foodservice establishments, the agency 
specifically requested the following data and information:
    1. L. monocytogenes levels in products stored in retail and 
foodservice establishments,
    2. Levels of environmental contamination and harborage of L. 
monocytogenes on food contact and nonfood contact surfaces in retail 
and foodservice establishments (e.g., equipment, workers, floor drains, 
etc.),

[[Page 22889]]

    3. Effects of short- and long-term refrigerated storage on levels 
of L. monocytogenes in retail and foodservice establishments,
    4. Impact of time and temperature on levels of L. monocytogenes in 
products stored in retail and foodservice establishments,
    5. Efficacy of cleaning procedures and sanitizing agents on 
environmental surfaces and utensils,
    6. Frequency of use and impact of adding inhibitors to food 
products in retail and foodservice establishments to reduce or prevent 
L. monocytogenes growth, and
    7. Effect of training regarding hygienic practices and sanitation 
on levels of L. monocytogenes in products in retail and foodservice 
establishments.
    Interested persons were given until May 3, 2005, to submit comments 
and scientific data and information.
    The agency has received a request for a 60-day extension of the 
comment period for the notice. The request conveyed concern that the 
current 60-day comment period does not allow sufficient time to develop 
a meaningful response to the notice.
    FDA has considered the request and is extending the comment period 
for the notice for an additional 60 days, until July 5, 2005. However, 
the agency does not anticipate granting any further extensions of the 
comment period.

II. Request for Comments and for Scientific Data and Information

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments, scientific data, and 
information on this document. Submit a single copy of electronic 
comments, scientific data, and information 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. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: April 28, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-8838 Filed 4-29-05; 11:30 am]

BILLING CODE 4160-01-S