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; Request for Comments and for Scientific Data and Information, 10650-10651 [05-4217]

Download as PDF 10650 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices The annual reporting burden hours to respondents for medical device tracking is estimated to be 247,082 hours, and recordkeeping burdens for respondents is estimated to be 3,160,102 hours. These numbers have been rounded up. The estimates cited in tables 1 and 2 of this document are based primarily upon the data and methods provided in FDA’s 1999 assessment entitled ‘‘A Cost Assessment of Medical Device Tracking.’’ Using implantation procedures from the National Center for Health Statistics, FDA applied a 2 percent annual growth rate to estimate the number of procedures for tracked implant devices from 1997–2006. The assessment also used unit shipment data in combination with various growth rates to estimate annual/sales distribution for the tracked l/s-l/s devices over the same time period. Additionally, the assessment estimates the industry burden for developing and maintaining tracking systems for these devices from 1997–2006. For the annual recordkeeping burden, the number of manufacturers subject to device tracking (229) is based on data from FDA’s manufacturers database. FDA issued tracking orders to 20 additional manufacturers during the time period 2002–2004. Under § 821.25(c), the additional manufacturers collectively bear a onetime burden of 10,560 hours to develop a device tracking system. FDA’s estimate of 17,000 distributor respondents contained in the assessment is derived from Dun & Bradstreet sources on medical equipment wholesalers, retailers, home care dealers, and rental companies. Health Forum, an American Hospital Association Co., provided statistics on hospitals. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4161 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1903. SUPPLEMENTARY INFORMATION: I. Background The Department of Health and Human [Docket No. 2005N–0065] Services Healthy People 2010 is a Risk Assessment of the Public Health comprehensive set of disease prevention Impact from Foodborne Listeria and health promotion objectives for the Monocytogenes in Smoked Finfish; Nation to achieve over the first decade of the new century. Created by scientists and Evaluation of Food Code both inside and outside of Government, Provisions That Address Preventive Controls for Listeria Monocytogenes in it identifies a wide range of public health priorities and specific, Retail and Foodservice measurable objectives. One of these Establishments; Request for objectives calls on Federal food safety Comments and for Scientific Data and agencies to reduce foodborne listeriosis Information (Ref. 1). In support of this goal, in 2003, AGENCY: Food and Drug Administration, FDA issued an assessment of the HHS. relative risk to the public health from ACTION: Notice; request for comments foodborne L. monocytogenes among and for scientific data and information. selected categories of RTE foods (Listeria risk assessment) (Ref. 2). The SUMMARY: The Food and Drug Listeria risk assessment formed the basis Administration (FDA) is requesting of the 2003 FDA/CDC Listeria Action comments and scientific data and Plan (Ref. 3), which identifies information that would assist the agency prevention and control activities that in its plans to conduct a risk assessment FDA and CDC will take to reduce the for Listeria monocytogenes in smoked incidence of foodborne listeriosis in the finfish (smoked finfish risk assessment), United States. The smoked finfish risk and evaluate the provisions of the 2001 assessment and the evaluation of the Food Code that address preventive Food Code (Ref. 4) provisions for controls for L. monocytogenes in retail preventive controls for L. and foodservice establishments. The monocytogenes in retail and foodservice purpose of the smoked finfish risk establishments are two of these assessment is to ascertain the impact on prevention and control activities that public health from the reduction and/or support the agency’s commitment to prevention of L. monocytogenes growth fulfilling the Listeria Action Plan. and recontamination during the Smoked Finfish Risk Assessment: The manufacturing and/or processing of hot- 2003 Listeria risk assessment used data and cold-smoked finfish. The smoked on food contamination at retail, the finfish risk assessment and the ability of the food to support growth, evaluation of the Food Code provisions and the impact of home storage time for preventive controls for L. and temperature to estimate the monocytogenes in retail and foodservice likelihood of a type of food to cause establishments support the agency’s listeriosis. The Listeria risk assessment commitment to the Listeria Action Plan determined that smoked seafood has a (revised 2003) that FDA and the Centers relatively high rate of contamination for Disease Control and Prevention and a high predicted per serving relative (CDC) developed to reduce L. risk, yet a lower per annum risk because monocytogenes illnesses associated with it is generally consumed only occasionally in small quantities and/or the consumption of ready-to-eat (RTE) eaten by a relatively small portion of the foods. population. DATES: Submit comments and scientific As a followup to the Listeria risk data and information by May 3, 2005. assessment, the smoked finfish risk ADDRESSES: Submit written comments assessment model will evaluate the and scientific data and information to sources of contamination, how the Division of Dockets Management individual steps in manufacturing and/ (HFA–305), Food and Drug or processing contribute to Administration, 5630 Fishers Lane, rm. contamination, and the effectiveness of 1061, Rockville, MD 20852. Submit various preventative strategies. The electronic comments, data, and objectives of the smoked finfish risk information to http://www.fda.gov/ assessment are to evaluate the impact on dockets/ecomments. public health from the reduction/ prevention of the following: (1) L. FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food Safety monocytogenes growth during the manufacturing and/or processing of and Applied Nutrition (HFS–06), Food smoked finfish, (2) L. monocytogenes and Drug Administration, rm. 2B–023, PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\04MRN1.SGM 04MRN1 Federal Register / Vol. 70, No. 42 / Friday, March 4, 2005 / Notices growth between the smoking process and distribution at retail, and (3) recontamination with L. monocytogenes during the manufacturing and/or processing of smoked finfish. Listeria monocytogenes contamination is a problem in coldsmoked finfish because the heat applied during processing is not sufficient to inactivate the organism, and the fish are consumed without further cooking. Cold-smoked finfish may become contaminated during processing due to inadequate sanitation, particularly because of insufficient cleaning and sterilizing of the slicer. For hot-smoked finfish, although L. monocytogenes is killed by adequate hot-smoking, recontamination after hot-smoking can result in high numbers of the organism in the finished products. Additionally, the ability of the organism to grow under both refrigerated aerobic and anaerobic conditions makes it a concern in products packed in permeable wrappers and under modified atmosphere or vacuum. This sealing of the product extends shelf-life and, therefore, provides additional time for the organism to grow. Preventive Controls for L. monocytogenes in Retail and Foodservice Establishments: FDA is evaluating the Food Code to determine whether it should consider recommending revisions to the provisions addressing preventive controls for L. monocytogenes in retail and foodservice establishments. Specifically, FDA will take the following steps: (1) Review the Food Code to determine whether it should consider recommending revisions to the provisions that address preventive controls, such as approved source, date marking, and cold holding times and temperatures; and (2) in conjunction with the Conference for Food Protection, issue guidance to the retail and food service industries and State and local regulatory professionals on the use of Hazard Analysis Critical Control Point (HACCP) principles to identify and control risk factors contributing to foodborne illness. FDA intends for such guidance to discuss intervention strategies that industry can use to control L. monocytogenes and other pathogens. II. Request for Comments and for Scientific Data and Information Smoked Finfish Risk Assessment: FDA requests comments on the risk assessment approach outlined previously in this document and the submission of data and any information relevant to this risk assessment. The agency specifically requests information VerDate jul<14>2003 19:07 Mar 03, 2005 Jkt 205001 for the following: (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 coldsmoked 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. Preventive Controls for L. monocytogenes in Retail and Foodservice Establishments: Under the FDA/CDC Listeria Action Plan, FDA is continuing its commitment to review the Food Code to determine whether it should consider recommending revisions to the provisions that address preventive controls for Listeria in retail and foodservice establishments. The agency specifically requests 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.); (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 should submit comments, scientific data, and PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 10651 information to the Division of Dockets Management (see ADDRESSES). Three copies of all comments, scientific data, and information are to be submitted. Individuals submitting written information or anyone submitting electronic comments may submit one copy. Submissions are to be identified with the docket number found in brackets in the heading of this document and may be accompanied by supporting information. Received submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Information submitted after the closing date will not be considered except by petition under 21 CFR 10.30. III. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. 1. U.S. Department of Health and Human Services, Healthy People 2010, v. 1. Washington, DC, 2000, http:// www.healthypeople.gov. 2. U.S. Department of Health and Human Services and U.S. Department of Agriculture/ Food Safety and Inspection Service, ‘‘Quantitative Assessment of Relative Risk to Public Health from Foodborne Listeria monocytogenes Among Selected Categories of Ready-to-Eat Foods,’’ September 2003, http://www.foodsafety.gov/~dms/lmr2– toc.html. 3. U.S. Department of Health and Human Services, Food and Drug Administration/ Centers for Disease Control and Prevention, ‘‘Reducing the Risk of Listeria monocytogenes FDA/CDC 2003 Update of the Listeria Action Plan,’’ November 2003, http:/ /www.cfsan.fda.gov/~dms/lmr2plan.html. 4. U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration, Food Code, 2001, http:/ /www.cfsan.fda.gov/~dms/fc01–toc.html. Dated: February 25, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–4217 Filed 3–3–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2005N–0058] Hospira, Inc. et al.; Withdrawal of Approval of 76 New Drug Applications and 60 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 70, Number 42 (Friday, March 4, 2005)]
[Notices]
[Pages 10650-10651]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-4217]


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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; Request for Comments and for 
Scientific Data and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments and for scientific data and 
information.

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

SUMMARY: The Food and Drug Administration (FDA) is requesting comments 
and scientific data and information that would assist the agency in its 
plans to conduct a risk assessment for Listeria monocytogenes in smoked 
finfish (smoked finfish risk assessment), and evaluate the provisions 
of the 2001 Food Code that address preventive controls for L. 
monocytogenes in retail and foodservice establishments. The purpose of 
the smoked finfish risk assessment is to ascertain the impact on public 
health from the reduction and/or prevention of L. monocytogenes growth 
and recontamination during the manufacturing and/or processing of hot- 
and cold-smoked finfish. The smoked finfish risk assessment and the 
evaluation of the Food Code provisions for preventive controls for L. 
monocytogenes in retail and foodservice establishments support the 
agency's commitment to the Listeria Action Plan (revised 2003) that FDA 
and the Centers for Disease Control and Prevention (CDC) developed to 
reduce L. monocytogenes illnesses associated with the consumption of 
ready-to-eat (RTE) foods.

DATES: Submit comments and scientific data and information by May 3, 
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://
www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Sherri B. Dennis, Center for Food 
Safety and Applied Nutrition (HFS-06), Food and Drug Administration, 
rm. 2B-023, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-
1903.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Health and Human Services Healthy People 2010 is 
a comprehensive set of disease prevention and health promotion 
objectives for the Nation to achieve over the first decade of the new 
century. Created by scientists both inside and outside of Government, 
it identifies a wide range of public health priorities and specific, 
measurable objectives. One of these objectives calls on Federal food 
safety agencies to reduce foodborne listeriosis (Ref. 1). In support of 
this goal, in 2003, FDA issued an assessment of the relative risk to 
the public health from foodborne L. monocytogenes among selected 
categories of RTE foods (Listeria risk assessment) (Ref. 2). The 
Listeria risk assessment formed the basis of the 2003 FDA/CDC Listeria 
Action Plan (Ref. 3), which identifies prevention and control 
activities that FDA and CDC will take to reduce the incidence of 
foodborne listeriosis in the United States. The smoked finfish risk 
assessment and the evaluation of the Food Code (Ref. 4) provisions for 
preventive controls for L. monocytogenes in retail and foodservice 
establishments are two of these prevention and control activities that 
support the agency's commitment to fulfilling the Listeria Action Plan.
    Smoked Finfish Risk Assessment: The 2003 Listeria risk assessment 
used data on food contamination at retail, the ability of the food to 
support growth, and the impact of home storage time and temperature to 
estimate the likelihood of a type of food to cause listeriosis. The 
Listeria risk assessment determined that smoked seafood has a 
relatively high rate of contamination and a high predicted per serving 
relative risk, yet a lower per annum risk because it is generally 
consumed only occasionally in small quantities and/or eaten by a 
relatively small portion of the population.
    As a followup to the Listeria risk assessment, the smoked finfish 
risk assessment model will evaluate the sources of contamination, how 
individual steps in manufacturing and/or processing contribute to 
contamination, and the effectiveness of various preventative 
strategies. The objectives of the smoked finfish risk assessment are to 
evaluate the impact on public health from the reduction/prevention of 
the following: (1) L. monocytogenes growth during the manufacturing 
and/or processing of smoked finfish, (2) L. monocytogenes

[[Page 10651]]

growth between the smoking process and distribution at retail, and (3) 
recontamination with L. monocytogenes during the manufacturing and/or 
processing of smoked finfish.
    Listeria monocytogenes contamination is a problem in cold-smoked 
finfish because the heat applied during processing is not sufficient to 
inactivate the organism, and the fish are consumed without further 
cooking. Cold-smoked finfish may become contaminated during processing 
due to inadequate sanitation, particularly because of insufficient 
cleaning and sterilizing of the slicer. For hot-smoked finfish, 
although L. monocytogenes is killed by adequate hot-smoking, 
recontamination after hot-smoking can result in high numbers of the 
organism in the finished products. Additionally, the ability of the 
organism to grow under both refrigerated aerobic and anaerobic 
conditions makes it a concern in products packed in permeable wrappers 
and under modified atmosphere or vacuum. This sealing of the product 
extends shelf-life and, therefore, provides additional time for the 
organism to grow.
    Preventive Controls for L. monocytogenes in Retail and Foodservice 
Establishments: FDA is evaluating the Food Code to determine whether it 
should consider recommending revisions to the provisions addressing 
preventive controls for L. monocytogenes in retail and foodservice 
establishments. Specifically, FDA will take the following steps: (1) 
Review the Food Code to determine whether it should consider 
recommending revisions to the provisions that address preventive 
controls, such as approved source, date marking, and cold holding times 
and temperatures; and (2) in conjunction with the Conference for Food 
Protection, issue guidance to the retail and food service industries 
and State and local regulatory professionals on the use of Hazard 
Analysis Critical Control Point (HACCP) principles to identify and 
control risk factors contributing to foodborne illness. FDA intends for 
such guidance to discuss intervention strategies that industry can use 
to control L. monocytogenes and other pathogens.

II. Request for Comments and for Scientific Data and Information

    Smoked Finfish Risk Assessment: FDA requests comments on the risk 
assessment approach outlined previously in this document and the 
submission of data and any information relevant to this risk 
assessment. The agency specifically requests information for the 
following: (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.
    Preventive Controls for L. monocytogenes in Retail and Foodservice 
Establishments: Under the FDA/CDC Listeria Action Plan, FDA is 
continuing its commitment to review the Food Code to determine whether 
it should consider recommending revisions to the provisions that 
address preventive controls for Listeria in retail and foodservice 
establishments. The agency specifically requests 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.); (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 should submit comments, scientific data, and 
information to the Division of Dockets Management (see ADDRESSES). 
Three copies of all comments, scientific data, and information are to 
be submitted. Individuals submitting written information or anyone 
submitting electronic comments may submit one copy. Submissions are to 
be identified with the docket number found in brackets in the heading 
of this document and may be accompanied by supporting information. 
Received submissions may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday. Information submitted 
after the closing date will not be considered except by petition under 
21 CFR 10.30.

III. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. U.S. Department of Health and Human Services, Healthy People 
2010, v. 1. Washington, DC, 2000, http://www.healthypeople.gov.
    2. U.S. Department of Health and Human Services and U.S. 
Department of Agriculture/Food Safety and Inspection Service, 
``Quantitative Assessment of Relative Risk to Public Health from 
Foodborne Listeria monocytogenes Among Selected Categories of Ready-
to-Eat Foods,'' September 2003, http://www.foodsafety.gov/dms/lmr2-
toc.html.
    3. U.S. Department of Health and Human Services, Food and Drug 
Administration/Centers for Disease Control and Prevention, 
``Reducing the Risk of Listeria monocytogenes FDA/CDC 2003 Update of 
the Listeria Action Plan,'' November 2003, http://www.cfsan.fda.gov/
dms/lmr2plan.html.
    4. U.S. Department of Health and Human Services, Public Health 
Service, Food and Drug Administration, Food Code, 2001, http://
www.cfsan.fda.gov/dms/fc01-toc.html.

    Dated: February 25, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-4217 Filed 3-3-05; 8:45 am]
BILLING CODE 4160-01-S