01-5378. Relative Risk to Public Health From Foodborne Listeria Monocytogenes Among Selected Categories of Ready-to-Eat Foods; Draft Risk Assessment Document and Risk Management Action Plan; Availability; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS, and Food Safety and Inspection Service, USDA.

ACTION:

Notice; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA), in cooperation with the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), and the Centers for Disease Control and Prevention, published a notice of availability of a draft risk assessment on the relationship between foodborne Listeria monocytogenes and human health and a proposed risk management action plan for L. monocytogenes in the Federal Register of January 19, 2001. Interested persons were given until March 20, 2001, to comment on these documents. Because a public meeting to receive comments on these documents has been scheduled close to the end of the comment period and in response to the requests of the National Food Processors Association and the LM Working Group for an extension of the comment period, FDA and FSIS are extending the comment period until May 21, 2001.

DATES:

Submit written comments by May 21, 2001.

ADDRESSES:

Submit written comments to the Dockets Management Branch (HFA-305), Docket No. 99N-1168, Food and Drug Administration, 5630 Fishers Lane, rm. 1060, Rockville, MD 20852. Two copies of any comments are to be submitted, except that individuals may submit one copy. Received comments may be reviewed at the FDA Dockets Management branch (address above) between 9 a.m. and 4 p.m., Monday through Friday.

Submit one original and two copies of written comments to FSIS Docket Clerk, Docket No. 00-048N, U.S. Department of Agriculture, Food Safety and Inspection Service, rm. 102, Cotton Annex, 300 12th Street SW., Washington, DC 20250-3700. All comments submitted in response to this notice will be available for public inspection in the Docket Clerk’s office between 8:30 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

For information concerning the draft risk assessment document: Sherri B. Dennis, Risk Assessment Coordinator, Center for Food Safety and Applied Nutrition (HFS-032), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-260-3984, FAX [phone], e-mail: [e-mail].

For information concerning the risk management action plan: Kathy Gombas, Center for Food Safety and Applied Nutrition (HFS-615), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4231, FAX [phone], e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

In the Federal Register of January 19, 2001, (66 FR 5515), the Department of Health and Human Services and USDA announced the availability of two documents: A draft risk assessment on the relationship between foodborne L. monocytogenes and human health and a draft risk management action plan. Comments were sought on the technical aspects of the draft risk assessment in the following areas: (1) The assumptions made, (2) the modeling technique, (3) the data used, and (4) the transparency of the draft risk assessment document. The agencies also invited comments on the risk management strategies as presented in the draft action plan. Interested persons were given until March 20, 2001, to comment on the draft risk assessment and draft risk management action plan. Because a public meeting to receive comments on these documents has been scheduled close to the end of the comment period, and in response to the requests of the National Food Processors Association and the LM Working scheduled close to the end of the comment period, and in response to the requests of the National Food Processors Association and the LM Working Group for an extension of the comment period, FDA and FSIS are extending the comment period until May 21, 2001.

To be considered, submit written comments to FDA Dockets Management Branch or the FSIS Dockets Clerk (addresses above) by May 21, 2001.

Printed copies of the draft risk assessment and the risk management action plan may be requested by faxing your name and mailing address with the names of the documents you are requesting to the CFSAN Outreach and Information Center at 1-877-366-3322. The documents may be reviewed at the FDA Dockets Management Branch or the FSIS Docket Clerk’s Office at the addresses and hours noted above. The draft risk assessment and the draft risk management action plan documents are also available electronically as follows: www.cfsan.fda.gov,, www.fsis.usda.gov,, www.foodsafety.gov. The draft risk assessment is also available electronically at www.foodriskclearinghouse.umd.edu.

Dated: February 28, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.