[Federal Register Volume 66, Number 99 (Tuesday, May 22, 2001)]
[Notices]
[Pages 28181-28182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-13055]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-1168]


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.

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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 (66 FR 5515). Interested persons 
were given until March 20, 2001, with an extension to May 21, 2001 (66 
FR 13545), to comment on these documents. The LM Working Group has 
requested a second extension of the comment period in part to collect 
and review new data and to evaluate the model and the appropriateness 
of the new data to improve the assessment. In response, FDA and USDA/
FSIS are extending the comment period to July 18, 2001; however, the 
agencies do not anticipate further extensions of the comment period for 
these draft documents.

DATES: Submit written comments by July 18, 2001.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Docket No. 99N-1168, Food

[[Page 28182]]

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 St, 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 202-260-9653, e-mail: 
<a href="/cdn-cgi/l/email-protection#b8cbdcddd6d6d1cbf8dbdecbd9d696dedcd996dfd7ce"><span class="__cf_email__" data-cfemail="bbc8dfded5d5d2c8fbd8ddc8dad595dddfda95dcd4cd">[email protected]</span></a>.
    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 202-260-0136, e-mail: <a href="/cdn-cgi/l/email-protection#c4afa3aba9a6a5b784a7a2b7a5aaeaa2a0a5eaa3abb2"><span class="__cf_email__" data-cfemail="f19a969e9c939082b1929782909fdf979590df969e87">[email protected]</span></a> or Charles 
Edwards, Food Safety and Inspection Service, U.S. Department of 
Agriculture, rm. 405, Cotton Annex, 300 12th St. SW., Washington, DC 
20250-3700, 202-205-0675, FAX 202-205-0080.

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 
action plan. FDA and USDA/FSIS extended the comment period to May 21, 
2001 (66 FR 13545, March 6, 2001), in response to the requests of the 
National Food Processors Association and the LM Working Group and 
because a public meeting to receive comments on these documents was 
scheduled on March 19, 2001, only 1 day before the close of the comment 
period. The LM Working Group has requested a second extension of the 
comment period in part to allow time to: (1) Collect and review new 
data, and (2) evaluate the model and the appropriateness of the new 
data to improve the assessment. In response, FDA and USDA/FSIS are 
extending the comment period to July 18, 2001; however, the agencies do 
not anticipate further extensions of the comment period for these draft 
documents.
    To be considered, submit written comments to FDA Dockets Management 
Branch or the FSIS Dockets Clerk (addresses above) by July 18, 2001.
    Printed copies of the draft risk assessment and the risk management 
action plan and/or a CD-ROM of the risk assessment model 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 action 
plan documents are also available electronically as follows: 
www.cfsan.fda.gov, www.fsis.usda.gov, www.foodsafety.gov.

    Dated: May 18, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-13055 Filed 5-18-01; 2:59 pm]
BILLING CODE 4160-01-S


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