[Federal Register: May 22, 2001 (Volume 66, Number 99)]
[Notices]
[Page 28181-28182]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my01-83]
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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:
sdennis@cfsan.fda.gov.
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: kgombas@cfsan.fda.gov 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