[Federal Register Volume 76, Number 205 (Monday, October 24, 2011)]
[Notices]
[Pages 65734-65735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-27382]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0733]


Guidance for Industry on Evaluating the Safety of Flood-Affected 
Food Crops for Human Consumption; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for Industry: Evaluating 
the Safety of Flood-Affected Food Crops for Human Consumption.'' 
Flooding events can present a potentially hazardous public health risk. 
Flood waters may have been exposed to sewage, chemicals, heavy metals, 
pathogenic microorganisms, or other contaminants. The growers are 
responsible to ensure the safety of the flood-affected food crops. The 
guidance is intended to provide growers information on how to evaluate 
the safety of flood-affected food crops for human consumption.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Plant and Dairy Food Safety, Center for Food Safety 
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740. Send one self-addressed 
adhesive label to assist that office in processing your requests. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Yinqing Ma, Center for Food Safety and 
Applied Nutrition/Office of Food Safety, Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD, 240-402-2479.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Evaluating the Safety of Flood-affected Food Crops for Human 
Consumption'' This guidance is being issued consistent with FDA's good 
guidance practices (GGP) regulation (Sec.  10.115 (21 CFR 10.115)). 
This guidance is being implemented without prior public comment because 
the Agency has determined that prior public participation is not 
feasible or appropriate (Sec.  10.115(g)(2)). The Agency made this 
determination because the guidance deals with highly time-sensitive 
issues and requires immediate implementation for public health reasons. 
Although this guidance document is immediately in effect, it remains 
subject to comment in accordance with the Agency's GGPs regulation.
    The guidance is intended to provide growers information on how to 
evaluate the safety of flood-affected food crops for human consumption. 
The recommendations in this guidance are consistent with existing FDA's 
positions on the safety of flood-affected food crops. This guidance 
reiterates FDA's positions and includes additional information to help 
growers assess the safety of food from flood-affected crops for human 
consumption. Specifically, the guidance addresses: (1) Safety of food 
crops when flood waters contacted the edible portions of the crops, (2) 
safety of food crops when flood waters did not contact the edible 
portions of the crops, (3) assessment of flood-affected fields before 
replanting, and (4) additional controls to avoid cross-contamination 
after flooding.
    The guidance represents the Agency's current thinking on the safety 
of flood-affected food crops for human consumption. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received

[[Page 65735]]

comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov. Always access an FDA guidance document 
by using FDA's Web site listed previously to find the most current 
version of the guidance.

    Dated: October 18, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-27382 Filed 10-21-11; 8:45 am]
BILLING CODE 4160-01-P