2011-27382. Guidance for Industry on Evaluating the Safety of Flood-Affected Food Crops for Human Consumption; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 (§ 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 (§ 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 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.