05-21642. Guidance for Industry: A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “A Notice from the Food and Drug Administration to Growers, Food Manufacturers, Food Warehouse Managers, and Transporters of Food Products on Decontamination of Transport Vehicles.” This guidance is intended to provide information and references that can be used for the decontamination of food transport vehicles following Hurricanes Katrina and Rita in August and September 2005. The scope of this guidance is limited to decontamination of trucks, rail cars, and cold storage units that were flooded or otherwise impacted by the hurricanes, before being placed back in service to transport or store food.

DATES:

This guidance is final upon the date of publication. Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Division of Plant Product Safety (HFS-305), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20747. Send one self-addressed adhesive label to assist that office in processing your requests or include a fax number to which the guidance may be sent. Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:

Michael E. Kashtock, Center for Food Safety and Applied Nutrition (HFS-305), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20747, 301-436-2022.

SUPPLEMENTARY INFORMATION:

I. Background

In the aftermath of Hurricanes Katrina and Rita, the Center for Food Safety and Applied Nutrition has received inquiries about how food transport units such as trucks, rail cars, and cold storage units that were flooded or otherwise impacted by the hurricanes may be decontaminated for return to service to transport food. FDA is announcing the availability of a guidance document that provides information and references addressing this subject.

FDA is issuing this document as a level 1 guidance consistent with FDA's good guidance practices regulation (§ 10.115 (21 CFR 10.115)). The guidance is being implemented immediately without prior public comment, under § 10.115(g)(2), because the agency has determined that prior public participation is not feasible or appropriate.

II. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this guidance. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. The guidance and 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 guidance document at http://www.cfsan.fda.gov/​guidance.html.

Dated: October 14, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.