Action Plan

Purpose
The Food and Drug Administration (FDA) has proposed rules regarding the establishment and maintenance of certain records. These records are needed by the Secretary of Health and Human Services for inspection to allow for the identification of the immediate previous sources and immediate subsequent recipients of food, including its packaging. These records will be used to address credible threats of serious adverse health consequences or death to humans or animals.

Determine applicability
You must first determine if you are subject to the recordkeeping requirements. Under the proposal, all domestic companies would have to establish and maintain records if they:
• Manufacture,
• Process,
• Pack,
• Transport,
• Distribute,
• Receive,
• Hold, or
• Import food intended for human or animal consumption in the U.S.

A foreign facility is excluded if food from it undergoes further manufacturing/processing (including packaging) by another facility outside the U.S. The facility is not exempted from recordkeeping if the processing or packaging activities of the subsequent facility are limited to the affixing of a label to a package or other de minimis activity. The facility that conducts the de minimis activity also must establish and maintain records.

Companies that would NOT have to comply with the regulations are:
• Farms;
• Restaurants;
• Non-profit organizations that prepare food for, or serve food directly to, consumers;
• Fishing vessels not engaged in processing; or
• Companies regulated exclusively by the U.S. Department of Agriculture.

Establish records
For manufacturers, processors, packers, distributors, receivers, holders, and importers of food, you must establish records that identify the immediate non-transporter previous sources of all foods received, whether foreign or domestic, which includes the following information:
• The name of the company and the responsible individual;
• Address;
• Telephone number;
• Fax number and e-mail address, if available;
• Type of food, including brand name and specific variety (e.g., Brand X Cheddar Cheese—not just cheese; romaine lettuce—not just lettuce);
• Date received;
• Lot number or other identifier if available;
• Quantity and type of packaging (e.g., 12 oz. bottles); and
• The name, address, telephone number—and, if available, fax number and e-mail address—of the transporter who brought it to the company.

The records must include information that is reasonably available to identify the specific source of each ingredient that was used to make every lot of finished product.

You would also have to keep records that identify the immediate non-transporter subsequent recipients of all foods released, which includes the following information:
• The name of the firm and the responsible individual;
• Address;
• Telephone number;
• Fax number and e-mail address, if available;
• Type of food, including brand name and specific variety;
• Date released;
• Lot number or other identifier if available;
• Quantity and type of packaging; and
• The name, address, telephone number—and, if available, fax number and e-mail address—of the transporter who transported the food from the company.

If you are a transporter, the records for each food transported would have to include:
• The name of the company and the responsible individual who had the food before them and their address, telephone number— and, if available, fax number and e-mail address—and the date the transporter received it.
• The name of the company and the responsible individual who had the food immediately after the transporter and their address; telephone number, and, if available, fax number and e-mail address, and the date it was delivered.
• The type of food, including brand name and specific variety; lot number or other identifier if available, quantity, and type of packaging.
• Identification of each and every mode of transportation used (e.g., company truck, private carrier, rail, air, etc.) and the individual responsible from when the food was first received until it was delivered.

Maintain records
The proposed rule would require records to be created when food is received, released, or transported.

FDA is specifying the information a covered entity must keep but not the form in which the records must be maintained. The records may be kept in any format, paper or electronic, provided they contain all the required information. The proposed regulation does not require duplication of existing records, if those records contain all the required information. Therefore, you should review existing records (i.e., bills of lading) and/or systems (i.e., computer databases) to determine conformance with the requirements of the proposal. It may be necessary to develop new or modify existing formats.

Retain records
Records for perishable foods not intended for processing into non-perishable foods, as well as records for animal food including pet food, would have to be retained for one year from the date they were created. Records for all other foods would have to be retained for two years after the date they were created.

Records must be maintained at the establishment where the activities covered in the records occurred (onsite) or at a reasonably accessible location. Review your current records storage system, whether it’s in paper or electronic format, to determine necessary changes.

Produce records
When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records or other information to which FDA has access must be available for inspection and photocopying or other means of reproduction within four hours if the request is made between 8:00 am and 6:00 pm, Monday through Friday, or within eight hours if the request is made at any other time. Review your current recordkeeping system to determine whether, if such a request were made, document retrieval would be feasible under the proposed requirements.

Assess impact the overall impact
Assess the overall impact the regulation changes will have on your operations. Discuss operation changes with vendors, suppliers, customers, and others who may be impacted.
You should communicate activities, needs, etc. with these individuals to establish an organized and effective system that documents the required record information. This process will also help them understand the applicability and, more importantly, the complexity of the proposed requirements.

Compliance date
After considering comments received on the proposed rule, FDA will publish a final rule by December 12, 2003. The proposed rule would require all businesses, except small and very small businesses, to comply with the final rule 6 months from its publication rule in the Federal Register. Small businesses (fewer than 500 but more than 10 full-time equivalent employees) would have to comply within 12 months from publication of the final rule, and very small businesses (10 or fewer full-time equivalent employees) would have to comply within 18 months from publication of the final rule.