Information provided courtesy of National Grocers Association

FDA Bioterrorism Regulations:

Recordkeeping Requirements for Grocers

October 17, 2005

I. Who must maintain records?

            1. Virtually all N.G.A. members—retailers, wholesalers, and manufacturers—are subject to the recordkeeping requirements;

            2. Domestic persons that manufacture, process, pack, transport, distribute, receive, hold or import food; foreign persons that transport food in the U.S; and persons who place food directly in contact with its finished container;

            3. The term “persons” includes individuals, partnerships, corporations and associations;

            4. Wholesalers are required to keep records on immediate transporter and non-transporter previous sources and subsequent recipients.  Retailers selling directly to consumers need only keep records for immediate transporter and non-transporter previous sources.  Retailers selling to non-consumers (i.e. businesses) are required to keep records for immediate transporter and non-transporter previous sources and immediate transporter and non-transporter subsequent recipients. 

II. When is compliance required?

            1. Businesses with 500 or more full-time equivalent employees must comply by December 9, 2005;

            2. Businesses with 11-499 full-time equivalent employees must comply by June 9, 2006;

            3. Businesses with 10 or fewer full-time equivalent employees must comply by December 9, 2006.

            The number of full-time equivalent employees is determined by dividing the total number of hours of salary or wages paid directly to employees of the person and all of its affiliates by the numbers of hours of work in one year, 2080 hours (i.e. 40 hours x 52 weeks).

III. How is food defined in this regulation?

            A. Food is defined as:

                        1. articles used for food or drink for man or other animals;

                        2. chewing gum;

                        3. articles used for components of food or drink.

IV. What records must be kept?

            FDA intended that these regulations require the maintenance of records that are generally kept in the ordinary course of business.

A.  For non-transporters of foods, records must be kept on:

            1.  Previous Sources:

Identify the immediate non-transporter previous sources, whether foreign or domestic, of all foods received, including the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety (e.g. Kraft Cheddar Cheese, not just cheese; romaine lettuce, not just lettuce); date received; quantity and type of packaging (e.g. 12 oz. bottles); and identify the immediate transporter previous sources including the name, address, telephone number—and, if available, fax number and e-mail address (a transporter is defined as a person who has possession, custody or control of an item for the sole purpose of transporting it). 

           2. Subsequent Recipients:

Identify the immediate non-transporter subsequent recipients of all foods released, including the name of the firm; address; telephone number; fax number and e-mail address, if available; type of food, including brand name and specific variety; date released; quantity and type of packaging; and identify the immediate transporter subsequent recipients, including the name, address, telephone number—and, if available, fax number and e-mail address.  Persons who manufacture, process or pack food also must include lot or code number or other identifier if the information exists.  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.

a. Retail sales to consumers:

Retailers selling directly to consumers are exempted from establishing and maintaining records to identify the immediate subsequent recipient.

                                    1.  The term consumers does not include businesses.

                        b. Retail sales to businesses:

Persons who operate retail food establishments that distribute food to persons who are not consumers must establish and maintain records to identify the immediate subsequent recipients only to the extent the information is reasonably available.

                                    1. Information is reasonably available if a system is already in place to capture the information.  FDA does not intend to require the reconfiguration of business operations.  For example, information is reasonably available when the purchaser has an established commercial account to which the food purchases are charged in an identifiable manner.

                                    2. Salvage:  Retailers who knowingly sell damaged goods to third party salvagers or reclamation centers for eventual resale to consumers are required to keep records of the immediate subsequent transporter recipient and immediate subsequent non-transporter recipient to the extent that such retailers are able to capture the transaction information (i.e. a commercial account exists).     

                                    3.  Nonprofit Organizations:  The release of food to nonprofit organizations is considered equivalent to direct distribution to a consumer and is exempt from recordkeeping.      

3.  Exceptions:

                        a.  Foods prepared in-store and ready for immediate consumption (e.g. in the deli) are exempt under the exception for restaurants.  Note that retailers selling foods to restaurants are required to maintain records of the sales if the information is reasonably available as outlined above.

                        b. Retailers and wholesalers are not required to track lot or code numbers. Only persons who manufacture, process or pack food are required to do so if the information exists. 

                        c. Separate sets of records are not required to be kept for intra-corporate transfers. 

                                    1.  Transfers to and among subsidiaries are not considered intra-corporate transfers and require separate sets of records.  A subsidiary is a distinct legal person and separate sets of records must be established and maintained documenting transfers.  This is applicable to any and all transfers to, among or between subsidiaries regardless of if they have the same controlling parent or are managed operationally as a single entity.

            B. For transporters of foods, records must include:

             The term transporters includes persons who have possession, custody, or control of an article of food in the U.S. for the sole purpose of transporting the food, whether by road, rail, water or air.  The term transporters also includes foreign persons that transport food in the U.S., regardless of whether the foreign persons have possession, custody, or control of food for the sole purpose of transporting it.

            For transporters, records have to include names of the transporter’s immediate previous source and the transporter’s immediate subsequent recipient, origin and destination points, date shipment received and date released, number of packages, description of freight, route of movement during the time the food was transported, and transfer points through which the shipment moved.

            1. Alternative Methods for Food Transporters to Satisfy Recordkeeping Requirements:

            The following table lists alternative methods for food transporters to comply with the recordkeeping requirements:

V. How must the records be maintained?

            1. The records may be maintained in any format, paper or electronic, provided they contain all required information.

            2. Existing records may be used to satisfy the requirements of these regulations provided they contain all required information.

VI. How long must records be retained?

            1. The records must be created when food is received, released or transported except to the extent the information is contained in existing records.  The period for which the records must be retained depends on the perishability of the food as stated in the following table:

            2. Records may be retained on-site or at a reasonably accessible location.

VII. What are the record availability requirements? 

            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 as soon as possible, not to exceed 24 hours from the time of receipt of the official request.  The records requested may be related to the manufacture, processing, packing, transporting, distribution, receipt, holding, or importation of such an article of food that are maintained by, or on behalf of, an entity subject to the recordkeeping regulation, and at any location.

VIII. What will happen if the records are not established and maintained?

            Persons who fail to establish and maintain the required records may be subject to civil and criminal actions brought by the federal government.  The federal government can bring a civil action in federal court to enjoin persons who commit a prohibited act.  The federal government can also bring a criminal action in federal court to prosecute persons who commit a prohibited act.

            Penalties include up to one year of prison or a fine of up to $1,000 for the first offense.  For a second offense or an offense with intent to defraud or mislead, penalties include up to three years of imprisonment and a fine of up to $10,000.   

Note:  As of December 12, 2003, the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 requires that wholesale grocers register with FDA.  Retail food establishments are exempt from registration.

For more information contact N.G.A.’s Director of Government Affairs, Erik Lieberman at (703) 516-0700 or elieberman@nationalgrocers.org.