The U.S. Food and Drug Administration (FDA) issued a final rule in the December 9, 2004 Federal Register on the Establishment and Maintenance of Records (Section 306) of the Bioterrorism Act of 2002. This final rule implements the fourth and final section of the Bioterrorism Act, which directed the agency to issue regulations requiring persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These required records would be used to identify the immediate previous source of all food received, as well as, the immediate subsequent recipient of all food released. The effective date of this rule is February 7, 2005, however, the agency specifies that all businesses covered by it must comply within 12 months from the date it was published in the Register [December 9, 2005], except small and very small businesses. Small businesses (11-499 full-time equivalent employees) must comply within 18 months from this date [June 9, 2006], and businesses with 10 or fewer full-time equivalent employees the compliance date is December 11, 2006. The rule specifies that for food transporters the maximum record retention period for all types of food is one year, and companies may keep the required information in any format, paper or electronic. These records have to include names of the transporter's immediate previous source and the transporter's immediate subsequent receipt, origin and destination points, date shipment received and date released, number of packages, description of the freight, route of movement during the time food was transported, and transfer point through which the shipment was moved. Of "key" interest to our industry, the FDA specifies that trucking companies do have alternative methods of meeting the rule's requirements. This "method" for motor carriers is establishing and maintaining specified information that is in records required by the Federal Motor Carrier Safety Administration (FMCSA) in 49 CFR §373.101 and §373.103. What this means is that motor carrier bills of lading and expense bills are acceptable alternative methods for meeting these recordkeeping requirements. On the same day, FDA issued a concurrent Register notice announcing a series of public meetings to discuss the final regulation implementing the Section 306 Recordkeeping rules. The dates and locations of these public meetings are as follows:
- January 13, 2005 - College Park, MD;
- January 25, 2005 - Chicago, IL and Seattle, WA;
- January 27, 2005 - San Francisco, CA and Orlando, FL; and
- February 1, 2005 - Philadelphia, PA and Boston, MA.
As noted earlier, the FDA has already issued the three other final rules under the Bioterrorism Act that are now all in effect: Administrative Detention (Section 303); Registration (Section 305); and Prior Notice (Section 307). By way of review, and of good news to the trucking industry, there are several "key" provisions in these rules that have been favorable to motor carriers. These four important components include:
1. trucking companies and terminals do not have to register as food facilities;
2. as mentioned earlier, the bill of lading and expense bills provided for in the FMCSA rules in §§373.101 and 373.103 are acceptable alternative records for trucking companies;
3. the maximum record retention requirement for transporters of all types of food is one year; and
4. records may be maintained in any format, paper or electronic, if the records contain all of the required information.