“The improved trace-back capabilities that would result from this proposal will prevent foodborne illness by allowing F.S.I.S. to conduct recalls of potentially contaminated raw ground products in a timelier manner,” said Brian Ronholm, U.S.D.A. deputy under-secretary for food safety. “By requiring retail outlets to maintain improved records on sources for ground products, the proposal will enable F.S.I.S. to quickly identify likely sources of contaminated product linked to an outbreak.”
Retail outlets including supermarkets and meat markets regularly make ground beef by mixing cuts of beef from various sources. The F.S.I.S. proposal, if finalized, would require them to keep clear records identifying the source, supplier and names of all materials used in the preparation of raw ground beef products.
Specifically, the F.S.I.S. is proposing to amend its recordkeeping regulations to require all federally inspected plants and retail stores that grind raw beef products for sale in commerce to keep records, for a period of two years, that disclose the identity of the supplier of all source materials that they use in the preparation of each lot of raw ground product and identify the names of those source materials. The required records would have to include the following information:
• The names, points of contact, phone numbers and establishment numbers of the manufacturers supplying the materials used to prepare each lot of raw ground beef product.
• All supplier lot numbers and production dates.
• The names of the supplied materials, including beef components and any materials carried over from one production lot to the next.
• The amount of the beef component used in each lot (in pounds).
• The date and time each lot of raw ground product is produced.
• The date and time when grinding equipment and related food-contact surfaces are cleaned and sanitized.
Trouble tracking sources
The F.S.I.S. noted despite previous F.S.I.S. actions and guidance on recordkeeping related to ground beef manufacturing, it has continued to experience significant impediments in connection with trace-backs of regulated products associated with consumer foodborne illness to the suppliers that produced the source materials. The F.S.I.S. said some official establishments and retail stores still do not keep and maintain records necessary to allow effective trace-back activities. The agency said it found records kept by these businesses vary in type and quality and are often incomplete or inaccurate.
“Overall, F.S.I.S. has concluded that voluntary recordkeeping by retail facilities that grind raw beef has not been sufficiently effective, as evidenced by continuing outbreaks linked to pathogens in raw ground beef that F.S.I.S. cannot trace back to the source,” the F.S.I.S. said. “The lack of specific information about supplier lot numbers, product codes, pack dates of source materials used to produce lots of raw ground beef, and when and whether grinding equipment has been cleaned and sanitized, has prevented or delayed F.S.I.S. from identifying businesses that produced the source materials for product that was positive, the specific product responsible for the outbreak, and, therefore, to accurately identify other product that might also be adulterated.”
The F.S.I.S. said recordkeeping with regard to the cleaning and sanitizing of equipment used to grind raw beef between lots or batches is important because it will help prevent the transfer of E. coli O157:H7 and other bacteria from one lot of product that may be contaminated to another lot of product ground on the same equipment that is not.
Elaborating on the need for the new regulation, the F.S.I.S. said it reviewed 28 foodborne disease investigations from October 2007 through 2012 in which beef products were ground or reground at retail stores. Twenty-two of the investigations were for outbreaks that occurred in 2009 or earlier, and the remainder occurred after 2009.
“Among the 22 investigations that took place in 2009 or earlier, seven had complete records, four had incomplete records and 11 had no records,” the F.S.I.S. said. “Among the six investigations that took place after 2009, four had complete records and two had incomplete records. Additionally, in 2013, F.S.I.S. reviewed three outbreaks. In two investigations, no records had been kept, while in the third complete records were available. Therefore, while the evidence suggests improvement, there remain retail stores or establishments that do not maintain complete records.”
The F.S.I.S. noted it was able to institute a recall of product from supply establishments in 6 of 11 investigations where complete records were kept. “In contrast, when records were not available or complete, F.S.I.S. was able to do so only two of 17 times.”
Effect of rule would be wide
The F.S.I.S. said it expects the proposed rule would affect 76,093 retail stores and official establishments that engage in grinding raw beef products. This number would include 64,380 supermarkets, 5,924 meat markets, 4,544 warehouse clubs and supercenters, and 1,245 official establishments.
The F.S.I.S. estimated the cost to industry of implementing the new recordkeeping requirements would total between $2.69 million and $4.39 million.
It said industry would realize benefits from lower direct costs for recalls because compliance would lead to more efficient, accurate and quicker identification of potentially adulterated product. Industry also would benefit from reduced damage to reputation during food safety events.
The F.S.I.S. said the agency itself would benefit from lower estimated costs for recalls and recovery of adulterated product because of expected increased efficiencies realized in identifying potentially adulterated ground beef.
The primary public benefit would be averted illnesses due to better recordkeeping practices at official and retail establishments.
The F.S.I.S. encouraged stakeholders to comment on the proposed regulation. Comments may be submitted via www.regulations.gov or mailed to the U.S. Department of Agriculture, F.S.I.S., 1400 Independence Ave. SW, Mailstop 3782, 8-163B, Washington, D.C. 20250-3700.