Salmonella, allergens top food safety hazards list

by Jay Sjerven
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Salmonella and undeclared allergens remained the two most common food safety hazards to be reported in the United States, according to the Food and Drug Administration, which recently published its second annual report on its Reportable Food Registry. “The Reportable Food Registry: Targeting inspection resources and identifying patterns of adulteration” assessed entries into the registry from Sept. 8, 2010, through Sept. 7, 2011. The F.D.A.’s first annual report on the registry assessed entries from Sept. 8, 2009, through Sept. 7, 2010.

The Reportable Food Registry (R.F.R.) was established by the F.D.A. in 2007. It is an electronic portal to which reports of reportable food safety hazards must be submitted to the F.D.A. within 24 hours. A reportable food safety hazard is defined by the F.D.A. as “an article of food or feed for which there is reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals.”

The total number of reports entered into the registry in its second year was 882 compared with 2,240 reports during its first year. The F.D.A. noted the difference in the number of reportable entries between the two years was the result of three primary reportable entries in year 1 that resulted in 1,284 subsequent reports. In particular, Salmonella found in hydrolyzed vegetable protein resulted in 1,070 subsequent reports that year. Without those subsequent reports, total reportable entries for year 1 would have been 956, or 74 more than was the case in the most recent year.

The F.D.A. said 225 primary reports were entered into the registry in year 2 compared with 229 in year 1. The primary reports generated 483 subsequent entries (upstream and downstream from the problems or events described in the primary reports) in year 2 compared with 1,872 in year 1. The number of primary reports that related to human food in year 2 was 206 compared with 201 in year 1.

The F.D.A. noted responsible parties provided 174 amended reports in year 2 compared with 139 in year 1. The 25% increase in amended reports suggested “more facilities are informing F.D.A. about their investigations of problems and their efforts to correct the causes.”

The F.D.A. indicated primary reports relating to produce totaled 27 in year 2 compared with 14 for year 1.

“The rise is attributable to the U.S. Department of Agriculture sampling program intended to establish current baseline values of contamination against which the effectiveness of new procedures to reduce or eliminate harmful microorganisms in certain fresh fruits and vegetables can be measured,” the F.D.A. explained.

The F.D.A. said primary reports entered for baked foods totaled 20 in year 2 compared with 16 in year 1. All of the bakery entries in the most recent year were related to undeclared allergens, whereas in the first year, 14 of 16 primary reports from the baking industry were related to undeclared allergens. The F.D.A. noted, “In response to the data from the year 1 report, one of the nation’s largest baking industry trade associations indicated it would review and enhance its industry guidance on avoiding undeclared allergens in bakery products. This new industry guidance is expected in 2012.”

The F.D.A. noted while primary reports related to Salmonella in spices and seasonings increased to 23 in year 2 from 16 in year 1, “new guidance developed by the American Spice Trade Association is expected to have a positive effect on reducing health risks from this commodity group.”

The F.D.A. pointed to three notable outcomes for the registry in year 2.

First, a primary report on frozen breaded seafood products was submitted because the soy flour breading contained an undeclared peanut protein. The products were recalled, and no adverse health events in the United States associated with the products have been reported.

Second, a pet treat distribution company submitted a report that its pig ear dog treats were contaminated with Salmonella. After the F.D.A.’s investigation, two lots of the affected pet treats that had been distributed to 18 states were recalled.

Third, a company that had packed and shipped grape tomatoes from a Florida farm submitted a primary report because the tomatoes tested positive for Salmonella. The tomatoes, which had been distributed to 10 states and Canada, were recalled. Ultimately, there were 64 subsequent reports resulting from the incident. No illnesses associated with these products have been reported.

The commodity sectors with the greatest number of primary report entries in the most recent year included produce (27 primary entries), bakery (20), dairy (16), frozen food (11), nuts/nut products/seed products (16), prepared foods (14), seafood (18), and spices and seasonings (25).

Two types of hazard — Salmonella and undeclared allergens — accounted for 71.5% of the primary entries in year 2 compared with 67.7% during year 1. There were 86 primary entries related to Salmonella in the most recent year, which accounted for 38.2% of all entries, and there were 75 primary entries related to undeclared allergens, which accounted for 33.3% of all entries. Forty primary entries, or 17.8% of all entries in the most recent year, were related to Listeria monocytogenes. No other individual food safety hazard accounted for more than 4% of total primary entries.

Data from the second year of operation of the R.F.R. indicated animal food/feed; nuts, nut products and seed products; produce, and spices and seasonings continued to account for the majority of Salmonella reports.

Undeclared allergens were reported most often by the bakery sector. Baking companies entered 20 primary reports of undeclared allergens. Within bakery, cookies (seven reports), breads/croissants (five), and batters/mixes (four) were the principal reported food types. The F.D.A. further noted, “The nine entries for frozen foods were caused predominantly by breading ingredients for frozen foods. The eight entries for snack foods were accounted for by potato and tortilla chips (four), popcorn/puffcorn (two), and trail mixes (two).”

Fifty-six of the primary reports submitted to the R.F.R. in the most recent year related to imported foods or food ingredients coming from at least 19 different countries. Salmonella was the most common health hazard indicated in primary reports relating to imported food, accounting for 37 reports, or 66.1% of all reports on imported food. Sixteen primary reports related to Salmonella in imported spices and seasonings.

“The Reportable Food Registry has already proved itself an invaluable tool to help prevent contaminated food from reaching the public,” said Michael R. Taylor, the Food and Drug Administration’s deputy commissioner for foods. “By providing early warning about potential public-health risks from reportable foods, the registry increased the speed with which the F.D.A., its state and local-level partners, and industry could remove hazards from the marketplace. The agency also can use the data to target inspections, plan work, identify and prioritize risks and develop guidance for industry on how to strengthen preventive controls. The F.D.A. will continue working closely with the food and feed industries to enhance this important and beneficial tool.”

F.D.A. seeks additional info through Reportable Food Registry

Responses to questionnaire, voluntary now, will become mandatory

The Food and Drug Administration on June 4 brought on-line a new Reportable Food Registry (R.F.R.) Rational Questionnaire that it said incorporates additional data elements as part of an effort to improve the R.F.R.’s information-gathering capability.

The R.F.R. is an electronic portal to which the food industry must, and public health officials may, report when they have information about a reportable food safety hazard. A reportable food safety hazard is an article of food or feed for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals. The F.D.A. said by gathering and analyzing the new data, it will improve its ability to track patterns of adulteration in human food and animal feed (including pet food) and to target its inspection resources.

The additional elements are:
1 — The reason the food has been determined to be reportable (agent).
2 — A description of the root cause of the reportable food, if applicable.
3 — A brief justification of the process used to determine which product(s), lot(s), or batch(es) were affected.
4 — Whether or not the submitter believes all of the reportable food has been removed from commerce.
5 — A brief description of the corrective actions taken to avoid repeating the reportable event.
6 — The commodity type of the reportable food.
7 — The dates that the product was manufactured.
8 — Whether or not the reportable food underwent treatment to reduce microorganisms.
9 — A brief description of the microbial reduction treatment.
10 — Whether or not a bacterial isolate is available for F.D.A. collection.
11 — For reportable foods intended for animal consumption, the animal species for which the reportable food was intended.
12 — For reportable foods intended for animal consumption, the life stage of the animal for which the reportable food was intended.
13 — Whether the responsible party has notified all of its immediate previous sources or suppliers of the reportable food, if applicable.
14 — Whether the responsible party has notified all of its immediate subsequent recipients or customers for the reportable food, if applicable.

The F.D.A. said providing information in response to the new data elements was voluntary for the time being; however, later this year, responses to these elements will become mandatory.

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