USDA-FSIS Recall Procedures Midwest FDC Conference April 28, 2010 Lisa Volk Recall Management Staff
Recall A firm s voluntary removal of distributed meat, poultry, or egg products from commerce when there is reason to believe they are adulterated or misbranded under the Federal Meat Inspection Act (FMIA) or the Poultry Products Inspection Act (PPIA). Recall does not include a market withdrawal or a stock recovery.
Recall Classification Class I: Reasonable probability that consumption of product will cause serious adverse health consequences or death (Lm in RTE product, E. coli O157:H7 in raw ground beef) Class II: Remote probability of adverse health consequences from use of the product (ineligible imports, small amounts of allergens such as soy) Class III: Use of product will not cause adverse health consequences (undeclared, non-allergenic, GRAS ingredient such as added water)
15 Field Offices
Jurisdiction matters FSIS Pepperoni pizza Open-faced sandwiches Processed egg products Exotic species @ slaughter Beef broth FDA Cheese pizza Closed sandwiches Shell eggs Elk, bison, etc. in commerce Chicken broth* (*varies)
USDA/FSIS Inspection Daily inspection presence 5360 plants (~ 1800 dual jurisdiction) Carcass by carcass inspection HACCP plans mandated for all plants Problems identified - Plant or inspection personnel (lab tests) - Customer complaints - Illnesses/Epidemiologic investigations - Other governmental bodies
Problem categories Pathogens - E. coli O157:H7 in ground beef - Lm or Salmonella in RTE foods Undeclared allergens Extraneous materials/chemical contaminants/residues Operating w/o inspection presence
Ingredients Driven Recalls Melamine in pet foods - animals held pending test results - no meat recalls Salmonellosis Outbreaks - PCA Peanut recall implicated handful of FSIS products - Hundreds of illnesses; Nearly 4000 products recalled - Spice recalls (black and red pepper) -Initially linked to Salami-type products HVP - FDA and FSIS jointly developed policy - No illnesses, recalls on-going
FSIS Recalls CY 2009 By Class (Total 69)
FSIS Recalls CY 2009 by Problem Type
FSIS Recalls CY 2009 by Source
Depth of a Recall Wholesale Level Product has been distributed to a warehouse or distribution center, where it is NOT under the direct control of the producing company (level between the manufacturer and the retailer) Retail Level Product has been received by retailers for sale to household consumers HRI Level The product has been received by hotels, restaurants, and other institution customers Consumer Level The product has been sold directly to household consumers (mail order)
Public Notification Recall Release for Class I & II recalls, post to FSIS Web site and distribute to media wire and outlet services in area of product distribution Publish Retail List for Class I Recalls only includes retail consignees that have or have had recalled products in their possession Recall Notification Report (RNR) Class III recalls or Class I & II distributed only to the wholesale level follows the same format and pre-release procedures as the Recall Release but is not distributed to media wire and outlet services Subscribers receive email notification of all recalls
Press Release The Recall Release: Clearly describes product(s) being recalled, along with identifying marks; provides reason for the recall, and describes the risks involved in consuming the product Provides name and telephone number of the company contact for consumers and media to call with any questions Provides general information about the product s destination (depth of recall) When possible, without slowing the public notification, FSIS will post an electronic picture of the product label on the FSIS website
Public Notification FSIS prepares and submits a draft copy of the Recall Release or RNR to the recalling firm 30 minutes prior to its release. The firm will have 30 minutes to review the Recall Release to verify its technical accuracy (i.e. product description, company contact information, product distribution information, etc.) If the firm DOES NOT respond in 30 minutes of receiving the release, FSIS will proceed to issue the Recall Release Recall Release uses a standard format to provide the public with pertinent, descriptive product information, therefore comments and additions outside of this format are not typically included Release is sent to media outlets, public health officials, subscribers, posted on the FSIS website and Twitter.
Effectiveness Checks Effectiveness checks are conducted throughout the distribution chain Risk based and primarily dependant on the class of the recall and total number of consignees District Office coordinates and directs FSIS personnel to conduct effectiveness checks for domestic recalls When an importer conducts the recall, process details are different
RECORDS! RECORDS! RECORDS! Good recordkeeping is essential to the recall process. Accurate detailed records can: Narrow the scope of the recall Demonstrate the microbiological separation of implicated products Help isolate the source of problem Clearly identify products involved both for the recall committee during deliberations and to the retailer/consumer in the event of a recall Provide support for the firm s position of why a recall may not be warranted Ensure distribution and product information obtained easily, quickly, and accurately
What Can Simplify the Process Be prepared to submit information electronically, including copies of labels Be able to obtain product and distribution information quickly (even for large amounts of product) Be able to identify specific consignees vs. a generic customer list
Useful Links http://www.fsis.usda.gov/oppde/rdad/fsisdire ctives/8080.1rev5.pdf http://www.fsis.usda.gov/fsis_recalls/ http://www.fsis.usda.gov/fact_sheets/fsis_foo d_recalls/index.asp http://www.fda.gov/safety/recalls/default.htm
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