FSIS Final Rule on Notice of Adulterated or Misbranded Food

On May 8, 2012 the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) published a Federal Register notice of a final rule implementing the provisions of the 2008 Farm Bill (Food, Conservation, and Energy Act of 2008, Public Law 110-246, 122 Stat 1651, 448-49) which require establishments subject to inspection to notify FSIS of adulterated or misbranded products, prepare and maintain written recall procedures, and document certain reassessments of hazard analysis and critical control points (HACCP) system plans. The Federal Register notice is available here.

Under the Federal Meat Inspection Act (FMIA) (21 USC 601 et seq.) and the Poultry Products Inspection Act (PPIA) (21 USC 451 et seq.) FSIS is responsible for ensuring that the meat and poultry supply in the US is safe, wholesome, and correctly labeled and packaged. Section 11017 of the 2008 Farm Bill (Food, Conservation, and Energy Act of 2008, Public Law 110-246, 122 Stat 1651, 448-49) amended FMIA and PPIA to require that establishments subject to inspection under these Acts that "believe or have reason to believe that an adulterated or misbranded meat or poultry product received by or originating from the establishment has entered into commerce, to notify the secretary with regard to the type, amount, origin, and destination of the meat or poultry product." The establishment is also required to (1) prepare and maintain written procedures for the recall of any of its products, (2) document each reassessment of the process control plans (HACCP plans), and (3) if requested, make the procedures/control plans available to the Secretary's inspectors.

Summary of Amendments

9 CFR Part 304 Application for Inspection; Grant of Inspection

• Before being granted Federal inspection, an establishment must have developed written recall procedures as required by part 418.

9 CFR Part 381 Poultry Products Inspection Regulations

• Before being granted Federal inspection, an establishment must have developed written recall procedures as required by part 418.

9 CFR Part 417 Hazard Analysis and Critical Control Point (HACCP) Systems
Document Reassessment

• Establishments are to document all reassessments of HACCP plans.
• Establishments are to make documentation of the HACCP plans available to inspection program personnel.
• Improved HACCP systems for establishments.

9 CFR Part 418 Recalls
Written Recall Procedures

• Establishments are to prepare and maintain recall procedures for all products they produce.
• Establishments will be able to act more effectively to remove adulterated or misbranded products from consumers.
• Establishments will be able to move quickly to disseminate information about the need to return product to it.
• Establishments will be able to maximize the amount of product they will be able to receive.
• Establishments are to notify local FSIS District Office within 24 hours of having reason to believe that an adulterated or misbranded product received or originating from the official establishment has entered commerce.

Written Recall Procedure Requirement

Making the recall plans available for copying allows the inspectors to verify the plans, without requiring establishments to submit their recall procedures to FSIS. Comments to the proposed rule expressed concern that if there were a requirement to submit the procedures to FSIS, the confidential business information they contained would be subject to the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)). FSIS reiterated that in the course of responding to a FOIA request, it is responsible for determining whether or not the recall information constitutes confidential business information; but, in the event that it cannot readily determine whether or not the details in the recall procedures are confidential, it will "obtain and consider" the opinion of the business, and allow the business an opportunity to object to any decision to disclose the information.

Notification Requirement

Establishments have to notify the local FSIS District Office within 24 hours of having reason to believe that an adulterated or misbranded product received or originating from the official establishment has entered commerce. The proposed rule required notification within 48 hours, but it was reduced to 24 hours after several consumer groups submitted comments contending that the time frame was too lax. FSIS determined that 24 hours was reasonable because establishments may notify the district office by phone.

The 24 hour period begins when the establishment has reason to believe that a product that has entered commerce is either adulterated or misbranded. For example, as soon as a lab test shows that ground beef contains a pathogen, the 24 hour period begins. In situations where lab results are not available, the establishment is to consider the probability of harm based on epidemiological evidence.

Establishments are only required to provide the information they have with regard to the destination of the product; the rule does not create a duty for establishments to seek out new information. It is understood that most establishments likely do not have information on the destination of the product beyond their direct consignees, and so this is all they are required to report, unless the establishment has knowledge of the product's destination beyond its direct consignees, in which case it is required to disclose this information.

Two comments argued that the reporting requirement is overly broad and that minor labeling errors should be excluded, as they do not constitute misbranding, and suggested that FSIS instead use a de minimis standard like the one FDA uses. FSIS did not adopt the de minimis standard because it could allow establishments to escape the notification requirement for products that could trigger a Class II or Class III recall.

Effective Date (Phased Implementation)

The proposed rule would have become effective for all establishments on the same date, regardless of the size of the establishment. However, in order to minimize the burden on small businesses, FSIS opted to use a phased implementation schedule. Large establishments, defined as those with 500 or more employees, will have six months, or until November 5, 2012, to implement the final rule. Small establishments, defined as those with less than 500 but more than 10 employees, and very small establishments, defined as those with less than 10 employees, will have one year from the date of publication, or until May 8, 2013.

For more information, please contact Melvin S. Drozen at drozen@khlaw.com or Laura C. Foley at foleyl@khlaw.com.