04-10030. Review of Establishment Data by Inspection Program Personnel

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Notice of Availability.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is announcing the availability of FSIS Directive 5000.2, “Review of Establishment Data by Inspection Program Personnel.” In December 2003, the Agency issued FSIS Notice 54-03 “Review of Establishment Data by Inspection Program Personnel” to clarify that FSIS inspection program personnel have access to a wide range of establishment food safety records under the Hazard Analysis and Critical Control Point (HACCP) Systems regulations and to ensure that inspection program personnel understand that certain food safety records kept by the establishment are subject to review on a regular basis. FSIS has revised Notice 54-03 and is reissuing it as an FSIS Directive.

ADDRESSES:

Copies of FSIS Directive 5000.2, “Review of Establishment Data by Inspection Program Personnel,” are available from the FSIS Docket Clerk, FSIS Docket Room, Room 102, 300 12th Street, SW., Washington, DC 20250-3700. An electronic copy of the document is also available on the Internet at: http://www.fsis.usda.gov/​OPPDE/​rdad/​FSISDirectives/​ 5000.2.pdf.

FOR FURTHER INFORMATION CONTACT:

Dr. Lynn Dickey, Director, Regulations and Petitions Policy Staff, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, [phone].

SUPPLEMENTARY INFORMATION:

Background

Under the FSIS HACCP regulations, establishments are required to conduct a hazard analysis to determine the food safety hazards reasonably likely to occur in their production processes and to identify the preventive measures that they can apply to control those hazards (9 CFR 417.2(a)). Whenever a hazard analysis reveals that a food safety hazard is reasonably likely to occur in the production process, establishments are required to develop and implement a written HACCP plan for each product that includes specified control measures for each hazard so identified (9 CFR 417.2(b) and (c)). Establishments are required to reassess their HACCP plans at least annually or whenever a change occurs that could affect a hazard analysis or a HACCP plan (9 CFR 417.4 (a)(3)).

In addition, the HACCP regulations require that establishments maintain certain records that document the establishments' HACCP plans (9 CFR 417.5). These records include, among other records, the written hazard analysis prescribed by 9 CFR 417.2(a), including all documentation that supports that analysis (9 CFR 417.5(a)). The HACCP regulations also require that establishments retain certain HACCP-related records, including records that document verification procedures and results, for a certain period of time. For slaughter activities or refrigerated products, establishments are required to retain records for at least one year (9 CFR 417.5(e)). For frozen preserved, or shelf-stable products, establishments are required to retain records for at least two years (9 CFR 417.5(e)). All records required under the HACCP regulations must be available to FSIS for official review and copying (9 CFR 417.5(f)). FSIS verifies the adequacy of an establishment's HACCP plan through various means, including on-site observations, record reviews, and sample collections and analyses (9 CFR 417.8).

Establishments may conduct certain testing or monitoring activities as part of their HACCP plans, or as programs that could affect the hazard analysis but that may or may not be referenced in the HACCP plan. For example, establishments may perform testing or monitoring activities as a part of a prerequisite program or conduct product testing to comply with the specifications of business customers. Because the results of such testing and monitoring activities could affect the establishment's hazard analysis, FSIS considers records that document the results of any monitoring or of any testing conducted by an establishment as supporting documentation for the hazard analysis, which, under 9 CFR 417.5, must be maintained by the establishment and be made available for FSIS review.

Furthermore, because the HACCP regulations require that establishments retain certain HACCP-related records for at least one year, or for frozen, preserved, or shelf-stable products, for at least two years, FSIS expects that establishments will retain records that document the results of any testing or any monitoring activities, including records that document the results of tests conducted to meet a purchaser's specifications, for this same period of time. The Agency has determined that such records are subject to the record retention provisions of the HACCP regulations because they document procedures and results that FSIS inspection program personnel may rely on to verify the adequacy of an establishments' HACCP plan. Records that document verification procedures and results are subject to the HACCP record retention provisions in 9 CFR 417.5 (e).

FSIS issued Notice 54-03 in December of 2003 to inform FSIS inspection program personnel that they should be aware of all monitoring and of all testing related to food safety conducted by an establishment and to verify these records as part of the HACCP inspection procedures. The Agency reissued the notice in April of 2004 as an FSIS Directive to make it consistent with Directive 10,010.1, “Microbiological Testing Program for Escherichia coli O157:H7 in Raw Ground Beef.” Directive 5000.2 instructs inspection program personnel to ask establishments to make available for review the data that is generated by any monitoring and any testing related to food safety to ensure that this data is available when inspection program personnel are verifying HACCP records. Directive 5000.2 makes clear that inspection program personnel should review any food safety data that has been generated by the establishment at the weekly HACCP meeting.

Directive 5000.2, as did Notice 54-03, instructs FSIS inspection program personnel to examine an establishment's testing and monitoring results to determine whether these documents indicate that the establishment has failed to recognize and correct any food safety concerns. Thus, the directive makes clear that records that document the results of any testing and of any monitoring related to food safety that are performed by an establishment, whether such activities are incorporated into the establishment's HACCP plan, referenced in a HACCP plan, or considered as separate food safety activities, are supporting documentation for the establishment's hazard analysis. The Agency expects that establishments will make such records available to FSIS inspection program personnel upon request.

To enhance its inspection program personnel's understanding of the policies described in FSIS Directive 5000.2, and to assist inspection program personnel develop the critical thinking skills that they need to apply these policies in the establishment setting, FSIS has issued new scenarios under its Interactive Knowledge Exchange (IKE) service. IKE is a tool available to all Field Operations employees to assist them in keeping current and correlated on regulatory requirements, directives, notices, HACCP, Sanitation SOP, and FSIS sampling programs.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to better ensure that the public, and in particular minorities, women, and persons with disabilities, are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at http://www.fsis.usda.gov.

The Regulations.gov Web site is the central online rulemaking portal of the United States government. It is being offered as a public service to increase participation in the Federal government's regulatory activities. FSIS participates in Regulations.gov and will accept comments on documents published on the site. The site allows visitors to search by keyword or Department or Agency for rulemakings that allow for public comment. Each entry provides a quick link to a comment form so that visitors can type in their comments and submit them to FSIS. The Web site is located at http://www.regulations.gov.

FSIS also will make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, recalls, and other types of information that could affect or would be of interest to our constituents and stakeholders. The update is communicated via Listserv, a free e-mail subscription service consisting of industry, trade, and farm groups, consumer interest groups, allied health professionals, scientific professionals, and other individuals who have requested to be included. The update also is available on the FSIS Web page. Through Listserv and the Web page, FSIS is able to provide information to a much broader, more diverse audience.

Done at Washington, DC, on April 28, 2004.

Barbara Masters,

Acting Administrator.