[Federal Register: May 4, 2004 (Volume 69, Number 86)]
[Page 24556-24558]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety and Inspection Service

[Docket No. 04-009N]

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/

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, 
(202) 720-5627.



    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

[[Page 24557]]

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: //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.

[[Page 24558]]

    Done at Washington, DC, on April 28, 2004.
Barbara Masters,
Acting Administrator.
[FR Doc. 04-10030 Filed 5-3-04; 8:45 am]