The above named guidance documents were published in the Federal Register on 3/19/03, and are designed primarily as aids for operators of food establishments (i.e. firms that produce, process, store, repack, relabel, distribute, or transport food or food ingredients) and food importers, warehouses, and filers. This guidance is voluntary and is not tied to existing regulations. The guidance documents identify preventive measures that these kinds of establishments can take to minimize the risk that food under their control will be subject to tampering or other malicious, criminal or terrorist actions. The documents set out goals in this regard and provide example strategies for achieving those goals.
You should not perform a comprehensive food security audit of the establishment, nor should you conduct an extensive interview in an attempt to determine the level of adoption of preventive measures listed in the guidance. The goal is to facilitate an exchange of information to heighten awareness of food security. Management of the establishment should be encouraged to voluntarily implement those preventive measures that are appropriate for their operations. Not all of the guidance contained in this document is appropriate or practical for every food establishment, food importer, warehouse, or filer, particularly smaller entities.
Food regulatory officials should cover the preventive measures during regular inspections or audits of food establishments, food importers, warehouses, and evaluation of filers. Based on conditions observed during the normal course of the inspection/audit, the appropriate material in the guidance documents should be discussed with management of the establishment and a copy of the guidance should be provided during the close-out meeting. Additionally, any opportunities for improvement or enhancement of the establishment's preventive measures that were identified during the inspection/audit should be discussed with management, but should not be listed as violations (e.g. on FDA's form FDA-483 Inspectional Observations) unless they likewise constitute deviations from Current Good Manufacturing Practice.
The fact that the discussion took place and that a copy of the guidance document was provided should be recorded in the inspection report (e.g. FDA's Establishment Inspection Report [EIR]) or evaluation report, but the details of the inspectional findings in this regard should not be recorded. For example, under a section heading titled, "Food Security," the regulator should only state, " A copy of the Food Security Guidance Document was provided to and food security issues were discussed with (name of food establishment official)." Additionally, you should minimize the quantity and detail of notes taken relative to the establishment's food security program, taking only those needed to serve as a "memory jog" during the discussion with management.
If management of the establishment has suggestions for improvement of the referenced guidance he/she should be encouraged to provide comments to the Agency via Docket # 01D-0583 (see Federal Register Notice of Availability dated January 9, 2002).
Two companion draft guidance documents were also published in the FR of 3/19/03. These address recommended preventive measures for food retail and food service establishments and cosmetic processors and transporters. These field instructions do not apply to retail, food service or cosmetic inspections or audit at this time. However, you should alert management of these establishments to the existence of the appropriate draft guidance document and encourage their comments to the docket (Docket # 03D-0092). These documents will be issued as final guidance following review of comments and appropriate revision of the documents.
Food Producers, Processors, and Transporters: Food Security Preventive Measures Guidance March 21, 2003
Importers and Filers: Food Security Preventive Measures Guidance March 21, 2003
Hypertext updated by las/cjm 2003-MAR-19