The APM is a centralized system that FSIS will use to capture information related to all reporting of instances of product adulteration, whether reported by official establishments or identified by FSIS personnel. The APM will be housed in the Public Health Information System (PHIS), FSIS’s inspectional database system. Although FSIS is initially rolling out the APM with limited functionality, the system will eventually be expanded to capture all reports of adulterated product, including establishment reports under 9 CFR § 418.2 and FSIS-generated reports on Form 8140-1. The APM will initially allow only FSIS to input information, although FSIS plans to provide industry access at a later date.
According to FSIS Notice 49-20, once fully implemented, the APM will include three main tools for industry and FSIS:
- Industry Report of Adulteration (IRA) — This tool will capture reports from industry under 9 CFR § 418.2. FSIS plans to eventually provide establishments with direct access to this tool, but initially FSIS personnel will generate these reports by entering information from 418.2 reports into the system.
- Industry Report of Adulteration-In Plant (IRA-IP) — This tool will let FSIS personnel input Form 8140-1 information electronically. This tool is not being used in the initial implementation, but is planned to come online in the future.
- Agency Report of Adulteration (ARA) — This tool will be used by District Offices (or Regional Offices for product outside official establishments) to document incidents where Agency personnel determine that adulterated or misbranded products have entered commerce or when referring reports of adulterated product to headquarters recall staff.
Currently, only FSIS personnel will have access to the system, and the system will use only the IRA and ARA tools. The IRA-IP is not currently active, and inspectors are to continue filling out Form 8140-1 as they are currently doing.
FSIS plans to use the APM to increase the Agency’s ability to track and communicate reports of adulterated product. FSIS personnel are supposed to evaluate every report entered in the APM to decide whether to refer the situation to headquarters recall staff and to document the referral decision. Further, District Offices are instructed to use the APM to communicate instances of adulterated product between FSIS personnel at shipping and receiving establishments and between District Offices, when multiple Districts are involved.
Although the APM does not create new responsibilities for the regulated industry, the new system could create opportunities for more critical review of instances of product adulteration, and potentially more recalls, by centralizing reports of adulteration and placing more internal emphasis within FSIS on evaluating every instance of reported adulteration. Importantly, because FSIS requires reporting of adulterated product more broadly than does FDA, the APM could place more situations under greater FSIS scrutiny.
We will continue to monitor developments related to the APM Module as tools become available to industry and FSIS begins implementation of the tools. Please contact us if you have any questions or if we can provide assistance on these issues.
FSIS Notice 49-20, Implementation of the Adulterated Product Monitoring Module of the Public Health Information System (Sept. 30, 2020)
Authored by Brian Eyink and Chris Forgues.