Are you prepared for an FSIS compliance visit?
Last month, the Food Safety and Inspection Service (FSIS) reissued seven directives relating to FSIS surveillance, investigation and enforcement activities. The directives are available at: http://bit.ly/FSIS0414directives.
Together, these directives provide a comprehensive set of instructions to FSIS investigators and other personnel for conducting surveillance activities and investigations to determine a regulated entity’s compliance with the Inspection Acts and related laws. The directives instruct investigators on how to collect evidence, such as accessing establishment records, taking photographs, collecting investigative samples, and interviewing and taking statements from subjects and witnesses. The directives also provide instructions for determining appropriate enforcement actions for alleged violations of the acts.
While FSIS investigators have detailed written procedures to follow, most establishments do not have similar procedures for handling government investigations or the enforcement actions that might arise out of them. Because of this, too often establishments and their employees allow investigators unbridled freedom to collect evidence, such as signed statements, without the establishment’s rights or other interests being protected. Unfortunately, establishments and their employees often do not recognize what they have done until they are faced with an enforcement action by the agency.
All establishments regulated by FSIS should have written procedures regarding how to handle government compliance visits and investigations. The procedures should cover, at a minimum:
- How to receive compliance officers, such as how to verify government credentials and how to notify establishment management when compliance visits occur outside of normal business hours;
- How to communicate company policies to investigators, such as the requirement that a company escort accompany the investigators at all times during the visit and that investigators follow establishment GMP and food safety procedures;
- How to handle requests for records, such as the requirement that all document requests be channeled through one person and approved by company management (with input from legal counsel as needed);
- How to respond to the agency’s collection of investigative samples, such as documenting what, when, where, how and why samples were taken and holding all products potentially implicated;
- How to respond to requests for photographs, which could include prohibiting photographs unless certain conditions are met and contacting legal counsel in the event investigators decline to comply;
- How to respond to requests for interviews and employee statements, such as requiring that all employee interviews take place on company premises with a company official or counsel present, and that no statements or documents be reviewed, signed, initialed or in any way approved (including verbally) by an employee until it is first reviewed by legal counsel; and
- How to conduct an exit interview with the investigators to determine areas of potential concern and corrective/preventive measures.
The establishment’s written procedures should also address how to respond to follow-up actions by FSIS, including promptly alerting management of any enforcement action that may be contemplated or taken by the agency. Particular attention should be given to FSIS letters titled “Notice of Alleged Violation.” These letters allege criminal violations of the acts and other laws, and provide establishments and/or individuals an opportunity to respond in writing – and request a meeting to discuss – the alleged violations before the agency decides whether to refer the matter to a U.S. Attorney’s Office for criminal prosecution. Because anything said or written in response to these letters may be used against an establishment or individual in a criminal proceeding, it is strongly recommended that anyone receiving this letter obtain legal representation prior to responding.
One final piece of advice: Do not take it on faith when an investigator claims the matter he/she is investigating is “minor” or not a “big deal.” Minor issues usually do not result in an investigators showing up at your doorstep. If you believe it is possible the establishment or one of its employees may be the subject of a criminal investigation, seek legal representation at the point when it really matters — at the beginning of the investigation and not after all the evidence is collected and an enforcement action is taken.