What’s an FSA?
A Food Safety Assessment (FSA), done randomly or in response to a problem, is an audit done by FSIS at federally inspected plants to assure that food safety procedures are effective. According to FSIS, a central goal of the FSA process is to “reduce recalls and enforcement actions by providing valuable information to plants about their food safety systems.”
An FSA is done by an FSIS Enforcement Investigations & Analysis Officer (EIAO) who visits your plant to review your food safety documents (HACCP, SSOPs, etc.) and to assess your plant in action.
Current FSIS practice is that every federally-inspected establishment will receive an FSA at least once every 4 years. BUT, an FSA can be justifiably requested at the district level for a long list of reasons, including:
- Positive (showing pathogens) laboratory findings
- To determine whether a plant has reassessed its HACCP plan or evaluated its SSOP.
- Food-borne illness outbreaks, recalls, or consumer complaints.
- Randomly selected by district office officials.
1. Be prepared for an FSA at any time.
2. Ask the EIAO why the FSA is being performed: FSIS does want you to know. You may be completely unaware of “issues” the inspector has communicated to the supervisor.
3. Request the regulatory basis for all findings made during the FSA. If the EIAO’s explanation is not sufficient, call the FSIS Office of Policy and Program Development (OPPD) in Omaha: (402) 344-5000. OPPD is available to comment on all matters related to the interpretation and application of current agency policy.
According to FSIS, OPPD should be the only FSIS unit contacted to settle disputes related to the interpretation and application of Agency policy. Do not start with your USDA district office. In some cases, a three way call (plant, district office, and OPPD) may help assure agreement on interpretation of regulations.
How to prepare for an FSA
The “EIAO draft tools,” designed to assist EIAOs in supporting FSA findings, can help you know what to expect during a FSA. The EIAO will use any relevant versions of these tools during an FSA, responding to each question as appropriate.
Find the tools here: EIAO draft tools
FSIS has also posted a series of presentations (ppt/pdf) to explain the FSA methodology. Find them here: FSA methodology presentations
One Mobile Unit’s FSA experience
The Island Grown Farmers Cooperative Mobile Slaughter Unit (Island Grown Farmers Cooperative case study), in Washington State, has gone through two food safety assessments (FSA) since it began operating in 2002: the first in 2008 and the second in 2009.
This schedule is unusual in two ways: (1) the first FSA didn’t happen for the first 6 years of operation, and (2) the second happened so soon after the first, when there had been no food safety issues or complaints.
IGFC passed both FSAs, but the two were very different.
The first, done by an EIAO from the USDA Denver office, went quickly. The EIAO spent a day with Barbara Thomas, IGFC’s HACCP Coordinator, going over their HACCP plan and other food safety documents and observing the MSU and plant in action. He wrote his report and then discussed his findings with IGFC, explaining the few changes he required them to make, which were minor. And that was it.
The second FSA began in mid-January 2009 and lasted until mid-April. The EIAO, from the USDA office in Bothell, WA, also went over the plans and observed the MSU and plant. He then continued to ask Barbara questions by email multiple times a week for many weeks, all of which she answered meticulously. The EIAO had two main concerns: IGFC’s testing lab and the Sanitary Standard Operating Procedures (SSOPs) for the IGFC cutting room.
IGFC had been using a lab that had been recommended by USDA and had always done a great job. But the EIAO required IGFC to ramp up its testing program for E.coli 0157:H7, saying that new USDA testing requirements were coming. IGFC’s lab wasn’t able to do the increased testing (the required equipment was too costly). The EIAO strongly encouraged IGFC to do their own testing, in-house.
Barbara looked into in-house testing and even found a testing kit manufacturer willing to donate the equipment to IGFC so they would only have to buy supplies. One of IGFC’s members, a cheesemaker, had her own lab, extremely clean and sanitary, where IGFC could have done the testing. Yet even with the equipment donated, in-house testing would still cost more using an outside lab, even including shipping.
Fortunately IGFC’s original lab was able to recommend another lab, which has worked out very well.
The EIAO was also concerned that the SSOPs for IGFC’s cutting room, which relied on time and temperature to assure product safety, were not adequate. However, Barbara was able to find research done by Dr. Steve Ingham, at the University of Wisconsin, that backed up this method in the specific way IGFC was doing it.
Additional concerns were minor, including small wording changes in the plans themselves. Barbara, a careful wordsmith herself, disagreed with a few of these suggestions, but they eventually worked through all of them. “It just takes time,” she says.
Key lessons for plant operators
- Always be prepared for an FSA, even if you had one recently.
- EIAOs are not all alike and may interpret the same regulation differently.
- Answer each of the EIAO’s questions fully and carefully. Think about everything you write and document it all.
- If you don’t know the answer, say, “I’m not sure, I’ll get back to you.” And then do your homework.
- Ask WHY: if you don’t understand an EIAO’s interpretation or requirement, ask for clarification. What is the specific regulation? What is the reasoning behind that regulation? “Because USDA says so” is not good enough.
- Once you understand the “why,” ask for guidance to solve the problem.
- Befriend your interlibrary loan librarians – you’ll need their help tracking down all the research papers you need for back up.
- Call on university extension meat scientists – in your state and beyond. Visit the State Affiliates page on the Niche Meat Processor Assistance Network website.