What looms on the horizon with regard to FSMA?

Although it may be out of necessity that so much has been written about the new Food Safety Modernization Act (FSMA) rules, such commentary now borders on overload. So, what are the salient points you need to know? In this final installment of my series on “government regulations,” I tackle that question and others involving FSMA.

It seems quite unlikely that the baking industry could be classified as high-risk, but it is. The extent of recalls, the frequency of their occurrences and the potential severity associated with them prompted the Food and Drug Administration (FDA) to classify the baking industry as a “high risk” industry. Just scan our industry magazines and daily papers to understand the cause for this classification. From May 1 to June 30 this year, FDA posted 68 recalls for the baking industry.

The reasons included products that either had or possessed the potential to contain one or more of the following contaminants: Listeria monocytogenes, potential or actual presence of small metal fragments, plastic pieces, E. coli O121 and undeclared milk, peanut, egg, walnuts, coconut and wheat allergens.

What is the upshot of all this? The baking industry will see more inspections. FDA is required by law to inspect bakeries, and all other registered food manufacturing facilities, every three years. And that leads right into FSMA, for when FDA inspects, FSMA will be the guidance its inspectors will be using.

Let’s start by being clear on the “when” of FSMA, which includes compliance dates tied to publication of the final rules on Sept. 17, 2015. Very small businesses — averaging less than $1 million annually in sales — have three years to comply (September 2018); businesses with fewer than 500 employees have two years (September 2017); and all others have one year (September 2016). And in all cases, compliance means FSMA-certified … no ifs, ands or buts!

FSMA requires establishing a documented food safety system that covers hazard analysis, preventive controls, oversight, and management, verification and thorough training of employees.

Hazard identification, the first step in the system, considers known or reasonably foreseeable biological, radiological, chemical and physical hazards. It doesn’t matter if these hazards occur naturally, are inadvertently introduced or are intentional — they must be addressed. Then, for each hazard, be it a process step, a food allergen or a sanitation requirement, preventive controls are required to minimize or prevent the risk.

FSMA standards also require that bakers design procedures to ensure the preventive measures are performed and corrective actions are taken when needed. Food facilities must then put in place a verification step that validates the required preventive controls are consistently implemented and effective as a part of the facility’s food safety system. Lastly, the program requires a defined recall program also be a component of the system.

There will need to be a “preventive controls qualified individual” who will be responsible for your food safety plan, validating your preventive controls; ensuring required recording, collection and adequacy of the records; reviewing corrective actions; and documenting that the training requirements of your program are met.

Management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. Employees must have the necessary combination of education, training and/or experience to perform their assigned tasks in a manner that guarantees the safety of the food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene. A “standardized training curriculum” — a structured program in which the training materials must meet FDA standards — must be used in conducting this required training.

What looms on the horizon with regard to FSMA?

Well, there are two efforts currently underway that warrant watching. To carry out its “additional recordkeeping for high-risk foods” initiative, FDA is directed to issue proposed rulemaking to establish recordkeeping requirements for facilities that manufacture, process, pack or hold foods that FDA designates as high-risk foods.

Meanwhile, for its “enhanced product tracing” effort, FDA has been directed to establish a system that will enhance its ability to track and trace both domestic and imported foods. In addition, the law instructs FDA to establish pilot projects to explore and evaluate methods to rapidly and effectively identify the recipients of food under scrutiny to prevent or control a foodborne illness outbreak.

This ends my primer. Have I missed something you feel is important? Got my facts wrong? I would like to hear from you, for this is important stuff for all of us.