Regulations that carry out the Food Safety Modernization Act (FSMA) have different deadlines depending on company size. Advance planning, however, will be vital for smooth transition to food manufacturing under the new rules. That’s what Bill Bremer, principal, Kestrel Management, a provider of operational risks management services, told Baking & Snack in an exclusive Q&A.
The timeline is one aspect. Very small businesses, those averaging less than $1 million in annual sales, have three years to comply; however, the records qualifying these companies as very small should have been in place by Jan. 1, 2016. Small businesses, those with fewer than 500 full-time employees, have two years. All others have one year.
The action plan is another, and some parts are enforceable now, according to Mr. Brewer.
Baking & Snack: With FSMA going into effect in September, where should companies be in their compliance programs now?
Bill Bremer: The rules will affect companies needing to comply with FSMA differently. The first step should be to conduct an analysis of requirements for developing a FSMA compliance plan. Some elements are currently enforceable — registering with the Food and Drug Administration (FDA) and establishing a food safety plan. Others have resulted in time to plan, based on the rulemaking process between industry and FDA. The sections under rulemaking begin with deadlines for specific for certain sections beginning October 2016. The most common of these is preventative controls under the HARCP (a.k.a. Hazard Analysis and Risk-Based Preventative Controls) designation.
FSMA rules seem to be very open-ended, and the agency talks a lot about flexibility. What does this mean to the baker or snack food maker being inspected under the new regulations?
The flexibility included the additional time for certain compliance under rulemaking. Additionally, the compliance deadline will vary depending on the size of the company; however, in all cases, a company’s compliance must meet the requirements of their customers.
How did FSMA change the responsibilities of top managers with respect to food safety?
Top management and all employees involved in food processing are legally responsible, both as part of the company and as individuals, for ensuring the distribution of safe, unadulterated and pure food. Top management must ensure qualified resources and food safety plans for their company and plants, and, through internal control level audits, confirm that the programs are effective.
What aspect of FSMA do you see as being the most challenging to bakers and snack food companies? (FYI: Many are working on kill step validation protocols now.)
Kill steps can be important depending on the product risk and must be determined through the preventative control process. This needs to be updated with Current Good Manufacturing Practices (cGMPs) that are current for the operations and the food risk as past food safety programs must be updated. Additionally, due to the variety of ingredients in the baking and snack food companies, allergen control presents a very challenging level of control leading to the label claims of the products.
What is the single most important step a baker can take to get ready for FSMA?Assess the changes required by FSMA. Ensure compliance with the existing FDA requirements (defined at 21 CFR 110) as they apply to specific companies and update programs to cover the specific new requirements.