FSMA rules have flexibility built in
April 5, 2016
by Laurie Gorton
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
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
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.