F.S.M.A. rules emphasize through testing and record-keeping as part of any food safety plan.

KANSAS CITY — The clock is ticking. Most food facilities face a September deadline for complying with regulations set out by the  U.S. Food and Drug Administration (F.D.A.) that enforce the Food Safety Modernization Act (F.S.M.A.).

Actually, the F.D.A.’s final rule covering preventive controls for the safety of human foods is effective now, having been published in the Federal Register of Sept. 17, 2015. And now means now.

Jack Payne
Jack Payne, vice-president of product management and solutions consulting for Aptean

“I would hope that most food facilities are on the way to compliance already,” said Jack Payne, vice-president of product management and solutions consulting for Aptean Inc., a provider of enterprise resources planning systems. “The scope of the rules has been known for three years or more, even if the actual regulations were only recently finalized and published. Documentation of preventive control plans should be in place now.”

Food safety experts such as Len Steed, manager of global innovation for AIB International, urge immediate action.

Len Steed
Len Steed, manager of global innovation for AIB International

“Companies should establish a team responsible for a successful transition to F.S.M.A. on time,” he said. “Every plant should set up a Gantt chart or project schedule to ensure they are in compliance on or about Sept. 17. This will allow them to prioritize what needs to be done by set dates in order to achieve compliance in the most efficient and logical path and manage the progress.”

Mr. Payne added, “If I’m a food manufacturer and don’t have a plan by now, then I’m in trouble.”

A different approach

F.S.M.A. marks a sweeping change for the F.D.A. It places the job of preventing foodborne illness on the shoulders of food processing facilities, and its rules are different than those of past F.D.A. regulations.

Justin Hamilton
Justin Hamilton, senior project engineer/project manager of the foods and consumer products group for Burns & McDonnell

“It takes the function of Hazard Analysis Critical Control Points (H.A.C.C.P) and makes it law,” said Justin Hamilton, senior project engineer/project manager of the foods and consumer products group for Burns & McDonnell, a civil engineering firm with a practice among consumer packaged goods clients. “H.A.C.C.P. is the foundation of preventive controls.”

It takes many H.A.C.C.P. components — for example, implementation of prerequisite programs, current Good Manufacturing Practices (cGMPs), analysis of potential problems and documentation — but shifts control measures into a prevention mode called Hazard Analysis and Risk-Based Preventive Controls (H.A.R.C.P.).

Robert Brackett
Robert Brackett, PhD., vice-president and director of the Institute for Food Safety and Health at Illinois Institute of Technology

“F.S.M.A. compliance with its emphasis on risk prevention is different than H.A.C.C.P.,” said Robert Brackett, PhD., vice-president and director of the Institute for Food Safety and Health (I.F.S.H.) at Illinois Institute of Technology.

Food facilities are required to implement written preventive controls plans. To establish the plan, the facility must evaluate hazards that could affect food safety; identify what preventive steps, or controls, will be put in place to minimize or prevent the hazard; describe how these controls will be monitored to ensure they are working; maintain routine records of such monitoring; and specify what actions the facility will take to correct problems that arise.

H.A.R.C.P. is not as prescriptive as H.A.C.C.P., according to Mr. Steed. “[This approach] allows the food safety team to set up steps for deciding what to do in case of failure of each preventive control identified. The foundation is prevention and response.”

“Most bakers and other food processors rightly put emphasis on prevention in their food safety programs,” Mr. Payne said, “but they also have to know how to act when problems occur and how to implement recalls effectively.”

Another big difference involves records access. F.S.M.A. beefed this up, giving the F.D.A. the authority to request the facility’s food safety plans and records that document the implementation of such plans.

Additionally, laboratories that supply test services to food facilities must be accredited.

FS.M.A. empowered the F.D.A. to give imported foods and food ingredients greater scrutiy. Regulations address importer accountability and third-party certification, and they offer the Voluntary Qualified Importer program. The law gives the F.D.A. the authority to refuse foreign foods entry into the U.S. if the agency is denied access by the processing facility or the country in which it is located.

Food imports
FS.M.A. empowered the F.D.A. to give imported foods and food ingredients greater scrutiny.

If things go wrong, and a company fails to voluntarily remove unsafe food from the market after an F.D.A. request, the agency can mandate such action.

“It’s important to do recalls correctly and promptly,” Mr. Payne said. “Under the law’s expanded administrative detention provision, if you don’t do your recall within a precise time, all your products can be pulled by the F.D.A. as potentially in violation.”

The F.D.A. can suspend the processing facility’s registration if it determines that the food made there poses a reasonable probability of serious adverse health consequences or death.

There are some very real costs involved. Consider the matter of inspections. With FS.M.A. now in effect, every food manufacturing facility registered in the U.S. can expect to be inspected periodically. The frequency is determined according to risk. All those making high-risk foods will be inspected within the next five years and every three years thereafter.

Hostess snack cakes recall
Most bakery recalls are due to mislabeling and allergens, such as Hostess' recall of certain snack cakes due to possible peanut residue.

Fortunately, bakery products are not typically considered to be high risk. Mr. Payne said, “Most bakery recalls are due to mislabeling and allergens, although I have seen a few related to bacterial problems in cream fillings and icings.”


Like previous practice, the initial F.D.A. inspection carries no cost to the facility, but then things change. If problems are found that require a second visit, the F.D.A. can charge the company for the hours that the inspector — or inspectors — is present in the facility, no matter how many times they have to return to make sure a compliance problem has been addressed.