FSMA’s potential pocketbook issues
Here’s what the law may cost you and how it will change your operations in the long run.
BakingBusiness.com, March 1, 2013
by Dan Malovany

Although the Food Safety Modernization Act (FSMA) was passed more than two years ago, more questions than answers still exist about how the law will affect bakeries and snack manufacturers.

To clarify the many convoluted issues surrounding this law, Baking & Snack Editor Dan Malovany interviewed Richard Stier, an expert on food safety and contributing editor to the magazine. Mr. Stier is a consulting food scientist with international experience in food safety including Hazard Analysis and Critical Control Point (HACCP) programs, food plant sanitation, quality systems, process optimization, good manufacturing practice (GMP) compliance and food microbiology.

The biggest issue with FSMA is that FDA has only now started issuing regulations to enforce the act. On Jan. 4, the agency announced two proposed rules, the first requiring food manufacturers to develop a written plan to prevent their foods from causing foodborne illness and the second covering farms. 

In this exclusive report, Mr. Stier talks about the myriad pocketbook concerns that may arise as the government issues regulations.

Baking & Snack: What’s the biggest lesson learned from the past year in food safety as it relates to bakeries and snack food operations?

Richard Stier: The biggest lesson is the importance of vendor quality, which incidentally is one of the elements in FSMA. The problems caused by the now defunct Peanut Corp. of America in 2009 seemed small compared with the number of recalls that resulted from mangoes, onions and ­especially the nuts and nut products distributed by Sunland, Inc., in New Mexico. In 2012, the Food and Drug Administration responded to an outbreak of salmonella linked to salted peanut ­butter product. To date, Sunland issued recalls on approximately 300 products, which ­resulted in excess of 100 companies ­having to make recalls of their own ­because they had either distributed Sunland products or used its ingredients without further processing.

Surprisingly, the list of companies affected by the Sunland recall includes large processors that should know better. Sunland’s problems were underscored by a third-­party audit, which highlighted various issues. And to top it off, FDA in November used its new authority under FSMA to suspend Sunland’s facility registration, thus effectively halting the company’s operations.

So, the message is this: Take a step back, and take a long look at your vendor quality program. Are you relying solely on certificates of analysis? A third-party a­udit? Or are your requirements more stringent? Small companies may have to take an even longer look because they often do not have the money, personnel and expertise to develop, implement and maintain a comprehensive and effective vendor quality program.

What can bakers expect from FSMA regulations in 2013?

When we saw drafts of regulations early this year, people must remember that they are only drafts. There will be a comment period, probably 60 to 90 days. Among the first responses to the draft regulation could well be requests to expand the comment period by one to two months. So, even with the draft regulations issued early this year, the comment period may last for five or six months. The agency will then need to evaluate all the comments and prepare the final regulation. Realistically, the industry will probably not see the final regulations until 2014.

Some experts speculate that FDA may also issue guidance documents to the industry. There are pros and cons to this tactic. In FDA-speak, guidance documents are not really guidance at all. Instead, they seem to have the force of law. For example, FDA investigators expect processors to follow the guidance — or clearly do something as effective as what is described in the document.

Since FSMA became law, what issues have surfaced that will need to be addressed?

Perhaps the biggest is the processors’ rights under current and upcoming regulations. In working with the industry, I have heard several reports of FDA investigators informing companies that they would be allowed to take photographs in–plant under FSMA provisions. This is not the case now, nor is there such a provision in the act.

Bakers and snack food producers must have a documented policy to deal with regulatory inspections. This policy should include how to work with investigators, what records the agency can access, a camera policy and rules regarding collection of samples. In addition, the camera policy should be posted in the main lobby.

Additionally, the company needs to make sure that all employees, including clerical staff, understand their roles in the event of an inspection. This is something that will need to change when the FSMA enforcement rules are finalized.

What are the biggest pocketbook issues posed by FSMA?

Food processors will face potential costs involving reinspections, recalls and proper development nnd validation of preventive controls.

Let’s look at reinspection first. The agency has already issued regulations that establish the costs for reinspection, which conveys the veiled message to get it right the first time. FDA’s guidance for fees can be found at www.fda.gov/Food/FoodSafety/FSMA/ucm257982.htm. There are no fees for an initial inspection, but if there are issues, the agency will come back, and it will cost the company. Fees include $221 per hour for inspections requiring no foreign travel and $289 per hour for projects involving foreign inspection. So, the cost for one 8-hour day for one domestic investigator is $1,768.

The second matter with potential hit to the pocketbook could be developing and validating all preventive controls and critical control points. The assumption in the industry has always been that if a food is baked, fried or cooked, then it is safe, but the salmonella outbreaks from breakfast cereals were an eye-opener. Some bakers and snack food processors are doing in-house ­research to evaluate their current processes. Are these cakes, pies, snacks or cookies actually receiving enough heat to kill microorganisms of public health significance? The validation work will determine if this is a myth or not.

Validation will entail a great deal of work for the industry. Large operations have the people and instrumentation to do this, but it will be a challenge to smaller operations. What large companies do will remain their proprietary data, unless they come to the realization that problems with small companies can potentially impact their business. Perhaps the ­baking trade associations can fund the research necessary to determine methods, target organisms, surrogate organisms and the other issues associated with validating baking processes.

What equipment design changes need to occur in the next couple of years to improve food safety?

What is needed — and what I ­believe is already being done — is that food process equipment manufacturers must make an even greater commitment to sanitary design of equipment and conveyors. The 10 Principles of Sanitary Design e­stablished by the American Meat Institute for ready-to-eat foods are really applicable across the board.

These principles should be used by all food equipment manufacturers. Because most food processing equipment is custom ­ordered and built, food processors should seriously consider working with the equipment manufacturer to make any modifications that ­ensure the equipment is easier to operate, clean and maintain. It may add to the initial cost, but the changes and benefits resulting from more efficient operations could very well end up paying for the equipment in short order.

What best practices should facilities adopt to deal with allergens and pathogens?

Allergen and pathogen control are two distinct activities. Their only real similarities are that both are potential food hazards and that good sanitation, especially cleaning and sanitizing, can help minimize potential problems.

First, let’s talk about cleaning. When developing an effective cleaning program, the key is validation. A validated program is one that is proven effective at removing soil from the surface. Once the cleaning procedures have been validated, you must implement programs to verify that the work was done properly. However, the real challenge in the baking and snack industries is that many operations cannot use water for cleaning.

The real difference between the two potential hazards is that allergen control is a function of the label, whereas pathogens must be eliminated from or kept out of the food. Because baked foods and snacks are low in water activity (Aw), they generally will not support the growth of pathogens. But if salmonella or ­another pathogen gets into the product, it could survive and cause an illness, as with the salmonella outbreaks attributed to puffed cereals and potato chips.

What is the best advice you have ever given or heard about for improving food safety?

Never skimp on training and education. A commitment to properly ­educating workforce and management is an investment in the future, especially if you can make it seem like a reward. For example, many plant workers never get a chance to get out of the plant on company business. Getting people out to a workshop education session, with lunch included, at a local hotel or business center can be perceived as a day off or a bonus. This kind of program builds goodwill.