New food safety law to enhance FDA's power
March 1, 2011
by Dan Malovany
According to a Georgetown University study last year, food-borne illnesses in the US cost $152 billion a year in lost productivity, medical bills and other expenses, not counting food industry costs when a product is recalled. The Food Safety Modernization Act (FSMA) established a framework for working toward eliminating such devastating costs for the industry. Baking & Snack
interviewed Richard Stier, an expert on food safety, about the potential impact of the act on bakeries and snack manufacturers. 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. Certified as a seafood HACCP instructor with the Association of Food & Drug Officials (AFDO) and by the HACCP Alliance, he has worked with a wide range of processing systems and products, including canning, freezing, dehydration, deep-fat frying, aseptic systems and meat processing. Baking & Snack: How will the Food Safety Modernization Act (FSMA) passed late last year change the relationship between food plants and federal regulators? Richard Stier:
I can’t envision that the Food Safety Modernization Act will change the current relationships with food processors too much. Of course, we will not know how enforcement will actually take place until the Food and Drug Administration (FDA) writes the appropriate regulations to enforce the act. Remember, acts of Congress are the law of the land, but they require regulations to be developed by the administering agency. The four biggest potential issues will be the ability of the FDA to 1) conduct more inspections and access to records, 2) force mandatory recalls 3) [detain] food based on a “reason to believe” the food is adulterated or misbranded and 4) suspend registration. The last three issues substantially increase the power of the FDA.
For the baking and snack industry, government access to records is minimal at the moment. With HACCP becoming mandatory for all processors regulated by FDA, HACCP plans, prerequisite programs and supporting documentation will now be made available to investigators. However, processors really should not be overly concerned about this. Why? Food safety has been driven by economic issues. Most bakeries, snack food producers and suppliers to those industries already have HACCP plans and the prerequisite programs essential for ensuring the production of safe foods. The third-party audits mandated by purchasers — whether [processors] are required to develop and implement one of the audit schemes mandated through the Global Food Safety Initiative (GFSI) or another audit — include all the technical requirements described in the act. The bottom line is, processors and ingredient suppliers have had to develop these programs to maintain their customer base. No HACCP program. No business. Even the act’s article that addresses internal audits to evaluate the potential for intentionally introduced hazards such as bioterrorism should not create too many problems as most of the third-party audits include a food defense section. How quickly can the law be enacted so that bakers and snack producers are affected and consumers see meaningful changes at their operations?
I can’t see the act having any major impacts on the way most processors are currently doing business. There will be more frequent inspections, which take time and create angst amongst the management team, but if the company is currently meeting the requirements of third-party audits, it should be able to handle anything that FDA throws at it. The baking and snack industry, and the products that [its members] manufacture, has not been a significant source for foodborne illness. There have been a few issues — such as salmonella in cereal, salmonella in potato chips that was sourced to the seasonings and others — but the industry has generally had a good safety record.
I also don’t envision that the appropriate regulations to enforce the act will be finalized for at least 1½ years and probably even longer — more like three years. The agency needs to draft the regulations and submit them for comment. In addition, it will also have to prepare guidance documents and white papers that address the new programs. Given the nature of the regulations and their potential impact, my guess is that one of the first things that will be seen is a request to “extend the commentary period.” So the bottom line is that we are probably looking at least two years before the regulations are finalized. In addition, I suspect that there may be a staggered implementation in that final regulation. The Mega-Reg for the meat and poultry industry had a 3-year implementation, allowing smaller operations more time to comply. In the latest budget discussions, Congress and the Obama administration recommend cuts in FDA funding. What are you hearing about the impact of such cuts on the enhancement of plant inspections under FSMA?
FDA recently asked for $4.2 billion to enforce FSMA. It will be interesting to see how this plays out since there is a push to reduce spending. The [Obama] administration’s proposed budget of $3.7 trillion will probably be chopped significantly. One of the biggest issues with the act itself is that Congress passed a law yet did not allocate any money to enforce it. Rather a cart-before-the-horse kind of thing, isn’t it? Read the full Q&A