Waiting for the regs

August 27, 2012
| By Pete Daly |
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The Food Safety Modernization Act that took effect in July is “the most significant overhaul of regulations affecting food processors since the 1930s,” according to a Varnum Law attorney who specializes in that industry.

Unfortunately, the fine print that explains exactly what the food industry must now do hasn’t been provided by the government, said Steve Kluting, a partner at Varnum and co-chair of its Food Industry Group.

“Most significantly, it requires that food processors adopt and implement a written food safety plan that focuses on identifying potential hazards and putting in place preventive controls to eliminate or mitigate the harm caused from such hazards,” said Kluting.

Just how complicated the regulations may be is reflected in the fact that not all food processors in the U.S. are subject to the FSMA, which is administered by the Food & Drug Administration. Kluting said processors of meat and poultry, for example, “are outside the scope of this law,” because they report to the U.S. Department of Agriculture.

The regulations from FDA “were supposed to come down in January — pretty far in advance.” But he added that the FDA “is running around pretty crazy. It’s being pulled in a lot of different directions by this,” which may explain the delay.

There are a lot of mandates on the FDA within the legislation, and it could be that the FDA doesn’t have enough funding to handle them, added Kluting.

In early January, the FDA was supposed to issue draft regulations outlining the contents of the required food safety plans. According to the original timeline, the proposed regulations would then undergo a public comment period before being finalized in time for the industry to properly comply with the new requirements in July.

Despite being well past the deadline, the proposed regulations haven’t been issued and whatever has been done is apparently “sitting on a desk” at the federal Office of Management & Budget, according to Kluting.

In the meantime, he said, the food industry “doesn't have the benefit of the underlying regulations describing what needs to be in those plans,” so the FDA has indicated it will not enforce the new requirements until the regulations have been issued and finalized.

“(The) industry has to deal with the risk that FDA will pull that promise not to enforce at any given time,” he added.

That might happen if the regulations are still unissued in the future and if there is “another incident,” he said.

He was referring to incidents like that in early 2009, which is what led to the new FSMA Act in the first place. That is when the FBI raided a peanut processing plant that was the source of salmonella contamination that sickened nearly 600 people in 44 states and was suspected in eight deaths. The highly publicized salmonella outbreak led to one of the largest food recalls in U.S. history.

Another recent emergency was the salmonella-contaminated eggs that made more than 1,000 people seriously ill in several western states in August 2010. More than 380 million eggs were recalled from stores.

Less than a year ago — in September 2011 — there was a listeria outbreak across the nation linked to tainted cantaloupes that killed more than a dozen people, the deadliest food contamination emergency in 10 years, according to Bloomberg News. The melons were all from Jenson Farms in Granada, Colo.

Listeria, a bacterium often found in soil and water, sickens about 1,600 people and kills about 260 in the U.S. each year, according to the Centers for Disease Control. More than 20 people died in 1998 after eating hot dogs contaminated with listeria.

Another dangerous pathogen that can contaminate food products is the norovirus.

Kluting said all FDA-regulated food facilities — essentially any facility that manufactures, processes, packs, or holds food for consumption by humans or animals in the United States — now must identify every potential hazard of contamination and implement controls to prevent it.

“This means that it affects nearly the whole industry, including animal feed manufacturers, pet food manufacturers, small processing operations, cold storage warehouses. There are a few exceptions, but this is widely effective and will require significant time and resources, including money, for many food processors to achieve compliance. One might expect prices to increase and consolidation to occur.”

The contamination wouldn’t just be biological, either. Metal shavings from cans or defective machinery or glass fragments are examples of non-biological contamination sometimes found in processed foods. If there is added expense for a food processor, a lot of it may be new equipment that detects or prevents non-biological contamination, said Kluting.

Kluting said that, up to now, the government role in food safety was to show up on a pre-determined day to inspect a facility and test the finished product.

“This new movement is moving away from an inspect-and-test approach to ‘let’s identify the hazards and prevent those hazards from occurring on the front end,’” he said.

One can easily identify many of the major food processors in West Michigan that would be subject to the new Act, such as Kellogg in Battle Creek and Grand Rapids, Gerber in Fremont and Heinz in Holland, plus a number of commercial bakeries in the Grand Rapids area.

Meijer would be another, said Kluting, because — among other reasons — this spring it acquired the former Bareman’s Dairy plant in Holland, where it plans to invest $8 million in its own dairy processing operation. It will be called Purple Cow Creamery, producing white and chocolate milk for 101 Meijer stores in Michigan. Dairy foods safety is not regulated by the USDA, but rather by the FDA.

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