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FDA to implement new regulations


By Sally Voth

New federal rules are coming to farms and food processing plants in a bid to curtail disease outbreaks.

Earlier this month, the U.S. Food and Drug Administration released proposed regulations overhauling the food industry and invited public comment.

They stem from the Food Safety Modernization Act of 2011, according to Ryan Davis, program manager for the Virginia Department of Agriculture and Consumer Services' Division of Animal and Food Industry Services -- Office of Dairy and Foods.

Reported outbreaks of food-borne illnesses have been on the rise, partly because more of them can be linked to a common source, he said.

"I think there's a need, and Congress saw a need, to upgrade or modernize our food safety system," Davis said. "It's really more reactive in nature, rather than proactive."

The crux of FSMA was the creation of five new regulations for producers, manufacturers and storers of food, he said.

"They're looking at farm to table protection, basically," Davis explained.

Two regulations were released earlier this month, and are the subject of a 120-day comment period. They are the proposed Produce Safety regulation and the proposed Food Safety Preventative Controls regulation.

The FDA doesn't have the personnel to inspect every food manufacturer, Davis said. Instead, the agency contracts with states to provide those services.

In Virginia, the FDA does some of the inspections, while the VDACS does some, too, according to Davis.

The 2011 act also would establish a national food safety system, he said. The system is currently fragmented, Davis said.

"So, in essence, everyone can be on a level playing field," Davis said. "We're all looking for the same things.

"One of the issues that became quite evident over the last few years is that a lot of the fruits or vegetables that we had thought were safe are not safe."

In the last few years, about 130 disease outbreaks led to 14,000 illnesses and 34 deaths linked to produce, Davis said.

"There are really six components to the produce safety rule, and many of these are components that have been identified as issues in the past in terms of avenues of contamination for raw agricultural produce," he said.

David said the standards wouldn't apply to foods meant to be cooked before they're eaten.

One of the standards relates to water supply. Some farms use pond water, which could be contaminated, he said. Another relates to soil. For instance, if manure is used as a fertilizer, time intervals could be established.

"Another issue is the health and hygiene of the workers," Davis said.

Many workers aren't aware of sanitation issues, especially when it comes to fecal to oral contamination, he said.

An additional issue is fecal contamination from domestic and wild animals in fields or on produce. Davis said.

"A couple of special requirements have to do with sprouts," he said.

Some sprouts are contaminated at the seed level, so the seeds would need treatment, Davis said.

"[The FDA is] hoping that given all of these requirements, that they're going to minimize the potential for contamination with respect to raw agricultural product," he said. "It's going to cover a lot of farms. They're estimating about 90 percent of the agricultural produce that's consumed in the U.S. is going to be covered by the regulation."

The amount of time farms have to comply will vary depending on size, Davis said.

On the manufacturing and food storage side, the FDA estimates the regulation will cover about 100,000 domestic facilities, and also will cover some foreign ones, according to Davis.

There really aren't any controls in place at some food production establishments currently, he said.

The new regulation will require food warehouses, packers and similar businesses to conduct hazard analyses, Davis said.

"Then, they're going to be required to put controls in place to minimize those hazards," he said.

Examples would involve food allergens, sanitation issues and recall protocols.

The food safety plans would have to be evaluated every three years by the manufacturers, Davis said.

"They're going to be required to keep records of preventative controls, of the monitoring that's been done, any corrective actions that need to occur," he said.

Some establishments would be exempt, such as farms producing small amounts of low-risk foods, or those selling foods that have already been identified as extremely hazardous and already have stringent regulations in place, such as low-acid canned foods, according to Davis.

Other regulations scheduled to come from FSMA relate to importing food, third-party certification and animal feed, Davis said.

As both a grower and a producer, National Fruit Product Co. in Winchester would be affected by both regulations. CEO David Gum said they believe they have a handle on most of it.

"Overall, I think it's a good thing," he said.

He said he expects his company's comments would come through the associations it's a part of, such as the Apple Processors Association.

"We kind of applaud it," Gum said of the proposed regulations. "A lot of that stuff we're already doing. I think the one thing we applaud the most would be the FDA's going to put some requirements on the importers.

"That's certainly one of our major concerns because we obviously compete with a lot of foreign foods in the apple segment. Obviously, we want to make sure that they have to abide by the same rules, and for our industry, we certainly want safe products and safe food."

Contact staff writer Sally Voth at 540-465-5137 ext. 164, or svoth@nvdaily.com


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