Food scientists discuss recent FDA revisions that enhance protection from foodborne illnesses.

MANHATTAN, Kan. – Each year in the United States, about 42,000 cases of salmonella infection are reported, according to the Centers for Disease Control and Prevention (CDC). Because many cases are not diagnosed or reported, the actual number of infections is estimated to be close to 1 million.

Salmonella infection is a common foodborne illness that can cause diarrhea, fever and abdominal cramps 12 to 72 hours after infection and can last four to seven days. In the last decade, people might recall salmonella outbreaks linked to a variety of foods, from peanut butter to cantaloupe to alfalfa sprouts.

“We know that foodborne illness can happen to people,” said Londa Nwadike, consumer food safety specialist for K-State Research and Extension and the University of Missouri Extension. “It is a problem, particularly in young children, older adults, pregnant women, and people who are sick and have weaker immune systems.”

Nwadike said many of the foods that can carry salmonella and other harmful bacteria are, in an uncontaminated state, healthy for people. Preventing contamination before the foods hit store shelves is key to making sure the foods remain healthy for consumers.

The Food Safety Modernization Act (FSMA), signed into law in 2011, focuses on preventing food safety problems, rather than responding to them. The act, developed by the U.S. Food and Drug Administration (FDA), includes seven proposed rules for those involved in food production to follow.

Nwadike said the FSMA is “the largest overhaul of the food safety regulatory system within the FDA in the past 70 years.”

“(The FDA) is trying to do more at the beginning of the food production chain to make sure contamination is going to be prevented along the way instead of just reacting to foodborne illness outbreaks,” she said. “If we can help to prevent foodborne illness problems before they actually happen, it’s much better for everyone involved.”

The FDA realizes many stakeholders are present in the food production chain and will need to be involved in the prevention effort, Nwadike said. Since the law was passed, the FDA has accepted comments from the public—food industry experts, producers, processors, retailers and consumers alike—on the proposed rules. Last month, the FDA announced it updated four of the seven rules based on these public comments.

The difficulty of balancing foodborne illness prevention while making sure the law is reasonable, fair and non-penalizing to farmers, food processors and retailers is evident, she said, which is why the FDA has been inclusive in the process.

And, the process remains on going, as comments to the rules, even the recently revised rules, are still being accepted by the FDA, said Fadi Aramouni, extension specialist and professor of food science at K-State.

What the revisions entail

The four recently revised rules to the FSMA include produce safety, preventative controls for human food, preventative controls for animal food and foreign supplier verification.

“I remember when the produce rule first came out, a lot of our small farm operations were concerned about any undue pressure it would put on them in testing irrigation water,” Aramouni said.

The quality standard and testing for water used to grow produce is now more flexible. This means farmers using water that does not initially meet the proposed microbial standard would have more time to allow the microbes to die off. In its revised rule, the FDA also adjusted its approach to manure and compost used in crop production pending further research.

Additionally, the FDA exempted operations making less than $25,000 annually in produce sales from having to comply with the produce rule. It gave four years after the produce rule has passed for very small businesses, those making between $25,000 and $250,000 annually, to comply; small businesses that make more than $250,000 but no more than $500,000 annually three years after the rule’s effective date to comply; and all other farms two years after the effective date to comply with the produce rule.

For the water testing specifically, the FDA granted an extra two years beyond the compliance dates.

Regarding preventative controls for human food, the FDA no longer requires farms to register as a food facility merely because they pack or hold raw agricultural commodities grown on another farm or owned by another farm.

“At first, people thought farms, even very small farms, would have to comply as processors of food products,” Aramouni said. “Now farms that only handle or pack produce could go under the produce regulation. They do not have to comply with the food processing regulation.”

The human food preventative controls rule also shows the definition of a very small business at less than $1 million in sales. Very small businesses would have three years to comply to the human food rule, while small businesses, those that employ less than 500 people but are not eligible for an exemption, would have two years. All other businesses would have one year.

Along with enhancing food safety for human foods, the FDA is proposing measures to enhance pet and other animal food safety.
“There have been some outbreaks with pet food,” Aramouni said. “(The FDA) wants to make sure that these products are also safe.”

Human food processors already complying with human food safety requirements would not need to implement additional safety measures for animal food products. They would, however, need to prevent physical and chemical contamination when holding or distributing a by-product for animal food.

Those by-products might include wet spent grains from distillers, fruit or vegetable peels, or liquid whey, as examples. Also, further processing of those by-products would require compliance with the animal food rule.

A very small animal food business would be defined as having less than $2.5 million in total annual sales. The same compliance dates as human food businesses apply to animal food businesses.

Lastly, the FDA revised its foreign supplier verification rule to allow importers to conduct a compliance status review of each imported food and each foreign supplier, and analyze potential hazards. Supplier verification measures can be based on risk and previous experience with the foreign suppliers.

“The foreign suppliers need to present verification that they are complying to the same regulations (as U.S. food suppliers),” Aramouni said. “We cannot ask our companies in the United States to comply with stricter regulations when we import food and let food operations that export to the United States not meet the same standards.”

In general, the compliance date for foreign supplier verification would be 18 months following publication of the regulations.

The consumer obligation

Due to the focus on foodborne illness prevention, Nwadike said consumers could hear about more food recalls, but that’s not necessarily a bad thing.

“If you hear that there’s a food recall happening, to some extent it means our food safety system is working,” she said. “It shows there are checks in place, and it shows that product is not going into our food supply.”

Additionally, food safety measures don’t stop at the retail level, as consumers also have food safety obligations once they bring foods home to prepare for themselves and their families, Nwadike said.

“The government sets regulations that affect the farmers, processors, retailers, restaurants, and so on,” she said. “But, consumers still need to do their part in handling, transporting things safely, washing their hands and using a food thermometer. Hopefully everyone can work together to make sure we’re producing the safest, healthiest food possible.”

Information from the FDA about the FSMA contributed to this story. You can read more about the revised rules on the FDA’s website (http://www.fda.gov/Food/GuidanceRegulation/FSMA/default.htm).

Story By: Katie Allen