Washington Insider - Thursday

Food Recalls and Safety

Here’s a quick monitor of Washington farm and trade policy issues from DTN’s well-placed observer.

Trump Wants Three-Year GSP Extension

Renewal of the Generalized System of Preferences (GSP) program for three years is what the Trump administration wants, according to a White House official. GSP expired at the end of 2017. Under GSP, duties are waived on thousands of goods from developing countries.

"The administration supports a three-year reauthorization of GSP and hopes to get it done early this year," the official said. The administration announced several actions under GSP late in the year but Congress left Washington before acting to extend the program.

Argentina Begins Phasing In Cuts to Its Soybean Export Tax

Argentina has cut its soybean export tax to 29.5% from a previous 30%, the initial step to gradually reduce the levy to 18% over two years, the agriculture ministry said in a statement. The plan will see the tax cut by one half percentage point per month for 24 consecutive months.

"The reduction is one of a number of measures taken over the last two years to increase competitiveness and predictability in the sector," the statement said. The government is also cutting the export tax on soyoil and soymeal, down as of this month to 26.5% from a previous 27%. Under the plan, the levy on soy derivatives is due to fall to 15% by 2020, the ministry's statement said.

Washington Insider: Food Recalls and Safety

Food product recalls are one of the most effective weapons the federal government has to increase food safety, but there are often disagreements over how and when they should be used. This week, Food Safety News is reporting that more “timely and efficient food recalls would cut down on foodborne illnesses, but the U.S. Food and Drug Administration has yet to figure out to do it.” A very tough criticism, indeed.

Still, that’s the bottom line of another report on FDA food recalls by the Office of the Inspector General for the federal Health and Human Services Department. The OIG put out an “early alert” on the work last June.

The latest report is an audit of the documentation “for 30 voluntary food recalls judgmentally selected from the 1,557 food recalls reported to FDA between Oct. 1, 2012, to May 4, 2015.”

The performance audit looked at FDA’s oversight of food businesses initiating recalls, monitoring of the recalls, and maintenance of food recall data. It appears that FDA is not always timely in evaluating health hazards, or efficient in handling audit checks or their assignments. And it’s status reports are not still complete or timely nor its data accurate.

FDA Commissioner Scott Gottlieb personally responded to the report on Dec. 26, saying he takes the agency’s food recall obligations “very seriously.” He said since the “early alert,” FDA has been working to improve its recall system.

However, the lag between FDA recall warnings and removing unsafe products from store shelves can take up to 10 months.

“FDA generally relies on firms to protect public health by voluntarily recalling food products that present a risk of injury or gross deception or are otherwise defective,” according to the OIG. “FDA monitors and assesses the adequacy of a firm’s recall efforts. According to FDA, recalls should be evaluated on a case-by-case basis because some recalls are more challenging or complex than others.”

Since the Food Safety Modernization Act was signed into law seven years ago, FDA has had the power to order firms to recall food, but it has only twice used that authority. FDA has to determine there is a “reasonable probability” of food adulteration before it orders a recall.

FSN says the finding were highly critical in six key areas. For example, it said that FDA did not always evaluate health hazards promptly (initiation), among other short comings.

As a result, FDA could not always ensure that firms initiated recalls promptly; therefore, some consumers became ill, and others were at risk of illness, or in some cases, death,” the OIG report says. “FDA relies primarily on voluntary recalls, which makes the timeliness of the recalls largely dependent on the firm’s willingness to take action.”

The report found it took from a median of 29 days to an average of 57 days for a business to issue a recall after FDA learned that a product was potentially hazardous. The time from discovery to recall ranged from nine to 303 days for the 30 voluntary recalls reviewed.

FDA also did not correctly monitor other recalls and failed to obtain complete or accurate data for others. Nor were timely or comprehensive status reports kept.

So, the stakes for Gottlieb and his agency are particularly high, since the recall issue has been festering for some time—and since about 48 million Americans continue to get sick from food-borne diseases each year, according to the agency. Of those, 128,000 are hospitalized and 3,000 die.

In addition, several long-time FDA critics are watching the agency’s performance very closely. For example, Representative Rosa DeLauro, D-Conn., a key appropriator. “The FDA’s response to food recalls is both slow and inadequate,” she said.

Dr. Gottlieb argues that most food recalls occur within four days of a problem being reported. Among the improvements the agency has made, he added, are establishing a team of senior staffers who review complex cases and try to expedite action.

The Food Safety Modernization Act, which President Obama signed into law in 2011, was intended to give the FDA more power to police food companies. The law gave the agency the authority to issue a mandatory recall when a company fails to voluntarily recall unsafe food after being asked to do so.

The New York Times also highlighted the concern, and recently reported that FDA has used its recall authority twice. Dr. Sidney Wolfe, senior adviser at Public Citizen, an advocacy group he founded, said six years after the law was signed, the FDA. should have made more progress.

“The kinds of things that the inspector general has found are things that might be excusable in the first couple of years,” said Dr. Wolfe. “But not seven years into it.”

Agency officials acknowledged that challenges remain. “We work cooperatively with industry in the overwhelming number of cases,” said Douglas Stearns, director of FDA’s office of enforcement and import operations. “At the same time, we are very dependent on what a firm tells us. Sometimes we do not get all the information we need, and sometimes the information provided is not accurate.”

Well, FDA has new much stronger authority these days, but criticism from within its own parent agency suggest that it needs to institute major changes, in a major hurry. These are, of course, often controversial but the risks involved seem to demand more direct action. This is a fight produces need to watch closely as it proceeds, Washington Insider believes.

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