Washington Insider -- Friday

Growing Concern about FDA Rceall Policies

EPA Administrator Scott Pruitt Resigns

Scandal-plagued EPA Administrator Scott Pruitt resigned Thursday following a long list of alleged ethical lapses and improper spending.

Pruitt, a former Oklahoma attorney general, is the fifth member of President Trump's cabinet to be forced out.

Trump announced the departure in a tweet, saying Pruitt's deputy, Andrew Wheeler, would become acting EPA administrator on Monday. Trump said Thursday that Pruitt had done an "outstanding job inside of the EPA" but acknowledged "obviously, the controversies." The president told reporters traveling with him to Montana that in his view there had been "no final straw" and that Pruitt had decided over the last couple of days that "he was a distraction"

Wheeler is a former lobbyist for the coal industry and a former worker at Growth Energy, both topics he likely will have to recuse himself from should he be pushed as the permanent administrator. He is expected to continue Pruitt's push to aggressively alter regulations negative to business investment or profitability while seeking to protect the environment and enforce environmental laws.


China May Rethink Push to Broaden Ethanol Use By 2020

China may have changed its mind on the plan announced last year to expand the use of ethanol in gasoline by 2020 as the country sought to chew through its massive corn stockpiles. Only one major project has been given a green light since the plan was announced, according to Reuters, with three other efforts by major producers stalled as the companies involved have not gained government approvals.

Experts say the country would have to have 15 million tonnes of ethanol capacity to meet the E10 goal for 2020. In 2017, ethanol capacity was put at just 3.45 million tonnes. The pending trade actions with the US could also figure into the mix as the level of corn needed to produce the ethanol will likely mean imports of either corn or ethanol.


Fri. July 6 Washington Insider Growing Concern About FDA Recall Policies

POLITICO is reporting the results of its investigation into FDA's capacity to keep dangerous food products out of the food chain. It found, for example, that the I.M. Healthy SoyNut Butter case was "emblematic of persistent weaknesses in the nation's food-safety system," and that some problems "haven't been corrected for two years after being flagged by the agency's inspector general."

POLITICO said that "two months elapsed between the first person sickened by eating I.M. Healthy SoyNut Butter on Jan. 4 and the recall orders that began on March 3 and expanded three more times until March 10."

The FDA, working through a national network of labs that identifies outbreaks, pinpointed the contamination on Feb. 22. The nine-day lag time in persuading the manufacturer to begin recalling the tainted products was a significant improvement over previous lag times — which were as high as 165 days in one infamous case, according to the inspector general. But victims maintain that the FDA should have ordered a recall on its own authority, given that a few days or even hours can make a difference in a deadly outbreak.

"They have the authority to mandate a recall and, in theory, that would go more quickly than a voluntary recall," said Sandra Eskin, who directs food safety at the Pew Charitable Trust. The FDA has used its authority to order recalls only three times since 2011. Instead, it usually waits to give companies time to decide whether to pull a product from shelves voluntarily.

There were complications, as well, in alerting customers to the fact of the recent recall. The FDA did not identify which retailers sold the contaminated batches of products. (The agency has traditionally considered this information to be trade secrets, and left it to manufacturers to alert retailers.) Thus, customers who saw only the FDA's recall notice had no way of knowing whether the products they bought were among those that were contaminated.

"They just did not effectively execute the recall," said Eskin. "You really have to monitor where the product is sold and reach out to the sellers online."

Indeed, the contaminated products remained available for months afterward. Linda Harris, a food-safety microbiologist for the University of California at Davis who researched the case for the victims, said she was able to buy a three-pack of I.M. Healthy Original Creamy SoyNut Butter on Amazon in September, five months after the recall. In addition, some stores either missed or ignored the recall and kept the product on the shelves, Harris discovered.

Part of the problem, critics contend, was a lack of urgency: The cautious language of the FDA's warning didn't mention potential illnesses until the third paragraph, and the only instruction offered was to return the product to the place it was bought to receive "a full refund."

"Amazon didn't provide the information about the seriousness of the recall and the reason," contended Sarah Sorscher, deputy director of regulatory affairs for the Center for Science in the Public Interest. "You should not have to click through to a government website while you're eating breakfast to find out that you have a deadly product in your kitchen."

The weaknesses in the soy nut butter case were all the more notable because they came 8½ months after the FDA's inspector general declared that it lacked adequate procedures for handling food outbreaks.

"We found that the FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation's food supply," Inspector General Daniel Levinson wrote on June 8, 2016. "This issue is a significant matter and requires the FDA's immediate attention."

Now, more than two years after the IG's warning, the agency is still updating its procedures, POLITICO said. In congressional hearings and blog posts earlier this year, FDA officials pledged to take specific steps to improve the recall system, including a proposed rule to alert the public to dangers before recalls are announced. Other promised changes include revealing which retailers sold the tainted products "in certain cases," developing a database to help the agency identify contaminated products and requiring companies to issue public warnings more quickly.

Meanwhile, the administration, seeking to improve safety standards, proposed in mid-June consolidating all food-safety functions in a new agency within the USDA as part of a broader reorganization that would require congressional approval. But few observers expect any congressional action in the near term.

The FDA said it responded promptly once it learned that the recalled products were being offered for sale.

The FDA has long been very nervous about imposing recalls, observers note. However, the agency has recent, much expanded authority to both keep dangerous products out of the food supply and to hold producers responsibility when food-borne illness outbreaks occur. At the same time, increased vigilance will be expensive, and therefore likely will continue to be controversial. This is an important issue to maintain the credibility of the US food system, and the safety rules debate should be watched closely as it proceeds, Washington Insider believes.


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(GH/BAS)