Friday, January 5, 2018

FDA Recalls Too Slow? Is Romaine Lettuce the Source of an E. coli Outbreak? A Food Safety Vortex

Last week, the US Inspector General issued a report that criticized the FDA for not moving quickly enough to recall foods.  At the same time, an E. coli outbreak has caused illness in 17 people in the US.  While Canada has identified romaine lettuce as the causative agent in E. coli cases that occurred there, the CDC and FDA have not followed the Canadians in blaming romaine lettuce.  Of course, the US agencies have been criticized  for this and Consumer Reports has issued a news release stating the consumers avoid romaine lettuce for now.

As romaine lettuce is being pulled from the store shelves (which, if considering the short shelf-life and the time frame of the outbreak, will not amount to much), we look back at the 2008 Salmonella outbreak where tomatoes were falsely accused, and can see why the federal agencies are acting in a judicious manner.  I guess we don't expect the federal agencies to have the correct answer immediately, especially considering the tediousness of conducting an outbreak investigation, but I do agree with others saying that the agencies should be providing more information about that investigation.  Not only will it let people decide for themselves (rather than having the Canadians decide for us), but will help inform all of us of the difficulties that are entailed in an outbreak investigation.

For the consumer, there is a lot of confusion.  If you have romaine lettuce in your refrigerator, do you return it?



USA Today
https://www.usatoday.com/story/opinion/2018/01/02/fda-food-recalls-still-too-slow-editorials-debates/993481001/
 Why is FDA so slow on food recalls?
The Editorial Board, USA TODAY
Published 5:54 p.m. ET Jan. 2, 2018 | Updated 6:59 p.m. ET Jan. 2, 2018



New report shows it can take up to 10 months to pull unsafe products off grocery shelves: Our view

Soon after the Food and Drug Administration discovered salmonella in a plant that made nut butters in 2014, several illnesses were linked to the product. But it took more than five months before the tainted food — which caused 14 illnesses in 11 states — was recalled that August.

Nor did the FDA consider using its mandatory recall authority until 161 days after the discovery. Four days later, nSpired Natural Foods voluntarily pulled the product.

That case is one of 30 food recalls from 2012 to 2015 analyzed by the Health and Human Services Department’s inspector general. In a recently released report, the IG found that it can take as long as 10 months to pull unsafe products from store shelves. Leading up to one of those recalls — in which the manufacturer knowingly distributed tainted cheese products — an infant's death and two fetal losses were linked to the contaminated food.

Tainted foods are like ticking time bombs. The problem is more significant and widespread than many people realize. Food-borne illnesses sicken as many as 47.8 million Americans each year, according to estimates by the Centers for Disease Control and Prevention. While most of those illnesses are mild and are seldom reported to authorities, an estimated 128,000 people are hospitalized and about 3,000 die as a result of contaminated food.

The FDA is the public’s last line of defense against such outcomes, yet the IG found several deficiencies in the agency's recall process. In some cases, the FDA was slow to evaluate health hazards. In all 30 cases, after the FDA became aware of the problem, “it did not prescribe a timeline for each firm to initiate a recall.”

Establishing deadlines could move businesses to faster action, as could the threat of a mandatory recall.

Before a new food safety law was enacted in 2011, the FDA did not have the authority to mandate a recall. It could pressure businesses, but it had to rely on their voluntary action. However, as of August 2016, the FDA had used this important tool just twice. 

The FDA also has failed, except on rare occasions, to use another valuable tool: making public the names of stores, restaurants, schools or other places where tainted food was available. The FDA points to a law stating such lists are confidential commercial information and asserts that in some cases, the information might not be needed to ensure public health. But the U.S. Department of Agriculture, which handles meat recalls, regularly releases that information for tainted meat.

And there should be no dispute that publicizing these locations will help people avoid contaminated foods and/or know that they or their children might have consumed it.

The FDA has argued that, on average, it recalls tainted products within four days, and that the 30 cases are among more than 1,550 food recalls it handled during the same period.

This misses the point. Even one recall that takes months after contamination is suspected is one too many, particularly where the problem can kill or cause serious illness, which was true in 23 of the cases the IG analyzed.

FDA Commissioner Scott Gottlieb says the FDA has taken major actions to improve its recall process, adding that “we still have more work to do.” That’s encouraging.

When companies fail to police themselves, refuse to act quickly, go to court to battle the FDA or even, as in one of the 30 cases, purposely distribute a tainted product, slow FDA action is dangerous and even deadly.

USA TODAY's editorial opinions are decided by its Editorial Board, separate from the news staff. Most editorials are coupled with an opposing view — a unique USA TODAY featu

TODAY 
https://www.today.com/health/romaine-lettuce-linked-outbreak-e-coli-13-states-t120778
Romaine lettuce linked to outbreak of E. coli in 13 states
Jan. 4, 2018 at 10:22 AM
Maggie Fox

People should stay away from romaine lettuce until U.S. and Canadian health officials get to the bottom of an outbreak of E. coli infections, Consumer Reports says.

The consumer advocacy group called on the Food and Drug Administration and Centers for Disease Control and Prevention to do more to warn people about the outbreak, which at last count had made 58 people sick in the U.S. and Canada. One person has died.

The CDC last reported on the outbreak on December 28. It said 17 people were sick in 13 states, dating back to November. The Public Health Agency of Canada has reported on 41 illnesses. The infections have occurred in California, Connecticut, Illinois, Indiana, Michigan, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Virginia, Vermont and Washington.

“The Public Health Agency of Canada has identified romaine lettuce as the source of the outbreak in Canada,” the CDC said in its Dec. 28 statement.

“In the United States, state and local public health officials are interviewing sick people to determine what they ate in the week before their illness started. CDC is still collecting information to determine whether there is a food item in common among sick people, including leafy greens and romaine,” it added.

“Because we have not identified a source of the infections, CDC is unable to recommend whether U.S. residents should avoid a particular food.”

Thorough cooking usually kills foodborne bacteria such as E. coli or salmonella, but lettuce is not usually cooked.

“Even though we can’t say with 100 percent certainty that romaine lettuce is the cause of the E. coli outbreak in the U.S., a greater degree of caution is appropriate given that romaine lettuce is almost always consumed raw,” said James Roger, food safety director at Consumer Reports.

Stronger warnings urged

Consumers Union’s Jean Halloran said people should get stronger warnings.

“The FDA should follow the lead of the Canadian government and immediately warn the public about this risk,” she said.

“The available data strongly suggest that romaine lettuce is the source of the U.S. outbreak. If so, and people aren’t warned, more may get sick.”

It can take weeks to track down the source of a food poisoning outbreak. Food is often shipped to central plants from various farms, where it is processed, mixed together, packaged, and redistributed.

Health officials can't say for sure that romaine lettuce is the cause of an outbreak of E. coli infections in the U.S., but Consumer Reports is warning people to avoid eating the raw lettuce for now.
“Whole genome sequencing is being performed on samples of bacteria making people sick in the United States to give us information about whether these illnesses are related to the illnesses in Canada. Preliminary results show that the type of E. coli making people sick in both countries is closely related genetically, meaning the ill people are more likely to share a common source of infection,” the CDC said.

The infections have occurred in California, Connecticut, Illinois, Indiana, Michigan, Nebraska, New Hampshire, New York, Ohio, Pennsylvania, Virginia, Vermont and Washington.

Consumer Reports said people should err on the side of caution and throw out romaine lettuce.

“Neither the U.S. nor Canadian health officials have provided information on where the romaine lettuce potentially involved in the illnesses was grown or processed, so for now, Consumer Reports says consumers should assume that any romaine lettuce, even when sold in bags and packages, could possibly be contaminated,” it advised.

“Do not buy romaine lettuce and don’t use any that you may have in your refrigerator until there is more information on the source of contamination. Consumers should also check salad blends and mixes, and avoid those that contain romaine.”

E. coli bacteria are just about everywhere and they are normally harmless residents of the digestive tract. But there are a few forms that can cause diseases. The CDC estimates that about one in six Americans are made sick by foodborne illnesses every year — that's about 48 million people. About 3,000 die.

The toxin produced by E. coli 0157 can cause severe stomach cramps, bloody diarrhea and vomiting. The most dangerous effect is hemolytic uremic syndrome (HUS), a type of kidney failure.

“Very young children and the elderly are more likely to develop severe illness and HUS than others, but even healthy older children and young adults can become seriously ill,” the CDC said.

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