Flawed U.S. food recalls leave unsafe food on shelves

WASHINGTON, DC, October 21, 2004 (ENS): The federal agencies responsible for recalling contaminated food "can do a better job," a scathing report by Congressional investigators concluded Wednesday. The Government Accountability Office (GAO) said that "weaknesses in systems for monitoring food recalls heighten the risk that unsafe food will remain in the food supply and ultimately be consumed."

The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) were the target of investigators' criticism. These agencies "do not know how promptly and completely companies are carrying out recalls," the GAO said.

Neither agency’s guidance provides time frames for companies on how quickly to initiate and carry out recalls. As a result, companies may have less motivation to notify downstream customers and remove potentially unsafe food from the marketplace, the GAO said.

The number of food recalls has generally increased over the past decade, with a record high of more than 500 in 2002. In addition, for fiscal year 2003, most recalls were Class I - for food that poses the greatest risk of illness or death.

Class I recalls accounted for 51 percent of the 77 food recalls for USDA in 2003.

For the Food and Drug Administration Class I recalls made up 54 percent of the 296 recalls that year.

One in depth study the GAO conducted was focused on the USDA's and FDA's attempt to identify and recall meat from a single cow infected with bovine spongiform encephalopathy (BSE), commonly known as mad cow disease, found in Washington State. It demonstrates how difficult and complicated a recall can be.

On December 9, 2003, the recalling company slaughtered 23 cows. USDA, in accordance with its BSE surveillance policy at the time, took a sample of one cow that was unable to walk, although the condition of the tested cow is now disputed. Test results indicated a presumptive positive for BSE on December 23, 2003.

USDA officials decided to conduct a Class II recall - beef from the BSE infected cow was believed to pose only a remote possibility of adverse health consequences. Even so, on December 24, 2003, the USDA’s Food Safety and Inspection Service (FSIS) sent inspectors to the recalling company’s primary customers to get secondary customer distribution lists and product shipping records. Tertiary customers were also contacted.

USDA officials contacted every customer that received the recalled meat. This 100 percent level of verification checks is well above the percentage of checks conducted by USDA district offices for even Class I recalls, the GAO said.

USDA officials checked 15 primary, 40 secondary, and 526 tertiary customers plus the recalling company, for a total of 582 verification checks.

But some customers could not supply complete and accurate lists of their customers, and confusing recordkeeping practices by grocery store distributors made tracking the BSE contaminated beef even more difficult.

The recall was also complicated by repeated mixing of recalled beef with nonrecalled beef, increasing the amount of meat involved in the recall. The recalling company slaughtered 23 cows on December 9, 2003, and shipped those and 20 other carcasses to a primary customer on December 10.

The recalling company’s carcasses were tagged to identify the slaughter date and the individual cow, but the primary customer removed the identification tags and mixed the 23 recalled carcasses with the 20 nonrecalled carcasses. Because the carcasses could not be distinguished, the recall included all 43 carcasses at the primary customer.

Mixing of meat from recalled and nonrecalled carcasses continued along the supply line until the mixing of beef from one BSE positive cow resulted in over 500 customers in six states receiving potentially contaminated beef.

The amount of beef recalled is also difficult to quantify. The USDA first stated that the recall involved 10,410 pounds of beef products, and the USDA recall coordinator for this recall told GAO investigators that downstream processors mixed the recalled beef with nonrecalled beef, for a total of more than 38,000 pounds of beef that was distributed at the secondary customer level.

According to USDA officials involved with the recall, the precise amount of meat that was sold at the retail level is unknown because retailers at the tertiary level further mixed nonrecalled meat with potentially contaminated meat.

"USDA told us that more than 64,000 pounds of beef was ultimately returned or destroyed by customers, and that, because of the mixing, it was not able to determine how much of the original 10,410 pounds of recalled beef was contained in the 64,000 pounds that were recovered," the GAO said. On March 1, the USDA declared that the recall was closed.

Parts of the BSE infected animal were not used for food but were sent to renderers to be separated into raw materials, such as proteins and blood. Rendered materials are used for many purposes, including cosmetics and vaccines. The FDA, rather than the USDA, has jurisdiction over renderers.

Two renderers were found to have parts of the diseased cow on their premises on December 24. They agreed to hold all product processed from the diseased cow and dispose of the product as directed by FDA and local authorities.

But on January 7, 2004, 15 containers of potentially contaminated, rendered material - meat and bone meal - were "inadvertently loaded on a ship," the GAO said. On January 8, 2004, the ship left Seattle, Washington bound for Asia. The renderer to steps to recover the material, so it could be disposed of as directed by FDA and local authorities. The ship returned to the United States on February 24, 2004, and the material was disposed of in a landfill on March 2, 2004.

In January, the FDA expanded its hold on the rendered material until it covered 2,000 tons of material. FDA officials confirmed that none of the potentially contaminated, rendered material entered commerce, and reported that no recall was necessary because no product was distributed commercially by the rendering companies.

In this case, investigators found that the two agencies worked well together, keeping one another informed of all activities. But in general, the GAO said, once a problem with food contamination is identified, the two agencies' data systems have not been used to effectively monitor and manage their recall programs.

Generally, the agencies do not track important dates to calculate how long companies take to carry out recalls and the percentage of food that is recovered, nor do managers receive routine reports on the progress of ongoing recalls.

GAO investigators found that the FDA’s food recall program staff maintain a recall data system that is separate from FDA’s official recall data system.

The FDA uses information from the staff's system to report to Congress because it contains the most accurate data, staff said. But, the GAO said, "the two systems do not contain consistent information, which brings into question the validity and reliability of FDA’s official system."

Monitoring the effectiveness of a company’s recall actions is supposed to be the agencies’ primary role in a food recall, but they do not promptly verify that recalls have reached all segments of the distribution chain, the GAO report says.

For the year 2003, the GAO examined in depth 10 recalls conducted by each agency. USDA staff took an average of 38 days to complete verification checks, and FDA staff averaged 31 days.

"These time frames exceeded the expected shelf life for some perishable foods that were recalled, such as fresh ground beef and fresh-cut bagged lettuce,"

The agencies’ procedures for selecting the sample of companies to check do not ensure that all segments of a food distribution chain are included.

There is a bright spot, investigators said. In May, the USDA issued new procedures to its staff with time frames for completing verification checks - within 13 days for Class I recalls. This class of recalls applies to foods that could cause serious, adverse health consequences or death, such as foods that contain listeria, salmonella, or E. coli O157:H7, or undeclared allergens such as peanuts and eggs.

The new procedures specify notification methods designed to reach all segments of the distribution chain. If they are implemented, the GAO said, these procedures should provide "reasonable assurance that recalls are effective."

But the methods used now by the USDA and FDA use to alert consumers to a recall - press releases and Internet postings - may not be effective, the GAO warned. Consumer groups say relatively few consumers see that information.

The agencies should notify the public by posting recall notices in grocery stores and directly notifying consumers using shoppers’ club information, investigators recommend.

The USDA and the FDA have only limited authority to order food recalls, compared to agencies responsible for the safety of other consumer products with more specific recall authority that may help them better protect consumers.

The Consumer Product Safety Commission, for instance, has the authority to require a company to notify the agency within 24 hours when it has distributed a potentially unsafe product, order a recall, establish recall requirements, and impose monetary penalties of up to $1.65 million if a company does not cooperate.

In fact, the FDA does have authority to order recalls of unsafe biological products and medical devices, and it has used this authority in the past. The FDA can impose penalties of up to $100,000 per day on companies that do not recall unsafe biological products, such as vaccines.

The GAO is proposing that Congress consider legislation that would require companies to alert USDA or FDA when they discover they have distributed potentially unsafe food and that would give both agencies mandatory food recall authority.

"We are also recommending that USDA and FDA better track and manage food recalls, achieve more prompt and complete recalls, and determine if additional ways are needed to alert consumers about recalled food that they may have in their homes," said the Government Accountability Office.

In commenting on a draft of this report, the USDA said it was factually accurate but said the procedures it adopted in May will address most of the weaknesses the GAO found.

The USDA objected to the recommendations to collect additional data generate more reports because they might be a burden to the agency and industry.

"We do not believe it would be burdensome to USDA because the department already generally collects these data in its inspection paperwork but does not systematically capture them in its Recall Web database, which should be able to generate the management reports we recommend, replied the GAO.

In its comments, the FDA said that the GAO investigators did not demonstrate that FDA recalls were lengthy because of system inefficiencies or that weaknesses in FDA’s recall process resulted in little recovery of food.

FDA officials did agree that the agency must eliminate the duplicate recall database, but they disagreed with the idea of specific time frames for companies’ actions and for recording the dates of company and agency actions in the Recall Enterprise System.

The GAO said, "We continue to believe that time frames are critical to reinforce the urgency for companies to act promptly to protect consumers and that tracking these dates is essential for FDA to effectively monitor ongoing recalls and assess actions to improve the timeliness of recalls."

Copyright Environment News Service (ENS) 2004. All Rights Reserved.

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