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
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
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
"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
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
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
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
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
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
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
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
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
"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
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
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
Copyright Environment News Service (ENS) 2004. All