Sludge Watch ==> US: Report says stingy funding put Food & Drug Admin in crisis

[Maureen Reilly]

Sludgewatch Admin:

With food safety crippled, it isn't wise to use sewer wastes (biosolids) to 
fertilize crops, and it isn't wise to use sewage effluent for the irrigation 
of leafy greens

The US regs have no mechanism for enforcement of sludge waiting periods ... 
the period that farmers are supposed to wait between spreading sludge and 
harvesting potatoes, carrots, hay, turf, etc.  The farmer doesn't generally 
have the permit to spread sludge...so since the farmer isn't the permit 
holder the farmer isn't bound to respect the 503 requirements.....the sludge 
hauler would have to have some kind of contract to make the thing 
enforceable in civil court.

Well how long would that take...? And who even knows if those contracts 
exist?  And where is the food in the meanwhile?

In the grocery story.


Here in Ontario the Ministry of Environment refuse to say how they are 
enforcing pathogen limits in sewage sludge... stats show that some biosolids 
are heading out  at 12 million fecal coliform per gram.
............................................


US: Report says stingy funding has put FDA in crisis
05.dec.07
CIDRAP News


http://www.cidrap.umn.edu/cidrap/content/fs/food-disease/news/dec0407fda.html

Safety inspectors still write their reports by hand, food processing plants 
are inspected once every 10 years at best, only two people work full-time on 
pet-food safety, and critical information is locked up in piles of 
warehoused paper documents.
Those are a few symptoms of the poor condition in which the US Food and Drug 
Administration (FDA) finds itself after decades of inadequate funding and 
growing responsibilities, according to a new report by a special FDA 
committee that was assigned to assess the agency's scientific and 
technological capabilities.

The bottom line is that "American lives are at risk," says the 60-page 
report, titled "FDA Science and Mission at Risk: Report of the Subcommittee 
on Science and Technology."
The report says the agency is losing its ability to keep up with scientific 
advances, its regular staff has stayed about the same size for 20 years, and 
its information technology (IT) systems are obsolete and unreliable.

"We found that FDA's resource shortfalls have resulted in a plethora of 
inadequacies that threaten our society—including, but not limited to, 
inadequate inspections of manufacturers, a dearth of scientists who 
understand emerging new technologies, inability to speed the development of 
new therapies, an import system that is badly broken, a food supply that 
grows riskier each year, and an information infrastructure that was 
identified as a source of risk in every Center and program reviewed by the 
Subcommittee," the report states.

The report suggests the agency may need as much as twice its current level 
of funding to equip it properly to fulfill its mission.

The document's release comes less than a month after the Bush administration 
released an import safety and food protection plan triggered by a series of 
tainted imports, including contaminated pet food and toys with lead paint, 
plus recent domestic food contamination episodes, such as instances of 
Salmonella in peanut butter and E coli in fresh produce.
The FDA' s mission includes regulating about 80% of food sold in the United 
States, plus all drugs, human vaccines, and medical devices, the report 
notes. The products the agency regulates account for about 25 cents of every 
consumer dollar spent—about $1 trillion per year.
A year ago, FDA Commissioner Andrew von Eschenbach asked his advisory board, 
called the FDA Science Board, to name a subcommittee to weigh whether the 
agency has the scientific and technologic capacity to support its regulatory 
mandate, the report says. The subcommittee that was subsequently appointed 
included three members of the Science Board and other experts representing 
industry, academia, and other government agencies.

Soaring demands, static funds


The subcommittee found two reasons for the "precarious" condition of science 
at the FDA:
* The demands on the agency have soared because of "the extraordinary 
advance of scientific discoveries, the complexity of the new products and 
claims submitted to FDA for pre-market review and approval, the emergence of 
challenging safety problems, and the globalization of the industries that 
FDA regulates."

* Funding has not kept pace with the scientific demands on the agency.
The funding shortage has forced the FDA to operate in a crisis-management or 
"firefighting" mode and kept it from building "a culture of proactive 
regulatory science," the report says. This is especially true of the 
agency's two food safety centers, the Center for Food Safety and Applied 
Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
Crisis management at the two centers "has drawn attention and resources away 
from FDA's ability to develop the science base and infrastructure needed to 
efficiently support innovation in the food industry, provide effective 
routine surveillance, and conduct emergency outbreak investigation 
activities to protect the food supply," the document reads.
It says the FDA needs a group of scientists who have the ability, freedom, 
and support to apply the latest tools of biology, chemistry, and 
bioinformatics to food safety regulation. "These individuals must be 
isolated from acute regulatory crises."

Food inspections 'appallingly' rare

The subcommittee found the FDA has "an appallingly low inspection rate" for 
both domestic and imported foods. "During the past 35 years, the decrease in 
FDA funding for inspection of our food supply has forced FDA to impose a 78 
percent reduction in food inspections, at a time when the food industry has 
been rapidly expanding and food importation has rapidly increased. FDA 
estimates that, at most, it inspects food manufacturers once every 10 
years," and it inspects no retail food stores or farms.

As an example of problems caused by scanty funding, the report cites the US 
experience with bovine spongiform encephalopathy (BSE), or mad cow disease. 
When BSE emerged in Europe, consumers and the cattle industry looked to the 
FDA to ensure that the disease would not spread to the United States via 
cattle feed, which the FDA regulates. "But Agency officials were denied the 
funds to bring the feed industry into rapid compliance with the new feed 
regulations, and the disease did appear in the US," the report says. (The 
first US case, found in December 2003, was in a Canadian-born cow; several 
more cases have been discovered since then.)
The recent problems with imported pet food contaminated with the chemical 
melamine also point up the FDA's struggles, the panel reported. Pet food 
sales total $15 billion to $20 billion a year, and the CVM received more 
than 18,000 phone calls about the melamine contamination—but the CVM "is 
able to devote only two people working full-time on pet food issues."
The authors recommend that the food safety centers collaborate more with 
other research programs, such as those of the Centers for Disease Control 
and Prevention, National Institutes of Health, and Department of Homeland 
Security. However, the centers still need their own scientific expertise, 
the report says.

Overall, the FDA doesn't have enough well-trained scientists, the report 
asserts. The number of "appropriated personnel" is about the same now as it 
was two decades ago, resulting in "major gaps of scientific expertise in key 
areas." The turnover rate for FDA scientists in key areas is twice that of 
other government agencies, and the agency spends too little on professional 
development to enable the staff to keep pace with scientific advances.

The agency should add several new positions to boost its scientific 
firepower and provide for a "coherent scientific structure and vision," the 
report says. First, the recently created position of deputy 
commissioner/chief medical officer should be broadened and renamed "deputy 
commissioner of scientific and medical affairs." This person should have 
authority to develop and oversee all science activities and ensure the 
adequacy of scientific expertise. Other recommended new jobs include chief 
scientific officer, a deputy director for science within each FDA center, 
and a director of extramural collaborations and training.

IT systems disturbingly poor

The report saves some of its strongest language for critiquing the FDA's IT 
infrastructure. The panel was "extremely disturbed" by the condition of the 
IT systems. The report continues, "The IT situation at FDA is problematic at 
best—and at worst it is dangerous. . . . Systems fail frequently, and even 
small systems are unstable—most recently during an E. coli food 
contamination investigation.
"More importantly, reports of product dangers are not rapidly compared and 
analyzed, inspectors' reports are still handwritten and slow to work their 
way through the compliance system, and the system for managing imported 
products cannot communicate with Customs and other government systems."

Because of inadequate backup systems, recent systems failures have erased 
FDA data, the report continues. Further, "Critical data reside in large 
warehouses sequestered in piles and piles of paper documents" for which 
there is no backup.

The report lists various estimates by others of the resources needed to 
restore the FDA's scientific capabilities. For example, the Coalition for a 
Stronger FDA has said that an increase of 15% a year for the next 5 years is 
needed. But the authors submit that this still would be inadequate. They 
suggest doubling the current funding—from about 1.5 cents to 3 cents per 
American per day. (Assuming a US population of 300 million, that would mean 
raising the budget from about $1.64 billion to $3.28 billion.)