Is The US Finally On The Road To Food Safety Reform?

June 5, 2009

The draft Food Safety Enhancement Act of 2009 lists a backlog of regulatory reforms that have accumulated in the desk drawers of Congressional legislators for a decade or more. And, with the backing of the Obama Administration, it has a good chance of becoming law.

The proposed Act provides for several key changes to the way the United States approaches food safety. What do some of these changes mean for the food industry and for consumers?

Mandatory Recall Authority

We, along with many others, have been advocating this change for a very long time. It will allow FDA to initiate a recall in those cases where a food company refuses the agency's request for a voluntary recall. The new authority will rarely need to be used. It's mere existence will be a stimulus to industry cooperation.

Universal HACCP

HACCP (Hazard Analysis and Critical Control Points) is a preventative approach to the production and processing of safe food. The meat and poultry industry adopted HACCP a decade ago at the insistence of USDA. FDA already requires some food industry sectors – seafood processors, for example – to operate under HACCP. Now, if the proposed bill becomes law, HACCP will be extended to the entire food industry. The program would be phased in, first in large companies – many of which already follow HACCP practices – then in smaller ones.

Annual Registration of All Food Operations, Including Warehouses, Food Brokers and Importers

The 2008/2009 Peanut Corporation of America fiasco was complicated by the apparent invisibility of the company's Texas facility. Although registered with FDA, the facility was not known to the Texas Department of State Health Services. As a result, it never was inspected by the State (which was operating under contract with FDA) until after the federal agency followed the evidence trail from Georgia to Texas. Annual registration may reduce the risk of this problem occurring again, but only if there is effective sharing of the registration information between FDA and state agencies. The $1,000 annual registration fee that is part of this mandate should help to defray the costs of information sharing.

Country of Origin Labeling

This already is a requirement for some foods (just check the labels on your supermarket fruits and veggies). If the proposed bill becomes law, all foods would need to be labeled with their country of origin. This is not, strictly speaking, a food safety issue – unless a food product or ingredient from a specific country has been fingered as the source of a problem (e.g., melamine adulteration). But many consumers want to be able to choose which countries they will support with their food dollars.

Reinspection and Recall Fees

Until now, FDA has been forced to swallow the entire cost of overseeing food safety recalls and of follow-up inspections needed to determine whether a food facility has corrected deficiencies noted during routine inspections. The proposed legislation will shift FDA's reinspection costs to the out-of-compliance facilities. And the extraordinary costs to FDA associated with product recalls also will be borne by the companies whose products have been recalled. Companies that cut corners on food safety will now risk paying a higher price for their mistakes. The Grocery Manufacturers Association has – not surprisingly – expressed its displeasure over what it described as an open-ended fee.

Whistleblower Protection

The draft bill offers protection to company employees who witness and report infractions or conditions at the workplace that might render a food product unsafe. The provision would prevent an employer from discriminating or retaliating against a whistleblower.

There is a lot more – 116 pages of draft legislation in all. Many of the provisions are long overdue. Many will be expensive to implement.

On June 3rd, the House of Representatives Sub-Committee on Health held an initial hearing on the draft bill. Witnesses included government, industry and consumer representatives. The last to testify was newly confirmed FDA Commissioner Margaret Hamburg.

After the hearing, Commissioner Hamburg was asked by reporters what she learned in her first Congressional appearance as FDA Commissioner. She replied, "That I have a lot to learn."

If passed, rapid and effective implementation of this monumental revamping of food safety laws will depend on Margaret Hamburg being a fast learner.

The Next Food Safety Czar: A Modest Proposal

May 21, 2009

One of Tom Vilsack’s first acts after being confirmed as Secretary of Agriculture was to name Ronald F. Hicks as Acting Deputy Undersecretary for Food Safety. In his memo announcing the appointment, Secretary Vilsack said of Mr. Hicks that his “… extensive experience will bring great benefit to the Agency as this administration shapes its vision for a productive transition.”

And what, exactly, does Ron Hicks bring to the food safety table? An academic background in veterinary science? In microbiology? In anything biological? Or, maybe, expertise in developing and implementing food safety programs – anywhere?

Not a chance! Ronald Hicks is an attorney by training and an administrator by temperament.  His previous position was Chief Operating Officer of FSIS, with emphasis on the “…design, operations and improvement of FSIS management systems.”  In short, Ron Hicks is a desk jockey with a law degree.

Hicks’ immediate boss was Elizabeth Johnson, the Acting Undersecretary for the Office of Food Safety (She left in December 2008). Johnson worked as a research dietitian within USDA, a nutritionist within the food labeling division of FDA, and as a consultant to government and the private sector on nutrition, farm credit and livestock issues. Food safety was not in her resumé.

Reporting to Hicks is Alfred Almanza, the present FSIS Administrator. Almanza began his career as an inspector with USDA 30 years ago, and has risen through the ranks. He is the only member of the senior USDA team who has direct training and experience in food safety issues.

Secretary Vilsack badly needs a senior team member with the knowledge and experience to guide USDA’s efforts to revamp food safety policies and enforcement. We have found the perfect candidate.

Dr. David Theno has all the necessary qualifications for the position of Undersecretary for the Office of Food Safety. After earning his degrees in animal sciences, he worked for large food companies, such as Armour Foods and Foster Farms. He has led his own independent consulting firm. In 1993, following a disastrous outbreak of E. coli O157:H7, Jack-In-The-Box recruited Dr. Theno to reinvent that organization’s tattered food safety program.

The program developed and implemented by David Theno earned awards both for the company and for him. Last year, Dr. Theno retired from Foodmaker (the parent of Jack-In-The-Box), and is now an independent consultant once again. 

Dr. Theno knows the meat industry, knows food safety, and knows how to get things done. Tom Vilsack needs him at the pinnacle of the food safety pyramid.

David Theno has the right stuff!

Who's Minding The [Food Safety] Store?

May 19, 2009

Yesterday, the Senate confirmed the appointment of Margaret Hamburg as the new FDA Commissioner. She joins HHS Secretary Kathleen Sibelius and Agriculture Secretary Tom Vilsack at the top of the US Food Safety triumvirate. 

Dr. David Acheson and Dr. Stephen Sundlof – holdovers from the Bush Administration – continue to fill supporting roles as FDA Associate Commissioner for Food, and Director of the Center for Food Safety and Applied Nutrition, respectively.

As usual, food safety is “tail-end Charlie” at USDA. The current FSIS Administrator, Alfred Almanza, is a holdover from the previous Administration. President Obama has yet to nominate a new Administrator for this most senior food safety position at USDA. Meanwhile, the positions of Undersecretary and Deputy Undersecretary of Agriculture for Food Safety also continue unfilled.

Vilsack, Sibelius and Hamburg most likely will guide US food safety policy for the remainder of President Obama’s first term. What do we know about them, and what do their appointments tell us about the President’s true commitment to revamping the US food safety infrastructure?

Secretary Tom Vilsack (Agriculture): Former Governor of Iowa. Secretary Vilsack was a supporter of biodiesel and ethanol production, health care reform and education reform during his tenure as Governor. He also led agricultural trade missions, promoting sales of his state’s agricultural products. The Secretary’s official biography makes no mention of his stance on food safety.

Secretary Kathleen Sibelius (Health and Human Services): Former Governor of Kansas; former Kansas Insurance Commissioner. The Secretary’s official biography does not even mention food safety. In her written testimony, submitted during her confirmation hearing, she stated, “… health reform would be my mission …”

FDA Commissioner Margaret “Peggy” Hamburg: Former Assistant Health Secretary in the Clinton Administration; Former New York City Health Commissioner. Dr. Hamburg is described as an expert in bio-terrorism. 

Secretaries Vilsack and Sibelius both were strong supporters of President Obama during his nomination campaign. Their appointments are highly political. Neither they, nor FDA Commissioner Hamburg, can claim any significant background or record regarding food safety. These are the people who now lead the President’s new Food Safety Working Group. 

The American consumer deserves – and should demand – the appointment of a Cabinet Secretary whose primary mission is food safety. This crucial public health sector must not continue to be a political football.

Mars Petcare Dog Food Recall: Follow-up

Why FDA Needs Mandatory Recall Authority

In 2007, 70 people in 19 states became infected with Salmonella Schwarzengrund. The first confirmed cases were reported in May in Pennsylvania. One month later, infections with the outbreak strain of Salmonella had turned up in Ohio and several other states.

Based on information uncovered by Pennsylvania health authorities and the CDC, suspicion fell on dry dog food as the source of the multi-state outbreak. Hot on the scent of the common link, investigators sampled 13 dog stool samples and 22 samples of dry dog food – and found the outbreak strain of Salmonella Schwarzengrund in 5 of the stools and in 2 dog food samples.

The implicated dog food was manufactured in the Pennsylvania plant of Mars Petcare. Pennsylvania Department of Health inspectors visited the Mars production plant on July 12th and collected 144 environmental swab samples for lab analysis. One of the samples yielded the outbreak strain of Salmonella Schwarzengrund.

Mars suspended production at its Pennsylvania plant for several months (July-November 2007) for a comprehensive clean-up and disinfection of the entire production facility. And it instituted a product recall – but only of the two specific products that were proven by FDA lab tests to be contaminated with Salmonella Schwarzengrund.

Mars Petcare's Pennsylvania facility produced dry dog food under 25 different brand names. Based on patient interviews and Salmonella-positive dog stools, some of these other brands – and some other production dates – also were implicated in the outbreak. The company, however, chose not to recall any products unless FDA could prove – based on Salmonella-positive lab results from unopened bags of dog food – that the products were contaminated.

Logically – given the scope of the outbreak, the confirmed presence of the outbreak strain in the production environment, the finding of Salmonella-contaminated dog food from two different batches, and the epidemiological evidence – the entire outstanding production from this plant should have been recalled. But FDA did not have the necessary authority to insist on a more extensive recall.

A report of the outbreak investigation appeared in this week's issue of Morbidity and Mortality Weekly Report, a CDC publication. The writer's frustration shines through clearly in the discussion of the recall. The Editorial Note to the report reads, in part, as follows:

"The case-control study found an association between infections in households and use of dry dog food or dry cat food produced by manufacturer A. In addition, the outbreak strain was isolated from 1) opened bags of dry dog food (brands A and B) that were produced in plant A by manufacturer A, 2) stool specimens from dogs in case-patient households that ate dry dog food produced in plant A, 3) an environmental sample from plant A, and 4) two bags (brands E and F) of previously unopened dry dog food produced in plant A.

A voluntary recall of specific-sized bags of two brands of dry dog food issued by the manufacturer in August 2007 was based only on lot-specific testing of finished unopened bags found to be positive for Salmonella by official FDA testing. Other sizes of bags of the two brands of dry dog food, although produced at plant A, were not recalled. Other brands of dry dog or cat food produced at plant A, including brands associated epidemiologically and microbiologically with illness, also were not included in the recall.

Plant A ceased operations during July--November 2007 to allow for cleaning and disinfection. However, because dry pet food has a 1-year shelf life and all contaminated products were not recalled, contaminated dry pet food might still be found in homes and could provide the potential for causing illness. Only an estimated 3% of Salmonella infections are laboratory-confirmed and reported to surveillance systems (2); therefore, this outbreak likely was larger than the 70 laboratory-confirmed cases identified."

Mars Petcare produces such familiar brands as Royal Canin, Pedigree and Nutro, as well as a large number of store brands. It is part of Mars, Incorporated – the company that has given the world M&Ms, Mars Bars and Uncle Ben's Rice.

The Mars Petcare dry dog foods have a one-year shelf life. Some of the dog food that was produced before the July 2007 plant shutdown is still in circulation. If you have purchased any dry dog food that was manufactured at Mars Petcare's Pennsylvania plant, please discard it. If you purchased a store brand or regional brand and are unsure of where it was made, contact your retailer and ask for the name of the manufacturer. Or call Mars North America's consumer hot line toll-free at: 1-800-627-7852.

Tasmanian Government Lays An Egg

Recently, the Australian state of Tasmania was hit by an outbreak of salmonellosis. The outbreak, which affected more than 80 people, has been tentatively linked to sauces made from raw eggs sold by one producer - Pitt's Poultry.

In response to political pressure, the government of Tasmania has decided to require raw eggs to carry a warning label. But the only eggs to be affected by this new requirement will be those produced by Pitt's Poultry.

I have to admit that the logic of this ruling escapes me. It isn't news to anyone in the food safety profession that raw eggs - even those still in clean and intact shells - carry a risk of Salmonella contamination. This is true for eggs produced in North America, where USDA estimates the risk at one egg in 20,000. It's true in the United Kingdom and the rest of the EU. For more details on this problem, read Chapter 3 of my book, Food Safety: Old Habits, New Perspectives.

If one egg producer in Australia is experiencing this problem, others will surely follow. The only sensible thing to do – assuming that a warning label is warranted – is to require that ALL raw shell eggs carry the same warning. Anything else, in my opinion, is simply pandering to political pressure.

Democratic Presidential Candidates: On Food Safety

Bill Marler posted this morning Hillary Clinton's policy proposals for our food safety system. The Clinton campaign press release , issued yesterday in the aftermath of the 143 million pound meat recall, covers several aspects of food safety, including mandatory recall authority, consolidation of responsibility for food safety oversight into a single agency, and carrying out an immediate audit to find the weaknesses in our present system.

I looked for, and found, Barack Obama's statement, also released yesterday, which I have quoted in full below.

Chicago, IL - Senator Barack Obama released a statement on the Department of Agriculture's decision to recall 143 million pounds of frozen beef that came from "downed" animals. The consumption of downed cattle can pose a higher risk of contamination from E. coli, salmonella or mad cow disease.

Senator Obama released the following statement:

"Senator Barack Obama released a statement on the Department of Agriculture's decision to recall 143 million pounds of frozen beef that came from "downed" animals. The consumption of downed cattle can pose a higher risk of contamination from E. coli, salmonella or mad cow disease.

"Senator Obama said: "Although the Department of Agriculture has now recalled the tainted beef, an estimated 37 million pounds has gone to school lunch programs, and unfortunately, officials believe that most of the meat has already been consumed by schoolchildren. This incident demonstrates yet again the inadequacy of the food recall process. Far too often, tainted food is not recalled until too late.

"When I am President, it will not be business as usual when it comes to food safety. I will provide additional resources to hire more federal food inspectors. I will also call on the Department of Agriculture to examine whether federal food safety laws need to be strengthened, in particular to provide greater protections against tainted food being used in the National School Lunch Program.

"As the parent of two young daughters, there are few issues more important to me than ensuring the safety of the food that our children consume. I commend the Humane Society of the United States for bringing this important issue to the public attention and believe that the mistreatment of downed cows is unacceptable and poses a serious threat to public health."

It would be nice to know what the co-sponsorship and voting records of both Senators has been on the various food safety bills that have been presented in Congress while they have been in office.

Lies, Damn Lies, and Statistics

Does the United States truly have the "world's safest food supply"?

This being a quiet news day (no recalls announced this morning, for a change), I decided to delve into some numbers. Here's what I found.

• The Centers for Disease Control and Prevention (CDC) estimates that there were 12.71 cases of Campylobacter and 14.81 cases of Salmonella per 100,000 people in the United States in 2006.
• The Food Standards Agency reports a total of 53,052 lab-reported cases of food-borne diseases for the year 2005. This translates to 88.4 cases per 100,00 people in the UK that year. The numbers for 2006 are not yet available.
• Overall, the European Union (EU) suffered 5710 outbreaks of food-borne disease in 2006, 0r 1.16 per 100,000 people. This total includes more than 175,000 cases of Campylobacter infection, and more than 160,000 cases of Salmonella, for a total of 68.2 cases due to these two pathogens per 100,000 people.
• Canada reported 106 food-borne disease outbreaks in 2005, or 0.35 per 100,000 people. There were 19.6 reported cases of Salmonella and 29.9 reported cases of Campylobacter per 100,000 people.

A first look at the numbers seems to support the US claim of having the world's safest food supply. But there is another complication. The great majority of cases of food-borne disease are never reported.

Official government statistics are based on reported incidents. This is not a reliable number, because it is based only on those victims who visited a doctor or emergency room. A visit to a doctor's office can be an expensive proposition in the U.S. for the more than 15% of the population that is without health insurance. And co-pay policies and waiting times in countries with universal health care affect a person's decision go to the "bother" of seeking medical attention for what is a relatively mild illness. Country-to-country comparisons of unadjusted food-borne disease statistics are misleading.

In 1999, US researchers estimated that more than one person in every four (more than 25%) suffered an incident of food-borne illness each year, for a total estimate of 76 million cases annually. That same year, British researchers estimated that country's annual food-borne illness rate at one person in every five (20%). Until more recent data demonstrate that this relative performance has changed, the US accurately cannot claim the title of "world's safest food supply".

Something Smells Fishy

The recent food safety agreement between the U.S. and China appears to be off to a rocky start, according to an article in today's Wall Street Journal.

Following the detection of prohibited chemicals in previous shipments of seafood from China, the FDA placed a hold on the importation of five types of seafood from that country until the shipments cleared lab testing (at the importer's expense). But an exception was made in September for seafood from one Chinese processor, Zhanjiang Guolian Aquatic Products Corp. Now it would appear that the exempted processor is on the Canadian government's import alert list due to the presence of nitrofuran in a shipment of seafood. The nitrofuran-contaminated shipment of seafood, rejected by Canadian authorities in October 2007, had been routed through the U.S.

The Wall Street Journal quotes Guolian's general manager, Chen Han, as saying that the Canadian action was a "mistake", and was due to another company having falsely used Guolian's name. Mr. Chen claims that his company has emailed the Canadian government about this situation but, according to the Canadian Food Inspection Agency, no such email has been received.

Some questions have apparently been raised about the Guolian exemption. A former FDA employee, Benjamin England, suggested in the Wall Street Journal article that the Company's political connections with the Chinese government might have been a factor in the decision. Mr. Chen denies this, saying that the exemption is due to the Company's "good quality" operation.

The U.S. government has stated that Guolian's import "hold" exemption was part of a pilot project under the U.S.-China food safety agreement. Yet Guolian was added to the FDA's import detention list in April 2007, and then removed from that list just five months later - in September - three months before the announced food safety agreement between the U.S. and China. Something doesn't add up.

Ethanol, Clean Energy and E. coli O157:H7

The U.S. Congress has been trying to agree on an energy bill. One of the provisions of this bill, which has already been passed in the House of Representatives but which is stalled in the Senate, provides incentives for alternative fuels, such as cellulosic ethanol.

Cellulosic ethanol can be produced from a variety of plant material. At present, about 80% of it is made using corn. But the production process doesn't use up all of the corn. What is left behind after the fermentation and clean-up is a by-product known as "spent grain" or "distiller's grain".

Distiller's grain is not without its uses, especially to the cattle industry. Feedlot operators have been feeding this relatively inexpensive grain to their cattle. And distillers are enjoying the windfall revenue from what would otherwise be waste material. There is, however, a cloud on the horizon.

Recently, researchers at Kansas State University announced that feeding distiller's grain to cattle resulted in a higher incidence of E. coli O157:H7 in the hindgut of the animals. This contradicts findings reported by another major agricultural school, the University of Nebraska - Lincoln. Nebraska researchers did not find any indication that adding distiller's grain to the diet produced an increased incidence of E. coli O157:H7.

So there you have it - one of those situations that turns a microbiologist's hair gray. The USDA's Agricultural Research Service lab in Clay Center, NE is in the midst of a similar study, which is scheduled to be completed by the end of 2008. Best two out of three, anyone?

The process of raising cattle for slaughter has undergone many changes over the decades - in feedlot environment, types of feeds, and handling of manure and runoff. Unfortunately, thought is usually only given to the microbiological impact of these changes after the fact. For once, it would be nice to see data supporting the microbiological safety or benefits of a significant change before that change is implemented.

Melamine in Pet Food - A Final Report

A tip of the hat to the University of Guelph (Canada) Laboratory Services Division. While everyone else was wondering why the melamine-laced pet food was so toxic to dogs and cats last spring, the Canadians figured it out in short order. Now their conclusion has been confirmed independently by Michigan State University toxicologists in a follow-up study.

When melamine was first detected in pet foods that had been linked to animal deaths, veterinary toxicologists were puzzled. Melamine was never thought to be toxic to companion animals at the levels found in the contaminated products. The second contaminant, cyanuric acid, also was not known to be toxic at the levels at which it was found in the food. But the combination of the two chemicals proved deadly.

On May 1st, the University of Guelph reported that they had found the likely answer to the toxicity puzzle. Their preliminary report concluded:

Although still under investigation, it now appears that the combination of melamine and cyanuric acid has been linked to the unusual outbreak of acute renal failure in cats and dogs that have eaten the suspect products.

The researchers reached this conclusion by adding both melamine and cyanuric acid to cat urine. The two chemicals, when both present in the urine, formed crystals that were identical to the crystals found in the urine of cats that had been sickened after eating the contaminated pet food. Neither melamine nor cyanuric acid alone produced these crystals.

The American Association of Veterinary Laboratory Diagnosticians commissioned Michigan State University to investigate fully the impact of the contaminated pet food and confirm the reason for its toxicity. University of Guelph and Colorado State University collaborated with MSU on the study. Their report has just been released, and the two main findings are:

1. The contaminated pet food was probably responsible for the death of more than 300 cats and dogs
2. The toxicity of the pet food likely resulted from the combination of melamine and cyanuric acid in the contaminated food.

So now we know for sure what the University of Guelph figured out more than 6 months ago. And we also know how many pets were probably lost due to the deliberate addition of melamine and cyanuric acid to wheat gluten by an off-shore manufacturer who was trying to gain an economic advantage.

Yesterday, Health and Human Services Secretary Leavitt announced that the U.S. and China had reached an agreement on food safety issues. The agreement provides for the eventual "embedding" of FDA inspectors in Chinese food processing facilities. But I don't expect this agreement to have a major impact. The FDA doesn't have nearly enough money in its budget - or trained personnel on its staff - to fulfill its domestic mandates.

Managing Risks - A Page from the Australian Playbook

When my husband and I were running our business and trying to ship products to Australia, we had to deal with that country’s tough meat and dairy product import regulations. Australia’s requirements seemed a bit paranoid to us at the time, but their strict import provisions stood the country in good stead. Australia has never experienced a case of mad cow disease.

Australia developed a risk-based approach to food import control that the FDA would do well to examine and learn from. Imported foods fall into one of three categories.

“Risk categorized foods” are those thought to present the greatest risk for food-borne disease. These foods are subjected to the most intensive scrutiny by Food Standards Australia. The first five shipments of each food on the high risk list from each foreign producer are inspected. After five consecutive shipments of a given food have passed muster, one in four shipments of that food from that producer are held for inspection. After 20 successful inspections, the frequency of inspection drops to one in 20 shipments. In all cases, shipments selected for inspection are held until results are known. Any unsatisfactory result causes the risk clock to reset and, of course, the unsatisfactory shipment is refused entry.

“Active surveillance foods” represent the next lower level of perceived risk. Ten percent of shipments of these foods from each and every supplying country are sampled for lab analysis. Because of the lower perceived risk, shipments of these foods are released after sampling.

“Random surveillance” covers all remaining foods not included in one of the two higher risk categories. Five percent of these shipments are sampled randomly for lab analysis.

Food Safety Australia reviews the results of these inspections periodically and, if appropriate, moves foods to a higher or lower risk category.

No system can ensure 100% safety, but basing a screening program on scientific risk assessment, and adjusting that assessment as more information become available seems a logical way to go.

FDA - An Agency in Crisis

One year ago, the Commissioner of the US Food and Drug Administration directed the agency's Science Board to review whether the FDA had the necessary personnel, science expertise, equipment and budget to carry out its various mandates effectively. The results of that review have just been made public.

The findings reported by the Science Board are shocking, but not surprising to anyone who has followed the deteriorating state of our food safety systems these last several years. Among its series of observations, the Board had this to say about the current state of the FDA (and these are direct quotes):

• The FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak.
• The FDA cannot fulfill its mission because its scientific workforce does not have sufficient capacity and capability.
• The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate.
• FDA does not have the capacity to ensure the safety of food for the nation.
  

Peter Barton Hutt, a former FDA Commissioner and a contributor to this report, observes that the FDA has been underfunded for decades, and faults both Democratic and Republican administrations for piling additional unfunded mandates onto the agencies plate. In Hutt's opinion, the FDA needs a doubling of its current budget and a 50% increase in manpower to begin to address its deficiencies.

The budget shortfalls and resultant lack of equipment, resources and personnel to carry out FDA's responsibilities have also seriously damaged the morale of agency personnel. This, in turn, has accelerated the loss of trained scientists and administrators - many of whom are difficult to replace.

While all parts of the agency are hurting, the two most seriously affected appear to be the Center for Food Safety and Nutrition (CFSAN), and the Center for Veterinary Medicine (CVM). The Board observes in its report that a simple lack of resources prevented the FDA from timely introduction and enforcement of new animal feed regulations to prevent the spread of mad cow disease in the United States. And even in the face of the recent pet food recalls, the CVM can only afford to have two people working on pet food issues.

The Food and Drug Administration once was one of the most respected agencies of the US government. In the 1970s, approximately 80% of Americans surveyed expressed confidence in the agency. That level of confidence has deteriorated (to 36% in 2006) along with the capabilities of the FDA to manage all of the statues that fall into its areas of responsibility.

Finally, the Science Board observes that "(r)ecommendations of excellent FDA reviews are seldom followed," and that failure to act on past recommendations "...has jeopardized the public's health." Let's hope that, this time, someone is listening.