Among other things, the bill will require food facilities to create and implement hazard plans to anticipate the most likely contaminants and food safety issues that could arise, increase inspection frequency overall and base frequency on high-risk facilities, implement better traceability to respond to outbreaks, give the FDA authority to order recalls of food and impose civil penalties on producers, and fund the FDA, in part, by requiring registration fees from producers.

Importantly, the version of the bill that was sent out of committee includes language on bisphenol-A that will protect infants, young children, pregnant women, and adults by directing the FDA to assess the effects of exposure to BPA in food and beverage containers and determining any approved uses. If the FDA determines that a currently approved use for BPA is unsafe, it will take action to revoke its approval and notify the public.

Food Safety Overhaul Approved by House Panel [CQ]
(Photo: cyanocorax)

In the end, food safety is something I take seriously, not just as your President, but as a parent. When I heard peanut products were being contaminated earlier this year, I immediately thought of my 7-year old daughter, Sasha, who has peanut butter sandwiches for lunch probably three times a week. No parent should have to worry that their child is going to get sick from their lunch. Just as no family should have to worry that the medicines they buy will cause them harm. Protecting the safety of our food and drugs is one of the most fundamental responsibilities government has, and, with the outstanding team I am announcing today, it is a responsibility that I intend to uphold in the months and years to come.

Obama also announced the creation of a working group charged with building a food safety framework that doesn't look like something out of the first Roosevelt administration.

Consumers Union has called on the FDA to inspect all food processing plants at least once every year. If the President really wants to make everyone happy he'll consolidate the food safety mandates spread across the government under a single all-powerful agency.

Still, nothing speaks louder than new funding, and we sure do like what the President is saying.

WEEKLY ADDRESS: President Barack Obama Announces Key FDA Appointments and Tougher Food Safety Measures [The White House]
President calls for FDA reform as Republicans continue to attack the budget [Consumer Reporter]
(Photo: Mike Licht, NotionsCapital.com, with cute dead skull from cutedeadthings.com.)

Audits are not required by the government, but food companies are increasingly requiring suppliers to undergo them as a way to ensure safety and minimize liability. The rigor of audits varies widely and many companies choose the cheapest ones, which cost as little as $1,000, in contrast to the $8,000 the Food and Drug Administration spends to inspect a plant.

Typically, the private auditors inspect only manufacturing plants, not the suppliers that feed ingredients to those facilities. Nor do they commonly test the actual food products for pathogens, even though gleaming production lines can turn out poisoned fare.

As in the Georgia peanut case, auditors are also usually paid by the food plants they inspect, which some experts said could deter them from cracking down. Yet food companies often point to an auditor's certificate as a seal of approval.

The baking institute, which is based in Manhattan, Kan., and is also known as AIB International, says it inspected more than 10,000 food production sites in 80 countries last year. James R. Munyon, its president and chief executive, said his group's inspections were reliable and tough, no matter who pays for them, but he declined to elaborate on specific audits.

Even worse, employees with safety concerns are told to defer to the private audits.

Both the government and industry are aware of the problem. The government's solution? "Expanding the role of private auditors to inspect the more than 200,000 foreign facilities that ship food to the United States."

Robert A. LaBudde, a food safety expert who has consulted with food companies for 30 years, said, "The only thing that matters is productivity." He added that "you only get in trouble if someone in the media traces it back to you, and that's rare, like a meteor strike."

Dr. LaBudde said a sausage plant hired him five years ago to determine the species of bacillus plaguing its meat. But the owner then refused to complete the testing. "I called them ‘anthrax sausages,' and said they could be killing older people in the state, and still they wouldn't do it," he said, declining to name the company.

Food Safety Problems Slip Past Private Inspectors [The New York Times]

The Senate hearings yesterday were a sad reminder of the problems in our food safety system. Whether it was due to underfunding, understaffing, or bureaucratic mismanagement, the FDA hadn't directly inspected the plant since 2001:

According to the FDA, it last inspected PCA's Blakely plant in 2001, before the company started producing peanut butter. It relied on state inspectors to review the factory in 2006, 2007 and 2008 — and those inspections showed unsanitary practices the FDA later said were "somewhat resolved."

"It was not until 2007, when the plant was inspected under FDA contract by the Georgia Department of Agriculture, that we recognized that in addition to just producing peanuts, they were producing peanut butter and peanut paste," Dr. Steve Sundlof of the agency's Food Safety and Applied Nutrition center told the Senate Agriculture Committee on Thursday.

When federal officials obtained the company's records, they discovered that 12 times in the past two years the company knowingly shipped products that initial tests showed were contaminated with salmonella.

PCA says further tests came back negative, which is why they shipped the products anyway, which seems to be the worst possible safety protocol to follow when it comes to the food supply (but a great one if you're only minding the bottom line, we suppose).

Even if the FDA had known that PCA produced peanut butter and peanut paste, and that the products had at one time tested positive for salmonella, the agency can't legally stop the company from shipping the product.

"The FDA does not have authority to force a manufacturer who's producing contaminated food to recall it," [former FDA associate commissioner William] Hubbard said. "They can beg them to, but they cannot order them to — and that's a flaw in the system."

And finally, the reason it took so long to trace the salmonella outbreak back to PCA was partly due to a lack of infrastructure that would allow doctors to aggregate data on patients in order to see trends. You'd think that by 2008, creating a database that can cross-reference patient variables and look for patterns would be a possibility, but when Senator Harkin asked a CDC official at yesterday's hearing why this wasn't the case, the official responded that there was no money to set up such a system.

FDA officials said they moved as fast as they could given the evidence they had. But Dr. Robert Tauxe, deputy director of the CDC's food-borne bacterial illness division, agreed the system is overly complicated, prone to delays and underfunded.

"The reality is that we have 50 different states, each with their own authorities, each with their own processes and each with their own budgets," Tauxe said.

Surely the savings that would result from reduced sick leave and fewer hospital bills would justify improvements. Hey Google, maybe you can help? Bill and Melinda Gates? Got any extra foundation money? It would be nice to have an infrastructure that works.

Hubbard said the result is "an embarrassment" to a 21st-century nation — about 5,000 deaths a year from food poisoning, with another 325,000 hospitalized and tens of millions sickened, according to CDC figures.

"We are losing the equivalent of the World Trade Center attacks every eight months to food-borne illness," Hubbard said.

"Poor oversight fueled salmonella outbreak, critics say" [CNN]

RELATED
"Vilsack Says Single Food-Inspection Agency Needed" [Bloomberg]
(Photo: Dano)

"We want the public to know that there were regular visits and inspections of the Blakely facility by federal and state regulators in 2008," Peanut Corp of America said.

"Independent audit and food safety firms also conducted customary unannounced inspections of the Blakely facility in 2008," it said in a statement, noting the plant got an overall superior rating on one visit and, in another, was found to "meet or exceed" audit expectations.

"Peanut Corp of America says plant was inspected" [Reuters]
"Inspection reports from peanut plant varied widely" [Associated Press]

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"Big Pharma Goes Before Supreme Court To Get State Lawsuits Banned"

PSC staff said FiOS "may form an electrically conductive path" and could create an electrical hazard. PSC spokesman James Dean called the public safety risk "minimal - however, there is a potential risk."

Under a plan submitted to the PSC last month, Verizon would review all of its fiber-optic installations to ensure connections are properly grounded and correct violations.

The company also said it would issue credits of up to $20 to customers for installations after Aug. 18 unless it meets standards at least 95 percent of the time. The credits would "compensate such customers for the inconvenience of the inspection (and, where applicable, remediation) process," according to documents filed with the PSC.

Verizon added that they take the Public Service Commission's concerns "very seriously."

Verizon offers plan to inspect FiOS wiring [Albany Times Union]
Violations cited in LI FiOS installations [Newsday]
(Photo: Getty)

The Philadelphia Inquirer used the Freedom of Information Act to obtain a 21-page FDA report, then had experts review it for feedback:

FDA inspectors spent a total of 30 days at the West Point plant between Nov. 26, 2007, and Jan. 17, 2008. The agency could go on to issue a warning letter and take other actions if its concerns are not addressed. The FDA declined repeated requests to comment.
 
The report cites cases where bulk lots of PEDVAX and ProQuad were contaminated. Unwanted "fibers" were found on the vial stoppers of MMR, the measles, mumps and rubella vaccine, among others. They were caused by "lesser quality" supplies from a vendor, the FDA report said.
 
The report noted defective vials had to be rejected twice to be discarded, and that one internal quality investigation went on for more than a year.
 
Several experts said no single finding was horrendous but that the overall pattern was troubling. "It's the sum of many small things that puts the whole operation in question," said consultant Wheelwright. 
"FDA report shows problems at Merck vaccine plant" [Philly.com]
(Photo: Getty)

The researchers freeze-dried the heparin and used a combination of nuclear magnetic resonance imaging and liquid chromatography-mass spectrometry to analyze its structure. In addition to a known impurity of heparin called dermatan sulfate, they found that contaminated lots contain a molecule that looks similar to heparin and showed it was almost certainly oversulfated chondroitin sulfate.

China says their tests show that only some of the Heparin that caused the problems contained the contaminants, so it therefore must be something else:

They said other contaminants, problems with the device used to inject the drug or health factors with the patients who used the drug could be to blame.

Estimates suggest more than 80 percent of all active ingredients used by U.S. drug manufacturers come from abroad. But the FDA only inspects foreign drug plants about once every 13 years, compared to every two to three years for domestic plants, according to the Government Accountability Office. The GAO finds that China's drug plants are inspected once every 30 to 40 years.
 
The FDA plans to establish permanent overseas offices in numerous countries, including China, to help address the problem. More foreign plant inspections than ever were conducted by the FDA in 2007, dedicating about $10 million to the process. But GAO analysis said it would cost the FDA $67 to $71 million each year to inspect the thousands of foreign plants on the agency's priority list.
 
Still, von Eschenbach told the House Subcommittee on Oversight and Investigations that in heparin's case, even if the Chinese plant had been inspected years ago, "we would not have detected that contamination" because the test to detect it was just developed.

The lawsuit is seeking class action status, and will include passengers who traveled on Southwest's planes from 2002 until this month— though presumably one would have to have flown on an MD-80?

Lew Garrison, a Birmingham lawyer who represents the passengers, said Tuesday the class could include hundreds of thousands of people who traveled on Southwest planes from January 2002 through last month.

Garrison, in a telephone interview, said the lawsuit primarily seeks reimbursement for tickets for those flights on the grounds that the Dallas-based airline did not comply with government regulations and did not honor its contract with its customers.

It looks like Toyota is attempting to avoid both an official recall and any sort of class-action suit by being pro-active in dealing with the problem vehicles, which is not a bad thing. The opportunity to make a profit off the purchase of your vehicle hassle-free is likely PR and not standard operating procedure, but it's a smart way to lure Tacoma owners in for the free inspection. "This is not a recall," writes the Toyota exec on their blog. "What's important is that we take care of our owners. We just thought you should know that.

"Living Up to Our Commitment" [Toyota Blog] (Thanks to Mark!)

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"Rusty Toyota Tacoma? Toyota May Buy Back Your Truck For 150% The Value" [Jalopnik]

"We expect this voluntary review, which is taking place on Delta's 117 MD-88 aircraft, to result in approximately 275 cancellations through early Friday, impacting about 3 percent of Delta's worldwide flight schedule. Based on the aggressive and proactive re-inspection schedule, Delta expects inspections to be complete on approximately 70 percent of its MD-88 fleet by early evening, with normal operations planned by early Friday."

"Delta, American cancel flights for safety inspections" [East Bay Business Times]
(Photo: Cubbie_n_Vegas)

Delta (DAL, Fortune 500) is inspecting the wiring of 117 MD-88 and 16 MD-90 aircraft. The airline says the checks are voluntary and are expected to be completed by week's end. American Airlines, meanwhile, is examining wiring secured to the MD-80 aircraft.

The [whistleblower] inspectors say FAA managers knew about the lapse in safety at Southwest, but decided to allow the airline to conduct the safety checks on a slower schedule because taking "aircraft out of service would have disrupted Southwest Airlines' flight schedule."

According to statements made by one of the FAA inspectors seeking whistle-blower status, a manager at the FAA "permitted the operation of these unsafe aircraft in a matter that would provide relief" to the airline, even though customers were on board.

Laura Brown, an FAA spokeswoman, told CNN that the administration has taken action and that a supervisor who was in charge of overseeing Southwest is "no longer in a supervisory position."

"The FAA penalty is related to one of many routine and redundant inspections on our aircraft fleet involving an extremely small area in one of the many overlapping inspections. These inspections were designed to detect early signs of skin cracking," the airline said in a statement Thursday evening.

"Southwest Airlines discovered the missed inspection area, disclosed it to the FAA, and promptly reinspected all potentially affected aircraft in March 2007. The FAA approved our actions and considered the matter closed as of April 2007."

(Thanks to Tzepish!)

"Records: Southwest Airlines flew 'unsafe' planes " [CNN]
(Photo: Boeing Photo)

Reuters helpfully explains, "Christmas crackers usually contain colored hats, small toys and jokes."

"A far from cracking surprise - a dead mouse" [Reuters]
(Photo: Getty)

The inspections point out one real problem retailers face in isolating and removing recalled products from their inventory—the manufacturers don't always make it easy:

Even after spotting the toy boat and suspecting it matched the one on the recall list, veteran state investigator Frank Carmody had to remove the product from its packaging and search the toy for several minutes before finding the model number on the boat's underside, printed in the same bright orange as the boat and nearly impossible to read. He then had to call the CPSC to verify that the toy he was holding and the one in his binder were the same.

Working with the state, the Monmouth County inspectors field-tested 75 children's items including a butterfly keychain, a backpack and a toddler's touch toy. They sent 16 of the 75 on to an independent lab for further testing; all 16 passed the more extensive test.

"Toy safety tops on NJ inspectors' holiday lists" [Newsday]
(Photo: What Rhymes With Nicole)

The report describes what it calls a "plethora of inadequacies," including:

• inadequate inspections of manufacturers, noting that foodmakers, for example, are inspected about once every 10 years.
• A "badly broken" food-import system and food supply "that grows riskier each year."
• A depleted FDA staff, which is about the same size as it was 15 years ago despite huge growth in agency responsibilities.
• A workforce with a "dearth" of scientists who understand emerging technologies.
• An "obsolete" information-technology system, with handwritten inspectors' reports and "piles and piles" of paper documents that are in warehouses with no backup, including clinical trial data.

"These people were horrified by what they found," [said William Hubbard, a former FDA associate commissioner]. While the subcommittee was supposed to look ahead to where the FDA needs to be, Hubbard says it came away concluding that "it cannot even do its job now."

The White House plan will also increase the power of the CPSC and the FDA (although we assume, based on where they stand philosophically, to a lesser degree than what Congress is proposing), and will cost lots and lots of money. Budget figures will be released after the President makes the formal announcement sometime today.

"White House to Offer Own Plan on Product Safety" [New York Times]
(Photo: Getty)

All of the banned poultry plants were major suppliers of U.S. poultry to Russia and are some of the most efficient facilities in the country, the export council said.

At least three of the poultry plants participate in a model U.S. Agriculture Department program to improve the efficiency of meat and poultry inspections and improve food safety, the council said.

The U.S. poultry industry has about 100 chicken plants and the loss of the 17 processing plants should not greatly disrupt business, said Paul Aho, an economist with the consulting firm Poultry Perspective.

"Russia banning us is not good news. But, it doesn't really influence things too much. There are 100 plants or more and the others ones can send it to Russia," said Aho.

Russia to ban some U.S. chicken/pork [Reuters]
(Photo: nukeit1)

• China's food system is fueled by hundreds of millions of private farms, "many no larger than a basketball court." These small private farms are often their proprietor's sole source of income; productivity is valued over safety.
• China's General Administration of Quality, Supervision, Inspection and Quarantine (GAQSIQ) is responsible for export quality control, but most supervision is left to local officials. Of course, "some voiced the opinion that some corruption was evident at the local level."
• "If the Chinese system worked as described, it would be a closed and therefore safe system. Committee staff, however, did not find an American or other multinational executive operating in China who believes that China has a competent, independent inspector stationed at each of the 3,700 plants that, according to Chinese officials, are fully HACCP-controlled. Committee staff also was unable to find anyone who believed that every single lot was sampled. It is further believed that the export certificates are subject to counterfeiting."

And this is the good news. The inspectors originally wanted to visit the two plants responsible for the melamine wheat gluten contamination. In response, the Chinese delayed the investigators' visas. By the time the investigators arrived on site, one plant had been bulldozed. The other was chained-off, its records held by the local police, and thus, confidential.

The team looked to Hong Kong and Japan for regulatory inspiration. In Hong Kong, the government extensively tests food samples and sends inspectors to foreign plants that export high-risk goods. In Japan, 15% of food imports are inspected, but those imports are only accepted from a small number of plants that are inspected annually by the Japanese. The downside to both models is cost, both to the government and to consumers, who pay a premium for quality imported goods.

The investigators believe that an inspection regime backed by adequate resources can improve the safety of our own food supply chain:

The United States, however, needs to sample enough so that detection becomes a deterrent. This will require some multiplying of our current efforts. It will also necessitate significantly more laboratory capacity for FDA.

Food from China: Can We Import Safely? (pdf) [House Energy and Commerce Committee]
(AP Photo/Wong Maye-E)

...the import safety panel is expected to push for expanded use of technology to more quickly identify risky imports. Leavitt has supported the use of technology at the border that could read the contents of a sports drink bottle, for example, looking for potentially toxic chemicals without opening it. The FDA is developing a food-safety strategy to be unveiled this fall that would rely on risk-based inspection but has not asked for more resources to pay for more inspections.

Technology Seen as Key To Upgrading Food Safety [Washington Post]
(AP Photo/Katsumi Kasahara)

"In one week we have gone from the largest U.S. manufacturer of frozen hamburgers to a company that cannot overcome the economic reality of a recall this large... We want to thank our loyal employees and customers who have supported us throughout the 67 years in which Topps Meat has been in business," D'Urso said. "Topps has always prided itself on providing the utmost quality and safety and never had a recall in our history until now. This has been a shocking and sobering experience for everyone."

According to the New York Times, Topps was "bought in 2003 by Strategic Investment and Holdings, an investment firm in Buffalo." Reports of sickness from the tainted meat have come from Pennsylvania, New Jersey, Connecticut, Maine, Florida, Indiana, Ohio and New York.

"Meat Recall Forces Topps Out of Business" [American Agriculturist]
(Photo: Getty)

The Chicago Tribune writes that "the requirement for a USDA inspection and stamp on meat that will be sold interstate hampers sales for smaller meat processors, according to beef industry advocates," and that the state of Minnesota feels its own state inspection procedures are equal to the those of the FDA. However, not all states have quality inspection procedures, or any at all.

The union that represents federal meat inspectors has argued against the measure:

"[It] would seriously endanger food safety by weakening the USDA federal meat and poultry inspection program and by increasing reliance on the more lenient, institutionally weaker state inspection programs — at a time when our nation's food supply is subject to increased risks from both accidental and intentional adulteration."

"Meat recalls point to possibility threat is growing" [USA Today]
"Bill would reduce meat inspections" [Chicago Tribune]
(Photo: Getty)

Heath and Human Services Secretary Mike Leavitt explains:

We're recommending the implementation of this strategy in six cross-cutting building blocks. Let me review them for you. The first is, advance a common vision. Let me give you some commentary on that point. There are many different organizations who have specific responsibilities. And in some cases, they have different priorities that need to be melded into one common vision. In other words, rather than just looking at whether the border is secure, we also need to make certain that the products that are crossing them are safe and we can use the same technology in many cases to detect both. So a common vision.

The second is increasing accountability enforcement and deterrence. I talk about prevention with verification. Clearly, we need to have strong enforcement. The third building block is focus on the risks over the life cycle of the imported product. I've given you some — that's basically going from a snapshot to a video.

The fourth — and I'll dwell on this a little more — is on building interoperable systems. We found that there were data systems that — used by, for example, the FDA, where an FDA inspector would need to have five passwords to get into five different parts of the FDA system. We found that the Customs and Border Protection would have seven different sections of their system, and neither could access data of the other. We found that there were substantial systems being developed among the shippers and the retail and wholesale community, and they were not integrated. So there is a remarkably important opportunity here to create interoperability among systems, so that we can see the life cycle of the product and have much more efficient capacity to track and to screen and to respond.

The fifth building block is a culture of collaboration. This is not a new problem within any federal or public/private enterprise, being able to break down silos. And sixth, promoting technological innovation with new science. We saw many instances where field tests, for example, were useable for inspectors to make on the spot determination, as opposed to needing to take samples and send them to a lab.

The working group's recommendations can only work in concert with an effective inspection system. It is unreasonable and unaffordable to inspect every item arriving at our ports, but the government should develop a system that both streamlines operations, and holds importers accountable for importing products that comply with our safety laws.

Press Briefing on Import Safety by Heath and Human Services Secretary Mike Leavitt and National Economic Director Al Hubbard [The White House via AP]
(AP Photo/Harry Rosettani)

• The Department of Health and the Consumer Protection Board will inspect retailers to ensure compliance with all recalls;
• Day care providers will be required to remove all recalled toys;
• The Department of Health will send notices to pediatricians reminding them to tell parents about the dangers of lead poisoning;
• The state will coordinate Toy Testing Days in November, which is apparently toy safety awareness month;
• 
  The Governor has also called upon the Legislature to impose civil and criminal fines against anyone who sells recalled toys after the announcement of a recall. New York's response should serve as a model to other states offended by the CPSC's negligent resistance to adequate funds or authority. It is unfortunate that the federal government must be goaded into action by states that have neither the capacity nor the mandate to uniformly protect American consumers.

  Governor Spitzer Acts To Protect New York Children From Lead-Poisoning Threat In Toys (Press Release) [New York State]
  (Photo: Getty)

Rather than contract its manufacturing out to the lowest bidder, Mattel owns the factories that assemble their toys destined for export. The integrity of the supply chain is paramount:

Elisha Chan, the director of product integrity and corporate responsibility, is charged with guarding against dangerous defects like lead-based paint. Suppliers are closely monitored, he says, and sending in fake or tainted supplies is a ticket to losing the contract with Mattel. And some vendors have, says Mr. Chan.

Professor Johnson of Dartmouth visited the Guanyao factory while it was under construction. "I was impressed that they were spending a lot more time and money building dorms," he said, comparing the factory with those of other companies. "Mattel's China partner working to build that factory could not understand why they'd be wasting this money on all these things."

Mattel says that it can control the quality of its toys better because it owns factories like this one. Before the company approves any of its new toys — some 5,000 each year — it produces small batches.

Once full-scale production begins, toys are pulled off the line periodically and supplies are tested as they come in the door.

Mattel's defeat at the hands of the Chinese Poison Train is a significant setback for our confidence in the ability of American companies to vouch for the quality of their imported goods. If Mattel isn't able to protect their goods, even with a system specifically designed to mitigate the risks of manufacturing in China, we're not sure what measures will keep the Chinese Poison Train at bay.

Toymaking in China, Mattel's Way [NYT]