Two stories today highlight the problems with tracking the path of contaminated food through the supply chain and how those problems impact public health.

In the first story, from Washington Post reporter Annys Shin, we learn federal officials are now backing away from their earlier claim that tomatoes are responsible for the recent outbreak of a rare strain of salmonella. The news — a significant step backwards in identifying the problem, ensuring public health, and restoring peace of mind — comes more than three weeks after the tomato scare burst into the headlines.

Shin quotes FDA food safety official David Acheson as saying, "The tomato trail is still hot. It's a question of whether other items are getting hotter."

The complexity of the supply chain — which shuffles tomatoes and other produce across state and national boundaries for processing, packaging, and distribution — makes identifying the source of the contamination nearly impossible for FDA. Combine that difficulty with the FDA's resource shortfalls and the Bush administration's rosy outlook on product safety and the situation becomes even grimmer.

Meanwhile, as Shin reports, "The outbreak has sickened 869 people in 36 states and the District of Columbia since mid-April." The latest case of illness was reported June 20, two weeks after FDA's national warning.

The other story, from Columbus Dispatch reporter Misti Crane, concerns a beef recall targeted in Ohio and Michigan. Nebraska Beef, which supplies Kroger grocery stores, announced the recall after an outbreak of E. coli. Unfortunately, Crane reports, the recall "does not give information that's likely to help you figure out if what's in your refrigerator or freezer is harmful."

So while the recall has only been linked to illnesses in Ohio thus far, its effects could be much broader:

The nearly 532,000 pounds in question might have been mixed into an undetermined number of pounds of ground beef. It is common practice in meat-grinding facilities to combine product from multiple sources.

Beef parts from Nebraska Beef went to other companies in the state and to companies in Colorado, Illinois, Michigan, New York, Pennsylvania and Texas.

In the area of food safety, it seems like history is repeating itself over and over. A public health crisis prompts a federal response; but officials soon realize they are handcuffed by lack of information and lack of resources. Consumers are left in the dark, barely placated by government promises and too ill-informed to make decisions that could help them protect themselves and their families. Eventually the problem just fades away (for those not sickened by the food in question), with lessons never learned.

According to Congress Daily reporter Anna Edney, "The Food and Drug Administration will not meet the September deadline that Congress imposed last year to have a registry up and running to help the agency track food contamination and better understand where to focus its limited resources." The deadline was set in a bill passed last September that aimed to reform FDA's drug safety regime but also contained provisions to enhance food safety.

Congress mandated creation of the registry, because FDA spent much of 2007 chasing food contamination crises instead of heading them off at the pass (spinach, peanut butter, and pet food to name a few). Lawmakers hope the registry will help prevent similar problems in the future.

The Department of Agriculture regulates meat, poultry, and eggs, and FDA regulates pretty much everything else — a big job to be certain. While USDA is required by law to inspect all meat and poultry destined for commerce, FDA-regulated foods do not require inspection before making their way onto grocery store shelves.

Because FDA is not required to inspect all the food under its jurisdiction, and because doing so would be too tall an order, the agency will use a risk-based approach. Put simply, FDA will try to figure out which foods are most susceptible to contamination and where in the supply chain contamination may occur. The agency will then use the information to target its inspection resources. Call it educated guessing.

Both Congress and FDA believe the registry is step one in the risk-based method, according to the Congress Daily article:

FDA has talked about using risk-based inspection methods because funding has not kept pace quickly enough for the agency to inspect food facilities at regular intervals. Lawmakers felt a comprehensive registry would produce data necessary to maximize a risk-based approach.

Of course, FDA will then need to use the information collected in the registry, which will be provided by both companies and local government officials, to police the food industry. Too often FDA has failed to take action on behalf of the public, even when it is aware of food safety problems.

In March, The Washington Post reported, "Since 2001, nearly half of all federal inspections of facilities that package fresh spinach revealed serious sanitary problems, but the Food and Drug Administration did not take 'meaningful' enforcement action" In April 2007, the Post reported, "In the peanut butter case, an agency report shows that FDA inspectors checked into complaints about salmonella contamination in a ConAgra Foods factory in Georgia in 2005. But when company managers refused to provide documents the inspectors requested, the inspectors left and did not follow up."

Speaking yesterday to the National Retail Federation, Nancy Nord, head of the Consumer Product Safety Commission, said a new federal standard limiting lead in children's products "might prove to be overly broad," according to BNA news service (subscription).

The limit on lead is contained in a product safety bill currently being considered by Congress. The bill would require CPSC to set a standard limiting lead in children's products to trace amounts (100 parts per million for the content and 90 parts per million for paint or coatings).

Americans need a strict federal standard on lead in children's products for two reasons. First, as we have known for decades, lead is dangerous. Children and fetuses are particularly susceptible to the effects of lead. Even at low levels, lead exposure can lead to reduced IQs, learning disabilities, or behavioral problems.

Second, American consumers have recently been facing big problems with lead contaminated products and are increasingly concerned. In 2007, CPSC announced 106 recalls of lead-contaminated children's products totaling 17,126,810 individual items — a 500 percent increase from 2006.

Considering the gravity of the situation, one would think Nord would want strong federal action — perhaps even preferring to err on the side of over-protection. Sadly, Nord, an appointee of President Bush and former lobbyist for corporate interests, does not seem interested in seeing that her agency fulfills its mission of protecting the public.

On a related note: What the heck happened to the CPSC reform bill, which includes the lead standard and other important provisions? The House bill (H.R. 4040) passed in December and the Senate bill (S. 2663) passed in early March.

Despite overwhelming support in both chambers, the conferencing process, where the differences between the two bills will be reconciled, is in its infancy. Leadership from both parties only got around to naming conferees in early May.

Democratic leaders had hoped to finalize the bill before last Christmas. But at the rate Congress is going, they'll be lucky to finish it by this Christmas. Meanwhile, CPSC continues to announce recalls of lead-contaminated children's products (here and here, for recent examples).

Yet Congressional leadership continues to leave consumers without a strong product safety regulator. Truly disappointing.

As Reg•Watch blogged last week, federal researchers have released a draft report which calls into question the safety of Bisphenol-A, a common chemical substance found in certain hard plastics and the linings of food cans.

Meanwhile, studies conducted by the Canadian government has led the country to ban the sale of baby bottles containing Bisphenol-A. A Canadian health minister said, "We believe it is our responsibility to ensure families, Canadians and our environment are not exposed to a potentially harmful chemical," according to The Washington Post.

Because of the Canadian ban and the U.S. study, retailers in both countries are beginning to pull products containing Bisphenol-A from store shelves. From the Post article:

Wal-Mart Canada began pulling all baby products containing BPA from its shelves this week, and the chain said it plans to stop selling products containing BPA in U.S. stores by next year. Playtex said it would offer free non-BPA bottles to parents and will stop using BPA in all products by year's end. Nalgene, the maker of reusable water bottles that are popular among athletes, said yesterday it would discontinue production of bottles made with the chemical and recall existing products already in its stores.

An editorial in today's New York Times condemns a policy, known as preemption, which prohibits consumers from suing manufacturers if a product harms a consumer, so long as that product is in some way regulated by the federal government. The editorial calls preemption a "perverse legal doctrine" and warns that as it "continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations."

Federal agencies are responsible for enforcing the positive law enacted by Congress. However, even when positive laws and regulations work, citizens must have an opportunity to seek legal redress if a product causes harm. Tort law provides that opportunity by allowing citizens to seek damages from the makers of those products.

A Times investigation into the birth control patch Ortho Evra proves why positive law sometimes does not work, and why tort law must be preserved:

For years, Johnson & Johnson obscured evidence that its popular Ortho Evra birth control patch delivered much more estrogen than standard birth control pills, potentially increasing the risk of blood clots and strokes, according to internal company documents.

But because the Food and Drug Administration approved the patch, the company is arguing in court that it cannot be sued by women who claim that they were injured by the product — even though its old label inaccurately described the amount of estrogen it released.

In their attempts to shirk accountability by erasing the possibility of tort claims, pharmaceutical companies and other industries have found a friend in the Bush administration. The administration has advanced a pro-preemption argument in a number of policy areas covering everything from cars to mattresses.

According to a recent paper from the Center for Progressive Reform, the administration has been fighting for preemption on two fronts. "One form has been to intervene on the side of industry in tort litigation by the filing of amicus briefs arguing that the plaintiff 's claims against the corporate defendant are preempted by the agency's regulations or its general authority over the health or safety matters at issue," the paper argues.

The Bush administration has also tried, and been largely successful, in writing regulations that expressly preempt tort law, according to the paper. Federal agencies, including the FDA and the Consumer Product Safety Commission, have inserted preemption language into the preamble of regulations.

Under Bush, agencies have been inserting the language at the last minute, after the public comment period has closed. In the case of an FDA regulation on drug labels, "FDA deprived most of the public — including state officials, Congress members, and interested individuals and citizen groups — of any chance to weigh in on the matter before the rule was finalized."

Sunday's Cleveland Plain Dealer ran an article by Stephen Koff highlighting a problem OMB Watch has been focusing on for the past few months: declining budgets and staffing levels at federal regulatory agencies.

As a result, agencies are finding it difficult to fulfill their missions, and regulatory failures like collapsing mines, recalled toys, and contaminated food dominate headlines. From the article:

The broader safety net - protecting children from dangerous toys, adults from tainted spinach and beef, factory workers from chemical dust that can sicken or explode, miners from underground passageways that collapse - has frayed, they say. The government's own records and statistics bear this out in many ways, showing shrinking agency budgets, personnel rosters that don't keep pace with inspection demands, and White House rejection of proposed safety rules.

As agency budget and staffing levels have shrunk, regulated entities have grown. In 1981, the Food Safety Inspection Service (FSIS) — the federal regulator in charge of meat, poultry, and egg products — employed about 190 workers per billion pounds of meat and poultry inspected and approved. By 2007, FSIS employed fewer than 88 workers per billion pounds, a 54 percent drop.

The Occupational Safety and Health Administration (OSHA) has also been unable to keep up with its responsibility to enforce safety regulations in the workplace. In 1980, OSHA had approximately three staff members for every 100,000 American workers. By 2006, it had only 1.5 staff members. In 1980, OSHA and state regulators conducted 1.77 inspections per 100,000 workers. By 2005, OSHA and the states conducted only 0.668 inspections per 100,000 workers — a 62 percent drop.

The resource shortfalls of the Consumer Product Safety Commission have been well-documented; but the situation appears even worse when comparing the agency's budget and staffing levels to one of the fastest-growing yet most dangerous products it regulates — all-terrain vehicles. In 1988, when CPSC began regulating ATVs after settling a lawsuit with manufacturers, the agency employed more than 36 staff members for every 100,000 four-wheel ATVs in use. By 2004, CPSC employed fewer than seven staff members for every 100,000 ATVs. Meanwhile, old regulations have expired and the Bush administration has stalled the development of new standards.

As Koff points out, the decisions by multiple presidents and congresses to shortchange federal agencies has undermined a long-standing national focus on public protection:

The result: The era of government as consumer protector, born of 1960s and '70s activism, has faded.

Find out more through OMB Watch's Bankrupting Government project.

Some investigative journalism at the Federal Times shows just how little rulemaking federal agencies have engaged in during the Bush administration:

Many regulatory agencies have submitted fewer rules during the current Bush administration's two terms than during Bill Clinton's tenure, or even during George H.W. Bush's single term.

The Food Safety and Inspection Service (FSIS), for example, submitted 91 new rules to the Office of Management and Budget during the first President Bush's term, and 83 during the Clinton administration. But during the current administration, when U.S. meat and poultry production has increased by nearly 10 percent, FSIS has proposed just 16 new rules.

And that pattern has been mirrored at other agencies. Compared with the Clinton administration, rulemaking is down more than 50 percent at the Food and Drug Administration (FDA); down 57 percent at the Environmental Protection Agency; and down almost 20 percent at the Federal Aviation Administration.

The article ties the administration's anti-regulatory attitude to a host of health and safety scandals that have dominated headlines:

Failures by [FSIS] led to the nation's largest-ever beef recall. A wave of imported "toxic toys," containing everything from lead paint to the date-rape drug, spooked consumers during the holiday season. And high-profile industrial accidents, like the explosion at a sugar plant in Georgia last month, raised questions about the Occupational Safety and Health Administration's effectiveness.

It's hard to pinpoint why agencies are submitting fewer rules to OMB, but Reg•Watch has two theories. Maybe the delay and politicization associated with the OMB review process has created a chilling effect in federal agencies. OMB's constant efforts to dismiss scientific conclusions (i.e. EPA's recent ozone standard), or the stall tactics the office uses to delay action (i.e. the rule to protect the North Atlantic right whale), may have depressed expectations that public protection standards can quickly move through the regulatory gauntlet unscathed.

Another theory is that political appointees inside federal agencies are nipping regulations in the bud. Throughout his administration, Bush has installed men and women with close ties to the industries they regulate who may not look favorably upon rules they believe would hurt corporate bottom lines. Considering the lack of transparency in most federal agencies, it would be relatively easy for one of these officials to kill a proposed regulation before the public is notified.

Maybe it's both, maybe neither, but one thing is for sure: when the book is closed on the Bush administration, there will be a lot of catching up to do and countless messes to clean up.

Wall Street Journal reporter Joseph Pereira writes today about state government efforts to limit the presence of certain substances in children's toys, particularly lead. Both the U.S. Congress and U.S. Consumer Product Safety Commission (CPSC) have been unable to quickly enact policies to respond to public concern over toy safety.

Numerous past congresses and presidents have allowed CPSC's budget and staffing levels to whither. As a result, the agency is unable to handle the rising tide of imported products on our store shelves. In the light of last year's record number of toy recalls and growing public concern, state legislatures and administrations have grown impatient:

Many state lawmakers are upset that Congress and federal regulators haven't done more since the recalls. "If the federal government would do something I would gladly defer to them, but they aren't, so we have to," says Illinois Rep. Elaine Nekritz…

The article breaks down toy standards in a handful of states that have chosen to pursue legislation or regulation stricter than federal requirements. Two notable substances which have become the target of regulation are lead and phthalates, a chemical used to soften plastics which studies have associated with developmental abnormalities.

Because of the differences among state standards, industry lobbyists are now complaining about the multiple requirements toy makers will have to meet. In the article, Carter Keithley, the president of the Toy Industry Association (TIA), the national lobbying arm for toy makers, says, "Having different standards for different states is just going to create complete chaos." The article also reports, "The TIA says it has hired lobbyists to battle legislative proposals in 10 states."

However, regardless of states' efforts, toy makers will find it harder and harder to sell their products to major retailers if those products contain phthalates or more than trace amounts of lead. Toys "R" Us has announced it will enforce a standard for lead in toys sold at its stores that will be stronger than the federal standard. The retailer has also announced it will phase out phthalates in its products by the end of the year. Target Corp. told The Wall Street Journal it will eliminate the use of phthalates in Target brand toys.

The TIA supports bills in both the U.S. House and Senate that would tighten the federal standard for lead and provide more resources for CPSC. TIA does not support standards for phthalates, claiming there is "no solid, scientific evidence that any person has ever been harmed by the presence of phthalates in toys." (Click here for TIA statements.)

Ultimately, getting lead, phthalates, and other harmful substances out of toys will be a great victory for consumers. But we should also take note as to who guided us on that path to victory. Instead of the federal government leading the way, strong action by concerned states and responsible retailers has relegated Congress and CPSC to mere followers.

Yesterday, the Senate passed in a 79-13 vote (roll call) legislation (S. 2663) to provide more funding and more authority to the Consumer Product Safety Commission. The bill will now need to be reconciled with a House version (H.R. 4040) passed in December.

The bill takes positive steps on several issues Reg•Watch has been blogging about:

Budget and Staff
The Senate bill would infuse the agency with much-needed resources, assuming future congresses appropriate the levels of funding outlined. The bill would nearly double the agency's budget to $156 million by FY 2015. The House bill would bring funding levels to $100 million by FY 2011. (See Graph below for inflation-adjusted forecast.) The Senate bill would also require the agency to employ a staff of at least 500 by the beginning of FY 2014.

Click to enlarge

Quorum
The Senate bill would allow CPSC to have a quorum and conduct formal business with only two commissioners for 9 months. The provision is necessary because CPSC's voting quorum has expired as a result of President Bush's refusal to nominate a suitable third commissioner. One of CPSC's three commissioners resigned in 2006. Under the Consumer Product Safety Act, CPSC can continue to conduct formal business with two commissioners for six months. That quorum expired in January 2007, but in August Congress passed legislation extending the quorum another six months. On Feb. 4, the quorum expired again. The House bill would also extend the quorum. Both bills would restore CPSC to a five-member commission.

Lead
Both bills would require CPSC to set tighter standards for lead in children's toys. The bills would call for a standard of 100 parts per million for the content of toys and 90 parts per million for paint or coatings on toys. In 2007, CPSC announced 106 recalls of lead-contaminated products totaling 17,126,810 individual items — a 500 percent increase from 2006.

Industry-funded travel
The Senate bill would ban industry-funded travel for CPSC commissioners. In November, a Washington Post investigation revealed Nord and former Chair Hal Stratton have taken nearly 30 trips financed by some industries that CPSC is responsible for regulating. According to the investigation, "The airfares, hotels and meals totaled nearly $60,000, and the destinations included China, Spain, San Francisco, New Orleans and a golf resort on Hilton Head Island, S.C."

The bill would also protect employees who blow the whistle on dangerous products, and enhance the ability of state attorneys general to enforce product safety laws and regulations when the feds drop the ball. Both of those provisions survived debate on the bill despite significant partisan wrangling.

The federal regulator of meat, poultry, and egg products, the Food Safety and Inspection Service (FSIS), faces resource limitations that make it more difficult for the agency to ensure the safety of the food supply. Although the agency's budget has risen since it was created, staffing levels have dropped steadily, according to a new article by OMB Watch. Widespread vacancies in the agency have spread FSIS's inspection force too thin. Meanwhile, the number of meat, poultry, and egg product recalls has risen, and a recent recall of 143 million pounds of beef is the largest in the nation's history.

Click here for more

Posted by Matt Madia, 01:38:31 PM

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