Last night, the House of Representatives gave its final approval to a bill to give more resources and authority to the Consumer Product Safety Commission (CPSC). House members approved a package, negotiated among House and Senate leaders earlier this week, by a vote of 424-1.

The overwhelming bipartisan support for this bill is a sign of how serious a concern product safety has become for consumers and policy makers. Last year's record number of recalls, many of which were for lead-contaminated toys, spotlighted the gaps in the nation's consumer product safety net and the inadequacies of the CPSC.

The bill would address many problems by providing CPSC with more money and staff, mandating a ban on lead in children's products, mandating standards for all-terrain vehicle safety, expanding protections for whistleblowers, creating a consumer complaint data base, and much more. One provision would ban phthalates pending further study, a revolutionary concept for the regulation of toxic substances (more on that here).

The Senate may vote on the bill as early as today. It is imperative that the Senate finish its work on this bill before it leaves for a lengthy recess. If the Senate does not act by tomorrow, consumers will have to wait until after Labor Day to see this legislation passed.

President Bush has expressed opposition to some provisions in the bill but has not threatened a veto. Bush should signal his support for the measure as soon as possible so that we can end the legislative debate and begin taking action to protect consumers.

Stay tuned to Reg•Watch for updates.

After a protracted House/Senate negotiating period, Democratic and Republican leaders came to an agreement on several controversial provisions in a bill to improve consumer product safety. Early reports indicate that negotiators came down on the side of public health on most or all of the issues that had proved difficult to hash out. CQ.com reports:

While the final provisions have not been released, advocates and lobbyists say there will be language to protect whistleblowers, make toy safety standards mandatory, regulate manufacturing of all-terrain vehicles and give state attorneys general certain decision-making powers….

One of the most controversial provisions in the Senate's bill, a restriction on phthalates — a plastic softener some believe can damage reproductive development — made it into the agreement in modified form.

According to House aides, the deal would ban three of the six suspect phthalates outright, for all children's toys. The other three phthalates would be banned temporarily in products that could be put into a child's mouth, pending further study and rulemaking.

The news on phthalates — that a ban would be enacted pending further study and would only end if the substances' safety is proven — is a radical departure from the way the federal government generally regulates chemicals. Usually, chemicals are released into the market and used without restriction. If initial toxicity studies show a potential health risk exists, researchers inside federal agencies may take a more in-depth look. If research shows a health risk exists (and overcome the often-specious claims from the anti-government crowd that more certainty is needed), all that's left is navigating the labyrinth of rulemaking requirements agencies must go through before an exposure standard or ban can take effect.

The safety-first approach embodied in Congress's phthalate ban would protect public health in the interim without condemning the substances to an eternal regulatory graveyard. The interim ban shifts the burden of proof onto phthalate manufacturers and users. If the safety of phthalates is proven, they're back on the market.

Congress's action on phthalates is a refreshing take on public health. As consumers, we are exposed to scads of chemicals every day. For many of these chemicals, some studies indicate a risk to public health, but more research is needed before we can paint an accurate portrait of how much of the substances we're exposed to and what they do in the human body.

The presumption that chemicals should be safe would reduce consumer exposure. It would also have the added bonus of creating a market incentive for quick, accurate completion of toxicity studies. Moreover, accurate, transparent scientific findings would provide consumers with a tool for making buying decisions they believe to be in their best interest. Sounds pretty logical, doesn't it?

Yesterday, Reg•Watch asked the question, "Will Congress Wrap Up Consumer Safety Bill?" The answer turned out to be "no," as lawmakers' talks stalled during a meeting intended to finalize a version of a bill to reform the Consumer Product Safety Commission.

Lawmakers did agree to set up a publicly searchable consumer product complaint database which was one of the controversial provisions that needed to be worked out.

Other sticking points remain, including a ban on phthalates, extended protections for whistleblowers, and federal preemption of state law. The House and Senate conference committee members hope to meet again next week to hash out the remaining differences.

In a few minutes, members of the House and Senate are set to meet to work on sorting out differences between their respective versions of consumer product safety legislation. Both versions of the bill would expand the budget and authority of the beleaguered Consumer Product Safety Commission, but other provisions have proved contentious.

Congress Daily (subscription) reports:

The House passed its CPSC reauthorization in December and the Senate approved its version in March. Conferees first met last month, when they agreed on 21 items. They left the more troublesome measures for today.

Among them, a ban on phthalates in children's products, which is included in the Senate version but not the House's. Studies have shown phthalate exposure to cause developmental abnormalities, particularly in fetuses and infants. The European Union and the state of California have already announced restrictions on phthalates.

The creation of a publicly accessible consumer complaint database, another Senate invention, has also stoked debate. Critics of the database say it would be too expensive, according to Congress Daily. The Senate version also includes protection for whistleblowers who report dangerous products from their perches at private firms. (Read more on the whistleblower issue here.)

Both bills include a provision that would preclude CPSC from establishing rules that preempt state and local law — an issue that has angered industry trade groups. The Bush administration has a penchant for including language in federal rules saying that if a product maker complies with federal regulation, the product maker is not liable under state common law. This legal doctrine, known as preemption, prevents consumers from seeking damages, or tort, claims after being injured by a product. Hopefully, the provision in the CPSC bill will survive the House/Senate conference.

CPSC is in dire need of reform after more than a year of product safety debacles. In 2007, CPSC was in the news for all the wrong reasons. Recalls of lead-contaminated children's products reached all-time highs. A long-term vacancy in the commission left it without a quorum, preventing it from conducting official business. President Bush nominated a product industry lobbyist to fill the vacancy, but the conflict of interest of a lobbyist regulating his former cronies was too much for Congress and the public to swallow, and the nomination was pulled. Finally, the acting commissioner, Nancy Nord, was caught taking lavish trips funded by the consumer product industry.

Mostly due to the outrage over lead in toys, Congress had hoped to finalize the legislation by Christmas 2007. After that convenient PR deadline passed, Democratic leadership let the bill slide down its list of priorities. Four months after passage of the Senate version, a conference of House and Senate leaders is only now working out the controversial aspects of the bill.

Reg•Watch Update: "On Consumer Product Bill, More Work Remains"

The New York Times has an article this morning further underscoring the problems the FDA has tracking the sources of food-borne illness outbreaks. The toll of the current salmonella outbreak has exceeded 1,000 victims "in what officials said Wednesday was the largest food-borne outbreak in the last decade."

Initially, tomatoes were thought to be the culprit of the outbreak. FDA then said it was expanding its search to other types of produce but emphasized tomatoes were still the lead suspect. But according to the article, "Federal investigators have now linked at least some of the outbreak to fresh jalapenos."

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 this or any other food-borne illness outbreak a major challenge for FDA. A retailer may buy produce from multiple distributors, each of which likely collects a variety of goods from multiple growers.

However, critics say the FDA itself is at least partially to blame. According to two consumer groups, Center for Science in the Public Interest and the Consumer Federation of America, FDA does not have the necessary safeguards in place to prevent and track food-borne illnesses. Those groups say, "Source traceability for produce, written food safety plans for farmers, processors, and packinghouses, and tighter controls on repacking" are necessary but lacking, despite repeated pleas from food safety advocates.

In the case of the salmonella outbreak, more than a month after the first nationwide warning FDA has been unable to tell consumers what type of produce to watch out for, and it isn't even sure whether the source is foreign or domestic.

Despite the worsening public health crisis and the growing embarrassment for FDA, the agency won't be changing its tune on food tracking. According to the Times article, "Dr. David Acheson, the agency's associate commissioner for foods, said in a telephone interview on Monday that the F.D.A. lacked authority to require full trace-back capability, adding, 'It's the industry's responsibility to put that kind of system in place, not ours.' "

Acheson was promoted at FDA last year to lead its food safety efforts. He started with a "commitment to making the wobbly global food-safety system work better," according to The Washington Post.

But based on his comment that FDA is not responsible for food tracking, Acheson clearly fits in well with the Bush administration's hands-off approach to regulating which leaves consumers fending for themselves. Acheson seems determined to make sure FDA repeats its failures.

The Times article also addresses the issue of whether FDA has the authority to track food through the supply chain:

But Dr. David A. Kessler, the F.D.A. commissioner in the Clinton and first Bush administrations, said the agency has the authority to require the industry to trace produce as it travels from "farm to table," but has lacked "the impetus" to do so.

"The technology exists to trace the entire chain of a food product," Dr. Kessler said. "The agency needs to require the industry to put into effect mechanisms to do full trace-back. That regulation could be put in place in months, not years."

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.