Governing product safety: are government regulatory agencies doing enough to ensure that consumer products are safe? Two attorneys from Consumers Union discuss the system's weaknesses and needed improvements.

To help keep consumers safe, government agencies promulgate safety regulations, test products, recall unreasonably dangerous products, educate the public on safe use and purchase behavior, and enforce manufacturers' compliance with the law. So why do dangerous and defective products still reach the marketplace ? Are government agencies' actions inadequate to protect the public?

Consumer groups often criticize agencies' handling of safety hazards. For example, several environmental groups are suing the EPA for its handling of issues related to pressure, treated wood containing arsenic: The industry recently completed a "voluntary phaseout" of the product, but the agency did not require a recall or rehabilitation of the wood in structure that are already in parks and backyards.

In addition, a Pennsylvania couple whose son was severely brain damaged by a BB from an allegedly defective air gun is suing the Consumer Product Safety Commission (CPSC): The commission sued the manufacturer in 2001 to force a recall but--under different agency leadership--settled the suit late last year, without requiring the recall.

Are these isolated failures or symptoms of a deeper problem in the regulatory system?

The nonprofit Consumers Union (CU), the publisher of Consumer Reports, focuses on issues of product safety. Besides testing products and publicizing safety issues, the group also works with government agencies and Congress to improve standards and compliance.

"We push hard for agencies to carry out their mandate to ensure the safety of products in the marketplace, to engage in rule-making, where needed, and to set adequate standards for all kinds of consumer products, "said SALLY GREENBERG, CU's senior product safety counsel. "We try to make sure there is a balance within federal agencies, because we know the manufacturers have a lot more people, a lot more money, and are in a position to wield more power."

"The mission of Consumers Union is 'Test, Inform, Protect,'" added JANELL MAYO DUNCAN, the organization's legislative and regulatory counsel. "If there's a problem with something that we've seen or tested, we work with Congress and the safety agencies to reduce or eliminate the risk to consumers."

Greenberg works on issues related to the National Highway Traffic Safety Administration (NHTSA) and CPSC. Duncan, formerly with the FDA's Office of Chief Counsel, works with that agency. They spoke to TRIAL Associate Editor SARA HOFFMAN JURAND at CU's Washington, D.C., office.

TRIAL: Why do government standards sometimes fall short of our safety expectations? What other interests are agencies considering when they lower their standards ?

DUNCAN: Government regulators are always under pressure from industry to regulate as little as possible, and there's a dearth of consumer voices to push a consumer agenda. Manufacturers have considerable resources to lobby Congress and the agencies.

GREENBERG: Moreover, agency decisions are too often a victim of political considerations. The auto industry, for example, is a potent force at NHTSA, which is part of the Department of Transportation and answers directly to the president. You have political appointees in leadership roles at the agencies and a legendary revolving door. And then you also have people who've been working at these agencies for many years, and some are, quite simply, bureaucrats who are not comfortable with swift, decisive action. Finally, too often there are statutes that prevent agencies from taking swift action.

For example, under the CPSC's Freedom of Information Act (FOIA) provisions, the agency has to notify the manufacturer and give it time to review the FOIA request before the agency can release information to the public. There are many roadblocks to getting the safest possible regulations in place.

DUNCAN: I think it depends on the people in the agency--for instance, who is truly safety conscious and who is not. But there are policy glitches in the system that are not allowing even the bold people to do what they need to do.

GREENBERG: There certainly are many dedicated staff doing good work in safety agencies, but ultimately, decisions are made at the top. Political or "cost benefit" considerations can block needed safety oriented actions.

For example, why wouldn't the CPSC require satiety registration cards with baby" and nursery products--cribs, strollers, playpens, swings? Children's lives are at stake, and at 50 cents or so per card, that's not too high a price to pay.

The CPSC votes to reject these child product registrations. The companies said, "We can't do it, it's too expensive"; meanwhile, they keep vast stores of marketing information on their customer base. So why can't they make it easy for customers to register and, in the event of a safety hazard, let the customer know and likely save a child's lift'? TRIAL: Let's tally specifically about NHTSA. Some consumer group's question the adequacy of that agency's standards. Do you think NHTSA's standards are in fact inadequate?

GREENBERG: NHTSA's standards are inadequate in a number of areas; any honest observer can see that. Vehicles should be manufactured with a strong emphasis on safety--strong sides, strong roofs, safety in all crash testing, effective seat belts and air bags, and more stability to prevent rollover.

Why hadn't NHTSA fixed the the standard until the Ford/Firestone crisis erupted in 2002? Why don't most rollover-prone vehicles have roofs that don't collapse? Why are we just now getting to tougher side-impact standards?

CU has launched a Kids, Cars, and Safety Campaign. NHTSA officials say there aren't enough injuries for them to focus all their attention on these hazards, that they need to focus on drunk driving and scat belts.

We agree on the importance of addressing drunk driving and scat belt issues, but according to Kids and Cars, a safety group, 91 kids were backed over and killed last year because drivers couldn't see behind their cars. We think that with the right technology showing drivers what's behind them or beeping if there's something behind them, this problem is eminently fixable.

Although NHTSA has been weak in a number of areas, it has done many other good things. It implemented a rollover-resistance test, which we supported, though we're not yet happy with how that information has been presented to consumers. If a vehicle tips up and fails the test, it can still get three stars out of five. We ask, why mask its poor performance? But this program also detected that the Saturn Vue's suspension was faulty and now GM has recalled the vehicle. So stability testing has helped protect consumers from a potentially hazardous vehicle.

TRIAL: Some consumer advocates complain that even though an agency acted, it did so too slowly or didn't do enough. A good example is the EPA and pressure-treated wood. Is slow action better than no action at all, and are there ways to make agencies take more timely action?

GREENBERG: Obviously taking some action is better than doing nothing, but you have to ask, if an agency has known about a problem for 15 years, what steps has it taken to address the problem in that period?

It's the same with the CPSC and fire safety standards. The agency's history is slow action or no action. Meanwhile, children are getting burned by flammable upholstered furniture--hundreds of people die in such fires each year, and from bedding fires, et cetera. All these hazards can be addressed by strong flammability standards, but the agency has failed to adopt them. So, delay is costly in terms of lives and money, and there are people who are living with permanent burn injuries who would have been protected had the right standards been in place.

DUNCAN: Especially for a vulnerable population. We're talking about arsenic-treated wood on playgrounds. There's really no excuse for not acting as soon as possible after the risk has been identified when untold numbers of children could be involved.

TRIAL: Let's move on to the FDA. The Washington Post reported that pharmaceutical companies regularly violate a 1997 federal law requiring them to disclose clinical trials. The FDA acknowledged it had not beets enforcing the law--and in fact, the law has no enforcement mechanism and provides no penalties. How can agencies like the FDA protect consumer safety if they don't open have authority to crack down on violators?

DUNCAN: The issue is a little murky. That law had some "musts" that were turned into "mays." The drug companies are supposed to provide information to the agency's database (clinicaltrials.gov), which is mostly for patient access.

My understanding is that with preapproval, companies are required to give both the positive and negative information. But postapproval is when things don't work so well, when companies are asked to conduct follow-up safety studies and they're not doing them--and the FDA is not following up.

The products are on the market, so what is the FDA going to do? The agency is not halting sales, so the companies just continue to sell them without providing valuable information to the FDA and to consumers.

We think the agency should have clear authority to demand compliance. And then that authority needs to have teeth, some way for the agency to enforce it. It needs to he a meaningful incentive to comply: for example, "If you don't give us the clinical information, you don't get a tax break."

TRIAL: FDA Chief Counsel Dan Troy has filed amicus briefs in several pharmaceutical failure-to-warn cases, arguing that manufacturers cannot include, on a drug's label any warning that the agency has not approved. Health and Human Services General Counsel Alex Azar has said that FDA regulations are the "ceiling" as well as the "floor" of requirements for drug makers. Has the FDA become more concerned with protecting the industry than with protecting consumers?

DUNCAN: We are concerned--looking at what will be in the best interest of consumers and what we believe the agency has the authority to do--that too many decisions right now are not based on science and are probably not consistent with past policy we supported.

TRIAL: Should consumers be able to hold manufacturers to a higher safety standard than the government agencies require?

GREENBERG: Yes, they should. Companies often fall back on the excuse "Well, it meets government standards." But government standards, to the extent they exist, are a floor; they are not a ceiling. They often cover minimal safety requirements. And manufacturers know that regulations often are not as tough as they could be.

For example, with roof crush in rollover situations, just because the government hasn't upgraded the standard in decades, this doesn't mean that roofs are as strong as they need to be. Just because the government doesn't have a rollover standard doesn't mean manufacturers don't have a role to play in preventing rollovers.

If manufacturers know there are ways to make consumers safer, they ought to be held to implementing that knowledge in their product designs. They are, we are pleased to note, installing anti-rollover technology in more and more SUVs, and doing so voluntarily because the public has become keenly aware that SUVs are more rollover-prone than cars. Having anti-rollover technology in SUVs helps sell these vehicles and, by the way, safety has become one of the top considerations for car buyers, unlike 20 years ago.

DUNCAN: Let's go to clinical trials. There's too much tension between the available information on the drug's safety and the bottom line. Manufacturers deliberately suppressed information they had, that they knew was negative information, that would potentially affect the market for their product. People need to know. Doctors need to know.

TRIAL: Two congressional committees are investigating the FDA's handling" of evidence pointing to a link between selective serotonin reuptake inhibitor (SSRI) antidepressants like Prozac and Paxil and an increased risk of suicide in children. Senate Finance Committee Chair Charles Grassley (R-Iowa) says his staff discovered that the agency pressured one of its scientists to keep quiet about his support of such a link. What questions do these allegations raise about agency misconduct?

DUNCAN: In this specific instance, these allegations need to be looked into. But generally some of the agencies' internal processes need to be overhauled. There are things that rise to the level of agency misconduct, and there are things that are a problem because of the tight relationship between the companies in a closely regulated industry and the agency. The rules that are on the books are not necessarily the way the agency operates.

There should be a close look at where the consumer could be losing out. What are the laws and the regulations that people think are being followed, where are they being disregarded? Is anyone being given special treatment? Why?

TRIAL: Critics claim politics influenced the CPSC's decision not to recall Daisy BB guns. Do you think the appointment of agency directors affects how agencies regulate product safety?

GREENBERG: Sometimes, and in this case I would say it did. I'm sorry to say that it appears as if two commissioners worried too much about the manufacturer and not enough about the safety of. consumers. And that isn't the mandate of the agency. It was clear, from the CPSC's opinion and from the press afterwards, that the deciding factor was that the company had said it might go bankrupt if it had to conduct a recall, because it would be a big, costly recall.

Probably the best thing I read was from Commissioner Thomas Moore, who said that this is not the "manufacturer product protection" comission or the "manufacturer economic well-being" commission, this is the Consumer Product Safety Commission; I'm mandated to protect consumers. He added that this decision was based on a reliance on the company's arguments that it might suffer economically. We agree. We don't think that's appropriate.

DUNCAN: If a company sells a product that is unreasonably dangerous or defective, then it really should not be in business. And in this case it did look like there was a lot of tortured analysis to get to the conclusion that there was some way to handle this other than a recall.

TRIAL: What can be done to safeguard the integrity of these regulatory agencies?

GREENBERG: We need agency heads who really put consumer safety first. We have to push really hard, no matter who is in positions of power, no matter who is in the White House. And that doesn't mean they have to be hostile to business. They can take into account all kinds of considerations, including the effects on the economy and the effects on the manufacturer. But consumer safety should be their top concern--to protect consumers--because that's all that consumers really have.

DUNCAN: If you have people at the top who have the will, Congress can choose not to limit their resources for them to be effective. That's the other thing needed--full funding of these agencies so they can implement the rules and regulations that they have.

It's also about getting inside the psyche of a business. You need people who know how businesses work and understand what would be the best incentives to make companies comply. Sally, how many times have you pushed for a reform and actually gotten it, and then companies in the industry actually went out of business?

GREENBERG: I can't think of a single case.

DUNCAN: There's a lot of hype. There are so many things that companies could have done to improve their products, but they say it costs too much.

TRIAL: Recalls are generally viewed as an important part of the remedy for getting defective and dangerous products off the market. But in an August 2004 article, Consumer Reports noted that the number of recalls is up, but unsafe products are still in stores and homes in large numbers. Why? What's wrong with the recall system?

GREENBERG: It doesn't work nearly as well as it could. What you want, ideally, is to not have your product recalled, which means rigorous premarket testing. Because once a product gets into the marketplace, it is very difficult to get it back, especially from consumers.

There are some things we can do to improve recalls. The manufacturers need to make sure that their products have been properly tested for hazards--state-of-the-art testing, not having 10 employees take it home for three months, saying, "Tell us how you like it." And we need registration cards for children's products, so if you have a crib and it gets recalled, the company knows how to reach you to fix it or exchange it.

It should be a simple registration-card system, not one that asks for your household income, but just your name, address, phone number, and e-mail that will be used to contact you only if the product needs to be recalled. Basic information with the promise it will not be shared. And the card should be postage paid. The manufacturers say that will cost about 55 cents; we've seen lower and higher numbers. But the point is, if you're selling a crib for $200, you ought to have a registration card with it. It seems to me a minimal expense. But the juvenile-products and toy industries have fought simple registration cards tooth and nail.

TRIAL: What is the status of the proposed legislation that would require registration card,'? GREENBERG: Its chances are minimal in Congress. There's just no motivation, no interest in making it happen.

In the House, there have been virtually no hearings on product safety. Without a crisis such as the Ford/Firestone flap, very little attention is paid to product safety--little or no oversight hearings of the agencies, with most people in Congress not really knowing much about how they do what they do.

The chances of a manufacturer getting a recalled product back from the consumer is about 15 percent to 30 percent. The Ford/Firestone recall rate was much higher, but the crisis received an unusually large amount of publicity. In fact, to its credit, the CPSC had a series of symposia on recalls. Some companies have done some really creative things: Williams Sonoma did a recall and found people who purchased the product through records of credit card charges.

But today, the vast majority of recalled products will never come back from consumers, will never be made safer. The system functions poorly and puts consumers at risk.

TRIAL: What recourse do consumers have when government standards don't demand enough safety measures from manufacturers?

GREENBERG: If people get hurt and a product is believed to be defective or unreasonably dangerous, they sometimes turn to trial lawyers, who act as de facto regulators on a case-by-case basis.

Lawsuits serve an important regulating function, and no question corporate America fears them. If it did not, corporations wouldn't try to pass bills to limit recovery of losses and to restrict class actions or medical malpractice suits. It shouldn't be that way. It shouldn't have to come to a lawsuit. But when government doesn't step in to protect citizens, lawyers will, unfortunately after an injury or a death.

DUNCAN: People should be able to rely on the expectation that the product they are using is not going to be harmful.

TRIAL: What else can lawyers do to help consumer product safety?

GREENBERG: I'd like to see lawyers get their clients who have been injured or lost loved ones to take a more public role, if they're comfortable with that, or take a more public role themselves. It's really important for lawyers to speak out on safety issues, to influence the market beyond their cases. They need to say, "Look, certainly I have a client involved here, but I'm also concerned about my children and my family and my neighbors. They could be hurt by this product too."

It's particularly helpful in states with more conservative, business-focused members of Confess who don't hear much from the little guy injured by a product.