Under Obama, Regulatory Agencies Step Up Enforcement - washingtonpost.com

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Consumer, Workplace Agencies More Active

By Lyndsey Layton
Washington Post Staff Writer
Tuesday, October 13, 2009

The Obama administration is taking on Cheerios. And popular cold remedies and swimming pool drains and rhinestones on children's clothing.

With much of Washington focused on efforts to revamp the health-care system and address climate change, a handful of Obama appointees have been quietly exercising their power over the trappings of daily life. They are awakening a vast regulatory apparatus with authority over nearly every U.S. workplace, 15,000 consumer products, and most items found in kitchen pantries and medicine cabinets.

Top appointees at the Food and Drug Administration, for example, have cracked down on dietary supplements with "steroid-like" substances that for years had been sold in gyms and health-food stores. In a move designed as much for symbolism as effect, the new chairman of the Consumer Product Safety Commission dispatched all 100 agency inspectors across the country last month to enforce a law that requires special drains on swimming pools to prevent children from entrapment. The agency shut down more than 200 pools.

The new regulators display a passion for rules and a belief that government must protect the public from dangers lurking at home and on the job -- one more way the new White House is reworking the relationship between government and business.

"In the Bush administration, the problem was that the political folks were hostile to the mission," said Michael A. Livermore, executive director of the Institute for the Study of Regulation at New York University Law School. "We've already seen the new direction of this White House play out in other regulatory aspects -- the Environmental Protection Agency and financial regulation. With the consumer protection agencies, you're going to see a lot more stuff happening because they fit Obama's broad vision for government."

The regulators still face significant hurdles if they want to dramatically expand government's reach. Most proposed regulations have to be vetted by a central White House office headed by another new appointee, Cass R. Sunstein, whose embrace of cost-benefit analyses may mean he will discourage expensive new rules. Some efforts to expand regulation are sure to face legal challenges from industry. And the private sector is likely to assert that new regulations would be an additional burden in a weak economy.

"The argument is going to be that this is going to hurt jobs and be bad for the economy," Livermore said. "That has resonance on the Hill and within the public. . . . That's the one big challenge."

Already, some have complained that the new political leaders are overzealous.

"It's 'shoot first and ask who we shot later,' " said Gary L. Yingling, a lawyer and pharmacist who worked for a decade in the FDA general counsel's office and now represents companies regulated by the agency. "My concern is whether they've dotted their i's, crossed the t's, understand the statutory regulations and understand what the agency did yesterday. That's a real concern."

Still, waves of recalls of dangerous foods and consumer products have created pressure for stronger federal oversight. The new administration focused first on the FDA, which oversees a quarter of the U.S. economy and during George W. Bush's presidency had been faulted by consumer advocates and members of Congress for not blocking contaminated foods and drugs and faulty medical devices.

In their first few months on the job, FDA Commissioner Margaret A. Hamburg and deputy Joshua M. Sharfstein -- both with backgrounds running public health agencies -- notified General Mills that it was violating the law with its two-year-old marketing campaign that said Cheerios can lower cholesterol by 4 percent. The FDA said the company was essentially making a drug claim, which would require clinical studies and agency approval before a product is put on the market. The food giant has removed that claim from its Web site and a spokeswoman said it is in discussions with the FDA.

While the FDA began looking into Cheerios before Obama's election, several lawyers who represent food and drugmakers said they think the agency under Bush would never have taken action against General Mills.

In June, Sharfstein defied pistachio producers and told the nation to stop eating the nuts out of concern over potential salmonella contamination, even though no illnesses had been reported and just one company was involved.

That same month, the FDA warned consumers to stop using popular cold medicines, Zicam Cold Remedy nasal gel and Zicam Cold Remedy swab products, citing evidence that some consumers could lose their sense of smell. The agency had known about the problem for years but had not addressed it.

"Companies must have a realistic expectation that if they are crossing the line, they will be caught, and that if they fail to act . . . we will," Hamburg told a gathering of lawyers representing food and drugmakers in August.

For industry, the costs of stronger enforcement are significant. Matrixx Initiatives, which makes Zicam, lost about $33 million as a result of the FDA's crackdown, executives told analysts.

At the Consumer Product Safety Commission, which regulates items as varied as aquariums and wheelbarrows, the new chairman, Inez Moore Tenenbaum, said her top priority is to implement a complex new law that includes the strongest consumer protections in a generation. Among other things, the law significantly lowers the amount of lead in children's products. Trade groups that make crystal and glass rhinestones and beads for children's fashions sought an exemption; Tenenbaum and the commission have turned them down. "We are enforcing the law; that's what we do," she said.

She also directed her agency to draft a mandatory safety standard for a new off-road recreational vehicle that has a tendency to tip over and has been linked to 59 deaths. Under Tenenbaum's predecessor, the agency prompted manufacturers to offer free repairs that were supposed to improve safety. But Tenenbaum has gone further -- pushing for a mandatory standard that would force the company to redesign the vehicle. The five-member commission has to approve a mandatory standard; the last time it took similar action was 2001.

Tenenbaum's determination to enforce the law is a reversal from her predecessor, said CPSC Commissioner Nancy A. Nord, a former lobbyist for Eastman Kodak who argued against many aspects of that law.

At the Occupational Safety and Health Administration, acting head Jordan Barab has already rankled the business community by reviving a hot-button issue -- rules to protect workers from repetitive-strain injuries. The injuries affect laborers from computer keyboard operators to poultry processors and cause about 60 percent of workplace injuries, according to OSHA studies.

The business community has long argued that ergonomics standards are not based on sound science and will require the costly redesign of millions of workplaces. Furthermore, the U.S. Chamber of Commerce and others say that repetitive strain injuries are specific to workplaces and broad government standards won't work as well as voluntary programs adopted by individual businesses.

Barab led the last attempt to enact ergonomics standards while at OSHA during the Clinton administration, when the GOP-controlled Congress and Bush repealed the rules two months after they took effect.

Awaiting Senate approval is Obama's nominee for OSHA director, David Michaels, an Energy Department assistant secretary under President Bill Clinton, who could further ruffle feathers. He has become a recent target of conservative bloggers, who say he is hostile to certain industries. Michaels has called for a more aggressive OSHA, saying that illnesses and death have resulted from the agency not issuing workplace safety rules. He also has argued that tobacco, chemical and other industries have exploited scientific uncertainty to slow or kill federal regulation, even when aware their products pose health risks. Public health organizations have applauded his selection.

Barab is unapologetic about an aggressive approach. "The law says that employers are responsible for workplace safety and health," he said in June. "And there's a new sheriff in town to enforce the law."