Bush Order Limits Agencies' 'Guidance'

By Cindy Skrzycki
Tuesday, January 30, 2007

On Jan. 18, when the headlines in the United States focused on the war in Iraq, the new Democratic Congress and actress Lindsay Lohan's alcohol problem, the Bush administration rewrote the book on federal regulation.

President Bush issued an executive order curbing the power of agencies to regulate industry through "guidance" -- informal advice that falls short of official rules yet can still cost companies millions of dollars to comply with. The order, which also calls on agencies to project the cost of new rules, among other demands, gives the White House more power to review how they write standards to regulate corporate behavior.

The amendments are "the most serious attempts by the executive branch to control the regulation mills of the hundreds of federal agencies," said William Kovacs, vice president of environment, technology and regulatory affairs at the U.S. Chamber of Commerce, the nation's largest business lobby.

The story behind those changes illustrates how important the competing sides consider rule writing. Even subtle word changes can have significant effects on what the chemical, oil, homebuilding, pharmaceutical and other highly regulated industries must spend.

"It's another thumb on the scale," said Sally Katzen, who headed the Office of Information and Regulatory Affairs, the top regulatory job, in the White House Office of Management and Budget during the Clinton administration. "There will be more boxes to check, more I's to dot, more T's to cross and more analysis."

Federal agencies issue guidance to interpret key policy and technical questions, often at the request of industry. The Labor Department's Occupational Safety and Health Administration, for example, issued 574 guidance documents between 2001 and 2005, many directed at the construction industry.

Though the guidance isn't legally binding, companies pay close attention to it. More than 30 individuals and groups, including those representing funeral directors and ornithologists, filed comments about "good guidance practices" for a bulletin issued with the executive order.

Some, such as the American Chemistry Council based in Arlington, said it was "frequently beneficial" for agencies to have the flexibility to issue guidance without a formal rule-writing process. Still, the council and most others who filed comments backed the plan to rein in the practice because of concern that guidance at times amounted to back-door rule writing.

Guidance should be subject to oversight by the OMB and public notice and comment, they argued.

General Electric, the world's second-largest company by market value, said the Environmental Protection Agency issued guidance on how to clean up toxic chemicals, which a court ruled in 2002 was actually a "legislative rule." The Fairfield, Conn., company recommended that agencies be required to maintain a list of all guidance documents on their Web sites.

Sanofi-Aventis, France's largest drugmaker, said guidance documents "can have significant impact on our business as well as on the ultimate lives of our customers -- patients."

The Paris company, whose U.S. headquarters is in Bridgewater, N.J., recapped an experience in which the Centers for Medicare and Medicaid Services switched its payment policy on four drugs last year, after the final rule had been approved.

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