Transforming the Rules on Federal RegulationsAuthor(s): NOREEN PARKSSource: BioScience, Vol. 57, No. 4 (April 2007), p. 322Published by: Oxford University Press on behalf of the American Institute of Biological SciencesStable URL: http://www.jstor.org/stable/10.1641/B570405 .

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In mid-January, as national attentionfocused on congressional reorganiza-

tion and the never-ending controversiessurrounding the Iraq war, the WhiteHouse rewrote key chapters of the bookon federal regulations. In one fellswoop, Executive Order 13422 madeeconomic criteria the primary basis forregulation, placed fresh restrictions onagencies, amplified the role of theWhite House Office of Managementand Budget (OMB), and extended thealready protracted process of rule-making. US Chamber of Commercespokesman William Kovacs hailed themoves as the “first truly significant attempt...to hold federal bureaucrats toaccount and insist they act with discre-tion when imposing new and expensiveburdens on businesses and consumers.”But government watchdogs contendthat the new order further politicizesthe regulatory system, subverts agen-cies’ abilities to fulfill their legal man-dates, and erodes Congress’s role insetting regulatory standards.

In brief, four important changeswere enacted, affecting the federalagencies responsible for public health,safety, and environmental regulation.First, agencies must justify proposednew regulations to OMB’s Office ofInformation and Regulatory Affairs(OIRA) by identifying and assessing thespecific “market failure” or other prob-lem that needs fixing. Second, withineach agency, a presidential appointeewill serve as regulatory policy officer,with broad control over rulemaking.Third, agencies must estimate the cu-mulative annual costs of compliance for rules they expect to publish over abudget year. And fourth, OIRA now willreview not only formal rules but also“significant” guidance documents,agency missives that clarify regulations.

The House Science and TechnologyCommittee held oversight hearings onthe executive order in February. Amongthose testifying was Sally Katzen, OIRA

administrator under former PresidentClinton. Katzen argued that the admin-istration had offered no explanation ofthe problems that prompted the neworder. Furthermore, the order followsother recent controversial White Housedirectives concerning informationquality, peer review standards for regu-latory science, risk assessments, andguidance practices. Together, Katzen asserted, these measures represent “asteady and unwavering effort to consol-idate authority in OMB and further re-strict agency autonomy and discretion.”

The most recent executive orderstates that “no rulemaking shall com-mence nor be included” for considera-tion without the approval of anagency’s regulatory policy officer, unlessspecifically authorized by the agencyhead. This means that presidential ap-pointees could quash efforts such asnew US Food and Drug Administrationrules for the use of nanotechnology inmedical devices, for example, or FCC(Federal Communications Commis-sion) requirements that lights at feder-ally licensed communications towers bechanged to make the towers less deadlyto migratory birds—before the publiceven learns that such regulations are being considered. “At any point in theprocess, the regulatory policy officerwill be able to intervene,” said Rick Mel-berth of OMB Watch, a Washington,DC–based nonprofit organization.

David Vladeck, of Georgetown Uni-versity School of Law and a member ofthe OMB Watch board of directors, de-cried the apparent sea change in regula-tory philosophy signaled by the marketfailure “super-mandate.” It “appearsnowhere in statute,” he testified, “and itcannot be reconciled with the domi-nant thrust of the health and safetystatutes, which are designed to preventdeaths and injuries by avoiding marketfailure, rather than waiting until it is toolate and market failure is evident.”

In his comments to the committee,the Chamber of Commerce’s Kovacsstated that agencies issue some 4000new regulations annually, as well asthousands of guidance documents.More than 110,000 regulations cur-rently exist, he said, with compliancecosts estimated to be as high as $1.13trillion (a figure disputed by Katzen).Kovacs lauded the expansion of WhiteHouse scrutiny of guidance documents,which have been used to accomplish“backdoor regulation,” he said.

“There’s a grain of truth to this,”Melberth conceded, as agencies arelooking for faster ways of doing theirjob. But Congress specifically exemptedguidance documents from the externalappraisals required for formal rules, hesaid, adding that saddling the systemwith additional layers of review—including scientific and technical re-view—that substitute OMB for agencyexpertise only delays actions requiredby law.

Likewise, Vladeck and others ex-pressed wariness over the new require-ment that agencies aggregate the annualcompliance costs of new rules, sayingthat doing so would open the door forOIRA to cap the compliance costs agen-cies may impose. “Nothing in thestatutes Congress has enacted givesOIRA the right to ration protections...through regulation,” Vladeck testified.

A Congressional Research Service re-port published 5 February character-ized the executive order as a “clearexpansion of presidential authorityover rulemaking” that meshes with theadministration’s view of the “unitaryexecutive.” It concluded that the ulti-mate impacts will depend on how thechanges are implemented.

Noreen Parks (e-mail: nmparks@pixi.com) is afreelance science and environmental writer based

in Hawaii.

doi:10.1641/B570405Include this information when citing this material.

Transforming the Rules on Federal RegulationsNOREEN PARKS

Washington Watch

322 BioScience • April 2007 / Vol. 57 No. 4 www.biosciencemag.org

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