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Office of Management and Budget
News Release



OMB Encourages Lifesaving Actions by Regulators

Washington, DC, September 18, 2001 -- The Office of Management and Budget today sent "prompt letters" to the Department of Health and Human Services and the Occupational Safety and Health Administration asking them to give greater priority to two lifesaving issues. One letter urges acceleration of an ongoing rulemaking concerning the labeling of trans fatty acid content in foods while the other promotes use of automated external defibrillators (AEDs) in the workplace. These actions represent the first time that OMB, through its Office of Information and Regulatory Affairs (OIRA), has publicly used its analytic resources to encourage new regulatory actions as opposed to reviewing decisions initiated by agencies.


The prompt letter is a new tool created by OIRA’s Administrator, John D. Graham, to highlight issues that may warrant the attention of regulators. At his confirmation hearing this past spring, Dr. Graham pledged to use OMB’s analytic resources to influence the priorities of regulatory agencies. These prompt letters are not meant to have legal authority but rather are designed to bring issues to the attention of agencies in a transparent manner that permits public scrutiny and debate.


"In addition to OIRA’s traditional role of providing regulatory oversight, we’re going to work more closely with the agencies at the beginning and throughout the rulemaking process. OMB Director Mitch Daniels and I believe that these and future prompt letters will be an important means of drawing agency and public attention to important issues that warrant consideration and action," said Dr. Graham.


Summary of Prompt Letters

Trans Fatty Acid Rule: In his prompt letter, Dr. Graham noted that there is a growing body of scientific evidence suggesting that consumption of trans fatty acids in foods increases the consumer’s risk of developing coronary heart disease (CHD). In November 1999, the Food and Drug Administration proposed a rule that would, among other things, require the amount of trans fatty acids present in foods to be included in the product’s Nutrition Facts panel. The FDA’s preliminary Regulatory Impact Analysis estimated that, 10 years after the effective date, the rule would prevent 7,600 to 17,100 cases of CHD and avert 2,500 to 5,600 deaths per year. Over a 20-year period, the FDA estimated the benefits of the proposed rule would range from $25 billion to $59 billion, while the costs would be $400 million to $850 million.

In his letter, Dr. Graham concluded, "We understand that FDA is in the process of drafting a final rule in response to comments received. If the regulatory impact analysis still suggests that the potential benefits of this rule far exceed the costs, then I strongly encourage you to finalize this rule or explain the rationale for not moving forward."


Automated External Defibrillators: In his prompt letter, Dr. Graham said that automated external defibrillators are a promising lifesaving technology, and when used promptly and properly can increase the rate of survival after cardiac arrest. Recent studies show that when AEDs are used on people who have sudden and unexpected cardiac arrest outside of hospitals they have a resuscitation success rate of between 17 percent and 38 percent, compared to a 2 percent to 5 percent resuscitation rate when AEDs are not available. Dr. Graham noted that some preliminary cost-effectiveness calculations conducted by OIRA staff indicated that AEDs in the workplace might prove to be very cost-effective.

In his letter, Dr. Graham concluded, "In requesting that OSHA consider making AEDs a priority, I understand that OSHA faces limited resources, legislative constraints, and numerous areas where steps can be taken to enhance the health and safety of workers. At this stage, I am simply asking OSHA to consider whether this matter should be a priority."


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