of Management and Budget
Encourages Lifesaving Actions by Regulators
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 OIRAs 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 OMBs 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 OIRAs traditional role of providing regulatory oversight,
were 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
of Prompt Letters
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
consumers 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 products
Nutrition Facts panel. The FDAs 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
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."