Politics, Policy & Law

Trump administration considering 10-year sunset for all rules

If enacted, proposal could have devastating effect on FDA, which issues large numbers of regulations

If enacted, the proposal could have a devastating effect on FDA, which issues large numbers of regulations.

The Trump administration has drafted a proposal that would make many government regulations automatically expire after 10 years unless government agencies undertook a formal process to renew them. The proposal is raising alarms at FDA and other government agencies.

The proposed rule has been circulated within federal agencies but has not been publicly released.  

If it goes into effect, the proposal could have a devastating effect on agencies such as FDA that issue large numbers of regulations. It is likely to be strongly opposed by industries that rely on the certainty provided by regulations.

Staff at agencies such as FDA would be forced to spend large amounts of time and resources researching existing regulations to determine if they fall under the shadow of the proposed rule, and for those that do, more time would be required to evaluate and document justifications for renewing or allowing them to expire.

The process would give the White House power to reconsider and potentially modify or block regulations promulgated by previous administrations.

Regulated industries would not be certain that rules would apply for longer than a decade.

According to a section of the proposed rule obtained by BioCentury, the idea is to make all regulations that impose a “significant economic impact upon a substantial number of small entities” subject to review every 10 years.

Government agencies would be required to assess all of their regulations every 10 years to determine if they create significant economic impacts on small entities. If such assessments were not performed, the regulations would automatically expire.

With a few exceptions, the proposed rule states that all regulations should be assessed and reviewed. “Assessments and Reviews should not be performed only on those Regulations issued after this proposed rule goes into effect. After all, it is likely that some Regulations promulgated decades ago may have become outdated.”

The proposal defines the start of the sunset period as “the calendar year the Regulation first became effective, irrespective of whether it was subsequently amended.” The definition is intended to prevent government agencies from restarting the clock by amending regulations.

It is far from certain that the proposal will be made public or that it could be put into effect. If it is, regulations in place at the time the proposed rule goes into effect, an agency would have two years from the rule’s effective date, or 10 years from the date of the regulation’s promulgation, whichever is later, to conduct the assessment. 

Regardless of the proposal’s fate, the Trump administration is likely to attempt additional de-regulatory measures in the coming weeks.