Expect that we are talking about the FDA here. A government entity.
Back in college o worked for the Army Corps of Engineers on a dam project in Puerto Rico. The project was being held up by results from freeze-thaw tests on the concrete.
Did I mention the dam is on Puerto Rico?
So I asked the obviously question. “Because it’s in the specs” was the answer.
I decided the and there not to work for the government after graduation, and eventually walked away from engineering.

I gotta believe the FDA is occupied by the same sort of minions.