Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (5th Cir. Aug. 16, 2023).pdf/72

 ‘significantly alters the stakes of judicial review’ as the result of a change that ‘could have not been reasonably anticipated,’” id. at 1266 (quoting Sierra Club v. EPA, 551 F.3d 1019, 1025 (D.C. Cir. 2008)).

This second type of reopening is called “constructive reopening.” Id. I would hold that constructive reopening applies here, rendering Plaintiffs’ challenge to the 2000 approval timely.

“A constructive reopening occurs if the revision of … regulations ‘significantly alters the stakes of judicial review.’” Sierra Club, 551 F.3d at 1025 (quoting Kennecott Utah Copper Corp. v. Dep’t of the Interior, 88 F.3d 1191, 1227 (D.C. Cir. 1996)). The paradigmatic example of this is when the agency unexpectedly removes “necessary safeguards,” thus giving “new significance” to the original action. Id. at 1025–26.

In Sierra Club, the EPA’s initial 1994 rule exempted pollutant-emitting plants from emission limits when the plants were starting up, shutting down, or malfunctioning. See id. at 1022. To be eligible for the exemption, a plant had to show it was doing its “reasonable best” to stay under the emission limits. Id.

But in the early 2000s, new EPA rules removed this “reasonable best” requirement. To qualify for the exemption, plants no longer had to show they were doing their best to limit emissions. See id. at 1023. This elimination of safeguards “significantly altered the stakes of judicial review” for the environmental plaintiffs, thereby triggering reopening. Id. at 1025 (cleaned up).

The same is true here. Just as the EPA initially authorized emissions under certain safeguards to minimize harm, the FDA initially authorized mifepristone under certain safeguards to minimize harm. Remove these safeguards, and you’ve significantly altered the stakes of judicial review. The