Page:Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration (N.D. Texas 2023).pdf/20

 to proceed where an agency has — either explicitly or implicitly — undertaken to reexamine its former choice.”) (internal marks omitted); CTIA-Wireless Ass’n v. F.C.C., 466 F.3d 105, 112 (D.C. Cir. 2006) (agency “reconsidered” policy by reaffirming policy and offering “two new justifications” not found in prior orders).

In the rulemaking context, courts have identified four non-exhaustive factors to apply the doctrine where the agency: (1) proposed to make some change in the rules or policies; (2) called for comment on new or changed provisions, but at the same time; (3) explained the unchanged, republished portions; and (4) responded to at least one comment aimed at the previously decided issue. Tripoli Rocketry Ass’n, Inc. v. U.S. Bureau of Alcohol, Tobacco & Firearms, No. 00CV0273(RBW), 2002 WL 33253171, at *6 (D.D.C. June 24, 2002) (internal marks omitted). But a court “cannot stop there” — it “must look to the entire context of the rulemaking including all relevant proposals and reactions of the agency to determine whether an issue was in fact reopened.” ''Pub. Citizen'', 901 F.2d at 150. For example, an agency can reopen a prior action if it removes restrictions or safeguards related to the first action or affects a “sea change” in the regulatory scheme. See Sierra Club v. EPA, 551 F.3d 1019, 1025 (D.C. Cir. 2008); Nat’l Biodiesel, 843 F.3d at 1017 (declining to apply doctrine when “the basic regulatory scheme remain[ed] unchanged”); ''Pub. Citizen'', 901 F.2d at 152 (agency reopens decision when it reiterates a policy in such a way as to render the policy “subject to renewed challenge on any substantive grounds”).

In the adjudication context, an agency need not solicit or respond to comments to reopen a decision because adjudication does not require notice and comment procedures. See 5 U.S.C. §§ 553(c), 554. The reopening doctrine has been applied in the adjudication context where an agency undertakes a “serious, substantive reconsideration” of “a prior administrative decision.” Chenault v. McHugh, 968 F. Supp. 2d 268, 275 (D.D.C. 2013); see also Battle v. Sec’y U.S. Dep’t