All. for Bio-Integrity v. Shalala - 116 F. Supp. 2d 166 (D.D.C. 2000)

Rule:

Policy statements must not impose any new rights or obligations, and must genuinely leave an agency and its decision-makers free to exercise discretion. In weighing these criteria, the ultimate issue is the agency's intent to be bound. An agency's own characterization of its statement deserves some weight, but it is not dispositive. Rather, courts will look to the actual language of the statement. 

Facts:

On May 29, 1992, the FDA published a "Statement of Policy: Foods Derived From New Plant Varieties" (Statement of Policy).  In the Statement of Policy, FDA announced that the agency would presume that foods produced through the rDNA process were "generally recognized as safe" (GRAS) under the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 321(s), and therefore not subject to regulation as food additives. While FDA recommended that food producers consult with it before marketing rDNA-produced foods, the agency did not mandate such consultation. In addition, FDA reserved the right to regulate any particular rDNA-developed food that FDA believed was unsafe on a case-by-case basis, just as FDA would regulate unsafe foods produced through conventional means. The Statement of Policy also indicated that rDNA modification was not a "material fact" under the FDCA, 21 U.S.C. § 321(n), and that therefore labeling of rDNA-produced foods was not necessarily required. FDA did not engage in a formal notice-and-comment process on the Statement of Policy, nor did it prepare an Environmental Impact Statement or Environmental Assessment. At least thirty-six foods, genetically altered through rDNA technology, have been marketed since the Statement of Policy was issued.  Plaintiffs filed a Complaint in this Court challenging the FDA's policy on six different grounds: (1) the Statement was not properly subjected to notice-and-comment procedures; (2) the FDA did not comply with the National Environmental Protection Act (NEPA) by compiling an Environmental Assessment or Environmental Impact Statement; (3) the FDA's presumption that rDNA-developed foods are GRAS and therefore do not require food additive petitions under 21 U.S.C. § 321(s) is arbitrary and capricious; (4) the FDA's decision not to require labeling for rDNA-developed foods is arbitrary and capricious; (5) the FDA's decision not to regulate or require labeling for rDNA-developed foods violates the Free Exercise Clause; and (6) the FDA's decision not to regulate or require labeling for rDNA-developed foods violates the Religious Freedom Restoration Act. Plaintiffs have also challenged on the third and fourth grounds each of FDA's specific decisions not to regulate 36 individual rDNA-produced products. The parties have filed cross-motions for summary judgment on all of Plaintiff's claims.

Issue:

Did the 1992 Policy Statement violate the Administrative Procedures Act, the National Environmental Policy Act, or the procedures mandated by the FDCA and FDA regulations?

Answer:

No.

Conclusion:

The court agreed that the policy statement was properly a matter of agency discretion, and was entitled to substantial deference from the court. The court distinguished the policy statement from formal rulemaking that would undergo a notice-and-comment procedure and could impose new rights or obligations. Policy statements must not impose any new rights or obligations, and must genuinely leave an agency and its decision-makers free to exercise discretion. In weighing these criteria, the ultimate issue is the agency's intent to be bound. An agency's own characterization of its statement deserves some weight, but it is not dispositive. Rather, courts will look to the actual language of the statement. The court found that no environmental impact statement was required, no food additive was involved, and no religious practice was impinged by the policy statement, and granted summary judgment for government defendants.