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ALLIANCE FOR BIO-INTEGRITY v. SHALALA

September 29, 2000

ALLIANCE FOR BIO-INTEGRITY, ET AL., PLAINTIFFS,
V.
DONNA SHALALA, ET AL., DEFENDANTS.



The opinion of the court was delivered by: Kollar-kotelly, District Judge.

MEMORANDUM OPINION

Technological advances have dramatically increased our ability to manipulate our environment, including the foods we consume. One of these advances, recombinant deoxyribonucleic acid (rDNA) technology, has enabled scientists to alter the genetic composition of organisms by mixing genes on the cellular and molecular level in order to create new breeds of plants for human and animal consumption. See Pls.' Statement of Material Facts Not in Dispute ¶¶ 1-3 ["Pls.' Stmt."]; Defs.' Statement of Material Facts Not in Dispute ¶¶ 6-7 ["Defs.' Stmt."]. These new breeds may be designed to repel pests, retain their freshness for a longer period of time, or contain more intense flavor and/or nutritional value. See Pls.' Stmt. ¶¶ 5-6; Defs.' Stmt. ¶ 8. Much controversy has attended such developments in bio-technology, and in particular the production, sale, and trade of genetically modified organisms and foods. The above-captioned lawsuit represents one articulation of this controversy.

Among Plaintiffs, some fear that these new breeds of genetically modified food could contain unexpected toxins or allergens, and others believe that their religion forbids consumption of foods produced through rDNA technology. See Pls.' Cross Mot. for Summ.J. ["Pls.' Mot. Summ.J."], Ex. 2 (Fagan Aff.); Ex. 3 (Lacey Aff.); Ex. 4 (Regal Aff.); Ex. 5 (Speck Aff.), Ex. 6 (Jaworowsky Aff.), Ex. 7 (Kedala Aff.). Plaintiffs, a coalition of groups and individuals including scientists and religious leaders concerned about genetically altered foods, have brought this action to protest the Food and Drug Administration's ("FDA") policy on such foods in general, and in particular on various genetically modified foods that already have entered the marketplace. The parties have filed cross-motions for summary judgment on plaintiffs' multiple claims. Upon careful consideration of the parties' briefs and the entire record, the Court shall grant Defendants' motion as to all counts of Plaintiffs' Complaint.

I. BACKGROUND

On May 29, 1992, the FDA published a "Statement of Policy: Foods Derived From New Plant Varieties" (Statement of Policy). See 57 Fed.Reg. 22,984; Pls.' Stmt. ¶ 16; Defs.' Stmt. ¶ 14. 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. See 57 Fed.Reg. 22,989-91. While FDA recommended that food producers consult with it before marketing rDNA-produced foods, the agency did not mandate such consultation. See id. at 22,991. 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. See id. at 22,990.

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. See id. at 22,991. 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. See id. at 23,004-05; Pls.' Stmt. ¶ 23. At least thirty-six foods, genetically altered through rDNA technology, have been marketed since the Statement of Policy was issued. See Pls.' Stmt. ¶ 30; Defs.' Stmt. ¶ 21.

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. See Pls.' Second Am.Compl. ¶¶ 129-159. Plaintiffs have also challenged on the third and fourth grounds each of FDA's specific decisions not to regulate 36 individual rDNA-produced products. See id. ¶¶ 160-696. The parties have filed cross-motions for summary judgment on all of Plaintiffs claims.

II. DISCUSSION

A litigant is entitled to summary judgment when "there is no genuine issue as to any material fact and the moving party is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(c). Summary judgment is only warranted where "the record, viewed in the light most favorable to the nonmoving party, reveals that there is no genuine issue as to any material fact." Aka v. Washington Hosp. Ctr., 156 F.3d 1284, 1288 (D.C.Cir. 1998) (en banc).

A. Subject Matter Jurisdiction

Defendants contend that Court lacks jurisdiction to hear plaintiffs' claims. See Defs.' Mot. to Dismiss, or Alternatively for Summ.J. at 15-17 ("Defs.' Mot. Summ.J."). Although Defendants have not presented this argument as a threshold to the Court's consideration of the entire case, raising it instead after developing several other arguments, the Court must treat it as such. See, e.g., Steel Co. v. Citizens for Better Env't, 523 U.S. 83, 94-95, 118 S.Ct. 1003, 140 L.Ed.2d 210 (1998) ("The requirement that jurisdiction be established as a threshold matter springs from the nature and limits of the judicial power of the United States and is inflexible and without exception") (internal citation omitted). In particular, Defendants argue that the Statement of Policy functioned as a way for the agency to "set its own enforcement agenda," and therefore, that this enforcement action belongs to agency discretion by Congressional mandate and is not subject to judicial review. See Defs.' Mot.Summ.J. at 13. Although the Supreme Court held that individual enforcement decisions are not subject to judicial review in Heckler v. Chaney, 470 U.S. 821, 831, 105 S.Ct. 1649, 84 L.Ed.2d 714 (1985), Defendants' attempt to extend this holding to agency decisions not to enforce against a whole class has not been accepted by this Circuit. See Shell Oil Co. v. EPA, 950 F.2d 741, 764 (D.C.Cir. 1991).

The Chaney Court reasoned that courts reviewing agency action "need a meaningful standard against which to judge the agency's exercise of discretion." Chaney, 470 U.S. at 830, 105 S.Ct. 1649. Individual agency decisions not to enforce a statute "involve a complicated balancing of a number of factors," and courts do not have a meaningful standard with which to evaluate the agency's balancing. Id. at 831, 105 S.Ct. 1649. Therefore, these decisions are "committed to agency discretion by law" and are not subject to judicial review. 5 U.S.C. § 701 (a)(2). The Court noted that an agency's enforcement discretion may be limited when Congress has "set[] substantive priorities, or . . . otherwise circumscrib[ed] an agency's power to discriminate among issues or cases it will pursue." Id. at 833, 105 S.Ct. 1649. When determining if an agency action is reviewable, courts looks to "whether the applicable statutes and regulations are drawn so that a court would have a meaningful standard against which to judge the agency's exercise of discretion." Nat'l Fed'n of Fed. Employees v. United States, 905 F.2d 400, 405 (D.C.Cir. 1990); C C Distrib., Inc. v. United States, 883 F.2d 146, 153 (D.C.Cir. 1989).

This Circuit has recognized a distinction between agency decisions not to regulate an entire class of conduct, which are essentially policy choices, and individual nonenforcement decisions. See Shell Oil Co., 950 F.2d at 764. When an agency has employed a formal procedure, such as notice and comment rulemaking, to announce a major policy decision not to regulate certain conduct, courts can use this procedure as "a focal point for judicial review." Nat'l Treasury Employees union v. Horner, 854 F.2d 490, 496 (D.C.Cir. 1988). In the instant case, even without actual notice and comment procedures, the FDA's formal publication of the Statement of Policy provides a focal point for this Court's review of the agency's action. Moreover, this Court has a meaningful standard against which to judge the Statement of Policy. Congress's passage of the various statutes on which Plaintiffs rely here — the Administrative Procedure Act, the Federal Food Drug and Cosmetic Act, the National Environmental Protection Act, and the Religious Freedom Restoration Act — has limited the FDA's enforcement discretion. Although the Court may not review FDA's policy-laden individual enforcement decisions, the Court has jurisdiction to review whether or not FDA's Statement of Policy comports with Congressional directives.

B. Notice and Comment

Plaintiffs argue that the Statement of Policy should be set aside because it was not subjected to notice and comment proceedings, as required under the Administrative Procedure Act ("APA"), 5 U.S.C. § 553. See Pls.' Mot.Summ.J. at 9. While conceding that the Statement of Policy did not undergo a formal notice and comment process, Defendants maintain that the Statement of Policy is a policy statement or an interpretive rule not subject to, notice and comment requirements.*fn1 See Defs.' Opp'n to Pls.' Mot.Summ.J. ["Defs.' Opp'n"] at 2; see also 5 U.S.C. § 553 (b)(3)(A) (1994) (exempting from notice and comment interpretive rules and general statements of policy). Plaintiffs contend instead that the Statement of Policy is a substantive rule, and that therefore it was improperly exempted from a formal notice and comment process. See Pls.' Mot.Summ.J. at 13.

A substantive rule, which must undergo a formal notice-and-comment process, is a rule that "implement[s]" a statute and has "the force and effect of law." Chrysler Corp. v. Brown, 441 U.S. 281, 302 n. 31, 99 S.Ct. 1705, 60 L.Ed.2d 208 (1979). Policy statements, on the other hand, are "statements issued by an agency to advise the public prospectively of the manner in which the agency proposes to exercise a discretionary power." Id. Although the distinction between these categories is not entirely clear,*fn2 in American Bus. Ass'n v. United States, 627 F.2d 525 (D.C.Cir. 1980), the Court of Appeals articulated a two-part test for determining when an agency action is a policy statement. Policy statements (1) must not impose any new rights or obligations, and (2) must "genuinely leave the agency and its decision-makers free to exercise discretion." Id. at 529. In weighing these criteria, "the ultimate issue is the agency's intent to be bound." Public Citizen v. United States Nuclear Regulatory Comm'n, 940 F.2d 679, 682 (D.C.Cir. 1991). An agency's own characterization of its statement deserves some weight, but it is not dispositive. See Truckers United for Safety v. Fed'l Highway Admin., 1998 WL 151182 (D.C.Cir. 1998). Rather, courts will look to the actual language of the statement. See Brock v. Cathedral Bluffs Shale Oil Co., 796 F.2d 533, 537-38 (D.C.Cir. 1986).

By its very name, the Statement of Policy announces itself as a policy statement. More importantly, the plain language of the Statement suggests that it does not have a binding effect. For example, the Statement does not declare that transferred genetic material will be considered GRAS; rather, it announces that "such material is presumed to be GRAS." 57 Fed.Reg. 22989 (emphasis added). This presumption of safety is rebuttable, because FDA will "require food additive petitions in cases where safety questions exist sufficient to warrant formal premarket review by FDA to ensure public health protection." Id. at 22990. Rebuttable presumptions leave an agency free to exercise its discretion and may therefore properly be announced in policy statements. See Panhandle Producers v. Econ. Regulatory Admin., 822 F.2d 1105, 1110 (D.C.Cir. 1987); Mada-Luna v. Fitzpatrick, 813 F.2d 1006, 1013 (9th Cir. 1987) ("To the extent that the directive merely provides guidance to agency officials in exercising their discretionary powers while preserving their flexibility and their opportunity to make individualized determination[s], it constitutes a ...


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