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