nitrite regulations. Accordingly, the Court upholds the agencies' conclusion that the USDA's pre-1958 nitrite regulations were issued for both coloring and preservative reasons.
B. Color Additive Amendments
The FDA has jurisdiction over all "color additives." 21 U.S.C. § 376. A "color additive," for purposes of the FDA Act, is defined as any "substance" which "when added . . . to a food . . . is capable (alone or through reaction with other substance) of imparting color thereto . . . ." 21 U.S.C. § 321(t). No exclusion from this definition exists analogous to the prior-sanction exemption from the term "food additive."
Plaintiffs contend that nitrite "imparts" color to bacon and thus is subject to the exclusive jurisdiction of the FDA. The defendants counter with three arguments. First, they maintain that nitrite does not "impart" color to bacon; it merely "fixes" bacon's natural color. Second, they claim that, under the current regulatory scheme, the color effects of nitrite in bacon are merely "incidental" to the substance's preservative qualities. Correspondingly, it is contended that the FDA lacks jurisdiction over substances which "impart color," but have other more critical functions. Third, some of the defendants maintain that, even if the FDA does have jurisdiction to regulate nitrite as a "color additive," the USDA retains concurrent jurisdiction to permit or require the use of nitrite in bacon as a botulism preventative.
Plaintiffs advance substantial arguments in opposition to these claims. As to the defendants' first claim, the parties have submitted detailed affidavits and reports. Plaintiffs point out, with affidavit support, that the mechanism by which nitrite allegedly "fixes" the color in bacon is the same as the mechanism by which nitrite, according to the FDA, "imparts" color to poultry.
In response to the defendants' second argument, plaintiffs urge that the statute and the FDA's own regulations strongly indicate that, no matter how relatively minor is a substance's color effect, its other functions do not withdraw the applicability of the Color Additive Amendments. The "color additive" definition in 21 U.S.C. § 321(t) suggests that only two exemptions exist. One involves "pesticides" and has no application here. 21 U.S.C. § 321(t)(3). The other reads: the "term ("color additive") does not include any material which the Secretary, by regulation, determines is used (or intended to be used) Solely for a purpose or purposes other than coloring." (Emphasis supplied.) 21 U.S.C. § 321(t)(1). The FDA has promulgated regulations implementing this provision and they state that in order for the exemption to come into play:
the material must be used in a way that any color imparted is clearly unimportant insofar as the appearance, value, marketability, or consumer acceptability is concerned. (It is not enough to warrant exemption if conditions are such that the primary purpose of the material is other than to impart color).