The opinion of the court was delivered by: GESELL
Plaintiffs seek to ban the use of nitrite in bacon. They contend that the United States Department of Agriculture ("USDA") no longer has authority to issue regulations permitting or requiring such use and ask the Court to declare that the Food and Drug Administration ("FDA"), by reason of its statutory authority over food and color additives, has sole authority to regulate the use of nitrite in bacon. Basic questions of standing, statutory construction and primary jurisdiction are presented. The case is before the Court on cross-motions for summary judgment which have been fully briefed and argued.
The USDA has permitted producers to add nitrite to bacon under controlled conditions for more than 50 years. Regulations issued in 1925 allowed only the use of sodium nitrite, in quantities up to 200 parts per million ("ppm"), but in 1941 potassium nitrite was afforded the same treatment. 6 Fed.Reg. 1144 (Feb. 26, 1941). The USDA further amended its meat additive regulations in 1945, but did not alter the rule permitting the addition of sodium nitrite and potassium nitrite to meats in quantities up to 200 ppm. 10 Fed.Reg. 3339 (March 29, 1945). This rule remained in effect until 1964, when new regulations were once again promulgated. No substantive change was then effected with respect to the permissible level of nitrite in meat; but, for the first time, the USDA specified in its regulations the "purpose" for which nitrite could be added to meat products. Only one purpose was so cited: "To fix color." According to the new regulations, this meant that the substance was "acceptable for use in the processing of products, provided (it is) used for the purpose(s) indicated . . . ." 29 Fed.Reg. 12580-81 (Sept. 4, 1964); See 9 C.F.R. § 318.7(c)(4) (1978).
In the early 1970's scientific investigation suggested that nitrite may combine with secondary and tertiary amines (organic chemicals that sometimes exist naturally in meats) to form nitrosamines, a concededly carcinogenic substance. Moreover, it was discovered that nitrosamines often appear with greater frequency in cooked bacon than in other varieties of cooked meat since bacon is typically fried at high temperatures. In the meantime, scientists discovered that nitrite also plays a role in inhibiting the growth of Clostridium botulinum, a bacterium that can produce botulism. It appears that no other substance has yet been discovered which has the same desirable effect.
Because this new information raised substantial questions about the use of nitrite in meat, the USDA established in 1973 an Expert Panel on Nitrites, Nitrates and Nitrosamines to review all aspects of the subject. After this panel issued various recommendations, the USDA published in 1975 a Notice of Proposed Rule-Making with respect to the addition of nitrite to bacon, inviting public comment. 40 Fed.Reg. 52614-16 (Nov. 11, 1975). Many comments were submitted, including some from the plaintiff organization. Finally, on May 16, 1978, the USDA promulgated new regulations governing the use of nitrite in bacon. 43 Fed.Reg. 20992-95. "(In) order to assure the prevention of toxin formation by Clostridium botulinum," Id. at 20994, sodium nitrite at 120 ppm or potassium nitrite at 148 ppm was Required to be added to all bacon. "(In) order to prevent the formation of nitrosamines in bacon cured with nitrites," Id. at 20995, the USDA further ruled that 550 ppm of sodium ascorbate or sodium crythorbate had to be added to all bacon treated with nitrite.
The Court must first address the question of standing. Plaintiffs are a public-interest organization and two individuals. The complaint alleges that Public Citizen has supporters and members of its staff who now are, and in the future will continue to be, consumers of bacon, and further is a group that filed comments with the USDA in connection with the promulgation of the May 1978 regulations. As to plaintiff Silverman, the complaint alleges that she currently consumes bacon, but would prefer to purchase nitrite-free bacon were it available at a reasonable price. It is alleged as to plaintiff Wolfe that he refuses and will continue to refuse to eat any but nitrite-free bacon available at a reasonable price.
The theory of plaintiffs' action is that the USDA lacked power to issue the May 1978 regulations because two amendments to the Food, Drug and Cosmetic Act of 1938, 21 U.S.C. §§ 301-392 (the "FDA Act"), have placed complete and sole responsibility for nitrite regulation in the FDA: The Food Additive Amendments of 1958, Pub.L. 85-929, 72 Stat. 1785, and the Color Additive Amendments of 1960, Pub.L. 86-618, 74 Stat. 399.
At the outset it appears that Public Citizen has not even met the rudimentary standing requirements of Hunt v. Washington State Apple Advertising Commission, 432 U.S. 333, 341-45, 97 S. Ct. 2434, 53 L. Ed. 2d 383 (1977),
or Sierra Club v. Morton, 405 U.S. 727, 735, 738-40, 92 S. Ct. 1361, 31 L. Ed. 2d 636 (1972). Public Citizen is not alleged to have any members or the like significantly and adversely affected by the USDA's action and it surely is not enough that its supporters and staff members eat bacon. The Court will, however, assume, for the purposes of this opinion, that Public Citizen represents individuals who fit within either of the two categories typified by the two individual plaintiffs.
The rules of standing have two sources. One is found in Article III of the United States Constitution, which permits the federal courts to hear only "cases or controversies." A necessary component of this requirement is that the particular agency action in controversy have actually and in fact injured the plaintiffs. Warth v. Seldin, 422 U.S. 490, 498-99, 95 S. Ct. 2197, 45 L. Ed. 2d 343 (1975). The second source is found in a set of judicially-created "prudential considerations." See id., 422 U.S. at 499-500, 95 S. Ct. 2197. One such consideration, recently reaffirmed by the Supreme Court, is that a plaintiff must assert "his own legal rights and interests rather than (base) his claim for relief upon the rights of third parties." Rakas v. Illinois, 439 U.S. 128, 139, 99 S. Ct. 421, 428, 58 L. Ed. 2d 387 (1978).
Both of these rules apply to bar standing in this case.
There can be little doubt that plaintiffs would have standing to challenge the substance of the USDA's May 1978 regulation. Such, however, is not this case. Plaintiffs argue solely that jurisdiction over the use of nitrites in bacon properly resides in the FDA rather than in the USDA. Plaintiffs are thus arguing on behalf of the interests of the FDA, a third party which the plaintiffs have in fact named here as a defendant. The rules of standing do not permit the vicarious assertion of rights and no one of the various restricted exceptions to this prudential rule applies here. See NAACP v. Alabama, 357 U.S. 449, 458-60, 78 S. Ct. 1163, 2 L. Ed. 2d 1488 (1958); Eisenstadt v. Baird, 405 U.S. 438, 443-46, 92 S. Ct. 1029, 31 L. Ed. 2d 349 (1972); Broadrick v. Oklahoma, 413 U.S. 601, 611-16, 93 S. Ct. 2908, 37 L. Ed. 2d 830 (1973).
More importantly, plaintiffs cannot be said to have been actually injured by the assumption of jurisdiction over the use of nitrite in bacon by the USDA rather than by the FDA. It is not enough that plaintiffs can claim that the USDA's action constituted an injury to their interest in the proper functioning of government. Such an injury is shared by the entire populace as citizens or as voters, and is not sufficient to confer standing. See Schlesinger v. Reservists Committee to Stop the War, 418 U.S. 208, 216-21, 94 S. Ct. 2925, 41 L. Ed. 2d 706 (1974). Plaintiffs, though, do go further and contend that they are injured because the USDA's May 1978 regulation prevents them from purchasing nitrite-free bacon. The answer to this is that it is entirely too speculative to say that the relief plaintiffs request a transfer of jurisdiction to the FDA can or will remedy their alleged injury. As stated by the Supreme Court, a plaintiff must show "an injury to himself that is likely to be redressed by a favorable decision." Simon v. Eastern Kentucky Welfare Rights Organization, 426 U.S. 26, 38, 96 S. Ct. 1917, 1924, 48 L. Ed. 2d 450 (1976). See Warth v. Seldin, supra, 422 U.S. at 504, 95 S. Ct. 2197; Linda R. S. v. Richard D., 410 U.S. 614, 93 S. Ct. 1146, 35 L. Ed. 2d 536 (1973).
Here, too many uncontrollable and uncertain factors may intervene between a judgment favorable to plaintiffs and any redressment of the injury they claim to be suffering. The Court need suggest only the ...