Source: https://law.justia.com/cases/federal/district-courts/FSupp/895/1178/1570801/
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Matched Legal Cases: ['§ 301', '§ 4321', '§ 500', '§ 2201', '§ 301', '§ 4321', '§ 10', '§ 10', '§ 10', '§ 360', '§ 706', '§ 360', '§ 514', '§ 360', '§ 360', '§ 514', '§ 321', '§ 360', '§ 514', '§ 343', '§ 321', '§ 4321', '§ 4332', '§ 1508', '§ 1501', '§ 1509', '§ 1508', '§ 1508', '§ 1508', '§ 1506', '§ 4332', '§ 1502', '§ 4332', '§ 4332']

Stauber v. Shalala, 895 F. Supp. 1178 (W.D. Wis. 1995) :: Justia
Justia › US Law › Case Law › Federal Courts › District Courts › Wisconsin › Western District of Wisconsin › 1995 › Stauber v. Shalala
Stauber v. Shalala, 895 F. Supp. 1178 (W.D. Wis. 1995)
US District Court for the Western District of Wisconsin - 895 F. Supp. 1178 (W.D. Wis. 1995)
895 F. Supp. 1178 (1995)
John STAUBER, Glenn Stoddard, on his own behalf and as next friend of Patrick Stoddard, Ronnie Cummins, and Marilyn Charbush, Plaintiffs,
Donna SHALALA, in her official capacity as Secretary of Health and Human Services, and David Kessler, M.D., in his official capacity as Commissioner of the Food and Drug Administration, Defendants,
Monsanto Company, Intervenor-Defendant.
No. 94-C-0090-C.
*1179 *1180 *1181 *1182 Jacqueline H. Eagle, Office of Consumer Litigation, Washington, DC, for Donna Shalala.
Leslie Kux, Assoc. Chief Cnsl. for Veterinary Medicine, Office of the General Counsel, Rockville, MD, for David Kessler.
Michael L. Zaleski, Quarles & Brady, Madison, WI, for Monsanto Co. (Intervenor).
This is a civil action for declaratory and injunctive relief brought pursuant to the Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394, the National Environmental Policy Act, 42 U.S.C. §§ 4321-4370d, and the Administrative Procedure Act, 5 U.S.C. §§ 500-706. Plaintiffs are American consumers of commercially sold dairy products. Defendants are Donna Shalala, Secretary of the Department of Health and Human Services, and Dr. David Kessler, Commissioner of the Food and Drug Administration. Plaintiffs challenge defendants' approval of intervenor-defendant Monsanto Company's new drug application for Posilac®, a milk production-enhancing, synthetic bovine growth hormone drug. Specifically, plaintiffs contend that: 1) the approval was arbitrary and capricious because the FDA failed to consider health and safety issues related to the use of Posilac; 2) defendants failed to require mandatory labeling of products from cows treated with Posilac; and 3) defendants failed to conduct an adequate environmental assessment or issue an environmental impact statement assessing the environmental effects of Posilac's approval. Plaintiffs request both a declaration under 28 U.S.C. § 2201 and Fed.R.Civ.P. 57 that defendants failed to perform their statutory duties in approving Posilac and a permanent injunction suspending *1183 the approval of Posilac until defendants comply with their statutory obligations.
The FDA considered IGF-1 when it evaluated the safety and effectiveness of Posilac and concluded that any increase in IGF-1 levels posed no significant health risks to consumers. This conclusion was based on the FDA's determinations that: 1) IGF-1 levels in milk from rbST-treated cows were not significantly higher than milk from untreated cows; 2) IGF-1 was not orally active; 3) even if IGF-1 from milk was absorbed intact, levels of IGF-1 in the human blood-stream are so much higher (100 to 1000 times) than the levels found in cows' milk that the addition of small amounts of IGF-1 from cows' milk would be physiologically insignificant; and 4) the manufacturing process for infant formula denatures almost all of the IGF-1 in cows' milk. The agency concluded that IGF-1 was unlikely to affect either the gastrointestinal track of adults or infants in general.
In their motion for summary judgment, defendants challenge plaintiffs' standing *1187 under both the Food, Drug, and Cosmetic Act and the National Environmental Policy Act. The constitutional requirements for standing derive from Article III's mandate that federal jurisdiction extends only to those situations in which plaintiffs can demonstrate a "case or controversy" between themselves and the defendant. Article III standing has three components: 1) an injury or threat of injury; 2) traceability of the injury to the defendant's conduct; and 3) the likelihood that a favorable decision would provide the plaintiff with a remedy. Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61, 112 S. Ct. 2130, 2136, 119 L. Ed. 2d 351 (1992). Defendants dispute whether plaintiffs can satisfy the first element of the test. To do so, plaintiffs must allege injuries or threatened injuries that are "concrete and particularized" and show that they have "an actual stake in the outcome [of the case] that goes beyond intellectual or academic curiosity." Family & Children's Ctr. v. School City, 13 F.3d 1052, 1058 (7th Cir. 1994) (quoting South East Lake View Neighbors v. Dept. of Housing and Urban Development, 685 F.2d 1027, 1033 (7th Cir.1982)); see also Schmidling v. City of Chicago, 1 F.3d 494, 498 (7th Cir. 1993) (injury or threat "must be both real and immediate, not conjectural or `hypothetical'"), cert. denied, ___ U.S. ___, 114 S. Ct. 555, 126 L. Ed. 2d 456 (1993). At the summary judgment stage, standing requires "a factual showing of perceptible harm." Lujan, 504 U.S. at 566, 112 S. Ct. at 2139. However, alleged injuries need not be particularly severe or costly: "even a minor or noneconomic injury will satisfy the strictures of Article III," Family & Children's Ctr., 13 F.3d at 1058, and "even a small probability of injury is sufficient to create a case or controversyto take a suit out of the category of the hypothetical...." Village of Elk Grove Village v. Evans, 997 F.2d 328 (7th Cir.1993).
The federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301-394, is intended to protect American consumers from the risks of consuming unsafe or ineffective food and drugs and thus requires new drug applicants to demonstrate the safety and effectiveness of new drugs before they may be marketed. One aspect of plaintiffs' challenge to the FDA's approval of rbST is that the agency did not hold Monsanto to its burden under the act of demonstrating the safety of Posilac. If this allegation is true, plaintiffs' injury is their exposure to a potentially dangerous drug whose safety has not been demonstrated in accordance with the act. Cutler v. Kennedy, 475 F. Supp. 838, 848-49 (D.C.Cir. 1979), overruled on other grounds in Chaney v. Heckler, 718 F.2d 1174, 1188 n. 35 (D.C.Cir.1983).
"[Defendants'] suggestion that [plaintiffs] lack standing because the injury they allege is speculative confuses the anticipated ... consequences of the [agency action] with the ... injury [plaintiffs] actually claim." Florida Audubon Society v. Bentsen, 54 F.3d 873, 879 (D.C.Cir.1995). Contrary to defendants' theory, plaintiffs need not show that rbST is actually harmful in order to satisfy the requirements of standing. The Food, Drug, and Cosmetic Act creates legal rights or interests for consumers, "`the invasion of which creates standing, even though no injury would exist without the statute.'" Cutler, 475 F. Supp. at 848 (quoting Linda R.S. v. Richard D., 410 U.S. 614, 617 n. 3, 93 S. Ct. 1146, 1148 n. 3, 35 L. Ed. 2d 536 (1973)). Because the act places the responsibility on the sponsor of the drug to demonstrate the drug's safety and directs the FDA to approve for marketing only those drugs whose safety has been demonstrated, any significant uncertainty regarding the drug's safety is a *1188 burden to be borne by the sponsor, not the consumer. If the FDA has failed to follow the dictates of the act, as plaintiffs allege, it has shifted the costs of uncertainty from the sponsor of the drug to the American consumer. This increased risk of potential harm that the consumer must bear is an injury in fact for standing purposes.
To have standing under the National Environmental Policy Act, 42 U.S.C. §§ 4321-4370d, plaintiffs must show that an agency's alleged noncompliance with the act has adversely affected them and that they are within the zone of interests protected by the act. Under the act, individuals are aggrieved by an agency's failure to prepare an environmental impact statement if they can show that the failure creates a reasonable risk that "`environmental impacts will be overlooked'" and that they have a "sufficient geographical nexus to the site of the challenged project that [they] may be expected to suffer whatever environmental consequences the project may have." Florida Audubon Society v. Bentsen, 54 F.3d at 877 (quoting City of Davis v. Coleman, 521 F.2d 661, 671 (9th Cir.1975)).
Defendants contend that plaintiffs have failed to exhaust their administrative remedies with respect to their labeling claim. Under FDA regulations, the secretary's decisions on new drug applications constitute final agency action for purposes of exhaustion. 21 C.F.R. §§ 10.25 and 10.45. Defendants do not argue that the agency's decision to approve Posilac was not final; rather, it appears that they consider the decision on labeling outside the scope of the agency's decision to approve Posilac, at least for exhaustion purposes. They assert that plaintiffs could have requested the agency to review its decision that labeling rbST-derived dairy products was not necessary by filing a citizen petition pursuant to 21 C.F.R. § 10.25 and they argue that an administrative ruling on such a petition would provide a reviewing court with a "better" record on the need for labeling, because the agency considered the issue only "informally" when it approved Posilac *1189 for marketing. Defendants note that none of the plaintiffs have filed a petition under 21 C.F.R. §§ 10.25 or 10.30 requesting the FDA to require labeling of food derived from rbST-treated cows.
Defendants' argument has some merit. Ordinarily, FDA review of new animal drug applications does not entail consideration whether food products derived from animals treated with the new drug should be labeled. It does not appear that any statute or regulation requires a determination of the question. Where new animal drug applications are concerned, usually the relevant focus is on proposed tolerance levels and withdrawal periods to assure that no residues from the animal drug make their way into animal products intended for human consumption. See 21 U.S.C. § 360b. Here, however, the FDA addressed the issue whether food products derived from cows treated with rbST should be labeled as such. After publishing notice in the federal register, 58 Fed.Reg. 21314 (April 20, 1993), the agency held a two-day meeting in May 1993 to receive oral and written testimony on the issue. Defts' Mem. Ex. 13 Vol. XVII. Andrew Kimbrell testified at the hearing on behalf of the Coalition for Responsible Technology, a Wisconsin group founded by plaintiff Stauber. On May 7, 1993, the agency's Food Advisory Committee and the Veterinary Medicine Advisory Committee deliberated the labeling issue. Defts' Mem.Ex. 13, Vol. XVIII. A final conclusion from the agency on the need to label food products does not appear in the conclusions section of the freedom of information summary, Defts' Exh. 1 Vol. I at 121-22. However, the agency's decision not to require labeling flowed a fortiori from its conclusion that it was unnecessary to establish a tolerance level or withdrawal time because there is no essential difference between milk derived from rbST-treated animals and regular milk. From a review of the administrative record, I conclude that the agency reached a final decision on the issue whether to require labeling of food derived from rbST-treated cows that is currently ripe for judicial review.
The decision of the FDA to approve a drug is an informal agency action. Scott v. Food and Drug Administration, 728 F.2d 322, 324 (6th Cir.1984); Upjohn Mfg. Co. v. Schweiker, 681 F.2d 480, 483 (6th Cir.1982). Federal court review of informal agency action is limited in scope: it may be set aside only if the agency's determination is arbitrary and capricious, an abuse of discretion or otherwise not in accordance with the law. Upjohn Mfg. Co. v. Schweiker, 681 F.2d at 483; 5 U.S.C. § 706(2) (A). The arbitrary and capricious standard is highly deferential: even if a reviewing court disagrees with an agency's action, the court must uphold the action if the agency considered all relevant factors and the court can discern a rational basis for the agency's choice. Camp v. Pitts, 411 U.S. 138, 143, 93 S. Ct. 1241, 1244, 36 L. Ed. 2d 106 (1973); Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 415-16, 91 S. Ct. 814, 823-24, 28 L. Ed. 2d 136 (1971), overruled on other grounds in Califano v. Sanders, 430 U.S. 99, 97 S. Ct. 980, 51 L. Ed. 2d 192 (1977). Moreover, when a decision goes to the core of an agency's expertise, generally the court must defer to the agency's more informed judgment. International Fabricare Institute v. U.S.E.P.A., 972 F.2d 384, 389 (D.C.Cir.1992) ("The rationale for deference is particularly strong when the [agency] is evaluating scientific data within its technical expertise."); Tri-Bio Laboratories, Inc. v. United States, 836 F.2d 135, 142 (3d Cir.1987) ("[I]n evaluating scientific evidence in the drug field, the FDA possesses an expertise entitled to respectful consideration by th[e] court") (citing Weinberger v. Bentex Pharmaceuticals, Inc., 412 U.S. 645, 653-54, 93 S. Ct. 2488, 2494, 37 L. Ed. 2d 235 (1973)), cert. denied, 488 U.S. 818, 109 S. Ct. 57, 102 L. Ed. 2d 35 (1988).
The Supreme Court has made clear that courts are precluded both from considering evidence that the agency never had a chance to review and from creating a record different from that considered by the agency. Camp v. Pitts, 411 U.S. at 142, 93 S. Ct. at 1244; see also Edwards v. United States Dept. of Justice, 43 F.3d 312, 314 (7th Cir.1994); Cronin v. United States Dept. of Agriculture, 919 F.2d 439, 443-44 (7th Cir. 1990). The district court may not undertake *1190 a de novo review of the agency's decision and its factual underpinnings. Cronin, 919 F.2d at 444 ("only in an emergency should a reviewing court ... conduct its own evidentiary hearing" in a review of agency action). This rule of evidence is derived from the arbitrary and capricious standard itself, which requires the court to ask not what it would have done if it had been in the agency's place, but rather whether the agency approached the problem in the right way, properly considered the evidence before it and issued a decision supported by the record in front of it. Bradley v. Weinberger, 483 F.2d 410, 414-15 (1st Cir.1973) (district court erred in considering affidavits submitted by the parties in a case challenging an FDA determination on labeling; review was limited to the administrative record). This rule is fully applicable to federal claims challenging the FDA's approval of new drug applications. See Upjohn Mfg. Co. v. Schweiker, 681 F.2d at 483.
The agency review is like a trial in a district court: it is supposed to be the main event. Plaintiffs challenging an agency action do not advance their cause by submitting to the reviewing court evidence that could have been presented to the agency but never was. Just as in an appeal from a district court trial, the rule is that if a piece of evidence was never introduced, for purposes of appeal, it does not exist. The one exception is that a reviewing court may consider evidence that is relevant to determining whether the agency decision was arbitrary and capricious. See Overton Park, 401 U.S. at 420-21, 91 S. Ct. at 825-26 (exception to rule limiting judicial review of agency action to administrative record made where supplemental evidence would explain process by which agency made its determination).
Plaintiffs did submit an affidavit from Dr. Richard Burroughs, who was employed by the FDA as a veterinary medical officer and was involved in the review process of Monsanto's application for Posilac. In his affidavit, Dr. Burroughs points out what he considers to be key flaws in the agency's review of the drug application and errors in Monsanto's safety testing of the drug. The information in Burroughs's affidavit might have been admissible as evidence tending to explain the record actually before the agency or the agency's decision-making process. Overton Park, 401 U.S. at 420-21, 91 S. Ct. at 825-26. However, in proposing findings of fact in support of their motion for summary judgment, plaintiffs rely on the Burroughs affidavit only once, in support of the proposition that "[o]ne of the major concerns is that rbST causes many potentially serious health problems in cows." I have accepted this fact as undisputed.
*1191 Throughout the application process, the burden is on the applicant or drug sponsor to show that the new animal drug is both effective and safe under the proposed conditions of use. 21 U.S.C. § 360b; 21 C.F.R. § 514.1(b) (8). Effectiveness must be demonstrated on the basis of "substantial evidence" that the drug "will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof." 21 U.S.C. § 360b(d) (3). The Food, Drug, and Cosmetic Act does not indicate the standard an applicant must meet to demonstrate a new drug's safety or the evidence upon which the FDA must base its safety determination. However, the act requires the FDA to consider four specific factors when assessing safety: 1) the likelihood that the drug or a substance formed in food because of the drug will be consumed; 2) the cumulative effect that the drug will be likely to have on man or other animals; 3) safety factors that experts consider appropriate for extrapolating from animal experimentation data; and 4) whether it is likely that the conditions of use proposed or suggested in the labeling will be followed. 21 U.S.C. § 360b(d) (2); 21 C.F.R. § 514.111(a) (4). The FDA is required to take into account the drug's effect on the health of the target animal. 21 U.S.C. § 321(u). A new drug application must contain "full reports of adequate tests by all methods reasonably applicable to show whether or not the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling." 21 U.S.C. § 360b(d) (1) (B). Such testing includes preclinical acute, subacute and chronic toxicity testing, clinical studies and filed investigations. 21 C.F.R. § 514.1(b) (8) (iii).
Under the Food, Drug, and Cosmetic Act, food is deemed misbranded if its labeling is "false or misleading in any particular." 21 U.S.C. § 343(a) (1). 21 U.S.C. § 321(n) provides further that:
The National Environmental Policy Act, 42 U.S.C. § 4321-4370d, requires federal agencies to prepare an environmental impact statement if the agency plans to undertake a "major" action "significantly affecting the quality of the human environment." 42 U.S.C. § 4332(2) (c). Congress requires that these environmental impact statements include *1194 a discussion of the environmental impact of the proposed action, any adverse environmental harms that cannot be avoided if the project goes forward, alternatives to the proposed action, the relationship between "local short-term uses of man's environment and the maintenance and enhancement of long-term productivity," and any "irreversible and irretrievable commitments of resources which would be involved in the proposed action should it be implemented." Id. An "environmental assessment" is a public document that "briefly provide[s] sufficient evidence and analysis for determining whether to prepare an environmental impact statement." 40 C.F.R. § 1508.9. If, on the basis of the environmental assessment, the agency determines that the proposed action will not have a significant effect on the quality of the human environment, then the agency prepares a "finding of no significant impact" in lieu of an environmental impact statement. 40 C.F.R. § 1501.4(e). A finding of no significant impact is an agency document explaining briefly the agency's reasons for concluding that the governmental action will not have a significant effect on the environment and that preparation of an environmental impact statement is unnecessary. 40 C.F.R. § 1509.13.
Plaintiffs contend that the FDA failed to comply with the National Environmental Policy Act when it determined that an environmental impact statement was unnecessary. In particular, plaintiffs contend that the decision not to prepare and environmental impact statement was arbitrary and capricious in light of the failure to address Posilac's socio-economic effects on the dairy farmer and Posilac's likely effects on human and bovine health in either the environmental assessment or the finding of no significant impact. In addition, plaintiffs challenge the failure to discuss feasible alternatives in the environmental assessment and the finding of no significant impact.
Regarding socioeconomic effects, the regulations promulgated under the National Environmental Policy Act provide that "economic or social effects are not intended by themselves to require preparation of the environmental impact statement." 40 C.F.R. § 1508.14. Plaintiffs are wrong when they assert that Posilac's socioeconomic effects on the dairy farmer require the preparation of an environmental impact statement. See Missouri Coalition for the Environment v. Corps of Engineers of United States Army, 866 F.2d 1025, 1031-32 (8th Cir.), cert. denied, 493 U.S. 820, 110 S. Ct. 76, 107 L. Ed. 2d 42 (1989). It is true that an environmental impact statement must discuss economic or social effects of the proposed action to the extent those effects interrelate to its natural or physical environmental effects, but the regulations do not contemplate an independent consideration of socioeconomic effects when there is no determination that the proposed agency activity will significantly effect the environment. Id.
Plaintiffs do not argue that the socioeconomic effects of Posilac would cause secondary environmental effects to such a significant degree as to require the preparation of an environmental impact statement. Rather, they contend merely that Posilac will cause both environmental and socioeconomic harms and that for this reason an environmental impact statement was necessary. This assertion is insufficient to satisfy the "interrelatedness" requirement of § 1508.14. I read 40 C.F.R. § 1508.14 to mean that it is only after an agency determines that the socioeconomic impact of the proposed agency action is likely to cause environmental harms itself that the agency needs to discuss the socioeconomic effects in the environmental impact statement. See Breckinridge v. Rumsfeld, 537 F.2d 864, 866 (6th Cir.1976) (accord), cert. denied, 429 U.S. 1061, 97 S. Ct. 785, 50 L. Ed. 2d 777 (1977). This reading fully comports with the plain language of the regulation and the FDA's stand on the issue. (The FDA's policy is not to include purely socioeconomic considerations in its environmental assessments. FDA, National Environmental Policy Act; Policies and Procedures; Final Rule, 50 Fed.Reg. 16636, 16648 (Apr. 26, 1985).) Because defendants were not required to include a discussion of socioeconomic effects in their environmental assessment, it was not arbitrary and capricious to omit consideration of those nonenvironmental *1195 effects from the environmental assessment.
40 C.F.R. § 1506.4 provides that "[a]ny environmental document in compliance with [the National Environmental Policy Act] may be combined with any other agency document to reduce duplication and paperwork." In Citizens for Safe Power v. Nuclear Regulatory Comm'n, 524 F.2d 1291 (D.C.Cir. 1975), the issue was whether the NRC had to consider separately and formally the risks and benefits associated with the grant of a nuclear power plant license under both the National Environmental Policy Act and the Atomic Energy Act. The court answered the question in the negative, explaining its position as follows:
[I]t would be pointless, and a waste of agency resources, to require the [Atomic Energy Commission] to reapply efforts that have already gone into its basic health and safety regulations ... in the absence of some evidence that a particular facility presents risks outside the parameters of the original rule making. And in evaluating the sufficiency of agency determinations in particular cases it would be stultifying formalism to disregard the whole record and test the [Atomic Energy Commission] compliance by only the evidence received at so-called `health and safety' hearings; or [National Environmental Policy Act] compliance only on the basis of so-called `environmental' hearings.
Id. at 1299. See also Environmental Defense Fund v. Mathews, 410 F. Supp. 336, 337 (D.D.C.1976) (National Environmental Policy Act does not supersede other statutory duties imposed upon an agency but rather supplements them to the extent that the two sets of duties are reconcilable). The lesson of Citizens for Safe Power, 524 F.2d 1291, applies with full force to the FDA action here. The concerns that motivated the Food, Drug, and Cosmetic Act with regard to animal and consumer safety are precisely the ones plaintiffs contend must be considered under the National Environmental Policy Act. The agency's consideration of those harms in its review of Monsanto's new animal drug application dispensed with any need for a re-review of those issues under National Environmental Policy Act. See id. Had plaintiffs been successful on their claim that the FDA did not comply with the Food, Drug, and Cosmetic Act, they might have had a claim that the National Environmental Policy Act requirements were not met either, because both statutes require a thorough evaluation of Posilac's effects on human and bovine health and safety. However, plaintiffs have failed in their challenge to the agency's compliance with the Food, Drug, and Cosmetic Act and in any event their National Environmental Policy Act claim is premised solely on the agency's failure to duplicate its work.
*1196 Plaintiffs' argument fails, however, for two interrelated reasons. First, at bottom, their argument is a purely informational one, which fails because they allege no harm stemming from the asserted procedural defect. Cf. Foundation for Economic Trends v. Lyng, 943 F.2d 79, 84-85 (D.C.Cir.1991) (informational injury alone is not enough to satisfy standing requirements under NEPA). Second, environmental assessments and findings of no significant impact are informal agency actions subject to judicial review under the arbitrary and capricious standard. As the Court of Appeals from the Seventh Circuit has stated, "a reviewing court may without violating the rule of SEC v. Chenery Corp., 332 U.S. 194, 67 S. Ct. 1575, 91 L. Ed. 1995 (1947), against the court's supplying a rationale for the agency's decision `uphold a decision of less than ideal clarity if the agency's path may be reasonably discerned.'" Cronin v. United States Dept. of Agriculture, 919 F.2d at 442 (quoting Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc., 419 U.S. 281, 286, 95 S. Ct. 438, 442, 42 L. Ed. 2d 447 (1974)). Judicial review of a decision of an agency not to prepare an environmental impact statement requires a court to decide whether the agency's determination is "sustainable on the [entire] administrative record made," and is not limited to a review of the agency's statements regarding the lack of a need for an environmental impact statement. Missouri Coalition for the Environment v. Corps of Engineers, 866 F.2d 1025 at 1031. Because the record reveals that defendants have done health and safety analyses, their failure to reference those analyses in the environmental assessment or the finding of no significant impact does not undermine the adequacy of the conclusions reached in those documents.
The final issue plaintiffs raise is the omission of any discussion of feasible alternatives from the environmental assessment and the finding of no significant impact. Plaintiffs argue that the agency should have considered the possibilities of a delay on approving the Posilac application until further studies on health and safety could be conducted, a lower recommended dosage to the cows, or approval of Posilac only as a prescription drug. (Plaintiffs proposed as fact that the environmental assessment did not address the alternative of approving the drug for marketing only when accompanied by detailed instructions or educational seminars regarding methods to minimize health risks, but they have not pursued this argument in their briefs.) The first alternative, a delay in approving the drug, was suggested to the agency. During the review process, the Foundation on Economic Trends, a non-profit consumer organization and a former plaintiff in this action, suggested that approval of the drug be postponed until further safety research could occur. However, plaintiffs have failed to offer evidence that the other two alternatives (a lower recommended dosage or prescription drug status) were ever presented to the agency for consideration. If an alternative is not presented to the agency for consideration, the agency cannot be attacked in federal court for not considering it. Upper West Fork River Watershed Assoc. v. Corps of Engineers, 414 F. Supp. 908, 920 (N.D.W.Va.1976) (when challenging agency's consideration of alternatives, plaintiffs may not rest upon naked conclusion that alternatives should have been considered). Plaintiffs have not shown that the agency was made aware of the two possible alternatives relating to lower dosages or making Posilac available only by prescription. Therefore, they may not challenge the agency's failure to consider them.
Even if I assume that plaintiffs made a presentation of their alternative of delayed approval pending further research into health and safety that was adequate to require the agency to consider the proposal, see Vermont Yankee Nuclear Power Corp. v. Natural Resources Defense Council, 435 U.S. 519, 98 S. Ct. 1197, 55 L. Ed. 2d 460 (1978) (proponents of alternatives must make a preliminary showing that proposed alternative merits review before agency required to consider alternative during agency proceedings), plaintiffs would still not meet their burden of showing that an environmental impact statement should have been prepared. When an *1197 agency determines that a proposed action poses a significant risk of harm to the environment, the agency must consider alternatives to the proposed action. See 42 U.S.C. § 4332(2) (c) (iii); 40 C.F.R. § 1502.14. However, if the agency determines that a proposed action will not significantly effect the environment, it is required to consider alternatives only when the proposal involves "unresolved conflicts concerning alternative uses of available resources." 42 U.S.C. § 4332(2) (E); River Road Alliance, Inc. v. Corps of Engineers of United States Army, 764 F.2d 445, 452 (7th Cir.1985), cert. denied, 475 U.S. 1055, 106 S. Ct. 1283, 89 L. Ed. 2d 590 (1986). In this situation, I cannot perceive any unresolved conflict concerning uses of available resources. Plaintiffs' proposed alternative involves only a delay in approving the drug until further tests have been conducted. This situation does not involve an "available resource" as the term is used in § 4332(2) (E).