Petitions for Review Denied.
a regulation or statute, even in the absences of a specific threat of enforcement, if the court need neither speculate nor attempt to anticipate whether that plaintiff will fall within the purview of the regulation, and the plaintiff alleges an intention to engage in a course of conduct that is clearly proscribed by statute.
Id. In such circumstances, the presence of the regulation is threat enough.
Id. at 986. The bar is not so high to show standing to assert a pre-enforcement
as applied challenge to a regulation or statute, however. Although subjective apprehensions of enforcement are still not enough,
see, e.g., Morrison v. Board of Educ. of Boyd County, 521 F.3d 602, 610 (6th Cir. 2008), a plaintiff asserting a pre-enforcement
as applied challenge need only demonstrate that a "credible threat of an injury exists," and may do so by showing (1) that the plaintiff was threatened with prosecution; (2) prosecution is likely; or (3) there is a credible threat of prosecution.
See, e.g, American Charities for Reasonable Fundraising Regulation, Inc. v. Pinellas County, 221 F.3d 1211, 1214 (11th Cir. 2000).
Injury is "fairly traceable" to the government conduct or regulation in question when there is an alleged causal connection between the government's conduct or regulation and the plaintiff's injury. Braden v. Wal-Mart Stores, Inc., 588 F.3d 585, 592 (8th Cir. 2009). Moreover, "`[w]hen government action . . . is challenged by a party who is a target or object of that action, . . . "there is ordinarily little question that the action . . . has caused him injury, and that a judgment preventing . . . the action will redress it."'" Monson v. Drug Enforcement Admin., 589 F.3d 952, 958 (8th Cir. 2009) (quoting Minnesota Citizens Concerned for Life v. Federal Election Comm'n, 113 F.3d 129, 131 (8th Cir. 1997), in turn quoting Lujan v. Defenders of Wildlife, 504 U.S. 555, 561-62 (1992), with alterations by the Monson court).
i. Standing of the direct purchaser plaintiffs. The six individual plaintiffs that the court has identified as the "direct purchaser plaintiffs" — Laurie Donnelly, Jennifer Allen, Dr. Joseph Heckman, Dane Miller, Cynthia Lee Rose, and Eric Wagoner, to the extent that his claim is based on the same conduct — allege that they purchased raw milk in a state where such purchases were allowed, then transported the raw milk to states where such purchases are not allowed to consume it or to give it to friends or family members to consume. The court finds that it is a very close question whether these plaintiffs have standing to assert a pre-enforcement as applied challenge to the regulations in question. On the present record, however, taking their allegations as true, and noting the defendants' failure to offer contrary evidence, the court finds that these plaintiffs have made a preliminary showing that a "credible threat of an injury exists" from possible enforcement of the regulations against them. American Charities for Reasonable Fundraising Regulation, Inc., 221 F.3d at 1214. This is so, because it is plausible to read "cause to be delivered into interstate commerce" within the meaning of § 1240.61 to apply to someone who purchased raw milk in one state, then transported it across state lines for purposes of personal consumption, and it is plausible to read "otherwise distribute [raw milk] after shipment in interstate commerce" within the meaning of § 1240.61 to apply to someone who transported raw milk across state lines, then fed it to other family members or friends. See Zanders, 573 F.3d at 594 (the plaintiffs must nudge their claim across the line from the conceivable to the plausible).
More specifically, a provision of the FDCA, 21 U.S.C. § 321(b), defines "interstate commerce" to mean "(1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body." Courts have interpreted the purpose behind the FDCA's interstate commerce regulation to be to "safeguard the consumer from the time the food is introduced into the channels of interstate commerce to the point that it is delivered to the ultimate consumer." United States v. Wiesenfeld Warehouse Co., 376 U.S. 86, 92 (1964); see also United States v. Sullivan, 332 U.S. 689, 696 (1948) (the provisions of the FDCA are "elements of an overall scheme designed to regulate the interstate flow of goods from the moment of their introduction into interstate commerce until the moment of their delivery to the ultimate consumer"). In other contexts, "interstate commerce" has been recognized to mean nothing more than persons, products, or contraband crossing state lines. See, e.g., Carr v. United States, ___ U.S. ___, ___, 130 S.ct. 2229, 2237 (2010) (a person traveled in interstate commerce, for purposes of the Sex Offender Registration and Notification Act (SORNA), 18 U.S.C. § 2250(a), if the person crossed state lines); United States v. Schmidt, 571 F.3d 743, 747 (8th Cir. 2009) (evidence that a firearm was manufactured in one state or foreign country before coming into a defendant's possession in another state was sufficient to show that the firearm was used in or affected interstate commerce within the meaning of 18 U.S.C. § 922(g)). Thus, the purchase of raw milk by one who traveled between states to obtain it, then traveled between states before consuming it or sharing it with friends or family members, plausibly implicates "commerce between any State . . . and any place outside thereof," see 21 U.S.C. § 321(b), "introduction of [raw milk] into the channels of interstate commerce" before delivery to an ultimate consumer, see Wiesenfeld Warehouse Co., 376 U.S. at 92, and "the interstate flow of goods" prior to delivery to an ultimate consumer, see Sullivan, 332 U.S. at 696. In short, such conduct plausibly involves "causing [raw milk] to be delivered into interstate commerce." 21 C.F.R. § 1240.61.
The court notes that the "general definitions" regulation for "Subpart A — General Provisions" of Part 1240 of the pertinent regulations does not define "interstate commerce" or "delivered" or "cause to be delivered into interstate commerce." See 21 C.F.R. § 1240.3. Although that regulation does define "interstate traffic," see 21 C.F.R. § 1240.3(h), that term appears in a regulation pertaining to "molluscan shellfish," 21 C.F.R. § 1240.60, not in the regulation pertaining to "milk," 21 C.F.R. § 1240.61. The court declines to read "interstate traffic" to be synonymous with "interstate commerce" absent any indication that the court should do so, where the difference in the choice of language used in the two regulations must be deemed to have some significance. Thus, nothing in the regulatory definitions broadens or narrows the "interstate commerce" language used in § 1240.61 beyond the scope of the statutory "interstate commerce" provisions.
Moreover, courts have recognized that there are circumstances in which intrastate activities so affect interstate commerce that they fall within Congress's power to regulate interstate commerce. See, e.g., Katzenbach v. McClung, 379 U.S. 294, 301-05 (1964). Thus, while the actual purchases by the direct purchaser plaintiffs were "intrastate," their travel across state lines to make such purchases, and their return with such products across state lines, may nevertheless have involved or have had sufficient effect on interstate commerce to fall within the "interstate commerce" element of § 1240.61.
The court also notes that, in the context of prohibitions on illegal drugs, the Eighth Circuit Court of Appeals has held that "[d]istribution under 21 U.S.C. § 841(a)(1) includes not only the sale of a controlled substance but also the non-commercial transfer from one person to another." United States v. Basewell, 792 F.2d 755, 760 n. 7 (8th Cir. 1986). Thus, by analogy, "distribution" of raw dairy products under § 1240.61 can also plausibly be read to include transfer to another person, such as a family member, and such a distribution has occurred "after shipment in interstate commerce," where the raw dairy product was purchased out-of-state, and transported into the state by the purchaser to share with friends or family members.
The direct purchaser plaintiffs also contend that the FDA's direction that plaintiff Wagoner destroy the raw milk that he had purchased for himself, along with all of the other raw milk that he was transporting from South Carolina to Georgia for distribution to members of his virtual farmers' market, demonstrates that there is not only a credible threat that the FDA will enforce the regulations against a direct purchaser plaintiff, but that the FDA has actually done so. On the present record, the court must take as true the plaintiffs' allegations that Wagoner was told to destroy the raw milk that he was transporting across state lines for himself, because he had purchased it for himself, as well as the raw milk that he was transporting across state lines to distribute to others. The FDA has made no attempt to present evidence that it neither ordered Wagoner to destroy the raw milk, state officials did, nor ordered Wagoner to destroy the raw milk because he was attempting to transport some of the raw milk across state lines for his own consumption.
Thus, on the present record, the direct purchaser plaintiffs have made sufficient showing that they face a credible threat of injury to have standing.
Contrary to the defendants' contentions, these plaintiff's standing also is not defeated by a lack of causal connection between their alleged injury and the regulation or the unlikelihood that a favorable result will redress that injury. See Gray, 567 F.3d at 984 (further requirements for standing). When government action is challenged by a party who is a target or object of the government's action or regulation — as is the case here for direct purchaser plaintiffs, where their conduct is plausibly proscribed by the regulation — not only is there ordinarily little question that the government's action or regulation has caused that person injury, but little question that the judicial action will redress it. Monson, 589 F.3d at 958. The FDA's argument to the contrary misses the point. The fact that unpasteurized milk cannot be sold in the states where these plaintiffs live, so that even in the absence of the federal regulations, sales of raw milk would be unlawful in their states, is irrelevant: A declaration that the federal regulations in question are invalid would allow these plaintiffs lawfully to obtain raw milk from another state.
Thus, on the present record, taking the direct purchaser plaintiffs' allegations as true, they do have standing. ii. Standing of the principal and agent. The standing of the "principal and agent plaintiffs," Anne Cooper and Eric Wagoner, to the extent that Wagoner's standing is also based on conduct involving his "virtual farmers' market," depends upon different circumstances. The defendants have largely ignored the difference in circumstances between these plaintiffs and the direct purchaser plaintiffs.
It is more than plausible, see Zanders, 573 F.3d at 594 (the plaintiffs must nudge their claim across the line from the conceivable to the plausible), it is likely and reasonable, to read the regulations in question as proscribing a principal (Cooper) from using an agent (Wagoner) to obtain raw milk out-of-state and to deliver it to the principal in the principal's home state, as Anne Cooper has allegedly done. Such conduct is plausibly proscribed by the prohibition on "caus[ing] [raw milk] to be delivered into interstate commerce," see 21 C.F.R. § 1240.61(a), where the principal and agent not only had a commercial relationship, but that relationship involves the interstate purchase and distribution of a good or commodity. Similarly, the conduct of the agent (Wagoner) is plausibly proscribed by the prohibition on "otherwise distribut[ing], or hold[ing] for sale or other distribution after shipment in interstate commerce any [raw milk]." See 21 C.F.R. § 1240.61(a). Wagoner alleges that he transports raw milk in interstate commerce, in that he transports the raw milk across state lines and delivers it to the members of his virtual farmers' market, pursuant to a commercial transaction.
These plaintiffs' standing also is not defeated by the defendants' contentions of a lack of causal connection between their alleged injury and the regulation or the unlikelihood that a favorable result will redress that injury. See Gray, 567 F.3d at 984 (further requirements for standing). When government action is challenged by a party who is a target or object of the government's action or regulation — as is the case here for plaintiffs Cooper and Wagoner, where their conduct is not only plausibly, but clearly proscribed by the regulation — not only is there ordinarily little question that the government's action or regulation has caused that person injury, but little question that the judicial action will redress it. Monson, 589 F.3d at 958. Again, the FDA's argument that, even in the absence of the federal regulations, sales of raw milk would be unlawful in their state, is irrelevant: A declaration that the federal regulations in question are invalid would allow these plaintiffs to obtain raw milk from another state.
Thus, the principal and agent plaintiffs do have standing.
iii. The producer plaintiff. The standing of the producer plaintiff, Michael Buck, depends upon yet another set of circumstances. Buck alleges that he owns a dairy in South Carolina, that he is licensed to and does sell raw milk on his farm and in retail stores in South Carolina, where it is legal to do so if one possesses a license, but he knows that some of the purchasers of his raw milk at his farm and in the retail stores come from out of state. Again, the defendants have largely ignored the differences between Buck's circumstances and those of the other plaintiffs.
Plaintiff Buck has made a preliminary showing that a "credible threat of an injury exists" from possible enforcement of the regulations against him. American Charities for Reasonable Fundraising Regulation, Inc., 221 F.3d at 1214. It is plausible to read the regulations in question to proscribe a producer, such as Buck, from selling raw milk in an intrastate transaction to purchasers from out of state. See Zanders, 573 F.3d at 594 (the plaintiffs must nudge their claim across the line from the conceivable to the plausible). Such a producer may plausibly be construed to have "cause[d] [raw milk] to be delivered into interstate commerce." 21 C.F.R. § 1240.61(a); see also Gray, 567 F.3d at 984-95 (the plaintiff has standing if his or her conduct is clearly proscribed by the government regulation); Wiesenfeld Warehouse Co., 376 U.S. at 92 (the purpose behind the FDCA's interstate commerce regulation is to "safeguard the consumer from the time the food is introduced into the channels of interstate commerce to the point that it is delivered to the ultimate consumer"). Even though the producer engaged in only intrastate transactions, he plausibly delivered or caused raw milk to be delivered into interstate commerce, when he made intrastate sales to persons he knew were traveling from out of state to purchase the raw milk, then returning with it to their home states to consume it. This is so, again, because there are circumstances in which intrastate activities so affect interstate commerce that they fall within Congress's power to regulate interstate commerce. See, e.g., Katzenbach, 379 U.S. at 301-05.
Moreover, Buck has made an adequate preliminary showing that the FDA has enforced the regulation against other allegedly similarly-situated persons to show that there is a credible threat of prosecution against him. See, e.g, American Charities for Reasonable Fundraising Regulation, Inc., 221 F.3d at 1214. In one of the incidents of alleged enforcement of the regulations against producers, according to a FDA warning letter, an investigation of the producers was apparently prompted by an outbreak of food-borne illness, but the producers were ultimately warned of possible enforcement action based on a FDA inspection that had determined that their dairy farm caused to be delivered into interstate commerce unpasteurized milk, in finished form for human consumption, and that doing so was a violation of the PHSA, 42 U.S.C. § 271(a), and 21 C.F.R. § 1240.61(a). See Plaintiffs' Resistance, Exhibit B, Affidavit of Kennedy, Attachment A. There is no indication in the warning letter whether the warning was based on the producer's intrastate or interstate sales of raw milk, even though the E. coli outbreak
This is so, notwithstanding that the court finds two of the cases of alleged actual enforcement cited by Buck to be clearly distinguishable. The FDA's warning letter to one producer warned of possible enforcement action for a violation of 42 U.S.C. § 271(a) and 21 C.F.R. § 1240.61(a), based on the producers' distribution of raw milk and cream produced in Indiana, in final package form for direct human consumption, to cooperatives in Michigan and Illinois for further distribution to the cooperative members. See Plaintiffs' Resistance (docket no. 17), Exhibit C, Affidavit of Bemis, Attachment A. Similarly, the FDA sent a warning letter to a producer in South Carolina warning of possible enforcement action, again for a violation of 42 U.S.C. §§ 264(a) and 271(a) and 21 C.F.R. § 1261.40, based on the sale of the producer's raw milk through raw milk "co-ops" in Georgia. See id., Exhibit B, Kennedy Affidavit, Attachment B. In both cases, the producers had unquestionably "cause[d] [raw milk] to be delivered into interstate commerce," because they had engaged in interstate commercial transactions to deliver raw milk to out-of-state entities that engaged in further commercial distribution of the raw milk. In Buck's case, however, his actual sales occurred intrastate.
Although the defendants attempt to distinguish this enforcement action on the basis that the raw milk was contaminated with E. coli, that contamination was not identified as the basis for the warning of enforcement for violations of § 1240.61. Id. The defendants also assert that courts have "consistently" found that merely receiving a warning letter does not confer standing, because such letters do not commit the FDA to enforcement action, citing Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1378 (9th Cir. 1983), and Clinical Reference Lab., Inc. v. Sullivan, 791 F. Supp. 1499, 1504 (D. Kan. 1992), and that Buck has not even received such a warning letter. Neither decision stands for the cited proposition, because the court in each case considered "ripeness," a separate principle of subject matter jurisdiction from "standing." See Biotics Research Corp., 710 F.2d at 1376 1378; Clinical Reference Lab., Inc., 791 F. Supp. 1503-04. The court will consider, below, whether the fact that Buck has not even received a warning letter demonstrates that his claim is not "ripe."
occurred across state lines. The affidavit of the attorney who represented the producers in question, however, avers that the criminal prosecution of the producers for a violation of 21 C.F.R. § 1240.61 was based on the producers' knowledge that residents of Oregon had traveled to Washington to obtain raw milk from the producers, then had taken the raw milk back across state lines into Oregon for human consumption. See id., Affidavit of Kennedy, ¶ 11. Buck expressly alleges that he also knows that some buyers of his raw milk are from out of state and that they take the raw milk back to their own states for human consumption. See Amended Complaint, ¶ 42. Thus, evidence of this enforcement action is sufficient to make a preliminary showing that Buck faces a credible threat of injury, and, therefore, has standing. Again, the defendants' assertions that Buck cannot show the necessary causal connection between his alleged injury and the regulations or that a favorable result will redress that injury, see Gray, 567 F.3d at 984 (further requirements for standing), are completely unpersuasive.
Thus, Buck, the producer plaintiff, also has standing.
c. Summary
That part of the defendants' Motion To Dismiss seeking dismissal of the plaintiffs' claims for lack of standing will be denied. 4. Ripeness
The defendants do not separately challenge the standing of the "organizational" or "associational" plaintiff, the Fund. Suffice it to say that the Fund has standing, because it has shown, through specific facts, that at least one of its members — indeed, two, Wagoner and Buck — would be directly affected by the challenged regulations, see Summers v. Earth Island Institute, 129 S.ct. 1142, 1151-52 (2009); Warth v. Seldin, 422 U.S. 490, 511 (1975), and the claims of those members are germane to the organization's purpose. Metropolitan St. Louis Sewer Dist., 569 F.3d at 834; see also Americans United for Separation of Church and State v. Prison Fellowship Ministries, Inc., 509 F.3d 406, 419 (8th Cir. 2007).
The defendants contend that, even if the plaintiffs or some of them have standing, their claims are not ripe for judicial consideration. Because the court found above that the plaintiffs have made sufficient preliminary showing that they have standing, the court turns to consideration of the defendants' challenges to the ripeness of the plaintiffs' claims.
a. Arguments of the parties
The defendants contend that the plaintiffs' claims are not fit for judicial consideration, because they do not raise purely legal issues. Rather, the defendants contend that the plaintiffs seek an advisory opinion from the court on mixed legal and factual issues, such as whether the many different actions purportedly taken by the plaintiffs to obtain raw milk from unidentified sources in numerous states would violate the FDA's regulations. The defendants contend that only in the context of specific enforcement action by the FDA will the agency have gathered the necessary evidence and made the requisite administrative determinations to permit meaningful judicial review. The defendants also argue that the plaintiffs posit a number of possible interpretations of the FDA's regulations that they contend could render their purported conduct unlawful, but that they do not show that the FDA has ever adopted such interpretations or ever used them as the basis for an enforcement action. The defendants also assert that the plaintiffs do not satisfy the "hardship" prong of the ripeness analysis, because they cannot demonstrate that they have sustained or are immediately in danger of sustaining some direct injury as the result of the challenged regulations. The defendants also argue that they have a strong institutional interest in this court withholding review, because finding that a ripe claim can be based on anyone's construction of FDA regulations, whether such a construction has ever been adopted or applied by the FDA, would waste the FDA's and the court's resources, leaving less resources for actual cases.
The plaintiffs agree that, in order for a declaratory judgment action to be "ripe," the issues should be largely legal in nature, those issues can be resolved without further factual development, and the resolution of the case will largely settle the parties' dispute. The plaintiffs contend that they satisfy these requirements, because they do face enforcement action from the FDA. They also argue that, because their allegations must be construed as true, the case presents purely legal issues of whether § 1240.61 and § 131.110 are unconstitutional as applied to them. Moreover, they contend that the issues should be addressed now to resolve this dispute so that the FDA and the plaintiffs can gain clarity on the application, scope, and extent of § 1240.61 and § 131.110.
In reply, the defendants assert that the plaintiffs are unabashedly seeking an advisory opinion, not adjudication of ripe claims, when they acknowledge that their claims are to "gain clarity" on the application, scope, and extent of the regulations.
b. Analysis
As the Eighth Circuit Court of Appeals has explained,
"The ripeness doctrine flows both from the Article III `cases' and `controversies' limitations and also from prudential considerations for refusing to exercise jurisdiction."
Nebraska Pub. Power Dist. v. MidAmerican Energy Co., 234 F.3d 1032, 1037 (8th Cir. 2000). The "basic rationale is to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements."
Abbott Labs. v. Gardner, 387 U.S. 136, 148, 87 S.ct. 1507,
18 L. Ed. 2d 681 (1967). It is well settled that the ripeness inquiry requires the examination of both "the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration."
Id. at 149, 87 S.ct. 1507. This court recently determined that "[a] party seeking judicial relief must necessarily satisfy both prongs to at least a minimal degree."
Nebraska Pub. Power, 234 F.3d at 1039.
Public Water Supply Dist. No. 10 of Cass County, Mo. v. City of Peculiar, Mo., 345 F.3d 570, 572-73 (8th Cir. 2003). The court will consider each of these prongs of the ripeness analysis in turn.
i. Fitness. The Eighth Circuit Court of Appeals has explained that "`[t]he `fitness for judicial decision' inquiry goes to a court's ability to visit an issue.'" Public Water Supply Dist. No. 10, 345 F.3d at 573 (quoting Nebraska Pub. Power, 234 F.3d at 1038). More specifically,
Whether a case is "fit" depends on whether it would benefit from further factual development.
See [Nebraska Pub. Power, 234 F.3d at 1038];
see also Nat'l Right to Life Political Action Comm. v. Conner, 323 F.3d 684, 692-93 (8th Cir. 2003). The case is more likely to be ripe if it poses a purely legal question and is not contingent on future possibilities.
See Nebraska Pub. Power, 234 F.3d at 1038.
Public Water Supply Dist. No. 10 of Cass County, Mo., 345 F.3d at 573. In contrast, the Eighth Circuit Court of Appeals has held that "to resolve an issue lacking factual development simply to avoid a threatened harm would be to favor expedition over just resolution."
Nebraska Pub. Power Dist. v. MidAmerican Energy Co., 234 F.3d 1032, 1039 (8th Cir. 2000);
see also Yankton Sioux Tribe v. Podhrasky, 606 F.3d 994, 1015 (8th Cir. 2010) (quoting
Nebraska Pub. Power District). Thus, where "a number of potentially important facts are missing" with respect to the purported application of a regulation or statute, the court may decline to consider the questions presented in the absence of a fully developed record.
Yankton Sioux Tribe, 606 F.3d at 1015. Similarly, "`[a] claim is not ripe for adjudication if it rests upon "contingent future events that may not occur as anticipated, or indeed may not occur at all."'"
Minnesota Pub. Utils. Comm'n v. FCC, 483 F.3d 570, 582 (8th Cir. 2007) (quoting
Texas v. United States, 523 U.S. 296, 300 (1998), in turn quoting
Thomas v. Union Carbide Agric. Prods. Co., 473 U.S. 568, 580-581 (1985)).
The court is not persuaded by the defendants' contention that the plaintiffs are seeking an advisory opinion from the court on mixed legal and factual issues, such as whether many different kinds of actions would violate the FDA's regulations. The court also is not persuaded by the defendants' argument that only in the context of specific enforcement action by the FDA will the agency have gathered the necessary evidence and made the requisite administrative determinations to permit meaningful judicial review. Indeed, the court finds that the defendants are challenging the ripeness of the wrong claims: The plaintiffs' claims are not, as the defendants seem to assert, whether the many different actions purportedly taken by the plaintiffs to obtain raw milk from unidentified sources in numerous states would violate the FDA's regulations, but whether the regulations are unconstitutional or otherwise invalid.
Contrary to the defendants' contentions, this case poses the following essentially legal questions or, at least, questions not contingent on future possibilities, see Public Water Supply Dist. No. 10 of Cass County, Mo., 345 F.3d at 573: (1) whether the regulations in question violate the rights of persons who travel from one state, where it is not legal to purchase raw milk, to another state, where it is legal to purchase raw milk, legally purchase raw milk, then return to the original state where they consume the raw milk themselves or give it to their friends or family members; (2) whether the regulations in question violate the rights of a principal and agent who agree that the agent will obtain raw milk out-of-state, where it is legal to do so, and deliver it to the principal in the principal's home state, where sales of raw milk are not permitted; and (3) whether the regulations in question violate the rights of a producer of raw milk who sells raw milk in an intrastate transaction to persons that he knows are from out of state. The defendants have failed to identify any potentially important facts that are missing with respect to the purported application of the regulations to these plaintiffs, so that it is not incumbent on the court to decline to exercise jurisdiction over their claims. Yankton Sioux Tribe, 606 F.3d at 1015. Although "`[a] claim is not ripe for adjudication if it rests upon "contingent future events that may not occur as anticipated, or indeed may not occur at all,"'" Minnesota Pub. Utils. Comm'n, 483 F.3d at 582 (quoting Texas, 523 U.S. at 300, in turn quoting Thomas, 473 U.S. at 580-581), the court does not believe that principle requires that the plaintiffs be subjected to an actual enforcement action for their claims to be ripe, or no pre-enforcement challenge would ever be ripe. Rather, the court reads that principle to apply to conduct of the plaintiffs, and here, there is no contingency concerning whether or what the plaintiffs have done and are continuing to do.
The court concludes that the plaintiffs' claims are "fit" for judicial review.
ii. Hardship. As to the "hardship" prong,
"[A]bstract injury is not enough. It must be alleged that the plaintiff has sustained or is immediately in danger of sustaining some direct injury as the result of the challenged statute or official conduct."
O'Shea v. Littleton, 414 U.S. 488, 494, 94 S.ct. 669,
38 L. Ed. 2d 674 (1974) (internal quotations and citations omitted). "The plaintiffs need not wait until the threatened injury occurs, but the injury must be `certainly impending.'"
Paraquad, Inc. v. St. Louis Hous. Auth., 259 F.3d 956, 958-59 (8th Cir. 2001) (quoting
Babbitt v. United Farm Workers Nat'l Union, 442 U.S. 289, 298, 99 S.ct. 2301,
60 L. Ed. 2d 895 (1979)).
Public Water Supply Dist. No. 10 of Cass County, Mo., 345 F.3d at 573.
The plaintiffs contend that denial of review would impose a hardship on them, because they are subject to imminent enforcement of the regulations in question against them. The defendants contend that they have not attempted to enforce the regulations against any of the plaintiffs, nor have they warned any of the plaintiffs of the possibility of enforcement action by warning letter, so that these plaintiffs cannot show that any injury is certainly impending. The defendants contend that even warning letters would not be enough to give the court subject matter jurisdiction over the plaintiffs' claims, because they do not commit the FDA to enforcement action, citing Biotics Research Corp. v. Heckler, 710 F.2d 1375, 1378 (9th Cir. 1983), and Clinical Reference Lab., Inc. v. Sullivan, 791 F. Supp. 1499, 1504 (D. Kan. 1992).
As noted above, the defendants cited these decisions in support of their contention that courts have "consistently" found that merely receiving a warning letter does not confer standing, because such letters do not commit the FDA to enforcement action. Neither decision stands for the proposition for which the defendants cite them, because the court in each case considered "ripeness," not "standing." See Biotics Research Corp., 710 F.2d at 1376 1378; Clinical Reference Lab., Inc., 791 F. Supp. 1503-04. This court will now consider the import of these decisions in the appropriate context of "ripeness."
The defendants contend that plaintiff Wagoner's allegations of actual enforcement action against him and against one of his principals, Cooper, are "bizarre" and unsupported. The defendants contend that, if the FDA, rather than state officials, had actually ordered the destruction of the raw milk as alleged, the FDA would have done so in a in rem seizure action, pursuant to the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 334, in which Wagoner (and presumably Cooper) would have had the opportunity to appear and object, but there is no evidence of any such action. Interestingly, the defendants do not dispute Wagoner's contention that a FDA agent was present at the destruction of the raw milk, nor do they offer any evidence demonstrating that the destruction of the raw milk was entirely on the authority of Georgia state officials, not the FDA. Under the circumstances, where the court has construed the defendants' challenge to subject matter jurisdiction as essentially facial, the court must take as true the plaintiffs' allegations that the FDA ordered the destruction of the raw milk that Wagoner was transporting across state lines to distribute to Cooper and others, so that Wagoner and Cooper have, indeed, already been subjected to enforcement action by the FDA pursuant to the regulations in question. Consequently, the court must conclude that the injury that Wagoner and Cooper fear is "certainly impending." Public Water Supply Dist. No. 10 of Cass County, Mo., 345 F.3d at 573 (citations omitted).
As to the "hardship" of the other plaintiffs, the court does not find that the lack of warning letters means that these plaintiffs' claims are not "ripe." The court acknowledges that, in Biotics Research Corporation and Clinical Reference Laboratory, other courts concluded that warning letters sent to the plaintiffs, warning of possible agency enforcement action, were not enough to make the plaintiffs' claims ripe, because the warning letters did not constitute final agency action that would have established sufficiently imminent injury. See Biotics Research Corp., 710 F.2d at 1376 1378; Clinical Reference Lab., Inc., 791 F. Supp. 1503-04. Here, none of the plaintiffs have alleged that they have even received warning letters. The court disagrees with the decisions in Biotics Research and Clinical Reference Laboratory to the extent that they could be read to require final agency action, or notice from an agency committing the agency to enforcement action, to establish sufficiently imminent injury to show "hardship" and, consequently, "ripeness." Such a rule would mean that no pre-enforcement challenge to agency regulations is ever ripe, but the test is whether the plaintiffs have alleged that they have sustained or are immediately in danger of sustaining some direct injury as the result of the challenged statute or official conduct. See Public Water Supply Dist. No. 10 of Cass County, Mo., 345 F.3d at 573. The "hardship" prong of the "ripeness" analysis does not require the plaintiff to wait until the threatened injury occurs. Id.
For much the same reason that the court found that the direct purchaser plaintiffs had made sufficient preliminary showing of a credible threat of injury, for standing purposes, the court now finds that they have made sufficient preliminary showing that they are in immediate danger of sustaining some direct injury, as the result of the challenged regulations, for ripeness purposes. These plaintiffs have made an essentially unchallenged showing that Wagoner, a similarly-situated plaintiff, was ordered to destroy milk that he had purchased for himself then transported across state lines and that such conduct plausibly falls within the prohibitions of the regulations. Furthermore, for much the same reason that the court found that the producer plaintiff, plaintiff Buck, had made sufficient preliminary showing of a credible threat of injury, for standing purposes, the court now finds that he has made sufficient preliminary showing that he is in immediate danger of sustaining some direct injury, as the result of the challenged regulations, for ripeness purposes. Plaintiff Buck has made an essentially unchallenged showing that a similarly-situated producer was subject to a FDA criminal enforcement action, because, like him, that producer knew that some buyers of his raw milk were from out of state and that they were taking the raw milk back to their own states for human consumption. See Amended Complaint, ¶ 42.
Therefore, the plaintiffs also satisfy the "hardship" prong of the "ripeness" analysis.
c. Summary
That part of the defendants' Motion To Dismiss seeking dismissal of the claims of the plaintiffs on "ripeness" grounds will be denied. 5. Foreclosure by Ewing
The last arrow in the defendants' quiver as they attempt to shoot down the plaintiffs' claims for lack of subject matter jurisdiction is that the plaintiffs' claims for declaratory and injunctive relief barring the government from applying the FDA's regulations are foreclosed by Ewing v. Mytinger Casselberry, Inc., 339 U.S. 594 (1950). The plaintiffs dispute the applicability of Ewing to their claims.
a. Arguments of the parties
The defendants assert that Ewing bars actions for judicial review at preliminary phases of the FDA's administrative procedures, such as whether or not to institute enforcement actions at all. The defendants argue that, if the FDA were to determine that the plaintiffs' alleged conduct violates FDA regulations prohibiting the interstate sale and distribution of unpasteurized milk, then the government would have the discretion to initiate a seizure or injunctive action pursuant to provisions of the FDCA, 21 U.S.C. §§ 332 and 334. At that time, the defendants argue, the plaintiffs would have the opportunity to raise and litigate the claims that they advance in the present action. At this time, however, the defendants contend, the plaintiffs' request is for this Court to enjoin all such future enforcement action, but that request is plainly foreclosed by Ewing and its progeny.
The plaintiffs contend that Ewing is simply not on point, because the Supreme Court has determined that Ewing does not apply to a declaratory judgment action, even a pre-enforcement action, in Abbott Laboratories v. Gardner, 387 U.S. 136 (1967). Although they acknowledge that Abbott has been overturned as to its holding that the Administrative Procedures Act (APA) grants federal courts an independent jurisdictional basis to hear challenges to agency action, they contend that Abbott is still controlling on the ability of litigants to bring declaratory judgment actions to challenge the application of final agency action.
In reply, the defendants argue that Ewing forecloses the plaintiffs' action, because the plaintiffs expressly prayed for injunctive relief enjoining further enforcement of the regulations against them. In a rather dramatic reformulation of their argument, however, the defendants also contend that the plaintiffs do not meet the Abbott ripeness standard, because the parties here do not agree that the issues presented are purely legal or that the regulations are directed at the plaintiffs in particular, and the FDA has not indicated that immediate compliance with its regulations is expected. Indeed, the FDA argues that it is by no means clear that the regulations in question even touch the plaintiffs' alleged conduct. The defendants contend that this case is more akin to Toilet Goods Association v. Gardner, 387 U.S. 158 (1967), in which the Supreme Court held that the judicial review was not appropriate where the court had no idea whether or when the challenged FDA regulation would be enforced or what reasons the Commissioner would give to justify the enforcement order. The defendants contend that the Court reached that conclusion in Toilet Goods, even though there was no question that the FDA's regulation constituted final agency action and the challenge to it was a purely legal question. The defendants argue that, just as in Toilet Goods, the present dispute requires additional factual development — whether through plaintiffs' submission of a citizen petition or a FDA investigation and enforcement action — before this court could have sufficient information to determine whether the challenged regulations even apply to the plaintiffs' conduct. b. Analysis
The court finds the defendants' reliance on Ewing to be particularly ill-founded. This is so, even though the defendants are correct that the plaintiffs pray, inter alia, for "[a]n injunction enjoining any further enforcement, civil, criminal, administrative or otherwise, of [the regulations] against Plaintiffs." Amended Complaint at 26, ¶ G. Although Ewing bars judicial review of and injunctive relief against preliminary phases of administrative procedures to enforce regulations, including the determination of whether or not to institute an enforcement action, see Ewing, 339 U.S. at 600-01, nothing in Ewing bars a court from hearing an action for declaratory judgment concerning the validity of final agency regulations in which there is an incidental, perhaps overbroad, prayer for injunctive relief pursuant to the declarations sought. The bar in Ewing on enjoining preliminary phases of administrative procedures to enforce regulations simply has no application, where there are no administrative procedures to enforce the regulations at issue currently afoot. The defendants' reading of Ewing would preclude any and all pre-enforcement declaratory challenges to regulations if there is a prayer for incidental injunctive relief. Ewing does not reach so far.
Moreover, contrary to the defendants' belated retrenchment, this case is closer to Abbott than to Toilet Goods. Contrary to the defendants' contentions, the court concluded above that the challenge by the plaintiffs poses the following legal questions, or at least questions not contingent on future possibilities: (1) whether the regulations in question violate the rights of persons who travel from one state, where it is not legal to purchase raw milk, to another state, where it is legal to purchase raw milk, legally purchase raw milk, then return to the original state where they consume the raw milk themselves or give it to their friends or family members; (2) whether the regulations in question violate the rights of a principal and agent who agree that the agent will obtain raw milk out-of-state, where it is legal to do so, and to deliver it to the principal in the principal's home state, where sales of raw milk are not permitted; and (3) whether the regulations in question violate the rights of a producer of raw milk who sells raw milk in an intrastate transaction to persons that he knows are from out of state. The defendants have failed to identify any potentially important facts that must be determined through a citizen petition or agency enforcement action that are necessary to determine the applicability of the regulations to the conduct of these plaintiffs, where the court held, above, that the plaintiffs have made an adequate preliminary showing that the regulations plausibly proscribe their conduct and that the FDA stands ready to enforce the regulations against conduct such as theirs.
Thus, the questions presented here are purely legal and based on undisputed factual circumstances, and it appears that the FDA does stand ready to enforce compliance with the regulations, to the extent that the FDA has purportedly already enforced them against these plaintiffs and allegedly similarly situated persons. Compare Abbott, 387 U.S. 146-47 (finding that an action for judicial review was not foreclosed by Ewing where the FDA had already formally promulgated the regulation in question, the regulation was "self-operative," and foreclosure of an action in such circumstances would immunize nearly all agency rule-making from review under the APA, and while Ewing barred interference with the early stages of administrative determinations as to specific facts, it did not bar well-established jurisdiction of the federal courts to hear suits under the Declaratory Judgment Act), with Toilet Goods, 387 U.S. at 163 (the Court found no jurisdiction where it had "no idea whether or when such an inspection will be ordered and what reasons the Commissioner will give to justify his order").
The defendants' final attack on the court's subject matter jurisdiction over the plaintiffs' claims, thus, fails, at least on the present record.
6. Summary
The court concludes — in light of the present submissions and the failure of the defendants to mount an unambiguously factual challenge to subject matter jurisdiction — that the plaintiffs have standing to pursue their claims and that those claims are ripe for judicial determination. The court reiterates, however, that these conclusions are preliminary, and turn in large part on the court's obligation to take as true the plaintiffs' jurisdictional allegations, in the absence of a full-fledged factual challenge to subject matter jurisdiction and a request for an evidentiary hearing by the defendants.
B. Failure To Exhaust Administrative Remedies
The defendants also mount several challenges pursuant to Rule 12(b)(6) to the plaintiffs' Amended Complaint on the ground that the Amended Complaint fails to state claims upon which relief can be granted. However, the court finds that only one of those challenges, the plaintiffs' alleged failure to exhaust administrative remedies, must be addressed at this time, in light of the court's strictly preliminary determination that the plaintiffs have standing and that their claims are ripe. Although failure to exhaust administrative remedies is not a jurisdictional impediment, see Teva Pharm. USA, Inc. v. Sebelius, 638 F. Supp. 2d 42, 51 (D.D.C. 2009), rev'd on other grounds, 595 F.3d 1303 (D.C. Cir. 2010), the defendants' failure-to-exhaust challenge is, nevertheless, another version of the defendants' overarching contention that the plaintiffs' claims are not yet ready for judicial determination.
1. Arguments of the parties
The defendants contend that dismissal is appropriate, where the plaintiffs have failed to avail themselves of the administrative process. They contend that the plaintiffs have made no attempt to avail themselves of, much less exhaust, administrative remedies available to them, consisting of a citizen's petition with the FDA pursuant to 21 C.F.R. §§ 10.25 and 10.30. The defendants contend that, pursuant to 21 C.F.R. § 10.45(b), before any legal action is filed in a court, a party must first file a citizen petition to request that the Commissioner take or refrain from taking any form of administrative action and, pursuant to 21 C.F.R. § 10.45(d), the FDA's response to such a petition constitutes reviewable final agency action. Here, the defendants argue that the plaintiffs' attempt to bypass the administrative process means that they have precluded meaningful and efficient judicial review, which would have allowed the FDA to consider and address the plaintiffs' concerns and which could have resolved or at least crystalized the issues.
The plaintiffs counter that exhaustion of administrative remedies does not apply to a declaratory judgment action such as this. The plaintiffs contend that there are no administrative remedies for them to exhaust, because the requirement for administrative proceedings, on its face, does not apply to an as-applied challenge to the constitutionality of the regulations through a declaratory judgment action. The plaintiffs also contend that promulgation of the regulations is reviewable final agency action. The plaintiffs next contend that the FDA lacks authority to rule on the constitutionality of the regulations in question, citing Mathews v. Diaz, 426 U.S. 67, 76 (1976). They also argue that the FDA has already exhibited its bias or predetermination of the issues, because it will not modify, amend, or revoke the regulations in question, where it has already been presented with a citizen's petition (by persons not parties here) asking the agency to amend or rescind the regulations in question, but the agency has taken no action upon that citizen's petition within the required time frame. Finally, assuming that an administrative remedy exists, the plaintiffs argue that pursuing that remedy would be an exercise in futility, because the FDA has made clear in public statements that it believes that raw milk should not be consumed by anyone and has refused to debate the issue in available public fora.
2. Analysis a. The administrative exhaustion requirement
Rule 12(b)(6) provides for a motion to dismiss for failure to state a claim upon which relief can be granted. The defendants assert that failure to exhaust administrative remedies under FDA regulations warrants dismissal pursuant to Rule 12(b)(6), citing Association of Am. Physicians Surgs., Inc. v. FDA, 539 F. Supp. 2d 4, 22 (D.D.C. 2008). This court will assume, without deciding, that failure to exhaust the FDA's administrative remedies warrants dismissal for failure to state a claim pursuant to Rule 12(b)(6), where exhaustion of administrative remedies is required by statute or regulation.
As the defendants point out, "[t]he basic purpose of the exhaustion doctrine is to allow an administrative agency to perform functions within its special competence — to make a factual record, to apply its expertise, and to correct its own errors so as to moot judicial controversies." See Parisi v. Davidson, 405 U.S. 34, 37 (1972). If interested parties were allowed to bypass administrative remedies, the entire regulatory process would be undermined, and "[c]ourts would constantly have to address new arguments that were never presented to the agency." Association of Am. Physicians Surgeons, Inc., 539 F. Supp. 2d at 22. Moreover, "[a]n administrative agency, which is not subject to Article III of the Constitution of the United States and related prudential limitations, may issue a declaratory order in mere anticipation of a controversy or simply to resolve an uncertainty." Pfizer, Inc. v. Shalala, 182 F.3d 975, 980 (D.C. Cir. 1999) (citing Metropolitan Council of NAACP Branches v. FCC, 46 F.3d 1154, 1161 (D.C. Cir. 1995)).
However, as the plaintiffs point out, a party "cannot `properly be required to exhaust a remedy which may not exist.'" Parisi, 405 U.S. at 44 (quoting Noyd v. Bond, 395 U.S. 683, 698 n. 11 (1969)). Moreover,
Courts have the discretion to decline to require exhaustion where a plaintiff would be irreparably harmed by delay, where the agency lacks the power to grant effective relief, or where exhaustion would be futile.
McCarthy v. Madigan, 503 U.S. 140, 146-49,
112 S.Ct. 1081,
117 L.Ed.2d 291 (1992). Exhaustion is futile when there is a certainty of an adverse decision,
Randolph-Sheppard Vendors v. Weinberger, 795 F.2d 90, 105 (D.C. Cir. 1986), or when the agency "has evidenced a strong position on the issue together with an unwillingness to reconsider."
James v. HHS, 824 F.2d 1132, 1137 (D.C. Cir. 1987).
Teva Pharm., 638 F. Supp. 2d at 51;
see also Chorosevic v. MetLife Choices, 600 F.3d 934, 945 (8th Cir. 2010) (also recognizing,
in the ERISA context, that exhaustion of
administrative remedies may be excused if they would be futile, but observing, "`Unsupported and speculative claims of futility do not excuse a claimant's failure to exhaust his or her administrative remedies,'" quoting Midgett v. Washington Group Int'l Long Term Disability Plan, 561 F.3d 887, 898 (8th Cir. 2009)). Matters outside the agency's power to grant effective relief include determination of the constitutionality of a statute, see McCarthy, 503 U.S. at 147-48, and, presumably, the constitutionality of a regulation.
b. The necessity of exhaustion of the present claims
These principles bring the court to the question of whether and for what questions administrative exhaustion is required by FDA regulations. As a colleague in a sister district has concisely explained, "FDA regulations require that, before filing suit in court, a party requesting that the FDA take or refrain from taking an action must first use the citizen petition process set forth in 21 C.F.R. § 10.25." Teva Pharm, 638 F. Supp. 2d at 51 (citing 21 C.F.R. § 10.45(b)). The FDA's response to a citizen petition is deemed to be a "`final agency action . . . reviewable in the courts.'" Pfizer, 182 F.3d at 979-80 (quoting 21 C.F.R. § 10.45(d)); Schering Corp. v. FDA, 51 F.3d 390, 393 (3d Cir. 1995).
Somewhat more specifically, 21 C.F.R. § 10.25(a) provides that "[a]n interested person may petition the Commissioner [1] to issue, amend, or revoke a regulation or order, or [2] to take or refrain from taking any other form of administrative action." (Emphasis added). That regulation provides, further, that "a petition must be either . . . [i]n the form specified [for specific agency actions], or . . . in the form of a citizen petition in § 10.30." 21 C.F.R. § 10.25(a). Section 10.45(b) makes certain administrative exhaustion mandatory:
(b) A request that the Commissioner
take or refrain from taking any form of administrative action must first be the
subject of a final administrative decision based on a petition submitted under § 10.25(a) or, where applicable, a hearing under § 16.1(b) before any legal action is filed in a court complaining of the action or failure to act.
If a court action is filed complaining of the action or failure to act before the submission of the decision on a petition under § 10.25(a) or, where applicable, a hearing under § 16.1(b),
the Commissioner shall request dismissal of the court action or referral to the agency for an initial administrative determination on the grounds of a failure to exhaust administrative remedies, the lack of final agency action as required by
5 U.S.C. 701 et seq., and the lack of an actual controversy as required by
28 U.S.C. 2201.
21 C.F.R. § 10.45(b) (emphasis added). Although this exhaustion requirement expressly applies to requests that the Commissioner "take or refrain from taking any form of administrative action," one category of requests that may be asserted in an administrative petition pursuant to § 10.25(a), conspicuous by its absence is any reference to the other category of requests identified in § 10.25(a), requests that the Commissioner "issue, amend, or revoke a regulation or order."
See 21 C.F.R. § 10.25(b).
Even so, this court is not convinced that the plaintiffs' claims fall into either of the categories of claims for which a citizen petition is appropriate or required pursuant to 21 C.F.R. § 10.25(b). If this action were for review of a specific administrative enforcement action, then it clearly would fall within the scope of the FDA's administrative remedies, as an action requesting that the Commissioner "refrain from taking [a] form of administrative action," and exhaustion of administrative remedies would clearly be required. 21 C.F.R. §§ 10.25(a) 10.45(b). It is not. It is, instead, a challenge to the validity and constitutionality of certain FDA regulations, and only incidentally seeks declaratory and injunctive relief against enforcement of the regulations against the plaintiffs on the basis of the unconstitutionality of the regulations. Moreover, a determination of the
constitutionality of the regulations falls outside the scope of agency expertise. Cf. McCarthy, 503 U.S. at 147-48 (matters outside the agency's power to grant effective relief include determination of the constitutionality of a statute). Even though the plaintiffs' challenge to the regulations is purportedly an "as applied" challenge, the FDA has not shown that it is necessary to make a factual record, apply its expertise, or correct its own errors in order to resolve the claims presented, see Parisi, 405 U.S. 37 (identifying areas of special competence of administrative agencies), where the question ultimately presented by the plaintiffs' claims is whether the regulations are constitutional. In short, this is a case in which an administrative remedy does not exist and, therefore, exhaustion of such a non-existent remedy cannot be required. Id.
The part of the defendants' Motion To Dismiss seeking dismissal of the plaintiffs' claims for failure to exhaust administrative remedies will be denied.
c. The prudence of exhaustion of questions ante
On the other hand, there are questions ante to the plaintiffs' constitutional claims that would fall within the scope of a citizen petition pursuant to § 10.25, if presented as a request that the FDA take administrative action to interpret the authorizing statutes and regulations. Such a request for agency action also falls squarely within the administrative agency's expertise.
More specifically, one of the fundamental disputes in this is that the plaintiffs assume, albeit supported by some circumstantial evidence, that the FDA believes that the plaintiffs' conduct falls within the proscriptions of § 1240.61, while the defendants' assert that the FDA has not and does not intend to enforce the regulations against any of the plaintiffs or persons similarly situated to the plaintiffs. In the context of this dispute, the precise question appropriate for administrative determination, in the first instance, is whether § 1240.61 applies to and proscribes the conduct of (1) persons who travel from one state, where it is not legal to purchase raw milk, to another state, where it is legal to purchase raw milk, legally purchase raw milk, then return to the original state where they consume the raw milk themselves or give it to their friends or family members; or (2) a principal and agent who agree that the agent will obtain raw milk out-of-state, where it is legal to do so, and to deliver it to the principal in the principal's home state, where sales of raw milk are not permitted; or (3) a producer of raw milk who sells raw milk in an intrastate transaction to persons that he knows are from out of state. This question presents constituent questions of the scope of the authorizing statutes and the regulations at issue, including whether the plaintiffs' conduct involves or affects "interstate commerce" sufficiently to fall within the proscriptions of § 1240.61, and, still more specifically, whether the plaintiffs' conduct constitutes "delivery [of raw dairy products] into interstate commerce" or "distribution" of raw dairy products after shipment in interstate commerce.
As noted above, even in the absence of a "live" controversy, "[a]n administrative agency, which is not subject to Article III of the Constitution of the United States and related prudential limitations, may issue a declaratory order in mere anticipation of a controversy or simply to resolve an uncertainty." Pfizer, 182 F.3d at 980. An administrative determination on these questions might, in turn, resolve finally the questions about the plaintiffs' standing and the ripeness of their claims, which the court has not finally resolved here, in the absence of a clear factual challenge. See Parisi, 405 U.S. at 37 (administrative exhaustion may, through the application of agency expertise, moot judicial controversies).
The court is not convinced by the plaintiffs' assertions that any administrative proceedings would be futile. See, e.g., Teva Pharm., 638 F. Supp. 2d at 51 (a claimant need not exhaust futile administrative remedies). The allegedly entrenched position attributed to the FDA by the plaintiffs — that raw milk should not be consumed by anyone — simply does not directly implicate any of the questions posed just above. Nor does the FDA's alleged inaction on a citizen petition by a non-party, asking the FDA to amend or rescind § 1240.61 and/or § 131.110 to allow the interstate shipment of raw dairy products between two different states in the United States that both allow the legal sale of raw dairy products, see Plaintiffs' Resistance, Exhibit D, demonstrate that a citizen petition posing different questions — the questions ante identified above — is necessarily futile. Indeed, the court finds the plaintiffs' contentions that administrative proceedings on any question would be futile to be, at best, speculative and, hence, insufficient to excuse exhaustion of the questions ante identified just above. Chorosevic, 600 F.3d at 945 ("`Unsupported and speculative claims of futility do not excuse a claimant's failure to exhaust his or her administrative remedies,'" quoting Midgett, 561 F.3d at 898).
Consequently, the court finds that the prudent course is to stay proceedings to allow the plaintiffs to determine whether or not to pursue a citizen petition presenting to the agency the questions ante posed above, then revisit, if necessary, the questions of standing, ripeness, and failure to state claims upon which relief can be granted.
III. CONCLUSION
Faced with the uncertain nature of the defendants' challenge to the court's subject matter jurisdiction, the court has construed the challenge as essentially a preliminary, facial one. The court finds, however, that the plaintiffs have made sufficient preliminary showing of standing and ripeness to deny the defendants' Motion To Dismiss for lack of subject matter jurisdiction, without prejudice to reassertion of a full factual challenge. Although the court does not find that administrative exhaustion is required for the plaintiffs' present claims, the court does find that it would be prudent to allow the plaintiffs time to pursue a citizen petition pursuant to 21 C.F.R. § 10.25 raising certain questions ante, identified above.
THEREFORE,
1. That part of the defendants' April 26, 2010, Motion To Dismiss (docket no. 10) asserting lack of subject matter jurisdiction is denied, but without prejudice to a full factual challenge to subject matter jurisdiction after expiration of the stay imposed below;
2. That part of the defendants' April 26, 2010, Motion To Dismiss (docket no. 10) asserting failure to state a claim upon which relief can be granted is denied as to failure to exhaust administrative remedies, but ruling is reserved on the remainder of the defendants' Motion To Dismiss asserting failure to state claims upon which relief can be granted;
3. Proceedings in this court are stayed for sixty days from the date of this order to allow the plaintiffs the opportunity to decide whether or not to pursue a citizen petition pursuant to 21 C.F.R. § 10.25 asking the Commissioner to take administrative action in the form of interpretation of the authorizing statutes and regulations in light of the questions ante posed herein.
a. If the plaintiffs choose to pursue a citizen petition, the court will continue the stay until the completion of the administrative proceedings on that petition or until the agency has failed to take timely action on the citizen petition.
b. If the plaintiffs decline to pursue a citizen petition raising the questions posed just above, the court will entertain a renewed, and clearly factual challenge to subject matter jurisdiction, and will address the remainder of the defendants' Motion To Dismiss for failure to state claims upon which relief can be granted.
c. The parties shall file, separately or jointly, a
status report at least every thirty days from the date of this order advising the court as to the necessity of continuing or lifting the stay.
4. The plaintiffs' July 24, 2010, Motion To Admit Newly Discovered Evidence (docket no. 24) is granted, and the court has considered the purportedly newly discovered evidence in question for whatever probative value the court found that such evidence had.
IT IS SO ORDERED.
DATED this 18th day of August, 2010.