N.R. SMITH, Circuit Judge:
The Supreme Court "has adopted what amounts to a two-tiered approach to analyzing state economic regulation under the
Id. at 579, 106 S.Ct. 2080 (citations omitted). Because the Alameda County Safe Drug Disposal Ordinance (the "Ordinance") passes constitutional muster under this two-tiered approach, we affirm the district court.
The facts are not in dispute. Alameda County ("Alameda") passed the Ordinance in July of 2012. The Ordinance requires that prescription drug manufacturers, who either sell, offer for sale, or distribute "Covered Drugs" in Alameda, operate and finance a "Product Stewardship Program." The term "Covered Drug" includes "all drugs in 21 U.S.C. § 321(g)(1) of the Federal Food, Drug and Cosmetic Act ... including both brand name and Generic Drugs." To operate and finance a Product Stewardship Program, the manufacturers must provide for the collection, transportation, and disposal of any unwanted Covered Drug — no matter which manufacturer made the drug in question.
Facially, the Ordinance applies equally to both manufacturers located within Alameda and manufacturers located outside the county. While some manufacturers have their corporate offices or principal places of business in Alameda, all prescription drugs currently sold arrive in Alameda via inter-county or interstate commerce; even drugs manufactured in Alameda are shipped to other counties for packaging and then shipped back into Alameda. Alameda estimates that its total 2010 prescription drug retail sales were approximately $965 million and neither party asserts that sales have declined since then.
Pursuant to the Ordinance, manufacturers must set up disposal kiosk sites throughout Alameda. The kiosks will consist of disposal bins located in areas "convenient and adequate to serve the [disposal] needs of Alameda County residents." Manufacturers must also promote the stewardship program to the public via "educational and outreach materials." After collection, the prescription drugs must be destroyed at medical waste facilities.
The manufacturers are free to individually operate separate product stewardship programs or to jointly operate a program with one or more other manufacturers. If manufacturers choose to operate a program jointly, the Ordinance requires that the program's costs be spread fairly and reasonably among the manufacturers. The manufacturers may run the stewardship program themselves, or they may pay a third-party to operate the stewardship program on their behalf. Assuming the manufacturers jointly operated a stewardship program, the start-up costs would approximate $1,100,000. Around $200,000 of the start-up costs consists of reimbursement to Alameda for the county's costs to administer the Ordinance. While Plaintiffs estimate the subsequent annual costs to maintain the stewardship program to be around $1,200,000, Alameda estimates annual maintenance costs of only $330,000.
Plaintiffs, non-profit trade organizations representing the manufacturers and distributors of pharmaceutical products, claim that the Ordinance violates the dormant Commerce Clause by requiring interstate drug manufacturers to conduct and pay for Alameda County's drug disposal program. The district court disagreed and granted Defendants' motion for summary judgment.
"We review de novo the district court's grant of summary judgment." Smith v. Clark Cnty. Sch. Dist., 727 F.3d 950, 954 (9th Cir.2013).
The Commerce Clause dictates that "Congress shall have Power ... [t]o regulate Commerce ... among the several States." U.S. Const. art. I, § 8, cl 3. "Though phrased as a grant of regulatory power to Congress, the Clause has long been understood to have a `negative' aspect that denies the States the power unjustifiably to discriminate against or burden the interstate flow of articles of commerce." Or. Waste Sys., Inc. v. Dep't of Envtl. Quality of State of Or., 511 U.S. 93, 98, 114 S.Ct. 1345, 128 L.Ed.2d 13 (1994). "The modern law of what has come to be called the dormant Commerce Clause is driven by concern about economic protectionism that is, regulatory measures designed to benefit in-state economic interests by burdening out-of-state competitors." Dep't of Revenue of Ky. v. Davis, 553 U.S. 328, 337-38, 128 S.Ct. 1801, 170 L.Ed.2d 685 (2008) (internal quotation marks omitted). We analyze dormant Commerce Clause claims using the Supreme Court's two-tiered approach. See Brown-Forman, 476 U.S. at 578-79, 106 S.Ct. 2080.
The first tier asks whether the Ordinance "either discriminates against or directly regulates interstate commerce." Greater L.A. Agency on Deafness, Inc. v. Cable News Network, Inc., 742 F.3d 414, 432 (9th Cir.2014). If the Ordinance does either of these things, "it violates the Commerce Clause per se, and we must strike it down without further inquiry." NCAA v. Miller, 10 F.3d 633, 638 (9th Cir.1993). The Ordinance does neither.
A statute is discriminatory if it "impose[s] commercial barriers or discriminates against an article of commerce by reason of its origin or destination out of State." C & A Carbone, Inc. v. Town of Clarkstown, N.Y., 511 U.S. 383, 390, 114 S.Ct. 1677, 128 L.Ed.2d 399 (1994). "Conversely, a statute that treats all private companies exactly the same does not discriminate against interstate commerce. This is so even when only out-of-state businesses are burdened because there are no comparable in-state businesses." Assoc. des Eleveurs de Canards et d'Oies du Quebec v. Harris, 729 F.3d 937, 948 (9th Cir. 2013) (internal quotation marks, alteration, and citation omitted).
Plaintiffs argue that the Ordinance is discriminatory, because "the real world effect of the Ordinance is indistinguishable from a tariff." The Commerce Clause forbids the use of tariffs "[b]ecause of their distorting effects on the geography of production." W. Lynn Creamery, Inc. v. Healy, 512 U.S. 186, 193, 114 S.Ct. 2205, 129 L.Ed.2d 157 (1994). The evil of a tariff is that it "artificially encourag[es] in-state production even when the same goods could be produced at lower cost in other States." Id. Tariff-like statutes similarly provide distinct advantages to in-state entities over out-of-state entities, so courts routinely strike them down. "[C]ases of this kind are legion." Id. at 194, 114 S.Ct. 2205 (collecting cases).
However, unlike any of these statutes, an ordinance that applies across-the-board provides no geographic advantages. This holds true even where the ordinance only affects interstate commerce due to an absence of intrastate businesses. See Assoc. des Eleveurs, 729 F.3d at 948. Given that the Ordinance applies across the board, it does not discriminate at all, let alone in the same way as a tariff.
Plaintiffs also argue that the Ordinance discriminates against interstate commerce by shifting costs to counties and states outside of Alameda. As the Supreme Court has observed,
United Haulers, 550 U.S. at 345, 127 S.Ct. 1786 (quoting S. Pac. Co. v. Ariz. ex rel. Sullivan, 325 U.S. 761, 767 n. 2, 65 S.Ct. 1515, 89 L.Ed. 1915 (1945)). In United Haulers, the Supreme Court upheld a statute and noted that it "bears mentioning" that the cost of the ordinances "is likely to fall upon the very people who voted for the laws." Id. It concluded that "[t]here [was] no reason to step in and hand local businesses a victory they could not obtain through the political process." Id.
Plaintiffs' political-restraints argument fails because, like in United Haulers, the Ordinance affects "interests within the [county]." Id. Even though all of the pharmaceutical drugs travel in interstate commerce before being sold in Alameda, three of Plaintiffs' members have their corporate headquarters or principal place of business in Alameda and two of Plaintiffs' members have facilities in Alameda
Moreover, the cost of running the disposal program has not been entirely shifted outside of the county. Plaintiffs assert that the manufacturers will cover the cost of the Ordinance by raising the price of their drugs. This will result in higher prices for everyone outside of Alameda, but it will also result in higher prices for residents of Alameda. Given these facts, we are satisfied that the burden imposed by the Ordinance was sufficiently subjected to "those political restraints normally exerted when interests within the state are affected." Id.
"[A] statute violates the dormant Commerce Clause per se when it directly regulates interstate commerce." Assoc. des Eleveurs, 729 F.3d at 949 (internal quotation marks omitted). "Direct regulation occurs when a state law directly affects transactions that take place across state lines or entirely outside of the state's borders." S.D. Myers, Inc. v. City and Cnty. of S.F., 253 F.3d 461, 467 (9th Cir. 2001) (internal quotation marks omitted). "The critical inquiry is whether the practical effect of the regulation is to control conduct beyond the boundaries of the State."
Two stipulations of the parties reveal that the Ordinance does not "control conduct beyond the boundaries of the [county]," see id.:
Unable to quarrel with these facts, Plaintiffs essentially assert four arguments as to how the Ordinance directly regulates interstate commerce.
First, Plaintiffs argue that the Ordinance "cannot be an exercise of the police power with an `incidental' effect on interstate commerce, but is necessarily an effort to directly regulate and burden [interstate commerce]." The problem with Plaintiffs' argument — aside from the fact that Plaintiffs cite not a single case to support this theory — is that it conflates the "direct regulation" doctrine and the second-tier, Pike balancing test, which asks whether the "State's interest is legitimate," Brown-Forman, 476 U.S. at 578-79, 106 S.Ct. 2080. Moreover, direct regulation of interstate commerce is more than the absence of a legitimate statutory purpose. Even assuming the State has no legitimate interest whatsoever in passing the Ordinance, it does not automatically follow that the Ordinance directly regulates interstate commerce.
Second, Plaintiffs argue that the Ordinance directly regulates interstate commerce, because "it regulates [manufacturers] whose only connection to Alameda is such interstate commerce." However, there is nothing unusual or unconstitutional
Plaintiffs suggest that the Ordinance is different, because it imposes an affirmative obligation. However, neither the Supreme Court nor this court has drawn such a distinction. See Pharm. Research, 538 U.S. at 668-69, 123 S.Ct. 1855 (rejecting a dormant commerce clause challenge to a Maine regulation that required drug manufacturers to enter into a rebate agreement with the state in order to compensate pharmacists for selling cheaper drugs); Greater L.A. Agency, 742 F.3d at 419, 432-33 (rejecting a dormant commerce clause challenge to a statute that "compell[ed] [CNN] to caption videos posted on its web site").
Third, Plaintiffs argue that the Ordinance directly regulates interstate commerce, because it "shift[s] the costs of Alameda's disposal responsibility and local government program from the County's consumers and taxpayers to the interstate market." This rationale applies when determining whether a statute discriminates against, rather than directly regulates, interstate commerce.
Fourth, Plaintiffs invite the panel to apply dormant Commerce Clause tax cases to the Ordinance. Specifically, Plaintiffs ask the panel to apply the "nexus" and "fairly apportioned" requirements. Plaintiffs cite no case, and we can find none, in which a court has applied the nexus and fairly apportioned requirements outside of the tax context. We decline the invitation to break this new legal ground.
The second tier of a dormant commerce clause analysis has come to be known as the Pike balancing test. See Pike v. Bruce Church, Inc., 397 U.S. 137, 142, 90 S.Ct. 844, 25 L.Ed.2d 174 (1970). Under Pike, we ask whether "the burden [the Ordinance] imposes on interstate commerce is `clearly excessive in relation to the putative local benefits.'" See S.D. Myers, Inc., 253 F.3d at 471 (quoting Pike, 397 U.S. at 142, 90 S.Ct. 844). "We have explained that under Pike, a plaintiff must first show that the statute imposes a substantial burden before the court will determine whether the benefits of the challenged laws are illusory." Assoc. des Eleveurs, 729 F.3d at 951-52 (internal quotation marks omitted). The analysis
The parties' briefs provide minimal discussion as to the burden imposed by the Ordinance. The county compares the cost of running the disposal program ($530,000-$1,200,000 per year) to the manufacturers' revenue-stream in Alameda County (approximately $950 million per year) to conclude that the burden is minimal. Plaintiffs' merely state that "the County cannot dispute that the Ordinance imposes some burdens on [manufacturers] engaged in interstate commerce."
Significantly, Plaintiffs provide no evidence that the Ordinance will interrupt, or even decrease, the "flow of goods" into or out of Alameda. See id. Further, assuming the manufacturers comply with the Ordinance, they can continue to sell pharmaceutical drugs in Alameda. Cf. Assoc. des Eleveurs, 729 F.3d at 952 (finding Plaintiffs failed to raise serious questions about whether a statute imposed a substantial burden even though it would "preclude Plaintiffs' `more profitable' method of producing foie gras" (emphasis added)). Without any evidence that the Ordinance will affect the interstate flow of goods, we cannot say that the Ordinance substantially burdens interstate commerce.
According to the joint-stipulation, "Plaintiffs agree that the Ordinance's environmental, health, and safety benefits are not contested for purposes of the cross-motions for summary judgment." And "regulations that touch upon safety ... are those that the [Supreme] Court has been most reluctant to invalidate. Indeed, if safety justifications are not illusory, the Court will not second-guess legislative judgment about their importance in comparison with related burdens on interstate commerce." Kassel v. Consol. Freightways Corp. of Del., 450 U.S. 662, 670, 101 S.Ct. 1309, 67 L.Ed.2d 580 (1981) (internal quotation marks and citations omitted).
In an attempt to avoid this "strong presumption of validity" see id. (internal quotation marks omitted), Plaintiffs contend that the purpose of the Ordinance is merely to shift costs away from the county and onto the manufacturers. Plaintiffs reason that, because Alameda County could run a drug disposal program that "would achieve precisely the same effects" as the program mandated by the Ordinance, the Ordinance "yields no public benefits." We reject this logic.
The fact that the county could run a similar program does not nullify the program's benefits.
The parties agree that the Alameda County Safe Drug Disposal Ordinance constitutes a "first-in-the-nation" ordinance. Opinions vary widely as to whether adoption of the Ordinance was a good idea. We leave that debate to other institutions and the public at large. We needed only to review the Ordinance and determine whether it violates the dormant Commerce Clause of the United States Constitution. We did; it does not.