MEMORANDUM OPINION AND ORDER REGARDING DEFENDANT’S MOTION FOR SUMMARY JUDGMENT
TABLE OF CONTENTS
I. INTRODUCTION AND BACKGROUND.1028
II. STANDARDS FOR SUMMARY JUDGMENT.1029
III. FINDINGS OF FACT. 1030
IV. LEGAL ANALYSIS .1032
A. Preemption Doctrine .1032
1. “Statutory” preemption. 1032
a. “Flavors” of statutory preemption.1033
b. Congressional intent.;. ...1034
e. The presumption against preemption.1034
2. “Agency” or “regulatory” preemption.. 1036
a. Source and legitimacy. 1036
b. Nature of the agency preemption inquiry.'..1036
i. The agency’s intent to preempt state law..1038
ii. The agency’s authority to preempt state law.1038
c. Deference to agency determinations to preempt state law.1040
i. The City of New York analysis.1042
ii. The applicability of Chevron..■.1044
iii. The continued relevance of congressional intent...1047
iv. Agency accountability.1048
v. The presumption against preemption. 1050
B. The Preemptive Effect of APHIS Regulations .1051
1. Prior decisions.1051
a. Lynnbrook Farms .1051
*1028 b. Other decisions.1055
2. This court’s preemption analysis.1057
a. APHIS’s intent to preempt.1057
b. Congressional authorization. 1060
c. Are the Garrelts’ claims preempted?.1069
C. Certification For Interlocutory Appeal.1070
V. CONCLUSION.1071
Defendant’s motion for summary judgment in this products liability action involving a cattle vaccine poses the question of whether certain state tort claims are barred by federal “agency” or “regulatory” preemption, as distinct from federal “statutory” preemption. Thus, not only does the scope of preemption here involve questions of federalism and supremacy among sovereigns, it also involves the still more complicated questions that arise when an agency, a delegatee of Congress, not Congress itself, exercises, or is asserted to be exercising, supreme federal power. These questions involve the judiciary in an intricate dance between fulfilling its role as a co-equal branch of government charged with reviewing the exercise of federal power and the deference the judiciary is nonetheless supposed to accord most federal agency interpretations of congressional acts. In other words, what is at stake here, in this court’s view, is both the concrete question of whether a particular individual has a remedy for alleged wrongs, and the abstract question of the constitutional scope of an agency’s power to determine its own jurisdiction.
In their complaint, plaintiffs allege that they suffered injuries when one of them accidentally inoculated himself with a veterinary vaccine for cattle manufactured by the defendant. The defendant has moved for summary judgment, asserting that the plaintiffs’ state-law claims are preempted by federal agency regulations. At its most basic level, the question raised by defendant’s motion for summary judgment, therefore, is whether regulations promulgated by a federal agency pursuant to the Virus-Serum-Toxin Act (VSTA), 21 U.S.C. §§ 151-159, preempt plaintiffs’ state tort claims, because plaintiffs’ claims are allegedly premised on inadequate labeling of a product whose label had been approved by the agency under its regulations.
I. INTRODUCTION AND BACKGROUND
Plaintiffs John W. Garrelts and Judith K. Garrelts filed their complaint in this action on October 11, 1995, against defendant SmithKline Beecham Corporation d/b/a SmithKline Beecham Animal Products (SBC). Subject matter jurisdiction is based on diversity of citizenship and sufficient amount in controversy. See 28 U.S.C. § 1332. The Garrelts allege that John suffered injuries when he accidentally inoculated himself with SBC’s Ultrabac 7 vaccine for cattle. The Garrelts allege that SBC’s Ultra-bac 7 vaccine was defective in that product labeling on the vaccine failed to warn against certain alleged dangers to humans in the event of accidental injection with the vaccine. SBC answered the complaint on December 13, 1995, denying, in the first instance, that its vaccine caused any injuries to the plaintiffs, and further asserting seven affirmative defenses. 1
SBC filed a motion for summary judgment on May 10, 1996, seeking dismissal of the *1029 Garrelts’ state-law claims on the ground that these claims are preempted by regulations promulgated pursuant to the Virus-Serum-Toxin Act (VSTA), 21 U.S.C. §§ 151-159, by the Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA). Specifically, SBC contends that the Garrelts’ state tort claims are premised upon allegedly inadequate labeling, but that such claims are preempted by APHIS regulations, because the claims would impose requirements different from or in addition to those imposed by APHIS. SBC contends that APHIS has declared its intention to preempt state tort causes of action, and that APHIS’s decision is reasonable and within the authority granted to it by Congress. The present motion for summary judgment therefore involves the issue of “agency” or “regulatory” preemption, as distinct from the more familiar issue of “statutory” preemption. Furthermore, the court finds but little authority from the Eighth Circuit Court of Appeals concerning agency preemption, as well as little authority from any jurisdiction on the question of the propriety of APHIS’s preemption of state tort actions. However, the court recognizes, as do the parties, that almost all of the courts to consider whether APHIS’s regulations properly preempt state tort actions have found the agency’s regulations did properly preempt the state tort claims presented. 2
The Garrelts resisted the motion for summary judgment on July 9, 1996. In essence, the Garrelts argue that the federal agency regulations do not preempt their state tort causes of action, because APHIS either did not intend, or was not authorized, to preempt causes of action based on injury to humans. In a reply brief filed July 19, 1996, SBC argues to the contrary, asserting that APHIS’s intent and authority to preempt state tort - causes of action sweep broadly enough to encompass the Garrelts’ claims.
The court held oral arguments on SBC’s motion for summary judgment on August 7, 1996. At the oral arguments, the Garrelts were represented by counsel John G. Martens of Sanderson, Ridout & Martens, in Estherville, Iowa. Defendant SBC was represented by counsel Scott A. Smith 3 of Pop-ham, Haik, Schnobrich &. Kaufman, Ltd., in Minneapolis, Minnesota, and Margaret M. Prahl of Heidman, Redmond, Fredregill, Patterson, Sehatz & Plaza, L.L.P., in Sioux City, Iowa. The parties have filed thorough and extensive briefs in support of their respective positions, and have supplemented those briefs from time to time with recent decisions involving identical issues. This matter is now deemed fully submitted.
II. STANDARDS FOR SUMMARY JUDGMENT
The Eighth Circuit Court of Appeals recognizes “that summary judgment is a drastic remedy and must be exercised with extreme care to prevent taking genuine issues of fact away from juries.”
Wabun-Inini v. Sessions,
The standard for granting summary judg- ■ ment is well established. Rule 56 of the Federal Rules of Civil Procedure states in pertinent part:
Rule 56. Summary Judgment
(b) For Defending Party. A party against whom a claim ... is asserted ... may, at any time, move for summary judgment in the party’s favor as to all or any part thereof.
(c) Motions and Proceedings There-on_ The judgment sought shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to judgment as a matter of law.
Fed.R.Civ.P.
56(b) & (c) (emphasis added);
see also Celotex,
III. FINDINGS OF FACT
Again, for the purpose of the court’s consideration of this motion for summary judgment only, defendant SBC concedes that the court should accept as true the material allegations contained in the Garrelts’ complaint. Thus, solely for the purposes of this summary judgment motion, the court finds the following facts to be undisputed.
Plaintiff John W. Garrelts is a farmer in Palo Alto County, Iowa. 6 John raises cattle on his farm. John sometimes vaccinates his own cattle and calves, and on May 28, 1994, he was doing just that. John had purchased Ultrabac 7 vaccine, which is manufactured by SBC, 7 from Dr. Roger Larson, d/b/a the Clay *1031 County Veterinary Clinic. While vaccinating a young calf, John accidentally inoculated himself with the Ultrabac 7 vaccine when the calf suddenly moved. John became ill following the inoculation and was subsequently taken by ambulance to the hospital. As a result of his accidental inoculation with Ultrabac 7 vaccine, John has suffered serious injuries, allegedly including continuing disability. 8
The label on the Ultrabac 7 vaccine container did not contain a telephone number or other means of contacting SBC in the event of accidental human inoculation with the Ul-trabac 7 vaccine. The label on the Ultrabac 7 vaccine did not warn of the possible danger to humans in the event of accidental inoculation with the vaccine, nor did the label instruct on the procedures to be taken in order to avoid self-inoculation. At the time of John’s accidental inoculation with the Ultra-bae 7 vaccine, SBC knew that accidental inoculations of humans with veterinary vaccines were occurring. Furthermore, SBC knew that humans may be seriously injured or killed if they are accidentally inoculated with the Ultrabac 7 vaccine.
In addition to these pertinent facts alleged in the complaint, and recognized as undisputed for the purposes of this summary judgment motion, SBC asserts that certain other facts are also undisputed. The Garrelts have not specifically challenged any of these facts in their resistance to SBC’s motion for summary judgment, nor have they asserted that any additional facts are either undisputed or disputed.
SBC’s additional undisputed facts are therefore as follows. Ultrabac 7 was licensed by APHIS for use on animals on May 30,1980, under USDA License No. 225, Code 7410.00. Through the licensing process and through post-licensing testing and evaluation, Ultrabac 7 has been determined by APHIS to. satisfy all requirements for purity, safety, potency, and efficacy contained in the APHIS standards. Furthermore, the vaccine has been designed, manufactured, and tested pursuant to APHIS standards and APHIS has approved the content and sufficiency of all design, manufacturing, and testing data submitted prior to licensing of the vaccine. In addition, the text, layout, and design of all labeling on the vaccine, including the packaging and product inserts, were specifically approved in writing by APHIS.
On December 6, 1995, following the decision of the Minnesota Court of Appeals in
Brandt v. Marshall Animal Clinic,
Thank you for your letter of December 6,1995, on behalf of your constituents Randy and Patty Brandt of Marshall, Minnesota, concerning their lawsuit against a USDA licensed manufacturer of veterinary biological products. Your letter requested a written clarification of the scope of our preemption of State law under the Virus-Serum-Toxin Act (VSTA), 21 U.S.C. 151, et seq.
On October 19, 1990, we published a proposed rule in the Federal Register (55 FR 42392). The purpose of the proposed *1032 rule was to clarify our regulations with respect to State restrictions on the use and distribution of veterinary biological products and to specify how a person could request that Federal restrictions be imposed on such products.
On August 27, 1992, we published our final rule (57 FR 38758). A copy of that rule is enclosed for your information. We stated in that rule that in order to maintain uniform national standards regarding veterinary biological products (including labeling), States are not free to impose requirements which are different from, or in addition to, those imposed by USDA regarding the safety, efficacy, potency, or purity of a product. We promulgated this rule in response to regulatory actions by certain States which attempted to impose requirements concerning USDA licensed veterinary biological products which were different from, or in addition to, those' imposed by USDA regarding the safety, efficacy, potency, or purity of a product.
Our intent in promulgating the rule was, and continues to be, to preempt States from imposing requirements either through statutes, regulations, or other means that are different from, or in addition to, those imposed by USDA regarding the safety, efficacy, potency, or purity of a product. Such requirements would include, but are not limited to production, testing, distribution, or labeling requirements. We did not intend to preempt state common law actions for damages arising from noneompliance with USDA regulatory standards.
Defendant’s Exhibit 1 to Affidavit of Smith, Letter from Medley to Wellstone (hereinafter, “Medley Letter”).
Because the facts are not in dispute, the disposition of SBC’s motion for summary judgment turns not on whether there are genuine issues of material fact, but whether, in light of the undisputed facts, SBC is entitled to judgment as a matter of law on the relatively narrow issue of whether the Gar-relts’ claims are preempted by APHIS regulations. The court therefore turns to its legal analysis of the issue raised by SBC’s motion for summary judgment.
TV. LEGAL ANALYSIS
A. Preemption Doctrine
The Supremacy Clause of the United States Constitution states that “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof ... shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or. Laws of any State to the Contrary notwithstanding.” U.S. Const, art. VI, cl. 2. This clause of the Constitution has given birth to the familiar, though not uncomplicated, doctrine of “statutory” preemption.
See New York State Conference of Blue Cross & Blue Shield Plans v. Travelers Ins.,
— U.S. -, -,
I. “Statutory” preemption
“Statutory” preemption is the child of congressional authority, found in the Supremacy Clause of the U.S. Constitution, and congressional action, embodied in enactment
*1033
of a statute.
See, e.g., New York State Conference of Blue Cross,
— U.S. at -,
While determination of the scope of express preemption does not occur in a contextual vacuum, context is the key to a determination of the existence and scope of implied preemption. Generally, federal statutory law can preempt state law without an express statement by Congress when the federal statute implies an intention to preempt state law or when state law directly conflicts with federal law.
Van Bergen v. State of Minn.,
a. “Flavors” of statutory preemption
The Eighth Circuit Court of Appeals has therefore observed that “[preemption traditionally comes in four ‘flavors’
(1) “express preemption,” resulting from an express Congressional directive ousting state law (Morales v. Trans World Airlines, Inc., [504] U.S. [374],112 S.Ct. 2031 ,119 L.Ed.2d 157 (1992); (2) “implied preemption,” resulting from an inference that Congress intended to oust state law in order to achieve its objective (Hines v. Davidowitz,312 U.S. 52 , 67,61 S.Ct. 399 , 404,85 L.Ed. 581 (1941); (3) “conflict preemption,” resulting from the operation of the Supremacy Clause when federal and state law actually conflict, even when Congress says nothing about it (Florida Lime & Avocado Growers, Inc. v. Paul,373 U.S. 132 , 143,83 S.Ct. 1210 , 1218,10 L.Ed.2d 248 (1963); and (4) “field preemption,” resulting from a determination that Congress intended to remove an entire area from state regulatory authority (Fidelity Fed. Savs. & Loan Ass’n v. de la Cuesta,458 U.S. 141 , 153,102 S.Ct. 3014 , 3022,73 L.Ed.2d 664 (1982)). See Pacific Gas & Elec. Co. v. State Energy Resources Conservation & Dev. Comm’n,461 U.S. 190 , 203-04,103 S.Ct. 1713 , 1721-22,75 L.Ed.2d 752 (1983); see generally, Burt Neuborn, An overview of Preemption (Fed. Jud. Center, Feb. 9, 1993).
Kinley,
Thus, federal law preempts state law not only where the two are plainly contradictory, but also where “‘the incompatibility between [them] is discernible only through inference.’”
Hankins v. Finnel,
b. Congressional intent
Congressional intent is the critical question in a statutory preemption analysis.
Kinley,
c. The presumption against preemption
Because congressional intent is the critical question in a statutory preemption analysis, the analysis of statutory preemption begins with a presumption:
[B]ecause the. States are independent sovereigns in our federal system, we have long presumed that Congress does not cavalierly pre-empt state-law causes of action. In all preemption cases, and particularly in those in which Congress has “legislated in a field which the States have traditionally occupied,” Rice v. Santa Fe Elevator Corp.,331 U.S. 218 , 230,67 S.Ct. 1146 , 1152,91 L.Ed. 1447 (1947), we “start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of *1035 Congress.” Id., at 230,67 S.Ct., at 1152 ; Hillsborough Cty.,471 U.S., at 715-716 ,105 S.Ct., at 2376 ; cf. Fort Halifax Packing Co. v. Coyne,482 U.S. 1 , 22,107 S.Ct. 2211 , 2223,96 L.Ed.2d 1 (1987).
Medtronic, Inc.,
— U.S. at-,
In Medtronic, the Supreme Court identified matters that fall within the historic police powers of the states:
Throughout our history the several States have exercised their police powers to protect the health and safety of their citizens. Because these are “primarily, and historically, ... matter[s] of local concern,” Hillsborough County v. Automated Medical Laboratories, Inc.,471 U.S. 707 , 719,105 S.Ct. 2371 , 2378,85 L.Ed.2d 714 (1985), the “States traditionally have had great latitude under their police powers to legislate as to the protection of the fives, limbs, 'health, comfort, and quiet of all persons.” Metropolitan Life Ins. Co. v. Massachusetts,471 U.S. 724 , 756,105 S.Ct. 2380 , 2398,85 L.Ed.2d 728 (1985) (internal quotation marks omitted).
Medtronic, Inc.,
— U.S. at -,
In order to overcome the presumption against preemption with a sufficient showing of congressional intent to preempt state law, the Supreme Court begins by examining the text of the statutory provision in question, then moves on, if need be, to the structure and purpose of the Act in which the specific statutory provision-occurs.
New York State Conference of Blue Cross,
— U.S. at -,
2. “Agency” or “regulatory”preemption
“Agency” or “regulatory” preemption is the half sister of statutory preemption, born of congressional authority, but agency action. 12 The question presented here is whether this half sister is illegitimate, not in parentage, but in the scope it has been given by the agency parent, and indeed by a litigant asserting the preemptive effect of agency action, in the case of particular agency regulations.
a. Source and legitimacy
The legitimacy of agency preemption as a general principle has been conclusively determined. The phrase “Laws of the United States” in the Supremacy Clause, the Supreme Court has held, encompasses both federal statutes and statutorily authorized
federal regulations. City of New York v. FCC,
b. Nature of the agency preemption inquiry
The Supreme Court has explained that the nature of the inquiry the court must pursue when “agency” preemption is at issue differs from that described above as applicable to the question of statutory preemption:
[H]ere the inquiry becomes whether the federal agency has properly exercised its own delegated authority rather than sim *1037 ply whether Congress has properly exer-eised the legislative power. Thus we have emphasized that in a situation where state law is claimed to be pre-empted by federal regulation, a “narrow focus on Congress’ intent to supersede state law [is] misdirected,” for “[a] pre-emptive regulation’s force does not depend on express congressional authorization to displace state law.” Fidelity Federal Savings & Loan Assn v. De la Cuesta,458 U.S. 141 , 154 [102 S.Ct. 8014 , 3023,73 L.Ed.2d 664 ] (1982). Instead, the correct focus is on the federal agency that seeks to displace state law and on the proper bounds of its lawful authority to undertake such action. The statutorily authorized regulations of an agency will pre-empt any state or local law that conflicts with such regulations or frustrates the purposes thereof. Beyond that, however, in proper circumstances the. agency may determine that its authority is exclusive and pre-empts any state efforts to regulate in the forbidden area. Crisp,467 U.S., at 700 [104 S.Ct. at 2701 ]; De la Cuesta, supra, at 152-154 [102 S.Ct. at 3022-3023 ]. It has long been recognized that many of the responsibilities conferred on federal agencies involve a broad grant of authority to reconcile conflicting policies. Where this is true, the Court has cautioned that even in the area of preemption, if the agency’s choice to pre-empt “represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by the statute, we should not disturb it unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned.” United States v. Shimer,367 U.S. 374 , 383 [81 S.Ct. 1554 , 1560,6 L.Ed.2d 908 ] (1961); see also Crisp, supra, at 700 [104 S.Ct. at 2701 ].
City of New York,
i. The agency’s intent to preempt state law. As
to the first prong of the analysis, whether the agency intended to preempt state law, the portion of
City of New York,
Where an agency has explicitly stated its intent to exercise exclusive authority in an area and to preempt state and local regulation, the case “does not turn on whether there is an actual conflict between federal and state law ... or whether compliance with both federal and state standards would be physically impossible.”
Id.
at 65-66,
However, where agency preemption is only implied, rather than express, the Court had previously observed that it was “even more reluctant to infer pre-emption from the comprehensiveness of regulations than from the comprehensiveness of statutes,” because
[a]s a result of their specialized functions, agencies normally deal with problems in far more detail than does Congress. To infer pre-emption whenever an agency' deals with a problem comprehensively is virtually tantamount to saying that whenever a federal agency decides to step into a field, its regulations will be exclusive. Such a rule, of course, would be inconsistent with the federal-state balance embodied in our Supremacy Clause jurisprudence.
Hillsborough County,
ii. The agency’s authority to preempt state law.
As to the second prong of the analysis, whether the agency acted within its delegated authority, “ ‘[a] pre-emptive regulation’s force does not depend on express congressional authorization to displace state law.’ ”
City of New York,
“First, an agency literally has no power to act, let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it. Second, the best way of determining whether Congress intended the regulations of an administrative agency to displace state law is to examine the nature and scope of the authority granted by Con *1039 gress to the agency.” Louisiana Public Service Gomm’n,476 U.S., at 374 [106 S.Ct. at 1901 ].
City of New York,
In
City of New York,
in determining the nature and scope of the authority delegated by Congress to the agency in question, the Federal Communications Commission (FCC), the Court began by reviewing the background of federal preemption on the particular issue in question, local technical standards for cable television signal quality.
City of New York,
In
Crisp,
the Court found that FCC regulations were “consistent with [the agency’s] congressionally defined charter.”
Crisp,
With that end in mind, the Commission has determined that only federal pre-emption of state and local regulation can assure cable systems the breathing space necessary to expand vigorously and provide a diverse range of program offerings to potential cable subscribers in all parts of the country. While that judgment may not enjoy universal support, it plainly represents a reasonable accommodation of competing policies committed to the FCC’s care, and we see no reason to disturb the agency’s judgment.
Crisp,
The Court therefore upheld the agency’s preemptive regulations as within the authority delegated to the agency by Congress. Id.
Similarly, in
de la Cuesta,
the Court found that the Federal Home Loan Bank Board (FHLBB) had “plenary” authority to issue the regulations in question by looking at the broad scope of the language of the authorizing statute, which specified each of the areas in which challenged preemptive regulations had been promulgated, and determined that the regulations were within the agency’s purview.
de la Cuesta,
By way of contrast, in
Louisiana Pub. Serv. Comm’n,
the Court found congressional authorization for the agency’s action was not only lacking, but had been denied.
Louisiana Pub. Serv. Comm’n,
c. Deference to agency determinations to preempt state law
Courts have from time to time read into this agency preemption inquiry the same sort of deference accorded other agency interpretations, attempting to reconcile
City of New York
with
Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc.,
There is ... one further twist to Chevron deference: it may not be obvious that this court’s obligation to defer to [an agency’s] interpretations of [the statute it is charged with implementing] attaches even when those interpretations address the scope of preemption of state law by federal regulation. I recognize that the law may be unsettled in general as to the application of Chevron to an agency’s determination of its own jurisdiction. See generally Cass R. Sunstein, Law and Administration After Chevron, 90 Colum.L.Rev. 2071, 2097-2101 (1990). Indeed, there is an inherent ten *1041 sion between Chevron deference, which only obtains where a statute is “silent or ambiguous,” Chevron,467 U.S. at 843 ,104 S.Ct. at 2782 , and preemption doctrine, which maintains that state law will not be preempted unless that is “the clear and manifest purpose of Congress,” Rice,331 U.S. at 230 ,67 S.Ct. at 1152 . So, to say that a court should defer to an agency’s determination that state law is preempted is seemingly paradoxical: the agency would command deference under Chevron only if the federal statute is ambiguous; but if the federal statute were ambiguous, then Congress’s intent to preempt seemingly would not be “clear and manifest.” Furthermore, although separation of powers (or institutional competence) concerns might counsel in favor of courts’ deferring to agencies in the resolution of ambiguous questions of statutory interpretation, countervailing federalism concerns offset this rationale for Chevron deference in preemption cases. Although federal agencies are more democratically accountable than courts, state legislatures are arguably yet more politically accountable. In the abstract, then, it is not at all clear that a state’s view that a federal statute does not preempt state law should give way to a federal agency’s view that the statute does preempt.
Teper v. Miller,
Fortunately, I need not completely untangle this knotty issue of jurisprudence in order to conclude that the [agency’s] interpretation [of the statute in question] is entitled to deference in this case. In City of New York v. FCC, a unanimous Court clarified the law sufficiently to settle the issue before us....
Teper,
An agency like the [Federal Election Commission (FEC) ], to which Congress has delegated broad discretion in interpreting and administering a complex federal regulatory regime, is entitled to significant latitude when acting within its statutory authority, even in its decisions as to the scope of preemption of state law. See also Fidelity Fed. Savings & Loan Ass’n v. de la Cuesta,458 U.S. 141 , 151-55,102 S.Ct. 3014 , 3022-23,73 L.Ed.2d 664 (1982). But cf. Louisiana Pub. Serv. Comm’n v. FCC,476 U.S. 355 ,106 S.Ct. 1890 ,90 L.Ed.2d 369 (1986) (overturning agency preemption determination without mention of Chevron deference). In other words, even if a statute is on its face ambiguous, Congress’s intent to preempt may be blear when the administrative agency expressly responsible for interpreting and implementing the statute has clarified it.
Teper,
Nor can the court agree with the analysis employed by the Seventh Circuit Court of Appeals in
Time Warner,
In light of the silence of the Eighth Circuit Court of Appeals on the question of how courts must approach determinations of “agency” preemption and this court’s specific disagreement with recent decisions of other circuit courts of appeals, this court must explain how it reads City of New York on the question of deference to any agency’s determination of its power, to preempt state law.
i. The City of New York analysis.
This court finds that an attempt to reconcile
City of New York
with
Chevron
is simply misdirected,
contra Teper,
The Court then scrutinized whether the FCC had the authority from Congress to preempt state and local regulation, reiterating that “ ‘an agency literally has no power to act, let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it.’ ”
Id.
at 66,
This application of the two-prong analysis is in keeping with the language the Court used in describing the nature of the inquiry. “[I]n proper circumstances,” the Court said, “the agency may determine that its authority is exclusive and pre-empts any state efforts to regulate in the forbidden area.”
Id.
at 64,
Thus, under this court’s reading of
City of New York,
deference to an agency’s determination to preempt state law arises only in very narrow circumstances; specifically, it arises only where (1) Congress confers on the agency “a broad grant of authority to reconcile conflicting policies,”
and
(2) the agency’s choice to preempt “represents a
reasonable
accommodation
of conflicting 'policies that were committed to the agency’s care by the statute.” See City of New York,
ii. The applicability of Chevron.
This court recognizes that such an interpretation of the Supreme Court’s analysis of the inquiry in agency preemption cases runs counter to the general principle of judicial deference to agency determinations articulated in
Chevron,
This court believes that some of the confusion about the applicability of
Chevron
to an agency’s determination of its power to preempt state regulation may have arisen because
Chevron
mirrors the deference language of the doctrine of agency preemption found in
Shimer,
the seminal Supreme Court decision on agency preemption. The Court in
Chevron
wrote that courts must accord considerable deference to an agency’s interpretation of a statute it is charged with implementing, and “‘should not disturb [the agency’s interpretation] unless it appears from the statute or the legislative history that the accommodation is not one that Congress would have sanctioned.’ ”
Chevron,
Nor is de la Cmsta, an agency preemption decision rendered prior to Chevron, to the contrary, although it too may be the source of some confusion. In de la Cuesta, the Court recognized a similarity between review of the exercise of agency discretion and review of agency preemption in certain circumstances:
Where Congress has directed an administrator to exercise his discretion, his judgments are subject to judicial review only to determine whether he has exceeded his statutory authority or acted arbitrarily. United States v. Shimer,367 U.S. 374 , 381-82 [81 S.Ct. 1554 , 1560,6 L.Ed.2d 908 ] (1961). When the administrator promulgates regulations intended to pre-empt state law, the court’s inquiry is similarly limited:
“If [h]is choice represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by the statute, we should not disturb it unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned.” Id., at 383 [81 S.Ct. at 1560 ].
de la Cuesta,
In addition to the language used by the Court, the analysis used in
de la Cuesta
is also consistent with this court’s reading of that decision and
City óf New York.
In
de la Cuesta,
the Court determined that Congress had authorized the FHLBB to make the necessary resolutions of conflicting policy.
Id.
at 168,
Thus, this court cannot agree with the Fifth Circuit Court of Appeals, which stated,
Agency decisions to preempt state law are entitled to judicial deference, and if an agency’s choice to preempt “represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by the statute, we should not disturb it unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned.” City of New York v. FCC,486 U.S. 57 , 64,108 S.Ct. 1637 , 1642,100 L.Ed.2d 48 (1988) (citing United States v. Shimer,367 U.S. 374 , 383,81 S.Ct. 1554 , 1560,6 L.Ed.2d 908 (1961)). First Gibraltar Bank, FSB v. Morales,19 F.3d 1032 , 1040 (5th Cir.), cert. denied, — U.S. -,115 S.Ct. 204 ,130 L.Ed.2d 134 (1994), vacated and superseded on other grounds,42 F.3d 895 (5th Cir.1995). 19 Rather, in this court’s view, the proper statement of the standard for review is as follows: Agency decisions to preempt state law are entitled to judicial deference only if an agency’s choice to preempt “represents a reasonable accommodation of conflicting policies that were committed to the agency’s care by the statute,” and when such a situation exists, “we should not disturb [the agency’s accommodation] unless it appears from the statute or its legislative history that the accommodation is not one that Congress would have sanctioned.” City of New York,486 U.S. at 64 ,108 S.Ct. at 1642 ; see also Feikema v. Texaco, Inc.,16 F.3d 1408 , 1416 (4th Cir.1994) (stating that “even if an agency, rather than Congress, resolves to preempt an area, its determination will be enforced to preempt conflicting state regulations so long as the determination represents ‘a reasonable accomihodation of conflicting policies that are within the agency’s domain,’ ” quoting Crisp,467 U.S. at 700 ,104 S.Ct. at 2701 ; emphasis added by this court). Thus, although the Tenth Circuit Court of Appeals attempted to reconcile Chevron with City of New York in Kansas ex rel. Todd,995 F.2d at 1509 , that court’s reconciliation comes nearer what this court holds to be the proper reading of when any deference is applicable. In Kansas ex rel. Todd, the Tenth Circuit Court of Appeals applied deference to an agency determination, specifically citing Chevron, but only to the question of whether the agency had “reasonably exercised its authority given to it by Congress,” not to the question of whether Congress had granted the agency such authority. Kansas ex rel. Todd,995 F.2d at 1509 . However, under this court’s reading, this application of deference is still too general, because it does not limit deference only to situations in which Congress has authorized the agency to make accommodations of conflicting policies committed to the agency’s care.
*1047 There are three farther reasons why this court concludes that the inquiry into agency preemption accords the agency no deference, except in the narrow circumstances of accommodation of policies committed to the agency by Congress. First, the intent of Congress has not been expunged from the analysis. Second, an assertion of an agency’s greater accountability, as compared to that of courts, is unpersuasive. Finally, agency preemption is subject to the same presumption against preemption of state regulation of police, health, and safety matters as is statutory preemption. The court will consider each of these reasons briefly in turn.
iii. The continued relevance of congressional intent.
One of the reasons this court concludes that an agency’s determination to preempt state law is, as a general matter, entitled to no particular deference, is that congressional intent remains a critical part of the analysis, and, under
City of New York,
a determination of congressional intent is entirely a matter for the court, without deference to the agency. Furthermore, in making that judicial determination of congressional intent, the court does not look to the agency’s interpretation of congressional expressions of its intent.
See City of New York,
depends upon satisfaction of the two prongs of what this court has called the
City of New York
inquiry.
Id.; de la Cuesta,
When the decisionmaker deciding whether or not to preempt state law is an agency, an entity one step removed from Congress itself, it of course makes sense that, in the first instance, a reviewing court should look at the agency’s intent to preempt state law rather than at Congress’s intent. The Supreme Court’s decision . in
Hillsborough County
demonstrates the efficacy of such an approach. In that decision, the agency deci-sionmaker had itself eschewed an intent to preempt state law.
Hillsborough County,
Nonetheless, that second step of the analysis remains critical. The Supreme Court has specifically postulated the importance of the second prong of the agency preemption analysis in part on what it shows about congressional intent. Thus, in both
City of New York
and
Louisiana Pub. Serv. Comm’n,
the Supreme Court justified the second prong of
*1048
the analysis on the ground that “ ‘the best way of determining whether Congress intended the regulations of an administrative agency to displace state law is to examine the nature and scope of the authority granted by Congress to the agency.’”
City of New York,
Because of this continued critical importance of congressional intent, and this court’s reading of
City of New York
and other decisions of the Supreme Court as according the agency no deference whatsoever in the determination of Congress’s intent to allow the agency to preempt state law, this court must respectfully, but specifically, disagree with the interpretation of
City of New York
offered by the Eleventh Circuit Court of Appeals in
Teper,
iv. Agency accountability. One justification for deference to an agency offered in Chevron, and consequently offered by some courts as a justification for deference to an agency’s preemption determination, is that an agency is more “accountable” than are courts. In Chevron, the Court made the following observations:
Judges are not experts in the field, and are not part of either political branch of Government. Courts must, in some cases, reconcile competing political interests, but not on the basis of the judge’s personal policy preferences. In contrast, an agency to which Congress has delegated policy-making responsibilities may, within the limits of that delegation, properly rely upon the incumbent administration’s views of vise policy to inform its judgments. While agencies are not directly accountable to the people, the Chief Executive is, and it is entirely appropriate for this political branch of the Government to make such policy choices — resolving the compet *1049 ing interests which Congress itself either inadvertently did not resolve, or intentionally left to be resolved by the agency charged with the administration of the .statute in light of everyday realities.
When a challenge to an agency construction of a statutory provision, fairly conceptualized, really centers on the wisdom of the agency’s policy, rather than whether it is a reasonable choice within a gap left open by Congress, the challenge must fail. In such a case, federal judges—who have no constituency—have a duty to respect legitimate policy choices made by those who do. The responsibilities for assessing the wisdom of such policy choices and resolving the struggle between competing views of the public interest are not judicial ones: “Our Constitution vests such responsibilities in the political branches.” TVA v. Hill,437 U.S. 153 , 195 [98 S.Ct. 2279 , 2302,57 L.Ed.2d 117 ] (1978).
Chevron,
However, the Eleventh Circuit Court of Appeals also quite correctly recognized that “countervailing federalism concerns offset this rationale for Chevron deference in preemption eases. Although federal agencies are more democratically accountable than courts, state legislatures are arguably yet more politically accountable.” Id. In this age of tort reform, the extent to which state legislatures have left intact common law actions or have codified them suggests that the “accountability” of the states should not be ignored in favor of the indirect and nebulous accountability of agencies. To put it another way, the persistence of state common law causes of action is an expression of the will of the governed, because the governed can, and often do, hold legislatures accountable when reform of common law is required.
One commentator has suggested other reasons the “accountability” argument should not be persuasive when the question is whether to accord deference to an agency’s determination of its jurisdiction or power to preempt state law. “[I]t would :.. seem[ ] exceedingly odd to suggest that [an agency] should be allowed to resolve ambiguities in a statute governing its own jurisdiction. The danger of bias and self-dealing is so great as to make-[the agency] an interested party.” Sunstein,
After Chevron,
90 Colum.L.Rev. at 2099. This court agrees that there is a danger of bias and self-dealing in such a situation. As the Supreme Court has said, “To permit an agency to expand its power in the face of a congressional limitation on its jurisdiction would be to grant to the agency power to override Congress. This we are both unwilling and unable to do.”
Louisiana Pub. Serv. Comm’n,
The same commentator cited above suggested a solution to the conflict between accountability and partiality: “Probably the best reconciliation of the competing considerations of expertise, accountability, and partiality is to say that no deference will be accorded to the agency when the issue is whether the agency’s authority extends to a broad area of regulation, or to a large category of cases, except to the extent that the answer to that question calls for determinations of fact and policy.” Id. at 2100. This solution parallels almost exactly this court’s reading of the point at which any deference is afforded an agency on a preemption issue under City of New York. Under this court’s reading of City of New York, deference to the agency only arises when the agency is addressing policy matters committed to it by Congress. This court therefore finds arguments based on agency “accountability” are not persuasive on the question of whether an agency should be accorded deference in a determination of the agency’s power to preempt state law.
*1050
v. The presumption against preemption.
Finally, the court concludes that a general deference to an agency’s determination to preempt state law would run counter to the requirement that courts entertain a presumption against preemption. Although the “nature of the inquiry” in an agency preemption case may be different from that in a statutory preemption case, the Supreme Court has nonetheless made clear that the same presumption mitigating against preemption applies. In an agency preemption case, the Court found that a serious impediment to preemption was “the presumption that state and local regulation of matters related to health and safety is not invalidated under the Supremacy Clause.”
Hillsborough County,
“Where ... the field that Congress is said to have pre-empted has been traditionally occupied by the States ‘we start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’ ” Jones v. Rath Packing Co.,430 U.S., at 525 [97 S.Ct. at 1309 ] (quoting Rice v. Santa Fe Elevator Corp.,331 U.S., at 230 ) (citations omitted).... Of course, the same principles apply where, as here, the field is said to have been pre-empted by an agency, acting pursuant to congressional delegation. Appellee must thus present a showing of implicit pre-emption of the whole field, or of a conflict between a particular local provision and the federal scheme, that is strong enough to overcome the presumption that state and local regulation of health and safety matters can constitutionally coexist with federal regulation.
Hillsborough County,
This court concludes further that the presumption applies even when the agency has expressly stated its intent to preempt state law, because the presumption persists unless dispelled by the “clear and manifest purpose of Congress,”
Rice,
To summarize, in those Supreme Court decisions in which the Court appeared to defer to an agency determination that its regulations should preempt state law, the Court had first determined that the agency had acted to accommodate conflicting policies committed to the agency’s care by statute.
See City of New York,
B. The Preemptive Effect of APHIS Regulations
Having established what this court deems to be the proper analysis of questions of agency preemption, and the proper circumstances under which agency determinations are due any deference in that analysis, the court turns to analysis of the preemptive effect of the agency regulations at issue here. Although no other court has applied an analysis of the preemptive effect of APHIS regulations in the manner this court has postulated is appropriate, nor has any court considered the preemptive effect of those regulations on tort claims of physical injury to humans, the court nevertheless begins with the existing, somewhat limited precedent concerning the preemptive effect of APHIS regulations before turning to its own analysis of the question.
1. Prior decisions
The leading decision on the preemptive effect of APHIS regulations on state tort causes of action is the decision of the Seventh Circuit Court of Appeals in
Lynnbrook Farms v. SmithKline Beecham Corp.,
a. Lynnbrook Farms
In
Lynnbrook Farms,
the plaintiff cattle producer sued the same manufacturer of livestock vaccines that is a defendant here, SBC, alleging that the cattle producer’s cattle were injured and many were killed after being inoculated with animal vaccines manufactured by SBC.
Lynnbrook Farms,
The Seventh Circuit Court of Appeals observed,
According to our research, all other courts that have addressed the issue, including the district court below, have reached a conclusion similar to that which we -reach today, ie., that state common law claims of the type asserted in this ease are preempted by the APHIS regulation. See Lynnbrook Farms v. SmithKline Beecham Corp.,887 F.Supp. 1100 (C.D.Ill.1995); Murphy v. SmithKline Beecham Corp.,898 F.Supp. 811 (D.Kan.1995); Brandt v. The Marshall Animal Clinic and SmithKline Beecham Corp.,540 N.W.2d 870 (Minn.Ct.App.1995).
Lynnbrook Farms,
The Seventh Circuit Court of Appeals found that SBC’s sole argument, there as here, was that APHIS expressly preempted all state law’ claims pursuant to the power delegated to it under VSTA, and thus in that case SBC was not relying in any way on a theory of implied preemption.
Id.
at 624 & n. I.
20
The court then stated the two-prong analysis of agency preemption established by
City of New York
and other Supreme Court precedent.
Id.
(“[T]he proper inquiry is to determine whether the power to preempt is within the bounds of authority granted to the agency by Congress, and if so, whether the agency has acted on this authority,” citing
City of New York,
The Court has made clear that the great deference generally afforded agency action is not discarded when the agency uses its delegated discretion to preempt. “Where Congress has directed an administrator to exercise his discretion,” and the administrator promulgates regulations intended to preempt state law, “his judgments are subject to judicial review only to determine whether he has exceeded his statutory authority or acted arbitrarily.” de la Cuesta,458 U.S. at 154-55 ,102 S.Ct. at 3023 ; see also Crisp,467 U.S. at 699-700 ,104 S.Ct. at 2700-01 .
Lynnbrook Farms,
The Seventh Circuit Court of Appeals undertook a three-part analysis of the question of whether APHIS’s regulatory actions preempted Lynnbrook Farms’ state law claims that, although somewhat different in its formulation, embodies the key parts of the Cüy of New York inquiry:
First, we must ascertain whether the power to preempt is within the authority delegated to the USDA and APHIS by Congress and is a rational exercise of that authority. If so, we then ask whether APHIS intended its regulations to preempt state common law claims. Finally, if APHIS did seek to preempt state common law, we consider whether the regulations preempt the specific causes of actions [sic] asserted by Lynnbrook.
Lynnbrook Farms,
As to the first prong of this analysis, the Seventh Circuit Court of Appeals looked first to “the congressional mandate that forms the basis of the agency’s authority.” Id. The court found as follows:
VSTA requires that all animal vaccines produced in the United States and all establishments that manufacture such vaccines be licensed by the USDA. 21 U.S.C. § 154. The Act also broadly confers on the USDA the authority to “make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation [and] sale ... of any worthless, contaminated, dangerous, or harmful.virus, serum, toxin, or analogous product for use in the treatment of domestic animals....” Id. The USDA has delegated this responsibility and authority to APHIS. . 9 C.F.R. § 101.2. APHIS, in turn, has promulgated an ex *1053 tensive regulatory scheme governing the design, manufacture, distribution, testing, and labelling of animal vaccines. See 9 C.F.R. §§ 101-24.
Id. The court next found that in response to judicial decisions holding that the scope of VSTA, and APHIS regulations promulgated thereunder, was limited to products made and sold in interstate commerce, and hence APHIS had no authority to regulate animal vaccines manufactured and sold within an individual state, Congress amended YSTA in 1985 to place both interstate and intrastate vaccines clearly within the ambit of federal control. Id. at 625 (citing 21 U.S.C. § .151; S.Rep. No. 145, 99th Cong., 1st Sess. 338-89 (1985), reprinted in 1985 U.S.Code Cong. & AdminNews 1676, 2004-05). Furthermore, the court found that “[t]he amendments reflect the Congressional finding that, federal regulation was ‘necessary to prevent and eliminate burdens on commerce and to effectively regulate such commerce.’ ” Id. (quoting 21 U.S.C. § 159). The court next briefly reviewed the somewhat sparse legislative history to the 1985 amendments, and concluded it “also evinces an unquestionable congressional intent to create national, uniform standards for the preparation and sale of animal vaccines,” because “Congress ... concluded that uniform, federal standards would better serve livestock owners, veterinarians, and the American public.” Id. (citing S.Rep. No. 145 at 339).
The Seventh Circuit Court of Appeals next examined APHIS’s express declaration of preemption, which states, in pertinent part, the following:
Where safety, efficacy, purity, and potency of biological products are concerned, it is the agency’s intent to occupy the field. This includes, but is not limited to the regulation of labeling. Under YSTA, Congress clearly intended that there be national uniformity in the regulation of these products.
* * * * * *
Seven commenters indicated that States should have the authority to add to Federal restrictions, as appropriate, based on a need to protect animal or human health and safety so long as such restrictions do not lessen the effect of Federal regulations _ APHIS ... does not agree that States should be allowed to add various restrictions ... based upon a need to protect domestic animals or the public health, interests or safety. Any restrictions, other than those which are necessary to address a local disease condition, should be Federally imposed so that they are uniform nationwide.
íH ífc * * H * 3*
States are not free to impose requirements which are different from, or in addition to, those imposed by USDA regarding the safety, efficacy, potency, or purity of a product. Similarly, labeling requirements which are different from or in addition to those in the regulations under the Act may not be imposed by the -States. Such additional or different requirements would thwart the Congressional intent regarding uniform national standards, and would usurp USDA’s authority to determine which biologies are pure, safe, potent and efficacious.
57 Fed.Reg. 38758, 38759 (August 27, 1992) (emphasis added);
see also Lynnbrook Farms,
We find that APHIS acted rationally and within the scope of the authority granted to it by Congress in issuing the above statement seeking to preempt state law. Congress granted the USDA and APHIS the broad regulatory power to promulgate and enforce “such rules and regulations as may be necessary” to prevent the production and sale of any “worthless, contaminated, dangerous or harmful” animal vaccines. Congress also delegated to the USDA and APHIS the responsibility to eliminate “undue burdens” on commerce in this area, and toward that end, to establish a national, uniform regulatory scheme. It is apparent that APHIS’ congressional mandate is to ensure safe and effective vaccines while at the same time minimize *1054 undue burdens on interstate commerce that often accompany varied state regulation. Given these powers and responsibilities, APHIS was acting rationally, and well within its congressionally delegated discretion, in creating a complex statutory scheme governing the safety, efficacy, purity, and potency of animal vaccines and in pronouncing this scheme to be the exclusive law in the area.
Lynnbrook Farms,
[njothing in the legislative history of either VSTA or its amendments indicates that APHIS’ actions would not be congressionally sanctioned. On the contrary, the course chosen serves only to further VSTA’s purposes — further indicating that the agency was acting within its authority and not acting arbitrarily. See de la Cuesta,458 U.S. at 159 ,102 S.Ct. at 3025 . Thus we decline to disturb the agency’s judgment to preempt state law.
Id.
The court found its conclusion bolstered by Supreme Court precedent on agency preemption, and furthermore rejected Lynn-brook Farms’ assertion that any distinction could or should be made between preemption of state regulations or statutes and preemption of state common-law causes of action.
Id.
at 626-27. The court also found that the presumption against preemption, and the heightened presumption in areas that have traditionally been the province of states, such as health and safety, “can be overcome by an agency’s clear declaration of intent to preempt state law.”
Id.
at 627 (citing
Hillsborough County,
Considering further whether APHIS intended to preempt state common-law causes of action, the Seventh Circuit Court of Appeals found,
As set forth above, APHIS’ preemption statement is clear and comprehensive. In an effort to fulfill its mandate to create a national, uniform system of regulations, APHIS announced it intended to “occupy the field” concerning “the safety, efficacy, purity and potency of biological products.” Toward this goal, APHIS decisively stated that “[sjtates are not free to impose requirements which are different from, or in addition to, those imposed by USDA regarding the safety, efficacy, potency, or purity of a product.”
Lynnbrook Farms,
We must agree with SBC that the correspondence confirms the interpretation that APHIS intended certain state tort claims *1055 to be preempted. Contrary to Lynn-brook’s argument that APHIS only intended to preempt positive enactments, the agency included in its preemptive scope additional requirements dictated by States via “regulations, statutes, or other means.” The phrase “or other means” clearly encompasses state tort claims. Moreover, APHIS’ letter signals that state tort claims are available when APHIS regulatory standards are violated or disregarded. The natural conclusion to draw from this statement is that when APHIS regulations are heeded, state, tort claims involving the safety, efficacy, potency, or purity of an animal vaccine do not survive. This dichotomy follows from the preemption language chosen by APHIS, as it is precisely when APHIS regulations have been satisfied that a common law action imposes requirements in' addition to, or different from, those mandated by APHIS. Where noncompliance is involved, a common law action could simply serve to impose the standards of APHIS. Thus, it is evident that APHIS intended to preempt common law claims relating to areas under its regulatory control (namely the safety, purity, potency, and efficacy of vaccines) which would impose additional or different requirements on vaccines, i.e., common law claims involving regulated areas in cases where the manufacturer has complied with all APHIS regulations and standards.
Id. at 629-30 (emphasis added). The court therefore turned to the final prong of its inquiry.
As to the question addressed in that final prong, whether Lynnbrook Farms’ claims fell within the preempted group of claims, the court concluded first that SBC’s vaccines, including Ultrabac 7/Somubac, “met APHIS standards for safety, purity, potency, and efficacy.” Id. at 630. Thus, whethér Lynn-brook Farms’ claims were preempted turned on the question of whether its “claims relate to these qualities, seeking to impose additional or different' requirements in these areas.” Id. The court then found strict products liability claims had been preempted as at least regarding safety, if not efficacy, purity, and potency, of the cattle vaccines to cattle. Id. The court next rejected as preempted claims of breach of implied warranties of fitness for a particular purpose and of merchantability as implicating efficacy and safety of the vaccines for cattle. Id. As with the strict liability claims, these claims were preempted, because they would impose additional or different duties beyond those imposed by APHIS regulations. Id. The' court also found Lynnbrook Farms’ claims of fraudulent misrepresentation and false advertising, based on allegations that SBC falsely represented the vaccines to be safe and effective for cattle when SBC knew they were not, had been preempted, because a jury would have to find, contrary to APHIS’s conclusions, that the vaccines were not’ safe and effective, and that they would require labeling requirements distinct from those dictated by APHIS. Id. This latter conclusion, the court determined, also meant that strict liability failure to warn claims were preempted. Id. Thus, the Seventh Circuit Court of Appeals held that all of Lynnbrook Farms’ claims, based on the injury to or death of its cattle following use of SBC’s vaccines, were preempted by APHIS regulations. Id.
b. Other decisions
Most of the decisions of other courts rendered prior to
Lynnbrook Farms
are very similar to that of the Seventh Circuit Court of Appeals, both in terms of the nature of the claims and the analysis of the preemption issue.
See Murphy v. SmithKline Beecham Corp.,
The first of these decisions is an unpublished ruling of the United States District Court for the Northern District of Georgia in
Gresham, v. Boehringer Ingelheim Animal Health, Inc.,
Civil No. 1:95-cv-3376-ODE (N.D.Ga. Aug. 7, 1996).
ha. , Gresham,
the plaintiff claimed that his cattle suffered permanent damage after receiving doses of a defective vaccine, called Alpha-7, manufactured by the defendant.
Gresham,
slip op. at 1. The plaintiff asserted claims under Georgia law based on strict liability, negligence, breach of express warranty, and breach of implied warranties of merchantability and fitness for a particular purpose.
Id.
The defendant moved for summary judgment asserting the plaintiffs state-law claims were preempted by APHIS regulations.
Id.
at 3. The district court acknowledged rulings, such as
Lynnbrook Farms,
In Medtronic, the Supreme Court rejected the defendant’s assertion that the plain language of § 360k(a) necessitated the preemption of all common law causes of action. A plurality of the Court reasoned that this interpretation of “requirement” was implausible given that it would “have the perverse effect of granting complete immunity from design defect liability to an entire industry.” Id. at *9. A plurality of the Court found that based on the législa-tive history of the statute and ambiguous language, Congress did not intend to preclude “most, let alone all, general common-law duties enforced by damages actions.” Id. at *11. The Court remanded the plaintiffs claims for negligent design and manufacture, failure to warn, and strict liability for further proceedings. Id. at *16.
While there are significant differences between the MDA and VSTA, Medtronic counsels against construing VSTA’s preemption provision so broadly as to leave Plaintiff no remedy in the instant ease. While Congress in enacting VSTA .was clearly concerned with eliminating burdens on interstate commerce, the “purpose of the Act is to assure that biologies used in the treatment of animals are pure, safe, potent, and efficacious.” 57 FR 38758. If VSTA is interpreted to completely insulate manufacturers from liability, it cannot achieve its purpose because manufacturers would have no incentive to maintain quality control after USDA approval.
With this in mind, the court turns to evaluate whether Plaintiffs specific causes of action would impose upon Defendant “requirements which are different from, or in addition to, those imposed by USDA regarding the safety, efficacy, potency, or purity of a product.” 57 FR 38759. In Medtronic, the Court held that similar language in § 360k(a) did not preempt claims based on a manufacturer’s failure to comply with FDA regulations. The Court reasoned that such claims were parallel to federal requirements rather than different from or in addition to such requirements. Id. at *12. Moreover, a letter issued on December 22, 1995 by the Acting Administrator of APHIS supports the extension of *1057 this finding to VSTA. That letter, as quoted in Lynnbrook Farms, states that APHIS “did not intend to preempt common law actions for damages arising from non-compliance with USDA regulatory standards.” Lynnbrook Farms,79 F.3d 620 , 629 (7th Cir.1996).
Plaintiff makes clear in his brief in opposition to Defendant’s motion for summary judgment that his negligence claim is premised on the notion that Defendant provided a “bad batch” of Alpha-7 to Plaintiff. Although he does not explain the context of his strict liability claim, claims for breach of implied warranties of merchantability and fitness, and claim for breach of express warranty, a review of the facts cited by Plaintiff indicates that these counts are also premised on the “bad batch” theory. To the extent that Plaintiff intends to prove that the particular batch of Alpha-7 which he received was not in compliance with federal regulations, these actions do not impose requirements different from or in addition to, those established by APHIS.
The court finds, therefore, that Defendant’s preemption arguments are without merit. Plaintiffs claims in the instant case may go forward to the extent that they are premised on a “bad batch” theory. It is important to note, however, that in prosecuting these claims Plaintiff may not challenge the adequacy of the federal regulations or the formula of Alphar-7 approved by the USDA. Such claims are preempted under VSTA.
Gresham, slip op. at 6-8 (footnotes omitted). The second ruling to call into question the preemptive reach of APHIS regulations, also unpublished, is Stegmaier v. SmithKline Beecham Animal Health, Inc., No. 4-95-CV-149 (D.Minn. Aug. 22, 1996). In Steg-maier, the plaintiff asserted claims based on “accidental self-injection of swine vaccine.” Stegmaier, slip op. at 1. In light of the Supreme Court’s decision in Medtronic, the United States District Court for the District of Minnesota concluded that the defendant animal vaccine maker’s motion for summary judgment grounded on preemption should be denied “without prejudice.” The court ordered the filing of supplemental briefs “on the effect, if any, of the Supreme Court’s [Medtronic ] decision on the case at bar.” Id.
Although the court cannot construe the Garrelts’ claims to assert “bad batch” theories, the Garrelts have contended that they are not seeking to enforce requirements that are different from or in addition to APHIS requirements, but are instead seeking to enforce USDA standards. They have also asserted that the Supreme Court’s decision in Medtronic changes the preemption analysis, or, more properly, changes the presumptions in the preemption analysis, sufficiently that their claims are not preempted. The court will consider below whether these arguments are persuasive.
2. This court’s preemption analysis
Finding that the prior decisions considering whether APHIS regulations preempt state tort claims are either unpersuasive or inapplicable, the court must embark on its own analysis of the preemptive effect of APHIS regulations on the specific tort claims raised here. Thus, -under
City of New York,
the court must first determine whether APHIS intended to preempt the state tort claims at issue here.
City of New York,
a. APHIS’s intent to preempt
SBC contends that APHIS’s intent to preempt state law, including state tort claims for personal injury, is manifest and unambig *1058 uous. SBC relies on APHIS’s statement of preemptive intent in 57 Fed.Rég. 38758, 38759 (August 27, 1992), and its confirmation in the Medley Letter in December of 1995. SBC contends that the Garrelts’ claims would impose requirements that are different from or in addition to those APHIS imposes, and hence are of the land APHIS expressly intended to preempt. As to whether APHIS expressly intended to preempt claims for injuries to humans, SBC points out that APHIS rejected public comments that states should be permitted to add various restrictions based upon a need to protect human health and safety, citing the following from the 1992 declaration of preemption:
Seven commenters indicated that States should have the authority to add to Federal restrictions, as appropriate, based on a need to protect animal or human health and safety so long as such restrictions do not lessen the effect of Federal regula-tions_ APHIS ... does not agree that States should be allowed to add various restrictions, as appropriate, based upon a need to protect domestic animals or the public health, interests, or safety. Any restrictions, other than those which are necessary to address a local disease condition, should be Federally imposed so that they are uniform nationwide.
Such additional or different requirements would thwart the Congressional intent regarding uniform national standards, and would usurp USDA’s authority to determine which biologies are pure, safe, potent and efficacious.
57 Fed.Reg. at 38579 (as excerpted and with emphasis as added by SBC). SBC argues that APHIS pays significant attention to human health and safety in the pre-market licensing approval process, because vaccines containing certain antigens, such as live Newcastle Disease virus and live rabies virus, are subject to special labeling requirements noting the extent to which exposure to the antigens can cause disease in humans, 9 C.F.R. § 112.7(a), while other additional restrictions may be imposed where APHIS determines that the protection of domestic animals or the public health, interest, or safety necessitate such restrictions. 9 C.F.R. § 102.5(e). Thus, SBC contends that APHIS intended to bar states from imposing “different” or “additional” restrictions regardless of whether a state’s restriction pertains to animal or human health.
The Garrelts counter that APHIS’s intent was clearly that state common law claims not be preempted. The Garrelts point out that APHIS requires no mandatory labels, but instead requires “[f]ull instructions for the proper use of the product, including vaccination schedules, warnings, cautions, and the like.” 9 C.F.R. § 112.2(a)(5). The Garrelts further argue that it is unreasonable to conclude that APHIS intended to preempt state common law claims when APHIS regulations permit manufacturers to include on labels “any other information which is not false or misleading,” but not disclaimers. 9 C.F.R. 112.2(b). The Garrelts also contend that APHIS’s lack of intent to preempt state common law claims is apparent from the Medley Letter, in which the Acting Director stated that APHIS regulations are not intended “to preempt common law actions for damages arising from non-compliance with USDA regulatory standards.” The proper interpretation of this statement, the Garrelts argue, is that claims arising from conduct violative of the USDA regulations are preserved. They further assert that such an interpretation would preserve the claims in this case, because warnings and cautions “appropriate” for the Ultrabac 7 vaccine were not included on the product label. 9 C.F.R. § 112.2(a)(5) (requiring “[f]ull instructions for the proper use of the product, including ... warnings, cautions_”). As their penultimate argument concerning APHIS’s intent, the Gar-relts assert that APHIS requires no testing for, or warning of, potential human harm from self-inoculation, suggesting APHIS’s lack of intent to regulate such warnings. Lastly, citing Medtronic, the Garrelts contend that APHIS’s intent should not be interpreted in such a way as to deprive the plaintiffs of any recourse.
The court concludes that APHIS has expressly stated its intent to preempt state common law claims based on injury to humans. In the absence of matters discussed *1059 below, the Garrelts’ reading of the agency’s intent might be persuasive. Agency rules do indeed require the manufacturer of an animal vaccine to include “[f]ull instructions for the proper use of the product, including vaccination schedules, warnings, cautions, and the like,” 9 C.F.R. § 112.2(a)(5), and do further permit the manufacturer to include on labels “any other information which is not false or misleading,” and is not a disclaimer. 9 C.F.R. 112.2(b). Warnings such as those the Garrelts assert should have been given in this case would seem to be permitted, perhaps even required, by these provisions of the rules. However, that does not mean that APHIS did not intend to preempt the Gar-relts’ state tort claims.
There are two barriers to a conclusion that APHIS did not intend to preempt claims for human injury as the result of inadequate labeling, both based on APHIS’s express statement of intent to preempt state law.
See City of New York,
The second impediment is APHIS’s own declaration as to the kinds of claims that it intended to preempt. In its declaration in the Federal Regulations, APHIS rejected the argument that state regulations “based on a need to protect animal or human health and safety” that “do not lessen the effect of Federal regulations” should be permitted. 57 Fed.Reg. at 38759. State tort claims such as the Garrelts’ are intended, at least arguably, not to lessen the effect of federal regulations, but actually to enforce those regulations. Nonetheless, APHIS concluded that states should- not be allowed to add such restrictions, because “[a]ny restrictions, other than those which are necessary to address a local disease condition, should be Federally imposed so that they are uniform nationwide.” Id. APHIS’s intent to occupy the field as regards restrictions to protect human health and safety is thereby express. 22
What, then, of APHIS’s disclaimer of intent to preempt certain kinds of claims?
Hillsborough County,
b. Congressional authorization
Having concluded that APHIS did indeed intend to preempt state law, and, more specifically, the state law claims asserted by the Garrelts for human injury, the next question is whether Congress intended or authorized APHIS to preempt the state law upon which the Garrelts’ claim is based.
City of New York,
The Garrelts’ arguments for a lack of congressional authorization are not altogether clear. In their brief, the Garrelts assert baldly that “APHIS clearly had no authority to ‘occupy the field’ of potential human injury claims arising out of the use of animal vaccines.” Plaintiffs’ Resistance To The Defendant’s Motion For Summary Judgment And Memorandum, pp. 13-14. However, they cite no indicia of the lack of such authority. They then reassert that the “regulatory gap” caused by APHIS’s failure to require information concerning potential human harm or warnings of such potential human harm shows that APHIS’s intent to preempt state claims for human injury went beyond both regulatory practice and regulatory authority. However, it is apparent from other portions of their brief and their oral arguments that the Garrelts contend that Medtronic counsels against finding congressional authorization, and that, without some clearer statement of congressional authorization, the presumption against preemption of state authority to police health and safety matters should weigh against finding congressional authorization here.
As this court has observed a number of times in this ruling, congressional intent remains critical to this second prong of the
City of New York
inquiry.
City of New York,
Like every recent decision to consider the extent of Congress’s authorization of agency preemption under VSTA, this court’s inquiry focuses, in the first instance, on the specific section of the act authorizing agency regulations, 21 U.S.C. § 154. That section of the statute provides as follows:
The Secretary of Agriculture is hereby authorized to make and promulgate from time to time such rules and regulations as may be necessary to prevent the preparation, sale, barter, exchange, or shipment as aforesaid of any worthless, contaminated, dangerous, or harmful virus, serum, toxin, *1062 or analogous product for use in the treatment of domestic animals or otherwise to carry out this paragraph, and to issue, suspend, and revoke licenses for the main- ' tenance of establishments for the preparation of viruses, serums, toxins, and analogous products, for use in the treatment of domestic animals, intended for sale, barter, exchange, or shipment as aforesaid.
21 U.S.C. § 154 (emphasis added). This court agrees with those decisions holding that the authorization “to make and promulgate from time to time such rules and regulations as may be necessary” is a congressional authorization for the agency to preempt state law.
See, e.g., Murphy,
Thus, the court believes it would be a mistake to read this statutory provision in isolation from the statutory provision identifying the purpose of VSTA itself, 21 U.S.C. § 151, in both its original form and as aménded in 1985. The codified provision stating Congress’s purpose in passing the legislation in 1913 is as follows:
It shall be unlawful for any person, firm, or corporation to prepare, sell, barter,- or exchange in the,District of Columbia, or in the Territories, or in any place under the jurisdiction of the United States, or to ship or deliver for shipment from one State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals, and no person firm, or corporation shall prepare, sell, barter, exchange, or ship as aforesaid any virus, serum, toxin, or analogous product manufactured within the United States and .intended for use in the treatment of domestic animals, unless and until the said virus, serum, toxin, or analogous product shall have been prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding an unsuspended and unre-voked license issued by the Secretary of Agriculture as hereinafter authorized.
21 U.S-.C. § 151 (1913) (emphasis added). The logical reading of this provision is that Congress was motivated by a concern over the possible worthlessness, contamination, dangerousness, or harmfulness of animal vaccines to domestic animals. Indeed, a purpose to protect human health or the public health is not given direct expression anywhere in the 1913 act.
Other insights into Congress’s purpose in enacting the original provisions of VSTA are few.
Animal Health Inst. v. United States Dep’t of Agric.,
In the first part of the next decade [meaning the 1910s] farmers were suffering considerable losses as a result of the somewhat motley manufacture and distribution of anti-hog cholera serum. The Department of Agriculture apparently felt that the authorization to regulate animal drugs contained in the Food and Drug Act of 1906 did not provide adequate authority to regulate anti-hog cholera serum; the Department procured the passage of the VSTA in response to the anti-hog cholera serum problem. See, Hall v. State,100 Neb. 84 ,158 N.W. 362 (1916). The.VSTA, then as now, provided for the regulation of animal biologicals shipped in interstate commerce, with no jurisdiction over biolog-ies merely having a component that had passed through interstate commerce. Responsibility for its administration was placed with the Bureau of Animal Industry, a subdivision of the Department of Agriculture. Appropriations Act of March 4, 1917, Ch. 179, 39 Stat. 1138.
Grand Labs., Inc. v. Harris,
The Department of Agriculture, realizing the losses that were resulting to the hog raisers of the country from the promiscuous manufacture and distribution of anti-hog cholera serum, secured the enactment of a law intended to regulate the preparation, sale, and distribution of such se-rum_ Act March 4, 1913, c. 145, 37 U.S. Stat. 832, 833.
Hall v. State,
Indeed, to the extent that there is any doubt as to whether Congress intended the VSTA to preempt causes of action based on
human
injury from animal vaccines, that doubt must be resolved against intent to preempt such claims. In the case of either statutory or agency preemption, there is a presumption that “ ‘the historic powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’ ”
Medtronic, Inc.,
— U.S. at -,
As amended in 1985, the “purpose” provision, 21 U.S.C. § 151, expanded the *1064 VSTA’s réach to include both interstate and intrastate manufacture and sale of animal vaccines. The amended section is as follows:
It shall be unlawful for any person, firm, or corporation to prepare, sell, barter, or exchange in the District of Columbia, or in the Territories, or in any place under the jurisdiction of the United States, or to ship or deliver for shipment in or from, the United States, the District of Columbia, any territory of the United States, or any place under the jurisdiction of the United States, any worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous product intended for use in the treatment of domestic animals, and no person, firm, or corporation shall prepare, sell, barter, exchange, or ship as aforesaid any virus, serum, toxin, or analogous product manufactured within the United States and intended for use in the treatment of domestic animals, unless and until the said virus, serum, toxin, or analogous product shall have been prepared, under and in compliance with regulations prescribed by the Secretary of Agriculture, at an establishment holding an unsuspended and un-revoked license issued by the Secretary of Agriculture as hereinafter authorized.
21 U.S.C. § 151 (1985) (emphasis added indicating changes from the 1913 version). A new section, 21 U.S.C. § 159, was also enacted in 1985 as part of the VSTA amendments. It provides as follows:
The procedures of sections 672, 673, and 674 of this title (relating to detentions, seizures and condemnations, and injunctions, respectively) shall apply to the enforcement of this chapter with respect to any product prepared, sold, bartered, exchanged, or shipped in violation of this chapter or a regulation promulgated under this chapter. The provisions (including penalties) of section 675 of this title shall apply to the performance of official duties under this chapter. Congress finds that (i) .the products and activities that are regulated under this chapter are either in interstate or foreign commerce or substantially affect such commerce or the free flow thereof, and (ii) regulation of the products and activities as provided in this chapter is • necessary to prevent and eliminate burdens on such commerce and to effectively regulate such commerce.
21 U.S.C. § 159. Although judicial comment on the legislative .history for these amendments is more extensive than that available for the original version of VSTA, this latter legislative history is still somewhat sparse.
The Seventh Circuit Court of Appeals accurately summarized this latter legislative history in
Lynnbrook Farms,
Prior to 1985, several courts held that the scope of VSTA, and hence the application of APHIS regulations, was limited to products made and sold in interstate commerce. In other words, VSTA did not grant the USDA and APHIS the authority to regulate animal vaccines manufactured and sold within an individual state. See Animal Health Institute v. U.S. Dept. of Agriculture,487 F.Supp. 376 (D.Colo.1980); Grand Lab., Inc. v. Harris,644 F.2d 729 (8th Cir.1981), cert. denied,456 U.S. 927 ,102 S.Ct. 1972 ,72 L.Ed.2d 442 (1982). In response, Congress amended VSTA in 1985 to clearly place both interstate and intrastate vaccines within the ambit of federal control. 21 U.S.C. § 151; S.Rep. No. 145, 99th Cong., 1st Sess. 338-39 (1985), reprinted in 1985 U.S.C.C.A.N. 1676, 2004-05. The amendments reflect the Congressional finding that federal regulation was “necessary to prevent and eliminate burdens on commerce and to effectively regulate such commerce.” 21 U.S.C. § 159.
The legislative history supporting the VSTA amendments also evinces an unquestionable congressional intent to create national, uniform standards for the preparation and sale of animal vaccines. S.Rep. No. 145 at 339. Congress found that animal agriculture has “changed drastically” since the original Í913 passage of VSTA, including the development of “truly national markets.” Id. It also noted that the industry recognized the need for national standards. Id. Congress thus concluded that uniform, federal standards would better serve livestock owners, veterinarians, and the American public. Id.
*1065
Lynnbrook Farms,
This court finds nothing about the expansion of VSTA to regulate intrastate manufacture and sale of animal vaccines as well as interstate manufacture and sale that expressly requires expansion of VSTA into the regulation of
human health risks
from such vaccines. Instead, the legislative history indicates that in making the 1985 amendments, Congress only intended to extend to “intrastate” vaccines the regulatory authority it had already given the agency with regard to “interstate” vaccines. S.Rep. No. 145, 99th Cong., 1st Sess. 338-39 (1985), reprinted in 1985 U.S.C.C.A.N. 1676, 2004-05; 131 Cong. Rec. H12499-02 (comments of Mr. Garza, Rep. Texas). As the court observed with regard to the 1913 version of 21 U.S.C. § 151, congressional intent, and consequent agency authority, extended only to preemption of state regulation of vaccines to address
animal health. Grand Labs., Inc.,
The court recognizes, however, that no such express authorization is required.
See, e.g., City of New York,
In
City of New York,
the Court looked not only at the specific language of the authorizing statute, but at the implications of the legislative history of that statute.
City of New York,
In
de la Cuesta,
the Court found that the authorizing statute gave the agency “plenary” authority to issue the regulations in question, because the authorizing statute specified each of the areas in which the challenged preemptive regulations had been promulgated.
de la Cuesta,
Not only are these precedents distinguishable in their implications of congressional intent, but the Supreme Court’s recent decision in
Medtronic
casts doubt on any implication of congressional intent that agency regulations should preempt claims for human injury, even if Congress intended, and hence authorized, the agency to preempt other state regulation that posed impediments to commerce. In
Medtronic,
the Court considered a statute, rather than an agency pronouncement, that forbade any “requirement” that altered incentives or imposed duties “different from, or in addition to” the standards promulgated by the responsible agency.
Medtronic, Inc.,
— U.S. at -,
Under Medtronic’s view of the statute, Congress effectively precluded state courts from affording state consumers any protection from injuries resulting from a defective medical device. Moreover, because there is no explicit private cause of action against manufacturers contained in the MDA, and no suggestion that the Act created an implied private right of action, Congress would have barred most, if not all, relief for persons injured, by defective medical devices. Medtronic’s construction of § 360k would therefore have the perverse effect of granting complete immunity from design defect liability .to an entire industry that, in the judgment of Congress, needed more stringent regulation in order “to provide for the safety and effectiveness of medical devices intended for ' human use, ” 90 St. 539 (preamble to Act). It is, to say the least, “difficult to believe that Congress would, without comment, remove all means of judicial recourse from those injured by illegal conduct,” Silkwood v. Kerr-McGee Corp.,464 U.S. 238 , 251,104 S.Ct. 615 , 623,78 L.Ed.2d 443 (1984), and it would take language much *1068 plainer than the text of § 360k to convince us that Congress intended that result.
Medtronic, Inc.,
— U.S. at-,
The plurality in
Medtronic
also examined the legislative history of the MDA, and found that “when Congress enacted § 360k, it was primarily concerned with the problem of specific, conflicting State statutes and regulations rather than the general duties enforced by common-law actions.”
Medtronic, Inc.,
— U.S. at -,
The plurality in
Medtronic
also confronted an argument, similar to that offered here by SBC concerning the import of Congress’s concern to unburden commerce. The argument in
Medtronic
was that the intent behind the MDA was at least in part to protect innovations in device technology from being stifled by unnecessary restrictions, and that this interest extended to the preemption of common-law claims, even in light of the express purpose of the act “ ‘to provide for the safety and effectiveness of medical devices intended for human use.’ ”
Medtronic, Inc.,
— U.S. at-,
While the Act certainly reflects some of these concerns, the legislative history indicates that any fears regarding regulatory burdens were related more to the risk of additional federal and state regulation rather than the danger of preexisting duties under common law_ Indeed, nowhere in the material relating to the Act’s history have we discovered a reference to a fear that product liability actions would hamper the development of medical devices. To the extent that Congress was concerned about protecting the industry, that intent was manifested primarily through fewer substantive requirements under the Act, not the pre-emption provision; furthermore, any such concern was far outweighed by concerns about the primary issue motivating the MDA’s enactment: the safety of those who use medical devices.
Medtronic, Inc.,
— U.S. at-,
In the present case, SBC argues that the congressional intent to unburden commerce in animal vaccines extends to the preemption of common-law claims for human injury from such vaccines. In this case, the rather limited legislative history suggests that the VSTA was enacted out of concern for a lack of uniform regulation
27
as interfering with corn-
*1069
merce rather than a fear of the danger of preexisting duties under the common law. Furthermore, nowhere in the material relating to the history of the 1985 amendments to VSTA has the court discovered a reference to a fear that product liability actions based on injuries to humans would hamper the development of commerce in animal vaccines. To the extent that Congress was concerned about protecting the animal vaccine industry from burdens on commerce, that intent was manifested primarily through bringing all such vaccines, “intrastate” and “interstate,” under the same standards relating to
animal
safety. 21 U.S.C. § 151 (1985) (including “intrastate” vaccines within the ambit of the VSTA);
Grand Labs., Inc.,
c. Are the Garrelts’ claims preempted?
This court finds no indication of congressional intent, either expressed or implied, for
agency
regulations under VSTA to preempt common-law claims based on failure to warn of the dangers to humans of self-inoculation from animal vaccines. Thus, even if APHIS intended to preempt such claims, thereby satisfying the first prong of the
City of New York
inquiry, APHIS’s action was not authorized by Congress, as required under the second prong of that inquiry, and agency preemption of such claims therefore is not permitted.
City of New York,
Yet, even were this court persuaded that both burdens on commerce and concerns about-human health were policies committed to the care of APHIS under the VSTA, and this court were therefore required to accord deference to APHIS’s determination to preempt human injury claims, this court would find APHIS’s regulations no bar to the claims presented in this case. In order to sustain the bar of agency preemption, “the agency’s choice to pre-empt [must] ‘represent a
reasonable accommodation
of conflicting policies that were committed to the agency’s care by the statute.’ ”
Id.
(quoting
Shimer,
Finally, the court is not persuaded that Congress would have sanctioned such sweeping agency preemption in light of the statute and its legislative history.
City of New York,
Thus, the court concludes, as to the question posed by SBC’s summary judgment motion, which is whether APHIS regulations preempt tort claims like the Garrelts’ for human injury, the answer is “no.”
C. Certification For Interlocutory Appeal
Although neither party has requested it, the court concludes that it should sua sponte grant SBC leave to pursue an interlocutory appeal of this order pursuant to 28 U.S.C. § 1292(b). 28 That statute provides, in pertinent part, as follows:
(b) When a district judge, in making in a civil action an order not otherwise appeal-able under this section, shall be of the opinion that such order involves a controlling question of law as to which there is substantial ground for difference of opinion and that an immediate appeal from the order may materially advance the ultimate termination of the litigation, he shall so state in writing in such order. The Court of Appeals which would have jurisdiction of an appeal of such action may thereupon, in its discretion, permit an appeal to be taken from such order, if application is made to it within ten days after the entry of the order: Provided, however, That application for an appeal hereunder shall not stay proceedings in the district court unless the district judge or the Court of Appeals or a judge thereof shall so order.
28 U.S.C. § 1292(b). As the Eighth Circuit Court of Appeals has observed, the statute provides for certification of controlling questions of law by the district court for interlocutory appeal in circumstances where an appeal is otherwise unavailable.
City of Fort Madison, Iowa v. Emerald Lady,
*1071
In a recent decision, the Eighth Circuit Court of Appeals considered the standards applicable to an interlocutory appeal pursuant to § 1292(b).
See White v. Nix,
The court is of the opinion that this decision presents an “exceptional ease” in which immediate interlocutory appeal should be permitted. Id. This court is of the opinion that this order involves a controlling question of law, specifically, whether the Gar-relts’ state-law claims have been preempted by APHIS regulations. Id. It is also clear to the court that “there is substantial ground for difference of opinion,” id., since no court has yet decided the preemption issue as regards human injury, and all of the decisions to address the preemptive effect of APHIS regulations on other kinds of state-law claims have found that the regulations properly preempted state law. Finally, certification will “materially advance the ultimate termination of the litigation,” id., because, if this court is incorrect in its conclusion that the Garrelts’ claims are not preempted, SBC is entitled to immediate summary judgment terminating the case. This matter will therefore be certified for interlocutory appeal pursuant to 28 U.S.C. § 1292(b) on the question of whether the Garrelts’ state-law claims are preempted by APHIS regulations. However, this court will not enter any stay of the proceedings in this case while such an interlocutory appeal is pending. 28 U.S.C. § 1292(b).
V. CONCLUSION
The court deems it useful briefly to recapitulate the steps leading it to the conclusion that the Garrelts’ claims for human injury are not preempted by APHIS regulations, and hence requiring the court to deny SBC’s motion for summary judgment. First, in order to determine whether APHIS regulations could preempt the Garrelts’ common-law claims, the court had to establish what, if any, deference was due a determination by the agency that it had such preemptive power. Although this court’s view is admittedly contrary to that of a number of other courts, a thorough review of the Supreme Court’s decision in
City of New York
and other Supreme Court decisions dealing with agency preemption has led this court to conclude that, as a general rule, no deference is due the agency’s determination to preempt state law. Rather, in only very narrow circumstances is the agency accorded any deference at all. Those narrow circumstances arise only where (1) Congress confers on the agency “a broad grant of authority to reconcile conflicting policies,”
and
(2) the agency’s choice to preempt “represents a
reasonable
accommodation
of conflicting policies that were committed to the agency’s care by the
*1072
statute
” authorizing the agency to act.
See City of New York,
Next, the court concluded that prior decisions considering . APHIS’s authority to preempt state law were either unpersuasive or inapplicable, because they either did not properly apply the City of New York analysis, as interpreted by this court, or did not involve claims for human injury, or both. Thus, the court was compelled to embark on its own analysis of the preemptive effect of APHIS regulations on the Garrelts’ state-law claims. In the first prong of that analysis, the court found that APHIS did indeed expressly state its intention to preempt even claims for human injury resulting from the manufacture or use of animal vaccines. First, APHIS stated its intention to preempt requirements, including state-law claims, imposing requirements “different” from or “additional” to those imposed by the agency, and claims for injuries to humans would impose such different or additional requirements. Second, APHIS stated its intention to preempt claims based on a need to protect animal or human health and safety. Although APHIS left open the door for state-law claims for damages for noncompliance with agency regulatory standards, which this court found authorized so-called “bad batch” claims, the Garrelts made no such claims.
It was upon the second prong of the City of New York analysis, examination of whether the agency’s action was authorized by Congress, that this court found agency preemption of the claims in this case foundered. Although the court found congressional authorization to preempt state law in 21 U.S.C. § 154, this court did not agree that the language of this statutory provision authorized agency preemption of state law at will, but only constituted an authorization to preempt state law to the extent that it was Congress’s intent that the agency act in a particular field. Thus, the court read the preemption authorization of § 154 in conjunction with the purpose provision of VSTA, 21 U.S.C. § 151, and looked at'that purpose in light of original passage of VSTA in 1913, and in light of amendments in 1985. Section 151, as originally enacted, this court found, indicated that Congress was motivated by a concern over the possible worthlessness, contamination, dangerousness, or harmfulness of animal vaccines to domestic animals. Nowhere in the statute is there any express statement of a purpose to protect human health. The few insights into Congress’s original intent in passing VSTA confirmed this interpretation, because they demonstrated that the stimulus for passage of VSTA was the worthlessness or dangerousness of vaccines to livestock in the face of a hog cholera epidemic. Thus, this court concluded, congressional intent, and consequently congressional authorization for preemption, in the VSTA was directed toward regulation of animal health. In light of any doubt on the subject, the court1 concluded that the presumption against preemption of historic state powers to regulate health and safety weighed against finding congressional authorization to ' preempt claims for injury to human health.
This court found nothing in the 1985 amendments to VSTA altering this conclusion, based on the purpose of VSTA and consequent congressional authorization for preemption. Nothing about expansion of VSTA to regulate intrastate manufacture and sale of animal vaccines as well as interstate manufacture and sale either expressly or implicitly requires expansion of VSTA into the regulation of human health risks from such vaccines. An authorization to regulate commerce in the vaccines, this court concludes, cannot be parlayed into an authorization to preempt state claims for injuries to humans. The Supreme Court’s decision in Medtronic counsels against giving such an expansive reading to congressional authorization.
Thus, although the first prong of the City of New York analysis was satisfied, the second prong was not, and the agency was entitled to no deference for its contrary conclusion, because the prerequisites for such deference had not been met. The court *1073 found no broad authority for APHIS to reconcile conflicting policies of unburdening commerce and protection from injury to humans, because the latter policy was never committed to the agency’s care. Even were the court persuaded that both burdens on commerce and concerns about human health were policies committed to the care of APHIS under VSTA, the court finds that, even affording the agency the deference it would then' be due, APHIS’s regulations pose no bar to the Garrelts’ claims. The court finds APHIS’s accommodation is not “reasonable,” because, inter alia, it wipes out an entire category of claims based on pre-exist-ing common-law duties in an entire industry in the interest of unburdening that industry, when Congress gave no hint of such an intention. In light of the statute and its legislative history, the court is not persuaded that Congress would have sanctioned such sweeping agency preemption. The intent of VSTA was the protection of animal health in 1913, and remained so after amendments in 1985; thus, with such congressional intent as the basis for the statute, the court deems it unlikely in the extreme that Congress would have sanctioned agency preemption of all common-law claims based on injury to humans.
SBC’s motion for summary judgment, based on the preemption of the Garrelts’ claims for human injury by APHIS regulá-tions, is therefore denied. However, finding that, in this court’s opinion, this decision involves a controlling question of law as to which there is substantial ground for difference of opinion, and that certification will materially advance the ultimate termination of the litigation, the court certifies this decision for interlocutory appeal pursuant to 28 U.S.C. § 1292(b) on the question of whether the Garrelts’ state-law claims are preempted by APHIS regulations.
IT IS SO ORDERED.
Notes
. SBC’s affirmative defenses Eire the following: the complaint fails to state a claim upon which relief can be granted; plaintiffs were contribu-torily or comparatively at fault; plaintiffs’ injuries, if any, were caused by third parties beyond SBC's control; plaintiffs' claims are barred by the "learned intermediary” doctrine; plaintiffs’ injuries, if any, were caused by the foreseeable or unforeseeable misuse of the product at issue; the product was designed, manufactured, tested, marketed, advertised, and sold in full conformity with applicable state-of-the-art at the time and in the region; Emd, finally, plaintiffs' claims are preempted by federal law, specifically, VSTA and regulations promulgated pursuant to VSTA.
. The exceptions are a decision of the United States District Court for the Northern District of Georgia,
Gresham v. Boehringer Ingelheim Animal Health, Inc.,
No. 1:95-cv-3376-ODE,
1996
WL 751126 (N.D.Ga. Aug. 7, 1996), and the unpublished decision of the United States District Court for the District of Minnesota in
Stegmaier v. SmithKline Beecham Animal Health, Inc.,
No. 4-95-cv-149,
. The court pressed Mr. Smith quite hard at the oral arguments on this matter, and the court was impressed with his courtesy, professionalism, responsiveness to questions, obvious preparation, and able arguments on behalf of his client.
. An issue of material fact is genuine if it has a real basis in the record.
Hartnagel,
. The court has considered in some detail the . standards applicable to disposition of a motion for summary judgment when factual disputes are asserted to be material, most recently in
Jones Distrib. Co., Inc. v. White Consol. Indus., Inc.,
. The complaint in this case, erroneously designated a "petition at law,” does not disclose plaintiff Judith K. Garrelts' relationship to plaintiff JohnW. Garrelts.
. The Garrelts alleged the name of the vaccine John used to be "Ultra-Vac Seven.” See, e.g., Complaint, ¶ 5. In its answer, SBC asserted that it manufactures no vaccine by that name, although it does manufacture one called "Ultrabac 7.” For the purposes of this summary judgment *1031 motion, the parties do not appear to dispute the identity of the vaccine in question as Ultrabac 7 or that it was manufactured by SBC.
. The Garrelts have since clarified that John's injuries allegedly include joint problems similar to arthritis and anaphylactoid reactions, such as anaphylactic shock. The nature of John's specific injuries is not at issue in these summary judgment proceedings. It is, however, undisputed that the injuries underlying the Garrelts’ corn-plaint are for physical injuries to John, not to John’s cattle or to John for economic loss from injury to or death of his cattle.
. Senator Wellstone's letter to APHIS is attached to the Affidavit of Scott A. Smith (docket no. 19) as Exhibit A.
. APHIS's response to Senator Wellstone's letter is attached to Scott A. Smith's Affidavit as Exhibit B.
. The present lawsuit does not involve a question of "statutory” preemption. Nonetheless, the court begins its analysis with statutory preemption in order to compare and contrast the analysis of a “statutory” preemption question with the analysis of an “agency" preemption question. The court’s reasons for indulging in such a comparison will become evident infra.
. The relationship between the two forms of preemption may actually be one step further removed, since "agency” preemption is not born directly of congressional authority drawn from the Supremacy Clause; rather, it is bom of congressional authority
delegated
to an agency.
See City of New York,
. The Eighth Circuit Court of Appeals has had little opportunity to pass upon the nature of the inquiry in an agency preemption case, or, for that matter, upon any other aspect of a claim of agency preemption. The Eighth Circuit Court of Appeals mentioned agency preemption in a quotation of a passage from
Louisiana Pub. Serv. Comm’n v. FCC,
. An accurate interpretation of the continued importance of congressional intent may be seen in Kansas ex rel. Todd, in which the Tenth Circuit Court of Appeals wrote the following:
The first step in this' preemption issue is to consider if Congress intended to supersede state law with the Federal Crop Insurance Act and its regulations. Louisiana Pub. Serv. Comm'n v. FCC,476 U.S. 355 , 369,106 S.Ct. 1890 , 1898,90 L.Ed.2d 369 (1986).... But this focus on Congress's intent is not so fixed' that it is dependent on " ‘express congressional authorization to displace state law.' " [City of] New York v. FCC,486 U.S. 57 , 64,108 S.Ct. 1637 , 1642,100 L.Ed.2d 48 (1988).
Kansas ex rel. Todd,
. Pursuant to the
Chevron
standard of review for agency interpretations of statutes the agency is charged with implementing, when a court is confronted with an instance in which neither Congress nor the statute in question provides guidance to the court for resolution of the correct interpretation of terms of the statute, the court may not automatically impose its own interpretation of the statute; instead, the court must apply the interpretation of the agency,
provided
the agency’s interpretation "is based on a permissible construction of the statute.”
Chevron,
. In the article to which Judge Kravitch refers, Professor Sunstein considered the question, "Does an agency have the authority to decide on its own jurisdiction?” and found that “Chevron does not say.” Cass R. Sunstein, Law and Administration After Chevron, 90 Columí.Rev. 2071, 2097 (1990) (hereinafter "After Chevron "). Professor Sunstein had these further, pungent observations:
In a few cases the Court appears to have deferred to agency decisions on questions that were at least plausibly jurisdictional. In a recent case, however, the Court said that while "agency determinations within the scope of delegated authority are entitled to deference," an agency " 'may not bootstrap itself into an area in which it has no jurisdiction.' ” [Adams Fruit Co. v. Barrett,494 U.S. 638 , 650,110 S.Ct. 1384 , 1391,108 L.Ed.2d 585 (1990) (quoting Federal Maritime Comm’n v. Seatrain Lines, Inc.,411 U.S. 726 , 745,93 S.Ct. 1773 , 1785,36 L.Ed.2d 620 (1973).] The passage suggests that jurisdictional determinations will not receive deference. But it is somewhat ambiguous, and there is as yet no clear answer to this question.
Because congressional instructions are crucial here, courts should probably refuse to defer to agency decisions with respect to issues of jurisdiction — again, if we assume that the distinction between jurisdictional and nonjuris-dictional questions is easily administrable. The principal reason is that Congress would be unlikely to want agencies to have the authority to decide on the extent of their own powers. To accord such power to agencies would be to allow them to be judges in their own cause, in which they are of course susceptible to bias. .... [I]t would have seemed exceedingly odd to suggest that [an agency] should be allowed to resolve ambiguities in a statute governing its own jurisdiction. The danger of bias and self-dealing is so great as to make [the agency] an interested party.
As Justice Scalia has emphasized, however, there would be some difficulty in administering the sometimes elusive distinction between jurisdictional and nonjurisdictional questions. [Mississippi Power & Light v. Mississippi ex rel. Moore,487 U.S. 354 , 377-84,108 S.Ct. 2428 , 2442-45,101 L.Ed.2d 322 (1988) (Scalia, J., concurring) ]. For these reasons, it would be at least plausible to suggest that a general rule of deference would be preferable even on jurisdictional questions, because of its greater ease of application and because the agency's competence bears on the resolution of jurisdictional ambiguities.
Sunstein, After Chevron, 90 Columí.Rev. at 2097-2100 (footnotes omitted). Professor Sunstein also proposed a solution to the question of when deference should apply to agency determinations of the agency’s jurisdiction:
Probably the best reconciliation of the competing considerations of expertise, accountability, and partiality is to say that no deference will be accorded to the agency when the issue is whether the agency's authority extends to a broad area of regulation, or to a large category of cases, except to the extent that the answer to that question calls for determinations of fact and policy. On this approach, there is no magic in the word "jurisdiction." Instead, the question is whether the agency is seeking to extend its legal power to an entire category of cases, rather than disposing of certain cases in a certain way or acting in one or a few cases. This distinction is not always extremely sharp, and it will call for an exercise of judgment. But in the vast majority of cases, it is easily administered.
It should also follow that agencies will not receive deference when they are denying their authority to deal with a large category of cases. Here too the agency determination is jurisdictional. Here too there is a risk of bias, in the form not of self-dealing, but instead of an abdication of enforcement power. Because abdication has been a major legislative fear, and *1042 because deference doctrine should not contain an antiregulatory bias, Chevron should be inapplicable here as well. Sunstein, After Chevron, 90 Colum.L.Rev. at 2100 (footnotes omitted).
. In
Hillsborough County,
the Court recognized that the agency’s statement that it
did not
intend to preempt state law would also not be disposi-tive if “subsequent developments reveal a change in that position.”
Hillsborough County,
. This court's reading of
City of New York
might be home out by the short shrift given an agency's assertion that it "cannot help but pre-empt state ... regulation ... if it is to fulfill its statutory obligation” in
Louisiana. Pub. Serv. Comm’n,
. In the superseding opinion, the Fifth Circuit Court of Appeals reaffirmed its belief that the agency must be accorded deference in its interpretation of its authority to preempt state law.
First Gibraltar Bank, FSB,
. The extent to which SBC relies on an implied preemption theory to encompass the Garrelts’ claims in this case will be addressed below.
. As noted below, the Seventh Circuit Court of Appeals did later expressly find, however, that ‘‘[t]he instant case of preemption reflects a prime example of ... an accommodation” of policies committed to the agency’s care.
Lynnbrook Farms,
. These conclusions do not, however, mean that the court embraces APHIS’s justification for such preemption. The court will return to the question of APHIS’s justifications for preemption when it turns to the second prong of the City of New York inquiry, which asks whether APHIS's preemption was authorized by Congress.
. APHIS’s intent to preempt a state tort claim founded on the assertion that APHIS regulations state the applicable duty to warn cannot be doubted, because, where APHIS has determined that its regulatory standards have been met, the claim would plainly impose different and additional requirements contrary to APHIS's findings.
Lynnbrook Farms,
. The Garrelts also argue that the record suggests that APHIS did not intend to preempt their claim for human injury, because APHIS requires no testing for, or warning of, potential harm to humans from self-inoculation. While "implied” preemption may be a recognized doctrine, implied lack of intent to preempt cannot survive in the face of expressed intent to preempt.
Cf. City of New York,
The court finds that the Garrelts’ final contention concerning APHIS's intent to preempt, based on the assertion that Medtronic counsels that APHIS's intent should not be interpreted in such a way as to deprive the plaintiffs of any recourse, should more properly be considered in the discussion of Congress’s intent concerning, and authorization of, preemption of state law.
. The pertinent portions of S.Rep. 145 are as follows:
The bill would clarify and update the Virus-Serum-Toxin Act of 1913 (the 'VST Act'), the statutory authority for U.S. Department of Agriculture regulation of animal vaccines and related products.
USDA’s Animal and Plant Health Inspection Service (‘APHIS’) has a long and successful history of assuring livestock owners, veterinarians, and the American public that there is an ample supply of safe and effective animal vaccines and other biological products. APHIS carries out its responsibilities pursuant to the VST Act.
But legislation designed to serve the interest of animal agriculture more than seven decades ago has been overtaken by modem events, due to the VST Act’s archaic concepts of authority for a federal regulatory agency, as compared to modem statutes.
Two recent federal court decisions have created confusion and concern among the producers of animal biological products and those who utilize them. The thrust of these decisions is that USDA has primary regulatory authority over finished products physically moving in interstate commerce, but all other products, such as those made and sold within a single state, are subject only to Food and Drug Administration jurisdiction. These ‘intrastate’ products are not subject to USDA licensure, and FDA has, so far, not asserted its authority over them in a comprehensive manner. In the meantime, 'interstate' products remain firmly under the jurisdiction of USDA.
The narrow 'intrastate' versus 'interstate' distinction found in the VSTA Act no longer exists for any class of comparable products. Federal laws make no such distinctions for human-use pharmaceuticals, animal drugs, food additives, color additives, medical devices, processed food, meat and poultry products, or pesticides; all are subject to uniform federal regulatory standards, whether they cross state lines or not.
Animal agriculture has changed drastically since 1913. One major alteration in the industry is the tremendous increase in interstate movement of animal and animal-derived foods. There are truly national markets for the live animals and their products, while USDA’s animal vaccine regulatory program is compelled by law to maintain an artificial distinction between 'intrastate' and 'interstate' commerce in the products used to treat these animals.
The need for uniform national standards has become recognized widely in recent years.
The major national livestock producer groups support these amendments, as does the Veterinarians' National Association. Furthermore, a number of states have enacted rules permitting only USDA-licensed animal vaccines to be sold or used within their borders.
According to a recent USDA survey, at least 15 states now routinely require that animal biologic products used within their boundaries be licensed by USDA, although some of these states permit certain types of unlicensed vaccines under limited special circumstances. These states are Alabama, Colorado, Florida, Hawaii, Idaho, Louisiana, Michigan, Minnesota, Mississippi, Montana, New York, Oklahoma, Pennsylvania, Utah and Wyoming. When the Oklahoma State Board of Agriculture adopted an 'emergency regulation’ to this effect in 1981, its justification was 'an imminent peril to the public welfare.’ USDA found that only two states, California and South Dakota, actively regulate 'intrastate' animal bio-logies. It must be assumed, therefore, that 'intrastate' animal biologic products are almost entirely free of any official scrutiny in the remaining 33 states.
USDA can effectively control the movement of diseased animals and contaminated food of animal origin through court-authorized seizure and injunctive powers. However, the VST Act presently does not give the department these essential means for the control of animal vaccines and related products. Expanded regulatory authority for USDA would be meaningless, if the department did not have the tools needed to bring about compliance. Presently, the only enforcement tool is a criminal misdemeanor prosecution. The bill would give USDA powers comparable to those available to regulate commerce in animals and animal-derived foods such as detention and court-ordered seizure and injunction.
The bill provides licensing exemptions for animal owners and veterinarians, who could continue to produce unlicensed vaccines for use in animals under their care (although enforcement actions against unsafe or ineffective products would be authorized). Biologies produced in states that have adequate testing/reg-ulatoiy programs could continue to be marketed 'intrastate' under those state programs without USDA licensing. In addition, all other 'intrastate' manufacturers would have four years from the date of enactment to phase into the USDA licensing system.
S.Rep. No. 145, 99th Cong., 1st Sess. 338-39 (1985), reprinted in 1985 U.S.C.C.A.N. 1676, 2004-05.
. Thus, in this court's reading, APHIS’s authority to regulate vaccines for Newcastle Disease and rabies, which are admittedly diseases dangerous to humans, stems from the fact that those viruses are also dangerous to livestock. Another distinction between these two diseases, dangerous to both humans and livestock, and the danger to humans the Garrelts allege Ultrabac 7 poses if accidentally self-injected, is that APHIS has required that manufacturers supply information concerning the presence of the Newcastle and rabies antigens, while it has required, and apparently received, no information from manufacturers concerning other kinds of health risks to humans posed by animal vaccines if accidental self-inoculation occurs.
. As to the 1985 amendments, the concern to add "intrastate" vaccines to the regulatory scheme was a concern over the lack of any official regulation of such vaccines, not just a *1069 lack of uniform regulation, in a majority of the ■ states. S.Rep. No. 145, 99th Cong., 1st Sess. 338-39 (1985), reprinted in 1985 U.S.C.C.A.N. 1676, 2004-05.
. This court’s reading of the plain language of the interlocutory appeal statute, that if the court “shall be of the opinion that such order” meets the criteria of the statute, it may certify the matter for interlocutory appeal, 28 U.S.C. § 1292(b), is that the statute grants the district court the authority to make the necessary certification for interlocutory appeal sua sponte.
. Because § 1292(b) provides for appeal of orders otherwise unappealable, and thus provides an avenue for resolving disputed and controlling questions of law, the resolution of which will .materially further the litigation, the appellate court reviews
de novo
the questions of law certified by the district court.
Simon v. G.D. Searle & Co.,
remain[s] free to consider " ‘ "such questions as are basic tó and underlie” ’ ’’ the questions certified by the district court. \In re Oil Spill. *1071 by the Amoco Cadiz,659 F.2d at 793 n. 5] (quoting Helene Curtis Indus., Inc. v. Church & Dwight Co.,560 F.2d 1325 , 1335 (7th Cir.1977) (quoting 9 J. Moore, Moore's Federal Practice ¶ 110.25[1], at 270)); Merican, Inc. v. Caterpillar Tractor Co.,713 F.2d 958 , 962 n. 7 (3d Cir.1983), cert. denied,465 U.S. 1024 ,104 S.Ct. 1278 ,79 L.Ed.2d 682 (1984); United States v. Connolly,716 F.2d 882 , 885 (Fed.Cir.1983), cert. denied,465 U.S. 1065 ,104 S.Ct. 1414 ,79 L.Ed.2d 740 (1984).
Simon,