Animal Health Institute v. United States Department of Agriculture

487 F. Supp. 376, 1980 U.S. Dist. LEXIS 10407
CourtDistrict Court, D. Colorado
DecidedMarch 10, 1980
DocketCiv. A. No. 78-K-796
StatusPublished
Cited by11 cases

This text of 487 F. Supp. 376 (Animal Health Institute v. United States Department of Agriculture) is published on Counsel Stack Legal Research, covering District Court, D. Colorado primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Animal Health Institute v. United States Department of Agriculture, 487 F. Supp. 376, 1980 U.S. Dist. LEXIS 10407 (D. Colo. 1980).

Opinion

MEMORANDUM OPINION AND ORDER

KANE, District Judge.

On August 7, 1978, plaintiffs, Animal Health Institute and Colorado Serum Company filed a complaint charging that defendants have established and continue to pursue a policy of not enforcing the provisions of the Virus-Serum-Toxin Act, 21 U. S.C. §§ 151-158, against unlicensed producers of veterinary biological drug products. Plaintiffs seek a declaratory judgment construing the provisions of 21 U.S.C. § 151, et seq., as prohibiting the preparation of veterinary biological drugs manufactured within the United States at any establishment that has not been licensed by the Secretary of Agriculture. Plaintiffs also seek a mandatory injunction directing defendants to enforce the provisions of 21 U.S.C. §§ 151, et seq., against these unlicensed manufacturers.

[377]*377In response to plaintiffs’ allegations, defendants maintain that federal licenses are required only of those manufacturers whose activities occur in areas under exclusive federal jurisdiction or involve interstate shipment of animal biologies. Defendants refer to manufacturers who confine their activities to one state as “intrastate” producers. They are characterized as such even though their activities could constitutionally be subjected to federal regulation; that is, they probably could be found to affect interstate commerce. Nevertheless, according to defendants, the Virus-Serum-Toxin Act does not authorize regulation of those producers whose activities are confined to one state. Thus, notwithstanding their effect on interstate commerce, in the absence of a congressional mandate, the Department of Agriculture is powerless to regulate their activities.

This case is before the court pursuant to the Administrative Procedure Act, 5 U.S.C. §§ 701-706; and 28 U.S.C. §§ 1331, 1337, 2201-02. No facts are in issue and the case can properly be decided on issues of law.

Plaintiffs urge that 21 U.S.C. § 151 sets forth two distinct prohibited acts: (1) preparation and sale of biological products that are “worthless, contaminated, dangerous, or harmful”, and (2) preparation that has not been under and in compliance with regulations prescribed by the Secretary of Agriculture, at a licensed establishment. This controversy arises from plaintiffs’ position that the licensing requirement as set forth in § 151, has broader application than the prohibition against the preparation and sale of worthless products. Although § 151 of the Virus-Serum-Toxin Act prohibits two types of conduct, the jurisdictional ambit of the licensing requirement is no broader than the prohibition against worthless products.

21 U.S.C. § 151 reads 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 unrevoked license issued by the Secretary of Agriculture as hereinafter authorized. (Emphasis added).

The primary source of controversy is the phrase, “as aforesaid”. Plaintiffs maintain incorrectly that a plain reading of this provision leads to the conclusion that “as aforesaid” only modifies the word ship, but not prepare, sell, barter or exchange. According to plaintiffs’ construction of this provision, “all establishments in which veterinary biological products are prepared must be licensed by the Secretary of Agriculture regardless of whether the products are subsequently distributed across state lines. (Complaint ¶ 13).

It is clear, however, that such a construction of § 151 is contrary to the plain language of the provision and the intent of Congress. It is equally clear that the Act does not, nor was it ever intended for it to extend federal regulation to the “intrastate” sale and manufacture of veterinary biological products. “As aforesaid” modifies prepare, sell, barter and exchange, in addition to ship. These five verbs should be construed as a unity. As defendants correctly state: .

The “license” provisions of section 151 repeat precisely the same five verbs used in the “worthless” products clause immediately preceding: prepare, sell, barter, exchange, or ship. Each of these verbs is [378]*378restricted geographically in the “worthless" products clause of the section; by far the most reasonable construction of the repetition of these five verbs in the next phrase is that Congress intended the same restrictions to apply to each of the verbs and used “as aforesaid” rather than repeating the somewhat cumbersome phraseology in full.

(Brief in Support of Defendants’ Motion for Summary Judgment, at pp. 6-7.)

Support for this construction is found in § 154 which provides:

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, or analogous product for use in the treatment of domestic animals, and to issue, suspend, and revoke licenses for the maintenance 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. (Emphasis added).

It is clear that in the first part of § 154, “as aforesaid” modifies preparation, sale, barter, and exchange, as well as shipment. To construe “as aforesaid” so as to modify only shipment leads to the incorrect result that § 154 authorizes the Secretary to promulgate rules to prevent the preparation, sale, barter or exchange of worthless and harmful products anywhere in the United States. Such a construction is wrong, since as plaintiffs admit, pursuant to the first clause of § 151 preparation, sale, barter or exchange of harmful products is prohibited only if federal territory or interstate shipment is involved.

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Cite This Page — Counsel Stack

Bluebook (online)
487 F. Supp. 376, 1980 U.S. Dist. LEXIS 10407, Counsel Stack Legal Research, https://law.counselstack.com/opinion/animal-health-institute-v-united-states-department-of-agriculture-cod-1980.