C.F.R. » Title 9 » CHAPTER I—ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE › SUBCHAPTER E—VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS › PART 104—PERMITS FOR BIOLOGICAL PRODUCTS

9 C.F.R. § 104.1

Permit required

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Unless otherwise authorized or directed by the Administrator, each permit to import a biological product into the United States shall be issued in accordance with the regulations in this part.

(a) No biological product shall be brought into the United States unless a permit has been issued for such product. A separate U.S. Veterinary Biological Product Permit shall be required for each shipment of biological product to be imported: Provided, That, a permit shall also be required for each transit shipment of biological products moved through the United States.

(b) Each person importing biological products shall hold an unexpired, unsuspended, and unrevoked permit issued by Animal and Plant Health Inspection Service. Such person shall reside within the United States, or operate a business establishment within the United States, or both.

[38 FR 32916, Nov. 29, 1973, as amended at 56 FR 66783, Dec. 26, 1991; 56 FR 66783, Dec. 26, 1991]
Notes of Decisions
Cited in 3 cases, 1997–2008 · leading case: Creekstone Farms Premium Beef, L.L.C v. Dep't of Agric., 539 F.3d 492 (D.C. Cir. 2008).
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Creekstone Farms Premium Beef, L.L.C v. Dep't of Agric., 539 F.3d 492 (D.C. Cir. 2008). · cites it 6× “9 C.F.R. § 104.1 (a). "Biological products" include "all viruses, serums, toxins, .”
Quiman, S.A. de C.V. v. United States, 39 Fed. Cl. 171 (Fed. Cl. 1997). “For examples of regulations involving this authority, see 9 C.F.R. §§ 104.1 to .3 (1996). . PL’s Ex.”
Creekstone Farms Premium Beef, L.L.C. v. U.S. Dep't of Agric., 517 F. Supp. 2d 8 (D.D.C. 2007). “As authority for that notice, USDA cited its regulations implementing the YSTA, specifically 9 C.F.R. §§ 104.1 -which requires a permit to import “biological products” — and 102.”
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