9 CFR § 95.4 - Restrictions on the importation of processed animal protein, offal, tankage, fat, glands, tallow, tallow derivatives, and serum due to bovine spongiform encephalopathy.
(a) Except as provided in this section, or in § 94.15, any of the materials listed in paragraph (b) in this section derived from animals, or products containing such materials, are prohibited importation into the United States.
(b) The restricted materials are as follows:
(2) Glands, unprocessed fat tissue, and blood and blood products;
(4) Derivatives of glands and blood and blood products.
(c) The import prohibition in paragraph (a) of this section does not apply if the following conditions are met prior to importation:
(1) The material is derived from one of the following:
(iv) Ovines or caprines, and the material is not ineligible for importation under the conditions of § 95.5.
(2) The facility demonstrates to APHIS that the materials intended for exportation to the United States were transported to and from the facility in a manner that would prevent cross-contamination by or commingling with prohibited materials.
(3) If the facility processes or handles any processed animal protein, inspection of the facility for compliance with the provisions of this section is conducted at least annually by a representative of the government agency responsible for animal health in the region, unless the region chooses to have such inspection conducted by APHIS. If APHIS conducts the inspections required by this section, the facility has entered into a cooperative service agreement executed by the operator of the facility and APHIS. In accordance with the cooperative service agreement, the facility must be current in paying all costs for a veterinarian of APHIS to inspect the facility (it is anticipated that such inspections will occur approximately once per year), including travel, salary, subsistence, administrative overhead, and other incidental expenses (including excess baggage provisions up to 150 pounds). In addition, the facility must have on deposit with APHIS an unobligated amount equal to the cost for APHIS personnel to conduct one inspection. As funds from that amount are obligated, a bill for costs incurred based on official accounting records will be issued to restore the deposit to the original level, revised as necessary to allow for inflation or other changes in estimated costs. To be current, bills must be paid within 14 days of receipt.
(4) The facility allows periodic APHIS inspection of its facilities, records, and operations.
(5) Each shipment to the United States is accompanied by an original certificate signed by a full-time, salaried veterinarian of the government agency responsible for animal health in the exporting region certifying that the conditions of paragraphs (c)(1) through (3) of this section have been met.
(6) The person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors by filing a permit application on VS Form 16–3, which may be obtained from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Unit 38, Riverdale, MD 20737–1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant.
(d) Insulin otherwise prohibited under paragraphs (a) and (b) of this section may be imported if the insulin is for the personal medical use of the person importing it and if the person importing the shipment has applied for and obtained from APHIS a United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors. To apply for a permit, file a permit application on VS Form 16–3, which is available from Strategy and Policy, Veterinary Services, APHIS, 4700 River Road, Riverdale, MD 20737–1231, or electronically at https://efile.aphis.usda.gov/s/vs-permitting-assistant. The application for such a permit must state the intended use of the insulin and the name and address of the consignee in the United States.
Insulin that is not prohibited from importation under this paragraph may be prohibited from importation under other Federal laws, including the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321 et seq.