(a) The importation of collagen derived from bovines is prohibited because of BSE unless:

(1) The collagen meets the requirements of either paragraph (b), (c), or (d), as well as the requirements of paragraph (e) of this section and all other applicable requirements of this part; or

(2) The collagen is authorized importation under paragraph (f) of this section and meets all other applicable requirements of this part:

(b) The collagen is derived from hides and skins, provided the collagen has not been commingled with materials ineligible for entry into the United States.

(c) The collagen is derived from the bones of bovines that originated from a region of negligible risk for BSE.

(d) The collagen is derived from the bones of bovines that originated from a region of controlled or undetermined risk for BSE and meets the requirements of paragraphs (d)(1) through (d)(4) of this section:

(1) The bones from which the collagen was derived were derived from bovines that passed ante-mortem and post-mortem inspection;

(2) The bones from which the collagen was derived did not include the skulls of bovines or the vertebral column of bovines 30 months of age or older;

(3) The bones were subjected to a process that includes all of the following steps, or to a process at least as effective in reducing BSE infectivity:

(i) Degreasing;

(ii) Acid demineralization;

(iii) Acid or alkaline treatment;

(iv) Filtration; and

(v) Sterilization at 138 °C (280.4 °F) or greater for a minimum of 4 seconds; and

(4) The collagen has not been commingled with materials ineligible for entry into the United States.

(e) The collagen is accompanied to the United States by an original certificate signed by a full-time salaried veterinary officer of the national government of the exporting region, or issued by a veterinarian designated by the national government of the exporting region and endorsed by a full-time salaried veterinary officer of the national government of the exporting region, representing that the veterinarian issuing the certificate was authorized to do so. The certificate must state that the requirements of paragraph (b), (c), or (d) of this section, as applicable, have been met and, for collagen other than that described in paragraph (b) of this section, must indicate the BSE risk classification of the exporting region.

(f) The Administrator determines that the collagen will not come into contact with ruminants in the United States and can be imported under conditions that will prevent the introduction of BSE into the United States, and the person importing the collagen has obtained 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 (available from APHIS, Veterinary Services, National Center for Import and Export, 4700 River Road Unit 38, Riverdale, MD 20737-1231, or electronically at http://www.aphis.usda.gov/animal__health/permits/). The application for such a permit must state the intended use of the collagen and the name and address of the consignee in the United States.

(Approved by the Office of Management and Budget under control number 0579-0393)

[78 FR 73003, Dec. 4, 2013]