§95.7. Collagen derived from bovines. — Inbound Citations

(iii) Bovines, and the material is not ineligible for importation under the conditions of § 95.5, § 95.6, § 95.7, § 95.8, § 95.9, § 95.10, or § 95.12; or

(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

(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

(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

(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