(a) The following materials from cattle are specified risk materials, except when they are from cattle from a country that can demonstrate that its bovine spongiform encephalopathy (BSE) risk status can reasonable be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States:
(1) The brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column (excluding the vertebrae of the tail, the transverse processes of the thoracic and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia from cattle 30 months of age and older and
(2) The distal ileum of the small intestine and the tonsils from all cattle.
(b) Specified risk materials are inedible and prohibited for use as human food.
(c) Specified risk materials must be removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with § 314.1 or § 314.3 of this subchapter. The spinal cord from cattle 30 months of age and older must be removed from the carcass at the establishment where the animal was slaughtered.
(d) Requirements for use of the small intestine for human food.
(1) The small intestine from all cattle may be used for human food if:
(i) It is derived from cattle that were inspected and passed in an official establishment in the United States or in a certified foreign establishment in a country eligible to export meat and meat products to the United States under 9 CFR 327.2(b) and it is otherwise eligible for importation under 9 CFR 327.1(b), and
(ii) The distal ileum is removed by a procedure that removes at least 80 inches of the uncoiled and trimmed small intestine as measured from the ceco-colic junction and progressing proximally towards the jejunum or by a procedure that the establishment demonstrates is effective in ensuring complete removal of the distal ileum.
(iii) If the conditions in paragraphs (d)(1)(i) or (ii) of this section are not met, the entire small intestine must be removed from the carcass, segregated from edible materials, and disposed of in accordance with §§ 314.1 or 314.3 of this subchapter.
(2) The requirements in paragraph (d)(1) of this section do not apply to materials from cattle from countries that can demonstrate that their BSE risk status can reasonably be expected to provide the same level of protection from human exposure to the BSE agent as prohibiting specified risk materials for use as human food does in the United States.
(e) Procedures for the removal, segregation, and disposition of specified risk materials.
(1) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must develop, implement, and maintain written procedures for the removal, segregation, and disposition of specified risk materials. These procedures must address potential contamination of edible materials with specified risk materials before, during, and after entry into the establishment. Establishments must incorporate their procedures for the removal, segregation, and disposition of specified risk materials into their HACCP plans or Sanitation SOPs or other prerequisite programs.
(2) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must take appropriate corrective action when either the establishment or FSIS determines that the establishment's procedures for the removal, segregation, and disposition of specified risk materials, or the implementation or maintenance of these procedures, have failed to ensure that specified risk materials are adequately and effectively removed from the carcasses of cattle, segregated from edible materials, and disposed of in accordance with paragraph (c) of this section.
(3) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must routinely evaluate the effectiveness of their procedures for the removal, segregation, and disposition of specified risk materials in preventing the use of these materials for human food and must revise the procedures as necessary whenever any changes occur that could affect the removal, segregation, and disposition of specified risk materials.
(4) Recordkeeping requirements.
(i) Establishments that slaughter cattle and establishments that process the carcasses or parts of cattle must maintain daily records sufficient to document the implementation and monitoring of the procedures for the removal, segregation, and disposition of the materials listed in paragraph (a) of this section, and any corrective actions taken.
(ii) Records required by this section may be maintained on computers provided that the establishment implements appropriate controls to ensure the integrity of the electronic data.
(iii) Records required by this section must be retained for at least one year and must be accessible to FSIS. All such records must be maintained at the official establishment for 48 hours following completion, after which they may be maintained off-site provided such records can be made available to FSIS within 24 hours of request.
(f) Sanitation of equipment used to cut through specified risk materials.
(1) If an establishment that slaughters cattle, or that processes the carcasses or parts from cattle, does not segregate the carcasses and parts from cattle 30 months of age and older from the carcasses and parts from cattle younger than 30 months during processing operations it must:
(i) Use dedicated equipment to cut through specified risk materials; or
(ii) Clean and sanitize equipment used to cut through specified risk materials before the equipment is used on carcasses or parts from cattle younger than 30 months of age.
(2) If an establishments that slaughters cattle, or that process the carcasses or parts from cattle, segregates the carcasses and parts of cattle 30 months of age and older from cattle younger than 30 months of age during processing operations, and processes the carcasses or parts from the cattle younger than 30 months first, it may use routine operational sanitation procedures on equipment used to cut through specified risk materials.
(g) Slaughter establishments may ship beef carcasses or parts that contain vertebral columns from cattle 30 months of age and older to another federally-inspected establishment for further processing if the establishment shipping these materials:
(1) Maintains control of the carcasses or parts while they are in transit or ensures that the carcasses or parts move under FSIS control;
(2) Ensures that the carcasses or parts are accompanied by documentation that clearly states that the carcasses or parts contain vertebral columns from cattle that were 30 months of age and older at the time of slaughter;
(3) Maintains records that identify the official establishment that received the carcasses or parts;
(4) Maintains records that verify that the official establishment that received the carcasses or parts removed the portions of the vertebral column designated as specified risk materials in paragraph (a)(1) of this section and disposed of them in accordance with § 314.1 or § 314.3 of this subchapter.
(h) The materials listed in paragraph (a)(1) of this section will be deemed to be from cattle 30 months of age and older unless the establishment can demonstrate through documentation that the materials are from an animal that was younger than 30 months of age at the time of slaughter.
[72 FR 38729, July 13, 2007, as amended at 84 FR 65268, Nov. 27, 2019]