Relevant communicable disease agent
(r) Relevant communicable disease agent or disease means: (1) (i) For all human cells and tissues, a communicable disease or disease agent listed as follows: (A) Human immunodeficiency virus, types 1 and 2; (B) Hepatitis B virus; (C) Hepatitis C virus; (D) Human transmissible spongiform encephalopathy, including Creutzfeldt-Jakob disease; and (E) Treponema pallidum. (ii) For viable, leukocyte-rich cells and tissues, a cell-associated disease agent or disease listed as follows: (A) Human T-lymphotropic virus, type I; and (B) Human T-lymphotropic virus, type II. (iii) For reproductive cells or tissues, a disease agent or disease of the genitourinary tract listed as follows: (A) Chlamydia trachomatis; and (B) Neisseria gonorrhea. (2) A disease agent or disease not listed in paragraph (r)(1) of this section: (i) For which there may be a risk of transmission by an HCT/P, either to the recipient of the HCT/P or to those people who may handle or otherwise come in contact with it, such as medical personnel, because the disease agent or disease: (A) Is potentially transmissible by an HCT/P and (B) Either of the following applies: