established chronic beryllium disease
(13) The term “established chronic beryllium disease” means chronic beryllium disease as established by the following: (A) For diagnoses on or after January 1, 1993 , beryllium sensitivity (as established in accordance with paragraph (8)(A)), together with lung pathology consistent with chronic beryllium disease, including— (i) a lung biopsy showing granulomas or a lymphocytic process consistent with chronic beryllium disease; (ii) a computerized axial tomography scan showing changes consistent with chronic beryllium disease; or (iii) pulmonary function or exercise testing showing pulmonary deficits consistent with chronic beryllium disease. (B) For diagnoses before January 1, 1993 , the presence of— (i) occupational or environmental history, or epidemiologic evidence of beryllium exposure; and (ii) any three of the following criteria: (I) Characteristic chest radiographic (or computed tomography (CT)) abnormalities. (II) Restrictive or obstructive lung physiology testing or diffusing lung capacity defect. (III) Lung pathology consistent with chronic beryllium disease. (IV) Clinical course consistent with a chronic respiratory disorder. (V) Immunologic tests showing beryllium sensitivity (skin patch test or beryllium blood test preferred).