Variola major and Variola minor viruses. (a) Volume not exceeding 50 ml. Material shall be placed in a securely closed, watertight container (primary container (test tube, vial, etc.)) which shall be enclosed in a second, durable watertight container (secondary container). Several primary containers may be enclosed in a single secondary container, if the total volume of all the primary containers so enclosed does not exceed 50 ml. The space at the top, bottom, and sides between the primary and secondary containers shall contain sufficient nonparticulate absorbent material (e.g., paper towel) to absorb the entire contents of the primary container(s) in case of breakage or leakage. Each set of primary and secondary containers shall then be enclosed in an outer shipping container constructed of corrugated fiberboard, cardboard, wood, or other material of equivalent strength. (b) Volume greater than 50 ml. Packaging of material in volumes of 50 ml. or more shall comply with requirements specified in paragraph (a) of this section. In addition, a shock absorbent material, in volume at least equal to that of the absorbent material between the primary and secondary containers, shall be placed at the top, bottom, and sides between the secondary container and the outer shipping container. Single primary containers shall not contain more than 1,000 ml of material. However, two or more primary containers whose combined volumes do not exceed 1,000 ml may be placed in a single, secondary container. The maximum amount of etiologic agent which may be enclosed within a single outer shipping container shall not exceed 4,000 ml. (c) Dry ice. If dry ice is used as a refrigerant, it must be placed outside the secondary container(s). If dry ice is used between the secondary container and the outer shipping container, the shock absorbent material shall be placed so that the secondary container does not become loose inside the outer shipping container as the dry ice sublimates. (d)(1) The outer shipping container of all materials containing etiologic agents transported in interstate traffic must bear a label as illustrated and described below: This list may be revised from time to time by Notice published in the FEDERAL REGISTER to identify additional agents which must be packaged in accordance with the requirements contained in this part. (2) The color of material on which the label is printed must be white, the symbol red, and the printing in red or white as illustrated. (3) The label must be a rectangle measuring 51 millimeters (mm) (2 inches) high by 102.5 mm (4 inches) long. (4) The red symbol measuring 38 mm (11⁄2 inches) in diameter must be centered in a white square measuring 51 mm (2 inches) on each side. (5) Type size of the letters of label shall be as follows: Etiologic agents-10 pt. rev. In case of damage or leakage-10 pt. rev. rev. 404-633-5313-10 pt. rev. (e) Damaged packages. The carrier shall promptly, upon discovery of evidence of leakage or any other damage to packages bearing an Etiologic Agents/Biomedical Material label, isolate the package and notify the Director, Center for Disease Control, 1600 Clifton Road, NE., Atlanta, GA 30333, by telephone: (404) 633-5313. The carrier shall also notify the sender. (f) Registered mail or equivalent system. Transportation of the following etiologic agents shall be by registered mail or an equivalent system which requires or provides for sending notification of receipt to the sender immediately upon delivery: Coccidioides immitis. Ebola virus. Francisella (Pasteurella) tularensis. Hemorrhagic fever agents including, but not limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo viruses, and Korean hemorrhagic fever viruses. Herpesvirus simiae (B virus). Histoplasma capsulatum. Lassa virus. Marburg virus. Pseudomonas mallei. Pseudomonas pseudomallei. Tick-borne encephalitis virus complex including, but not limited to, Russian springsummer encephalitis, Kyasanur forest dieease, Omsk Hemorrhagic fever, and Central European encephalitis viruses, Variola minor, and Variola major. Variola major, Variola minor, and Whitepox viruses. Yersinia (Pasteurella) pestis.3 $72.4 Notice of delivery; failure to receive. When notice of delivery of materials known to contain or reasonably believed to contain etiologic agents listed in §72.3(f) is not received by the sender within 5 days following anticipated delivery of the package, the 3This list may be revised from time to time by Notice published in the FEDERAL REGISTER to identify additional agents which must be transported in accordance with requirements contained in § 72.3(f). APPENDIX A TO PART 75-STANDARDS FOR AC- APPENDIX B TO PART 75-STANDARDS FOR AC- APPENDIX G TO PART 75-STANDARDS FOR LICENSING DENTAL HYGIENISTS AND DENTAL ASSISTANTS IN DENTAL RADIOGRAPHY AUTHORITY: Sec. 979 of the Consumer-Patient Radiation Health and Safety Act of 1981, Pub. L. 97-35, 95 Stat. 599-600 (42 U.S.C. 10004). SOURCE: 50 FR 50717, Dec. 11, 1985, unless otherwise noted. $75.1 Background and purpose. (a) The purpose of these regulations is to implement the provisions of section 979 of the Consumer-Patient Radiation Health and Safety Act of 1981, 42 U.S.C. 10004, which requires the establishment by the Secretary of Health and Human Services of standards for the accreditation of programs for the education of certain persons who administer radiologic procedures and for the credentialing of such persons. (b) Section 979 requires the Secretary, after consultation with specified Federal agencies, appropriate agencies of States, and appropriate professional organizations, to promulgate by regulation the minimum standards described above. These standards distinguish between the occupations of (1) radiographer, (2) dental hygienist, (3) dental assistant, (4) nuclear medicine technologist, and (5) radiation therapy technologist. In the interest of public safety and to prevent the hazards of improper use of medical radiation identified by Congress in its determination of the need for standards, the Secretary is also authorized to prepare standards for other occupational groups utilizing ionizing and non-ionizing radiation as he/she finds appropriate. However, the standards set out below are limited to the five occupational groups listed above, utilizing ionizing radiation. Nothing in these accreditation standards is intended to discriminate against proprietary schools. $75.2 Definitions. All terms not defined herein shall have the meaning given them in the Act. As used in this part: Accreditation, as applied to an educational program, means recognition, by a State government or by a nongovernmental agency or association, of a specialized program of study as meeting or exceeding certain established qualifications and educational standards. As applied to a health care or educational institution, accreditation means recognition, by a State government or by a nongovernmental agency or association, of the institution as meeting or exceeding certain established standards or criteria for that type of institution. Act means the Consumer-Patient Radiation Health and Safety Act of 1981, 42 U.S.C. 10001-10008. Continuing competency means the maintenance of knowledge and skills and/or demonstrated performance that are adequate and relevant to professional practice needs. Credentialing means any process whereby a State Government or nongovernmental agency or association grants recognition to an individual who meets certain predetermined qualifications. Dental hygienist means a person licensed by the State as a dental hygienist. Dental assistant means a person other than a dental hygienist who assists a dentist in the care of patients. Educational program means a set of formally structured activities designed to provide students with the knowledge and skills necessary to enter an occupation, with evaluation of student performance according to predetermined objectives. Energized laboratory means any facility which contains equipment that generates ionizing radiation. This does not include facilities for training students when the equipment is not powered to emit ionizing radiation, e.g., practice in setting controls and positioning of patients. Formal training means training or education, including either didactic or clinical practicum or both, which has a specified objective, planned activities for students, and suitable methods for measuring student attainment, and which is offered, sponsored, or approved by an organization or institution which is able to meet or enforce these criteria. Ionizing radiation means any electromagnetic or particulate radiation (Xrays, gamma rays, alpha and beta particles, high speed electrons, neutrons, and other nuclear particles) which interacts with atoms to produce ion pairs in matter. Licensed practitioner means a licensed doctor of medicine, osteopathy, dentistry, podiatry, or chiropractic. Licensure means the process by which an agency of State government grants permission to persons meeting predetermined qualifications to engage in an occupation. Nuclear medicine technologist means a person other than a licensed practitioner who prepares and administers radio-pharmaceuticals to human beings and conducts in vivo or in vitro detection and measurement of radioactivity for medical purposes. Permit means an authorization issued by a State for specific tasks or practices rather than the entire scope of practice in an occupation. Radiation therapy technologist means a person other than a licensed practitioner who utilizes ionizing radiationgenerating equipment for therapeutic purposes on human subjects. Radiographer means an individual other than a licensed practitioner who (1) performs, may be called upon to perform, or who is licensed to perform a comprehensive scope of diagnostic radiologic procedures employing equip ment which emits ionizing radiation, and (2) is delegated or exercises responsibility for the operation of radiationgenerating equipment, the shielding of patient and staff from unnecessary ra diation, the appropriate exposure of radiographs, or other procedures which contribute to any significant extent to the site or dosage of ionizing radiation to which a patient is exposed. Radiographers are distinguished from personnel whose use of diagnostic procedures is limited to a few specific body sites and/or standard procedures, from those personnel in other clinical specialties who may occasionally be called upon to assist in diagnostic radiology, and from those technicians or assistants whose activities do not, to any significant degree, determine the site or dosage of radiation to which a patient is exposed. Radiologist means a physician certified in radiology by the American Board of Radiology or the American Osteopathic Board of Radiology. $75.3 Applicability. (a) Federal Government. Except as provided in section 983 of the Act, the credentialing standards set out in the Appendixes to this part apply to those individuals who administer or propose to administer radiologic procedures, in each department, agency and instrumentality of the Federal Government as follows: (1) Radiographer Standards apply to all individuals who are radiographers as defined in §75.2 and who are not practitioners excepted by the Act. (2) Nuclear Medicine Technologist ↑ Standards apply to all individuals who are nuclear medicine technologists as defined in §75.2, who perform in vivo nuclear medicine procedures, and who are not practitioners excepted by the Act. For purposes of this Act, any administration of radiopharmaceuticals to human beings is considered an in vivo procedure. (3) Radiation Therapy Technologist Standards apply to all individuals who perform radiation therapy and who are not practitioners excepted by the Act. (4) Dental Hygienist Standards apply to all dental hygienists who perform dental radiography. (5) Dental Assistant Standards apply to all dental assistants who perform dental radiography. (6) The following persons are deemed to have met the requirements of these standards: (i) Persons employed by the Federal government as radiologic personnel prior to the effective date of this regulation and who show evidence of current or fully satisfactory performance or certification of such from a licensed practitioner: (ii) Uniformed military personnel who receive radiologic training from or through the Armed Forces of the United States and who meet standards established by the Department of Defense or components thereof, provided that those standards are determined by such Department or component to offer equivalent protection of patient health and safety: (iii) Foreign national employed by the Federal government in positions outside of the United States who show evidence of training, experience, and competence determined by the employing agency to be equally protective of patients health and safety; and (iv) Persons first employed by the Federal government as radiologic personnel after the effective date of this regulation who (a) received training from institutions in a State or foreign jurisdiction which did not accredit training in that particular field at the time of graduation, or (b) practiced in a State or foreign jurisdiction which did not license that particular field or which did not allow special eligibility to take a licensure examination for those who did not graduate from an accredited educational program; provided that such persons show evidence of training, experience, and competence determined by the Office of Personnel Management or the employing agency to be equally protective of patient health and safety. (7) The following persons are exempted from these standards: (1) Persons who are trained to perform, or perform, covered radiologic procedures in emergency situations which preclude use of fully qualified personnel; and (ii) Students in approved training programs. (8) A department, agency, or instrumentality of the Federal government may, after consultation with the Secretary, use alternative criteria which it determines would offer equivalent protection of patient health and safety. (b) States. The States may, but are not required to, adopt standards for accreditation and credentialing that are consistent with the standards set out in the appendixes to this part. APPENDIX A TO PART 75-STANDARDS FOR ACCREDITATION OF EDUCATIONAL PROGRAMS FOR RADIOGRAPHERS A. Description of the Profession The radiographer shall perform effectively by: 1. Applying knowledge of the principles of radiation protection for the patient, self, and others. 2. Applying knowledge of anatomy, positioning, and radiographic techniques to accurately demonstrate anatomical structures on a radiograph. 3. Determining exposure factors to achieve optimum radiographic technique with a minimum of radiation exposure to the patient. 4. Examining radiographs for the purpose of evaluating technique, positioning, and other pertinent technical qualities. 5. Exercising discretion and judgment in the performance of medical imaging procedures. 6. Providing patient care essential to radiologic procedures. 7. Recognizing emergency patient conditions and initiating lifesaving first aid. B. Sponsorship 1. Accreditation will be granted to the institution that assumes primary responsibility for curriculum planning and selection of course content; coordinates classroom teaching and supervised clinical education; ap |