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than five years, or both for an individual; and a fine for an organization. (61 FR 55199, Oct. 24, 1996)

APPENDIX A TO PART 72-SELECT

AGENTS

or

or toxin listed in Appendix A of this part. The term also includes:

(1) Genetically modified microorganisms or genetic elements from organisms on Appendix A of this part, shown to produce or encode for a factor associated with a disease, and

(2) Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins on Appendix A of this part, or their toxic submits.

Single geographic site means a building or complex of buildings at a single mailing address.

Transfer means:

(1) The conveyance movement from a point or origination to a point of destination either:

(i) From one state or territory to another or;

(ii) Entirely within one contiguous state or territory.

(2) Intrafacility transfers within a registered facility located at a single geographic site are not covered by the provisions of $72.6 (d), (e), and (f) provided that:

(i) The intended use of the agent remains consistent with that specified in the most current transfer form; and

(ii) For each intrafacility transfer, the facility maintains records that include the name and location of the recipient; the amount of agent transferred, and the date transferred. Such records must be maintained for a period of five (5) years after the date of transfer or for five (5) years after the agents are consumed or properly disposed, whichever is longer.

Transferor means any person who transfers or seeks to transfer through any means a select agent subject to this part to any other person. [61 FR 55197, Oct. 24, 1996)

Viruses 1. Crimean-Congo haemorrhagic fever virus 2. Eastern Equine Encephalitis virus 3. Ebola viruses 4. Equine Morbillivirus 5. Lassa fever virus 6. Marburg virus 7. Rift Valley fever virus 8. South American Haemorrhagic fever vi. ruses (Junin, Machupo, Sabia, Flexal Guanarito) 9. Tick-borne encephalitis complex viruses 10. Variola major virus (Smallpox virus) 11. Venezuelan Equine Encephalitis virus 12. Viruses causing hantavirus pulmonary syndrome 13. Yellow fever virus Exemptions: Vaccine strains of viral agents (Junin Virus strain candid #1, Rift Valley fever virus strain MP-12, Venezuelan Equine encephalitis virus strain TC-83, Yellow fever virus strain 17-D) are exempt.

Bacteria

1. Bacillus anthracis 2. Brucella abortus, B. melitensis, B. suis 3. Burkholderia (Pseudomonas) mallei 4. Burkholderia (Pseudomonas) pseudomallei 5. Clostridium botulinum 6. Francisella tularensis 7. Yersinia pestis Exemptions: vaccine strains as described in Title 9 CFR, 78.1 are exempt.

Rickettsiae 1. Coriella burnetii 2. Rickettsia propazekii 3. Rickettsia rickettsii

Fungi 1. Coccidioides immitis

8 72.7 Penalties.

Individuals in violation of this part are subject to a fine of no more than $250,000 or one year in jail, or both. Violations by organizations are subject to a fine or no more than $500,000 per event. A false, fictitious, or fraudulent statement or representation on the Government forms required in the part for registration of facilities or for transfers of select agents is subject to a fine or imprisonment for not more

Torins 1. Abrin 2. Aflatoxins 3. Botulinum toxins 4. Clostridium perfringens epsilon torin 5. Conotoxins 6. Diacetoxyscirpenol 7. Ricin 8. Saxitoxin 9. Shigatoxin 10. Staphylococcal enterotoxins 11. Tetrodotoxin 12. T-2 toxin Exemptions: Toxins for medical use, inactivated for use as vaccines, or toxin preparations for biomedical research use at an LD

APPENDIX D TO PART 75-STANDARDS FOR AC

CREDITATION OF EDUCATIONAL PROGRAMS

FOR NUCLEAR MEDICINE TECHNOLOGISTS APPENDIX E TO PART 75-STANDARDS FOR AC

CREDITATION OF EDUCATION PROGRAMS

FOR RADIATION THERAPY TECHNOLOGISTS APPENDIX FTO PART 75-STANDARDS FOR LI

CENSING RADIOGRAPHERS, NUCLEAR MEDI-
CINE

TECHNOLOGISTS, AND RADIATION
THERAPY TECHNOLOGISTS
APPENDIX G TO PART 75-STANDARDS FOR LI-

CENSING 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.

for vertebrates of more than 100 nanograms per kilogram body weight are exempt. National standard toxins required for biologic potency testing as described in 9 CFR Part 113 are exempt. RECOMBINANT ORGANISMS/MOLECULES

1. Genetically modified microorganisms or genetic elements from organisms on Appendix A, shown to produce or encode for a factor associated with a disease.

2. Genetically modified microorganisms or genetic elements that contain nucleic acid sequences coding for any of the toxins listed in this Appendix, or their toxic subunits.

OTHER RESTRICTIONS

The deliberate transfer of a drug resistance trait to microorganisms listed in this Appendix that are not known to acquire the trait naturally is prohibited by NIH “Guidelines for Research Involving Recombinant DNA Molecules," if such acquisition could compromise the use of the drug to control these disease agents in humans or veterinary medicine.

ADDITIONAL EXEMPTIONS

1. Products subject to regulation under the Federal Insecticide Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.) and the Toxic Substances Control Act (15 U.S.C. 2601 et seq.) are exempt.

2. Additional exemptions for otherwise covered strains will be considered when CDC reviews and updates the list of select agents in this Appendix. Individuals seeking an exemption should submit a request to CDC that specifies the agent or strain to be exempted and explains why such an exemption should be granted. Future exemptions will be published in the FEDERAL REGISTER for review and comment prior to inclusion in this Appendix. (61 FR 55199, Oct. 24, 1996)

875.1 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.

PART 75-STANDARDS FOR THE ACCREDITATION OF EDUCATIONAL PROGRAMS FOR AND THE CREDENTIALING OF RADIOLOGIC PERSONNEL

Sec. 75.1 Background and purpose. 75.2 Definitions. 75.3 Applicability. APPENDIX A TO PART 75-STANDARDS FOR AC

CREDITATION OF EDUCATION PROGRAMS

FOR RADIOGRAPHERS APPENDIX B TO PART 75–STANDARDS FOR AC

CREDITATION OF DENTAL RADIOGRAPHY

TRAINING FOR DENTAL HYGIENISTS APPENDIX CTO PART 75–STANDARDS FOR AC

CREDITATION OF DENTAL RADIOGRAPHY
TRAINING FOR DENTAL ASSISTANTS

$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 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 equipment 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 radiation, the appropriate exposure of radiographs, or other procedures which contribute to any significant extent to the site or dosage of ionizing radiation to

which 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

an

a

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 875.2 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

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 ef ctive 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:

(i) 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.

as

APPENDIX A TO PART 75-STANDARDS

FOR ACCREDITATION OF EDUCATIONAL
PROGRAMS FOR RADIOGRAPHERS

3. Reference Materials. Adequate up-to-date scientific books, periodicals, and other reference materials related to the curriculum and profession shall be readily accessible to students.

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; appoints faculty to the program; receives and processes applications for admission; and grants the degree or certificate documenting completion of the program.

2. Educational programs may be established in:

(a) Community and junior colleges, senior colleges, and universities;

(b) Hospitals;
(c) Medical schools;

(d) Postsecondary vocational/technical schools and institutions, and

(e) Other acceptable institutions which meet comparable standards.

3. The sponsoring institutions and affiliate(s) must be accredited by a recognized agency. When the sponsoring institution and affilitate(s) are not so recognized, they may be considered as meeting the requirements of accreditation if the institution meets or exceeds established equivalent standards.

D. Clinical Education 1. The clinical phase of the educational program shall provide an environment for supervised competency-based clinical education and experience and offer a sufficient and well-balanced variety of radiographic examinations and equipment.

2. An acceptable ratio of students to registered technologists shall be maintained in the clinical teaching environment.

3. A clinical instructor(s), who shall be responsible for supervising students according to objectives, shall be identified for each primary clinical education center.

4. The maximum student enrollment shall not exceed the capacity recommended on the basis of volume and variety of radiographic procedures, resources, and personnel available for teaching purposes.

5. In programs where didactic and clinical experience are not provided in the same institution, accreditation shall be given only to the institution responsible for admissions, curriculum, and academic credit. The accredited institution shall be responsible for coordinating the program and assuring that the activities assigned to the students in the clinical setting are educational. There shall be a uniform contract between the accredited institution and each of its affiliate hospitals, clearly defining the responsibilities and obligations of each.

E. Curriculum 1. The structure of the curriculum shall be based on not less than two calendar years of full-time study or its equivalent.

2. Instruction shall follow a planned outline that includes:

(a) The assignment of appropriate instructional materials;

(b) Classroom presentations, discussions and demonstrations; and

(c) Examinations in the didactic and clinical aspects of the program.

3. All professional courses, including clinical education, must include specific curriculum content that shall include, but shall not be limited to:

(a) Introduction to radiologic technology; (b) Medical ethics; (c) Imaging: (d) Radiographic processing technique; (e) Human structure and function; (f) Medical terminology; (g) Principals of radiographic exposure; (h) Radiographic procedures; (i) Principles of radiation protection; (j) Radiographic film evaluation; (k) Methods of patient care;

C. Instructional Facilities 1. General. Appropriate classroom and clinical space, modern equipment, and supplies for supervised education shall be provided.

2. Laboratory. Energized laboratories utilized for teaching purposes shall be certified as required for compliance with Federal and/ or State radiation safety regulations. The use of laboratories shall be governed by established educational objectives.

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