[Title 42 CFR F]
[Code of Federal Regulations (annual edition) - October 1, 2008 Edition]
[Title 42 - PUBLIC HEALTH]
[Chapter I - PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN]
[Subchapter F - QUARANTINE, INSPECTION, LICENSING]
[From the U.S. Government Printing Office]
42PUBLIC HEALTH12008-10-012008-10-01falseQUARANTINE, INSPECTION, LICENSINGFSUBCHAPTER FPUBLIC HEALTHPUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SUBCHAPTER F_QUARANTINE, INSPECTION, LICENSING
PART 70_INTERSTATE QUARANTINE--Table of Contents
Sec.
70.1 General definitions.
70.2 Measures in the event of inadequate local control.
70.3 All communicable diseases.
70.4 Report of disease.
70.5 Certain communicable diseases; special requirements.
70.6 Apprehension and detention of persons with specific diseases.
70.7 Responsibility with respect to minors, wards, and patients.
70.8 Members of military and naval forces.
70.9 Vaccination clinics.
Authority: Secs. 215 and 311 of the Public Health Service (PHS) Act,
as amended (42 U.S.C. 216, 243); section 361-369, PHS Act, as amended
(42 U.S.C. 264-272); 31 U.S.C. 9701.
Source: 65 FR 49908, Aug. 16, 2000, unless otherwise noted.
Sec. 70.1 General definitions.
As used in this part, terms shall have the following meaning:
(a) Communicable diseases means illnesses due to infectious agents
or their toxic products, which may be transmitted from a reservoir to a
susceptible host either directly as from an infected person or animal or
indirectly through the agency of an intermediate plant or animal host,
vector, or the inanimate environment.
(b) Communicable period means the period or periods during which the
etiologic agent may be transferred directly or indirectly from the body
of the infected person or animal to the body of another.
(c) Conveyance means any land or air carrier, or any vessel as
defined in paragraph (h) of this section.
(d) Incubation period means the period between the implanting of
disease organisms in a susceptible person and the appearance of clinical
manifestation of the disease.
(e) Interstate traffic means:
(1) The movement of any conveyance or the transportation of persons
or property, including any portion of such movement or transportation
that is entirely within a State or possession--
(i) From a point of origin in any State or possession to a point of
destination in any other State or possession; or
(ii) Between a point of origin and a point of destination in the
same State or possession but through any other State, possession, or
contiguous foreign country.
(2) Interstate traffic does not include the following:
(i) The movement of any conveyance which is solely for the purpose
of unloading persons or property transported from a foreign country, or
loading persons or property for transportation to a foreign country.
(ii) The movement of any conveyance which is solely for the purpose
of effecting its repair, reconstruction, rehabilitation, or storage.
(f) Possession means any of the possessions of the United States,
including Puerto Rico and the Virgin Islands.
(g) State means any State, the District of Columbia, Puerto Rico,
and the Virgin Islands.
(h) Vessel means any passenger-carrying, cargo, or towing vessel
exclusive of:
(1) Fishing boats including those used for shell-fishing;
(2) Tugs which operate only locally in specific harbors and adjacent
waters;
(3) Barges without means of self-propulsion;
(4) Construction-equipment boats and dredges; and
(5) Sand and gravel dredging and handling boats.
Sec. 70.2 Measures in the event of inadequate local control.
Whenever the Director of the Centers for Disease Control and
Prevention determines that the measures taken by health authorities of
any State or possession (including political subdivisions thereof) are
insufficient to prevent the spread of any of the communicable diseases
from such State or possession to any other State or possession, he/she
may take such measures to prevent such spread of the diseases as he/she
deems reasonably necessary, including inspection, fumigation,
disinfection, sanitation, pest extermination, and destruction of animals
or
[[Page 422]]
articles believed to be sources of infection.
Sec. 70.3 All communicable diseases.
A person who has a communicable disease in the communicable period
shall not travel from one State or possession to another without a
permit from the health officer of the State, possession, or locality of
destination, if such permit is required under the law applicable to the
place of destination. Stop-overs other than those necessary for
transportation connections shall be considered as places of destination.
Sec. 70.4 Report of disease.
The master of any vessel or person in charge of any conveyance
engaged in interstate traffic, on which a case or suspected case of a
communicable disease develops shall, as soon as practicable, notify the
local health authority at the next port of call, station, or stop, and
shall take such measures to prevent the spread of the disease as the
local health authority directs.
Sec. 70.5 Certain communicable diseases; special requirements.
The following provisions are applicable with respect to any person
who is in the communicable period of cholera, plague, smallpox, typhus
or yellow fever, or who, having been exposed to any such disease, is in
the incubation period thereof:
(a) Requirements relating to travelers. (1) No such person shall
travel from one State or possession to another, or on a conveyance
engaged in interstate traffic, without a written permit of the Surgeon
General or his/her authorized representative.
(2) Application for a permit may be made directly to the Surgeon
General or to his/her representative authorized to issue permits.
(3) Upon receipt of an application, the Surgeon General or his/her
authorized representative shall, taking into consideration the risk of
introduction, transmission, or spread of the disease from one State or
possession to another, reject it, or issue a permit that may be
conditioned upon compliance with such precautionary measures as he/she
shall prescribe.
(4) A person to whom a permit has been issued shall retain it in
his/her possession throughout the course of his/her authorized travel
and comply with all conditions prescribed therein, including
presentation of the permit to the operators of conveyances as required
by its terms.
(b) Requirements relating to operation of conveyances. (1) The
operator of any conveyance engaged in interstate traffic shall not
knowingly:
(i) Accept for transportation any person who fails to present a
permit as required by paragraph (a) of this section; or
(ii) Transport any person in violation of conditions prescribed in
his/her permit.
(2) Whenever a person subject to the provisions of this section is
transported on a conveyance engaged in interstate traffic, the operator
thereof shall take such measures to prevent the spread of the disease,
including submission of the conveyance to inspection, disinfection and
the like, as an officer of the Public Health Service designated by the
Surgeon General for such purposes deems reasonably necessary and
directs.
Sec. 70.6 Apprehension and detention of persons with specific diseases.
Regulations prescribed in this part authorize the detention,
isolation, quarantine, or conditional release of individuals, for the
purpose of preventing the introduction, transmission, and spread of the
communicable diseases listed in an Executive Order setting out a list of
quarantinable communicable diseases, as provided under section 361(b) of
the Public Health Service Act. Executive Order 13295, of April 4, 2003,
contains the current revised list of quarantinable communicable
diseases, and may be obtained at http://www.cdc.gov, or at http://
www.archives.gov/federal--register. If this Order is amended, HHS will
enforce that amended order immediately and update this reference.
[68 FR 17559, Apr. 10, 2003]
[[Page 423]]
Sec. 70.7 Responsibility with respect to minors, wards, and patients.
A parent, guardian, physician, nurse, or other such person shall not
transport, or procure or furnish transportation for any minor child or
ward, patient or other such person who is in the communicable period of
a communicable disease, except in accordance with provisions of this
part.
Sec. 70.8 Members of military and naval forces.
The provisions of Sec. Sec. 70.3, 70.4, 70.5, 70.7, and this
section shall not apply to members of the military or naval forces, and
medical care or hospital beneficiaries of the Army, Navy, Veterans'
Administration, or Public Health Service, when traveling under competent
orders: Provided, That in the case of persons otherwise subject to the
provisions of Sec. 70.5 the authority authorizing the travel requires
precautions to prevent the possible transmission of infection to others
during the travel period.
Sec. 70.9 Vaccination clinics.
(a) The Director may establish vaccination clinics, through contract
or otherwise, authorized to administer vaccines and/or other
prophylaxis.
(b) A vaccination fee may be charged for individuals not enrolled in
Medicare Part B to cover costs associated with administration of the
vaccine and/or other prophylaxis. Such fee is to be collected at the
time that the vaccine is administered. The vaccination fee, if imposed,
is shown in the following table:
------------------------------------------------------------------------
Effective
Vaccine dates Amount
------------------------------------------------------------------------
Fluarix..................................... \1\1/25/05 \2\ $25.00
------------------------------------------------------------------------
\1\ Continuing for one year.
\2\ $7.00 for the vaccine and $18.00 for administration.
[70 FR 3493, Jan. 25, 2005]
PART 71_FOREIGN QUARANTINE--Table of Contents
Subpart A_Definitions and General Provisions
Sec.
71.1 Scope and definitions.
71.2 Penalties.
71.3 Designation of yellow fever vaccination centers; Validation stamps.
Subpart B_Measures at Foreign Ports
71.11 Bills of health.
Subpart C_Notice of Communicable Disease Prior to Arrival
71.21 Radio report of death or illness.
Subpart D_Health Measures at U.S. Ports: Communicable Diseases
71.31 General provisions.
71.32 Persons, carriers, and things.
71.33 Persons: Isolation and surveillance.
71.34 Carriers of U.S. military services.
71.35 Report of death or illness on carrier during stay in port.
Subpart E_Requirements Upon Arrival at U.S. Ports: Sanitary Inspection
71.41 General provisions.
71.42 Disinsection of imports.
71.43 Exemption for mails.
71.44 Disinsection of aircraft.
71.45 Food, potable water, and waste: U.S. seaports and airports.
71.46 Issuance of Deratting Certificates and Deratting Exemption
Certificates.
71.47 Special provisions relating to airports: Office and isolation
facilities.
71.48 Carriers in intercoastal and interstate traffic.
Subpart F_Importations
71.51 Dogs and cats.
71.52 Turtles, tortoises, and terrapins.
71.53 Nonhuman primates.
71.54 Etiological agents, hosts, and vectors.
71.55 Dead bodies.
71.56 African rodents and other animals that may carry the monkeypox
virus.
Authority: Secs. 215 and 311 of Public Health Service (PHS) Act. as
amended (42 U.S.C. 216, 243); secs. 361-369, PHS Act, as amended (42
U.S.C. 264-272).
Source: 50 FR 1519, Jan. 11, 1985, unless otherwise noted.
Subpart A_Definitions and General Provisions
Sec. 71.1 Scope and definitions.
(a) The provisions of this part contain the regulations to prevent
the introduction, transmission, and spread of communicable disease from
foreign countries into the States or possessions of the United States.
Regulations pertaining to preventing the interstate
[[Page 424]]
spread of communicable diseases are contained in 21 CFR parts 1240 and
1250.
(b) As used in this part the term:
Carrier means a ship, aircraft, train, road vehicle, or other means
of transport, including military.
Communicable disease means an illness due to a specific infectious
agent or its toxic products which arises through transmission of that
agent or its products from an infected person or animal or a reservoir
to a susceptible host, either directly, or indirectly through an
intermediate animal host, vector, or the inanimate environment.
Contamination means the presence of undesirable substances or
material which may contain infectious agents or their toxic products.
Controlled Free Pratique means permission for a carrier to enter a
U.S. port, disembark, and begin operation under certain stipulated
conditions.
Deratting Certificate means a certificate issued under the
instructions of the Director, in the form prescribed by the
International Health Regulations, recording the inspection and deratting
of the ship.
Deratting Exemption Certificate means a certificate issued under the
instructions of the Director, in the form prescribed by the
International Health Regulations, recording the inspection and exemption
from deratting of the ship which is rodent free.
Detention means the temporary holding of a person, ship, aircraft,
or other carrier, animal, or thing in such place and for such period of
time as may be determined by the Director.
Director means the Director, Centers for Disease Control, Public
Health Service, Department of Health and Human Services, or his/her
authorized representative.
Disinfection means the killing of infectious agents or inactivation
of their toxic products outside the body by direct exposure to chemical
or physical agents.
Disinfestation means any chemical or physical process serving to
destroy or remove undesired small animal forms, particularly arthropods
or rodents, present upon the person, the clothing, or the environment of
an individual, or upon animals and carriers.
Disinsection means the operation in which measures are taken to kill
the insect vectors of human disease present in carriers and containers.
Educational purpose means use in the teaching of a defined
educational program at the university level or equivalent.
Exhibition purpose means use as a part of a display in a facility
comparable to a zoological park or in a trained animal act. The animal
display must be open to the general public at routinely scheduled hours
on 5 or more days of each week. The trained animal act must be routinely
scheduled for multiple performances each week and open to the general
public except for reasonable vacation and retraining periods.
Ill person means a person who:
(1) Has a temperature of 100 [deg]F. (or 38 [deg]C.) or greater,
accompanied by a rash, glandular swelling, or jaundice, or which has
persisted for more than 48 hours; or
(2) Has diarrhea, defined as the occurrence in a 24-hour period of
three or more loose stools or of a greater than normal (for the person)
amount of loose stools.
International Health Regulations means the International Health
Regulations of the World Health Organization, adopted by the Twenty-
Second World Health Assembly in 1969, as amended by the Twenty-Sixth
World Health Assembly in 1973, the Thirty-Fourth World Health Assembly
in 1981, and as may be further amended.
International voyage means: (1) In the case of a carrier, a voyage
between ports or airports of more than one country, or a voyage between
ports or airports of the same country if the ship or aircraft stopped in
any other country on its voyage; or (2) in the case of a person, a
voyage involving entry into a country other than the country in which
that person begins his/her voyage.
Isolation means: (1) When applied to a person or group of persons,
the separation of that person or group of persons from other persons,
except the health staff on duty, in such a manner as to prevent the
spread of infection; or (2) when applied to animals, the separation of
an animal or group of animals
[[Page 425]]
from persons, other animals, or vectors of disease in such a manner as
to prevent the spread of infection.
Military services means the U.S. Army, the U.S. Air Force, the U.S.
Navy, and the U.S. Coast Guard.
Scientific purpose means use for scientific research following a
defined protocol and other standards for research projects as normally
conducted at the university level. The term also includes the use for
safety testing, potency testing, and other activities related to the
production of medical products.
Surveillance means the temporary supervision of a person who may
have or has been exposed to a communicable disease.
U.S. port means any seaport, airport, or border crossing point under
the control of the United States.
United States means the several States, the District of Columbia,
Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the
Virgin Islands, American Samoa, and the Trust Territory of the Pacific
Islands.
Vector means an animal (including insects) or thing which conveys or
is capable of conveying infectious agents from a person or animal to
another person or animal.
Sec. 71.2 Penalties.
Any person violating any provision of these regulations shall be
subject to a fine of not more than $1,000 or to imprisonment for not
more than 1 year, or both, as provided in section 368 of the Public
Health Service Act (42 U.S.C. 271).
Sec. 71.3 Designation of yellow fever vaccination centers; Validation stamps.
(a) Designation of yellow fever vaccination centers. (1) The
Director is responsible for the designation of yellow fever vaccination
centers authorized to issue certificates of vaccination. This
responsibility is delegated by the Director to a State or territorial
health department with respect to yellow fever vaccination activities of
non-Federal medical, public health facilities, and licensed physicians
functioning within the respective jurisdictions of a State or
territorial health department. Designation may be made upon application
and presentation of evidence satisfactory to a State or territorial
health department that the applicant has adequate facilities and
professionally trained personnel for the handling, storage, and
administration of a safe, potent, and pure yellow fever vaccine. Medical
facilities of Federal agencies are authorized to obtain yellow fever
vaccine without being designated as a yellow fever vaccination center by
the Director.
(2) A designated yellow fever vaccination center shall comply with
the instruction issued by the Director or by a delegated officer or
employee of a State or territorial health department for the handling,
storage, and administration of yellow fever vaccine. If a designated
center fails to comply with such instruction, after notice to the
center, the Director or, for non-Federal centers, a State or territorial
health department, may revoke designation.
(b) Validation stamps. International Certificates of Vaccination
against cholera and yellow fever issued for vaccinations performed in
the United States shall be validated by:
(1) The Seal of the Public Health Service; or
(2) The Seal of the Department of State; or
(3) The stamp of the Department of Defense; or
(4) The stamp issued to the National Aeronautics and Space
Administration; or
(5) The stamp issued by a State or territorial health department; or
(6) An official stamp of a design and size approved by the Director
for such purpose.
Subpart B_Measures at Foreign Ports
Sec. 71.11 Bills of health.
A carrier at any foreign port clearing or departing for any U.S.
port shall not be required to obtain or deliver a bill of health.
[[Page 426]]
Subpart C_Notice of Communicable Disease Prior to Arrival
Sec. 71.21 Radio report of death or illness.
(a) The master of a ship destined for a U.S. port shall report
immediately to the quarantine station at or nearest the port at which
the ship will arrive, the occurrence, on board, of any death or any ill
person among passengers or crew (including those who have disembarked or
have been removed) during the 15-day period preceding the date of
expected arrival or during the period since departure from a U.S. port
(whichever period of time is shorter).
(b) The commander of an aircraft destined for a U.S. airport shall
report immediately to the quarantine station at or nearest the airport
at which the aircraft will arrive, the occurrence, on board, of any
death or ill person among passengers or crew.
(c) In addition to paragraph (a) of this section, the master of a
ship carrying 13 or more passengers must report by radio 24 hours before
arrival the number of cases (including zero) of diarrhea in passengers
and crew recorded in the ship's medical log during the current cruise.
All cases of diarrhea that occur after the 24 hour report must also be
reported not less than 4 hours before arrival.
(Approved by the Office of Management and Budget under control number
0920-0134)
Subpart D_Health Measures at U.S. Ports: Communicable Diseases
Sec. 71.31 General provisions.
(a) Upon arrival at a U.S. port, a carrier will not undergo
inspection unless the Director determines that a failure to inspect will
present a threat of introduction of communicable diseases into the
United States, as may exist when the carrier has on board individual(s)
reportable in accordance with Sec. 71.21 or meets the circumstances
described in Sec. 71.42. Carriers not subject to inspection under this
section will be subject to sanitary inspection under Sec. 71.41 of this
part.
(b) The Director may require detention of a carrier until the
completion of the measures outlined in this part that are necessary to
prevent the introduction or spread of a communicable disease. The
Director may issue a controlled free pratique to the carrier stipulating
what measures are to be met, but such issuance does not prevent the
periodic boarding of a carrier and the inspection of persons and records
to verify that the conditions have been met for granting the pratique.
Sec. 71.32 Persons, carriers, and things.
(a) Whenever the Director has reason to believe that any arriving
person is infected with or has been exposed to any of the communicable
diseases listed in an Executive Order, as provided under section 361(b)
of the Public Health Service Act, he/she may isolate, quarantine, or
place the person under surveillance and may order disinfection or
disinfestation, fumigation, as he/she considers necessary to prevent the
introduction, transmission or spread of the listed communicable
diseases. Executive Order 13295, of April 4, 2003, contains the current
revised list of quarantinable communicable diseases, and may be obtained
at http://www.cdc.gov and http://www.archives.gov/federal--register. If
this Order is amended, HHS will enforce that amended order immediately
and update this reference.
(b) Whenever the Director has reason to believe that any arriving
carrier or article or thing on board the carrier is or may be infected
or contaminated with a communicable disease, he/she may require
detention, disinfection, disinfestation, fumigation, or other related
measures respecting the carrier or article or thing as he/she considers
necessary to prevent the introduction, transmission, or spread of
communicable diseases.
[68 FR 17559, Apr. 10, 2003]
Sec. 71.33 Persons: Isolation and surveillance.
(a) Persons held in isolation under this subpart may be held in
facilities suitable for isolation and treatment.
(b) The Director may require isolation where surveillance is
authorized in this subpart whenever the Director
[[Page 427]]
considers the risk of transmission of infection to be exceptionally
serious.
(c) Every person who is placed under surveillance by authority of
this subpart shall, during the period of surveillance:
(1) Give information relative to his/her health and his/her intended
destination and report, in person or by telephone, to the local health
officer having jurisdiction over the areas to be visited, and report for
medical examinations as may be required;
(2) Upon arrival at any address other than that stated as the
intended destination when placed under surveillance, or prior to
departure from the United States, inform, in person or by telephone, the
health officer serving the health jurisdiction from which he/she is
departing.
(d) From time to time the Director may, in accordance with section
322 of the Public Health Service Act, enter into agreements with public
or private medical or hospital facilities for providing care and
treatment for persons detained under this part.
(Approved by the Office of Management and Budget under control number
0920-0134)
[50 FR 1519, Jan. 11, 1985; 50 FR 3910, Jan. 29, 1985]
Sec. 71.34 Carriers of U.S. military services.
(a) Carriers belonging to or operated by the military services of
the United States may be exempted from inspection if the Director is
satisfied that they have complied with regulations of the military
services which also meet the requirements of the regulations in this
part. (For applicable regulations of the military services, see Army
Regulation No. 40-12, Air Force Regulation No. 161-4, Secretary of the
Navy Instruction 6210.2, and Coast Guard Commandant Instruction 6210.2).
(b) Notwithstanding exemption from inspection of carriers under this
section, animals or articles on board shall be required to comply with
the applicable requirements of subpart F of this part.
Sec. 71.35 Report of death or illness on carrier during stay in port.
The master of any carrier at a U.S. port shall report immediately to
the quarantine station at or nearest the port the occurrence, on board,
of any death or any ill person among passengers or crew.
(Approved by the Office of Management and Budget under control number
0920-0134)
Subpart E_Requirements Upon Arrival at U.S. Ports: Sanitary Inspection
Sec. 71.41 General provisions.
Carriers arriving at a U.S. port from a foreign area shall be
subject to a sanitary inspection to determine whether there exists
rodent, insect, or other vermin infestation, contaminated food or water,
or other insanitary conditions requiring measures for the prevention of
the introduction, transmission, or spread of communicable disease.
Sec. 71.42 Disinfection of imports.
When the cargo manifest of a carrier lists articles which may
require disinfection under the provisions of this part, the Director
shall disinfect them on board or request the appropriate customs officer
to keep the articles separated from the other cargo pending appropriate
disposition.
Sec. 71.43 Exemption for mails.
Except to the extent that mail contains any article or thing subject
to restrictions under subpart F of this part, nothing in the regulations
in this part shall render liable to detention, disinfection, or
destruction any mail conveyed under the authority of the postal
administration of the United States or of any other Government.
Sec. 71.44 Disinsection of aircraft.
(a) The Director may require disinsection of an aircraft if it has
left a foreign area that is infected with insect-borne communicable
disease and the aircraft is suspected of harboring insects of public
health importance.
(b) Disinsection shall be the responsibility of the air carrier or,
in the case of aircraft not for hire, the pilot in command, and shall be
subject to monitoring by the Director.
[[Page 428]]
(c) Disinsection of the aircraft shall be accomplished immediately
after landing and blocking.
(1) The cargo compartment shall be disinsected before the mail,
baggage, and other cargo are discharged.
(2) The rest of the aircraft shall be disinsected after passengers
and crew deplane.
(d) Disinsection shall be performed with an approved insecticide in
accordance with the manufacturer's instructions. The current list of
approved insecticides and sources may be obtained from the Division of
Quarantine, Center for Prevention Services, Centers for Disease Control,
Atlanta, GA 30333.
Sec. 71.45 Food, potable water, and waste: U.S. seaports and airports.
(a) Every seaport and airport shall be provided with a supply of
potable water from a watering point approved by the Commissioner of Food
and Drugs, Food and Drug Administration, in accordance with standards
established in title 21, Code of Federal Regulations, parts 1240 and
1250.
(b) All food and potable water taken on board a ship or aircraft at
any seaport or airport intended for human consumption thereon shall be
obtained from sources approved in accordance with regulations cited in
paragraph (a) of this section.
(c) Aircraft inbound or outbound on an international voyage shall
not discharge over the United States any excrement, or waste water or
other polluting materials. Arriving aircraft shall discharge such matter
only at servicing areas approved under regulations cited in paragraph
(a) of this section.
Sec. 71.46 Issuance of Deratting Certificates and Deratting Exemption
Certificates.
Valid Deratting Certificates or Deratting Exemption Certificates are
not required for ships to enter a U.S. seaport. In accordance with
Article 17 of the International Health Regulations, the Public Health
Service may perform rodent infestation inspections and issue Deratting
Certificates and Deratting Exemption Certificates.
Sec. 71.47 Special provisions relating to airports: Office and isolation
facilities.
Each U.S. airport which receives international traffic shall provide
without cost to the Government suitable office, isolation, and other
exclusive space for carrying out the Federal responsibilities under this
part.
Sec. 71.48 Carriers in intercoastal and interstate traffic.
Carriers, on an international voyage, which are in traffic between
U.S. ports, shall be subject to inspection as described in Sec. Sec.
71.31 and 71.41 when there occurs on board, among passengers or crew,
any death, or any ill person, or when illness is suspected to be caused
by insanitary conditions.
Subpart F_Importations
Sec. 71.51 Dogs and cats.
(a) Definitions.
As used in this section the term:
Cat means all domestic cats.
Confinement means restriction of a dog or cat to a building or other
enclosure at a U.S. port, en route to destination and at destination, in
isolation from other animals and from persons except for contact
necessary for its care or, if the dog or cat is allowed out of the
enclosure, muzzling and keeping it on a leash.
Dog means all domestic dogs.
Owner means owner or agent.
Valid rabies vaccination certificate means a certificate which was
issued for a dog not less than 3 months of age at the time of
vaccination and which:
(1) Identifies a dog on the basis of breed, sex, age, color,
markings, and other identifying information.
(2) Specifies a date of rabies vaccination at least 30 days before
the date of arrival of the dog at a U.S. port.
(3) Specifies a date of expiration which is after the date of
arrival of the dog at a U.S. port. If no date of expiration is
specified, then the date of vaccination shall be no more than 12 months
before the date of arrival at a U.S. port.
(4) Bears the signature of a licensed veterinarian.
[[Page 429]]
(b) General requirements for admission of dogs and cats--(1)
Inspection by Director. The Director shall inspect all dogs and cats
which arrive at a U.S. port, and admit only those dogs and cats which
show no signs of communicable disease as defined in Sec. 71.1.
(2) Examination by veterinarian and confinement of dogs and cats.
When, upon inspection, a dog or cat does not appear to be in good health
on arrival (e.g., it has symptoms such as emaciation, lesions of the
skin, nervous system disturbances, jaundice, or diarrhea), the Director
may require prompt confinement and give the owner an opportunity to
arrange for a licensed veterinarian to examine the animal and give or
arrange for any tests or treatment indicated. The Director will consider
the findings of the examination and tests in determining whether or not
the dog or cat may have a communicable disease. The owner shall bear the
expense of the examination, tests, and treatment. When it is necessary
to detain a dog or cat pending determination of its admissibility, the
owner shall provide confinement facilities which in the judgment of the
Director will afford protection against any communicable disease. The
owner shall bear the expense of confinement. Confinement shall be
subject to conditions specified by the Director to protect the public
health.
(3) Record of sickness or death of dogs and cats and requirements
for exposed animals. (i) The carrier responsible for the care of dogs
and cats shall maintain a record of sickness or death of animals en
route to the United States and shall submit the record to the quarantine
station at the U.S. port upon arrival. Dogs or cats which have become
sick while en route or are dead on arrival shall be separated from other
animals as soon as the sickness or death is discovered, and shall be
held in confinement pending any necessary examination as determined by
the Director.
(ii) When, upon inspection, a dog or cat appears healthy but, during
shipment, has been exposed to a sick or dead animal suspected of having
a communicable disease, the exposed dog or cat shall be admitted only if
examination or tests made on arrival reveal no evidence that the animal
may be infected with a communicable disease. The provisions of paragraph
(b)(2) of this section shall be applicable to the examination or tests.
(4) Sanitation. When the Director finds that the cages or other
containers of dogs or cats arriving in the United States are in an
insanitary or other condition that may constitute a communicable disease
hazard, the dogs or cats shall not be admitted in such containers unless
the owner has the containers cleaned and disinfected.
(c) Rabies vaccination requirements for dogs. (1) A valid rabies
vaccination certificate is required at a U.S. port for admission of a
dog unless the owner submits evidence satisfactory to the Director that:
(i) If a dog is less than 6 months of age, it has been only in a
country determined by the Director to be rabies-free (a current list of
rabies-free countries may be obtained from the Division of Quarantine,
Center for Prevention Services, Centers for Disease Control, Atlanta, GA
30333); or
(ii) If a dog is 6 months of age or older, for the 6 months before
arrival, it has been only in a country determined by the Director to be
rabies-free; or
(iii) The dog is to be taken to a research facility to be used for
research purposes and vaccination would interfere with its use for such
purposes.
(2) Regardless of the provisions of paragraph (c)(1) of this
section, the Director may authorize admission as follows:
(i) If the date of vaccination shown on the vaccination certificate
is less than 30 days before the date of arrival, the dog may be
admitted, but must be confined until at least 30 days have elapsed since
the date of vaccination;
(ii) If the dog is less than 3 months of age, it may be admitted,
but must be confined until vaccinated against rabies at 3 months of age
and for at least 30 days after the date of vaccination;
(iii) If the dog is 3 months of age or older, it may be admitted,
but must be confined until it is vaccinated against rabies. The dog must
be vaccinated within 4 days after arrival at destination but no more
than 10 days after arrival at a U.S. port. It must be kept in
[[Page 430]]
confinement for at least 30 days after the date of vaccination.
(3) When a dog is admitted under paragraph (c)(2) of this section,
the Director shall notify the health department or other appropriate
agency having jurisdiction at the point of destination and shall provide
the address of the specified place of confinement and other pertinent
information to facilitate surveillance and other appropriate action.
(d) Certification requirements. The owner shall submit such
certification regarding confinement and vaccination prescribed under
this section as may be required by the Director.
(e) Additional requirements for the importation of dogs and cats.
Dogs and cats shall be subject to such additional requirements as may be
deemed necessary by the Director or to exclusion if coming from areas
which the Director has determined to have high rates of rabies.
(f) Requirements for dogs and cats in transit. The provisions of
this section shall apply to dogs and cats transported through the United
States from one foreign country to another, except as provided below:
(1) Dogs and cats that appear healthy, but have been exposed to a
sick or dead animal suspected of having a communicable disease, need not
undergo examination or tests as provided in paragraph (b)(3) of this
section if the Director determines that the conditions under which they
are being transported will afford adequate protection against
introduction of communicable disease.
(2) Rabies vaccination is not required for dogs that are transported
by aircraft or ship and retained in custody of the carrier under
conditions that would prevent transmission of rabies.
(g) Disposal of excluded dogs and cats. A dog or cat excluded from
the United States under the regulations in this part shall be exported
or destroyed. Pending exportation, it shall be detained at the owner's
expense in the custody of the U.S. Customs Service at the U.S. port.
(Approved by the Office of Management and Budget under control number
0920-0134)
Sec. 71.52 Turtles, tortoises, and terrapins.
(a) Definitions.
As used in this section the term:
Turtles includes all animals commonly known as turtles, tortoises,
terrapins, and all other animals of the order Testudinata, class
Reptilia, except marine species (Families Dermochelidae and
Cheloniidae).
(b) Importation; general prohibition. Except as otherwise provided
in this section, live turtles with a carapace length of less than 4
inches and viable turtle eggs may not be imported into the United
States.
(c) Exceptions. (1) Live turtles with a carapace length of less than
4 inches and viable turtle eggs may be imported into the United States,
provided that such importation is not in connection with a business, and
the importation is limited to lots of fewer than seven live turtles or
fewer than seven viable turtle eggs, or any combinations of such turtles
and turtle eggs totaling fewer than seven, for any entry.
(2) Seven or more live turtles with a carapace length of less than 4
inches, or seven or more viable turtle eggs or any combination of
turtles and turtle eggs totaling seven or more, may be imported into the
United States for bona fide scientific or educational purposes or for
exhibition when accompanied by a permit issued by the Director.
(3) The requirements in paragraphs (c)(1) and (c)(2) of this section
shall not apply to the eggs of marine turtles excluded from these
regulations under Sec. 71.52(a).
(d) Application for permits. Applications for permits to import
turtles, as set forth in paragraph (c)(2) of this section, shall be made
by letter to the Director, and shall contain, identify, or describe, the
name and address of the applicant, the number of specimens, and the
common and scientific names of each species to be imported, the holding
facilities, the intended use of the turtles following their importation,
the precautions to be undertaken to prevent infection of members of the
public with Salmonella and Arizona bacteria, and any other information
and assurances the Director may require.
[[Page 431]]
(e) Criteria for issuance of permits. A permit may be issued upon a
determination that the holder of the permit will isolate or otherwise
confine the turtles and will take such other precautions as may be
determined by the Director to be necessary to prevent infection of
members of the public with Salmonella and Arizona bacteria and on
condition that the holder of the permit will provide such reports as the
Director may require.
(f) Interstate Regulations. Upon admission at a U.S. Port, turtles
and viable turtle eggs become subject to Food and Drug Administration
Regulations (21 CFR 1240.62) regarding general prohibition.
(g) Other permits. Permits to import certain species of turtles may
be required under other Federal regulations (50 CFR parts 17 and 23)
protecting such species.
(Approved by the Office of Management and Budget under control number
0920-0134)
Sec. 71.53 Nonhuman primates.
(a) Definitions.
As used in this section the term:
Importer means any person or corporation, partnership, or other
organization, receiving live nonhuman primates from a foreign country
within a period of 31 days, beginning with the importation date, whether
or not the primates were held for part of the period at another
location. The term importer includes the original importer and any other
person or organization receiving imported primates within the 31-day
period.
Nonhuman primates means all nonhuman members of the Order Primates,
including, but not limited to, animals commonly known as monkeys,
chimpanzees, orangutans, gorillas, gibbons, apes, baboons, marmosets,
tamarin, lemurs, and lorises.
(b) General prohibition. No person or organization may import live
nonhuman primates into the United States unless registered as an
importer in accordance with applicable provisions of this section.
(c) Uses for which nonhuman primates may be imported and
distributed. Live nonhuman primates may be imported into the United
States and sold, resold, or otherwise distributed only for bona fide
scientific, educational, or exhibition purposes. The importation of
nonhuman primates for use in breeding colonies is also permitted
provided that all offspring will be used only for scientific,
educational, or exhibition purposes. The maintenance of nonhuman
primates as pets, hobby, or an avocation with occasional display to the
general public is not a permissible use.
(d) Registration of importers. (1) Importers of nonhuman primates
shall register with the Director in a manner prescribed by the Director.
(2) Documentary evidence that an importer will use all nonhuman
primates solely for the permitted purposes is required.
(3) Registration shall inlcude certification that the nonhuman
primates will not be shipped, sold, or otherwise transferred to other
persons or organizations without adequate proof that the primates will
be used only for the permitted purposes.
(4) Registration shall be for 2 years, effective the date the
application for registration is approved by the Director.
(5) Registration may be renewed by filing a registration application
form with the Director not less than 30 days nor more than 60 days
before expiration of the current registration.
(e) Recordkeeping and reporting requirement for registered
importers. (1) Importers shall maintain records on each shipment of
imported nonhuman primates received. The record on each shipment shall
include the number of primates received, species, country of origin,
date of importation, the number of primates in the shipment that die
within 90 days after receipt, and cause(s) of deaths. If any primates in
the shipment are sold or otherwise distributed within 90 days after
receipt, the record shall include the number of primates in each
shipment or sale, the dates of each shipment or sale, and the identity
of the recipients. In addition, the record shall contain copies of
documents that were presented to the importer to establish that the
recipient would use the primates solely for the permitted purposes. The
records shall be maintained in an organized manner in a central location
at or in close
[[Page 432]]
proximity to the importer's primate holding facility. The records shall
be maintained for a period of 3 years and shall be available for
inspection by the Director at any time.
(2) Importers shall report to the Director by telephone within 24
hours the occurrence of any illness in nonhuman primates that is
suspected of being yellow fever, monkeypox, or Marburg/Ebola disease.
(3) Importers also shall report to the Director by telephone within
24 hours the occurrence of illness in any member of their staff
suspected of having an infectious disease acquired from nonhuman
primates.
(f) Disease control measures. Upon receipt of evidence of exposure
of nonhuman primates to a communicable disease that may constitute a
threat to public health, the Director may provide for or require
examination, treatment, detention, isolation, seizure, or destruction of
exposed animals. Any measures required shall be at the owner's expense.
(g) Disposal of excluded nonhuman primates. Nonhuman primate(s)
excluded from the United States by provisions of this section shall, at
the owner's option and expense, be exported, destroyed, or given to a
scientific, educational, or exhibition facility under arrangements
approved by the Director. If the owner fails to dispose of the nonhuman
primate by one of the approved options or fails to select a method of
disposal within 7 days, the Director will select the method of disposal.
Pending disposal, the nonhuman primate(s) shall be detained at the
owner's expense in custody of the U.S. Customs Service at the U.S. port.
(h) Revocation of an importer's registration. (1) An importer's
registration may be revoked by the Director, upon notice to the importer
holding such registration, if the Director determines that the importer
has failed to comply with any applicable provisions of this section. The
notice shall contain a statement of the grounds upon which the
revocation is based.
(2) The importer may file an answer within 20 days after receipt of
the notice. Answers shall admit or deny specifically, and in detail,
each allegation in the notice. Allegations in the notice not denied by
answer shall be deemed admitted. Matters alleged as affirmative defenses
shall be separately stated and numbered. Failure of the importer to file
an answer within 20 days after receipt of the notice may be deemed an
admission of all allegations of fact recited in the notice.
(3) The importer shall be entitled to a hearing with respect to the
revocation upon filing a written request, either in the answer or in a
separate document, with the Director within 20 days after the effective
date of revocation. Failure to request a hearing shall be deemed a
waiver of hearing and as consent to the submission of the case to the
Director for decision based on the written record. The failure both to
file an answer and to request a hearing shall be deemed to constitute
consent to the making of a decision on the basis of available
information.
(4) As soon as practicable after the completion of any hearing
conducted pursuant to the provisions of this section, the Director shall
render a final decision. A copy of such decision shall be served on the
importer.
(5) An importer's registration which has been revoked may be
reinstated by the Director upon inspection, examination of records,
conference with the importer, and receipt of information and assurances
of compliance with the requirements of this section.
(i) Other permits. In addition to the requirements under this
section, permits to import certain species of nonhuman primates may also
be required under other Federal regulations (50 CFR parts 17 and 23)
protecting such species.
(Approved by the Office of Management and Budget under control number
0920-0134)
Sec. 71.54 Etiological agents, hosts, and vectors.
(a) A person may not import into the United States, nor distribute
after importation, any etiological agent or any arthropod or other
animal host or vector of human disease, or any exotic living arthropod
or other animal capable of being a host or vector of human disease
unless accompanied by a permit issued by the Director.
(b) Any import coming within the provisions of this section will not
be
[[Page 433]]
released from custody prior to receipt by the District Director of the
U.S. Customs Service of a permit issued by the Director.
Sec. 71.55 Dead bodies.
The remains of a person who died of a communicable disease listed in
Sec. 71.32(b) may not be brought into a U.S. port unless the body is
(a) properly embalmed and placed in a hermetically sealed casket, (b)
cremated, or (c) accompanied by a permit issued by the Director.
Sec. 71.56 African rodents and other animals that may carry the monkeypox
virus.
(a) What actions are prohibited? What animals are affected? (1)
Except as provided in paragraphs (a)(2) and (a)(3) of this section,
(i) You must not import or attempt to import any rodents, whether
dead or alive, that were obtained, directly or indirectly, from Africa,
or whose native habitat is Africa, any products derived from such
rodents, any other animal, whether dead or alive, whose importation the
Director has prohibited by order, or any products derived from such
animals; and
(ii) You must not prevent or attempt to prevent the Centers for
Disease Control and Prevention (CDC) from causing an animal to be
quarantined, re-exported, or destroyed under a written order.
(2) The prohibitions in paragraph (a)(1) of this section do not
apply if you have written permission from CDC to import a rodent that
was obtained, directly or indirectly, from Africa, or whose native
habitat is Africa, or an animal whose importation the Director has
prohibited by order.
(i) To obtain such written permission from CDC, you must send a
written request to Division of Global Migration and Quarantine, National
Center for Infectious Diseases, Centers for Disease Control and
Prevention, 1600 Clifton Rd., Atlanta, GA 30333. You may also fax your
request to the Division of Global Migration and Quarantine (using the
same address in the previous sentence) at 404-498-1633.
(ii) Your request must state the reasons why you need an exemption,
describe the animals involved, describe the number of animals involved,
describe how the animals will be transported (including carrying
containers or cages, precautions for handlers, types of vehicles used,
and other procedures to minimize exposure of animals and precautions to
prevent animals from escaping into the environment), describe any
holding facilities, quarantine procedures, and/or veterinarian
evaluation involved in the animals' movement, and explain why an
exemption will not result in the spread of monkeypox within the United
States. Your request must be limited to scientific, exhibition, or
educational purposes.
(iii) We will respond in writing to all requests, and we also may
impose conditions in granting an exemption. If we deny your request, you
may appeal that denial. Your appeal must be in writing and be submitted
to the CDC official whose office denied your request, and you must
submit the appeal within two business days after you receive the denial.
Your appeal must state the reasons for the appeal and show that there is
a genuine and substantial issue of fact in dispute. We will issue a
written response to the appeal, which shall constitute final agency
action.
(3) The prohibitions in paragraph (a) of this section do not apply
to products derived from rodents that were obtained, directly or
indirectly, from Africa, or whose native habitat is Africa, or products
derived from any other animal whose importation the Director has
prohibited by order if such products have been properly processed to
render them noninfectious so that they pose no risk of transmitting or
carrying the monkeypox virus. Such products include, but are not limited
to, fully taxidermied animals and completely finished trophies; and they
may be imported without written permission from CDC.
(b) What actions can CDC take? (1) To prevent the monkeypox virus
from spreading and becoming established in the United States, we may, in
addition to any other authorities under this part:
(i) Issue an order causing an animal to be placed in quarantine,
[[Page 434]]
(ii) Issue an order causing an animal to be re-exported,
(iii) Issue an order causing an animal to be destroyed, or
(iv) Take any other action necessary to prevent the spread of the
monkeypox virus.
(2) Any order causing an animal to be quarantined, re-exported, or
destroyed will be in writing.
(c) How do I appeal an order? If you received a written order to
quarantine or re-export an animal or to cause an animal to be destroyed,
you may appeal that order. Your appeal must be in writing and be
submitted to the CDC official whose office issued the order, and you
must submit the appeal within 2 business days after you receive the
order. Your appeal must state the reasons for the appeal and show that
there is a genuine and substantial issue of fact in dispute. We will
issue a written response to the appeal, which shall constitute final
agency action.
[68 FR 62369, Nov. 4, 2003]
PART 72 [RESERVED]
PART 73_SELECT AGENTS AND TOXINS--Table of Contents
Sec.
73.1 Definitions.
73.2 Purpose and scope.
73.3 HHS select agents and toxins.
73.4 Overlap select agents and toxins.
73.5 Exemptions for HHS select agents and toxins.
73.6 Exemptions for overlap select agents and toxins.
73.7 Registration and related security risk assessments.
73.8 Denial, revocation, or suspension of registration.
73.9 Responsible Official.
73.10 Restricting access to select agents and toxins; security risk
assessments.
73.11 Security.
73.12 Biosafety.
73.13 Restricted experiments.
73.14 Incident response.
73.15 Training.
73.16 Transfers.
73.17 Records.
73.18 Inspections.
73.19 Notification of theft, loss, or release.
73.20 Administrative review.
73.21 Civil money penalties.
Authority: 42 U.S.C. 262a; sections 201-204, 221 and 231 of Title II
of Public Law 107-188, 116 Stat. 637 (42 U.S.C. 262a).
Source: 70 FR 13316, Mar. 18, 2005, unless otherwise noted.
Sec. 73.1 Definitions.
For purposes of this part:
Administrator means the Administrator, Animal and Plant Health
Inspection Service, or any person authorized to act for the
Administrator.
Animal and Plant Health Inspection Service (APHIS) means the Animal
and Plant Health Inspection Service of the U.S. Department of
Agriculture.
Attorney General means the Attorney General of the United States or
any person authorized to act for the Attorney General.
Biological agent means any microorganism (including, but not limited
to, bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious
substance, or any naturally occurring, bioengineered, or synthesized
component of any such microorganism or infectious substance, capable of
causing death, disease, or other biological malfunction in a human, an
animal, a plant, or another living organism; deterioration of food,
water, equipment, supplies, or material of any kind; or deleterious
alteration of the environment.
CDC means Centers for Disease Control and Prevention of the
Department of Health and Human Services.
Diagnosis means the analysis of specimens for the purpose of
identifying or confirming the presence or characteristics of a select
agent or toxin provided that such analysis is directly related to
protecting the public health or safety, animal health or animal
products, or plant health or plant products.
Entity means any government agency (Federal, State, or local),
academic institution, corporation, company, partnership, society,
association, firm, sole proprietorship, or other legal entity.
HHS means the Department of Health and Human Services.
HHS Secretary means the Secretary of the Department of Health and
Human Services or his or her designee, unless otherwise specified.
HHS select agent and/or toxin means a biological agent or toxin
included in Sec. 73.3.
[[Page 435]]
Overlap select agent and/or toxin means a biological agent or toxin
listed in Sec. 73.4 and 9 CFR part 121.4.
Principal investigator means the one individual who is designated by
the entity to direct a project or program and who is responsible to the
entity for the scientific and technical direction of that project or
program.
Proficiency testing means the process of determining the competency
of an individual or laboratory to perform a specified test or procedure.
Responsible Official means the individual designated by an entity
with the authority and control to ensure compliance with the regulations
in this part.
Select agent and/or toxin means unless otherwise specified, all of
the biological agents or toxins listed in Sec. Sec. 73.3 and 73.4.
Specimen means samples of material from humans, animals, plants or
the environment or isolates or cultures from such samples for the
diagnosis, verification, or proficiency testing.
State means any of the several States of the United States, the
Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto
Rico, the District of Columbia, Guam, the Virgin Islands of the United
States, or any other territory or possession of the United States.
Toxin means the toxic material or product of plants, animals,
microorganisms (including, but not limited to, bacteria, viruses, fungi,
rickettsiae, or protozoa), or infectious substances, or a recombinant or
synthesized molecule, whatever their origin and method of production,
and includes any poisonous substance or biological product that may be
engineered as a result of biotechnology, produced by a living organism;
or any poisonous isomer or biological product, homolog, or derivative of
such a substance.
United States means all of the States.
USDA means the United States Department of Agriculture.
Verification means the demonstration of obtaining established
performance (e.g., accuracy, precision, and the analytical sensitivity
and specificity) specifications for any procedure used for diagnosis.
Sec. 73.2 Purpose and scope.
This part implements the provisions of the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002 setting forth the
requirements for possession, use, and transfer of select agents and
toxins. The biological agents and toxins listed in this part have the
potential to pose a severe threat to public health and safety, to animal
health, or to animal products. Overlap select agents and toxins are
subject to regulation by both CDC and APHIS.
Sec. 73.3 HHS select agents and toxins.
(a) Except for exclusions under paragraphs (d) and (e) of this
section, the HHS Secretary has determined that the biological agents and
toxins listed in this section have the potential to pose a severe threat
to public health and safety.
(b) HHS select agents and toxins:
Abrin
Cercopithecine herpesvirus 1 (Herpes B virus)
Coccidioides posadasii
Conotoxins
Crimean-Congo haemorrhagic fever virus
Diacetoxyscirpenol
Ebola viruses
Lassa fever virus
Marburg virus
Monkeypox virus
Reconstructed replication competent forms of the 1918 pandemic influenza
virus containing any portion of the coding regions of all eight gene
segments.
Ricin
Rickettsia prowazekii
Rickettsia rickettsii
Saxitoxin
Shiga-like ribosome inactivating proteins
South American Haemorrhagic Fever viruses (Junin, Machupo, Sabia,
Flexal, Guanarito)
Tetrodotoxin
Tick-borne encephalitis complex (flavi) viruses (Central European Tick-
borne encephalitis, Far Eastern Tick-borne encephalitis [Russian Spring
and Summer encephalitis, Kyasanur Forest disease, Omsk Hemorrhagic
Fever])
Variola major virus (Smallpox virus) and Variola minor virus (Alastrim)
Yersinia pestis
(c) Genetic Elements, Recombinant Nucleic Acids, and Recombinant
Organisms:
(1) Nucleic acids that can produce infectious forms of any of the
select
[[Page 436]]
agent viruses listed in paragraph (b) of this section.
(2) Recombinant nucleic acids that encode for the functional form(s)
of any of the toxins listed in paragraph (b) of this section if the
nucleic acids:
(i) Can be expressed in vivo or in vitro, or
(ii) Are in a vector or recombinant host genome and can be expressed
in vivo or in vitro.
(3) HHS select agents and toxins listed in paragraph (b) of this
section that have been genetically modified.
(d) HHS select agents or toxins that meet any of the following
criteria are excluded from the requirements of this part:
(1) Any HHS select agent or toxin that is in its naturally occurring
environment provided the select agent or toxin has not been
intentionally introduced, cultivated, collected, or otherwise extracted
from its natural source.
(2) Non-viable HHS select agents or nonfunctional HHS toxins.
(3) HHS toxins under the control of a principal investigator,
treating physician or veterinarian, or commercial manufacturer or
distributor, if the aggregate amount does not, at any time, exceed the
following amounts: 100 mg of Abrin; 100 mg of Conotoxins; 1,000 mg of
Diacetoxyscirpenol; 100 mg of Ricin; 100 mg of Saxitoxin; 100 mg of
Shiga-like ribosome inactivating proteins; or 100 mg of Tetrodotoxin.
(e) An attenuated strain of a HHS select agent or toxin may be
excluded from the requirements of this part based upon a determination
that the attenuated strain does not pose a severe threat to public
health and safety.
(1) To apply for an exclusion, an individual or entity must submit a
written request and supporting scientific information. A written
decision granting or denying the request will be issued. An exclusion
will be effective upon notification to the applicant. Exclusions will be
published periodically in the notice section of the Federal Register and
will be listed on the CDC Web site at http://www.cdc.gov/.
(2) If an excluded attenuated strain is subjected to any
manipulation that restores or enhances its virulence, the resulting
select agent or toxin will be subject to the requirements of this part.
(3) An individual or entity may make a written request to the HHS
Secretary for reconsideration of a decision denying an exclusion
application. The written request for reconsideration must state the
facts and reasoning upon which the individual or entity relies to show
the decision was incorrect. The HHS Secretary will grant or deny the
request for reconsideration as promptly as circumstances allow and will
state, in writing, the reasons for the decision.
(f) Any HHS select agent or toxin seized by a Federal law
enforcement agency will be excluded from the requirements of this part
during the period between seizure of the select agent or toxin and the
transfer or destruction of such agent or toxin provided that:
(1) As soon as practicable, the Federal law enforcement agency
transfers the seized select agent or toxin to an entity eligible to
receive such agent or toxin or destroys the agent or toxin by a
recognized sterilization or inactivation process,
(2) The Federal law enforcement agency safeguards and secures the
seized select agent or toxin against theft, loss, or release, and
reports any theft, loss, or release of such agent or toxin, and
(3) The Federal law enforcement agency reports the seizure of the
select agent or toxin to CDC or APHIS.
(i) The seizure of Ebola viruses, Lassa fever virus, Marburg virus,
South American Haemorrhagic Fever virus (Junin, Machupo, Sabia, Flexal,
Guanarito), Variola major virus (Smallpox virus), Variola minor
(Alastrim), or Yersinia pestis must be reported within 24 hours by
telephone, facsimile, or e-mail. This report must be followed by
submission of APHIS/CDC Form 4 within seven calendar days after seizure
of the select agent or toxin.
(ii) For all other HHS select agents or toxins, APHIS/CDC Form 4
must be submitted within seven calendar days after seizure of the agent
or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for three years.
(4) The Federal law enforcement agency reports the final disposition
of
[[Page 437]]
the select agent or toxin by submission of APHIS/CDC Form 4. A copy of
the completed form must be maintained for three years.
[70 FR 13316, Mar. 18, 2005, as amended at 70 FR 61049, Oct. 20, 2005]
Sec. 73.4 Overlap select agents and toxins.
(a) Except for exclusions under paragraphs (d) and (e) of this
section, the HHS Secretary has determined that the biological agents and
toxins listed in this section have the potential to pose a severe threat
to public health and safety, to animal health, or to animal products.
(b) Overlap select agents and toxins:
Bacillus anthracis
Botulinum neurotoxins
Botulinum neurotoxin producing species of Clostridium
Brucella abortus
Brucella melitensis
Brucella suis
Burkholderia mallei (formerly Pseudomonas mallei)
Burkholderia pseudomallei (formerly Pseudomonas pseudomallei)
Clostridium perfringens epsilon toxin
Coccidioides immitis
Coxiella burnetii
Eastern Equine Encephalitis virus
Francisella tularensis
Hendra virus
Nipah virus
Rift Valley fever virus
Shigatoxin
Staphylococcal enterotoxins
T-2 toxin
Venezuelan Equine Encephalitis virus
(c) Genetic Elements, Recombinant Nucleic Acids, and Recombinant
Organisms:
(1) Nucleic acids that can produce infectious forms of any of the
overlap select agent viruses listed in paragraph (b) of this section.
(2) Recombinant nucleic acids that encode for the functional form(s)
of any overlap toxins listed in paragraph (b) of this section if the
nucleic acids:
(i) Can be expressed in vivo or in vitro, or
(ii) Are in a vector or recombinant host genome and can be expressed
in vivo or in vitro.
(3) Overlap select agents and toxins listed in paragraph (b) of this
section that have been genetically modified.
(d) Overlap select agents or toxins that meet any of the following
criteria are excluded from the requirements of this part:
(1) Any overlap select agent or toxin that is in its naturally
occurring environment provided that the select agent or toxin has not
been intentionally introduced, cultivated, collected, or otherwise
extracted from its natural source.
(2) Non-viable overlap select agents or nonfunctional overlap
toxins.
(3) Overlap toxins under the control of a principal investigator,
treating physician or veterinarian, or commercial manufacturer or
distributor, if the aggregate amount does not, at any time, exceed the
following amounts: 0.5 mg of Botulinum neurotoxins; 100 mg of
Clostridium perfringens epsilon toxin; 100 mg of Shigatoxin; 5 mg of
Staphylococcal enterotoxins; or 1,000 mg of T-2 toxin.
(e) An attenuated strain of an overlap select agent or toxin may be
excluded from the requirements of this part based upon a determination
that the attenuated strain does not pose a severe threat to public
health and safety, to animal health, or to animal products.
(1) To apply for an exclusion, an individual or entity must submit a
written request and supporting scientific information. A written
decision granting or denying the request will be issued. An exclusion
will be effective upon notification to the applicant. Exclusions will be
published periodically in the notice section of the Federal Register and
will be listed on the CDC Web site at http://www.cdc.gov/.
(2) If an excluded attenuated strain is subjected to any
manipulation that restores or enhances its virulence, the resulting
overlap select agent or toxin will be subject to the requirements of
this part.
(3) An individual or entity may make a written request to the HHS
Secretary for reconsideration of a decision denying an exclusion
application. The written request for reconsideration must state the
facts and reasoning upon which the individual or entity relies to show
the decision was incorrect. The HHS Secretary will grant or deny the
request for reconsideration as promptly as circumstances allow and will
[[Page 438]]
state, in writing, the reasons for the decision.
(f) Any overlap select agent or toxin seized by a Federal law
enforcement agency will be excluded from the requirements of this part
during the period between seizure of the select agent or toxin and the
transfer or destruction of such agent or toxin provided that:
(1) As soon as practicable, the Federal law enforcement agency
transfers the seized select agent or toxin to an entity eligible to
receive such agent or toxin or destroys the agent or toxin by a
recognized sterilization or inactivation process,
(2) The Federal law enforcement agency safeguards and secures the
seized select agent or toxin against theft, loss, or release, and
reports any theft, loss, or release of such agent or toxin, and
(3) The Federal law enforcement agency reports the seizure of the
overlap select agent or toxin to CDC or APHIS.
(i) The seizure of Bacillus anthracis, Botulinum neurotoxins,
Brucella melitensis, Francisella tularensis, Hendra virus, Nipah virus,
Rift Valley fever virus, or Venezuelan equine encephalitis virus must be
reported within 24 hours by telephone, facsimile, or e-mail. This report
must be followed by submission of APHIS/CDC Form 4 within seven calendar
days after seizure of the select agent or toxin.
(ii) For all other overlap select agents or toxins, APHIS/CDC Form 4
must be submitted within seven calendar days after seizure of the select
agent or toxin.
(iii) A copy of APHIS/CDC Form 4 must be maintained for three years.
(4) The Federal law enforcement agency reports the final disposition
of the overlap select agent or toxin by the submission of APHIS/CDC Form
4. A copy of the completed form must be maintained for three years.
Sec. 73.5 Exemptions for HHS select agents and toxins.
(a) Clinical or diagnostic laboratories and other entities that
possess, use, or transfer a HHS select agent or toxin that is contained
in a specimen presented for diagnosis or verification will be exempt
from the requirements of this part for such agent or toxin contained in
the specimen, provided that:
(1) Unless directed otherwise by the HHS Secretary, within seven
calendar days after identification, the select agent or toxin is
transferred in accordance with Sec. 73.16 or destroyed on-site by a
recognized sterilization or inactivation process,
(2) The select agent or toxin is secured against theft, loss, or
release during the period between identification of the select agent or
toxin and transfer or destruction of such agent or toxin, and any theft,
loss, or release of such agent or toxin is reported, and
(3) The identification of the select agent or toxin is reported to
CDC or APHIS and to other appropriate authorities when required by
Federal, State, or local law.
(i) The identification of any of the following HHS select agents or
toxins must be immediately reported by telephone, facsimile, or e-mail:
Ebola viruses, Lassa fever virus, Marburg virus, South American
Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito),
Variola major virus (Smallpox virus), Variola minor (Alastrim), or
Yersinia pestis. This report must be followed by submission of APHIS/CDC
Form 4 within seven calendar days after identification.
(ii) For all other HHS select agents or toxins, APHIS/CDC Form 4
must be submitted within seven calendar days after identification.
(iii) Less stringent reporting may be required based on
extraordinary circumstances, such as a widespread outbreak.
(iv) A copy of APHIS/CDC Form 4 must be maintained for three years.
(b) Clinical or diagnostic laboratories and other entities that
possess, use, or transfer a HHS select agent or toxin that is contained
in a specimen presented for proficiency testing will be exempt from the
requirements of this part for such agent or toxin contained in the
specimen, provided that:
(1) Unless directed otherwise by the HHS Secretary, within 90
calendar days of receipt, the select agent or toxin is transferred in
accordance with Sec. 73.16 or destroyed on-site by a recognized
sterilization or inactivation process,
[[Page 439]]
(2) The select agent or toxin is secured against theft, loss, or
release during the period between identification of the select agent or
toxin and transfer or destruction of such agent or toxin, and the theft,
loss, or release of such agent or toxin is reported, and
(3) The identification of the select agent or toxin, and its
derivative, is reported to CDC or APHIS and to other appropriate
authorities when required by Federal, State, or local law. To report the
identification of a select agent or toxin, APHIS/CDC Form 4 must be
submitted within 90 calendar days of receipt of the select agent or
toxin. A copy of the completed form must be maintained for three years.
(c) Unless the HHS Secretary issues an order making specific
provisions of this part applicable to protect public health and safety,
products that are, bear, or contain listed select agents or toxins that
are cleared, approved, licensed, or registered under any of the
following laws, are exempt from the provisions of this part insofar as
their use meets the requirements of such laws:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.),
(2) Section 351 of the Public Health Service Act pertaining to
biological products (42 U.S.C. 262),
(3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C.
151-159), or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136 et seq.).
(d) The HHS Secretary may exempt from the requirements of this part
an investigational product that is, bears, or contains a select agent or
toxin, when such product is being used in an investigation authorized
under any Federal Act and additional regulation under this part is not
necessary to protect public health and safety.
(1) To apply for an exemption, an individual or entity must submit a
completed APHIS/CDC Form 5.
(2) The HHS Secretary shall make a determination regarding the
application within 14 calendar days after receipt, provided the
application meets all of the requirements of this section and the
application establishes that the investigation has been authorized under
the cited Act. A written decision granting or denying the request will
be issued.
(3) The applicant must notify CDC or APHIS when an authorization for
an investigation no longer exists. This exemption automatically
terminates when such authorization is no longer in effect.
(e) The HHS Secretary may temporarily exempt an individual or entity
from the requirements of this part based on a determination that the
exemption is necessary to provide for the timely participation of the
individual or entity in response to a domestic or foreign public health
emergency. With respect to the emergency involved, the exemption may not
exceed 30 calendar days, except that one extension of an additional 30
calendar days may be granted. To apply for an exemption or an extension
of an exemption, an individual or entity must submit a completed APHIS/
CDC Form 5 establishing the need to provide for the timely participation
of the individual or entity in a response to a domestic or foreign
public health emergency. A written decision granting or denying the
request will be issued.
Sec. 73.6 Exemptions for overlap select agents and toxins.
(a) Clinical or diagnostic laboratories and other entities that
possess, use, or transfer an overlap select agent or toxin that is
contained in a specimen presented for diagnosis or verification will be
exempt from the requirements of this part for such agent or toxin
contained in the specimen, provided that:
(1) Unless directed otherwise by the HHS Secretary or Administrator,
within seven calendar days after identification, the select agent or
toxin is transferred in accordance with Sec. 73.16 or 9 CFR part 121.16
or destroyed on-site by a recognized sterilization or inactivation
process,
(2) The select agent or toxin is secured against theft, loss, or
release during the period between identification of the select agent or
toxin and transfer or destruction of such agent or toxin, and any theft,
loss, or release of such agent or toxin is reported, and
(3) The identification of the select agent or toxin is reported to
CDC or
[[Page 440]]
APHIS and to other appropriate authorities when required by Federal,
State, or local law.
(i) The identification of any of the following overlap select agents
or toxins must be immediately reported by telephone, facsimile, or e-
mail: Bacillus anthracis, Botulinum neurotoxins, Brucella melitensis,
Francisella tularensis, Hendra virus, Nipah virus, Rift Valley fever
virus, or Venezuelan equine encephalitis virus. This report must be
followed by submission of APHIS/CDC Form 4 within seven calendar days
after identification.
(ii) For all other overlap select agents or toxins, APHIS/CDC Form 4
must be submitted within seven calendar days after identification.
(iii) Less stringent reporting may be required based on
extraordinary circumstances, such as a widespread outbreak.
(iv) A copy of APHIS/CDC Form 4 must be maintained for three years.
(b) Clinical or diagnostic laboratories and other entities that
possess, use, or transfer an overlap select agent or toxin that is
contained in a specimen presented for proficiency testing will be exempt
from the requirements of this part for such agent or toxin contained in
the specimen, provided that:
(1) Unless directed otherwise by the HHS Secretary or Administrator,
within 90 calendar days of receipt, the select agent or toxin is
transferred in accordance with Sec. 73.16 or 9 CFR part 121.16 or
destroyed on-site by a recognized sterilization or inactivation process,
(2) The select agent or toxin is secured against theft, loss, or
release during the period between identification of the select agent or
toxin and transfer or destruction of such agent or toxin, and the theft,
loss, or release of such agent or toxin is reported, and
(3) The identification of the select agent or toxin, and its
derivative, is reported to CDC or APHIS and to other appropriate
authorities when required by Federal, State, or local law. To report the
identification of an overlap select agent or toxin, APHIS/CDC Form 4
must be submitted within 90 calendar days of receipt of the select agent
or toxin. A copy of the completed form must be maintained for three
years.
(c) Unless the HHS Secretary issues an order making specific
provisions of this part applicable to protect public health and safety,
products that are, bear, or contain listed select agents or toxins that
are cleared, approved, licensed, or registered under any of the
following laws, are exempt from the provisions of this part insofar as
their use meets the requirements of such laws:
(1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et
seq.),
(2) Section 351 of the Public Health Service Act pertaining to
biological products (42 U.S.C. 262),
(3) The Act commonly known as the Virus-Serum-Toxin Act (21 U.S.C.
151-159), or
(4) The Federal Insecticide, Fungicide, and Rodenticide Act (7
U.S.C. 136 et seq.).
(d) The HHS Secretary, after consultation with Administrator, may
exempt from the requirements of this part an investigational product
that is, bears, or contains an overlap select agent or toxin, may be
exempted when such product is being used in an investigation authorized
under any Federal Act and additional regulation under this part is not
necessary to protect public health and safety.
(1) To apply for an exemption, an individual or entity must submit a
completed APHIS/CDC Form 5.
(2) The HHS Secretary shall make a determination regarding the
application within 14 calendar days after receipt, provided the
application meets all of the requirements of this section and the
application establishes that the investigation has been authorized under
the cited Act. A written decision granting or denying the request will
be issued.
(3) The applicant must notify CDC or APHIS when an authorization for
an investigation no longer exists. This exemption automatically
terminates when such authorization is no longer in effect.
(e) The HHS Secretary may temporarily exempt an individual or entity
from the requirements of this part based on a determination that the
exemption is necessary to provide for the timely participation of the
individual or entity in response to a domestic or
[[Page 441]]
foreign public health emergency. With respect to the emergency involved,
the exemption may not exceed 30 calendar days, except that one extension
of an additional 30 calendar days may be granted. To apply for an
exemption or an extension of an exemption, an individual or entity must
submit a completed APHIS/CDC Form 5 establishing the need to provide for
the timely participation of the individual or entity in a response to a
domestic or foreign public health emergency. A written decision granting
or denying the request will be issued.
(f) Upon request of the Administrator, the HHS Secretary may exempt
an individual or entity from the requirements of this part, for 30
calendar days if the Administrator has granted the exemption for
agricultural emergency. The HHS Secretary may extend the exemption once
for an additional 30 calendar days.
Sec. 73.7 Registration and related security risk assessments.
(a) Unless exempted under Sec. 73.5, an individual or entity shall
not possess, use, or transfer any HHS select agent or toxin without a
certificate of registration issued by the HHS Secretary. Unless exempted
under Sec. 73.6 or 9 CFR part 121.6, an individual or entity shall not
possess, use, or transfer overlap select agents or toxins, without a
certificate of registration issued by the HHS Secretary and
Administrator.
(b) As a condition of registration, each entity must designate an
individual to be its Responsible Official. While most registrants are
likely to be entities, in the event that an individual applies for and
is granted a certificate of registration, the individual will be
considered the Responsible Official.
(c)(1) As a condition of registration, the following must be
approved by the HHS Secretary or Administrator based on a security risk
assessment by the Attorney General:
(i) The individual or entity,
(ii) The Responsible Official, and
(iii) Unless otherwise exempted under this section, any individual
who owns or controls the entity.
(2) Federal, State, or local governmental agencies, including public
accredited academic institutions, are exempt from the security risk
assessments for the entity and the individual who owns or controls such
entity.
(3) An individual will be deemed to own or control an entity under
the following conditions: \1\
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\1\ These conditions may apply to more than one individual.
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(i) For a private institution of higher education, an individual
will be deemed to own or control the entity if the individual is in a
managerial or executive capacity with regard to the entity's select
agents or toxins or with regard to the individuals with access to the
select agents or toxins possessed, used, or transferred by the entity.
(ii) For entities other than institutions of higher education, an
individual will be deemed to own or control the entity if the
individual:
(A) Owns 50 percent or more of the entity, or is a holder or owner
of 50 percent or more of its voting stock, or
(B) Is in a managerial or executive capacity with regard to the
entity's select agents or toxins or with regard to the individuals with
access to the select agents or toxins possessed, used, or transferred by
the entity.
(4) An entity will be considered to be an institution of higher
education if it is an institution of higher education as defined in
section 101(a) of the Higher Education Act of 1965 (20 U.S.C. 1001(a)),
or is an organization described in 501(c)(3) of the Internal Revenue
Code of 1986, as amended (26 U.S.C. 501(c)(3)).
(5) To obtain a security risk assessment, an individual or entity
must submit the information necessary to conduct a security risk
assessment to the Attorney General.
(d) To apply for a certificate of registration that covers only HHS
select agents or toxins, an individual or entity must submit the
information requested in the registration application package (APHIS/CDC
Form 1) to CDC. To apply for a certificate of registration that does not
cover only HHS select agents or toxins (i.e., covers at least one
overlap select agent and/or toxin, or covers any combination of HHS
select agents and/or toxins and USDA select agents and/or toxins), an
[[Page 442]]
individual or entity must submit the information requested in the
registration application package (APHIS/CDC Form 1) to CDC or APHIS, but
not both.
(e) Prior to the issuance of a certificate of registration, the
Responsible Official must promptly provide notification of any changes
to the application for registration by submitting the relevant page(s)
of the registration application.
(f) The issuance of a certificate of registration may be contingent
upon inspection or submission of additional information, such as the
security plan, biosafety plan, incident response plan, or any other
documents required to be prepared under this part.
(g) A certificate of registration will be valid for one physical
location (a room, a building, or a group of buildings) where the
Responsible Official will be able to perform the responsibilities
required in this part, for specific select agents or toxins, and for
specific activities.
(h) A certificate of registration may be amended to reflect changes
in circumstances (e.g., replacement of the Responsible Official or other
personnel changes, changes in ownership or control of the entity,
changes in the activities involving any select agents or toxins, or the
addition or removal of select agents or toxins).
(1) Prior to any change, the Responsible Official must apply for an
amendment to a certificate of registration by submitting the relevant
page(s) of the registration application.
(2) The Responsible Official will be notified in writing if an
application to amend a certificate of registration has been approved.
Approval of the amendment may be contingent upon an inspection or
submission of additional information, such as the security plan,
biosafety plan, incident response plan, or any other documents required
to be prepared under this part.
(3) No change may be made without such approval.
(i) An entity must immediately notify CDC or APHIS if it loses the
services of its Responsible Official. In the event that an entity loses
the services of its Responsible Official, an entity may continue to
possess or use select agents or toxins only if it appoints as the
Responsible Official another individual who has been approved by the HHS
Secretary or Administrator following a security risk assessment by the
Attorney General and who meets the requirements of this part.
(j) A certificate of registration will be terminated upon the
written request of the entity if the entity no longer possesses or uses
any select agents or toxins and no longer wishes to be registered.
(k) A certificate of registration will be valid for a maximum of
three years.
Sec. 73.8 Denial, revocation, or suspension of registration.
(a) An application may be denied or a certificate of registration
revoked or suspended if:
(1) The individual or entity, the Responsible Official, or an
individual who owns or controls the entity is within any of the
categories described in 18 U.S.C. 175b,
(2) The individual or entity, the Responsible Official, or an
individual who owns or controls the entity as reasonably suspected by
any Federal law enforcement or intelligence agency of:
(i) Committing a crime specified in 18 U.S.C. 2332b(g)(5),
(ii) Knowing involvement with an organization that engages in
domestic or international terrorism (as defined in 18 U.S.C. 2331) or
with any other organization that engages in intentional crimes of
violence, or
(iii) Being an agent of a foreign power (as defined in 50 U.S.C.
1801).
(3) The individual or entity does not meet the requirements of this
part, or
(4) It is determined that such action is necessary to protect public
health and safety.
(b) Upon revocation or suspension of a certificate of registration,
the individual or entity must:
(1) Immediately stop all use of each select agent or toxin covered
by the revocation or suspension order,
(2) Immediately safeguard and secure each select agent or toxin
covered by the revocation or suspension order from theft, loss, or
release, and
(3) Comply with all disposition instructions issued by the HHS
Secretary
[[Page 443]]
for the select agent or toxin covered by the revocation or suspension.
(c) Denial of an application for registration and revocation of
registration may be appealed under Sec. 73.20. However, any denial of
an application for registration or revocation of a certificate of
registration will remain in effect until a final agency decision has
been rendered.
Sec. 73.9 Responsible Official.
(a) An individual or entity required to register under this part
must designate an individual to be the Responsible Official. The
Responsible Official must:
(1) Be approved by the HHS Secretary or Administrator following a
security risk assessment by the Attorney General,
(2) Be familiar with the requirements of this part,
(3) Have authority and responsibility to act on behalf of the
entity,
(4) Ensure compliance with the requirements of this part, and
(5) Ensure that annual inspections are conducted for each laboratory
where select agents or toxins are stored or used in order to determine
compliance with the requirements of this part. The results of each
inspection must be documented, and any deficiencies identified during an
inspection must be corrected.
(b) An entity may designate one or more individuals to be an
alternate Responsible Official, who may act for the Responsible Official
in his/her absence. These individuals must have the authority and
control to ensure compliance with the regulations when acting as the
Responsible Official.
(c) The Responsible Official must report the identification and
final disposition of any select agent or toxin contained in a specimen
presented for diagnosis or verification.
(1) The identification of any of the following select agents or
toxins must be immediately reported by telephone, facsimile, or e-mail:
Bacillus anthracis, Botulinum neurotoxins, Brucella melitensis,
Francisella tularensis, Ebola viruses, Hendra virus, Marburg virus,
Lassa fever virus, Nipah virus, Rift Valley fever virus, South American
Haemorrhagic Fever viruses (Junin, Machupo, Sabia, Flexal, Guanarito),
Variola major virus (Smallpox virus), Variola minor (Alastrim),
Venezuelan equine encephalitis virus, or Yersinia pestis. The final
disposition of the agent or toxin must be reported by submission of
APHIS/CDC Form 4 within seven calendar days after identification. A copy
of the completed form must be maintained for three years.
(2) To report the identification and final disposition of any other
select agent or toxin, APHIS/CDC Form 4 must be submitted within seven
calendar days after identification. A copy of the completed form must be
maintained for three years.
(3) Less stringent reporting may be required based on extraordinary
circumstances, such as a widespread outbreak.
(d) The Responsible Official must report the identification and
final disposition of any select agent or toxin contained in a specimen
presented for proficiency testing. To report the identification and
final disposition of a select agent or toxin, APHIS/CDC Form 4 must be
submitted within 90 calendar days of receipt of the agent or toxin. A
copy of the completed form must be maintained for three years.
Sec. 73.10 Restricting access to select agents and toxins; security risk
assessments.
(a) An individual or entity required to register under this part may
not provide an individual access to a select agent or toxin, and an
individual may not access a select agent or toxin, unless the individual
is approved by the HHS Secretary or Administrator, following a security
risk assessment by the Attorney General.
(b) An individual will be deemed to have access at any point in time
if the individual has possession of a select agent or toxin (e.g.,
ability to carry, use, or manipulate) or the ability to gain possession
of a select agent or toxin.
(c) Each individual with access to select agents or toxins must have
the appropriate education, training, and/or experience to handle or use
such agents or toxins.
[[Page 444]]
(d) To apply for access approval, each individual must submit the
information necessary to conduct a security risk assessment to the
Attorney General.
(e) An individual's security risk assessment may be expedited upon
written request by the Responsible Official and a showing of good cause
(e.g., public health or agricultural emergencies, national security, or
a short term visit by a prominent researcher). A written decision
granting or denying the request will be issued.
(f) An individual's access approval will be denied or revoked if the
individual is within any of the categories described in 18 U.S.C. 175b,
(g) An individual's access approval may be denied, limited, or
revoked if:
(1) The individual is reasonably suspected by any Federal law
enforcement or intelligence agency of committing a crime specified in 18
U.S.C. 2332b(g)(5), knowing involvement with an organization that
engages in domestic or international terrorism (as defined in 18 U.S.C.
2331) or with any other organization that engages in intentional crimes
of violence, or being an agent of a foreign power (as defined in 50
U.S.C. 1801), or
(2) It is determined such action is necessary to protect public
health and safety.
(h) An individual may appeal the HHS Secretary's decision to deny,
limit, or revoke access approval under Sec. 73.20.
(i) Access approval is valid for a maximum of five years.
(j) The Responsible Official must immediately notify CDC or APHIS
when an individual's access to select agents or toxins is terminated by
the entity and the reasons therefore.
Sec. 73.11 Security.
(a) An individual or entity required to register under this part
must develop and implement a written security plan. The security plan
must be sufficient to safeguard the select agent or toxin against
unauthorized access, theft, loss, or release.
(b) The security plan must be designed according to a site-specific
risk assessment and must provide graded protection in accordance with
the risk of the select agent or toxin, given its intended use. The
security plan must be submitted upon request.
(c) The security plan must:
(1) Describe procedures for physical security, inventory control,
and information systems control,
(2) Contain provisions for the control of access to select agents
and toxins,
(3) Contain provisions for routine cleaning, maintenance, and
repairs,
(4) Establish procedures for removing unauthorized or suspicious
persons,
(5) Describe procedures for addressing loss or compromise of keys,
passwords, combinations, etc. and protocols for changing access numbers
or locks following staff changes,
(6) Contain procedures for reporting unauthorized or suspicious
persons or activities, loss or theft of select agents or toxins, release
of select agents or toxins, or alteration of inventory records, and
(7) Contain provisions for ensuring that all individuals with access
approval from the HHS Secretary or Administrator understand and comply
with the security procedures.
(d) An individual or entity must adhere to the following security
requirements or implement measures to achieve an equivalent or greater
level of security:
(1) Allow access only to individuals with access approval from the
HHS Secretary or Administrator,
(2) Allow individuals not approved for access from the HHS Secretary
or Administrator to conduct routine cleaning, maintenance, repairs, or
other activities not related to select agents or toxins only when
continuously escorted by an approved individual,
(3) Provide for the control of select agents and toxins by requiring
freezers, refrigerators, cabinets, and other containers where select
agents or toxins are stored to be secured against unauthorized access
(e.g., card access system, lock boxes),
(4) Inspect all suspicious packages before they are brought into or
removed from the area where select agents or toxins are used or stored,
(5) Establish a protocol for intra-entity transfers under the
supervision of an individual with access approval
[[Page 445]]
from the HHS Secretary or Administrator, including chain-of-custody
documents and provisions for safeguarding against theft, loss, or
release,
(6) Require that individuals with access approval from the HHS
Secretary or Administrator refrain from sharing with any other person
their unique means of accessing a select agent or toxin (e.g., keycards
or passwords),
(7) Require that individuals with access approval from the HHS
Secretary or Administrator immediately report any of the following to
the Responsible Official:
(i) Any loss or compromise of keys, passwords, combination, etc.,
(ii) Any suspicious persons or activities,
(iii) Any loss or theft of select agents or toxins,
(iv) Any release of a select agent or toxin, and
(v) Any sign that inventory or use records for select agents or
toxins have been altered or otherwise compromised, and
(8) Separate areas where select agents and toxins are stored or used
from the public areas of the building.
(e) In developing a security plan, an entity or individual should
consider, the document entitled ``Laboratory Security and Emergency
Response Guidance for Laboratories Working with Select Agents. Morbidity
and Mortality Weekly Report December 6, 2002; 51:RR-19:1-6.'' The
document is available on the Internet at: http://www.cdc.gov/mmwr.
(f) The plan must be reviewed annually and revised as necessary.
Drills or exercises must be conducted at least annually to test and
evaluate the effectiveness of the plan. The plan must be reviewed and
revised, as necessary, after any drill or exercise and after any
incident.
Sec. 73.12 Biosafety.
(a) An individual or entity required to register under this part
must develop and implement a written biosafety plan that is commensurate
with the risk of the agent or toxin, given its intended use. The
biosafety plan must contain sufficient information and documentation to
describe the biosafety and containment procedures.
(b) The biosafety and containment procedures must be sufficient to
contain the select agent or toxin (e.g., physical structure and features
of the entity, and operational and procedural safeguards).
(c) In developing a biosafety plan, an individual or entity should
consider:
(1) The CDC/NIH publication, ``Biosafety in Microbiological and
Biomedical Laboratories'', including all appendices. Copies may be
obtained from the Superintendent of Documents, U.S. Government Printing
Office, Post Office Box 371954, Pittsburgh, Pennsylvania, 75250-7954 or
from the CDC Web site at http://www.cdc.gov/. Copies may be inspected at
the Centers for Disease Control and Prevention, 1600 Clifton Road, Mail
Stop E-79, Atlanta, Georgia.
(2) The Occupational Safety and Health Administration (OSHA)
regulations in 29 CFR parts 1910.1200 and 1910.1450.
(3) The ``NIH Guidelines for Research Involving Recombinant DNA
Molecules,'' (NIH Guidelines). Copies may be obtained from the Centers
for Disease Control and Prevention, 1600 Clifton Road, Mail Stop E-79,
Atlanta, Georgia, 30333 or from the CDC Web site at http://www.cdc.gov/.
Copies may be inspected at the Centers for Disease Control and
Prevention, 1600 Clifton Road, Mail Stop E-79, Atlanta, Georgia.
(d) The plan must be reviewed annually and revised as necessary.
Drills or exercises must be conducted at least annually to test and
evaluate the effectiveness of the plan. The plan must be reviewed and
revised, as necessary, after any drill or exercise and after any
incident.
Sec. 73.13 Restricted experiments.
(a) An individual or entity may not conduct a restricted experiment
with a HHS select agent or toxin unless approved by and conducted in
accordance with any conditions prescribed by the HHS Secretary. In
addition, an individual or entity may not conduct a restricted
experiment with an overlap select agent or toxin unless approved by and
conducted in accordance with any
[[Page 446]]
conditions prescribed by the HHS Secretary, after consultation with
Administrator.
(b) Restricted experiments:
(1) Experiments utilizing recombinant DNA that involve the
deliberate transfer of a drug resistance trait to select agents that are
not known to acquire the trait naturally, if such acquisition could
compromise the use of the drug to control disease agents in humans,
veterinary medicine, or agriculture.
(2) Experiments involving the deliberate formation of recombinant
DNA containing genes for the biosynthesis of select toxins lethal for
vertebrates at an LD50 < 100 ng/kg body weight.
(c) The HHS Secretary may revoke approval to conduct any of the
experiments in paragraph (b) of this section, or revoke or suspend a
certificate of registration, if the individual or entity fails to comply
with the requirements of this part.
(d) To apply for approval to conduct any of the experiments in
paragraph (a) of this section, an individual or entity must submit a
written request and supporting scientific information. A written
decision granting or denying the request will be issued.
Sec. 73.14 Incident response.
(a) An individual or entity required to register under this part
must develop and implement a written incident response plan.\2\ The
incident response plan must be coordinated with any entity-wide plans,
kept in the workplace, and available to employees for review.
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\2\ Nothing in this section is meant to supersede or preempt
incident response requirements imposed by other statutes or regulations.
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(b) The incident response plan must fully describe the entity's
response procedures for the theft, loss, or release of a select agent or
toxin, inventory discrepancies, security breaches (including information
systems), severe weather and other natural disasters, workplace
violence, bomb threats, suspicious packages, and emergencies such as
fire, gas leak, explosion, power outage, etc. The response procedures
must account for hazards associated with the select agent and toxin and
appropriate actions to contain such select agent or toxin.
(c) The incident response plan must also contain the following
information:
(1) The name and contact information (e.g., home and work) for the
individual or entity (e.g., responsible official, alternate responsible
official(s), biosafety officer, etc.),
(2) The name and contact information for the building owner and/or
manager, where applicable,
(3) The name and contact information for tenant offices, where
applicable,
(4) The name and contact information for the physical security
official for the building, where applicable,
(5) Personnel roles and lines of authority and communication,
(6) Planning and coordination with local emergency responders,
(7) Procedures to be followed by employees performing rescue or
medical duties,
(8) Emergency medical treatment and first aid,
(9) A list of personal protective and emergency equipment, and their
locations,
(10) Site security and control,
(11) Procedures for emergency evacuation, including type of
evacuation, exit route assignments, safe distances, and places of
refuge, and
(12) Decontamination procedures.
(d) The plan must be reviewed annually and revised as necessary.
Drills or exercises must be conducted at least annually to test and
evaluate the effectiveness of the plan. The plan must be reviewed and
revised, as necessary, after any drill or exercise and after any
incident.
Sec. 73.15 Training.
(a) An individual or entity required to register under this part
must provide information and training on biosafety and security to each
individual with access approval from the HHS Secretary or Administrator
before he/
[[Page 447]]
she has such access.\3\ In addition, an individual or entity must
provide information and training on biosafety and security to each
individual not approved for access from the HHS Secretary or
Administrator before he/she works in or visits areas where select agents
or toxins are handled or stored (e.g., laboratories, growth chambers,
animal rooms, greenhouses, storage areas, etc.). The training must
address the particular needs of the individual, the work they will do,
and the risks posed by the select agents or toxins.
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\3\ The training need not duplicate training provided under the OSHA
Bloodborne Pathogen Standard set forth at 29 CFR 1910.1030.
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(b) Refresher training must be provided annually.
(c) A record of the training provided to each individual must be
maintained. The record must include the name of the individual, the date
of the training, a description of the training provided, and the means
used to verify that the employee understood the training.
Sec. 73.16 Transfers.
(a) Except as provided in paragraphs (c) and (d) of this section, a
select agent or toxin may only be transferred to individuals or entities
registered to possess, use, or transfer that agent or toxin. A select
agent or toxin may only be transferred under the conditions of this
section and must be authorized by CDC or APHIS prior to the transfer.\4\
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\4\ This section does not cover transfers within an entity when the
sender and the recipient are covered by the same certificate of
registration.
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(b) A transfer may be authorized if:
(1) The sender:
(i) Has at the time of transfer a certificate of registration that
covers the particular select agent or toxin to be transferred and meets
all requirements in this part,
(ii) Meets the exemption requirements for the particular select
agent or toxin to be transferred, or
(iii) Is transferring the select agent or toxin from outside the
United States and meets all import requirements.
(2) At the time of transfer, the recipient has a certificate of
registration that includes the particular select agent or toxin to be
transferred and meets all of the requirements of this part.
(c) A select agent or toxin that is contained in a specimen for
proficiency testing may be transferred without prior authorization from
CDC or APHIS provided that, at least seven calendar days prior to the
transfer, the sender reports to CDC or APHIS the select agent or toxin
to be transferred and the name and address of the recipient.
(d) On a case-by-case basis, the HHS Secretary may authorize a
transfer of a select agent or toxin, not otherwise eligible for transfer
under this part under conditions prescribed by the HHS Secretary.
(e) To obtain authorization for transfer, APHIS/CDC Form 2 must be
submitted.
(f) The recipient must submit a completed APHIS/CDC Form 2 within
two business days of receipt of a select agent or toxin.
(g) The recipient must immediately notify CDC or APHIS if the select
agent or toxin has not been received within 48 hours after the expected
delivery time, or if the package containing select agents or toxins has
been damaged to the extent that a release of the select agent or toxin
may have occurred.
(h) An authorization for a transfer shall be valid only for 30
calendar days after issuance, except that such an authorization becomes
immediately null and void if any facts supporting the authorization
change (e.g., change in the certificate of registration for the sender
or recipient, change in the application for transfer).
(i) The sender must comply with all applicable laws concerning
packaging and shipping.
Sec. 73.17 Records.
(a) An individual or entity required to register under this part
must maintain complete records relating to the activities covered by
this part. Such records must include:
(1) Accurate, current inventory for each select agent (including
viral genetic elements, recombinant nucleic acids, and recombinant
organisms) held in long-term storage (placement in a system designed to
ensure viability for
[[Page 448]]
future use, such as in a freezer or lyophilized materials), including:
(i) The name and characteristics (e.g., strain designation, GenBank
Accession number, etc.),
(ii) The quantity acquired from another individual or entity (e.g.,
containers, vials, tubes, etc.), date of acquisition, and the source,
(iii) Where stored (e.g., building, room, and freezer),
(iv) When moved from storage and by whom and when returned to
storage and by whom,
(v) The select agent used and purpose of use,
(vi) Records created under Sec. 73.16 and 9 CFR 121.16 (Transfers),
(vii) For intra-entity transfers (sender and the recipient are
covered by the same certificate of registration), the select agent, the
quantity transferred, the date of transfer, the sender, and the
recipient, and
(viii) Records created under Sec. 73.19 and 9 CFR part 121.19
(Notification of theft, loss, or release),
(2) Accurate, current inventory for each toxin held, including:
(i) The name and characteristics,
(ii) The quantity acquired from another individual or entity (e.g.,
containers, vials, tubes, etc.), date of acquisition, and the source,
(iii) The initial and current quantity amount (e.g., milligrams,
milliliters, grams, etc.),
(iv) The toxin used and purpose of use, quantity, date(s) of the use
and by whom,
(v) Where stored (e.g., building, room, and freezer),
(vi) When moved from storage and by whom and when returned to
storage and by whom including quantity amount,
(vii) Records created under Sec. 73.16 and 9 CFR part 121.16
(Transfers),
(viii) For intra-entity transfers (sender and the recipient are
covered by the same certificate of registration), the toxin, the
quantity transferred, the date of transfer, the sender, and the
recipient,
(ix) Records created under Sec. 73.19 and 9 CFR part 121.19
(Notification of theft, loss, or release), and
(x) If destroyed, the quantity of toxin destroyed, the date of such
action, and by whom,
(3) A current list of all individuals that have been granted access
approval from the HHS Secretary or Administrator,
(4) Information about all entries into areas containing select
agents or toxins, including the name of the individual, name of the
escort (if applicable), and date and time of entry,
(5) Accurate, current records created under Sec. 73.9 and 9 CFR
part 121.9 (Responsible Official), Sec. 73.11 and 9 CFR part 121.11
(Security), Sec. 73.12 and 9 CFR part 121.12 (Biosafety), Sec. 73.14
and 9 CFR part 121. 14 (Incident response), and Sec. 73.15 and 9 CFR
part 121.15 (Training), and
(6) A written explanation of any discrepancies.
(b) The individual or entity must implement a system to ensure that
all records and data bases created under this part are accurate, have
controlled access, and that their authenticity may be verified.
(c) All records created under this part must be maintained for three
years and promptly produced upon request.
Sec. 73.18 Inspections.
(a) Without prior notification, the HHS Secretary, shall be allowed
to inspect any site at which activities regulated by this part are
conducted and shall be allowed to inspect and copy any records relating
to the activities covered by this part.
(b) Prior to issuing a certificate of registration to an individual
or entity, the HHS Secretary may inspect and evaluate the premises and
records to ensure compliance with this part.
Sec. 73.19 Notification of theft, loss, or release.
(a) Upon discovery of the theft or loss of a select agent or toxin,
an individual or entity must immediately notify CDC or APHIS and
appropriate Federal, State, or local law enforcement agencies. Thefts or
losses must be reported even if the select agent or toxin is
subsequently recovered or the responsible parties are identified.
[[Page 449]]
(1) The theft or loss of a select agent or toxin must be reported
immediately by telephone, facsimile, or e-mail. The following
information must be provided:
(i) The name of the select agent or toxin and any identifying
information (e.g., strain or other characterization information),
(ii) An estimate of the quantity lost or stolen,
(iii) An estimate of the time during which the theft or loss
occurred,
(iv) The location (building, room) from which the theft or loss
occurred, and
(v) The list of Federal, State, or local law enforcement agencies to
which the individual or entity reported, or intends to report the theft
or loss.
(2) A completed APHIS/CDC Form 3 must submitted within seven
calendar days.
(b) Upon discovery of a release of an agent or toxin causing
occupational exposure or release of a select agent or toxin outside of
the primary barriers of the biocontainment area, an individual or entity
must immediately notify CDC or APHIS.
(1) The release of a select agent or toxin must be reported by
telephone, facsimile, or e-mail. The following information must be
provided:
(i) The name of the select agent or toxin and any identifying
information (e.g., strain or other characterization information),
(ii) An estimate of the quantity released,
(iii) The time and duration of the release,
(iv) The environment into which the release occurred (e.g., in
building or outside of building, waste system),
(v) The location (building, room) from which the release occurred,
(vi) The number of individuals potentially exposed at the entity,
(vii) Actions taken to respond to the release, and
(viii) Hazards posed by the release.
(2) A completed APHIS/CDC Form 3 must be submitted within seven
calendar days.
Sec. 73.20 Administrative review.
An individual or entity may appeal a denial, revocation, or
suspension of registration under this part. An individual may appeal a
denial, limitation, or revocation of access approval under this part.
The appeal must be in writing, state the factual basis for the appeal,
and be submitted to the HHS Secretary within 30 calendar days of the
decision. Where the denial, revocation, or suspension of registration or
the denial, limitation, or revocation of an individual's access approval
is based upon an identification by the Attorney General, the request for
review will be forwarded to the Attorney General. The HHS Secretary's
decision constitutes final agency action.
Sec. 73.21 Civil money penalties.
(a) The Inspector General of the Department of Health and Human
Services is delegated authority to conduct investigations and to impose
civil money penalties against any individual or entity in accordance
with regulations in 42 CFR part 1003 for violations of the regulations
in this part, as authorized by the Public Health Security and
Bioterrorism Preparedness and Response Act of 2002 (Pub. L. 107-188).
The delegation of authority includes all powers contained in section 6
of the Inspector General Act of 1978 (5 U.S.C. App.).
(b) The administrative law judges in, assigned to, or detailed to
the Departmental Appeals Board have been delegated authority to conduct
hearings and to render decisions in accordance with 42 CFR part 1005
with respect to the imposition of civil money penalties, as authorized
by the Public Health Security and Bioterrorism Preparedness and Response
Act of 2002 (Pub. L. 107-188). This delegation includes, but is not
limited to, the authority to administer oaths and affirmations, to
subpoena witnesses and documents, to examine witnesses, to exclude or
receive and give appropriate weight to materials and testimony offered
as evidence, to make findings of fact and conclusions of law, and to
determine the civil money penalties to be imposed.
(c) The Departmental Appeals Board of the Department of Health and
Human Services is delegated authority to make final determinations with
respect to the imposition of civil money
[[Page 450]]
penalties for violations of the regulations of this part.
PART 75_STANDARDS FOR THE ACCREDITATION OF EDUCATIONAL PROGRAMS FOR AND THE
CREDENTIALING OF RADIOLOGIC PERSONNEL--Table of Contents
Sec.
75.1 Background and purpose.
75.2 Definitions.
75.3 Applicability.
Appendix A to Part 75--Standards for Accreditation of Educational
Programs for Radiographers
Appendix B to Part 75--Standards for Accreditation of Dental Radiography
Training for Dental Hygienists
Appendix C to Part 75--Standards for Accreditation of Dental Radiography
Training for Dental Assistants
Appendix D to Part 75--Standards for Accreditation of Educational
Programs for Nuclear Medicine Technologists
Appendix E to Part 75--Standards for Accreditation of Educational
Programs for Radiation Therapy Technologists
Appendix F to Part 75--Standards for Licensing Radiographers, Nuclear
Medicine Technologists, and Radiation Therapy Technologists
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.
Sec. 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.
Sec. 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.
[[Page 451]]
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 (X-rays, 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 radiation-generating 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 equipment which emits ionizing radiation, and (2) is delegated
or exercises responsibility for the operation of radiation-generating
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 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.
Sec. 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 Sec. 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 Sec. 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
[[Page 452]]
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:
(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.
Sec. 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; 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
[[Page 453]]
(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.
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.
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.
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;
(l) Pathology;
(m) Radiologic physics; and
(n) Radiation biology.
Related subjects added to the professional curriculum shall meet the
requirements of the degree-granting institution.
F. Finances
Financial resources for operation for the educational program shall
be assured through regular budgets, gifts, grants, endowments, or fees.
G. Faculty
1. Program Director. A program director shall be designated who is
credentialed in radiography. The program director's responsibilities in
teaching, administration, and coordination of the educational program in
radiography shall not be adversely affected by educationally unrelated
functions.
(a) Minimum qualifications. A minimum of two years of professional
experience and proficiency in instructing, curriculum design, program
planning, and counseling.
(b) Responsibilities. (1) The program director, in consultation with
the medical director/advisor (G. 2.) shall be responsible for the
organization, administration, periodic review, records, continued
development, and general policy and effectiveness of the program.
(2) Opportunities for continuing education shall be provided for all
faculty members.
2. Medical Director/Medical Advisor--(a) minimum qualifications. The
medical director/ medical advisor shall be a qualified radiologist,
certified by the American Board of Radiology, or shall possess suitable
equivalent qualifications.
(b) Responsibilities. The medical director/medical advisor shall
work in consultation with the program director in developing the goals
and objectives of the program and implementing the standards for their
achievement.
[[Page 454]]
3. Instructors. All instructors shall be qualified through academic
preparation and experience to teach the assigned subjects.
H. Students
Admission
(a) Candidates for admission shall satisfy the following minimum
requirements: Completion of four years of high school; successful
completion of a standard equivalency test; or certification of
equivalent education by an organization recognized by the United States
Department of Education. Courses in physics, chemistry, biology,
algebra, and geometry are strongly recommended.
(b) The number of students enrolled in each class shall be
commensurate with the most effective learning and teaching practices and
should also be consistent with acceptable student-teacher ratios.
I. Records
Records shall be maintained as dictated by good educational
practices.
Note: Educational programs accredited by an organization recommended
by the United States Department of Education are considered to have met
these standards.
Sec. Appendix B to Part 75--Standards for Accreditation of Dental
Radiography Training for Dental Hygienists
A. Sponsorship
Sponsorship must be by an entity that assumes primary responsibility
for the planning and conduct of competency-based didactic and clinical
training in dental radiography.
1. This responsibility must include: defining the curriculum in
terms of program goals, instructional objectives, learning experiences
designed to achieve goals and objectives, and evaluation procedures to
assess attainment of goals and objectives; coordinating classroom
teaching and supervised clinical experiences; appointing faculty;
receiving and processing applications for admission; and granting
documents of successful completion of the program.
2. The formal training in dental radiography may be a part of a
total program of dental hygiene education accredited by an organization
recognized by the United States Department of Education.
3. The sponsoring entity and the dental radiography training must be
approved by the State entity responsible for approving dental hygiene
education programs or the State entity responsible for credentialing
dental personnel in radiography.
B. Curriculum
Dental radiography training for dental hygienists must provide
sufficient content and instructional time to assure competent
performance.
1. The dental radiography curriculum content and learning
experiences must include the theoretical aspects of the subject as well
as practical application of techniques. The theoretical aspects should
provide content necessary for dental hygienists to understand the
critical nature of the radiological procedures they perform and of the
judgments they make as related to patient and operator radiation safety.
2. The dental radiography curriculum must include content in seven
areas: radiation physics; radiation biology; radiation health, safety,
and protection; X-ray films and radiographic film quality; radiographic
techniques; darkroom and processing techniques; and film mounting.
--Radiation Physics. Curriculum content should include: historical
background; role of radiology in modern dentistry; types of radiation;
X-ray production principles; operation of X-ray equipment; properties of
X-radiation; and X-radiation units, detection and monitoring devices.
--Radiation Biology. Curriculum content should include: Interaction of
ionizing radiation with cells, tissues, and matter; factors influencing
biological response of cells and tissues to ionizing radiation; somatic
and genetic effects of radiation exposure; and cumulative effects of X-
radiation and latent period.
--Radiation Health, Safety, and Protection. Curriculum content should
include: Sources and types of radiation exposure; public health
implications and public concerns; principles of radiological health
including collimation and filtration; radiation protection methods in
the dental office; necessity for high diagnostic yield with a reduction
of X-radiation exposure; and monitoring devices.
--X-ray Films and Radiographic Film Quality. Curriculum content should
include: X-radiation production and scatter; X-ray beam quality and
quantity; factors influencing radiographic density, contrast,
definition, and distortion; film characteristics; dosage related to film
speed; types of films, cassettes, and screens; and film identification
systems.
--Radiographic Techniques. Curriculum content should include: imagery
geometry; patient positioning; film/film holder positioning; cone
positioning and exposure settings for the intraoral paralleling
technique, bisecting the angle technique, and techniques for occlusal
radiographs; extaroral panoramic techniques; and patient variations that
affect the above techniques.
[[Page 455]]
--Darkroom and Processing Techniques. Curriculum content should include:
solution chemistry and quality maintenance; darkroom equipment and safe
lighting; film processing techniques; automatic film processing; and
processing errors.
--Film Mounting. Curriculum content should include: anatomical landmarks
essential to mounting films; film mounting procedures; and diagnostic
quality of radiographs.
3. The curriculum must also include clinical practice assignments.
--Clinical practice assignments must be an integral part of the
curriculum so that Dental Hygienists have the opportunity to develop
competence in making radiographs. Faculty supervision must be provided
during a student's radiographic technique experience. Students must
demonstrate competence in making diagnostically acceptable radiographs
prior to their clinical practice where there is not direct supervision
by faculty.
--Dental hygienists must demonstrate knowledge of radiation safety
measures before making radiographs and, where possible, should
demonstrate competence on manikins before making radiographs on
patients. Radiographs must be exposed for diagnostic purposes and not
solely to demonstrate techniques or obtain experience.
--The clinical experience should provide opportunity to make a variety
of radiographs and radiographic surveys including primary, mixed, and
permanent dentitions, as well as edentulous and partially edentulous
patients.
C. Student Evaluation
Evaluation procedures must be developed to assess performance and
achievement of dental radiography program objectives.
D. Faculty
The dental radiography training must be conducted by faculty who are
qualified in the curriculum subject matter.
1. This may include a D.D.S./D.M.D. degree; graduation from an
accredited dental assisting or dental hygiene education program with a
certificate or an associate or baccalaureate degree; status as a
Certified Dental Assistant certified by the Dental Assisting National
Board; or recognition as equivalently qualified by the State entity
which approved the training program in dental radiography.
2. The faculty-to-student ratio must be adequate to achieve the
stated objectives of the curriculum.
E. Facilities
Adequate radiographic facilities must be available to permit
achievement of the dental radiography training objectives. The design,
location, and construction of radiographic facilities must provide
optimum protection from X-radiation for patients and operators.
Equipment shall meet State and Federal laws related to radiation.
Monitoring devices shall be worn by dental personnel. Lead aprons must
be placed to protect patients. Safe storage for films must be provided.
Darkroom facilities and equipment must be available and of a quality
that assures that films will not be damaged or lost.
F. Learning Resources
A wide range of printed materials, instructional aids, and equipment
must be available to support instruction. Current specialized reference
texts should be provided; and models, replicas, slides, and films which
depict current techniques should be available for use in instruction. As
appropriate self-instructional materials become available, they should
be provided for the student's use.
Note: Educational programs accredited by an organization recognized
by the United States Department of Education are considered to have met
these standards. Under existing licensure provisions in all States,
becoming a dental hygienist requires graduation from a dental hygiene
education program accredited by an organization recognized by the United
States Department of Education. In lieu of this requirement, Alabama
accepts graduation from a State-approved preceptorship program.
Sec. Appendix C to Part 75--Standards for Accreditation of Dental
Radiography Training for Dental Assistants
A. Sponsorship
Sponsorship must be an entity that assumes primary responsibility
for the planning and conduct of competency-based didactic and clinical
training in dental radiography.
1. This responsibility must include: Defining the curriculum in
terms of program goals, instructional objectives, learning experiences
designed to achieve goals and objectives, and evaluation procedures to
assess attainment of goals and objectives; coordinating classroom
teaching and supervised clinical experiences; appointing faculty;
receiving and processing applications for admission; and granting
documents of successful completion of the program.
2. Dental radiography training may be freestanding (as a continuing
education course offered by State dental/dental auxiliary societies, or
by dental/dental auxiliary education programs); or be a part of an
educational program in dental assisting. Such dental assisting education
programs may be
[[Page 456]]
accredited by an organization recognized by the United States Department
of Education; or located in a school accredited by an institutional
accrediting agency recognized by the United States Department of
Education or approved by the State agency responsible for secondary and
postsecondary education, or approved by a Federal agency conducting
dental assistant education in that Agency.
3. The sponsoring entity and the dental radiography training must be
approved by the State entity responsible for approving dental assisting
education programs, or the State entity responsible for credentialing
dental personnel in radiography.
B. Curriculum
Dental radiography training for dental assistants must provide
sufficient content and instructional time to assure competent
performance.
1. The dental radiography curriculum content and learning
experiences must include the theoretical aspects of the subject as well
as practical application of techniques. The theoretical aspects should
provide content necessary for dental assistants to understand the
critical nature of the radiological procedures they perform and of the
judgments they make as related to patient and operator radiation safety.
2. The dental radiography curriculum must include content in seven
areas: radiation physics; radiation biology; radiation health, safety,
and protection; X-ray films and radiographic film quality; radiographic
techniques; darkroom and processing techniques; and film mounting.
--Radiation Physics. Curriculum content should include: Historical
background; role of radiology in modern dentistry; types of radiation;
X-ray production principles; operation of X-ray equipment; properties of
X-radiation; and X-radiation units, detection and monitoring devices.
--Radiation Biology. Curriculum content should include: interaction of
ionizing radiation with cells, tissues, and matter; factors influencing
biological response of cells and tissues to ionizing radiation; somatic
and genetic effects of radiation exposure; and cumulative effects of X-
radiation and latent period.
--Radiation Health, Safety, and Protection. Curriculum content should
include: sources and types of radiation exposure; public health
implications and public concerns; principles of radiological health
including collimation and filtration; radiation protection methods in
the dental office; necessity for high diagnostic yield with a reduction
of X-radiation exposure; and monitoring devices.
--X-ray Films and Radiographic Film Quality. Curriculum content should
include: X-radiation production and scatter; X-ray beam quality and
quantity; factors influencing radiographic density, contrast,
definition, and distortion; film characteristics; dosage related to film
speed; types of films, cassettes, and screens; and film identification
systems.
--Radiographic Techniques. Curriculum content should include: imagery
geometry; patient positioning; film/film holder positioning; cone
positioning and exposure settings for the intraoral paralleling
technique, bisecting the angle technique, and techniques for occlusal
radiographs; extraoral panoramic techniques; and patient variations that
affect the above techniques.
--Darkroom and Processing Techniques. Curriculum content should include:
Solution chemistry and quality maintenance; darkroom equipment and safe
lighting; film processing techniques; automatic film processing; and
processing errors.
--Film Mounting. Curriculum content should include: anatomical landmarks
essential to mounting films; film mounting procedures; and diagnostic
quality of radiographs.
3. The curriculum must also include clinical practice assignments.
--Clinical practice assignments must be an integral part of the
curriculum so that Dental Assistants have the opportunity to develop
competence in making radiographs. The clinical experience may be
conducted in the dental office in which the Dental Assistant is employed
or is serving an externship. Faculty and/or employing dentist
supervision must be provided during a student's radiographic technique
experience. Students must demonstrate competence in making
diagnostically acceptable radiographs prior to their clinical practice
when there is not direct supervision by faculty and/or the employing
dentist.
--Dental Assistants must demonstrate knowledge of radiation safety
measures before making radiographs, and where possible should
demonstrate competence on manikins before making radiographs on
patients. Radiographs must be exposed for diagnostic purposes and not
solely to demonstrate techniques or obtain experience.
--The clinical experience should provide opportunity to make a variety
of radiographs and radiographic surveys, including primary, mixed, and
permanent dentitions, as well as edentulous and partially edentulous
patients.
C. Student Evaluation
Evaluation procedures must be developed to assess performance and
achievement of dental radiography program objectives.
[[Page 457]]
D. Faculty
The dental radiography training must be conducted by faculty who are
qualified in the curriculum subject matter.
1. This may include a D.D.S./D.M.D. degree; graduation from an
accredited dental assisting or dental hygiene education program with a
certificate or an associate or baccalaureate degree; status as a
Certified Dental Assistant certified by the Dental Assisting National
Board; or recognition as equivalently qualified by the State entity (or
Federal agency where appropriate) which approves the educational program
in dental radiography.
2. The faculty-to-student ratio must be adequate to achieve the
stated objectives of the curriculum.
E. Facilities
Adequate radiographic facilities must be available to permit
achievement of the dental radiography training objectives. The design,
location, and construction of radiographic facilities must provide
optimum protection from X-radiation for patients and operators.
Equipment shall meet State and Federal laws related to radiation.
Monitoring devices shall be worn by dental personnel. Lead aprons must
be placed to protect patients. Safe storage for films must be provided.
Darkroom facilities and equipment must be available and of a quality
that assures that films will not be damaged or lost.
F. Learning Resources
A wide range of printed materials, instructional aids, and equipment
must be available to support instruction. Current specialized reference
texts should be provided; and models, replicas, slides, and films which
depict current techniques should be available for use in instruction. As
appropriate self-instructional materials become available, they should
be provided for the student's use.
Note: Educational programs accredited by an organization recognized
by the United States Department of Education are considered to have met
these standards.
Sec. Appendix D to Part 75--Standards for Accreditation of Educational
Programs for Nuclear Medicine Technologists
A. 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 and clinics;
(c) Laboratories;
(d) Medical schools;
(e) Postsecondary vocational/technical schools and institutions; and
(f) Other acceptable institutions which meet comparable standards.
3. The sponsoring institution and affiliate(s) must be accredited by
a recognized agency. When the sponsoring institution and affiliate(s)
are not so recognized, they may be considered as meeting the
requirements of accreditation if the institution meets or exceeds
established equivalent standards.
4. Responsibilities of the sponsor and each affiliate for program
administration, instruction, supervision, etc., must be carefully
described in written affiliation agreements.
B. Curriculum
Instruction must follow a plan which documents:
1. A structured curriculum including clinical education with clearly
written syllabi which describe learning objectives and competencies to
be achieved. The curriculum shall be based on not less than one calendar
year of full-time study or its equivalent.
2. The minimum professional curriculum that includes the following:
(a) Methods of patient care;
(b) Radiation safety and protection;
(c) Nuclear medicine physics;
(d) Radiation physics;
(e) Nuclear instrumentation;
(f) Statistics;
(g) Radionuclide chemistry;
(h) Radiopharmacology;
(i) Departmental organization and function;
(j) Radiation biology;
(k) Nuclear medicine in vivo and in vitro procedures;
(l) Radionuclide therapy;
(m) Computer applications; and
(n) Clinical practicum.
3. Assignment of appropriate instructional materials.
4. Classroom presentations, discussions, and demonstrations.
5. Supervised practice, experience, and discussions. This shall
include the following:
(a) Patient care and patient recordkeeping;
(b) Participation in the quality assurance program;
(c) The preparation, calculation, identification, administration,
and disposal of radiopharmaceuticals;
[[Page 458]]
(d) Radiation safety techniques that will minimize radiation
exposure to the patient, public, fellow workers, and self;
(e) The performance of an adequate number and variety of imaging and
non-imaging procedures; and
(f) Clinical correlation of nuclear medicine procedures.
6. Evaluation of student's knowledge, problem-solving skills, and
motor and clinical competencies.
7. The competencies necessary for graduation.
C. Resources
1. The program must have qualified program officials. Primary
responsibilities shall include program development, organization,
administration, evaluation, and revision. The following program
officials must be identified:
(a) Program Director--(1) Responsibilities. The program director of
the educational program shall have overall responsibility for the
organization, administration, periodic review, continued development,
and general effectiveness of the program. The director shall provide
supervision and coordination to the instructional staff in the academic
and clinical phases of the program. Regular visits to the affiliates by
the program director must be scheduled.
(2) Qualifications. The program director must be a physician or
nuclear medicine technologist. The program director must demonstrate
proficiency in instruction, curriculum design, program planning, and
counseling.
(b) Medical Director--(1) Responsibilities. The medical director of
the program shall provide competent medical direction and shall
participate in the clinical instruction. In multiaffiliate programs each
clinical affiliate must have a medical director.
(2) Qualifications. The medical director must be a physician
qualified in the use of radionuclides and a diplomate of the American
Board(s) of Nuclear Medicine, or Pathology, or Radiology, or possess
suitable equivalent qualifications.
(c) Clinical Supervisor. Each clinical affiliate must appoint a
clinical supervisor.
(1) Responsibilities. The clinical supervisor shall be responsible
for the clinical education and evaluation of students assigned to that
clinical affiliate.
(2) Qualifications. The clinical supervisor must be a technologist
credentialed in nuclear medicine technology.
2. Instructional Staff--(a) Responsibilities. The instructional
staff shall be responsible for instruction in the didactic and/or
clinical phases of the program. They shall submit course outlines for
each course assigned by the program director; evaluate students and
report progress as required by the sponsoring institution; and cooperate
with the program director in the periodic review and upgrading of course
material.
(b) Qualifications. The instructors must be qualified,
knowledgeable, and effective in teaching the subjects assigned.
(c) Instructor-to-student ratio. The instructor-to-student ratio
shall be adequate to achieve the stated objectives of the curriculum.
(d) Professional development. Accredited programs shall assure
continuing education in the health profession or occupation and ongoing
instruction for the faculty in curriculum design and teaching
techniques.
3. Financial resoures for continued operation of the educational
program must be assured.
4. Physical Resources. (a) General. Adequate classrooms,
laboratories, and other facilities shall be provided.
(b) Equipment and Supplies. Modern nuclear medicine equipment,
accurately calibrated, in working order, and meeting applicable Federal
and State standards, if any, must be available for the full range of
diagnostic and therapeutic procedures as outlined in the curriculum.
(c) Reference Materials. Reference materials appropriate to the
curriculum shall be readily accessible to students.
(d) Records. Records shall be maintained as dictated by good
educational practices.
5. Instructional Resources. Instructional aids such as clinical
materials, reference materials, demonstration and other multimedia
materials must be provided.
D. Students
Admission Requirements
Persons admitted into nuclear medicine technology programs shall
have completed high school or its equivalent. They shall have completed
postsecondary courses in the following areas:
(1) Human anatomy and physiology;
(2) Physics;
(3) Mathematics;
(4) Medical terminology;
(5) Oral and written communications;
(6) General chemistry; and
(7) Medical ethics.
Prerequisites may be completed during nuclear medicine training.
Educational institutions such as junior colleges, universities, and
technical vocational institutes may provide these prerequisite courses
as part of an integrated program in nuclear medicine technology (i.e.,
two to four years).
E. Operational Policies
Students may not take the responsibility nor the place of qualified
staff. However, students may be permitted to perform procedures after
demonstrating proficiency, with careful supervision.
[[Page 459]]
F. Continuing Program Evaluation
1. Periodic and systematic review of the program's effectiveness
must be documented.
2. One element of program evaluation shall be the initial employment
of graduates of the program.
Note: Educational programs accredited by an organization recognized
by the United States Department of Education are considered to have met
these standards.
Sec. Appendix E to Part 75--Standards for Accreditation of Educational
Programs for Radiation Therapy Technologists
A. Sponsorship
1. Educational programs may be established in:
(a) Community and junior colleges, senior colleges, and
universities;
(b) Hospitals, clinics, or autonomous radiation oncology centers
meeting the criteria for major cancer management centers or meeting
demonstrably equivalent standards;
(c) Medical schools; and
(d) Postsecondary vocational/technical schools and institutions.
2. The sponsoring institution and affiliates, if any, must be
accredited by recognized agencies or meet equivalent standards. When
more than one clinical education center is used, each must meet the
standards of a major cancer management center.
3. When didactic preparation and supervised clinical education are
not provided in the same institution, accreditation must be obtained by
the sponsoring institution for the total program. This institution will
be the one responsible for admission, curriculum, and academic credit.
The accredited institution shall be responsible for coordinating the
program and assuring that the activities assigned to the student in the
clinical setting are educational. There shall be a uniform, written,
affiliation agreement between the accredited institution and each
clinical education center, clearly defining the responsibilities and
obligations of each.
B. Curriculum
Educational programs of 24 months and 12 months or their equivalents
may be developed. A 24-month program shall admit those candidates with a
high school diploma (or equivalent) as outlined in D.1. The 12-month
program shall be designed for those students admitted with backgrounds
as outlined in D.2.
Instruction must follow a plan which documents:
1. A structured curriculum with clearly written course syllabi which
describe competencies and learning objectives to be achieved. The
curriculum shall include but not necessarily be limited to the
following:
(a) Orientation to radiation therapy technology;
(b) Medical ethics and law;
(c) Methods of patient care;
(d) Medical terminology;
(e) Human structure and function;
(f) Oncologic pathology;
(g) Radiation oncology;
(h) Radiobiology;
(i) Mathematics;
(j) Radiation physics;
(k) Radiation protection;
(l) Radiation oncology technique;
(m) Radiographic imaging; and
(n) Clinical dosimetry.
The curriculum must include a plan for well-structured competency-based
clinical education.
2. Assignment of appropriate instructional materials.
3. Classroom presentations, discussions, and demonstrations.
4. Supervised clinical education and laboratory practicum.
5. Evaluation of students to assess knowledge, problem-solving
skills, and motor and clinical competencies.
6. Program graduates must demonstrate competencies including, but
not limited to, the following:
(a) Practice oral and written communications;
(b) Maintain records of treatment administered;
(c) Perform basic mathematical functions;
(d) Demonstrate knowledge of human structure, function, and
pathology;
(e) Demonstrate knowledge of radiation physics in radiation
interactions and radiation protection techniques;
(f) Provide basic patient care and cardiopulmonary resuscitation;
(g) Deliver a planned course of radiation therapy;
(h) Verify physician's prescribed course of radiation therapy and
recognize errors in computation;
(i) Demonstrate awareness of patterns of physical and emotional
stress exhibited by patients;
(j) Produces and utilize immobilization and beam directional
devices;
(k) Prepare commonly used brachytherapy sources;
(l) Demonstrate knowledge of methods of calibration of equipment,
and quality assurance;
(m) Prepare isodose summations;
(n) Detect malfunctioning equipment;
(o) Apply rules and regulations for radiation safety, and detect
defects which might pose a radiation hazard;
(p) Understand the function of equipment and accessories;
[[Page 460]]
(q) Demonstrate knowledge of methods of continuing patient
evaluation (follow up);
(r) Apply wedge and compensating filters;
(s) Recognize patients' clinical progress, complications, and
demonstrate knowledge of when to withhold treatment until consultation
with the physician; and
(t) Interact with patients and families concerning the physical and
psychological needs of patients.
C. Resources
1. Program Officials. The program must have a qualified program
official or officials. Primary responsibilities shall include program
development, organization, administration, evaluation, and revision. A
program director is necessary; other program officials may be required.
(a) Program Director--(1) Responsibilities.
--The director of the educational program shall be responsible for the
organization, administration, periodic review, continued development,
and general effectiveness of the program. The program director's
responsibilities in teaching, administration, and coordination of the
educational program in radiation therapy technology shall not be
adversely affected by educationally unrelated functions.
--In a college-sponsored program, or a hospital-sponsored multiple
affiliate program, the program director shall be an employee of the
sponsoring institution. A schedule of regular affiliate visits must be
maintained.
(2) Qualifications.
--Must be a technologist qualified in radiation therapy technology and
educational methodologies.
--Must be credentialed in radiation therapy technology or possess
suitable equivalent qualifications.
--Must have at least two years' experience as an instructor in an
accredited educational program.
(b) Clinical Supervisor. Each clinical education center shall
appoint a clinical supervisor.
(1) Responsibilities. The clinical supervisor shall be responsible
for the clinical education and evaluation of students assigned to that
clinical education center.
(2) Qualifications. Must be a technologist, with suitable
experience, qualified in radiation therapy technology and educational
methodologies and must be credentialed in radiation therapy technology.
(c) Medical Director/Medical Advisor--
(1) Responsibilities. The medical director/medical advisor shall
work in consultation with the program director in developing the goals
and objectives of the program and implementing the standards for
achievement.
(2) Qualifications. The medical director/medical advisor shall be a
qualified radiation oncologist certified by the American Board of
Radiology, or shall possess suitable equivalent qualifications.
2. Instructional Staff-- (a) Responsibilities. The instructional
staff shall be responsible for submitting course outlines for each
course assigned by the program director; evaluating students and
reporting progress as required by the sponsoring institution; and
cooperating with the program director in the periodic review and
upgrading of course material.
(b) Qualifications. The instructors must be individually qualified,
must be effective in teaching the subjects assigned, and must meet the
standards required by the sponsoring institution.
(c) Instructor-to-Student Ratio. The instructor-to-student ratio
shall be adequate to achieve the stated objectives of the curriculum.
(d) Professional Development. Programs shall have a policy that
encourages continuing education in radiation therapy technology and
assures ongoing instruction for the faculty in curriculm design and
teaching strategies.
3. Financial Resources. Financial resources for continued operation
of the educational program must be assured.
4. Physical Resources--(a) General. Adequate classrooms,
laboratories, and other facilities shall be provided. All affiliated
institutions shall provide space required for these facilities.
(b) Equipment and Supplies. Appropriate modern equipment and
supplies in sufficient quantities shall be provided.
(c) Laboratory. Energized laboratories must meet Federal and/or
State radiation and safety regulations.
(d) Reference Materials. An adequate supply of up-to-date books,
periodicals, and other reference materials related to the curriculum and
the profession shall be readily available to students.
(e) Records. Records shall be maintained as dictated by good
educational practices.
5. Instructional Resources. Instructional aids such as clinical
materials, reference materials, and demonstration and other multimedia
materials must be provided.
D. Students
Admission
1. Applicants must be high school graduates (or equivalent) with an
educational background in basic science and mathematics.
2. For admission to a 12-month program, the candidate must satisfy
one of the following requirements:
(a) Graduation from an accredited or equivalent program in
radiography.
(b) Successful completion or challenge of courses in the following
prerequisite content areas:
[[Page 461]]
--Radiation physics;
--Human structure and function;
--Radiation protection;
--Medical ethics and law;
--Methods of patient care;
--Medical terminology; and
--Mathematics.
(c) Successful demonstration of the following competencies:
--Practice oral and written communications;
--Perform basic mathematical functions;
--Demonstrate knowledge of human structure and function;
--Demonstrate knowledge of radiation physics in radiation interactions
and radiation protection techniques;
--Provide basic patient care and cardiopulmonary resuscitation;
--Demonstrate awareness of patterns of physical and emotional stress
exhibited by patients;
--Apply rules and regulations for radiation safety, detect defects which
might pose a radiation hazard, and maintain control, if a radiation
accident occurs; and
--Interact with patients and families concerning patients physical and
psychological needs.
E. Continuing Program Evaluation
1. A process for periodic and systematic review of the program's
effectiveness must be documented and reflected in policies.
2. Program evaluation shall include the employment performance of
recent graduates.
Note: Educational programs accredited by an organization recognized
by the United States Department of Education are considered to have met
these standards.
Sec. Appendix F to Part 75--Standards for Licensing Radiographers,
Nuclear Medicine Technologists, and Radiation Therapy Technologists
The following section describes basic elements to be incorporated in
credentialing programs of States that choose to regulate personnel who
perform radiologic procedures.
A. Licensure
1. Only eligible applicants who have passed the licensure
examination shall be licensed as Radiographers, Nuclear Medicine
Technologists, or Radiation Therapy Technologists.
2. Licenses shall be renewed at periodic intervals.
B. Eligibility
1. For regular eligibility to take the licensure examination,
applicants shall have successfully completed an accredited program of
formal education in radiography, nuclear medicine technology, or
radiation therapy technology.
2. Special eligibility to take the licensure examination shall be
provided for applicants whose training and/or experience are equal to,
or in excess of, those of a graduate of an accredited educational
program.
C. Examination
A criterion-referenced examination in radiography, nuclear medicine
technology, or radiation therapy technology shall be utilized to test
the knowledge and competencies of applicants.
D. Continuing Competency
The licensed Radiographer, Nuclear Medicine Technologist, or
Radiation Therapy Technologist shall maintain continuing competency in
the area in which he/she is practicing.
E. Policies and Procedures
An organization that seeks to be recognized for the certifying of
personnel shall adopt definite policies to ensure validity, objectivity,
and fairness in the certifying process. The National Commission for
Health Certifying Agencies (NCHCA) has published suitable criteria for a
certifying organization to adopt with respect to policies for: (1)
Determination of appropriate examination content (but not the actual
content for any specific occupation); (2) construction of examinations;
(3) administration of examinations; and (4) fulfilling responsibilities
to applicants. An organization (whether an NCHCA member or not) that
adopts these or equivalent criteria will meet all of the requirements of
this section of these standards.
Sec. Appendix G to Part 75--Standards for Licensing Dental Hygienists
and Dental Assistants in Dental Radiography
The following section describes basic elements to be incorporated in
credentialing programs of States that choose to regulate personnel who
perform radiologic procedures.
Currently, Dental Hygienists are credentialed through individual
State licensure processes, all of which include assessment of competence
in dental radiography. In all States, Dental Hygienists are required to
be licensed prior to practicing. The existing State dental hygiene
licensure processes
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meet the intent and purpose of the Consumer-Patient Radiation Health and
Safety Act of 1981 and the standards for licensing Dental Hygienists in
dental radiography set forth below.
A. Licensure/Permit
1. To those who have passed a licensure or designated dental
radiography examination, a license or permit shall be issued by the
State entity responsible for credentialing dental personnel.
2. Licenses or permits shall be renewed at periodic intervals.
B. Eligibility
1. An individual shall provide proof of graduating student status or
graduation from an accredited or approved dental hygiene or dental
assisting education program.
2. For dental assistants, special eligibility to take the
examination shall be provided to applicants with appropriate
combinations of training and/or experience.
C. Examination
A criterion-referenced examination in dental radiography shall be
utilized to test the knowledge and competencies of applicants.
D. Continuing Competency
The Dental Hygienist or Dental Assistant shall be required to
maintain continuing competency in the area in which he/she is
practicing.
E. Policies and Procedures
An organization that seeks to be recognized for the certifying of
personnel shall adopt definite policies to ensure validity, objectivity,
and fairness in the certifying process. The National Commission for
Health Certifying Agencies (NCHCA) has published suitable criteria for a
certifying organization to adopt with respect to policies for: (1)
Determination of appropriate examination content (but not the actual
content for any specific occupation); (2) construction of examinations;
(3) administration of examinations; and (4) fulfilling responsibilities
to applicants. An organization (whether an NCHCA member or not) that
adopts these or equivalent criteria will meet all of the requirements of
this section of these standards.
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