[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\
---------------------------------------------------------------------------

    \1\ These conditions may apply to more than one individual.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------

    \2\ Nothing in this section is meant to supersede or preempt 
incident response requirements imposed by other statutes or regulations.
---------------------------------------------------------------------------

    (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.
---------------------------------------------------------------------------

    \3\ The training need not duplicate training provided under the OSHA 
Bloodborne Pathogen Standard set forth at 29 CFR 1910.1030.
---------------------------------------------------------------------------

    (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\
---------------------------------------------------------------------------

    \4\ This section does not cover transfers within an entity when the 
sender and the recipient are covered by the same certificate of 
registration.
---------------------------------------------------------------------------

    (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:


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--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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