6 \
uX 5
federal register

 

te

   

eo

  

WEDNESDAY, AUGUST 8, 1973

WASHINGTON, D.C.

Volume 38 ™@ Number 152

 

Notices

 

DEPARTMENT OF HEALTH,
EDUCATION, AND WELFARE

Food and Drug Administration

X-RAY BAGGAGE INSPECTION SYSTEMS
Notice to State Radiati ‘ontrol Agencies
of Radiation ‘ecommendations

The Bureau of Radiological Health,
Food and Drug Administration, Depart-
ment of Health, Education, and Welfare,
under the authority conferred by the
Public Health Service Act (42 U.S.C. 241

and 243), advises and promotes coopera-
tion among states on matters relating to

EW notice of sata) recommendations for

the protection of the public health
against radiation hazards. The Radiation
Control for Health and Safety Act of
1968 (42 U.S.C. 263b et seq.), an amend-
ment to the Public Health Service Act,
further provides for the establishment of
an electronic product radiation control
program designed to protect the public
health and safety.

The Food and Drug Administration on
April 27, 1973, issued, to State radia-
tion control agencies, recommendations
(guidelines) on radiation safety aspects
in the design and use of x-ray systems
for routine inspection of hand carried
(earry-on) luggage in airline terminals.

These recommendations are concep-
tual in nature and minor variations pro-
viding equivalent radiation protection
may be appropriate to meet the needs of
individual radiation control programs.

The recommendations were developed
following consultation with the Federal
Aviation Administration (Department of
Transportation), the National Bureau
of Standards (Department of Com-
merce), the Occupational Safety and
Health Administration (Department of
Labor), the Executive Committee of the
Conference of Radiation Control Pro-
gram Directors, and manufacturers. The
Federal Aviation Administration (FAA),
in addition to specifying certain image
quality features for x-ray luggage in-
spection systems and certain require-
ments on their use, has stated in a direc-
tive to its Regional Directors, that “the
airline should obtain or require that the
manufacturer obtain the permission or
license from the State in which the de-
vice will be used.”

There are presently no Federal stand-
ards or regulations specifically directed
to the overall radiation safety aspects of
these systems. Federal and State agen-
cies have become increasingly concerned
with the need for effective and uniform
controls on x-ray baggage inspection sys-

tems which will assure adequate radia- .

tion protection for operators as well as
the general public. The manufacture of
several of these x-ray systems will be
subject to a radiation safety performance
standard which is under development
and will be published in the Feprran
REGISTER as a notice of proposed rule
making.

During development of the guidelines,
representatives of the Bureau of Radio-
logical Health visited six manufacturers
of x-ray baggage systems to obtain back-
ground information on these systems
planned for commercial distribution,
Guidelines proposed for the State radia-
tion control agencies were discussed with
the manufacturers during these visits.
The manufacturers agreed that the pro-
posed guidelines are practical, do not
unnecessarily restrict functional objec-
tives of the equipment, and would be
desirable to provide uniform evaluation
and control among the states.

Concurrently, a survey of all State
radiation control agencies was conducted
by the Food and Drug Administration to
assess the extent of involvement of the
states in evaluation of these devices.
Over one-half of the State programs re-

SEP 14 1873

ported that they had been contacted by
airlines, manufacturers, and industrial
agents regarding the need for registra-
tion of x-ray baggage systems and radia-
tion safety requirements. Eight states
indicated that they had issued special
requirements for such systems. Several
indicated that their industrial radiog-
raphy requirements would be applied
to the x-ray baggage inspection systems,
The states indicated that guidance from
the Bureau of Radiological Health would
be useful in conducting evaluations and
granting approval for use of these x-ray
devices.

Because of rapid developments in the
design of x-ray systems for the inspec-
tion of baggage at airline terminals, pro-
liferation in applications, and requests
for guidance from State radiation con-
trol programs, it is the opinion of the
Food and Drug Administration that radi-
ation safety considerations for this
equipment should be outlined in a man-
ner useful for establishing uniform and
effective controls.

The Commisisoner concludes that the
recommendations issued to the State
radiation control agencies on April 27,
1973, as set forth below, should help to
provide radiation protection for opera-
tors, passengers, and others involved in
the use of x-ray baggage inspection sys-
tems. Therefore, the Commissioner urges
that these guidelines be used as a basis
for a uniform policy by states granting
approval for such equipment.

RECOMMENDATIONS TO STATE RADIATION
~  ContrRoL AGENCIES

These recommendations are applicable
to x-ray systems used in airline terminals
for routine inspection of carry-on
baggage.

1. It shall not be possible to insert any
part of the body into the primary beam.

2. Radiation exposure shall not exceed
0.5 mR in any one hour at a distance of
five centimeters from any point on the
external surface of the system when op-
erated under “worst case” conditions.

3. The control panel shall be equipped
with a key lock. It shall not be possible
to remove the key in the “on” position.

4. Doors and access panels which pre-
vent entry to an area where the exposure
may exceed 0.5 mR in one hour shall be
interlocked.

5. Means shall be provided to indicate
to the operator when x-rays are being
produced.

6. A deadman switch shall be provided
on the exposure controls. The location of
the switch will be such that the operator
has a clear view of the x-ray system.

RATIONALE AND EXPLANATION OF
RECOMMENDATIONS

RECOMMENDATION 1.

The most significant hazard associated
with these systems is human exposure
to the primary beam of radiation. Gen-
erally, operators are not well trained in
the hazards of radiation and may not
apply diligent caution to prevent ex-
posure of personnel. To minimize ex-
posure, this recommendation is intended
to necessitate engineered safeguards to

FEDERAL REGISTER, VOL, 38, NO. 152-—WEDNESDAY, AUGUST 8, 1973
prevent, during routine operations, direct
beam exposure of any part of the body,
including extremities. —

RECOMMENDATION 2.

In the absence of conclusive data re-
garding the effects of low level irradia-
tion, the underlying philosophy of radia-
tion protection is to maintain radiation
exposure of personnel as low as practica-
ble, The guideline of 0.5 mR in any one
hour at 5 centimeters from the external
surface of the device has been developed
for other electronic products used in
areas accessible to the public. Due to the
nature of operation, it is anticipated: that
the actual exposure to any individual

' will be considerably less than that gen-
erally considered acceptable by national
and international standards-setting or-
ganizations. -

It is intended that test measurements
be made under conditions which maxi-
mize radiation levels at accessible areas.
In those situations where ports are pro-
vided to transport objects into or out of
the system, the external surface should
be considered as the imaginary plane

vacross the opening.

RECOMMENDATION 3. .

Since this equipment is used in public

areas and could be hazardous when oper-
ated without supervision, it is essential
that provisions be provided to secure the
system to prevent unauthorized use. It
is intended that the key lock feature will
provide this security.

Likewise, it is important that the sys-
tem is capable of benig turned off at any
time. It is thus recommended that the
key be captured in the “on” position to
prevent someone inadvertently carrying
off, or otherwise losing, the key when the
system is energized.

RECOMMENDATION 4.

Doors and access panels are frequently
provided as a means of preventing access
to areas where excessive radiation levels
may be present. Recommendations for
interlocking is provided to insure that
X-radiation production is automatically
terminated when access to the source of
radiation is possible. This prevents risk
of unnecessary radiation exposure when
protective features are removed or
opened. . :

RECOMMENDATION 5.

An “X-RAY ON” indicator is recom-
mended to clearly indicate the status of
X-ray production and potential for ex-
posure,

RECOMMENDATION 6,

The deadman switch feature is rec-
ommended to insure operator control of
thé system at all times when x-rays are
being produced. It is also recommended
that the device be located in a position
such that the operator can maintain sur-
veillance of the system and have the
means available to immediately termi-
nate x-radiation production in emer-
gency situations.

Those interested persons who wish to
submit comments or suggestion in con-

nection with the recommendations listed
above should send them to Hearing Clerk,
Food and Drug Administration, Room 6-
86, 5600 Fishers Lane, Rockville, MD
20852, on or before September 7, 1973.
The comments will be considered during
further development of the recommenda-
tions for use by states in evaluation of
x-ray baggage inspection systems.

Dated: August 1, 1973.

Sam D. Fixe,
Associate Commissioner
for Compliance.

[FR Doc.73-16340 Filed 8-7-73;8:45 am]