Effective Date: 01/08/97
Title: Section 16.12 - Radiation symbol, signs, labels and control devices

16.12 Radiation symbol, signs, labels, and control devices.

(a) Standard radiation symbol. Unless otherwise authorized by the department, the symbol prescribed by this section shall use the colors magenta, or purple, or black on yellow background. The symbol prescribed is the three-bladed design and shall be as illustrated below:

(1) Cross-hatched area is to be magenta, or purple, or black, and

(2) The background is to be yellow.

(3) Exception to color requirements for standard radiation symbol. Notwithstanding the requirements of section 16.12(a), licensees or registrants are authorized to label sources, source holders, or device components containing sources of radiation that are subjected to high temperatures, with conspicuously etched or stamped radiation caution symbols and without a color requirement.

(4) Additional information on signs and labels. In addition to the contents of signs and labels prescribed in this Part, the licensee or registrant shall provide, on or near the required signs and labels, additional information, as appropriate, to make individuals aware of potential radiation exposures and to minimize the exposures.

(b)(1) Posting requirements.

(i) Posting of radiation areas. The licensee or registrant shall post each radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIATION AREA".

(ii) Posting of high radiation areas. The licensee or registrant shall post each high radiation area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, HIGH RADIATION AREA" or "DANGER, HIGH RADIATION AREA".

(iii) Posting of very high radiation areas. The licensee or registrant shall post each very high radiation area with a conspicuous sign or signs bearing the radiation symbol and words "GRAVE DANGER, VERY HIGH RADIATION AREA".

(iv) Posting of airborne radioactivity areas. The licensee or registrant shall post each airborne radioactivity area with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, AIRBORNE RADIOACTIVITY AREA" or "DANGER, AIRBORNE RADIOACTIVITY AREA".

(v) Posting of areas or rooms in which licensed material is used or stored. The licensee shall post each area or room in which there is used or stored an amount of licensed material exceeding 10 times the quantity of such material specified in Appendix 16-A, Table 9 with a conspicuous sign or signs bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL(S)" or "DANGER, RADIOACTIVE MATERIAL(S)".

(2) Exceptions to posting requirements.

(i) A licensee or registrant is not required to post caution signs in areas or rooms containing sources of radiation for periods of less than 8 hours, if each of the following conditions is met:

(a) The sources of radiation are constantly attended during these periods by an individual who takes the precautions necessary to prevent the exposure of individuals to sources of radiation in excess of the limits established in Part 16; and

(b) The area or room is subject to the licensee's or registrant's control.

(ii) Rooms or other areas in hospitals that are occupied by patients are not required to be posted with caution signs pursuant to paragraph (1) of this subdivision provided that the patients are not required to be confined for radiation protection purposes pursuant to this Part.

(iii) A room or area is not required to be posted with a caution sign because of the presence of a sealed source provided the radiation level at 30 centimeters from the surface of the sealed source container of housing does not exceed 0.05 mSv (0.005 rem) per hour.

(iv) A room or area is not required to be posted with a caution sign because of the presence of a diagnostic x-ray system used solely for healing arts purposes.

(c) Labeling containers and radiation machines.

(1) The licensee or registrant shall ensure that each container of licensed material bears a durable, clearly visible label bearing the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL". The label shall also provide information, such as the radionuclides present, an estimate of the quantity of radioactivity, the date for which the activity is estimated, radiation levels, kinds of materials, and mass enrichment, to permit individuals handling or using containers, or working in the vicinity of the containers, to take precautions to avoid or minimize exposures.

(2) Each licensee shall, prior to removal or disposal of empty uncontaminated containers to unrestricted areas, remove or deface the radioactive material label or otherwise clearly indicate that the container no longer contains radioactive materials. (3) Each registrant shall ensure that each radiation machine is labeled in a conspicuous manner which cautions individuals that radiation is produced when it is energized.

(4) Exemptions to labeling requirements. A licensee or registrant is not required to label:

(i) Containers holding licensed material in quantities less than the quantities listed in Appendix 16-A, Table 9, infra; or

(ii) Containers holding licensed material in concentrations less than those specified in Appendix 16-C, Table 3, infra.

(iii) For laboratory containers, such as beakers, flasks, and test tubes, used transiently in laboratory procedures (i.e. for a period of a few hours) in the presence of an authorized user; or

(iv) Containers when they are in transport and packaged and labeled in accordance with the regulations of the U. S. Department of Transportation;(5) or

(v) Containers that are accessible only to individuals authorized to handle or use them, or to work in the vicinity of the containers, if the contents are identified to these individuals by a readily available written record. Examples of containers of this type are containers in locations such as water-filled canals, storage vaults, or hot cells. The record shall be retained as long as the containers are in use for the purpose indicated on the record; or

(vi) Installed manufacturing or process equipment, such as chemical process equipment, piping, and tanks.

(d) Control of access to high radiation areas.

(1) The licensee or registrant shall ensure that each entrance or access point to a high radiation area has one or more of the following features:

(i) A control device that, upon entry into the area, causes the level of radiation to be reduced below that level at which an individual might receive a deep dose equivalent of 1 mSv (0.1 rem) in 1 hour at 30 centimeters from the source of radiation from any surface that the radiation penetrates; or;

(ii) A control device that energizes a conspicuous visible or audible alarm signal so that the individual entering the high radiation area and the supervisor of the activity are made aware of the entry; or

(iii) Entryways that are locked, except during periods when access to the areas is required, with positive control over each individual entry.

(2) In place of the controls required by subparagraph (i) of this paragraph for a high radiation area, the licensee or registrant may substitute continuous direct or electronic surveillance that is capable of preventing unauthorized entry.

(3) The licensee or registrant may use alternative methods for controlling access to high radiation areas found by the department to be effective at accomplishing such control.

(4) The licensee or registrant shall establish the controls required by paragraphs (1) and (3) of this subdivision in a way that does not prevent individuals from leaving a high radiation area.

(5) The licensee or registrant is not required to control each entrance or access point to a room or other area that is a high radiation area solely because of the presence of radioactive materials prepared for transport and packaged and labeled in accordance with section 16.17 of this Part, provided that:

(i) The packages do not remain in the area longer than 3 days; and

(ii) The dose rate at 1 meter from the external surface of any package does not exceed 0.1 mSv (0.01 rem) per hour.

(6) The licensee or registrant is not required to control entrance or
access to rooms or other areas in hospitals solely because of the presence of patients containing radioactive material, provided that there are personnel in attendance who are taking the necessary precautions to prevent the exposure of individuals to radiation or radioactive material in excess of the established limits in Part 16 and to operate within the ALARA provisions of the licensee's or registrant's radiation protection program.

(7) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a high radiation area as described in this paragraph if the registrant has met all the specific requirements for access and control specified in other applicable sections of these regulations, such as those regulating x-ray equipment in the healing arts and particle accelerators.

(e) Control of access to very high radiation areas.

(1) In addition to the requirements in paragraph (2) of this subdivision, the licensee or registrant shall institute additional measures to ensure that an individual is not able to gain unauthorized or inadvertent access to areas in which radiation levels could be encountered at 5 Gy (500 rad) or more in 1 hour at 1 meter from a source of radiation or any surface through which the radiation penetrates. This requirement does not apply to rooms or areas in which diagnostic x-ray systems are the only source of radiation, or to non-self-shielded irradiators. (2) The registrant is not required to control entrance or access to rooms or other areas containing sources of radiation capable of producing a very high radiation area as described in paragraph (1) of this subdivision if the registrant has met all the specific requirements for access and control specified in other applicable sections of these regulations, such as those regulating x-ray equipment in the healing arts or particle accelerators.

(f) Control of access to very high radiation areas -- irradiators.

(1) This subdivision applies to licensees or registrants with sources of radiation in non-self-shielded irradiators. This subdivision does not apply to sources of radiation that are used in teletherapy, in industrial radiography, or in completely self-shielded irradiators in which the source of radiation is both stored and operated within the same shielding radiation barrier and, in the designed configuration of the irradiator, is always physically inaccessible to any individual and cannot create a radiation level of 5 Gy (500 rad) or more in 1 hour at 1 meter in an area that is accessible to any individual.

(2) Each area in which there may exist radiation levels in excess of 5 Gy (500 rad) in 1 hour at 1 meter from a source of radiation that is used to irradiate materials shall meet the following requirements:

(i) Each entrance or access point shall be equipped with entry control devices which:

(a) Function automatically to prevent any individual from inadvertently entering a very high radiation area; and

(b) Permit deliberate entry into the area only after a control device is actuated that causes the radiation level within the area, from the source of radiation, to be reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and

(c) Prevent operation of the source of radiation if it would produce radiation levels in the area that could result in a deep dose equivalent to an individual in excess of 1 mSv (0.1 rem) in 1 hour.

(ii) Additional control devices shall be provided so that, upon failure of the entry control devices to function as required by paragraph (2)(i) of this subdivision:

(a) The radiation level within the area, from the source of radiation, is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and

(b) Conspicuous visible and audible alarm signals are generated to make an individual attempting to enter the area aware of the hazard and at least one other authorized individual, who is physically present, familiar with the activity, and prepared to render or summon assistance, aware of the failure of the entry control devices.

(iii) The licensee or registrant shall provide control devices so that, upon failure or removal of physical radiation barriers other than the sealed source's shielded storage container:

(a) The radiation level from the source of radiation is reduced below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour; and

(b) Conspicuous visible and audible alarm signals are generated to make potentially affected individuals aware of the hazard and the licensee or registrant or at least one other individual, who is familiar with the activity and prepared to render or summon assistance, aware of the failure or removal of the physical barrier.

(iv) When the shield for stored sealed sources is a liquid, the licensee or registrant shall provide means to monitor the integrity of the shield and to signal, automatically, loss of shielding to a level at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour.

(v) Physical radiation barriers that comprise permanent structural components, such as walls, that have no credible probability of failure or removal in ordinary circumstances need not meet the requirements of subparagraphs (iii) and (iv) of this paragraph.

(vi) Each area shall be equipped with devices that will automatically generate conspicuous visible and audible alarm signals to alert personnel in the area before the source of radiation can be put into operation and in time for any individual in the area to operate a clearly identified control device, which must be installed in the area and which can prevent the source of radiation from being put into operation

(vii) Each area shall be controlled by use of such procedures and devices as are necessary to ensure that the area is cleared of personnel prior to each use of the source of radiation. (viii) Prior to the first individual's entry into each very high radiation area after any use of the source of radiation, the area shall be checked by a radiation me asurement. The area may not be used unless the radiation level from the source of radiation in the area is below that at which it would be possible for an individual to receive a deep dose equivalent in excess of 1 mSv (0.1 rem) in 1 hour.

(ix) The entry control devices required in subparagraph (i) of paragraph (2) of subdivision 16.12(f) shall have been tested for proper functioning. (See section 16.14(h) for recordkeeping requirements).

(a) Testing shall be conducted prior to initial operation with the source of radiation on any day, unless operations were continued uninterrupted from the previous day; and

(b) Testing shall be conducted prior to resumption of operation of the source of radiation after any unintentional interruption; and

(c) The licensee or registrant shall submit and adhere to a schedule for periodic tests of the entry control and warning systems.

(x) The licensee or registrant shall not conduct operations, other than those necessary to place the source of radiation in safe condition or to effect repairs on controls, unless control devices are functioning properly.

(xi) Entry and exit portals that are used in transporting materials to and from the irradiation area, and that are not intended for use by individuals, shall be controlled by such procedures and devices as are necessary to physically protect and warn against inadvertent entry by any individual through these portals. Exit portals for irradiated materials shall be equipped to detect and signal the presence of any loose radioactive material that is carried toward such an exit and to automatically prevent loose radioactive material from being carried out of the area.

(3) Licensees, registrants, or applicants for licenses or registrations for sources of radiation within the purview of subparagraph (2) of this subdivision which will be used in a variety of positions or in
locations, such as open fields or forests, that make it impracticable to comply with certain requirements of paragraph (2) of this subdivision, such as those for the automatic control of radiation levels, may apply to the Department for approval of alternative safety measures. Alternative safety measures shall provide personnel protection at least equivalent to those specified in paragraph (2) of this subdivision. At least one of the alternative measures shall include an entry- preventing interlock control based on a measurement of the radiation that ensures the absence of high radiation levels before an individual can gain access to the area where such sources of radiation are used.

(4) The entry control devices required by paragraph (2) and (3) of this subdivision shall be established in such a way that no individual will be prevented from leaving the area.

(g) Unnecessary use of signs and labels. Cautionary signs and labels shall not be used except as required by subdivisions (b) and (c) of this section.

__________ (5) FOOTNOTE: Labeling of packages containing radioactive materials is required by the U.S. Department of Transportation if the amount and type of radioactive material exceeds the limits for an excepted quantity or article as defined and limited by U.S. Department of Transportation regulations 49 CFR 173.403(m) and (w) and 173.421-424. (See section 16.200 for reference.)




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