1. To begin with we need to review some of your radiation units - see below
2. Then we will go over NRC regulations and definitions
3. We will also take an in-depth look at how the NRC classifies radiation exposure levels, note the maximum limits to each, and review some (but not all of) the regulations that govern safe radiation practice
.  Specifically, 10CFR Parts 19, 20 and 35

4. In order to apply the appropriate conversions you will need to also remember your prefixes

http://www.nrc.gov/reading-rm/doc-collections/cfr/part019/index.html

Comments regarding Part 19

• 19.1 Purpose.
• 19.11 Posting of notices to workers.
• NRC Form 3 is a map of the United States that breaks down the different NRC regions. http://www.nrc.gov/reading-rm/doc-collections/forms/.
• Note! Current copies of 10 CFR 19 and 20 must be available at all licensed facilities
• All communications from the NRC must be made available to departmental personnel
• All operating procedures must be made available to departmental personnel
• 19.12 Instruction to workers.
  •    What type of instructions are you suppose to give to the radiation worker
• 19.16 Requests by workers for inspections.
• If you think there is something going wrong that needs to be reported you can request an inspection by contacting the NRC
• 19.20 Employee protection. – you are protected by law if you "blow the whistle"
  • Violations and criminal penalties are also defined

http://www.nrc.gov/reading-rm/doc-collections/cfr/part020/index.html

Comments regarding Part 20

Parts of Subpart A - General Provisions

• 20.1004 Units of radiation dose. (see below)
• 20.1005 Units of radioactivity. (see below)

Subpart B - Radiation Protection Programs

• 20.1101 Radiation protection programs. – Every facility must have an ALARA program

Parts of Subpart C - Occupational Dose Limits

• 20.1201 Occupational dose limits for adults. (see the chart below)
• 20.1207 Occupational dose limits for minors. (see the chart below)
• 20.1208 Dose to an embryo/fetus. (see the chart below)

Parts of Subpart D - Radiation Dose Limits for Individual Members of the Public

• 20.1301 Dose limits for individual members of the public.
  •   Define the levels

Who should be monitored? (Regulatory Guide 8.7.C.1.2) Any individual who will exceed 10% of an applicable limit

No Parts to Subpart E - Radiological Criteria for License Termination

Part of Subpart F - Surveys and Monitoring

• 20.1502 Conditions requiring individual monitoring of external and internal occupational dose.
  •    Why and when should a radiation worker wear a radiation detection device?

Subpart G  - Control of Exposure From External Sources in Restricted Areas

• 20.1601 Control of access to high radiation areas.
• Definition - 0.1 rem (1 mSv) in 1 hour at 30 centimeters from the radiation source
• What special precautions must be made and how is access limited to this area?
• 20.1602 Control of access to very high radiation areas.
• Definition - 500 rads (5 grays) or more in 1 hour at 1 meter from a radiation source
• Does this concern a nuclear medicine department?

No Parts of Subpart H - Respiratory Protection and Controls to Restrict Internal Exposure in Restricted Areas

Part of Subpart I - Storage and Control of Licensed Material

• 20.1801 Security of stored material.

Parts of Subpart J - Precautionary Procedures

• 20.1901 Caution signs.

• 20.1902 Posting requirements.
• The following are the different labels that are found on a radiation sign
• CAUTION, RADIATION AREA
• CAUTION, HIGH RADIATION AREA or DANGER, HIGH RADIATION AREA.
• GRAVE DANGER, VERY HIGH RADIATION AREA
• CAUTION, AIRBORNE RADIOACTIVITY AREA or DANGER, AIRBORNE RADIOACTIVITY AREA
• CAUTION, RADIOACTIVE MATERIAL(S) or DANGER, RADIOACTIVE MATERIAL(S)
• Note the above limits stated in 20.1601 and 20.1062
• 20.1903 Exceptions to posting requirements.
• 20.1904 Labeling containers.
• Must contain "Caution, Radioactive Material" label
• Have the following information: type of radionuclide, amount, calibration date/time, radiation levels or activity
• The container that houses the radioactive material must be free of any contamination and defaced prior to discarding

• 20.2003 Disposal by release into sanitary sewerage.


• 20.2004 Treatment or disposal by incineration.

Appendix C to Part 20--Quantities of Licensed Material Requiring Labeling

Appendix G to Part 20--Requirements for Transfers of Low-Level Radioactive Waste Intended for Disposal at Licensed Land Disposal Facilities and Manifests

Parts of Subpart L - Records

• 20.2102 Records of radiation protection programs.
• 20.2103 Records of surveys.
• 20.2104 Determination of prior occupational dose.
• 20.2106 Records of individual monitoring results.
• 20.2107 Records of dose to individual members of the public.
• 20.2108 Records of waste disposal.

• 20.2201 Reports of theft or loss of licensed material.
• 20.2203 Reports of exposures, radiation levels, and concentrations of radioactive material exceeding the constraints or limits.
• 20.2204 Reports of planned special exposures.
• 20.2205 Reports to individuals of exceeding dose limits.
• 20.2206 Reports of individual monitoring.

Subpart O Discusses Enforcement and Penalties

• 20.2401 Violations


• 20.2402 Criminal penalties
  

Medical Use Of Byproduct Material – 10 CFR 35

http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/index.html

General technical requirements include, but not limited to:

• 35.50 Possession, use, calibration, and check of dose calibrators.
• 35.51 Calibration and check of survey instruments.
• 35.53 Measurement of dosages of unsealed byproduct material for medical use.
• 35.60 Syringe shields and labels.
• 35.61 Vial shields and labels.
• 35.70 Surveys for contamination and ambient radiation exposure rate.
• 35.75 Release of patients or human research subjects containing radiopharmaceuticals or permanent implants.
• 35.90 Storage of volatiles and gases.
• 35.92 Decay-in-storage.

It should be noted that in order to have a viable nuclear medicine facility there are two requirements that must be met:

1. The facility must have a radioactive material license (specific or broad)
2. The physician must be on the license and he/she has to be approved for any or all of 10 CFR Parts 35.100, 200, 300, 400, 500, 600
3. The specific Parts are noted below

Specific issues related to 10 CFR 35:

Subpart D--Unsealed Byproduct Material--Written Directive Not Required

35.100 Use of unsealed byproduct material for uptake, dilution, and excretion studies.

• What would this include?
• For specific rules on written directives see 35.40

35.200 Use of unsealed by product material for imaging and localization studies.

• What would this include?

Subpart E--Unsealed Byproduct Material--Written Directive Required

35.300 Use of unsealed by product material for therapeutic administration.

• What would this include?

Subpart F--Manual Brachytherapy

35.400 Use of sources for brachytherapy.

• Is this a nuclear medicine issue?

Subpart G--Sealed Sources for Diagnosis

35.500 Use of sealed sources for diagnosis.

• Iodine-125, americium-241, or gadolinium-153 as a sealed source in a device for bone mineral analysis
• Most department have gone to instruments that have x-ray tubes instead of seal sources
• Attenuation correction using Gd-153, Co-57, or Cs-137

Subpart H--Photon Emitting Remote Afterloader Units, Teletherapy Units, and Gamma Stereotactic Radiosurgery Units

35.600 Use of a sealed source in a teletherapy unit.

• Is this a nuclear medicine issue?

All subparts are linked to Part 35 - scroll to the end of the document

Subpart J -- Training and Experience Requirements

• Discusses the training requirement for individuals that work with by-product material
• Radiation Safety Officer
• Required training by the physician for all of the above stated in Part 35
• Training for nuclear pharmacists
• Ironically there is no requirement for the training of a Nuclear Medicine Technologist, however, the approved physician and the hospital license "accept" the responsibility

Subpart L--Records

• Take a good look at this.  A lot of information relates to how long do you have to keep certain records.  The NMTCB has been know to ask questions of this nature

Subpart M--Reports

Subpart N--Enforcement

As you can see there are many requirements (laws) identified by the NRC when it comes to handling radiation! The rationale for all of this is to protect not just you, the radiation worker, but also the general public. Failure to comply with these rules and regulations may result in you or your facility to be fined and in extreme situations the penalty could include the inability to ever work in nuclear medicine or even time spent behind bars.

Always consider proper and safe radiation practices wherever you work, your loved ones depend on it!

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