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An RMUA gives a principal investigator (the authorized user) authority to order, receive, use, and dispose of the types of radioactive materials specified in the RMUA. Each new RMUA is reviewed and approved by the RSC.

3.1 Application and Interim Approval

A new investigator who needs to order and use radioactive material or a radiation-generating machine must submit an RMUA and details of his or her training and experience to the RSO. An RMUA must be submitted before the first order of radioactive material is placed. Interim approval may be requested by the PI submitting a new application or amendment, to be reviewed by the Chair of the RSC and the RSO.

RMUA and RMUA Amendment forms are available directly in Forms Central.

3.1.1 Information Included in the RMUA

The RMUA requests the following information:

  1. Which radionuclides are to be used (3H,14C, etc.);
  2. Total amount of radioactive materials possessed in the lab at any one time;
  3. Specific lab procedures to be performed;
  4. Security measures for the storage of radioactive material;
  5. Names of lab staff using radioactive materials;
  6. Locations of radioactive material storage and use;
  7. Emergency contact persons; and
  8. Statement of Training and Experience of new PI.

For use of sealed sources, LinAc, or animal work, complete the addendum form.

3.1.2 Approval Criteria

Each new RMUA application requires that the RSO visit the lab, contact the PI, or send a representative to discuss the facilities available to the PI. The following criteria must be met before an investigator is allowed to order or use radioactive material at the Fred Hutchinson Cancer Research Center:

  1. An RMUA is satisfactorily completed and submitted to the RSO.
  2. A sufficient number of radiation detection instruments are available in the lab and are on an annual calibration schedule.
  3. The PI's staff is adequately trained in radioactive material usage or scheduled to receive training.
  4. Contamination survey procedures are established.
  5. Radioactive waste disposal procedures are established.
  6. Appropriate animal facilities are available if animals will be used in conjunction with radioactive materials.
  7. Adequate lab facilities, including shielding, radioisotope, or chemical fume hoods and storage facilities are available.

RMUAs are also used to track use of radiation-producing machines; not all portions of the RMUA may be applicable in those cases.

3.1.3 Interim Approval by the RSO

After a new RMUA is submitted, the RSO and RSC chairperson can give interim approval for 120 days if the RMUA is complete and the radioactive material will be used safely according to the RMUA. Interim approval allows the PI to order radioactive material. By the end of 120 days, the RMUA will have been reviewed by the RSC and if satisfactory, approved. If approved, the investigator is then termed an authorized user and may use radioactive material within listed locations for five years.

At any time during the approval process, the RSO or any member of the RSC can request further information from the RMUA applicant or can request that equipment be obtained to ensure safe use of the radioactive material.

Permission to use radioactive material can be revoked at any time by a simple majority of the RSC if the PI cannot prove that radioactive material under his or her supervision is being used properly and safely, or if the rules and regulations of the state DOH or this manual are not being followed in the lab(s) under that investigator's direction.

A postdoctoral fellow, staff scientist, or other person who operates under his or her own grant in a lab of an authorized PI is considered to be working under that PI's RMUA.

3.2 Amendments

Revisions to an existing RMUA must be submitted to the RSO on an RMUA Amendment Form or in a letter to the RSO. Amendments must be made for the following circumstances:

  1. An addition of a new radionuclide;
  2. Any increase or decrease in the maximum amount of activity to be possessed at any one time;
  3. Use of a different type of compound that increases risk to staff (e.g., switching from 125I-labeled compounds to NaI);
  4. Addition of new labs or removal of lab from RMUA;
  5. A change in any procedure that increases the risk to staff; or
  6. Changes in animal protocols that involve in vivo radioactive material use.

New staff will be added to the lab when the RSO receives the Radiation Worker and Dosimeter Application. Lab staff changing labs should notify the RSO by submitting the same application form with only the top section filled out.

3.3 Renewals

An RMUA is approved for five years. At the end of five years, the RSO will request that the PI complete and submit a new RMUA application incorporating all amendments made over the last five years. All renewals involving radioactive materials use in labs must be reviewed and approved by the RSC.

3.4 Radioactive Material Inventory Limit

The radioactive material inventory limit is the maximum activity of a radionuclide that a PI can have on hand at any one time. The PI proposes an inventory limit on the RMUA or amendment for each radionuclide to be used. An inventory limit can be changed by submitting an RMUA amendment to EH&S.

The inventory limit is used to:

  1. Decide which type of review is needed;
  2. Set a limit on the amount of radioactive material that can be in the possession of a PI at any one time;
  3. Evaluate the need for shielding or engineering controls needed; and
  4. Ensure Fred Hutch does not violate its own license limits.

3.5 Approval Process For RMUA Amendments

The type of approval process an RMUA amendment goes through depends on the inventory limit. The larger the inventory limit, the more stringent the approval process. This helps focus the RSC's attention on the higher-risk uses of radioactive material.

If the inventory limit (new or amended) is equal to or less than those listed in Table 3.5.1, the RSO can approve the RMUA amendment and submit a summary at the next RSC meeting. At that time, the committee can request changes or additional information from the PI.

Table 3.5.1: Inventory Limits the RSO Can Approve

Radionuclide

mCi

Radionuclide

mCi

Radionuclide

mCi

H-3

100

Ni-63

100

I-123

50

C-14

100

Ga-67

100

I-125

10

Na-22

10

Se-75

100

I-129

10

Na-24

50

Br-82

100

I-131

10

P-32

100

Kr-85

100

Xe-133

100

S-35

100

Rb-86

100

Cs-137

10

Cl-36

10

Sr-89

100

Gd-153

50

K-42

100

Sr-90

1

Gd-159

100

Ca-45

10

Zr-88

100

Sm-153

100

Cr-51

100

Y-90

100

Ho-166

100

Fe-55

100

Mo-99

100

Ir-193

100

Fe-59

50

Tc-99m

100

Ra-226

1

Co-57

100

Cd-109

100

Am-241

10

Co-60

10

In-111

100

Cf-252

10

The inventory limit for radionuclides not listed is 10 mCi. These values represent, at most, 10% of the quantity limits for broad licenses (WAC 246-235-140 Schedule B, Column 1).

If the inventory limit is greater than the limits in Table 3.5.1, the RMUA amendment may receive interim approval by the RSC chairperson and the RSO and submitted at the next RSC meeting. The committee may request changes or additional information from the PI at the committee review. The RSO can approve all use of the irradiators and x-ray-generating machines.