April 3, 2008

Dear Radiation Safety Officer:

As you may know, the Radiation Control Program of the Texas Department of State Health Services recently announced changes to 25 Texas Administrative Code (TAC) which regulates sources of radiation in Texas.  Specifically, changes were made to 25 TAC §289.257 Packaging and Transportation of Radioactive Material which will affect the return of spent and unused bulk and unit doses from your facility to NuTech by our delivery personnel.

Prior to this change, the upper limit for Tc-99m activity that could be returned to NuTech in an ammo box without a shipping paper under the limited quantity package exception was 21.6mCi, which allowed most used unit doses and many unused doses to be returned on the same day as being dispensed.  After the change, the maximum limit for Tc-99m is now only 11.0 mCi per package.  This significant change will make it impossible for you to return many unused doses on the same day as dispensed without generating a shipping paper and properly labeling the container.  Obviously, this will not be an issue for customers who receive only one delivery run from us daily, but all other customers will be affected by this change.

As an example of the effect of this change, to return a single unused 30 mCi HDP, MDP, Myoview, or Cardiolite unit-dose on the same day as being dispensed, you, as the HAZMAT (Hazardous Materials) shipper, would be required to generate a shipping paper, perform surveys and wipes, complete the shipping paper, and properly label and mark the container as a White-I or Yellow-II.  Failure to complete these requirements is a violation of 49 CFR §107.329 and could subject your facility to a penalty and fine.  As you can see, it is imperative that each package returned to us fall below the new 11.0 mCi limit for Tc-99m so that the shipping paper and other requirements do not apply.

In order to comply with this change, we are asking our customers to take steps to prevent any doses from being returned to us that exceed this limit.  As a general rule, retaining any unused unit or bulk doses in your facility for 18 hours from dose calibration time will achieve compliance.  Alternately, you may perform assays or calculations specific to your unused dose(s) to determine compliance with the 11.0 mCi limit per package.    

As a reminder, compliance with the activity limit is only the first of four requirements that a package must meet in order to be shipped without a shipping paper.  The others are: 2) the package surface survey reading does not exceed 0.5mR/hr; 3) the package surface removable contamination does not exceed 220 dpm/cm²; and 4) the outside of the package bears the markings “Radioactive” and UN2910.

Also as a reminder, any facility personnel who function as a HAZMAT Employee, which includes Nuclear Medicine Technologists who prepare packages for return to the pharmacy, must be trained according to the requirements of 49 CFR §172.704 within 90 days of employment and every 3 years thereafter.  Failure to properly train may subject the employer to penalties and fines. 

Since HAZMAT Employees of the shipper are responsible for preparing packages for transport, beginning April 7, NuTech delivery drivers will be trained to pick up for return only packages that are already closed and marked and labeled as being in compliance with the conditions and limitations required for excepted packages for limited quantities of Class 7 (radioactive) materials.  This means that our drivers will no longer be allowed to assist in the preparation of packages in any way since the regulations make it clear that this activity is solely the responsibility of the shipper.

Please confirm that your HAZMAT Employees understand and will comply with these conditions and limitations. 

Thank you for your cooperation in meeting this new requirement.  Please contact us if you have any questions, if you need help with HAZMAT training, or if we may help you in any way.

Sincerely,

Monty Ingram, BCNP

New Activity Limits for transport as Excepted Package – Limited Quantity*

(*This table also appears on the inside flap of our ammo boxes.)