The Growth and Modernization of Radiation Safety at NIH

From the beginning of a time when "Safety" was first recognized as an office within the NIH, radiation safety has found itself alternately located in the Division of Business Operations, the National Institute of Arthritis, Metabolism and Digestive Diseases, the Plant Safety Branch, the Nuclear Medicine Department, and the Division of Administrative Services.  This was through a period of growth when NIH grew from 2,900 employees in 1950 to over 13,000 in 1972 – no doubt all campus programs experienced growth and were shifted and reorganized. 

The 1970s were a tumultuous time for the radiation safety program.  The Atomic Energy Commission (AEC), predecessor to the Nuclear Regulatory Commission (NRC), had declared in 1971 that the radiation safety program at NIH was "the worst in the 13 State area" that the AEC region serviced.  As a result of this assessment by NIH's regulator, major changes ensued.  The radiation safety program expanded its oversight functions to comply with AEC licenses and regulations and reorganized its management processes.  An emphasis on safety culture was proclaimed from the NIH Director on down to staff.  

In 1976, an AEC inspection noted a positive turn-around and deemed the radiation safety program effective at managing worker safety.  By 1979, when the Radiation Safety Branch (RSB) joined the new Office of Research Services (ORS), the program was on solid ground and able to tackle new challenges.  From 1979, let's walk through the decades of challenges faced and see where radiation safety is now.

                The 1980s brought a steady increase in the use of radioactive materials in research as new scientific discoveries opened new frontiers.  This trend complicated the tasks of inventory control and waste management.  Ensuring everyone was trained, wearing dosimetry and undergoing bioassays in accordance with requirements was also a herculean task involving thousands upon thousands of index cards.  Daunting was the requirement that any record related to internal or external dose to workers had to be kept forever – a law still in place today.  The 1980s also saw the christening of the NIH Cyclotron Facility, which required oversight for the production and use of high levels of energetic radioactivity not previously used at NIH before.

                The RSB made a forward-thinking decision in the 1980s to develop a comprehensive database system in order to keep track of all things radiation safety.  This has proven to be the most impactful decision it has ever made.  The genius in this decision was not just to have a database but rather to create a customizable and expandable database that could handle future needs. While many university/hospital radiation safety programs utilize off-the-shelf database software products, these products are usually not customizable and have limitations.  In contrast, the NIH database has evolved through the use of dedicated computer programmers to meet all the needs of the NIH Radiation Safety Program. The database tracks and cross-references all aspects of ordering, receipt, delivery, usage, surveys, training, waste disposal, incidents, and everything in between.

                The 1990s continued the trend of increased radioactive material use at NIH, especially with efforts to sequence the human genome.  Expanded NIH funding meant expanded lab space. The increase in radioactive material use was felt in RSB with the opening of several lab locations off campus.  NIDA and NIA labs in Baltimore also were added to the NIH license under RSB jurisdiction.  RSB continued to provide oversight in this expanded era of radioactive materials use, and the Branch staffing grew as well.

                However, the defining event of the 1990s for RSB was in 1995 when radioactive P-32 was found in a worker's lunch and a water cooler in a lab building.  This resulted in a pregnant researcher ingesting a detectable (small) amount of P-32, along with 20+ other individuals ingesting trace amounts after drinking from the water cooler.  The response and investigation into this event consumed RSB for nearly three years as the NRC was heavily involved in the follow-up activity.  This event also brought attention from outside law enforcement and national media.

                The 2000s were framed by the September 11, 2001 terrorist attacks.  RSB – now named the Division of Radiation Safety (DRS) – spent considerable time evaluating the security of radioactive materials, especially those that could conceivably be used in a "dirty bomb" scenario.  Security requirements – not popular with the researchers – were enacted and enforced.  The use of radioactive materials began to decline from its 1990s peak, but DRS' workload was shifted to accommodate two significant NRC directives that were mandated in 2005.  The first was to implement "Increased Controls" on the possession and access to radioactive materials in quantities of concern.  This necessitated the assignment of a full-time health physicist to implement these new security requirements, which are still in effect across NIH today.  The second was to place the regulation of cyclotron-produced radioactive materials under NRC authority.  This meant that cyclotron production needed its own NRC license and radiation safety additional oversight.  Again, DRS had to reassign a full-time health physicist to implement this new license program area.

                Another important change in radiation safety operations occurred in the early 2000s with changes to NRC guidance on decommissioning former radioactive material use space.  Instead of simple clearance surveys to demonstrate a space was free of contamination, a much more rigorous decommissioning regime was imposed. This regime necessitated a contracted operation for surveying and sampling at a time when NIH was beginning to renovate full buildings.

                DRS greatly enhanced its customer service to NIH in the early 2010s, as the comprehensive database allowed for the roll-out of an online portal for radiation users to conduct various tasks themselves.  This includes administrative tasks, such as submission of forms as well as completion of most routine training.  The 2010s also continued the slow decline of bench-top radioactive material use at NIH, but counteracted by a steady increase in clinical applications using more radioactive materials and x-ray radiation in diagnostic scans.  The 2010s also brought a large increase in the number of researchers wishing to work with cyclotron-produced radioactive material, requiring the use of Hot Cells for these high-energy nuclides.  DRS was there to help design and operate these facilities in a safe and compliant manner. 

                DRS has come a long way since the 1950s and the future holds more programmatic changes to come.  The 2020s are expected to see additional clinical modalities using more exotic isotopes than before, both in diagnostic and therapeutic applications.  DRS also expects that its comprehensive database will evolve further to make the radiation safety program nearly paperless.  What won't change is the numerous collaborative relationships DRS has forged with nearly every aspect of safety, security and life sciences research program areas.

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