MILLBURN, NJ – Board certified health physicist Patrick McDermott presented his findings to Millburn’s Township Committee with regard to Advanced Accelerator Application’s (AAA) intent to manufacture cancer-fighting drugs using radioactive isotopes in Millburn. McDermott was retained as an independent subject matter expert by the Township to provide an assessment of the potential risks associated with AAA’s management of radioactive materials.
AAA is a global radiopharmaceutical company that develops molecular nuclear medical products and is intending to locate its North American headquarters and manufacturing facilities on E. Willow St. A radioactive isotope, Leutetium-177 (Lu-177), is used to produce Lutathera, which is an orphan drug that attaches to tumor cells and destroys targeted tissues.
McDermott, the current Radiation Safety Officer at Rutgers University and President of RyCon Solutions, stated that there is “close to zero without being zero risk” of the public being subjected to a radioactive dose in the ordinary operations of manufacturing the drug or in a disaster scenario of fire and flooding on the site.
He gave an example. If a building containing the same amount of radioactive material that AAA intends to store in Millburn was on fire, it was burning for two continuous days and a person was standing within the 200 foot “hotspot” of the flames for four days (96 consecutive hours), the highest calculated dose of radiation this fictitious person would absorb is below the 100 millirems (mrems) per year under normal operating conditions.
A millirem, which is one thousandth of a rem, is often used for dosages commonly encountered with an amount of radiation received from an x-ray or background sources.
To put this example in context, the average U.S. resident receives about 620 mrems from all sources, which causes no measureable harm. These sources include cosmic radiation, terrestrial radiation, radiation from medical procedures and even from foods that we eat. Bananas, potatoes, carrots, red meat, beer (uh oh) and lima beans are some examples. Basically anything containing potassium is radioactive, albeit in extremely small doses. Even our bodies are radioactive due, at least in part, to radionuclides like carbon-14 and uranium.
In the event of a flood, McDermott provided this scenario. Assuming a 15,000 s.f. building is flooded with four feet of water. Assuming 10% of the total inventory was mixed in the water, one would have to drink a gallon of that water to receive a 100 mrem dose of radiation. In reality, there would likely be a thousand times this volume passing through the AAA facility which would require someone to drink hundreds, if not thousands, of gallons to receive even a small dose. Sewage and other environmental waste in the water would be more harmful.
“Going almost to the absurd with the scenarios, I could not find a reasonable mechanism for any meaningful or measureable dose”, said McDermott. “Barring any crazy events, there is no pathway for radioactive exposure to the residents of Millburn.”
In an interview with James Cook, AAA’s Chief Operations Officer, he said, “There is a misconception that radiopharmaceuticals are new to Millburn.”
Several years ago on the same street where AAA is currently located, Advanced Diagnostic Imaging of Millburn (ADI) was operating a facility using nuclear medicine. They were using radiopharmaceuticals similar to the products that AAA uses. In the case of ADI, they were using Florine-18, a gamma emitter that could perhaps be of more concern than Lu-177, a beta emitter.
According to Cook, radiopharmaceutical manufacturers are not that unique. He commented there are over 400 such operations throughout the U.S. and about 10 in New Jersey. He pointed to well-known local institutions like St. Barnabas Hospital and GE Healthcare in Livingston and Overlook Hospital in Summit.
“Those are pharmacies or manufacturers. So they are making products just like we are.” Cook noted. “Some of them have accelerators that are actually creating radioactivity, called cyclotrons (particle accelerators). We don’t have that.”
Millburn was chosen as an ideal site for AAA due to its proximity to Manhattan, train stations, size of the facility and an attractive downtown.
TAP also spoke with Bill Diamantopoulos, AAA’s Site Manager in Millburn. When asked about safety standards, he commented, “The difference between manufacturers [like us] and radiopharmacy is that we are held to a higher standard of regulation.”
McDermott, Cook and Diamantopoulos expressed very similar, if not exactly the same, sentiments with regard to safety precautions that are in place at the facility, adherence to state and federal regulations and safeguards instituted throughout the AAA supply chain. It is anticipated that the New Jersey Department of Environmental Protection will state similar views.
McDermott stated AAA was welcoming, transparent and supportive of his investigation. He was granted access to facilities, documents, diagrams, proprietary SOPs (standard operating procedures) and responded to all queries.
“The process and the amount of infrastructure they [AAA] are putting into the site are substantive.” Said McDermott. “It’s a very impressive plan that they have.”