Mine Rescue Gases

Resulting from a number of recent highly publicized disasters, the mining industry is moving to increase worker safety. One outgrowth of this activity is the development of devices referred to as mine safety/rescue chambers. This article will examine how the development of these devices is impacting the gases industry, what regulatory issues these devices are creating, and how the industry is moving to solve these issues.

While they take many forms, in general, mine safety chambers are engineered to be safe havens that contain the basic elements miners need to survive a mine cave in or other disaster. In addition to food, water and other survival items, these devices also incorporate a supply of oxygen to sustain life. Informally, FDA has been allowing Oxygen USP to be sold for this application. FDA is using their enforcement discretion, even though under FDA’s traditional interpretation of the Food Drug & Cosmetic Act and the cGMP regulations, mines are not qualified healthcare facilities and the oxygen is not being prescribed by a doctor to an individual. Without the agency’s informal enforcement discretion, the only other gas that could be supplied for mine safety chambers would be aviator breathing oxygen (ABO), as the MSDS documents supplied by almost all of the major gas firms state unequivocally that industrial oxygen is not suitable for human respiration.

Recently, mine operators have begun requesting 40-50 percent oxygen concentration balance nitrogen mixtures for their rescue chambers. This opens a whole other can of worms, as there are no labeling or testing guidelines for this type of product. High oxygen concentration O2/N2 mixtures are not established medical mixtures, and there is no USP/NF medical gas monograph to follow. To produce this gas as a medical mixture, the firm would be required to go through the new drug application process, which is both very time-consuming and expensive. The other option would be to supply a mixture labeled as an industrial gas, which technically is not suitable for human consumption.

High oxygen concentration O2/N2 mixtures are not established medical mixtures, and there is no USP/NF medical gas monograph to follow.

Another area FDA apparently failed to consider is that mine owners, rather than bring these cylinders to the surface and return them to the supplier for refilling, would want to fill/top off these cylinders in situ. A key consideration which is yet to be answered regards the issue of registration and listing. For example, if the mine safety chambers are filled/refilled with medical gases by the mine operators, are they required to register with FDA as medical gas manufacturers, and meet all applicable cGMP requirements applicable to medical gas manufacturers?

All of this leaves our industry and the supply of life-sustaining gases for mine safety chambers in an untenable position. Those who have been around as long as I have know that FDA can reinterpret their enforcement policy at some point in the future, ultimately leaving the supply of life-sustaining gases to mine operators in limbo.

In order to resolve these regulatory issues, GAWDA has adopted a proactive problem-solving approach. Rather than wait for this to become an issue, together with CGA, we have begun identifying the full range of issues and are in the process of determining, from our industry’s perspective, the appropriate means of resolution. Once that process is complete, together with CGA, we will approach FDA for discussions on achieving resolution. While this is not likely to happen overnight, the end result should result in documented industry/FDA guidance that manufacturers and mine owners can rely on.

Gases and Welding Distributors Association
Meet the Author
GAWDA Medical Gases Consultant J. Robert Yeoman is president & CEO of B&R Compliance Associates LLC in Lehigh Valley, Pennsylvania. Members can reach him at (610) 868-7183 and at bob.yeoman@brcompliance.com.