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• Standard Number: 1910.119

November 14, 1994

Mr. Bruce S. Miller Rhone Poulenc Rorer Pharmaceuticals, Inc. Integrated Environmental Services 10 East 6th Avenue Conshohocken, PA 19428

Dear Mr. Miller:

This is in response to your May 24 letter, requesting interpretation of the Process Safety Management (PSM) of Highly Hazardous Chemicals (HHCs) standard, 29 CFR 1910.119. Specifically, you requested confirmation that the storage and application of a shellac-based pharmaceutical glaze at your manufacturing facility in Fort Washington, Pennsylvania are not subject to the PSM standard. Your workplace scenario and our reply follow. Please accept our apology for the delay in responding.

Scenario: The shellac-based (65% ethyl alcohol, flammable liquid) pharmaceutical glaze material is stored in a designated storage area consisting of a refrigerated vault with walls having a 4-hour fire rating and a fire door in addition to the refrigerated door. This storage system effectively isolates the material from the rest of the materials at Rhone Poulenc Rorer's (RPR's) facility.

Due to the time required for quality control and the nature of the product supply, RPR is required to store in excess of 10,000 pounds (4535.9 kg) of this material in the refrigerated vault. Five-gallon plastic car-boys are stacked on skids, 24 to a skid. The approximate weight of one car-boy is 38.5 pounds (17.46 kg), giving a skid capacity of 924 pounds (419.12 kg) of material. The storage area normally contains 10 to 20 skids of material. During a September 19 telecon between you and Mr. Ronald Davies of my staff, it was discerned that the car-boys of flammable pharmaceutical glaze are delivered to the RPR facility by way of commercial carriers.

The material is received and stored in 5-gallon (18.9 liter) plastic car-boys. These car-boys, while sealed, are not designed for pressures other than atmospheric operation. The material is stored in a refrigerated storage area in order to maintain product integrity. Since the material has a boiling point of 173 degrees Fahrenheit (83.89 degrees Centigrade), cooling is not required to maintain it below its boiling point.

Therefore, even without refrigeration, this material would be below its boiling point. Paragraph 1910.119(a)(1)(ii)(B) excepts material stored in atmospheric tanks below the material's boiling point.

The material is used in a tablet-coating operation. Material is removed from storage one skid (924 lb) at a time and moved to the production area. There is no direct connection (pipe or duct) from the storage area to the other processing areas. In the production area, material is removed and used one car-boy at a time, with the maximum application rate of 84 pounds (38.10 kg) per hour. At any given time, the maximum quantity of material in any of the production areas (other than storage) is approximately 1,500 pounds (680.38 kg).

No other area of the facility (except the refrigerated material storage area) or process has 10,000 pounds or more in combination of this material and other flammable materials.

Reply: Unless additional, unaddressed circumstances require coverage, the flammable pharmaceutical glaze in the refrigerated vault is considered a process excepted by paragraph 1910.119(a)(1)(ii)(B) from coverage by the PSM standard. This interpretation is based on the following factors.

1. The process only includes the activities of storage and associated transfer of the flammable liquid glaze; and

2. The flammable liquid is in Department of Transportation approved car-boys (which are considered equivalent to storage in atmospheric tanks); and

3. Although refrigeration is used to maintain product integrity, such refrigeration is not required to keep the flammable liquid below its normal boiling point.

The process involving the activities of on-site movement, handling, and use of the flammable liquid glaze is considered a separate process from the aforementioned storage process and would not be covered unless this production process contained a threshold quantity, that is, 10,000 lbs (4535.9 kg) of flammable liquids at any one point in time. Please note that when determining threshold quantity, flammable liquids in a process are considered in aggregate.

We appreciate your interest in employee safety and health. If we can be of further assistance, please contact Mr. Ronald Davies of my staff, telephone 202-219-8031, extension 110.

Sincerely,

John B. Miles, Jr., Director Directorate of Compliance Programs


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