(1) You must keep documentation you develop, of the processing, use, or handling of products made from or containing EtO, that conclusively demonstrates that the action level or STEL for EtO cannot be exceeded under any foreseeable conditions of use.

(2) You must include the following in the documentation record:

(a) The product that is the subject of the documentation;

(b) The source of the data;

(c) Any testing protocol, results of testing, and/or analysis of the product for the release of EtO;

(d) A description of the operation where the product is used and how the data support your conclusion; and

(e) Other data relevant to the operations, materials, processing, or employee exposures covered by your conclusion.

(3) You must maintain the documentation record for as long as you rely on your conclusion that the action level and STEL cannot be exceeded.