Title: Section 1006.3 - Proprietary Information

1006.3 Proprietary Information

(a) For purposes of this Part only, proprietary information may consist of any information subject to disclosure pursuant to this Part the disclosure of which would compromise a manufacturer's competitive position. Any proprietary information submitted or divulged to the Department of Health pursuant to this Part shall not be available for, or subject to, public disclosure. Proprietary information shall include, but is not limited to, any:

(1) Commercially valuable plan, formula, process, or device that is used for the making,

preparing, or processing of vapor products, e-cigarettes, or their components, and that can be said to be the end product of either innovation or substantial effort. There must be a direct relationship between the proprietary information and the productive process; or

(2) Valuable data or information which is used in a manufacturer’s business and is of a type customarily held in strict confidence or regarded as privileged and not disclosed to any member of the public by the person to whom it belongs.

(b) A manufacturer submitting information to the Department pursuant to this Part may designate part or all of the information in such records as exempt from disclosure. The Manufacturer may make this designation either at the time the records are submitted to the Department or within a reasonable time thereafter. Such designation must be in writing and must set forth the reasons why the information should be excepted from disclosure as proprietary information, including, as appropriate:

(1) the specific information requested to be considered proprietary information, including, where applicable, page, form, line, chart or table designation;

(2) the confidential nature of the record, including a description of the nature and extent of the injury to the manufacturer’s competitive position such as unfair economic or competitive damage which would be incurred were the information to be disclosed;

(3) whether the information is treated as confidential by the manufacturer, including whether it has been made available to any other manufacturer or to the public;

(4) whether any patent, copyright, or similar legal protection exists for the information;

(5) whether the public disclosure of such information is otherwise restricted by law, and the specific source and contents of such restrictions;

(6) the date upon which such information will no longer need to be kept confidential, if applicable;

(7) whether the request itself constitutes information which, if disclosed, would defeat the purpose for which proprietary status is sought;

(8) whether the information is known outside of the business of the manufacturer, and the extent to which the record is known by the employees and others involved in the business of the manufacturer;

(9) the value of the information to the manufacturer and to its competitors;

(10) the amount of effort or money expended by the manufacturer in developing the information, and the ease or difficulty with which the information could be properly acquired or duplicated by others;

(11) any other factors considered relevant.

(c) When information designated as proprietary information has been submitted to the Department, it shall be excepted from disclosure and maintained apart by the Department from all other records until 15 days after the entitlement to such exception has been finally determined by the Commissioner or such further time as ordered by a court of competent jurisdiction.

(d) A denial of an exception from disclosure requested pursuant to this section shall be final.

(e) The Commissioner shall not approve any exceptions under this section with respect to any ingredient that is a chemical of concern on one or more lists identified by the Commissioner.