Regulatory Affairs ManualSeries 100

Ozone Depleting Substances PolicyPolicy 109.1

OZONE DEPLETING SUBSTANCES POLICY

NATIONAL DISTRIBUTION CENTER SPECIFIC (NDC)

I. SCOPE

The National Distribution Center (NDC) at Somerville, NJ, which will inventory any Class 1 Ozone depletors that Fisher Scientific distributes. Regulatory Affairs located in Pittsburgh, who will maintain records of customer certifications.

II. POLICY STATEMENT

It is the policy of Fisher Scientific (the “Company”) to comply with the Environmental Protection Agency’s Clean Air Act, in particular, Section 604 which limits the production and consumption by issuing allowances or permits that are expended in the production and importation of these chemicals.

III. COMPANY RESPONSIBILITIES

  1. The Corporate Regulatory Affairs Department, in particular the Director of Product Support (DPS) and the Manager, Product Stewardship (MPS), are responsible for implementing this policy and assuring that it is understood by employees and their supervisors.
  1. The Purchasing Department for each manufacturing division is responsible for understanding this regulation and must communicate with Regulatory Affairs any wishes to purchase Class 1 ozone depletors for sale to our customers.
  1. The Marketing Department for each manufacturing division is responsible to provide Regulatory Affairs with information on new chemicals and their intended use as sold, or if an intended use happens to change.
  1. Inventory Control at NDC is responsible for ensuring that Class 1 ozone depletors are held in the cage in order to ensure the customers fill out proper paperwork before the material leaves the cage to be shipped.

III. PROCEDURES AND COMPLIANCE PROGRAMS

  1. All Class One ozone depletors are to be identified as such, by the use of the control code field on the mainframe (IMEN Screen 2). This code is to be populated with an “O”.
  2. All Class One ozone depletors are assigned a limited stock code to “SMV” only so that receipt into another warehouse is not permitted.
  3. All Class One ozone depletors are to be stored in the secure cage at NDC, which is also used to store DEA List 1 chemicals.
  4. All Class One ozone depletors are only to be sold after a customer certification (see attachment) is filled out annually. These certifications are kept on file in both NDC and Corporate Regulatory Affairs. Regulatory Affairs organizes the certifications in a database, by account number. This database is sent to NDC periodically (biweekly).
  1. Order procedure:
  2. Customers place an order for an ozone depletor.
  3. NDC receives the order.
  4. NDC checks the copy of the customer certification database that Regulatory Affairs provides.
  5. If the customer’s certification and date of certification are present and active within a year, NDC ships the product.
  6. If no certification is found on file, NDC verifies that they have no recent paperwork in the timeframe since their last update, and requests the certification from the customer to be FAXed to them. NDC sends a copy to Regulatory Affairs for entry into the database, with the customer’s account number written on the document or FAX.

Approved By: , Vice President of Regulatory Affairs

Mandatory Discretionary 

Effective Date: 01/04Rev. # 1Page1 of 2