Lessons learned from industry inspections

The CWC Regulations (CWCR) (15 CFR 710 et seq.) require commercial facilities engaged in the production, processing, or consumption of certain toxic chemicals and their precursors to submit annual declarations and to provide access for on-site inspections conducted by the Organization for the Prohibition of Chemical Weapons (OPCW), which administers the Convention. 

BIS acts as the host and escort for OPCW inspection teams during inspections of U.S. facilities subject to the CWCR (see part 716 of the CWCR). In addition, BIS provides advance preparation assistance for after a facility is notified of an inspection.  Although all facilities have unique characteristics and proprietary concerns, there are common issues that have arisen in preparation for and during inspections.  

Your entire “declared” plant site is subjected to verification activities conducted by OPCW inspection teams.  While there are common conceptions of what the terms "plant site" and "plant" mean to U.S. industry, the CWCR contains precise definitions (see 710.1) that should be followed and assist in establishing the scope and conduct of on-site verification activities. 

Plant site is defined by the CWCR as the local integration of one or more plants, with any intermediate administrative levels, which are under one operational control, and includes "common infrastructure" (e.g., medical center, central analytical laboratory, utilities, warehouse storage). Operational control is the key criterion and does not necessarily equate to ownership. Although there is no treaty-based criterion for determining operational control, the operator is likely responsible for budget, profits, production planning, and decision making for declared and undeclared "plants" under its control within a chemical complex. Typically, a plant site is delineated by fence line or the property line. However, a company with multiple separate/independent on-site business units can use the operator criterion as the baseline for determining the appropriate plant site delineation. 

Plants are defined as relatively self-contained areas, structures, or buildings containing one or more units (items of equipment, including vessels and vessel set up, necessary for the production, processing, or consumption of a chemical) with "auxiliary and associated infrastructure" (e.g., storage/handling areas for feedstock and products, waste treatment), under one operational control, plus "common infrastructure," whether or not controlled by this operator. "Auxiliary and associated infrastructure" usually are dedicated to the declared plant's operations (i.e., not shared among declared or undeclared plants) and under the plant site operator's control. 

If the "declared plant site" is not the company's fence-line, it is useful if the plant site name on the declaration is unique to the declared area (i.e., not the name of the chemical complex). This notifies inspection teams prior to arrival on-site that the "declared plant site" will not be equivalent to the fence line and facilitates discussions of plant site delineation during the inspection. Companies are responsible for demonstrating that the delineation of declared plant sites is in accordance with the definition with official documentations. 

The key to a successful inspection is have a comprehensive pre-inspection briefing (PIB). The PIB sets the tone of the inspection, affording company representatives the opportunity to inform and orient the inspection team to the facility and propose a methodology for demonstrating compliance while minimizing burdens on operations. 

Section 716.4(c) of the CWCR outlines required and suggested topics for the PIB. A PIB template can be found here.

A "windshield" tour is normally conducted right after the PIB and helps orient the inspection team to the declared plant site. Although the tour is not a regulatory requirement, it facilitates inspection activities.  All areas comprising the declared plant site (i.e., declared and undeclared plants, auxiliary/associated infrastructure, common infrastructure) should be included on the windshield tour along with explanations of the purpose of each area, building, or structure. The windshield tour normally includes visual access to all areas on the plant sites.  Since verifying the absence of Schedule 1 chemicals is a primary aim of all inspections, the facility should point out the lack of indicators of Schedule 1 chemicals during the windshield tour (see discussion below on indicators of Schedule 1 chemicals). 

Facilities, in cooperation with BIS Host Team, should plan tour routes in advance of inspection team arrival to avoid sensitive areas and information. 

Sites should expect an inspection team to "verify that activities are consistent with the information provided by the inspected State Party in the declarations." This includes a number of other data elements included in declarations that will be verified. Of particular interest to inspection teams is ownership and product group codes (PGCs). 

Very often, ownership can be demonstrated through official documents from a local governmental agency (local or federal) to the company (permits, tax, license, etc.). To verify the PGCs identified in the declaration, site can provide documentation such as SDS to show the type of chemicals or family of chemicals produced the site.