PART 716—INITIAL AND ROUTINE INSPECTIONS OF DECLARED FACILITIES Authority: 22 U.S.C. 6701 et seq.; Source: 71 FR 24929, Apr. 27, 2006, unless otherwise noted. § 716.1 General information on the conduct of initial and routine inspections. This part provides general information about the conduct of initial and routine inspections of declared facilities subject to inspection under CWC Verification Annex Part VI(E), Part VII(B), Part VIII(B) and Part IX(B). See part 717 of the CWCR for provisions concerning challenge inspections. (a) Overview. (b) Declared facilities subject to initial and routine inspections Schedule 1 facilities. (ii) If you are a new Schedule 1 production facility pursuant to § 712.4 of the CWCR, your facility is subject to an initial inspection within 200 days of submitting an initial declaration. Note to § 716.1( b All Schedule 1 facilities submitting a declaration are subject to inspection. (2) Schedule 2 plant sites Inspection thresholds for Schedule 2 plant sites. (A) 10 kg of chemical BZ: 3-Quinuclidinyl benzilate (see Schedule 2, Part A, paragraph 3 in supplement no. 1 to part 713 of the CWCR); (B) 1 metric ton of chemical PFIB: 1,1,3,3,3-Pentafluoro-2(trifluoromethyl)-1-propene or any chemical belonging to the Amiton family (see Schedule 2, Part A, paragraphs 1 and 2 in supplement no. 1 to part 713 of the CWCR); or (C) 10 metric tons of any chemical listed in Schedule 2, Part B (see supplement no. 1 to part 713 of the CWCR). (ii) Initial inspection for new Schedule 2 plant sites. Note to § 716.1( b The applicable inspection threshold for Schedule 2 plant sites is ten times higher than the applicable declaration threshold. Only declared plant sites, comprising at least one declared plant that exceeds the applicable inspection threshold, are subject to inspection. (3) Schedule 3 plant sites. Note to § 716.1( b The methodology for determining a declarable and inspectable plant site is different. A Schedule 3 plant site that submits a declaration is subject to inspection only if the aggregate production of a Schedule 3 chemical at all declared plants on the plant site exceeds 200 metric tons. (4) Unscheduled discrete organic chemical plant sites. Note 1 to § 716.1( b You must include amounts of unscheduled discrete organic chemicals containing phosphorus, sulfur or fluorine in the calculation of your plant site's aggregate production of unscheduled discrete organic chemicals. Note 2 to § 716.1( b All UDOC plant sites that submit a declaration based on § 715.1(a)(1)(i) of the CWCR are subject to a routine inspection. Note 3 to paragraph ( b Any UDOC plant site that is eligible, in accordance with § 715.1(d)(2) of the CWCR, to submit a Change in Inspection Status Form or an Annual Declaration on Past Activities by December 15th of the current calendar year ( i.e. (c) Responsibilities of the Department of Commerce. (1) Lead on-site inspections; (2) Provide Host Team notification to the facility of an impending inspection; (3) Take appropriate action to obtain an administrative warrant in the event the facility does not consent to the inspection; (4) Dispatch an advance team to the vicinity of the site to provide administrative and logistical support for the impending inspection and, upon request, to assist the facility with inspection preparation; (5) Escort the Inspection Team on-site throughout the inspection process; (6) Assist the Inspection Team with verification activities; (7) Negotiate the development of a site-specific facility agreement, if appropriate (see § 716.6); and (8) Ensure that an inspection adheres to the Convention, the Act and any warrant issued thereunder, and a site-specific facility agreement, if concluded. [71 FR 24929, Apr. 27, 2006, as amended at 72 FR 14409, Mar. 28, 2007] § 716.2 Purposes and types of inspections of declared facilities. (a) Schedule 1 facilities Purposes of inspections. (i) The facility is not used to produce any Schedule 1 chemical, except for the declared Schedule 1 chemicals; (ii) The quantities of Schedule 1 chemicals produced, processed or consumed are correctly declared and consistent with needs for the declared purpose; and (iii) The Schedule 1 chemical is not diverted or used for purposes other than those declared. (2) Types of inspections Initial inspections. (B) For new Schedule 1 production facilities declared pursuant to § 712.4 of the CWCR, the U.S. National Authority, in coordination with BIS, will conclude a facility agreement with the OPCW before the facility begins producing above 100 grams aggregate of Schedule 1 chemicals. (ii) Routine inspections. (b) Schedule 2 plant sites Purposes of inspections. (A) The absence of any Schedule 1 chemical, especially its production, except in accordance with the provisions of the Convention; (B) Consistency with declarations of production, processing or consumption of Schedule 2 chemicals; and (C) Non-diversion of Schedule 2 chemicals for activities prohibited under the Convention. (ii) During initial inspections, Inspection Teams shall collect information to determine the frequency and intensity of subsequent inspections by assessing the risk to the object and purpose of the Convention posed by the relevant chemicals, the characteristics of the plant site and the nature of the activities carried out there. The Inspection Team will take the following criteria into account, inter alia: (A) The toxicity of the scheduled chemicals and of the end-products produced with them, if any; (B) The quantity of the scheduled chemicals typically stored at the inspected site; (C) The quantity of feedstock chemicals for the scheduled chemicals typically stored at the inspected site; (D) The production capacity of the Schedule 2 plants; and (E) The capability and convertibility for initiating production, storage and filling of toxic chemicals at the inspected site. (2) Types of inspections Initial inspections. (ii) Routine inspections. (c) Schedule 3 plant sites Purposes of inspections. (2) Routine inspections. (d) Unscheduled discrete organic chemical plant sites Purposes of inspections. (2) Routine inspections. § 716.3 Consent to inspections; warrants for inspections. (a) The owner, operator, occupant or agent in charge of a facility may consent to an initial or routine inspection. The individual giving consent on behalf of the facility represents that he or she has the authority to make this decision for the facility. (b) In instances where consent is not provided by the owner, operator, occupant or agent in charge for an initial or routine inspection, BIS will seek administrative warrants as provided by the Act. § 716.4 Scope and conduct of inspections. (a) General. (b) Scope Description of inspections. (i) Will receive a pre-inspection briefing from facility representatives; (ii) Will visually inspect the facilities or plants producing scheduled chemicals or UDOCs, which may include storage areas, feed lines, reaction vessels and ancillary equipment, control equipment, associated laboratories, first aid or medical sections, and waste and effluent handling areas, as necessary to accomplish their inspection; (iii) May visually inspect other parts or areas of the plant site to clarify an ambiguity that has arisen during the inspection; (iv) May take photographs or conduct formal interviews of facility personnel; (v) May examine relevant records; and (vi) May take samples as provided by the Convention, the Act and consistent with the requirements set forth by the Director of the United States National Authority, at 22 CFR part 103, and the facility agreement, if applicable. (2) Scope of consent. (3) ITAR-controlled technology. (c) Pre-inspection briefing. (1) The pre-inspection briefing will address: (i) Facility health and safety issues and requirements, and associated alarm systems; (ii) Declared facility activities, business and manufacturing operations; (iii) Physical layout; (iv) Delimitation of declared facility; (v) Scheduled chemicals on the facility (declared and undeclared); (vi) Block flow diagram or simplified process flow diagram; (vii) Plants and units specific to declared operations; (viii) Administrative and logistic information; and (ix) Data declaration updates/revisions. (2) The pre-inspection briefing may also address, inter alia: (i) Introduction of key facility personnel; (ii) Management, organization and history; (iii) Confidential business information concerns; (iv) Types and location of records/documents; (v) Draft facility agreement, if applicable; and (vi) Proposed inspection plan. (d) Visual plant inspection. (e) Records review. (2) The facility must provide access to these supporting materials and documentation in appropriate formats (e.g., paper copies, electronic remote access by computer, microfilm, or microfiche), through the U.S. Government Host Team to Inspection Teams, during the inspection period or as otherwise agreed upon by the Inspection Team and Host Team Leader. (3) The facility must provide the Inspection Team with appropriate accommodations in which to review these supporting materials and documentation. (4) If a facility does not have access to supporting materials and documentation for activities that took place under previous ownership, because such records were not transferred to the current owner of the facility by the previous owner (e.g., as part of the contract involving the sale of the facility), the previous owner must make such records available to the Host Team for provision to the Inspection Team in accordance with section 305 of the Act. However, the current owner of a facility, upon receiving notification of an inspection (see § 716.5 of the CWCR), is responsible for informing BIS if the previous owner did not transfer records for activities that took place under the previous ownership—this will allow BIS to contact the previous owner of the facility, to arrange for access to such records, if BIS deems them relevant to the inspection activities. (f) Effect of facility agreements. (g) Hours of inspections. (h) Health and safety regulations and requirements. (i) Preliminary findings. [71 FR 24929, Apr. 27, 2006, as amended at 72 FR 14409, Mar. 28, 2007] § 716.5 Notification, duration and frequency of inspections. (a) Inspection notification Content of notice. (A) The type of inspection; (B) The basis for the selection of the facility or location for the type of inspection sought; (C) The time and date that the inspection will begin and the period covered by the inspection; and (D) The names and titles of the Inspection Team members. (ii) Consent to inspection. (iii) The following table sets forth the notification procedures for inspection: Table to § 716.5( a Activity Agency action Facility action (A) OPCW notification inspection ( 1 Acknowledges receipt of facsimile. ( 2 i ii ( A B (B) Preparation for inspection ( 1 If advance team support is provided, facility works with the advance team on inspection-related issues. ( 2 The current owner of the facility must inform BIS if the previous owner of the facility did not transfer (to the current owner) records for activities that took place under the previous ownership. (2) Timing of notice Schedule 1 facilities. (ii) Schedule 2 plant sites. (iii) Schedule 3 and UDOC plant sites. (b) Period of inspections Schedule 1 facilities. (2) Schedule 2 plant sites. (3) Schedule 3 and UDOC plant sites. (c) Frequency of inspections. (1) Schedule 1 facilities. (2) Schedule 2 plant sites. (3) Schedule 3 plant sites. (4) UDOC plant sites. § 716.6 Facility agreements. (a) Description and requirements. (1) Schedule 1 facilities. (2) Schedule 2 plant sites. (3) Schedule 3 and UDOC plant sites. (b) Notification; negotiation of draft and final facility agreements; and conclusion of facility agreements. (c) [Reserved] (d) Further information. [71 FR 24929, Apr. 27, 2006, as amended at 73 FR 78183, Dec. 22, 2008] § 716.7 Samples. The owner, operator, occupant or agent in charge of a facility must provide a sample as provided for in the Convention and the Act and consistent with requirements set forth by the Director of the United States National Authority in 22 CFR part 103. Analysis will be restricted to verifying the absence of undeclared scheduled chemicals, unless otherwise agreed after consultation with the facility representative. § 716.8 On-site monitoring of Schedule 1 facilities. Declared Schedule 1 facilities are subject to verification by monitoring with on-site instruments as provided by the Convention. For facilities subject to the CWCR, however, such monitoring is not anticipated. The U.S. Government will ensure that any monitoring that may be requested by the OPCW is carried out pursuant to the Convention and U.S. law. § 716.9 Report of inspection-related costs. Pursuant to section 309(b)(5) of the Act, any facility that has undergone any inspections pursuant to the CWCR during a given calendar year must report to BIS within 90 days of an inspection on its total costs related to that inspection. Although not required, such reports should identify categories of costs separately if possible, such as personnel costs (production-line, administrative, legal), costs of producing records, and costs associated with shutting down chemical production or processing during inspections, if applicable. This information should be reported to BIS on company letterhead at the address given in § 716.6(d) of the CWCR, with the following notation: “Attn: Report of inspection-related costs.” § 716.10 Post-inspection activities. BIS will forward a copy of the final inspection report to the inspected facility for their review upon receipt from the OPCW. Facilities may submit comments on the final inspection report to BIS, within the time-frame specified by BIS ( i.e. Supplement No. 1 to Part 716—Notification, Duration and Frequency of Inspections Schedule 1 Schedule 2 Schedule 3 Unscheduled discrete organic chemicals Notice of initial or routine inspection to USNA 72 hours prior to arrival of Inspection Team at the point of entry (initial); 24 hours prior to arrival of Inspection Team at the point of entry (routine) 48 hours prior to arrival of Inspection Team at the plant site 120 hours prior to arrival of Inspection Team at the plant site 120 hours prior to arrival of Inspection Team at the plant site. Duration of inspection As specified in facility agreement 96 hours 24 hours 24 hours. Maximum number of inspections Determined by OPCW based on characteristics of facility and the nature of the activities carried out at the facility 2 per calendar year per plant site 2 per calendar year per plant site 2 per calendar year per plant site. Notification of challenge inspection to USNA* 12 hours prior to arrival of inspection team at the point of entry. Duration of Challenge inspection* 84 hours. * See part 717 of the CWCR. Supplement Nos. 2-3 to Part 716 [Reserved]