# Chemical Weapons Convention Regulations > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A04-26517 ## Record - **Collection:** Federal Register - **Document type:** Proposed Rule - **Published:** December 7, 2004 - **Citation:** 69 FR 70754 ## Text DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Parts 710, 711, 712, 713, 714, 715, 716, 717, 718, 719, 720, 721, 722, 723, 724, 725, 726, 727, 728 and 729 [Docket No. 990611158-4077-03] RIN 0694-AB06 Chemical Weapons Convention Regulations AGENCY: Bureau of Industry and Security, Commerce. ACTION: Proposed rule and request for comments. SUMMARY: On April 25, 1997, the United States ratified the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on Their Destruction, also known as the Chemical Weapons Convention (CWC or Convention). The Bureau of Industry and Security (BIS) published an interim rule, on December 30, 1999, that established the Chemical Weapons Convention Regulations (CWCR) to implement the provisions of the CWC affecting U.S. industry and other U.S. persons. The CWCR include requirements to report certain activities, involving scheduled chemicals and unscheduled discrete organic chemicals, and to provide access for on-site verification by international inspectors of certain facilities and locations in the United States. This proposed rule revises the CWCR by updating them to include additional requirements identified in the implementation of the CWC and to clarify other CWC requirements. DATES: Comments on this rule must be received January 6, 2005. ADDRESSES: You may submit comments, identified by RIN 0694-AB06, by any of the following methods: • Federal eRulemaking Portal: http://www.regulations.gov . Follow the instructions for submitting comments. • E-mail: wfisher@bis.doc.gov . Include “RIN 0694-AB06” in the subject line of the message. • Fax: (202) 482-3355. Please alert the Regulatory Policy Division, by calling (202) 482-2440, if you are faxing comments. • Mail or Hand Delivery/Courier: Willard Fisher, U.S. Department of Commerce, Bureau of Industry and Security, Regulatory Policy Division, 14th Street & Pennsylvania Avenue, NW., Room 2705, Washington, DC 20230, ATTN: RIN 0694-AB06. FOR FURTHER INFORMATION CONTACT: For questions of a general or regulatory nature, contact the Regulatory Policy Division, telephone: (202) 482-2440. For program information on declarations, reports, advance notifications, chemical determinations, recordkeeping, inspections and facility agreements, contact the Treaty Compliance Division, Office of Nonproliferation and Treaty Compliance, telephone: (703) 605-4400; for legal questions, contact Rochelle Woodard, Office of the Chief Counsel for Industry and Security, telephone: (202) 482-5301. SUPPLEMENTARY INFORMATION: Background I. Summary of CWCR Changes Contained in This Proposed Rule On April 25, 1997, the United States ratified the Convention on the Development, Production, Stockpiling and Use of Chemical Weapons and on Their Destruction, also known as the Chemical Weapons Convention (CWC or Convention). The CWC, which entered into force on April 29, 1997, is an arms control treaty with significant non-proliferation aspects. As such, the CWC bans the development, production, stockpiling or use of chemical weapons and prohibits States Parties to the CWC from assisting or encouraging anyone to engage in a prohibited activity. The CWC provides for declaration and inspection of all States Parties' chemical weapons and chemical weapon production facilities, and oversees the destruction of such weapons and facilities. To fulfill its arms control and non-proliferation objectives, the CWC also establishes a comprehensive verification scheme and requires the declaration and inspection of facilities that produce, process or consume certain “scheduled” chemicals and unscheduled discrete organic chemicals, many of which have significant commercial applications. The CWC also requires States Parties to report exports and imports and to impose export and import restrictions on certain chemicals. These requirements apply to all entities under the jurisdiction and control of States Parties, including commercial entities and individuals. States Parties to the CWC, including the United States, have agreed to this verification scheme in order to provide transparency and to ensure that no State Party to the CWC is engaging in prohibited activities. The Chemical Weapons Convention Implementation Act of 1998 (the Act or CWCIA) (22 U.S.C. 6701 et seq. ), enacted on October 21, 1998, authorizes the United States to require the U.S. chemical industry and other private entities to submit declarations, notifications and other reports and also to provide access for on-site inspections conducted by inspectors sent by the Organization for the Prohibition of Chemical Weapons. Executive Order (E.O.) 13128 delegates authority to the Department of Commerce to promulgate regulations, obtain and execute warrants, provide assistance to certain facilities, and carry out appropriate functions to implement the CWC, consistent with the Act. The Department of Commerce implements CWC import restrictions under the authority of the International Emergency Economic Powers Act, the National Emergencies Act, and E.O. 12938, as amended by E.O. 13128. The Departments of State and Commerce have implemented the CWC export restrictions under their respective export control authorities. E.O. 13128 designates the Department of State as the United States National Authority (USNA) for purposes of the CWC and the Act. On December 30, 1999, the Bureau of Industry and Security (BIS), U.S. Department of Commerce, published an interim rule that established the Chemical Weapons Convention Regulations (CWCR) (15 CFR Parts 710-722). The CWCR implemented the provisions of the CWC, affecting U.S. industry and U.S. persons, in accordance with the provisions of the Act. This proposed rule revises the CWCR by updating them to include additional requirements identified necessary for the implementation of the CWC provisions and to clarify other CWC requirements. Specifically, this rule proposes to make the following revisions to the CWCR: A. Proposed Revisions to Section 710.1 of the CWCR (Definitions of Terms Used in the CWCR) This proposed rule revises § 710.1 of the CWCR by amending the definition of “domestic transfer” to clarify that the term, as applied to the declaration requirements for Schedule 2 or Schedule 3 chemicals under the CWCR, means the movement of a Schedule 2 or Schedule 3 chemical, in quantities and concentrations greater than the specified thresholds in the convention, outside the geographical boundary of a facility in the United States to another destination in the United States, for any purpose. This proposed rule adds a definition for the term “intermediate” to § 710.1 of the CWCR in order to clarify the use of that term in § 712.5(c) and Supplement No. 2 to part 715 of the CWCR. Section 710.1 of the CWCR would define “intermediate” as “a chemical formed through chemical reaction that is subsequently reacted to form another chemical.” The term “intermediate” also clarifies its use in §§ 712.5(d), 713.2(a)(2)(ii) and 714.1(a)(2)(ii), whereby Schedule 1, Schedule 2 and Schedule 3 chemicals that are intermediates, but not transient intermediates, must be considered when determining if a chemical is subject to declaration. Lastly, Supplement No. 2 to part 715 of the CWCR, which provides examples of unscheduled discrete organic chemicals (UDOCs) and UDOC production, indicates that intermediate UDOCs used in a single or multi-step process to produce another declared UDOC are not subject to declaration requirements under the CWCR. In addition, this proposed rule adds a definition of the term “advance notification” to § 710.1 of the CWCR to clarify the use of that term in part 712 of the CWCR. Section 710.1 of the CWCR would define “advance notification” to mean “a notice informing BIS of a company's intention to export to or import from a State Party a Schedule 1 chemical.” Advance notifications must be submitted to BIS at least 45 days prior to the proposed export or import, except for exports or imports of saxitoxin for medical/diagnostic purposes which may be submitted to BIS at least 3 days prior to export or import. The definition proposed by this rule also indicates that this notification requirement is in addition to any export license requirement under the Export Administration Regulations (EAR) (15 CFR Parts 730-799) or the International Traffic in Arms Regulations (ITAR) (22 CFR Parts 120-130), or import license requirement under the Alcohol, Tobacco, Firearms and Explosives Regulations (27 CFR part 447). The definition of the term “production” in § 710.1 of the CWCR is revised by adding certain notes that incorporate decisions by the Organization for the Prohibition of Chemical Weapons' Conference of the States Parties (OPCW/CSP) regarding the production of Schedule 1, 2, and 3 chemicals. The first note would clarify that the production of Schedule 1 chemicals includes “formation through chemical synthesis as well as processing to extract and isolate Schedule 1 chemicals.” The second note would clarify that the “production” of a Schedule 2 or Schedule 3 chemical “means all steps in the production of a chemical in any units within the same plant through chemical reaction, including any associated processes ( e.g. , purification, separation, extraction, distillation, or refining) in which the chemical is not converted into another chemical. The exact nature of any associated process ( e.g. , purification, etc.) is not required to be declared.” This proposed rule adds a definition of the term “production by synthesis” in § 710.1 of the CWCR to clarify the use of the term in § 715.1 of the CWCR ( i.e. , declaration of production by synthesis of UDOCs for purposes not prohibited by the CWC) and Supplement No. 2 to part 715 of the CWCR ( i.e. , examples of activities that are not considered to be production by synthesis under part 715 of the CWCR). Section 710.1 of the CWCR would define “production by synthesis” to mean “production of a chemical that is isolated for use or sale.” Finally, this proposed rule amends § 710.1 of the CWCR by adding a definition of the term “transient intermediate” in order to clarify the scope of the declaration requirements that apply to the production of certain scheduled chemicals. Section 710.1 of the CWCR would define the term “transient intermediate” to mean “any chemical that is produced in a chemical process, but that only exists for a very short period of time and cannot be isolated, even by modifying or dismantling the plant, altering the chemical production process operating conditions, or stopping the chemical production process altogether.” B. Proposed Amendments to Section 710.2 of the CWCR (Scope of the CWCR) This proposed rule amends § 710.2(a) of the CWCR by removing the phrase “The CWCR declaration, reporting, and inspection requirements apply . . . .” from that paragraph. Removal of this phrase will clarify which persons and facilities are generally subject to the provisions of the CWCR. C. Proposed Amendments to Section 710.6 of the CWCR (Relationship Between the CWCR and the Export Administration Regulations) This proposed rule amends § 710.6 of the CWCR to include a reference to Export Control Classification Number (ECCN) 1C395 on the Commerce Control List (CCL), which is in Supplement No. 1 to part 774 of the EAR. ECCN 1C395 controls the following items: (i) Mixtures that contain more than 10 percent, but less than 30 percent, by weight of any single CWC Schedule 2 chemical identified in ECCN 1C350.b; and (ii) certain medical, analytical, diagnostic and food testing kits that contain CWC Schedule 2 or Schedule 3 chemicals controlled by ECCN 1C350.b or .c, respectively, in an amount not exceeding 300 grams per chemical. D. Proposed Amendments to Supplement No. 1 to Part 710 of the CWCR (List of States Parties to the CWC) This proposed rule amends Supplement No. 1 to part 710 of the CWCR (States Parties to the Convention on The Prohibition of The Development, Production, Stockpiling, and Use of Chemical Weapons and on Their Destruction) by updating the list of States Parties to include the following recent additions: Afghanistan, Andorra, Azerbaijan, Cape Verde, Chad, Colombia, Dominica, Eritrea, Gabon, Guatemala, Jamaica, Kazakhstan, Kiribati, Kyrgyzstan, Malaysia, Marshall Islands, Micronesia (Federated States of), Mozambique, Nauru, Palau, Rwanda, Saint Kitts and Nevis, Saint Vincent and the Grenadines, Samoa, San Marino, Sao Tome and Principe, Thailand, Timor Leste, Tonga, Uganda, United Arab Emirates, Yemen, and Zambia. As of June 20, 2004, 164 countries had become States Parties to the CWC. E. Proposed Amendments to Part 711 of the CWCR (General Information Regarding Declaration, Reporting and Advance Notification Requirements) This proposed rule adds a new § 711.3 that establishes BIS's authority to contact any company to determine whether it is in compliance with the CWCR. Information requested may relate to the production, processing, consumption, export, import, or other activities involving scheduled chemicals and UDOCs described in Parts 712 through 715 of this subchapter. Any person or facility subject to the CWCR and receiving such a request for information will be required to provide a response to BIS within the time-frame specified in the request. However, this requirement does not, in itself, impose a requirement to create new records or maintain existing records. This proposed rule amends § 711.3 of the CWCR by moving it to § 711.4 and specifying a time period within which the BIS will respond to chemical determination requests. BIS will respond, in writing, to a chemical determination request within 10 working days of receipt of the request. This proposed rule removes the declaration and reporting requirements in § 711.4 of the CWCR concerning activities that occurred prior to December 30, 1999, since these requirements should already have been satisfied. A new § 711.7 is proposed to provide information on where to submit declarations, advance notifications, and reports. New § 711.8 is added with instructions for applying for authorization to submit electronic declarations and reports in order to fulfill requirements under the Government Paperwork Elimination Act (44 U.S.C. 3504). F. Proposed Amendments to Part 712 of the CWCR (Activities Involving Schedule 1 Chemicals) This proposed rule adds a new § 712.2(a) that prohibits production of Schedule 1 chemicals for protective purposes. This proposed rule clarifies that initial declarations submitted in February 2000 remain valid until they are either amended or rescinded. If you plan to alter the technical layout of your declared facility, you must submit an amended declaration to BIS at least 200 calendar days prior to making any such change to your facility. This proposed rule revises § 712.3 of the CWCR by moving the annual declaration requirements for Schedule 1 facilities to new § 712.5. This proposed rule amends § 712.4 of the CWCR to clarify the declaration requirements that apply to the establishment of new Schedule 1 chemical production facilities. If a Schedule 1 chemical production facility has never been declared in a previous calendar year or its initial declaration has been withdrawn in accordance with the requirements of amended § 712.5(f) of this proposed rule, you must submit an initial declaration (including a current detailed technical description of the facility) to BIS at least 200 calendar days prior to commencing production of Schedule 1 chemicals at the facility in quantities greater than 100 grams aggregate per year. Such facilities are considered to be “new Schedule 1 chemical production facilities” and are subject to an initial inspection within 200 calendar days of the submission of the initial declaration to BIS. This proposed rule revises the remainder of part 712 of the CWCR, as follows: (1) Advance notification and annual report requirements for Schedule 1 chemical exports and imports are proposed to be moved from § 712.5 of the CWCR to § 712.6; (2) provisions for Table 1 to § 712.6 of the CWCR are proposed to be moved to new Supplement No. 2 to part 712 of the CWCR; (3) procedures concerning declarations and reports returned without action by BIS are proposed to be described in new § 712.8 of the CWCR; and (4) the due date for Annual Declarations for Anticipated Activities is changed from August 3 to September 3 thereby giving Schedule 1 facilities an additional 30 days in which to complete and submit their declarations. This proposed rule amends the CWCR provisions that require advance notification of exports and imports of Schedule 1 chemicals by establishing an exception to the requirement that BIS must be notified at least 45 calendar days prior to the export or import of a Schedule 1 chemical to or from another State Party. Advance notification of the export or import of 5 milligrams or less of Saxitoxin-B (7), which is listed in Supplement No. 1 to part 712 of the CWCR, for medical or diagnostic purposes only, would have to be submitted to BIS at least 3 calendar days (rather than 45 calendar days) prior to the date of export or import. This proposed rule amends the CWCR provisions concerning requirements for amending Schedule 1 declarations and reports. Section 712.7 of the CWCR is proposed to be amended by clarifying and specifying deadlines for: (i) The types of changes to information on Schedule 1 chemicals and activities in the Annual Declaration of Past Activities that would require submission of an amended declaration to BIS; (ii) the types of changes to export or import information in the Annual Reports on Exports and Imports from undeclared facilities, trading companies and U.S. persons that would require submission of an amended report to BIS; and (iii) the types of changes to Schedule 1 chemical facility information ( e.g. , change in company name, address, declaration point of contact, ownership) that would require submission of an amended declaration or report to BIS. In addition, this proposed rule adds a new § 712.7(d) to the CWCR that will provide guidance concerning the submission of inspection-related amendments. Amended declarations, based on the final inspection report, would have to be submitted to BIS within 45 calendar days of the date of BIS's post inspection letter. This proposed rule adds a new § 712.8 to the CWCR that provides guidance concerning certain Schedule 1 declarations and reports that are returned without action. In these cases, BIS would return without action (RWA) any Schedule 1 declarations or reports that are determined to be not required by the CWCR. The returned declaration or report would be accompanied by a cover letter explaining why the declaration or report is being returned without action. BIS would retain a copy of the RWA letter, but would not maintain copies of any declarations or reports that were returned without action. Finally, the provisions in § 712.6 and Table 1 to § 712.6 of the CWCR, which contain information on the deadlines for submitting Schedule 1 declarations, reports, advance notifications and amendments to BIS, are updated and moved to § 712.9 and Supplement No. 2 to part 712 of the CWCR, respectively. G. Proposed Amendments to Part 713 of the CWCR (Activities Involving Schedule 2 Chemicals) This proposed rule adds a prohibition against exports of Schedule 2 chemicals to States not Party to the CWC in § 713.1(a). Currently, the CWCR prohibit imports of Schedule 2 chemicals from States not Party to the CWC, but do not prohibit Schedule 2 chemical exports to such countries. However, note that § 742.18 of the EAR currently requires a license for exports of Schedule 2 chemicals to States not Party to the CWC and BIS applies a general policy of denial to license applications for such exports. A license is also required for export of Schedule 2 chemicals controlled under the ITAR. This proposed rule revises § 713.1(b), which exempts certain mixtures containing Schedule 2 chemicals from the export and import prohibitions contained in § 713.1(a) of the CWCR, as proposed by this rule. Currently, § 713.1(b) of the CWCR exempts mixtures containing 10 percent or less, by weight, of any single Schedule 2 chemical. This rule revises § 713.1(b) of the CWCR to exempt the following mixtures: (i) Mixtures containing 1 percent or less, by weight, of any single Schedule 2A or 2A* chemical; (ii) mixtures containing 10 percent or less, by weight, of any single Schedule 2B chemical; and (iii) products identified as consumer goods packaged for retail sale for personal use or packaged for individual use. However, note that the consumer goods exemption for mixtures that contain Schedule 2 chemicals identified under ECCN 1C350 on the CCL (Supplement No. 1 to part 774 of the EAR) applies only to products identified as consumer goods not packaged for retail sale for personal use and not to products packaged for individual use (the latter are exempt only by the CWCR and not by the Australia Group controls under the EAR). In addition, this proposed rule: (i) Removes the provisions concerning declarations on past production of Schedule 2 chemicals for chemical weapons purposes (currently found in § 713.2 of the CWCR); (ii) removes the provisions currently found in §§ 713.3(a)(1)(i) and 713.4(c)(1) and (2) on Schedule 2 initial declarations and initial reports on exports and imports; (iii) amends the provisions providing guidance concerning amendments to declarations and reports (currently found in § 713.7 of the CWCR); (iv) moves the provisions concerning the frequency and timing of declarations and reports (currently found in § 713.6 of the CWCR) to § 713.7; and (v) provides a description of the procedures that BIS will follow concerning declarations and reports RWA'd in § 713.6 of the CWCR. This proposed rule moves and revises § 713.3 of the CWCR to § 713.2 to clarify the scope of Schedule 2 production activities to include any associated processing steps of the Schedule 2 chemical and intermediates. Only transient intermediates are exempted. This will ensure that the CWCR requirements will apply to Schedule 2 chemical production where Schedule 2 chemicals are below the applicable concentration threshold when reacted, but subsequently are concentrated above the threshold during in-line processing. The provisions in § 713.6 and Table 1 to § 713.6 of the CWCR, which contain information on the deadlines for submitting declarations, reports, advance notifications, and amendments to BIS, are proposed to be moved to § 713.7 and Supplement No. 2 to part 713 of the CWCR, respectively. In addition, the CWCR provisions on amended declarations and reports for Schedule 2 chemicals are proposed to be moved from § 713.7 of the CWCR to § 713.5 and amended by clarifying and specifying deadlines for: (i) The types of changes to information on Schedule 2 chemicals and activities in the Annual Declaration of Past Activities or the combined declaration and report that would require submission of an amended declaration to BIS; (ii) the types of changes to export or import information in the Annual Reports on Exports and Imports from undeclared facilities, trading companies and U.S. persons that would require submission of an amended report to BIS; and (iii) the types of changes to Schedule 2 chemical facility information ( e.g. , change in company name, address, declaration point of contact, ownership) that would require submission of an amended declaration or report to BIS. In addition, this proposed rule moves and revises § 713.6(d) of the CWCR to § 713.5(d) to provide guidance concerning the submission of inspection-related amendments. Amended declarations, based on the final inspection report, would have to be submitted to BIS within 45 calendar days of the date of BIS's post inspection letter. This proposed rule adds § 713.6 of the CWCR to provide guidance concerning the return of certain Schedule 2 declarations and reports without action. BIS would RWA any Schedule 2 declarations or reports that are determined not required by the CWCR. The returned declaration or report would be accompanied by a cover letter explaining why the declaration or report is being returned without action. BIS would retain a copy of the RWA letter, but would not maintain copies of any declarations or reports that were returned without action. Finally, the provisions in § 713.6 and Table 1 to § 713.6 of the CWCR, which contain information on the deadlines for submitting Schedule 2 declarations, reports, and amendments to BIS, are updated and moved to § 713.7 and Supplement No. 2 to part 713 of the CWCR, respectively. H. Proposed Amendments to Part 714 of the CWCR (Activities Involving Schedule 3 Chemicals) This proposed rule amends part 714 of the CWCR by removing certain provisions concerning the past production of Schedule 3 chemicals in § 714.1. The requirements concerning when and how to amend declarations and reports for Schedule 3 chemicals, currently in § 714.6 of the CWCR, are proposed to be revised by this rule and moved to § 714.4. This rule also proposes to revise § 714.5 of the CWCR, which currently addresses the frequency and timing of Schedule 3 declarations, to describe the BIS procedures for returning declarations and reports without action. Section 714.5 is proposed to be moved to new § 714.6 and revised to address deadlines for submitting Schedule 3 declarations, reports, and amendments. Section 714.2 of the CWCR, as proposed to be moved to new § 714.1 by this rule, will clarify the scope of Schedule 3 production activities, as defined by the CWCR, to include any associated processing steps of a Schedule 3 chemical and intermediates. Only transient intermediates are exempted. This will ensure that the CWCR requirements will apply to Schedule 3 chemical production where Schedule 3 chemicals are below the applicable concentration threshold when reacted, but subsequently are concentrated above the threshold during processing. In addition, this proposed rule moves and revises § 714.2 of the CWCR to § 714.1 to clarify the procedures that must be followed when determining the range of Schedule 3 chemical production for your plant site during the previous calendar year. Specifically, this rule proposes to include a statement in § 714.1(c)(1) of the CWCR to indicate that you should not aggregate amounts of production from plants on your plant site that did not individually produce a Schedule 3 chemical in an amount exceeding the applicable declaration threshold ( i.e. , greater than 30 metric tons). In short, only the production amounts from those plants on your plant site that individually produced greater than 30 metric tons of a Schedule 3 chemical should be aggregated for the purpose of calculating the total amount of a Schedule 3 chemical produced at your plant site during the previous calendar year. The CWCR provisions on amended declarations and reports for Schedule 3 chemicals are proposed to be moved from § 714.6 of the CWCR to § 714.4 and amended by clarifying and specifying deadlines for: (i) The types of changes to information on Schedule 3 chemicals and activities in the Annual Declaration of Past Activities or the combined declaration and report that would require submission of an amended declaration to BIS; (ii) the types of changes to export or import information in the Annual Reports on Exports and Imports from undeclared facilities, trading companies and U.S. persons that would require submission of an amended report to BIS; and (iii) the types of changes to Schedule 3 chemical facility information ( e.g. , change in company name, address, declaration point of contact, ownership) that would require submission of an amended declaration or report to BIS. In addition, this proposed rule amends the CWCR to provide guidance in § 714.4(d) concerning the submission of inspection-related amendments. Amended declarations, based on the final inspection report, would have to be submitted to BIS within 45 calendar days of the date of BIS's post inspection letter. This proposed rule revises adds § 714.5 of the CWCR to provide guidance concerning the return of certain Schedule 3 declarations and reports without action. BIS would RWA any Schedule 3 declarations or reports that are determined not required by the CWCR. The returned declaration or report would be accompanied by a cover letter explaining why the declaration or report is being returned without action. BIS would retain a copy of the RWA letter, but would not maintain copies of any declarations or reports that were returned without action. Finally, the provisions in § 714.5 and Table 1 to § 714.5 of the CWCR, which contain information on the deadlines for submitting Schedule 3 declarations, reports, and amendments to BIS, are proposed to be updated and moved to § 714.6 and Supplement No. 2 to part 714 of the CWCR, respectively. I. Proposed Amendments to Part 715 of the CWCR (Activities Involving Unscheduled Discrete Organic Chemicals (UDOCs)) This proposed rule amends § 715.1(a)(1)(ii) (which describes the annual declaration requirements for the production of UDOCs containing the elements phosphorus, sulfur or fluorine, referred to as “PSF-chemicals”) to clarify how to calculate the production by synthesis of PSF chemicals at your plant site during the previous calendar year. Specifically, this proposed rule indicates that when determining the quantity of each PSF-chemical produced by a PSF plant on your plant site, you should only aggregate the PSF chemical production quantities from plants that individually produced a PSF chemical in an amount exceeding 30 metric tons. However, note that § 715.1(a)(1)(i) indicates that when determining UDOC production by synthesis on your plant site, you should aggregate all quantities of UDOCs and PSF-chemicals produced regardless of the amount of PSF chemicals produced ( i.e. , aggregate any PSF chemicals produced). This proposed rule also revises § 715.1(b)(1) of the CWCR by removing the initial declaration requirement and replacing it with the annual declaration requirement, and adding a new subsection that creates a new form called the “No Changes Authorization” form that may be submitted to BIS if there are no updates or changes to any information (other than the certifying official and dates signed and submitted) contained in the annual declaration on past activities previously submitted by your plant site. In addition, § 715.1(b)(1)(ii) of the CWCR, as proposed by this rule, would include a statement indicating that your plant site's UDOC activities would continue to be declared to the OPCW and that your plant site would remain subject to inspection (if applicable) based upon the data reported in your previous ( i.e. , most recent) annual declaration on past activities. The CWCR provisions on amended declarations for UDOCs are moved from § 715.3 of the CWCR to § 715.2 and revised by clarifying and specifying deadlines for: (i) The types of changes to information on UDOCs and activities in the Annual Declaration of Past Activities that would require submission of an amended declaration to BIS; and (ii) the types of changes to UDOC plant information ( e.g. , change in company name, address, declaration point of contact, ownership) that would require submission of an amended declaration to BIS. In addition, this proposed rule amends the CWCR to provide guidance in § 715.2(c) concerning the submission of inspection-related amendments. Amended declarations, based on the final inspection report, would have to be submitted to BIS within 45 calendar days of the receipt of BIS's post inspection letter. This proposed rule adds § 715.3 of the CWCR to provide guidance concerning the return of certain UDOC declarations without action. BIS would RWA any UDOC declarations that are determined not required by the CWCR. The returned declaration would be accompanied by a cover letter explaining why the declaration is being returned without action. BIS would retain a copy of the RWA letter, but would not maintain copies of any declarations that were returned without action. Finally, the provisions in the CWCR that currently contain information on the deadlines for submitting UDOC declarations and amendments to BIS (§ 715.2 and Table 1 to § 715.2), are proposed to be updated and moved to § 715.4 and Supplement No. 3 to part 715 of the CWCR, respectively. J. Proposed Amendments to Part 716 of the CWCR (Initial and Routine Inspections of Declared Facilities) As part of their obligation under the Convention, each State Party to the CWC is subject to inspection of its chemical facilities engaged in certain activities involving scheduled chemicals. Part 716 of the CWCR 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). This proposed rule amends § 716.2(a)(2)(i) of the CWCR to clarify that a facility agreement will be concluded by the U.S. National Authority (in coordination with BIS) with the OPCW before a new Schedule 1 facility, declared pursuant to § 712.4 of the CWCR, can produce above threshold. This proposed rule amends § 716.4(b)(1) of the CWCR to clarify the scope of inspections by specifying that inspections under part 716 of the CWCR may include visual inspection of parts or areas of the plant site, in addition to the facilities or plants producing scheduled chemicals, in order to address any ambiguity that might arise during the inspection. In addition, photographs may be taken and formal interviews of facility personnel may be conducted. Section 716.4(b)(3) of the CWCR is amended to indicate that: (i) Technology subject to the ITAR shall not be divulged to the Inspection Team without U.S. Government authorization; and (ii) each facility that is inspected is responsible for identifying ITAR-controlled technology to the BIS Host Team, if known. This proposed rule also clarifies the pre-inspection briefing requirements described in § 716.4(c) of the CWCR and the requirements in § 716.4(e) of the CWCR concerning the availability of records. The U.S. facility must provide the Inspection Team and the U.S. Government Host Team with appropriate accommodations in which to review relevant documents and must ensure that all relevant information will be available to the teams. In addition, this rule provides that, whenever a facility does not have access to records for activities that took place under a previous ownership, the previous owner must make such records available to the Host Team (for provision to the Inspection Team). Section 716.7 of the CWCR, which describes requirements concerning the provision of samples by declared facilities, is revised to restrict the analysis of such samples to the verification of the absence of undeclared scheduled chemicals, unless otherwise agreed after consultation with the facility representative. Finally, this proposed rule adds a new § 716.10 to clarify that, upon receipt of the final inspection report from the OPCW, BIS will send a copy of the final inspection report to the facility for its review. Facilities may submit comments on the final inspection report to BIS, and BIS will consider those comments, to the extent possible, when commenting on the final report. BIS will also send facilities a post-inspection letter with instructions based on decisions made during the inspection. K. Proposed Amendments to Part 717 of the CWCR (Clarification of Possible Non-Compliance With the Convention; Challenge Inspection Procedures) Article IX of the CWC contains procedures for States Parties to clarify issues concerning compliance with the CWC. A State Party may request the OPCW to conduct an on-site challenge inspection of any facility or location in the territory or in any other place under the jurisdiction or control of any other State Party. A challenge inspection may be conducted solely for the purpose of clarifying and resolving any questions concerning possible non-compliance with the CWC. This proposed rule amends § 717.1(b) of the CWCR to clarify that BIS will attempt to contact a person or facility that is subject to the Article IX clarification procedures as early as practical prior to the issuance of an official written request for clarification and that such person or facility must provide the information required by BIS, pursuant to an Article IX clarification request, within five working days of the receipt of BIS's written request for clarification. In addition, this proposed rule amends § 717.2 (Challenge Inspections) by adding a new provision in § 717.2(b)(2)(ii) explaining that if consent is not granted within four hours of a facility's receipt of BIS's inspection notification, BIS will assist the Department of Justice in seeking a criminal warrant. A new provision, § 717.2(d)(5), also has been added that describes the requirements concerning pre-inspection briefings for challenge inspections. Section 717.2(d)(5) will require that, prior to the commencement of the challenge inspection, facility representatives must provide the Inspection Team and Host Team with a pre-inspection briefing on the facility that will include the following: (i) The types of activities being conducted at the facility ( e.g. , business and manufacturing operations); (ii) safety procedures that must be followed during the inspection; and (iii) administrative and logistical arrangements necessary to facilitate the inspection. Section 717.3 of the CWCR, which describes requirements concerning the provision of samples by declared facilities, is revised to restrict analysis of samples to verifying the presence or absence of scheduled chemicals or appropriate degradation products, unless agreed otherwise. Finally, this proposed rule adds a new § 717.5 to clarify that, upon receipt of the final inspection report from the OPCW, BIS will forward a copy to the facility, for comment, and will give consideration to the facility's comments prior to responding to the OPCW via the U.S. National Authority. In addition, proposed § 717.5 will provide that, upon receipt of the final inspection report, BIS will send the facility a post inspection letter detailing the issues that require follow-up action. II. Summary of Public Comments on the December 30, 1999, Interim CWCR Rule On December 30, 1999, the Bureau of Industry and Security (BIS) published an interim rule in the Federal Register (64 FR 73744), with a request for comments, establishing the Chemical Weapons Convention Regulations (CWCR) to implement provisions of the Chemical Weapons Convention (CWC) and the Chemical Weapons Convention Implementation Act of 1998 (the Act or CWCIA) (22 U.S.C. 6701 et seq. ), which was enacted on October 21, 1998. BIS received comments from five respondents. Following is a summary of those comments, along with BIS's responses. A. Preamble to the December 30, 1999, Interim CWCR Rule Comment: One respondent is concerned about the statement in 64 FR 73754, Part II (Public Comments on the Proposed Rule) of the preamble stating that “the United States cannot withhold conclusion of a facility agreement with the OPCW because of facility concerns.” The respondent suggests: (1) Because facility agreements are not required for Schedule 3 or unscheduled discrete organic chemical (UDOC) facilities, the United States could withhold conclusion of a facility agreement for such a facility because of facility concerns; (2) in the case of Schedule 1 or 2 facilities, the facility's legitimate concerns would become the U.S. Government's concerns; and (3) that these issues be addressed in the preamble. Response: The CWC does not provide for facility approval of the facility agreement for any facility agreement concluded between the United States and Organization for the Prohibition of Chemical Weapons (OPCW). This includes facility agreements for Schedule 3 and UDOC facilities. Although Schedule 3 and UDOC facility agreements will only be pursued at the facility's request, the same negotiating procedures will apply as with Schedule 1 and 2 facility agreements. The U.S. Government will provide facilities the opportunity to express concerns at several stages throughout the facility agreement process. However, as the facility agreement and inspection process is a U.S. government-led enterprise, it will ultimately be the decision of the U.S. Government whether to include reference to facility concerns and comments in the facility agreement. B. Supplement No. 1 to Part 710—States Parties to the Convention Comment: One respondent is concerned that, unlike Hong Kong, which was identified as part of China, Taiwan's status has not been resolved. Due to the volume of legitimate trade (imports/exports) that occurs with Taiwan, the respondent believes Taiwan's status should be resolved and communicated. The respondent commented on this issue on the proposed rule, but BIS had not previously responded to this comment. Response: BIS responded to this respondent's concern in the interim-final rule dated December 30, 1999, under Section III Public Comments on Declarations and Reporting Forms and Handbooks. Supplement 3 to the Declaration and Report Handbook was changed to add a new Destination Code “TAI” for Taiwan for declaring or reporting exports to or imports from Taiwan of Schedule 2 or Schedule 3 chemicals. Schedule 2 chemicals may no longer be exported to or imported from Taiwan, which is not a State Party. Schedule 3 chemicals require an End-Use Certificate for exports to Taiwan or a license is required. Additionally, Supplement 3 to the Declaration and Report Handbook indicates that transfers to Taiwan do not imply recognition of the Taiwan authorities or an official relationship with Taiwan. C. Part 711—General Information Regarding Declaration, Reporting and Advance Notification Requirements Comment: Two respondents suggest that a new section (§ 711.7) be added to the final rule to specify the department and address for submittal of completed declarations and reports. Additionally, each declaration and report handbook should provide the same information in the “Introduction” section, and each declaration and report form should contain the information on where such form should be submitted. Response: BIS created a new § 711.7 which provides the mailing address to which declarations and reports must be submitted. BIS also updated the Declaration and Report Handbook to include the applicable mailing address. D. Sections 712.6, 713.7 and 714.6—Amended Declarations Comment: Three respondents request that BIS eliminate the requirement for an amended declaration for minor changes, such as a change in company name. The respondents assert that a change in company name is not substantive and has no impact on CWC verification activities, the object and purpose of the CWC and/or plant site identification code, and results in a paperwork burden. Response: See BIS's response to the following comment. Comment: One respondent requests that deadlines be provided for submission of amended declarations. Currently the regulations only require that companies submit amended declarations. Given that accurate declarations are important for on-site verification, the respondent contends that amendments should be submitted within 90 days of the event that triggered a requirement for an amended declaration, the same amount of time given for annual declarations following the close of a calendar year. Response: Based upon the experience gained in implementing the CWC, BIS has determined that certain amended information is necessary to assist in the timely processing of inspection notifications and in effective communication with company personnel subject to inspection. As currently written, the CWCR do not adequately explain the amendment procedures required of companies, or the reasons why BIS requires that information. Accordingly, BIS has clarified the requirements and timelines for submitting amended declarations. BIS has established different timelines for submitting an amendment based upon the type of change that is being made to a declaration and the time it will take for BIS to receive and process data in order to submit relevant changes to the OPCW. Any company changes to declaration or report information dealing with the chemicals, quantities, activities, end-use purposes, additions, deletions, or similar changes that are submitted, via the U.S. National Authority, to the OPCW must be received by BIS within 15 days of the change in information. Changes to internal company information that is not submitted to the OPCW, such as a declaration or inspection point of contact, telephone numbers, or changes in company ownership, must be received by BIS within 30 days of the change to the information. Additionally, amendments required based upon an inspection finding must be submitted to BIS within 45 days after the company is notified of the required amendments. Finally, in lieu of submitting an amended declaration or report form, you may submit your amended information to BIS in a letter on company letterhead. E. Section 713.3—Annual Declaration Requirements for Schedule 2 Plant Sites Comment: Two respondents state that the interim rule is unclear on the requirements for annual declarations on past activities involving Schedule 2 chemicals. Specifically, the note to § 713.3(a)(1)(ii) creates confusion by basing the annual declaration requirement on three years of activity and conflicts with the CWC's and the CWCIA's time frame for annual declarations. Moreover, the CWCIA and CWC require annual declarations for a single year and not a series of years as presented in the note to § 713.3(a)(1)(ii). Since Section 401 of the CWCIA commits the U.S. government to require only the minimal information necessary to satisfy the requirements of the CWC and the CWCIA, these respondents oppose a three-year time frame for purposes of reporting on annual activities. Response: BIS is upholding the CWCIA's commitment to require only minimum information necessary to satisfy the requirements of the treaty. The CWCR only require an annual Schedule 2 declaration on past activities for the previous calendar year. This declaration requirement is based upon the activities that occurred at the plant site during “any of the previous three calendar years” as provided in the note to § 713.2(a)(1)(i)(B). BIS refers to this CWC requirement as the “three-year lookback.” F. Section 713.5—Advance Declaration Requirements for Additionally Planned Production, Processing, or Consumption of Schedule 2 Chemicals Comment: One respondent notes that this section states that facilities are allowed, but not required, to submit an amended declaration if they are merely listing additional countries for export. However, then the section goes on to state “not to exceed 10 countries.” The respondent proposes that these provisions be clarified, perhaps in the preamble, to state whether this means a limit of ten additional countries or ten total countries, and how this amendment should be done. Response: New § 713.4 (previously § 713.5) requires submission of a Declaration on Additionally Planned Activities if any additional activity is planned after submission of the Annual Declaration on Anticipated Activities. This requirement is not an amendment, but rather is a specific type of declaration that must be submitted to the OPCW. Section 713.4 has been changed in this proposed rule to eliminate the limit on the total number of destinations that may be declared in both the Annual Declaration on Anticipated Activities and the Declaration on Additionally Planned Activities, as well as for question 2-3.7, on Form 2-3, on actual past exports. The forms required for submitting a Declaration on Additionally Planned Activities are identified in the new Supplement 2 to part 713 of the CWCR. G. Sections 714.2 and 715.1—Annual Declaration Requirements Comment: One respondent suggests that in some portions of the regulations it is not clear whether facilities are expected to aggregate quantities of chemicals among all the plants at the same plant site or whether each plant should be considered individually. This respondent proposes revisions to §§ 714.2(a)(l)(i) and (ii), 714.2(b)(l), (2), and (3), and 715.1(a)(l)(ii) that use the model in § 713.3(c)(1)(i) (“Do not aggregate amounts of production, processing or consumption among plants on the plant site that did not individually produce, process or consume a Schedule 2 chemical in amounts greater than the applicable threshold”). Response: The model paragraph identified by the respondent, new § 713.2(c)(1)(i) (previously § 713.3(c)(1)(i)), provides the specific requirements for “quantities to be declared” in a Schedule 2 declaration by determining if a Schedule 2 plant's activities must be aggregated with the quantities of other plants' activities that may have exceeded the specific declaration threshold. Similarly, § 714.1(c)(1) (previously § 714.2(c)(1)) provides the same requirements for “quantities to be declared” for a Schedule 3 plant thereby requiring that “* * * you must aggregate the production quantities of all plants on the plant site that produced the Schedule 3 chemical in amounts greater than 30 metric tons.” For purposes of clarity, however, BIS has added the following sentence to § 714.1(c)(1), which states: “Do not aggregate amounts of production from plants on the plant site that did not individually produce a Schedule 3 chemical in amounts greater than 30 metric tons.” BIS also has clarified the requirements for unscheduled discrete organic chemicals in a note to § 715.1(a)(1)(ii) to state: “In calculating the aggregate production quantity of each individual PSF chemical produced by a PSF plant, do not include production of a PSF chemical that was produced in quantities less than 30 metric tons. Include only production quantities from those PSF plants that produced more than 30 metric tons of an individual PSF chemical.” H. Section 715.1—Annual Declaration Requirements for Unscheduled Discrete Organic Chemicals (UDOCs) Comment: Two respondents interpret the exemption of UDOCs produced by synthesis that are ingredients or byproducts in foods and are designed for consumption by humans and/or animals to include dietary supplements, as defined under Section 201 of the Federal Food, Drug and Cosmetic Act (FFDCA), 21 U.S.C. Section 321. One respondent encouraged BIS to reference the FFDCA in interpreting § 715.1(a)(2)(ii)(E). Additionally, in response to BIS's request for public comment on the impact of the CWCR on facilities that produce UDOCs solely as consumer goods packaged for retail sale, two respondents recommend that BIS exempt facilities that process edible oils and edible oil byproducts solely for use in packaged consumer goods other than those intended for consumption by humans or animals, such as soaps, shampoos, detergents and consumer personal care products. Respondents argue that the concentration, distribution and reaction of these constituents vary from lot to lot, resulting in an unnecessary and costly analysis of mixtures made in-house expressly for incorporation into consumer products. Respondents argue that reporting of basic processing of edible oils operations is not consistent with the intent and purposes of the CWC. Edible oils are not discrete chemical entities and trying to “force-fit” them into the CWC's definition of UDOCs creates additional workplace burdens on facility personnel and forces changes in plant equipment and operations. Given the noticeable absence of any direct threat to the object and purpose of the Convention, these respondents recommend that BIS adopt an exemption for facilities involved exclusively in the processing of indiscrete edible oils for use in packaged consumer products. They argue in favor of a similar exemption for facilities which conduct acid-base reactions as a normal consumer product formulation. This type of reaction is pervasive in product formulation, is formulation specific, and is not currently quantified by most manufacturers. Therefore, according to respondents, quantifying this type of reaction would be technically difficult, costly and provide little information pertinent to the scope and objectives of the CWC. Response: BIS will review, on a case-by-case basis, requests for chemical determinations of dietary supplements, edible oil products, and consumer products other than those intended for consumption by humans and animals. BIS has determined that only undifferentiated edible oils that are not discrete organic chemicals are exempt from the requirements of part 715 of the CWCR. Discrete organic chemicals are defined in part 710 of the CWCR. Comment: One respondent suggests that the language for the exemption for polymers and oligomers in § 715.1(a)(2)(ii)(A) is confusing and that it need only say, “Polymers and oligomers consisting of two or more repeating units.” Response: BIS agrees with the recommendation and has changed 715.1(a)(2)(ii)(A) accordingly. BIS notes, however, that this change does not have any impact on those polymers and oligomers that are exempted. I. Section 716.1—General Information on the Conduct of Initial and Routine Inspections Comment: One respondent suggests that the list of responsibilities of BIS during inspections include: Assisting in the protection of confidential business information; consultation with facility representatives regarding facility concerns; serving as intermediary between the facility and the Inspection Team; and representing the interests of the facility, where appropriate. Response: Part 716.1 is purposefully broad to allow for accommodation of the needs of the U.S. Government, the Inspection Team, and the facility during inspections. J. Section 716.3—Consent to Inspections; Warrants for Inspections Comment: One respondent states that the interim rule fails to expressly incorporate the following language from the CWCIA: “The owner or the operator, occupant, or agent in charge of the premises to be inspected may withhold consent for any reason or no reason.” In comments to the interim rule, as captured in the preamble (64 FR 73755), it was suggested that this be incorporated in § 716.3. Response: The facility's right to withhold consent is included in the general reference to the CWCIA in 716.3(b). Comment: Further, this respondent states that the interim rule should be amended to state that the owner, occupant, or agent in charge of the premises to be inspected may withdraw consent at any time and that withdrawal of consent will not be a violation under § 719.2(a)(1) of the CWCR (as stated in the 64 FR 73755). Response: The CWCIA explicitly states that consent may be withheld and therefore no further regulation amendment is required. BIS does not see any need to further define who may withhold consent. Comment: One respondent acknowledges that, if time passes without a facility expressing consent to an inspection, eventually BIS will need to make preparations for a warrant. However, there may be times when the facility voices its consent after BIS has initiated those preparations. BIS should clarify that it will not continue to seek (or serve) a warrant if the facility has consented to inspection and has not withdrawn its consent. The respondent suggests that this clarification does not require any change to the wording of the regulations, but it would be sufficient to provide a response to the public comment in the preamble of the final regulations. Response: Whether BIS follows through with a warrant exercise is dependent upon at which stage a facility consents after not having consented to an inspection. If, for example, a facility has not consented and BIS initiates the warrant process, and is before a magistrate to obtain the warrant when a facility consents, it is highly likely that at that stage, BIS will obtain the warrant and the inspection will be continued under its terms. In certain instances, it may be more efficient for BIS to follow through with obtaining a warrant, and therefore, such circumstances will be reviewed on a case by case basis. Comment: One respondent states that the requirement that the person who gives consent to an inspection “represents that he or she has authority to make this decision for the facility” serves no purpose and proposes that the applicable Declaration and/or Reporting forms have a place to designate (by name or job title) persons who are authorized to consent to inspections. Response: As with a declaration made to BIS pursuant to the CWCR, an agreement to consent must be an official decision from the facility. Sections 304(b) and 305(a) of the CWCIA require that the owner, operator, occupant, or agent in charge of a facility be sent the notice of an inspection, and advise the U.S. Government of whether the facility consents to the inspection. It is for that reason that BIS requires that consent be made by a person with authority to speak on behalf of the company. In practice, BIS sends a written notice of inspection, including a request for consent via facsimile to the inspection point of contact (I-POC) listed on the declaration. If for some reason, the I-POC does not have authority to grant consent on behalf of the company, he or she would escalate the request to the appropriate official. Because this procedure is in place, there is no need to change the existing CWCR. K. Section 716.4—Scope and Conduct of Inspections Comment: One respondent states that when an owner, occupant or agent in charge of the premises consents to an initial or routine inspection, he or she is not consenting to provide access to, and has the right to deny access to: (1) Research and development laboratories; (2) pilot plants; and (3) non-relevant production units, including, but not limited to, plants and production units that are exempted from UDOC declaration requirements and plants and production units producing chemicals by fermentation, extraction, purification, distillation, and/or filtration. The respondent references a presentation made by the U.S. Arms Control and Disarmament Agency to industry in 1993, during which these assurances were made under discussions on “industry rights” and “declared plants.” Response: An inspected facility at any point may withhold consent during the inspection. Such a withholding of consent would require the U.S. Government to obtain a warrant to continue the inspection. However, when consent is granted to conduct the inspection, the boundary of that consent is understood to be the declared facility or plant site, which, in some cases, includes common infrastructure that support both the declared plant and other activities located within the definition of the plant site. BIS will consult with plant sites to determine the access appropriate to comply with the mandate of the inspection while protecting confidential business information to the extent practicable. However, the BIS Host Team Leader has the responsibility under the CWCR (§ 716.4(b)(2)) to determine the appropriate access. Comment: One respondent suggests that § 716.4(b)(2) should either: (1) Be deleted because the paragraph serves no purpose when consent is not given or is withdrawn; or (2) revised to state that inspection activities apply only to areas of a facility subject to inspection and that consent does not constitute a waiver of rights provided by the Act or other law. Response: Section 716.4(b)(2) is appropriately included to define the scope of consent and to clarify that the areas of the facility subject to inspection pursuant to consent will be consistent with those subject to inspection pursuant to Section 305 of the CWCIA. No further waiver of rights provided by the CWCIA or law is implied by the consent provisions. Existing language to that effect is unnecessary and has therefore not been included. Comment: One respondent suggests that § 716.4(c) (pre-inspection briefing (PIB)) should be revised to make the following items mandatory topics: (1) Plant, or plant site, health and safety and alarms; (2) protection of confidential business information; and (3) proposed inspection plan. The respondent also suggests that the term “process flow” be a “simplified block flow diagram of the process,” and that § 716.4(c)(1)(vii) should say “Units or plants specific to declared operations.” This respondent also suggests that BIS make a template for the PIB available on the Internet to let facilities do advance preparation. Response: The regulations for PIB requirements have been amended to include plant site health and safety issues and requirements, and associated alarm systems in existing subparagraph 716.4(c)(1)(i). The CWCR already include as an optional topic discussion of confidential business information during pre-inspection briefings in 716.4(c)(2)(iii). Inclusion of this topic is at the discretion of the plant site and some plant sites may not wish to identify confidential business information. Therefore, it is not necessary to make this topic mandatory. As suggested by the respondent, the requirements of 716.4(c)(1)(vi) have been amended to require presentation of a block flow diagram or simplified process flow diagram as opposed to process flow in order to accurately reflect the intended detail of such presentations. Also, as suggested by the respondent, the requirements of 716.4(c)(1)(vii) have been amended to require presentation of units and plants specific to declared operations to more accurately reflect the intended scope of such presentation. The discussion of a proposed inspection plan remains optional in § 716.4(c)(2)(vi) (previously § 716.4(c)(2)(vii)) because it is not required by the CWC. BIS has developed a PIB template for downloading from its Web site at www.cwc.gov. Comment: One respondent suggests that § 716.4(e) (Records review) is unnecessary because part 721 already deals with recordkeeping and should be deleted or substantially edited. If edited, the areas of concern are: (1) The idea that records must be provided “on the inspection site” as “paper copies or via electronic remote access by computer” is inconsistent with part 721 in several respects—“paper copies” implies duplicates, providing only two options (paper or electronic) disqualifies other media such as microfilm or microfiche, “electronic remote access” seems to forbid local access by computer, and records must be provided “on the inspection site” which may distinguish it from the plant site; and (2) the wording says the Inspection Team and the Host Team leader may agree on other formats for records, not providing for consultation with the site. Response: Section 716.4(e) is addressing an issue separate from the recordkeeping provisions of part 721. Specifically, § 716.4(e) is referring to the records to be made available during an inspection of a facility, and the ease with which such records may be made available. The recordkeeping requirements of part 721 of the CWCR separately address the obligation on how records should be maintained. L. Section 716.5—Notification, Duration and Frequency of Inspections Comment: One respondent suggests that, in order to ensure that facilities can express consent within four hours, inspection notification via telephone is also necessary to cover possible contingencies. To implement this, revisions to § 716.5(a)(l)(i) and the accompanying table are proposed. Response: BIS generally provides inspection notification to facility inspection points of contact via telephone. However, we send written notification of inspection with the request for consent that is required by the CWCIA via facsimile. Because BIS has these notification procedures in place, there is no need to change the existing CWCR. Comment: One respondent stated that, although §§ 716.5(a)(1)(i)(D) and 717.2(b)(2)(i)(D) state that a written inspection notice will tell the “names and titles” of each member of the Inspection Team, it would be useful to also know the nationality of each inspector. The respondent notes that this will perhaps become less important if the State Department revises the ITAR requirements. Facilities face the dilemma of possibly having to deny certain access in order to comply with ITAR requirements, although the CWC and the Act require sites to allow the Inspection Team into their facilities. Sites will need that information to make informed decisions. Response: BIS forwards facilities the official OPCW inspection notification as part of its Host Team Notification requesting consent. The OPCW notification only contains inspector names and titles, which fulfills the relevant requirement under § 304(b)(3)(A)(iv) of the CWCIA. BIS provides facilities with the nationality of inspectors during Advance Team activities upon request. If technical data subject to the ITAR is present on an inspection site, its disclosure to any foreign person, regardless of nationality, would require a license from the Department of State. Since the Department of State has not instituted an ITAR license exception for purposes of CWC inspections, the policy of BIS is to deny access to any item or technology subject to ITAR to any inspector absent U.S. Government authorization (see § 716.4(b)(3). Therefore, no change has been made to the existing CWCR. M. Sections 716.7 and 717.3—Samples Comment: One respondent states that the regulations are worded in a manner that could result in unfair “double penalties” for a single violation. For example, a failure to comply with the State Department's regulations on samples would also constitute a violation of BIS's regulations which require compliance with the State Department's regulations. The respondent recommends that these provisions simply mention that the State Department's regulations address the topic of samples, without the requirement of compliance. Response: Sections 716.7 and 717.3 serve as cross-references to the applicable sampling provisions in the State Department regulations. They are properly included in the CWCR to identify the existence of obligations under the State Department regulations. Since they reference the State Department regulations, only the State Department penalties would apply—there is no risk of duplicative violations. N. Sections 716.9 and 717.4—Report of Inspection-Related Costs Comment: One respondent proposed that these sections be modified to allow facilities to report the cost of preparing the report on inspection-related costs, in addition to the other required information for the submission. This respondent contends that BIS could have met Congress' needs in a manner that would have imposed fewer additional costs to facilities in compiling the information for the repot. The respondent insists that BIS should have provided a mechanism through which facilities could supply Congress information related to the costs incurred in preparing the reference report. Response: The provisions of the CWCIA require the Department of Commerce to submit a report to Congress on the costs incurred by U.S. industry as a result of CWC inspections. In order to compile this report, BIS has required companies to submit information related to the costs incurred from the conduct of a CWC inspection. In the interest of reducing the burden of reporting on companies, the CWCR requests that only the minimum amount of information necessary to show these costs be submitted to BIS, which ordinarily is only an accounting of the total cost incurred by the facility as a result of the inspection. Companies can interpret this requirement in many ways, and they may include in this calculation all costs they feel are relevant to the inspection, which conceivably could include the costs associated with preparing the report. While BIS encourages facilities to provide additional detail as necessary, information beyond that relating to the costs of the inspection is not required by the CWCIA, and therefore, BIS is not obligated to include that information in its submission to Congress. However, BIS will consider all information submitted by companies when it prepares the cost report for submission. Comment: One respondent suggested that BIS provide a written reminder a week or two after an inspection so that the facility would not forget to prepare the required cost report. Response: Under the current regulations, BIS sends the Inspection Point of Contact a post-inspection letter ( see new §§ 716.10 and 717.5). This letter is sent upon receipt of the Final Inspection Report from the Organization for the Prohibition of Chemical Weapons. The letter reminds the company of any declaration changes suggested and that its report of inspection-related costs is required. As a matter of policy, the companies are also contacted again if the report on inspection-related costs is not received within 90 days. Companies may also prepare the report during the inspection and provide it to the BIS Host Team Leader prior to BIS's departure from the site. O. Section 717.1—Clarification Procedures; Challenge Inspection Requests Pursuant to Article IX of the Convention Comment: One respondent stated that a domestic company should have more than five working days to respond to an information request. Because the Convention requires the U.S. government to respond to the requesting State Party within ten days, the respondent proposes that there be advance communication to the extent practicable, so that the formal information request does not come as a surprise and documentation collection can begin in advance. Response: BIS will contact any domestic company as early as practical in the clarification process ( see amended § 717.1(b)). Section 717.1 applies to official requests made by BIS. All official requests require a compliance deadline. Companies have five days to respond to a request for information. This gives the U.S. Government time to review and possibly clarify with the facility any additional information that may need to be provided. P. Section 717.2—Challenge Inspections Comment: One respondent states that BIS should clarify that, if consent is granted after the government has begun seeking, or has obtained, a criminal warrant, the warrant will not be served while the consent remains in effect. Response: As stated above, whether BIS follows through with a warrant exercise is dependent upon at which stage a facility consents after having not consented to an inspection. In certain instances, it may be more efficient for BIS to follow through with obtaining a warrant, and the circumstances of each case will be reviewed on a case by case basis. Comment: One respondent states that notification of a challenge inspection should be given in every case, not simply “if such notification is deemed appropriate.” Response: Section 304(b)(2) of the CWCIA provides the circumstances under which notice is provided for a challenge inspection. Specifically, it states that “[n]otice for a challenge inspection shall be provided at any appropriate time determined by the United States National Authority.” Therefore, it is true that a notice is required for routine inspections, but provision of notice of a challenge inspection is done at the decision of the USNA. Therefore, provision of notice in the instance of a challenge inspection is dependent upon a decision of the USNA. However, BIS recognizes that the CWCR is unclear on the timeline for notice in a challenge inspection, and therefore, Section 717.2(b) has been amended to include the phrase: “if possible, and when such notification is deemed appropriate.” Comment: One respondent questioned the language of § 717.2(b)(2)(ii), indicating that the U.S. Government may make an “advance team” available to assist with preparation for a challenge inspection. The concern is that the Act provides that (in the absence of consent) challenge inspections will be conducted under a criminal warrant. Under this situation, it is not clear how the Advance Team should be treated. The respondent requests that BIS clarify whether the U.S. Government will provide any immunity or other protection to enable sites to work freely with an Advance Team in conjunction with a challenge inspection. Response: No change to the CWCR is required. Although BIS may provide an Advance Team for those inspections, it is not obliged to do so. Given the broad range of possible circumstances covered by the challenge provisions of the CWC, it may not always be appropriate for BIS to provide Advance Team services. Immunity or other comparable protection is not appropriate in the inspection contest and has therefore not been included. Comment: One respondent notes that BIS added provisions in a number of locations saying the Host Team will consult with the site before making certain decisions about inspections. However, it appears that § 717.2(c) does not provide for consultation with the site before agreeing to extend a challenge inspection. This respondent feels this section should be revised to provide for consultation. Response: The respondent is correct that in certain sections of the CWCR, there is explicit provision for BIS to consult with facility representatives, when appropriate, but that in the challenge inspection context, there are no similar provisions. Since this is a U.S. Government-led inspection, BIS has the decision-making authority to extend a challenge inspection and is under no obligation to consult with the facility before extending the timeline for a challenge inspection. BIS is acting on behalf of the U.S. Government in fulfilling its obligations under the CWC for the conduct of a challenge inspection. It is therefore the responsibility of BIS to take whatever measures are necessary, and reasonable, to ensure that the inspection is completed and the Inspection Team meets the goals of their mandate. BIS will make every effort to consult with facility representatives and to take facility concerns under consideration when making decisions during inspections. Q. Section 718.1—Definitions Comment: Two respondents state that the definition of Confidential Business Information (CBI) in § 718.1 of the interim rule must be revised to conform to the much broader definition of CBI set forth in Section 103(g) of the CWCIA ( i.e. , that no inspection shall extend to financial data, sales and marketing data, pricing data, personnel data, research data, patent data, data maintained for compliance with environmental or occupational health and safety regulations, or personnel and vehicles entering and personnel and personal passenger vehicles exiting the facility). Response: CBI, as defined in § 718.1, follows the definition in the CWCIA, and therefore that paragraph requires no revision. Not only are the relevant sections of the Act referenced in § 718.1, but the definition of CBI is also included in that paragraph. Comment: In § 718.1(h), one respondent notes a reference to “personnel passenger vehicles” (64 FR 73803). The term used in the CWC Verification Annex is “personal passenger vehicles.” The CWCR should be changed to reflect the terminology used in the CWC. Response: BIS notes the difference in terms and agrees with the respondent. Accordingly, § 718.1(h) has been amended to follow the CWC, which reads, in Part X, paragraph 30 of the Verification Annex, “* * * personnel and personal passenger vehicles * * *.” R. Section 718.2—Identification of Confidential Business Information Comment: One respondent suggests that there is a gap in this section because some confidential business information (CBI) may be disclosed directly to an international Inspection Team, rather than through the Host Team ( e.g. , visual access or employee interview). The respondent suggests that a new paragraph be added as follows: “(e) In any situation not addressed by paragraphs (b) through (d) of this section, where confidential business information is disclosed to the Inspection Team, the facility shall identify to the Host Team that the information is confidential. The Host Team shall then take appropriate steps to inform the Inspection Team of its obligation to safeguard the information from further disclosure.” Response: Because the Host Team is the U.S. Government representative at the U.S. Government-led inspection, it will act as the intermediary between the facility and the Inspection Team. As such, any discussion, or any transfer of information, orally or in writing, should be reviewed and effectively cleared by the Host Team before being relayed to the Inspection Team. CBI relevant to inspection aims that is known to the facility must be identified to the Host Team, at best, before the inspection begins, or at the least, before disclosure to Inspection Teams. It is imperative that facilities and facility representatives be fully versed in the location of physical CBI on the facility and the presence of CBI in records or other documentation that could be reviewed by the Inspection Team. BIS does not anticipate, or wish to promote, the possibility of disclosure of CBI to the Inspection Team without the Host Team's knowledge, and therefore has not codified procedures in the CWCR whereby a facility would have opportunity to unilaterally release information to the Inspection Team. Nonetheless, in the unlikely event of CBI disclosure directly to the Inspection Team without prior disclosure to, or discussion with, the Host Team, facility representatives must immediately inform the Host Team so that appropriate measures contemplated by § 718.2(d) may be taken. Comment: One respondent notes that the proposed rule indicates that companies could not shroud irrelevant confidential information unless the Host Team agreed to allow it, but that, in response to comments, BIS changed the language of § 718.2(d)(1) to say irrelevant confidential information may be shrouded “as determined by” the Host Team. The respondent argues that this change makes no real difference as it does not provide a role for the facility to express its legitimate concerns. Although the right to shroud irrelevant confidential information is a right granted to the State Party, the loss of confidential information is a harm to the facility. In order to be consistent with changes made elsewhere in the regulations, the respondent suggests that BIS provide for consultation with the facility before the Host Team makes its determination. Response: BIS Host Teams are cognizant of facility concerns about protection of CBI and will work with facilities to protect the release of CBI that is unrelated to the inspection as much as possible. However, there are instances where release of CBI to the Inspection Team is unavoidable, and under those circumstances, the Inspection Team will be advised that the information is CBI and that it should be protected under the CWC's confidentiality provisions. Shrouding is one of many means through which CBI is protected, but it is not always the most reasonable means of protection, particularly considering the obvious nature of the shroud. Frequently, there are other alternatives employed to protect release of CBI to the Inspection Team, such as revising their inspection route through the facility, or taping over the words or symbols on tanks or drums. The BIS Host Team will work with the company in deciding the most appropriate method for protecting unrelated CBI, but ultimately, since this is a U.S. Government-led inspection, the Host Team will be the final decision- making authority on which protective method will be employed. Since prior consultation with the company, as appropriate, will generally be pursued, the recommended change to the regulatory text has not been made. S. Section 718.3—Disclosure of Confidential Business Information Comment: One respondent states that, although § 718.3(c)(4)(ii) provides for notice of disclosure to the owner of the confidential business information with certain exceptions, notice is of limited value unless the owner has an opportunity to be heard. Section 404(c)(2)(B) of the Act expressly provides a right to a hearing to object to disclosure and requires the United States National Authority (USNA) to provide its decision no later than 10 days before the scheduled or rescheduled date for the disclosure. However, the CWCR do not discuss this. Respondents suggest revising § 718.3(c)(4) to specify the right to a hearing, how and when to request a hearing, what the hearing generally will consist of, how and when the decision will be communicated, and what avenue of redress is available to the owner of the information if the USNA decides to disclose the information. Response: The respondent has referenced the hearing requirements that relate to the domestic release of company CBI that is in the possession and control of BIS. Under the referenced circumstances ( e.g. , pending investigation, request of Congress, national interest, etc. ) where CBI may be released, the company has a right to a hearing on the record prior to the release of such information. This hearing exercise is separate and distinct from the release of CBI during facility inspections. There is no right to a hearing during the inspection process, which is why all CBI must be identified to the Host Team prior to the start of the inspection in order for BIS to take measures to control access to CBI or prevent its release. Comment: One respondent notes that because §§ 718.2(c) and 718.3(b) state that certain information is not subject to the CBI provisions of the Act, that this reference will therefore be misunderstood to mean that the information cannot be protected as confidential business information. Other provisions in the CWCR (such as §§ 718.3(b)(1) and (2)) indicate that this was not BIS's intent and that other laws will protect the information and provide the procedures to be followed. The respondent suggests that BIS clarify §§ 718.2(c) and 718.3(b) to say that the information, although not subject to the CBI provisions of the Act, may be protected under other laws. Response: The reference to protection by other laws is already included in the text of the CWCR in § 718.3(a). That section specifically states that confidentiality of all information will be maintained consistent with the Act and the other listed statutes and regulations. There is no need to repeat this reference elsewhere in part 718. T. Section 719.3—Violations of the IEEPA Subject to Judicial Enforcement Proceedings Comment: One respondent noted that the 45 calendar day reference in § 719.3(a)(l)(iv) could be taken literally to allow for advance notification on only a single day. The respondent proposes that the wording of § 719.3 be revised to provide that the notice is required “not less than 45 calendar days” before the import. Response: As suggested by the respondent, § 719.3(a)(1)(iv) has been amended to provide that notice is required “not less than” 45 calendar days before the import. U. Section 719.6—Request for Hearing and Answer Comment: One respondent is concerned that this section allows only fifteen days from “the date of the Notice of Violation and Assessment (NOVA)” to request a hearing. If the regulations do not provide sufficient time, the site's attorney will have to file a request for hearing automatically, as a precautionary measure, even though ultimately the company may decide that no hearing was necessary. As the fifteen-day period is specified by statute, the respondent suggests one of the following: (a) Interpret the word “days” to mean “working days” to address weekends and holidays; (b) interpret the term “date of the NOVA” to mean the date of receipt of the NOVA to address any delays in the mail; or (c) commit to provide a telephone call to let the company know that a NOVA is coming, with a follow-up facsimile if requested. Response: BIS agrees with the respondent regarding the 15-day time period and the “date” of the NOVA. Accordingly, BIS has amended § 719.6(a) to state “15 business days” and has inserted the words “from the postmarked date of the NOVA” in the relevant sections of the CWCR. As to the respondent's suggestion in (c), BIS cannot guarantee a phone-call in these circumstances, but will note that the recipients should contact BIS in the event an extension is required for response time to these provisions. V. Section 719.8—Filing and Service of Papers Other Than the NOVA Comment: One respondent suggests that the idea that all papers must be served “simultaneously” with their filing is not achievable and that the word “simultaneously” be changed to “contemporaneously.” Response: Simultaneously and contemporaneously are interpreted by BIS as synonyms. BIS expects all motions and supporting documentation be served at the same time, and therefore, BIS requires simultaneous filing. This represents normal legal procedure. W. Section 719.20—Record for Decision Comment: One respondent notes that this section allows the Administrative Law Judge (ALJ), after an enforcement case, to transfer documents from the closed portion to the open portion of the record if the information becomes unrestricted through the passage of time without expressly providing notice or an opportunity for the owner of the information to be heard. In the preamble to the interim rule, BIS defended this by saying that the ALJ would necessarily make some sort of inquiry before transferring the records. The respondent is concerned that the ALJ may not have all the necessary information without allowing for notice and an opportunity to be heard. Response: BIS cannot impose additional requirements upon the ALJ other than those authorized by the Act. It is unnecessary to include additional direction for the ALJ in the CWCR, unless such direction is uniquely related to the CWC implementation process. The issue raised by the respondent is not CWC-specific, and therefore does not meet that test. X. Section 719.21—Payment of Final Assessment Comment: One respondent suggests that, in order to prevent an ALJ from requiring payment within an unreasonably short time, that § 719.21(a) be revised to say “or within a longer time specified in the order.” This respondent commented on this provision in the proposal, but BIS has not addressed the comment. Response: As suggested by the respondent, § 719.21(a) has been amended to provide that payment shall be made within 30 days of the effective date of the order or within such longer period of time as may be specified in the order. Y. Section 721.1—Inspection of Records Comment: One respondent suggests that this section begin, “Upon formal request * * *” to avoid confusion over whether a request has been made and to assist in determining compliance. Response: Requests made by the Department of Commerce may be made formally or informally, by telephone, in person, or through written correspondence. It is not necessary to distinguish between the types of requests that could be made. Therefore, no change has been made to the existing CWCR language. Z. Section 721.2—Recordkeeping Comment: Two respondents propose that the recordkeeping requirements recognize industry's records management programs in the interest of additional costs to and interruption of ordinary business and as recognized under other statutes. Respondents request that they be able to use whatever type of records normally used in the ordinary course of business (originals or duplicates), be allowed to use any duplication system normally used in the ordinary course of business, be able to store records in logical locations that do not unduly impair inspections (on or off the declared plant site), and be allowed but not required to provide personnel and equipment to assist with records. Response: The existing regulatory language is designed to allow for accessibility of records within the time limitations imposed by the CWC. That language is further designed to require retention only of those records (or copies thereof) necessary to verify compliance with the CWCR. Unfortunately, based on the implementation of the CWCR to date, certain required records may not be kept in the ordinary course of business and certain document retention and duplication policies that are used in the ordinary course of business may likewise not adequately protect necessary documentation. As a result, the existing regulatory language has been largely retained. AA. Section 721.3—Destruction or Disposal of Records Comment: Two respondents state that the requirements of this section undermine records management programs. Respondents argue that the CWCR do not require that the governmental agency must justify requesting the record, that once a record has been provided to the government it should be of no concern whether the company retains its copy thereafter, that there is no ending date specified, that these requirements exceed BIS's authority, and that the regulations do not impose any standards on the agency's decision to grant or deny permission to dispose of the records. For these reasons, § 721.3 should either be deleted or revised to allow disposal of records after they are provided to the government. Response: Section 404 of the Act provides for the release of certain CWC-related records in the national interest to Congress, enforcement agencies, or other federal agencies, as necessary. The Act provides guidelines for requesting records, the protection of the information contained in the records, and hearings related to their release. As the Act specifically addresses the handling of records, and since the Act is applicable to all government agencies, there is no need for BIS to further delineate those requirements in its regulations. BB. Miscellaneous Comments Comment: It is one respondent's understanding that the OPCW recently amended the requirements relating to transfers of saxitoxin and recommended that these changes be incorporated into all parts of the regulations that relate to the reporting of saxitoxin transfers. In addition, the Handbook for Schedule 1 Declarations and Reports should be amended to reflect these changes. Furthermore, the respondent contends that such OPCW amendments should initiate notice and comment rulemaking to change the CWCR where it does not conflict with the CWCIA. Response: Based upon an OPCW Decision on transfers of the Schedule 1 chemical saxitoxin, BIS has changed the advance notification period for transfers of 5 milligrams or less of saxitoxin, only when the chemical will be used for medical/diagnostic purposes. The advance notification for these transfers must be submitted to BIS at least 3 calendar days prior to export or import. CC. CWC Declaration Forms Comment: Two respondents encourage BIS to allow another possible means of determining the latitude and longitude of a declarable plant site, namely Land View III Mapping Software. Respondents understand that various industries already rely on this software for such determinations and suggest BIS allow the use of this and similar software in the course of CWC inspections as a means to further minimize the CWC's compliance costs to industry. Response: BIS has updated Supplement 1 to the Declaration and Report Handbook to clarify that the tools listed in the Handbook were only suggested options for industry to use in determining their facility's latitude and longitude coordinates. BIS did not intend to limit industry's activities to only these listed tools. There are a wide variety of commercial products available that may be used. Upon request, BIS will also assist companies in identifying their geographical coordinates. Comment: One respondent notes that “rounding rules” have been provided for Schedule 1, Schedule 2, and Schedule 3 substances in mixtures and that these rounding rules are necessary for UDOCs for the very same reasons, i.e.: Low concentrations do not pose a risk to the aims of the Convention; low concentrations are not readily amenable to diversion; the producer may not even know that a substance is present, if the concentration is very low; low concentrations may reflect inadvertent production of an impurity; and, minor fluctuations in very low concentrations may make it difficult to provide an accurate estimate of the annual quantity. In addition, UDOCs are farther removed from possible “chemical weapons” use than any of the scheduled chemicals and may be present in large numbers in a product stream in different concentrations that fluctuate. In the absence of any “rounding rule,” additional Declarations and Reports will increase the cost of compliance without providing a corresponding benefit. The respondent proposes that any constituent less than 5% in a mixture be excluded; if not, perhaps the same “0.5% round down to zero” that applies to Schedule 1 substances could apply. Response: BIS will review on a case-by-case basis requests for determinations of mixtures containing low concentrations of UDOCS. Comment: According to § 718.2(b)(2) and a footnote to Supplement No. 1 to part 718, companies must submit an up-front, written rationale to claim certain information is confidential. One respondent suggests that this requirement be deleted to reduce the regulatory burden and require written substantiation only in cases where a challenge is raised to the confidentiality of the information. The respondent contends this was consistent with the reporting requirements of many different federal, state and local agencies. Response: Due to the explicit definitional requirements provided in the Act pertaining to “confidential business information,” BIS has included in the CWCR the requirement that companies provide justification for why certain information should be considered CBI. BIS requests this “rationale” in writing in order to clearly ascertain that all elements of the Act's definition of CBI are met by the company information. Additionally, this written justification assists BIS in keeping track of confidential business information identified by the company during the inspection process. As such, this requirement is an important tool that assists BIS in complying with the Act and meeting the needs of the companies. Comment: One respondent suggests that BIS adopt a generic policy that no more than two significant digits are required. This will greatly reduce the rounding burdens, without harming the regulatory program in any way. Response: This issue is currently under discussion at OPCW. Accordingly, BIS will not implement a policy until a final decision on this matter has been agreed upon by all States Parties. Comment: One respondent contends that the choices for “purpose of production” leave a gap in reporting transfers to another company within the same industry. The respondent proposed revising the Schedule 3 import/export forms to say, “Transfer to other company or industry.” Response: BIS has changed the “purpose(s) of production” question on Schedule 3 Form 3-3 as suggested by the respondent. Rulemaking Requirements 1. This proposed rule has been determined to be significant for purposes of E.O. 12866. 2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule proposes to revise an existing collection of information subject to the requirements of the PRA. This collection has been approved by OMB under Control Number 0694-0091 (Chemical Weapons Convention—Declaration and Report Forms), which carries burden hour estimates of 10.6 hours for Schedule 1 Chemicals, 11.9 hours for Schedule 2 chemicals, 2.5 hours for Schedule 3 chemicals, 5.3/5.1 for unscheduled discrete organic chemicals, and 0.17 hours for Schedule 1 notifications. This rule proposes to add a new Section 711.3 to the Chemical Weapons Convention Regulations (CWCR) that would authorize BIS to contact any facility to request information concerning production, processing, consumption, export, import, or other activities involving scheduled chemicals and UDOCs, described in Parts 712 through 715 of the CWCR, in order to determine whether or not the facility is in compliance with the CWCR. This new requirement would apply to all persons and facilities that are subject to the reporting or declaration provisions of the CWCR, as set forth in Part 721. The total estimated annual burden hours for the compliance reviews authorized under new Section 711.3 would be 85 hours and the total estimated annual cost would be $3,236.46. This rule also proposes to add a new requirement for the submission of amendments (to previously submitted declarations and reports) resulting from inspection findings. The total estimated annual burden hours for this new amendment requirement would be 112 hours and the total estimated annual cost would be $4,267. Note that the estimated burden hours and cost for inspection related amendments are already included in the information collection authorization from OMB. Therefore, to avoid double counting the information, it does not appear as a separate line item under the revision to the information collection for this proposed rule. Finally, this rule proposes to add a new reporting form, entitled “No Changes” Certification Form, for UDOC facilities to use, if appropriate, for certifying that there are no changes to the information declared in the facilities prior year's annual declaration on past activities. This new form will reduce industry's estimated annual burden by 15 hours and $571.50. Note that, like the information related to inspection-related amendments, the estimated burden hours and cost for implementing the “No Changes” Certification Form are included in a prior information collection authorization from OMB. In conclusion, the total estimated annual burden hours for declarations, reports, amendments, and requests for compliance-related information under this proposed rule will increase from 4401 burden hours to 4471 burden hours. The changes proposed by this rule are addressed under two separate information collection submissions. Comments are invited on: (i) Whether the collection of information is necessary for the functions of the agency, including whether the information shall have practical utility; (ii) the accuracy of the agency's estimate of the burden of the proposed collection of information; (iii) ways to enhance the quality, utility, and clarity of the information to be collected; and (iv) ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden, to David Rostker, Office of Management and Budget (OMB), by e-mail to David_Rostker@omb.eop.gov, or by fax to (202) 395-7285; and to the Regulatory Policy Division, Bureau of Industry and Security, Department of Commerce, P.O. Box 273, Washington, DC 20044. 3. This rule does not contain policies with Federalism implications as that term is defined in Executive Order 13132. 4. The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601 et seq. , generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to the notice and comment rulemaking requirements under the Administrative Procedure Act (5 U.S.C. 553) or any other statute, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Under section 605(b) of the RFA, however, if the head of an agency certifies that a rule will not have a significant economic impact on a substantial number of small entities, the statute does not require the agency to prepare a regulatory flexibility analysis. Pursuant to section 605(b), the Chief Counsel for Regulations, Department of Commerce, certified to the Chief Counsel for Advocacy, Small Business Administration, that this proposed rule, if promulgated, will not have a significant economic impact on a substantial number of small entities for the reasons explained below. Consequently, BIS has not prepared a regulatory flexibility analysis. Small entities include small businesses, small organizations and small governmental jurisdictions. For purposes of assessing the impacts of this proposed rule on small entities, small entity is defined as: (1) A small business according to RFA default definitions for small business (based on SBA size standards), (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000, and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. BIS has determined that this proposed rule would affect only the first category of small entities ( i.e. , small businesses). The President reported to the Congress, in December 2003, as required under Section 309 of the CWC Implementation Act, that 297 U.S. companies representing 691 facilities, plant sites, and trading companies were subject to the declaration and reporting requirements under the Chemical Weapons Convention Regulations (CWCR). Although BIS estimates that the majority of these 297 companies are substantially sized businesses, having more than 500 employees, BIS does not have sufficient information on these companies to definitively characterize them as large entities. The Small Business Administration (SBA) has established standards for what constitutes a small business, with respect to each of the Standard Industrial Classification (SIC) code categories for “Chemicals and Allied Products.” However, BIS is not able to determine which of these SIC code categories apply to the companies that are subject to the declaration, reporting, advance notification, recordkeeping or inspection requirements of this rule. Therefore, for the purpose of assessing the impact of this proposed rule, BIS will assume that the 297 companies are small entities. Although this proposed rule would affect a substantial number of small entities ( i.e. , 297 companies), if adopted, the additional recordkeeping and reporting requirements that would be imposed by this rule would not have a significant economic impact on these entities. First, this rule proposes to add a new Section 711.3 that would authorize BIS to contact any facility to determine whether or not it is in compliance with the CWCR. The information that BIS would be authorized to request would concern production, processing, consumption, export, import, or other activities involving scheduled chemicals and UDOCs described in Parts 712 through 715 of the CWCR. This new requirement would apply to all persons and facilities subject to the reporting or declaration provisions of the CWCR, as set forth in Part 721. The total estimated annual burden hours for the compliance reviews authorized under new Section 711.3 would be 85 hours and the total estimated annual cost would be $3,236.46. Second, this rule proposes to add a new requirement for the submission of amendments (to previously submitted declarations and reports) resulting from inspection findings. The total estimated annual burden hours for the new amendment requirement would be 112 hours and the total estimated annual cost would be $4,267. Finally, this rule proposes to add a new reporting form, entitled “No Changes” Certification Form, for UDOC facilities to use, if appropriate, for certifying that there are no changes to the information declared in the facilities prior year's annual declaration on past activities. This new form will reduce industry's estimated annual burden by 15 hours and $571.50. The total estimated increase in annual burden hours to implement the additional recordkeeping and reporting requirements described above would be 197 burden hours and the total estimated annual cost would be $7,503.46. The total cost of these recordkeeping and reporting requirements would represent only a small percentage of the revenues generated by the affected companies. Although the proposed rule would affect a substantial number of small entities ( i.e. , 297 companies), the total economic impact on the affected entities ( i.e. , $7,503.46) would not be significant. Since the proposed revisions to the CWCR would not impose a significant economic impact on a substantial number of small entities, BIS did not prepare a regulatory flexibility analysis for this rule. Finally, the changes proposed by this rule should be viewed in light of the fact that BIS's discretion in formulating the declaration, reporting and advance notification, and recordkeeping requirements of the CWCR is limited by the Chemical Weapons Convention (the Convention). The Organization for the Prohibition of Chemical Weapons (OPCW) has issued forms for States Parties to use for declarations. In drafting the CWCR requirements and the forms for U.S. persons to use, BIS has consistently interpreted the Convention's requirements as narrowly as possible to ensure that only information that the United States National Authority must declare to the OPCW is to be submitted to BIS. Other States Parties, such as Canada, have imposed much broader reporting requirements on their industries, with the government taking on the responsibility of determining which of the information collected must be declared to the OPCW. In addition, certain declaration requirements of the Convention are subject to interpretation by States Parties. Until the Conference of States Parties establishes clear rules for these requirements, States Parties may use their “national discretion” to implement them. “National discretion” generally means a reasonable interpretation of the requirement. For requirements currently subject to “national discretion,” BIS has adopted in this rule the minimum requirements consistent with a reasonable reading of the Convention, keeping in mind its purposes and objectives. List of Subjects 15 CFR Part 710 Chemicals, Exports, Foreign Trade, Imports, Treaties. 15 CFR Part 711 Chemicals, Confidential business information, Reporting and recordkeeping requirements. 15 CFR Part 712 Chemicals, Exports, Foreign Trade, Imports, Reporting and recordkeeping requirements. 15 CFR Part 713 Chemicals, Exports, Foreign Trade, Imports, Reporting and recordkeeping requirements. 15 CFR Part 714 Chemicals, Exports, Foreign Trade, Imports, Reporting and recordkeeping requirements. 15 CFR Part 715 Chemicals, Exports, Foreign Trade, Imports, Reporting and recordkeeping requirements. 15 CFR Part 716 Chemicals, Confidential business information, Reporting and recordkeeping requirements, Search warrant, Treaties. 15 CFR Part 717 Chemicals, Confidential business information, Reporting and recordkeeping requirements, Search warrant, Treaties. 15 CFR Part 718 Confidential business information, Reporting and recordkeeping requirements. 15 CFR Part 719 Administrative proceedings, Exports, Imports, Penalties, Violations. 15 CFR Part 720 Penalties, violations. 15 CFR Part 721 Reporting and recordkeeping requirements. Accordingly, the Chemical Weapons Convention Regulations (15 CFR, Chapter VII, Subchapter B, Parts 710-729) are proposed to be revised to read as follows: PART 710—GENERAL INFORMATION AND OVERVIEW OF THE CHEMICAL WEAPONS CONVENTION REGULATIONS (CWCR) Sec. 710.1 Definitions of terms used in the Chemical Weapons Convention Regulations (CWCR). 710.2 Scope of the CWCR. 710.3 Purposes of the Convention and CWCR. 710.4 Overview of scheduled chemicals and examples of affected industries. 710.5 Authority. 710.6 Relationship between the Chemical Weapons Convention Regulations and the Export Administration Regulations, the International Traffic in Arms Regulations, and the Alcohol, Tobacco, Firearms and Explosives Regulations. Supplement No. 1 to Part 710—States Parties to the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on Their Destruction Supplement No. 2 to Part 710—Definitions of Production Authority: 22 U.S.C. 6701 et seq. ; E.O. 13128, 64 FR 36703, 3 CFR, 1999 Comp., p. 199. § 710.1 Definitions of terms used in the Chemical Weapons Convention Regulations (CWCR). The following are definitions of terms used in the CWCR (parts 710 through 729 of this subchapter, unless otherwise noted): Act (The). Means the Chemical Weapons Convention Implementation Act of 1998 (22 U.S.C. 6701 et seq. ). Advance Notification. Means a notice informing BIS of a company's intention to export to or import from a State Party a Schedule 1 chemical. This advance notification must be submitted to BIS at least 45 days prior to the date of export or import (except for transfers of 5 milligrams or less of saxitoxin for medical/diagnostic purposes, which must be submitted to BIS at least 3 days prior to export or import). BIS will inform the company in writing of the earliest date the shipment may occur under the advance notification procedure. Additionally, this advance notification requirement is imposed in addition to any export license requirements under the Department of Commerce's Export Administration Regulations (15 CFR Parts 730 through 799) or the Department of State's International Traffic in Arms Regulations (22 CFR Parts 120 through 130) or any import license requirements under the Department of Justice's Bureau of Alcohol, Tobacco, Firearms and Explosives Regulations (27 CFR part 447). Bureau of Industry and Security (BIS). Means the Bureau of Industry and Security of the United States Department of Commerce, including Export Administration and Export Enforcement. By-product. Means any chemical substance or mixture produced without a separate commercial intent during the manufacture, processing, use or disposal of another chemical substance or mixture. Chemical Weapon. Means the following, together or separately: (1) Toxic chemicals and their precursors, except where intended for purposes not prohibited under the Chemical Weapons Convention (CWC), provided that the type and quantity are consistent with such purposes; (2) Munitions and devices, specifically designed to cause death or other harm through the toxic properties of those toxic chemicals specified in paragraph (1) of this definition, which would be released as a result of the employment of such munitions and devices; (3) Any equipment specifically designed for use directly in connection with the employment of munitions or devices specified in paragraph (2) of this definition. Chemical Weapons Convention (CWC or Convention). Means the Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on Their Destruction, and its annexes opened for signature on January 13, 1993. Chemical Weapons Convention Regulations (CWCR). Means the regulations contained in 15 CFR parts 710 through 729. Consumption. Consumption of a chemical means its conversion into another chemical via a chemical reaction. Unreacted material must be accounted for as either waste or as recycled starting material. Declaration or report form. Means a multi-purpose form to be submitted to BIS regarding activities involving Schedule 1, Schedule 2, Schedule 3, or unscheduled discrete organic chemicals. Declaration forms will be used by facilities that have data declaration obligations under the CWCR and are “declared” facilities whose facility-specific information will be transmitted to the OPCW. Report forms will be used by entities that are “undeclared” facilities or trading companies that have limited reporting requirements for only export and import activities under the CWCR and whose facility-specific information will not be transmitted to the OPCW. Information from declared facilities, undeclared facilities and trading companies will also be used to compile U.S. national aggregate figures on the production, processing, consumption, export and import of specific chemicals. See also related definitions of declared facility, undeclared facility and report. Declared facility or plant site. Means a facility or plant site that submits declarations of activities involving Schedule 1, Schedule 2, Schedule 3, or unscheduled discrete organic chemicals above specified threshold quantities. Discrete organic chemical. Means any chemical belonging to the class of chemical compounds consisting of all compounds of carbon, except for its oxides, sulfides, and metal carbonates, identifiable by chemical name, by structural formula, if known, and by Chemical Abstract Service registry number, if assigned. (Also see the definition for unscheduled discrete organic chemical.) Domestic transfer. Means, with regard to declaration requirements for Schedule 1 chemicals under the CWCR, any movement of any amount of a Schedule 1 chemical outside the geographical boundary of a facility in the United States to another destination in the United States, for any purpose. Also means, with regard to declaration requirements for Schedule 2 and Schedule 3 chemicals under the CWCR, movement of a Schedule 2 or Schedule 3 chemical in quantities and concentrations greater than specified thresholds, outside the geographical boundary of a facility in the United States, to another destination in the United States, for any purpose. Domestic transfer includes movement between two divisions of one company or a sale from one company to another. Note that any movement to or from a facility outside the United States is considered an export or import for reporting purposes, not a domestic transfer. (Also see definition of United States. ) EAR. Means the Export Administration Regulations (15 CFR parts 730 through 799). Explosive. Means a chemical (or a mixture of chemicals) that is included in Class 1 of the United Nations Organization hazard classification system. Facility. Means any plant site, plant or unit. Facility Agreement. Means a written agreement or arrangement between a State Party and the Organization relating to a specific facility subject to on-site verification pursuant to Articles IV, V, and VI of the Convention. Host Team. Means the U.S. Government team that accompanies the inspection team from the Organization for the Prohibition of Chemical Weapons during a CWC inspection for which the regulations in this subchapter apply. Host Team Leader. Means the representative from the Department of Commerce who heads the U.S. Government team that accompanies the Inspection Team during a CWC inspection for which the regulations in this subchapter apply. Hydrocarbon. Means any organic compound that contains only carbon and hydrogen. Impurity. Means a chemical substance unintentionally present with another chemical substance or mixture. Inspection Notification. Means a written announcement to a plant site by the United States National Authority (USNA) or the BIS Host Team of an impending inspection under the Convention. Inspection Site. —Means any facility or area at which an inspection is carried out and which is specifically defined in the respective facility agreement or inspection request or mandate or inspection request as expanded by the alternative or final perimeter. Inspection Team. Means the group of inspectors and inspection assistants assigned by the Director-General of the Technical Secretariat to conduct a particular inspection. Intermediate. Means a chemical formed through chemical reaction that is subsequently reacted to form another chemical. ITAR. Means the International Traffic in Arms Regulations (22 CFR parts 120 through 130). Organization for the Prohibition of Chemical Weapons (OPCW). Means the international organization, located in The Hague, the Netherlands, that administers the CWC. Person. Means any individual, corporation, partnership, firm, association, trust, estate, public or private institution, any State or any political subdivision thereof, or any political entity within a State, any foreign government or nation or any agency, instrumentality or political subdivision of any such government or nation, or other entity located in the United States. Plant. Means a relatively self-contained area, structure or building containing one or more units with auxiliary and associated infrastructure, such as: (1) Small administrative area; (2) Storage/handling areas for feedstock and products; (3) Effluent/waste handling/treatment area; (4) Control/analytical laboratory; (5) First aid service/related medical section; and (6) Records associated with the movement into, around, and from the site, of declared chemicals and their feedstock or product chemicals formed from them, as appropriate. Plant site. Means the local integration of one or more plants, with any intermediate administrative levels, which are under one operational control, and includes common infrastructure, such as: (1) Administration and other offices; (2) Repair and maintenance shops; (3) Medical center; (4) Utilities; (5) Central analytical laboratory; (6) Research and development laboratories; (7) Central effluent and waste treatment area; and (8) Warehouse storage. Precursor. Means any chemical reactant which takes part, at any stage in the production, by whatever method, of a toxic chemical. The term includes any key component of a binary or multicomponent chemical system. Processing. Means a physical process such as formulation, extraction and purification in which a chemical is not converted into another chemical. Production. Means the formation of a chemical through chemical reaction, including biochemical or biologically mediated reaction ( see Supplement No. 2 to this part). Notes: 1. Production of Schedule 1 chemicals means formation through chemical synthesis as well as processing to extract and isolate Schedule 1 chemicals. 2. Production of a Schedule 2 or Schedule 3 chemical means all steps in the production of a chemical in any units within the same plant through chemical reaction, including any associated processes ( e.g. , purification, separation, extraction, distillation, or refining) in which the chemical is not converted into another chemical. The exact nature of any associated process ( e.g. , purification, etc. ) is not required to be declared. Production by synthesis. Means production of a chemical that is isolated for use or sale. Protective purposes in relation to Schedule 1 chemicals. Means any purpose directly related to protection against toxic chemicals and to protection against chemicals weapons. Further means the Schedule 1 chemical is used for determining the adequacy of defense equipment and measures. Purposes not prohibited by the CWC. Means the following: (1) Any peaceful purpose related to an industrial, agricultural, research, medical or pharmaceutical activity or other activity; (2) Any purpose directly related to protection against toxic chemicals and to protection against chemical weapons; (3) Any military purpose of the United States that is not connected with the use of a chemical [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A04-26517. Public record. Not legal advice.