Title 15—Commerce and Foreign Trade--Volume 1
PART 712—ACTIVITIES INVOLVING SCHEDULE 1 CHEMICALS
§ 712.1   Round to zero rule that applies to activities involving Schedule 1 chemicals.
Facilities that produce, export or import mixtures containing less than 0.5% aggregate quantities of Schedule 1 chemicals (see supplement no. 1 to this part) as unavoidable by-products or impurities may round to zero and are not subject to the provisions of this part 712. Schedule 1 content may be calculated by volume or weight, whichever yields the lesser percent. Note that such mixtures may be subject to the regulatory requirements of other federal agencies.
§ 712.2   Restrictions on activities involving Schedule 1 chemicals.
(a) You may not produce Schedule 1 chemicals for protective purposes.
(b) You may not import any Schedule 1 chemical unless:
(1) The import is from a State Party;
(2) The import is for research, medical, pharmaceutical, or protective purposes;
(3) The import is in types and quantities strictly limited to those that can be justified for such purposes; and
(4) You have notified BIS at least 45 calendar days prior to the import, pursuant to § 712.6 of the CWCR.
Pursuant to § 712.6, advance notifications of import of saxitoxin of 5 milligrams or less for medical/diagnostic purposes must be submitted to BIS at least 3 days prior to import.
For specific provisions relating to the prior advance notification of exports of all Schedule 1 chemicals, see § 745.1 of the Export Administration Regulations (EAR) (15 CFR parts 730 through 774). For specific provisions relating to license requirements for exports of Schedule 1 chemicals, see § 742.2 and § 742.18 of the EAR for Schedule 1 chemicals subject to the jurisdiction of the Department of Commerce and see the International Traffic in Arms Regulations (22 CFR parts 120 through 130) for Schedule 1 chemicals subject to the jurisdiction of the Department of State.
(c)(1) The provisions of paragraphs (a) and (b) of this section do not apply to the retention, ownership, possession, transfer, or receipt of a Schedule 1 chemical by a department, agency, or other entity of the United States, or by a person described in paragraph (c)(2) of this section, pending destruction of the Schedule 1 chemical;
(2) A person referred to in paragraph (c)(1) of this section is:
(i) Any person, including a member of the Armed Forces of the United States, who is authorized by law or by an appropriate officer of the United States to retain, own, possess transfer, or receive the Schedule 1 chemical; or
(ii) In an emergency situation, any otherwise non-culpable person if the person is attempting to seize or destroy the Schedule 1 chemical.
§ 712.3   Initial declaration requirements for declared facilities which are engaged in the production of Schedule 1 chemicals for purposes not prohibited by the CWC.
Initial declarations submitted in February 2000 remain valid until amended or rescinded. If you plan to change/amend the technical description of your facility submitted with your initial declaration, you must submit an amended initial declaration to BIS 200 calendar days prior to implementing the change (see § 712.5(b)(1)(ii) of the CWCR).
§ 712.4   New Schedule 1 production facility.
(a) Establishment of a new Schedule 1 production facility. (1) If your facility has never before been declared under § 712.5 of the CWCR, or the initial declaration for your facility has been withdrawn pursuant to § 712.5(g) of the CWCR, and you intend to begin production of Schedule 1 chemicals at your facility in quantities greater than 100 grams aggregate per year for research, medical, or pharmaceutical purposes, you must provide an initial declaration (with a current detailed technical description of your facility) to BIS in no less than 200 calendar days in advance of commencing such production. Such facilities are considered to be “new Schedule 1 production facilities” and are subject to an initial inspection within 200 calendar days of submitting an initial declaration.
(2) New Schedule 1 production facilities that submit an initial declaration pursuant to paragraph (a)(1) of this section are considered approved Schedule 1 production facilities for purposes of the CWC, unless otherwise notified by BIS within 30 days of receipt by BIS of that initial declaration.
(b) Types of declaration forms required. If your new Schedule 1 production facility will produce in excess of 100 grams aggregate of Schedule 1 chemicals, you must complete the Certification Form, Form 1-1 and Form A. You must also provide a detailed technical description of the new facility or its relevant parts, and a detailed diagram of the declared areas in the facility.
(c) Two hundred days after a new Schedule 1 production facility submits its initial declaration, it is subject to the declaration requirements in § 712.5(a)(1) and (a)(2) and § 712.5(b)(1)(ii) of the CWCR.
§ 712.5   Annual declaration requirements for facilities engaged in the production of Schedule 1 chemicals for purposes not prohibited by the CWC.
(a) Declaration requirements —(1) Annual declaration on past activities. You must complete the forms specified in paragraph (b)(2) of this section if you produced at your facility in excess of 100 grams aggregate of Schedule 1 chemicals in the previous calendar year. As a declared Schedule 1 facility, in addition to declaring the production of each Schedule 1 chemical that comprises your aggregate production of Schedule 1 chemicals, you must also declare any Schedule 1, Schedule 2, or Schedule 3 precursor used to produce the declared Schedule 1 chemical. You must further declare each Schedule 1 chemical used (consumed) and stored at your facility, and domestically transferred from your facility during the previous calendar year, whether or not you produced that Schedule 1 chemical at your facility.
(2) Annual declaration on anticipated activities. You must complete the forms specified in paragraph (b)(3) of this section if you anticipate that you will produce at your facility more than 100 grams aggregate of Schedule 1 chemicals in the next calendar year. If you are not already a declared facility, you must complete an initial declaration (see § 712.4 of the CWCR) 200 calendar days before commencing operations or increasing production which will result in production of more than 100 grams aggregate of Schedule 1 chemicals.
(b) Declaration forms to be used —(1) Initial declaration. (i) You must have completed the Certification Form, Form 1-1 and Form A if you produced at your facility in excess of 100 grams aggregate of Schedule 1 chemicals in calendar years 1997, 1998, or 1999. You must have provided a detailed current technical description of your facility or its relevant parts including a narrative statement, and a detailed diagram of the declared areas in the facility.
(ii) If you plan to change the technical description of your facility from your initial declaration completed and submitted pursuant to § 712.3 or § 712.4 of the CWCR, you must submit an amended initial declaration to BIS 200 calendar days prior to the change. Such amendments to your initial declaration must be made by completing a Certification Form, Form 1-1 and Form A, including the new description of the facility. See § 712.7 of the CWCR for additional instructions on amending Schedule 1 declarations.
(2) Annual declaration on past activities. If you are subject to the declaration requirement of paragraph (a)(1) of this section, you must complete the Certification Form and Forms 1-1, 1-2, 1-2A, 1-2B, and Form A if your facility was involved in the production of Schedule 1 chemicals in the previous calendar year. Form B is optional.
(3) Annual declaration on anticipated activities. If you anticipate that you will produce at your facility in excess of 100 grams aggregate of Schedule 1 chemicals in the next calendar year you must complete the Certification Form and Forms 1-1, 1-4, and Form A. Form B is optional.
(c) Quantities to be declared. If you produced in excess of 100 grams aggregate of Schedule 1 chemicals in the previous calendar year, you must declare the entire quantity of such production, rounded to the nearest gram. You must also declare the quantity of any Schedule 1, Schedule 2 or Schedule 3 precursor used to produce the declared Schedule 1 chemical, rounded to the nearest gram. You must further declare the quantity of each Schedule 1 chemical consumed or stored by, or domestically transferred from, your facility, whether or not the Schedule 1 chemical was produced by your facility, rounded to the nearest gram. In calculating the amount of Schedule 1 chemical you produced, consumed or stored, count only the amount of the Schedule 1 chemical(s) in a mixture, not the total weight of the mixture (i.e., do not count the weight of the solution, solvent, or container).
(d) For the purpose of determining if a Schedule 1 chemical is subject to declaration, you must declare a Schedule 1 chemical that is an intermediate, but not a transient intermediate.
(e) “Declared” Schedule 1 facilities and routine inspections. Only facilities that submitted a declaration pursuant to paragraph (a)(1) or (a)(2) of this section or § 712.4 of the CWCR are considered “declared” Schedule 1 facilities. A “declared” Schedule 1 facility is subject to initial and routine inspection by the OPCW (see part 716 of the CWCR).
(f) Approval of declared Schedule 1 production facilities. Facilities that submit declarations pursuant to this section are considered approved Schedule 1 production facilities for purposes of the CWC, unless otherwise notified by BIS within 30 days of receipt by BIS of an annual declaration on past activities or annual declaration on anticipated activities (see paragraphs (a)(1) and (a)(2) of this section). If your facility does not produce more than 100 grams aggregate of Schedule 1 chemicals, no approval by BIS is required.
(g) Withdrawal of Schedule 1 initial declarations. A facility subject to §§ 712.3, 712.4 and 712.5 of the CWCR may withdraw its initial declaration at any time by notifying BIS in writing. A notification requesting the withdrawal of the initial declaration should be sent on company letterhead to the address in § 711.6 of the CWCR. BIS will acknowledge receipt of the withdrawal of the initial declaration. Facilities withdrawing their initial declaration may not produce subsequently in excess of 100 grams aggregate of Schedule 1 chemicals within a calendar year unless pursuant to § 712.4.
§ 712.6   Advance notification and annual report of all exports and imports of Schedule 1 chemicals to, or from, other States Parties.
Pursuant to the Convention, the United States is required to notify the OPCW not less than 30 days in advance of every export or import of a Schedule 1 chemical, in any quantity, to or from another State Party. In addition, the United States is required to provide a report of all exports and imports of Schedule 1 chemicals to or from other States Parties during each calendar year. If you plan to export or import any quantity of a Schedule 1 chemical from or to your declared facility, undeclared facility or trading company, you must notify BIS in advance of the export or import and complete an annual report of exports and imports that actually occurred during the previous calendar year. The United States will transmit to the OPCW the advance notifications and a detailed annual declaration of each actual export or import of a Schedule 1 chemical from/to the United States. Note that the advance notification and annual report requirements of this section do not relieve you of any requirement to obtain a license for export of Schedule 1 chemicals subject to the EAR or ITAR or a license for import of Schedule 1 chemicals from the Department of Justice under the Alcohol, Tobacco, Firearms and Explosives Regulations in 27 CFR part 447. Only “declared” facilities, as defined in § 712.5(e) of the CWCR, are subject to initial and routine inspections pursuant to part 716 of the CWCR.
(a) Advance notification of exports and imports. You must notify BIS at least 45 calendar days prior to exporting or importing any quantity of a Schedule 1 chemical, except for exports or imports of 5 milligrams or less of Saxitoxin—B (7)—for medical/diagnostic purposes, listed in supplement no. 1 to this part to or from another State Party. Advance notification of export or import of 5 milligrams or less of Saxitoxin for medical/diagnostic purposes only, must be submitted to BIS at least 3 calendar days prior to export or import. Note that advance notifications for exports may be sent to BIS prior to or after submission of a license application to BIS for Schedule 1 chemicals subject to the EAR and controlled under ECCN 1C351 or to the Department of State for Schedule 1 chemicals controlled under the ITAR. Such advance notifications must be submitted separately from license applications.
(1) Advance notifications should be on company letterhead or must clearly identify the reporting entity by name of company, complete address, name of contact person and telephone and facsimile numbers, along with the following information:
(i) Chemical name;
(ii) Structural formula of the chemical;
(iii) Chemical Abstract Service (CAS) Registry Number;
(iv) Quantity involved in grams;
(v) Planned date of export or import;
(vi) Purpose (end-use) of export or import (i.e., research, medical, pharmaceutical, or protective purposes);
(vii) Name(s) of exporter and importer;
(viii) Complete street address(es) of exporter and importer;
(ix) U.S. export license or control number, if known; and
(x) Company identification number, once assigned by BIS.
(2) Send the advance notification either by fax to (202) 482-1731 or by mail or courier delivery to the following address: Treaty Compliance Division, Bureau of Industry and Security, U.S. Department of Commerce, Room 4515, 14th Street and Pennsylvania Avenue, NW., Washington, DC 20230, and mark it “Attn: Advance Notification of Schedule 1 Chemical [Export] [Import].”
(3) Upon receipt of the advance notification, BIS will inform the exporter or importer of the earliest date after which the shipment may occur under the advance notification procedure. To export a Schedule 1 chemical subject to an export license requirement either under the EAR or the ITAR, the exporter must have applied for and been granted a license (see § 742.2 and § 742.18 of the EAR, or the ITAR at 22 CFR parts 120 through 130).
(b) Annual report requirements for exports and imports of Schedule 1 chemicals. Any person subject to the CWCR that exported or imported any quantity of Schedule 1 chemical to or from another State Party during the previous calendar year has a reporting requirement under this section.
(1) Annual report on exports and imports. Declared and undeclared facilities, trading companies, and any other person subject to the CWCR that exported or imported any quantity of a Schedule 1 chemical to or from another State Party in a previous calendar year must submit an annual report on exports and imports.
(2) Report forms to submit —(i) Declared Schedule 1 facilities. (A) If your facility declared production of a Schedule 1 chemical and you also exported or imported any amount of that same Schedule 1 chemical, you must report the export or import by submitting either:
( 1 ) Combined declaration and report. Submit, along with your declaration, Form 1-3 for that same Schedule 1 chemical to be reported. Attach Form A, as appropriate; Form B is optional; or
(2) Report. Submit, separately from your declaration, a Certification Form, Form 1-1, and a Form 1-3 for each Schedule 1 chemical to be reported. Attach Form A, as appropriate; Form B is optional.
(B) If your facility declared production of a Schedule 1 chemical and exported or imported any amount of a different Schedule 1 chemical, you must report the export or import by submitting either:
( 1 ) Combined declaration and report. Submit, along with your declaration, a Form 1-3 for each Schedule 1 chemical to be reported. Attach Form A, as appropriate; Form B is optional; or
( 2 ) Report. Submit, separately from your declaration, a Certification Form, Form 1-1, and a Form 1-3 for each Schedule 1 chemical to be reported. Attach Form A, as appropriate; Form B is optional.
(ii) If you are an undeclared facility, trading company, or any other person subject to the CWCR, and you exported or imported any amount of a Schedule 1 chemical, you must report the export or import by submitting a Certification Form, Form 1-1, and a Form 1-3 for each Schedule 1 chemical to be reported. Attach Form A, as appropriate; Form B is optional.
(c) Paragraph (a) of this section does not apply to the activities and persons set forth in § 712.2(b) of the CWCR.
§ 712.7   Amended declaration or report.
In order for BIS to maintain accurate information on previously submitted facility declarations, including information necessary to facilitate inspection notifications and activities or to communicate declaration or report requirements, amended declarations or reports will be required under the following circumstances described in this section. This section applies only to annual declarations on past activities and annual reports on exports and imports submitted for the previous calendar year or annual declarations on anticipated activities covering the current calendar year, unless specified otherwise in a final inspection report.
(a) Changes to information that directly affect inspection of a declared facility's Annual Declaration of Past Activities (ADPA) or Annual Declaration on Anticipated Activities (ADAA). You must submit an amended declaration or report to BIS within 15 days of any change in the following information:
(1) Types of Schedule 1 chemicals produced (e.g., additional Schedule 1 chemicals);
(2) Quantities of Schedule 1 chemicals produced;
(3) Activities involving Schedule 1 chemicals; and
(4) End-use of Schedule 1 chemicals (e.g., additional end-use(s)).
(b) Changes to export or import information submitted in Annual Reports on Exports and Imports from undeclared facilities, trading companies and U.S. persons. You must submit an amended report or amended combined declaration and report for changes to export or import information within 15 days of any change in the following export or import information:
(1) Types of Schedule 1 chemicals exported or imported (e.g., additional Schedule 1 chemicals);
(2) Quantities of Schedule 1 chemicals exported or imported;
(3) Destination(s) of Schedule 1 chemicals exported;
(4) Source(s) of Schedule 1 chemicals imported;
(5) Activities involving exports and imports of Schedule 1 chemicals; and
(6) End-use(s) of Schedule 1 chemicals exported or imported (e.g., additional end-use(s)).
(c) Changes to company and facility information previously submitted to BIS in the ADPA, the ADAA, and the Annual Report on Exports and Imports —(1) Internal company changes. You must submit an amended declaration or report to BIS within 30 days of any change in the following information:
(i) Name of declaration/report point of contact (D-POC), including telephone number, facsimile number, and e-mail address;
(ii) Name(s) of inspection point(s) of contact (I-POC), including telephone number(s), and facsimile number(s);
(iii) Company name (see § 712.7(c)(2) of the CWCR for other company changes);
(iv) Company mailing address;
(v) Facility name;
(vi) Facility owner, including telephone number, and facsimile number; and
(vii) Facility operator, including telephone number, and facsimile number.
(2) Change in ownership of company or facility. If you sold or purchased a declared facility or trading company, you must submit an amended declaration or report to BIS, either before the effective date of the change or within 30 days after the effective date of the change. The amended declaration or report must include the following information:
(i) Information that must be submitted to BIS by the company selling a declared facility:
(A) Name of seller ( i.e. , name of the company selling a declared facility);
(B) Name of the declared facility and U.S. Code Number for that facility;
(C) Name of purchaser ( i.e. , name of the new company purchasing a declared facility) and identity of contact person for the purchaser, if known;
(D) Date of ownership transfer or change;
(E) Additional details on sale of the declared facility relevant to ownership or operational control over any portion of that facility (e.g., whether the entire facility or only a portion of the declared facility has been sold to a new owner); and
(F) Details regarding whether the new owner will submit the next declaration or report for the entire calendar year during which the ownership change occurred, or whether the previous owner and new owner will submit separate declarations or reports for the periods of the calendar year during which each owned the facility or trading company.
( 1 ) If the new owner is responsible for submitting the declaration or report for the entire current year, it must have in its possession the records for the period of the year during which the previous owner owned the facility.
( 2 ) If the previous owner and new owner will submit separate declarations for the periods of the calendar year during which each owned the facility (“part-year declarations”), and if, at the time of transfer of ownership, the previous owner's activities are not above the declaration thresholds set forth in §§ 712.4 and 712.5 of the CWCR, the previous owner and the new owner must still submit declarations to BIS with the below threshold quantities indicated.
( 3 ) If the part-year declarations submitted by the previous owner and the new owner are not, when combined, above the declaration threshold set forth in §§ 712.4 and 712.5 of the CWCR, BIS will return the declarations without action as set forth in § 712.8 of the CWCR.
( 4 ) If part-year reports are submitted by the previous owner and the new owner as required in § 712.5 of the CWCR, BIS will submit both reports in the OPCW.
(ii) Information that must be submitted to BIS by the company purchasing a declared facility:
(A) Name of purchaser ( i.e. , name of company purchasing a declared facility;
(B) Mailing address of purchaser;
(C) Name of declaration point of contact (D-POC) for the purchaser, including telephone number, facsimile number, and e-mail address;
(D) Name of inspection points of contact (I-POC) for the purchaser, including telephone number(s), facsimile number(s) and e-mail address(es);
(E) Name of the declared facility and U.S. Code Number for that facility;
(F) Location of the declared facility;
(G) Owner and operator of the declared facility, including telephone number, and facsimile number; and
(H) Details on the next declaration or report submission on whether the new owner will submit the declaration or report for the entire calendar year during which the ownership change occurred, or whether the previous owner and new owner will submit separate declarations or reports for the periods of the calendar year during which each owned the facility or trading company.
( 1 ) If the new owner is taking responsibility for submitting the declaration or report for the entire current year, it must have in its possession the records for the period of the year during which the previous owner owned the facility.
( 2 ) If the previous owner and new owner will submit separate declarations for the periods of the calendar year during which each owned the facility, and, at the time of transfer of ownership, the previous owner's activities are not above the declaration thresholds set forth in §§ 712.4 and 712.5 of the CWCR, the previous owner and the new owner must still submit declarations to BIS with the below threshold quantities indicated.
( 3 ) If the part-year declarations submitted by the previous owner and the new owner are not, when combined, above the declaration threshold set forth in §§ 712.4 and 712.5 of the CWCR, BIS will return the declarations without action as set forth in § 712.8 of the CWCR.
( 4 ) If part-year reports are submitted by the previous owner and the new owner as required in § 712.5 of the CWCR, BIS will submit both reports to the OPCW.
You must submit an amendment to your most recently submitted declaration or report for declaring changes to internal company information (e.g., company name change) or changes in ownership of a facility or trading company that have occurred since the submission of this declaration or report. BIS will process the amendment to ensure current information is on file regarding the facility or trading company (e.g., for inspection notifications and correspondence) and will also forward the amended declaration to the OPCW to ensure that they also have current information on file regarding your facility or trading company.
You may notify BIS of change in ownership via a letter to the address given in § 711.6 of the CWCR. If you are submitting an amended declaration or report, use Form B to address details regarding the sale of the declared facility or trading company.
For ownership changes, the declared facility or trading company will maintain its original U.S. Code Number, unless the facility or trading company is sold to multiple owners, at which time BIS will assign new U.S. Code Numbers for the new facilities.
(d) Inspection-related amendments. If, following completion of an inspection (see parts 716 and 717 of the CWCR), you are required to submit an amended declaration based on the final inspection report, BIS will notify you in writing of the information that will be required pursuant to §§ 716.10 and 717.5 of the CWCR. You must submit an amended declaration to BIS no later than 45 days following your receipt of the BIS post-inspection letter.
(e) Non-substantive changes. If, subsequent to the submission of your declaration or report to BIS, you discover one or more non-substantive typographical errors in your declaration or report, you are not required to submit an amended declaration or report to BIS. Instead, you may correct these errors in a subsequent declaration or report.
(f) Documentation required for amended declarations or reports. If you are required to submit an amended declaration or report to BIS pursuant to paragraph (a), (b), (c), or (d) of this section, you must submit either:
(1) A letter containing all of the corrected information required, in accordance with the provisions of this section, to amend your declaration or report; or
(2) Both of the following:
(i) A new Certification Form ( i.e. , Form 1-1); and
(ii) The specific forms (e.g., annual declaration on past activities) containing the corrected information required, in accordance with the provisions of this part 712, to amend your declaration or report.
§ 712.8   Declarations and reports returned without action by BIS.
If you submit a declaration or report and BIS determines that the information contained therein is not required by the CWCR, BIS will return the original declaration or report to you, without action, accompanied by a letter explaining BIS's decision. In order to protect your confidential business information, BIS will not maintain a copy of any declaration or report that is returned without action (RWA). However, BIS will maintain a copy of the RWA letter.
§ 712.9   Deadlines for submission of Schedule 1 declarations, reports, advance notifications, and amendments.
Declarations, reports, advance notifications, and amendments required under this part must be postmarked by the appropriate date identified in supplement no. 2 to this part 712. Required declarations, reports, advance notifications, and amendments include:
(a) Annual declaration on past activities (Schedule 1 chemical production during the previous calendar year);
(b) Annual report on exports and imports of Schedule 1 chemicals from facilities, trading companies, and other persons (during the previous calendar year);
(c) Combined declaration and report (production of Schedule 1 chemicals, as well as exports or imports of the same or different Schedule 1 chemicals, by a declared facility during the previous calendar year);
(d) Annual declaration on anticipated activities (anticipated production of Schedule 1 chemicals in the next calendar year);
(e) Advance notification of any export to or import from another State Party;
(f) Initial declaration of a new Schedule 1 chemical production facility; and
(g) Amended declaration or report, including combined declaration and report.