2025-00723. Controls on Certain Laboratory Equipment and Related Technology To Address Dual Use Concerns About Biotechnology  

  • Control(s) Country chart (see Supp. No. 1 to part 738)
    NS applies to entire entry NS Column 2.
    RS applies to entire entry To or within Macau or a destination specified in Country Group D:5 of supplement no. 1 to part 740 of the EAR. See § 742.6(a)(12) of the EAR.
    AT applies to entire entry AT Column 1.

    List Based License Exceptions (See Part 740 for a Description of All License Exceptions)

    LVS: N/A

    GBS: Yes, except N/A for destinations subject to the RS control in 3A999.

    List of Items Controlled

    Related Controls: See also 3A999 for specific processing equipment, n.e.s.. See also 3E069 for technology for the “development” and “production” of items detailed in 3A069.

    License Requirement Note: Excluded from the scope of this entry are flow cytometers and mass spectrometers that are devices, as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 321(h), that have been authorized for marketing by the Food and Drug Administration under section 510(k), section 513, or section 515 of the FD&C Act, 21 U.S.C. 360(k), 21 U.S.C. 360c, 21 U.S.C. 360e, or are exempt from the requirement of premarket notification under section 510(k) of the FD&C Act, 21 U.S.C. 360(k), and that are included in a list required by section 510(j) of the FD&C Act, 21 U.S.C. 360(j).

    Related Definitions: N/A

    Items:

    a. Flow cytometers and cell sorters that are “specially designed” for spectral analysis or contain 26 or greater detectors or channels.

    b. Liquid chromatography mass spectrometry instruments (LC/MS and LC-MS/MS) “specially designed” for top-down proteomic analysis.

    * * * * *

    3A999 Specific Processing Equipment, n.e.s., as Follows (See List of Items Controlled).

    License Requirements

    Reason for Control: RS, AT

    Control(s) Country chart (see Supp. No. 1 to part 738)
    RS applies to entire entry A license is required for items controlled by this entry for export or reexport to Iraq or Pakistan or transfer within Iraq or Pakistan for regional stability reasons. The Commerce Country Chart is not designed to determine RS license requirements for this entry. See §§ 742.6 and 746.3 of the EAR for additional information.
    AT applies to entire entry A license is required for items controlled by this entry to North Korea for anti-terrorism reasons. The Commerce Country Chart is not designed to determine AT licensing requirements for this entry. See § 742.19 of the EAR for additional information.

    List Based License Exceptions (See Part 740 for a Description of All License Exceptions)

    LVS: N/A

    GBS: N/A

    List of Items Controlled

    Related Controls: (1) See also 3A225 (for frequency changers capable of operating in the frequency range of 600 Hz and above) and 3A233. (2) Certain auxiliary systems, equipment, “parts” and “components” for isotope separation plants made of or protected by UF6 resistant materials are subject to the export licensing authority of the Nuclear Regulatory Commission (see 10 CFR part 110). (3) See also 3A069 for flow cytometers and cell sorters that are “specially designed” for spectral analysis or contain 26 or greater detectors or channels as well as liquid chromatography mass spectrometry instruments (LC/MS and LC-MS/MS) “specially designed” for top-down proteomic analysis.

    Related Definitions: N/A

    Items:

    a. Frequency changers capable of operating in the frequency range from 300 up to 600 Hz, n.e.s;

    b. Mass spectrometers n.e.s;

    c. All flash x-ray machines, and “parts” or “components” of pulsed power systems designed thereof, including Marx generators, high power pulse shaping networks, high voltage capacitors, and triggers;

    d. Pulse amplifiers, n.e.s.;

    e. Electronic equipment for time delay generation or time interval measurement, as follows:

    e.1. Digital time delay generators with a resolution of 50 nanoseconds or less over time intervals of 1 microsecond or greater; or

    e.2. Multi-channel (three or more) or modular time interval meter and chronometry equipment with resolution of 50 nanoseconds or less over time intervals of 1 microsecond or greater;

    f. Chromatography and spectrometry analytical instruments, n.e.s.

    * * * * *

    E. “Technology”

    * * * * *

    3E001 “Technology” according to the General Technology Note for the “development” or “production” of commodities controlled by 3A (except 3A069, 3A901, 3A904, 3A980, 3A981, 3A991, 3A992, or 3A999), 3B (except 3B001.a.4, c, d, f.1, f.5, k to n, p.2, p.4, r, 3B002.c, 3B903, 3B904, 3B991, 3B992, 3B993, or 3B994) or 3C (except 3C907, 3C908, 3C909, or 3C992) .

    License Requirements

    Reason for Control: NS, MT, NP, RS, AT

    Control(s) Country chart (see Supp. No. 1 to part 738)
    NS applies to “technology” for commodities controlled by 3A001, 3A002, 3A003, 3B001 (except as noted in the heading), 3B002 (except 3B002.c), or 3C001 to 3C006 NS Column 1.
    MT applies to “technology” for commodities controlled by 3A001 or 3A101 for MT Reasons MT Column 1.
    NP applies to “technology” for commodities controlled by 3A001, 3A201, or 3A225 to 3A234 for NP reasons NP Column 1.
    RS applies to “technology” for commodities controlled in 3A090, when exported from Macau or a destination specified in Country Group D:5 Worldwide (see § 742.6(a)(6)(ii)).
    RS applies to “technology” for commodities controlled by 3A001.z, 3A090 (except for 3A090.c) To or within destinations specified in Country Groups D:1, D:4, and D:5 of supplement no. 1 to part 740 of the EAR, excluding any destination also specified in Country Groups A:5 or A:6. See § 742.6(a)(6)(iii) of the EAR.
    RS applies to “technology” for commodities controlled by 3A090.c To or within Macau or a destination specified in Country Group D:5 of supplement no. 1 to part 740 of the EAR. See § 742.6(a)(6)(i)(B) of the EAR.
    RS applies to “technology” for commodities controlled by 3A001.a.15 or b.13, 3A004, 3B003, 3C007, 3C008, or 3C009 RS Column 2.
    AT applies to entire entry AT Column 1.

    License Requirements Note: See § 744.17 of the EAR for additional license requirements for microprocessors having a processing speed of 5 GFLOPS or more and an arithmetic logic unit with an access width of 32 bit or more, including those ( print page 4617) incorporating “information security” functionality, and associated “software” and “technology” for the “production” or “development” of such microprocessors.

    Reporting Requirements

    See § 743.1 of the EAR for reporting requirements for exports under License Exceptions and Validated End-User authorizations.

    List Based License Exceptions (See Part 740 for a Description of All License Exceptions)

    TSR: Yes, except N/A for MT, and “technology” for the “development” or “production” of: (a) vacuum electronic device amplifiers described in 3A001.b.8, having operating frequencies exceeding 19 GHz; (b) solar cells, coverglass-interconnect-cells or covered-interconnect-cells (CIC) “assemblies,” solar arrays and/or solar panels described in 3A001.e.4; (c) “Monolithic Microwave Integrated Circuit” (“MMIC”) amplifiers in 3A001.b.2; (d) discrete microwave transistors in 3A001.b.3; and (e) commodities described in 3A090.

    Note: See § 740.2(a)(9)(ii) of the EAR for license exception restrictions for ECCN 3E001 “technology” for commodities controlled by 3A001.z, 3A090.

    IEC: Yes, for “technology” for equipment controlled by 3B001.q, see § 740.2(a)(22) and § 740.24 of the EAR.

    Special Conditions for Strategic Trade Authorization (STA)

    STA: License Exception STA may not be used to ship or transmit “technology” according to the General Technology Note for the “development” or “production” of equipment specified by ECCNs 3A002.g.1 or 3B001.a.2 to any of the destinations listed in Country Group A:6 (see supplement no.1 to part 740 of the EAR). License Exception STA may not be used to ship or transmit “technology” according to the General Technology Note for the “development” or “production” of components specified by ECCN 3A001.b.2, b.3, commodities specified in 3A090, to any of the destinations listed in Country Group A:5 or A:6 (see supplement no. 1 to part 740 of the EAR).

    List of Items Controlled

    Related Controls: (1) “Technology” according to the General Technology Note for the “development” or “production” of certain “space-qualified” atomic frequency standards described in Category XV(e)(9), MMICs described in Category XV(e)(14), and oscillators described in Category XV(e)(15) of the USML are “subject to the ITAR” (see 22 CFR parts 120 through 130). See also ECCNs 3E101, 3E201 and 9E515. (2) “Technology” for “development” or “production” of “Microwave Monolithic Integrated Circuits” (“MMIC”) amplifiers in 3A001.b.2 is controlled in this ECCN 3E001; 5E001.d refers only to that additional “technology” “required” for telecommunications.

    Related Definition: N/A.

    Items: The list of items controlled is contained in the ECCN heading.

    Note 1: 3E001 does not control “technology” for equipment or “components” controlled by 3A003.

    Note 2: 3E001 does not control “technology” for integrated circuits controlled by 3A001.a.3 to a.14 or z, having all of the following:

    (a) Using “technology” at or above 0.130 μm; and

    (b) Incorporating multi-layer structures with three or fewer metal layers.

    * * * * *

    3E069 “Technology” according to the General Technology Note for the “development” or “production” of items controlled by 3A069.

    License Requirements

    Reason for Control: NS, RS, AT

    Control(s) Country chart (see Supp. No. 1 to part 738)
    NS applies to entire entry NS Column 2.
    RS applies to entire entry To or within Macau or a destination specified in Country Group D:5 of supplement no. 1 to part 740 of the EAR. See § 742.6(a)(13) of the EAR.
    AT applies to entire entry AT Column 1.

Document Information

Effective Date:
1/16/2025
Published:
01/16/2025
Department:
Industry and Security Bureau
Entry Type:
Rule
Action:
Interim final rule.
Document Number:
2025-00723
Dates:
This rule is effective January 16, 2025.
Pages:
4612-4617 (6 pages)
Docket Numbers:
Docket No. 250108-0012
RINs:
0694-AJ95: Control of Laboratory Equipment and Related Technology and Software
RIN Links:
https://www.federalregister.gov/regulations/0694-AJ95/control-of-laboratory-equipment-and-related-technology-and-software
Topics:
Administrative practice and procedure, Exports, Reporting and recordkeeping requirements, Terrorism
PDF File:
2025-00723.pdf
CFR: (4)
15 CFR 740
15 CFR 742
15 CFR 758
15 CFR 774