Notice of Issuance of Final Determination Concerning Electroenceplogram (EEG) Cutaneous Electrodes, 25297-25299 [2019-11373]

Download as PDF Federal Register / Vol. 84, No. 105 / Friday, May 31, 2019 / Notices Dated: May 24, 2019. Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2019–11337 Filed 5–30–19; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning Electroenceplogram (EEG) Cutaneous Electrodes U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of final determination. AGENCY: This document provides notice that U.S. Customs and Border Protection (‘‘CBP’’) has issued a final determination concerning the country of origin of Rhythmlink International L.L.C’.s, Electroencephalogram (EEG) Cutaneous Electrodes. Based upon the facts presented, CBP has concluded in the final determination that the last substantial transformation of the Electroencephalogram (EEG) Cutaneous Electrode Product occurs in the United States. DATES: The final determination was issued on May 24, 2019. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within July 1, 2019. khammond on DSKBBV9HB2PROD with NOTICES SUMMARY: attachment of a lead wire to the U.S. origin Electroencephalogram (EEG) Cutaneous Electrodes by crimping or gluing in China is not a substantial transformation. Therefore, the last substantial transformation of the Rhythmlink Electroencephalogram (EEG) Cutaneous Electrode product occurs in the United States. Section 177.29, CBP Regulations (19 CFR 177.29), provides that notice of final determinations shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register. Dated: May 24, 2019. Craig T. Clark, Acting Executive Director, Regulations and Rulings, Office of International Trade. HQ H300745 May 24, 2019 OT:RR:CTF:VS H300745 RSD Origin David S. Robinson Nexsen Pruet, PLLC 4141 Parklake Avenue Suite 200 Raleigh, NC 27612 RE: U.S. Government Procurement; Title III, Trade Agreements Act of 1979 (19 U.S.C. § 2511); Subpart B, Part 177, CBP Regulations; Electroencephalogram (EEG) Cutaneous Electrodes; Substantial Transformation CATEGORY: FOR FURTHER INFORMATION CONTACT: Dear Mr. Robinson: Robert Dinerstein, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202–325–0132). SUPPLEMENTARY INFORMATION: Notice is hereby given that on May 24, 2019, pursuant to subpart B of part 177, Customs and Border Protection (CBP) Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of the Electroencephalogram (EEG) Cutaneous Electrodes which may be offered to the United States Government under an undesignated government procurement contract. This final determination, in HQ H300745, was issued at the request of Rhythmlink International, L.L.C. under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511–18). In the final determination, CBP concluded that the assembly and This is in response to your letter, dated September 10, 2018, requesting a final determination on behalf of Rhythmlink International, LLC. (Rhythmlink) pursuant to subpart B of Part 177 of the U.S. Customs and Border Protection (CBP) Regulations (19 C.F.R. Part 177). This final determination concerns the country of origin of various selfadhesive cutaneous electrode products. As a U.S. importer, Rhythmlink is a party-at-interest within the meaning of 19 C.F.R. § 177.22(d)(1) and is entitled to request this final determination. Samples of three versions of the product have been submitted for our review. VerDate Sep<11>2014 16:42 May 30, 2019 Jkt 247001 FACTS: Rhythmlink is headquartered in Columbia, North Carolina and manufactures and distributes medical devices. It seeks a country of origin determination for the purposes of PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 25297 United States government procurement for a line of Electroencephalogram (EEG) Electrode products. An EEG is a test that detects electrical activity in the brain using electrodes attached to the scalp. Doctors use an EEG test to help diagnose certain neurological conditions, such as epilepsy and sleep disorders. The EEG electrode allows for a physical connection between a patient and medical diagnostic equipment. To use the EEG electrodes, the patient’s scalp is cleaned, and the cutaneous electrodes are attached to the patient’s skin using a small amount of an adhesive conductive gel or paste, either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation. To accomplish its function, the EEG electrode uses a glassfilled ABS plastic mold with a silverchloride coating. It is designed and manufactured to specifications as a U.S. Food and Drug Administration (FDA) medical regulated ‘‘cutaneous electrode’’, mainly for the recording of its electrical conductor function. Rhythmlink’s EEG electrodes are disposable. The product comes in varying lengths/styles and the end user can customize the color of the connecting wire. The electrodes’ function is common to all lengths and is unchanged by the color of the connecting wire. There are three EEG electrode products that have common construction and function: the Disposable Slim Cup, the Disposable Deep Cup, and Disposable Webb. Rhythmlink conducts all engineering and design of the EEG electrodes in the United States. The actual production and manufacture of the cutaneous electrodes is outsourced to a third party subcontractor located in the United States. The single-source manufacturer supplies the finished EEG electrodes to Rhythmlink, marked ‘‘Country of Origin: USA.’’ The manufacturer must further certify that, ‘‘This uniform silver coating applied to precision molded products enhances the mechanical and electrical performance of the finished electrode products so they can meet or exceed applicable AAMI Standards.’’ The fully assembled, packaged end product for medical use consists of five elements: the cutaneous electrode, the lead wire, a miniscule amount of crimp or glue, a heat shrink tube, and packaging. The subcontractor-supplied cutaneous electrodes are shipped from the United States to China where a lead wire is attached. You state that the lead wire acts as an electrical conductor that transfers low voltage electrical signals from the electrode to medical diagnostic E:\FR\FM\31MYN1.SGM 31MYN1 25298 Federal Register / Vol. 84, No. 105 / Friday, May 31, 2019 / Notices equipment. The lead wire used in the product is a commercially available 26gauge twisted copper wire comprising 19 strands of 38-gauge copper wire with medical grade PVC covering (in a total of 25 color options). The Korean supplier of this wire, cuts the wire, crimps a socket pin, and attaches a connector to one end of the wire and then ships the wire to China. Neither the wire nor the connectors are proprietary and are common electrical materials. In China, to support certain optional user preferences, the EEG electrodes are either attached to the lead wire of Korean origin, using a crimp produced in the United States or China. Crimp is a mix of tin, copper and nickel and represents only a tiny portion of the product’s cost. Alternatively, the process will utilize a German conductive adhesive glue, which is a mix of silver and epoxy and also represents a very small percentage of the product’s cost. The lead wire is crimped or glued to the electrode. The crimping process takes roughly five seconds (six operators can professionally crimp 6,000 products in a day). The alternative gluing process takes roughly 20 seconds (six operators can professionally glue 1,500 products in a day). Next, a heat shrink from either the United States or Japan is used to cover the joint. The heat shrink tube is an off-the-shelf product from a third party contractor from the United States or Japan that is available in almost 40 different diameters. The product is ultrasonically cleaned and dried (spin and convention drying), a heat shrink cover is added, and the product is inserted into a plastic pouch and cardboard packaging. After the EEG electrodes are shipped back to the United States, the products are subjected to randomized testing and sampling for quality control purposes. khammond on DSKBBV9HB2PROD with NOTICES ISSUE: Where does the last substantial transformation of the adhesive cutaneous EEG product occur for purposes of U.S. Government procurement? LAW AND ANALYSIS: CBP issues country of origin advisory rulings and final determinations as to whether an article is or would be a product of a designated country or instrumentality for the purposes of granting waivers of certain ‘‘Buy American’’ restrictions in U.S. law or practice for products offered for sale to the U.S. Government, pursuant to subpart B of Part 177, 19 C.F.R. § 177.21 et seq., which implements Title III of the Trade Agreements Act of 1979, as VerDate Sep<11>2014 16:42 May 30, 2019 Jkt 247001 amended (19 U.S.C. § 2511 et seq.) (TAA). Under the rule of origin set forth under 19 U.S.C. § 2518(4)(B): An article is a product of a country or instrumentality only if (i) it is wholly the growth, product, or manufacture of that country or instrumentality, or (ii) in the case of an article which consists in whole or in part of materials from another country or instrumentality, it has been substantially transformed into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was so transformed. See also 19 C.F.R. § 177.22(a). In rendering advisory rulings and final determinations for purposes of U.S. Government procurement, CBP applies the provisions of subpart B of Part 177 consistent with Federal Acquisition Regulations. See 19 C.F.R. § 177.21. In this regard, CBP recognizes that the Federal Acquisition Regulations restrict the U.S. Government’s purchase of products to U.S.-made or designated country end products for acquisitions subject to the TAA. See 48 C.F.R. § 25.403(c)(1). The Federal Acquisition Regulations define ‘‘U.S.-made end product’’ as: . . . an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with a name, character, or use distinct from that of the article or articles from which it was transformed. In reaching its country of origin determinations, the Court of International Trade has examined the essential character of an article to determine whether its identity has been substantially transformed through assembly or processing. For example, in Uniroyal, Inc. v. United States, 3 CIT 220, 225, 542 F. Supp. 1026, 1030 (1982), aff’d, 702 F.2d 1022 (Fed. Cir. 1983), the court held that imported shoe uppers added to an outer sole in the United States were the ‘‘very essence of the finished shoe’’ and thus the character of the product remained unchanged and did not undergo a substantial transformation. See also National Hand Tool Corp. v. United States,16 CIT 308 (1992), aff’d, 989 F.2d 1201 (Fed. Cir. 1993). Similarly, in National Juice Products Association v. United States, 10 CIT 48, 61, 628 F. Supp. 978, 991 (1986), the court held that imported orange juice concentrate ‘‘imparts the essential character’’ to the completed orange juice and thus was not substantially transformed into a product of the United States. PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 For products used in medical-related applications, we have held that no substantial transformation occurs when the critical components which impart the essential character of the product subsequently undergo simple assembly and processing. In HQ H296072, dated July 13, 2018, CBP considered the processing of a subdermal needle electrode. The processing was quite similar to the processing that the electrodes undergo in this case, and included attaching a lead wire to the electrode, adding a heat shrink and protective cover, and packaging. In HQ H296072, the subdermal needle electrodes of U.S. origin were attached by soldering in China. CBP held that the stimulating probes of the subdermal needle electrodes were not substantially transformed by the Chinese processing. HQ H300744, dated February 20, 2019, concerned the country of origin of various stimulating probes for purposes of U.S. government procurement. The probes were produced in the United States by cutting U.S. origin raw stainless steel rods to specified lengths. After cutting, the rods were ground to a precise diameter on a precision lathe. In China, the steel probes were attached to a lead wire of Korean origin using Chinese solder, and the probes were covered with a heat shrink from China, Japan, or the United States. The probes were attached to a hand grip consisting of a U.S.-origin handle insert and a Korean origin plastic handle. CBP held that the stimulating probes were not substantially transformed by the processing that occurred in China. Although a handle was added to the stimulating probes, CBP noted that the handles were not necessary to the functioning of the probes, but rather only added to their ease of use. In this case, the product’s main function is provided by the EEG cutaneous electrode, which allows for a physical connection between a patient and the medical diagnostic equipment when the electrode is applied directly to a patient’s skin to record physiological signals. Attaching the lead wire to the EEG electrode allows the EEG to be used, but the EEG electrode does not lose its individual identity by the simple assembly in China. Consequently, the U.S. cutaneous EEG electrodes, rather than the Korean-origin lead wire, determine the essence of the finished product. As in HQ H296072 and HQ H300744, the processing in China which involves the attaching of the lead wire by simple assembly through crimping or gluing is a minor operation that leaves the identity of the U.S. made self-adhesive cutaneous EEG electrodes intact. Both E:\FR\FM\31MYN1.SGM 31MYN1 Federal Register / Vol. 84, No. 105 / Friday, May 31, 2019 / Notices the crimping and gluing require only a low level of skill and technology. The crimping process takes roughly five seconds to perform, while the alternative gluing process takes roughly 20 seconds to complete. The remaining processing of the Product, consisting of cleaning and drying (spin and convention drying), adding the heat shrink cover, and inserting the Product into the plastic pouch and cardboard packaging are likewise simple, minor, and low-skill operations. Therefore, we find that the name, character, and use of the cutaneous electrode remain unchanged after the lead wire and other components are attached in China. As such, the U.S. origin cutaneous EEG electrodes which are processed in China by attaching a lead wire and being covered with a heat shrink, are not substantially transformed. Accordingly, for purposes of government procurement, we find that the last substantial transformation of the product is in the United States. HOLDING: Based on the information provided, the last substantial transformation of the self-adhesive cutaneous EEG electrode product occurs in the United States. Notice of this final determination will be given in the Federal Register, as required by 19 C.F.R. § 177.29. Any party-at-interest other than the party which requested this final determination may request, pursuant to 19 C.F.R. § 177.31, that CBP reexamine the matter anew and issue a new final determination. Pursuant to 19 C.F.R. § 177.30, any party-at-interest may, within 30 days after publication of the Federal Register notice referenced above, seek judicial review of this final determination before the Court of International Trade. Sincerely, Craig T. Clark Acting Executive Director, Regulations and Rulings, Office of Trade [FR Doc. 2019–11373 Filed 5–30–19; 8:45 am] khammond on DSKBBV9HB2PROD with NOTICES BILLING CODE P VerDate Sep<11>2014 16:42 May 30, 2019 Jkt 247001 DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [Docket No. FWS–R1–ES–2019–N054; FXES11140100000–190–FF01E00000] Final Environmental Impact Statement and Final Habitat Conservation Plan for the Skookumchuck Wind Energy Project, Lewis and Thurston Counties, Washington Fish and Wildlife Service, Interior. ACTION: Notice of availability. AGENCY: We, the U.S. Fish and Wildlife Service, announce the availability of a final environmental impact statement (EIS) and a final habitat conservation plan (HCP) addressing the Skookumchuck Wind Energy Project (project) in Lewis and Thurston Counties, Washington. The Skookumchuck Wind Energy Project LLC (applicant) is requesting an incidental take permit (ITP) covering the take of one threatened species listed under the Endangered Species Act, and two non-listed federally protected species (collectively referred to as covered species) likely to be caused by the operation of the project over a 30year period. The HCP describes the steps the applicant will take to minimize, mitigate, and monitor incidental take of the covered species. The final EIS has been prepared in response to the ITP application in accordance with the requirements of the National Environmental Policy Act. DATES: The Service’s ITP decision will occur no sooner than 30 days after publication of the U.S. Environmental Protection Agency’s notice of the final EIS in the Federal Register, and will be documented in a record of decision (ROD). SUMMARY: You may obtain copies of the documents by any of the following methods: • Internet: http://www.regulations.gov under Docket No. FWS–R1–ES–2019– N054. • Upon Request: You may call Curtis Tanner at 360–753–4326 to request alternative formats of the documents or make an appointment to inspect the documents during normal business hours at the U.S. Fish and Wildlife Service, Washington Fish and Wildlife Office, 510 Desmond Dr. SE, Suite 102, Lacey, WA 98503. FOR FURTHER INFORMATION CONTACT: Curtis Tanner, U.S. Fish and Wildlife Service, Washington Fish and Wildlife Office (see ADDRESSES); telephone: 360– 753–4326; email: Curtis_Tanner@ ADDRESSES: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 25299 fws.gov. Hearing or speech impaired individuals may call the Federal Relay Service at 800–877–8339 for TTY assistance. We, the U.S. Fish and Wildlife Service (Service), announce the availability of a final environmental impact statement (EIS) and a final habitat conservation plan (HCP) addressing the Skookumchuck Wind Energy Project (project) in Lewis and Thurston Counties, Washington. The Skookumchuck Wind Energy Project LLC (applicant) is requesting an incidental take permit (ITP) covering the take of one threatened species listed under the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531 et seq.), and two non-listed federally protected species (collectively referred to as covered species) likely to be caused by the operation of the project over a 30-year period. The HCP describes the steps the applicant will take to minimize, mitigate, and monitor incidental take of the covered species. The final EIS has been prepared in response to the ITP application, in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321 et seq.). The applicant is seeking an ITP authorizing take of the following covered species: Marbled murrelet (Brachyramphus marmoratus), bald eagle (Haliaeetus leucocephalus), and golden eagle (Aquila chrysaetos). The murrelet is listed as threatened under the ESA. Bald and golden eagles are not listed under the ESA, but are protected under the Bald and Golden Eagle Protection Act (BGEPA; 16 U.S.C. 668– 668d). If issued, the ITP would authorize take of the covered species that may occur as a result of their collision with project wind turbines, and as a result of the applicant carrying out site management and maintenance activities over the 30-year permit term. The applicant is not seeking ITP coverage for the construction phase of the project, which includes, without limitation, the construction of roads and turbine pads, and the erection of 38 commercial wind turbines, transmission lines, and meteorological towers. The applicant is also not seeking ITP coverage for the decommissioning of project facilities. The applicant anticipates completing project construction prior to implementation of the HCP. The HCP describes the anticipated amount of take of each covered species, and the steps the applicant will implement to minimize and mitigate the impacts of that taking. The HCP also describes the life history and ecology of SUPPLEMENTARY INFORMATION: E:\FR\FM\31MYN1.SGM 31MYN1

Agencies

[Federal Register Volume 84, Number 105 (Friday, May 31, 2019)]
[Notices]
[Pages 25297-25299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11373]


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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection


Notice of Issuance of Final Determination Concerning 
Electroenceplogram (EEG) Cutaneous Electrodes

AGENCY: U.S. Customs and Border Protection, Department of Homeland 
Security.

ACTION: Notice of final determination.

-----------------------------------------------------------------------

SUMMARY: This document provides notice that U.S. Customs and Border 
Protection (``CBP'') has issued a final determination concerning the 
country of origin of Rhythmlink International L.L.C'.s, 
Electroencephalogram (EEG) Cutaneous Electrodes. Based upon the facts 
presented, CBP has concluded in the final determination that the last 
substantial transformation of the Electroencephalogram (EEG) Cutaneous 
Electrode Product occurs in the United States.

DATES: The final determination was issued on May 24, 2019. A copy of 
the final determination is attached. Any party-at-interest, as defined 
in 19 CFR 177.22(d), may seek judicial review of this final 
determination within July 1, 2019.

FOR FURTHER INFORMATION CONTACT: Robert Dinerstein, Valuation and 
Special Programs Branch, Regulations and Rulings, Office of 
International Trade (202-325-0132).

SUPPLEMENTARY INFORMATION: Notice is hereby given that on May 24, 2019, 
pursuant to subpart B of part 177, Customs and Border Protection (CBP) 
Regulations (19 CFR part 177, subpart B), CBP issued a final 
determination concerning the country of origin of the 
Electroencephalogram (EEG) Cutaneous Electrodes which may be offered to 
the United States Government under an undesignated government 
procurement contract. This final determination, in HQ H300745, was 
issued at the request of Rhythmlink International, L.L.C. under 
procedures set forth at 19 CFR part 177, subpart B, which implements 
Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 
2511-18). In the final determination, CBP concluded that the assembly 
and attachment of a lead wire to the U.S. origin Electroencephalogram 
(EEG) Cutaneous Electrodes by crimping or gluing in China is not a 
substantial transformation. Therefore, the last substantial 
transformation of the Rhythmlink Electroencephalogram (EEG) Cutaneous 
Electrode product occurs in the United States.
    Section 177.29, CBP Regulations (19 CFR 177.29), provides that 
notice of final determinations shall be published in the Federal 
Register within 60 days of the date the final determination is issued. 
Section 177.30, CBP Regulations (19 CFR 177.30), provides that any 
party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial 
review of a final determination within 30 days of publication of such 
determination in the Federal Register.

    Dated: May 24, 2019.
Craig T. Clark,
Acting Executive Director, Regulations and Rulings, Office of 
International Trade.

HQ H300745

May 24, 2019

OT:RR:CTF:VS H300745 RSD

CATEGORY: Origin

David S. Robinson
Nexsen Pruet, PLLC
4141 Parklake Avenue
Suite 200
Raleigh, NC 27612

RE: U.S. Government Procurement; Title III, Trade Agreements Act of 
1979 (19 U.S.C. Sec.  2511); Subpart B, Part 177, CBP Regulations; 
Electroencephalogram (EEG) Cutaneous Electrodes; Substantial 
Transformation
Dear Mr. Robinson:
    This is in response to your letter, dated September 10, 2018, 
requesting a final determination on behalf of Rhythmlink International, 
LLC. (Rhythmlink) pursuant to subpart B of Part 177 of the U.S. Customs 
and Border Protection (CBP) Regulations (19 C.F.R. Part 177).
    This final determination concerns the country of origin of various 
self-adhesive cutaneous electrode products. As a U.S. importer, 
Rhythmlink is a party-at-interest within the meaning of 19 C.F.R. Sec.  
177.22(d)(1) and is entitled to request this final determination. 
Samples of three versions of the product have been submitted for our 
review.

FACTS:

    Rhythmlink is headquartered in Columbia, North Carolina and 
manufactures and distributes medical devices. It seeks a country of 
origin determination for the purposes of United States government 
procurement for a line of Electroencephalogram (EEG) Electrode 
products.
    An EEG is a test that detects electrical activity in the brain 
using electrodes attached to the scalp. Doctors use an EEG test to help 
diagnose certain neurological conditions, such as epilepsy and sleep 
disorders. The EEG electrode allows for a physical connection between a 
patient and medical diagnostic equipment. To use the EEG electrodes, 
the patient's scalp is cleaned, and the cutaneous electrodes are 
attached to the patient's skin using a small amount of an adhesive 
conductive gel or paste, either to record physiological signals (e.g., 
the electroencephalogram) or to apply electrical stimulation. To 
accomplish its function, the EEG electrode uses a glass-filled ABS 
plastic mold with a silver-chloride coating. It is designed and 
manufactured to specifications as a U.S. Food and Drug Administration 
(FDA) medical regulated ``cutaneous electrode'', mainly for the 
recording of its electrical conductor function. Rhythmlink's EEG 
electrodes are disposable.
    The product comes in varying lengths/styles and the end user can 
customize the color of the connecting wire. The electrodes' function is 
common to all lengths and is unchanged by the color of the connecting 
wire. There are three EEG electrode products that have common 
construction and function: the Disposable Slim Cup, the Disposable Deep 
Cup, and Disposable Webb.
    Rhythmlink conducts all engineering and design of the EEG 
electrodes in the United States. The actual production and manufacture 
of the cutaneous electrodes is outsourced to a third party 
subcontractor located in the United States. The single-source 
manufacturer supplies the finished EEG electrodes to Rhythmlink, marked 
``Country of Origin: USA.'' The manufacturer must further certify that, 
``This uniform silver coating applied to precision molded products 
enhances the mechanical and electrical performance of the finished 
electrode products so they can meet or exceed applicable AAMI 
Standards.''
    The fully assembled, packaged end product for medical use consists 
of five elements: the cutaneous electrode, the lead wire, a miniscule 
amount of crimp or glue, a heat shrink tube, and packaging. The 
subcontractor-supplied cutaneous electrodes are shipped from the United 
States to China where a lead wire is attached. You state that the lead 
wire acts as an electrical conductor that transfers low voltage 
electrical signals from the electrode to medical diagnostic

[[Page 25298]]

equipment. The lead wire used in the product is a commercially 
available 26-gauge twisted copper wire comprising 19 strands of 38-
gauge copper wire with medical grade PVC covering (in a total of 25 
color options). The Korean supplier of this wire, cuts the wire, crimps 
a socket pin, and attaches a connector to one end of the wire and then 
ships the wire to China. Neither the wire nor the connectors are 
proprietary and are common electrical materials.
    In China, to support certain optional user preferences, the EEG 
electrodes are either attached to the lead wire of Korean origin, using 
a crimp produced in the United States or China. Crimp is a mix of tin, 
copper and nickel and represents only a tiny portion of the product's 
cost. Alternatively, the process will utilize a German conductive 
adhesive glue, which is a mix of silver and epoxy and also represents a 
very small percentage of the product's cost. The lead wire is crimped 
or glued to the electrode. The crimping process takes roughly five 
seconds (six operators can professionally crimp 6,000 products in a 
day). The alternative gluing process takes roughly 20 seconds (six 
operators can professionally glue 1,500 products in a day). Next, a 
heat shrink from either the United States or Japan is used to cover the 
joint. The heat shrink tube is an off-the-shelf product from a third 
party contractor from the United States or Japan that is available in 
almost 40 different diameters. The product is ultrasonically cleaned 
and dried (spin and convention drying), a heat shrink cover is added, 
and the product is inserted into a plastic pouch and cardboard 
packaging. After the EEG electrodes are shipped back to the United 
States, the products are subjected to randomized testing and sampling 
for quality control purposes.

ISSUE:

    Where does the last substantial transformation of the adhesive 
cutaneous EEG product occur for purposes of U.S. Government 
procurement?

LAW AND ANALYSIS:

    CBP issues country of origin advisory rulings and final 
determinations as to whether an article is or would be a product of a 
designated country or instrumentality for the purposes of granting 
waivers of certain ``Buy American'' restrictions in U.S. law or 
practice for products offered for sale to the U.S. Government, pursuant 
to subpart B of Part 177, 19 C.F.R. Sec.  177.21 et seq., which 
implements Title III of the Trade Agreements Act of 1979, as amended 
(19 U.S.C. Sec.  2511 et seq.) (TAA).
    Under the rule of origin set forth under 19 U.S.C. Sec.  
2518(4)(B):

    An article is a product of a country or instrumentality only if (i) 
it is wholly the growth, product, or manufacture of that country or 
instrumentality, or (ii) in the case of an article which consists in 
whole or in part of materials from another country or instrumentality, 
it has been substantially transformed into a new and different article 
of commerce with a name, character, or use distinct from that of the 
article or articles from which it was so transformed.

See also 19 C.F.R. Sec.  177.22(a).
    In rendering advisory rulings and final determinations for purposes 
of U.S. Government procurement, CBP applies the provisions of subpart B 
of Part 177 consistent with Federal Acquisition Regulations. See 19 
C.F.R. Sec.  177.21. In this regard, CBP recognizes that the Federal 
Acquisition Regulations restrict the U.S. Government's purchase of 
products to U.S.-made or designated country end products for 
acquisitions subject to the TAA. See 48 C.F.R. Sec.  25.403(c)(1). The 
Federal Acquisition Regulations define ``U.S.-made end product'' as:
. . . an article that is mined, produced, or manufactured in the United 
States or that is substantially transformed in the United States into a 
new and different article of commerce with a name, character, or use 
distinct from that of the article or articles from which it was 
transformed.
    In reaching its country of origin determinations, the Court of 
International Trade has examined the essential character of an article 
to determine whether its identity has been substantially transformed 
through assembly or processing. For example, in Uniroyal, Inc. v. 
United States, 3 CIT 220, 225, 542 F. Supp. 1026, 1030 (1982), aff'd, 
702 F.2d 1022 (Fed. Cir. 1983), the court held that imported shoe 
uppers added to an outer sole in the United States were the ``very 
essence of the finished shoe'' and thus the character of the product 
remained unchanged and did not undergo a substantial transformation. 
See also National Hand Tool Corp. v. United States,16 CIT 308 (1992), 
aff'd, 989 F.2d 1201 (Fed. Cir. 1993). Similarly, in National Juice 
Products Association v. United States, 10 CIT 48, 61, 628 F. Supp. 978, 
991 (1986), the court held that imported orange juice concentrate 
``imparts the essential character'' to the completed orange juice and 
thus was not substantially transformed into a product of the United 
States.
    For products used in medical-related applications, we have held 
that no substantial transformation occurs when the critical components 
which impart the essential character of the product subsequently 
undergo simple assembly and processing. In HQ H296072, dated July 13, 
2018, CBP considered the processing of a subdermal needle electrode. 
The processing was quite similar to the processing that the electrodes 
undergo in this case, and included attaching a lead wire to the 
electrode, adding a heat shrink and protective cover, and packaging. In 
HQ H296072, the subdermal needle electrodes of U.S. origin were 
attached by soldering in China. CBP held that the stimulating probes of 
the subdermal needle electrodes were not substantially transformed by 
the Chinese processing.
    HQ H300744, dated February 20, 2019, concerned the country of 
origin of various stimulating probes for purposes of U.S. government 
procurement. The probes were produced in the United States by cutting 
U.S. origin raw stainless steel rods to specified lengths. After 
cutting, the rods were ground to a precise diameter on a precision 
lathe. In China, the steel probes were attached to a lead wire of 
Korean origin using Chinese solder, and the probes were covered with a 
heat shrink from China, Japan, or the United States. The probes were 
attached to a hand grip consisting of a U.S.-origin handle insert and a 
Korean origin plastic handle. CBP held that the stimulating probes were 
not substantially transformed by the processing that occurred in China. 
Although a handle was added to the stimulating probes, CBP noted that 
the handles were not necessary to the functioning of the probes, but 
rather only added to their ease of use.
    In this case, the product's main function is provided by the EEG 
cutaneous electrode, which allows for a physical connection between a 
patient and the medical diagnostic equipment when the electrode is 
applied directly to a patient's skin to record physiological signals. 
Attaching the lead wire to the EEG electrode allows the EEG to be used, 
but the EEG electrode does not lose its individual identity by the 
simple assembly in China. Consequently, the U.S. cutaneous EEG 
electrodes, rather than the Korean-origin lead wire, determine the 
essence of the finished product.
    As in HQ H296072 and HQ H300744, the processing in China which 
involves the attaching of the lead wire by simple assembly through 
crimping or gluing is a minor operation that leaves the identity of the 
U.S. made self-adhesive cutaneous EEG electrodes intact. Both

[[Page 25299]]

the crimping and gluing require only a low level of skill and 
technology. The crimping process takes roughly five seconds to perform, 
while the alternative gluing process takes roughly 20 seconds to 
complete. The remaining processing of the Product, consisting of 
cleaning and drying (spin and convention drying), adding the heat 
shrink cover, and inserting the Product into the plastic pouch and 
cardboard packaging are likewise simple, minor, and low-skill 
operations. Therefore, we find that the name, character, and use of the 
cutaneous electrode remain unchanged after the lead wire and other 
components are attached in China. As such, the U.S. origin cutaneous 
EEG electrodes which are processed in China by attaching a lead wire 
and being covered with a heat shrink, are not substantially 
transformed. Accordingly, for purposes of government procurement, we 
find that the last substantial transformation of the product is in the 
United States.

HOLDING:

    Based on the information provided, the last substantial 
transformation of the self-adhesive cutaneous EEG electrode product 
occurs in the United States.
    Notice of this final determination will be given in the Federal 
Register, as required by 19 C.F.R. Sec.  177.29. Any party-at-interest 
other than the party which requested this final determination may 
request, pursuant to 19 C.F.R. Sec.  177.31, that CBP reexamine the 
matter anew and issue a new final determination. Pursuant to 19 C.F.R. 
Sec.  177.30, any party-at-interest may, within 30 days after 
publication of the Federal Register notice referenced above, seek 
judicial review of this final determination before the Court of 
International Trade.

    Sincerely,
Craig T. Clark
Acting Executive Director, Regulations and Rulings, Office of Trade
[FR Doc. 2019-11373 Filed 5-30-19; 8:45 am]
BILLING CODE P