[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.

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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]
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