[Federal Register Volume 79, Number 134 (Monday, July 14, 2014)]
[Notices]
[Pages 40772-40774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-16424]


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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection


Notice of Issuance of Final Determination Concerning Certain 
Carbon Dioxide Sampling Line Products

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 certain carbon dioxide sampling line products 
known as ``FilterLine'' and ``CapnoLine.'' Based upon the facts 
presented, CBP has concluded that Israel is the country of

[[Page 40773]]

origin for purposes of U.S. Government procurement.

DATES: The final determination was issued on July 8, 2014. 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 August 13, 2014.

FOR FURTHER INFORMATION CONTACT: Grace A. Kim, Valuation and Special 
Programs Branch, Regulations and Rulings, Office of International Trade 
(202) 325-7941.

SUPPLEMENTARY INFORMATION: Notice is hereby given that on July 8, 2014 
pursuant to subpart B of Part 177, U.S. Customs and Border Protection 
Regulations (19 CFR part 177, subpart B), CBP issued a final 
determination concerning the country of origin of certain carbon 
dioxide sampling line products known as ``FilterLine'' and 
``CapnoLine,'' which may be offered to the U.S. Government under an 
undesignated government procurement contract. This final determination, 
HQ H248851, was issued 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, based upon the facts presented, the assembly operations 
performed in China, using Israeli components, do not substantially 
transform the sampling line components. Therefore, the country of 
origin is Israel for purposes of U.S. Government procurement.
    Section 177.29, CBP Regulations (19 CFR 177.29), provides that a 
notice of final determination 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: July 8, 2014.
Sandra L. Bell,
Executive Director, Regulations and Rulings, Office of International 
Trade.

Attachment

HQ H248851
July 8, 2014
OT:RR:CTF:VS H248851 GaK
CATEGORY: Origin
Michelle L. Butler
Hyman, Phelps & McNamara, P.C.
700 13th Street NW., Suite 1200
Washington, DC 20005.
RE: U.S. Government Procurement; Country of Origin of FilterLine Set 
and CapnoLine; Substantial Transformation

Dear Ms. Butler:

    This is in response to your letter, dated November 6, 2013, 
requesting a final determination on behalf of Oridion Medical 1987 Ltd. 
(``Oridion''), pursuant to subpart B of part 177 of the U.S. Customs 
and Border Protection (``CBP'') Regulations (19 CFR part 177). Under 
these regulations, which implement Title III of the Trade Agreements 
Act of 1979 (``TAA''), as amended (19 U.S.C. Sec.  2511 et seq.), 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. Your letter was forwarded to 
this office by the National Commodity Specialist Division on December 
12, 2013. By letters dated February 19, May 15, and May 28, 2014, 
additional explanation was provided for our consideration in connection 
with the request for a final determination.
    This final determination concerns the country of origin of 
Oridion's carbon dioxide sampling lines, specifically the FilterLine 
Set Adult/Pediatric (``FilterLine'') and the Smart CapnoLine H Plus 
O2 (``CapnoLine''). We note that as a foreign manufacturer 
of the products at issue, Oridion is a party-at-interest within the 
meaning of 19 CFR Sec.  177.22(d)(1) and is entitled to request this 
final determination. Photographs were submitted with your request.
FACTS
    The products at issue are referred to as carbon dioxide 
(``CO2'') sampling lines: medical devices designed to carry 
a patient's breath to a monitor. Each sampling line includes tubing, a 
means of connecting to the patient, referred to as the patient 
interface, and a means of connection to a monitor.
    These sampling lines are classified into two product families: (1) 
The Filterline set sampling lines for intubated patients, designed to 
connect to ventilator tubing carrying oxygenated air from a ventilator 
to a patient through an airway adaptor, and (2) the Capnoline sets for 
non-intubated patients, which provide a nasal or oral/nasal 
``interface'' for the patient.

FilterLine

The components of the FilterLine include:
    (1) CO2 tube (manufactured in Israel and cut to length 
in China),
    (2) Universal Airway Adapter (manufactured in China), and
    (3) Quick Seal Connector (itself assembled in China using an 
Israeli origin Quick Seal Filter Housing, Chinese origin Hollofiber and 
an end connector called the Quick Seal LD Orange Golden).
    The Hollofiber is a fiber membrane filter that prevents liquids, 
particles, or bacteria from reaching the monitor which can contaminate 
the breath sample. The Hollofiber is placed inside the Quick Seal 
Filter Housing, which is connected to the Quick Seal LD Orange Golden. 
The Universal Airway Adapter is connected to the CO2 tube 
and the Quick Seal Connector is adhered to the other end of the 
CO2 tube.
    The CO2 tube delivers the patient's breath to the 
monitor, which you claim is the essential function of the finished 
product. The tube is of a patented design. In order to prevent blockage 
from mucus and blood, the tube must be able to handle moisture in a 
very precise manner. In addition, the tube's diameter cannot be too 
narrow, which would increase the likelihood of blockage, or too wide, 
which would create a delay in measurements. The FilterLine is assembled 
in China. It is then sent to Israel for quality control, final 
inspections, and packaging.

CapnoLine

The Components of the CapnoLine Include
    (1) CO2 tube (manufactured in Israel and cut to length 
in China),
    (2) Cannula, which is connected to the patient (manufactured in 
Israel),
    (3) Quick Seal Connector (itself assembled in China using an 
Israeli origin Quick Seal Filter Housing, Chinese origin Hollofiber and 
an end connector called the Quick Seal LD Yellow Golden),
    (4) O2 tube (manufactured in Israel and cut to length in 
Israel),
    (5) Miscellaneous tubing (manufactured in Israel),
    (6) Nafion dryer, used to reduce the humidity of the breath 
(manufactured in the U.S.),
    (9) connector/slides to hold the O2 and CO2 
tubing in place (manufactured in China).
    In China, the cannula is connected to the Nafion dryer on the right 
side and to the tubing on the left side. The other end of the Nafion 
dryer is attached to

[[Page 40774]]

the CO2 tube. The CO2 tube and the miscellaneous 
tubing from the Cannula are held together with a connector/slide and 
connected to the O2 tube. Then, the Quick Seal Connector, is 
attached to the end of the CO2 tube.
    As with the FilterLine, the CO2 tube and in this case 
the O2 tube deliver the patient's breath to the monitor, 
which you claim is the essential function of the finished product. The 
finished CapnoLine is sent to Israel for quality control and packaging.
LAW AND ANALYSIS:
    Pursuant to Subpart B of Part 177, 19 CFR 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.), 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.
    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 CFR Sec.  177.22(a).
    In order to determine whether a substantial transformation occurs 
when components of various origins are assembled into completed 
products, CBP considers the totality of the circumstances and makes 
such determinations on a case-by-case basis. The country of origin of 
the item's components, extent of the processing that occurs within a 
country, and whether such processing renders a product with a new name, 
character, and use are primary considerations in such cases. No one 
factor is decisive, the key issue is the extent of operations performed 
and whether the parts lose their identity and become an integral part 
of the new article. Belcrest Linens v. United States, 573 F.Supp. 1149 
(Ct. Int'l Trade 1983), aff'd, 741 F.2d 1368 (Fed. Cir. 1984). Assembly 
operations that are minimal or simple, as opposed to complex or 
meaningful, will generally not result in a substantial transformation. 
See C.S.D. 80-111, C.S.D. 85-25, C.S.D. 89-110, C.S.D. 89-118, C.S.D. 
90-51, and C.S.D. 90-97. Additionally factors such as the resources 
expended on product design and development, extent and nature of post-
assembly inspection and testing procedures, and the degree of skill 
required during the actual manufacturing process may be relevant when 
determining whether a substantial transformation has occurred.
    In HQ 560613, dated October 28, 1997, CBP held that U.S.-origin 
components were not substantially transformed in Ireland when made into 
a pregnancy test kit. The test kit was made from the following U.S. 
components: top and bottom housing, paper, antibody, wick, laminate, 
and nitrocellulose. In addition, a splash guard from Ireland and rayon 
from Germany was used. The critical components of the pregnancy test 
kit were found to be the three U.S.-origin antibodies. CBP recognized 
that the U.S.-origin components imparted the essential character of the 
pregnancy test kit and that the simple assembly of placing the 
antibodies onto the rayon membrane, and subsequent assembly of the 
strips into a plastic housing did not result in a substantial 
transformation.

FilterLine

    You believe that the country of origin of the FilterLine is Israel 
because it is the country in which the CO2 tube was 
manufactured. We agree that the CO2 tube performs the 
essential function of the finished product, which is the delivery of 
breath for monitoring the CO2 level in a patient's breath. 
The assembly process in China consists of cutting to length and 
attaching the CO2 tube with four other components from 
Israel and China. Under the described assembly process, the 
CO2 tube is attached to other components that facilitate its 
function and it does not lose its individual identity. Consistent with 
HQ 560613, we find that the Israel-origin CO2 tube is not 
substantially transformed by the cutting to length and assembly 
operations performed in China to produce the FilterLine. We conclude, 
based upon these specific facts, that the country of origin of the 
FilterLine for purposes of U.S. Government procurement is Israel.

CapnoLine

    You believe that the country of origin of the CapnoLine is Israel 
because it is the country in which the CO2 tube and 
O2 tube were manufactured. As with the FilterLine, the 
CO2 tube and O2 tubes in the CapnoLine perform 
the essential function, which is the delivery of breath for monitoring 
the CO2 level in a patient's breath while delivering 
O2 to the patient. The assembly process in China consists of 
cutting to length and connecting the CO2 tube to several 
different components from Israel, U.S. and China by inserting 
components and adhering them with a solvent. The CO2 tube is 
not physically altered, aside from being cut to length. Based on the 
information before us, and consistent with HQ 560613, we find that the 
Israel-origin CO2 tube and the O2 tube impart the 
essential character of the CapnoLine and is not substantially 
transformed by the assembly operations performed in China. We note that 
the Cannula and Quick Seal Filter Housing are also of Israeli origin. 
Therefore, based upon these specific facts, the country of origin of 
the CapnoLine for purposes of U.S. Government procurement is Israel.
HOLDING
    The FilterLine and the CapnoLine are not substantially transformed 
when they are assembled in China with Israeli and U.S. components. As a 
result, the country of origin of Oridion's sampling lines, specifically 
the FilterLine and the CapnoLine, for purposes of U.S. Government 
procurement is Israel.
    Notice of this final determination will be given in the Federal 
Register, as required by 19 CFR Sec.  177.29. Any party-at-interest 
other than the party which requested this final determination may 
request, pursuant to 19 CFR Sec.  177.31, that CBP reexamine the matter 
anew and issue a new final determination. Pursuant to 19 CFR Sec.  
177.30, any party-at-interest may, within 30 days of publication of the 
Federal Register Notice referenced above, seek judicial review of this 
final determination before the Court of International Trade.

Sincerely,

Sandra L. Bell,
Executive Director,
Regulations and Rulings, Office of International Trade.

[FR Doc. 2014-16424 Filed 7-11-14; 8:45 am]
BILLING CODE 9111-14-P