[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