MAR-2-05 RR:TC:SM 560613 MLR
Stewart K. Hall, Esq.
Selfcare, Inc.
200 Prospect Street
Waltham, MA 02154
RE: Country of Origin Marking on pregnancy test kit;
Assembly; Antibodies; Ireland
Dear Mr. Hall:
This is in reference to your letter of July 23, 1997,
to Customs in New York requesting a ruling regarding the
country of origin marking on an early pregnancy test kit
("test kit"). A sample of the article and test kit
literature were submitted with your request.
FACTS:
It is stated that the test kit is designed for home use
and indicates whether the user is pregnant by producing a
reaction when it comes in contact with a urine sample. The
test kit consists of a plastic housing that holds a
cellulose strip which is connected to a media that is
impregnated with certain antibodies. If the user is
pregnant, the antibodies react with the human chorionic
gonadotropic hormone present in the woman's urine.
It is stated that the test kit consists of the
following components:
Component Origin
(1) top
housing........................................................U.S.
(2) bottom
housing..................................................U.S
(3)
cap..................................................................... U.S.
(4)
wick....................................................................U.S.
(5) 939
paper............................................................U.S.
(6) 901
paper............................................................U.S.
(7) monoclonal antibody 107 ("MAb
107").............U.S.
(an anti-human chorionic gonadotropic monoclonal
antibody)
(8) monoclonal antibody 105 ("MAb
105").............U.S.
(an anti-human chorionic gonadotropic monoclonal
antibody
(9) control antibody (goat anti-mouse
antibody)......U.S.
(10)
laminate.............................................................U.S.
(11)
nitrocellulose.....................................................U.S.
(12) splash
guard.......................................................Ireland
(13) 8 millimeter
rayon.............................................Germany
(14) hydrogen tetra chlorauric
hydrate......................U.S.
All of the components are shipped to Ireland for assembly.
It is stated that the critical components of the test
kit are the three antibodies which are produced in the U.S.
In addition to the assembly, the antibodies shipped to
Ireland in liquid form are placed on a solid material. The
MAb 105 and control antibody are sprayed onto the
nitrocellulose in two thin lines and dried. In a telephone
conversation with a member of my staff on October 28, 1997,
it was stated that in Ireland the hydrogen tetra chlorauric
hydrate is diluted with water to result in chlorauric acid
which is then boiled in water and sodium citric acid to
result in gold solution of pinkish/purple color. This gold
solution is coated with the MAb 107 and dried onto the rayon
membrane. It is stated that the purpose of the gold
solution is to impart color so that the pregnancy test may
be read once the urine reacts with the antibody. The
nitrocellulose and rayon are then placed on a laminated
paper with the 901 and 939 paper which has been soaked in a
detergent solution and dried. These laminates are then cut
into 6.9 mm strips. The strips are then assembled into the
housing which consists of a top part, a bottom part, and a
cap. A wick is added, and the completed sticks are then
placed in a foil pouch with a desiccant (both of Irish
origin) and sealed.
It is stated that the function of the antibody, to
detect the presence of the human pregnancy hormone, is not
transformed in the process, but its handling characteristics
are merely simplified. It is stated that the antibody in
its native state still reacts with the pregnancy hormone in
the same way, and the addition of a solid material only
simplifies consumer handling.
ISSUE:
Whether the test kit components are substantially
transformed by the processes performed in Ireland.
LAW AND ANALYSIS:
The marking statute, section 304, Tariff Act of 1930,
as amended (19 U.S.C. 1304), provides that, unless excepted,
every article of foreign origin (or its container) imported
into the U.S. shall be marked in a conspicuous place as
legibly, indelibly and permanently as the nature of the
article (or its container) will permit, in such a manner as
to indicate to the ultimate purchaser in the U.S. the
English name of the country of origin of the article.
Congressional intent in enacting 19 U.S.C. 1304 was "that
the ultimate purchaser should be able to know by an
inspection of the marking on the imported goods the country
of which the goods is the product. The evident purpose is
to mark the goods so that at the time of purchase the
ultimate purchaser may, by knowing where the goods were
produced, be able to buy or refuse to buy them, if such
marking should influence his will." United States v.
Friedlaender & Co. Inc., 27 CCPA 297, 302, C.A.D. 104
(1940).
Part 134, Customs Regulations (19 CFR Part 134)
implements the country of origin marking requirements and
exceptions of 19 U.S.C. 1304. Section 134.1(b), Customs
Regulations {19 CFR 134.1(b)}, defines "country of origin"
as the country of manufacture, production or growth of any
article of foreign origin entering the U.S. Further work or
material added to an article in another country must effect
a substantial transformation in order to render such other
country the "country of origin" within the meaning of the
marking laws and regulations.
For country of origin marking purposes, a substantial
transformation of an imported article in the U.S. occurs
when it is used in manufacture, which results in an article
having a name, character, or use differing from that of the
imported article. If such substantial transformation
occurs, then the manufacturer is the "ultimate purchaser" of
the imported article, and the article is excepted from
marking and only the outermost container is required to be
marked. See 19 CFR 134.35. On the other hand, if the
manufacturing or combining process is merely a minor one
which leaves the identity of the imported article intact, a
substantial transformation has not occurred and an
appropriate marking must appear on the imported article so
that the consumer can know the country of origin. Uniroyal,
Inc. v. United States, 3 CIT 220, 542 F. Supp. 1026, 1029
(1982), aff'd, 702 F.2d 1022 (Fed. Cir. 1983).
In this case it is claimed that placing the MAb 105 and
the Control antibody onto the nitrocellulose and the MAb 107
onto a rayon membrane, which are both placed on a laminated
paper, and the subsequent assembly of the strips into a
plastic housing does not result in a substantial
transformation in Ireland. It is alleged that while the
antibodies are placed on a solid material, the critical
components are the antibodies of U.S. origin that react with
the pregnancy hormone.
In National Juice Products Association v. United
States, 628 F. Supp. 978 (CIT 1986), the court upheld
Customs ruling that manufacturing concentrate used to make
frozen concentrated orange juice and reconstituted orange
juice was not substantially transformed. The manufacturing
concentrate is the "major part of the end product, when
measured by cost, value or quantity" and the further
processing in the U.S. to make the manufacturing concentrate
into frozen concentrated orange juice was considered a minor
manufacturing process. The court noted that the imported
product was the very essence of the retail product and that
the addition of water, orange essences and oils to the
concentrate, while making it suitable for retail sale, did
not change the fundamental character of the product.
In Headquarters Ruling Letter (HRL) 733248 dated August
22, 1990, Customs considered whether immune serum globulin
intravenous ("IGIV"), a human blood fraction, was
substantially transformed in Belgium. The IGIV was first
made from human blood, collected from U.S. donors, which
underwent various precipitating, centrifuging, and filter
processes. During these processes, proteins were removed
and reagents were added to the plasma, to result in a
product known as Immune Globulin (Human) Fraction II paste.
It was noted that in this form, with the addition of a
diluent, it could be used for intramuscular injection in
patients. The Fraction II was then sent to Belgium where it
underwent additional filtering, buffering, and other
processes to change it from bulk into dosage form which
rendered the IGIV fit to be administered intravenously. In
HRL 733248, Customs found that while the Belgian processes
were necessary to make the product useable in intravenous
form, the Fraction II was the major part of the end product
and the Belgian processes did not change the fundamental
character of the product.
Similarly, in this case it is our opinion that the
processes performed before the antibodies are shipped to
Ireland are the processes which are more fundamental in
creating the function of the pregnancy test kit. It is also
stated that the antibody in its native state still reacts
with the pregnancy hormone in the same way, and that the
addition of the solid material in Ireland only simplifies
consumer handling. Additionally, while the gold solution is
used to impart color once the test is used so that the user
may read the result of the test, we agree that the antibody
of U.S. origin itself reacts with the urine sample to yield
the result. Accordingly, we find that since the essential
character of the test kit is imparted by the antibodies
which are of U.S. origin, the placement of the antibodies
onto solid materials and the simple assembly thereof into
the housing in Ireland do not result in a substantial
transformation. Accordingly, since the antibodies are of
U.S. origin, we find that the imported test kits are not
subject to the country of origin marking requirements of 19
U.S.C. 1304. See also 19 CFR 134.32(m). However, the
determination of whether the test kits may be marked "Made
in U.S.A." is within the jurisdiction of the Federal Trade
Commission, Division of Enforcement, located at Suite 4636,
601 Pennsylvania Ave., NW, Washington, D.C. 20580.
HOLDING:
Based upon the information and sample provided, we find
that the placement of U.S.-origin antibodies on solid
material and the simple assembly of components does not
result in a substantial transformation in Ireland since we
find that the U.S.-origin antibodies represent the essential
character of the finished test kits. Accordingly, no
marking under 19 U.S.C. 1304 will be required on the
finished test kits. However, the Federal Trade Commission
should be contacted regarding the use of U.S. origin claims.
A copy of this ruling letter should be attached to the
entry documents filed at the time the goods are entered. If
the documents have been filed without a copy, this ruling
should be brought to the attention of the Customs officer
handling the transaction.
Sincerely,
John Durant, Director
Commercial Rulings Division