MAR-2-05 RR:CR:SM 561002 MLR
Robert J. Leo, Esq.
Meeks & Sheppard
330 Madison Avenue
39th Floor
New York, NY 10017
RE: Country of Origin Marking on surgical instruments;
machined Hungary; Pakistan; Germany forgings; 19 CFR
134.32(c) and (o); 19 CFR 134.43(a)
Dear Mr. Leo:
This is in reference to your letter of May 15, 1998,
requesting a ruling on behalf of Johnson & Johnson
Professional Inc. ("J & J"), concerning the country of
origin marking on certain surgical instruments. Samples
were submitted with your request.
FACTS:
It is stated that J & J plans to manufacture various
surgical instruments, including forceps and surgical
scissors, in Germany using German stainless steel which are
forged to the shape of the particular instrument required.
Samples of three forgings and their respective finished
instruments (straight 5 inch long halsted mosquito forceps,
straight 6 3/4 inch long mayo scissors, and straight 8 inch
long rochester-ochsner forceps) were submitted. The German
forgings are then shipped to either Hungary or Pakistan. In
Hungary or Pakistan, the forgings will be milled and boxlock
pins in the hinge joint will be inserted. They will also be
ground, beveled, and if necessary heat treated, tested for
hardness, polished, and cleaned. The instrument will be
stamped with the word "Stainless" followed by the word,
"Germany".
It is stated that the instruments will then be returned
to Germany for final, intensive inspection and adjustment if
necessary. The instruments that pass inspection will then
be shipped to Switzerland where they will each be packaged
in a clear PVC bag attached to a card. The card is labeled
with the name "Johnson & Johnson Orthopaedics", the brand
name "Codman", and "Johnson & Johnson Professional Inc.,
Raynham, MA 02767-0350" and phone number. On the same side
of the card, below the phone number, the card is marked
"Made in Germany".
ISSUE:
Whether the proposed marking consisting of "Stainless"
and "Germany" on the finished instruments and the marking on
the card attached to the PVC bag satisfies the marking
requirements of 19 U.S.C. 1304.
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 occurs when it is used in the manufacture,
which results in an article having a name, character, or use
differing from that of the imported article. 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 National Hand Tool Corp. v. United States, 16 CIT
308 (1992), aff'd, 989 F.2d 1201 (Fed. Cir. 1993), the court
considered sockets and flex handles which were either cold
formed or hot forged into their final shape prior to
importation, speeder handles which were reshaped by a power
press after importation, and the grip of flex handles which
were knurled in the U.S. The imported articles were then
heat treated which strengthened the surface of the steel,
and cleaned by sandblasting, tumbling, and/or chemical
vibration before being electroplated. In certain instances,
various components were assembled together which the court
stated required some skill and dexterity. The court
determined that the imported articles were not substantially
transformed and that they remained products of Taiwan. In
making its determination, the court focused on the fact that
the components had been cold-formed or hot-forged "into
their final shape before importation", and that "the form of
the components remained the same" after the assembly and
heat-treatment processes performed in the U.S. Although the
court stated that a predetermined use would not necessarily
preclude a finding of a substantial transformation, it noted
that such determination must be based on the totality of the
evidence. The court then concluded that no substantial
change in name, character or use occurred as a result of the
processing performed in the U.S.
In Headquarters Ruling Letter (HRL) 559847 January 2,
1997, Customs considered U.S.-origin stainless steel sheets
cut into strips of suitable width, which were further cut
into blanks. The blanks were then heated and hammer forged.
The forgings were annealed and trimmed, and cold stamped to
straighten the trimmed forgings. The forgings were then
shipped to Pakistan where they underwent milling operations
to cut the box, rachet, and jaw serrations into the forceps;
assembled; ground; filed; heat treated, including tempering
and testing for hardness; acid pickled; polished; chemical
cleaned; and buffed. It was held that inasmuch as the
forgings resembled the shape and size of the completed
instruments upon importation into Pakistan, the operations
performed in Pakistan did not substantially transform the
forgings into a new and different article of Pakistani
origin. Accordingly, the origin of the finished instruments
was the U.S. See also HRL 560441 dated November 18, 1997
(no substantial transformation when German rough forgings
were machined, assembled, rough polished, heat treated, and
cleaned in Hungary); and HRL 558747 dated January 20, 1995.
We find the processes in this case to be similar to the
ones considered in HRL 560441 and HRL 559847. Accordingly,
pursuant to those rulings and National Hand Tool, we find
that there is no substantial transformation of the forgings
in Hungary (or Pakistan), and the country of origin of the
finished instruments for marking purposes will be Germany.
Therefore, the finished surgical instruments may be marked
"Stainless Germany", "Product of Germany", or "Made in
Germany". We also find that the U.S. address on the card
attached to the PVC bag which holds the surgical instrument
triggers the requirements of 19 CFR 134.46. However, the
marking on the card, "Made in Germany", below the telephone
and U.S. address satisfies the requirements of 19 CFR
134.46.
HOLDING:
Based upon the information provided, we find that the
country of origin of the finished surgical instruments is
Germany. Therefore, the finished surgical instruments may
be marked "Stainless Germany", "Product of Germany", or
"Made in Germany". Furthermore, the U.S. address on the
card attached to the PVC bag which holds the surgical
instrument triggers the requirements of 19 CFR 134.46, but
the marking, "Made in Germany", below the telephone and U.S.
address satisfies its requirements.
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