MAR-2-05 CO:R:C:V 731002 jd
Ms. Loredana Pollonio-Lister
President
Lima International Corporation
44 Amaral Street
East Providence, Rhode Island 02915
RE: Country of origin marking requirements applicable to
orthopedic implants and fixators
Dear Ms. Pollonio-Lister:
This is in response to your letter of January 14, 1988
(resubmitted on November 15, 1988), requesting a ruling on the
application of country of origin marking requirements to
orthopedic implants and fixators. We regret the delay in
responding and your patience has been much appreciated.
FACTS:
Your company imports orthopedic products from Italy.
Sample catalog pages depict various products such as prosthetic
devices for resectioning bones, and fixators for properly
aligning and holding in place broken bones being repaired. Where
possible, the manufacturer's name and stock number are marked on
pieces by means of a laser beam. It appears from the catalog
pages that these articles are grouped according to their intended
application, e.g., all pieces necessary to set a broken leg bone
are assembled on a metal tray, and the metal tray is contained in
a metal box. Some small pieces are in plastic pouches and the
pouch is imprinted with the country of origin of its contents.
You have asked several questions relative to the marking of
these articles: is laser beam marking of the word "ITALY" on
these articles an acceptable method of marking; would it be
appropriate to mark "ITALY" only on the boxes holding the trays;
must all the items be marked;and where marking of small pieces
would be impossible or present significant difficulties, may an
exception from marking be granted?
We add to this list of issues an inquiry into who is the
ultimate purchaser of these articles. Our resolution to that
issue makes it clear that the question of the sufficiency of
marking the metal box holding the trays is the only remaining
point needing attention.
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ISSUES:
Who is the ultimate purchaser of orthopedic implants and
fixator devices?
If various pieces of an orthopedic implant kit are grouped
together and packaged on a metal tray, such metal tray then
placed in a metal box, is country of origin marking on the metal
box sufficient for purposes of 19 U.S.C. 1304?
LAW AND ANALYSIS:
Section 304 of the Tariff Act of 1930, as amended (19
U.S.C. 1304), requires that, unless excepted, every article of
foreign origin (or its container) imported into the United States
shall be marked in a conspicuous place as legibly, indelibly and
permanently as the nature of the article (or container) will
permit in such a manner as to indicate to the ultimate purchaser
in the United States the English name of the country of origin of
the article. Section 134.1(d), Customs Regulations (19 CFR
134.1(d)), defines ultimate purchaser as "generally the last
person in the U.S. who will receive the article in the form in
which it was imported."
Section 134.32, Customs Regulations (19 CFR 134.32), sets
forth a list of circumstances which except articles from the
requirement that they be individually marked. One such
circumstance of relevance to the implants and fixators under
consideration is { 134.32(d), "[a]rticles for which the marking
of the containers will reasonably indicate the origin of the
articles".
Section 134.43, Customs Regulations (19 CFR 134.43), lists
various classes and kinds of articles which under provisions of
the Tariff Act of 1930 were required to be marked by certain
methods. One class of articles listed is "surgical instruments."
The current Customs Regulations do not list Harmonized Tariff
Schedule heading numbers, but previous editions of the
regulations listed Tariff Schedules of the United States (TSUS)
item number 709.56, "Bone and joint prostheses, bone plates,
screws, and nails, and other internal fixation devices and
appliances" as surgical instruments subject to specific marking
method requirements. We mention these provisions here for sake
of completeness, and for instances in the future when orthopedic
implants and fixators might be imported not packaged as in the
present circumstance. However, the special marking provisions of
{ 134.43 are subject to the general statutory exception available
under 19 U.S.C 1304(a)(3)(D), implemented as { 134.32(d), Customs
Regulations.
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Congressional intent in enacting the marking law, as
explained in United States v. Friedlander & Co., 27 C.C.P.A. 297
at 302 (1940), 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."
It is the opinion of this office that the doctor, surgeon
or other medical professional that implants or affixes these
medical appliances in or on a patient is the ultimate purchaser
of the implant or fixator. These professionals are the parties
involved capable of using the disclosure of country of origin of
a medical appliance in making an informed decision to use or not
use a particular implant or fixator. Provided the metal box will
remain with the appliance until receipt by the ultimate purchaser
(which appears very likely since the box is made of metal and is
customized to securely hold its contents), country of origin
marking appearing on the outside of the box indicating the
contents are of Italian origin is sufficient for purposes of 19
U.S.C. 1304.
This determination is supported by resort to { 134.1(d),
Customs Regulations which states the ultimate purchaser of an
article is the last person in the U.S. to receive it in the form
in which it was imported. By the time a patient "receives" an
implant or fixator it has been subjected to a highly
sophisticated assembly process and the separate pieces have been
merged into a functioning medical appliance.
HOLDING:
Country of origin marking on the outside of a metal box
indicating the origin of the orthopedic implants or fixators
contained in the box will satisfy the requirements of 19 U.S.C.
1304. If the U.S. address of the distributor of these products
appears anywhere on the box, the country of origin disclosure
must appear in close proximity and in comparable size lettering
to that U.S. address.
Sincerely,
Marvin M. Amernick
Chief, Value, Special Programs
and Admissibility Branch