MAR-2-05 CO:R:C:V 732498 KG
Lewis Stein
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, N.J. 08933-7002
RE: Country of origin marking of disposable suture removal kit
and shave prep pack
Dear Mr. Stein:
This is in response to your letter of June 19, 1989,
requesting a ruling on the country of origin marking of a
imported disposable suture removal kit and a imported shave prep
pack. You submitted a sample of the disposable suture removal
kit for examination.
FACTS:
The disposable suture removal kit contains a Littauer
scissors, forceps and gauze sponge. The scissors will be made in
Israel. Although you state that they will be marked with the
country of origin, the sample was unmarked. The forceps and
gauze sponge will be manufactured in the U.S. The plastic
container will be molded in Mexico of U.S. origin materials. The
paper cover on the plastic container is marked "Made in U.S.A."
without any specification as to what is made in the U.S.A.
The shave prep pack will contain two disposable razors, a
soap sponge, two linen protectors, two towels and two cotton-
tipped applicator packed in a twin compartment tray. The tray
will be molded in Mexico and the disposable razors will be
assembled in Mexico of U.S. components sent to Mexico ready for
assembly.
The suture removal kits and the shave prep packs will be
packed into shipping containers, with 48 units in each container.
The suture removal kits are sold through distributors to
hospitals, emergency clinics and physicians only. The shave prep
packs are sold through distributors only to hospitals. In both
cases the smallest unit of sale is the container of 48 units.
You state that the containers will be marked to show the country
of origin of the scissors, the country of assembly of the razors
and the country of origin of the plastic containers.
ISSUE:
What is the proper country of origin marking for imported
disposable suture removal kits and shave prep kits.
LAW AND ANALYSIS:
Section 304 of the Tariff Act of 1930, as amended (19
U.S.C. 1304), provides that, unless excepted, every article of
foreign origin imported into the U.S. 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 U.S. the
English name of the country of origin of the article. The U.S.
Court of International Trade stated in Koru North America v.
United States, 701 F.Supp. 229, 12 CIT (CIT 1988), "In
ascertaining what constitutes the country of origin under the
marking statute, a court must look at the sense in which the term
is used in the statute, giving reference to the purpose of the
particular legislation involved. The purpose of the marking
statute is outlined in United States v. Friedlaender & Co., 27
CCPA 297, 302, C.A.D. 104 (1940), where the court stated that:
'Congress intended that the ultimate purchaser should be able to
know by an inspection of the marking on 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."
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 the 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 this part. Therefore, pursuant
to 19 CFR 134.1(b), each piece within a kit maintains its own
country of origin which must be marked if it is of foreign origin
unless the packaging of the pieces together effects a substantial
transformation. A substantial transformation occurs when
articles lose their identity and become new articles having a new
name, character or use. United States v. Gibson-Thomsen Co., 27
C.C.P.A. 267 at 270 (1940), National Juice Products Association
v. United States, 10 CIT ___, 628 F.Supp. 978 (Ct. Int'l Trade
1986), Koru North America v. United States, 12 CIT ___, 701
F.Supp. 229 (Ct. Intl Trade 1988).
In the case of the suture removal kit, the packaging
together of the scissors and forceps and gauze sponge is similar
to HQ ruling 731460 (May 26, 1989), which involved the
repackaging of imported screwdriver bits with U.S. made screws.
In that ruling, the repackaging was held not to be a substantial
transformation because the separate items are in their finished
form, are not modified or affixed to each other, or combined in a
permanent manner. In this case, the scissors and forceps are not
permanently changed or combined in any way. The packaging
together of the scissors, forceps and gauze is not a substantial
transformation. Since the forceps and gauze are not imported,
they are not required by 19 U.S.C. 1304 to be marked. However,
the scissors are imported and must be marked with their country
of origin.
Because the scissors are packaged in a sealed sterile
container which is not transparent, the country of origin must be
marked so as to inform the ultimate purchaser of the country of
origin prior to their making a purchase. Pursuant to 19 U.S.C.
1304(a)(3)(D) and section 134.32(d), Customs Regulations (19 CFR
134.32(d)), Customs excepts from individual marking requirements
imported articles for which the marking of the containers will
reasonably indicate the origin of the articles. In this case,
the suture kits are sold in containers of 48 packaged units only
and are not individually sold. Therefore, marking the shipping
containers holding 48 units will satisfy 19 U.S.C. 1304 and 19
CFR Part 134.
The shave prep kit is also not substantially transformed by
packaging. The disposable razors which are assembled in Mexico
of U.S. components must be marked in accordance with section
10.22, Customs Regulations (19 CFR 10.22), which states that
assembled articles are considered products of the country of
assembly for country of origin marking purposes. Therefore, the
disposable razors are considered to be made in Mexico. If the
assembled article is made entirely of U.S. materials, the legend
"Assembled in ____ from material of U.S. origin" or a similar
phrase may be used. For the reasons discussed above in relation
to the suture kit, the shave prep kits are entitled to the
exception set forth in 19 U.S.C. 1304(a)(3)(D) and 19 CFR
134.32(d) and marking the shipping container will satisfy the
marking requirements. The phrase "Assembled in Mexico from
material of U.S. origin or a similar phrase will satisfy 19 CFR
10.22.
The plastic container for the suture kits and the shave
prep kits, if imported empty to be filled, may be excepted from
individual marking pursuant to section 134.24(c)(1), Customs
Regulations (19 CFR 134.24(c)(1)), if the outside wrapping or
packages containing the containers is clearly marked to indicate
the country of origin.
HOLDING:
The suture removal kit must be marked to inform the ultimate
purchaser of the country of origin of the scissors. Marking the
shipping container which contains 48 units which reach the
ultimate purchaser will satisfy 19 U.S.C. 1304 and 19 CFR Part
134.
The shave prep kit must be marked to inform the ultimate
purchaser of the country of origin of the disposable razors.
Marking the shipping container which contains 48 units which will
reach the ultimate purchaser will satisfy 19 U.S.C. 1304 and 19
CFR Part 134. The phrase used to mark the shipping container may
indicate the razors are made in Mexico of components of U.S.
origin.
Sincerely,
John Durant
Director,
Commercial Operations