CBP Says Turkey Is Country of Origin for Certain Surgical Masks

The final determination was issued at the request of Berkley Surgical Company.

(CBP issues country of origin advisory rulings and final determinations on whether an article is or would be a product of a designated country or instrumentality for the purpose of granting waivers of certain “Buy American” restrictions in U.S. law or practice for products offered for sale to the U.S. government.)

Made in Turkey Mostly from Turkey Fabrics, U.S.-Origin Eye Shield Added in U.S.

The product at issue is a surgical face mask with an eye shield which is made to be compliant with the Food and Drug Administration’s (FDA) requirements for such medical devices.

Berkley imports the fluid resistant surgical face masks without the eye shields from Turkey, where they are made mostly from Turkey-origin non-woven fabrics, netting, and components, with only certain melt-blown polypropylene fabric of U.S. origin The masks have an outer facing, two filters, an inner facing, a nose wire, edge tapes, tie tapes, and ear loops.

After the surgical masks are imported into the U.S., a transparent eye shield is permanently attached to it through an ultrasonic bonding process. The eye shield provides the wearer splash protection for the eyes, nose and mouth area in a single-device, eliminating the need for separate and more expensive eye-wear. The eye-shield is made in the U.S. of U.S.-origin optical quality polyester film. The eye-shield accounts for more than 68% of the total value of the finished product.

The final product is packaged in the U.S. with packer boxes and shipper boxes manufactured in the U.S.

Product of Turkey as Mask Production Complex, Eyeshield Only an Enhancement

CBP explains that, because the surgical mask is classified in the Harmonized Tariff Schedule as a textile product, its country of origin is governed by the country of origin rules for textile products, which is set forth in 19 USC 3592 (19 CFR 102.21).

Of the two manufacturing processes, CBP believes the surgical face mask is the more important because even without the protective eyeshield, the mask can still be worn across the face and be used when performing surgical procedures. In addition, the manufacture of the surgical facial mask from the various fabrics seems to be a more complex operation than the relatively simple assembly operation of using an ultrasonic bonding process to attach the protective eye-shield to the surgical face mask.

In contrast, the protective eyeshield must be attached to the surgical mask or it is rendered completely useless. CBP also considers the assembly of the eye-shield to the surgical mask a mere enhancement to the surgical face mask, not something that changes the fundamental nature or the basic use of the product.

Consequently, CBP concludes that the manufacture of the surgical face mask from various non-woven fabrics occurring in Turkey is the most important process involved in producing the finished product. Therefore, it finds in accordance with 19 CFR 102.21(c)(4), that the country of origin of the surgical face mask with a protective eye-shield for purposes of government procurement is Turkey.

Any Party-at-Interest May Request Judicial Review by Nov 13

CBP states that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination by November 13, 2011. In addition, under 19 CFR 177.31, any party-at-interest other than the party which requested this final determination may request that CBP reexamine the matter anew and issue a new final determination.

CBP contact - Robert Dinerstein (202) 325-0132

(FR Pub 10/14/11, HQ H175429)