CLA-1-32:OT:RR:NC:N3:136
Juan C. Moreno
Zisser Customs Law Group
9355 Airway Road
San Diego, CA 92154
RE: Eligibility for duty-free treatment under subheading 9817.00.96, Harmonized Tariff Schedule of the United States (HTSUS), of a “Ostomy Appliance Belt” and “Stomahesive Paste”
Dear Mr. Moreno:
In your letter dated July 15, 2021, on behalf of your client, ConVatec, you requested a ruling on
the eligibility for duty-free treatment under subheading 9817.00.96, HTSUS, of a “Ostomy
Appliance Belt” and “Stomahesive Paste.”
You state that an ostomy is a surgical procedure in the abdomen where the intestine is brought up on
to the surface of the skin and sutured in place to form a stoma (opening). This allows bodily waste
to pass through the surgically created stoma into a prosthetic known as a ‘pouch’ or ‘ostomy bag’ on the outside of the body. An ostomy procedure is essential for colorectal cancer, bladder cancer, Crohn’s disease, ulcerative colitis, birth defects, spinal cord injuries, and other intestinal or urinary medical conditions. For individuals suffering from such conditions, ostomy surgery is both lifesaving and life changing.
You describe ostomy belts as an accessory for the ostomy pouching system. They are designed to wrap around the abdomen and help hold the ostomy pouch in place. They are used by ostomates as an added stay-in-place support, or as an alternative to adhesives. ConvaTec offers the “Ostomy Appliance Belt,” an adjustable belt (up to 42 inches) that wraps around the abdomen and attaches to the belt loops found on the Natura® Pouches and Consecura® Lockring pouches. The “Ostomy Appliance Belt” is made of soft and comfortable material (nylon elastic with polyester stitching), and it is specially designed for ostomates to improve the use of the ostomy pouch by providing an added sense of security, additional comfort, support, and discretion. ConvaTec manufactures the “Ostomy Appliance Belt” in the United States and sends it to the Dominican Republic to be packaged. In their condition as imported, they are packaged and ready for distribution to hospitals, specialty clinics, and authorized distributors for sale to individuals.
You describe ostomy pastes as a key accessory for ostomy care and treatment. They are used to fill in uneven skin contours to help create a flatter surface. A flatter surface is important because the ostomy wafer/skin barrier will adhere better if it is completely flush against the abdomen. If there are gaps between the wafer and the skin, the ostomy wafer will not stay in place and can become dislodged completely or it can start to leak. The “Stomahesive Paste” is a protective, hydrocolloid skin barrier that is used as a filler in uneven skin surfaces to help increase an ostomy system’s wear-time, reduce skin inflammation, redness, irritation, and create a more secure seal to prevent leakage. It is specially formulated with non-sensitizing ingredients and a high alcohol content, making it applicable for use only by ostomy patients. The “Stomahesive Paste” can be applied onto the ostomy wafer/skin barrier or directly to the skin. ConvaTec ships the “Stomahesive Paste” from the Dominican Republic in 2-ounce tubes. In their condition as imported, they are packaged and ready for distribution to hospitals, specialty clinics, and authorized distributors for sale to individuals.
The applicable subheading for the “Ostomy Appliance Belt” will be 3006.91.0000,
HTSUS, which provides for: Pharmaceutical goods specified in note 4 to this chapter: Sterile
surgical catgut, similar sterile suture materials (including sterile absorbable surgical or dental yarns)
and sterile tissue adhesives for surgical wound closure; sterile laminaria and sterile laminaria tents;
sterile absorbable surgical or dental hemostatics; sterile surgical or dental adhesion barriers, whether
or not absorbable: Other: Appliances identifiable for ostomy use. The general rate of duty will 4.2
% ad valorem.
The applicable subheading for “Stomahesive Paste” will be 3214.10.0020, HTSUS, which provides for: Glaziers’ putty, grafting putty, resin cements, caulking compounds and other mastics: Mastics: Other. The general rate of duty will be 3.7% ad valorem.
As you state that the belt is made in the United States and sent to the Dominican Republic, the “Ostomy Appliance Belt” may also be eligible for duty-free treatment as American Goods Returned under subheading 9801.00.1028, HTSUS, which provides for: Products of the United States when returned after being exported…without having been advanced in value or improved in condition by any process of manufacture or other means while abroad: Other: Articles provided for in chapter 30, provided the documentary requirements of 19 C.F.R. § 10.1 are satisfied. More information on the production processes that are performed in each country must be submitted in order to determine whether the product qualifies for this subheading.
You also requested consideration of the subject products under the Nairobi Protocol. You state that the products at issue are specially designed or adapted for the handicapped within the meaning of the Nairobi Protocol, and therefore, eligible for duty-free treatment under subheading 9817.00.96, HTSUS. The Nairobi Protocol to the Agreement on the Importation of Educational, Scientific, and Cultural Materials Act of 1982, established the duty-free treatment for certain articles for the handicapped. Presidential Proclamation 5978 and Section 1121 of the Omnibus Trade and Competitiveness Act of 1988, provided for the implementation of the Nairobi Protocol into subheadings 9817.00.92, 9817.00.94, and 9817.00.96, HTSUSA. These tariff provisions specifically state that "[a]rticles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons" are eligible for duty-free treatment. U.S. Note 4(a), subchapter XVII, Chapter 98, HTSUSA, states that, "the term 'blind or other physically or mentally handicapped persons' includes any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one's self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working."
U.S. Note 4(b), subchapter XVII, Chapter 98, HTSUSA, which establishes limits on classification of products in these subheadings, states as follows: (b) Subheadings 9817.00.92, 9817.00.94 and 9817.00.96 do not cover-- (i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or (iv) medicine or drugs.
The primary issue is whether the articles are specially designed or adapted for the “use or benefit of the handicapped” within the meaning of Nairobi Protocol. Although the legislative history of the Nairobi Protocol discusses the concerns of Congress that the design, modification or adaptation of an article must be significant so as to clearly render the article for use by handicapped individuals, no specific definition of these terms was established by Congress. See, Senate Report (Finance Committee) No. 97-564, September 21, 1982). See also, Headquarters Ruling Letter (HRL) 951004 dated March 3, 1992. Since it is difficult to establish a clear definition of what is “specially designed or adapted," various factors must be utilized on a case-by-case basis to determine whether a given article is "specially designed or adapted" within the meaning of this statute.
In previous rulings, U.S. Customs and Border Protection has considered patients that have
undergone an ostomy surgery to be “physically disabled” under the Nairobi Protocol program
criteria. It is our opinion that the “Ostomy Appliance Belt” and “Stomahesive Paste” described
above are considered to be specially designed or adapted for the handicapped, and therefore, eligible
for duty free treatment under subheading 9817.00.96, which provides for Articles specially designed
or adapted for the use or benefit of the blind or other physically or mentally handicapped persons;
parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are
specially designed or adapted for use in the foregoing articles: Other. The general rate of duty will
be free.
Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided on the World Wide Web at https://hts.usitc.gov/current.
This merchandise may be subject to the Federal Food, Drug, and Cosmetic Act and/or The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (The Bioterrorism Act), which are administered by the U.S. Food and Drug Administration (FDA). Information on the Federal Food, Drug, and Cosmetic Act, as well as The Bioterrorism Act, can be obtained by calling the FDA at 1-888-463-6332, or by visiting their website at www.fda.gov.
This ruling is being issued under the provisions of Part 177 of the Customs Regulations (19 C.F.R. 177).
A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, contact National Import Specialist Nuccio Fera at [email protected].
Sincerely,
Steven A. Mack
Director
National Commodity Specialist Division