HQ H026663
CLA-2 OT:RR:CTF:TCM H026663 MG
Port Director
200 East Bay Street
Charleston, SC 29401
RE: Application for Further Review of Protest no. 1601-07-100279; Disposable Gloves from Malaysia
Dear Port Director:
This is our decision regarding the Application for Further Review (AFR) of Protest Number 1601-07-100279, timely filed by counsel, on behalf of Foodhandler, Inc. (Foodhandler), concerning the classification of disposable gloves from Malaysia (Foodhandler’s gloves) under the Harmonized Tariff Schedule of the United States (HTSUS). In reaching our decision we have taken into consideration arguments made by counsel in the memorandum in support of protest and application for further review, dated July18, 2007. Samples were submitted to this office for examination and were considered in conjunction with this request. We have also considered arguments presented by protestant during an in-person conference held in Headquarters, on May 6, 2010, as well as two supplemental submissions, filed on May 3, 2010 and May 14, 2010.
FACTS:
The articles under consideration are various styles of Foodhandler and Sysco Brand disposable, unsterilized latex rubber and non-latex (nitrile) gloves, powder and powder-free with “textured fingertips’ for food handling use. These gloves are manufactured and imported from Malaysia and packaged in dispenser boxes of 100 gloves which are not marked for medical use. One of the sample
boxes of the Foodhandler gloves provided describes the merchandise as “NSF protocol P155 Disposable Food Contact Gloves.” According to the invoice, the Foodhandler gloves are ambidextrous, with beaded cuffs, Acceptable Quality Level (AQL) 1.5, manufactured according to American Society for Testing and Materials (ASTM) D3578-77 (re-approved 1988) standard.
The merchandise at issue was entered between February 6, 2006 and July 14, 2006, as medical use gloves, under subheading 4015.19.0510, Harmonized Tariff Schedule of the United States Annotated, HTSUSA, which provides for: “Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanized rubber other than hard rubber: Gloves, mittens and mitts: Other: Medical: Of natural rubber” and under subheading 4015.19.0550, HTSUSA, which provides for: Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanized rubber other than hard rubber: Gloves, mittens and mitts: Other: Medical: Other.
On January 19, 2007, CBP liquidated all six entries under 4015.19.1010, HTSUSA, which provides for: “Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanized rubber other than hard rubber: Gloves, mittens and mitts: Seamless: Disposable.”
ISSUE:
What is the correct classification of Foodhandler’s disposable gloves from Malaysia under the HTSUS?
LAW AND ANALYSIS:
Initially, we note that the matter protested is protestable under 19 U.S.C. §1514(a)(2) as a decision on classification. The protest was timely filed on July 19, 2007, within 180 days of liquidation of the first entry. (Miscellaneous Trade and Technical Corrections Act of 2004, Pub.L. 108-429, § 2103(2)(B)(ii), (iii) (codified as amended at 19 U.S.C. § 1514(c)(3) (2006))).
Further Review of Protest No. 1601-07-100279 was properly accorded to protestant pursuant to 19 C.F.R. § 174.24 because the decision against which the protest was filed involves matters previously ruled upon by the Commissioner of Customs but the facts and legal arguments are different from those considered in the original ruling.
Merchandise imported into the U.S. is classified under the HTSUS. Tariff classification is governed by the principles set forth in the General Rules of Interpretation (GRIs) and, in the absence of special language or context that requires otherwise, by the Additional U.S. Rules of Interpretation. The GRIs and the Additional U.S. Rules of Interpretation are part of the HTSUS and are to be considered statutory provisions of law.
GRI 1 requires that classification be determined first according to the terms of the headings of the tariff schedule and any relative section or chapter notes and, unless otherwise required, according to the remaining GRIs taken in order. GRI 6 requires that the classification of goods in the subheadings of headings shall be determined according to the terms of those subheadings, any related subheading notes and mutatis mutandis, to the GRIs.
Additional U.S. Rule of Interpretation 1(a) requires that "a tariff classification controlled by use (other than actual use) is to be determined in accordance with the use in the United States at, or immediately prior to, the date of importation, of goods of that class or kind to which the imported goods belong, and the controlling use is the principal use."
The 2006 HTSUS provisions under consideration are as follows:
4015
Articles of apparel and clothing accessories (including
gloves, mittens and mitts), for all purposes, of vulcanized
rubber other than hard rubber:
4015.19
Other:
4015.19.05
Medical
4015.19.0510
Of natural rubber
4015.19.0550
Other
Other:
4015.19.10
Seamless
4015.19.1010
Disposable
The Port classified the merchandise as disposable gloves under subheading 4015.19.1010, HTSUS, as the gloves are labeled and marketed for non-medical use and used in the food service industry. Protestant states that because Foodhandler’s gloves meet the Food and Drug Administrations (FDA) standards for medical use gloves, they should be classified as medical use gloves under subheading 4015.19.0510, HTSUS.
Specifically, protestant argues that the Foodhandler gloves meet the FDA standards for medical use gloves as they are made on the same equipment and materials as medical gloves and are of the same quality as latex examination gloves. Protestant posits that our determination in Headquarters Ruling (HQ) 964838, dated May 2, 2001, does not apply to the Foodhandler gloves.
Protestant states that in HQ 964838, CBP followed the rationale that the gloves at issue were of a quality which “did not meet the FDA standards for medical gloves.” In this regard, protestant states that, unlike the gloves in HQ 964838, the Foodhandler’s gloves can be considered medical use gloves as they have been subject to the same random inspection and have met the testing criteria which the FDA performs on medical gloves. We note that importer has failed to present any documentation or evidence demonstrating that that the Foodhandler’s gloves have been inspected by the FDA.
Protestant further argues that Foodhandler’s gloves are NSF certified which entails much stricter testing than the FDA conducts for examination gloves, such as physical dimensions, tensile, elongation, bioburden, powder and protein levels, visible defects, and barrier integrity of 1.5 AQL conducted according to the applicable medical ASTM test methods. Protestant further asserts that “a detailed formulation review is conducted for compliance to the U.S. Code of Federal Regulations, title 21, and unannounced annual factory audits are conducted for compliance to current Good Manufacturing Practices covering issues such as personnel, plant and grounds, sanitary operations and controls.”
The merchandise in HQ 964838 consisted of disposable unsterilized latex rubber gloves produced in Malaysia and packaged in dispenser boxes of 100 gloves marketed “For Industrial Use Only.” The gloves were sold to electronic, pharmaceutical, chemical and food processing industries but are not sold for surgical or medical use. (Emphasis provided). In that ruling, we stated that classification of gloves imported and labeled for non-medical use is in subheading 4015.19.10, HTSUS, the provision for "[A]rticles of apparel and clothing accessories (including gloves), for all purposes, of vulcanized rubber other than hard rubber: [G]loves: [O]ther: [S]eamless."
United States v. The Carborundum Company (“Carborundum”), 536 F. 2d 373 (citations omitted) sets forth the test to determine principal use in consideration of “all the pertinent circumstances”, and enumerates several factors which could be taken into consideration in making this determination. These factors are commonly referred to as “Carborundum Factors.” In this regard the court stated:
To determine whether the imported [merchandise] is of the same class or kind … we must look to all the pertinent circumstances.” Id., at 377. Factors considered to be pertinent in determining whether imported merchandise falls within a particular class or kind include: (1) the general physical characteristics of the merchandise; (2) the expectations of the ultimate purchaser; (3) the channels, class or kind of trade in which the merchandise moves; (4) the environment of sale (i.e., accompanying accessories and the manner in which the merchandise is advertised and displayed); (5) the use, if any, in the same manner as the merchandise which defines the class; (6) the economic practicality of so using the import; and (7) the recognition in the trade of this use. United States v. The Carborundum Company, 536 F.2d 373, 377 (C.C.P.A. 1976).
Analyzing the factors listed in Carborundum for the instant merchandise reveals the following: the general physical characteristics of a lot of non-medical use gloves may include a higher percentage of leaks, tears or pinholes than found in medical use gloves. See HQ 965530, dated July 15, 2002. In this regard, protestant claims that the Foodhandler gloves meet the FDA standards for medical use gloves as they are manufactured in the same machines and with the same materials as medical gloves and have the same quality. The Foodhandler gloves are imported for use in the food service industry. We note that, in general, gloves marked for industrial use may or may not meet the standards while medical gloves must meet the standards of the FDA, set forth in 21 CFR 801, et seq. Although another agency's regulations are not controlling in Customs classification decisions, where Customs must apply a "use" provision to merchandise, the controlling regulatory scheme is indeed relevant.
Information on medical and non-medical gloves can be found on the FDA website. In this regard, an FDA publication entitled “Guidance for Industry and FDA Staff, Medical Glove Guidance Manual” (Guidance Manual), issued on January 22, 2008, and hereinafter referred to as “The FDA Manual,” is instructive. Medical gloves are medical devices subject to the general controls set forth in section 513(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360c(a)(1)(A). By contrast, food service gloves are regulated by the Center for Food safety and Applied Nutrition and are not medical devices subject to a medical device pre-market review process and not cleared for marketing by FDA’s Center for Devices and Radiological Health. According to the Guidance Manual, labeling of food service gloves should not, in any way, represent or suggest that they may be used for medical purposes, which may include the brand name and company name.
The expectation of the ultimate purchaser is another important factor. As stated in HQ 965530, the expectation of the ultimate purchaser of medical gloves is that the glove serves as an effective barrier between blood-borne pathogens, that may be lethal, and the wearers’ skin. The expectation of the purchaser of non-medical use gloves is that the gloves will protect the wearer against chemicals and other irritants and will create a generally hygienic environment for handling food, cosmetics and other products. Protestant states that the Foodhandler gloves are NSF certified which entails much stricter testing than the FDA conducts for examination gloves. However, with the words "Not For Medical Use" and the brand “Foodhandler” marked on the box of gloves showing a hand wearing the gloves handling food, the ultimate purchaser can not know that the gloves are of a greater quality than medical use gloves. Rather, the expectations about the quality of the non-medical gloves and food service gloves are generally lower than those of the ultimate purchasers of medical use gloves.
Medical use gloves follow channels of trade to clinical settings. However, the Food handler gloves do not appear in the clinical settings in which medical use gloves are used. The environment of the sale includes a label stating that the Foodhandler gloves are not for medical use and show food on the label. The actual usage of gloves labeled specifically for non-medical use can not be a medical use because such use is prohibited by the FDA. See 21 CFR 801, et seq. The recognition in the trade of medical use is apparent by the labeling "for medical use."
With regard to the economic practicality of use, Protestant claims that the higher price paid by Foodhandler for acquiring the instant gloves weighs in favor of the gloves being considered medical. Protestant further asserts that Foodhandler’s gloves incurred all the additional costs associated with the higher cost of medical gloves. Protestant concludes that it is not economically impractical to use Foodhandler’s gloves as medical gloves inasmuch as they would simply have to be placed in a different box. The fact that Protestant claims to pay a higher price for these gloves was discussed during the in-person meeting held at Headquarters where Foodhandler indicated that this was a marketing decision made to distinguish their gloves as better quality gloves for the food service industry. In this regard, we note that not only is it impracticable to sell the Foodhandler gloves to the medical community, it is impossible to do so, in their condition as imported, given the regulatory regime.
Furthermore, the cost of production of the gloves is not the only cost involved in producing medical use gloves. Protestant has not submitted any evidence that the cost is commensurable with that of medical gloves. On balance, application of the Carborundum factors reveals that the instant merchandise does not belong to the class or kind of goods principally used as medical gloves.
Accordingly, by application of GRI 1, the Foodhandler’s gloves are classified in heading, 4015, HTSUS. They are specifically provided for in subheading, 4015.19.1010, HTSUSA, which provides for: “Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanized rubber other than hard rubber: Gloves, mittens and mitts: Seamless: Disposable.”
HOLDING:
By application of GRI 1, the Foodhandler’s gloves are classified in heading, 4015, HTSUS. They are specifically provided for in subheading, 4015.19.1010, HTSUSA, which provides for: “Articles of apparel and clothing accessories (including gloves, mittens and mitts), for all purposes, of vulcanized rubber other than hard rubber: Gloves, mittens and mitts: Seamless: Disposable.” The 2006 column one, general rate of duty is 3% ad valorem.
Since the rate of duty under the classification indicated above is the same as the liquidated rate, you are instructed to deny the protest in full. In accordance with Sections IV and VI of the CBP Protest/Petition Processing Handbook (HB 3500-08A, December 2007, pp. 24 and 26), you are to mail this decision, together with the CBP Form 19, to the protestant no later than 60 days from the date of this letter.
No later than 60 days from the date of this letter, the Office of International Trade, Regulations and Rulings, will make the decision available to CBP personnel, and to the public on the CBP homepage on the World Wide Web at www.cbp.gov, by means of the Freedom of Information Act, and other methods of public distribution.
Sincerely,
Myles B. Harmon, Director
Commercial and Trade Facilitation Division