CLA-2 RR:CR:GC 964836 AM
Mr. Scott D. Johnson
C.H. Robinson International, Inc.
21820 76th Ave. S.
Kent, WA 98032
Re: HQ 957522 revoked; non-medical use latex gloves
Dear Mr. Johnson:
This is in reference to Headquarters Ruling (HQ) 957522, dated May 24, 1995, and issued to the Port Director, of Customs, Seattle, Washington, concerning protest 3001-94-100631, which you filed on behalf of Lyons Safety Inc., on October 24, 1994, against the classification, under the Harmonized Tariff Schedule of the United States (HTSUS), of non-medical use latex rubber gloves. In that ruling it was determined that the subject gloves were classifiable under subheading 4015.11.00, HTSUS, which provides for "[A]rticles of apparel and clothing accessories (including gloves), for all purposes, of vulcanized rubber other than hard rubber: [G]loves: [S]urgical and medical."
In reviewing an unrelated protest, 1001-99-100923, dated February 24, 1999, submitted to the Port Director, of Customs, New York, also concerning the classification of non-medical use latex rubber gloves, we have reconsidered HQs 951033 dated June 8, 1992, 951586, dated June 23, 1992, 957561, dated May 24, 1995, and 961270, dated April 15, 1998. This ruling revokes HQ 957522. HQs 964837, 964838, and 964839 of this date, revoke HQs 951033 and 951586, 957561 and 961270, respectively. These revocations set forth Customs position as to the classification of these goods and have no effect upon protests as to past importations.
Pursuant to section 625 (c), Tariff Act of 1930, as amended (19 U.S.C. 1625(c)), notice of the proposed revocation of HQs 951033, 951586, 957522, 957561 and 961270, was published on March 14, 2001, in Volume 35, Number 11, of the CUSTOMS BULLETIN. Two comments were received in opposition to the proposed revocation. After careful consideration of the comments, as set forth in this ruling, we have determined to proceed with the revocations.
The articles under consideration are disposable, unsterilized latex rubber gloves imported in bulk from Malaysia and repackaged in dispenser boxes of 100 gloves which are marked for non-medical use. The gloves are sold to electronic, pharmaceutical, chemical and food processing industries but are not sold for surgical or medical use.
Whether seamless, disposable latex rubber gloves for industrial use are classifiable under subheading 4015.11.00, HTSUS.
LAW AND ANALYSIS:
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. In interpreting the HTSUS, the Explanatory Notes (ENs) of the Harmonized Commodity Description and Coding System may be utilized. The ENs, although not dispositive or legally binding, provide a commentary on the scope of each heading, and are (official interpretation of the Harmonized System at the international level) generally indicative of the proper interpretation of the HTSUS. See T.D. 8980, 54 Fed. Reg. 35127 (August 23, 1989).
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 following HTSUS subheadings are relevant to the classification of this product:
4015 Articles of apparel and clothing accessories (including gloves), for all purposes, of vulcanized rubber other than hard rubber:
4015.11.00 Surgical and medical
* * * * *
The EN for subheading 4015.11, states as follows: "[S]urgical gloves are thin, highly tear-resistant articles manufactured by immersion, of a kind worn by surgeons. They are generally presented in sterile packs."
Subheading 4015.11, HTSUS, is a principal use provision. The court in E. M. Chemicals v. United States, 20 C.I.T. 382, 923 F. Supp. 202 (1996 Ct. Intl. Trade) explained the application of these types of HTSUS provisions thus:
When applying a "principal use" provision, the Court must ascertain the class or kind of goods which are involved and decide whether the subject merchandise is a member of that class. See supra Additional US Rule of Interpretation 1 to the HTSUS. In determining the class or kind of goods, the Court examines factors which may include: (1) the general physical characteristics of the merchandise; (2) the expectation of the ultimate purchasers; (3) the channels of trade in which the merchandise moves; (4) the environment of the sale (e.g., the manner in which the merchandise is advertised and displayed); (5) the usage of the merchandise; (6) the economic practicality of so using the import; and (7) the recognition in the trade of this use. United States v. Carborundum Co., 63 C.C.P.A. 98, 102, 536 F.2d 373, 377, cert. denied, 429 U.S. 979, 50 L. Ed. 2d 587, 97 S. Ct. 490 (1976); see also Lenox Coll., 20 C.I.T., Slip Op. 96-30, at page 5.
Our decisions in HQs 951033, 951586, 957522, 957561, and 961270, classifying disposable latex gloves for industrial use in subheading 4015.11.00, HTSUS, the provision for surgical and medical latex gloves, were based on the premise that industrial use gloves and medical use gloves are actually the same product and hence belong to the same class or kind of merchandise. In those rulings, we noted that both industrial use and medical use gloves were made on the same machines and of the same materials. We went on to state that: "there does not appear to be any basis for distinguishing between these gloves and medical use latex gloves." We now believe this statement is in error.
Both commentors argue that non-medical use gloves belong to the same class or kind of merchandise as medical use gloves. At the outset, we note that, if this is the case, then it is no more incumbent upon Customs to classify all latex gloves as "surgical and medical" gloves than it would be to classify all the gloves as "other latex gloves." The commentors state that latex gloves which bear the medical-use label are sold by the same retailers and used in the same way as general purpose non-medical gloves, thus, inadvertently arguing that the class or kind of goods to which all latex gloves belong is "other latex gloves," against their stated position for classification as "medical gloves."
The International language of the tariff does not refer to medical gloves at all. Through historical happenstance, the term "Surgical and medical" was carried over from the Tariff Schedule of the United States ("TSUS"), the precursor to the HTSUS, to subheading 4015.11, HTSUS. The U.S. International Trade Commission is considering bringing the HTSUS in conformity with the international language. Nevertheless, we must interpret the language of the HTSUS as presently worded.
One commentor points out that the text of the EN refers only to surgical gloves in sterile packs. We disagree. Given the history noted above, it is at least ambiguous whether EN 4015.11 applies to only surgical gloves, or whether, in the HTSUS, where the subheading is entitled "surgical and medical", Congress intended for the EN to apply to both terms. Regardless, there is a general concern, elicited by the EN, that the gloves classified in subheading 4015.11 be of a quality different from those classified as "other" latex gloves. In the United States, that quality difference is governed by Food and Drug Administration ("FDA") regulations, which, in turn, governs the use of the gloves. Such gloves undergo stringent testing of their leak resistance and adulteration. (21 CFR 800.20). According to the FDA, industrial use gloves are latex gloves that have failed this test or were not tested. Manufacturers may then sell the untested, adulterated or leaky gloves to the cosmetic, food handling, electronic and other industries. There are strict penalties for attempting to insert industrial use gloves into the medical use market because they are of differing quality. (21 CFR 800.55). The quality difference and marketing of these gloves, where the tear resistance of the article is specifically noted in the EN, distinguishes the surgical and medical use gloves from the non-medical use gloves.
Both commentors argue that the distinctions made in the proposed revocation are not based on any real physical difference in the medical and non-medical use gloves. Correct application of the Carborundum factors, the legal standard for analysis of principal use provisions, reveals distinctions between medical and non-medical use latex gloves based on real differences in the use of the gloves, whether or not any particular glove, from a box labeled "not for medical use" could theoretically form an effective barrier against blood-borne pathogens and other bodily fluids.
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. Commentors point out that a particular non-medical use glove is likely to be physically exactly the same as a medical use glove. While this may be true, the imported product is non-medical use gloves packaged for retail sale. A given box of non-medical use gloves likely contains a higher number of defective gloves than a given box of medical use gloves.
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. Expectations about the quality of the glove are much higher among the ultimate purchasers of medical use gloves. So much so, that the FDA has proposed a new rule requiring additional testing of the tear resistance and degradation potential of medical use gloves due to concerns that medical use gloves be of a very high quality. (64 FR 41710, July 30, 1999). One commentor concedes this point by revealing that testing a particular lot of gloves for labeling as medical use gloves increases the marketing potential of the gloves because the ultimate purchaser prefers the assurance of a high quality product.
Medical use gloves follow channels of trade to clinical settings. Commentors state that non-medical use gloves are sold through the same retailers as medical use gloves. However, non-medical use gloves do not enter the same industries as medical use gloves. Medical-use gloves appear in clinical settings where non-medical use gloves are prohibited from use under FDA guidelines (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.
The environment of the sale includes a label stating that non-medical use gloves are only for industrial use or for non-medical use. One commentor stated that medical use gloves have greater consumer appeal because of their assurance of quality and are marketed accordingly.
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 (21 CFR 801 et seq.).
According to commentors, there is a slight cost difference in medical and non-medical use gloves but, they claim, this does not interfere with the use of medical gloves as non-medical use gloves. However, the proposed new rule by the FDA, which would require additional testing of medical use gloves, may again make using medical-use latex gloves as industrial or general purpose latex gloves prohibitive due to the difference in cost of the gloves. Nevertheless, the cost difference is not the only factor to consider.
The recognition in the trade of industrial use is apparent by the labeling "not for medical use."
On balance, application of the Carborundum factors reveals that the correct classification for gloves imported for and labeled for non-medical use is in subheading 4015.19.10, 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".
Latex gloves labeled for non-medical use are classified 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."
EFFECT ON OTHER RULINGS:
HQ 957522 is revoked. Although there is no consequence of this action with regards to protest 3001-94-100631, future imports occurring on or after this ruling's effective date should be classified consistent with this ruling.
John Durant, Director
Commercial Rulings Division