March 2, 2005 CBP Bulletin Notice on Protamine Sulfate
In the March 2, 2005 issue of the U.S. Customs and Border Protection Bulletin (CBP Bulletin) (Vol. 39, No. 10), CBP issued a notice proposing to revoke a classification ruling on Protamine Sulfate. CBP states that it is also proposing to revoke any treatment it has previously accorded to substantially identical transactions that are contrary to its position in this notice.
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CBP states that any party who has received a contrary ruling or decision on the merchandise that is subject to the proposed ruling, or any party involved with a substantially identical transaction, should advise CBP by April 1, 2005, the date that written comments on the proposed ruling are due. Furthermore, CBP states that an importer's failure to advise CBP of such rulings, decisions, or substantially identical transactions may raise issues of reasonable care on the part of the importer or its agent for importations subsequent to the effective date of the final decision in this notice.
CBP also states that this notice covers any rulings on the subject merchandise that may exist but have not been specifically identified.
Proposed Revocation of Classification Ruling
Protamine Sulfate. At issue is Protamine Sulfate which is a polypeptide with specific amino acid sequences, extracted and isolated from salmon milt obtained from the testes of the fish. It is used in insulin preparations for the treatment of Diabetes and as a Heparin antagonist in the treatment of clotting disorders.
CBP is proposing to issue HQ 967368 in order to revoke NY K81624 and reclassify the Protamine Sulfate in HTS 3001.20.0000 as "extracts of glands or other organs or of their secretion for organotherapeutic uses, etc." rather than in HTS 3504.00.5000 which provides for "peptones and their derivatives; other protein substances and their derivatives, not elsewhere specified or included; hide powder, whether or not chromed: other."
CBP states that the Protamine Sulfate is derived from testes, which is a type of gland included in Explanatory Note (EN) 30.01. In addition, CBP states that 'organotherapy' is defined as 'a treatment of disease by the administration of animal organs or their extracts,' and notes that Protamine Sulfate is used in the medical treatment of diabetes and clotting disorders.
Therefore, CBP states that the Protamine Sulfate is described by the terms of heading 3001 as a glandular extract for organo-therapeutic uses, and is precluded from classification in heading 3504 because it is specified elsewhere.
proposed: 3001.20.0000, duty-free; current: 3504.00.5000, 4%.
March 2, 2005 CBP Bulletin (Vol. 39, No. 10) available at http://www.cbp.gov/xp/cgov/toolbox/legal/bulletins_decisions/bulletins_2005/vol39_%2003022005_no10/