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HQ 226218

March 19, 1996

PRO-2-02/BON-2-RR:IT:EC 226218 PH


Port Director of Customs c/o Protest and Control Section
300 South Ferry Street
Terminal Island, California 90731

RE: Protest No. 2720-94-101049; Protest No. 2720-95-100155; FDA Notice of Sampling; Notice of Redelivery; Timeliness; 19 CFR 113.62; 19 CFR 141.113; Ruling HQ 225807; 19 U.S.C. 1514

Dear Sir or Madam:

The above-referenced protests were forwarded to this office for further review. We have considered the evidence provided, and the points raised, by your office and the protestant. Our decision follows.


According to the file, on April 8, 1994, the protestant imported the merchandise under consideration, certain dried fish. Immediate delivery was requested, on April 8, 1994, according to the form for requesting such delivery (Customs Form (CF) 3461). The CF 3461 was stamped with a signed and dated (April 14, 1994) FDA Notice of Sampling which stated: "This shipment must be held intact, FDA Notice of Sampling, This entry may be removed from cargo control for sampling in the FDA district sampling area". Regarding this request for a sample, the protestant states that "[t]he importer, however, was unable to provide FDA with a sample."

In a letter to Customs dated May 3, 1994, and captioned "REDELIVERY REQUEST", the FDA stated that the entry under consideration was for merchandise subject to FDA jurisdiction which had not been made available for FDA examination. FDA stated that it was "... hereby requesting a redelivery of these articles [the protested entry is cited] to Customs custody".

Customs issued a Notice to Mark and/or Notice to Redeliver (CF 4647) for the merchandise under consideration. The CF 4647 was signed and dated June 10, 1994, and in the "Remarks ..." portion of the CF 4647, it was stated "[m]erchandise must be exported or destroyed by August 31, 1994 ... [p]lease submit proof of exportation or destruction to our office."

A protest of the Notice to Redeliver (demand for redelivery) was filed on June 28, 1994. (There was some confusion in the processing of this protest, and the protest filed on June 28, 1994, was not entered on Customs Records until October 7, 1994. As a result of this confusion, there are two protests (cited above) of this matter.) Further review was requested and granted.

Liquidation of the entry did not occur until after the demand for redelivery was issued and the protest of that demand was filed (i.e., initial liquidation was on July 29, 1994, followed by a voluntary reliquidation, under 19 U.S.C. 1501, on October 7, 1994).


Was the Notice of Redelivery timely in this case?


Initially, we note that the protest, with application for further review, was timely filed under the statutory and regulatory provisions for protests (see 19 U.S.C. 1514 and 19 CFR Part 174). We also note that the decision to issue a Notice of Redelivery is protestable under the Customs protest statute (see 19 U.S.C.

The Customs Regulations governing the timeliness of the recall of merchandise released from Customs custody are described below. Under 19 CFR 141.113(c):

If at any time after entry the port director finds that any merchandise contained in an importation is not entitled to admission into the commerce of the United State for any reason not enumerated in paragraph (a) or (b) of this section [those paragraphs are not applicable in this case], he shall promptly demand the return to Customs custody of any such merchandise which has been released.

Under 19 CFR 141.113(d):

If the importer has not promptly complied with a request for samples or additional examination packages made by the port director pursuant to [19 CFR 151.11], the port director may demand the return of the necessary merchandise to Customs custody.

Under 19 CFR 141.113(g):

A demand for the return of merchandise to Customs custody shall not be made after the liquidation of the entry covering such merchandise has become final.

Under 19 CFR 113.62(d) (section 113.62 contains the conditions of the basic importation and entry bond):

If merchandise is released conditionally from Customs custody to the principal before all required evidence is produced, before its quantity and value are determined, or before its right of admission into the United States is determined, the principal agrees to redelivery timely, on demand by Customs, the merchandise released if it:

(1) Fails to comply with the laws or regulations governing admission into the United States;

(2) Must be examined, inspected, or appraised as required by 19 U.S.C. 1499; or

(3) Must be marked with the country of origin as required by law or regulation.

It is understood that any demand for redelivery will be made no later than 30 days after the date that the merchandise was released or 30 days after the end of the conditional release period (whichever is later).

Under 19 CFR 151.11:

If the port director requires samples or additional examination packages of merchandise which has been released from Customs custody, he shall send the importer a written request, on Customs Form 28, Request for Information, or other appropriate form, to submit the necessary samples of packages. If the request is not promptly complied with, the port director may make a demand under the bond for the return of the necessary merchandise to Customs custody in accordance with [19 CFR 141.113].

In addition to the foregoing regulatory framework, the Food and Drug Administration has statutory and regulatory provisions applying to these issues. Section 801 of the Federal Food, Drug, and Cosmetic Act, as amended (21 U.S.C. 381(a)), provides, in part, that:

The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. * * *

The Food and Drug Administration has issued regulations under the authority of this provision. Under 21 CFR 1.90:

When a sample of an article offered for import has been requested by the district director [of the FDA], the collector of customs having jurisdiction over the article shall give to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or consignee shall hold such article and not distribute it until further notice from the district director or the collector of customs of the results of examination of the sample.

The Court of Appeals for the Federal Circuit has considered the applicability of this statutory and regulatory scheme to foods in three recent cases (United States v. Imperial Food Imports, 6 Fed. Cir. (T) 37, 834 F. 2d 1013 (1987); United States v. Utex, 6 Fed. Cir. (T) 166, 857 F. 2d 1408 (1988); and United States v. Toshoku, 7 Fed. Cir. (T) 104, 879 F. 2d 815 (1989)). In the Toshoku case, the Court quoted Imperial Food Imports as describing the interplay between the FDA and Customs as follows:

When importing foodstuffs the importer or its broker must notify the FDA, which may issue a may proceed notice.' However, the FDA may determine that the merchandise should not be permitted to enter the country without proof of compliance with [21 U.S.C. 381(a)(3)], which concerns adulterated food. In such a case, the FDA will issue a Notice of Sampling [21 CFR 1.90], and often a Notice of Detention and Hearing [21 CFR 1.94]. If the importer does not respond to the Notice of Detention within ten days, a Notice of Refusal of Admission is issued [21 CFR 1.94]. The importer then has ninety days to either export or destroy the foodstuffs. If the importer has not acted after ninety days, Customs issues a Notice of Redelivery [19 CFR 141.113]. If the importer fails to comply by delivering the goods, the importer breaches its bond with Customs. [7 Fed. Cir. (T) at 107-108, quoting from 6 Fed. Cir. (T) at 38]

Customs has thoroughly considered the interpretation of the foregoing provisions (see rulings 088880, dated March 19, 1992; 223538, dated October 1, 1992; 224566 and 951300, both dated August 3, 1993, 224854, dated July 6, 1994; 224872, dated July 5, 1994; and 225807, dated December 4, 1995). Customs position now is that a Notice of Redelivery must be "promptly" issued (see Customs Service Decisions (C.S.D.'s) 90-99, 89-100, and 86-21). "Promptly", for this purpose, means either: (1) no later than 30 days after the date the merchandise is released if there is no occurrence establishing a different conditional release period; or (2) if there is an occurrence establishing a conditional release period, no later than 30 days after the end of that period (e.g., if information or a sample is requested under 19 CFR 151.11, a conditional release period is established and a Notice of Redelivery must be issued within 30 days from the date of receipt by Customs of the information or sample). As provided in 19 CFR 141.113(g) (see above), a Notice of Redelivery may never be issued after liquidation of the merchandise become final (see also, Utex, supra).

The actions in this case were consistent with the above. Not later than 30 days after release of the merchandise, FDA gave notice that the merchandise must be held intact and could be removed for sampling by FDA (see 21 CFR 1.90; see also Imperial Food Imports, as quoted above (7 Fed. Cir. (T) 107-108)). This created a conditional release period which would have ended, if a sample had been provided, when notice was given from FDA or Customs of the results of the examination of the sample (21 CFR 1.90, quoted above). In this case, as the protestant concedes, no sample was provided. Thus, the conditional release period was not ended. Since the Notice of Redelivery was issued before liquidation of the merchandise became final, the Notice of Redelivery was timely (see, in addition to above-cited Court cases, United States v. Commodities Export Co., 15 CIT 1, 6, 755 F. Supp. 418 (1991)).

(Regarding other issues raised by the protestant (the request for a sample by FDA instead of Customs; and the lack of a time limit for compliance on the FDA request for a sample), these issues are addressed in ruling 225807, dated December 4, 1995. The law and analysis of that ruling, as applicable in this protest, are adopted by reference in this ruling. In regard to the protestant's argument that if there is no formal notification that the merchandise is inadmissible the Notice of Redelivery must be canceled, see United States v. Toshoku America, Inc., 11 CIT 641 (1987) (reversed on other grounds, see citation above), in which the Court stated that "... a demand for redelivery to Customs custody is in reality no different than a decision to exclude merchandise from entry or delivery" (11 CIT at 644). Furthermore, we note that the provision of the Customs Regulations (19 CFR 113.62(d)(1)) cited by the protestant in this regard provides that the principal agrees to redeliver timely, on demand by Customs, the merchandise released if it "[f]ails to comply with the laws or regulations governing admission into the United States". One of such regulations is 21 CFR 1.90, quoted above, which requires the owner or consignee to hold the merchandise and not distribute it until further notice of the result of examination of the sample. The protestant did "[f]ail to comply with [this] regulation ....")

Procedurally, as noted above, Customs records show that there are two protests in this matter (2720-94-101049 and 2720-95-100155). Customs procedural processing of this matter should be as follows. The first protest should be denied for the substantive reasons set forth above. As for the second protest, 19 U.S.C. 1514(c) provides that "[o]nly one protest may be filed for each entry of merchandise, except that where the entry covers merchandise of different categories, a separate protest may be filed for each category [and] [i]n addition, separate protests [may be filed in certain described situations]." (Note also that, in a case such as this, a protest of the Notice of Redelivery and a protest of an issue such as tariff classification could be separately filed.) None of the exceptions are applicable in this case. Accordingly, the second protest should be denied on this procedural basis (i.e., that only one protest may be filed for each entry of merchandise).


The Notice of Redelivery was timely in this case. Both protests are DENIED (the first because the Notice of Redelivery was timely, the second on procedural grounds).

In accordance with Section 3A(11)(b) of Customs Directive 099 3550-065, dated August 4, 1993, Subject: Revised Protest Directive, this decision should be mailed by your office, with the Customs Forms 19, to the protestant no later than 60 days from the date of this letter. Any reliquidation of the entry in accordance with the decision must be accomplished prior to mailing of the decision. Sixty days from the date of the decision the Office of Regulations and Rulings will take steps to make the decision available to Customs personnel via the Customs Rulings Module in ACS and the public via the Diskette Subscription Service, Freedom of Information Act, and other public access channels.


William G. Rosoff

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