Full opinion text
MEMORANDUM OPINION AND ORDER NORDBERG, District Judge. This action is before the court on motion of Amexchem International, Inc. (“Amexchem”), the claimant of the articles seized in this case, for exportation in lieu of destruction. For the reasons set forth below, this court must defer ruling pending further hearings. Twelve shipments of animal drugs imported by Amexchem were seized by the Food and Drug Administration (“FDA”). The drugs have been condemned by consent decree as being adulterated under section 501(a)(5) of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 351(a)(5), because they are unapproved new animal drugs. Most of the lots have also been condemned as misbranded under either section 502(c) or 502(f)(1) of the FDCA, 21 U.S.C. §§ 352(c) or 352(f)(1), or both. The sole issue before the court is whether Amexchem may reexport these condemned drugs under § 304(d)(1), 21 U.S.C. § 334(d)(1), or whether they may be destroyed by the FDA. Section 304(d)(1) provides for the disposition of any “food, drug, device or cosmetic” condemned under the section. It specifically provides for the reexportation of imported articles as follows: If the article was imported into the United States and the person seeking its release establishes (A) that the adulteration, misbranding, or violation did not occur after the article was imported, and (B) that he had no cause for believing that it was adulterated, misbranded, or in violation before it was released from customs custody, the court may permit the article to be delivered to the owner for exportation in lieu of destruction upon a showing by the owner that all of the conditions of section 381(d) of this title can and will be met: Provided, however, That the provisions of this sentence shall not apply where condemnation is based upon violation of section 342(a)(1), (2), or (6), section 351(a)(3), section 352(j), or section 361(a) or (d) of this title: And provided further, That where such exportation is made to the original foreign supplier, then clauses (1) and (2) of section 381(3) of this title and the foregoing proviso shall not be applicable; and in all cases of exportation the bond shall be conditioned that the article shall not be sold or disposed of until the applicable conditions of section 381(d) of this title have been met. Any article condemned by reason of its being an article which may not, under section 344 or 355 of this title, be introduced into interstate commerce, shall be disposed of by destruction. Thus, Amexchem must establish that (1) the adulteration, misbranding or violation occurred before the article was imported; (2) that Amexchem had no cause to believe the article was adulterated, misbranded or in violation before it was released from customs, and (3) that it can comply with the conditions section 801(d)(1) of the Act, 21 U.S.C. § 381(d)(1), unless the articles will be returned to the original suppliers, in which case it need not comply with section 801(d)(1) and (2), 21 U.S.C. § 381(d)(1)(A) and (B). Amexchem asserts that it can establish all three of these requirements, and requests the court to exercise its discretion under section 304(d) to permit reexportation. The FDA raises a number of arguments against reexportation, and instead requests the court to authorize destruction of the seized drugs. First, the FDA argues that unapproved new animal drugs that have been imported, seized and condemned cannot be reexported under section 304(d) as a matter of law. FDA relies on the sentence in section 801(d)(1), which states, “This paragraph does not authorize the exportation of any new animal drug, or an animal feed bearing or containing a new animal drug, which is unsafe within the meaning of section 360b of this title.” The FDA asserts that, since section 304(d)(1) requires compliance with section 801(d)(1), this sentence in section 801(d)(1) prohibits reexportation of the seized new animal drugs of Amexchem under section 304(d)(1). However, the FDA’s interpretation ignores the specific language of these provisions and the legislative intent of Congress. The last sentence of section 801(d) states that “this paragraph ” (emphasis added) does not authorize the export of new animal drugs. It does not prohibit export authorized by other paragraphs, such as section 304(d)(1). In addition, section 304(d)(1) permits export of articles that are “adulterated, misbranded, or in violation ” (emphasis added). If a drug is not adulterated or misbranded, the only way it can violate the FDCA is by being new and unapproved. Thus, by including “violative” drugs, Congress seems to have contemplated the export of new unapproved drugs. Moreover, if Congress intended to impose any additional requirements on export or bar the export of any particular products, it could have done so expressly when amending section 304(d)(1). Congress did in fact specify in the amendment to section 304(d)(1) products which it would not permit to be exported under section 304(d)(1). A proviso to the export provision of section 304(d)(1) expressly states that, if goods are condemned under any of the sections of the Act specifically listed, they cannot be exported under section 304(d)(1). Each of the sections listed concerns substances dangerous to health. Congress therefore expressly specified the types of goods which could not be exported because of their dangerous nature. If Congress intended to prohibit the export of new animal drugs under section 304(d)(1), it could have included section 501(a)(5), 21 U.S.C. § 351(a)(5), the section governing new drugs, in that proviso. By not including section 501(a)(5), under the well-established principle of expressio unites est exclusio alterius, Congress evidenced an intent that new drugs not be subject to any special prohibition from the export privilege created by the amendment to section 304(d)(1). This interpretation is consistent with the legislative history of section 304(d)(1) and reflects Congress’ intent in amending this provision. Since the original enactment of the FDCA in 1938, section 801(a) has given importers the unqualified right to reexport imported drugs if a failure to comply with U.S. requirements is discovered at the point of entry before the drugs are released by customs. 21 U.S.C. § 381(a). However, the 1938 Act had no equivalent provision permitting reexport of violative drugs which were for some reason released into commerce before the violation was discovered. If the articles were seized after they were released, section 304 required their destruction unless the drugs could be brought into compliance with the Act. This resulted in unequal treatment of importers, with the right to reexport dependent upon whether the violation of U.S. drug law was discovered before or after the drugs were released from customs. The ability to reexport therefore often depended upon the imperfect and highly variable screening process at the point of entry. In apparent response to this perceived inequity, Congress amended the FDCA in 1957 to permit the reexport of imported drugs which violate the FDCA if the conditions specified above could be met. Testimony at legislative hearings in the amendment indicates that the purpose of the bill was to apply the same reexport procedure whether the merchandise is seized at the point of entry or at some later time. Amendments to Federal Food, Drug, and Cosmetic Act. Hearings on H.R. 10519 Before the Subcommittee on Health and Science of the House Committee on Interstate and Foreign Commerce (“Hearings”), 84th Cong., 2d Sess. 27-33, 39-43 (1956) (statement of Harry S. Radcliffe). The Deputy Commissioner of the Food and Drug Administration interpreted the amendment to section 304 as follows: This bill seeks to amend section 304(d) of the Federal Food, Drug, and Cosmetic Act in a manner to allow a United States judge to authorize exportation of seized drugs or cosmetics, where those goods had originally been imported and their faulty condition was not detected at the port of entry, and they subsequently entered the channels of domestic commerce and later were discovered to have been in violation of the act, and they are seized under domestic sections of the law. It is the settled judicial interpretation now that where such seizures are made, the provision to simply reexport them will not lie. # * * # * * This bill seeks to authorize the exportation of such seized goods (1) if the importer or owner proposes simply to send them back to the person he got them from by a simple court order authorizing him to do so under appropriate bond which is exonerated when it is found he has done so. Id. at 39. From these hearings, it seems that Congress intended the amendments to section 304 to allow the export of goods seized after admission to same extent as section 801(a) allowed the export of goods rejected before admission, except for the additional requirements Congress chose to specifically impose. Thus, Congress presumably chose to permit the virtually unrestricted export allowed under section 801(a), except to the extent it specifically limited that export in section 304(d). The only products not exportable under section 304(d) are those condemned under the provisions specifically listed. There is no basis in the statute itself or the legislative history for concluding that Congress intended the one sentence in section 801(d) relied on by the FDA, which by its own terms does not purport to preclude export of new animal drugs under any other provisions of the Act, to place an additional restriction on exports under section 304, which is complete in itself. The court therefore finds that the sentence in section 801(d) prohibiting export under that section of domestically produced new animal drugs does not, preclude export of imported new animal drugs, as a matter of law, under section 304. The FDA next argues that, even if new animal drugs may be reexported as a matter of. law, Amexchem cannot meet the requirements of section 304(d)(1). First, the FDA describes the factual circumstances of each of the twelve lots of drugs. It argues that Amexchem cannot meet the requirements of section 304 for each of these lots. However, Amexchem has not responded to this aspect of FDA’s memorandum, apparently taking the position that only legal issues should be addressed now, and that these factual matters should be resolved at a later time. The court therefore will not now analyze each lot to determine if the requirements of section 304 can be met. FDA also makes a second legal argument regarding Amexchem’s ability to comply with section 304. It asserts that Amexchem cannot reexport under section 304, because it will not be sending the drugs back to the original foreign manufacturer. As discussed above, for a claimant to reexport under section 304, it must show that it “can and will” meet the requirements of section 801(d)(1), unless it exports to the original foreign supplier. In that case, the claimant need only comply with subsections (C) and (D) of section 801(d)(1), not with subsections (A) and (B). The government argues that “original foreign supplier” means the original manufacturer of the drugs. Amexchem intends to reexport to Chemtraco B.V., in the Netherlands, the broker from which it purchased the drugs. Since these drugs were not manufactured by Chemtraco, the FDA asserts that it is not the original supplier. It therefore contends that Amexchem must comply with section 801(d)(1)(B), which allows export only if the drug is not in conflict with the laws of the country to which it is intended for export. The FDA offers no support for its argument that “original foreign supplier” means “original foreign manufacturer.” It asserts only that to allow reexport to a broker would defeat this country’s policy against “dumping” dangerous or adulterated drugs abroad. However, if Congress had intended to permit reexport only to the original manufacturer, it would have so stated. Instead, it chose the word “supplier,” which does not connote that the goods may be sent only to the original creator of the product. The legislative history of section 304(d)(1) supports this interpretation. As quoted above, the Deputy Commissioner of the FDA stated that the bill sought to authorize the exportation of goods “if the importer or owner proposes only to send them back to the person he got them from ...” Hearings, supra, at 39. In addition, Congressman Dies, in commenting on the bill, also recognized that it was intended to permit the importer to “send it back to the man who sold it.” Id. at 30-31. Congress therefore intended to permit reexport to the person who sold goods to the importer. No evidence of a Congressional intent to limit export under section 304(d) only to the original manufacturer has been presented. Therefore, under the plain language of the statute, and in the absence of any contrary authority, the court concludes that export is permitted under section 304 to a foreign supplier, such as Chemtraco. Amexchem could therefore export the drugs in question to Chemtraco as the original foreign supplier without complying with section 801(d)(1)(A) and (B). Since the factual circumstances of each shipment have not been fully presented to the court, it is impossible at this time to apply the facts to the standards set forth in section 304(d) as interpreted above. The court therefore defers making a final determination on whether to permit export of the drugs seized in this case pending further hearing on the matter. ON MOTION FOR RE-EXPORTATION I. Introduction These consolidated cases concern twelve lots of drugs intended for use in the manufacture of medicated animal feed, which the United States Government (“Government”) seized at the request of the Food and Drug Administration (“FDA”). The motion of claimant, Amexchem, International, Inc. (“Amexchem”), for re-exportation of the drugs in lieu of destruction is presently before the court. The court notes the extreme urgency of this motion, given that the Government seized the drugs in August and September of 1984, and the drugs are rapidly losing their effectiveness. The court held a hearing on this motion on June 24-26, July 2-3 and July 12, 1985. The court has reviewed the pleadings and the statutory provisions related to the motion for re-exportation in lieu of destruction, and has heard the opening statements and closing arguments of counsel and the testimony of witnesses. The court has considered all the evidence presented and has drawn what it concludes to be the correct reasonable inferences from this evidence. The court has also evaluated the legal arguments presented by the parties. In judging the credibility of each witness and the weight to be given the testimony of each, the court has taken into account for each witness the intelligence, the ability and opportunity to observe, the age, the memory, the manner while testifying, any interest, bias, or prejudice the witness may have, and the reasonableness of the testimony considered in the light of all the evidence in the case. The court has reviewed its extensive hearing notes, including its references concerning the credibility of witnesses and the conclusions drawn from the evidence. Based on all the evidence and legal arguments presented, and for the reasons set forth below, the court grants Amexchem’s motion for exportation in lieu of destruction, making the following findings of fact and conclusions of law. II. Facts Amexchem is the importer and claimant of the twelve seized shipments which are the subject of this proceeding. Heinz Dali is the President of Amexchem. In 1982, Amexchem began importing trace minerals and vitamins for resale to animal feed manufacturers. Several of Amexchem’s customers requested Amexchem to also import certain drugs used in animal feed. Dali Aff. ¶ 4. These animal feed manufacturers wanted to purchase imported drugs of the same type as sold domestically at lower prices than were available in the United States. Dali Aff. 114, Dali, Hospodka, Hasiak, Adkins, and Lane Hearing Testimony. In answer to this request, Amexchem began importing certain drugs used in animal feed from Chemtraco B.V., a brokerage house in the Netherlands. The twelve shipments of drugs involved in this action are as follows: (1) Oxytetracyline 262, 67, 53, 120, 779 and 80; (2) Terramycin 167 and 154; (3) Tylosin 203; (4) Flavomycin 40 and 200; and (5) Elancoban 40. The court will now examine the particular facts and circumstances surrounding each imported and seized animal drug. A. Qxytetracyline 262, 67, 53, 120, 779 and 80 V.P.O., Inc. (“V.P.O.”), of Omaha, Nebraska, is a manufacturer of animal feed and one of Amexchem’s customers. In late 1982, William Winstrom, the President of V.P.O., and Dali discussed the possibility of Amexchem supplying V.P.O. with oxytetracycline (“OTC”) manufactured in China and Hungary. Dali Aff. II5. V.P.O. was, and is, authorized to use OTC from those sources. Stipulation at Hearing. Between December, 1982 and the Spring of 1983, V.P.O. gave Amexchem several oral orders for OTC, which were followed by written purchase orders. Altogether, V.P.O. ordered a total of 30,000 kilograms of OTC from Amexchem during this period. Dali Aff. ¶¶ 6, 7. Each of V.P.O.’s Purchase Orders specified a delivery date. From December, 1982 through July, 1983, thirteen shipments of the ordered OTC arrived and were transferred to V.P.O. Sigler Group Exhibit. Some of these shipments arrived in time to meet the purchase order delivery date. However, a large percent of the shipments arrived after the delivery date. Dali Aff. II8. In the Spring of 1983, Dali and Winstrom met to discuss the delivery problems encountered during the 1982-1983 season. Winstrom stated that V.P.O. would like to continue to order OTC from Amexchem, because of the comparatively low price and the high quality of the OTC Amexchem imported. However, Winstrom indicated that he was not sure V.P.O. would be able to continue ordering OTC from Amexchem because of Amexchem’s chronic failure to meet delivery deadlines. Dali Aff. 119. In response to Winstrom’s reservations, Dali proposed that Amexchem purchase and import OTC which it could then hold for V.P.O.’s use as needed. Winstrom stated that he would be pleased with such an arrangement. He also stated that, although he could not commit V.P.O. to any specific orders for the 1983-1984 season right then, V.P.O.’s business had increased over the years and he expected V.P.O. to produce at least as much in the 1983-1984 season as it had in the 1982-1983 season. Thus, Amexchem and V.P.O., through Dali and Winstrom, reached an informal understanding that Amexchem would have OTC available for V.P.O. which could be delivered expeditiously, and V.P.O. would place specific orders for OTC as needed. Dali Aff. II10. Of course, V.P.O.’s prospective purchases of OTC would be contingent on the competitiveness of Amexchem’s price, but Amexchem was willing to meet any competitive price. Dali Aff. 1f 10. Based on this informal understanding, Amexchem ordered OTC from its supplier, Chemtraco, for V.P.O. On July 21, 1983, Amexchem ordered 60 tons of OTC 10%. Stipulation 8(a). Later that summer, Amexchem ordered 6,325 kilograms of pure (base) OTC. Stipulations 7(a), 10(a), 11(a) and 12(a). According to Dali, this was a conservative quantity when compared to the 30,000 kilograms of OTC V.P.O. ordered in the 1982-1983 season. Dali Aff. ¶11. During the Summer of 1983, Dali spoke with Winstrom frequently concerning V.P. O.’s need for OTC. On each occasion, Winstrom informed Dali that V.P.O. was not yet ready to place a specific order, but asked Dali to keep in touch. Dali Aff. ¶ 12. In October, 1983, Smithkline acquired V.P.O. Winstrom stayed on as a consultant with SmithKline. After the acquisition, Winstrom assured Dali that there was no reason why SmithKline would not continue to do business with Amexchem. Again, Winstrom expressed that V.P.O. did not at that time need OTC, but V.P.O. would need OTC further into the 1983-1984 season. Dali Aff. 1114. Beginning in December, 1983 through February, 1984, the OTC Amexchem ordered pursuant to its informal understanding with V.P.O./SmithKline arrived in the United States. Amexchem transferred the OTC shipments to storage warehouses in Iowa in order to avoid the much higher New York warehousing fees and to keep the OTC at a location from which Amexchem would readily deliver the OTC to V.P.O. Once in storage, the six OTC shipments remained in storage until the Government seized the shipments. In February, 1984, Dali met with James Meier and Richard Smythe of SmithKline. Smythe, a purchasing agent for SmithKline, repeated what Winstrom had told Dali in October, 1983: that there was no reason why SmithKline and Amexchem could not continue the relationship which V.P.O. and Amexchem had established, but that SmithKline currently had a sufficient supply of OTC. Smythe told Dali that SmithKline would purchase OTC from Amexchem when the need arose, if Amexchem’s price was competitive. Dali Aff. ¶ 16. As further evidence of SmithKline’s willingness to continue business with Amexchem, in early March, 1984, SmithKline solicited a quote from Amexchem for OTC. Again, SmithKline postponed making a purchase because it had an adequate supply of OTC at the time. Dali Hearing Testimony. Meanwhile,, with the approach of the end of the 1983-1984 season, Dali became doubtful that V.P.O. would purchase an amount of OTC equivalent to the amount V.P.O. had purchased in the 1982-1983 season. Therefore, Dali requested Chemtraco to sell in Europe the balance of the OTC yet to be delivered. Dali Aff. ¶ 17; Amexchem Exhibit 2. The OTC which had been delivered remained, unaltered and unopened, in warehouses. Dali Aff. ¶ 21; Stipulations 7(f)-(i), 8(dMf), 10(dMh), ll(fHh), 12(dMh). Amexchem did not attempt to sell the delivered OTC to any manufacturer in the United States except V.P.O./SmithKline and, on one occasion, Pfizer. Dali Aff. II18. Pfizer, a manufacturer of OTC itself, was not interested in purchasing the OTC from Amexchem. As outlined earlier, V.P.O./SmithKline continued to express interest in purchasing the OTC from Amexchem through the Spring of 1984. It was not until November, 1984, long after U.S. Marshals had seized the six shipments, that SmithKline, for the first time, informed Amexchem that it would not purchase the OTC under any circumstances. Dali Aff. ¶ 19. B. Terramycin 167 and 154 In December, 1983, Amexchem ordered Pfizer terramycin from Oberdale, Ltd., an affiliate of Chemtraco also located in the Netherlands. Amexchem intended to sell the terramycin to Custom Feed Blenders in Iowa. Amexchem received a telex from Oberdale on December 19, 1983, in which Oberdale stated that it would ship Pfizer terramycin with Italian labels. Dali Aff. 1124; Amexchem Exhibit 6; Stipulation 5(a). Amexchem immediately responded, notifying Oberdale that Italian labels would not be acceptable and that Amexchem required terramycin manufactured in the United States with English labels. On December 27, 1983, Oberdale sent another telex to Amexchem apologizing for the error and confirming that the terramycin would be “U.S.” Dali Aff. II25; Amexchem Exhibit 7; Stipulation 5(a). The first shipment of terramycin, the terramycin 167 shipment, arrived in New York on February 21, 1984. Stipulation 5(b). The FDA issued a “may proceed” notice for this shipment on February 27, 1984. The shipment arrived at Amexchem on or about March 2, 1984. Amexchem Exhibit 8. From March 2-6, 1984, Dali, who personally checks Amexchem’s imports for proper labeling, was out of Amexchem’s office. By the time Dali returned, the terramycin 167 shipment had already been sent to Custom Feed Blenders in Iowa. Amexchem was therefore unaware of any problems with the shipment prior to its delivery to Custom Feed Blenders. Dali Aff. ¶ 26. The terramycin 167 shipment arrived at Custom Feed Blenders on March 12, 1984. Stipulation 5(c) and (d). On that date, Custom Feed Blenders called to inform Amexchem that the terramycin had Italian labels. Stipulation 5(a). Prior to this call, Amexchem was completely unaware of any labeling problem with the terramycin. Dali Aff. 1128. Amexchem had expected Oberdale to ship terramycin with English labels, given the exchange of telexes in December, 1983 and previous assurances from, and reliable performance by, Chemtraco, Oberdale’s affiliate. Dali Aff. 1129. Upon hearing of the Italian labels, Amexchem directed Custom Feed Blenders to send the terramycin 167 shipment on to White Transfer and Storage. Amexchem then began to make efforts to find a lawful use for the terramycin. A foreign division of Pfizer, a highly reputable firm, had manufactured the terramycin; the FDA, therefore, did not and could not assert that the terramycin was dangerous or contaminated. Dali Aff. 1147; Hospodka Testimony. Amexchem, in order to cure the labeling defect, attempted to find a manufacturer with the FDA authority to verify the composition of the terramycin and rebag it with proper labels. Dali, Hasiak, Adkins and Hospodka Hearing Testimony. Amexchem tried to find a company holding an FDA “356” authorization to blend certain drugs from high “base” concentrations to lower concentrations. IMS in Omaha, Nebraska, held a 356 for blending Pfizer terram. On May 15, 1984, Dali telephoned Quentin Hospodka of IMS and asked if IMS would be interested in purchasing the Italian labeled terramycin. Dali made it clear that the proposed sale would be subject to FDA approval — that Amexchem would not receive payment for, and IMS would not use, the drugs absent FDA approval. Dali Testimony. Hospodka agreed to purchase the terramycin, subject to FDA approval. On May 31, 1984, the terramycin arrived at IMS. Hospodka Testimony. Dali then made many attempts to secure FDA approval of his plan to “recondition” the terramycin through chemical verification and repackaging. Dali spoke informally with FDA officers in the Brooklyn, New York office about his “reconditioning” plan in the Spring of 1984. On June 12, 1984, Dali formally proposed his plan to James McDonald, a compliance officer in the FDA’s Kansas City office. Dali followed his oral proposal with one in writing, per McDonald’s request. Dali Testimony; McDonald Deposition Attachments 1 and 2. On July 16, 1984, Dali met with FDA officers in Rockville, Maryland. At this time, the FDA rejected Dali’s “reconditioning” plan and informed Dali that it was planning to seize the terramycin. Dali Testimony. Upon learning of the FDA’s decision, Dali immediately removed the terramycin from IMS to a storage warehouse in Chicago. Dali Testimony. Dali then explored the possibility of exporting the terramycin to Canada. Government Exhibits 1034, 1149 and 1150. However, the State of Illinois issued a stop sale order for the terramycin 167 shipment on August 17, 1984, and, on September 27, 1984, the U.S. Marshals in Chicago seized the terramycin 167 shipment. Stipulation. The terramycin 154 shipment was part of the December, 1983 order along with the terramycin 167 shipment. However, the terramycin 154 shipment did not arrive in New York until March 27, 1984. Stipulation. As set out above, Amexchem did not know of the foreign labeling on the terramycin 167 shipment until March 12, 1984, when Custom Feed Blenders notified Amexchem of the problem. By that time, Chemtraco had already sent the terramycin 154 shipment and Amexchem could no longer verify the labeling on the terramycin 154 shipment. Dali affidavit 1130. On April 5, 1984, Amexchem inspected the shipment at its office, found Italian labels, and immediately changed the shipping instructions to direct the shipment to White Transfer and Storage. Dali Affidavit ¶ 31; Amexchem Exhibit 9; Stipulation 6(d). At the time Amexchem sent the terramycin 154 shipment to Iowa for storage, Dali was attempting to secure FDA approval of his “reconditioning” plan. Dali hoped to include the terramycin 154 shipment in any approved reconditioning. In a letter dated April 16, 1984, Dali formally notified the FDA of his plan to find an animal feed manufacturer with 356 authorization to blend terramycin, who could chemically verify and repackage the terramycin. Government Exhibit 999. In a July 9, 1984 letter, Dali identified the 356 holder as International Nutrition. Government Exhibit 951. As stated above, the FDA rejected Dali’s “reconditioning” plan at the July 16, 1984 meeting. The terramycin 154 shipment, like the 167 shipment, involved Pfizer terramycin. The FDA does not assert that the terramycin in the 154 or 167 shipment is dangerous or contaminated. The terramycin from both shipments remains unchanged in its original containers. Dali Testimony. On June 7,1984, the State of Iowa issued a stop sale order against the terramycin 154 shipment. U.S. Marshals in Cedar Rapids, Iowa, seized this shipment on August 15, 1984. C. Tylosin 203 Between June and December of 1983, Amexchem received four shipments of Tylosin from Chemtraco, all of which were manufactured by Eli Lilly in the United States and labeled in English. Dali Affidavit 1136. In October, 1983, Amexchem ordered more tylosin, specifying, as always, that the tylosin was to be manufactured in the United States and labeled in English. Amexchem intended to sell the tylosin to V.P.O. Dali Affidavit it 33. The shipment arrived in New York on December 15, 1983. That same day, the FDA issued a “may proceed” notice on the shipment. Stipulations 4(b) and (c). The foreman of the trucking company hired by Amexchem to pick up the tylosin called Amexchem, after the pickup, to inform Amexchem that the labeling was not in English. As it turned out, Eli Lilly’s Belgium division had manufactured the tylosin in the 203 shipment, and the labels were in French and Dutch. Dali Affidavit ¶ 34. The shipment was to go directly to V.P.O. During the telephone call, Dali directed the trucking company to divert the tylosin to Continental Warehouse in Des Moines, Iowa. Stipulation 4(a), Amexchem Exhibit 10; Dali Affidavit ¶ 35. Amexchem was not expecting, and had no reason to expect, foreign made and labeled tylosin, in light of the four previous tylosin shipments and prior conversations with Chemtraco. Dali Affidavit ¶ 36. However, knowing that the FDA did not, and could not, assert that there were any health or safety problems with the tylosin 203 shipment, given that a division of Eli Lilly, a well-respected drug manufacturer, had manufactured the tylosin, Amexchem decided to try to secure FDA approval for “reconditioning” of the tylosin. International Nutrition had 356 authorization to blend tylosin. In May, 1984, Amexchem contacted International Nutrition, proposing a sale of the foreign labeled tylosin, subject to FDA approval. International Nutrition agreed to purchase the tylosin, but all parties understood that International Nutrition would not pay Amexchem or use the tylosin absent FDA approval. The tylosin 203 shipment arrived at International Nutrition on June 4, 1984. Meanwhile, Dali attempted to secure FDA approval of his “reconditioning” plan for the tylosin 203 shipment and, as previously mentioned, the terramycin 167 and 154 shipments. In early June, 1984, Dali met with Joseph McCallion of the FDA’s Brooklyn, New York office, and informally discussed the “reconditioning” plan. A formal proposal to FDA officer McDonald followed in mid-June. Dali Testimony; Government Exhibit McDonald Attachment 1 and 2. On July 9, 1984, McCallion informed Dali and Reid Adkins of International Nutrition that the Kansas City FDA office would decide whether to approve of the “reconditioning” plan, and, until approval, neither Amexchem nor International Nutrition were to use the tylosin. Government Exhibit McCallion 1. At the July 16, 1984 meeting with the FDA in Rockville, Maryland, the FDA disapproved Amexchem’s “reconditioning” plan as to both the tylosin and the terramycin, and indicated that it planned to seize these shipments. Dali Testimony. Amexchem then moved the tylosin from International Nutrition to a storage warehouse in Chicago. Government Exhibit Hasiak Attachment. Once the tylosin arrived in Chicago, Amexchem looked into the possibility of exporting it to Canada. Government Exhibits 1149, 1150, 1199C. However, on August 17, 1984, the State of Illinois issued a stop sale order on the tylosin, and on September 27,1984 United States Marshals in Chicago seized the tylosin 203 shipment. Stipulation. D. Flavomycin 40 and 200 In early 1983, Dali discussed importing flavomycin with Albert Lane of Lane Agri. Lane Agri, until that time, had purchased only minerals from Amexchem and had apparently purchased flavomycin from another importer. Stipulation 1(d). All flavomycin is manufactured outside of the United States, and flavomycin manufactured by Hoechst, a West German company, is approved for use in the United States. Dali Affidavit ¶ 37. American Hoechst, a subsidiary of Hoechst in West Germany, imports 4% flavomycin, which it then blends to a 2.2% concentration level for resale in the United States. Lane Hearing Testimony. In their discussions regarding the importation of flavomycin, Dali and Lane discussed the requirement of English labeling, but not concentration levels. Dali assumed that all Hoechst flavomycin came in one concentration level, 4%, and that the flavomycin Lane Agri had previously purchased had been at that level. Dali Affidavit 1138; Dali Hearing Testimony. In fact, Lane Agri had only purchased and used 2.2% flavomycin, but Dali was unaware of this fact. Lane and Dali Hearing Testimony. Based on his discussions with Lane, Dali ordered flavomycin from Chemtraco for resale to Lane Agri in early 1983. On February 21, 1983, Chemtraco confirmed the Amexchem order for flavomycin, noting the 4% concentration level. Dali knew, then, that Amexchem was importing for resale flavomycin 4%. Stipulation. The flavomycin 40 shipment arrived in the United States on March 19, 1983. The FDA issued a “may proceed” notice for the shipment on March 24, 1983, although the documents which Amexchem rendered to Customs and the FDA stated that the flavomycin was 4%. Stipulations 1(b), 1(c), Dali Affidavit II40; Amexchem Exhibits 11, 32. The flavomycin 40 shipment arrived later than expected, and, in the meantime, Lane Agri had purchased needed flavomycin from American Hoechst. Lane Hearing Testimony. Therefore, Amexchem did not immediately deliver the flavomycin to Lane Agri. Instead, Amexchem stored the shipment, reminding Lane Agri in an April, 1983 letter that the flavomycin 4% was on hand. Amexchem Exhibit 47. On June 22,1983, Amexchem shipped the flavomycin and mailed the invoice, which specified the 4% concentration, to Lane Agri. In late July, 1983, Lane informed Dali that Lane Agri was not authorized to use flavomycin 4%. Amexchem immediately removed the flavomycin to Continental Warehouse in Des Moines, Iowa, for storage. Stipulation; Dali Hearing Testimony. Amexchem then attempted to find a legal use for the flavomycin 40 shipment. Dali requested Lane to try to secure FDA approval for blending the flavomycin down to 2.2%. By the time Dali became fully aware that such approval would not be forthcoming, it was too late to stop delivery on the second flavomycin shipment. Dali Hearing Testimony. That flavomycin 200 shipment left Antwerp, Belgium on August 16, 1983, and arrived in New York on September 2, 1983. Stipulation. As with the first shipment, the FDA issued a “may proceed” notice on the flavomycin 200 shipment. Stipulation 2(c). Upon this shipment’s release from Customs, Amexchem sent the shipment directly to Continental Warehouse, pending authorization for use or reexportation. Stipulation 2(d); Dali Affidavit ¶ 44; Dali Hearing Testimony; Amexchem Exhibit 48. The shipment arrived at Continental Warehouse on September 13, 1983. On June 6,1984, the State of Iowa issued a stop sale order on both shipments of flavomycin. The U.S. Marshals in Des Moines, Iowa seized the shipments of flavomycin on August 3, 1984. All the flavomycin remains unchanged, unused, and in the original containers. Dali Hearing Testimony. As Hoechst manufactured the flavomycin, the FDA does not assert that there is a health or safety problem with the flavomycin. E. Elancoban 40 On November 24, 1982, Dali wrote a letter to Lane concerning the importation of elancoban for Lane Agri. Elancoban is Eli Lilly’s tradename for a drug generically known as monensin. Lane and Dali Hearing Testimony. In the letter, Dali wrote that Amexchem is “very competitive with monensin 10%.” Lane Exhibit 1. Monensin 10% and 13% are approved concentrations of monensin in the United States. Lane Hearing Testimony; Stipulation. Amexchem ordered monensin 10% from Chemtraco on May 14,1983, with the intent to resell the monensin to Lane Agri. However, the monensin which arrived in New York on June 23, 1983 was monensin 20%, which is not an approved concentration in the United States. Dali did not know, and had no reason to know, that the monensin was 20% concentration until the shipment arrived in Amexchem’s New Jersey warehouse. Dali Affidavit If 45; Dali Hearing Testimony. As soon as Dali discovered the potency problem, on June 30, 1983, he had the monensin taken directly to Continental Warehouse. Stipulations 3(d) and (e); Dali Affidavit If 45. The State of Iowa issued a stop sale order on the monensin on June 6, 1984, and U.S. Marshals in Des Moines seized the monensin on August 3, 1984. As the monensin was manufactured by Eli Lilly, the FDA does not assert that there is a health or safety problem with the monensin. The monensin 40 shipment remains unchanged, unused in its original containers. Dali Hearing Testimony. III. Procedural History On July 30, 1984, August 2, 1984 and September 6, 1984, the United States filed complaints in three districts seeking the condemnation of the twelve lots of drugs. This court consolidated all three cases in an order dated February 14, 1985. On February 21, 1985, Amexchem filed an answer admitting all the allegations of the complaints and requesting permission to reexport the drugs to its original foreign supplier. The court entered a consent decree of condemnation as to the twelve lots subject to seizure on March 7, 1985. The decree condemned all twelve lots as adulterated under section 501(a)(5) of the Food, Drug and Cosmetic Act (“FDCA”), 21 U.S.C. § 351(a)(5), because they are unapproved new animal drugs. In addition, the decree condemned some of the lots as being misbranded under 21 U.S.C. § 352(c) for foreign labeling, and all but two of the lots as being misbranded under 21 U.S.C. § 352(f)(1) for failure to bear adequate directions for use. The court, in the decree, deferred ruling on the reexportation issue. On February 22, 1985, Amexchem again moved for reexportation in lieu of destruction. The Government objected, and, on May 30, 1985, this court issued an order determining several legal issues the Government had raised with regard to the FDCA’s reexportation provisions. In that order, this court deferred making a final determination of Amexchem’s motion for reexportation of the seized drugs in lieu of destruction, pending a factual hearing. As stated above, the court held a factual hearing on Amexchem’s motion for reexportation in June and July, 1985. On December 18,1985, this court, by oral ruling, granted Amexchem’s motion for reexportation in lieu of destruction. This opinion reiterates, in much greater detail, that oral ruling. IV. Statutory Requirements for Reexportation of Condemned Drugs Section 304(d)(1) of the FDCA, 21 U.S.C. § 334(d)(1), and section 801(d)(1) of the FDCA, 21 U.S.C. § 381(d)(1), which is incorporated reference in section 304(d)(1), permit the reexportation of condemned imported drugs, provided certain requirements have been met. Importers seeking to reexport drugs under these provisions have the burden of pleading and proving satisfaction of the statutory requirements. United States v. 76,552 Pounds of Frog Legs, 423 F.Supp. 329, 337 (S.D.Tex.1976). Amexchem has stated that it intends to reexport the articles of drugs to Chemtraco, Amexchem’s original foreign supplier. Under § 304(d)(1), if articles are to be reexported to the “original foreign supplier,” the requirements found in § 801(d)(1)(A) and (B) need not be met. In its May 30,1985 opinion, this court concluded that the phrase “original foreign supplier” in § 304(d)(1) is not limited to the original manufacturer. Therefore, Amexchem need only show that it meets the following four requirements for reexportation: (1) the adulteration or misbranding of the articles, or any other violation, did not occur after the articles were imported, § 304(d)(1)(A); (2) the person or firm seeking to reexport the articles had no cause for believing the articles were adulterated, misbranded or in violation before they were released from Customs custody, § 304(d)(1)(B); (3) the articles are labeled on the outside of the shipping package that they are intended for export, § 801(d)(1)(C); and (4) the articles are not sold or offered for sale in domestic commerce, § 801(d)(1)(D). Satisfaction of all four of the requirements does not mandate an order of reexportation in lieu of destruction; the court, in its discretion, may order reexportation once all the requirements have been met. Frog Legs, 423 F.Supp. at 337. As set out below, the court now finds that Amexchem has satisfied all four statutory criteria, and, in its discretion, orders reexportation in lieu of destruction. A. Section 304(d)(1)(A): No Adulteration, Misbranding or Violation After Importation Amexchem has established that the adulteration, misbranding or violation did not occur after the articles were imported. The evidence Amexchem presented during the hearing clearly establishes that all of the drugs in all 12 shipments remain packaged in their original containers and that Amexchem has not processed or altered any of the drugs in any way. Indeed, the FDA does not contend that Amexchem has repackaged or processed the drugs since Customs released the drugs from custody. The Government does contend, however, that Amexchem misbranded the terramycin 167 and the flavomycin 40 and 200 shipments after importation. According to the Government, Amexchem’s shipment of the terramycin to IMS and the flavomycin to Lane Agri constituted “misbranding” under section 502 of the FDCA, 21 U.S.C. § 352(f)(1), because neither firm had authorization from the FDA to use those products. The Government’s argument fails both in its factual account and its statutory interpretation. First of all, at the time Amexchem sent the terramycin 167 shipment to IMS, IMS was, in fact, an authorized blender of Pfizer terramycin. However, as both IMS and Amexchem understood, IMS was not authorized to “recondition” the Italian labeled terramycin, absent FDA approval and supervision. Also, as stated above, Dali’s testimony at the hearing, which was corroborated by highly credible documentary evidence, established that Amexchem never sent the flavomycin 200 shipment to Lane Agri. Amexchem sent that shipment directly to Continental Warehouse. Second, the Government misinterprets section 502(f)(1). That section merely provides that a drug is misbranded unless its labeling bears adequate directions for use. Neither subsection (f)(1) of section 502, nor any other subsection of section 502, refer to shipment to an unauthorized purchaser as “misbranding.” Given that section 502 specifies numerous circumstances in which a drug may be considered “misbranded,” but fails to mention shipment as such a circumstance, the court now finds that, under the doctrine of expressio unius est exclusio alterius, a drug is not “misbranded” merely because it is shipped to an unauthorized purchaser. Furthermore, in the consent decree of March 7,1985, the terramycin and flavomycin shipments were condemned as “misbranded” under § 352(f)(1) for failing to bear labels with adequate directions for use, and the terramycin shipments were also condemned as “misbranded” under § 352(c), for bearing foreign labels. The reference in section 304(d)(1)(A) to “the” misbranding refers to the misbranding which led to the seizure of the drugs, in this case, the misbranding charged in the consent decree, and not any subsequent alleged misbranding. The misbranding charged in the consent decree clearly did not occur after Amexchem imported the drugs. B. Section 304(d)(1)(B): No Cause For Believing The Drugs Were Adulterated, Misbranded Or In Violation Before Release From Customs Custody The Government asserts that Amexchem had actual or constructive knowledge that several of the shipments were violative before Customs released the shipments. According to the Government, Amexchem had actual knowledge that the six oxytetracycline shipments were “misbranded” before release from Customs because Dali was aware that the FDA required a specific customer on all imported OTC shipments, and Amexchem had no specific orders for the six OTC shipments prior to importation. The Government also contends that Amexchem had actual knowledge that the flavomycin 200 shipment was not approved for sale in the United States prior to release from Customs, because Lane advised Dali in June and July of 1983 that Lane Agri could not use flavomycin 4%. The Government, in addition, argues that Amexchem had constructive knowledge of the violative condition of the flavomycin 40 and 200 and the elancoban 40 shipments prior to release from Customs. Flavomycin 4% and Elancoban 20% do not appear in the lists of approved drugs in the Code of Federal Regulations, 21 C.F.R. §§ 558.95, 558.355. Therefore, the Government claims Amexchem had constructive knowledge, through the Code of Federal Regulations, that these shipments were violative, and such constructive knowledge is sufficient to meet the “cause to believe” requirement of § 304(d)(1)(B). The court now addresses each of these arguments below. 1. Actual Knowledge That The OTC Shipments Were Misbranded Prior To Customs Release It is at this juncture that the court first addresses itself to a problem pervasive in this action, that is, the FDA’s failure to adopt its unwritten, varying, and highly intrusive “policies” as written, published regulations. Here, the FDA claims it has a policy of requiring a specific customer pri- or to the importation of all OTC shipments. This is referred to as the “matching letter” policy, because the FDA requires the importer and the authorized purchaser to submit “matching letters” establishing a firm order before Customs releases the drugs. This matching letter and prompt action policies are not contained in the FDCA, the FDA regulations, or the FDA’s internal manuals. In addition, if the matching letter policy exists at all, it is inconsistently followed by the FDA. It is this court’s position that the FDA should have published the matching letter and prompt action policies, as official rules or regulations, in the Federal Register, pursuant to the Administrative Procedure Act, 5 U.S.C. § 500 et seq. (“APA”), and the Freedom of Information Act, 5 U.S.C. § 552 (“FOIA”). The FDA’s failure to so publish the policies now prohibits the FDA from enforcing the policies against Amexchem in this action. Section 553 of the APA sets out the procedure for agency rule making. Under that section, an agency must publish in the Federal Register a general notice of proposed rule making, and must allow interested persons to participate in the rule making procedure. Section 553 exempts certain agency actions from its scope; however, as outlined below, none of those exemptions apply in this case. Section 553(a) exempts from coverage agency actions involving the military or foreign affairs functions of the United States, agency management or personnel, or public property, loans, grants, benefits or contracts. First, the Government does not, and cannot, contend that these policies involve the military or public property, loans, grants, benefits or contracts. Second, although policies affecting imports and exports may implicate foreign affairs, the foreign affairs exemption does not ap- ply here, for these policies do not “provoke definitely undesirable international consequences.” Yassini v. Crosland, 618 F.2d 1356, 1360 n. 4 (9th Cir.1980). Third, the policies do not merely involve agency management or personnel. See, e.g., United States v. Hayes, 325 F.2d 307 (4th Cir.1963) (holding that an order of the Comptroller General giving an employee the authority to certify copies of office records need not be published in the Federal Register because it falls within the similar internal management exemption in section 552, now deleted). Section 553(b) exempts from coverage agency interpretive rules, general statements of policy, rules of agency organization, procedure or practice, and agency action for which notice and public procedure would be impracticable, unnecessary, or contrary to the public interest. First, the policies in this case are not “interpretive rules.” An interpretive rule is an administrative construction of a statutory provision on a question of law reviewable in the courts. Pickus v. United States Parole Board, 507 F.2d 1107, 1113 (D.C.Cir.1973); Aiken v. Obledo, 442 F.Supp. 628, 649 (E.D.Cal.1977). Interpretive rules clarify and explain existing statutes and regulations, and have neither force of law nor a substantial impact on those regulated. Herron v. Heckler, 576 F.Supp. 218, 231 (N.D.Cal.1983). See also Powderly v. Schweiker, 704 F.2d 1092, 1098 (9th Cir.1983). The matching letter and prompt action policies do not explain existing statutes or regulations; neither the FDCA nor the FDA regulations mention such requirements. These policies have the force of law in that they constitute, in effect, further prerequisites an importer must satisfy before he or she can reexport safe, albeit violative, merchandise. Having the force of law, these policies are clearly not interpretive rules. Aiken, 442 F.Supp. at 653. Second, these policies, although labeled as “policies” by the FDA, do not constitute “general statements of policy” under section 553(b). A general statement of policy is “a declaration which is used as a ‘touchstone for future administrative action.’ ” Aiken, 442 F.Supp. at 653 (quoting Ash Grove Cement Co. v. Federal Trade Commission, 519 F.2d 934, 935 (D.C.Cir.1976). Here, the policies are not “touchstones for future action” by the FDA; rather, the policies constitute “particularized mandate^] ... [which] impose rights and obligations ... and ... have a substantial impact on those regulated." Aiken, 442 F.Supp. at 653 (citations omitted). Third, the matching letter and prompt action policies are not rules of agency organization, procedure or practice. Although these policies do involve some procedural aspects, in essence, they establish standards of entitlement, rather than methods of operation. See Aiken, 442 F.Supp. at 649. Fourth, the FDA has not, for good cause, found that a notice and comment procedure concerning the two policies would be “impracticable, unnecessary, or contrary to the public interest.” In Yassini, 618 F.2d 1356, the court found the good cause exception applicable to a directive by the Commissioner of the Immigration and Naturalization Service rescinding a deferred departure date previously granted to Iranian nationals. The court found persuasive the Government’s argument that the good cause exception applied because “public interest warranted a prompt response to the embassy takeover in Iran.” Yassini, 618 F.2d at 1360. In the present case, the Government does not contend that the good cause exception applies, and this court now finds there is no basis in the facts of this case for application of the good cause exception. In summary, the court finds that the matching letter and good faith policies are not exempt from the notice and comment requirements of Section 553. They are not interpretive rules, general statements of policy, rules of agency organization, procedure or practice, or rules for which notice and comment would be impracticable, unnecessary or contrary to the public interest. On the contrary, the two policies are “substantive rules of general applicability” as that term is defined in the statutes and cases. Section 551(4) defines a “rule” as follows: (4) “rule” means the whole or a part of an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or describing the organization, procedure, or practice requirements of an agency and includes the approval or prescription for the future of rates, wages, corporate or financial structures or reorganizations thereof, prices, facilities, appliances, services or allowances therefor or of valuations, costs, or accounting, or practices bearing on any of the foregoing; The two policies clearly fit within this statutory definition: they are agency statements which are prospectively applicable to a class of importers generally and designed to prescribe law. Also, the policies are “rules” as the courts have construed that term: they are generally binding on importers, the affected public, they provide specific standards to regulate future conduct, and they make a substantive impact on the rights and duties of persons subject to their limitations. See Herron, 576 F.Supp. at 230. The policies are substantive, rather than interpretive or procedural, rules. Substantive rules effect a change in existing law or policy. Powderly, 704 F.2d at 1098. They impose mandatory obligations upon members of the public, directly affecting pre-existing legal rights or obligations. Appalachian Power Co. v. Train, 566 F.2d 451, 455 (4th Cir.1977). As the Fourth Circuit has stated: [A substantive rule is] of such a nature that knowledge of it is needed to keep the outside interests informed of the agency’s requirements in respect to any subject within its competency, as a guide in their conduct of day-to-day affairs, and to instruct them in regard to the presentation to the agency of any subject for impartial consideration or action thereon. Hayes, 325 F.2d at 309 (citations omitted). The matching letter and prompt action policies are thus substantive rules. They create precise, objective limitations where none previously existed; they create law. Also, importers subject to the policies need to know about the policies in order to conduct their businesses within the legal limits. As substantive rules of general applicability, the FDA was not only required to comply with the notice and comment provisions of section 553 of the APA with regard to the policies. The FDA was also required to comply with the publication provision in section 552(a) of the FOIA. Under section 552(a)(1)(D), the FDA is required to publish in the Federal Register “substantive rules of general applicability.” Section 552(a) also provides that a person may not be adversely affected by a matter required to be published and not so published, “[e]xcept to the extent that a person has actual and timely notice of the terms thereof.” In this case, Amexchem did not have actual and timely notice of the policies which were required to be published in the Federal Register under section 552(a)(1)(D). The policies should not therefore adversely affect Amexchem in this action. In fact, the policies cannot adversely affect any importer in any action. Section 706 of Title 5 of the United States Code provides: The reviewing court shall— $ ‡ ‡ ‡ $ J|t (2) hold unlawful and set aside agency action, findings, and conclusions found to be— (A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law____ The FDA “adopted” both the matching letter and prompt action policies in violation of the notice and comment provisions of section 553 of the APA and the publication provision of section 552 of the FOIA. Therefore, the court, for purposes of this case, declares void and sets aside the two policies. See Aiken, 442 F.Supp. at 650. Voiding these two policies for “what at first blush appears to be a technicality is not as pointless as it may seem,” because sections 552 and 553 serve important interests. Aiken, 442 F.Supp. at 651 (quoting Kelly v. United States Department of Interior, 339 F.Supp. 1095, 1102 (E.D.Cal.1972)). First, as the Kelly court noted: [T]he 30-day notice rule [in section 553] serves an important interest, the right of the people to present their views to the government agencies which increasingly permeate their lives. The interchange of ideas between the government and its citizenry provides a broader base for intelligent decision-making and promotes greater responsiveness to the needs of the people, especially in cases such as this where Congress has only roughed in its program. Kelly, 339 F.Supp. at 1102. In this case, public input and scrutiny would have ensured, and will ensure, if the FDA validly enacts the policies as rules or regulations following this decision, that the policies are reasonable and well-tailored to both the needs of future animal drug importers and the American public. Also, the notice and comment and publication requirements ensure that those subject to agency actions will be informed and thus able to conduct day-to-day affairs within any legal limits set by the agency. Hayes, 325 F.2d at 309. Certainly, in this case, written official rules or regulations would have greatly aided Amexchem, which never intended or schemed to evade the FDCA or FDA regulations, but which never received clear guidance as to its legal obligations. Finally, the requirements of sections 552 and 553 also prohibit agency officials from engaging in ad hoc decision making in order to possibly confuse, and thereby maintain control over, those subject to agency actions. In National Wildlife Federation v. Clark, 577 F.Supp. 825, 828-29 (D.D.C.1984), the court held that the Secretary of the Interior was bound by a prior regulation, which directed him to withdraw lands from coal leasing, until the agency rescinded the regulation through section 553 notice and comment procedures. In rendering void the Secretary’s attempted rescission, the court stated that the Secretary’s action could not withstand “the rising number of appellate decisions condemning ad hoc actions by Department heads.” Clark, 577 F.Supp. at 828. The court distinguished NLRB v. Bell Aerospace Co., 416 U.S. 267, 94 S.Ct. 1757, 40 L.Ed.2d 134 (1974), overruled on other grounds, NLRB v. Hendricks County Rural Electric Membership Corp., 454 U.S. 170, 102 S.Ct. 216, 70 L.Ed.2d 323 (1981), in which the Supreme Court gave the NLRB a choice between setting a certain standard through rule making or enforcement proceedings. According to the Clark court, both procedures in Bell Aerospace were judicially reviewable; however, the Secretary’s attempted ad hoc rescission would not have been judicially reviewable. In this case, the FDA’s ad hoc policy making also fails to withstand the appellate decisions condemning ad hoc decision making. See Clark, 577 F.Supp. at 828, and cases cited therein. The FDA cannot, and should not, sporadically and inconsistently create or rely on policies, which are not in accordance with law, in order to maintain control over those regulated or to escape judicial review. 2. Actual Knowledge That The Flavomycin 200 Shipment Was In Violation Prior To Customs Release The Government contends that Amexchem actually knew that the flavomycin 200 shipment was not approved for sale in the United States because Lane so advised Dali in June and July of 1983. The court finds to the contrary for several reasons. First, as set out above in the facts, Lane did not inform Dali that Lan