Peter Xuong Lam: Debarment Order

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) debarring Peter Xuong Lam for a period of 20 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Lam was convicted of four felonies under Federal law for conduct relating to the importation into the United States of an article of food. After being given notice of the proposed debarment and an opportunity to request a hearing within the timeframe prescribed by regulation, Mr. Lam failed to request a hearing. Mr. Lam's failure to request a hearing constitutes a waiver of his right to a hearing concerning this action.

DATES:

This order is effective December 14, 2009.

ADDRESSES:

Submit applications for termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Kenny Shade, Division of Compliance Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 240-632-6844.

SUPPLEMENTARY INFORMATION:

I. Background

Section 306(b)(1)(C) of the act (21 U.S.C. 335a(b)(1)(C)) permits FDA to debar an individual from importing an article of food or offering such an article for import into the United States if FDA finds, as required by section 306(b)(3)(A) of the act (21 U.S.C. 335a(b)(3)(A)), that the individual has been convicted of a felony under Federal law for conduct relating to the importation into the United States of any food.

On October 29, 2008, Mr. Lam was convicted in the United States District Court for the Central District of California of one count of conspiracy, in violation of 18 U.S.C. 371, for conspiring to violate 18 U.S.C. 545 (importation contrary to law) and 21 U.S.C. 331(a) and (c) and 21 U.S.C. 333(a)(2) (felony delivery and receipt of misbranded food) and of three counts of violating 18 U.S.C. 545 and 18 U.S.C. 2(b) (trafficking in fish contrary to 18 U.S.C. 541 and 21 U.S.C. 331(a)). Judgment was entered against Mr. Lam on May 22, 2009.

FDA's finding that debarment is appropriate is based on three felony convictions for trafficking in illegally imported merchandise and one felony conviction for conspiracy. The factual basis for those convictions is as follows: From May 2004 until on or about October 2006, Mr. Lam conspired to falsely identify, mislabel, and fraudulently declare certain imports of frozen fillets of Pangasius hypophthalmus, commonly referred to as “Vietnamese catfish” or “basa,” in order to evade antidumping duties and to then market them, still falsely labeled. Mr. Lam sold the imported frozen Vietnamese catfish fillets in the United States, mislabeled as other types of fish, for a lower price than would have been necessary if the antidumping duties had been paid. He told purchasers who had specifically ordered Vietnamese catfish, and who questioned the subsequently received boxes of fish labeled as other species, or invoices identifying the fish as other species, that, among other things, the names used were alternative names for what the purchasers had ordered, or that the factory had made an error with the boxes, but the contents of the box were in fact the Vietnamese catfish that the purchasers had ordered. On or about November 17, 2004, Mr. Lam filled an order for 800 cases of “catfish fillet (Basa)” with 800 cases of “conger pike fillet,” and then represented to the purchaser that “conger pike fillet” was the scientific name for basa and that the product sold to the purchaser was basa.

On or about November 7, 2004, December 7, 2004, February 3, 2005, and February 27, 2005, in violation of 18 U.S.C. 545 and 18 U.S.C. 2(b), Mr. Lam made and knowingly submitted to a customs broker a false record, account, and label for false identification of fish with a market value greater than $350. The documents and labels identified the fish as “common carp,” “sole,” and “conger pike,” though Mr. Lam knew the fish was Vietnamese catfish which had been transported in foreign commerce and imported with intent to sell.

FDA sent Mr. Lam by certified mail on September 11, 2009, a proposal to debar Mr. Lam for a period of 20 years from importing an article of food or offering such an article for import into the United States. The proposal was based on a finding under section 306(b)(1)(C) of the act that Mr. Lam was convicted of four felonies under Federal law for conduct relating to the importation into the United States of any food, and a determination, after consideration of the factors set forth in section 306(c)(3) of the act (21 U.S.C. 335a(c)(3)), that the full periods of debarment shall run consecutively as provided by section 306(c)(2)(A)(iii) of the act (21 U.S.C. 335a(c)(2)(A)(iii)). The proposal also offered Mr. Lam an opportunity to request a hearing, providing him 30 days from the date of receipt of the letter in which to file the request, and advised him that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Mr. Lam did not request a hearing and has, therefore, waived his opportunity for a hearing and waived any contentions concerning his debarment (21 CFR part 12).

II. Findings and Order

Therefore, the Acting Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(1)(C) of the act, and under authority delegated to the Acting Director (Staff Manual Guide 1410.35), finds that Mr. Peter Xuong Lam has been convicted of four felonies under Federal law for conduct relating to the importation of an article of food into the United States and that the full periods of debarment shall run consecutively under section 306(c)(2) of the act (21 U.S.C. 335a(c)(2)).

As a result of the foregoing finding, Mr. Lam is debarred for a period of 20 years from importing articles of food or offering such articles for import into the United States, effective (see DATES). Under section 301(cc) of the act (21 U.S.C. 331(cc)), the importing or offering for import into the United States of an article of food by, with the assistance of, or at the direction of Mr. Lam is a prohibited act.

Any application by Mr. Lam for termination of debarment under section 306(d)(1) of the act (21 U.S.C. 335a(d)(1)) should be identified with Docket No. FDA-2009-N-0293 and sent to the Division of Dockets Management (see ADDRESSES). All such submissions are to be filed in four copies. The public availability of information in these submissions is governed by 21 CFR 10.20(j).

Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.