[Federal Register Volume 74, Number 238 (Monday, December 14, 2009)]
[Notices]
[Pages 66133-66134]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-29715]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0293]


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:

[[Page 66134]]

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.

    Dated: November 20, 2009.
Brenda Holman,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. E9-29715 Filed 12-11-09; 8:45 am]
BILLING CODE 4160-01-S