[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26765-26766]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10958]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0879]


David H.M. Phelps: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The U.S. Food and Drug Administration (FDA) is issuing an 
order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
debarring David H.M. Phelps 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. Phelps was 
convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21 
U.S.C. 335a(l)(1)(B)), of 10 felony counts under Federal law for 
conduct relating to the importation into the United States of an 
article of food. Mr. Phelps was given notice of the proposed debarment 
and an opportunity to request a hearing within the timeframe prescribed 
by regulation. As of March 31, 2012 (30 days after receipt of the 
notice), Mr. Phelps had not responded. Mr. Phelps's failure to respond 
constitutes a waiver of his right to a hearing concerning this action.

DATES: This order is effective May 7, 2012.

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, Office of Regulatory 
Affairs, Food and Drug Administration, 12420 Parklawn Drive, Rockville, 
MD 20857, 301-796-4640.

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 306(b)(1)(C) of the FD&C 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 FD&C Act (21 U.S.C. 
335a(b)(3)(A)), that the individual has been convicted of a felony for 
conduct relating to the importation into the United States of any food.
    On May 4, 2011, Mr. Phelps was convicted, as defined in section 
306(l)(1)(B) of the FD&C Act, when the U.S. District Court for the 
Southern District of Alabama accepted his plea of guilty and entered 
judgment against him for the following offenses: One count of 
conspiracy to commit offenses against the laws of the United States, in 
violation of 18 U.S.C. 371; nine counts of false labeling under the 
Lacey Act, in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A); two 
counts of receipt of merchandise imported contrary to law, in violation 
of 18 U.S.C. 545; and one count of misbranding, in violation of 21 
U.S.C. 331(a), 333(a)(2), and 343(a)(1) and (b).
    FDA's finding that debarment is appropriate is based on the felony 
convictions referenced herein for conduct relating to the importation 
into the United States of any food. The factual basis for these 
convictions is as follows: As stated in the factual resume accompanying 
the plea agreement referenced above and alleged in the indictment filed 
against Mr. Phelps, Mr. Phelps was co-owner, vice president, and 
secretary of CSE Inc., which was used to buy and sell seafood. He was 
also a co-owner and vice president of RF Inc. RF Inc. also sold 
seafood, including but not limited to shrimp, oysters, Lake Victoria 
perch, and types of catfish, commonly called basa, swai, and sutchi.
    Beginning on or about January 1, 2004, and continuing through on or 
about November 8, 2006, Mr. Phelps knowingly, willingly, and unlawfully 
combined, conspired, confederated, and agreed with his coconspirators 
to commit offenses against the laws of the United States related to 
importation of food. This conduct was in violation of 18 U.S.C. 371. 
Specifically, Mr. Phelps received and bought 81,000 pounds of fish of 
the genus Pangasius (a type of catfish commonly called basa, swai, or 
sutchi) that he knew had been unlawfully imported from Vietnam. He knew 
that the fish was falsely labeled as sole when it was imported, and 
that it was imported without the required antidumping duty having been 
paid. He created or caused others to create false invoices and labeling 
for this fish, and other fish of the genus Pangasius bought and sold to 
customers, totaling approximately 101,078 pounds. Mr. Phelps sold and 
invoiced the fish as grouper or sole, allowing him to sell the fish in 
interstate commerce at higher profit margins and more readily than if 
the fish had been accurately labeled and described.
    From on or about February 9, 2005, through on or about June 27, 
2005, Mr. Phelps knowingly made and caused to be made a false record, 
account, and label for, and false identification of fish, that had been 
and was intended to be

[[Page 26766]]

transported in interstate and foreign commerce, having a market value 
greater than $350, and that involved the sale and purchase, the offer 
of sale and purchase, and the intent to sell and purchase fish, and the 
importation of fish, in that he created and caused to be created 
invoices, boxes, and other documents that falsely identified the fish. 
Specifically, Mr. Phelps falsely identified fish as sole and 
Cynoglossus bilineatus, when in fact it was fish of the genus 
Pangasius, a type of catfish. This conduct was in violation of 16 
U.S.C. 3372(d)(2) and 3373(3)(A).
    From about March 30, 2005, through April 4, 2005, Mr. Phelps 
knowingly received, concealed, bought, sold, and facilitated the 
transportation, concealment, and sale of merchandise after importation, 
specifically frozen fish fillets of the genus Pangasius, knowing it to 
have been imported and brought into the United States contrary to law, 
that is falsely declared and with applicable duties having been paid. 
This conduct was in violation of 18 U.S.C. 545.
    From approximately March 30, 2005, through approximately June 22, 
2005, with intent to defraud and mislead, Mr. Phelps introduced and 
delivered and caused to be introduced and delivered into interstate 
commerce food, specifically frozen fish fillets, that was misbranded in 
that it had been falsely and misleadingly labeled and described as sole 
and Cynoglossus bilineatus, when in fact the fish was of the genus 
Pangasius. This conduct in violation of 21 U.S.C. 331(a), 333(a)(2), 
and 343(a)(1) and (b).
    As a result of his conviction, on February 17, 2012, FDA sent Mr. 
Phelps a notice by certified mail proposing to debar him for a period 
of 20 years from importing articles of food or offering such articles 
for import into the United States. The proposal was based on a finding 
under section 306(b)(1)(C) of the FD&C Act that Mr. Phelps was 
convicted of 10 felony counts under Federal law for conduct relating to 
the importation into the United States of an article of food because 
he: Conspired to and committed offenses related to the importation of 
fish into the United States; falsely identified fish; concealed, 
bought, sold, and facilitated the transportation, concealment, and sale 
of frozen fish fillets after importation, knowing it to have been 
imported and brought into the United States contrary to law; and 
introduced and delivered misbranded fish into interstate commerce. The 
proposal was also based on a determination, after consideration of the 
factors set forth in section 306(c)(3) of the FD&C Act (21 U.S.C. 
335a(c)(3)), that Mr. Phelps should be subject to a 20-year period of 
debarment. The proposal also offered Mr. Phelps 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. Phelps 
failed to respond within the timeframe prescribed by regulation 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 Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(b)(1)(C) of the FD&C Act, and 
under authority delegated to the Director (Staff Manual Guide 1410.35), 
finds that Mr. David H.M. Phelps has been convicted of 10 felony counts 
under Federal law for conduct relating to the importation of an article 
of food into the United States and that he is subject to a 20-year 
period of debarment.
    As a result of the foregoing finding, Mr. Phelps 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). 
Pursuant to section 301(cc) of the FD&C 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. Phelps 
is a prohibited act.
    Any application by Mr. Phelps for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2011-N-0879 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: April 24, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2012-10958 Filed 5-4-12; 8:45 am]
BILLING CODE 4160-01-P