[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26766-26767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-10960]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0880]


Karen L. Blyth: 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 Karen L. Blyth 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 Ms. Blyth 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. Ms. Blyth was given notice of the proposed debarment 
and an opportunity to request a hearing within the time frame 
prescribed by regulation. As of March 23, 2012 (30 days after receipt 
of the notice), Ms. Blyth had not responded. Ms. Blyth's failure to 
respond constitutes a waiver of her 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, Ms. Blyth 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 her plea of

[[Page 26767]]

guilty and entered judgment against her 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 Ms. Blyth, Ms. Blyth was a co-owner, president, and treasurer 
of CSE Inc., which was used to buy and sell seafood. She was also a co-
owner, president, and chief executive officer of RF Inc. from on or 
about October 1, 2004, through on or about March 2007. 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, Ms. Blyth knowingly, willingly, and unlawfully 
combined, conspired, confederated, and agreed with her 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, Ms. Blyth received and bought 81,000 pounds of fish of 
the genus Pangasius (a type of catfish commonly called basa, swai, or 
sutchi) that she knew had been unlawfully imported from Vietnam. She 
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. She 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. Ms. Blyth 
sold and invoiced the fish as grouper or sole, allowing her 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, Ms. Blyth 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 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 she created and 
caused to be created invoices, boxes, and other documents that falsely 
identified the fish. Specifically, Ms. Blyth 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, Ms. Blyth 
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 is in violation of 18 U.S.C. 545.
    From approximately March 30, 2005, through approximately June 22, 
2005, with intent to defraud and mislead, Ms. Blyth 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 is in violation of 21 U.S.C. 331(a), 333(a)(2) 
and 343(a)(1) and (b).
    As a result of her conviction, on February 17, 2012, FDA sent Ms. 
Blyth a notice by certified mail proposing to debar her 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 Ms. Blyth 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 she: 
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 
Ms. Blyth should be subject to a 20-year period of debarment. The 
proposal also offered Ms. Blyth an opportunity to request a hearing, 
providing her 30 days from the date of receipt of the letter in which 
to file the request, and advised her that failure to request a hearing 
constituted a waiver of the opportunity for a hearing and of any 
contentions concerning this action. Ms. Blyth failed to respond within 
the timeframe prescribed by regulation and has, therefore, waived her 
opportunity for a hearing and waived any contentions concerning her 
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 Ms. Karen L. Blyth 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 she is subject to a 20-year 
period of debarment.
    As a result of the foregoing finding, Ms. Blyth 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 Ms. Blyth is 
a prohibited act.
    Any application by Ms. Blyth for termination of debarment under 
section 306(d)(1) of the FD&C Act (21 U.S.C. 335a(d)(1)) should be 
identified with Docket No. FDA-2011-N-0880 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. 2012-10960 Filed 5-4-12; 8:45 am]
BILLING CODE 4160-01-P