[Federal Register Volume 78, Number 38 (Tuesday, February 26, 2013)]
[Notices]
[Pages 13068-13069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04389]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0714]
Richard Stowell: 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 Richard Stowell for a period of 3 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. Stowell was
convicted, as defined in section 306(l)(1)(B) of the FD&C Act (21
U.S.C. 335a(l)(1)(B)), of three felony counts under Federal law for
conduct relating to the importation into the United States of an
article of food. Mr. Stowell was given notice of the proposed debarment
and an opportunity to request a hearing within the timeframe prescribed
by regulation. As of December 14, 2012, Mr. Stowell had not responded.
Mr. Stowell's failure to respond constitutes a waiver of his right to a
hearing concerning this action.
DATES: This order is effective February 26, 2013.
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 Dr., 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 July 27, 2011, Mr. Stowell 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 Florida accepted his plea of guilty and entered
judgment against him for the following offenses: One count of
conspiracy to falsely label and misbrand seafood, in violation of 18
U.S.C. 371; one count of false labeling of seafood under the Lacey Act,
in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii); and one
count of misbranding food, in violation of 21 U.S.C. 331(a), 343(a)(1),
and 333(a)(2).
FDA's finding that debarment is appropriate is based on the felony
[[Page 13069]]
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: Mr. Stowell was the president and sole
shareholder of United Seafood Imports, Inc. (United), a Florida based
seafood wholesaler engaged in various aspects of purchasing, importing,
processing, packing, selling, and exporting seafood products, including
shrimp.
Beginning in or around January 25, 2007, and continuing through on
or about August 7, 2009, Mr. Stowell did knowingly and with the intent
to further the object of a conspiracy combine, conspire, confederate,
and agree with others to commit an offense against the United States.
Specifically, Mr. Stowell's company United purchased approximately one
million pounds of shrimp in boxes labeled ``Shrimp, Product of
Thailand,'' ``Shrimp, Product of Malaysia,'' and ``Shrimp, Product of
Indonesia.'' Mr. Stowell then sent the shrimp to another company,
Shifco, and instructed them to repackage and relabel the shrimp as
``Shrimp, Product of Panama,'' ``Shrimp, Product of Ecuador,'' and
``Shrimp, Product of Honduras.'' United, and employees under Mr.
Stowell's direction and control, managed and directed the labeling
operations of Shifco by providing instructions and other directives to
them. Mr. Stowell's company then sold the shrimp that was relabeled to
a company who in turn subsequently sold the shrimp to a supermarket
chain. This was in violation of 18 U.S.C. 371.
On or about January 26, 2007, Mr. Stowell purchased 180 cases of
shrimp valued at approximately $24,912 and knowingly created and caused
to be created individual labels, preprinted bags, and other documents
falsely identifying the shrimp as being ``Shrimp, Product of Ecuador,''
when in truth and in fact he knew the shrimp was a product of Malaysia.
This was in violation of 16 U.S.C. 3372(d)(2) and 3373(d)(3)(A)(ii).
On or about July 2, 2009, Mr. Stowell knowingly engaged in an
offense that involved the introduction and delivery for introduction
into interstate commerce of a food that was misbranded, that is,
approximately 52 cases of shrimp, with the intent to defraud or
mislead, in that Mr. Stowell created and caused to be created
individual labels, preprinted bags, and other documents falsely
identifying the shrimp as being a product of Panama when in truth and
in fact, he knew the shrimp was a product of Indonesia. This was in
violation of 21 U.S.C. 331(a), 333(a)(2), and 343(a)(1).
As a result of his conviction, on September 24, 2012, FDA sent Mr.
Stowell a notice by certified mail proposing to debar him for a period
of 3 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. Stowell was
convicted of three felony counts under Federal law for conduct relating
to the importation into the United States of an article of food because
he: Conspired to falsely label and misbrand seafood, falsely labeled
seafood under the Lacey Act, and misbranded food.
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. Stowell should be subject to a 3-year
period of debarment. The proposal also offered Mr. Stowell 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. Stowell failed to request a hearing 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 Associate Commissioner for Regulatory Affairs,
Office of Regulatory Affairs, under section 306(b)(1)(C) of the FD&C
Act, and under authority delegated to the Associate Commissioner (Staff
Manual Guide 1410.21), finds that Mr. Richard Stowell has been
convicted of three 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 3-year period of debarment.
As a result of the foregoing finding, Mr. Stowell is debarred for a
period of 3 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. Stowell
is a prohibited act.
Any application by Mr. Stowell for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2012-N-0714 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: February 8, 2013.
Melinda K. Plaisier,
Acting Associate Commissioner for Regulatory Affairs, Office of
Regulatory Affairs.
[FR Doc. 2013-04389 Filed 2-25-13; 8:45 am]
BILLING CODE 4160-01-P