[Federal Register Volume 86, Number 238 (Wednesday, December 15, 2021)]
[Notices]
[Pages 71270-71271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-27053]
[[Page 71270]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0346]
Jeffrey A. Styron: Final Debarment Order
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring
Jeffrey A. Styron for a period of 5 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. Styron was convicted of a
felony count under Federal law for conduct relating to the importation
into the United States of an article of food. Mr. Styron was given
notice of the proposed debarment and an opportunity to request a
hearing within the timeframe prescribed by regulation. As of September
29, 2021 (30 days after receipt of the notice), Mr. Styron has not
responded. Mr. Styron's failure to respond and request a hearing
constitutes a waiver of Mr. Styron's right to a hearing concerning this
matter.
DATES: This order is applicable December 15, 2021.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, or at
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement (ELEM-4029), Office of Strategic Planning and Operational
Policy, Office of Regulatory Affairs, Food and Drug Administration,
12420 Parklawn Dr., Rockville, MD 20857, 240-402-8743, or at
[email protected].
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, that the
individual has been convicted of a felony for conduct relating to the
importation into the United States of any food. On March 9, 2021, Mr.
Styron was convicted as defined in section 306(l)(1)(A) of the FD&C
Act, in the U.S. District Court for the Eastern District of North
Carolina, when the court accepted Mr. Styron's plea of guilty and
entered judgment against him for the offense of Lacey Act False
Labeling and Aiding and Abetting in violation of 16 U.S.C. 3372(d),
3372(d)(1), 3372(d)(2), 3373(d)(3)(A)(i), 3373(d)(3)(A)(ii), and 18
U.S.C. 2.
FDA's finding that the debarment is appropriate is based on the
felony conviction referenced herein. The factual basis for this
conviction is as follows: As contained in the Plea Agreement filed in
his case on September 3, 2020, Mr. Styron admitted that he knowingly
made or submitted and caused to be made or submitted a false record,
account, label for, or identification of any fish or wildlife, as set
forth in the Criminal Information. The Criminal Information, filed July
22, 2020, sets forth that Mr. Styron was an owner-operator of Garland
Fulcher Seafood Company, Inc. (GFS) and the manager and supervisor of
the company's facility in North Carolina. GFS was in the business of
purchasing, processing, packaging, and selling seafood, including
crabmeat. Beginning at least as early as January 2014 and continuing
through December 2017, Mr. Styron and his company were unable to
satisfy customer demand for domestically harvested blue crab. Mr.
Styron caused the company to purchase foreign crabmeat from South
America and Asia. Mr. Styron then directed his employees to repack
foreign crabmeat into containers labeled ``Product of the USA,'' which
was then sold to customers as jumbo domestically harvested ``fresh''
blue crab. Mr. Styron knew that the crabmeat sold during that time
period was labeled and represented as domestically harvested crabmeat
when, in truth and in fact, it was or contained foreign crabmeat.
Within this time period, at his direction GFS purchased and repackaged
thousands of pounds of foreign jumbo crabmeat from South America and
Asia. The foreign jumbo crabmeat was repacked into containers labeled
``Product of USA.''
As a result of this conviction FDA sent Mr. Styron, by certified
mail on August 18, 2021, a notice proposing to debar him for a period
of 5 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. Styron's felony
conviction of violating the Lacey Act False Labeling and Aiding and
Abetting in violation of 16 U.S.C. 3372(d), 3372(d)(1), 3372(d)(2),
3373(d)(3)(A)(i), 3373(d)(3)(A)(ii), and 18 U.S.C. 2 constitutes
conduct relating to the importation into the United States of an
article of food because the offense involved Mr. Styron and his company
falsely labeling crabmeat that was imported from a number of foreign
countries as crabmeat that was a ``Product of USA.''
The proposal was also based on a determination, after consideration
of the relevant factors set forth in section 306(c)(3) of the FD&C Act,
that Mr. Styron should be subject to a 5-year period of debarment. The
proposal also offered Mr. Styron an opportunity to request a hearing,
providing Mr. Styron 30 days from the date of receipt of the letter in
which to file the request, and advised Mr. Styron that failure to
request a hearing constituted a waiver of the opportunity for a hearing
and of any contentions concerning this action. Mr. Styron 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 Assistant Commissioner, Office of Human and Animal
Food Operations, under section 306(b)(1)(C) of the FD&C Act, under
authority delegated to the Assistant Commissioner, finds that Mr.
Styron has been convicted of a felony count under Federal law for
conduct relating to the importation into the United States of an
article of food and that he is subject to a 5-year period of debarment.
As a result of the foregoing finding, Mr. Styron is debarred for a
period of 5 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 Jeffrey A.
Styron is a prohibited act.
Any application by Mr. Styron for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2021-N-0346 and sent to the Dockets Management Staff (see
ADDRESSES). The public availability of information in these submissions
is governed by 21 CFR 10.20.
Publicly available submissions will be placed in the docket and
will be viewable at https://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday, 240-402-7500.
[[Page 71271]]
Dated: December 9, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27053 Filed 12-14-21; 8:45 am]
BILLING CODE 4164-01-P