[Federal Register Volume 85, Number 53 (Wednesday, March 18, 2020)]
[Notices]
[Page 15480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05581]
[[Page 15480]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-3731]
Michael P. Casey: 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
Michael P. Casey 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. Casey was convicted, as
defined in the FD&C Act, of a felony count under Federal law for
conduct relating to the importation into the United States of an
article of food. Mr. Casey was given notice of the proposed permanent
debarment and an opportunity to request a hearing within the timeframe
prescribed by regulation. As of November 4, 2019 (30 days after receipt
of the notice), Mr. Casey has not responded. Mr. Casey's failure to
respond and request a hearing constitutes a waiver of his right to a
hearing concerning this matter.
DATES: This order is applicable March 18, 2020.
ADDRESSES: Submit applications for termination of debarment to the
Dockets Management Staff, Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of
Enforcement, 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 July 18, 2019, Mr. Casey was convicted as defined in section
306(l)(1)(B) of the FD&C Act, in the United States District Court for
the Eastern District of Virginia, when the court accepted his plea of
guilty and entered judgment against him for the offense of conspiracy
to violate the Lacey Act in violation of 18 U.S.C. 371 and 16 U.S.C.
3372(d) and 3373(d)(3)(A)(i).
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 Stipulation of Facts
incorporated into Mr. Casey's Plea Agreement, filed on July 18, 2019,
from on or about 2010 to June 2015, while serving as the Vice President
for Marketing and Operations of Casey's Seafood, Inc. (``the
Company''), Mr. Casey and the Company regularly purchased foreign crab
meat from a variety of sources and from a number of different
countries. Mr. Casey also purchased foreign crab meat that had been
recalled, returned, or that was approaching or beyond its posted ``best
used by'' dates. Mr. Casey knew that company employees were directed to
unpack the foreign crab meat from containers and re-pack the crab meat
into company containers, all of which were labeled ``Product of USA.''
During that time period, employees routinely emptied foreign crab meat
onto tables, comingling crab meat from different sources, and then re-
packaged the crab meat into company containers, all of which were
labeled ``Product of USA.'' From on or about July 1, 2012, and
continuing until June 17, 2015, Mr. Casey aided and abetted James R.
Casey, the President of the Company, in processing approximately 90,868
pounds of crab. From on or about July 1, 2012, and continuing until
June 17, 2015, Mr. Casey aided and abetted the President of the Company
in selling 367, 765 pounds of crab meat falsely labeled ``Product of
USA'' with a total wholesale value of approximately $4, 324, 916.
As a result of this conviction, FDA sent Mr. Casey by certified
mail on September 30, 2019, 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. Casey's
felony conviction of conspiracy to violate the Lacey Act in violation
of 18 U.S.C. 371 and 16 U.S.C. 3372(d) and 3373(d)(3)(A)(i) constitutes
conduct relating to the importation into the United States of an
article of food because the offense he committed involved falsely
labeling crab meat that was imported from a number of foreign countries
as ``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. Casey should be subject to a 5-year period of debarment. The
proposal also offered Mr. Casey 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. Casey 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. Casey
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. Casey 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 Mr. Casey is
a prohibited act.
Any application by Mr. Casey for termination of debarment under
section 306(d)(1) of the FD&C Act should be identified with Docket No.
FDA-2019-N-3731 and sent to the Dockets Management Staff (see
ADDRESSSES). 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.
Publicly available submissions will be placed in the docket, and
will be viewable at http://www.regulations.gov or at the Dockets
Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 12, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05581 Filed 3-17-20; 8:45 am]
BILLING CODE 4164-01-P