Document ID: FDA-2019-N-3731-0002
Agency: fda
Document Type: Notice
Title: Michael P. Casey: Final Debarment Order
Posted Date: 2020-03-18T04:00Z

[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 
debarments@fda.hhs.gov.

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