Document ID: FDA-2019-N-1537-0002
Agency: fda
Document Type: Notice
Title: James R. Casey: Final Debarment Order
Posted Date: 2019-11-29T05:00Z

[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65819-65820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25848]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1537]

James R. Casey: Final Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing an order 
under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring 
James R. 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 June 30, 2019 (thirty days after receipt of the 
notice), Mr. Casey had 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 November 29, 2019.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management, Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa (ELEM-4029) Division of 
Enforcement, Office of Strategic Planning and Operational Policy, 
Office of Regulatory Affairs, Food and Drug Administration, 12420 
Parklawn Dr., Rockville, MD 20857 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 (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 January 9, 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)(ii).
    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 September 26, 
2018, from on or about 2010 to June 2015, while serving as the owner, 
operator, and President of Casey's Seafood, Inc. (``the company''), Mr. 
Casey 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 
directed company employees 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 caused to be sold at least 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 May 22, 2019, a notice proposing to debar him 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 (21 U.S.C. 335a(b)(1)(C)) 
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)(ii) 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

[[Page 65820]]

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-1537 and sent to the Dockets Management Staff (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.
    Publicly available submissions will be placed in the docket, and 
will be viewable at http://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 22, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25848 Filed 11-27-19; 8:45 am]
 BILLING CODE 4164-01-P