James R. Casey: Final Debarment Order, 65819-65820 [2019-25848]
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Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Notices
Estimated Total Annual Burden
Hours: 627.
Comments: The Department
specifically requests comments on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority for the IRG information
collection activities is: (1) 42 U.S.C.
652(a)(7), which requires the federal
OCSE to provide technical assistance to
state child support enforcement
agencies to help them establish effective
systems for collecting child and spousal
support; (2) 42 U.S.C. 666(f), which
requires states to enact the Uniform
Interstate Family Support Act; (3) 45
CFR 301.1, which defines an
intergovernmental case to include cases
between states and tribes; (4) 45 CFR
303.7, which requires state CSE agencies
to provide services in intergovernmental
cases); and (5) 45 CFR 309.120, which
requires a tribal child support program
to include intergovernmental
procedures in its tribal IV–D plan.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–25851 Filed 11–27–19; 8:45 am]
BILLING CODE 4184–01–P
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.
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
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SUMMARY:
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16:49 Nov 27, 2019
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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.
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Frm 00044
Fmt 4703
Sfmt 4703
65819
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
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65820
Federal Register / Vol. 84, No. 230 / Friday, November 29, 2019 / Notices
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 https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0879]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Procedures for the
Safe and Sanitary Processing and
Importing of Fish and Fishery Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by December
30, 2019.
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SUMMARY:
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0354. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Procedures for the Safe and Sanitary
Processing and Importing of Fish and
Fishery Products—21 CFR part 123
OMB Control Number 0910–0354—
Extension
This information collection supports
regulations in part 123 (21 CFR part
123), which mandate the application of
hazard analysis and critical control
point (HACCP) principles to the
processing of seafood. HACCP is a
preventive system of hazard control
designed to help ensure the safety of
foods. The regulations were issued
under FDA’s statutory authority to
regulate food safety, including section
402(a)(1) and (4) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
342(a)(1) and (4)).
Certain provisions in part 123 require
that processors and importers of seafood
collect and record information. The
HACCP records compiled and
maintained by a seafood processor
primarily consist of the periodic
observations recorded at selected
monitoring points during processing
and packaging operations, as called for
in a processor’s HACCP plan (e.g., the
values for processing times,
temperatures, acidity, etc., as observed
at critical control points). The primary
purpose of HACCP records is to permit
a processor to verify that products have
been produced within carefully
established processing parameters
(critical limits) that ensure that hazards
have been avoided.
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Sfmt 4703
HACCP records are normally
reviewed by appropriately trained
employees at the end of a production lot
or at the end of a day or week of
production to verify that control limits
have been maintained, or that
appropriate corrective actions were
taken if the critical limits were not
maintained. Such verification activities
are essential to ensure that the HACCP
system is working as planned. A review
of these records during the conduct of
periodic plant inspections also permits
FDA to determine whether the products
have been consistently processed in
conformance with appropriate HACCP
food safety controls.
Section 123.12 requires that importers
of seafood products take affirmative
steps and maintain records that verify
that the fish and fishery products they
offer for import into the United States
were processed in accordance with the
HACCP and sanitation provisions set
forth in part 123. These records are also
to be made available for review by FDA
as provided in § 123.12(c).
The time and costs of these
recordkeeping activities will vary
considerably among processors and
importers of fish and fishery products,
depending on the type and number of
products involved, and on the nature of
the equipment or instruments required
to monitor critical control points. The
burden estimate in table 1 includes only
those collections of information under
the seafood HACCP regulations that are
not already required under other
statutes and regulations. The estimate
also does not include collections of
information that are a usual and
customary part of businesses’ normal
activities. For example, the tagging and
labeling of molluscan shellfish
(§ 1240.60 (21 CFR 1240.60)) is a
customary and usual practice among
seafood processors. Consequently, the
estimates in table 1 account only for
information collection and recording
requirements attributable to part 123.
Description of Respondents:
Respondents to this collection of
information include processors and
importers of seafood.
In the Federal Register of September
4, 2019 (84 FR 46544), we published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
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]]>Agencies
[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 [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 (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 https://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
