[Federal Register Volume 85, Number 206 (Friday, October 23, 2020)]
[Notices]
[Pages 67552-67553]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23485]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0862]


Captain Neill's Seafood, Inc.: Final Debarment Order

AGENCY: Food and Drug Administration

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 
Capt. Neill's Seafood, Inc. (Capt. Neill's or the Company) 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 Capt. Neill's 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. The Company 
was given notice of the proposed permanent debarment and an opportunity 
to request a hearing within the timeframe prescribed by regulation. As 
of 30 days after receipt of the notice (July 13, 2020), Capt. Neill's 
has not responded. Capt. Neill's failure to respond and request a 
hearing constitutes a waiver of the Company's right to a hearing 
concerning this matter.

DATES: This order is effective October 23, 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, 240-402-7500.

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

[[Page 67553]]

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 January 9, 2020, Capt. Neill's was convicted as defined in 
section 306(l)(1)(B) of the FD&C Act, in the U.S. District Court for 
the Eastern District of North Carolina, when the court accepted the 
Company's plea of guilty and entered judgment against it for the 
offense of violating the Lacey Act and Aiding and Abetting. This 
offense was in violation of 16 U.S.C. 3372(d)(1), 3373(d)(3)(A)(i) and 
(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 Indictment, filed on June 
26, 2019, Capt. Neill's is a North Carolina corporation in the business 
of purchasing, processing, packaging, transporting, and selling seafood 
and seafood products, including crab meat from domestically harvested 
Atlantic blue crab, and products made from Atlantic blue crab. From as 
early as January 1, 2012 and continuing through December 31, 2015, 
Capt. Neill's purchased foreign crab meat from South American and Asia. 
Capt. Neill's employees repacked the foreign crab meat into containers 
labeled ``Product of USA.'' Capt. Neill's employees then knowingly sold 
those containers of foreign crab meat as jumbo domestically harvested 
blue crab to customers. During the relevant time frame, Capt. Neill's 
sold approximately 200,536 pounds of crab meat falsely labeled 
``Product of USA'' with a total retail market value of $4,082,841.
    As a result of this conviction FDA sent Capt. Neill's, by certified 
mail on May 6, 2020, 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 Capt. Neill's felony 
conviction of violating the Lacey Act and Aiding and Abetting in 
violation 16 U.S.C. 3372(d)(1), 3373(d)(3)(A)(i) and (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 Capt. Neill's 
employees falsely labeling crabmeat that was imported from foreign 
countries and purporting that the crabmeat 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 Capt. Neill's should be subject to a 5-year period of debarment. 
The proposal also offered Capt. Neill's an opportunity to request a 
hearing, providing the Company 30 days from the date of receipt of the 
letter in which to file the request, and advised Capt. Neill's that 
failure to request a hearing constituted a waiver of the opportunity 
for a hearing and of any contentions concerning this action. Capt. 
Neill's failed to respond within the timeframe prescribed by regulation 
and has, therefore, waived the Company's opportunity for a hearing and 
waived any contentions concerning Capt. Neill's 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 Capt. 
Neill's 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 the Company is subject to a 5-year period of 
debarment.
    As a result of the foregoing finding, Capt. Neill's 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 Capt. 
Neill's Seafood, Inc. is a prohibited act.
    Any application by Capt. Neill's for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2020-N-0862 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 (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: October 19, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23485 Filed 10-22-20; 8:45 am]
BILLING CODE 4164-01-P


