[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58109-58110]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20710]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0316]


Roy Tuccillo, Sr.: 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 Roy 
Tuccillo, Sr. 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. Tuccillo was convicted of a 
felony count under Federal law for conduct relating to the importation 
into the United States of an article of food. Mr. Tuccillo was given 
notice of the proposed debarment and an opportunity to request a 
hearing within the timeframe prescribed by regulation. As of July 17, 
2022 (30 days after receipt of the notice), Mr. Tuccillo has not 
responded. Mr. Tuccillo'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 September 23, 2022.

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, or at https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Jaime Espinosa, Division of 
Enforcement (ELEM-4029), 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 November 9, 2021, Mr. Tuccillo was convicted as defined in 
section 306(l)(1)(A) of the FD&C Act, in the U.S. District Court for 
the Eastern District of New York, when the court accepted his plea of 
guilty and entered judgment against him for the offense of conspiracy 
to commit wire fraud in violation of 18 U.S.C. 371 and 1343.
    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 stated in the indictment, filed September 
26, 2018, transcript of guilty pleas, filed December 26, 2019, and 
Magistrate Judge Steven Locke's report and recommendation, filed May 
10, 2020, all from Mr. Tuccillo's case, Mr. Tuccillo was the owner, 
president, and chief operating officer of Anchor Foods, Inc. and 
Advanced Frozen Foods, Inc. (collectively, ``Anchor Foods''), and had 
overall responsibility

[[Page 58110]]

for the operation of both businesses and their employees. Both Anchor 
Foods companies were located in Westbury, New York.
    From on or about February 2011 and continuing through January 2014, 
Mr. Tuccillo knowingly and willfully conspired with Anchor Foods, Roy 
Tuccillo, Jr., and others to import giant squid from Peru to Mr. 
Tuccillo's companies' location in Westbury, New York and repackage and 
sell that squid falsely labeled and identified as ``octopus.'' Mr. 
Tuccillo sold the falsely labeled squid in interstate commerce to 
grocery stores in New Jersey, Texas, and Massachusetts. Mr. Tuccillo 
used email and fax to sell and receive payments for the squid falsely 
labeled as octopus. In total, Mr. Tuccillo's companies made 
$1,128,388.50 worth of fraudulent sales of squid.
    As a result of this conviction, FDA sent Mr. Tuccillo, by certified 
mail on June 6, 2022, 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. Tuccillo's felony 
conviction of conspiracy to commit wire fraud in violation of 18 U.S.C. 
371 and 1343, constitutes conduct relating to the importation into the 
United States of an article of food because Mr. Tuccillo knowingly and 
willfully conspired with Anchor Foods, Roy Tuccillo, Jr., and others to 
import giant squid from Peru to his companies' location in Westbury, 
New York and repackage and sell that squid falsely labeled and 
identified as ``octopus'' in interstate commerce, using email and fax 
to sell and receive payments for the falsely labeled squid. 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 (21 
U.S.C. 335a(c)(3)), that Mr. Tuccillo should be subject to a 5-year 
period of debarment. The proposal also offered Mr. Tuccillo 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. Tuccillo 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. 
Tuccillo 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. Tuccillo is debarred for 
a period of 5 years from importing articles of food or offering such 
articles for import into the United States, applicable (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 Roy 
Tuccillo, Sr., is a prohibited act.
    Any application by Mr. Tuccillo for termination of debarment under 
section 306(d)(1) of the FD&C Act should be identified with Docket No. 
FDA-2022-N-0316 and sent to the Dockets Management Staff (ADDRESSES). 
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 (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday, 240-402-7500.

    Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20710 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P