
[Federal Register: August 13, 2010 (Volume 75, Number 156)]
[Notices]               
[Page 49497]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13au10-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0305]

 
John Bonnes: 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 (the act) debarring John 
Bonnes 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. Bonnes was convicted of a felony 
under Federal law for conduct relating to the importation into the 
United States of an article of food. Mr. Bonnes has notified FDA that 
he acquiesces to debarment, and therefore has waived his opportunity 
for a hearing concerning this action.

DATES: This order is effective April 19, 2010.

ADDRESSES: Submit applications for termination of debarment to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Kenny Shade, Division of Compliance 
Policy (HFC-230), Office of Enforcement, Office of Regulatory Affairs, 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
240-632-6844.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(1)(C) of the act (21 U.S.C. 335a(b)(1)(C)) permits 
FDA to debar an individual from importing an article of food or 
offering such article for import into the United States if FDA finds, 
as required by section 306(b)(3)(A) of the act (21 U.S.C. 
335a(b)(3)(A)), that the individual has been convicted of a felony 
under Federal law for conduct relating to the importation into the 
United States of any food. Section 306(l)(1)(C) of the act (21 U.S.C. 
335a(l)(1)(C)) provides that, for purposes of section 306, a person is 
considered to have been convicted of a criminal offense ``when the 
person has entered into participation in a first offender, deferred 
adjudication, or other similar arrangement or program where judgment of 
conviction has been withheld.''
    On April 17, 2010, Mr. Bonnes entered into a deferred prosecution 
agreement with the United States Attorney's Office, Eastern District of 
New York. FDA's finding that debarment is appropriate is based on the 
following facts, as set forth in the deferred prosecution agreement. 
Between April 1, 2006, and August 1, 2006, Mr. Bonnes did knowingly and 
willfully make materially false, fictitious, and fraudulent statements 
and representations, in a matter within the jurisdiction of the 
executive branch of the Government of the United States, in violation 
of 18 U.S.C. 1001(a)(2). Specifically, Mr. Bonnes' company, Ameritech 
Laboratories, provided seventeen certificates of analysis to a client 
certifying that fresh produce the client wished to import into the 
United States from the Dominican Republic was free of any pesticides. 
Mr. Bonnes signed each of the certificates of analysis as the director 
of Ameritech Laboratories.
    Each of these certificates of analysis was false. Although the 
certificates stated that Ameritech Laboratories performed pesticide 
tests on the produce, Ameritech Laboratories did not perform a chemical 
analysis to certify that the produce was free of any pesticides. Mr. 
Bonnes knew at the time he prepared the certificates that they were 
false, and he also knew that the client intended to submit certificates 
to FDA's District Office in Queens, New York, in support of importing 
the produce into the United States for sale as human food.
    Mr. Bonnes' actions and his deferred prosecution agreement make him 
subject to permissive debarment as described under section 306(b)(3)(A) 
of the act. Pursuant to the deferred prosecution agreement, Mr. Bonnes 
expressly acquiesced to permissive debarment under section 306(b)(1)(C) 
of the act for the conduct described in this document. In accordance 
with section 306(c)(2)(B) of the act (21 U.S.C. 335a(c)(2)(B)), Mr. 
Bonnes notified FDA of his acquiescence to debarment in a letter dated 
April 19, 2010. A person subject to debarment is entitled to an 
opportunity for an agency hearing on disputed issues of material fact 
under section 306(i) of the act (21 U.S.C. 335a(i)), but by acquiescing 
to debarment Mr. Bonnes waived his opportunity for a hearing and to 
raise any contentions concerning his debarment. The maximum period of 
debarment under section 306(c)(2)(A)(iii) of the act (21 U.S.C. 
335a(c)(2)(A)(iii)) is 5 years. FDA concludes that the nature and scope 
of Mr. Bonnes' conduct supports the maximum possible period of 
debarment.

II. Findings and Order

    Therefore, the Director, Office of Enforcement, Office of 
Regulatory Affairs, under section 306(b)(1)(C) of the act, under 
authority delegated to the Director (Staff Manual Guide 1410.35), finds 
that Mr. John Bonnes has entered into a deferred prosecution agreement 
as the result of conduct relating to the importation of an article of 
food into the United States that makes him subject to permissive 
debarment.
    As a result of the foregoing finding, Mr. Bonnes 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). 
Under section 301(cc) of the 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. Bonnes is a 
prohibited act.
    Any application by Mr. Bonnes for termination of debarment under 
section 306(d)(1) of the act should be identified with Docket No. FDA-
2010-N-0305 and sent to the Division of Dockets Management (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(j).
    Publicly available submissions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 2, 2010.
Howard R. Sklamberg,
Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2010-19981 Filed 8-12-10; 8:45 am]
BILLING CODE 4160-01-S

