[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)]
[Notices]
[Pages 8877-8880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-04195]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0901]


Meunerie Sawyerville, Inc.; Denial of Hearing; Final Debarment 
Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
denying a request for a hearing submitted by Meunerie Sawyerville, Inc. 
(Meunerie Sawyerville) and is issuing an order under the Federal Food, 
Drug, and Cosmetic Act (FD&C Act) debarring Meunerie Sawyerville for 5 
years from importing articles of food or offering such articles for 
import into the United States. FDA bases this order on a finding that 
Meunerie Sawyerville was convicted of felony offenses for conduct 
relating to the importation of food into the United States. In 
determining the appropriateness and period of Meunerie Sawyerville's 
debarment, FDA has considered the relevant factors listed in the FD&C 
Act. Meunerie Sawyerville has failed to file with the Agency 
information and analyses sufficient to create a basis for a hearing 
concerning this action.

DATES: The order is applicable March 1, 2018.

ADDRESSES: Any application by Meunerie Sawyerville for special 
termination of debarment under section 306(d) of the FD&C Act 
(application) may be submitted as follows:

Electronic Submissions

     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. An application 
submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because 
your application will be made public, you are solely responsible for 
ensuring that your application does not include any confidential 
information that you or a third party may not wish to be posted, such 
as medical information, your or anyone else's Social Security number, 
or confidential business information, such as a manufacturing process. 
Please note that if you include your name, contact information, or 
other information that identifies you in the body of your application, 
that information will be posted on https://www.regulations.gov.
     If you want to submit an application with confidential 
information that you do not wish to be made available to the public, 
submit the application as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For a written/paper application submitted to the Dockets 
Management Staff, FDA will post your application, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: Your application must include the Docket No. FDA-
2017-N-0901. An application will be placed in the docket and, unless 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an application with 
confidential information that you do not wish to be made publicly 
available, submit your application only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS

[[Page 8878]]

CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including 
the claimed confidential information, in its consideration of your 
application. The second copy, which will have the claimed confidential 
information redacted/blacked out, will be available for public viewing 
and posted on https://www.regulations.gov. Submit both copies to the 
Dockets Management Staff. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your application 
and you must identify this information as ``confidential.'' Any 
information marked as ``confidential'' will not be disclosed except in 
accordance with 21 CFR 10.20 and other applicable disclosure law. For 
more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket, go to https://www.regulations.gov 
and insert the docket number, found in brackets in the heading of this 
document, into the ``Search'' box and follow the prompts and/or go to 
the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Nathan R. Sabel, Office of Scientific 
Integrity, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 1, Rm. 4206, Silver Spring, MD 20993, 301-796-8588.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 9, 2015, in the U.S. District Court for the District of 
Vermont, Meunerie Sawyerville pled guilty to two felony counts related 
to the importation of food into the United States. Both offenses 
occurred from on or about September 12, 2012, to on or about January 
15, 2013. With respect to Count One, Meunerie Sawyerville admitted to 
knowingly and intentionally making and using a false writing that 
contained a materially fictitious statement in a matter within the 
jurisdiction of the executive branch of the United States government in 
violation of 18 U.S.C. 1001(a)(3) ``by submitting a false Automated 
Commercial Environment Manifest listing a fictitious importer, namely, 
Ted Taft, and presenting such documents to Customs and Border 
Protection [Customs] officials . . . knowing and believing that Ted 
Taft was not the true importer of the goods'' described in the 
manifest. With respect to Count Two, Meunerie Sawyerville admitted to 
causing the introduction of an adulterated drug (i.e., cattle feed 
containing monensin) into interstate commerce with the intent to 
defraud and mislead in violation of sections 301(a), 303(a)(2), and 
501(a)(6) of the FD&C Act (21 U.S.C. 331(a), 333(a)(2), and 351(a)(6)). 
Under section 501(a)(6), a drug is adulterated if it is an animal feed 
bearing or containing a new animal drug that is unsafe within the 
meaning of the FD&C Act.
    Under section 306(b)(1)(C) of the FD&C Act (21 U.S.C. 
335a(b)(1)(C)), FDA is authorized to debar Meunerie Sawyerville from 
importing articles of food or offering food for import into the United 
States based on a finding, under section 306(b)(3)(A) of the FD&C Act, 
that Meunerie Sawyerville was convicted of a felony for conduct 
relating to the importation of food into the United States. By letter 
dated July 21, 2017, the Office of Regulatory Affairs (ORA) notified 
Meunerie Sawyerville of a proposal to debar it for 5 years from 
importing articles of food or offering such articles for import into 
the United States and provided an opportunity for Meunerie Sawyerville 
to request a hearing. In proposing a debarment period, ORA weighed the 
considerations in section 306(c)(3) it considered applicable to 
Meunerie Sawyerville's offenses, concluded that each of these felony 
offenses independently warranted a 5-year period of debarment, and 
proposed that these debarment periods be served concurrently under 
section 306(c)(2)(A). By letter dated August 14, 2017, Meunerie 
Sawyerville requested a hearing on the proposal.
    The Director of the Office of Scientific Integrity (OSI) has 
reviewed Meunerie Sawyerville's request for a hearing, as well as the 
materials offered in support, and finds that Meunerie Sawyerville has 
not established a basis for a hearing because hearings will be granted 
only if there is a genuine and substantial issue of fact for resolution 
at a hearing. Hearings will not be granted on issues of policy or law, 
on mere allegations, denials, or general descriptions of positions and 
contentions, or on data and information insufficient to justify the 
factual determination urged (see 21 CFR 12.24(b)). OSI has considered 
Meunerie Sawyerville's arguments and concludes that they are 
unpersuasive and fail to raise a genuine and substantial issue of fact 
requiring a hearing.

II. Arguments

    Meunerie Sawyerville does not dispute that it is subject to 
debarment under section 306(b)(1)(C) of the FD&C Act because it 
committed two felony offenses related to the importation of food. Nor 
does Meunerie Sawyerville dispute any of ORA's factual findings 
contained in the proposal to debar. Further, Meunerie Sawyerville does 
not dispute ORA's conclusion based on these findings that both the 
nature and seriousness of the offenses and the nature and extent of 
Meunerie Sawyerville management's participation in the offenses are 
both considerations favoring debarment.
    Against this backdrop, Meunerie Sawyerville argues only: (1) That 
ORA failed to consider as an applicable factor, under section 
306(c)(3)(D) of the FD&C Act, the operational changes Meunerie 
Sawyerville contends it has made that would prevent it from shipping 
adulterated animal feed again in the future, specifically, 
discontinuing the use of monensin in its animal feed, (2) that 
voluntary mitigation of the offenses should not count as an unfavorable 
consideration under section 306(c)(3)(C) because Meunerie Sawyerville 
pled guilty and no specific harm occurred that Meunerie Sawyerville 
could mitigate, and (3) that debarment is not an appropriate remedy 
when customers are not defrauded and when debarment would hurt Meunerie 
Sawyerville's business.
    Section 306(c)(3) requires FDA to consider, ``where applicable,'' 
certain factors ``[i]n determining the appropriateness and the period 
of debarment'' for debarment under section 306(b)(3) of the FD&C Act. 
The proposal to debar Meunerie Sawyerville set forth five potentially 
applicable considerations for debarment actions related to food 
importation imposed under section 306(b)(1)(C): (1) The nature and 
seriousness of the offense under section 306(c)(3)(A); (2) the nature 
and extent of management participation in the offense under section 
306(c)(3)(B); (3) the nature and extent of voluntary steps taken to 
mitigate the impact on the public under section 306(c)(3)(C); (4) the 
extent that ownership, management, or operations changes have corrected 
the causes of the offense and provide reasonable assurances that the 
offense will not recur under 306(c)(3)(D); and (5) prior convictions 
involving matters within the jurisdiction of FDA under section 
306(c)(3)(F). In its proposal, ORA found that the first three 
considerations weigh in favor of debarring Meunerie Sawyerville and 
noted that the fifth consideration weighs against debarment because the 
Agency was unaware of any prior convictions involving matters within 
the jurisdiction of FDA. ORA

[[Page 8879]]

found the fourth consideration inapplicable.
    Meunerie Sawyerville's now represents that it no longer ships 
animal feed containing monensin and argues that changes in its 
operations should be counted as a consideration weighing against 
debarment under section 306(c)(3)(D). Beyond removing monensin from its 
production process, Meunerie Sawyerville points to no other changes in 
ownership, management, or operations that would address the causes of 
the offenses and provides no other reasonable assurance that the 
criminal conduct underlying the offenses will not recur. As ORA's 
proposal finds and Meunerie Sawyerville concedes, the same management 
remains in charge at Meunerie Sawyerville, including president and 
owner Yves Bolduc, who Meunerie Sawyerville admits devised and executed 
the fraudulent scheme forming the basis for the offenses:

    [A]fter the medicated feed at issue was sampled at the border, 
found to contain monensin at a concentration above that allowed by 
FDA, and the driver was ordered to warehouse the feed pending 
further testing from FDA, Mr. Bolduc instructed the driver to 
deliver the feed to a Vermont farmer as planned, without informing 
the farmer that the feed had been sampled and ordered held by FDA. 
Mr. Bolduc then engineered a plan that a sham shipment of similar-
looking cattle feed cross the border under false Customs 
documentation to be stored on an unrelated piece of land in Vermont 
until requested for redelivery by Customs and Border Protection. 
Upon request by Customs and Border Protection, Mr. Bolduc ordered 
that the sham shipment be presented for redelivery, accompanied by 
the fictitious documentation, offering up the sham shipment feed to 
the U.S. government as the held tainted feed.

    Meunerie Sawyerville has admitted to knowingly and intentionally 
orchestrating this presentation of false documents to Customs as part 
of a larger scheme to defraud government regulators about the nature of 
a shipment offered for import and to introducing adulterated product 
into interstate commerce with the intent to defraud and mislead. 
Meunerie Sawyerville does not dispute this conduct.
    Meunerie Sawyerville also argues in its hearing request that the 
majority of its business going forward, if Meunerie Sawyerville is not 
debarred, would involve offering animal feed for import into the United 
States from Canada, necessarily requiring Meunerie Sawyerville to 
provide Customs with an ongoing stream of information about its 
products in the future. As an FDA-regulated product, animal feed can 
become adulterated in numerous ways, not merely through the addition of 
too much monensin (see, generally, section 402 of the FD&C Act (21 
U.S.C. 342)). In addition to adulteration, there are also many other 
reasons an unscrupulous importer might attempt to deceive Customs. Any 
regular importer of food will be required to submit import documents to 
Customs repeatedly that detail the nature, value, quantity, and 
condition of product offered for import. As a result, simply removing 
monensin from Meunerie Sawyerville's process does not sufficiently 
address the causes of the offenses and provides little assurance that 
Meunerie Sawyerville would handle future food import matters without 
resorting to the knowing and intentional deception of government 
regulators and the introduction of adulterated product that forms the 
basis of these offenses. Therefore, even assuming as true that Meunerie 
Sawyerville has stopped adding monensin to its animal feed, Meunerie 
Sawyerville has not sufficiently corrected the causes that resulted in 
the offenses and has not provided reasonable assurances that these 
offenses will not recur. As a result, the Director of OSI finds that 
the consideration in section 306(C)(3)(D) should not be considered as 
weighing against debarment for these offenses.
    Next, Meunerie Sawyerville argues that the nature and extent of 
steps taken to mitigate the impact of its offenses on the public under 
section 306(c)(3)(C) of the FD&C Act should be a consideration weighing 
against debarment. Meunerie Sawyerville argues that there was no 
evidence that specific members of the public were harmed such that 
mitigation of that harm was possible and that it pled guilty as the 
only possible mitigation step. OSI disagrees that Meunerie 
Sawyerville's actions suggest significant voluntary mitigation of the 
harm related to the offenses at issue. Although the government exposed 
Meunerie Sawyerville's offenses in progress and thereby prevented harm 
to any specific victims for the offenses at issue, other voluntary 
mitigation efforts were available to Meunerie Sawyerville beyond simply 
pleading guilty when apprehended. Indeed, with respect to voluntary 
mitigation for the offense in Count Two, Meunerie Sawyerville devised 
the fraudulent scheme underlying the offense in Count One to compound, 
rather than mitigate, its earlier criminal conduct of shipping an 
adulterated product to its customer in Vermont. Rather than admitting 
the earlier misconduct to Customs and FDA to mitigate any harm from its 
earlier tainted shipment and avoid continuing to undermine the 
government's ability to regulate imports, Meunerie Sawyerville engaged 
in additional criminal conduct and devised the sham shipment and 
fictitious documents that formed the basis for the offense in Count 
One. Further, with respect to Count One itself, because this offense 
was devised to conceal other criminal conduct, the primary opportunity 
to mitigate the associated harm to the government's regulatory 
authority occurred throughout Meunerie Sawyerville's efforts to devise 
and execute the scheme described in Count One. Rather than take steps 
to mitigate the harm from the earlier criminal offense, Meunerie 
Sawyerville chose to take affirmative steps to compound that harm. In 
this context, Meunerie Sawyerville deserves no credit for a guilty plea 
when its scheme was uncovered. Therefore, considering the facts and the 
context of these offenses, the Director of OSI finds that the extent of 
voluntary efforts to mitigate the impact of these offenses should not 
be considered in favor of Meunerie Sawyerville under section 
306(c)(3)(C).
    Lastly, Meunerie Sawyerville argues that debarment is inappropriate 
as a matter of policy because it would harm Meunerie Sawyerville's 
business and force its customers to consider other suppliers for their 
animal feed. As already noted, a hearing will not be granted on issues 
of policy such as these (see 21 CFR 12.24(b)). Also, the considerations 
Meunerie Sawyerville raises, such as the impact of debarment on 
Meunerie Sawyerville's business, are not appropriate considerations 
under section 306(c)(3) for determining the length of a period of 
debarment. Finally, the remedial purpose of the debarment statute is 
designed to accomplish exactly the result to which Meunerie Sawyerville 
objects by protecting the public from food from importers whose 
criminal conduct demonstrates, based on the applicable considerations, 
that they warrant debarment. As such, these arguments do not support 
Meunerie Sawyerville's request for a hearing on this matter.

III. Findings and Order

    Because OSI has assumed as true that Meunerie Sawyerville has 
discontinued using monensin in its process and Meunerie Sawyerville 
raises no other arguments that would present genuine and substantial 
issues of fact that would require resolution at an evidentiary hearing, 
Meunerie Sawyerville's request for an evidentiary hearing is denied.

[[Page 8880]]

    Considering all applicable factors under 306(c)(3) of the FD&C Act, 
OSI concurs with ORA's proposal that a 5-year period of debarment for 
each offense is warranted. On this record, OSI finds that the nature 
and seriousness of the offenses and the nature and extent of Meunerie 
Sawyerville management's participation in the offenses are factors 
weighing heavily in favor of debarment. For the reasons already 
discussed, even assuming Meunerie Sawyerville has discontinued using 
monensin in its operations, OSI finds that operational change 
insufficient under section 306(c)(3)(D) to demonstrate correction of 
the causes of these offenses and to provide reasonable assurances that 
the offenses will not recur. Further, even after taking into account 
Meunerie Sawyerville's guilty plea under section 306(c)(3)(C), OSI 
finds that Meunerie Sawyerville's conduct related to this consideration 
weighs in favor of debarment. Although Meunerie Sawyerville's lack of a 
prior conviction under 306(c)(3)(F) is a factor weighing against 
debarment, this consideration is substantially outweighed by the nature 
and seriousness of the offenses, the nature and extent of management's 
participation in the offenses, and the nature and extent of voluntary 
steps to mitigate the impact of the offenses on the public. Therefore, 
considering all of these factors together and the record as a whole, 
OSI finds that a 5-year period of debarment is warranted for each 
offense.
    Therefore, the Director of OSI, under section 306(b)(3)(A) of the 
FD&C Act and under authority delegated to him by the Commissioner of 
Food and Drugs, finds that Meunerie Sawyerville has been convicted of a 
felony for conduct relating to the importation of food into the United 
States. FDA has considered the relevant factors listed in section 
306(c)(3) of the FD&C Act and determined that a debarment of 5 years is 
appropriate for each of these felony offenses. These periods will run 
concurrently under section 306(c)(2)(A). As a result of the foregoing 
findings, Meunerie Sawyerville 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). Under section 301(cc) of the 
FD&C Act, 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 Meunerie Sawyerville is a prohibited act.

    Dated: February 26, 2018.
George M. Warren,
Director, Office of Scientific Integrity.
[FR Doc. 2018-04195 Filed 2-28-18; 8:45 am]
 BILLING CODE 4164-01-P