83 FR 8877 - Meunerie Sawyerville, Inc.; Denial of Hearing; Final Debarment Order
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 41 (March 1, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 41 (March 1, 2018)
| Page Range | 8877-8880 | |
| FR Document | 2018-04195 |
[Federal Register Volume 83, Number 41 (Thursday, March 1, 2018)] [Notices] [Pages 8877-8880] From the Federal Register Online [www.thefederalregister.org] [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 SubmissionsFederal 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.thefederalregister.org/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
![Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices 8877
DEPARTMENT OF HEALTH AND renewed for a 2-year period through termination of debarment under section
HUMAN SERVICES February 19, 2020. 306(d) of the FD&C Act (application)
FOR FURTHER INFORMATION CONTACT: may be submitted as follows:
Centers for Disease Control and Nancy Anderson, MMSc, MT(ASCP),
Prevention Electronic Submissions
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and Human Services (HHS). and Services Office, has been delegated application will be made public, you are
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SUMMARY: This gives notice under the meetings and other committee confidential information that you or a
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October 6, 1972, that the Advisory Centers for Disease Control and such as medical information, your or
Committee to the Director (ACD), Prevention and the Agency for Toxic anyone else’s Social Security number, or
Centers for Disease Control and Substances and Disease Registry. confidential business information, such
Prevention (CDC), Department of Health as a manufacturing process. Please note
and Human Services, has been renewed Elaine L. Baker, that if you include your name, contact
for a 2-year period through February 1, Director, Management Analysis and Services information, or other information that
2020. Office, Centers for Disease Control and identifies you in the body of your
Prevention. application, that information will be
FOR FURTHER INFORMATION CONTACT:
[FR Doc. 2018–04131 Filed 2–28–18; 8:45 am] posted on https://www.regulations.gov.
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the authority to sign Federal Register
notices pertaining to announcements of [Docket No. FDA–2017–N–0901] ‘‘Instructions’’).
meetings and other committee Written/Paper Submissions
management activities, for both the Meunerie Sawyerville, Inc.; Denial of
Hearing; Final Debarment Order Submit written/paper submissions as
Centers for Disease Control and
follows:
Prevention and the Agency for Toxic AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for
Substances and Disease Registry. HHS. written/paper submissions): Dockets
Elaine L. Baker, ACTION: Notice. Management Staff (HFA–305), Food and
Director, Management Analysis and Services Drug Administration, 5630 Fishers
SUMMARY: The Food and Drug
Office, Centers for Disease Control and Lane, Rm. 1061, Rockville, MD 20852.
Administration (FDA or the Agency) is
Prevention. • For a written/paper application
denying a request for a hearing
[FR Doc. 2018–04130 Filed 2–28–18; 8:45 am] submitted to the Dockets Management
submitted by Meunerie Sawyerville, Inc.
BILLING CODE 4163–18–P Staff, FDA will post your application, as
(Meunerie Sawyerville) and is issuing
well as any attachments, except for
an order under the Federal Food, Drug,
information submitted, marked and
and Cosmetic Act (FD&C Act) debarring
DEPARTMENT OF HEALTH AND identified, as confidential, if submitted
Meunerie Sawyerville for 5 years from
HUMAN SERVICES as detailed in ‘‘Instructions.’’
importing articles of food or offering Instructions: Your application must
Centers for Disease Control and such articles for import into the United include the Docket No. FDA–2017–N–
Prevention States. FDA bases this order on a finding 0901. An application will be placed in
that Meunerie Sawyerville was the docket and, unless submitted as
Clinical Laboratory Improvement convicted of felony offenses for conduct ‘‘Confidential Submissions,’’ publicly
Advisory Committee (CLIAC); Notice of relating to the importation of food into viewable at https://www.regulations.gov
Charter Renewal the United States. In determining the or at the Dockets Management Staff
appropriateness and period of Meunerie between 9 a.m. and 4 p.m., Monday
AGENCY: Centers for Disease Control and
Sawyerville’s debarment, FDA has through Friday.
Prevention (CDC), Department of Health
considered the relevant factors listed in • Confidential Submissions—To
and Human Services (HHS).
the FD&C Act. Meunerie Sawyerville submit an application with confidential
ACTION: Notice of charter renewal. has failed to file with the Agency information that you do not wish to be
information and analyses sufficient to
amozie on DSK30RV082PROD with NOTICES
SUMMARY: This gives notice under the made publicly available, submit your
Federal Advisory Committee Act of create a basis for a hearing concerning application only as a written/paper
October 6, 1972, that the Clinical this action. submission. You should submit two
Laboratory Improvement Advisory DATES: The order is applicable March 1, copies total. One copy will include the
Committee (CLIAC), Centers for Disease 2018. information you claim to be confidential
Control and Prevention, Department of ADDRESSES: Any application by with a heading or cover note that states
Health and Human Services, has been Meunerie Sawyerville for special ‘‘THIS DOCUMENT CONTAINS
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![8878 Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
CONFIDENTIAL INFORMATION.’’ The Meunerie Sawyerville admitted to under section 306(b)(1)(C) of the FD&C
Agency will review this copy, including causing the introduction of an Act because it committed two felony
the claimed confidential information, in adulterated drug (i.e., cattle feed offenses related to the importation of
its consideration of your application. containing monensin) into interstate food. Nor does Meunerie Sawyerville
The second copy, which will have the commerce with the intent to defraud dispute any of ORA’s factual findings
claimed confidential information and mislead in violation of sections contained in the proposal to debar.
redacted/blacked out, will be available 301(a), 303(a)(2), and 501(a)(6) of the Further, Meunerie Sawyerville does not
for public viewing and posted on FD&C Act (21 U.S.C. 331(a), 333(a)(2), dispute ORA’s conclusion based on
https://www.regulations.gov. Submit and 351(a)(6)). Under section 501(a)(6), these findings that both the nature and
both copies to the Dockets Management a drug is adulterated if it is an animal seriousness of the offenses and the
Staff. If you do not wish your name and feed bearing or containing a new animal nature and extent of Meunerie
contact information to be made publicly drug that is unsafe within the meaning Sawyerville management’s participation
available, you can provide this of the FD&C Act. in the offenses are both considerations
information on the cover sheet and not Under section 306(b)(1)(C) of the favoring debarment.
in the body of your application and you FD&C Act (21 U.S.C. 335a(b)(1)(C)), FDA Against this backdrop, Meunerie
must identify this information as is authorized to debar Meunerie Sawyerville argues only: (1) That ORA
‘‘confidential.’’ Any information marked Sawyerville from importing articles of failed to consider as an applicable
as ‘‘confidential’’ will not be disclosed food or offering food for import into the factor, under section 306(c)(3)(D) of the
except in accordance with 21 CFR 10.20 United States based on a finding, under FD&C Act, the operational changes
and other applicable disclosure law. For section 306(b)(3)(A) of the FD&C Act, Meunerie Sawyerville contends it has
more information about FDA’s posting that Meunerie Sawyerville was made that would prevent it from
of comments to public dockets, see 80 convicted of a felony for conduct shipping adulterated animal feed again
FR 56469, September 18, 2015, or access relating to the importation of food into in the future, specifically, discontinuing
the information at: https://www.gpo.gov/ the United States. By letter dated July the use of monensin in its animal feed,
fdsys/pkg/FR-2015-09-18/pdf/2015- 21, 2017, the Office of Regulatory (2) that voluntary mitigation of the
23389.pdf. Affairs (ORA) notified Meunerie offenses should not count as an
Docket: For access to the docket, go to Sawyerville of a proposal to debar it for unfavorable consideration under section
https://www.regulations.gov and insert 5 years from importing articles of food 306(c)(3)(C) because Meunerie
the docket number, found in brackets in or offering such articles for import into Sawyerville pled guilty and no specific
the heading of this document, into the the United States and provided an harm occurred that Meunerie
‘‘Search’’ box and follow the prompts opportunity for Meunerie Sawyerville to Sawyerville could mitigate, and (3) that
and/or go to the Dockets Management request a hearing. In proposing a debarment is not an appropriate remedy
Staff, 5630 Fishers Lane, Rm. 1061, debarment period, ORA weighed the when customers are not defrauded and
Rockville, MD 20852. considerations in section 306(c)(3) it when debarment would hurt Meunerie
considered applicable to Meunerie Sawyerville’s business.
FOR FURTHER INFORMATION CONTACT: Section 306(c)(3) requires FDA to
Sawyerville’s offenses, concluded that
Nathan R. Sabel, Office of Scientific each of these felony offenses consider, ‘‘where applicable,’’ certain
Integrity, Food and Drug independently warranted a 5-year factors ‘‘[i]n determining the
Administration, 10903 New Hampshire period of debarment, and proposed that appropriateness and the period of
Ave., Bldg. 1, Rm. 4206, Silver Spring, these debarment periods be served debarment’’ for debarment under
MD 20993, 301–796–8588. concurrently under section 306(c)(2)(A). section 306(b)(3) of the FD&C Act. The
SUPPLEMENTARY INFORMATION: By letter dated August 14, 2017, proposal to debar Meunerie Sawyerville
I. Background Meunerie Sawyerville requested a set forth five potentially applicable
hearing on the proposal. considerations for debarment actions
On November 9, 2015, in the U.S. The Director of the Office of Scientific related to food importation imposed
District Court for the District of Integrity (OSI) has reviewed Meunerie under section 306(b)(1)(C): (1) The
Vermont, Meunerie Sawyerville pled Sawyerville’s request for a hearing, as nature and seriousness of the offense
guilty to two felony counts related to the well as the materials offered in support, under section 306(c)(3)(A); (2) the
importation of food into the United and finds that Meunerie Sawyerville has nature and extent of management
States. Both offenses occurred from on not established a basis for a hearing participation in the offense under
or about September 12, 2012, to on or because hearings will be granted only if section 306(c)(3)(B); (3) the nature and
about January 15, 2013. With respect to there is a genuine and substantial issue extent of voluntary steps taken to
Count One, Meunerie Sawyerville of fact for resolution at a hearing. mitigate the impact on the public under
admitted to knowingly and intentionally Hearings will not be granted on issues section 306(c)(3)(C); (4) the extent that
making and using a false writing that of policy or law, on mere allegations, ownership, management, or operations
contained a materially fictitious denials, or general descriptions of changes have corrected the causes of the
statement in a matter within the positions and contentions, or on data offense and provide reasonable
jurisdiction of the executive branch of and information insufficient to justify assurances that the offense will not
the United States government in the factual determination urged (see 21 recur under 306(c)(3)(D); and (5) prior
violation of 18 U.S.C. 1001(a)(3) ‘‘by CFR 12.24(b)). OSI has considered convictions involving matters within
submitting a false Automated Meunerie Sawyerville’s arguments and the jurisdiction of FDA under section
Commercial Environment Manifest concludes that they are unpersuasive 306(c)(3)(F). In its proposal, ORA found
amozie on DSK30RV082PROD with NOTICES
listing a fictitious importer, namely, Ted and fail to raise a genuine and that the first three considerations weigh
Taft, and presenting such documents to substantial issue of fact requiring a in favor of debarring Meunerie
Customs and Border Protection hearing. Sawyerville and noted that the fifth
[Customs] officials . . . knowing and consideration weighs against debarment
believing that Ted Taft was not the true II. Arguments because the Agency was unaware of any
importer of the goods’’ described in the Meunerie Sawyerville does not prior convictions involving matters
manifest. With respect to Count Two, dispute that it is subject to debarment within the jurisdiction of FDA. ORA
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![Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices 8879
found the fourth consideration become adulterated in numerous ways, misconduct to Customs and FDA to
inapplicable. not merely through the addition of too mitigate any harm from its earlier
Meunerie Sawyerville’s now much monensin (see, generally, section tainted shipment and avoid continuing
represents that it no longer ships animal 402 of the FD&C Act (21 U.S.C. 342)). to undermine the government’s ability
feed containing monensin and argues In addition to adulteration, there are to regulate imports, Meunerie
that changes in its operations should be also many other reasons an Sawyerville engaged in additional
counted as a consideration weighing unscrupulous importer might attempt to criminal conduct and devised the sham
against debarment under section deceive Customs. Any regular importer shipment and fictitious documents that
306(c)(3)(D). Beyond removing of food will be required to submit formed the basis for the offense in Count
monensin from its production process, import documents to Customs One. Further, with respect to Count One
Meunerie Sawyerville points to no other repeatedly that detail the nature, value, itself, because this offense was devised
changes in ownership, management, or quantity, and condition of product to conceal other criminal conduct, the
operations that would address the offered for import. As a result, simply primary opportunity to mitigate the
causes of the offenses and provides no removing monensin from Meunerie associated harm to the government’s
other reasonable assurance that the Sawyerville’s process does not regulatory authority occurred
criminal conduct underlying the sufficiently address the causes of the throughout Meunerie Sawyerville’s
offenses will not recur. As ORA’s offenses and provides little assurance efforts to devise and execute the scheme
proposal finds and Meunerie that Meunerie Sawyerville would described in Count One. Rather than
Sawyerville concedes, the same handle future food import matters take steps to mitigate the harm from the
management remains in charge at without resorting to the knowing and earlier criminal offense, Meunerie
Meunerie Sawyerville, including intentional deception of government Sawyerville chose to take affirmative
president and owner Yves Bolduc, who regulators and the introduction of steps to compound that harm. In this
Meunerie Sawyerville admits devised adulterated product that forms the basis context, Meunerie Sawyerville deserves
and executed the fraudulent scheme of these offenses. Therefore, even no credit for a guilty plea when its
forming the basis for the offenses: assuming as true that Meunerie scheme was uncovered. Therefore,
Sawyerville has stopped adding considering the facts and the context of
[A]fter the medicated feed at issue was
sampled at the border, found to contain monensin to its animal feed, Meunerie these offenses, the Director of OSI finds
monensin at a concentration above that Sawyerville has not sufficiently that the extent of voluntary efforts to
allowed by FDA, and the driver was ordered corrected the causes that resulted in the mitigate the impact of these offenses
to warehouse the feed pending further testing offenses and has not provided should not be considered in favor of
from FDA, Mr. Bolduc instructed the driver reasonable assurances that these Meunerie Sawyerville under section
to deliver the feed to a Vermont farmer as 306(c)(3)(C).
planned, without informing the farmer that
offenses will not recur. As a result, the
Director of OSI finds that the Lastly, Meunerie Sawyerville argues
the feed had been sampled and ordered held that debarment is inappropriate as a
by FDA. Mr. Bolduc then engineered a plan consideration in section 306(C)(3)(D)
should not be considered as weighing matter of policy because it would harm
that a sham shipment of similar-looking
cattle feed cross the border under false against debarment for these offenses. Meunerie Sawyerville’s business and
Customs documentation to be stored on an force its customers to consider other
Next, Meunerie Sawyerville argues suppliers for their animal feed. As
unrelated piece of land in Vermont until
that the nature and extent of steps taken already noted, a hearing will not be
requested for redelivery by Customs and
Border Protection. Upon request by Customs to mitigate the impact of its offenses on granted on issues of policy such as these
and Border Protection, Mr. Bolduc ordered the public under section 306(c)(3)(C) of (see 21 CFR 12.24(b)). Also, the
that the sham shipment be presented for the FD&C Act should be a consideration considerations Meunerie Sawyerville
redelivery, accompanied by the fictitious weighing against debarment. Meunerie raises, such as the impact of debarment
documentation, offering up the sham Sawyerville argues that there was no on Meunerie Sawyerville’s business, are
shipment feed to the U.S. government as the evidence that specific members of the not appropriate considerations under
held tainted feed. public were harmed such that section 306(c)(3) for determining the
Meunerie Sawyerville has admitted to mitigation of that harm was possible length of a period of debarment. Finally,
knowingly and intentionally and that it pled guilty as the only the remedial purpose of the debarment
orchestrating this presentation of false possible mitigation step. OSI disagrees statute is designed to accomplish
documents to Customs as part of a larger that Meunerie Sawyerville’s actions exactly the result to which Meunerie
scheme to defraud government suggest significant voluntary mitigation Sawyerville objects by protecting the
regulators about the nature of a of the harm related to the offenses at public from food from importers whose
shipment offered for import and to issue. Although the government criminal conduct demonstrates, based
introducing adulterated product into exposed Meunerie Sawyerville’s on the applicable considerations, that
interstate commerce with the intent to offenses in progress and thereby they warrant debarment. As such, these
defraud and mislead. Meunerie prevented harm to any specific victims arguments do not support Meunerie
Sawyerville does not dispute this for the offenses at issue, other voluntary Sawyerville’s request for a hearing on
conduct. mitigation efforts were available to this matter.
Meunerie Sawyerville also argues in Meunerie Sawyerville beyond simply
its hearing request that the majority of pleading guilty when apprehended. III. Findings and Order
its business going forward, if Meunerie Indeed, with respect to voluntary Because OSI has assumed as true that
Sawyerville is not debarred, would mitigation for the offense in Count Two, Meunerie Sawyerville has discontinued
amozie on DSK30RV082PROD with NOTICES
involve offering animal feed for import Meunerie Sawyerville devised the using monensin in its process and
into the United States from Canada, fraudulent scheme underlying the Meunerie Sawyerville raises no other
necessarily requiring Meunerie offense in Count One to compound, arguments that would present genuine
Sawyerville to provide Customs with an rather than mitigate, its earlier criminal and substantial issues of fact that would
ongoing stream of information about its conduct of shipping an adulterated require resolution at an evidentiary
products in the future. As an FDA- product to its customer in Vermont. hearing, Meunerie Sawyerville’s request
regulated product, animal feed can Rather than admitting the earlier for an evidentiary hearing is denied.
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![8880 Federal Register / Vol. 83, No. 41 / Thursday, March 1, 2018 / Notices
Considering all applicable factors Dated: February 26, 2018. Guidance for Industry, Researchers,
under 306(c)(3) of the FD&C Act, OSI George M. Warren, Patient Groups, and Food and Drug
concurs with ORA’s proposal that a 5- Director, Office of Scientific Integrity. Administration Staff on Meetings With
year period of debarment for each [FR Doc. 2018–04195 Filed 2–28–18; 8:45 am]
the Office of Orphan Products
offense is warranted. On this record, Development
BILLING CODE 4164–01–P
OSI finds that the nature and OMB Control Number 0910–0787—
seriousness of the offenses and the Extension
nature and extent of Meunerie DEPARTMENT OF HEALTH AND This information collection supports
Sawyerville management’s participation HUMAN SERVICES Agency guidance regarding staff
in the offenses are factors weighing
meetings with the Office of Orphan
heavily in favor of debarment. For the Food and Drug Administration Products Development (OOPD). Each
reasons already discussed, even year, the OOPD staff participates in
assuming Meunerie Sawyerville has [Docket No. FDA–2014–D–0313] meetings with stakeholders who seek
discontinued using monensin in its guidance or clarification relating to
operations, OSI finds that operational Agency Information Collection orphan drug or humanitarian use device
change insufficient under section Activities; Submission for Office of (HUD) designation requests, OOPD grant
306(c)(3)(D) to demonstrate correction of Management and Budget Review; programs, or other rare disease issues.
the causes of these offenses and to Comment Request; Guidance for These meetings can be ‘‘informal’’ or
provide reasonable assurances that the Industry, Researchers, Patient Groups, ‘‘formal’’ and help build a common
offenses will not recur. Further, even and Food and Drug Administration understanding on FDA’s thoughts on
after taking into account Meunerie Staff on Meetings With the Office of orphan products, which may include
Sawyerville’s guilty plea under section Orphan Products Development drugs, biological products, devices, or
306(c)(3)(C), OSI finds that Meunerie medical foods for a rare disease or
Sawyerville’s conduct related to this AGENCY: Food and Drug Administration, condition. These meetings may
consideration weighs in favor of HHS. represent critical points in the orphan
debarment. Although Meunerie product development process and may
ACTION: Notice. even have an impact on the eventual
Sawyerville’s lack of a prior conviction
under 306(c)(3)(F) is a factor weighing availability of products for patients with
against debarment, this consideration is SUMMARY: The Food and Drug rare diseases and conditions. It is
substantially outweighed by the nature Administration (FDA) is announcing important that these meetings be
and seriousness of the offenses, the that a proposed collection of scheduled within a reasonable time,
nature and extent of management’s information has been submitted to the conducted effectively, and documented
participation in the offenses, and the Office of Management and Budget where appropriate.
(OMB) for review and clearance under Topics addressed in this guidance
nature and extent of voluntary steps to include: (1) Clarification of what
mitigate the impact of the offenses on the Paperwork Reduction Act of 1995.
constitutes an ‘‘informal’’ or ‘‘formal’’
the public. Therefore, considering all of DATES: Fax written comments on the meeting, (2) program areas within OOPD
these factors together and the record as collection of information by April 2, that may be affected by this draft
a whole, OSI finds that a 5-year period 2018. guidance, (3) procedures for requesting
of debarment is warranted for each and scheduling meetings with OOPD,
offense. ADDRESSES: To ensure that comments on (4) description of what constitutes a
the information collection are received, meeting package, and (5) procedures for
Therefore, the Director of OSI, under
OMB recommends that written the conduct and documentation of
section 306(b)(3)(A) of the FD&C Act
comments be faxed to the Office of meetings with OOPD. This guidance
and under authority delegated to him by
Information and Regulatory Affairs, provides consistent procedures to
the Commissioner of Food and Drugs,
OMB, Attn: FDA Desk Officer, Fax: 202– promote well-managed meetings
finds that Meunerie Sawyerville has
been convicted of a felony for conduct 395–7285, or emailed to oira_ between OOPD and stakeholders.
relating to the importation of food into submission@omb.eop.gov. All Burden estimate. Table 1 provides an
the United States. FDA has considered comments should be identified with the estimate of the annual reporting burden
the relevant factors listed in section OMB control number 0910–0787. Also associated with the recommendations
include the FDA docket number found found in the guidance.
306(c)(3) of the FD&C Act and
in brackets in the heading of this Request for a meeting. Based upon
determined that a debarment of 5 years information collected from OOPD
is appropriate for each of these felony document.
program areas, approximately 2,332
offenses. These periods will run FOR FURTHER INFORMATION CONTACT: informal and 51 formal meetings were
concurrently under section 306(c)(2)(A). Amber Sanford, Office of Operations, requested with OOPD in fiscal year (FY)
As a result of the foregoing findings, Food and Drug Administration, Three 2016 regarding orphan drug designation
Meunerie Sawyerville is debarred for a White Flint North, 10A–12M, 11601 requests, HUD designation requests, rare
period of 5 years from importing articles Landsdown St., North Bethesda, MD pediatric disease designation requests,
of food or offering such articles for 20852, 301–796–8867, PRAStaff@ funding opportunities through the
import into the United States, fda.hhs.gov. Orphan Products Grants Program and
amozie on DSK30RV082PROD with NOTICES
applicable (see DATES). Under section the Pediatric Device Consortia Grants
301(cc) of the FD&C Act, the importing SUPPLEMENTARY INFORMATION: In Program, and orphan product patient-
or offering for import into the United compliance with 44 U.S.C. 3507, FDA related issues. FDA anticipates that the
States of an article of food by, with the has submitted the following proposed number of meeting requests and
assistance of, or at the direction of collection of information to OMB for stakeholders will remain the same or
Meunerie Sawyerville is a prohibited review and clearance. will slightly increase and therefore
act. estimates the total number of meeting
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Document Created: 2018-02-28 23:58:02
Document Modified: 2018-02-28 23:58:02
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The order is applicable March 1, 2018. | |
| 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. | |
| FR Citation | 83 FR 8877 |
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