UNITED STATES OF AMERICA v. MILL STREAM CORPORATION et al

Filing 7

CONSENT DECREE. It is hereby ORDERED that any motion for attorney's fees shall be filed within the time specified in Local Rule 54.2 of this Court. By JUDGE JON D. LEVY. (akr)

IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MAINE
____________________________________
)
UNITED STATES OF AMERICA,
)
)
Civil No.: 1:16-cv-00080-JDL
Plaintiff,
)
v.
)
CONSENT DECREE OF PERMANENT
)
INJUNCTION
MILL STREAM CORPORATION,
)
a corporation, doing business as
)
SULLIVAN HARBOR FARM
)
and IRA J. (JOEL) FRANTZMAN
)
an individual,
)
)
Defendants.
)
____________________________________ )

Plaintiff, the United States of America (the “United States”), by its undersigned attorneys,
having filed a complaint for injunctive relief (the “Complaint”) against Mill Stream Corporation, a
Maine corporation doing business as Sullivan Harbor Farm (“Corporate Defendant”), and
individual Ira J. Frantzman (together, “Defendants”), and Defendants having appeared and having
consented to entry of this Consent Decree of Permanent Injunction (“Decree”) without contest,
solely for the purpose of settling this case and without admitting or denying the allegations, and
before any testimony has been taken, and the United States having consented to this Decree;
IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:
1.

This Court has jurisdiction over the subject matter and over all parties to this action.

2.

The Complaint states a cause of action against Defendants under the Federal Food,

Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq. (the “Act”).
3.

The Complaint alleges that Defendants receive raw fish and prepare, process, pack,

hold, and distribute refrigerated, vacuum packed, ready-to-eat cold and hot smoked fish or fishery
products in interstate commerce, at and/or from their manufacturing facility, located at 1545 U.S.

Highway 1, Hancock, Maine (the “1545 Facility”). The Complaint alleges that Defendants violate
the Act, 21 U.S.C. § 331(a), by causing to be introduced or delivered for introduction into interstate
commerce articles of food, within the meaning of 21 U.S.C. § 321(f), namely fish or fishery
products, that are adulterated within the meaning of 21 U.S.C. § 342(a)(4), in that they have been
prepared, packed, or held under insanitary conditions whereby they may have become contaminated
with filth or may have been rendered injurious to health.
4.

The Complaint alleges that Defendants violate the Act, 21 U.S.C. § 331(k), by

causing articles of food within the meaning of 21 U.S.C. § 321(f), namely fish or fishery products,
to become adulterated within the meaning of 21 U.S.C. § 342(a)(4) while held for sale after
shipment of one or more components in interstate commerce.
5.

Defendants represent to Plaintiff and the Court that Defendant Frantzman is a co-

owner of the Ironbound Restaurant and Inn, located at 1513 Highway 1, Hancock, Maine (the
“Restaurant”), and that the Restaurant has sold and served to its retail customers smoked or cured
fish or fishery products manufactured by the Defendants for their customers’ end-point
consumption. Defendants further represent that the Corporate Defendant owns and operates a retail
store on or adjacent to the premises of the 1545 Facility (the “Retail Store”). The Retail Store has
held, sold, and/or distributed fish or fishery products manufactured by Defendants as well as other
merchandise and food products manufactured by wholly unrelated third-party suppliers.
6.

Defendants and each and all of their officers, agents, employees, representatives,

successors, assigns, attorneys, and any and all persons in active concert or participation with any of
them (including individuals, directors, corporations, subsidiaries, affiliates, and partnerships) who
have received actual notice of this Decree by personal service or otherwise are hereby permanently
restrained and enjoined, under the provisions of 21 U.S.C. § 332(a) and the equitable authority of
this Court, from directly or indirectly receiving, preparing, processing, packing, labeling, holding,
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and distributing articles of food, including but not limited to cold and hot smoked fish or fishery
products, at or from the 1545 Facility and/or any other location(s) at or from which any Defendant,
now or in the future, receive, prepare, process, pack, label, hold, or distribute articles of food
(“Defendants’ Facility”), unless and until:
(A)

Defendants retain, at their expense, an independent laboratory (the

“Laboratory”) having no personal or financial ties (other than the retention agreement) to
Defendants or their families, and that is qualified to collect and analyze product samples collected
at Defendants’ Facility for water phase salt levels and environmental and product samples for the
presence of Listeria monocytogenes (“L. mono”) at Defendants’ Facility in a manner that is
acceptable to the United States Food and Drug Administration (“FDA”). Defendants shall notify
FDA in writing immediately upon retaining such laboratory and shall provide FDA a copy of the
service contract. Such service contract shall contain provisions acceptable to FDA;
(B)

Defendants retain, at their expense, an independent expert or experts (the

“Expert(s)”) having no personal or financial ties (other than the retention agreement) to Defendants
or their families, and who, by reason of background, education, training, and experience, is qualified
to:
(1)

develop adequate Hazard Analysis and Critical Control Point

(“HACCP”) plans for Defendants’ fish or fishery products, as required by 21 C.F.R.
§§ 123.6(a)-(c);
(2)

verify and ensure the adequacy of Defendants’ HACCP plans,

including, but not limited to, conducting scientific validation studies of the adequacy of the critical
limits listed in Defendants’ HACCP plans for fish or fishery products including, but are not limited
to, smoked salmon, trout, and char;
(3)

develop procedures for processing Defendants’ fish or fishery
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products to achieve water phase salt levels that adequately control Clostridium botulinum (“C. bot”)
hazards;
(4)

develop adequate written Sanitation Standard Operating Procedures

(“SSOPs”) in accordance with paragraph 6(C)(3), below;
(5)

develop a Listeria Monitoring Program in accordance with paragraph

(6)

evaluate Defendants’ compliance with current good manufacturing

6(C)(4), below;

practice (“cGMP”) requirements for food, as set forth under 21 C.F.R. Part 110;
(7)

develop and conduct employee training programs on the seafood

HACCP and cGMP regulations, and SSOPs, HACCP plans, and Listeria Monitoring Program
approved by FDA pursuant to paragraph 6(E) below; and
(8)

inspect Defendants’ Facility and determine whether their methods,

facilities, and controls are operated and administered in conformity with the Act, its implementing
regulations, and this Decree.
Defendants shall notify FDA in writing of the name(s) and qualifications of the Expert(s)
under paragraph 6(B) as soon as they retain such Expert(s).
(C)

after review of all FDA inspectional observations of deficiencies from

February 2004 to the present, Defendants’ Expert(s), in conjunction with Defendants, has:
(1)

developed, to FDA’s satisfaction, adequate written HACCP plan(s),

as required by 21 C.F.R. Part 123, for each type of fish and/or fishery products received, prepared,
processed, packed, labeled, held, or distributed by Defendants.

Such HACCP plan(s) shall

effectively control food-safety hazards reasonably likely to occur for each type of fish or fishery
product that Defendants intend to process, in accordance with 21 C.F.R. Part 123, including, but
not limited to, C. bot. growth and toxin formation in smoked fish or fishery products; and
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(2)

developed and conducted, to FDA’s satisfaction, scientific validation

studies of the adequacy of the critical limits listed in Defendants’ HACCP plans for their fish and/or
fishery products, and made changes to the HACCP plan(s), as necessary, based on the results of the
studies. Such studies shall, at a minimum, confirm that the critical limits established for refrigerated
vacuum-packaged, hot and cold smoked fish or fishery products are sufficient to consistently
achieve a water phase salt level of 3.5% or higher;
(3)

developed, to FDA’s satisfaction, written SSOPs specific to

Defendants’ Facility and operations and that shall conform with the procedures set forth at 21
C.F.R. §§ 123.11(a)-(d), and shall ensure that Defendants’ operations comply with the Act and 21
C.F.R. Part 110;
(4)

developed and implemented, to FDA’s satisfaction, a written Listeria

Monitoring Program that shall include, at a minimum, the following:
(a)

effective sanitation methods, facilities, and controls for

receiving, preparing, processing, packing, labeling, holding, and distributing articles of food to
minimize the risk of introducing L. mono, other pathogenic organisms, and filth into Defendants’
food, and to ensure that foods are not adulterated within the meaning of 21 U.S.C. § 342(a);
(b)

an effective program for environmental monitoring and

testing of Defendants’ Facility to ensure that organisms such as Listeria species (“L. spp.”) are
systemically controlled and that L. mono does not occur in finished products. Sampling shall be
conducted using specified frequencies and methods (e.g., how, where, and when to sample; the
number and frequency of samples to be collected; the methods of analyses) that are approved by
FDA prior to implementation. Defendants shall ensure that the results of all analyses conducted
pursuant to paragraph 6(C)(4)(b) are sent to FDA within two (2) calendar days after receipt by
Defendants; and
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(c)

an effective, written remedial action plan that Defendants

shall implement should L. spp., L. mono, or any pathogenic organism be detected.
(5)

developed and conducted, to FDA’s satisfaction, an employee

training program (in English and any other language necessary to convey the substance of the
training) on the seafood HACCP and cGMP regulations and FDA-approved HACCP plans, SSOPs,
and Listeria Monitoring Program approved by FDA pursuant to paragraph 6(E), and documented
that Defendants, each of their officers, and any other person(s) who performs duties related to
receiving, preparing, processing, packing, labeling, holding, and/or distributing food at Defendants’
Facility on Defendants’ behalf have received such training. Notwithstanding the requirements of
this paragraph, Defendant Frantzman need not participate in such training so long as he: (i) is no
longer affiliated in any capacity, directly or indirectly, with the Corporate Defendant or any of its
affiliates, successors and/or assigns, and (ii) does not engage, directly or indirectly (other than by
virtue of his ownership in the Restaurant), in receiving, preparing, processing, packing, labeling,
holding, or distributing fish or fishery products; and
(6)

submitted to FDA the written HACCP plans and all associated

records (including monitoring records), validation studies, SSOPs, Listeria Monitoring Program,
and employee training program developed by the Expert(s) pursuant to paragraph 6(C); and
documentation demonstrating that the Expert(s) has completed the training described in paragraph
6(C)(5);
(D)

Defendants assign continuing responsibility for implementing and

monitoring the FDA-approved HACCP plans, SSOPs, and Listeria Monitoring Program to a person
(or persons) who, by reason of background, experience, or education, is qualified to maintain
Defendants’ Facility in a sanitary condition, coordinate with the Laboratory, implement any
necessary correction, and provide such person(s) with the authority to achieve any necessary
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correction;
(E)

FDA has approved, in writing, the HACCP plan(s), validation studies,

SSOPs, Listeria Monitoring Program, and employee training program and documentation
developed by the Expert(s), as specified in paragraphs 6(C)(1)-(6). Within thirty (30) business
days, or as soon as practicable in the event that FDA representatives are attending to FDA matters
that cannot be rescheduled, of receiving what Defendants represent to FDA to be their complete
and final submission of all the materials required under paragraph 6(C)(6), FDA will notify
Defendants in writing of its evaluation of such submission;
(F)

Defendants make the FDA-approved HACCP plans, SSOPs, and Listeria

Monitoring Program available and accessible to all their employees and any other person(s) who
performs duties at Defendants’ Facility for Defendants in English and any other language necessary
to convey the substance of such documents;
(G)

Defendants successfully complete the FDA-approved employee training

program described in paragraph 6(C)(5);
(H)

Defendants, at their expense, clean and sanitize Defendants’ Facility and

equipment therein and make improvements, thereby rendering their Facility and equipment suitable
for receiving, preparing, processing, packing, holding, labeling, and distributing articles of food in
accordance with this Decree, the Act, and all applicable regulations, and Defendants ensure that
their Facility and equipment therein will be continuously maintained in a sanitary condition;
(I)

the Expert(s) conducts a comprehensive inspection of Defendants’ Facility

and the methods and controls used to receive, prepare, process, pack, label, hold, and distribute
foods to determine whether Defendants are operating in compliance with this Decree, the Act, and
all applicable regulations. The Expert(s) shall verify, with supporting documentation, that (i)
Defendants have corrected all of the seafood HACCP and cGMP deficiencies observed by FDA
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during all prior FDA inspections, specifying each FDA observation and Defendants’ corrections
thereof, and (ii) Defendants’ Facility and the methods and controls used to receive, prepare, process,
pack, label, hold, and distribute foods are, in the Expert’s opinion, in compliance with this Decree,
the Act, and its implementing regulations. The Expert(s) shall submit, in writing, all findings and
supporting documentation to Defendants and FDA concurrently, within fifteen (15) calendar days
after completion of the inspection;
(J)

Defendants destroy, under FDA’s supervision (which may be, in FDA’s sole

discretion, by review of documentation and photographs, rather than in-person observation), and in
accordance with a written destruction plan approved in writing by FDA prior to implementation,
all smoked fish or fishery products in Defendants’ custody, control, or possession as of the date of
entry of this Decree;
(K)

FDA, as it deems necessary to evaluate Defendants’ compliance with the

terms of this Decree, the Act, and all applicable regulations, conducts inspections of Defendants’
Facility, including the buildings, sanitation-related systems, equipment, utensils, and all articles of
food and relevant records contained therein. Provided that FDA finds that Defendants’ submissions
under paragraphs 6(A), (B), (C)(6), (I), and (J) appear to be satisfactory and notifies Defendants of
such finding in writing, FDA will initiate the inspection within thirty (30) calendar days of such
written notification, or as soon as practicable in the event that FDA representatives are attending to
FDA matters that cannot be rescheduled;
(L)

Defendants have paid all costs of inspection, analyses, review,

investigations, examination, and supervision for FDA’s oversight with respect to paragraphs 6(A)
through 6(K), at the rates set forth in paragraph 14 below; and
(M)

FDA has notified Defendants in writing that Defendants appear to be in

compliance with the requirements set forth in paragraphs 6(A) through 6(L) of this Decree, the Act,
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and its implementing regulations.
(N)

Nothing in this paragraph 6 shall preclude Defendants from receiving,

processing, packing, and holding food products for the limited purposes of conducting validation
studies, testing equipment, training employees, and conducting analyses that may be necessary to
develop standard operating procedures and/or HACCP Plans.
7.

Immediately upon resuming operations after completing the requirements of

paragraph 6, Defendants shall, in consultation with the Expert(s), continuously implement the FDAapproved HACCP plans, SSOPs, and Listeria Monitoring Program. In the event that Defendants
or their Expert(s) determine that the FDA-approved Listeria Monitoring Program needs to be
revised, Defendants shall provide proposed changes to FDA in writing at least twenty (20) calendar
days prior to their implementation, and shall not implement their proposed changes until FDA
approves those changes in writing. The alternative L. mono control program submitted to FDA
shall consist of methods and controls that are shown to FDA’s satisfaction to systemically control
organisms such as L. spp. and ensure that L. mono does not occur in finished products. Defendants
further shall comply with the following requirements:
(A)

Defendants shall have their finished products tested, by the Laboratory

retained pursuant to paragraph 6(A), for water phase salt level in the following manner:
(1)

Defendants shall have tested a randomly collected, representative

sample from every lot of finished fish or fishery products that they process for the first fifteen (15)
consecutive production days, and all such samples shall have a water phase salt level that adheres
to the critical limits set forth in the HACCP plans approved by FDA pursuant to paragraph 6(E);
(2)

after satisfying the requirements of paragraph 7(A)(1), Defendants

shall have tested a randomly collected, representative sample from one lot of each type of finished
fish or fishery products that they process each week for the next three (3) months;
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(3)

after satisfying the requirements of paragraph 7(A)(2), Defendants

shall have tested a randomly collected, representative sample from one lot of each type of finished
fish or fishery products they process each month for the next twelve (12) months; and
(4)

after satisfying the requirements of paragraph 7(A)(3), Defendants

shall have tested a randomly collected, representative sample from one lot of each type of finished
fish or fishery products they process every three (3) months thereafter.
Defendants shall send copies of the results of tests conducted pursuant to paragraph 7(A) to
FDA within two (2) calendar days after receipt by Defendants. If any sample analysis conducted
pursuant to paragraph 7(A) shows a water phase salt level that does not adhere to the critical limits
set forth in the FDA-approved HACCP plans, Defendants shall immediately destroy the affected
lot(s) at Defendants’ expense, under FDA’s supervision (which may be, in FDA’s sole discretion,
by review of documentation and photographs, rather than in-person observation), and pursuant to a
destruction plan approved in writing by FDA prior to implementation. Further, Defendants shall
reassess their operations to determine the cause of the deviation, correct the deviation, revise their
HACCP plan(s) accordingly, and submit such revisions for FDA’s written approval.

After

correcting the cause of the deviation, Defendants shall reinstate the complete sequence of testing
under paragraph 7(A) anew.
8.

If, after notifying FDA of the name of the Laboratory retained to conduct sample

collection and analyses pursuant to paragraph 6(A), Defendants terminate or in any way alter their
service contract with the Laboratory, Defendants shall notify FDA within seven (7) calendar days.
If Defendants terminate their service contract, Defendants shall provide a copy of the service
contract with the new laboratory to FDA within five (5) business days of execution.
9.

Within thirty (30) calendar days after Defendants resume their operations after

completing the requirements of paragraph 6, the Expert(s) shall conduct an audit of Defendants’
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Facility and the methods and controls used to receive, prepare, process, pack, label, hold, and
distribute foods to determine whether Defendants are operating in compliance with this Decree, the
Act, and all applicable regulations. The Expert(s) shall submit an Audit Report documenting all
findings to Defendants and FDA concurrently, within twenty-one (21) calendar days after
completing the audit. Thereafter, the Expert(s) shall conduct one audit every three (3) months for
one year, and then one audit every six (6) months for the next two (2) years. Beginning in the fourth
year after Defendants resume their operations after completing the requirements of paragraph 6, the
Expert(s) shall conduct audits annually unless FDA informs Defendants in writing that more
frequent expert inspections and reporting are required. If, at any time, Defendants retain a different
or additional Expert(s), Defendants shall notify FDA of the identity and credentials of the new
Expert(s) within seven (7) calendar days.
(A)

During each audit conducted by the Expert(s), the Expert(s) shall verify that

Defendants’ Facility and the methods and controls Defendants use to receive, prepare, process,
pack, label, hold, and distribute articles of food are in compliance with the requirements of this
Decree, the Act, and all applicable regulations.
(B)

If the Audit Report contains any observations indicating that Defendants are

not in compliance with this Decree, the Act, or its implementing regulations, Defendants shall,
within fifteen (15) business days after receipt of the Audit Report, make all necessary corrections,
unless FDA notifies Defendants in writing that a shorter timeframe is required or that a longer
timeframe is appropriate. If, after receiving the Audit Report, Defendants believe that a longer time
period will be necessary to complete some or all of the corrections, Defendants shall, within ten
(10) business days after receiving the Audit Report submit to FDA a proposed schedule for
completing the corrections along with explanations for why the additional time is needed. The
proposed schedule shall not be effective unless and until FDA approves it in writing.
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10.

Defendants’ operation of the Restaurant and Retail Store are not subject to the

requirements of paragraphs 6-9 of this Decree, provided that the Restaurant and Retail Store operate
only as retail establishments within the meaning of 21 C.F.R. § 123.3(k)(2)(iii).
11.

Defendants, and each and all of their officers, agents, employees, representatives,

successors, assigns, attorneys, and any and all persons in active concert or participation with any of
them (including individuals, directors, corporations, subsidiaries, affiliates, and partnerships) who
receive actual notice of this Decree, are permanently restrained and enjoined under the provisions
of 21 U.S.C. § 332(a) from directly or indirectly doing or causing any act that:
(A)

violates the Act, 21 U.S.C. § 331(a), by introducing or delivering for

introduction, or causing to be introduced or delivered for introduction, into interstate commerce,
any article of food within the meaning of 21 U.S.C. § 321(f) that is adulterated within the meaning
of 21 U.S.C. § 342(a)(4);
(B)

violates the Act, 21 U.S.C. § 331(k), by causing any article of food within

the meaning of 21 U.S.C. § 321(f) to become adulterated under 21 U.S.C. § 342(a)(4) while such
article is held for sale after shipment of one or more of their components in interstate commerce; or
(C)

results in the failure to implement and continuously maintain the

requirements of this Decree.
12.

FDA shall be permitted, without prior notice and as and when FDA deems necessary,

to take any other measures necessary to monitor and ensure continuing compliance with the terms
of this Decree, the Act, and its implementing regulations. During inspections, FDA shall be
permitted to (i) have immediate access to buildings, equipment, raw ingredients, in-process and
finished articles of food, containers, and packaging material therein (ii) take photographs and make
video recordings, (iii) take samples of Defendants’ raw ingredients, in-process and finished articles
of food, containers, and packaging material; and to examine and copy all records related to
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receiving, preparing, processing, packing, holding, labeling, and distributing any and all articles of
food. The inspections shall be permitted upon presentation of a copy of this Decree and appropriate
credentials. The inspection authority granted by this Decree is apart from, and in addition to, the
authority to make inspections under the Act, 21 U.S.C. § 374.
13.

Defendants shall notify FDA in writing at least fifteen (15) calendar days before any

change in ownership, name or character of their business, including reorganization, relocation,
dissolution, assignment, or lease or sale of the business or any assets of the business, such as
buildings, equipment, or inventory, that may affect compliance with the obligations arising from
this Decree. Defendants shall provide any prospective successor or assign with a copy of this
Decree at least ten (10) calendar days before the assignment or change in business, and shall provide
FDA with an affidavit of compliance with this paragraph within ten (10) calendar days of providing
a copy of this Decree to a prospective successor or assign.
14.

Defendants shall pay all costs of FDA’s supervision, inspections, investigations,

analyses, examinations, and reviews that FDA deems necessary to evaluate Defendants’
compliance with this Decree, at the standard rates prevailing at the time costs are incurred, and
Defendants shall make payment in full to FDA within (30) calendar days of receiving written
notification from FDA of the costs. As of the date that this Decree is signed by the parties, these
rates are (i) $89.35 per hour and fraction thereof per representative inspection work, (ii) $107.09
per hour or fraction thereof per representative analytical or review work, (iii) $0.575 per mile for
travel by automobile, (iv) the government rate or the equivalent for travel by air or other means,
and (v) the published government per diem rate or the equivalent for the areas in which the
inspections are performed per representative and per day for subsistence expenses, where necessary.
In the event that the standard rates applicable to FDA supervision of court-ordered compliance are
modified, these rates shall be increased or decreased without further order of the Court.
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15.

If, at any time after entry of this Decree, FDA determines, based on the results of an

inspection, audit, analysis of a sample, report submitted by the Expert(s), or other information, that
Defendants have failed to comply with any provision of this Decree, have violated the Act or its
implementing regulations, or that additional corrective actions are necessary to achieve compliance
with this Decree, the Act, or its implementing regulations, FDA may, as and when it deems
necessary, notify Defendants in writing and order Defendants to take appropriate action, including,
but not limited to, ordering Defendants immediately to take one or more of the following actions:
(A)

cease receiving, preparing, processing, packing, labeling, holding, and

distributing any articles of food;
(B)

recall all articles of food that have been distributed and/or are under the

custody and control of Defendants’ agents, distributors, customers, or consumers;
(C)

submit additional samples to a qualified laboratory for analysis;

(D)

institute or re-implement any of the requirements set forth in this Decree; and

(E)

take any other corrective actions as FDA deems necessary to protect the

public health or bring Defendants into compliance with this Decree, the Act, and its
implementing regulations.
Any FDA order issued pursuant to this paragraph shall state the noncompliance giving rise
to the order.
The provisions of this paragraph shall be separate and apart from, and in addition to, all
other remedies available to FDA. Defendants shall pay all costs of recalls and other corrective
actions, including the costs of FDA’s supervision, inspections, investigations, analyses,
examinations, review, travel, and subsistence expenses to implement and monitor recalls and other
actions, at the rates specified in paragraph 14 of this Decree.
16.

Upon receipt of any order issued by FDA pursuant to paragraph 15, Defendants shall
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immediately and fully comply with the terms of the order. Any cessation of operations or other
action as described in paragraph 15 shall be implemented immediately upon notice from FDA and
shall continue until Defendants receive written notification from FDA that Defendants appear to be
in compliance with the Decree, the Act, and its implementing regulations, and that Defendants may
resume operations. After a cessation of operations, and while determining whether Defendants are
in compliance with this Decree, the Act, and its implementing regulations, FDA may require
Defendants to re-institute or re-implement any of the requirements of this Decree.
17.

Defendants shall maintain copies of their HACCP plans, along with copies of all

records required by such plans, 21 C.F.R. Part 123, and this Decree, at their Facility in a location
where they are readily available for reference and inspection by FDA. Defendant may maintain
such records in paper and/or electronic form. All records required to be kept by Defendants’
HACCP plans, FDA regulations, and this Decree shall be retained for at least three (3) years after
the date the records are prepared and shall be presented immediately to FDA investigators
upon request.
18.

If either Defendant fails to comply with the provisions of the Act, its implementing

regulations, or this Decree, then Defendants shall pay to the United States of America (i) liquidated
damages in the sum of one thousand five hundred dollars ($1,500) for each day that such violation
continues, (ii) an additional sum of one thousand dollars ($1,000) in liquidated damages per day for
each violation of the Act, its implementing regulations, or this Decree (e.g., two violations that
occurred for two days would incur liquidated damages of $7,000), and (iii) a further sum in
liquidated damages equal to twice the retail value of each shipment of food that is adulterated or
otherwise in violation of the Act, its implementing regulations, or this Decree. Defendants
understand and agree that the liquidated damages specified in this paragraph are not punitive in
nature and their imposition does not in any way limit the ability of the United States to seek, and
Page 15 of 22

this Court to impose, additional civil or criminal penalties based on the conduct that may also be
the basis for payment of liquidated damages pursuant to this paragraph.
19.

Should the United States bring and prevail in a contempt action to enforce the terms

of this Decree, then Defendants shall, in addition to other remedies, reimburse the United States for
its attorneys’ fees, travel expenses incurred by attorneys and witnesses, expert witness fees,
administrative and court costs, investigation and analytical expenses incurred in bringing the
contempt action, and any other costs or fees related to the contempt proceedings.
20.

All decisions specified in this Decree shall be vested in the discretion of FDA and

shall be final. If contested by Defendants, FDA’s decisions under this Decree shall be reviewed by
the Court under the arbitrary and capricious standard set forth in 5 U.S.C. § 706(2)(A). Review
shall be based exclusively on the written record before the FDA at the time the decision was made.
No discovery shall be taken by either party.
21.

Within ten (10) calendar days after entry of this Decree, Defendants shall provide a

copy of this Decree by personal service or certified mail (return receipt requested), or electronic
mail with acknowledged receipt, to each and all of their officers, agents, employees, representatives,
successors, assigns, attorneys, and any and all persons in active concert or participation with any of
them (including individuals, directors, corporations, subsidiaries, affiliates, and partnerships).
Defendants shall provide to FDA, within thirty (30) calendar days of the date of the entry of this
Decree, an affidavit of compliance with this paragraph stating the fact and manner of compliance
and identifying the names and positions of all persons so notified and attaching copies of the
executed certified mail return receipts, electronic mail acknowledgements, or other proof of service
if the Decree was delivered by personal service.
22.

Defendants shall prominently post a copy of this Decree (in English and any other

language necessary to convey the substance of the Decree) in an employee common area at
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Defendants’ Facility within ten (10) calendar days of the entry of this Decree and shall ensure that
the Decree remains posted for as long as the Decree remains in effect.
23.

Defendants shall, within ten (10) calendar days of the entry of this Decree, hold a

general meeting or a series of smaller meetings for employees of their Facility, at which they shall
describe the terms and obligations of this Decree (in English and any other language necessary to
convey the substance of the Decree). Defendants shall provide to FDA, within thirty (30) calendar
days of the entry of this Decree, an affidavit of compliance with this paragraph stating the fact and
manner of compliance and identifying the names and positions of all meeting attendees and
attaching a copy of the meeting sign-in sheet(s).
24.

In the event that either Defendant becomes associated with any additional officers,

agents, employees, representatives, successors, assigns, attorneys, or any additional persons in
active concert or participation with any of them (including individuals, directors, corporations,
subsidiaries, affiliates, and partnerships) at any time after entry of this Decree, Defendants shall
immediately provide a copy of this Decree, by personal service, certified mail (return receipt
requested), or electronic mail with acknowledged receipt to such persons. Within ten (10) calendar
days of each instance that any Defendant becomes associated with any such person, Defendants
shall provide to FDA an affidavit stating the fact and manner of Defendants’ compliance with this
paragraph, identifying the names, addresses, and positions of all persons who received a copy of
this Decree pursuant to this paragraph, and attaching a copy of the executed certified mail return
receipts, proof of service, or electronic mail acknowledgements.
25.

Defendants shall address all communications required under this Decree to the

Director, New England District Office, Food and Drug Administration, One Montvale Avenue,
Stoneham, Massachusetts 02180, and shall reference this civil action by case name and civil action
number and shall prominently mark “Decree Correspondence” in such communication. All
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communications from FDA to Defendants shall be addressed to Mill Stream Corporation at 1545
US Highway 1, Hancock, Maine 04640-3831, Ira J. Frantzman at PO Box 96, Sullivan, Maine
04664, as well as to the Individual Successor in the event paragraph 27 is exercised.
26.

No sooner than five (5) years after entry of this Decree, Defendants may petition

FDA for leave to ask this Court for relief from this Decree. If, at the time of the petition, in FDA’s
judgment, Defendants have maintained a state of continuous compliance with this Decree, the Act,
and its implementing regulations for at least five (5) years, Plaintiff will not oppose the petition,
and Defendants may request the Court to grant such relief.
27.

If Defendant Frantzman ceases to be affiliated in any capacity (e.g., as owner,

director, officer, employee, or consultant), directly or indirectly, with the Corporate Defendant or
any of its affiliates (including but not limited to its franchises, “doing business as” entities,
subsidiaries, successors, or assign), and is no longer engaging in, directly or indirectly, receiving,
preparing, processing, packing, labeling, holding, or distributing fish or fishery products, then
Defendant Frantzman shall notify FDA in writing and provide supporting documentation.
(A)

Defendants may, after FDA has issued written notification to Defendants

pursuant to paragraph 6(M) stating that they appear to be in compliance with paragraphs 6(A) - (L)
of this Decree, the Act, and its implementing regulations, under the circumstances identified in this
paragraph, and upon prior written notice to FDA of thirty (30) business days, jointly petition the
Court to release Defendant Frantzman from this Decree, provided that as part of this petition,
Defendants shall designate an individual of similar position and responsibility to be substituted as
an individual successor (“Individual Successor”), and Defendants and the Individual Successor
jointly petition the Court to add the Individual Successor as a Defendant to the Decree.
(B)

So long as by the time of the petition, FDA has issued a written notification

pursuant to paragraph 6(M) stating that Defendants appear to be in compliance with paragraphs
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6(A)-(L) of this Decree, the Act, and its implementing regulations, and so long as FDA finds, in its
judgment, at the time of the petition, that: (i) Defendant Frantzman has ceased to be affiliated in
any capacity, directly or indirectly, with the Corporate Defendant or any of its affiliates, (ii)
Defendant Frantzman has ceased to engage, directly or indirectly, in receiving, preparing,
processing, packing, labeling, holding, or distributing fish or fishery products, and (iii) the
Individual Successor has a similar position and responsibilities to those of Defendant Frantzman
before he ceased any direct or indirect involvement in the Corporate Defendant or any of its
affiliates, then Plaintiff will not oppose the release of Defendant Frantzman from this Decree
pursuant to such petition. Plaintiff will not oppose the release of Defendant Frantzman from this
Decree solely because of his ownership of the Restaurant, provided that Defendants otherwise
comply with the terms of this Decree. Defendant Frantzman shall continue to be subject to the
terms of this Decree prior to the time the Court releases him from this Decree.
(C)

If Defendant Frantzman wishes to be released from this Decree under

paragraph 27, then he shall follow the procedures set forth herein only after this Court enters
this Decree and FDA has issued a written notification pursuant to paragraph 6(M) stating that
Defendants appear to be in compliance with paragraphs 6(A)-(L) of this Decree, the Act, and its
implementing regulations. This requirement applies regardless of whether any change in affiliation
occurs before or after such entry.
(D)

Defendant Frantzman, upon his release from this Decree, may continue to

lease the 1545 Facility to the Corporate Defendant without once again requiring him to be subject
to this Decree, provided, however, that Defendant Frantzman shall have no role in the operation
of the 1545 Facility for directly or indirectly receiving, preparing, processing, packing, holding,
labeling, and/or distributing of fish or fishery products. Under no circumstances shall Defendant
Frantzman’s role as landlord be construed to excuse the Corporate Defendant and/or Individual
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Successor from taking any and all actions necessary to comply with this Decree, the Act, and its
implementing regulations, including but not limited to making any repairs and/or improvements to
the 1545 Facility.
(E)

Defendant Frantzman may provide a one-time loan to the Corporate

Defendant and/or Individual Successor in the amount of $35,000.00 (USD) without once again
requiring Defendant Frantzman to be subject to this Decree, provided, however, that Defendant
Frantzman shall have no role in the operation of the Corporate Defendant’s and/or Individual
Successor’s business of receiving, preparing, processing, packing, holding, labeling, and/or
distributing of fish or fishery products (including, but not limited to, in the event of default).
(F)

An Individual Successor added to this Decree shall be bound by the Decree

in the same manner as the Defendants originally named in the Decree.
(G)

If Defendant Frantzman is released from this Decree under this paragraph 27

but, at any time while the Decree remains in effect, again decides to engage in, directly or indirectly,
receiving, preparing, processing, packing, labeling, holding, or distributing fish or fishery products
either at or from Defendants’ Facility or any other location, then Defendant Frantzman shall notify
FDA in writing no less than thirty (30) days prior to engaging in any such activities and Defendants
shall not oppose a motion by Plaintiff to reinstate him as a Defendant who is subject to this Decree
and any requirements set forth herein. Plaintiff will not seek Defendant Frantzman’s reinstatement
as a Defendant to this Decree solely because of his ownership of the Restaurant, provided that the
Restaurant does not process fish and fishery products within the meaning of 21 C.F.R. Part 123 and
operates only as a retail establishment within the meaning of 21 C.F.R. § 123.3(k)(2)(iii).
28.

This Court retains jurisdiction of this action and the parties hereto for the purpose of

enforcing and modifying this Decree and for the purpose of granting such additional relief as may
be necessary or appropriate.
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SO ORDERED.
Dated: February 12, 2016
/s/ Jon D. Levy
U.S. DISTRICT JUDGE

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For Defendants:

For Plaintiff:
THOMAS E. DELAHANTY II
United States Attorney
District of Maine

_____________________________
IRA J. (JOEL) FRANTZMAN,
Individually

Andrew Lizotte
Assistant United States Attorney
U.S. Attorney’s Office, District of Maine
100 Middle Street, East Tower, 6th Floor
Portland, Maine 04101
Tel. [phone]
Fax. [phone]
[e-mail]

/s/ Lauren E. Handel
LAUREN E. HANDEL, pro hac vice
Foscolo & Handel PLLC
75 Washington Valley Rd., CN 753 #416
Bedminster, NJ 07921
Tel. [phone]
Fax. [phone]
Email: [e-mail]
/s/ Richard Silver
RICHARD SILVER
Lanham, Blackwell & Baber
133 Broadway
Bangor, ME 04401
Tel. [phone]
Email: [e-mail]
Attorneys for Mill Stream Corporation, dba
Sullivan Harbor Farm and Ira J. (Joel)
Frantzman

/s/ Thomas E. Ross
THOMAS E. ROSS
Trial Attorney
United States Dept. of Justice
Consumer Protection Branch
450 5th Street NW, Rm. 6400
Washington, DC 20001
Tel. [phone]
Fax. [phone]
E-mail: [e-mail]
Of Counsel:
WILLIAM B. SCHULTZ
General Counsel
U.S. Dept. of Health & Human Services
ELIZABETH H. DICKINSON
Chief Counsel
Food and Drug Administration
PERHAM GORJI
Deputy Chief Counsel, Litigation
YEN HOANG
Associate Chief Counsel for Enforcement
U.S. Dept. of Health & Human Services
Office of the General Counsel
Food and Drug Division
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Tel: [phone]
[e-mail]

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