Federal District Court Opinions
U.S. v. BLUE RIBBON SMOKED FISH, INC., (E.D.N.Y. 2001) 179
F. Supp.2d 30 UNITED STATES of America, Plaintiff, v. BLUE
RIBBON SMOKED FISH, INC., et alia, Defendants. No.
CV-01-3887 (CPS). United States District Court, E.D. New
York. November 19, 2001. West Page 31
[EDITORS’ NOTE: THIS PAGE CONTAINS HEADNOTES. HEADNOTES ARE NOT AN OFFICIAL PRODUCT OF THE COURT, THEREFORE THEY ARE NOT DISPLAYED.] West Page 32
[EDITORS’ NOTE: THIS PAGE CONTAINS HEADNOTES. HEADNOTES ARE NOT AN OFFICIAL PRODUCT OF THE COURT, THEREFORE THEY ARE NOT DISPLAYED.] West Page 33
Charles S. Kleinberg, United States Attorney’s Office,
Civil Division, Brooklyn, NY, Allison M. Harnisch, Office
of Consumer Litigation, U.S. Dept. of Justice, Washington,
DC, for plaintiff.
Russell K. Statman, Plattsburgh, NY, for defendants.
MEMORANDUM AND ORDER
SIFTON, Senior District Judge.
The United States brings this action for injunction
against defendants Blue Ribbon Smoked Fish, Inc. (“Blue
Ribbon”), Jay A. Suttenberg (“Suttenberg”), Pablo Negron
(“Negron”), and Susan Dozortsev (“Dozortsev”)
(collectively, the “defendants”) under 21 U.S.C. §
332(a), the Federal Food, Drug and Cosmetic Act (the “Act”
or “FDCA”). Specifically, the United States seeks to enjoin
the defendants from violating 21 U.S.C. § 331(a) and
(k) by introducing into interstate commerce food (1) that
is adulterated within the meaning of the Act or (2) that
will become adulterated after shipment.
Defendants Suttenberg, Negron, and Dozortsev
(collectively, the “individual defendants”) move pursuant
to Fed.R.Civ.P. 12(b)(6) to dismiss the complaint against
them in their individual capacities. The United States
moves pursuant to Fed.R.Civ.P. 56 for summary judgment in
its favor, enjoining the defendants from further violations
of the FDCA on the ground that there are no material issues
in dispute.
For the reasons set forth below, the individual
defendants’ motion is denied, and the United States’ motion
is granted.
BACKGROUND
The following facts are taken from the parties’ submissions
in connection with the present motions and are undisputed
except as noted. For the purpose of the individual
defendants’ motion to dismiss the complaint, I assume the
facts alleged in the complaint to be true. I will not
consider any matters outside the pleadings submitted by
either party and will not treat the individual defendants’
motion as one for summary judgment. See Fed.R.Civ.P.
12(b)(6). For the purpose of plaintiff’s motion for summary
judgment, I assume that all uncontroverted Rule 56.1
factual assertions are not disputed. See Titan Indemnity Co.
v. Triborough Bridge & Tunnel Authority, 135 F.3d 831, 835
(2d Cir. 1998).
Blue Ribbon, a New York corporation, is engaged in
preparing, processing, holding, and distributing a variety
of seafood products, including brined fish, hot- and West
Page 34 cold-smoked fish products, and seafood salads. It’s
facility is located at 5901 Foster Avenue, Brooklyn, New
York (the “plant”). All three individual defendants work at
the plant, are co-owners of Blue Ribbon, and are corporate
officers responsible for plant operations. Suttenberg is
president and co-owner of Blue Ribbon with ultimate
authority over the plant’s operations. According to the
complaint, his responsibilities include food processing,
plant sanitation, product distribution, and implementation
of Hazard Analysis Critical Control Point (“HACCP”) plans
necessary for controlling food safety hazards.[fn1] Negron
is vice president and co-owner of Blue Ribbon. He was
previously Blue Ribbon’s president, and as vice president
he supervises the day-to-day operations of the plant, which
includes overseeing the processing of the seafood, as well
as the processes of fish thawing, brining, and smoking.
Dozortsev is the secretary and treasurer of Blue Ribbon and
a co-owner. Her duties, like those of Negron, include
supervising the day-to-day operations of the plant,
including overseeing the processing of the seafood,
preparing HACCP plans, and monitoring sanitation controls.
Plaintiff alleges that the U.S. Food and Drug
Administration (“FDA”) and the New York State Department of
Agriculture and Markets (“NYSDAM”) have documented,
throughout the last seven years, insanitary conditions at
the facility as well as defendants’ failure to establish
and implement adequate HACCP plans necessary to control
food safety hazards. The FDA and the NYSDAM have documented
(1) numerous insanitary conditions at the plant; (2)
defendant’s failure to implement appropriate HACCP plans;
and (3) the presence of Listeria Monocytogenes
(“L.monocytogenes”), a bacteria that causes disease, in
certain smoked fish products and in the plant environment.
Proper HACCP Plans
Seafood processors are required to establish and implement
HACCP plans pursuant to 21 C.F.R. § 123.6(b). HACCP
is a management system designed to prevent the occurrence
of potential food safety problems. According to FDA
regulations, a processor of fish and fishery products is
required to assess biological, chemical, and physical
hazards at all stages of processing, from production of the
raw materials, to procurement and handling, manufacturing,
distribution and consumption of the finished products.
After assessing the health and safety risks that each
particular food presents, the processor must determine
necessary steps to control the identified risks. 21 C.F.R.
§ 123.6(a) & (b). A specific analysis must be done
for each fish or fishery product, unless the food safety
hazards, critical control points, critical limits, and
procedures to be followed are identical for two or more
fish products. 21 C.F.R. § 123.6(b)(2). The
processor is then required to document these analyses in
HACCP plans, as well as keep records to document the
monitoring of the actual values and observations obtained
when fish processing. 21 C.F.R. § 123.6(c)(7).
During the August 2000 inspection, the FDA found that Blue
Ribbon failed to comply with FDA regulations regarding
HACCP plans. According to the FDA’s Establishment
Inspection Report (“EIR”), the inspection team noted that
“the firm lacked a written HACCP plan, a process schedule,
and process monitoring records for a lot of brined and
dried salmon pieces, removed from bones, used to produce a
batch of cream cheese & lox.” Blue West Page 35 Ribbon
recalled this lot of cream cheese and lox[fn2] and promised
to correct the HACCP deficiencies. In the follow-up
inspection of January 2001, the FDA’s EIR again noted HACCP
deficiencies, stating, in part:
The firm processes cold smoked Nova Salmon with an
incomplete written HACCP Plan, incomplete Monitoring
Records and Verification Procedures that do not document
the accuracy of temperature measuring devices or
Salometers used in the brining operation. There is no
verification of raw materials (incoming fish) containing
levels of microorganisms that will not produce food
poisoning or other disease in humans, and the firm
operates with inadequate HACCP controls. There is no
written HACCP Plans for Nova Salmon Bits (produced from
pieces of salmon removed from bones) or smoked Sea Bass.
The EIR detailed the specific deficiencies that the
inspection team observed in the HACCP plans. The following
problems were identified with the cold smoked Nova salmon
HACCP plan: the plan was signed but not dated, as required
by 21 C.F.R. § 123.6(d); it erroneously listed
scombrotoxin formation as a food safety hazard relating to
salmon production; there was no critical limit for internal
fish temperature; no time was specified for thawing frozen
fish; no procedure was included for monitoring brine
solution or fish temperature during brining; it was
inconsistent with the firm’s written procedure for
brining;[fn3] there was no procedure to check the accuracy
of thermometers, salometers, thermostats; and there was
inadequate monitoring of critical control points. The EIR
also detailed the lack of HACCP plans for Nova salmon bits
and noted that this deficiency had been brought to Blue
Ribbon’s attention during the August 2000 inspection. It
was also observed that Blue Ribbon did not have a written
HACCP plan for smoked sea bass. These deficiencies were
discussed with Suttenberg and Dozortsev.
Defendants do not dispute the FDA findings that the HACCP
plans were inadequate or non-existent at the time of these
inspections. The defendants maintain that, as of now, Blue
Ribbon has implemented an effective HACCP plan, which the
company now follows.
Insanitary Plant Conditions
Inspections of the plant were conducted in 1994, 1995,
1996, 1999, 2000, and 2001. According to Jerome G.
Woyshner, Director, Investigations Branch, New York
District, Northeast Region of the FDA, Department of Health
and Human Services (“Woyshner”), the FDA conducted the most
recent plant inspection from January 17 to 26, 2001. The
January 2001 inspection revealed the following insanitary
conditions: old seafood product residue on food contact
surfaces; mold in the cooler, freezer, and ceiling of the
slicing and packing room; a plastic dividing curtain that
touched the floor and came into contact with fish; liquid
dripping onto West Page 36 seafood from other seafood
stored above; and old dripping product residue on the walls
and fan shrouds in the cold smoking/drying room. The
inspection found the inadequate cleaning and sanitizing
processes, including a failure to adequately sanitize and
wash cutting boards, knives, and slicing machine. The
inspection also revealed employees touching unclean
surfaces and then touching ready-to-eat fish without
sanitizing their gloves, wearing street cloths in the
processing areas without protective coverings, eating and
drinking in the processing areas, inadequate hand washing
and sanitizing, and wearing of unrestrained hair and
beards. The FDA also found that the plant’s construction
was not designed to prevent bacterial contamination and
filth and that there were inadequate doors or barriers
between the slicing and packing room and the garage and
toilet, lack of control over foot traffic and product flow
to prevent cross-contamination of the finished ready-to-eat
product and that surfaces were in disrepair making adequate
cleaning impossible.
In August 2000, the FDA conducted two inspections and
found insanitary plant conditions. For instance, the
ceiling in the processing room was in disrepair and rusted;
condensation was dripping from the ceiling into uncovered
tanks of brining fish; dried encrusted food residue was
observed in processing and packing areas; and used, stained
boxes for receiving raw fish were stacked on top of the
table in the packing area and on top of a refrigerator. On
January 12, 2000, the NYSDAM issued a final determination,
based on various inspections and product sampling, revoking
Blue Ribbon’s food processing establishment license. After
subsequent satisfactory testing and sampling by NYSDAM,
Blue Ribbon was reissued its license. A joint inspection
conducted by the FDA and NYSDAM in October 1999 observed an
employee drop a fish on the floor that then continued to be
processed, a piece of cardboard and plastic tubing hanging
into a brining tank, and the ceiling in disrepair and
rusted. Earlier inspections in 1994, 1995, and 1996 found
similar insanitary conditions and poor employee
practices.[fn4]
Defendants do not dispute that the insanitary conditions
observed by the FDA existed during the prior seven years of
documented inspections. Defendants allege, however, that,
since Suttenberg became president of Blue Ribbon on August
24, 2000, conditions at Blue Ribbon have improved. After
the January 2001 inspection, Suttenberg wrote to the FDA
outlining thirty corrective actions that Blue Ribbon would
take to correct the conditions that had been observed.
According to Suttenberg, Blue Ribbon has upgraded its
physical plant, a wall has been constructed segregating the
slicing area, seams in the cold smoking room were sealed
and repaired, and the cutting table was replaced with a
seamless frame unit. Plant walls were reinforced, and a new
thermometer was installed to ensure the accuracy of
existing thermostats that monitor fish temperatures. In
addition, Suttenberg states that all cooler and freezer
doors were painted and are scrubbed daily to keep them
clean. Sanitary footpads are West Page 37 placed at all
entry points into the plant. Restrooms have been moved, new
tile installed, and walls have been constructed to isolate
the restrooms from the processing areas. Blue Ribbon has
also designated an employee to be responsible for
supervising sanitation.
Presence of L. Monocytogenes
During inspections of the plant, the FDA found instances of
L. monocytogenes contamination in seafood products and in
the plant environment. According to the government, L.
monocytogenes is a bacterium that causes the disease
listeriosis, and food contaminated with this bacterium is
harmful to human health. Listeriosis can be serious and
even fatal for high-risk groups such as infants, the
elderly, pregnant women, and those with impaired immune
systems. The most serious consequence of infections in
susceptible individuals is septicemia, a condition in which
bacteria enter the bloodstream and multiply, thereby
poisoning the bloodstream. Complications in pregnant women
include miscarriage, stillbirth, bacteria in the bloodstream
of the newborn, and meningitis. In other susceptible
children and adults, complications commonly include
problems with the central nervous system, pneumonia,
endocarditis, localized abscesses, skin lesions, and
conjunctivitis. Although listeriosis can be treated with
antimicrobial drugs, it can be fatal, and for susceptible
individuals who become infected, the mortality rate is
between 20 and 30 percent.
In recognition of the health risk associated with
listeriosis, the FDA has adopted a “zero-tolerance” policy
with regard to L. monocytogenes and has established
procedures for fish processors to follow to eliminate and
control its presence in food. According to the government’s
expert, Mary E. Losikoff, FDA Consumer Safety Officer, a
processor must test incoming raw materials for the presence
of the bacteria, implement and follow strict sanitation
measures, conduct environmental monitoring, and implement
testing of the finished product. These steps are required
particularly in the processing of cold-smoked fish, which
are not subjected to heat sufficient to eliminate L.
monocytogenes. In addition, as discussed above, a processor
must have and follow HACCP plans.
Defendants dispute the seriousness of the risk that small
amounts of L. monocytogenes poses to human health. They
note that the bacteria does not ordinarily present a risk
to healthy individuals, noting that the United Nations Food
and Agriculture Organization (“UNFAO”) records the
incidence of disease associated with the bacteria as of
approximately two to ten cases per million people and that
epidemiological studies show a 1 in 59 million chance of
infection from a 50 gram serving of fish containing 100
bacteria per gram. While L. monocytogenes is frequently
found in fish, there have been few instances of listeriosis
from fish products. At least one group of researchers has
stated that “[l]isteria contaminated fish products should
not represent a serious impact on human health.”
FDA inspections at the plant revealed the presence of L.
monocytogenes in food samples and in the plant environment.
During the January 2001 inspection, FDA analysis revealed
the bacteria in a sample of Nova salmon bits and in floor
drains in a processing area of the plant. During the August
2000 inspection, FDA analysis revealed the presence of L.
monocytogenes in a sample of sliced smoked Nova salmon and
a sample of cream cheese and lox, as well as on the plant
floor near the brining cooler. The NYSDAM inspection at the
same time found samples of whitefish salad and smoked baked
salmon salad contaminated with L. monocytogenes. On the
West Page 38 basis of the FDA and NYSDAM findings in August
2000, Blue Ribbon recalled implicated lots of cream cheese
and lox, frozen sliced Nova salmon, frozen deli-cut Nova
boards, smoked whitefish salad, and smoked basked salmon
salad. During the October 1999 joint inspection by the FDA
and NYSDAM, samples of whitefish salad and smoked sable
were contaminated with L. monocytogenes, as well as the
cleaning room floor. In November 1999, Blue Ribbon recalled
fish lots that were found to be contaminated. The FDA and
NYSDAM found similarly contaminated food and plant
environment samples in September 1999, November 1996,
November 1995, and January 1994.
Defendants do not dispute that the FDA and NYSDAM found L.
monocytogenes in food samples and in the plant. The
defendants dispute that Blue Ribbon caused the
contamination and suggest that L. monocytogenes is widely
present in the environment, occurs naturally on raw fish,
and is a problem faced by every fish processing facility,
not just Blue Ribbon. Defendants point to a 1997 FDA study
which found that 17.5 percent of cold-smoked fish products
sampled nationwide between 1991 and 1995 tested positive
for L. monocytogenes. That study found L. monocytogenes in
ten of sixteen New York smoked fish processing plants.
Other studies and surveys indicate that the FDA study was
not an anomaly: a survey of vacuum-packed processed meats
in retail stores found 53 percent of samples contaminated
with the bacteria; vegetables have been found contaminated
with the bacteria; and another study of food samples in the
United Kingdom found an incidence rate of 6 percent. One
article states that, once bacteria has contaminated the
fish, contamination during subsequent processing becomes
almost impossible to control, even with stringent
sanitation procedures in place. Recalls of contaminated
fish are not infrequent, and according to the UNFAO,
between 1987 and 1992 there were 970 recalls of
ready-to-eat foods from 109 firms in the United States.
In addition to occurring naturally in some raw fish,
defendants also argue that it is impossible to prevent the
presence of some amount of L. monocytogenes bacteria on
cold-smoked fish. Lox, for example, is produced by the
cold-smoking process and is not prepared by being subjected
to sufficient heat to destroy L. monocytogenes. Rather,
smoked salmon subjected to sufficient heat would not be
recognized by consumers as lox. In light of this,
defendants dispute that the FDA’s “zerotolerance” with
respect to L. monocytogenes policy is appropriate. The
UNFAO has taken the position that “[a]pplying a strict zero
tolerance policy for this organism would effectively put a
number of products out of the market, such as precooked
shrimp and smoked fish.” Many European countries and Canada
have set tolerance levels graduated with the health risk
posed by the contamination.
Furthermore, defendants dispute that there are ongoing
problems of L. monocytogenes contamination at the plant.
NYSDAM tested Blue Ribbon samples on April 2, 2001, April
30, 2001, May 10, 2001, June 6, 2001, and August 21, 2001.
NYSDAM did not notify the defendants of any contamination.
Proposed Judgment Ordering Permanent Injunction
The United States has proposed terms of a permanent
injunction to be entered should it prevail on its motion
for summary judgment and defendants are found to have
violated Sections 331(a) and 331(k) of the FDCA. First,
defendants and all directors, officers, agents,
representatives, employees, successors, assigns, attorneys,
and any and all persons in active concert West Page 39
with the defendants would be permanently restrained from
the processing, preparing, packing, holding, and
distributing of food at the plant or at any other locations
unless and until certain conditions are met. These
conditions include the following:
(1) Defendants must thoroughly clean and sanitize the
plant and make certain structural changes to prevent
condensation from dripping onto food;
(2) Defendants must select a person, other than an
employee of Blue Ribbon, to act as a “Listeria expert” who
is qualified to develop a testing program, a Sanitation
Standard Operation Procedure (“SSOP”), employee training
procedures, and a monitoring protocol, to detect, prevent,
and control the introduction and spread of L.
monocytogenes in the plant environment and in the raw
ingredients and processed food products, especially for
food products that will not receive a heat process (like
cold smoked fish products);
(3) The United States Food and Drug Administration
(“USDA”) must approve the raw ingredient testing and
treatment program, SSOP, training program, and monitoring
program developed by the Listeria expert;
(4) Defendants must, under FDA supervision and by a
method detailed by the proposed permanent injunction,[fn5]
examine all lots of smoked and brined fishery products on
hand at the plant for L. monocytogenes;
(5) For any fish or fishery products for which there is
no HACCP plan, defendants must conduct a hazard analysis
and develop a plan, which is to be approved by the FDA;
and
(6) Prior to resuming operations, the FDA must notify
defendants in writing that they are in compliance with all
requirements set forth by the proposed injunction and 21
C.F.R. Parts 110 and 123.[fn6]
Once defendants meet the above conditions and the FDA
certifies that the defendants are in compliance with the
requirements of 21 C.F.R. Pts. 110 and 123, the plant may
resume operations, subject to additional conditions. These
conditions require that the defendants implement and
maintain a protocol to control the presence of L.
monocytogenes. The protocol must include a program for
treatment or testing of susceptible raw materials for food
products, such as cold-brined or cold-smoked fish that do
not receive a heat treatment sufficient to kill the
bacteria. Similarly, the protocol must include effective
and diligent sanitation procedures, environmental
monitoring, and additional controls to monitor the finished
product after processing. The FDA will be permitted to
inspect the plant, without prior notice to defendants, to
ensure continuing compliance with the permanent injunction.
Pursuant to the proposed injunction, this inspection
authority would be apart from, West Page 40 and in
addition to, the FDA’s authority to inspect, granted by 21
U.S.C. § 374.
By the terms of the proposed injunction, in the event that
the defendants and/or their agents violate Section 331(a)
or (k) of the FDCA, defendants shall immediately cease the
processing, preparing, packing, holding, and distributing
of food. Likewise, defendants must cease production if the
FDA notifies them in writing that any article of food at
the plant is adulterated, that there appear to be
insanitary conditions at the plant, or that the defendants
are not in compliance with the terms of the injunction, FDA
regulations, or the FDCA. If the FDA deems it necessary,
the defendants must also recall all articles of their
products, and all costs of such a recall must be borne by
the defendants. In the event that the FDA requires
defendants to cease production, they may not resume until
the FDA certifies that the defendants are in compliance
with the terms of the injunction, FDA regulations, and the
FDCA.
The proposed injunction provides that all decisions
specified shall be vested in the discretion of the FDA and
that the decisions will be final, subject only to review by
this Court under the arbitrary and capricious standard set
forth in 5 U.S.C. § 706(2)(A). No discovery may be
had by either party. The United States as plaintiff shall
recover the costs of the present action, including
attorneys fees, and the costs of any subsequent action
necessary to enforce the terms of the injunction, should it
prevail.
DISCUSSION
This Court has jurisdiction over this action pursuant to
28 U.S.C. § 1331 and 21 U.S.C. § 332, the
latter providing district courts with jurisdiction, for
cause shown, to restrain violations of 21 U.S.C. §
331.
Individual Defendants’ Motion to Dismiss
The individual defendants assert that the present action
against them for an injunction is improper because they are
distinct from Blue Ribbon, which is the corporate entity
that should be the sole focus of the government’s
injunction, and because the complaint does not state a
claim against them. A motion under Rule 12(b)(6) should be
granted only if “`it appears beyond doubt that the
plaintiff can prove no set of facts in support of his claim
which would entitle him to relief.'” Cohen v. Koenig, 25
F.3d 1168, 1172 (2d Cir. 1994) (quoting Conley v. Gibson,
355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957)). “The
court’s function on a Rule 12(b)(6) motion is not to weigh
the evidence that might be presented at trial but merely to
determine whether the complaint itself is legally
sufficient.” Goldman v. Belden, 754 F.2d 1059, 1067 (2d
Cir. 1985).
The Supreme Court has established that “the public interest
in the purity of its food is so great as to warrant the
imposition of the highest standard of care on
distributors.” United States v. Park, 421 U.S. 658, 671, 95
S.Ct. 1903, 44 L.Ed.2d 489 (1975) (citations and internal
quotation marks omitted). Food processing companies, and
not consumers, are best positioned to protect public
health: “Congress has preferred to place it upon those who
have at least the opportunity of informing themselves of
the existence of conditions imposed for the protection of
consumers before sharing in illicit commerce, rather than
to throw the hazard on the innocent public who are wholly
helpless.” United States v. Dotterweich, 320 U.S. 277, 285,
64 S.Ct. 134, 88 L.Ed. 48 (1943). The responsibility rests
on the corporate entities, as well as its agents, and as
such the FDA’s statutory authority empowers the government
to seek relief West Page 41 against executives, as well as
legal entities, in enforcement action. See United States v.
Undetermined Quantities of Articles of Drug, 145 F. Supp.2d
692, 694 (Md. 2001) (citing Park, 421 U.S. at 672, 95 S.Ct.
1903). “[C]orporate agents vested with the responsibility,
and power commensurate with that responsibility, to devise
whatever measures are necessary to ensure compliance with
the Act bear a `responsible relationship’ to, or have a
`responsible share’ in, violations.” Park, 421 U.S. at 672,
95 S.Ct. 1903.
Thus, to state a claim against the individual defendants,
the government must allege in the complaint that
Suttenberg, Negron, and Dozortsev had responsible
relationships to, or responsible shares in, the furtherance
of the transactions outlawed by the Act.
According to the complaint, Suttenberg is Blue Ribbon’s
president with “ultimate authority” and is “in charge of
overall operations of Blue Ribbon.” Negron is Blue Ribbon’s
vice president and “manages and supervises day-to-day
operations of the firm, including food processing, product
thawing, brining, and smoking processes.” Dozortsev is
secretary and treasurer and “manages and supervises
day-to-day operations of the firm, including monitoring
food processing, preparing HACCP plans, and monitoring
sanitation controls.” Assuming the facts of the complaint
to be true, the government has set forth facts that
establish that corporate officers Suttenberg, Negron, and
Dozortsev are responsible for the sanitation of the plant
and the safety of the food it produces.
The individual defendants argue that an injunction against
corporate officers is unnecessary where there is an
injunction against the corporate entity, because agents are
generally bound by restrictions placed on the principal.
Nevertheless, courts have enjoined corporate officers in
civil cases brought under the FDCA, when the corporate
entity was likewise enjoined. See United States v.
Universal Management Serv. Inc., 191 F.3d 750 759 (6th Cir.
1999) (applying Park and Dotterweich to an FDCA injunction
case against corporate office due to supervisory and
managerial role); cert. denied, 530 U.S. 1274, 120 S.Ct.
2740, 147 L.Ed.2d 1005 (2000); Undetermined Quantities of
Articles of Drug, 145 F. Supp.2d at 694 (enjoining company
president who had responsible relationship to or
responsible share in FDCA violations, despite assertions
that he did not personally participate in manufacture,
sale, or distribution of adulterated articles); United
States v. Sene X Eleemosynary Corp., 479 F. Supp. 970,
976-77 (S.D.Fla. 1979) (individual defendants’ positions of
authority and responsibility in the operation states a
claim under the FDCA against them). While an injunction
against corporate official might appear to the individual
defendants to be duplicative, the Supreme Court has stated:
“The requirements of foresight and vigilance imposed on
responsible corporate agents are beyond question demanding,
and perhaps onerous, but they are no more stringent than
the public has a right to expect of those who voluntary
assume positions of authority in business enterprises whose
services and products affect the health and well-being of
the public that supports them.” Park, 421 U.S. at 672, 95
S.Ct. 1903.
The individual defendants’ motion to dismiss the complaint
against them is denied.
Government’s Motion for Summary Judgment
Plaintiff has moved for a summary judgment pursuant to
Rule 56(c) of the Federal Rules of Civil Procedure. Summary
judgment must be granted if there is no genuine issue as to
any material fact and if the moving party is entitled to
judgment as a West Page 42 matter of law. See Fed.R.Civ.P.
56(c). The moving party has the burden of demonstrating the
absence of any disputed material facts, and the court must
resolve all ambiguities and draw all inferences in favor of
the party against whom summary judgment is sought. See
Thompson v. Gjivoje, 896 F.2d 716, 720 (2d Cir. 1990).
While the court views the evidence in the light most
favorable to the nonmoving party, see O’Brien v. National
Gypsum Co., 944 F.2d 69, 72 (2d Cir. 1991), “the mere
existence of some alleged factual dispute between the
parties will not defeat an otherwise properly supported
motion for summary judgment.”
The FDCA, Section 331 of Title 21 of the United States
Code, prohibits:
(a) The introduction or delivery for introduction into
interstate commerce of any food . . . that is adulterated
or misbranded.
(k) [T]he doing of any . . . act with respect to [] a
food . . . while such article is held for sale . . . after
shipment in interstate commerce and results in such
article becoming adulterated or misbranded.
21 U.S.C. § 331(a) & (k). The elements for
establishing a violation of either of these provisions are
essentially the same: (1) the product in question must be a
food; (2) the food must be adulterated; and (3) there must
be an interstate commerce nexus. The only difference
between subsections (a) and (k) of Section 331 is the
timing of the interstate commerce element: Section 331(a)
prohibits introducing adulterated food into interstate
commerce after processing, while Section 331(k) prohibits
adulterating food after its components have traveled in
interstate commerce. I address these three violation
elements in turn.
Defendant’s Products are “Food”
The FDCA defines “food” as “(1) articles used for food or
drink for man or other animals, (2) chewing gum, and (3)
articles used for components of any such article.” 21
U.S.C. § 321(f). Under the FDCA, a court may take
judicial notice that an article is food where it is common
knowledge that the article is used for food. United States
v. H.B. Gregory Co., 502 F.2d 700, 704 (7th Cir. 1974);
United States v. O.F. Bayer & Co., 188 F.2d 555, 557 (2d
Cir. 1951). Moreover, defendants do not dispute that the
fish products it processes and distributes are food.
Nexus to Interstate Commerce
The FDCA defines interstate commerce as “commerce between
any State or Territory and any place outside thereof.” 21
U.S.C. § 321(b). The FDCA also provides that “[i]n
any action to enforce the requirements of [the FDCA]
respecting a food . . . the connection with interstate
commerce required for jurisdiction in such action shall be
presumed to exist.” 21 U.S.C. § 379a. The
government, in addition, has submitted evidence to
establish that Blue Ribbon receives raw fish to be
processed from Norway, Chile, and the Faroe Islands. Blue
Ribbon ships its finished product to retailers in New
Jersey and Pennsylvania. Moreover, defendants do not
dispute that it is engaged in interstate commerce.
Adulteration of Defendants’ Products
It is a violation of the FDCA to move in interstate
commerce food that has become adulterated. Food is
adulterated as defined by the FDCA:
(1) [i]f it bears or contains any poisonous or
deleterious substance which may render it injurious to
health; but in case the substance is not an added
substance such food shall not be considered West Page 43
adulterated under this clause if the quantity of such
substance in such food does not ordinarily render it
injurious to health[; or]
(4) [i]f it has been prepared, packed, or held under
insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been
rendered injurious to health.
21 U.S.C. § 342(a)(1) & (4). According to the United
States, defendants’ products are adulterated pursuant to
this definition on the basis of three alternative grounds.
First, plaintiff alleges the food is adulterated as defined
by Section 342(a)(4) because defendants had an inadequate
HACCP plan for smoked Nova salmon and had no HACCP plans
for Nova salmon bits and smoked sea bass. Second, plaintiff
alleges that the FDA’s and NYSDAM’s continued observance of
insanitary conditions at the plant, including but not
limited to the detection of L. monocytogenes at the plant,
demonstrates that defendants’ seafood may have become
contaminated with filth or otherwise rendered injurious to
health pursuant to Section 342(a)(4). Plaintiff alleges a
third and independent basis of adulteration pursuant to
Section 342(a)(1) due to the presence of L. monocytogenes
in defendants’ seafood, alleged to be a “poisonous or
deleterious substance which may render it injurious to
health.” Because the absence of a dispute of material facts
presented by any one of these allegations will support
plaintiffs motion for summary judgment, I will address each
basis of adulteration in turn.
1. Lack of an HACCP Plan. The FDA regulations that
establish the requirements of the HACCP plan states that
the “[f]ailure of a processor to have an implement a HACCP
plan that complies with this section whenever a HACCP plan
is necessary . . . shall render the fish or fishery
products of that fishery of that processor adulterated
under section [342(a)(4)] of the [FDCA].” 21 C.F.R.
§ 123.6(g). The government alleges that the HACCP
plan deficiencies observed and reported by the FDA during
August 2000 and January 2001 allow, as a matter of law,
this Court to find Blue Ribbon’s food adulterated under the
FDCA.
Defendants do not dispute that the FDA has observed,
documented, and warned Blue Ribbon and the individual
defendants about the problems with the existing HACCP plan
for smoked Nova salmon and the problematic lack of HACCP
plans for Nova salmon bits and smoked sea bass. Defendants
argue, in sum, that Blue Ribbon has in fact “implemented an
effective HACCP Plan,” which is “effective and followed by
Blue Ribbon.” Furthermore, defendants complain that “[i]f
the Government means to allege that the HACCP Plan is
somehow deficient, it has not specified what is wrong with
it. Dozortsev, who is HACCP-certified, confirms that it is
effective as implemented.”
Defendants provide this Court with two HACCP plans, which
Dozortsev declares are currently effective. Even a cursory
inspection reveals these are the same HACCP plans in effect
at Blue Ribbon at the time of the January 2001 inspection
and found to be inadequate by the FDA. One plan is labeled
cold-smoked fish and one is labeled hot-smoked fish. In
handwriting on the former HACCP plan, someone has written
“Product: salmon – nova.” On the hot smoked fish
HACCP plan, unidentified handwriting identifies the plan as
operating as to whitefish, chubbs, whiting, trout, winter
carp, and butter fish.
As discussed in some detail above, in August 2000, the FDA
found Blue Ribbon did not have a HACCP plan for Nova salmon
bits, and Blue Ribbon promised to correct this deficiency
and implement a written HACCP plan. By January 2001, West
Page 44 Blue Ribbon had not implemented a HACCP plan for
Nova salmon bits. At the time Dozortsev provided the
current HACCP plans to this Court by declaration dated
October 12, 2001, there was still no HACCP plan for Nova
salmon bits. The FDA also observed, documented, and
discussed with defendants the need for an HACCP plan to
cover the processing of smoked sea bass. The HACCP plans
provided to this Court do not encompass sea bass. Neither
was the smoked Nova salmon HACCP plan amended in any way in
response to the FDA’s January 2001 inspection which
revealed a number of critical deficiencies in the current
HACCP plan, even though the FDA was assured by Suttenberg
that Blue Ribbon promised to correct all HACCP plan
violations.[fn7] Defendants’ claims that they are unaware
as to the nature of any HACCP plan deficiencies is both
incredible and irrelevant, given the content of the FDA
inspection reports from August 2000 and January 2001,
defendants’ “promise” to undertake the plans’ corrections,
and the absence of any scienter requirement in the relevant
regulations.
Because the defendants’ HACCP plans are inadequate and do
not comply with the FDA regulations, the food Blue Ribbon
processes pursuant to them is adulterated as a matter of
law, as defined by Section 342(a)(4) of the FDCA. However,
because the scope of an injunction entered against Blue
Ribbon to remedy FDCA violations may vary depending on the
nature of adulteration of defendants’ seafood, I next
consider the government’s other two bases for asserting
adulteration.
2. Insanitary Plant Conditions. The government also
contends that defendants’ seafood is adulterated under 21
U.S.C. § 342(a)(4) because the undisputed facts show
insanitary conditions and practices. A food is deemed
adulterated under 21 U.S.C. § 342(a)(4) if
“processed under insanitary conditions, whether [the food
has] actually . . . become dangerous to health or not.”
United States v. 1250 Cans, Pasteurized Frozen Whole Eggs,
339 F. Supp. 131, 140 (N.D.Ga. 1972); see also United
States v. Nova Scotia Food Prod. Corp., 568 F.2d 240, 247
(2d Cir. 1977) (“[F]ood does not have to be actually
contaminated during processing and packing but simply
[shown] that `it may have been rendered injurious to
health,’ § 342(a)(4), by inadequate sanitary
conditions of prevention.”). To prove adulteration under
Section 342(a)(4), the government must show a “reasonable
possibility” that, by virtue of the insanitary conditions
under which the food is prepared, packed, or held, an
article of food may have been rendered filthy or injurious
to health. See Berger v. United States, 200 F.2d 818, 821
(8th Cir. 1952) (“The condition condemned by the statute .
. . is one which would with reasonable possibility result
in contamination.”); United States v. H.B. Gregory, 502
F.2d 700, 704-05 (7th Cir. 1974) (“[T]he definitive
`reasonable possibility’ test [is] now generally accepted
in cases involving adulterated food under §
342(a)(4).”). The word “filth,” as used in the statute,
has West Page 45 been construed to have its usual and
ordinary meaning, and is not confined to any scientific or
medical definition. See United States v. Swift & Co., 53 F.
Supp. 1018 (M.D.Ga. 1943).
Some of the insanitary conditions observed during the
course of the FDA and NYSDAM inspections since 1994 are
detailed above. The defendants do not dispute that these
conditions were observed and documented by the FDA and
NYSDAM. The government has submitted a large bound volume
of inspection reports going back as far as 1994 detailing
recurring violations, laboratory results indicating the
presence of L. monocytogenes in food products and the plant
environment, press releases of Blue Ribbon recalls due to
contaminated seafood, letters to Blue Ribbon corporate
agents specifying insanitary conditions observed during
inspections and warning that a seizure or injunction may
result if the conditions are not rectified, and letters of
assurances by Blue Ribbon agents that the insanitary
conditions would be fixed.
Defendants do not deny that they have been processing
seafood under insanitary conditions for the last seven
years, but claim that these conditions have been rectified
under Suttenberg’s relatively new management of the plant
presenting an issue of fact for a jury. Defendants’ submit
that since the January 2001 inspection, NYSDAM has tested
Blue Ribbon’s products for L. monocytogenes five times,
have each time found no trace of the bacteria.
Defendants’ “new management” defense does not present a
material issue of fact for a jury with respect to the
question of whether defendants’ seafood products are
adulterated. Whether Blue Ribbon has finally cleaned up its
plant does not change the fact that between 1994 and the
summer of this year the FDA and the NYSDAM documented
critical deficiencies in the plant’s conditions and
cleanliness, sufficient to establish as a matter of law
that there is a reasonable possibility that the food has
become filthy or injurious to health. Moreover, while Blue
Ribbon may have not tested positive for the presence of L.
monocytogenes since the January 2001 inspection, numerous
inspections by the NYSDAM since then have revealed
continued insanitary conditions at the plant. The March 12,
2001 inspection found a number of violations including: no
handwash sign; unshielded light source; soiled fan guards;
dust-laden vent cover; an unscreened entrance; an uneven,
soiled floor; debris and litter on the floor; a damaged
freezer door gasket; the accumulation of dark residues of
air curtain to processing room; exposed fish in a freezer;
a lack of thermometers in some retail display cases; and
improper record-keeping of internal temperatures of
processing fish. A subsequent inspection by NYSDAM on April
30, 2001, revealed a “critical deficiency” caused by the
improper processing of Nova smoked bits. General
deficiencies were also observed, such as: soiled doors;
heavy ice accumulation in freezers; employees with no hair
restraints; an unscreened entrance; and dead flies and a
dead beetle. NYSDAM assessed Blue Ribbon a fine of $300.
During a subsequent inspection on June 6, 2001, the day
after the United States filed the present complaint, NYSDAM
again found both critical and general deficiencies in the
plant’s operation and environment, including improper fish
processing procedures, and insanitary plant conditions,
including mouse droppings, cockroaches, live flies, debris,
and refuse. Blue Ribbon was assessed a fine of $600. On
these facts, as a matter of law, there is a reasonable
possibility that Blue Ribbon’s food has been “prepared,
packed, or held under insanitary conditions whereby it may
have become contaminated with filth, or whereby West Page
46 it may have been rendered injurious to health.” 21
U.S.C. § 342(a)(4).
3. Presence of L. Monocytogenes. The government argues
that Blue Ribbon’s seafood is adulterated because L.
monocytogenes is a “poisonous or deleterious substance,”
the presence of which renders the seafood “injurious to
health.” 21 U.S.C. § 342(a)(1). If L. monocytogenes
is an “added substance,” according to the FDCA and the
FDA’s zero-tolerance policy, any trace of it in a food
product renders that product adulterated. If L.
monocytogenes is not an added substance, defendants’ fish
are adulterated only if the quantity of the bacteria
“ordinarily render[s] it injurious to health.” 21 U.S.C.
§ 342(a)(1) (emphasis added).
Defendants’ argue first that L. monocytogenes is not an
“added substance” and that, therefore, 21 U.S.C. §
342(a)(1) provides that food is not adulterated if it
contains a quantity of L. monocytogenes not ordinarily
injurious to health. Defendants argue alternatively that,
if L. monocytogenes is an “added substance,” the FDA’s
failure to set a “tolerance level” pursuant to 21 U.S.C.
§ 346 is a violation of the FDCA.
Added Substance
The FDCA does not define the terms “added substance,” but
FDA regulations define the relevant terms as follows:
(c) A naturally occurring poisonous or deleterious
substance is a poisonous or deleterious substance that is
an inherent natural constituent of a food and is not the
result of environmental, agricultural, industrial, or
other contamination.
(d) An added poisonous or deleterious substance is a
poisonous or deleterious substance that is not a naturally
occurring poisonous or deleterious substance. When a
naturally occurring poisonous or deleterious substance is
increased to abnormal levels through mishandling or other
intervening acts, it is an added poisonous or deleterious
substance to the extent of such increase.
21 C.F.R. § 109.3(c) & (d) (italics in original).
Defendants argue that L. monocytogenes is not an added
substance because it “occurs in seafood naturally in the
wild.” Defendants cite United States v. 1232 Cases American
Beauty Brand Oysters, 43 F. Supp. 749 (W.D.Mo. 1942), which
held that fish bones and oyster shell fragments, while
deleterious, were not artificially added substances. Id. at
750-51. Yet the defendants themselves submit evidence that
readily distinguishes the occurrence of L. monocytogenes in
fish and the occurrence of fish bones in fish. The UNFAO
report submitted by defendants notes that fish are not born
with L. monocytogenes but, rather, are contaminated with
the bacteria by coming into contact with it in the
environment. George W. Bierman, Ph.D., defendants’ proposed
expert, states that the “[FDA] and the Food Safety
Inspection Service of the U.S. Department of Agriculture
(“FSIS”) have acknowledged that `[b]ecause L. Monocytogenes
is widely present in the environment, it would be
impossible to prevent animals from coming into contact with
the bacteria'” and states that the same is true of raw
fish. “Raw fish procured by processors are likely to have
come into contact with the organism in the wild,” Bierman
concludes. L. monocytogenes is, thus, not an inherent
natural constituent of fish but, rather, a bacterial
organism present in the environment that comes into contact
with, and contaminates, some fish. See United States v.
Union Cheese Co., 902 F. Supp. 778, 786 (N.D.Ohio 1995)
(finding L. monocytogenes not to be an inherent natural
constituent of cheese but rather the result of
environmental contamination); cf. United States v. An
Article of Food Consisting of Cartons of Swordfish, 395 F.
Supp. 1184 (S.D.N.Y. West Page 47 1975) (finding mercury
to be an added substance because it does not occur
naturally in swordfish).
Even if L. monocytogenes existed naturally in fish, it
would still be considered an “added substance” under the
FDCA because the spread of the bacteria to other
uncontaminated fish is “increased to abnormal levels
through mishandling or other intervening acts” and is
therefore considered an “added substance” under the FDA
regulations. 21 C.F.R. § 109.3(b). Defendants do not
dispute but rather advance the argument that L.
monocytogenes contamination can be spread by intervening
acts of man: “Contamination takes place not only in the
wild, but on fishing boats or during filleting, or
potentially anywhere else in the chain from ocean to
fishing boat to trade to processor to wholesaler to
retailer to consumer.” Defendants do not dispute the
insanitary conditions observed by the FDA and NYSDAM going
back as far as 1994. The government’s expert, Losikoff,
states without dispute that the conditions observed during
the January 2001 inspection were such that could result in
the cross-contamination of previously uncontaminated fish
products, specifically, product residue on food contact
surfaces, like the slicer and cutting boards; cutting
boards and knives not sanitized before use as specified in
the plant’s sanitation procedures; cutting boards that were
worn from use and gouged with nicks and scrapes making
cleaning and sanitizing difficult; cooler and freezer door
handles that were caked with residue; and plastic strips
used as room-dividing curtains that touched the floor and
were then allowed to drag across uncovered processed sea
bass as the employee pulled a cart from one room to the
next. Other employee practices observed constitute
intervening acts increasing the amount of the bacteria in
the plant’s fish, like employees touching unclean surfaces
then handling ready-to-eat fish, the lack of protective
clothing over employee street clothes, and bare arms and
beards. “Insanitary conditions, which are the intervening
acts of humans, are sufficient grounds upon which to
conclude that a deleterious substance has been `added.'”
Union Cheese Co., 902 F. Supp. at 786; see also Continental
Seafoods, Inc. v. Schweiker, 674 F.2d 38, 43 (D.C. Cir.
1982) (affirming similar holding with respect to salmonella
in shrimp). Accordingly, I conclude based on the undisputed
facts that L. monocytogenes is an added substance under the
FDCA.
Injurious to Health
Defendants seek to raise a material and disputed issue of
fact as to whether L. monocytogenes is a “poisonous or
deleterious substance which may render [food] injurious to
health,” as required by 21 U.S.C. § 342(a)(1).
Defendants first state that “[t]he bacterium does not
ordinarily present a risk to healthy individuals.” (Bierman
Decl. § 87, 8; FDA, Center for Food Safety and
Applied Nutrition, Foodborne Pathogens Microorganisms and
Natural Toxins Handbook (“Bad Bug Book”)). Defendants
further note that “healthy people do not develop
listeriosis except in extremely rare cases” and that
“epidemiological studies showing a 1 in 59 million chance
of infection from a 50 gram serving of fish containing 100
bacteria per gram” focus on the risk of disease to the
population at large rather than to susceptible individuals
such as the young, old, and pregnant. As to the susceptible
population, the FDA’s Bad Bug Book also states as of data
from 1987 that “there are at least 1600 cases of
listeriosis with 415 deaths per year in the U.S.” and that
“manifestations of listeriosis include septicemia,
meningitis (or meningoencephalitis), encephalitis, West
Page 48 and intrauterine or cervical infections in pregnant
women, which may result in spontaneous abortion . . . or
stillbirth.” An article submitted by defendants states that
“[l]isteria monocytogenes causes listeriosis, a disease
that can be serious and is often fatal to susceptible
individuals. . . . Accordingly, regulatory agencies in the
United States have adopted a zero-tolerance policy towards
the incidence of the organism in ready-to-eat food
products.” M. Eklund et al., U.S. Dept. of Commerce, NOAA,
National Marine Fisheries Service, “Incidence and Sources
of Listeria monocytogenes in Cold Smokes Fishery Products
and Processing Plants,” Journal of Food Protection, Vol. 58
(1995). The UNFAO report provided by defendants states
that, “[r]ecognizing the potential for fishery products to
be a vehicle for large outbreaks of listeriosis, it is
prudent to seek appropriate strategies to minimize human
exposure to infectious doses of [L. Monocytogenes].” United
Nations Food and Agriculture Organization Fisheries Report
No. 604. Another article provided by defendants states
that “listeriosis is an atypical foodborne disease of major
public health concern because of the severity and the
nonenteric nature of the disease (meningitis, septicemia,
and abortion), a high case-fatality rate (around 20 to 30%
of cases), a frequently long incubation time, and a
predilection for individuals who have underlying conditions
which lead to impairment of T-cell-mediated immunity.” J.
Rocourt et al., Listeria Monocytogenes, from Food
Microbiology Fundamentals and Frontiers (1997). The legal
question posed by defendants’ arguments is simply whether
the substance must be deleterious to the entire population
or simply to significant segments of the population such as
the old, the young, and pregnant women. To pose the
question is to answer it. Because L. monocytogenes is a
poisonous or deleterious substance that may render Blue
Ribbon’s fish products injurious to the health of
significant populations of consumers, such products are
adulterated within the meaning of Section 342(a)(1) of the
FDCA.
Zero-Tolerance Policy
Sections 342(a)(2)(A) and 346 of the FDCA provide that
some added poisonous or added deleterious substances in
food will not render the food adulterated if the quantity
of the offending substance is below a “tolerance level”
established by the FDA.[fn8] Defendants argue that the
FDA’s zero-tolerance policy violates the FDCA and that the
FDA must promulgate minimum tolerance levels in recognition
of the prevalence of L. monocytogenes in smoked fish plants
and on cold-smoked fish products. Putting aside the fact
that the government need not rely on a finding that the
food is adulterated pursuant to Section 342(a)(2)(A),
because it can show that the added substance is actually
injurious to health and adulterated as per Section
342(a)(1), the defendants’ argument is without merit.
According to Section 346,[fn9] West Page 49 “[a]ny
quantity of added poisonous or added deleterious substance
is . . . “unsafe,” unless the substance is required in food
production or cannot be avoided by good manufacturing
practice.” Young, 476 U.S. at 977, 106 S.Ct. 2360 (emphasis
in original). “For these latter substances, `the Secretary
shall promulgate regulations limiting the quantity therein
or thereon to such extent as he finds necessary for the
protection of public health.'” Id. (citing 21 U.S.C.
§ 346). Since the enactment of the FDCA in 1938,
“the FDA has interpreted this provision to give it the
discretion to decide whether to promulgate a § 346
regulation, which is known in the administrative vernacular
as a “tolerance level.”” Id. The FDA is not required to
promulgate a § 346 regulation to set a tolerance
level for L. monocytogenes, and this Court is not permitted
to second guess the agency’s determination unless its
decision is shown to be arbitrary and capricious and in
violation of the Administrative Procedure Act, 5 U.S.C.
§ 706(2)(A) (“APA”), which is not the case
here.[fn10] See United States v. Royal Baltic Ltd., No.
94-CV-1178 (E.D.N.Y. Oct. 3, 2001) (finding that the FDA
has the discretion not to set a tolerance level for L.
monocytogenes).
Furthermore, the defendants’ own evidence belies the
assertion that it would be impossible to produce
contamination-free cold-smoked products. Bierman,
defendants’ expert, points to a number of positive
advancements in the smoked fish industry that, if properly
implemented, significantly decrease the incidence of L.
monocytogenes, specifically, the development and
implementation of adequate HACCP plans, strict monitoring of
the firm’s fish processing procedures and sanitation, and
the testing of raw materials before they are allowed to
enter and contaminate the plant. It is a matter of
undisputed fact that the defendants have failed time and
time again to take these necessary precautions.
There is no factual dispute that defendants have violated
Section 331(a) and (k) of the FDCA by introducing into
interstate commerce food that is adulterated or by causing
food to become adulterated after its introduction into
interstate commerce.
Jurisdiction to Enter Permanent Injunction
The FDCA expressly authorizes district courts to grant
injunctiver West Page 50 relief to enforce its provisions.
21 U.S.C. § 332(a).[fn11] Where the government is
enforcing a statute designed to protect the public
interest, it is not required to show irreparable harm to
obtain injunctive relief. United States v. Diapulse Corp.
of America, 457 F.2d 25, 27-28 (2d Cir. 1972); United
States v. Schmitt, 734 F. Supp. 1035, 1049 (E.D.N.Y. 1990).
The statute’s enactment constitutes Congress’ “implied
finding that violations will harm the public and ought, if
necessary, be restrained.” Diapulse Corp., 457 F.2d at 28
(citing United States v. City and County of San Francisco,
310 U.S. 16, 60 S.Ct. 749, 84 L.Ed. 1050 (1940)). To enjoin
future behavior, the government must show that defendants
have violated the FDCA and that there is some reasonable
likelihood that the violations may recur. See Diapulse
Corp., 457 F.2d at 28-29; Schmitt, 734 F. Supp. at 1049.
The probability of future violations may be inferred from
past unlawful conduct. Commodity Futures Trading Comm’n v.
British American Commodity Options Corp., 560 F.2d 135, 144
(2d Cir. 1977); United States v. Odessa Union Warehouse
Co-op, 833 F.2d 172, 176 (9th Cir. 1987).
As established above, the evidence shows that the
defendants have violated the FDCA by distributing
adulterated seafood on a continued basis throughout the
years. Their behavior has persisted despite a series of
inspections, warnings from the state and federal
government, the temporary revocation of their license by
NYSDAM, and a number of monetary fines. Given the extent
and numerosity of past warnings to Blue Ribbon and its
agents, defendants cannot satisfy the burden to establish
that “there is no reasonable expectation that the wrong
will be repeated.” United States v. W.T. Grant, 345 U.S.
629, 633, 73 S.Ct. 894, 97 L.Ed. 1303 (1953).
The defendants oppose the substance and form of the
government’s proposed permanent injunction on basically two
grounds. First, defendants argue that the effect of the
permanent injunction will be to shut down Blue Ribbon,
causing its eleven employees, including the three
defendants, to lose their jobs. The injunction, however,
will not require Blue Ribbon to stop processing fish but,
rather, to stop processing fish that is or has become
adulterated. The Second Circuit has held that a business
may not complain “that the injunction is impermissible
because it will put him out of business.” Diapulse Corp.,
457 F.2d at 29. A business “`can have no vested interest in
a business activity found to be illegal.'” Id. (citing
United States v. Walsh, 331 U.S. 432, 67 S.Ct. 1283, 91
L.Ed. 1585 (1947)).[fn12] Second, defendants argue that the
proposed injunction would “empower [the] FDA to
micro-manage Blue Ribbon’s facility” and that they should
not have to pay for FDA inspections to ensure their
compliance with the injunction or hire an outside
consultant to monitor food safety. These objections to the
proposed injunction do not merit an alteration of its
terms. These terms of the proposed injunction, including
the responsibility for costs and monitoring by outside
consultants, have been routinely accepted and imposed by
other courts faced with similar proof of FDCA violations.
See, e.g., United States v. Syntrax Innovations, Inc., 149
F. Supp.2d 880, 882-891 (E.D.Mo. West Page 51 2001)
(granting government’s motion on summary judgment for
misbranding in violation of the FDCA and imposing permanent
injunction providing for very similar terms); United States
v. Union Cheese Co., 902 F. Supp. 778, 787-90 (N.D.Ohio
1995) (granting preliminary injunction against cheese
factory due to presence of L. monocytogenes with almost
precisely the same terms). I recognize that this Court’s
equitable powers “should be exercise in harmony with the
overall objectives of the legislation,” Commodity Futures
Trading Comm’n v. Hunt, 591 F.2d 1211, 1219 (7th Cir.
1979), and that the FDCA’s “overriding purpose [is] to
protect the public health.” United States v. Article of
Drug, Bacto-Unidisk, 394 U.S. 784, 798, 89 S.Ct. 1410, 22
L.Ed.2d 726 (1969). By keeping contaminated fish processed
under conditions of filth off consumers’ tables, this
permanent injunction will serve that important purpose.
CONCLUSION
The individual defendants’ motion to dismiss the complaint
against them is denied. The government’s motion for summary
judgment is granted. The government is directed to settle a
judgment on notice within thirty days of the date of this
decision.
The Clerk is directed to furnish a filed copy of the within
to all parties and to the magistrate judge.
SO ORDERED.
[fn1] In defendants’ answer, defendants deny that Suttenberg
is responsible for these areas and admit only that
Suttenberg is president of Blue Ribbon and that he performs
his duties at the plant in Brooklyn.
[fn2] The press release that announced the product recall
stated, in part:
It was revealed during FDA laboratory testing that [the
implicated lots] may have the potential to be contaminated
with Listeria monocytogenes, an organism which can cause
serious and sometimes fatal infections in young children,
frail elderly people, and others with weakened immune
systems. Although healthy people may suffer only
short-term symptoms, such as high fever, severe headache,
nausea, abdominal pain and diarrhea, listeria infection
can cause miscarriages and stillbirths among pregnant
women. To date there have been no reported illnesses.
[fn3] Specifically, the HACCP plan states brining time is
four hours, and the firm’s written procedures and
monitoring records indicate brining time to be six hours.
[fn4] Based on the January 1994 inspection, the FDA issued
a warning letter to Blue Ribbon on March 2, 1994. The
warning letter documented insanitary conditions, such as
live cockroaches in the customer pickup and loading areas,
existence of standing water, dried and encrusted fish on
racks and fans, deeply scored cutting boards, the failure
of employees to properly wash their hands, whole raw salmon
on the floor awaiting processing, and the presence of L.
monocytogenes. On March 30, 1994, defendant Negron, as vice
president, responded to the warning letter and detailed
several corrective actions to be taken.
[fn5] Specifically, the defendants would be required to
select an FDA-approved laboratory to perform the L.
monocytogenes testing, and the FDA must receive written
reports detailing the laboratory results within two days
after the defendants receive the results. The FDA would be
authorized to conduct additional analyses and examine food
products and raw ingredients as it deems necessary. Any
fishery products that contain L. monocytogenes would have
to be destroyed or reconditioned under FDA supervision. All
FDA expenses relating to supervision, analyses, and
examination shall be bourne by the defendants, at rates
specified in the proposed permanent injunction.
[fn6] 21 C.F.R. Pt. 110 details guidelines for “current
good manufacturing practice in manufacturing, packing, or
holding human food,” and 21 C.F.R. Pt. 123 relates to fish
and fishery products.
[fn7] As discussed earlier, the Nova smoked salmon HACCP
plan did not comply with FDA regulations and continues not
to comply because (1) the plan is signed but not dated as
required by 21 C.F.R. § 123.6(d), (2) there is no
critical limit for internal fish temperature required by 21
C.F.R. § 123.6(c)(4), no time was specified for
thawing frozen fish, as required by 21 C.F.R. §
123.6(c)(2)(i), no procedure was included for monitoring
brine solution or fish temperature during brining required
by 21 C.F.R. § 123.6(c)(4), there was no procedure
to check the accuracy of thermometers, Salometers, and
thermostats required by 21 C.F.R. § 123.6(c)(4), and
there was inadequate monitoring of critical control points,
as required by 21 C.F.R. § 123.6(c)(7).
[fn8] Section 342(a)(2)(A) of the FDCA provides that a food
shall be deemed adulterated “if it bears or contains any
added poisonous or added deleterious substance (other than
[exceptions not relevant here]) that is unsafe within the
meaning of section 346 of this title.” 21 U.S.C. §
342(a)(2)(A).
[fn9] Section 346 of the FDCA states in full:
Any poisonous or deleterious substance added to any food,
except where such substance is required in the production
thereof or cannot be avoided by good manufacturing
practice shall be deemed to be unsafe for purposes of the
application of clause (2)(A) of section 342(a) of this
title; but when such substance is so required or cannot be
so avoided, the Secretary shall promulgate regulations
limiting the quantity therein or thereon to such extent as
he finds necessary for the protection of public health,
and any quantity exceeding the lim its so fixed shall
also be deemed to be unsafe for purposes of the
application of clause (2)(A) of section 342(a) of this
title. While such a regulation is in effect limiting the
quantity of any such substance in the case of any food,
such food shall not, by reason of bearing or containing
any added amount of such substance, be considered to be
adulterated within the meaning of clause (1) of section
342(a) of this title. In determining the quantity of such
added substance to be tolerated in or on different
articles of food the Secretary shall take into account
the extent to which the use of such substance is required
or cannot be avoided in the production of each article,
and the other ways in which the consumer may be affected
by the same or other poisonous or deleterious substances.
21 U.S.C. § 346.
[fn10] The APA provides that an agency action may be
overturned only if it is “arbitrary, capricious, and an
abuse of discretion, or otherwise not in accordance with
the law.” 5 U.S.C. § 706(2)(A); Marsh v. Oregon
Natural Resources Council, 490 U.S. 360, 375-78, 109 S.Ct.
1851, 104 L.Ed.2d 377 (1989). Although the Court may
consider whether the agency has made a clear error of
judgment, the Court “is not empowered to substitute its own
judgment for that of the agency.” Id. at 377, 109 S.Ct.
1851. Moreover, “[a] reviewing court must generally be at
its most deferential when the determination is guided by
the agency’s scientific expertise, unless the agency’s
views have no basis in fact or are irrational.” Henley v.
FDA, 77 F.3d 616, 620 (2d Cir. 1996). Here, defendants have
not demonstrated that the FDA’s policy is without basis in
fact or is irrational.
[fn11] Section 332(a) of Title 21 states in full that
“[t]he district courts of the United States and the United
States courts of the Territories shall have jurisdiction,
for cause shown[,] to restrain violations of section 331 of
this title.”
[fn12] In addition, it is noted that the government is not
seeking a harsher remedy, like criminal penalties, pursuant
to 21 U.S.C. § 333, or seizure of defendants’
products, pursuant to 21 U.S.C. § 334.