UNITED STATES DISTRICT COURT 

NORTHERN DISTRICT OF ILLINOIS 

EASTERN DIVISION 

UNITED STATES OF AMERICA, 

 Plaintiff, 

v. 

EASTERN SEAFOOD, INC., et al., 

 Defendants. 

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No. 02 C 5129 

Judge Kennelly 

UNITED STATES’ OPPOSITION TO DEFENDANTS’ 

PETITION TO VACATE CONSENT DECREE OF PERMANENT INJUNCTION 

Introduction 

The court should deny defendants Eastern Seafood, Inc. and Mario Falco’s motion to 

vacate the Consent Decree of Permanent Injunction to which they agreed in 2002. Food and 

Drug Administration investigators have documented violations of the consent decree as recently 

as last year, during their April 2014 inspection of Eastern Seafood. Among other things, 

investigators found an employee of defendants creating documentation that should have been 

prepared at or near the time of the events the documents recorded. They observed a mold-like 

substance on the ceiling above ingredients used in food processing and on a tarp covering food 

processing equipment. They saw an employee handling food without washing or sanitizing his 

hands, other employees walking through the food processing area and storage cooler without 

proper hair covering, and condensate dripping from a condenser onto uncovered raw fish. They 

also saw old, food-like residue on the blade of a saw used to cut fish products, even though the 

defendants’ records represented that the equipment had been “cleaned and sanitized” to a 

“satisfactory level.” These and other documented violations, combined with comments made 

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during the inspection by Defendant Falco, Eastern Seafood’s president, that the consent decree 

“means nothing” to him and was “garbage,” amply demonstrate that the consent decree and the 

oversight it provides remain necessary to ensure that the defendants comply with the Federal 

Food, Drug, and Cosmetic Act and its implementing regulations. 

Background 

I. Regulation of Processors of Fish and Fishery Products 

Defendants Eastern Seafood, Inc. and Marion Falco process fish and fishery products. As 

such, they are required to conduct a hazard analysis to determine whether there are food safety 

hazards that are reasonably likely to occur for each product they process, and to identify the 

preventive measures that can be applied to control those hazards. 21 C.F.R. § 123.6(a). If they 

identify that any food safety hazards are likely to occur, defendants are required to develop, 

implement, and verify appropriate plans, referred to as Hazard Analysis and Critical Control 

Point (“HACCP”) plans, specific to each of their products. 21 C.F.R. § 123.6(b). Each HACCP 

plan must include appropriate steps related to monitoring, verification, recordkeeping, corrective 

actions, and sanitization-control procedures to ensure the plan is effectively implemented. 21 

C.F.R. §§ 123.6–123.11. By developing, implementing, and verifying adequate written HACCP 

plans specific to each of their products, fish and fishery products processors control the health 

risks associated with these products. See generally Declaration of Jane Cluster (“Cluster Decl.”) 

¶ 4, attached as Exhibit 1. 

 Food is adulterated within the meaning of the Act, 21 U.S.C. § 342(a)(4), if it “has been 

prepared, packed, or held under insanitary conditions . . . whereby it may have been rendered 

injurious to health.” Fish and fishery products processed without adequate written HACCP plans 

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are adulterated as a matter of law under 21 U.S.C. § 342(a)(4). 21 C.F.R. § 123.6(g); see also 

Blue Ribbon Smoked Fish, 179 F. Supp. 2d 30, 35 (E.D.N.Y. 2001) (“Because the defendants’ 

HACCP plans are inadequate and do not comply with the FDA regulations, the food [defendant] 

processes pursuant to them is adulterated as a matter of law, as defined by Section 342(a)(4) of 

the FDCA.”), aff’d in relevant part, 56 Fed. Appx. 542 (2003); see also Cluster Decl., Exhibit 1, 

¶ 5. 

II. Procedural History 

 In July 2002, the United States filed a complaint for injunction, alleging that defendants 

violated the Act, 21 U.S.C. § 331(k), by causing articles of food, namely scrombrotoxin fish 

products, to become adulterated while held for sale after shipment in interstate commerce. 

Complaint ¶ 1. Defendants’ fish products were adulterated within the meaning of the Act, 21 

U.S.C. § 342(a)(4), in that they had been prepared, packed, and held under insanitary conditions 

whereby they may have been rendered injurious to health. Id. ¶ 6. Specifically, because 

defendants failed to develop and implement an adequate HACCP plan for their fresh 

scrombrotoxin fish products as required by FDA’s regulations found at 21 C.F.R. Part 123, the 

food they produced was adulterated within the meaning of 21 U.S.C. § 342(a)(4). Id. ¶ 9. 

 In August 2002, this court entered a Consent Decree of Permanent Injunction that, among 

other things, required defendants to “have in place and implement[] a HACCP plan that contains 

an ongoing scrombrotoxin control program, and ongoing verification procedures in the HACCP 

plan that ensure that the plan continuously controls the scrombrotoxin hazard and that the plan is 

being consistently followed.” Decree ¶ V. The decree further restrained and enjoined 

defendants “from doing or causing to be done, directly or indirectly, any act that violates 21 

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U.S.C. § 331(k) by causing food to become adulterated within the meaning of 21 U.S.C. 

§ 342(a)(4) after shipment in interstate commerce.” Id. ¶ VIII. 

III. Evidence of Defendants’ Violative Conduct since 2009 

During FDA’s most recent inspection of Eastern Seafood conducted on March 31 and 

April 2, 2014, FDA investigators observed and documented numerous significant HACCP 

violations, including but not limited to, the following: 

 (1) failure to record information in defendants’ records at the time observed, in 

violation of 21 C.F.R. § 123.9(a). The fact that defendants’ employee was observed creating 

records during the inspection that should have been documented contemporaneously (more than 

one month before) is extremely troubling and calls into question all of defendants’ recordkeeping 

practices; 

 (2) failure to implement monitoring and recordkeeping procedures listed in 

defendants’ HACCP plan, in violation of 21 C.F.R. § 123.6(b); 

 (3) failure to calibrate process-monitoring equipment, in violation of 21 C.F.R. 

123.8(a)(2)(ii); 

 (4) failure to include an adequate corrective action plan in accordance with 21 C.F.R. 

§ 123.7(b) to prevent potentially unsafe food from entering commerce when a HACCP deviation 

occurs, in violation of 21 C.F.R. § 123.6(c)(5); 

 (5) failure to monitor sanitation conditions and practices with sufficient frequency to 

ensure conformance with current good manufacturing practice, including the prevention of crosscontamination from insanitary objects and the protection of food, food packaging material, and 

food contact surfaces from adulteration, in violation of 21 C.F.R. § 123.11(b); and 

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 (6) failure to accurately document sanitization practices, in violation of 21 C.F.R. 

§ 123.11(c). 

See Declaration of Nicholas Lyons (“Lyons Decl.) ¶ 8, attached here as Exhibit 2. 

During the 2014 inspection, among other things, investigators found an employee of 

defendants creating documentation that should have been prepared at or near the time of the 

events the documents recorded. See Exhibit 3, Declaration of FDA Investigator Patrick Gainer at 

Exhibit A, Observation 1. They observed a mold-like substance on the ceiling above ingredients 

used in food processing and on a tarp covering food processing equipment. Id. Observation 5. 

They saw an employee handling food without washing or sanitizing his hands, other employees 

walking through the food processing area and storage cooler without proper hair covering, and 

condensate dripping from a condenser onto uncovered raw fish. Id. They also saw old, food-like 

residue on the blade of a saw used to cut fish products, even though the defendants’ records 

represented that the equipment had been “cleaned and sanitized” to a “satisfactory level.” Id. 

Observation 6. Additionally, when the lead investigator handed Falco a copy of the consent 

decree pursuant to which the inspection was being conducted, Falco told the FDA investigators 

that the decree “means nothing” to him and was “garbage.” Lyons Decl., Exhibit 2, at ¶ 10; 

Gainer Decl., Exhibit 3, at ¶ 4. At the conclusion of the inspection, FDA investigators issued a 

List of Inspectional Observations (“Form FDA 483”) to defendant Falco. Lyons Decl., Exhibit 

2, at ¶ 11; Gainer Decl., Exhibit 3, Ex. A. . These observations constitute violations of the Act 

and the HACCP regulations. Cluster Decl., Exhibit 1, ¶ 6.1

 1

 FDA began an inspection of Eastern on April 7, 2015, approximately one year since the 

last inspection. This inspection was planned before the defendants filed their Motion to Vacate 

the Decree. Lyons Decl. ¶ 18. 

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 During FDA’s inspection of Eastern Seafood conducted between November 18 and 

December 8, 2009, investigators identified numerous significant HACCP violations, many of 

which were the same as those identified during FDA’s 2014 inspection, as follows: (1) failure to 

develop a written HACCP plan that controls a food safety hazard that is reasonably likely to 

occur, in violation of 21 C.F.R. § 123.6(b); (2) failure to establish and implement any written 

verification procedures to ensure that imported fishery products are processed in compliance 

with HACCP regulations, in violation of 21 C.F.R. § 123.12(a)(2); (3) failure to list adequate 

monitoring frequencies to prevent the food safety hazard of Clostridium botulinum growth and 

toxin, in violation of 21 C.F.R. § 123.6(c)(4); (4) failure to include an adequate corrective action 

plan in accordance with 21 C.F.R. § 123.7(b) to prevent potentially unsafe food from entering 

commerce when a HACCP deviation occurs, in violation of 21 C.F.R. § 123.6(c)(5); (5) failure 

to calibrate process monitoring equipment, in violation of 21 C.F.R. § 123.8(a)(2)(ii); (6) failure 

to adequately verify the implementation of their HACCP plan and to list adequate verification 

procedures to ensure that their HACCP plans are adequate and effectively implemented, in 

violation of 21 C.F.R. §§ 123.6(c)(6) and 123.8(a)(2); (7) failure to accurately document 

sanitization practices, in violation of 21 C.F.R. § 123.11(c); and (8) failure to monitor sanitation 

conditions and practices with sufficient frequency to assure conformance with current good 

manufacturing practice, in violation of 21 C.F.R § 123.11(b). Lyons Decl. ¶ 14; Cluster Decl. 

¶ 7. 

 At the conclusion of the 2009 inspection, the FDA investigators issued a Form FDA 483 

to Defendant Falco, and discussed the violative conditions with him. Lyons Decl., Exhibit 2, 

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¶ 15 and Exhibit C. By letter dated January 21, 2010, FDA again notified defendants that they 

were not complying with the Act, its implementing regulations, or the decree. Id. ¶ 17.2

Argument 

I. Defendants’ Failure to Comply with the Act and the Decree 

 

 As discussed above, FDA’s investigators have observed and documented defendants’ 

significant deviations from FDA’s HACCP regulations, most recently in April 2014 and 

previously in 2009. These inspections demonstrate that defendants have repeatedly failed to 

establish and implement HACCP plans that include adequate monitoring, verification, 

recordkeeping, corrective action plans, and sanitization control procedures. Therefore, because 

defendants’ HACCP plans do not comply with 21 C.F.R. Part 123, the food defendants’ process 

pursuant to them is adulterated as a matter of law under 21 U.S.C. § 342(a)(4). 3

 Defendants’ argument that the decree should be vacated because they have not been 

“cited with violations” since 2002 (Defs’ Mot. at 2) betrays a misunderstanding of the law and 

FDA’s regulatory processes. FDA does not cite processors with violations during an inspection. 

Rather, at the conclusion of an inspection, FDA investigators issue to the firm’s most responsible 

person a Form FDA 483 documenting their inspectional observations and they discuss those 

 2

 FDA inspected Eastern Seafood in 2010 and 2011 and did not observe any significant 

violations of the decree or the Act. Lyons Decl. ¶ 13. 

 3

 To the extent that defendants attempt to narrow the scope of the decree to cover only 

scrombroid toxin fish products, we note that paragraph VIII restrains defendants from 

introducing any food into interstate commerce that is adulterated under 21 U.S.C. § 342(a)(4), 

which includes any fish or fishery products processed without adequate HACCP plans. Further, 

although FDA investigators did not observe defendants processing any scrombroid toxin fish 

during the 2014 inspection, they noted that defendants’ “Weekly Restaurant Price List” includes 

mahi-mahi (a scrombroid toxin fish) as available for sale. Lyons Decl. ¶ 9. Most importantly, 

although the HACCP plans FDA reviewed during the 2014 inspection were not for scrobroid 

toxin fish products, the violations observed during that inspection reveal that defendants are 

unable or unwilling to comply with the requirements of 21 C.F.R. Part 123 generally. 

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observations with that person. Lyons Decl. ¶ 6. The investigators then draft an Establishment 

Inspection Report which, along with the Form FDA 483, is reviewed by compliance officers in 

FDA’s district office and/or the relevant product center. Id. ¶ 7. The Agency then assigns the 

inspection a classification that reflects the compliance status of the establishment at the time of 

the inspection taking into account the investigators’ factual observations and the input of other 

agency officials with expertise in the subject-matter area. Id. Here, FDA classified the 2014 and 

2009 inspections of Eastern Seafood as “Official Action Indicated,” which means that significant 

objectionable conditions or practices were found and regulatory action was warranted to address 

the firm’s lack of compliance with the Act and/or its regulations. Id. ¶¶ 12, 16. 

 The fact that FDA has not found actual contamination at defendants’ facility or in their 

fish products (see Defs’ Mot. at 2) is legally irrelevant. It is well established that actual 

contamination need not be shown in order for food to be deemed adulterated under 21 U.S.C. 

§ 342(a)(4). See United States v. H. B. Gregory Co., 502 F.2d 700, 704-05 (7th Cir. 1974) (“It is 

clear that the congressional intent is to make it a criminal offense for a person to . . . hold food 

under such insanitary conditions that it may become contaminated. It is not necessary that it 

actually become contaminated. . . . The statute is designed to prevent adulterations ‘in their 

incipiency’ by condemning insanitary conditions which may result in contamination.”) (internal 

quotes omitted) (emphasis added). 

 Because defendants have failed to develop, implement, and verify adequate written 

HACCP plans, there is an increased likelihood of food safety hazards and consequently, 

increasing risk of injury or illness for consumers. See Cluster Decl. ¶ 8. The intent of the decree 

was to ensure that defendants complied with the law to best protect the public from adulterated 

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food. Contrary to defendants’ assertion that the “intent” of the decree has been achieved (Def.s’ 

Mot. at 2), there is an ongoing need for this decree to remain in effect in light of defendants’ 

ongoing failure to comply with the HACCP regulations. Separately, defendants’ apparent 

disregard of the decree, see Lyons Decl. ¶ 10, is further evidence of the need for this court to 

maintain jurisdiction over defendants and for the decree’s requirements to be in full force. 

 Finally, defendants assert that they should be relieved of the decree because they claim to 

have satisfied FDA’s typical “sunset provision” which, they argue, is “virtually always 5 years” 

(Defs’ Mot. at 2). But this decree is an order of permanent injunction and does not contain any 

sunset provision. And, even if it had included such a provision, defendants could not avail 

themselves of it because they have not maintained compliance for five years. See FDA’s 

Regulatory Procedures Manual (“RPM”) § 6-2-16 (available at (http://www.fda.gov/ 

ICECI/ComplianceManuals/RegulatoryProceduresManual/ucm176734.htm#6-2-16_-

_Vacating_Injunctions) (explaining that FDA does not ordinarily oppose a motion to vacate a 

decree if (a) the agency has recent evidence that the defendant is in compliance with the Act, 

applicable regulations, and the decree; (b) the defendant has remained in continuous compliance 

with the Act, applicable regulations, and the decree for a period of five years; and (c) the 

defendant has given FDA an opportunity to consider whether to object to the motion). In this 

case, because defendants have not been in continuous compliance with the Act or the decree for 

the past five years, FDA objects to this motion.4

 4

 Defendants did not give FDA an opportunity to consider whether to object to a motion 

to vacate prior to filing their motion with the court. Accordingly, none of the conditions 

identified in the RPM are met here. 

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II. Defendants Do Not Satisfy Requirements for Vacating a Court Order

Although defendants do not cite any law in support of their motion, the relief they seek is 

governed by Rule 60 of the Federal Rules of Civil Procedure. See Rufo v. Inmates of Suffolk 

County Jail, 502 U.S. 367, 378 (1992) (explaining that a consent decree “is an agreement that the 

parties desire and expect will be reflected in, and be enforceable as, a judicial decree that is 

subject to the rules generally applicable to other judgments and decrees.”); see also United States 

v. Krilich, 303 F.3d 784, 789 (7th Cir. 2002). Rule 60(b) provides for relief from a final 

judgment for the following reasons: 

 (1) mistake, inadvertence, surprise, or excusable neglect; 

 (2) newly discovered evidence that, with reasonable diligence, could not have been 

 discovered in time to move for a new trial under Rule 59(b); 

 (3) fraud . . . , misrepresentation, or misconduct by an opposing party; 

 (4) the judgment is void; 

 (5) the judgment has been satisfied, released or discharged; it is based on an earlier 

 judgment that has been reversed or vacated; or applying it prospectively is no 

 longer equitable; or 

 (6) any other reason that justifies relief. 

Fed. R. Civ. P. 60(b). 

 “Relief under Rule 60(b) is an extraordinary remedy granted only in exceptional 

circumstances.” Nelson v. Napolitano, 657 F.3d 586, 589 (7th Cir. 2011). Here, defendants do 

not argue that any of the conditions supporting vacating a decree exist. However, giving 

defendants the benefit of the doubt, their motion could be construed as arguing that the decree 

should be vacated under Rule 60(b)(5) because applying it “prospectively is no longer 

equitable.” See Defs’ Mot. at 2 (arguing that “to continue to hold defendants beholden to the 

order is unnecessary and oppressive” and “it would be fair, equitable, and just, to vacate the 

order”). Defendants cannot make such a showing, however. 

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 To satisfy the Rule 60(b)(5) standard, the party seeking to modify the consent decree 

“‘bears the burden of establishing that a significant change in circumstances warrants revision of 

the decree.’” O’Sullivan v. City of Chicago, 396 F.3d 843, 861 (7th Cir. 2005) (quoting Rufo, 

502 U.S. at 383). The moving party may meet this burden “‘by showing a significant change 

either in factual conditions or in law.’” O’Sullivan, 396 F.3d at 861 (quoting Rufo, 502 U.S. at 

384). If the moving party meets this initial burden, “a district a court should consider whether 

the proposed modification is ‘suitably tailored to the changed circumstances.’” O’Sullivan, 396 

F.3d at 861 (quoting Rufo, 502 U.S. at 383). 

 Defendants have made no showing of a significant change in either the factual 

circumstances or the law. The fact that continuing to comply with the decree’s requirements is 

inconvenient is an insufficient ground for vacating the decree. See Rufo, 502 U.S. at 383 (an 

assertion that it is “no longer convenient to live with the terms of a consent decree” is 

insufficient). Any financial burdens or other obligations required by the decree were or should 

have been anticipated by defendants at the time they voluntarily (and with counsel) signed the 

decree. Rufo, 502 U.S. at 384 (“Ordinarily . . . modification should not be granted where a 

parties relies upon events that actually were anticipated at the time it entered into a decree.”). 

Lastly, the Supreme Court has stated that a court may consider vacating a decree when 

dissolution will benefit the public. See Rufo, 502 U.S. at 384. Here, in light of defendants’ 

recent non-compliance with the decree and the Act, vacating the decree would be contrary to the 

public interest; indeed, it would increase the likelihood that the public would be exposed to 

Defendants’ adulterated products. 

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None of the other grounds for relief in Rule 60(b) are either alleged or available to 

defendants. Defendants do not raise either mistake, inadvertence, surprise, or excusable neglect 

(Rule 60(b)(1)), newly discovered evidence (Rule 60(b)(2)), or fraud or misrepresentation (Rule 

60(b)(3)).5

 Because there is no reason to believe that the court lacked jurisdiction or did not 

follow due process, the decree is not void under Rule 60(b)(4). See United States v. Krilich, 152 

F. Supp. 2d 983, 991 (N.D. Ill. 2001) (“A judgment is void if it is without subject matter 

jurisdiction, there was no personal jurisdiction over a party, or the judgment was entered without 

due process of law.”). 

 Defendants also are not entitled to relief under Rule 60(d)(6)’s “catch-all” provision. 

Relief from a decree under this provision “is warranted only upon a showing of extraordinary 

circumstances that create a substantial danger that the underlying judgment was unjust.” 

Margoles v. Johns, 798 F.2d 1069, 1073 (7th Cir. 1986) (emphasis added). Defendants have not 

argued that any “extraordinary circumstances” support their motion. Rather, this case involves 

nothing more than Defendant Falco attempting to avoid the obligations of a resolution that he 

entered into voluntarily and violated as recently as one year ago. Rule 60(b) thus does not 

provide grounds for relief from the decree. 

 5

 Relief under Rule 60(b)(1), (2), and (3) is also not available to defendants because their 

motion is untimely. See Fed. R. Civ. P. 60(c) (“A motion under Rule 60(b) must be made within 

a reasonable time — and for reasons (1), (2), and (3) no more than a year after entry of the 

judgment or order of the date of the proceeding.”). 

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Conclusion 

 For the foregoing reasons, the court should deny the defendants’ motion for relief from 

the decree.. 

Respectfully submitted, 

 

 ZACHARY T. FARDON 

 United States Attorney 

 By: s/ Donald R. Lorenzen 

 DONALD R. LORENZEN 

 Assistant United States Attorney 

 219 South Dearborn Street 

 Chicago, Illinois 60604 

 (312) 353-5330 

 donald.lorenzen@usdoj.gov 

Of counsel: 

WILLIAM B. SCHULTZ 

General Counsel 

ELIZABETH H. DICKINSON 

Chief Counsel, Food and Drug Division 

ANNAMARIE KEMPIC 

Deputy Chief Counsel for Litigation 

MICHELE SVONKIN 

Senior Counsel 

Office of the Chief Counsel 

Food and Drug Administration 

10903 New Hampshire Avenue 

Bldg. 32, Room 4308 

Silver Spring, Maryland 20993-002 

Dated: April 10, 2015 

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