IN THE UNITED STATES DISTRICT COURT 

FOR THE NORTHERN DISTRICT OF ILLINOIS 

EASTERN DIVISION 

UNITED STATES OF AMERICA, ) 

 ) 

 Plaintiff, ) 

 ) 

 vs. ) No. 02 C 5129 

 ) 

EASTERN SEAFOOD, INC. ) 

and MARIO FALCO, ) 

 ) 

 Defendants. ) 

MEMORANDUM OPINION AND ORDER

MATTHEW F. KENNELLY, District Judge: 

 Eastern Seafood, Inc. processes and distributes fish products. Mario Falco is 

Eastern's president and sole owner. In July 2002, the federal government sued Eastern 

and Falco, alleging that they were violating the Federal Food, Drug, and Cosmetic Act 

(the Act), 21 U.S.C. § 331(k), by causing adulterated articles of food to be introduced 

into interstate commerce. In August 2002, the Court entered a consent decree of 

permanent injunction, which, among other things, permanently restrained and enjoined 

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

21 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." Consent Decree of 

Permanent Inj. § VIII. Now, nearly thirteen years later, defendants have moved to 

vacate the consent decree, arguing that its intent has been achieved and that its 

continued enforcement is unnecessary and oppressive. The government opposes the 

motion. 
2 

 For the reasons set forth below, the Court denies defendants' motion to vacate. 

But given the decree's already long life, the Court is inclined to modify it to include a 

"sunset" provision allowing the court to terminate it if defendants are in continuous 

compliance for a period of three years. The Court orders the parties to show cause why 

such a modification would be inappropriate. 

Background 

 In its complaint, filed in 2002, the government alleged that defendants had failed 

to develop and implement a Hazard Analysis and Critical Control Point (HACCP) plan 

for their fresh scombroid-forming fishery products (scombrotoxin fish products). 

According to the government, 21 C.F.R. § 123.6 required defendants to establish and 

implement a HACCP plan for their scombrotoxin fish products and to maintain a 

recordkeeping system to document the monitoring of critical control points for such 

products. Because defendants failed to establish and implement an HACCP plan and 

failed to maintain the proper recordkeeping system, the food they produced was 

adulterated within the meaning of 21 U.S.C. § 342(a)(4), and thus defendants violated 

21 U.S.C. § 331(k) by causing their articles of food to become adulterated while held for 

sale after shipment in interstate commerce. 

 In August 2002, the Court entered the decree. Among other things, the decree: 

 restrained and enjoined defendants from processing scombrotoxin fish products 

unless and until an independent HACCP expert prepared a HACCP plan that 

defendants implemented to the FDA's satisfaction; 

 required defendants to implement a HACCP plan and maintain a HACCP control 

program for scombrotoxin once defendants' scombrotoxin fish products 
3 

operations resumed; 

 permitted the FDA to make inspections of defendants' facilities without prior 

notice and when the FDA deems it necessary; 

 required defendants to pay the costs of the FDA's inspections conducted 

pursuant to the decree; and 

 restrained and enjoined defendants "from doing or causing to be done, directly 

or indirectly, any act that violates 21 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." 

Decree § VIII. Under the decree, if the FDA determines that defendants have violated 

the decree, the Act, or FDA regulations, it may order cessation of defendants' 

operations or recall of defendants' products. Any decisions the FDA makes pursuant to 

the decree are considered final and reviewable by the Court only under an "arbitrary 

and capricious" standard. 

 The decree itself does not contain a "sunset" provision, but internal FDA 

guidelines provide, at least currently, that FDA may agree not to oppose a motion to 

vacate a consent decree injunction if the following conditions are met: (1) the agency 

has recent evidence that the defendant is in compliance with the Act, applicable 

regulations, and the decree; (2) the defendant has remained in "continuous compliance" 

for the "life of the sunset provision (virtually always five years)"; and (3) the defendant 

has provided FDA with an opportunity to consider whether to object to the motion. U.S. 

Food & Drug Admin., Regulatory Procedures Manual § 6-2-16 (2011), available at

http://www.fda.gov/downloads/ICECI/ComplianceManuals/RegulatoryProceduresManua
4 

l/UCM074317.pdf (last visited July 28, 2015). The government contends that none of 

these conditions has been met here. It objects to defendants' motion on the ground that 

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

past five years. 

 Defendants contend that, during the decree's lifetime, they have been 

cooperative and compliant with the Act, FDA regulations, and the decree and that the 

FDA has not found contamination in any of their products and has not cited them with 

any official "violations" of the Act. As section IV of the decree required of defendants if 

they wanted to resume processing scombrotoxin fish products, they selected a HACCP 

expert who revised their HACCP plan, which the FDA ultimately approved and 

defendants implemented in 2002. Defendants note that in addition to implementing 

their upgraded HACCP plan, they have made upgrades to their processing facility and 

equipment to ensure compliance with the Act. These upgrades include: (1) hanging 

water hoses from the ceiling to prevent contact with food while not in use, (2) 

connecting waters sources to "backflow prevention devices" to prevent the formation of 

scombrotoxin bacteria, (3) using new digital temperature monitoring devices to ensure 

accurate monitoring, (4) upgrading the cooler containing shellfish and fresh fish to 

prevent spoilage and contamination, and (5) posting signs reminding employees to wear 

hair guards, aprons, and gloves in areas where necessary. 

 The government does not dispute defendants' contention that the FDA has 

discovered no actual contamination of defendants' fish products. The government 

denies, however, that defendants have remained in compliance with the Act. As 

evidence of defendants' noncompliance, the government provides examples, with 
5 

supporting signed declarations from FDA officials, of "significant" HACCP violations 

observed and documented by FDA investigators during inspections conducted in 

November–December 2009, March–April 2014, and April 2015. The FDA classified the 

2009 and 2014 inspections as "Official Action Indicated" (OAI).1 Though the 

government has not provided the inspection classification given for the 2015 inspection, 

the violations observed during that investigation were the same as or similar to those 

observed during the 2009 and 2014 investigations. In addition to classifying the 

inspections of Eastern as OAI, the FDA sent Falco a letter in 2010 informing him that 

Eastern was not in compliance with the Act, FDA regulations, or the decree and 

threatened issuing a shutdown notice, pursuant to the decree, if Eastern did not come 

into compliance. 

 Though not all of the cited violations involve the processing of scombrotoxin fish 

products, they do include defendants' failure to follow the procedures listed in their 

HACCP plans or to take the necessary steps to ensure that their HACCP plans were 

adequate to control food safety hazards. Defendants are thus alleged to be violating 

the same HACCP regulations, 21 C.F.R. § 123.6, that formed the basis for the 

 

1

 Following an FDA inspection, an establishment may receive one of three 

classifications respecting its compliance status. U.S. Food & Drug Admin. 

Transparency Task Force, FDA Transparency Initiative 27 (2010), available at

http://www.fda.gov/downloads/AboutFDA/Transparency/PublicDisclosure/GlossaryofAcr

onymsandAbbreviations/UCM212110.pdf (last visited July 28, 2015). A classification of 

"No Action Indicated" (NAI) is given where the inspection revealed no objectionable 

conditions or practices or where no further actions would be justified. Id. A "Voluntary 

Action Indicated" (VAI) classification is given where the inspection reveals "more 

technical violations" or where objectionable practices or conditions do not meet the 

threshold of regulatory significance. Id. A classification of OAI is given where 

"significant objectionable conditions or practices [are] found and regulatory action is 

warranted . . . ." Id. 
6 

government's initial complaint in 2002. 

 In addition to the apparent noncompliance the FDA inspections revealed, the 

government also emphasizes what it characterizes as Falco's personal disregard for the 

decree's authority. The government cites, for example, to reports from FDA 

investigators stating that Falco told them on multiple occasions that the decree does not 

apply to him. 

Discussion 

 Where, as here, a consent decree does not itself provide for the terms of its 

dissolution, parties seeking to modify or vacate the decree may do so pursuant to 

Federal Rule of Civil Procedure 60(b). United States v. Krilich, 303 F.3d 784, 789 (7th 

Cir. 2002). Though defendants do not specify the particular basis under Rule 60(b) on 

which they seek relief—indeed, they do not mention Rule 60(b)—the Court reads their 

petition as a request for relief under Rule 60(b)(5), which allows a court to modify or 

vacate a final judgment if "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." Fed. R. Civ. P. 60(b)(5).2

 The party seeking to 

modify or vacate a consent decree pursuant to Rule 60(b)(5) "bears the burden of 

establishing that a significant change in circumstances warrants revision of the decree." 

Rufo v. Inmates of Suffolk Cnty. Jail, 502 U.S. 367, 383 (1992). The significant change 

may either be a change in "factual conditions or in law." Id. 

 

2

 The only other ground for relief that might seem to apply, Rule 60(b)(6)'s catch-all 

provision, applies only where "extraordinary circumstances" justify modification. Choice 

Hotels Int'l, Inc. v. Grover, No. 14 C 3294, 2015 WL 4081169, at *1 (7th Cir. July 7, 

2015). But defendants have not argued for relief on the basis of any extraordinary 

circumstances here.
7 

 In addition, the Supreme Court has held that, in the context of institutional reform 

litigation, a critical question in the Rule 60(b)(5) inquiry is whether the objective of the 

initial order has been achieved. Home v. Flores, 557 U.S. 433, 450 (2009) (reviewing 

denial of State of Arizona's request to modify decree declaring State to be in violation of 

federal education laws). "If a durable remedy has been implemented, continued 

enforcement of the order is not only unnecessary, but improper." Id.; see also Bd. of 

Educ. of Oklahoma City Pub. Sch., Indep. Sch. Dist. No. 89, Oklahoma Cnty., Okl. v. 

Dowell, 498 U.S. 237, 247 (1991) (holding, in desegregation litigation, that finding that 

school board was unlikely to "return to its former ways" would be finding that litigation's 

purposes had been fully achieved). Though Horne and Dowell involved federal decrees 

binding state and local governments and thus raised federalism concerns not present 

here, the general equitable principle they express seems applicable. Where a party can 

persuade a court that it has cured its initial violations and has taken steps to prevent 

future violations, it will no longer be equitable to continue to burden the party with a 

decree's continued prospective application. 

 Defendants' petition emphasizes the lack of "cited violations" during the decree's 

lifetime as well as defendants' "ongoing efforts to be compliant with the [Act and FDA 

regulations.]" Defs.' Reply at 7. Without any violations and without any attempts by the 

FDA to enforce the order in court, defendants argue, the intent of the order—

defendants' implementation of a proper HACCP plan and the prevention of 

scombrotoxin contamination—has been achieved. Further, defendants say, if the Court 

vacates the decree, they still will be obligated to adhere to the Act and to FDA 

regulations and will be subject to periodic FDA inspections—albeit without having to pay 
8 

for them, as the decree requires. For these reasons, defendants contend, the continued 

operation of the decree serves no useful purpose and will only continue to burden 

defendants with the obligation to pay for FDA inspections that could or would occur 

even in the absence of the decree. 

 As discussed above, the Court agrees with defendants that it would be 

inequitable to continue to impose a decree whose primary effect is to shift investigation 

costs on a party that has taken steps to address the initial violation underlying the 

decree and has remained in compliance since the decree's entry. But that is not the 

case here, at least not at the present time. Rather, the government has provided 

evidence of defendants' recent noncompliance, and FDA has classified that 

noncompliance as OAI, a classification designating significant objectionable practices or 

conditions. Furthermore, the decree serves a purpose beyond cost shifting. Among 

other things, the purpose of the decree, given defendants' noncompliance with the Act 

prior to 2002, was to allow the FDA the opportunity to easily inspect defendants' 

establishment for evidence of additional noncompliance and to take swift action to 

protect the public health if needed. Thus until defendants are in full compliance, the 

decree's provisions—particularly those granting FDA the ability to cease defendants' 

operations or to recall food products—continue to serve a purpose by enabling the FDA 

to act quickly to protect the public from potentially adulterated food. Indeed, FDA 

believed it was necessary to threaten defendants with the possibility of issuing a 

shutdown notice pursuant to section IX of the decree as recently as January 2010. 

 Defendants imply that the noncompliance presented by the government is so 

insignificant that the Court should overlook it. For example, they cite the court's warning 
9 

in another case that "strict enforcement, by the F.D.A., of section 402 of the Act would 

result in the banning of literally all processed foods." United States v. General Foods 

Corp., 446 F. Supp. 740, 745 (N.D.N.Y.) aff'd, 591 F.2d 1332 (2d Cir. 1978). But the 

court in General Foods was referring specifically to the Act's provisions regarding levels 

of filth in food, under which a "violation is proven once the presence in the food of any 

quantity of filth is established." Id. at 744 (emphasis added). Thus any "expert armed 

with the proper equipment, could detect filth in virtually every food marketed." Id. at 

745. The violations cited here—for example, failure to list adequate monitoring 

frequencies, verification procedures, or critical control points—are not the types of 

violations that likely would exist in the most compliant establishments. 

 Defendants have also listed, and have provided photographs to document, a 

number of updates they have made to their facilities, equipment, and policies. Had 

such updates resulted in defendants' continuous compliance with the Act, FDA 

regulations, and the decree, the Court might conclude that there has been a "significant 

change[s] in factual conditions," Rufo, 502 U.S at 383, or that defendants have 

implemented a "durable remedy," Horne, 557 U.S. at 450, thus warranting entry of an 

order vacating the decree. But FDA's discovery of apparent noncompliance as recently 

as April 2015 makes clear that any change in factual conditions or remedy implemented 

has not been "significant" or "durable" enough to allow the Court to do away with the 

decree at this time.3

 

3

 Falco's claimed statements suggesting disregard for the decree do not help 

defendants' argument that they have been cooperative and continually attempting to 

comply with the decree. But because the specific instances of noncompliance cited by 

the government are sufficient to require the Court to deny defendants' motion, Falco's 
10 

 That said, it bears noting that the decree has been in existence for almost 

thirteen years. An express sunset provision ought to be added, to avoid question in the 

future over the circumstances under which the Court may vacate the decree. The Court 

also notes that the government has not advised the Court of any violations prior to 

2009, suggesting that there may have been an extended period of compliance by 

defendants before the more recent episodes the government now cites. And none of 

the violations the government cites evidently was serious enough to cause the 

government to come back to court to seek relief under the decree. Given these 

circumstances, the Court is of the view that there should be a three-year sunset period, 

not the five-year period that the Court might have set had the issue come up at the time 

it entered the decree. 

Conclusion

 For the reasons stated above, the Court denies defendants' petition to vacate the 

consent decree [dkt. no. 3]. The Court proposes to modify the decree to allow for its 

dissolution upon a showing that defendants have been in continuous compliance with 

the decree, the Act, and applicable FDA regulations for three years. The parties are 

directed to show cause, by no later than August 14, 2015, why such a modification 

would be inappropriate. The case is set for a status hearing on August 26, 2015 at 9:30 

a.m. 

 

Date: July 31, 2015 ________________________________ 

 MATTHEW F. KENNELLY 

 United States District Judge 

 

claimed negative attitude and beliefs about the decree do not factor into the Court's 

decision.