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United States v. Captain's Select Seafood, Inc.: US District Court : FDA | FOOD - injunction after long operation without proper Hazard Analysis and Critical Control Point

-1-
UNITED STATES DISTRICT COURT
DISTRICT OF MINNESOTA
UNITED STATES OF AMERICA,
Plaintiff,
v.
CAPTAINS SELECT SEAFOOD, INC., a
corporation, and CAROLYN M. YOUNG
and WILLIAM J. YOUNG, individuals,
Defendants.
Case No. 0:08-CV-1658 (PJS/RLE)
ORDER FOR INJUNCTION AND
ENTRY OF JUDGMENT
Gerald C. Kell, UNITED STATES DEPARTMENT OF JUSTICE, for plaintiff.
Thomas P. Kane, Steven H. Silton, and Mark T. Berhow, HINSHAW & CULBERTSON
LLP, for defendants.
This matter is before the Court on the governments motion for summary judgment and
entry of a permanent injunction. Also pending are two motions of defendants. Each of
defendants motions takes the form of a motion seeking an enlargement of time to respond to the
governments summary-judgment motion. In fact, though, defendants papers address the
governments motion on the merits, and include a number of exhibits submitted in opposition to
the governments motion. For the reasons that follow, the Court grants defendants motions for
enlargement of time, but also grants summary judgment to the government.
The 1 facts are undisputed, except as indicated in the text.
2For ease of exposition, the Court generally refers to defendants collectively as
Captains.
3The Young affidavit responding to the Becoat declaration was filed as Exhibit B to one
of defendants motions for enlargement of time [Docket No. 42]. That affidavit has additional
exhibits that are also designated by letters. For example, copies of letters from restaurants that
did business with Captains are Exhibit A to the Young affidavit which, as noted, is itself
Exhibit B to one of defendants motions.
The Court suggests that if a party files exhibits that themselves have exhibits, the two
types of exhibits should use different labeling schemes. For instance, primary exhibits might be
labeled A and B, and exhibits to those primary exhibits might be labeled A-1 and B-1.
In this case, Exhibit A to one of defendants motions for enlargement of time is the affidavit of
William Spinali; Exhibit A to that affidavit is a letter from the FDA; and these two Exhibits A
must be distinguished from Exhibit A to the Young affidavit (itself exhibit B to the motion), just
as Exhibit B to the motion (the Young affidavit) must be distinguished from Exhibit B to the
Spinali affidavit (itself Exhibit A to the motion). It is hard to keep these exhibits straight, and
even harder to cite them concisely and coherently.
4The acronym HACCP is pronounced hass-cp or hass-ip.
-2-
I. BACKGROUND1
Defendants Carolyn and William Young owned and operated defendant Captains Select
Seafood, Inc. (Captains) for about thirteen years, until they closed Captains in August 2008.2
Young Aff. (First) at 14, 16 [Docket No. 22]. While it was in operation, Captains supplied
seafood to many high-end restaurants in the Twin Cities. Young Aff. Resp. Becoat Decl. Ex. A.3
As a seafood processor, Captains was required to comply with regulations promulgated
by the United States Food and Drug Administration (FDA). In particular, Captains had to
adopt what is known as a Hazard Analysis and Critical Control Point or HACCP plan.4 See
21 C.F.R. part 123. FDA regulations provide that seafood prepared in the absence of a proper
HACCP plan is deemed adulterated for purposes of 21 U.S.C. 342(a)(4). 21 C.F.R.
-3-
123.6(g). And under 21 U.S.C. 331(k), causing food to become adulterated is unlawful. 21
U.S.C. 331(k).
Representatives of the FDA inspected Captains four times between April 2004 and July
2007. Becoat Decl. 10-11 [Docket No. 14 Ex. 2]. The FDA concluded, after each inspection,
that Captains did not have an adequate HACCP plan. Id. 11, 19. After the most recent
inspection, in July 2007, the FDA issued a form detailing Captains regulatory violations, and the
FDA inspector discussed those violations with Carolyn Young, who promised to correct them.
Id. 18 & Ex. 2(B).
Captains submitted revised HACCP plans to the FDA in April and May of 2008. Id.
24; Samuels Decl. [Docket No. 14 Ex. 1] Exs. 1(B), 1(C), 1(D). On May 30, 2008, the FDA
wrote a letter to Captains identifying numerous alleged deficiencies in the May 2008 HACCP
plan. Samuels Decl. Ex. 2(J). Captains submitted yet another revised plan on June 1, 2008. Id.
Ex. 1(D).
The FDA found the June 1, 2008 plan unsatisfactory and filed this suit on June 6, 2008.
The FDA seeks to enjoin Captains from operating until it adopts an acceptable HACCP plan and
passes FDA inspections. The FDAs proposed injunction would also limit the ability of Carolyn
and William Young to work in the food-service industry.
II. DISCUSSION
A. Standard of Review
Summary judgment is appropriate if the pleadings, the discovery and disclosure
materials on file, and any affidavits show that there is no genuine issue as to any material fact and
that the movant is entitled to judgment as a matter of law. Fed. R. Civ. P. 56(c). A dispute over
-4-
a fact is material only if its resolution might affect the outcome of the suit under the governing
substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). A dispute over a
fact is genuine only if the evidence is such that a reasonable jury could return a verdict for
either party. Ohio Cas. Ins. Co. v. Union Pac. R.R., 469 F.3d 1158, 1162 (8th Cir. 2006). In
considering a motion for summary judgment, a court must view the evidence and the inferences
that may be reasonably drawn from the evidence in the light most favorable to the non-moving
party. Winthrop Res. Corp. v. Eaton Hydraulics, Inc., 361 F.3d 465, 468 (8th Cir. 2004).
B. Basis for Injunction
According to the FDA, Captains long history of having inadequate HACCP plans
establishes that Captains violated 21 U.S.C. 331(k) by selling adulterated seafood. The FDA
seeks an injunction forbidding Captains and the Youngs from operating any food-related
business until the FDA has approved a HACCP plan developed for them by an independent
expert and the FDA has given them permission to resume operations. Proposed Order IV.
In opposing the FDAs motion for summary judgment, Captains argues primarily that the
June 1, 2008 HACCP plan complies with FDA regulations. Captains relies mainly on the
testimony of its consultant, William Spinali, who worked with Captains to revise its HACCP
plans and to respond to the May 30, 2008 letter from the FDA identifying deficiencies. Spinali
Aff. [Docket No. 23]. In his own letter dated May 30, 2008, Spinali took issue with the
ostensible deficiencies identified in the FDAs May 30 letter. Id. Ex. B. And in his affidavit
dated June 5, 2008, Spinali asserted that Captains current HACCP Plans are in full compliance
with all FDA regulations. Spinali Aff. 6.
Again, to be clear, this means merely 5 that Captains handled food at a time when it did
not have an adequate HACCP plan. It does not mean that anything was wrong with the food that
Captains was supplying to its customers.
-5-
If summary judgment turned on whether the HACCP plan proposed by Captains on
June 1, 2008 complied with FDA regulations, the Court would be unable to grant summary
judgment. On the one hand, Spinali who appears to be a qualified food-safety expert says
that the June 1, 2008 HACCP plan complies with FDA regulations. On the other hand, Robert
Samuels, an FDA employee who works in the area of seafood safety, disagrees. Samuels Decl.
26-33. The Court would require additional evidence to resolve this disagreement among
experts.
But for purposes of this case, the Court need not decide whether the June 1, 2008
HACCP plan complies with FDA regulations. Captains does not dispute the FDAs assertion
that from 2004 through at least early 2008, Captains did not have a HACCP plan that complied
with FDA regulations. This lengthy and undisputed history is sufficient to establish that
Captains violated 21 U.S.C. 331(k) on countless occasions by handling food in a manner that
rendered that food adulterated.5
Section 332(a) of Title 21 of the United States Code empowers district courts to enjoin
violations of 331. 21 U.S.C. 332(a). Accordingly, because the government has established
that Captains violated 331(k), the government is entitled to an injunction if it also establishes a
cognizable danger of recurrent violations. See United States v. Diapulse Corp. of Am., 457 F.2d
25, 28 (2d Cir. 1972) (The passage of the [Food, Drug, and Cosmetic Act] is, in a sense, an
implied finding that violations will harm the public and ought, if necessary, be restrained.);
United States v. SeneX Eleemosynary Corp., 479 F. Supp. 970, 980-81 (S.D. Fla. 1979). Given
-6-
the lengthy history of admitted violations by Captains, the Court finds that the government has
established a likelihood of additional violations if Captains resumes operations as a seafood
processor or if the Youngs resume work as seafood suppliers.
The injunction sought by the government, however, is overly broad in light of the conduct
of Captains and the Youngs. In particular, the governments proposed injunction would forbid
the Youngs to prepare, pack, hold, or distribute[] any food unless they come up with a HACCP
plan approved by the government. Proposed Order IV. This would seem to prevent the
Youngs from working in the food industry in any capacity. But the history of Captains
violations does not suggest that the Youngs are incapable of acting as, for instance, food servers
at someone elses restaurant.
Further, the governments proposed injunction gives the FDA almost total discretion over
whether to approve a HACCP plan proposed by Captains. The Court believes that, under the
circumstances of this case, Captains should have the ability to seek judicial review of the FDAs
decision with respect to a proposed HACCP plan. The Court has fashioned its injunction
accordingly.
ORDER
Based on the foregoing, and on all of the files, records, and proceedings herein, IT IS
HEREBY ORDERED THAT:
1. The governments motion for summary judgment [Docket No. 11] is GRANTED.
2. Defendants motions for enlargement of time to respond to the governments
motion through October 27, 2008 [Docket Nos. 42 and 43] are GRANTED.
-7-
3. Defendants Captains Select Seafood, Inc., Carolyn M. Young, and William J.
Young are ENJOINED from violating 21 U.S.C. 331(a) and (k) as follows:
a. Defendants must not introduce or deliver for introduction into interstate
commerce any food that is adulterated under 21 U.S.C. 342(a)(4).
b. Defendants must not do anything to cause food being held for sale after
shipment in interstate commerce to become adulterated under 21 U.S.C.
342(a)(4).
4. Defendants Captains Select Seafood, Inc., Carolyn M. Young, and William J.
Young are ENJOINED from operating, either directly or indirectly, Captains
Select Seafood, Inc., any food-supply business, or any food-related business
involving seafood, unless either the FDA or a federal district court approves the
businesss HACCP plan in accordance with the following procedures:
a. Before operating, either directly or indirectly, Captains Select Seafood,
Inc., any food-supply business, or any food-related business involving
seafood, defendants must give the FDA 90 days notice of their intention to
operate such a business and must provide the FDA with a copy of the
HACCP plan under which they propose to operate.
b. If the FDA approves the HACCP plan, defendants may operate the
proposed business covered by the plan.
c. If the FDA does not approve the HACCP plan, and if the FDA wishes to
prevent defendants from beginning to operate the proposed business
covered by the plan, the FDA must bring an enforcement action in federal
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district court within 90 days of receipt of the plan to enjoin defendants
from operating the proposed business.
d. If the FDA brings such an enforcement action, defendants will not be
permitted to operate, directly or indirectly, the proposed business unless
they prevail in the enforcement proceeding. Defendants will not be
permitted to operate, directly or indirectly, the proposed business during
the pendency of the enforcement action unless the court in which the
action is pending orders otherwise.
5. Defendants Captains Select Seafood, Inc., Carolyn M. Young, and William J.
Young must provide a copy of this order within 15 days of the date of this order
by personal service or by certified mail, return receipt requested, to all of
defendants officers, agents, servants, employees, and attorneys, and to all other
persons who are in active concert or participation with defendants or with their
officers, agents, servants, employees, and attorneys.
6. Defendants must provide the Director of the FDA Minnesota District Office and
the governments attorney, within 20 days of the date of this order, an affidavit
based on personal knowledge identifying all persons, and the positions of those
persons, who received copies of this order pursuant to the preceding paragraph,
and stating for each person whether the order was provided personally or by mail.
7. All communications with the FDA required by this order must be provided to:
Director
FDA Minnesota District Office
250 Marquette Ave., Suite 600
-9-
Minneapolis, MN 55401
8. Defendants must post a copy of this order in the employee common areas of any
food-processing facility currently owned, leased, or operated, directly or
indirectly, by any of the defendants.
9. Defendants must provide a copy of this order to any new employee hired by
Captains Select Seafood, Inc., within 15 days of that persons hiring date.
10. Defendants must notify the FDA in writing at least 20 days in advance of:
a. any change in the ownership or character of Captains Select Seafood, Inc.,
such as dissolution, assignment, bankruptcy, sale of the company, creation
or dissolution of subsidiaries, or any other change in the companys
corporate structure; or
b. the sale or assignment of any business assets, such as buildings,
equipment, or inventory, if that sale or assignment may affect compliance
with this order.
11. At least 15 days before making any assignment or transferring any interest in
Captains Select Seafood, Inc., or its assets as described in the preceding
paragraph, defendants must provide a copy of this order to any proposed successor
or assignee. Defendants must provide the FDA with an affidavit based on
personal knowledge stating how and when defendants complied with the notice
provision in this paragraph.
12. In accordance with Rule 65(d)(2) of the Federal Rules of Civil Procedure, this
order binds not only defendants, but also the following who receive actual notice
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of it: defendants officers, agents, servants, employees, and attorneys; and other
persons who are in active concert or participation with defendants or with their
officers, agents, servants, employees, and attorneys.
13. This order does not in any way limit the FDAs ability under generally applicable
federal laws and regulations to regulate, monitor, inspect, and supervise Captains
Select Seafood, Inc., or any business operated, directly or indirectly, by Carolyn
M. Young or William J. Young. This order also does not in any way relieve
Captains Select Seafood, Inc., Carolyn M. Young, or William J. Young of their
obligations to comply with generally applicable federal laws and regulations.
LET JUDGMENT BE ENTERED ACCORDINGLY.
Dated: February 17, 2009 s/Patrick J. Schiltz
Patrick J. Schiltz
United States District Judge
 

 
 
 

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