Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_06-cv-06610/USCOURTS-cand-3_06-cv-06610-0/pdf.json

Nature of Suit Code: 620
Nature of Suit: Forfeiture and Penalty - Food and Drug Acts
Cause of Action: 21:841 Forfeiture Property-Drugs

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28 CONSENT DECREE - Case No. 3:06-cv-6610 1

PETER D. KEISLER

Assistant Attorney General

EUGENE M. THIROLF, Director

DANIEL K. CRANE-HIRSCH, Trial Attorney (Massachusetts BBO #643302)

Office of Consumer Litigation 

Civil Division, U.S. Department of Justice

P.O. Box 386

Washington, D.C. 20044-0386

Telephone: 202-616-8242

Facsimile: 202-514-8742

E-mail: daniel.crane-hirsch@usdoj.gov

Attorneys for Plaintiff, the United States of America

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORNIA

SAN FRANCISCO DIVISION

UNITED STATES OF AMERICA,

Plaintiff,

v.

SCANDINAVIAN SMOKE HOUSE, INC., a

corporation, and ODD ANDERS HOLM, an

individual,

Defendants.

Case No. 3:06-cv-6610-EMC

CONSENT DECREE OF PERMANENT INJUNCTION

Plaintiff, the United States of America, by its undersigned counsel, having filed a

complaint for injunctive relief against Scandinavian Smoke House, Inc. (“Scandinavian Smoke

House”) and Odd Anders Holm (collectively, “defendants”), and defendants having appeared

and having consented to entry of this Decree without contest and before any testimony has been

taken, and the United States of America having consented to this Decree:

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28 CONSENT DECREE - Case No. 3:06-cv-6610 2

IT IS HEREBY ORDERED, ADJUDGED, AND DECREED that:

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

2. The complaint for injunction states a claim for relief against defendants under the

Federal Food, Drug, and Cosmetic Act (the “Act”), 21 U.S.C. § 301 (2000) et seq.

3. Defendants violate the Act, 21 U.S.C. § 331(a), by causing to be introduced into

interstate commerce articles of food, as defined by 21 U.S.C. § 321(f), namely cold-smoked

fishery products, that are adulterated within the meaning of 21 U.S.C. § 342(a)(1) and 21 U.S.C.

§ 342(a)(4); and 21 U.S.C. § 331(k), by causing articles of food, cold-smoked fishery products,

to become adulterated within the meaning of 21 U.S.C. § 342(a)(1) and 21 U.S.C. § 342(a)(4)

after shipment in interstate commerce.

4. Defendants represent to the Court that, at the time of entry of this Decree, they are not

engaged in processing, preparing, packing, holding, or distributing any type of food. If

defendants later intend to resume processing, preparing, packing, holding, or distributing food,

they must first notify the United States Food and Drug Administration (“FDA”) in writing at

least ninety (90) calendar days in advance of resuming operations what type(s) of food

defendants intend to process and distribute and whether they intend to proceed under paragraph 5

herein. Defendants shall not resume operations until receiving written notice from FDA, as

required by paragraph 5(H) of this Decree, and then shall resume operations only to the extent

authorized in the written notice from FDA.

5. Defendants and each and all of their officers, agents, employees, successors, assigns,

attorneys, and those persons in active concert or participation with any of them, are perpetually

restrained and enjoined under the provisions of 21 U.S.C. § 332(a) from processing, preparing,

packing, holding, or distributing, at or from their facility located at 250 Napoleon Street, Unit M,

San Francisco, California, and any new locations at or from which defendants process, prepare,

pack, hold, or distribute food, including any cold-smoked fishery products. This perpetual

restraint and injunction shall continue until:

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28 CONSENT DECREE - Case No. 3:06-cv-6610 3

(A) Defendants thoroughly clean and sanitize the facility and equipment therein,

and made improvements, thereby rendering the facility and equipment suitable for processing,

preparing, packing, holding, and distributing articles of food;

(B) Defendants select a person (“Listeria expert”), who is without any personal

or financial ties (other than a consulting agreement) to the defendants or their families, and who, 

by reason of background, experience and education, is qualified to develop a raw ingredient

testing program, a Sanitation Standard Operation Procedure (“SSOP”), an employee training

program on sanitary food handling techniques and personal hygiene practices, and an

environmental microbial monitoring program for the Listeria genus (“L. spp.”) for the

processing of cold-smoked fishery products;

(C) The Listeria expert develops a written raw ingredient testing and treatment

program for Listeria monocytogenes (“L. monocytogenes”), an SSOP, an employee training

program, and an environmental microbial monitoring program for L. spp. for the processing of

cold-smoked fishery products; 

(D) FDA approves in writing the raw ingredient testing and treatment program,

SSOP, training program, and environmental microbial monitoring program developed by the

Listeria expert;

(E) Defendants conduct appropriate hazard analyses and prepare Hazard Analysis

Critical Control Point (“HACCP”) plans as required by 21 C.F.R. § 123.6(b) for all foods

processed at the facility, including all cold-smoked fishery products; said analyses and plans

must be performed and designed to the satisfaction of FDA;

(F) FDA, as it deems necessary to evaluate defendants’ compliance with the

terms of this paragraph 5, conducts inspections of the facility; 

(G) Defendants pay the costs of inspections, supervision, analyses, and

examination by FDA at the rates specified in paragraph 8; and

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28 CONSENT DECREE - Case No. 3:06-cv-6610 4

(H) FDA notifies defendants in writing that defendants appear to be in

compliance with the requirements set forth in paragraphs 5(A)-(G) and with all requirements of

21 C.F.R. Parts 110 and 123.

6. After completing the requirements of paragraph 5, and upon resuming operations,

defendants shall implement an ongoing program of adequate measures to control L.

monocytogenes (“Listeria program”). The Listeria program shall include the following

procedures, unless defendants submit for and receive FDA’s written approval an alternative L.

monocytogenes control program, consisting of validated methods and controls, that is shown to

FDA’s satisfaction to eliminate L. monocytogenes in the finished product:

(A) Treatment or testing of susceptible raw ingredients for cold-smoked fish

products. Raw material testing for L. monocytogenes shall be performed in accordance with

timetables and methods submitted to and approved in writing by FDA before testing begins. 

Defendants shall select a competent, independent laboratory to perform the testing. The name of

the laboratory shall be submitted to FDA before testing begins. The results of all testing

conducted pursuant to this paragraph shall be submitted to FDA within two (2) calendar days

after receipt by defendants. Where a sample analysis shows the presence of L. monocytogenes in

any raw ingredient, the finished product lot made in whole or in part from that raw ingredient

shall be placed on hold or recalled, as FDA deems appropriate, and shall, as FDA deems

appropriate, be destroyed by defendants under FDA’s supervision, or reconditioned under FDA’s

supervision pursuant to a reconditioning plan approved by FDA. All expenses of such

supervision, analyses, and examination by FDA shall be paid by defendants at the rates specified

in paragraph 8;

(B) Effective and diligent sanitation procedures for cleaning and sanitizing

manufacturing equipment and environment to minimize the risk of reintroducing L.

monocytogenes. These procedures shall consist of the SSOP and the training program developed

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28 CONSENT DECREE - Case No. 3:06-cv-6610 5

by the Listeria expert pursuant to the provisions of paragraph 5 and shall be implemented on a

continuous basis; 

(C) An effective program for environmental monitoring and testing of

manufacturing and storage environment to ensure that L. spp. are controlled within the facility

and L. monocytogenes does not occur in the finished product. The ongoing environmental

microbial monitoring program shall ensure that the SSOP continues to eliminate the L.

monocytogenes hazard and that the SSOP is consistently being followed. Environmental

monitoring shall include collecting swab samples from food contact surfaces, equipment, and

other environmental sites throughout the facility (where the fish is received, prepared, packed,

and held, up to and including final packaging, and common areas that could be reservoirs for

cross-contamination), and analyzing such samples for the presence of L. spp. Environmental

testing for L. spp. shall be performed in accordance with timetables and methods submitted to

and approved in writing by FDA before testing begins. Defendants shall select a competent,

independent laboratory to perform the testing and submit the name of the laboratory to FDA

before testing begins. The results of all testing conducted pursuant to this paragraph shall be

submitted to FDA within two (2) calendar days after receipt by defendants;

(D) Additional finished product control measures. Defendants shall implement

additional control measures to prevent growth of L. monocytogenes in finished products. 

Defendants shall notify FDA regarding the control method they select. These control measures

shall continue until, in the finished product testing described in paragraph 6(E), the laboratory

test results continuously do not show the presence of L. monocytogenes for six consecutive

months. If, after such six-month period, a laboratory test result shows the presence of L.

monocytogenes, defendants shall resume the additional finished product control measures under

this paragraph and continue them until the laboratory test results continuously do not show the

presence of L. monocytogenes for six consecutive months; and

(E) Finished product testing. Defendants shall test finished products as follows:

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28 CONSENT DECREE - Case No. 3:06-cv-6610 6

(i) immediately upon resuming operations and after completing the

requirements in paragraph 5, defendants shall test for L. monocytogenes in each lot of finished

product for at least five consecutive production days;

(ii) immediately after the completion of testing under paragraph 6(E)(i),

defendants shall test at least one lot per day for at least the next 20 production days;

(iii). immediately after the completion of testing under paragraph 6(E)(ii),

defendants shall test at least one lot per every five production days for the next three months; and

(iv) immediately after the completion of testing under paragraph 6(E)(iii),

defendants shall test at least one lot during each three month period thereafter.

If any laboratory test listed in subparagraphs 6(E)(i)-(iv) shows the presence of L.

monocytogenes in any product, defendants must, before resuming any production, determine and

correct the cause of the microbial contamination and start the complete sequence of testing

again.

7. Within thirty (30) days of the entry of this Decree, all food that is in the defendants’

possession at the time this Decree is signed by the parties shall be destroyed by the defendants,

at their own cost and under FDA’s supervision, or reconditioned under FDA’s supervision

pursuant to a reconditioning plan approved in writing and in advance by FDA.

8. Defendants shall pay the costs of FDA’s supervision, inspection, review, examination,

and analyses conducted pursuant to this Decree at the standard rates prevailing at the time the

activities are accomplished. As of the date this Decree is signed by the parties, these rates are: 

$76.10 per hour and fraction thereof per representative for inspection and supervision work other

than laboratory and analytical work; $91.18 per hour and fraction thereof per representative for

laboratory and analytical work; $0.445 per mile for travel by automobile; the government rate or

equivalent for travel by air; and the published government per diem rate or the equivalent for the

areas in which the inspections are performed per day per representative for subsistence expenses,

where necessary. In the event that the standard rates generally applicable to FDA supervision,

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28 CONSENT DECREE - Case No. 3:06-cv-6610 7

inspection, review, examination, or analysis are modified, these rates shall be increased or

decreased without further order of the Court.

9. Duly authorized representatives of FDA shall be permitted, as FDA deems necessary

and without prior notice, to make inspections of the defendants’ facilities, including any new

locations, and all equipment, finished and unfinished materials and products, containers, labeling

and other promotional material; to take photographs and make videotape recordings; to collect

samples of any finished and unfinished materials and products, containers, and labeling; and to

examine and copy all records relating to the receipt, processing, packing, labeling, promotion,

holding and distribution of any and all of the defendants’ products to ensure continuing

compliance with the terms of this Decree. During inspections, defendants shall cooperate fully

with the FDA, by, among other things, promptly providing FDA investigators with requested

documents and materials. The costs of all such inspections, supervision, review, examination,

and analyses are to be borne by defendants at the rates specified in paragraph 8. The inspections

shall be permitted upon presentation of a copy of this Decree and appropriate credentials. The

inspection authority granted by this Decree is apart from, and in addition to, the authority to

make inspections under the Act, 21 U.S.C. § 374.

10. After the requirements of paragraph 5(A)-(G) are met, defendants and each and all of

their officers, agents, employees, successors, assigns, attorneys, and those persons in active

concert or participation with any of them, are permanently restrained and enjoined from doing or

causing to be done, directly or indirectly, any act that violates 21 U.S.C. § 331(a), by causing the

introduction into interstate commerce articles of food that are adulterated within the meaning of

21 U.S.C. § 342(a)(1) or 21 U.S.C. § 342(a)(4); and 21 U.S.C. § 331(k), by causing articles of

food to become adulterated within the meaning of 21 U.S.C. § 342(a)(1) or 21 U.S.C.

§ 342(a)(4) after shipment in interstate commerce.

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

inspection, analysis of a sample or samples, or other information, that the defendants have failed

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28 CONSENT DECREE - Case No. 3:06-cv-6610 8

to comply with any provision of this Decree, have violated FDA regulations or the Act, or that

additional corrective actions are necessary to achieve compliance with this Decree, FDA

regulations, or the Act, FDA may, as and when it deems necessary, notify the defendants in

writing of the noncompliance and order the defendants to take appropriate action, including, but

not limited to, ordering the defendants to immediately take one or more of the following actions:

(A) Cease receiving, processing, preparing, packing, holding, and distributing

any article of food;

(B) Recall all articles of food that have been distributed or are under the custody

and control of defendants’ agents, distributors, customers, or consumers; or 

(C) Take any other corrective actions as FDA deems necessary to bring the

defendants into compliance with this Decree, FDA regulations, and the Act. 

Defendants shall pay all costs of such recalls and corrective actions, including the costs

of FDA supervision, inspections, analyses, examinations, review, travel, and subsistence

expenses to implement recalls and other corrective actions, at the rates specified in paragraph 8. 

This provision shall be separate and apart from, and in addition to, all other remedies available to

FDA.

12. Any cessation of operations as described in paragraph 11 shall continue until

defendants receive written notification from FDA that defendants appear to be in compliance

with the Decree, FDA regulations, and the Act. After a cessation of operations, and while

determining whether defendants are in compliance with the Decree and the Act, FDA may

require that defendants re-institute or re-implement any of the requirements of this Decree.

13. Defendants shall maintain copies of their HACCP plans, along with copies of any

HACCP records required by the plans and by 21 C.F.R. §§ 123.6(c)(7), 123.7(d) and 123.8(d), at

their facility in a location where they are readily available for reference and inspection by FDA

officials. All records required to be kept by the HACCP plans and by these sections of the Code

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28 CONSENT DECREE - Case No. 3:06-cv-6610 9

of Federal Regulations shall be retained for at least three (3) years after the date the records are

prepared.

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

FDA’s decisions shall be final and, to the extent that these decisions are subject to review, shall

be reviewed by the Court under the arbitrary and capricious standard set forth in 5 U.S.C.

§ 706(2)(A). Review shall be based on the written record before FDA at the time the decision

was made. No discovery shall be had by either party.

15. Defendants shall provide a copy of this Decree to each of defendants’ directors,

officers, and employees within ten (10) calendar days from the date of entry of this Decree by

the Court, and shall provide to FDA within thirty (30) calendar days of the date of entry of this

Decree, an affidavit of compliance with this paragraph stating the fact and manner of compliance

and identifying the names and positions of all persons so notified.

16. Defendants shall, in writing, notify FDA at least thirty (30) calendar days before any

change in ownership, character, or name of Scandinavian Smoke House, including

reorganization, relocation, dissolution, assignment, or sale resulting in the emergence of a

successor entity or corporation; the creation or dissolution of subsidiaries or any other change in

athe corporate structure or identity of Scandinavian Smoke House; or the sale or assignment of

any business assets, such as buildings, equipment, or inventory that may affect obligations

arising out of this Decree. Defendants shall serve a copy of this Decree on any prospective

successor or assign no later than thirty (30) calendar days prior to such sale or change in business

and shall furnish FDA with an affidavit of compliance with this paragraph within fifteen (15)

calendar days of such service on a prospective successor or assign.

17. Any notices, test results or other information this Decree requires defendants to give

to FDA shall be given in writing to the District Director, FDA San Francisco District Office,

1431 Harbor Bay Parkway, Alameda, CA 94502-7070.

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28 CONSENT DECREE - Case No. 3:06-cv-6610 10

18. Plaintiff, the United States, shall have and recover from defendants the costs of this

action as taxed by the Court.

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

of this Decree, defendants agree to pay attorneys’ fees (including overhead), travel expenses

incurred by attorneys and witnesses, court costs, expert witness fees and investigational and

analytical expenses incurred in bringing such action.

20. This Court shall retain jurisdiction of this action for the purpose of enforcing or

modifying this Decree and for the purpose of granting such additional relief as may be necessary

or appropriate.

SO ORDERED:

Dated this ________ day of _____________, 2006.

________________________________

UNITED STATES DISTRICT JUDGE

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lst December MAGISTRATE

UNITED STATES DISTRICT COURT

NORTHERN DISTRICT OF CALIFORN

I

A

IT IS SO ORDERED

Judge Edward M. Chen

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28 CONSENT DECREE - Case No. 3:06-cv-6610 11

We hereby consent to the entry of the foregoing Decree.

FOR DEFENDANTS:

Dated: October _____, 2006 ________________________________ODD ANDERS HOLM,

individually and on behalf of Scandinavian

Smoke House, Inc.

Dated: October _____, 2006 ________________________________

Nancy E. Lofdahl (CA Bar No. 182047)

Counsel to Scandinavian Smoke House, Inc.,

and to Odd Anders Holm

870 Market St., Suite 1112

San Francisco, CA 94102

Telephone: 415-314-7088

Facsimile: 415-421-2858

E-mail: nancylofdahl@yahoo.com

FOR PLAINTIFF THE UNITED STATES

OF AMERICA:

PETER D. KEISLER

Assistant Attorney General

Dated: October 24, 2006

EUGENE M. THIROLF

Director, Office of Consumer Litigation

U.S. Department of Justice

 /s Daniel K. Crane-Hirsch 

DANIEL K. CRANE-HIRSCH

Attorney of record

Trial Attorney, Office of Consumer Litigation

U.S. Department of Justice

P.O. Box 386

Washington, D.C. 20044-0386

Telephone: 202-616-8242

Facsimile: 202-514-8742

E-mail: daniel.crane-hirsch@usdoj.gov

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28 CONSENT DECREE - Case No. 3:06-cv-6610 12

Of Counsel for Plaintiff the United States:

DANIEL MERON

General Counsel

SHELDON T. BRADSHAW

Associate General Counsel

Food and Drug Division

ERIC M. BLUMBERG

Deputy Chief Counsel, Litigation

JAMES R. JOHNSON

Assistant Chief Counsel

U.S. Department of Health and Human

Services

Office of the General Counsel

5600 Fishers Lane, GCF-1

Rockville, MD 20857

Telephone: 301-827-5212

Facsimile: 301-827-3076

E-mail: james.johnson@fda.hhs.gov

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