A Little Knowledge Goes a Long Way: Prosecuting Food Companies

A Little Knowledge Goes a Long Way:

Prosecuting Food Companies and Their

Officials for Food Safety Violations

Alyssa Rebensdorf

Faegre Baker Daniels LLP

Minneapolis, MN*

A Little Knowledge Goes A Long Way:

Prosecuting Food Companies and Their Officials for Food Safety Violations

In April 2015, Austin “Jack” DeCoster and his son Peter DeCoster were sentenced to three

months’ incarceration in a federal prison following their misdemeanor guilty pleas for

introducing adulterated eggs into interstate commerce. The sentences were later upheld on

appeal to the Eighth Circuit and the U.S. Supreme Court denied the DeCosters’ petition for writ

of certiorari. The sentences surprised many in the food industry because incarcerating corporate

executives is a rare punishment for food safety violations. This article discusses the DeCoster

case and other federal criminal prosecutions of food companies and their officials for Food, Drug

and Cosmetic Act violations, outlining the factual scenarios that have lead the Justice

Department to charge members of the food industry with a variety of federal felony and

misdemeanor crimes. The article also explores the “responsible corporate officer” doctrine and

its legal underpinnings, United States v. Dotterweich

and United States v. Park,

otherwise

known as “the Park doctrine.” In light of DeCoster and other recent high profile prosecutions,

the article closes with some risk management considerations for corporate officials involved in

significant food safety and leadership roles within their companies.

I. STATUTORY BASIS FOR CRIMINAL PROSECUTION OF CORPORATIONS

AND CORPORATE OFFICIALS FOR FOOD SAFETY VIOLATIONS.

The Federal Food, Drug, and Cosmetics Act (“FDCA”)

outlines more than two dozen

prohibited acts impacting food safety and public health, ranging from selling adulterated or

misbranded food, to failing to establish or maintain required food safety records, to refusing to

permit facility inspections. The offense most frequently cited in prosecutions of food industry

corporate officials is the introduction of adulterated or misbranded food into interstate

commerce, 21 U.S.C. § 331 (a).

320 U.S. 277 (1943).

421 U.S. 658 (1975).

21 U.S.C. § 301, et seq (2012).

Depending on the nature and extent of the misconduct, a Section 331(a) violation may be

charged as a misdemeanor or a felony. Under the FDCA’s misdemeanor provisions, any person

who commits a prohibited act as a first offense with no intent to defraud or mislead faces up to

one year of imprisonment and a fine of not more than $1,000.

If the defendant has a prior

Section 331 conviction, or acts with the intent to defraud or mislead, the defendant faces up to

three years’ imprisonment and a fine of up to $10,000.

In addition to the FDCA’s criminal provisions, the general criminal fines statute

authorizes

substantially increased financial penalties, even for misdemeanor violations.

For individuals,

the statute increases the maximum fine for a Class A misdemeanor that does not result in death

to $100,000; for a felony or a misdemeanor resulting in death, the maximum fine increases to

$250,000.

For organizations, the maximum fine for a Class A misdemeanor that does not result

in death rises to $200,000; for a felony or a misdemeanor resulting in death, the maximum fine

rises to $500,000.

These fines can be further increased by twice the defendant’s financial gain

or the victim’s financial loss, whichever is greater.

These augmented fines, together with the increasing use of traditional white collar charges—mail

fraud, wire fraud, criminal conspiracy and obstruction of justice—have slowly changed the face

of federal prosecutions in the food industry and created significant exposure for a corporate

official charged with food safety-related offenses. Importantly, even in a misdemeanor context,

the possibility of incarceration exists. Under Section 2N2.1 of the U.S. Sentencing Guidelines, a

violation of a food law such as the FDCA carries a base offense level corresponding to a

sentencing range of zero to six months of imprisonment (for an individual with no criminal

history).

In the commentary following Section 2N2.1, the Sentencing Commission advises that

this guideline “assumes a regulatory offense that involved knowing or reckless conduct”. Where

only negligence is involved, a downward departure may be warranted.”

However, the guideline

also provides for upward departures where the offense “created a substantial risk of bodily injury

or death; or bodily injury, death, extreme psychological injury, property damage, or monetary

21 U.S.C. § 333(a)(1).

21 U.S.C. § 333(a)(2).

18 U.S.C. § 3571 (2012).

Pursuant to sentencing reforms enacted in 1984, sentencing judges are able to enhance the otherwise meager fine

provisions of various federal laws, including the FDCA. “[The bill] brings Federal criminal fines into the 1980’s. It

authorizes substantially increased fines for all Federal offenses. This is particularly important in the areas of drug

offenses and corporate and white collar crime, where the criminal often views a fine as a cost of doing business.”

130 CONG. REC. 21486, 21490 (1984) (statement of Rep. Rodino). Notably, one commentator has observed that

when the sentencing reforms were put into place, the increased fines were considered not only a deterrence to

profiteering from criminal conduct, but also as an alternative to incarceration. “For individuals, the goal was to set a

monetary fine that would equal the monetary value of a prison term so that fines would be seen as an effective

alternative to prison sentences. For corporations, the Act was intended to remove the chance of the corporation’s

retaining any of the ill-gotten gains.” AMERICAN BAR ASSOCIATION, SENTENCING GUIDELINES IN

ANTITRUST: A PRACTITIONER’S HANDBOOK 9 (Robert Engelbrecht Hauberg ed.) (citing Senate Judiciary

Committee Report, S.R. 98-225, 98th Congr. 2d Sess).

18 U.S.C. § 3571(b).

18 U.S.C. § 3571(c).

18 U.S.C. § 3571(d).

U.S. SENTENCING GUIDELINES § 2N2.1 (U.S. SENTENCING COMM’N 2014).

Id. § 2N2.1 cmt. n. 1.

loss resulted from the offense.”

Consequently, even under the best of circumstances for a

defendant, where no loss of life has occurred, there is no criminal history, and the underlying

conduct is not deemed to be knowing or reckless, a food industry official prosecuted under the

FDCA for a federal misdemeanor food safety violation still faces the possibility of

imprisonment, home detention or, at minimum, a sentence involving federal probation.

For these reasons, members of the food industry should understand how federal prosecution

under the FDCA has been interpreted in seminal Supreme Court decisions, and how a corporate

official in today’s food safety climate can be found criminally liable for a food safety offense and

be incarcerated even absent proof of knowledge or active misconduct.

II. THE PARK DOCTRINE—WHAT IT IS AND WHAT IT IS NOT

The Park doctrine allows the government to seek a misdemeanor conviction of a food industry

official for a food safety violation without proving that the official knew of or actively

participated in the violation. The key is proving that the official was in a position of sufficient

responsibility or authority to prevent or remedy the food safety concerns but failed to do so.

The origin of the Park doctrine traces back to United States v. Dotterweich,

a 1943 Supreme

Court opinion establishing the contours of an FDCA-based criminal prosecution of a corporate

official. Joseph Dotterweich was the president and general manager of a company that

purchased drugs from manufacturers, repacked them under the company’s label, and shipped

them in interstate commerce.

Dotterweich and his company were charged with misdemeanors

for shipping adulterated and misbranded products, and a jury found Dotterweich, but not the

company, guilty.

Dotterweich appealed, arguing that the corporation was the only “person”

subject to prosecution under the FDCA, and further, that he was immune from prosecution under

the Act’s “guaranty” provision, which allowed him to rely on the manufacturer’s representations

of product wholesomeness. The Supreme Court rejected Dotterweich’s narrow interpretation of

the FDCA and affirmed his conviction, articulating a strict liability standard for the misdemeanor

prosecution of corporate officials for “public welfare” safety violations and setting the stage for

the later establishment of the “responsible corporate officer” doctrine.

Observing that in a modern industrial world, certain matters involving the lives and health of

people are “largely beyond self-protection,” the Dotterweich Court instructed:

The prosecution to which Dotterweich was subjected is based on a now familiar

type of legislation whereby penalties serve as effective means of regulation. Such

legislation dispenses with the conventional requirement for criminal conduct—

awareness of some wrongdoing. In the interest of the larger good it puts the

burden of acting at hazard upon a person otherwise innocent but standing in

responsible relation to a public danger.”

Id. § 2N2.1 cmt. n. 3.

320 U.S. 277 (1943).

Id. at 278.

Id.

Id. at 280-81.

The Court acknowledged the potentially broad reach of this strict liability standard. “Hardship

there doubtless may be under a statute which thus penalizes the transaction though consciousness

of wrongdoing be totally wanting.”

Nevertheless, the Court declined to define “responsible

relation” or to delineate a class of employees who might stand in such relation to the transaction.

The Court preferred to place its faith in the evidence produced at trial, and “the good sense of

prosecutors, the wise guidance of trial judges, and the ultimate judgment of juries.”

Thirty-two years later, in United States v. Park, the Supreme Court again upheld a misdemeanor

conviction of a food industry official for a public welfare offense, but this time the Court

elaborated on the concept of “responsibility” left open by the Dotterweich court.

John Park was

the chief executive officer of Acme Markets, a national retail food chain with 36,000 employees,

847 retail outlets and sixteen warehouses. Park and Acme were charged in a five-count

Information for allowing food to become contaminated with rodent filth while in storage in an

Acme warehouse in Baltimore.

Park conceded at trial that he was “responsible for the entire

operation of the company,” but he also testified that he assigned sanitation in his large

organization to “dependable subordinates” and that his Baltimore division vice president had

specifically confirmed to him that an investigation was underway into the known rodent

infestation problem and corrective action was being taken in the Baltimore warehouse.

However, Park also admitted receiving a warning letter addressed to him from the FDA

regarding unsanitary conditions at Acme’s Philadelphia warehouse one and a half years prior to

his notice of the problems in Baltimore, and he acknowledged that the company’s system for

handling sanitation “wasn’t working perfectly” since problems had now surfaced in Baltimore.

The jury found Park guilty on all five misdemeanor counts and he was sentenced to pay a fine of

$50 on each count.

Park argued on appeal that even if his lack of awareness of wrongdoing was not a defense, the

government still needed to prove he had committed some wrongful act or omission. The Court

of Appeals agreed, but the Supreme Court reinstated the conviction, finding that it was enough

that Park had failed to exercise his authority and supervisory responsibility, resulting in a food

safety violation.

[T]he Government establishes a prima facie case when it introduces evidence

sufficient to warrant a finding by the trier of the facts that the defendant had, by

reason of his position in the corporation, responsibility and authority either to

prevent in the first instance, or promptly to correct, the violation complained of,

and that he failed to do so.

Id. at 284.

Id. at 284-85.

421 U.S. 658 (1975).

Id. at 660.

Id. at 664.

Id. at 664–65.

Id. at 665.

Id. at 671.

Id. at 673-74.

Conscious that it was articulating a standard whereby conviction might be predicated on

corporate status alone, the Court observed that an effective set of jury instructions, particularly

when viewed in the context of the whole trial, could prevent this undesired outcome. The main

issue for jury determination was “not respondent’s position in the corporate hierarchy, but rather

his accountability, because of the responsibility and authority of his position, for the conditions

which gave rise to the charges against him.”

Thus, the Court concluded:

We are satisfied that the [FDCA] imposes the highest standard of care and permits

conviction of responsible corporate officials who, in light of this standard of care,

have the power to prevent or correct violations its provisions.

In his dissent, Justice Stewart lamented that the majority’s tautological definition of

“responsibility” left it to the jury to not only apply the law to the facts of the case, but to

determine the law itself. It was not only unconstitutional to put this much power into the jury’s

hands, Justice Stewart opined, but also insupportable to apply this murky standard to criminal—

and potentially felony—convictions. Foreshadowing future challenges, Justice Stewart wrote:

So the standardless conviction approved today can serve in another case

tomorrow to support a felony conviction and a substantial prison sentence.

However highly the Court may regard the social objectives of the Food, Drug, and

Cosmetic Act, that regard cannot serve to justify a criminal conviction so wholly

alien to fundamental principles of our law.

Today, Park is often mistakenly used as a shorthand reference to any prosecution of a corporate

official whose company is involved in a serious FDCA safety violation. In fact, a “pure-Park”

case is no more and no less than a misdemeanor prosecution of a “responsible corporate officer”

under a strict liability standard, meaning the government does not have to prove that the official

knew of or actively participated in the underlying wrongdoing in order to obtain a conviction.

Importantly, once a prosecutor charges a corporate official with an FDCA violation with intent to

defraud or mislead, it is no longer technically a Park case because mens rea becomes an element

of the government’s burden of proof. Nonetheless, the Park doctrine often surfaces in plea

negotiations and sentencing matters, so food industry officials need to understand how the

doctrine has been used since it was formally articulated in 1975.

III. EARLY POST-PARK PROSECUTIONS OF FOOD INDUSTRY OFFICIALS

Three years after Park, the Supreme Court heard United States v. U.S. Gypsum Co.,

a Sherman

Act case in which the Court reaffirmed that Park was consistent with and supportive of laws

designed to protect the nation’s food supply. In a footnote to the Gypsum opinion (which

conveyed a general disfavor of strict liability schemes

), the Court clarified that while Park had

set out a strict liability standard, “antitrust laws differ in this regard from, for example, laws

Id. at 675.

Id. at 676.

Id. at 683 (Stewart, J., dissenting).

438 U.S. 422 (1978).

See id. at 440–43.

designed to insure that adulterated food will not be sold to consumers. In the latter situation,

excessive caution on the part of producers is entirely consistent with the legislative purpose.”

With the Supreme Court backing the use of a strict liability standard to prosecute food company

officials for misdemeanor FDCA violations, FDA and DOJ began to collaborate on low level

prosecutions. Attorney John R. Fleder, who left the Justice Department in 1993 after nearly two

decades as a prosecutor in the department’s Office of Consumer Litigation, reflected:

For the first eight or so years there, almost all of the criminal cases the

government brought under the FDCA were Park “strict liability” cases. Most

often, those cases included charges against food companies and their officials

alleging that they had maintained insanitary facilities at their companies. Those

cases were internally referred to as “dirty warehouse” cases. In addition, the DOJ

brought some drug and device cases under the Park doctrine.

Fleder suggests that Park doctrine misdemeanor prosecutions eventually fell out of favor with

federal prosecutors because the limited sanctions did not justify the significant resources

necessary to investigate and prosecute these cases.

Felony prosecutions for FDCA violations were even less common. In the early 1990s, a federal

working group convened to study and formulate sentencing recommendations for organization

convictions under the FDCA observed that in fiscal year 1993, sixteen of the twenty-two cases

resolved that year were misdemeanors, while only five involved felony convictions and one case

included both felony and misdemeanor counts.

Moreover, seventeen of the cases involved

misbranded /diverted prescription drugs, or adulterated meat.

Felony prosecutions in the

processed food industry were few and far between, but there was at least one notable exception:

the felony prosecution of Beech-Nut executives for knowingly selling adulterated and

misbranded juice products marketed to babies and young children.

• Beech-Nut (1986)

In 1986, federal prosecutors indicted Beech-Nut, a subsidiary of Nestle S.A., for intentionally

shipping adulterated and misbranded apple juice to twenty states, Puerto Rico, the Virgin Islands

and five foreign countries with intent to defraud and mislead.

Also charged were Neil Hoyvald,

President and Chief Executive Officer of Beech-Nut at the time of the indictment and John

Id. at 441–42 n.17.

See John R. Fleder, The Park Criminal Liability Doctrine: Is it Dead or is it Awakening?, FOOD & DRUG LAW

INST, ENFORCEMENT CORNER 48, 49 (Sept./Oct.2009); http://www.hpm.com/pdf/FLEDERPARK.PDF.

John R. Fleder, Douglas B. Farquhar & Thomas Scarlett, “FDA and the Park Doctrine” Webinar presented by

Hyman, Phelps & McNamara, P.C. at 30 (Oct. 8, 2010) http://www.fdalawblog.net/files/fda-and-the-park-

doctrine.pdf (last visited May 26, 2015).

U.S. SENTENCING COMMISSION, FOOD AND DRUG WORKING GROUP FINAL REPORT (1995),

available at http://www.ussc.gov/training/organizational-guidelines/food-and-drug-working-group.

Id.

United States v. Beech-Nut Nutrition Corp., 871 F.2d 1181 (2d Cir. 1989).

Lavery, Vice President for Operations and the person responsible for the purchasing and

processing of apple juice concentrates used in Beech-Nut's apple juice and mixed juice product.

With the corporation deeply in debt and enticed by an opportunity for significant cost savings,

Beech-Nut officials signed an agreement in 1977 with a wholesaler to purchase apple juice

concentrate well below market price.

R&D and plant officials immediately expressed concerns

about the quality of the concentrate to Lavery, and repeated these warnings over the course of

several years, particularly as it became clear that the apple juice product being marketed by

Beech-Nut to children was in fact derived not from apple juice concentrate but from a

concentrate manufactured from various sugar ingredients.

Ignoring pleas to change suppliers

and recall the product, Lavery responded by securing a hold harmless agreement from the

supplier, ordering that the concentrate be used in mixed juice products (effectively diluting the

adulterated concentrate), and threatening his colleagues with dismissal for their lack of team

play.

Hoyvald was also advised of these issues and his eventual response was to direct that

finished product be moved into domestic and foreign markets as quickly as possible to avoid

FDA seizure and recall.

In October 1982, under FDA pressure, the company finally issued a

national product recall for its “pure” apple juice products but it continued to sell mixed juice

products made from the contaminated inventory into spring of the following year.

Three years later, Beech-Nut, Hoyvald and Lavery were charged with one count of conspiring

with their suppliers to violate the FDCA, twenty counts of mail fraud, and 429 counts of

introducing adulterated and misbranded apple juice into interstate commerce.

Beech-Nut

pleaded guilty to 215 counts charging that it shipped mislabeled juice with intent to defraud and

mislead the public in violation of 21 U.S.C. Sections 331(a) and 333(b) and agreed to pay a $2

million fine and reimburse FDA $140,000 in investigative costs.

At the time, the Justice

Department described this as the “largest fine ever paid under the Food, Drug and Cosmetic Act

by at least sixfold since the act’s enactment in 1938.”

Meanwhile, Hoyvald and Lavery chose

to go to trial. Lavery was convicted on 448 counts of mail fraud, conspiracy, and FDCA

violations. Hoyvald was also convicted of 350 counts of violating the FDCA, but a mistrial was

declared on the conspiracy and mail fraud charges against him because the jury was unable to

reach a verdict. Based on the mail fraud and conspiracy convictions, Lavery was facing a five-

year term of imprisonment; Hoyvald faced a maximum of three years in prison and a $10,000

fine. Both pleaded for leniency, but in June 1988, they were sentenced to a year and a day in jail,

Id. at 1183. The lengthy story of the Beech-Nut prosecution is well documented in a Second Circuit opinion

regarding Hoyvald and Lavery’s appeals of their initial convictions, and in a New York Times article, Into the

Mouth of Babes. The details exceed the scope of this article; interested readers should consult these and other

sources for a full picture of the conduct underlying the convictions. See James Traub, Into the Mouth of Babes, N.Y.

TIMES, July 24, 1988, available at http://www.nytimes.com/1988/07/24/magazine/into-the-mouths-of-babes.html.

Beech-Nut Nutrition Corp., 871 F.2d at 1184.

Id. at 1185.

Id.

Id. at 1185–86.

Id. at 1186.

Id. at 1187.

Id.

Leonard Buder, Beech-Nut is Fined $2 Million for Sale of Fake Apple Juice, N.Y. TIMES, Nov. 14, 1987,

available at http://www.nytimes.com/1987/11/14/business/beech-nut-is-fined-2-million-for-sale-of-fake-apple-

juice.html.

and required to pay $100,000 fines. The sentencing judge, Thomas C. Platt, was described in

media reports as “troubled” by the task before him.

[H]ere was Niels Hoyvald, fifty-four years old, tall, silver-haired, immaculately

dressed, standing before Judge Platt with head bowed, as his attorney, Brendan V.

Sullivan Jr., described him as ’a person we would be proud to have in our family.’

When it was Hoyvald's turn to address the judge, he spoke firmly, but then his

voice cracked as he spoke of his wife and mother: ‘I can hardly bear to look at

them or speak to them,’ he said. ‘I ask for them and myself, please don't send me

to jail.’

Judge Platt was clearly troubled. He spoke in a semiaudible mutter that had the

crowd in the courtroom craning forward. Though it was ’unusual for a corporate

executive to do time for consumer fraud,’ he said, he had ’no alternative’ but to

sentence Hoyvald to a prison term of a year and a day, plus fines totaling

$100,000. He then meted out the same punishment to the fifty-six-year-old

Lavery, who declined to speak on his own behalf. He received his sentence with

no show of emotion.

Hoyvald and Lavery appealed. The Second Circuit, ruling that the trial had been held in the

wrong district, overturned all of Hoyvald’s convictions, as well as Lavery’s convictions for

FDCA violations.

The guilty verdict against Lavery for mail fraud and conspiracy, however,

was allowed to stand.

A second trial against Hoyvald ended in a mistrial, but Hoyvald

eventually pleaded guilty to ten felony counts of violating the FDCA and was sentenced to five

years’ probation and six consecutive months of full-time community service.

Meanwhile, the

U.S. Supreme Court rejected Lavery’s appeal, allowing the mail fraud and conspiracy

convictions and the sentence of imprisonment to stand.

Beech-Nut is not a Park doctrine case and given that the decision to prosecute Hoyvald and

Lavery was made thirty years ago, it does not reflect current DOJ policy. Nevertheless, the

felony prosecution of these two high level food industry officials is an instructive reminder, in

that it follows a classic “profit over food safety” narrative and ends with a federal judge

reticently sentencing two corporate executives to prison, probation and/or community service for

their knowing and active participation in food adulteration. Notably, there were no allegations of

physical harm to any of the consumers, i.e., no claims that babies developed health problems

linked to their consumption of the company’s fake juice products. Hoyvald tried to impress upon

the jury that he had no choice but to act to protect the company, because to act otherwise would

have been tantamount to shuttering the doors at Beech-Nut. The jury was unimpressed with this

form of loyalty; while Beech-Nut survived, Hoyvald and Lavery’s failure to remedy the product

adulteration occurring on their watch—and with their knowledge—cost them dearly. Arguably,

Traub, supra note 38.

Id.

Beech-Nut Nutrition Corp., 871 F.2d at 1189.

Id.

United States v. Beech-Nut Nutrition Corp., 925 F.2d 604, 606 (2d Cir. 1991).

Lavery v. United States, 493 U.S. 933, 933 (1989) (denying certiorari).

it was precisely their knowledge of the adulteration and their active participation in corporate

fraud that led to not only to their prosecution, but also to the relatively harsh sentences for that

era, including terms of incarceration. As the sentencing judge commented, however unusual it

may be for a corporate executive to do time for consumer fraud, he felt as if he had “no

alternative.”

IV. THE ROLE OF THE PARK DOCTRINE AND THE CORPORATE OFFICIAL’S

KNOWLEDGE AND CONDUCT IN RECENT FOOD INDUSTRY

PROSECUTIONS

In the years following Beech-Nut, there was no shortage of food adulteration events that could

have led to prosecution of corporate officials pursuant to the criminal liability provisions of the

FDCA, at least in the misdemeanor context. Between 1985 and 2006, hundreds of consumer

illnesses were linked to food contaminated with bacteria such as Listeria monocytogenes, E. coli

O157:H7, and Salmonella; many of these food safety failures resulted in consumer deaths.

Significant foodborne illness outbreaks included:

• In 1985, Listeria contaminated Mexican-style soft cheese made by Jalisco Mexican

Products, Inc., a Los Angeles food manufacturer, sickened over 100 people; many of

the victims were pregnant women who later miscarried; at least forty-eight deaths

were linked to the outbreak.

• Also in 1985, an outbreak of salmonellosis occurred in Illinois, Indiana, Iowa,

Michigan and Wisconsin. The outbreak was traced to cartons of two percent milk

sold under Jewel Food Store’s Bluebrook brand and the Hillfarm label. At least 5,770

laboratory confirmed cases were reported, and nine deaths were attributed to the

outbreak.

• In 1993, after eating ground beef contaminated with E. coli O157:H7 at Jack in the

Box restaurants in Seattle, California, Idaho, Texas and Nevada, four children died

and an estimated total of 732 customers fell ill.

• In 1996, Odwalla Inc. issued a nationwide recall of juice products containing apple

juice after Washington state health officials confirmed a link between Odwalla juice

and an outbreak of E. coli O157:H7 infections. More than sixty people suffered

injury, including long term kidney damage from hemolytic uremic syndrome and one

sixteen-month old child died of kidney failure.

• In 1998, 15 million pounds of Ball Park hot dogs and Sara Lee deli meats were

recalled after Listeria monocytogenes was found in the Michigan processing plant;

dozens of consumers suffered illness and at least fifteen people died as a result of the

outbreak.

• In 2000, sixty-four cases of E. coli-related illness were linked to Sizzler restaurants in

Wisconsin. A three-year old girl died from complications caused by her infection.

• In 2002, sliced turkey meats from Pilgrim’s Pride were responsible for a multistate

listeriosis outbreak; eight deaths were linked to the outbreak.

• In 2006, Dole spinach contaminated with E. coli led to hospitalizations in twenty-six

states. Three people died, thirty-one suffered kidney failure, and 200 suffered illness.

Traub, supra note 38.

The contamination is suspected to have occurred when a spinach farmer grew his

produce on land leased from a cattle ranch.

These serious foodborne illness outbreaks led to many civil lawsuits and also spurred on

enforcement actions and food safety reforms. However, only two of these outbreaks led to

federal criminal prosecution.

In 1998, Odwalla Inc. pleaded guilty to federal charges of

shipping adulterated food products in interstate commerce and agreed to pay a $1.5 million fine,

the largest ever associated with a foodborne illness outbreak to that date.

In 2001, Sara Lee

Corporation pleaded guilty to one misdemeanor charge and agreed to pay $4.4 million in civil

and criminal penalties for producing and distributing contaminated hotdogs and deli meats,

causing fifteen deaths.

After recalling contaminated meat products, Sara Lee closed some lines

in its Michigan plant and spent $25 million on renovations to a site that government inspectors

said was infested with roaches and contained old meat and debris. Still, Phillip J. Green, the

United States attorney in Grand Rapids, Mich., said the company was not charged with a felony

because investigators found no evidence that Sara Lee intentionally produced or distributed

adulterated meats, and the company had cooperated with the investigation.

“It is tragic that

people died,” Green said, “but the law does not provide for a felony charge unless we can show

that the company knew and intended to ship adulterated foods.”

Most of the FDA and Justice Department’s collaborative resources for criminal prosecutions in

this era appeared focused on the pharmaceutical industry.

In the food industry, other than the

Jalisco Mexican Products, Inc. and its president, Gary McPherson, were charged in California state court with

sixty misdemeanor violations of state agriculture, health and safety laws. Jalisco pleaded no contest to eleven of the

counts, the president to ten. A company vice president, Jose Luis Medina, pleaded no contest to twelve of sixty

misdemeanor counts. Scott Harris, 60 Criminal Counts Filed in Jalisco Cheese Epidemic, L.A. TIMES, Mar. 28,

1986, available at http://articles.latimes.com/1986-03-28/news/mn-622_1_jalisco-cheese-epidemic. Medina and

McPherson, were sentenced to sixty days and thirty days, respectively, in Los Angeles County jail and fined a total

of about $48,000. Janny Scott & Ronny L. Soble, Final Report Traces 1985 Outbreak of Listeriosis, L.A. TIMES,

Sept. 29, 1988, available at http://articles.latimes.com/1988-09-29/local/me-5951_1_final-report-traces.

Odwalla Pleads Guilty, CNN MONEY (July 23, 1998, 4:41 PM),

http://money.cnn.com/1998/07/23/companies/odwalla/.

David Barboza, Sara Lee Corp. Pleads Guilty in Meat Case, N.Y. TIMES, June 23, 2001, available at

http://www.nytimes.com/2001/06/23/us/sara-lee-corp-pleads-guilty-in-meat-case.html.

Id.

In 2007, following a five-year investigation, federal prosecutors determined that a pharmaceutical company,

Purdue Frederick, and three of its high level employees had deviated from FDA-approved labeling by marketing the

painkiller OxyContin as less addictive and less subject to abuse than other opioid medications. Under the FDCA, an

FDA-approved drug is “misbranded” if its manufacturer makes promotional statements about the drug that deviate

from the drug’s FDA-approved labeling. Purdue Frederick pleaded guilty to felony misbranding charges and paid

$600 million in criminal and civil penalties to settle the case. Meanwhile, the company’s president and CEO, general

counsel, and chief medical officer pleaded guilty to Park misdemeanors. Expressing regret that he could not

sentence the individual defendants to prison terms due to lack of evidence that the officials knew of the wrongdoing,

federal judge James P. Jones sentenced each defendant to three years’ probation and 400 hours of community

service. Barry Meier, 3 Executives Spared Prison in OxyContin Case, N.Y. TIMES, July 21, 2007, available at

http://www.nytimes.com/2007/07/21/business/21pharma.html. In 2009, four executives of Synthes, a spinal implant

manufacturer, were charged as responsible corporate officers with knowing and intentional FDCA violations

stemming from clinical trials conducted on 200 spinal surgery patients without FDA approval. Though charged with

felony offenses, the executives each pleaded guilty to misdemeanor misbranding and were sentenced to prison terms

ranging from five to nine months. Peter Loftus, Former Synthes Officers Receive Prison Sentences, WALL STREET

Odwalla and Sara Lee prosecutions, FDA more often used its authority in civil actions to enjoin

companies from conducting further business until food safety violations were corrected. For

example, in 2001, FDA successfully argued that a fish processor lacked proper food safety

protocols (cited by FDA officials as a continuing problem over the course of several years of

inspections) and as a result, had processed fish under unsanitary conditions and introduced fish

contaminated with Listeria into interstate commerce.

FDA obtained a permanent injunction

restraining the defendants from further fish processing until the unsanitary conditions at the

facility were corrected.

In 2010, ongoing congressional oversight of FDA practices—and pointed congressional criticism

of FDA’s management of its Office of Criminal Investigations—led FDA Commissioner

Margaret Hamburg to write a much-publicized letter to Senator Charles Grassley, confirming

that among the remedial measures under discussion at FDA was a plan to increase misdemeanor

prosecutions of responsible corporate officers.

The following year, FDA published an updated

Regulatory Procedures Manual with criteria for evaluating Park doctrine prosecutions for

referral to the Justice Department.

Like the Park opinion itself, the manual does not define

categories of persons subject to prosecution or provide examples to guide personnel in making a

referral decision. Rather, the FDA advises:

When considering whether to recommend a misdemeanor prosecution against a

corporate official, consider the individual’s position in the company and

relationship to the violation, and whether the official had the authority to correct

or prevent the violation. Knowledge of and actual participation in the violation

are not a prerequisite to a misdemeanor prosecution but are facts that may be

relevant when deciding whether to recommend charging a misdemeanor

violation.

Other non-exhaustive factors to be considered are:

(1) whether the violation involves actual or potential harm to the public;

(2) whether the violation is obvious;

(3) whether the violation reflects a pattern of illegal behavior and/or failure to heed

prior warnings;

(4) whether the violation is widespread;

(5) whether the violation is serious;

JOURNAL, Nov. 22, 2011. available at

http://www.wsj.com/articles/SB10001424052970204443404577052173679627572.

United States v. Blue Ribbon Smoked Fish, Inc., 179 F. Supp. 2d 30 (E.D.N.Y. 2001).

Id.

Letter from Commissioner Margaret A. Hamburg to Senator Charles E. Grassley (Mar. 4, 2010), available at

http://www.fdalawblog.net/files/fda-grassley-ltr.pdf

REGULATORY PROCEDURES MANUAL, U.S. FOOD & DRUG ADMIN. § 6-5-3, available at

http://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/default.htm.

Id.(emphasis added).

(6) the quality of the legal and factual support for the proposed prosecution; and

(7) whether the proposed prosecution is a prudent use of agency resources.

Although FDA had clearly signaled its intent to increase misdemeanor prosecutions of

responsible corporate officers, it was less clear whether agency resources would continue to

focus on the pharmaceutical industry or whether the new emphasis on Park doctrine prosecutions

would be applied to the food industry. Conditions were certainly ripe for prosecutorial interest to

shift to the food company officials. The year 2010 marked passage of the Food Safety

Modernization Act, an indicator of strong Congressional interest in promoting and enforcing

food safety. Also, the nation was recovering from a forty-six-state outbreak of salmonellosis

traced to contaminated peanuts processed by Peanut Corporation of America (PCA).

Congressional hearings on this high profile outbreak revealed egregious conduct on the part of

PCA officials, and a case against PCA and its officials seemed inevitable. The stage was set for

the government to begin actively using federal criminal law as a food safety enforcement tool.

• Peanut Corporation of America (2013)

The federal investigation into activity at Peanut Corporation of America (PCA) began in late

2008, as FDA collaborated with CDC and various state health officials to identify the source of a

multistate salmonellosis outbreak. As of April 2009, CDC reported that 714 people across forty-

six states had been infected, leading to at least nine deaths.

The outbreak strain of Salmonella

Typhimurium was traced to a PCA peanut roasting plant in Blakely, Georgia. PCA peanut

butters and peanut paste were so widely used as ingredients in food products manufactured by

other companies that it led to the nation’s largest recall of food products. PCA declared

bankruptcy in early 2009 and the recall ultimately cost industry an estimated $1 billion.

In February 2013, PCA owner, Stewart Parnell, 63, his brother Michael Parnell, 55, who worked

as a broker, and two PCA managers were indicted on federal criminal charges. A third company

official was charged by information.

Based on the apparent strength of the evidence against

PCA, the government charged all five corporate defendants with multiple felony counts. Daniel

Kilgore, the operations manager, and Samuel Lightsey, the plant manager, who had both worked

at the Blakely plant, pleaded guilty in exchange for their testimony at trial. The Parnell brothers

and Mary Wilkerson, who was PCA’s quality-assurance manager at Blakely, went to trial in July

2014. After a seven-week jury trial, the Parnells were found guilty on a combined ninety-seven

felony counts, including fraud, conspiracy, obstruction of justice and introducing adulterated

food into interstate commerce. Some of the charges carry a maximum sentence of twenty years

Id.

Multistate Outbreak of Salmonella Typhimurium Infections Linked to Peanut Butter, 2008–2009, CDC (May 11,

2010), http://www.cdc.gov/salmonella/typhimurium/update.html.

Jeannine Stein, The Salmonella Outbreak of 2008, Deconstructed, L.A. TIMES, Aug. 17, 2011, available at

http://articles.latimes.com/2011/aug/17/news/la-heb-salmonella-peanuts-20110817.

Press Release, Office of Public Affairs, U.S. Dep’t of Justice, Former Officials and Broker of Peanut Corporation

of America Indicted Related to Salmonella-Tainted Peanut Products (Feb. 21, 2013),

http://www.justice.gov/opa/pr/former-officials-and-broker-peanut-corporation-america-indicted-related-salmonella-

tainted

in prison. The jury convicted Wilkerson on a single count of federal felony obstruction of

justice, which carries a maximum five-year prison term.

Reflecting the importance of the mens rea element that was to be the government’s burden of

proof on the felony offenses, lawyers representing Stewart Parnell publically maintained from

the outset that their client “never intentionally shipped or intentionally caused to be shipped any

tainted products capable of harming P.C.A.’s customers.”

At trial, the government presented

forty-five witnesses and voluminous documentary evidence of Stewart and Michael Parnell’s

alleged acts of fraud and conspiracy, along with evidence of widespread sanitation issues at the

Blakely, GA plant, and multiple instances of specific food-safety violations. The evidence

included fabricated certificates of analysis, documented claims that products that had never been

tested for the presence of Salmonella were pathogen-free, incidents where products that had

tested positive for Salmonella were knowingly shipped into interstate commerce, and false

statements made to an FDA investigator that there were no known positive Salmonella test

results for peanut products distributed by PCA’s Blakely plant.

In one particularly damaging

email, Stewart Parnell was told by an employee that peanut meal needed to fill an order was

covered in dust and rat feces, to which he responded, “Clean ‘em all up and ship them . . . .”

Stewart Parnell was ultimately sentenced to 28 years, Michael Parnell to 20 years, and Wilkerson

to 5 years. All three are serving time in federal prisons pending appeals. Based on the nature of

the felony charges against Stewart Parnell and others, it is important to remember that the PCA

prosecutions are not Park doctrine cases. Nevertheless, the convictions serve as fair warning to

food industry executives and managers that the Department of Justice and FDA will engage in a

full-throated investigation and prosecution of responsible corporate officials where the public

was substantially harmed, economic losses were significant and the evidence suggests that

sanitation problems and food safety violations were repeatedly ignored, or in the case of PCA,

swept under the rug. After the verdicts came in against the Parnells, then-U.S. Attorney General

Eric Holder pronounced, “The verdict demonstrates that the Department of Justice will never

waver in our pursuit of those who break our laws and compromise the safety of America’s food

supply for financial gain. All Americans must be able to rely on the safety of the food they

purchase. And any individual or company that puts the health of consumers at risk by criminally

selling tainted food will be caught, prosecuted, and held accountable to the fullest extent of the

law.”

Special Verdict at 57, United States v. Parnell, No. 1:13-CR-12-WLS (M.D. Ga. Sept. 19, 2014).

Sabrina Tavernise, Charges Filed in Peanut Salmonella Case, N.Y. TIMES, Feb. 21, 2013, available at

http://www.nytimes.com/2013/02/22/business/us-charges-former-owner-and-employees-in-peanut-salmonella-

case.html?_r=0

See Indictment, United States v. Parnell, No. 1:13-CR-12-WLS (M.D. Ga. Feb. 15, 2013); Press Release, Office

of Public Affairs, U.S. Dep’t of Justice, Peanut Corporation of America Former Officials and Broker Convicted on

Criminal Charges Related to Salmonella-Tainted Peanut Products (Sept. 14, 2014),

http://www.justice.gov/opa/pr/peanut-corporation-america-former-officials-and-broker-convicted-criminal-charges-

Id. at 29.

Press Release, Office of Public Affairs, U.S. Dept. of Justice, Peanut Corporation of America Former Officials

and Broker Convicted on Criminal Charges Related to Salmonella-Tainted Peanut Products (Sept. 19, 2014),

http://www.justice.gov/opa/pr/peanut-corporation-america-former-officials-and-broker-convicted-criminal-charges-

related.

• Jensen Farms (2013)

In September 2013, brothers Eric Jensen, thirty seven, and Ryan Jensen, thirty three, owners of

Jensen Farms in Colorado, surrendered to U.S. Marshals on federal charges of introducing

adulterated food into interstate commerce. The arrests stemmed from the 2011 multistate

Listeria outbreak linked to cantaloupe grown by Jensen Farms. The precipitating events began

in May 2011, when the Jensens installed new conveyor equipment in their packing facility. The

equipment featured a specially modified catch pan and chlorine sprayer for use in cleaning the

cantaloupe. The Jensens did not hook up the chlorine spray system, choosing instead to wash the

fruit using fresh city water that had been chlorinated for drinking. This ultimately proved

ineffective in reducing the microbial contamination of the fruit.

In July 2011, a food-safety inspector subcontracted by Primus Labs was hired by the Jensens to

conduct an audit of their packing facility to satisfy a distributor’s food safety requirements. The

facility received a “superior” score of ninety-six percent. No recommendations were made to the

Jensens to connect the chlorine sprayer or otherwise modify their cleaning practices. In fact, as

the brothers maintained at sentencing, they had been motivated to replace their prior processing

system of washing fruit with recirculated chlorinated water because a different Primus Labs

auditor had advised them a year earlier that this was a potential “hot spot.”

By September 2011, the CDC had begun tracking a major listeriosis outbreak and quickly

determined that people living in twenty-eight states had all consumed contaminated cantaloupe

shipped from Jensen Farms. The Jensens recalled their product within days of FDA inspection

and positive product tests and environmental swabbing of their facility, but dozens of consumers

nonetheless became ill or died after eating contaminated cantaloupe from Jensen Farms. Two

years later, in September 2013, federal prosecutors filed a six-count Information against the

Jensens, charging them with introducing adulterated cantaloupe into interstate commerce and

aiding and abetting the same.

The government presented no evidence to suggest the Jensens

were motivated by financial gain or had a history of engaging in criminally negligent food safety

practices. Following the Jensens’ guilty pleas to all six misdemeanor counts, prosecutors

recommended a sentence of probation for the brothers, citing, among other factors, their lack of

intent and knowledge.

The court sentenced the Jensens to five years’ probation, sixth months of home detention and

$150,000 ($25,000 per count) in restitution to their victims. No fine was imposed since the

defendants were noted to have no ability to pay a fine.

The restitution order was later modified

to reflect that the government received declarations of losses from only three individuals, totaling

$13,184.00. Other victims presumably were involved in civil litigation against Primus Labs, the

Sentencing Memorandum at 4, United States v. Jensen, No. 13-mj-01138-MEH (Colo. Jan. 14, 2014).

Aiding and abetting is typically used where the evidence shows that a crime was committed, but it is less clear

that the defendant himself personally carried out the alleged offense. Under 18 U.S.C. § 2, “those who provide

knowing aid to persons committing federal crimes, with the intent to facilitate the crime, are themselves committing

a crime.” Central Bank of Denver, N. A. v. First Interstate Bank of Denver, N. A., 511 U.S. 164, 181 (1994); see

also Rosemond v. United States, 134 S. Ct. 1240 (2014). The “intent” element necessarily requires proof of mens

rea, making the aiding and abetting charge an interesting bedfellow for a pure-Park prosecution.

Courtroom Minutes at 3, United States v. Jensen, No. 13-mj-01138-MEH (D. Colo. Jan. 28, 2014).

auditor that had given Jensen Farms a 96% score on their operations at the same time the farm

was starting to ship contaminated cantaloupes nationwide.

As a pure-Park doctrine case, the Jensen prosecution gives insight into the impact that

widespread public harm may have on prosecutorial discretion. Unlike the profit-seeking

storyline underlying the Beech-Nut and PCA’s prosecutions, Eric Jensen’s attorneys and

supporters described him in presentence documents as a person who would never put profit over

people—a thirty-seven-year old fourth generation farmer who served as a coach, church elder

and school bus driver.

The Jensens acknowledged they had the responsibility and authority to

maintain a clean packing facility, but as the probation officer specifically noted, no facts had

been found to suggest the brothers had cut corners to save money.

In short, there was no

evidence that either Eric or Ryan Jensen had acted with criminal intent or knowledge of

wrongdoing.

As Assistant U.S. Attorney Jaime Pena summarized in the Government’s Sentencing Statement:

Without a doubt, any offense that results in 33-40 deaths is a serious offense

which must be given careful consideration by a sentencing court. However, the

seriousness of the offense is tempered in this case by the lack of willful,

intentional or knowing state of mind. These defendants were at worst negligent or

reckless in their acts and omissions.

In recommending a sentence of probation, the government also highlighted that the Jensens

immediately sought to recall the product upon learning of the contamination, and then offered

substantial cooperation and assistance during the investigation that led to their own arrest. The

brothers also spoke directly with many of the victims and their families “in an attempt to provide

the victims a sense of comfort and closure.”

Given the widespread support for the Jensens as

decent farmers who fully accepted responsibility for the outbreak—support that came not only

from their fellow community members, but also from the probation officer and the prosecutor

himself—and considering that other food safety violators in recent years had not been subject to

criminal liability, why were the Jensens prosecuted? Using almost apologetic language, the

government provided this simple and direct answer in its pre-sentencing papers:

[T]his prosecution can fairly be characterized as unusual under a historical

retrospective view of the enforcement efforts of the relevant statutes. The

Jensen Farms later sued Primus Labs, claiming, inter alia, that Primus Labs was negligent in auditing their

cantaloupe fields and packing facility in July 2011. District of Colorado Case No. 13-cv-003285. The Jensens then

assigned all rights in the litigation to the victims of the outbreak, represented by attorney Bill Marler. Presumably,

this arrangement allowed the Jensens to compensate for their inability to pay a large fine. In February 2015, Primus

Labs announced the settlement of all claims related to the Jensen Farms Listeria outbreak. The amount of settlement

was not disclosed. See PrimusLabs Dismissed From Jensen Farms Litigation, PRIMUSLABS

http://www.primuslabs.com/Services/DetailEventsNews.aspx?NewID=64 (last visited May 26, 2015).

Sentencing Memorandum at 4, United States v. Jensen, No. 13-mj-01138-MEH (D. Colo. Jan. 14, 2014).

Id. at 3.

Sentencing Statement at 14, United States v. Jensen, No. 13-mj-01138-MEH (D. Colo. Jan. 17, 2014).

Id.

government was compelled to exercise its enforcement discretion in large part

because of the devastating results associated with this case.

The Jensen Farms Listeria outbreak caused or contributed to 147 illnesses, thirty-three deaths

and one miscarriage, making it one of the largest foodborne illness outbreaks in U.S. history.

The prosecution of Eric and Ryan Jensen demonstrates that significant widespread public harm

alone can serve as a sufficient basis for federal prosecutors to invoke the Park doctrine and

prosecute corporate officials for food safety violations. This is not to say that evidence of

knowledge and active wrongdoing—or lack thereof—has no relevance. For the Jensen brothers,

their widely acknowledged lack of active wrongful conduct likely served to not only keep the

charging decision within misdemeanor parameters, but also to keep them out of federal prison. It

may also have helped their cause that they assigned all rights to the proceeds of their lawsuit

against Primus Labs to the victims of this outbreak.

The court did choose to sentence the Jensen brothers beyond the government’s recommended

term of probation. However, while home detention is undisputedly a restriction on personal

liberty, it is not federal prison and the sentence is at least arguably consistent with the view that

strict liability misdemeanor prosecutions should not be accompanied by onerous sentences,

particularly terms of imprisonment.

• DeCoster/Quality Egg (2014)

In July 2010, the CDC identified a sustained nationwide increase in the usual number of cases of

Salmonella Enteritidis (SE), a strain typically associated with eggs. The increase began in May

2010 and CDC continued to receive reports of approximately 200 SE infections every week

during late June and early July. Many of the infections displayed a common PFGE pattern and

traceback investigations led health officials to Wright County Egg and Hillandale Farms of Iowa.

Laboratory testing of nearly 600 environmental samples from these two egg operations identified

the same pattern, thereby linking the outbreak to Quality Egg, an Iowa egg producer led by

Austin “Jack” DeCoster (trustee of the DeCoster Revocable Trust which owned Quality Egg)

and his son Peter DeCoster (the company’s Chief Operating Officer).

A voluntary recall of

millions of eggs began in August 13, 2010, with two expanded recall notices issued the

following week. The exact number of illnesses attributed to Quality Egg products is unknown.

In its final update, CDC concluded that from May 1 to November 30, 2010, based on

epidemiological data, 1,939 reported illnesses were likely associated with the outbreak.

CDC

estimated that for every reported case, twenty-nine other cases go unreported, leading to

Sentencing Statement at 14, United States v. Jensen, No. 13-mj-01138-MEH (D. Colo. Jan. 17, 2014).

See, e.g., Morisette v. United States, 342 U.S. 246, 25 (1952); accord Staples v. United States, 511 U.S. 600, 616–

18 (1994) (quoting 4 WILLIAM BLACKSTONE, COMMENTARIES *21) (expressing general disfavor of strict

liability offenses, but recognizing that “the small penalties attached to such offenses complemented the absence of a

mens rea requirement: In a system that generally requires a ‘vicious will’ to establish a crime, . . . imposing severe

punishments for offenses that require no mens rea would seem incongruous). See also Andrew Baird, The New Park

Doctrine: Missing the Mark, 91 N.C.L. Rev. 949 (2013).

Quality Egg operated under the names Wright County Egg, Environ and Lund/Wright Company, and also

operated two egg processing facilities under an agreement with Hillandale Farms.

Multistate Outbreak of Human Salmonella Enteritidis Infections Associated with Shell Eggs, CDC (Dec. 2, 2010),

http://www.cdc.gov/salmonella/enteritidis/ (last visited May 26, 2015).

estimates that more than 56,000 persons in the United States may have been sickened by the SE

outbreak in 2010 linked to Quality Egg.

In 2014, Jack and Peter DeCoster were charged with shipping and selling adulterated food in

interstate commerce in violation of 21 U.S.C. §§ 331 and 333(a)(1). Both men quickly pleaded

guilty to this single misdemeanor charge and Quality Egg pleaded guilty to the misdemeanor sale

of adulterated food as well as two felony charges: bribing a public official and selling

misbranded food with intent to defraud or mislead (a felony violation pursuant to 21 U.S.C. §

333(a)(2)).

Based on the significant economic losses and number of victims, as well as culpability factors,

Quality Egg agreed to a fine of $6,690,000. There was some speculation early on that this large

fine might keep the DeCosters out of jail.

Attorneys for the DeCosters maintained from the

outset that it would be unconstitutional to sentence their clients to incarceration or confinement

based on the absence of proof of criminal knowledge or intent that accompanied the strict

liability offenses to which they pleaded. Indeed, the parties stipulated in the plea agreements that

the government’s investigation to date had not identified anyone employed by or associated with

Quality Egg, including the DeCosters, who knew during the time frame from January 10 through

August 12, 2010 that eggs sold by Quality Egg were contaminated with SE.

However, the

defendants acknowledged in their plea agreements that the offense to which they pleaded carried

a statutory maximum penalty of up to one year of imprisonment. For its part, the government

agreed to leave it to the Court’s discretion whether to impose a sentence of incarceration, home

confinement or probation but reserved the right to oppose any motions challenging the

constitutionality the sentence.

Prior to sentencing, Jack and Peter DeCoster filed motions challenging the constitutionality of a

sentence of incarceration, which the government opposed. The core of Defendants’ contention

was that a term of incarceration (including a sentence of home confinement, as the Jensen

brothers had received) without proof of mens rea would violate their due process rights, as well

as their rights under the Sixth and Eighth Amendments because they had “no knowledge of the

violation and no knowledge of the conduct underlying the offense.”

The government

responded that defendants knew that SE was in their facilities, were aware of how to prevent SE

contamination, and understood the risk of product adulteration. Moreover, the government

Gov’t Sentencing Memorandum at 4, United States v. Quality Egg, LLC, No. 14-CR-3024-MWB (N.D. Iowa

Apr. 6, 2015).

Dan Flynn, Big Fine and Guilty Pleas Might Keep DeCosters out of Jail, FOOD SAFETY NEWS (June 3, 2014),

http://www.foodsafetynews.com/2014/06/7-million-fine-might-keep-jack-and-peter-decoster-out-of-

jail/#.VWYDn89VhBc.

Quality Egg Plea Agreement at 7, ¶ 9(o) United States v. Quality Egg, LLC, No. 14-CR-3024-MWB (N.D. Iowa

Apr. 18, 2014); Austin DeCoster Plea Agreement at 3, ¶ 7(c) United States v. Quality Egg, LLC, No. 14-CR-3024-

MWB (N.D. Iowa Apr. 18, 2014); Peter DeCoster Plea Agreement at 3, ¶ 7(c) United States v. Quality Egg, LLC,

No. 14-CR-3024-MWB (N.D. Iowa Apr. 18, 2014).

Austin DeCoster Plea Agreement at 5, ¶ 12; Peter DeCoster Plea Agreement at 5, ¶ 12.

Memorandum in Support of Defendant Austin DeCoster’s Motion that a Sentence of Incarceration or

Confinement is Unconstitutional at 1–3, United States v. Quality Egg, LLC, No. 14-CR-3024-MWB (N.D. Iowa

Oct. 8, 2014).

argued, even if they didn’t have this knowledge, a sentence of incarceration would not violate

defendants’ Fifth or Eighth Amendment rights.

In a sixty-eight-page order, Judge Mark W. Bennett rejected defendants’ constitutional challenge

and sentenced each defendant to three months in federal prison.

Relying in part on those

portions of the pre-sentence investigation report to which no objections had been made, Judge

Bennett made particular note of the following evidence:

• Quality Egg personnel routinely falsified documents and misrepresented information

to third party auditors who inspected Quality Egg facilities between 2007 and 2010.

This included fabricating documentation related to food safety and sanitation

practices, creating fake maintenance reports and pest control logs, and providing false

statements and records about Salmonella prevention strategies used at the plants;

• Quality Egg employees bribed a USDA official to release eggs that had been retained

for failing to meeting minimum quality grade standards (although there was no

evidence that either DeCoster knew that the bribe was going to occur);

• Quality Egg personnel regularly changed the processing dates on eggs and sold them

with false dates or shipped them with no dates in order to mislead state regulators and

customers about the age of the eggs (again, there was no evidence that either

defendant knew of the mislabeling practices);

• FDA’s 483 Report of its August 12, 2010 and August 30, 2010 inspections of Quality

Egg’s facilities documented unsanitary conditions and a complete failure to

implement appropriate pest control or SE prevention measures. Among other things,

FDA inspectors observed live and dead mice, frogs, beetles and flies in many areas;

missing vent covers and holes in walls and baseboards; traps with either dead rodents

or no bait;

• There was pervasive SE contamination throughout the Wright County Egg

operations;

• Defendants were “generally aware” of positive SE results as they were received from

early 2006–10, yet did not test or divert eggs from the market;

• Peter DeCoster misrepresented to major customers, including Walmart, the nature and

extent of the company’s food safety practices;

• Both DeCosters had prior criminal records. In 2003, Jack DeCoster had appeared in

the same court on charges of: (1) employing undocumented aliens, for which he was

sentenced to five years’ probation and ordered to pay $875,000 in restitution, and (2)

conspiring to harbor undocumented aliens, for which he received five years of

supervision; Peter DeCoster’s 2003 prosecution for conspiracy to harbor

undocumented aliens was deferred via a pretrial diversion program.

United States’ Resistance to Defendants Austin DeCoster’s and Peter DeCoster’s Motions that a Sentence or

Confinement is Unconstitutional at 4, 6, United States v. Quality Egg, LLC, No. 14-CR-3024-MWB (N.D. Iowa

Oct. 23, 2014).

Memorandum Opinion and Order Regarding Defendant’s Motions Prior to Sentencing at 68, United States v.

Quality Egg, LLC, No. 14-CR-3024-MWB (N.D. Iowa Apr. 14, 2015).

See generally Memorandum Opinion, supra note 93.

Judge Bennett found on this record that defendants knew that their processing plants were

contaminated with SE, and also knew how to effectively address SE contamination, but they took

no steps to minimize the risk that their eggs would be contaminated.

The judge noted that

whether or not such findings were made, it would have no impact on maximum offense penalties

or the statutorily authorized sentencing range available to him -- penalties and ranges that

defendants acknowledged in their plea agreements.

The judge rejected defendants’ Eighth Amendment challenge that a sentence of incarceration

would be grossly disproportionate to their offenses, observing that thousands of consumers were

harmed by the outbreak, and citing the example of one boy forced to wear steel caps over teeth

that had been weakened by antibiotic therapy to treat his illness. Defendants admitted they were

responsible for Quality Egg’s operations, yet the record of sustained misconduct supported the

inference that defendants had created a work environment where employees not only felt

comfortable disregarding regulations and bribing USDA officials, but may have even felt

pressure to do so. The case was thus distinguishable from one involving a “mere unaware

corporate executive” who could be deterred from future misconduct by a probationary

sentence.

Judge Bennett also summarily denied defendants’ Fifth Amendment challenge to imprisonment

or confinement for a strict liability offense, pointing out that Supreme Court precedent (including

Park and Dotterweich) and other lower court case law imposes no constitutional limitation on the

imposition of criminal punishment, including incarceration, for violations of the public welfare

laws like the FDCA absent mens rea. As for defendants’ contentions that penalties for FDCA

violations must be “relatively small” and that imprisonment would be incompatible with reduced

culpability for misdemeanor regulatory offenses, the judge referred to other instances in which

individuals convicted of strict liability offenses had been sentenced to jail terms under one year,

and to the FDCA itself, which expressly provides for a sentence of up to one year of

imprisonment for misdemeanor violations.

In addition to three months’ imprisonment followed by one year of supervised release, each

DeCoster was fined $100,000. Along with Quality Egg, the DeCosters were ordered to make

restitution to outbreak victims in the amount of $83,008.19. Quality Egg was sentenced to three

years’ probation and must pay a fine of $6.79 million and forfeit $10,000.

In a post-sentencing press release, Kevin W. Techau, U.S. Attorney for the Northern District of

Iowa, issued this clear and simple warning to food industry officials: “The message this

prosecution and sentence sends is a stern one to anyone tempted to place profits over people’s

welfare. Corporate officials are on notice. If you sell contaminated food you will be held

responsible for your conduct. Claims of ignorance or ‘I delegated the responsibility to someone

else’ will not shield them from criminal responsibility.”

Memorandum Opinion, supra note 93, at 41.

Id.

Id. at 47.

Press Release, FDA Office of Criminal Investigations, Quality Egg, Company Owner and Top Executive

Sentenced in Connection with Distribution of Adulterated Eggs (Apr. 13, 2014), available at

http://www.fda.gov/ICECI/CriminalInvestigations/ucm443585.htm

The DeCosters remained free on appeal but in a 2-1 ruling, the Eighth Circuit Court of Appeals

rejected the defendants’ due process challenge to the sentences of incarceration.

Writing for the

majority, Circuit Judge Diana Murphy dismissed the argument that responsible corporate official

convictions were akin to vicarious liability crimes, which under substantive due process could

not be punished by prison terms. She reasoned that under the FDCA, a corporate officer is held

accountable not for the acts or omissions of others, but rather for his own failure to prevent or

remedy food safety violations. Then, expanding on Judge Bennett’s application of negligence

principles to this Park doctrine prosecution, Judge Murphy cited the district court’s findings that

the defendants “knew or should have known” of the insanitary conditions at the egg facility and

the need to respond, and ruled that in failing to so act, they were “liable for negligently failing to

prevent the salmonella outbreak.”

100

After essentially endorsing the use of a “knew or should have known” negligence standard of

liability in a Park misdemeanor prosecution, Judge Murphy sidestepped Defendants’ argument

that their sentences of incarceration violated due process because they did not know that the eggs

were contaminated with Salmonella. Citing to Staples v. United States, 511 U.S. 600, in which

the U.S. Supreme Court ruled that eliminating the mens rea requirement in public welfare cases

does not violate Due Process where the penalties are “relatively small,” Judge Murphy

summarily characterized Defendants’ three month prison sentences as “relatively short” (as

compared to a sentence in excess of one year) and observed that Defendants’ reputation would

not be harmed because they would not be “branded as felons.”

101

She also dismissed the

dissent’s concern that the FDCA has no express congressional directive to omit a mens rea

requirement. Relying on Supreme Court precedent in Park and the gravity of public welfare

crimes, she wrote: “Although the ‘requirements of foresight and vigilance imposed on

responsible corporate agents [in 21 U.S.C. § 331(a)] are beyond question demanding, and

perhaps onerous, [ ] they are no more stringent’ than required to protect the unknowing public

from consuming hazardous food, such as salmonella infected eggs.”

102

Writing in concurrence, Judge Gruender underscored his view that Park requires a finding of

negligence to convict a responsible corporate official of a strict liability misdemeanor crime and

expose him to a sentence of incarceration.

103

First, Judge Gruender observed that in Park, the

Supreme Court strongly suggested, if not outright asserted, that a negligence showing was

required, and he also pointed out that the dissent in Park expressly concluded as much.

104

Second, Judge Gruender observed that the few courts that have considered imprisonment based

on vicariously liability have ruled that such sentences violate due process, therefore, as a matter

of constitutional avoidance, Park necessarily established a negligence standard.

105

Finally,

Judge Gruender found that requiring a negligence finding was consistent with Supreme Court

United States v. DeCoster, 828 F.3d 626 (8

Cir. 2016).

100

Id. at 633.

101

Id.

102

Id. at 634.

103

Id. at 637 (Gruender, J., concurring).

104

Id.

105

Id. at 638.

practice of avoiding the criminalization of a broad range of conduct where the underlying statute

failed to state a specific mens rea requirement.

106

In his dissent, Judge Beam agreed with the majority that a vicarious liability standard could not

support a sentence of incarceration, but he concluded that a finding of negligence was also

insufficient. Emphasizing among other things that the government had stipulated that their

investigation had not identified any Quality Egg employee, including Defendants, who knew that

the company’s eggs were in fact contaminated with Salmonella, and that the record was clear

that the DeCosters lacked mens rea, he wrote there “is no precedent” that supports imprisonment

“without establishing some measure of a guilty mind on the part of these two individuals, and

none is established in this case.”

107

With Supreme Court’s subsequent rejection of the DeCosters’ petition for writ of certiorari, the

Eighth Circuit has left the food industry with a clear directive that actual knowledge of food

contamination is not required for a misdemeanor conviction under the FDCA. Rather, a finding

that a company official “should have known” about significant food safety problems and the

need to act to protect the public is sufficient to expose that official to a penalty of incarceration

of up to one year.

• ConAgra Grocery Products (2015)

On May 19, 2015, in a move anticipated in the food industry, ConAgra Grocery Products

Company, LLC pleaded guilty to a one-count Information charging the company with the

introduction into interstate commerce of adulterated food, in violation of 21 U.S.C. §§ 331(a),

342(a) and 333(a)(1).

108

The misdemeanor violation arises out ConAgra’s sale and distribution

of Peter Pan and private label peanut butter contaminated with Salmonella I 4,[5],12:i:- in 2006–

07. The CDC identified more than 700 cases of salmonellosis linked to the outbreak strain and

estimated “thousands” of additional related cases were not reported.

109

The CDC did not

identify any deaths related to the outbreak.

110

The plea agreement provides that ConAgra will pay a criminal fine of $8 million and forfeit

assets of $3.2 million. The Justice Department identifies this as the largest fine ever paid in a

food safety case.

111

In addition, the government agrees to not seek probation, in light of the

absence of any further known food safety violations in the Sylvester, GA plant since the 2007

recall.

112

As part of the plea agreement, ConAgra and the government have stipulated to a number of facts,

including:

106

Id.

107

Id. at 649-642 (Beam, J., dissenting).

108

Plea Agreement, United States v. ConAgra Grocery Prods. Co., No. 1:15-cr-24 (M.D. Ga. May 19, 2015).

109

Id. at 6.

110

Id.

111

Press Release, Office of Public Affairs, U.S. Dep’t of Justice, ConAgra Subsidiary Agrees to Enter Guilty Plea in

Connection with 2006 through 2007 Outbreak of Salmonella Poisoning Related to Peanut Butter (May 20, 2015),

http://www.justice.gov/opa/pr/conagra-subsidiary-agrees-enter-guilty-plea-connection-2006-through-2007-outbreak-

salmonella [hereinafter DOJ Press Release, May 20, 2015).

112

Plea agreement, supra note 99, at 3.

• Prior to the 2007 recall, “the food industry generally” considered peanut butter to be

low risk for Salmonella contamination;

• ConAgra was aware of some risk of contamination, and during routine testing on two

occasions in 2004, it identified the “potential presence” of Salmonella in finished

peanut butter samples, held product pending further testing, and destroyed

contaminated product in its facility;

• In 2004-05, ConAgra employees identified a number of potential contributors to the

Salmonella problem and had begun addressing the issues. However, the conditions

were not fully corrected until after the 2007 outbreak;

• ConAgra was not aware that some employees charged with conducting and analyzing

finished product tests did not know how to properly interpret test results and failed to

detect Salmonella in peanut butter;

• ConAgra immediately shut down the Sylvester plant after the recall and initiated

remedial measures to fully correct the source of the problems;

• ConAgra shared learnings about the safe manufacture of peanut butter with

competitors and government regulatory agencies.

113

The plea agreement also includes a unique provision addressing any potential transfer of assets

or business lines within the ConAgra family of companies and confirming that this record of

misdemeanor conviction would also transfer under any such reorganization of corporate

holdings. As a result, a second FDCA violation would expose the assignees, successors-in-

interest, or transferees to potential felony criminal liability under 21 U.S.C. § 333(a)(2).

114

Following the presentation of the plea, DOJ representatives once again alerted the food industry

that criminal prosecution remains an arrow in the government’s food safety quiver. Commenting

on the ConAgra misdemeanor conviction, Acting Associate Attorney General Stuart F. Delery

said:

As parents, we can make sure that our kids look both ways before they cross the

street and wear a helmet when they ride their bikes. But we have to rely on the

companies that make their food to make sure it is safe. That’s why the

Department of Justice is dedicated to using all the tools we have to ensure the

processors and handlers of our food live up to their legal obligations to keep the

public’s safety in mind.

115

Michael J. Moore, the U.S. Attorney of the Middle District of Georgia, had sharper words of

warning:

We, as consumers, take for granted that the food we feed our families is safe. We

count on the companies who prepare and package the things we eat to be just as

concerned with the product we put in our mouths as they are with the profit they

put in their pockets. The proposed criminal fine and sentence in this case should

sound the alarm to food companies across the country—we are watching, and we

113

Plea agreement, supra note 99, at 4–7.

114

Id. at 2.

115

DOJ Press Release, supra note 102.

are expecting you to hold yourselves to a standard reflective of the trust that your

consumers have placed in you. No more excuses. A lot of people got very sick

because of the conduct in this case and we are committed to doing all we can to

make sure that does not happen again.

116

V. LESSONS LEARNED: THE PARK DOCTRINE AND THE ROLE OF

“KNOWLEDGE” IN THE PROSECUTION OF FOOD INDUSTRY COMPANIES

AND RESPONSIBLE CORPORATE OFFICIALS.

A. Companies today should expect that serious foodborne illness outbreaks will be

investigated by federal officials for possible criminal prosecution, regardless of

whether company officials knew about or played an active role in creating the

conditions leading to food safety violations or the sale of adulterated food products.

While the factual record confirms the Jensen brothers were aware of the generalized risk of

product contamination if adequate sanitation practices were not in place, there was no evidence

of any Listeria contamination on their farm or in their fruit washing equipment at the time they

shipped cantaloupes for nationwide distribution. The record also showed they relied on the

advice of recommended third-party food safety auditors and at the time of the outbreak were

acting in good faith (albeit, in the wrong way) to remedy a potential food safety issue that an

auditor had pointed out. Nevertheless, the Listeria outbreak associated with their cantaloupes led

to an estimated thirty three to forty deaths, causing the government to bring individual criminal

charges against them. Said plaintiff’s counsel and food safety advocate Bill Marler when

interviewed about the case: “I think if their product had not been linked with 147 people sick and

33 people dead, this would not be happening. I think it was hard for the U.S. Attorney’s office to

ignore the fact that 33 people died.”

117

Marler’s views are consistent with the prosecuting

attorney’s later statement in presentencing documents: “The government was compelled to

exercise its enforcement discretion in large part because of the devastating results associated

with this case.”

118

The ConAgra plea agreement also supports this premise, given that the CDC identified more

than 700 cases of salmonellosis linked to the ConAgra peanut butter outbreak and estimated that

“thousands” of additional related cases went unreported. However, it is worth noting that no

deaths were linked to the outbreak, and still, the company was prosecuted.

B. In some cases, foodborne illness outbreaks may lead to misdemeanor prosecution of

only individual corporate officials; in other cases, charges may be brought against

the company alone or in combination with charges against corporate officials;

evidence of the official’s actual prior knowledge of food safety issues does not

appear to be the distinguishing factor.

116

DOJ Press Release, supra note 102.

117

Lauren Maria Alexander, Food Safety Lawyer Offers Insight on Jensen Farms Case, GROWING PRODUCE

(Nov. 8, 2013), http://www.growingproduce.com/vegetables/food-safety-lawyer-offers-perspective-and-takeaways-

on- jensen-farms-case/.

118

Government Sentencing Statement at 14, United States v. Eric Jensen and Ryan Jensen, No. 13-mj-01138-MEH

(D. Colo. Jan. 17, 2014).

The FDA’s Regulatory Practices Manual somewhat cryptically advises its employees who are

evaluating a case for potential referral for misdemeanor prosecution under the Park doctrine to

consider evidence of knowledge: “Knowledge of and actual participation in the violation are not

a prerequisite to a misdemeanor prosecution but are facts that may be relevant when deciding

whether to recommend charging a misdemeanor violation.”

119

This guideline is consistent with

the Park doctrine, which confirms the strict liability, “no mens rea” standard for conviction of

responsible corporate officers. But recent misdemeanor cases offer few clues as to how prior

knowledge of food safety problems impacts the decision to prosecute corporate officers for

misdemeanor offenses, instead of, or in addition to charging the companies they lead.

The plea agreement in the ConAgra case reflects that company officials had limited awareness of

Salmonella in the Sylvester, GA processing facility several years prior to the outbreak and were

working to address the issues, but corrective measures had not been completed. Under those

facts, the government obtained a misdemeanor guilty plea from ConAgra Grocery Products

Company, LLC, but did not prosecute individual corporate officers within the ConAgra system.

Meanwhile, no charges were brought against Jensen Farms, but Eric and Ryan Jensen were

charged with individual misdemeanor FDCA offenses, even where the evidence indicated they

had no knowledge that Listeria was in their facility, let alone that adulterated produce had been

shipped into interstate commerce. Quality Egg and two corporate officials were charged with

criminal liability, with the DeCosters being charged with and pleading to misdemeanor counts

and Quality Egg pleading to felony and misdemeanor charges. Three outbreaks, three different

charging scenarios and outcomes.

Corporate size, corporate form, and corporate financial strength may explain part of the

difference between the outcomes in these cases. ConAgra, a Fortune 500 publically-held

corporation, like Odwalla and Sara Lee before it, was able to pay a significant criminal fine, in

fact, the largest criminal penalty ever obtained from a food company following a foodborne

illness outbreak.

120

By contrast, Jensen Farms was a privately held fourth-generation farming

operation that filed for Chapter 11 bankruptcy within a year of the 2011 Listeria outbreak. This

reportedly served to free up millions of dollars in insurance and other funds for victim

compensation, but there was clearly no source of funds from which to pay a hefty criminal

fine.

121

Similarly, no fine was imposed on the Jensen brothers because, as the sentencing court

observed, they were unable to pay a fine. PCA also declared bankruptcy within months of the

outbreak, well before prosecutors determined to charge the Parnells with individual federal

criminal liability.

C. There are “Park-like” or “hybrid Park” cases, where corporate officials plead to

misdemeanor offenses under the FDCA, but evidence of knowledge still plays a

significant role in sentencing.

119

Id. (emphasis added).

120

Because the alternative fines provision of 18 U.S.C. § 3571 authorizes the assessment of significant fines based

on the defendant’s financial gain or the victim’s financial loss even for misdemeanor offenses, some corporate

defendants may be able to escape felony liability and still satisfy criminal sentencing imperatives.

121

Michael Booth, Jensen Farms Files Bankruptcy in Wake of Cantaloupe Listeria Deaths, Denver Post (May 25,

2012, 4:46 PM), http://www.denverpost.com/ci_20713035/jensen-farms-files-bankruptcy-wake-cantaloupe-deaths.

The DeCosters were charged with the misdemeanor offense of introducing adulterated product

into interstate commerce, while their company, Quality Egg, was charged with felony

misbranding under the FDCA. In the DeCoster case, the individual defendants did not stipulate

in their plea agreement to having knowledge of the events leading up to the outbreak, and

because they pleaded to misdemeanor offenses, the government was not required to prove mens

rea. However, when the defendants challenged the constitutionality of potential incarceration

absent proof of mens rea beyond a reasonable doubt, the prosecutors prepared to put on evidence

at the sentencing hearing of the DeCosters’ pre-outbreak knowledge. Relying in considerable

part on the stipulated facts in the plea agreements and on the pre-sentence investigation reports,

the sentencing judge specifically found that the DeCosters had knowledge of the increased risk

of Salmonella in their facilities and did not address it. This finding, together with the criminal

history of the defendants, may well have impacted the district court’s decision to impose a

sentence that included three months’ incarceration. The judge rejected the defendants’

constitutional challenge, relying on the language of the FDCA, Park, and cases prosecuted under

the Park doctrine as unequivocal authority for sentencing misdemeanor defendants to terms of

imprisonment or home detention.

On appeal, the DeCosters challenged the constitutionality of the sentence of incarceration for a

strict liability offense, but the misdemeanor sentences were not outside the guideline ranges or

statutorily-prescribed penalties, and were entirely consistent with Supreme Court precedent.

Moreover, the specific record on appeal in this case contained evidence of not only the visibly

deplorable conditions at the Iowa egg facility and the concerning pathogen test results, but also

evidence of Salmonella issues previously addressed at another DeCoster-owned facility in

Maine. This record led the appellate court to determine that even if the DeCosters did not know

that the eggs were in fact contaminated with Salmonella, they “knew or should have known” that

there were significant problems with Salmonella at the Iowa facility that required action on their

part to prevent potential widespread public harm.

A variant of the hybrid-Park scenario that has played out with the DeCosters involves cases

where corporate officials are charged with felony FDCA offenses (i.e., introducing adulterated

products into interstate commerce with intent to defraud or mislead) but ultimately plead to Park

misdemeanors. The government’s ability to prove criminal intent in this scenario will of course

depend on the strength of the evidence of the defendant’s prior knowledge of food safety issues

and violations. In either scenario, the existence of facts suggesting the corporate official had

some prior knowledge becomes highly relevant to the analysis of what the official “should have

known” and therefore, the official’s ultimate fate.

D. Felony charges for intentional violations of the FDCA will be used against

companies and their officials where the evidence reflects purposeful disregard of

food safety issues and financial self-interest.

The PCA prosecution, like the Beech-Nut prosecution of thirty years prior, confirms that in those

cases where the evidence tends to show that corporate officials knew of but ignored food safety

issues and demonstrated profit-over-safety motives, the Justice Department will use its full slate

of federal felony charges (including mail and wire fraud and conspiracy, as well as the

introduction of adulterated food into interstate commerce with intend to defraud and mislead) to

prosecute companies and their officials and secure significant fines. To a certain extent, the

DeCoster case also exemplifies this type of prosecution, in light of the fact that Quality Egg was

charged with and pleaded guilty to felony adulteration and will pay a $6.8 million fine.

VI. RISK MANAGEMENT CONSIDERATIONS FOR CORPORATIONS AND

THEIR OFFICIALS

Based on events of the past seven years, there is little doubt today that if a serious foodborne

illness outbreak has been traced to a company’s product or facility, the company and the officials

who lead it may now face federal investigation and the prospect of criminal charges, significant

fines and potential incarceration. Evidence of prior knowledge of food safety concerns will

continue to play an important role in the criminal prosecution of food safety violations, but every

food company and high level official should understand that even where the evidence may

demonstrate only a negligent failure to address food safety issues, the risk of criminal penalties is

now significant. What can food industry representatives do to mitigate this risk?

1. The only sure way to protect yourself, your company and your brand is by

protecting your customers. Be a company (or in the case of individuals, work for and lead a

company) where the culture demands rigorous compliance with industry food safety standards

and regulations, including good manufacturing practices and the requirements of the Food Safety

Modernization Act.

2. Food safety, quality and defense should be a key part of your corporate

governance structure at the C-suite and board level. It must be a top responsibility of every

employee, which means it cannot be relegated to the “Quality” department.

3. For individuals in positions of responsibility and with authority to prevent or

remedy food safety issues, a little knowledge (or a sense of what you “should have known”)

potentially has a big impact on your exposure to criminal liability. You must take notice of each

and every food safety concern personally and promptly act to remedy the issue.

4. Create a clear food safety reporting process within your company and thoroughly

document every food safety issue as you become aware of it, including the results of your

investigation and any actions taken.

5. Write as if your document is a trial exhibit and if you can’t give it the proper

context, consider whether it needs to be written at all. Don’t overlook the value of a phone call

or in- person meeting, particularly as an alternative to email communications. A poorly-written

communication can sidetrack the best of intentions, plans or actions.

6. Listen carefully for the sound of a whistle blowing. If a food safety issue is

brought to your attention by an employee, treat the employee respectfully and fully investigate

his/her concerns. Remember that the Food Safety Modernization Act protects employees against

retaliation for reporting a food safety violation or giving testimony in a legal proceeding

following an alleged violation.

122

Moreover, consider that many whistleblowers start off as loyal

long-term employees trying to help their employers do the right thing. If you fail to

acknowledge an employee’s good faith belief and concerns, you have not only undermined your

122

21 U.S.C. § 399d (2012).

obligation to your company, the brand and the public, but you have also taken the first step

toward creating a witness who can testify against you in a criminal proceeding.

7. Listen also to your suppliers, distributors, licensees, franchisees and others in your

supply chain. Moreover, listen to your customers. Social media posts are sometimes an early

warning signal. Look at impressions, net sentiment and other analytics.

8. Be prepared. Develop detailed recall and crisis management plans contemplating

a variety of scenarios and conduct mock inspections and mock recalls.

9. Regulators and health officials are more likely to be reasonable and open to a

science- based approach when you have earned their respect and trust. You cannot build respect

and trust during a crisis. Get to know them and respect what they do.

10. Audits are important, but the lesson from Jensen Farms is that you cannot drive

compliance simply by auditing. Audit processes, like insurance, supplier contracts with adequate

indemnification and assurances, and trace back capabilities, make good food safety and business

sense, but “risk transfer” is always incomplete because it’s still YOUR brand.

11. If a foodborne illness outbreak should occur, retain qualified outside food safety

experts, cooperate with federal investigators and issue a recall immediately upon confirmation

that the outbreak strain has been traced to your product or facility. Under the Food Safety

Modernization Act, FDA now has the authority to order a recall anyway, so you gain nothing by

stalling or failing to rigorously evaluate your facilities and processes in the face of alleged food

safety violations.

12. Publicly express your remorse, and mean it. Take appropriate action that

demonstrates your concern for individuals who are impacted by an outbreak linked to your

company.

13. To address potential conflicts of interest, the company and each individual

employee who is subject to government investigation should immediately retain separate

counsel.

The author expresses her appreciation to Paul Benson and Don Becker for their thoughtful contributions and to

Kelly Fermoyle, whose diligent work with an unusual set of citations brought this article across the finish line.