Technological Advances in Food Safety Monitoring Present Enforcement Risks, Compliance Opportunities for the Food Manufacturing Industry

At the annual Food Safety Summit in Rosemont, Illinois, the Department of Justice’s increased focus on food safety enforcement was a key topic of discussion. While it was quite clear that the DOJ’s increased enforcement activity in high-profile food contamination cases involving companies such as Dole Foods and Chipotle Mexican Grill in 2016 caught the attention of the industry, discussion at the Food Safety Summit focused on proactive steps food companies can take to ensure the safety of their products while simultaneously reducing their risk of non-compliance with the Food, Drug, and Cosmetic Act (FDCA) and the Food Safety Modernization Act (FSMA).

The stakes remain high for the food industry, as both companies and individuals may face criminal charges under the strict liability-based Park Doctrine, even if they were unaware of the circumstances that led to contamination.  The key question when assessing potential liability under the Park Doctrine is whether a responsible corporate officer was in a position of authority to prevent or correct the violation.

Within this environment, technological advances in the food safety industry are providing companies and regulators with new compliance and enforcement tools. For example, whole-genome sequencing is a process that determines the complete DNA sequence of an organism.  With whole-genome sequencing, foodborne pathogens, such as Salmonella, Listeria, and E. coli, can be identified more quickly, reliably, and cost-effectively than under previous outbreak surveillance systems.  Regulatory agencies are using whole-genome sequencing technologies to link pathogens to food, manufacturing facilities, and food illnesses.

With the increased use of whole-genome sequencing of samples, food manufacturers should closely monitor facility-related hazards that exist. In one high profile food recall, whole-genome sequencing revealed that the same strain of Listeria existed in samples obtained from sick consumers from 2010-2015, indicating that the bacteria likely existed within the manufacturing facility for five years.  Such a long contamination period raises obvious questions of how the bacteria entered the facility, and how it could have thrived for five years.

In developing the written food safety plan required under the Food Safety Modernization Act and related FDA regulations, companies should address those questions head-on in the following steps:

  • Hazard analysis: identification of hazards, whether they come from upstream suppliers, transportation of goods from those upstream suppliers, or risks unique to the facility, that could enable a contaminant to (1) enter a facility; and (2) survive once introduced to a facility.
  • Preventative Controls: designing measures to minimize or prevent the risk presented by the hazards identified in the first step.
  • Oversight and Management: continuous monitoring, corrective actions, and verification to ensure that the preventative controls are functioning as designed to minimize or prevent identified risks.

While the DOJ’s continued focus on food safety compliance may present enforcement risks, the data available from technological advances in sample testing provide the food industry with an opportunity to proactively design an appropriate food safety plan that identifies and addresses the risks unique to the facility.

9th Circuit Clarifies Elements of Misprision of Felony

A Ninth Circuit panel recently issued a decision in United States v. Olson, affirming the conviction of the former Alaska executive director of the U.S. Department of Agriculture’s (“USDA”) Farm Service Agency for misprision of felony under 18 U.S.C. § 4. Specifically, the panel held that the former director was correctly convicted of misprision of felony “for concealing and failing to notify authorities of her business partner’s submission of false statements” to the USDA’s Rural Development Program in connection with a federal grant application.

In so holding, the Ninth Circuit provided critical clarification of the type of knowledge the government must prove to establish “misprision of felony.” Misprision of felony is one of the oldest federal crimes, and was first enacted in a “functionally identical” version as part of the Crimes Act of 1790.

Elements of “Misprision of Felony”

The panel affirmed the long-established federal rule that “[t]o establish misprision of a felony,” under 18 U.S.C. § 4, “the government must prove beyond a reasonable doubt: ‘(1) that the principal . . . committed and completed the felony alleged; (2) that the defendant had full knowledge of that fact; (3) that he failed to notify the authorities; and (4) that he took affirmative steps to conceal the crime of the principal.”

The panel, however, also provided additional clarification as to the knowledge element. It held for the first time that “the government must prove not only that the defendant knew the principal engaged in conduct that satisfies the essential elements of the underlying felony, but also that the defendant knew that the conduct was a felony.” Continue Reading

Supreme Court Reins In SEC’s Disgorgement Power

This week the Supreme Court trimmed the SEC’s power to seek disgorgement of unlawful gains by securities law violators by unanimously holding in Kokesh v. Securities and Exchange Commission that SEC disgorgement constitutes a penalty and such claims must be brought within five years of their accrual. This decision resolved the circuit split described in a previous post.

SEC Does Not Have Limitless Power to Impose Penalties

Kokesh involved the SEC’s effort to collect $34.9 million in disgorgement for conduct going back as far as 1995, and an additional $18.1 million in prejudgment interest. The Court noted that statutes of limitations are “vital to the welfare of society” and set a fixed date when exposure to Government enforcement efforts end. Continue Reading

U.K. Court Orders Disclosure of Internal Investigation Documents to Criminal Prosecutors

In a controversial ruling, London’s High Court has held that interview notes and other documents created by outside legal counsel and forensic accountants as part of an internal investigation into foreign bribery allegations are not protected by the legal professional privilege.  While the appeals process is already underway, the May 8th decision by the Honourable Mrs Justice Andrews is a noteworthy victory for the U.K.’s Serious Fraud Office (SFO), an agency akin to the U.S. Department of Justice (DOJ).

Eurasian Natural Resources Corporation (ENRC), the U.K. division of a multinational mining conglomerate operating in the Middle East and Africa, is the subject of an ongoing SFO criminal investigation. At times, ENRC appears to have been in a cooperation posture with the SFO; but earlier this year, the SFO filed a petition seeking to force ENRC to produce documents the company claimed were privileged.  The London High Court agreed with the SFO, ruling that almost all of the documents at issue were not privileged and should be disclosed to the SFO. Continue Reading

Investigation into Odebrecht Bribes in Mexico Highlights Need For Prompt Implementation of New National Anti-Corruption System

As Mexico works towards implementing its new National Anti-Corruption System, the largest foreign bribery case in history, arising out of Brazil, serves to highlight historic weaknesses in Mexican anti-corruption efforts and just how necessary the National Anti-Corruption System will be to help combat corruption in Mexico.

The Odebrecht and Braskem Plea Agreement

In December 2016, Brazilian construction conglomerate Odebrecht S.A. (“Odebrecht”) (along with Brazilian petrochemical company, Braskem S.A. (“Braskem”)) pleaded guilty to making hundreds of millions of dollars in corrupt payments to government officials in order to secure business, preferential tax treatment, and other commercial benefits. The companies agreed to pay a combined total penalty of $3.5 billion to resolve charges with authorities in the United States, Brazil, and Switzerland, but admitted that their conduct spanned numerous countries throughout Latin America and the world, including Angola, Argentina, Brazil, Colombia, the Dominican Republic, Ecuador, Guatemala, Mexico, Mozambique, Panama, Peru, and Venezuela. With respect to Mexico, Odebrecht admitted to paying approximately $10.5 million in bribes to Mexican government officials in exchange for public works contracts between 2010 and 2014, and realizing over $39 million in benefits as a result. According to public records, all of Odebrecht’s public works projects in Mexico during that time were commissioned by state-owned oil company Petróleos Mexicanos (“Pemex”). Continue Reading

The First 100 Days: Insider Trading Enforcement to Hold Steady?

In the months leading up to President Trump’s inauguration and even during his first 100 days in office, speculation has persisted on whether white-collar enforcement will continue to be robust and, if so, which areas will be targeted. Although Attorney General Jeff Sessions recently reinforced a general commitment to continue pursuing white-collar criminals in his remarks at the Ethics and Compliance Initiative Annual Conference, details remain sketchy.

In particular, it is unclear whether insider trading prosecutions will remain a priority given the current administration’s pro-business leanings. Although insider trading is considered to be a “bread and butter” type of white-collar prosecution, there has been little guidance whether that will hold steady. Adding to this uncertainty, several key leadership positions are still vacant at two crucial enforcers: the Securities and Exchange Commission (SEC), which is supposed to ensure that material, non-public information is not used for trading; and the U.S. Attorney’s Office for the Southern District of New York (SDNY), which has traditionally acted as a key gatekeeper in deterring insider-trading activity in light of its proximity to the nation’s financial markets. Specifically, the recently-confirmed Chairman of the SEC, Jay Clayton, has not yet appointed a new Enforcement Director, the majority of the SEC’s Commissioners are not in place, and a new SDNY U.S. Attorney has not even been named.

Despite this uncertainty, the SEC and SDNY federal prosecutor’s office have stayed the course in pursuing insider trading cases in these first 100 days. Continue Reading

The First 100 Days: Uncertainty in FCPA Enforcement

President Trump’s 2012 criticism of the Foreign Corrupt Practices Act (FCPA) is well-documented. At the time, news outlets reported that business mogul Trump commented on Wal-Mart’s alleged facilitation payments in Mexico to obtain various licenses and permits, opining that FCPA was a “horrible law and it should be changed,” and adding that it put U.S. businesses at a “huge disadvantage.” Trump went on to say, “[w]e are like the policemen for the world, it’s ridiculous.”

FCPA Under Previous Administrations

The FCPA was enacted nearly 40 years ago, but its enforcement only really began under President George W. Bush. The Obama administration stepped up enforcement further, opening more FCPA cases than all prior administrations combined. While the DOJ under Obama averaged 12 corporate FCPA resolutions each year from 2011 to 2015, 2016 was a record year for FCPA enforcement with a record 25 corporate resolutions and $2.43 billion in corporate fines and penalties collected by the DOJ and the SEC.

The FCPA Under President Trump Continue Reading

The First 100 Days: A Renewed Commitment to Health Care Enforcement

Healthcare fraud enforcement, which has received much less media attention than Republican-led efforts to repeal and replace the Affordable Care Act during the first 100 days of President Donald Trump’s administration, nevertheless had some key developments that provide signals for future trends in the space. Continue Reading

SEC Suffers Rare Loss in Insider Trading Case Before Agency Judge

Marking a rare loss for the Securities and Exchange Commission (SEC) in its favored administrative forum, SEC Administrative Law Judge (ALJ) James E. Grimes ruled against the agency on April 18, 2017, in In the Matter of Charles L. Hill, Jr.  Ironically, the SEC fought hard to keep the case in the administrative forum, after Respondent Hill filed an action in federal district court claiming the SEC’s “home court” forum was unconstitutional.  The district court enjoined the SEC, but the 11th Circuit vacated the district court’s order, and the case proceeded on the SEC’s administrative court.  There, the ALJ found the SEC’s circumstantial evidence not only to be insufficient, but fatally undermined by the credibility of witnesses who offered testimony favorable to Hill.

Continue Reading

SEC Disgorgement Power – Time Running Out?

On April 18, 2017, the U.S. Supreme Court heard oral argument in Kokesh v. Securities and Exchange Commission—a case which could determine whether the Securities and Exchange Commission’s power to disgorge ill-gotten gains is subject to a statute of limitations.  The SEC currently uses disgorgement as a tool to take in billions of dollars in payments annually from defendants in its enforcement actions.  Continue Reading

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