Rising Environmental Enforcement in the Food and Drug Sector: How to Stem the Tide for Your Facility

Kelley Drye Client Advisory

Food and drug manufacturing facilities are an increasing target for federal and state environmental enforcement actions.  Recent enforcement actions have highlighted the extent to which these facilities are subject to a host of environmental requirements applicable to a facility’s operations, including stormwater and wastewater discharges; air emissions; risk management planning; spill prevention plans; and waste management.  While an overview of some of these recent enforcement actions provides some perspective as to some of the issues that need to be addressed to ensure a facility’s compliance with applicable state and federal environmental regulations, there are proactive steps a company can utilize to identify and address compliance issues, while mitigating or even eliminating potential enforcement consequences.

Stormwater and Wastewater Management

Many industrial facilities, including food and drug manufacturing facilities, are subject to regulations under the federal Clean Water Act (CWA), and are required to manage their stormwater and wastewater discharges under permits issued either by the United States Environmental Protection Agency (EPA), or by a state which has been delegated EPA’s authority to operate the CWA program.  A facility will be subject to monitoring, recordkeeping and reporting requirements, and is also responsible for designing its operations to prevent wastewater discharges from commingling with stormwater discharges (i.e., discharges from rainfall that must be managed at the facility) from the facility.

Similarly, a facility must obtain a permit to authorize wastewater discharges from its operations.  This permit will include limits on the types of contaminants that can be discharged, and the volumes of such authorized discharges.  Monitoring, recordkeeping, and reporting requirements will also be specified.

Recent EPA enforcement actions highlight the importance of complying with these requirements.

  • A sugar processing facility was fined $1 million and required to conduct certain corrective actions estimated to cost an additional $5 million for allegedly discharging untreated wastewater into a nearby creek, resulting in a fish kill.
  • A beer manufacturing and distribution company was penalized $2.8 million for violations of its industrial wastewater permit over a period of ten years.  The alleged violations included discharges above permitted limits, as well as failure to comply with monitoring and reporting requirements.  In addition to the penalty, the enforcement action resulted in corrective action estimated at $7 million.

In addition, citizen groups and other affected parties can also bring enforcement actions to enforce federal laws, under certain circumstances.  In one such example, a poultry processing company was fined $1.4 million for allegedly violating its wastewater discharge limits.  The agreement resolving the case also required the company to make equipment upgrades and assess actions that could be taken to cease or reduce wastewater discharges.

Clean Air Act

Food and drug manufacturing facilities may be subject to the federal Clean Air Act, or similar state requirements based on the nature of their operations and the resulting potential emissions.  Often, the trigger for such requirements is the facility’s use of a refrigeration system.  Such a system may also require a facility to develop and implement a risk management program.  Issues may also arise from nuisance or dust emissions, as well as emissions from other operations inherent with a manufacturing operation.  Permitting requirements may also be triggered depending on a facility’s operations.  A meat processing facility was the subject of an EPA enforcement action for a series of alleged anhydrous ammonia releases.  In addition to payment of a penalty of $3.95 million, EPA required the company to conduct audits of over 20 facilities to determine its compliance with risk management program requirements, and to perform non-destructive testing on the piping of its refrigeration systems at these facilities.

Multi-Media Enforcement

EPA and state environmental inspections often address compliance issues in more than one program area.  For example, an agency may bring multiple inspectors to a facility to assess the facility’s compliance with air, water and waste regulations.  EPA brought such a case against a pharmaceutical manufacturing facility, alleging violations of federal and state air, water and waste requirements.  The associated inspections documented alleged unauthorized emissions of hazardous air pollutants from the facility’s wastewater operations; unauthorized emissions from leaking equipment; discharges of effluent above permitted limits; the failure to make required hazardous waste determinations: the failure to comply with labeling requirements; illegal storage of hazardous waste; and the failure to properly manifest the shipment of hazardous waste.  The enforcement action resulted in a penalty of $2.5 million, and corrective actions estimated to cost an additional $2.5 million.

Most recently, EPA brought a multi-media enforcement action against a tuna processing facility alleging wastewater permit exceedances; failure to provide adequate secondary containment for its aboveground storage tanks; failure to comply with Spill Prevention Control and Countermeasure requirements; and failure to properly operate and maintain its ammonia, butane, and chlorine systems.  The company was fined $6.3 million and required to make significant equipment upgrades and process changes.  The company also agreed to develop and implement an environmental management system, conduct periodic multi-media audits, and conduct environmental training for its employees.

Environmental Audits

EPA and several states have audit programs that can be used by companies to assess their own compliance with applicable environmental requirements.  Some states have enacted legislation to establish environmental audit programs.  Texas, for example, provides an audit privilege and penalty immunity provided a company meets statutory requirements.  Through these programs, a company may conduct its own inspection, identify any compliance gaps, develop corrective actions, and determine what, if any, disclosures should be made to the environmental agency.  Because audit program requirements are specific to each environmental agency, it is important that a company work with legal counsel to ensure that the audit complies with applicable requirements so that the company can appropriately avail itself of the benefits of the audit program.


While one may think EPA focuses its enforcement resources on larger facilities, such as refineries and chemical plants, food and drug manufacturing facilities have become a more frequent target of federal and state enforcement authorities.  These facilities are subject to broad regulatory requirements addressing air emissions, discharges to water, and waste handling issues, among others.  The consequences for failing to comply with applicable environmental requirements can be significant.  Given the significant consequences, it is to a facility’s advantage to determine the applicable environmental requirements and assess the facility’s compliance with those requirements.  Applicable environmental audit programs are a valuable tool in making these determinations and assessments.  The audit process, when used in consultation with experienced legal counsel, can allow a company to identify and address potential compliance issues, while mitigating or even eliminating potential enforcement consequences.