In January 2011, the Food Safety Modernization Act (FSMA) became law in the United States. With roughly 15 percent of the U.S. food supply imported, this law was intended to strengthen the food safety system. Previously, the Public Health Security and Bioterrorism Preparedness Response Act had been signed into law following the events of Sept. 11, 2001. It gave the Food and Drug Administration (FDA) the detention authority over food items if there is a credible threat of serious health consequences or death.
The law also requires any facility engaged in the manufacture, processing, packing or holding of food for consumption in the United States to be registered with the secretary of Health and Human Services, and allows the debarment of importers with a history of repeated or serious food import violations. These two pieces of legislation granted the FDA the power to confiscate adulterated food and potentially close a business.
The FDA also has resurrected usage of the Park Doctrine, which is based on a 1975 Supreme Court decision affirming the right to bring criminal charges against corporate executives according to a strict liability theory. This enables the FDA to charge executives with a criminal misdemeanor for violations of the Federal Food, Drug and Cosmetic Act (FD&C) of 1938. Penalties for these violations are a maximum of one year in prison and/or a $100,000 fine if the violation does not result in a death. In a case involving death, the fine is $250,000.
Keep in mind that these penalties are just for the executives. The organization can be fined $250,000 for a case not involving death and $500,000 if a death is involved. If the violation is found to have been committed with the intent to defraud or mislead, or occurs after a prior conviction, the penalties are up to three years of imprisonment and/or a fine of $250,000 and $500,000.
Please note that these violations can result in hefty fines and possible prison sentences for executives regardless of the intent or knowledge of violations occurring within an individual’s area of responsibility. It is also important to understand that the definition of executives includes plant managers.
FSMA Regulations
The FSMA has created six new types of criminal violations under the FD&C and brought about the implementation of a seventh. These violations are:
- Operating a facility not in compliance with the FSMA Preventive Controls Regulations (for both human and animal food)
- Failure to comply with the FSMA Produce Safety Regulation
- Failure to comply with the FSMA Food Defense Regulation
- Refusal or failure to comply with an FDA recall order
- Knowing and willful failure to comply with consumer recall notification requirements
- The importing or offering for importation of a food if the importer does not have a foreign supplier verification program in compliance with the FSMA Foreign Supplier Verification Program Regulation
- Failure to comply with the Sanitary Food Transportation Act Regulation
In September 2013, two melon farmers in Colorado were arrested for violations of the FD&C Act following a deadly listeria outbreak that was traced back to their produce. They pled guilty to the charges and were sentenced to five years of probation, with the first six months under house arrest, 100 hours of community service and $150,000 to the victims of the outbreak.
In September of the following year, the former owner, president and CEO of the Peanut Corporation of America was found guilty on 67 federal felony counts associated with a salmonella outbreak. His brother, who was the vice president of the company, was found guilty on 30 charges.
While these are extreme examples, it is apparent the FDA is not taking violations of the law lightly. It is also easy to see how plant managers and others could be held criminally liable for food being “adulterated” or contaminated with oils and greases used in manufacturing and other related processes of food production.
Other changes outlined in the FSMA include fees associated with reassessments conducted by the FDA. The rate for these fees is $221 per hour for domestic travel and $285 per hour for international travel, which can add up quickly. These fees are to be paid by the “responsible party” within 90 days of receiving the invoice.
A Focus on Prevention
One of the cornerstones of the FSMA is the realization that the FDA likely would not be staffed sufficiently to oversee all the changes mandated by the law. Much of the burden falls on a company’s CEO and board of directors to ensure that the food they produce is safe. The primary guiding principle is the application of the Hazard Analysis and Critical Control Points (HACCP) to the roughly 80 percent of the food supply regulated by the FDA. This represents a major shift in ideology. Previously, the focus had been on responding to contamination in the U.S. food supply. Now the focus is on prevention.
Section 103 of the Food Safety Modernization Act deals specifically with prevention. It requires the owner, operator or agent in charge of a human or animal food facility which manufactures, processes, packs or holds food to evaluate hazards that could affect food safety, identify and implement preventive controls to prevent those hazards, monitor those controls and maintain monitoring records, and conduct verification and reverification activities. In addition, the responsible parties are to identify and evaluate hazards that may be intentionally introduced, including acts of sabotage or terrorism, as well as develop a written analysis of the hazards.
A major piece of the required documentation is a “food safety plan.” This plan addresses, among many other things, lubricants and lubrication. It should also include written hazard analysis, preventive controls, a supply chain program, procedures for monitoring preventive controls, corrective action procedures, verification procedures and a recall plan.
HACCP Principles
The HACCP system provides a logical, scientific approach for controlling safety issues in food production. The seven principles that make up an HACCP plan are: to conduct a hazard analysis, identify critical control points, set critical limits for each critical control point, create monitoring procedures, determine corrective actions, develop record-keeping procedures, and establish verification procedures.
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Hazard Analysis
According to the HACCP principle, conducting a hazard analysis involves preparing a list of steps in the process where significant hazards occur and describing preventive measures. A food safety hazard is defined as “any biological, chemical or physical property that may cause a food to be unsafe for human consumption.” The focus of this article is on the chemical properties.
Based on the U.S. Department of Agriculture’s “Guidebook for the Preparation of HACCP Plans,” chemical hazards fall into two categories: naturally occurring poisons, chemicals or deleterious substances that are natural constituents of foods and are not the result of environmental, agricultural, industrial or other contamination; and added poisons, chemicals or deleterious substances that are intentionally or unintentionally added to foods at some point in growing, harvesting, storage, processing, packing or distribution. This second group of chemicals can include lubricants, cleaners, paints and coatings.
The U.S. Department of Agriculture stresses the importance of being aware of chemical hazards at the following points: prior to receiving chemicals at your facility, upon receiving chemicals, at any point where a chemical is used during processing, during the storage of chemicals, during the use of any cleaning agents or maintenance chemicals, prior to shipment of the finished product, and in trucks used to ship the finished product.
Once the types of hazards and how they occur have been identified, it is possible to conduct an analysis for each process and/or product to be covered under your HACCP plan. This plan should be as specific to each individual facility as possible. Separate the analysis into two activities: brainstorming and risk assessment. Also, if one does not already exist, develop a process flow diagram to identify each step in the process. This may include a walkdown of the facility, starting at the raw material delivery stage and continuing through to loading of the finished product.
The hazard analysis can be divided into three steps: First, ensure that the prerequisite sanitation standard operating procedures and others are in place, and evaluate your operation for hazards. Next, observe the actual operating practices. Finally, assess the likelihood and severity of the hazard’s occurrence.
The analysis should allow for the identification of all significant biological, chemical and physical hazards for each step and each ingredient. You then will need to identify measures to prevent these hazards from compromising the safety of the finished product. These measures may include using only approved chemicals, such as food-grade lubricants, having detailed product specifications for chemicals entering the plant, inspecting trucks used to ship the finished product, properly labeling and storing all chemicals, and training employees who handle chemicals.
Critical Control Points
A critical control point is defined as “a point, step or procedure in a food process at which a control can be applied and, as a result, a food safety hazard can be prevented, eliminated or reduced to acceptable levels.” After the hazards and preventive measures have been determined, it is possible to identify the points in the process where the preventive measures can be applied to prevent, eliminate or reduce the hazard to an acceptable level.
Critical Limits for Critical Control Points
A critical limit is defined as “the maximum or minimum value to which a physical, biological or chemical hazard must be controlled at a critical control point to prevent, eliminate or reduce to an acceptable level the occurrence of the identified food safety hazard.” In the case of lubricants, the FDA has set this limit at zero parts per million for non-food-grade lubricant contamination.
Monitoring Procedures
Monitoring is essential to an HACCP system. It can warn of an impending loss of control so action can be taken before a critical limit is exceeded. Monitoring generally will be more effective if the personnel responsible for monitoring understand its purpose and importance, and are clearly identified and properly trained. Monitoring procedures usually relate to online processes.
Corrective Actions
Once the HACCP plan is implemented, corrective actions must be taken any time a critical limit is not met. These actions should include determining the disposition of a non-compliant product, correcting the cause of the non-compliance to prevent a repeat, examining the process or product again at the control point to ensure the results are within the limits, and maintaining a record of the corrective actions and results of the applicable testing.
Under HACCP, the actions to be taken in the event a critical limit is not met at a critical control point must be established in advance. Personnel responsible for monitoring the critical control points should understand the process and be trained on how to perform the corrective actions. All corrective actions should also be documented, with the responsible personnel signing an acknowledgement.
If a corrective action is required that has not been previously identified in the HACCP plan, this should be documented as well. It may be necessary for the product to be held for further investigation. This investigation may include product testing, consultation with a third party or processing authority, or a thorough records review.
Record-keeping Procedures
Accurate and complete records are important because they serve as written documentation of compliance with the HACCP plan. These records will allow you to trace the history of an ingredient, finished product or in-process operation should problems arise. They can also help you identify trends in an operation that could result in a deviation.
HACCP systems should include records for critical control points, establishment of critical limits, how deviations were handled and the results of verification activities. These records must contain the product identification, critical criteria, time and date of the observation, and the monitor’s and reviewer’s signatures.
Verification Procedures
The HACCP system should be assessed periodically to ensure it is working correctly. Among the points to evaluate would include the monitoring equipment’s calibration process, any corrective actions, and observations of monitors and monitoring activity. A periodic evaluation of employees is also recommended to ensure that corrective actions are performed and documented properly.
Validation of the HACCP plan will demonstrate that it prevents, eliminates or reduces all identified microbiological, chemical and physical hazards to a regulated and/or commercially feasible level. The responsibility for this validation rests on the regulated industry. The validation assembles the data to prove that the HACCP plan developed and implemented by a company will control the process and prevent food safety hazards.
A reassessment should be performed at least annually to determine if the HACCP system is adequate. A reassessment is also necessary any time new hazards have been identified or when changes have occurred in the process, ingredients, raw materials, vendor, product volume, personnel, packaging, distribution or any other factor that could affect the hazard analysis.
In conclusion, as the FDA continues its efforts to fully implement the Food Safety Modernization Act, companies that manufacture food and beverage products must prepare for the changing requirements. If they fail to comply, their plant managers could face hefty fines, criminal prosecution or even imprisonment.
Read more on food-grade lubricants:
The Basics of Food-grade Lubricants
Food-grade Lubricants and Their Place in the HACCP Program
Food Grade Lubricant Selection
What You Need to Know About Food-grade Lubricants
