By: Tom Neltner, J.D., Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant, Environmental Defense Fund
Since September 17, 2016, most facilities storing, processing, or manufacturing food are required to identify and, if necessary, control potential hazards in food under a Preventive Controls Rule promulgated by the Food and Drug Administration (FDA) pursuant to the FDA Food Safety Modernization Act of 2011 (FSMA). Some foods have had similar requirements in place for years. For example, fruit and vegetable juice processors have been required to have a Hazard Analysis and Critical Control Point (HACCP) Plan since the early 2000s.
Record numbers of consumers rate chemicals as their top food safety concern A Food Safety Plan required by FDA is an effective means to respond to this concern and proactively manage risks posed by chemicals instead of reacting to often preventable incidents.
The driving force behind the law and the rules has been reducing the hazard of pathogenic contamination in food. However, the Preventive Controls Rule defines a hazard broadly to include any chemical, whether a contaminant or an additive, that “has the potential to cause illness or injury.”
In this blog, we will explore how the requirements of the Preventive Controls Rule apply to chemical hazards using lead as an example. We chose lead because it is known to cause injury and clearly meets the definition of a hazard. It is well-established that there is no safe level of lead in the blood of children leading to lower IQ and academic achievement, and increases in attention related behaviors. We also know it is all too common in food that toddlers eat. And scientific evidence indicates that much of the lead in food gets into children’s blood.
Four potential sources of lead in the food supply chain
Lead can get into food in different ways including:
- Absorption from contaminated soil into the roots, leaves, and, possibly, fruit. Soil may be contaminated from past use of lead arsenate pesticides or air deposition from burning leaded gasoline.
- Contact with contaminated soil during production or harvesting. For example, soil may get into a head of lettuce or on an apple that falls to the ground.
- Leaching from food handling equipment such as that made from brass or plastic that had lead intentionally added. Until 2014, brass used in drinking water applications could contain up to 8% lead and still be called lead-free. If such brass were used in pumps and valves in food production, leaching of lead into food may occur. Similarly, lead has also been used in PVC plastic as a stabilizer, although it has been phased out in U.S. and Europe. It is important to note that lead is not approved by FDA to be intentionally added to anything that contacts food. If any leaches into food from these sources, the lead would be considered an unapproved food additive. That would render the food adulterated and, therefore, illegal to sell. Note that a supplier’s claim that a material is “food grade” is no guarantee that its use is legal.
- Contamination of food or food contact materials during processing such as lead from deteriorated paint in the building.
Elements of a Food Safety Plan
Under the Preventive Controls Rule, most facilities storing, processing or manufacturing food must have a written Food Safety Plan that consists of seven items:
- A hazard analysis to identify and evaluate known or reasonably foreseeable hazards;
- Preventive controls to ensure hazards are significantly minimized or prevented and food will not be adulterated;
- Risk-based supply chain program to protect raw materials and ingredients from hazards;
- Plan for recalls should they be necessary;
- Procedures to monitor preventive controls to assure they are consistently performed;
- Corrective action procedures if preventive controls are not properly implemented; and
- Verification procedures to validate that preventive controls are adequate and effective, other procedures are being followed, and plan is reevaluated at least once every three years.
The path forward
The FSMA food safety planning requirements put in place a systematic approach for food manufacturers to prevent food safety problems rather than react when they arise. This includes problems that can result from chemical hazards as well as pathogens. The goal is to ensure that consumers are not exposed to adulterated food, whether because it contains “any poisonous or deleterious substance which may render it injurious to health” or it contains an unapproved food or color additive.A robust food safety plan for lead and other chemicals such as perchlorate would go a long way to protect children and pregnant women from unnecessary exposures to chemicals known to impair brain development, and the businesses from unnecessary risk.
What a Food Safety Plan would say for lead
To comply with the regulations and mitigate risk, the food manufacturer/processor’s written food safety plan is required to identify lead as a hazard if it is reasonably foreseeable that lead could get into food either as a contaminant or from its intentional addition to materials such as brass or plastic used in food handling equipment.
If the plan identifies lead as a hazard, the company must evaluate the risk by assessing (1) the severity of the illness or injury if the hazard were to occur, and (2) the probability that the hazard will occur in the absence of preventive controls. The plan must also develop and implement preventive controls to assure lead levels are significantly minimized or prevented and the food is not adulterated. The controls would likely include:
- Setting the maximum amount of lead allowed in the raw materials, food contact substances, ingredients, and final product and establishing a testing program to assure the limits are met. For food products marketed to pregnant woman, infants, and young children, any detectable level of lead poses a health risk. For other foods, a limit such as the 5 ppb set by FDA for bottled water could be used as guidance. Note that the American Academy of Pediatrics recommends 1 ppb for tap water in schools.
- A program to manage the risk-based supply chain to prevent lead from getting into the materials suppliers provide. This program would include procedures to ensure that brass, plastic, and other materials that contact food do not contain any added lead that may leach into food. One way to accomplish this is to verify all equipment is certified as compliant with NSF-51 by the National Sanitation Foundation.
- Verifying suppliers are following appropriate preventive controls in production and harvest.
Next, the company must identify how the preventive controls would be monitored to spot implementation problems, explain how a recall would be conducted if lead were found to exceed the maximum amount identified in the plan or is present as an unapproved food additive, and describe what corrective action would be taken to prevent future recalls.
Finally, the food manufacturer/processor must reanalyze its Food Safety Plan at least every three years or when:
- There is a significant change in the activities conducted at the facility that creates a reasonable potential for a new hazard or creates a significant increase in a previously identified hazard;
- The food manufacturer becomes aware of new information about potential hazards associated with the food;
- An unanticipated food safety problem occurs; or
- The food manufacturer finds the preventive control, combination of preventive controls, or the food safety plan as a whole is ineffective.
The Food Safety Plans are not made publicly available, but they must be made available to FDA on request or during an inspection. Potential downstream buyers and retailers most likely can obtain a copy through their own supply chain management programs.