Food industry leaders just set new guidelines for use of specific chemicals in food packaging

By Tom Neltner, J.D.Chemicals Policy Director at Environmental Defense Fund and Maricel Maffini, Ph.D., Consultant

Last week, we spent two days at a Chemical Watch food packaging conference with manufacturers and suppliers trying to better understand the process for bringing innovative products to market. They learned what the Food and Drug Administration (FDA) and other countries will demand and what challenges they need to anticipate. While regulatory aspects are complicated, the attendees often talked about the difficulties of navigating requirements from companies and reacting to consumer expectations about packaging chemicals.

These concerns were timely. On March 9, the Food Safety Alliance for Packaging (FSAP), a part of the Institute of Packaging Professionals, released “Food Packaging Product Stewardship Considerations,” a set of best practices. This marks the first public recognition by a sector of the packaging industry of the expectations and demands from food manufacturers, retailers, and consumers.

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FDA is reevaluating its tolerances for lead in food, and food manufacturers should too

By Tom Neltner, J.D., EDF Chemicals Policy Director and Maricel Maffini, Ph.D., Consultant

Until recently, we have known very little about food’s contribution to children’s exposure to lead. Surprisingly, a recent report from the EPA found that two-thirds of one-year olds get most of their exposure from food. FDA has been reviewing its testing methods and standards for a while and just published FAQs regarding lead in food. Leading companies should take notice.

We have written about the health risk of lead exposure from major sources such as paint and water and the well-known fact that there is no safe level of lead in the blood of children. We also wrote about what agencies such as the Environmental Protection Agency (EPA) and Centers for Disease Control and Prevention (CDC) are doing to reduce or eliminate persistent sources of lead exposure as recommended by the American Academy of Pediatrics (AAP). Food remains a poorly understood source of exposure.

In its FAQs for lead in food, FDA describes what it has done, its current standards, and its planned next steps. The agency makes no reference to EPA’s assessment and attributes the lead in food to contaminated soil. The agency say it seeks to limit lead in food to the greatest extent possible and set the following tolerances:

To limit lead in food to the greatest extent possible, FDA set the following tolerances:

  • Bottled water: 5 parts per billion (ppb);
  • Juices from berries and other small fruits, including grapes, and passion fruits: 50 ppb;
  • Other fruit juices and nectars, including apple: 30 ppb;
  • Candy likely to be consumed by small children: 100 ppb; and
  • Dried fruits, including raisins: 100 ppb.

Only the bottled water tolerance is established in regulations. For the rest, FDA provides only guidance.

How did FDA set the tolerances?

The 5 ppb limit in bottled water was established by FDA in 1995 based on the inability to reliably measure below that level and that only 2 of 48 (4%) samples collected by FDA exceeded those levels. For comparison, in 2016, the AAP recommended lead levels in drinking water at schools be less than 1 ppb.

The fruit juice limits are based on international food standards set by the Codex Alimentarius Commission (Codex), an organization representing 188 countries and the European Union. Those standards were designed to ensure that only about 5% of the juice samples would exceed them. While Codex recognizes the risks posed by lead, its standard was not based on those risks.

For all other foods, FDA relies on a maximum daily intake level of 6 micrograms of lead per day (µg/day) for young children that it established in 1993 based on CDC’s Level of Concern of 10 micrograms of lead per deciliter of blood (µg/dL).

One million children exceed FDA’s current maximum daily intake level

In the FAQs, FDA affirmed that “there is no known identified safe blood lead level” and acknowledges that scientific information has become available in the last decade that indicates neurotoxic effects at low levels of exposure to lead. It notes that the evidence has prompted EPA to lower its air quality standard, CDC to strengthen its standards, and the Joint WHO and FAO Expert Committee on Food Additives (JECFA) to withdraw its limit for lead because it concluded there was no safe level in food. With this backdrop, FDA is reevaluating “its methods for determining when it should take action with respect to measured levels of lead in particular foods, including those consumed by infants and toddlers.”

At EDF, we are pleased to see FDA has undertaken this long overdue reevaluation. EPA’s draft report estimates that more than 5% of children between 2 and 7 years consume more than the 6 µg of lead/day FDA says is tolerable. This estimate excludes drinking water. With 20 million children in those age groups, that means 1 million children exceed the maximum daily intake level. And, by all accounts, this 1993 level does not reflect the mounting scientific evidence that has led other science-based organizations to reduce their standards. We are also encouraged to see that FDA is willing to be more protective of children’s health by conducting its own assessment rather than just following the Codex standards for fruit juices.

Food manufacturers and retailers can better earn consumer trust and avoid more costly changes by updating their preventive controls and supply chain management programs now to reduce lead levels in food.

Why Food Safety Plans must consider chemical hazards

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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:

    1. A hazard analysis to identify and evaluate known or reasonably foreseeable hazards;
    2. Preventive controls to ensure hazards are significantly minimized or prevented and food will not be adulterated;
    3. Risk-based supply chain program to protect raw materials and ingredients from hazards;
    4. Plan for recalls should they be necessary;
    5. Procedures to monitor preventive controls to assure they are consistently performed;
    6. Corrective action procedures if preventive controls are not properly implemented; and
    7. 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:

    1. 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.
    2. 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.
    3. 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:

  1. 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;
  2. The food manufacturer becomes aware of new information about potential hazards associated with the food;
  3. An unanticipated food safety problem occurs; or
  4. 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.

For FDA reviews of “generally recognized as safe” ingredients, time is not an issue­­

Behind the Label_FIn our work with retailers and food manufacturers, EDF strongly recommends submitting all ingredients for U.S. Food and Drug Administration (FDA) safety review, especially those additives deemed ‘generally recognized as safe’ (GRAS). This includes things such as flavors, sweeteners, preservatives and the like. If an unreviewed ingredient is identified in a recipe, we also recommend that the grocer or manufacturer require the supplier to send the ingredient through an FDA GRAS review.

One question we often get is, “Doesn’t that take a long time?” Quite simply, the answer is no. But some players in the food industry try to perpetuate that myth so they can continue to self-certify safety and bypass FDA’s scrutiny.

GRASIn the 2014 report, “Generally Recognized as Secret: Chemicals Added to Food in the United States,” more than fifty companies were shown to be deliberately avoiding FDA reviews of 275 chemical additives marketed for food uses. On their own, the companies determined that the substances’ uses were GRAS, without making the safety assessment of the chemical publicly available or submitting it for review by FDA. It’s tough to imagine how it could be “generally recognized” if the safety studies are kept secret.

One reason these companies gave for avoiding the agency’s review: FDA is too slow, resulting in delays in product marketing and sales.

So, are FDA reviews so long as to justify bypassing the agency? Read more

Why EDF May Decline a Seat at the Consensus Standard Table

Have you ever looked at the tag on your power supply and wondered what all those symbols meant? Many of them represent a voluntary consensus standard designed to protect the safety and health of the user.

Since we believe these types of standards can serve a valuable purpose, we wanted to explain why and how we make the decision to participate – and why we and other NGOs recently withdrew from one such effort by NSF International, funded by the Grocery Manufacturers Association (GMA).

LabelsConsensus Standards

Put simply, a voluntary consensus standard means a relevant and balanced group of stakeholders got together and reached agreement on how to do something voluntarily and consistently that serves national needs.

For example, NSF/ANSI Standard 61: Drinking Water System Components sets health effects criteria for many water system components such as pipes and faucets. Such standards, overseen by the American National Standards Institute (ANSI), can create assurance that might otherwise require regulation.

As you’ll read below, the ANSI due process guidance for consensus standards require balance in the range of viewpoints considered. EDF increasingly finds itself invited to represent the public interest point of view. Read more