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:

  • 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:

  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:

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.

New CSPI report investigates "clean label" foods, offers key recommendations

Slightly more than a third of Americans think “clean-label” products are free from artificial ingredients. About a third think it means organic or natural. And roughly a third of Americans don’t know what clean label means. For retailers, restaurants, and food manufacturers, that creates a challenging landscape – and one with few [1] defined guardrails.

Today, the Center for Science in the Public Interest (CSPI) released a new report, Clean Labels: Public Relations or Public Health?, that assesses efforts by four restaurants – Chipotle Mexican Grill, Noodles & Company, Panera Bread, and Papa John’s – and nine grocers – Ahold Delhaize (Food Lion, Giant Food, Stop and Shop), Aldi, H-E-B, Kroger, Meijer, Supervalu, Target, Wakefern (ShopRite), and Whole Foods  – to deliver what they interpreted a “clean label” product to mean. The report is well worth the read.

EDF agrees with the CSPI report statement that, “[m]ost substances added to food—even ones with long chemical names—are safe… But some are not, and many have been poorly tested. Indeed, the system intended to ensure the safety of ingredients added to food is deeply flawed.”

We also agree with CSPI that, “To the extent that clean label products are healthier than their non-clean label counterparts, because they are made with actual foods instead of cheap chemical imitations, they deserve praise. Still, the absence of artificial ingredients does not make a food healthy, since it could still be loaded with saturated fat, salt, or added sugars and be largely devoid of dietary fiber and nutrients.” For EDF, clean labels also provide no assurance about other unknown and hazardous food additives such as those used in packaging like perchlorate or that enter food during manufacturing and processing like phthalates.

What should make the report of interest to all engaged in the business of food, from those making it to eating it, are the well-substantiated recommendations for addressing food ingredients in clean-label programs. The CSPI report defines and then assesses the suite of best-in-class clean label efforts by supermarkets and restaurants across three major components:  ingredients covered, food and beverage products covered, and transparency. In general, transparency efforts are strongest, coverage across products is weakest, with ingredient reformulation somewhere in the middle.

The report concludes with a trio of target recommendations and action steps, including:

  • Prioritize public health – Clean-label commitments should be accompanied by meaningful improvements to the nutritional quality of the foods and beverages sold.
  • Comprehensive policies – Lists of prohibited ingredients should apply to all products a restaurant makes or sells, including beverages, and supermarkets should expand clean label policies to all of their private-label brands.
  • Transparency – Restaurants should provide complete ingredient and nutrition information for all menu items, both on-site and on their website, and supermarkets should provide this information on their websites.

Given that natural is an artificial, and often erroneous, synonym for healthy, Clean Labels: Public Relations or Public Health? does just what CSPI intended – provides a useful assessment of clean label efforts that give direction and guidance to companies committed to improving the health and safety of the food they make and sell.

For companies seeking to improve their own food offerings, EDF+Business invites you to visit Behind the Label: A Blueprint for Safer Food Additives in the Marketplace. This online resource details best practices for the five pillars of leadership, offers a model policy and case example, as well as tracking corporate efforts in this space.

[1] “Certified organic” is a federally defined and regulated status.

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

Consumer Concern About Chemicals in Food Continues to Grow

Behind the Label_FFor the second year in a row, more than a third of consumers participating in the annual food industry survey rated chemicals in food as their most important food safety issue. Every year for the past decade, the International Food Information Council (IFIC) has surveyed more than 1,000 Americans aged 18-80, to gain insight into their attitudes towards food and diet. Although the way they have polled on these topics has changed over the years, the research shows a clear and steady rise in the number of Americans concerned about chemicals in their food.

In 2016, IFIC broke down the ‘chemicals in food’ option from 2015 into more specific concerns: chemicals in food (arsenic, mercury, BPA); carcinogens or cancer-causing chemicals in food; and food additives and ingredients (caffeine, MSG, flavors, colors, preservatives, etc.).

food-survey-graphics_block_2_croppedFor 38 percent of the respondents, these three specific sub-categories of chemicals in food combined were the most important food safety issue, a two-point jump since last year. And these concerns are being felt in the market: 40% of consumers who stated that chemicals were of great concern to them reported changing their eating habits.

Growing concern driving food supply chain changes

Consumers’ growing concern about chemicals reflects an increased awareness about the harmful effects they may have on human health and, importantly, a shift in how consumers are defining the issue of “safety” in food. As we reported a few months ago, a report from Deloitte, the Food Marketing Institute and the Grocery Manufacturers Association found that consumers are increasingly concerned about the short-term health effects of chemicals in food (e.g., no toxins) as well as the long-term effects (e.g. no carcinogens).

To their credit, the food industry is beginning to respond to these concerns. Read more

Consumers’ Changing Views on Food Safety, and the Opportunity for Action

Behind the Label_FConsumers demand safe food, and they prioritize purchasing from brands that they trust to be safe. The food industry knows this and wisely makes safety a top priority. But consumers’ definition of safety is changing, and the food industry needs to evolve its practices to keep pace with consumer demand.

Customers have traditionally defined safety as “free of harmful elements.” Last year, more than thirty-six percent of consumers said chemicals in their food was their top food safety concern. A new report from Deloitte, the Food Marketing Institute (FMI) and Grocery Manufacturers Association (GMA) found that definition of safety has expanded — that consumers consider safety both a short-term (e.g., toxin free) as well as a long-term (e.g., no carcinogens) concern and, as a result, it aligns with their health and wellness concerns.

Deloitte-FMI-GMA-report-coverThis expanded definition of safety includes attributes such as clear and accurate labeling; clear information on ingredients, both label and sourcing; fewer ingredients, processing and no artificial additives; and better nutritional content.

The message is clear: Retailers and food manufacturers need to adapt, or they risk losing market share to competitors who meet evolving customer demands with safer ingredients and improved transparency.

Read more

What’s in Your Product’s Flavor? Here’s Why You Should Find Out.

Behind the Label_FAs we discuss frequently on this blog, maintaining transparency and control of your company’s supply chain can help limit potential risks to your business. With some food additives, however, transparency is not enough and certain chemicals should be removed from your products, or risk having to reformulate quickly at significant cost or having to recall products with those ingredients.

A set of seven carcinogenic flavor chemicals under review by the Food and Drug Administration (FDA) offers a good example of these risks. On Jan. 4, 2016, the FDA announced that it is considering whether to rescind its 1964 approval of – effectively banning – seven flavoring chemicals as food additives. Read more