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.

Behind the Label: the Blueprint for Safer Chemicals in the Marketplace

Behind the Label - the blueprint for safer chemicals in the marketplaceIf you’re in the business of using chemicals to make consumer products – things like shampoo or baby lotions, spray cleaners or laundry soap – the last few years have likely been anything but dull. State legislatures have been passing laws restricting certain chemicals from products; consumers are demanding more transparency about product ingredients; and some of the nation’s biggest retailers, including Walmart and Target, have issued chemical policies of their own.

Having worked for years to reduce the public’s exposures to hazardous chemicals and drive incentives for safer innovations in chemistry, Environmental Defense Fund is encouraged to see the growing demand for ingredient transparency and chemical safety. But for companies impacted by these new policies, adjusting to new demands may be challenging. As a business strategy, waiting to respond to the next chemical of concern or the next regulatory action, as opposed to taking proactive steps to improve transparency and chemical safety, is an unsustainable means for addressing risk.

What if your company didn’t have to worry about the next retailer’s list of priority chemicals, the next set of state or federal policy changes or regulations, or the next chemical of concern du jour to light up social media outlets?

Into the Lion's Den: An Enviro at GlobalChem

I entered the room with more than a little trepidation; as a toxicologist and risk assessor, I know how heated the debate can get regarding the safety of chemicals used in consumer products.  As an employee of EDF, I also knew that I was outnumbered by industry.  Also, the title of the panel, for which I was a speaker, was loaded:  Market Sustainability – The Retail Regulator.  Not only does industry have to worry about being regulated by Federal and State governments, but retailers, too!But my message was (and is) essentially a positive one:  there are many benefits for formulators to commit to a program of sustainability and green chemistry, substituting known hazardous chemicals with safer chemical substitutes.  These benefits include: safer working conditions and reduced need for engineering controls and protective equipment, fewer releases of hazardous chemicals to the environment, less hazardous waste disposal, safer consumer products (even when misused!), and such down-stream benefits as fewer chemicals going down the drain and into wastewater treatment plants.  How could anyone NOT like this? Read more