Tom Neltner, J.D., Chemicals Policy Director and Boma Brown-West, Senior Manager.
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“Even though the levels of a metal in any particular food is low, our overall
exposure adds up because many of the foods we eat contain them in small amounts.”
Dr. Conrad Choiniere, leader of FDA’s Toxic Elements Workgroup on April 20, 2018
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Heavy metals such as arsenic, cadmium, and lead are present in most foods, whether conventional or organic, usually as the result of environmental contamination. Because heavy metals pose significant threats even at low levels, the Food and Drug Administration (FDA) has made reducing cumulative exposure a priority. The Baby Food Council – consisting of Beech-Nut Nutrition Company, Happy Family Organics, Earth’s Best, and Gerber Products Company and supported by Healthy Babies Bright Futures (HBBF), Cornell University and EDF – shares this goal and seeks to reduce heavy metals in the companies’ products to as low as reasonably achievable using best-in-class management practices.
Through the Council, EDF is coordinating a proficiency testing program to enable retailers, food manufacturers, ingredient suppliers, and others to identify laboratories that are capable of measuring arsenic, cadmium, and lead at levels in the low parts per billion (ppb). The Council has arranged for FAPAS, a leading proficiency testing provider for the food and water testing industries, to manage the testing program.
Why is proficiency testing important?
A lab result that says heavy metals in a food ingredient are non-detectable is ideal. However, if the lab did not use a sensitive enough analytical method, or if their procedures lack adequate precision, the non-detectable result may unintentionally mask a potential problem. It can create difficult situations when buyers, FDA, or the public runs tests using another lab and finds the substances in a company’s product.
For example, EDF encountered this situation in 2018 when we reached out to 79 companies whose children’s foods FDA had tested for these heavy metals using an extremely sensitive method that the agency developed. We communicated with 40 of the companies and learned that some did not use the most sensitive method and could not measure the heavy metals below 100 ppb. We published a blog in June 2018 providing the results of our investigation. Later, Consumer Reports and HBBF also published results of their own baby food testing investigations, reinforcing that heavy metal contamination continues to exist in some products.
To avoid surprises and disruption to their markets, companies should ensure testing is conducted with inductively coupled plasma mass spectrometry (ICP-MS) equipment that has a sensitivity similar to that in FDA’s Elemental Analytical Method 4.7 (EAM 4.7). Third-party proficiency testing such as the program offered by FAPAS and the Baby Food Council, is an excellent means to evaluate the lab’s capability to help a company understand in which foods heavy metals may be present at levels of concern.
How does this proficiency testing program work?
FAPAS will prepare samples of a vegetable puree with known concentrations of arsenic, cadmium, and lead and send samples to invited labs. The concentrations will range from around one-half to ten times the limit of quantification (LOQ) established by FDA for its EAM 4.7. The labs will have four to six weeks to provide FAPAS with the results of the analysis for each of the three metals. Speciation of arsenic into its organic and inorganic forms is not required.
FAPAS will evaluate the information, score the results, and provide the Council with a report summarizing the results. While the report will not identify the participating labs, FAPAS will send each lab its own report, and those that perform well are encouraged to share their results with the Council and be considered for listing on the Council’s website.
How can a lab get invited?
Companies, including labs, interested in participating should contact EDF’s Boma Brown-West at bbrown@edf.org by February 15.
Is heavy metals testing required?
FDA requires that the food facility, as part of its Food Safety Plan, assess the known and reasonably foreseeable hazards that may be present in food at the facility and, if necessary, establish preventive controls to protect the food that leaves the facility. The agency’s draft guidance identifies heavy metals as a chemical hazard[i] that should be evaluated as part of a facility’s Food Safety Plan because they are in or on raw agricultural commodities or may leach from equipment, containers, or utensils.
The type of required control depends on how the heavy metal could get into your food product. The agency’s draft guidance states that
“Heavy metals are principally a concern in raw agricultural commodities grown in soils that are contaminated either naturally or through industrial activity. If you determine through your hazard analysis that a heavy metal hazard requires a preventive control, and that control is applied by your supplier, you would have a supply-chain program in which you would verify that suppliers source raw agricultural commodities from regions that do not have high levels of heavy metal contamination in soil, and specifications that heavy metals in raw materials and other ingredients will be within permitted levels.” [Section 4.6.3 Heavy Metals]
Testing is usually an important aspect of any verification program, especially when labs are offering testing at less than $100 per sample. FDA guidance provides an example saying “sampling and testing (by supplier or receiving facility) to verify supplier control for chemical hazards such as pesticides, drug residues, heavy metals, and mycotoxins, when a supply-chain-applied control has been applied for such hazards” [Table 5-3 on Supply Chain Preventive Controls]
In addition, the Codex Alimentarius’ Code of Practice for Lead, says that “where possible, farmers should test lead levels in soils that are near lead sources or that are suspected of having elevated lead levels to determine if lead levels exceed recommendations for planting by local authorities” and “food processors should occasionally test incoming raw materials and finished products for lead to verify that their control measures are functioning effectively.” In its Code of Practice for Arsenic in Rice, Codex recommends monitoring the concentrations of the metal as well.
EDF also has specific testing recommendations for arsenic, cadmium, and lead in food, food ingredients, and food packaging. Beyond labs that test food, we are also evaluating methods that can provide quick, reliable results in the field for metals in food handling equipment.
Summary
It is essential that anyone evaluating foods for arsenic, cadmium, and lead use a laboratory that is capable of measuring precisely at the level of concern – the low ppb range. With this effort by the Baby Food Council, any lab can demonstrate that capability through the FAPAS proficiency testing program and potentially be listed on the Council’s website.
[i] See Draft Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry – January 2018. Section 3.4.1.3: “When your hazard analysis identifies a heavy metal that requires a preventive control, the type of control would depend on how the heavy metal could get into your food product. In some cases, high levels of heavy metals may result from the environment (e.g., high lead levels in carrots that were grown in lead-contaminated soil). If your food product contains a food crop that is known to have been contaminated with a heavy metal through contaminated soil, a preventive control such as a supply-chain control with a verification program to ensure that the grower conducts an assessment of the growing region prior to its use for agriculture may be appropriate. In other cases, an unsafe level of a heavy metal such as lead could be introduced into a food product as a result of a food-contact surface constructed with lead solder. CGMP controls, such as the controls on equipment and utensils in 21 CFR 117.40, generally can control chemical hazards such as heavy metals that can leach from food-contact surfaces.”