Tag Archives: heavy metals

Jennifer Allen
Food Safety Attorney

Protecting the Nation’s Tiniest Consumers

By Jennifer Allen
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Jennifer Allen

Does your company need to worry about regulations relating to foods designed for infants (considered to be anyone aged 0-12 months)? If you manufacture infant formula, then of course the answer is yes. But what if you manufacture baby food—those cute little jars of liquified goodness? Traditionally, those types of food haven’t been subject to any special FDA regulations. Manufacturers simply need to follow the regulations that govern all foods designed for consumption by humans of any age. That, however, is changing.

There is a growing push to limit, and ultimately eliminate, heavy metals, such as inorganic arsenic, lead, cadmium, and mercury, present in baby food. These elements are present in our food chain in amounts that are concerning to members of the U.S. Congress and other stakeholders because of modern manufacturing techniques, and they have an outsized effect on infant health.

Pending Legislation

On March 25, 2021, the Baby Food Safety Act was introduced in Congress. As of the time this article was written, it had not yet passed. If it passes, it will require manufacturers, within one year of its enactment, to reduce levels of inorganic arsenic in non-cereal foods to 10 ppb and in cereals to 15 ppb, levels of cadmium and lead to 5 ppb in non-cereals and 10 ppb in cereals, and levels of mercury to 2 ppb in non-cereals and cereals. Within three years of enactment, the Act requires that final regulatory levels be set that reduce these levels to an even lower amount. It also requires reevaluation of the current regulatory levels every five years thereafter.

But the Act would do much more than simply setting limits for heavy metals in baby food. It would also:

  • Add regulations to the Food Drug and Cosmetics Act requiring FDA to specifically regulate foods for consumers up to 36 months old
  • Require manufacturers to report levels of heavy metals biannually on their websites
  • Give FDA mandatory recall authority
  • Mandate creation of public awareness campaigns
  • Offer grants for farming research

Current FDA Actions

The FDA is already working to reduce heavy metals in baby foods. In August 2020, the FDA finalized guidance setting the limit for inorganic arsenic in baby rice cereals to 100 micrograms per kilogram. Fortunately, most manufacturers had already achieved those limits; sampling from 2018 showed that 76% of manufacturers were in compliance, up from 47% in 2014 and from just 36% between 2011 and 2013.

In early 2021, FDA launched an action plan to address heavy metals in foods consumed by infants and young children, called Closer to Zero. The overarching purpose of the plan is to gather data about heavy metal levels and then set tolerances for those substances, with the input from all stakeholders. Thus, the FDA has signaled its intent to act regardless of what Congress has in store.

More recently, the FDA issued draft guidance, titled “Action Levels for Lead in Food Intended for Babies and Young Children,” recommending that levels of lead be limited to 10 ppb in fruits, some vegetables, and yogurt, and to 20 ppb in root vegetables and dry cereal. The guidance is focused on processed foods, including foods served in jars, pouches, tubs, and boxes intended for children under two.

Whatever the ultimate outcome of these initial steps taken by Congress and FDA, one thing is clear: Concerns about heavy metals in the foods consumed by our tiniest citizens isn’t going away. So, if the product you manufacture or grow may be destined for a jar of baby food—even if you don’t think you manufacture baby food—it’s time to begin working to address the issue in your facilities and your fields.

Jonathan Sharp, Environmental Litigation Group
In the Food Lab

How Baby Food Companies Can Minimize the Concentration of Heavy Metals in Products

By Jonathan Sharp
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Jonathan Sharp, Environmental Litigation Group

On February 4, 2021, the U.S. House of Representatives made public a report concerning the existence of heavy metals in baby food. The heavy metals of concern were cadmium, arsenic, lead and mercury, which pose a tremendous hazard to developing children’s health. After reviewing internal documents and test results from seven of the largest baby food manufacturers in the country, the Subcommittee on Economic and Consumer Policy found each company’s products to contain dangerously high concentrations of heavy metals.

Four of the companies, Nurture, Beech-Nut, Hain and Gerber, responded to the request. They provided internal testing policies, test results for ingredients and finished products, and documentation about how they handled finished products and ingredients that exceeded their internal testing limits.

On the other hand, Walmart, Campbell and Sprout Organic Foods refused to partake in the investigation. The Subcommittee on Economic and Consumer Policy members are very concerned that the lack of cooperation of these manufacturers could obstruct the presence of even higher levels of heavy metals in their products than their competitors.

Practical Measures Baby Food Companies Can Take to Ensure Products Are Safe for Children

Baby food manufacturers may not intentionally add heavy metals to their products, but their lack of testing and a lack of regulation in this sense is a cause for great concern. The main ingredients in baby foods such as rice, sweet potatoes, wheat, and carrots absorb heavy metals from the soil and water and metal-containing pesticides and industrial pollution.

Therefore, the companies that manufacture baby food should tackle the issue of heavy metals at the root of the problem and abide by strict safety measures and protocols to ensure low concentrations of heavy metals, particularly arsenic. Some of the steps that they could take to minimize this issue are the following:

  • Sourcing cereals, fruits, and vegetables from fields with lower arsenic concentrations in the earth
  • Growing crops with natural soil additives that reduce heavy metal uptake
  • Using strains of food that are less prone to absorb heavy metals
  • Altering irrigation practices
  • Preparing the food with excess water that is afterward poured off
  • Blending it with lower arsenic grains in multi-grain products

Subsequently, when the end product is finished, manufacturers should collect a sample from the finite product and test it for cadmium, arsenic, lead and mercury. Fortunately, nowadays, testing baby food for heavy metals is easier than ever and cost-efficient. Every food facility that must comply with FSMA must implement HACCP and establish preventive controls. HACCP, which is recognized internationally, ensures the health and safety of consumers by avoiding hazardous toxins in food. When it comes to baby food companies, they should focus on chemistry testing, as it addresses chemical and physical hazards, including heavy metals.

Alternatively, baby food companies can test their products by using the guidelines of the Environmental Defense Fund. The non-profit advocacy group advises manufacturers to prohibit arsenic, cadmium explicitly, and lead in any packaging or food handling equipment and strictly avoid brass and bronze unless they are confident that no heavy metal was added. Manufacturers of baby food should test the products per se, the ingredients, and the packaging for arsenic, cadmium, and lead. More specifically, companies should:

  • Consistently test baby food and their main ingredients that may be contaminated with arsenic, cadmium, or lead by using the method approved by the FDA and examine potential sources of heavy metals where measurable concentrations are found
  • Periodically test the packaging that comes in contact with food anywhere along the supply chain for arsenic, cadmium, or lead through a CPSC-accepted, third-party certified lab that evaluates baby food for heavy metals

In December of 2019, the cost of heavy metal testing was between $50 and $100 per sample. Nevertheless, companies that produce baby food should invest in heavy metal testing, no matter how small or large. This is the only way of making sure they put exclusively clean and safe products of high quality on the market.

To make sure baby food companies keep following the guidelines concerning heavy metals and do not fail to test their products for these neurotoxins regularly, the authority of the FDA should be expanded. Accordingly, the agency should be able to request a recall of adulterated or misbranded baby food whose concentration of heavy metals exceeds the safe limit. Moreover, the FDA should establish health-protective standards for each heavy metal and implement a testing program for neurotoxins in foods eaten by infants and toddlers that could be similar to the agenda of the Consumer Product Safety Commission for children’s toys.

The Ethical Measures Baby Food Companies Should Take to Avoid Selling Tainted Products

Baby food companies should exercise their social and moral capacity at all times. Nonetheless, while few people achieve the extent of influence necessary to change society itself, the food industry can drastically change societies. Moreover, it can also act in morally beneficial or detrimental ways, which inevitably affects people, the environment, and, ultimately, the planet itself.

To prevent your baby food company from developing unethical conducts, such as allowing dangerous concentrations of heavy metals in the products that end up on the market, there are a series of measures you and the other people who are in charge of the business can take, the paramount being the following:

  • Hiring accredited, trustworthy and competent people is perhaps the most important, as well as the first, step you can take to ensure no foul play will occur, as they will be unlikely to cover up essential information from you and the other higher-ups
  • Sourcing your ingredients from ethical suppliers, that are, preferably, local farmers, as they usually employ transparent business practices
  • Make sure that your facilities are maintained clean 24/7 by hiring the right people to take care of this not-so-easy job as if you neglect the condition of your facilities. Other contaminants may end up in the food you sell
  • Systematically testing your baby food for cadmium, arsenic, lead and mercury to ensure the products you allow to go on the market do not contain dangerous levels of heavy metals
  • Partnering with experienced laboratories to have your baby food regularly tested for heavy metals, which may help you save money if it is going to be a win-win situation
  • Having clear labels, even if you add ingredients that are not so healthy in your products, which will result in the consumers you target trusting you as a company
  • Voluntarily recalling a line of baby food products as soon as you receive the positive test results for one or multiple heavy metals, which will spare you some liability if you willingly take your food off the market

The Changes the Baby Food Safety Act May Bring About if the Bill Becomes Effective

On March 26, 2021, Representative Raja Krishnamoorthi introduced the Baby Food Safety Act, a bill to set maximum limits for each heavy metal in infant and toddler food, which is defined as food manufactured for children younger than 36 months. The initiative was taken because the concentration of neurotoxins in baby food is poorly regulated in our country. There is only a maximum limit for arsenic set by the FDA, which is considered dangerous by multiple other health agencies. It applies solely to infant rice cereals. The other three harmful heavy metals are not regulated at all.

If the Baby Food Act of 2021 becomes effective, companies that manufacture, process, pack or hold baby food need to ensure that their food complies with the limits on heavy metals set by the bill. Furthermore, baby food companies would also have to provide public information, such as test results for neurotoxins in their infant and toddler.

Susanne Kuehne, Decernis
Food Fraud Quick Bites

The Sun Does Not Shine on This Food Staple

By Susanne Kuehne
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Susanne Kuehne, Decernis
Rice fraud, Australia
Find records of fraud such as those discussed in this column and more in the Food Fraud Database, owned and operated by Decernis, a Food Safety Tech advertiser. Image credit: Susanne Kuehne

Organized crime in Eastern Europe has targeted a well-known top-level brand in Australia, shipping counterfeit rice to countries around the world under their brand. Rice grown and processed under uncontrolled conditions can bode a risk to human health due to unsanitary processing conditions and contamination from heavy metals. The affected company has initiated thorough investigations into this matter and indeed seized some counterfeit product in Saudi Arabia.

Resource

  1. Taylor, P. (July 7, 2021). “Criminal gang counterfeits Aussie rice brand SunRice”. Securing Industry.

Mitigate Food Contamination Risk

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Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what food products contain and help comply with food safety regulations.

Nuts containing mould, frozen strawberries contaminated with hepatitis pathogens, and pesticide-laden vegetables – more than 3,000 products were objected by EU authorities in 2013. With increasing government, industry and consumer concerns about the hazards of food contaminants, and the risks they pose, food manufacturers, governments and non-governmental agencies, are implementing policies and processes to monitor and reduce contaminants.

Key food contaminants

Food contaminants cover a wide range of potential substances including:

  • Dioxins: Produced as unintentional by-products of industrial processes such as waste incineration, chemical manufacturing and paper bleaching, dioxins can be found in the air, in water and contaminated soil.
  • Allergens: Virtually all of the known food allergens are proteins that can subsist in large quantities and often survive food processing.
  • Genetically modified organisms (GMOs): Banned in a number of countries, controversy still exists with regard to the use of GMOs. Selling food and/or feed that is non-GMO in restricted markets places the burden of proof on the supply chain.
  • Heavy metals: Whilst heavy metals, such as lead (Pb), cadmium (Cd), mercury (Hg) and arsenic (As), can be found in nature, industrial and environmental pollutants have resulted in their increased presence in food and feed.
  • Hormones: Commonly used in animal husbandry to promote growth, hormone residues can be found in the food supply.
  • Melamine: Harmful to animal and human health, melamine is not a permitted food additive.
  • Mycotoxins: Produced by several strains of fungi found on food and feed products, mycotoxins are often invisible, tasteless, and chemically stable both at high temperatures and during long periods of storage.
  • Pesticide residues: Over-use of pesticides can lead to dangerous levels of hazardous chemicals entering the food chain with fresh fruit and vegetables being most susceptible to pesticide residues.
  • Polychlorinated biphenyls (PCBs): Used in many products, some PCBs are toxic and stable enough to resist breaking down even when released into the environment.
  • Radiation contamination: There are three ways that foodstuffs can become contaminated by radiation: surface, ground and water contamination.
  • Veterinary drug residues: Used in the treatment of animals, veterinary drugs can leave residues in animals subsequently sent into the food chain. The impact of contaminants varies. Depending on their toxicity and the level of contamination their effects can range from causing skin allergies, to more serious illnesses (including cancers and neurological impairments) and, in the most extreme cases, death.

To ensure that your food and feed products are fit for consumption, you need to test for specific contaminants throughout the value chain. For example, in concentrated levels, melamine, antibiotics and hormones can be harmful to animals and humans. Only thorough contaminant testing will determine if the above-mentioned impurities, among others, are present. After identification the relevant goods can be eliminated from the production and distribution chain.

Maximum levels and regulations

In order to protect consumers, maximum levels permitted in food products have been set by food safety legislation in many countries. Disappointingly, and despite efforts in some product areas, maximum levels are rarely harmonized across national borders. This inconsistency places responsibility for compliance firmly with the food supply chain. A comprehensive testing program can verify that your products meet maximum levels and the safety standards they represent.

In the European Union (EU), it is the food business operator who carries primary responsibility for food safety and the General Food Law Regulation (EC) 178/20022 is the primary EC legislation on general food safety. More specific directives and regulations compliment this, for example, EU regulations concerning non-GMO/GMO products, include Directive 2001/18/EC and regulations 1829/2003 and 1830/2003.

The U.S. Food and Drugs Administration has overseen the development and signing into law of the Food Safety Modernization Act (FSMA). Within the U.S., state regulators retain the right to apply additional regulations and laws. As result, rules regarding maximum levels, for example, vary from state to state.

In China, the Food Safety Law (FSL) was passed into law by the Chinese government in 2009. It introduced enhanced provision for monitoring and supervision, improved safety standards, recalls for substandard products and dealing with compliance failures.

Brazil’s food safety agency, Anvisa, coordinates, supervises and controls activities to assure health surveillance over food, beverages, water, ingredients, packages, contamination limits, and veterinary residues for import. No specific restrictions have been established yet for export.

Monitoring

Monitoring programs are frequently used to identify any contamination issues. From seeds, through the growing process and harvest, transportation, collection, storing and processing to the market channel, independent monitoring delivers credible and independently collected data on both quality and contaminants.

With so many policies and standards, both nationally and internationally, anyone involved in the food industry needs to be sure of accurate and up-to date information on food contaminant regulations. Whether mycotoxins or microbiological values, heavy metals or pesticides – independent sampling and testing provide an objective and comprehensive overview of what grain and food products contain.

For more information, please visit: www.SGS.com/foodsafety.