AFI Association of Food Industries

AFI Serving the U.S. Food Import Sector

2021 President’s Report

Bob Bauer
Association of Food Industries

Elsewhere in this publication is an article about the 10th anniversary of the Food Safety Modernization Act. While not many members trade in baby food, the recent issues with findings of high levels of heavy metals in baby food likely will provide a good example of how FSMA works.

FSMA takes a risk-based approach to food safety. So, when a Congressional report entitled “Baby Foods are Tainted with Dangerous Levels of Arsenic, Lead, Cadmium and Mercury” was released, that certainly identified a risk with food given to an especially vulnerable segment of the population. That meant there was no question FDA would need to take some action and that industry would be impacted.

That impact became clear when FDA issued a letter to industry reminding baby and toddler food manufacturers “of their existing responsibilities related to these efforts”- essentially, the Preventive Controls for Human Food Rule. 

Under the PC Rule, manufacturers must, through a hazard analysis, consider chemical hazards that may be present in foods they produce. Chemical hazards include “radiological hazards, substances such as pesticide and drug residues, natural toxins, decomposition, unapproved food or color additives and food allergens.” Although natural toxins, including heavy metals, are present in the environment – in air, water and soil – and are unavoidable in the general food supply, even relatively low levels can be dangerous, particularly in the foods of babies, young children and other vulnerable populations.

Because of that, the PC Rule requires facilities have and implement a written food safety plan with a hazard analysis – including analysis of natural toxins. The hazard analysis must:

  • Identify and evaluate, based on experience, illness data, scientific reports and other information, known or reasonably foreseeable hazards for each type of food manufactured, processed, packed or held at the facility.
  • Assess the severity of the illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive control.
  • If it’s determined that there is a hazard could occur, a preventive control must be established and maintained.

In this case, the emphasis is on the natural toxins/heavy metals of arsenic, mercury, cadmium and lead which occur naturally in the environment, so can be in the ingredients used for baby and toddler foods. But because they can cause serious health risks in these vulnerable populations, they need to be significantly limited in their foods. So heavy metals would constitute a chemical hazard requiring a preventive control to significantly minimize the potentially high levels of the toxic elements at or below the regulated levels. And that hazard analysis and the determined preventive controls must be included in the written food safety plan.

As FDA speakers at AFI meetings have said for years, when a problem is detected in your industry segment, you can expect to see increased inspections, sampling, etc. within that segment. FSMA builds on that strategy. Though it’s too soon to have statistics, it’s almost-certain FDA immediately increased its level of surveillance in the baby food sector, which means baby food producers, whether foreign or domestic, and importers of those products should be more prepared than ever for an inspection. The first steps: immediately review your plan, testing records, audit information, etc. to make sure your plan addresses this risk and has proof the risk is being mitigated or eliminated. Don’t wait until FDA knocks on the door to think about this. 

It works the same for other products. If there’s an import alert or warning letter issued on a product, producers and importers of that product (or products with similar risks) should immediately look at their plan to make sure the same thing can’t happen to their product.

This ongoing monitoring of food safety developments with the products a company trades is a key responsibility outlined in FSMA. Remember to think not only of your products but products that have similar risks.

FDA likely will publish updated information on heavy metals in baby foods and other types of foods as it follows up on this issue. If heavy metals are a risk with your product(s), FSMA requires you to be aware of developments in that area. Be sure you are.

Quick Note: All of us have been impacted at some level by the Covid-19 pandemic. On behalf of the AFI staff, board of directors and fellow industry members, I wish all reading this good health, prosperity and a quick trip to whatever the new normal will be. Let’s hope conditions allow for us to be together in person again very soon.


Association of Food Industries: Serving the U.S. Food Import Trade Since 1906
3301 Route 66, Ste. 205, Bldg. C • Neptune, NJ 07753
(732) 922-3008 • Fax: (732) 922-3590 • •