Source - Food and Beverage Litigation and Regulatory Update

Food Contact Chemicals Study Could Spur More Research, Government Oversight

On September 17, 2024, the Journal of Exposure Science and Environmental Epidemiology (JESEE) published a paper on the potential human exposure to food contact chemicals (FCCs). Led by a research team at the Food Packaging Forum Foundation, the study synthesized data from published sources that analyzed a total of over 14,000 FCCs known to exist in food contact articles. While the study revealed some evidence that FCCs could potentially migrate to humans, overall, health risks are still largely unknown.

The article is a review of pre-existing databases on human chemical exposures and cell metabolites, some of them created previously by the authors, to all of the 14,000 known chemicals that have potential for food contact. The study found that of the known FCCs, only 25% (approximately 3,600 out of the 14,000) were present in human samples. The FCCs appeared inside skin, hair, blood, urine, breast milk and tissue samples. 

The research compared the list of these known FCCs to the scientific literature and eight databases/data compilations that report the total environmental exposure of individuals throughout their lives and the chemicals that have been reported present in human tissue samples. The FCCs present in humans were then compiled into an interactive database called “FCChumon.” This database is free and can be used to track where the presence in humans of any specific chemical was reported.

The study consisted of two primary steps: the first compared total FCCs to biomonitoring and metabolome/exposome databases, and the second analyzed only frequently detected FCCs and mapped their potential presence in humans.

The study then categorized the FCCs and labeled them as “high,” “medium” or “other” concern. One such category was per- and polyfluroalkyl substances (PFAS), often termed a “forever chemical.” 

Because the study found ample monitoring for chemicals of concern, such as some forms and types of PFAS, bisphenol A (BPA, which recently received scrutiny regarding plastic in baby bottles), phthalates (hormone disrupters, infertility), and oligomers (another byproduct of plastic manufacture), the current litigation landscape around these chemicals could indicate future litigation around FCCs. Further, at least two of these chemicals face potential bans in the European Union in the coming years. Therefore, the attention of the European Union could spur the U.S. Food and Drug Administration (FDA) or the Centers for Disease Control and Prevention (including the Agency for Toxic Substances and Disease Registry) to become involved with either regulation or monitoring for some of these chemicals.

Here are four key takeaways from the study and its significance:

  • Food Contact Substances: A food contact substance is any form of substance that comes into contact with food but does not have a technical effect or component make-up to the food itself. This could include containers, packaging, food preparation surfaces or cookware. Federal law states that any food contact substance must be authorized before it is marketed in the United States. 21 CFR Parts 170-199. Within this approval process, FDA conducts a detailed safety assessment using scientific and technical information and examines how much “migration” will occur once the substance comes into contact with the food. A food contact substance inventory is available to the public and maintained by FDA. Currently, FDA is set to hold a public meeting to discuss the agency’s approach to food contact regulations.
  • Current Regulation of FCCs/PFAS: Recently, the Environmental Protection Agency (EPA) designated PFAS as “hazardous substances” under the federal Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, commonly known as Superfund), 42 U.S.C. § 9601 et seq. PFAS oversight is not new within this regulatory landscape. While FCC oversight is more novel, increased EPA regulation is likely to occur, especially if research from published studies like JESEE continue to develop.
  • Data: One limitation in the database and in this particular study is it cannot be used to quantify the level of any specific chemical. Also, the study cannot determine if human exposure to a specific chemical was from food, as other sources of exposure for most of the FCCs are listed. One of the biggest issues moving forward are those chemicals known to be present in food contact materials (FCMs). For many of the FCMs (>10,000) there is either no human monitoring data or the potential hazard is unknown due to lack of data. With the publication of these databases, more and more researchers are likely to be supplementing the data.
  • Unknown Health Risks: Overall, the long-term health effects of most FCCs are still largely unknown, and the potential effects of exposure to individual FCCs remain inconclusive and research is continuing. In addition, the regulatory landscape around food labeling and FCCs is largely uncharted, which leaves open the possibility of litigation.

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