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CPSC: The Other Packaging Regulatory Agency to Watch

[The CPSC] will evaluate whether packaging — particularly packaging of toys — has intrinsic play value requiring the package to be regulated as a toy.

Everyone in the converting industry is familiar with the preeminent role of the Food and Drug Administration (FDA) in the area of food packaging safety. Materials that come in contact with food must be “safe,” and there are many ways to demonstrate safety.

A material may be the subject of a food additive petition, may be deemed safe under a “no migration” or “no food additive” determination, may be “generally recognized as safe”(GRAS), or may be otherwise deemed safe under a variety of technical and legal analyses. But what about possible physical hazards associated with food packaging?

The FDA and the US Consumer Product Safety Commission (CPSC) have delineated their respective areas of jurisdiction with respect to food, food containers, and food-related articles or equipment under a longstanding memorandum of understanding (MOU).

From time to time, the CPSC investigates the safety of food and other packaging, from 5-gal plastic buckets, to tin, aluminum, and other cans, to child-proof packaging. It will also evaluate whether packaging — particularly packaging of toys — has intrinsic play value requiring the package to be regulated as a toy. Thus, it is useful to review the jurisdictional boundaries between the FDA and the CPSC.

The CPSC administers, among many other statutes, the Consumer Product Safety Act (CPSA), the Federal Hazards Substances Act (FHSA), and the Poison Prevention Packaging Act (PPPA). The CPSA's definition of a “consumer product” excludes “food,” as defined in §201(f) of the FDCA. Substances that are “foods” under the FDCA similarly are excluded from the definition of a “hazardous substance” under the FHSA. On the other hand, the PPPA allows the CPSC to subject “foods” and other FDA-regulated products to special child-resistant packaging requirements.

The MOU establishes that articles having food-contact surfaces, such as food containers, cooking utensils, etc., from which there is migration of a substance from the contact surface to the food or food components, are subject to FDA regulatory authority as a “food.”

The agencies have agreed explicitly, however, that the CPSC has regulatory authority over the same article for hazards unrelated to migration into food. Thus, food packaging or containers that present mechanical risks of injuries not related to food contamination or spoilage, such as sharp edges, flammability, etc., are subject to CPSC's jurisdiction.

When the CPSC obtains information that suggests a possible issue with a consumer product or package, usually through a consumer complaint submitted to the agency, it routinely forwards the information to the manufacturer, distributor, or retailer.

The CPSC may initiate investigations and also has the power to order recalls or propose regulations. Packaging-related recalls have most frequently involved violations of child-resistant packaging requirements over the years. The agency attempted to propose regulations some years ago on 5-gal plastic buckets, which became associated with toddler drownings when workers took them from worksites and left them partially filled with water or liquids in areas accessible to young children. The CPSC formally proposed a rule to require buckets to be redesigned but abandoned the rule when Congressional critics noted that the changes actually would be detrimental to the safety of the primary user population.

In short, where packaging safety is concerned, members of the converting industry should remember that while the FDA is the primary agency with jurisdiction over the safety of packaging in contact with food, its jurisdiction may not be exclusive. In circumstances where other physical safety issues could be presented, and especially where children are concerned, the CPSC may attempt to exert authority.

Sheila A. Millar, a partner with Keller and Heckman LLP, counsels both corporate and association clients. Contact her at 202/434-4143; e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.; web site: PackagingLaw.com.

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