I have been told that when evaluating the risk posed by benzene residues in food the FDA uses a virtually safe dose (VSD) of 0.5 parts per billion of benzene in the food. Exposure to benzene at levels below 0.5 ppb in the food would be deemed to be safe. However, I have also heard that when evaluating benzene migration from packaging materials to food the FDA does not “allow” one specific application to “take up” all the VSD. In other words, FDA would not allow benzene migration from a single packaging application to result in 0.5 ppb in food, an amount equal to the VSD. Instead, FDA would consider benzene migration from a single packaging application to be safe only if the total amount of benzene in food resulting from a particular packaging application would not exceed 10% of the VSD, i.e., 0.05 ppb in the food. Have you heard of this approach by FDA regarding benzene in particular and the VSDs in general? @ Ask The Experts

Sal Pellingra
Ampac Flexibles
Innovation and Marketing Director
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Sal Pellingra is Innovation and Marketing Director of Ampac Flexibles, a Division of Ampac Packaging, LLC in Cincinnati, Ohio. Sal joined Ampac Flexibles in 2007, and leads all corporate marketing and innovation initiatives. Prior to Ampac Flexibles, Sal spent 25 years with ExxonMobil Films Business working in product development, marketing development, and most recently as the Americas Market Segment Manager for four core market segments. Sal has 9 US patents on polypropylene coextruded packaging films and holds BS and MBA degrees from the Rochester Institute of Technology. Sal is also an Adjunct Professor in Packaging at The Rochester Institute of Technology and the University of Cincinnati.

Flexible Packaging Q&A

I have been told that when evaluating the risk posed by benzene residues in food the FDA uses a virtually safe dose (VSD) of 0.5 parts per billion of benzene in the food. Exposure to benzene at levels below 0.5 ppb in the food would be deemed to be safe. However, I have also heard that when evaluating benzene migration from packaging materials to food the FDA does not “allow” one specific application to “take up” all the VSD. In other words, FDA would not allow benzene migration from a single packaging application to result in 0.5 ppb in food, an amount equal to the VSD. Instead, FDA would consider benzene migration from a single packaging application to be safe only if the total amount of benzene in food resulting from a particular packaging application would not exceed 10% of the VSD, i.e., 0.05 ppb in the food. Have you heard of this approach by FDA regarding benzene in particular and the VSDs in general?

Asked September 17th, 2009

A difficult question, and actually one better suited for chemists involved in testing for FDA compliance than a packaging expert! There are several universities and lab resources that are equipped for these types of inquiries. As a packaging and film expert, I will give you an “unqualified” answer with help from one of my university resources and to the best of my ability.

I believe the issue you’re raising is that the higher amount, 0.5 ppb, is deemed to be a virtually safe dose (VSD). First, there is no way to define an absolute human exposure level. A VSD is exactly that, a virtual value based on extrapolation from testing. The value is based on the outcome of either safety assessment or quantitative risk assessment (low-dose extrapolation) and is the definition of the daily or weekly exposure that is acceptable, tolerable, or virtually safe. The concentrations of the chemical in different foods are then established for a food additive or contaminant such that the intake by a high consumer would not exceed the safe intake. (Handbook of Food Toxicology, S.S. Deshpande). So I believe the confusion is that the 0.5 ppb is the former, the VSD, where the 0.05 ppb is the latter - the concentration in a food that wouldn’t exceed the safe intake.

Based on your information, you would not need to ensure that the packaging contains <0.05 ppb. You need to ensure that the packaging is not contributing any more than 10% of that or 0.05 ppb in the food it is coming into contact with in the normal course of package containment. So, manufacturers should test for extractions showing less than 0.05 ppb in the food, or food simulant, itself. Again, this answer is my understanding based on available resources. My suggestion is to contact a university or lab that specializes in FDA compliance testing to be sure you get a “qualified” answer and have extraction tests performed on packaged food or food simulants to ensure the package is fit for use and compliant. It should be tested in the manner it is used. For example, if it is a microwaveable package, it should be tested at the temperatures and times it would see in a microwave. When it comes to the packaging of foods or healthcare products, extra diligence should be taken. The cost of outside lab testing is a small price to pay to ensure compliance, safety, and peace of mind. I hope this was helpful!

Sal Pellingra

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