Food and Pharma
I want to combat mold growth on my pallets by treating them with chemicals, but I don’t know what’s permitted. Do I need to worry about federal regulation?
Yes. At minimum, if your chemical is considered a “pesticide” by EPA, you need to follow EPA requirements. In addition, if you will be using the chemical to treat a “food contact” article, you also need to consider whether FDA requirements apply.
What is a “food contact” article? Are pallets or wooden crates considered food contact articles?
A food contact article is an item that comes into direct contact with food. A wooden crate may be a food contact article if it is used to carry unpackaged raw produce, for example. Typically, a wood pallet would not be a food contact article, because it is most frequently used to hold and transport food items that are packaged in cans, boxes, or other packaging, and the pallet does not come into direct contact with unpackaged food. Nevertheless, companies may be concerned with the use of chemicals on pallets, even if the pallets will not be used with unpackaged foods, because of the frequency with which pallets are brought directly into food facilities or manufacturing facilities. While these companies may want to prevent mold growth on pallets that will enter their facilities, they may also be concerned that the chemicals used to treat the pallets may contaminate the food inside those facilities. Therefore, as both a legal and a practical matter, when considering what antimicrobial chemicals may be used to treat pallets, crates, or other wood items that will be used in connection with food, it may be advisable to view all such items as though they were “food contact” articles in order to determine which chemicals can lawfully be used, and for purposes of responding to customer inquiries. By using only substances approved for use on food contact articles when treating pallets (and wooden crates), one is able to ensure food industry customers that the pallets are safe for their use.
Who regulates chemical treatment of food contact articles – EPA or FDA?
Both. EPA and FDA both have some jurisdiction over antimicrobial treatment of food contact articles. For any particular antimicrobial chemical, whether one, the other, or both agencies will govern depends on the food contact article and the intended use of the antimicrobial. In all instances, use of the chemical must be consistent with the intended use(s) authorized by the regulators.
How do I know which agency’s requirements I have to meet?
Consider what the chemical treatment will be used for:
• If the chemical will have its antimicrobial effect on the surface of a food contact article or equipment (other than food packaging), EPA will regulate under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”). FDA will consider the chemical to be a “pesticide chemical” and will defer jurisdiction to EPA, so there will be no FDA-related requirements.
• If the chemical will have its antimicrobial effect on any part of the food contact article other than the surface, or if the chemical has no antimicrobial effect in or on the finished food contact article, FDA will regulate the chemical, typically as a “food additive,” under the Federal Food, Drug, and Cosmetic Act (“FFDCA”). The chemical might also be subject to EPA registration requirements, if the chemical meets the definition of a “pesticide” under FIFRA.
If EPA regulates, what requirements does the chemical have to meet?
EPA regulates these chemicals as “pesticide chemicals.” In order to be used lawfully under FIFRA, the chemical must be registered with EPA as a pesticide, and its use must be consistent with – and cannot exceed –those uses that are authorized under the registration.
If FDA regulates, what requirements does the chemical have to meet? Does the chemical have to be GRAS? Does it have to be FDA-approved? What is the difference?
FDA regulates these chemicals as “food additives”. The FFDCA broadly defines “food additive” to include any substance whose intended use affects or could affect the characteristics of any food, including substances used in food packaging and in food contact materials. An antimicrobial that has an effect on a food contact article other than the surface meets the definition of “food additive.” A food additive can only be used lawfully if FDA has issued a regulation that specifies the conditions under which use of the additive is safe.
Substances that are “generally recognized as safe” for their intended use (“GRAS”) are exempt from the definition of “food additive.”
In order to be GRAS, a substance must be generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use. Whereas FDA must issue a regulation to authorize the use of a food additive, no regulation is required if a specific use of a substance is GRAS. Importantly, while only FDA can issue a food additive regulation, private persons can determine that a use of a substance is GRAS.
Importantly, it is not enough for the substance to be “generally recognized as safe”; rather, the substance must be “generally recognized as safe” for the particular intended use. So even if an antimicrobial chemical is GRAS for other purposes, it must also be GRAS for antimicrobial treatment of food contact articles in order to be used to treat pallets and crates.
How do I know if a chemical I’m interested in using is GRAS for my intended use?
There are several means by which a chemical may be deemed GRAS.
• Some GRAS uses of substances are listed in FDA regulations (21 C.F.R. Parts 182, 184, among others).
• A company can determine that a use of a substance is GRAS and then voluntarily submit a GRAS notice to FDA, in which it notifies FDA of (and provides scientific evidence to support) its view that the substance is GRAS for its intended use, and is therefore not subject to the food additive regulation requirement. FDA will review the notice, and will issue a response that is publicly available on the FDA website. Importantly, FDA will not expressly “approve” the chemical or state its own conclusion that the substance is GRAS. Instead, the best possible outcome is a response that indicates FDA “does not question the basis for the notifier’s conclusion.”
• A company can determine that the use of a substance is GRAS, but decide not to notify FDA.
Can you give me some examples of chemical applications that will be regulated by EPA vs. FDA?
Example 1: A chemical will be applied to a pallet, and the chemical’s labeled effect is to treat only the surface of the pallet. This chemical will be subject only to EPA regulation (meaning it must be registered with EPA as a pesticide and its use must conform to the registration). Questions of FDA GRAS or approval (i.e. food additive regulation) status are not applicable.
Example 2: A chemical will be applied to a pallet in order to penetrate and have an antimicrobial effect beneath the surface. This chemical will be subject to FDA regulation, and can only be used (a) in accordance with an applicable FDA food additive regulation; or (b) if the substance is GRAS for the particular application. In addition, if the chemical is a “pesticide” under FIFRA, it must also be registered with EPA as a pesticide and its use must conform to the registration.
FAQ cited from the Nation Wooden Pallet & Container Association (Content prepared by Polsinelli law firm on behalf of NWPCA)