Issue link: http://palletcentral.uberflip.com/i/1115386
18 PalletCentral • March-April 2019 palletcentral.com (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. Q. Can you give me some examples of chemical applications that will be regulated by EPA vs. FDA? A. 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. The FDA Final Rule is at Palletcentral.com. Look for "Issue Briefs" from the Advocacy tab, scroll to "Food Safety Modernization Act." PC FAQS 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.