We have previously reported on criticism of the so-called “GRAS Exemption” and FDA’s GRAS Notification Program by the Pew Charitable Trusts, the Natural Resources Defense Council, and the Center for Science in the Public Interest. In response to these criticisms, the Grocery Manufacturers Association (GMA) recently announced a 5-part initiative to improve the procedures used by the food industry to determine if a food ingredient is generally recognized as safe (GRAS) and to assure the public that ingredients used in processed foods are safe. While the GMA initiative is focused on self determinations, rather than GRAS Notifications, it will likely have a significant impact on all companies producing or using GRAS ingredients.
The initiative is comprised of 5 separate projects: (1) a Publicly Available Standard (PAS) that will establish guidelines for conducting a GRAS assessment; (2) a GMA-sponsored database that will contain information on GRAS substances; (3) a Code of Practice (COP) that requires that any GRAS ingredient purchased by a GMA member has been evaluated in accordance with the PAS; (4) expansion of GMA’s current educational programs, including GMA support of the Center for Research and Ingredient Safety at Michigan State University; and (5) an expanded communications plan to inform the public “of the steps being taken by industry to increase the integrity of procedures used to assess ingredient safety.”
During a recent presentation describing the initiative, GMA representatives stated that the PAS will be developed by an independent standard setting agency, such as the American National Standards Institute (ANSI), and that GMA has issued a Request for Proposal (RFP) for this project to three groups. GMA estimates that the standard will take about two years to develop. GMA also stated that while details of the PAS will be determined independently, the standard will require 3rd party certification of all companies, toxicologists or consultants conducting GRAS determinations. To receive certification, the company or consultant will need to establish a standard operating procedure (SOP) for GRAS evaluations and have the procedure approved before performing a certified review. The standard would only apply to “self determinations” that are based on scientific procedures, i.e., would not apply to determinations based on common use in food prior to January 1, 1958. While the PAS would not apply to determinations submitted to FDA as part of GRAS Notifications, it is likely that it will indirectly become a requirement for these determinations, as well. GMA also stated that ingredients currently used in compliance with a self-determination would be exempt from the PAS for the current applications, but new uses would not be exempt. Substances that are the subject of GRAS review by the Flavorings and Extracts Manufacturers Association (FEMA) would also be exempt from the PAS.
All companies preparing GRAS determinations in compliance with the PAS will be required to submit the supporting information, including a list of the safety studies reviewed and the exposure data used, to the GMA-sponsored database. The database will reportedly include three classes of information, including information that will be made available to the public, information that will be submitted to FDA, and information that will be available to GMA members. GMA is asking for input on how to delineate the three categories. It is not clear whether other trade associations will be permitted to participate in the database and gain access to the information for their members.
GMA’s Board of Directors has approved a new COP regarding the use of GRAS ingredients and reportedly all GMA members have agreed to abide by the COP. GMA has not yet released the COP, but has said that it requires all members to purchase only GRAS ingredients that have been certified for compliance with the PAS. The COP will become effective January 5, 2015. GMA did not discuss how the COP will address the use of ingredients deemed to be GRAS after the COP goes into effect, but before the PAS is adopted.
While compliance with the GMA PAS will not be required under the Federal Food, Drug and Cosmetic Act or FDA regulations, its impact may be similar to a new FDA regulation. GMA membership includes many of the largest food processing companies in the United States, including The Hershey Company, The Campbell Soup Company, and McCormick and Company. It is our understanding that once the GMA-sponsored PAS is adopted, any company opting not to have its GRAS determinations conducted by certified specialists will be precluded from a large percentage of the possible market. Thus, as a practical matter, suppliers will need to comply with the PAS.