FSIS Proposes to Lift the General Prohibition against Sodium Benzoate, Benzoic Acid, and Sodium Propionate in Meat and Poultry

By Riëtte van Laack –

Last week, the Food Safety and Inspection Service (“FSIS”) issued a proposal to lift the general prohibition against the use of sodium benzoate, benzoic acid, and sodium propionate in meat and poultry.  Historically, the use of these substances in meat and poultry has been prohibited because they might conceal damage or inferiority or make a meat or poultry product appear better or of greater value.  See 9 C.F.R. § 424.23.  Notwithstanding the general prohibition, FSIS can allow specific uses of the substances in meat and poultry, but the agency must do so through rulemaking.

In 2007, Kraft Foods petitioned FSIS to amend the regulations and allow the use of certain combinations of sodium benzoate and sodium propionate, and other already permitted substances as antimicrobials in certain ready-to-eat (“RTE”) meat and poultry products.  Subsequently, in 2010, Kemin Food Technologies petitioned FSIS to permit the use of the same substances (but in different combinations) in various RTE meat and poultry products.  Both Petitions included data regarding the suitability of the formulations as antimicrobial (specifically as anti-listerial) agents and data regarding the effect of the substances on the shelf life and other quality parameters.  In support of safety, the Petitions referred to FDA’s GRAS affirmation regulations, 21 C.F.R. §§ 184.1021, 184.1733, and 184.1784.  However, those GRAS affirmation regulations were promulgated in 1973 and 1979, a time period during which use of these substances was generally prohibited in meat and poultry.

FSIS states that it concluded, based on data included in the Petitions, that the proposed uses of sodium benzoate, benzoic acid, and sodium propionate are suitable, i.e., do not mask or conceal damage or inferiority and do not extend shelf life of the RTE meat and poultry products.  However, instead of engaging in rulemaking to allow the specific uses that are the subject of the Petitions, FSIS proposes to lift the general prohibition on the use of these substances altogether.  By lifting the general prohibition rather than amending the regulations to allow specific uses, FSIS avoids future rulemaking regarding additional uses of these substances.  As explained in the proposal, under a 2000 Memorandum of Understanding (“MOU”), FSIS and FDA collaborate on the review of submissions each agency receives regarding the use of food ingredients used in the production of meat or poultry products.  Under this MOU, FDA evaluates safety of the intended use and FSIS evaluates suitability of the intended use.  When FSIS concludes that an ingredient is safe and suitable for its intended use, FSIS includes the ingredient in FSIS Directive 7120.1. This determination does not involve FSIS rule making. 

Comments are due by July 6, 2012.

REMINDER: HP&M is hosting a webinar, Garbage Runs, Fake Identities, and Surprise Home Visits; Strategies to Deal With FDA's Nontraditional Investigative Tools, on Wednesday, June 20, 2012 from 12:30 – 2:00 p.m. ET.  Click here to register.