Agency Response Letter GRAS Notice No. GRN 000408
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CFSAN/Office of Food Additive Safety
March 6, 2012
Advanced Food Technologies
P.O. Box 1208
Fairhope, AL 36533
Re: GRAS Notice No. GRN 000408
Dear Mr. Mixon:
The Food and Drug Administration (FDA) is responding to the notice, dated October 12, 2011, that you submitted on behalf of Advanced Food Technologies, LLC (AFT), in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on October 13, 2011, filed it on October 14, 2011, and designated it as GRAS Notice No. GRN 000408.
The subject of the notice is a solution of sulfuric acid and sodium sulfate. The notice informs FDA of the view of AFT that a solution of sulfuric acid and sodium sulfate is GRAS, through scientific procedures, for use as an acidifier or antimicrobial agent on meat and poultry to reduce levels of microorganisms and to prevent microbial growth. The product is intended for use on the surface of meat or poultry at a pH range of 1.0 to 2.2, which amounts to a 1/25 to 1/500 volumetric dilution of the product with water, respectively.The product is intended for use directly on meat and poultry surfaces as a spray, wash, or dip.
AFT identifies the substance as a solution of sulfuric acid and sodium sulfate in purified water and describes it as a clear, colorless-to-light amber liquid. For a 1:100 v/v dilution with neutral water, the pH of the solution ranges from 1.4 to 1.6 and has a specific gravity of 1.38 at 25°C.
AFT describes the method of preparation for the solution of sulfuric acid and sodium sulfate. The notifier states that the reagents used in the manufacture of the solution are food grade as per specifications presented in the Food Chemicals Codex, 6th Edition (2008). The production process uses concentrated sulfuric acid diluted with purified water. Sodium sulfate (anhydrous) crystal is added to the diluted acid solution. AFT states that the solution is prepared under current good manufacturing practices (cGMPs).
The notifier provides the composition of the solution of sulfuric acid and sodium sulfate. The amount of sulfuric acid in the solution ranges from 38.5% weight (wt) to 39.5% wt; sodium sulfate ranges from 4.5% wt to 5.5% wt; and water ranges from 55.0% wt to 57.0% wt.
AFT discusses the safety of the solution of sulfuric acid and sodium sulfate by reviewing the regulatory status of each component. Sulfuric acid is affirmed as GRAS under 21 CFR 184.1095, for use as a pH control agent and as a processing aid in food when used in accordance with cGMPs. Sodium sulfate is approved for use in a chewing gum base under 21 CFR 172.615 and as a boiler water additive or processing aid under 21 CFR 173.310. Additionally, AFT notes that sodium sulfate is the soluble salt formed by sulfuric acid and sodium hydroxide. Like sulfuric acid, sodium hydroxide is also affirmed as GRAS under 21 CFR 184.1763 for use as a pH control agent and processing aid in food when used in accordance with cGMPs. Sulfuric acid and sodium hydroxide completely ionize in water to form sodium sulfate ions and water. AFT states that the solution will drip off, evaporate, or otherwise leave no significant chemical residue and have no lasting technical effect.
In support of its GRAS determination, AFT also refers to GRN 000003 for sodium bisulfate (the sodium salt of sulfuric acid) for use as a pH control agent and processing aid for use in foods at levels not to exceed cGMPS. FDA had no questions regarding the conclusion that the use was GRAS. AFT states that the United States Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS) considers AFT's solution of sodium sulfate and sulfuric acid to be equivalent to sodium bisulfate. AFT states that the use range, method of application, and targeted products for AFT's solution of sulfuric acid and sodium sulfate will be the same as those for sodium bisulfate when used as a pH control agent.
AFT included in its notice data from studies to determine potential chemical residues in the skin, fat, and meat of carcasses following application of the solution. AFT reports that no chemical residues remained. In a study of beef trimmings to which the solution was applied prior to grinding, AFT states that there was no statistical difference in residual levels of sodium sulfate or sulfuric acid reported in ground beef made from the treated trimmings versus ground beef made from untreated trimmings.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000408, FDA consulted with the Risk and Innovations Management Division (RIMD) of the FSIS of the USDA. Under the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.
Regarding suitability, FSIS has no objection to the use of a solution of sulfuric acid and sodium sulfate as an acidifier or antimicrobial agent for the treatment of meat and poultry to reduce levels of microorganisms and to prevent microbial growth.
Any additional questions regarding regulatory guidance from FSIS should be directed to: William Shaw, Jr., Director, Risk, Innovations, and Management Division, Office of Policy and Program Development, Food Safety and Inspection Service, Mail Stop 3782, Patriots Plaza III, 8-163A, 1400 Independence Ave., SW., Washington,DC 20250-3700.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FD&C Act to, among other things, add section 301(ll). Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of AFT's notice that a solution of sulfuric acid and sodium sulfate is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods to which the solution has been applied. Accordingly, this response should not be construed to be a statement that foods to which a solution of sulfuric acid and sodium sulfate has been applied, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by AFT, as well as other information available to FDA, the agency has no questions at this time regarding AFT's conclusion that a solution of sulfuric acid and sodium sulfate is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of a solution of sulfuric acid and sodium sulfate. As always, it is the continuing responsibility of AFT to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000408, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.
Dennis M. Keefe, Ph.D.
Office of Food Additive Safety
Center for Food Safety
and Applied Nutrition
cc: William K. Shaw Jr., Ph.D.
Mail Stop 3782
Patriots Plaza III, Cubicle 8-163A
1400 Independence Avenue
Washington, DC 20250-3700