Agency Response Letter GRAS Notice No. GRN 000316
CFSAN/Office of Food Additive Safety
June 28, 2010
Miriam J. Guggenheim
Covington & Burling LLP
1201 Pennsylvania Avenue, N.W.
Washington, DC 20004
Re: GRAS Notice No. GRN 000316
Dear Ms. Guggenheim:
The Food and Drug Administration (FDA) is responding to the notice, dated January 7, 2010, that you submitted on behalf of ICL Performance Products LP (ICL) 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 January 8, 2010, filed it on January 8, 2010, and designated it as GRAS Notice No. GRN 000316.
The subject of the notice is sodium potassium hexametaphosphate (SKMP). The notice informs FDA of the view of ICL that SKMP is GRAS, through scientific procedures, for use in food generally, including meat and poultry products, to achieve a variety of technical effects in food at levels in accordance with current good manufacturing practices (GMP).
ICL describes the chemical identity and composition of SKMP (also known as glassy sodium potassium phosphate, or metaphosphoric acid sodium potassium salt). The notifier identifies SKMP by the Chemical Abstracts Service Registry Number 67183-30-6, with an empirical formula (Na, K)(n+2)PnO(3n+1) (where n is approximately 14), and average molecular weight approximately 1670. ICL describes SKMP as amorphous, glassy, colorless or white granules that are very soluble in water.
ICL states that SKMP is prepared from an aqueous solution containing food grade phosphoric acid, potassium hydroxide, and sodium hydroxide or sodium carbonate. The solution is heated in a furnace to evaporate the water to form a product that on cooling forms into a solid amorphous glass, which is then milled and screened to obtain the appropriate granule size for use as a food ingredient. The notifier provides specifications for food grade SKMP, including phosphorus pentoxide (P2O5) content, and limits for lead and arsenic.
ICL states that the use of SKMP would be the same as the uses for sodium hexametaphosphate, listed as GRAS for use as a sequestrant in accordance with GMP in 21 CFR 182.6760. ICL also notes that the use of SKMP is not expected to increase the overall consumption of phosphate; it will likely be used to replace sodium hexametaphosphate in reduced-sodium food applications.
As part of the safety review of SKMP in GRN 000316, ICL incorporates by reference the safety review of phosphates conducted by the Select Committee on GRAS Substances (SCOGS).1 The 1975 SCOGS report (SCOGS-32), reviewed the safety of phosphates including sodium hexametaphosphate. The Select Committee concluded that “[t]there is no evidence in the available information on …(a number of phosphates including sodium hexametaphosphate)… that demonstrates, or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or might reasonably be expected in the future.”
ICL states that after reviewing the SCOGS report, they have determined that the conclusions by the SCOGS regarding the GRAS status of the food grade phosphates remain valid. In support of this statement, ICL searched the publicly available literature several times, including the fall of 2009, and discovered no information that would impact the safety data for SKMP. ICL concludes that SKMP is GRAS when used in accordance with GMP based on: (1) the safety information on sodium hexametaphosphate reported in the SCOGS report, (2) dietary phosphate levels are not expected to increase, and (3) dietary potassium would only increase slightly in certain food applications.
Standards of Identity
In the notice, ICL states its intention to use SKMP in foods, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Use in Products under USDA Jurisdiction
During its evaluation of GRN 000316, FDA consulted with the Risk and Innovations Management Division (RIMD) of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture. 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.
FSIS advised that numerous phosphates have been approved by FSIS for use in meat and poultry products to decrease the amount of cooked out juices. FSIS has considered GMP for phosphates for application to meat and poultry products to be up to 0.5 percent of product formulation. Therefore, FSIS would not have any objection to the use of SKMP in meat and poultry products, except where otherwise prohibited by the meat or poultry inspection regulations, to decrease the amount of cooked out juices, provided the phosphate does not exceed 0.5 percent of product formulation. FSIS further advised that, SKMP would need to be listed by its common or usual name in the ingredients statement on the label for any meat or poultry product in which it is used.
FSIS requested that FDA advise ICL to seek regulatory guidance from FSIS, RIMD, about the use of SKMP in meat and poultry products. ICL should direct such an inquiry to Dr. John M. Hicks, Jr., RIMD, Office of Policy and Program Development, Food Safety and Inspection Service, United States Department of Agriculture, George Washington Carver Center (GWCC), 5601 Sunnyside Avenue, Mail Stop 5271, Beltsville, MD 20705-5271. The telephone number for that office is (301) 504-0884 and the telefax number is (301) 504-0876.
Section 301 (ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, 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 ICL’s notice that SKMP is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing SKMP. Accordingly, this response should not be construed to be a statement that foods that contain SKMP, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by ICL, as well as other information available to FDA, the agency has no questions at this time regarding ICL’s conclusion that SKMP 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 SKMP. As always, it is the continuing responsibility of ICL 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 000316, 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 via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: John M. Hicks, Jr. DVM, MPH
Risk and Innovations Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
United States Department of Agriculture
George Washington Carver Center (GWCC)
5601 Sunnyside Ave., Mailstop 5271
Beltsville, MD 20705-5271
1FDA contracted with the Life Sciences Research Office (LSRO) of the Federation of American Societies for Experimental Biology as part of its comprehensive review of GRAS and prior sanctioned food ingredients. To aid in that review, LSRO established the Select Committee on GRAS Substances.