April 20, 2001

April F. Kates
American Ingredients Company
3947 Broadway
Kansas City, MO 64111

Re: GRAS Notice No. GRN 000071

Dear Ms. Kates:

The Food and Drug Administration (FDA) is responding to the notice, dated March 5, 2001, that you submitted on behalf of American Ingredients Company (American Ingredients) 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)). FDA received the notice on March 7, 2001 and designated it as GRAS Notice No. GRN 000071.

The subject of the notice is white mineral oil, USP (viscosity ISO 100),⁽¹⁾ (Chemical Abstract Service (CAS) registry number 8012-95-1). The notice informs FDA of the view of American Ingredients that white mineral oil, USP (viscosity ISO 100) is GRAS, through scientific procedures, for use as an ingredient in a non-stick lubricant to be applied to potato processing equipment, such as moving belts, product chutes, and shakers. This would result in the addition of white mineral oil to food at a level of no more than 5 milligrams per kilogram (mg/kg; equivalent to 5 parts per million (ppm)).⁽²⁾

American Ingredient's previous GRAS notice for the use of mineral oil as a release agent

In a previous submission to FDA (GRAS Notice No. GRN 000040), American Ingredients informed FDA of its view that mineral oil (viscosity not specified) is GRAS, through experience based on common use in food, for use as a release agent sprayed on food processing equipment resulting in a presence on food of no more than 5 ppm. In GRN 000040, American Ingredients described the use of mineral oil in food applications before 1958 and the regulatory status of mineral oil in the U.S. in 1960. American Ingredients also explained that it considered its intended use of mineral oil as a release agent sprayed on food processing equipment to be similar to the use of mineral oil as a release agent and lubricant in bakery products, which FDA approved as a food additive (21 CFR 172.878). American Ingredients contrasted the level of mineral oil in food products from its intended use on food processing equipment (no more than 5 ppm) with the level of mineral oil in food products from its approved uses in bakery products (1500 ppm). American Ingredients described a recent amendment to FDA's food additive regulations regarding mineral oil to approve an increased level of use of mineral oil as a dust control agent for rice. Finally, American Ingredients described a number of studies pertaining to mineral oil that have been published in the scientific literature. Some of these studies show effects, such as hepatic and mesenteric microgranulomas, in Fischer 344 rats that consumed low viscosity mineral oil. American Ingredients noted that these results have not been observed in other strains of rats.

In our response to GRN 000040 (Ref. 1), FDA advised that the information provided by American Ingredients about the regulatory status of mineral oil in the U.S. in 1960 evidences both that the agency was aware of some pre-1958 use of mineral oil and that, in 1960, it was FDA's position that this pre-1958 use of mineral oil was not sufficient to demonstrate safety. FDA also informed American Ingredients that GRN 000040 provided no basis to re-evaluate the position of the agency that the use before 1958 does not support a general recognition of safety.

In our response to GRN 000040, FDA also advised that our recent approval of an increased level of use of mineral oil as a dust control agent for rice was limited to mineral oil with a viscosity of ISO 100. FDA tied this limitation to the effects that American Ingredients described in Fischer 344 rats that consumed low viscosity mineral oil; these effects have not been observed in Fischer 344 rats fed mineral oil that has a relatively high viscosity, such as a viscosity of ISO 100. In approving this expanded use of mineral oil, FDA calculated that the increased level of use of mineral oil would result in an estimated daily intake of approximately 2 milligrams per person per day. According to FDA's calculations, this additional intake would be less than one percent of the cumulative estimated dietary intake for mineral oil from previously approved uses of mineral oil as a direct food ingredient.

Data and information that American Ingredients presents in GRN 000071

In GRN 000071, American Ingredients limits the scope of its GRAS determination to "mineral oil, USP (viscosity ISO 100)" - i.e., the white mineral oil that FDA recently approved for use at an increased level as a dust control agent for rice. American Ingredients also narrows the scope of its GRAS determination from "food processing equipment" to "potato processing equipment."

In discussing the basis for its determination that this high viscosity mineral oil is GRAS for use as an ingredient in a non-stick lubricant to be applied to potato processing equipment, American Ingredients reiterates the information that it described in GRN 000040. American Ingredients also estimates that total dietary exposure to mineral oil as a result of this intended use would increase by approximately 2.3 milligrams per person per day. American Ingredients comments that this estimate of increased dietary exposure is comparable to the increase in dietary exposure that FDA calculated when it approved the increased level of use of mineral oil as a dust control agent for rice.

FDA's evaluation of the data and information in GRN 000071

American Ingredients' notice describes generally available studies conducted with mineral oil with a viscosity of ISO 100. As FDA informed American Ingredients in our letter regarding GRN 000040, FDA evaluated those studies and relied on them in its recent approval of an increased level of use of mineral oil as a dust control agent for rice.

American Ingredients' notice suggests that FDA's approval of a use of a food additive, combined with public availability of the data that FDA relied on in reaching its safety conclusion, constitutes general recognition of safety within the meaning of section 201(s) of the Federal Food, Drug, and Cosmetic Act (the Act). FDA does not agree with this suggestion. The Act requires premarket approval of the use of a substance in food unless that use is GRAS, and requires that FDA publish its conclusion regarding safety. Absent a basis to conclude that qualified experts independent of FDA also have evaluated the relevant data and concluded that these data establish the safety of the use of the substance, such an agency conclusion, even if based upon generally available data and information, is not equivalent to general recognition by qualified experts that the subject use is safe.

FDA raised this issue in its response to GRAS Notice No. GRN 000006 (Ref. 2). In that notice, Cytec Industries, Inc., informed FDA of its view that dioctyl sodium sulfosuccinate (DSS) is GRAS for use as a dispersing agent and stabilizer in flavor emulsions used in the production of carbonated and non-carbonated soft drinks at levels up to 10 ppm of the finished beverage. FDA had previously approved DSS as a food additive for use as a wetting agent in fumaric acid-acidulated foods, as a processing aid in the production of unrefined cane sugar, as a solubilizing agent on gums and hydrophilic colloids, as an emulsifying agent for cocoa fat, and as a dispersing agent in cocoa (21 CFR 172.810). As described in GRN 000006, publicly available toxicological studies on DSS, which provided the basis for FDA's approval of the use of DSS as a food additive, have also been reviewed by experts at JECFA and provided the basis for JECFA's determination of an acceptable daily intake (ADI) for DSS. Because Cytec Industries provided a basis to conclude that qualified experts independent of FDA evaluated these studies, FDA had no questions about the conclusion of Cytec Industries that their intended use of DSS is GRAS.

American Ingredients provides no basis to conclude that qualified experts independent of FDA have evaluated the published studies conducted with high viscosity mineral oil and concluded that these studies establish the safety of such mineral oil. Thus, American Ingredients does not provide a sufficient basis to conclude that the intended use of high viscosity mineral oil is GRAS. However, we are aware of a published report by JECFA, which documents that JECFA has evaluated these studies and established an ADI for mineral oil with a viscosity of ISO 100 (Ref. 3). The ADI established by JECFA is similar to the daily intake that FDA considered acceptable when it approved an increased level of use of mineral oil as a dust control agent for rice.

Conclusions

Based on the information provided by American Ingredients, as well as other information available to FDA, the agency has no questions at this time regarding American Ingredients' conclusion that "white mineral oil, USP (viscosity ISO 100)" is GRAS under the intended conditions of use, provided that this mineral oil fully conforms with 21 CFR 172.878(a) and (b), and provided that this mineral oil otherwise complies with the specifications for mineral oil in the Food Chemicals Codex. The agency has not, however, made its own determination regarding the GRAS status of the subject use of mineral oil with a viscosity of ISO 100. As always, it is the continuing responsibility of American Ingredients 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, as well as a copy of the information in the notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval's homepage on the Internet (at http://www.cfsan.fda.gov/~lrd/foodadd.html).

References

1. Letter dated December 11, 2000, from Alan Rulis of FDA to April Kates. Available at http://www.cfsan.fda.gov/~lrd/foodadd.html.

2. Letter dated December 28, 1998, from Alan Rulis of FDA to Ralph Simmons. Available at http://www.cfsan.fda.gov/~lrd/foodadd.html.

3. World Health Organization, International Programme on Chemical Safety, "Toxicological Evaluation of Certain Food Additives and Contaminants in Food," WHO Food Additives Series 35, Prepared by the forty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), pp. 193-206, 1996.

⁽¹⁾"Viscosity ISO 100" means that the viscosity of the mineral oil is equal to 100 centistokes at 100 degrees Fahrenheit.

⁽²⁾In GRN 000071, American Ingredients describes the ingredient as "mineral oil." Both FDA's regulation in 21 CFR 172.878 and the Food Chemicals Codex describe the ingredient as "white mineral oil." The CAS registry numbers for "mineral oil" and "white mineral oil" are the same. The Joint Food and Agriculture Organization/World Health Organization's (FAO/WHO) Expert Committee on Food Additives (JECFA) describes the ingredient as "Mineral Oil" and lists "White Mineral Oil" as a synonym. Because both FDA's regulations and the Food Chemicals Codex describe the ingredient as "white mineral oil," FDA is describing the subject of GRN 000071 as "white mineral oil." For simplicity, FDA is using the term "mineral oil" in the remainder of the letter.

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