Daily Rules, Proposed Rules, and Notices of the Federal Government
Submit written objections in the following ways:
In a notice published in the
The use of SDBS is currently approved in washing or to assist in the peeling of fruits and vegetables under § 173.315 provided its use is followed by a potable water rinse. In addition, FDA food additive regulations permit the use of SDBS as an indirect food additive for use as a component of single and repeated use food contact substances (21 CFR 177.1010, 177.1200, 177.1630, 177.2600, and 177.2800), in sanitizing solutions (21 CFR 178.1010), and in the production of animal glue (21 CFR 178.3120).
The definition of “pesticide chemical” under section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 321(q)(1)(B)(i)), excludes an antimicrobial added to water that comes into contact with food, in the preparing, packing, or holding of the food for commercial purposes. This exclusion applies whether the water is to contact raw agricultural commodities or processed food. Consequently, such an antimicrobial is a “food additive” under section 201(s) of the FD&C Act and subject to the requirements in section 409 of the FD&C Act (21 U.S.C. 348). The petitioned use of SDBS as an antimicrobial agent in processing water is for a food additive use in certain food service facilities. Although the petitioned use of SDBS is regulated under section 409 of the FD&C Act as a food additive, this intended use of SDBS may nevertheless be subject to regulation as a pesticide under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Therefore, manufacturers intending to use this food additive for this intended use should contact the Environmental Protection Agency to determine whether this use requires a pesticide registration under FIFRA.
Under the general safety standard in section 409 of the FD&C Act, a food additive cannot be approved for a particular use unless a fair evaluation of the data available to FDA establishes that the additive is safe for that use. FDA's food additive regulations (21 CFR 170.3(i)) define “safe” as “a reasonable certainty in the minds of competent scientists that the substance is not harmful under the intended conditions of use.”
To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, FDA considers the projected human dietary intake of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to FDA. As part of FDA's safety evaluation, FDA reviewed data from published studies in animals on the safety of SDBS, including a 2-year carcinogenicity study in rats and a multigeneration reproductive study with rats. Based on the results from these studies and FDA's estimated dietary intake to SDBS from current and the proposed food uses, FDA concludes that there is a reasonable certainty of no harm and the petitioned use of SDBS is safe within the meaning of section 409 of the FD&C Act.
FDA reviewed data in the petition and other available relevant material to evaluate the safety of SDBS as an antimicrobial agent for use in wash water for fruits and vegetables without the requirement of a potable water rinse. Based on this information, FDA concludes that the proposed use of the additive is safe and the additive will achieve its intended technical effect as an antimicrobial agent under the proposed conditions of use. Therefore, the regulations in part 173 should be amended as set forth in this document.
In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that FDA considered and relied upon in reaching its decision to approve the petition will be made available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see
FDA has carefully considered the potential environmental effects of this action. FDA has concluded that the action will not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA's finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Division of Dockets Management (see
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see
FDA's review of this petition was limited to section 409 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) (21 U.S.C. 331(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 (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Director, Center for Food Safety and Applied Nutrition, 21 CFR part 173 is amended as follows:
21 U.S.C. 321, 342, 348.
Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0) may be safely used in accordance with the following prescribed conditions:
(a) The additive is an antimicrobial agent used in wash water for fruits and vegetables. The additive may be used at a level not to exceed 111 milligrams per kilogram in the wash water. Fruits and vegetables treated by the additive do not require a potable water rinse.
(b) The additive is limited to use in commissaries, cafeterias, restaurants, retail food establishments, nonprofit food establishments, and other food service operations in which food is prepared for or served directly to the consumer.
(c) To assure safe use of the additive, the label or labeling of the additive container shall bear, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with the provisions of this section.