Food Additives Permitted for Human Consumption:

Federal Register Volume 76, Number 136 (Friday, July 15, 2011)

Rules and Regulations

Pages 41687-41689

From the Federal Register Online via the Government Printing Office [www.gpo.gov]

FR Doc No: 2011-17928

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration 21 CFR Part 172

Docket No. FDA-2010-F-0103

Food Additives Permitted for Direct Addition to Food for Human

Consumption; Hydroxypropyl Cellulose

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations for hydroxypropyl cellulose by lowering the minimum permitted viscosity from 145 centipoises (cPs) to 10 cPs and to permit its use as a binder in dietary supplements. This action is in response to a petition filed by Nisso America, Inc.

DATES: This rule is effective July 15, 2011. Submit either electronic or written objections and requests for a hearing by August 15, 2011.

See section VII of this document for information on the filing of objections.

ADDRESSES: You may submit either electronic or written objections and requests for a hearing, identified by Docket No. FDA-2010-F-0103, by any of the following methods:

Electronic Submissions

Submit electronic objections in the following way:

Federal eRulemaking Portal: http://www.regulations.gov.

Follow the instructions for submitting comments.

Written Submissions

Submit written objections in the following ways:

Fax: 301-827-6870.

Mail/Hand delivery/Courier (for paper, disk, or CD-ROM submissions): Division of Dockets Management (HFA-305), Food and Drug

Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the Agency name and Docket No. FDA-2010-F-0103 for this rulemaking. All objections received will be posted without change to http://www.regulations.gov, including any personal information provided. For detailed instructions on submitting objections, see the ``Objections'' heading of the

SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or objections received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of

Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Laura Dye, Center for Food Safety and

Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint

Branch Pkwy., College Park, MD 20740-3835, 240-402-1275.

SUPPLEMENTARY INFORMATION:

1. Background

   In a notice published in the Federal Register of April 8, 2010 (75

   FR 17928), FDA announced that Nisso America Inc., 45 Broadway, Suite 2120, New York, NY 10006, filed a food additive petition (FAP 0A4780).

   The petition proposed to amend the food additive regulations in Sec. 172.870 (21 CFR 172.870), by lowering the minimum permitted viscosity of hydroxypropyl cellulose (HPC) identified in Sec. 172.870(a)(1) from 145 cPs to 10 cPs and to permit its use as a binder in dietary supplements.

   Section 172.870 includes both high-substituted HPC, which contains not more than 4.6 hydroxypropyl groups per anhydroglucose unit (Sec. 172.870(a)(1)), and low-substituted HPC, which contains on average 0.1 to 0.4 hydroxypropyl groups per anhydroglucose unit (Sec. 172.870(a)(2)). High-substituted HPC can be used, in accordance with good manufacturing practice, as an emulsifier, film former, protective colloid, stabilizer, suspending agent and thickener (Sec. 172.870(b)(1)). Low-substituted HPC can be used, in accordance with good manufacturing practice, as a binder and disintegrator in tablets or wafers containing dietary supplements (Sec. 172.870(b)(2)). It is the high-substituted HPC regulated under Sec. 172.870(a)(1) and (b)(1) that is the subject of this petition.

2. Evaluation of Safety

   Under the general safety standard in section 409 of the Federal

   Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348), 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

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   a food additive is not harmful under its intended conditions of use,

   FDA considers the estimated human dietary intake of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to the Agency.

   Both high-substituted HPC (the subject of this petition) and low- substituted HPC are forms of cellulose and cellulose derivatives. The safety of cellulose and cellulose derivatives has been studied extensively in animals and humans. These studies show that cellulose and cellulose derivatives pass unchanged through the gastrointestinal tract and can be quickly detected in the feces of test animals and humans when consumed, confirming that the consumption of cellulose and cellulose derivatives at the proposed viscosity and use level will not result in toxicity. The Joint Food and Agriculture Organization and the

   World Health Organization (FAO/WHO) Expert Committee for Food Additives

   (JECFA) has evaluated the food uses of modified celluloses, including

   HPC, and has concluded that, as a group, modified celluloses are of very low toxicity at the levels of intake necessary to achieve the desired effect and do not pose a hazard to health (Ref. 1). Viscosity is not specified by the JECFA as a factor related to the safety of these additives.

   Although there is no available safety testing directly on HPC with a viscosity of