Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3, 37255-37258 [05-12699]

Download as PDF Federal Register / Vol. 70, No. 124 / Wednesday, June 29, 2005 / Rules and Regulations requirements of U.S. Standards for Milled Rice. DEPARTMENT OF HEALTH AND HUMAN SERVICES Need for Correction Food and Drug Administration As published, the direct final rule contains errors which may prove to be confusing and needs to be clarified. In Section 868.310(f) U.S. Sample grade, the word ‘‘re’’ should read ‘‘or’’; in § 868.311, the correct wording for that section should read ‘‘Grades and grade requirements for the class Second Head Milled Rice. (See also § 868.315)’’, instead of ‘‘Grades and grade requirements for the class Second Head Milled Rice. (See also § 868.305.)’’; and in § 868.312, the correct wording for that section should read ‘‘Grades and grade requirements for the class Screenings Milled Rice. (See also § 868.315.)’’, instead of ‘‘Grades and grade requirements for the class Brewers Milled Rice. (See also § 868.315).’’ List of Subjects in 7 CFR Part 868 Agricultural commodities, Rice. PART 868—GENERAL REGULATIONS AND STANDARDS FOR CERTAIN AGRICULTURAL COMMODITIES 1. The authority citation for part 868 continues to read as follows: I Authority: Secs. 202–208, 60 Stat. 1087, as amended (7 U.S.C. 1621 et seq.). 2. Amend § 868.310 by revising note (f) of the table to read as follows: I § 868.310 Grades and grade requirements for the classes Long Grain Milled Rice, Medium Grain Milled Rice, Short Grain Milled Rice, and Mixed Milled Rice. (See also § 868.315.) * * * * * (f) Contains two or more live or dead weevils or other insects, insect webbing, or insect refuse; * * * * * 3. Revise the heading of § 868.311 read as follows: I § 868.311 Grades and grade requirements for the class Second Head Milled Rice. (See also § 868.315.) 4. Revise the heading of § 868.312 to read as follows: I § 868.312 Grade and grade requirements for the class Screenings Milled Rice. (See also § 868.315.) David R. Shipman, Acting Administrator, Grain Inspection, Packers and Stockyards Administration. [FR Doc. 05–12815 Filed 6–28–05; 8:45 am] BILLING CODE 3410–EN–P VerDate jul<14>2003 16:25 Jun 28, 2005 Jkt 205001 21 CFR Part 172 [Docket No. 2003F–0370] Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. SUMMARY: The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of vitamin D3 as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight. This action is in response to a petition filed by Unilever United States, Inc. (Unilever). DATES: This rule is effective June 29, 2005. The Director of the Office of the Federal Register approves the incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 CFR 172.380 as of June 29, 2005. Submit written or electronic objections and requests for a hearing by July 29, 2005. See section VI of this document for information on the filing of objections. ADDRESSES: You may submit written objections and requests for a hearing, identified by Docket No. 2003F–0370, by any of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Agency Web site: https:// www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. • E-mail: fdadockets@oc.fda.gov. Include Docket No. 2003F–0370 in the subject line of your e-mail message. • 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 number for this rulemaking. All objections received will be posted without change to https://www.fda.gov/ ohrms/dockets/default.htm, including any personal information provided. For detailed instructions on submitting objections, see the ‘‘Objections’’ heading PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 37255 of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read background documents or objections received, go to https:// www.fda.gov/ohrms/dockets/ default.htm 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: Judith L. Kidwell, Center for Food Safety and Applied Nutrition (HFS– 265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1071. SUPPLEMENTARY INFORMATION: I. Introduction In a notice published in the Federal Register of August 21, 2003 (68 FR 50541), FDA announced that a food additive petition (FAP 3A4746) had been filed by Unilever United States, Inc., 390 Park Ave., New York, NY 10022–4698. The petition proposed that the food additive regulations be amended in § 172.380 Vitamin D3 (21 CFR 172.380) to provide for the safe use of vitamin D3 as a nutrient supplement in certain foods for special dietary use, such as meal replacement products and snack replacement products. Foods specifically identified in the petition were meal replacement bars, other-type bars, and soy-protein based meal replacement beverages that are represented for special dietary use in reducing or maintaining body weight. Vitamin D3 currently is approved for use as a nutrient supplement in calcium-fortified fruit juice and fruit juice drinks under § 172.380. Vitamin D1, including vitamin D3, also is affirmed as generally recognized as safe (GRAS) for use in food under § 184.1950 (21 CFR 184.1950) with the following limitations: Category of Food Breakfast cereals Grain products and pasta Maximum Levels in Food (as served) 350 International Units (IU)/100 grams (g) 90 IU/100 g 1 Vitamin D comprises a group of fat-soluble secosterols and comes in many forms. The two major physiologically relevant forms are vitamin D2 and vitamin D3. Vitamin D without a subscript represents either D2 or D3. Section 184.1950 includes crystalline vitamin D2, crystalline vitamin D3, vitamin D2 resin, and vitamin D3 resin. Section 172.380 includes only crystalline vitamin D3. E:\FR\FM\29JNR1.SGM 29JNR1 37256 Federal Register / Vol. 70, No. 124 / Wednesday, June 29, 2005 / Rules and Regulations Category of Food Maximum Levels in Food (as served) Milk 42 IU/100 g Milk products 89 IU/100 g Additionally, under § 184.1950(c)(2) and (c)(3) vitamin D is affirmed as GRAS for use in infant formula and margarine, respectively. Vitamin D3, also known as cholecalciferol, is the chemical 9,10seco(5Z,7E)-5,7,10(19)-cholestatrien-3ol. Humans synthesize vitamin D3 in skin from its precursor, 7dehydrocholesterol under exposure to ultraviolet B radiation in sunlight. Vitamin D3 does not accumulate significantly in the body as a result of sun exposure because it is metabolized and removed during normal skin cell turnover. Other sources of naturally occurring vitamin D are foods such as butter, buttermilk, cheese, cream, eggs, fish, goat milk, meat fats and organ meats, and mushrooms. Vitamin D is essential for human health. The major function of vitamin D is the maintenance of blood serum concentrations of calcium and phosphorus by enhancing the absorption of these minerals in the small intestine. Vitamin D deficiency can lead to abnormalities in calcium and bone metabolism such as rickets in children or osteomalacia in adults. At high levels, vitamin D may be toxic. Excessive intake of vitamin D elevates blood plasma calcium levels by increased intestinal absorption and/or mobilization from the bone. To ensure that vitamin D is not added to the U.S. food supply at levels that could raise safety concerns, FDA affirmed vitamin D as GRAS with specific limitations, as listed in § 184.1950. Under 21 CFR 184.1(b)(2), an ingredient affirmed as GRAS with specific limitations may be used in food only within such limitations, including the category of food(s), functional use(s), and level(s) of use. Any addition of vitamin D to food beyond those limitations set out in § 184.1950 requires either a food additive regulation or an amendment of § 184.1950. To support the safety of the proposed uses of vitamin D3, Unilever submitted dietary intake estimates from current and proposed uses and naturally occurring sources of vitamin D and compared these exposure estimates to the tolerable upper intake level (UL) for vitamin D established by the Institute of Medicine (IOM) of the National Academies. The petitioner also submitted a number of publications VerDate jul<14>2003 16:25 Jun 28, 2005 Jkt 205001 pertaining to human clinical studies on vitamin D. Based on this information, which is discussed in section II of this document, the petitioner concluded that the proposed use of vitamin D3 in meal replacement bars and other-type bars represented for special dietary use in reducing or maintaining body weight at levels not to exceed 100 IU per 40 g product is safe. The petitioner also concluded that the proposed use of vitamin D3 in soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight at levels not to exceed 140 IU per 240 milliliter product is safe. II. Evaluation of Safety To establish with reasonable certainty that a food additive is not harmful under its intended conditions of use, FDA considers the projected human dietary exposure to the additive, the additive’s toxicological data, and other relevant information (such as published literature) available to the agency. FDA compares an individual’s estimated daily intake (EDI) of the additive from all sources to an acceptable intake level established by toxicological data. The EDI is determined by projections based on the amount of the additive proposed for use in particular foods and on data regarding the consumption levels from all sources of the additive. A. Acceptable Daily Intake for Vitamin D for Adults and Children In 1997, the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board at IOM conducted an extensive review of toxicology and metabolism studies on vitamin D published through 1996. The IOM published a detailed report that included a UL for vitamin D for infants, children, and adults. The IOM UL for vitamin D for children 1 to 18 years of age and adults is 2,000 IU per person per day (IU/p/d). The UL for infants is 1,000 IU/p/d. The IOM considers the UL as the highest usual intake level of a nutrient that poses no risk of adverse effects when the nutrient is consumed over long periods of time. The UL is determined using a risk assessment model developed specifically for nutrients and considers intake from all sources: Food, water, nutrient supplements, and pharmacological agents. The dose-response assessment, which concludes with an estimate of the UL, is built upon three toxicological concepts commonly used in assessing the risk of exposures to chemical substances: No-observed-adverse-effect PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 level, lowest-observed-effect level, and an uncertainty factor. B. Estimated Daily Intake for Vitamin D The petitioner provided average and 90th percentile vitamin D intake estimates for consumers of meal replacement bars, other-type bars, and soy-protein based meal replacement beverages represented for special dietary use from the following: (1) The proposed food uses, (2) current food uses (including naturally occurring sources of vitamin D), (3) current and proposed food uses, and (4) current and proposed food uses and dietary supplements. The proposed uses are for foods intended for use by adults as part of a weight control diet. Although these special dietary foods are not intended for use by children, the petitioner acknowledged that some sporadic use by children may occur, especially among older children. Therefore, intake estimates for adults and children over the age of 9 years were provided. The agency has determined that the methodology used to calculate these estimates is appropriate. For the proposed food uses, dietary intake of vitamin D3 for 90th percentile consumers of meal replacement bars, other-type bars, and soy-protein based meal replacement beverages was estimated to be 215 IU/p/d for consumers 9 years of age and older. The corresponding mean intake was estimated to be 127 IU/p/d. For currently regulated uses in conventional foods (under § 184.1950 and § 172.380) and naturally occurring sources, mean dietary exposure to vitamin D for consumers of meal replacement bars, other-type bars, and soy-protein based meal replacement beverages was estimated to be 470 IU/ p/d for consumers 9 years of age and older. Intake at the 90th percentile was estimated to be 957 IU/p/d. For consumers 9 years of age and older, mean and 90th percentile dietary intakes from current (including naturally occurring sources) and proposed food uses of vitamin D were estimated to be 565 IU/p/d and 995 IU/ p/d, respectively. The petitioner also considered the intake of vitamin D from dietary supplements. The National Health and Nutrition Examination Survey III (NHANES III) data indicate that approximately 40 percent of the U.S. population 2 months of age and older take dietary supplements. The NHANES III data also show that, when vitamin D is taken as a dietary supplement, the most frequent level is 400 IU/p/d. As a conservative estimate of intake of vitamin D from dietary supplements and E:\FR\FM\29JNR1.SGM 29JNR1 Federal Register / Vol. 70, No. 124 / Wednesday, June 29, 2005 / Rules and Regulations food uses, the petitioner assumed that all consumers of meal replacement bars, other-type bars, and soy-protein based meal replacement beverages represented for special dietary use would take dietary supplements containing 400 IU of vitamin D. They then added this value to the mean and 90th percentile intake estimates from current and proposed food uses. For consumers of meal replacement bars, other-type bars, and soy-protein based meal replacement beverages, mean and 90th percentile dietary intakes from current and proposed food uses and dietary supplements were estimated to be 965 IU/p/d and 1,395 IU/p/d for consumers 9 years of age and older, respectively. FDA concurs with these exposure estimates. C. Safety Assessment To support the safety of their proposed uses for vitamin D3, Unilever submitted 16 scientific articles published subsequent to the IOM report and issuance of the 2003 final rule permitting the use of vitamin D3 in calcium-fortified fruit juices and fruit juice drinks within the prescribed limitations (68 FR 9000, February 27, 2003). Unilever concluded that the recent publications continue to support the safe use of vitamin D supplementation in both animals and humans. FDA concurs with Unilever’s conclusions. FDA considered the UL established by IOM for children and adults relative to the intake estimates provided by the petitioner as the primary basis for assessing the safety of the proposed use of vitamin D3 in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages represented for special dietary use. For all children and adults 9 years of age and older, mean and 90th percentile intake estimates from current and proposed food uses of vitamin D are well below the IOM UL of 2,000 IU/p/d. Additionally, when dietary supplements are included in the calculations, intake estimates remain below the UL. Because the EDI of vitamin D from all sources is less than the UL, the agency concludes that dietary exposure of vitamin D3 from its use as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight will not pose a safety concern. III. Conclusion Based on all data relevant to vitamin D3 reviewed by the agency, FDA concludes that there is a reasonable VerDate jul<14>2003 16:25 Jun 28, 2005 Jkt 205001 certainty that no harm will result from the use of vitamin D3 as a nutrient supplement in meal replacement bars, other-type bars, and soy-protein based meal replacement beverages represented for special dietary use in reducing or maintaining body weight. Thus, vitamin D3 is safe for its proposed use and the agency concludes that the food additive regulations should be amended as set forth in this document. To ensure that only food grade vitamin D3 is used in food, the additive must meet the specifications set forth in this document. Based on a request by the petitioner, FDA also is updating § 172.380 by citing the 5th edition of the Food Chemicals Codex rather than the 4th edition. Section 172.380(b) currently states that vitamin D3 must meet the specifications of the Food Chemicals Codex, 4th ed., 1996. The agency compared specifications for vitamin D3 in the 4th and 5th editions and found them to be identical. Therefore, the agency is making this requested editorial change. In addition, the agency is making an editorial update to § 172.380(b) to reflect the new address for the National Academy Press. The agency also is making editorial changes to § 172.380(c) for clarification. 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 are available for inspection at the Center for Food Safety and Applied Nutrition by appointment with the information contact person (see FOR FURTHER INFORMATION CONTACT). As provided in § 171.1(h), the agency will delete from the documents any materials that are not available for public disclosure before making the documents available for inspection. IV. Environmental Effects 37257 VI. Objections Any person who will be adversely affected by this regulation may file with the Division of Dockets Management (see ADDRESSES) written or electronic objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provisions of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state. Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection. Three copies of all documents are to be submitted and are to be identified with the docket number found in brackets in the heading of this document. Any objections received in response to the regulation may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. List of Subjects in 21 CFR Part 172 Food additives, Incorporation by reference, Reporting and recordkeeping requirements. I Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 172 is amended as follows: PART 172—FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION The agency has previously considered the environmental effects of this rule as announced in the notice of filing for FAP 3A4746 (68 FR 50541). No new information or comments have been received that would affect the agency’s previous determination that there is no significant impact on the human environment and that an environmental impact statement is not required. I V. Paperwork Reduction Act of 1995 * 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. PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 1. The authority citation for 21 CFR part 172 continues to read as follows: Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e. 2. Section 172.380 is amended by revising paragraphs (b) and (c) and removing paragraph (d) to read as follows: I § 172.380 Vitamin D3. * * * * (b) Vitamin D3 meets the specifications of the Food Chemicals Codex, 5th ed. (2004), pp. 498–499, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by E:\FR\FM\29JNR1.SGM 29JNR1 37258 Federal Register / Vol. 70, No. 124 / Wednesday, June 29, 2005 / Rules and Regulations reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the National Academy Press, 500 Fifth St. NW., Washington, DC 20001 (Internet address https://www.nap.edu). Copies may be examined at the Center for Food Safety and Applied Nutrition’s Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: https://www.archives.gov/ federal_register/ code_of_federal_regulations/ ibr_locations.html. (c) The additive may be used as follows: (1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 33 percent of the reference daily intake (RDI) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants. (2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 10 percent of the RDI of calcium per 240 mL, excluding fruit juice drinks that are specially formulated or processed for infants. (3) At levels not to exceed 140 IU per 240 mL (prepared beverage) in soyprotein based meal replacement beverages (powder or liquid) that are represented for special dietary use in reducing or maintaining body weight in accordance with § 105.66 of this chapter. (4) At levels not to exceed 100 IU per 40 grams in meal replacement bars or other-type bars that are represented for special dietary use in reducing or maintaining body weight in accordance with § 105.66 of this chapter. Dated: June 20, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–12699 Filed 6– 28–05; 8:45 am] BILLING CODE 4160–01–S VerDate jul<14>2003 16:25 Jun 28, 2005 Jkt 205001 DEPARTMENT OF THE TREASURY DEPARTMENT OF THE TREASURY Internal Revenue Service Internal Revenue Service 26 CFR Part 1 26 CFR Parts 26 and 602 [TD 9208] [TD 9207] RIN 1545–BB54 RIN 1545–AX93 Election Out of GST Deemed Allocations Assumption of Partner Liabilities; Correction Internal Revenue Service (IRS), Treasury. AGENCY: ACTION: Correction to final regulations. SUMMARY: This document corrects final regulation (TD 9207) that were published in the Federal Register on Thursday, May 26, 2005 (70 FR 30334). The final regulation relates to the definition of liabilities under section 752 of the Internal Revenue Code. This correction is effective on May 26, 2005. DATES: FOR FURTHER INFORMATION CONTACT: Laura Fields (202) 622–3050 (not a tollfree number). SUPPLEMENTARY INFORMATION: Background The final regulations (TD 9207) that is the subject of this correction are under sections 358, 704, 705, 737 and 752 of the Internal Revenue Code. Internal Revenue Service (IRS), Treasury. ACTION: Final regulation. AGENCY: SUMMARY: This document contains final regulations providing guidance for making the election under section 2632(c)(5)(A)(i) of the Internal Revenue Code to not have the deemed allocation of unused generation-skipping transfer (GST) tax exemption under section 2632(c)(1) apply with regard to certain transfers to a GST trust, as defined in section 2632(c)(3)(B). The final regulations also provide guidance for making the election under section 2632(c)(5)(A)(ii) to treat a trust as a GST trust. The regulations primarily affect individuals. DATES: Effective Date: The regulations are effective June 29, 2005. Applicability Date: For dates of applicability, see § 26.2632–1(e). FOR FURTHER INFORMATION CONTACT: Mayer R. Samuels, (202) 622–3090 (not a toll-free number). SUPPLEMENTARY INFORMATION: Paperwork Reduction Act The collection of information contained in these final regulations has As published, TD 9207 contains an been reviewed and approved by the error that may prove to be misleading Office of Management and Budget in and is in need of clarification. accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Correction of Publication 3507(d)) under control number 1545– I Accordingly, the publication of the 1892. The collection of information in these final regulations (TD 9207), that was the subject of FR Doc. 05–10266, is corrected final regulations is in § 26.2632– 1(b)(2)(iii) and (b)(3). This information as follows: is required by the IRS for taxpayers who I On page 30337, column 3, that elect to have the automatic allocation paragraph heading ‘‘4. Section 752–7 rules not apply to the current transfer Liability’’, the language ‘‘4. Section 752– and/or to future transfers to the trust or 7 Liability’’ is corrected to read ‘‘4. to terminate such election. This Section 1.752–7 Liability’’. information is also required by the IRS for taxpayers who elect to treat trusts Cynthia Grigsby, described in section 2632(c)(3)(B)(i) Acting Chief, Publications and Regulations through (vi) as GST trusts or to Branch, Legal Processing Division, Associate terminate such election. Chief Counsel (Procedure and An agency may not conduct or Administration). sponsor, and a person is not required to [FR Doc. 05–12757 Filed 6–28–05; 8:45 am] respond to, a collection of information BILLING CODE 4830–01–M unless the collection of information displays a valid control number. Books or records relating to this collection of information must be Need for Correction PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\FR\FM\29JNR1.SGM 29JNR1

Agencies

[Federal Register Volume 70, Number 124 (Wednesday, June 29, 2005)]
[Rules and Regulations]
[Pages 37255-37258]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-12699]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. 2003F-0370]

Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D3

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of vitamin
D3 as a nutrient supplement in meal replacement bars, other-
type bars, and soy-protein based meal replacement beverages represented
for special dietary use in reducing or maintaining body weight. This
action is in response to a petition filed by Unilever United States,
Inc. (Unilever).

DATES: This rule is effective June 29, 2005. The Director of the Office
of the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain
publications in 21 CFR 172.380 as of June 29, 2005. Submit written or
electronic objections and requests for a hearing by July 29, 2005. See
section VI of this document for information on the filing of
objections.

ADDRESSES: You may submit written objections and requests for a
hearing, identified by Docket No. 2003F-0370, by any of the following
methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: https://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
E-mail: fdadockets@oc.fda.gov. Include Docket No. 2003F-
0370 in the subject line of your e-mail message.
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 number for this rulemaking. All objections received will be
posted without change to https://www.fda.gov/ohrms/dockets/default.htm,
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 https://www.fda.gov/ohrms/dockets/default.htm
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: Judith L. Kidwell, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1071.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal Register of August 21, 2003
(68 FR 50541), FDA announced that a food additive petition (FAP 3A4746)
had been filed by Unilever United States, Inc., 390 Park Ave., New
York, NY 10022-4698. The petition proposed that the food additive
regulations be amended in Sec. 172.380 Vitamin D3 (21 CFR 172.380) to
provide for the safe use of vitamin D3 as a nutrient
supplement in certain foods for special dietary use, such as meal
replacement products and snack replacement products. Foods specifically
identified in the petition were meal replacement bars, other-type bars,
and soy-protein based meal replacement beverages that are represented
for special dietary use in reducing or maintaining body weight.
Vitamin D3 currently is approved for use as a nutrient
supplement in calcium-fortified fruit juice and fruit juice drinks
under Sec. 172.380. Vitamin D\1\, including vitamin D3,
also is affirmed as generally recognized as safe (GRAS) for use in food
under Sec. 184.1950 (21 CFR 184.1950) with the following limitations:
---------------------------------------------------------------------------

\1\ Vitamin D comprises a group of fat-soluble seco-sterols and
comes in many forms. The two major physiologically relevant forms
are vitamin D2 and vitamin D3. Vitamin D
without a subscript represents either D2 or
D3. Section 184.1950 includes crystalline vitamin
D2, crystalline vitamin D3, vitamin
D2 resin, and vitamin D3 resin. Section
172.380 includes only crystalline vitamin D3.

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Category of Food Maximum Levels in Food (as served)
------------------------------------------------------------------------
Breakfast 350 International Units (IU)/100 grams (g)
cereals
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Grain products 90 IU/100 g
and pasta
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[[Page 37256]]

Milk 42 IU/100 g
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Milk products 89 IU/100 g
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Additionally, under Sec. 184.1950(c)(2) and (c)(3) vitamin D is
affirmed as GRAS for use in infant formula and margarine, respectively.
Vitamin D3, also known as cholecalciferol, is the
chemical 9,10-seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol. Humans
synthesize vitamin D3 in skin from its precursor, 7-
dehydrocholesterol under exposure to ultraviolet B radiation in
sunlight. Vitamin D3 does not accumulate significantly in
the body as a result of sun exposure because it is metabolized and
removed during normal skin cell turnover. Other sources of naturally
occurring vitamin D are foods such as butter, buttermilk, cheese,
cream, eggs, fish, goat milk, meat fats and organ meats, and mushrooms.
Vitamin D is essential for human health. The major function of
vitamin D is the maintenance of blood serum concentrations of calcium
and phosphorus by enhancing the absorption of these minerals in the
small intestine. Vitamin D deficiency can lead to abnormalities in
calcium and bone metabolism such as rickets in children or osteomalacia
in adults. At high levels, vitamin D may be toxic. Excessive intake of
vitamin D elevates blood plasma calcium levels by increased intestinal
absorption and/or mobilization from the bone.
To ensure that vitamin D is not added to the U.S. food supply at
levels that could raise safety concerns, FDA affirmed vitamin D as GRAS
with specific limitations, as listed in Sec. 184.1950. Under 21 CFR
184.1(b)(2), an ingredient affirmed as GRAS with specific limitations
may be used in food only within such limitations, including the
category of food(s), functional use(s), and level(s) of use. Any
addition of vitamin D to food beyond those limitations set out in Sec.
184.1950 requires either a food additive regulation or an amendment of
Sec. 184.1950.
To support the safety of the proposed uses of vitamin
D3, Unilever submitted dietary intake estimates from current
and proposed uses and naturally occurring sources of vitamin D and
compared these exposure estimates to the tolerable upper intake level
(UL) for vitamin D established by the Institute of Medicine (IOM) of
the National Academies. The petitioner also submitted a number of
publications pertaining to human clinical studies on vitamin D. Based
on this information, which is discussed in section II of this document,
the petitioner concluded that the proposed use of vitamin D3
in meal replacement bars and other-type bars represented for special
dietary use in reducing or maintaining body weight at levels not to
exceed 100 IU per 40 g product is safe. The petitioner also concluded
that the proposed use of vitamin D3 in soy-protein based
meal replacement beverages represented for special dietary use in
reducing or maintaining body weight at levels not to exceed 140 IU per
240 milliliter product is safe.

II. Evaluation of Safety

To establish with reasonable certainty that a food additive is not
harmful under its intended conditions of use, FDA considers the
projected human dietary exposure to the additive, the additive's
toxicological data, and other relevant information (such as published
literature) available to the agency. FDA compares an individual's
estimated daily intake (EDI) of the additive from all sources to an
acceptable intake level established by toxicological data. The EDI is
determined by projections based on the amount of the additive proposed
for use in particular foods and on data regarding the consumption
levels from all sources of the additive.

A. Acceptable Daily Intake for Vitamin D for Adults and Children

In 1997, the Standing Committee on the Scientific Evaluation of
Dietary Reference Intakes of the Food and Nutrition Board at IOM
conducted an extensive review of toxicology and metabolism studies on
vitamin D published through 1996. The IOM published a detailed report
that included a UL for vitamin D for infants, children, and adults. The
IOM UL for vitamin D for children 1 to 18 years of age and adults is
2,000 IU per person per day (IU/p/d). The UL for infants is 1,000 IU/p/
d.
The IOM considers the UL as the highest usual intake level of a
nutrient that poses no risk of adverse effects when the nutrient is
consumed over long periods of time. The UL is determined using a risk
assessment model developed specifically for nutrients and considers
intake from all sources: Food, water, nutrient supplements, and
pharmacological agents. The dose-response assessment, which concludes
with an estimate of the UL, is built upon three toxicological concepts
commonly used in assessing the risk of exposures to chemical
substances: No-observed-adverse-effect level, lowest-observed-effect
level, and an uncertainty factor.

B. Estimated Daily Intake for Vitamin D

The petitioner provided average and 90th percentile vitamin D
intake estimates for consumers of meal replacement bars, other-type
bars, and soy-protein based meal replacement beverages represented for
special dietary use from the following: (1) The proposed food uses, (2)
current food uses (including naturally occurring sources of vitamin D),
(3) current and proposed food uses, and (4) current and proposed food
uses and dietary supplements. The proposed uses are for foods intended
for use by adults as part of a weight control diet. Although these
special dietary foods are not intended for use by children, the
petitioner acknowledged that some sporadic use by children may occur,
especially among older children. Therefore, intake estimates for adults
and children over the age of 9 years were provided. The agency has
determined that the methodology used to calculate these estimates is
appropriate.
For the proposed food uses, dietary intake of vitamin D3
for 90th percentile consumers of meal replacement bars, other-type
bars, and soy-protein based meal replacement beverages was estimated to
be 215 IU/p/d for consumers 9 years of age and older. The corresponding
mean intake was estimated to be 127 IU/p/d.
For currently regulated uses in conventional foods (under Sec.
184.1950 and Sec. 172.380) and naturally occurring sources, mean
dietary exposure to vitamin D for consumers of meal replacement bars,
other-type bars, and soy-protein based meal replacement beverages was
estimated to be 470 IU/p/d for consumers 9 years of age and older.
Intake at the 90th percentile was estimated to be 957 IU/p/d. For
consumers 9 years of age and older, mean and 90th percentile dietary
intakes from current (including naturally occurring sources) and
proposed food uses of vitamin D were estimated to be 565 IU/p/d and 995
IU/p/d, respectively.
The petitioner also considered the intake of vitamin D from dietary
supplements. The National Health and Nutrition Examination Survey III
(NHANES III) data indicate that approximately 40 percent of the U.S.
population 2 months of age and older take dietary supplements. The
NHANES III data also show that, when vitamin D is taken as a dietary
supplement, the most frequent level is 400 IU/p/d. As a conservative
estimate of intake of vitamin D from dietary supplements and

[[Page 37257]]

food uses, the petitioner assumed that all consumers of meal
replacement bars, other-type bars, and soy-protein based meal
replacement beverages represented for special dietary use would take
dietary supplements containing 400 IU of vitamin D. They then added
this value to the mean and 90th percentile intake estimates from
current and proposed food uses. For consumers of meal replacement bars,
other-type bars, and soy-protein based meal replacement beverages, mean
and 90th percentile dietary intakes from current and proposed food uses
and dietary supplements were estimated to be 965 IU/p/d and 1,395 IU/p/
d for consumers 9 years of age and older, respectively. FDA concurs
with these exposure estimates.

C. Safety Assessment

To support the safety of their proposed uses for vitamin
D3, Unilever submitted 16 scientific articles published
subsequent to the IOM report and issuance of the 2003 final rule
permitting the use of vitamin D3 in calcium-fortified fruit
juices and fruit juice drinks within the prescribed limitations (68 FR
9000, February 27, 2003). Unilever concluded that the recent
publications continue to support the safe use of vitamin D
supplementation in both animals and humans. FDA concurs with Unilever's
conclusions.
FDA considered the UL established by IOM for children and adults
relative to the intake estimates provided by the petitioner as the
primary basis for assessing the safety of the proposed use of vitamin
D3 in meal replacement bars, other-type bars, and soy-
protein based meal replacement beverages represented for special
dietary use. For all children and adults 9 years of age and older, mean
and 90th percentile intake estimates from current and proposed food
uses of vitamin D are well below the IOM UL of 2,000 IU/p/d.
Additionally, when dietary supplements are included in the
calculations, intake estimates remain below the UL.
Because the EDI of vitamin D from all sources is less than the UL,
the agency concludes that dietary exposure of vitamin D3
from its use as a nutrient supplement in meal replacement bars, other-
type bars, and soy-protein based meal replacement beverages represented
for special dietary use in reducing or maintaining body weight will not
pose a safety concern.

III. Conclusion

Based on all data relevant to vitamin D3 reviewed by the
agency, FDA concludes that there is a reasonable certainty that no harm
will result from the use of vitamin D3 as a nutrient
supplement in meal replacement bars, other-type bars, and soy-protein
based meal replacement beverages represented for special dietary use in
reducing or maintaining body weight. Thus, vitamin D3 is
safe for its proposed use and the agency concludes that the food
additive regulations should be amended as set forth in this document.
To ensure that only food grade vitamin D3 is used in food,
the additive must meet the specifications set forth in this document.
Based on a request by the petitioner, FDA also is updating Sec.
172.380 by citing the 5th edition of the Food Chemicals Codex rather
than the 4th edition. Section 172.380(b) currently states that vitamin
D3 must meet the specifications of the Food Chemicals Codex,
4th ed., 1996. The agency compared specifications for vitamin
D3 in the 4th and 5th editions and found them to be
identical. Therefore, the agency is making this requested editorial
change. In addition, the agency is making an editorial update to Sec.
172.380(b) to reflect the new address for the National Academy Press.
The agency also is making editorial changes to Sec. 172.380(c) for
clarification.
In accordance with Sec. 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 are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person (see FOR FURTHER INFORMATION CONTACT). As
provided in Sec. 171.1(h), the agency will delete from the documents
any materials that are not available for public disclosure before
making the documents available for inspection.

IV. Environmental Effects

The agency has previously considered the environmental effects of
this rule as announced in the notice of filing for FAP 3A4746 (68 FR
50541). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.

V. Paperwork Reduction Act of 1995

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.

VI. Objections

Any person who will be adversely affected by this regulation may
file with the Division of Dockets Management (see ADDRESSES) written or
electronic objections. Each objection shall be separately numbered, and
each numbered objection shall specify with particularity the provisions
of the regulation to which objection is made and the grounds for the
objection. Each numbered objection on which a hearing is requested
shall specifically so state. Failure to request a hearing for any
particular objection shall constitute a waiver of the right to a
hearing on that objection. Each numbered objection for which a hearing
is requested shall include a detailed description and analysis of the
specific factual information intended to be presented in support of the
objection in the event that a hearing is held. Failure to include such
a description and analysis for any particular objection shall
constitute a waiver of the right to a hearing on the objection. Three
copies of all documents are to be submitted and are to be identified
with the docket number found in brackets in the heading of this
document. Any objections received in response to the regulation may be
seen in the Division of Dockets Management between 9 a.m. and 4 p.m.,
Monday through Friday.

List of Subjects in 21 CFR Part 172

Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 172 continues to read as
follows:

Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Section 172.380 is amended by revising paragraphs (b) and (c) and
removing paragraph (d) to read as follows:

Sec. 172.380 Vitamin D3.

* * * * *
(b) Vitamin D3 meets the specifications of the Food
Chemicals Codex, 5th ed. (2004), pp. 498-499, which is incorporated by
reference. The Director of the Office of the Federal Register approves
this incorporation by

[[Page 37258]]

reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may
obtain copies from the National Academy Press, 500 Fifth St. NW.,
Washington, DC 20001 (Internet address https://www.nap.edu). Copies may
be examined at the Center for Food Safety and Applied Nutrition's
Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740, or at the National Archives and Records Administration
(NARA). For information on the availability of this material at NARA,
call 202-741-6030, or go to: https://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
(c) The additive may be used as follows:
(1) At levels not to exceed 100 International Units (IU) per 240
milliliters (mL) in 100 percent fruit juices (as defined under Sec.
170.3(n)(35) of this chapter) that are fortified with greater than or
equal to 33 percent of the reference daily intake (RDI) of calcium per
240 mL, excluding fruit juices that are specially formulated or
processed for infants.
(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks
(as defined under Sec. 170.3(n)(35) of this chapter) that are
fortified with greater than or equal to 10 percent of the RDI of
calcium per 240 mL, excluding fruit juice drinks that are specially
formulated or processed for infants.
(3) At levels not to exceed 140 IU per 240 mL (prepared beverage)
in soy-protein based meal replacement beverages (powder or liquid) that
are represented for special dietary use in reducing or maintaining body
weight in accordance with Sec. 105.66 of this chapter.
(4) At levels not to exceed 100 IU per 40 grams in meal replacement
bars or other-type bars that are represented for special dietary use in
reducing or maintaining body weight in accordance with Sec. 105.66 of
this chapter.

Dated: June 20, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-12699 Filed 6- 28-05; 8:45 am]
BILLING CODE 4160-01-S

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