Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Rules and Regulations 11019 

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 

172.379, which is established by this rule, includes 

only crystalline vitamin D2. 

Name of product/data/publication/information/service Current fee New fee 

Nightly DMSP–OLS Mosaics, Visible and Thermal Band Data from One Satellite .................................... 201.00 223.00 

Global DMSP–OLS Nighttime Lights Lunar Cycle Composite from One Satellite ...................................... 5,624.00 6,020.00 

Radiance Calibrated Global DMSP-OLS Nighttime Lights Annual Composite from One Satellite ............. 67,922.00 77,177.00 

Research Data Series CD–ROM/DVD ......................................................................................................... 25.00 25.00 

Custom Analog Plotter Prints ....................................................................................................................... 49.00 60.00 

NOS Bathymetric Maps and Miscellaneous Archived Publication Inventory ............................................... 6.00 7.00 

Global DMSP–OLS Annual Composite of Persistent Nighttime Lights on Monthly Increments from One 

Satellite ..................................................................................................................................................... .......................... 7,665.00 

* New prices for these products are not included since these products are now available under a different category of NODC products. 

[FR Doc. E9–5590 Filed 3–13–09; 8:45 am] 

BILLING CODE 3510–22–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 172 

[Docket No. FDA–2007–F–0274] (formerly 

Docket No. 2007F–0355) 

Food Additives Permitted for Direct 

Addition to Food for Human 

Consumption; Vitamin D2

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 D2 as a nutrient 

supplement in soy-based food products. 

This action is in response to a petition 

filed by Dean Foods Co. (Dean Foods). 

DATES: This rule is effective March 16, 

2009. Submit written or electronic 

objections and requests for a hearing by 

April 15, 2009. See section VII of this 

document for information on filing 

objections. The incorporation by 

reference of certain publications listed 

in the rule is approved by the Director 

of the Federal Register as of March 16, 

2009. 

ADDRESSES: You may submit written or 

electronic objections and requests for a 

hearing, identified by Docket No. FDA– 

2007–F–0274 (formerly Docket No. 

2007F–0355), by any of the following 

methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written submissions 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. 

To ensure more timely processing of 

objections, FDA is no longer accepting 

objections submitted to the agency by email. FDA encourages you to continue 

to submit electronic objections by using 

the Federal eRulemaking Portal, as 

described in the Electronic Submissions 

portion of this paragraph. 

Instructions: All submissions received 

must include the agency name and 

docket number 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 

comments 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: 

Judith 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 October 4, 2007 (72 FR 

56768), FDA announced that a food 

additive petition (FAP 7A4769) had 

been filed by Dean Foods Co., c/o Hogan 

and Hartson LLP, 555 13th St., NW., 

Washington, DC 20004–1109. The 

petition proposed to amend the food 

additive regulations in part 172 (21 CFR 

part 172) Food Additives Permitted for 

Direct Addition to Food for Human 

Consumption to provide for the safe use 

of vitamin D2 as a nutrient supplement 

in soy-based food products. The petition 

pertains only to the use of crystalline 

vitamin D2 and not the resin form of the 

vitamin. Foods identified in the petition 

are soy beverages, soy beverage 

products, soy-based butter substitute 

spreads, soy-based cheese substitutes, 

and soy-based cheese substitute 

products. The petitioner requested that 

part 172 be amended to permit the use 

of crystalline vitamin D2 as a nutrient 

supplement at levels not to exceed 50 

International Units (IU) per 100 grams 

(g) of soy beverages, 89 IU per 100 g of 

soy beverage products, 330 IU per 100 

g of soy-based butter substitute spreads, 

and 270 IU per 100 g of soy-based 

cheese substitutes and soy-based cheese 

substitute products. 

Vitamin D1, including vitamin D2, is 

affirmed as generally recognized as safe 

(GRAS) for use in food under 21 CFR 

184.1950 (§ 184.1950) with the 

following specific limitations: 

Category of Food Maximum Levels in Food (as Served) 

Breakfast cereals 350 International Units (IU)/100 grams (g) 

11020 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Rules and Regulations 

Category of Food Maximum Levels in Food (as Served) 

Grain products and pasta 90 IU/100 g 

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 formulas and 

margarine, respectively. Under 

§ 172.380, vitamin D3 also is approved 

for use as a nutrient supplement in 

calcium-fortified fruit juices and fruit 

juice drinks; meal replacement and 

other type bars, soy protein-based meal 

replacement beverages represented for 

special dietary use in reducing or 

maintaining body weight; and cheese 

and cheese products as defined therein. 

Vitamin D2, also known as 

ergocalciferol, is the chemical 9,10- 

seco(5Z,7E,22E)-5,7,10(19),22- 

ergostatetraen-3-ol. The additive that is 

the subject of this petition is vitamin D2

that is produced by ultraviolet 

irradiation of ergosterol isolated from 

yeast and is purified by crystallization. 

In contrast to the description of vitamin 

D2 set forth in § 184.1950, this petition 

does not cover vitamin D2 that may be 

produced from ergosterol isolated from 

fungi other than yeast. 

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. High 

levels of 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, functional use, and 

level 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 D2, Dean Foods 

submitted dietary intake estimates from 

current and proposed uses and from 

naturally-occurring sources of vitamin 

D, and compared these intake 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 D2 in soybased food products 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 intake of 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 food 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 amount consumed 

from all food sources of the additive. 

The agency commonly uses the EDI for 

the 90th percentile consumer of a food 

additive as a measure of high chronic 

dietary intake. 

A. Estimated Daily Intake for Vitamin D 

The petitioner provided mean and 

90th percentile vitamin D intake 

estimates for consumers of soy 

beverages, soy beverage products, soybased butter substitute spreads, soybased cheese substitutes, and soy-based 

cheese substitute products from the 

following: (1) The proposed food uses; 

(2) current food uses (including 

regulated uses, naturally-occurring 

sources of vitamin D, and dietary 

supplements); and (3) combined current 

and proposed food uses. The petitioner 

provided intake estimates for the overall 

U.S. population and nine population 

subgroups. For the purpose of the 

estimate, Dean Foods assumed that 

current consumers of dairy products 

would substitute their consumption of 

milk and dairy products with the 

corresponding soy beverages and soybased dairy alternative products. The 

agency has determined that the 

methodology used to calculate these 

estimates is appropriate. 

The petitioner’s estimates of intake of 

vitamin D from all food sources include 

the proposed food uses, currentlyregulated uses in conventional foods 

(under §§ 184.1950 and 172.380), 

dietary supplements, and naturallyoccurring sources of the vitamin. For the 

overall U.S. population, including 

consumers of the soy-based food 

products identified in the petition, the 

90th percentile dietary intake of vitamin 

D was estimated to be 1,012 IU per 

person per day (IU/p/d). For the 

population subgroup of infants less than 

12 months of age, including consumers 

of the soy-based food products 

identified in the petition, the 90th 

percentile dietary intake of vitamin D 

was estimated to be 907 IU/p/d. FDA 

concurs with these intake estimates. 

B. Acceptable Intake Level for Vitamin 

D 

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/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 

Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Rules and Regulations 11021 

substances: No-observed-adverse-effect 

level, lowest-observed-effect level, and 

an uncertainty factor. 

C. Safety Assessment 

To support the safety of the proposed 

uses for vitamin D2, Dean Foods 

submitted 14 scientific articles 

published subsequent to the IOM report 

and issuance of the November 2005 

final rule (70 FR 69435) for the use of 

vitamin D3 in cheese and cheese 

products. Dean Foods concluded that 

these recent publications continue to 

support vitamin D supplementation in 

humans. FDA concurs with Dean Foods’ 

conclusions. 

FDA considered the ULs established 

by IOM relative to the intake estimates 

provided by the petitioner as the 

primary basis for assessing the safety of 

petitioned uses of vitamin D. FDA also 

reviewed the scientific articles 

submitted by the petitioner. Finally, 

FDA reviewed studies on vitamin D that 

have published since the IOM report in 

the agency’s evaluation of three 

previous food additive petitions for 

fortifying a variety of foods with vitamin 

D3. The most recent petition resulted in 

FDA’s amendment of the food additive 

regulations in § 172.380 to allow for the 

safe use of vitamin D3 as a nutrient 

supplement in cheese and cheese 

products at levels above those allowed 

under § 184.1950 (70 FR 69435). The 

two earlier food additive petitions also 

resulted in amendments of the food 

additive regulations to allow for the safe 

use of vitamin D3 as a nutrient 

supplement in certain foods (70 FR 

37255; June 29, 2005, 70 FR 36021; June 

22, 2005, and 68 FR 9000; February 27, 

2003). 

The estimated intake of vitamin D 

from all food sources, including the 

proposed uses, at the 90th percentile for 

the overall U.S. population is 1,012 IU/ 

p/d, which is below the IOM UL of 

2,000 IU/p/d. For infants less than 12 

months of age, the estimated intake of 

vitamin D from all food sources, 

including the proposed uses, at the 90th 

percentile is 907 IU/p/d, which is below 

the IOM UL of 1,000 IU/p/d. Because 

the 90th percentile EDI of vitamin D 

from all current and proposed food 

sources is less than the IOM UL in both 

cases, the agency concludes that dietary 

intake of vitamin D2 from its proposed 

use as a nutrient supplement in soy 

beverages, soy beverage products, soybased butter substitute spreads, soybased cheese substitutes, and soy-based 

cheese substitute products will not pose 

a safety concern. 

III. Conclusion 

Based on all data relevant to vitamin 

D2 reviewed by the agency, FDA 

concludes that there is a reasonable 

certainty that no harm will result from 

the use of vitamin D2 as a nutrient 

supplement in soy beverages, soy 

beverage products, soy-based butter 

substitute spreads, soy-based cheese 

substitutes, and soy-based cheese 

substitute products within the limits 

proposed by the petitioner. Thus, 

vitamin D2 is safe for the 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 crystalline vitamin 

D2 is used in food under this rule, the 

additive must meet the specifications 

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 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 

The agency has previously considered 

the environmental effects of this rule as 

announced in the notice of filing for 

FAP 7A4769. 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. Section 301(ll) of the Federal Food, 

Drug, and Cosmetic Act 

FDA’s review of this petition was 

limited to section 409 of the Federal 

Food, Drug, and Cosmetic Act (the act). 

This final rule is not a statement 

regarding compliance with other 

sections of the act. For example, the 

Food and Drug Administration 

Amendments Act of 2007, which was 

signed into law on September 27, 2007, 

amended the act to, among other things, 

add section 301(ll). Section 301(ll) of 

the act (21 U.S.C. 301(ll)) prohibits the 

introduction or delivery for introduction 

into interstate commerce of any food 

that contains a drug approved under 

section 505 of the 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 

exemptions in section 301(ll)(1) through 

(4) applies. In our review of this 

petition, FDA did not consider whether 

section 301(ll) or any of its exemptions 

apply to food containing this additive. 

Accordingly, this final rule should not 

be construed to be a statement that a 

food containing this additive, if 

introduced or delivered for introduction 

into interstate commerce, would not 

violate section 301(ll). Furthermore, this 

language is included in all food additive 

final rules and therefore should not be 

construed to be a statement of the 

likelihood that section 301(ll) applies. 

VII. 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. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

11022 Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Rules and Regulations 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Director, Center for Food Safety and 

Applied Nutrition, 21 CFR part 172 is 

amended as follows: 

PART 172—FOOD ADDITIVES 

PERMITTED FOR DIRECT ADDITION 

TO FOOD FOR HUMAN 

CONSUMPTION 

■ 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 172.379 is added to subpart 

D to read as follows: 

§ 172.379 Vitamin D2. 

Vitamin D2 may be used safely in 

foods as a nutrient supplement defined 

under § 170.3(o)(20) of this chapter in 

accordance with the following 

prescribed conditions: 

(a) Vitamin D2, also known as 

ergocalciferol, is the chemical 9,10- 

seco(5Z,7E,22E)-5,7,10(19),22- 

ergostatetraen-3-ol. Vitamin D2 is 

produced by ultraviolet irradiation of 

ergosterol isolated from yeast and is 

purified by crystallization. 

(b) Vitamin D2 meets the 

specifications of the Food Chemicals 

Codex, 6th ed. (2008), pp. 1013 and 

1014, which is incorporated by 

reference. The Director of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C 

552(a) and 1 CFR part 51. You may 

obtain a copy from the United States 

Pharmacopeial Convention, 12601 

Twinbrook Pkwy., Rockville, MD 20852 

(Internet address: http://www.usp.org). 

You may inspect a copy at the Center for 

Food Safety and Applied Nutrition’s 

Library, Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1071, 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: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(c) The additive may be used as 

follows: 

Category of Food Maximum Levels in Food (as Served) 

Soy beverages 50 International Units (IU)/100 grams (g) 

Soy beverage products 89 IU/100 g 

Soy-based butter substitute spreads 330 IU/100 g 

Soy-based cheese substitutes and soy-based cheese substitute products 270 IU/100 g 

Dated: February 23, 2009. 

Leslye M. Fraser, 

Director, Office of Regulations and Policy, 

Center for Food Safety and Applied Nutrition. 

[FR Doc. E9–5549 Filed 3–13–09; 8:45 am] 

BILLING CODE 4160–01–S 

PENSION BENEFIT GUARANTY 

CORPORATION 

29 CFR Part 4001, 4010, and 4044 

RIN 1212–AB09 

Annual Financial and Actuarial 

Information Reporting; Pension 

Protection Act of 2006 

AGENCY: Pension Benefit Guaranty 

Corporation. 

ACTION: Final rule. 

SUMMARY: This is a final rule to amend 

PBGC’s regulation on Annual Financial 

and Actuarial Information Reporting. 

The amendments implement the 

provisions of the Pension Protection Act 

of 2006, Public Law 109–280 (PPA 

2006), which changed the standards for 

determining which persons are required 

to report under section 4010 (Authority 

to Require Certain Information) of the 

Employee Retirement Income Security 

Act of 1974 and made other changes to 

the reporting requirements. In addition 

to providing guidance on implementing 

the PPA 2006 changes, the final rule 

waives reporting in certain cases for 

controlled groups with aggregate plan 

underfunding of $15 million or less, 

modifies the standards for determining 

which plans are exempt from the 

actuarial information requirements, 

revises the actuarial information 

requirements to conform with other PPA 

2006 changes, and provides other 

clarifications. 

DATES: Effective April 15, 2009. (See 

Applicability in SUPPLEMENTARY

INFORMATION.) 

FOR FURTHER INFORMATION CONTACT: John 

H. Hanley, Director, Legislative and 

Regulatory Department; or Catherine B. 

Klion, Manager, or Grace H. Kraemer, 

Attorney, Regulatory and Policy 

Division, Legislative and Regulatory 

Department, Pension Benefit Guaranty 

Corporation, 1200 K Street, NW., 

Washington, DC 20005–4026; 202–326– 

4024. (TTY/TDD users may call the 

Federal relay service toll-free at 1–800– 

877–8339 and ask to be connected to 

202–326–4024.) 

SUPPLEMENTARY INFORMATION: 

Background 

Pension Benefit Guaranty Corporation 

(PBGC) administers the pension 

insurance programs under Title IV of 

the Employee Retirement Income 

Security Act of 1974 (ERISA). In order 

to give PBGC an opportunity to 

anticipate and attempt to minimize 

potential liabilities that may arise from 

the termination of significantly 

underfunded plans, ERISA section 4010 

requires the reporting of actuarial and 

financial information by controlled 

groups with pension plans that have 

significant underfunding. That 

information is exempt from disclosure 

under the Freedom of Information Act 

(5 U.S.C. 552) and may not be made 

public, except as may be relevant to any 

administrative or judicial action or 

proceeding. 

Pursuant to ERISA section 4010, 

PBGC issued its initial regulation on 

Annual Financial and Actuarial 

Information Reporting in 1995 (29 CFR 

part 4010). The regulation specifies the 

items of identifying, financial, and 

actuarial information that filers must 

submit under ERISA section 4010. 

PBGC reviews the information that is 

filed and enters it into an electronic 

database for more detailed analysis. 

Computer-assisted analysis of this 

information helps PBGC to anticipate 

possible major demands on the pension 

insurance system and to focus PBGC 

resources on situations that pose the 

greatest risks to that system. Because 

other sources of information are usually