Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2, 11019-11022 [E9-5549]
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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: https://
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 https://
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 https://
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
Category of Food
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:
350 International Units (IU)/100 grams (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
13:57 Mar 13, 2009
SUPPLEMENTARY INFORMATION:
Maximum Levels in Food (as Served)
Breakfast cereals
VerDate Nov<24>2008
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1071.
Jkt 217001
vitamin D3. Vitamin D without a subscript
represents either D2 or D3. Section 184.1950
includes crystalline vitamin D2, crystalline vitamin
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Frm 00019
Fmt 4700
Sfmt 4700
D3, vitamin D2 resin, and vitamin D3 resin. Section
172.379, which is established by this rule, includes
only crystalline vitamin D2.
E:\FR\FM\16MRR1.SGM
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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 9,10seco(5Z,7E,22E)-5,7,10(19),22ergostatetraen-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
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13:57 Mar 13, 2009
Jkt 217001
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
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Frm 00020
Fmt 4700
Sfmt 4700
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
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Federal Register / Vol. 74, No. 49 / Monday, March 16, 2009 / Rules and Regulations
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.
VerDate Nov<24>2008
13:57 Mar 13, 2009
Jkt 217001
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
PO 00000
Frm 00021
Fmt 4700
Sfmt 4700
11021
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
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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 9,10seco(5Z,7E,22E)-5,7,10(19),22ergostatetraen-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
Category of Food
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: https://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: https://www.archives.gov/
federal_register/
code_of_federal_regulations/
ibr_locations.html.
(c) The additive may be used as
follows:
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
DATES: Effective April 15, 2009. (See
Applicability in SUPPLEMENTARY
INFORMATION.)
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
VerDate Nov<24>2008
13:57 Mar 13, 2009
Jkt 217001
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.
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
PO 00000
Frm 00022
Fmt 4700
Sfmt 4700
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
E:\FR\FM\16MRR1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 49 (Monday, March 16, 2009)]
[Rules and Regulations]
[Pages 11019-11022]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5549]
=======================================================================
-----------------------------------------------------------------------
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: https://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 e-mail. 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 https://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 https://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 D\1\, including vitamin D2, is affirmed as
generally recognized as safe (GRAS) for use in food under 21 CFR
184.1950 (Sec. 184.1950) with the following specific limitations:
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\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
172.379, which is established by this rule, includes only
crystalline vitamin D2.
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Category of Food Maximum Levels in Food (as Served)
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Breakfast cereals 350 International Units (IU)/100
grams (g)
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[[Page 11020]]
Grain products and pasta 90 IU/100 g
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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 formulas and margarine,
respectively. Under Sec. 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 Sec. 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 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, functional use, and level 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
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 soy-based 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, soy-
based butter substitute spreads, soy-based 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
soy-based 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, currently-regulated uses in
conventional foods (under Sec. Sec. 184.1950 and 172.380), dietary
supplements, and naturally-occurring 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
[[Page 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 Sec. 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 Sec. 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, soy-based butter substitute spreads, soy-based 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 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 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 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 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.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
[[Page 11022]]
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
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 172.379 is added to subpart D to read as follows:
Sec. 172.379 Vitamin D2.
Vitamin D2 may be used safely in foods as a nutrient
supplement defined under Sec. 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: https://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: https://www.archives.gov/federal_register/
code_of_federal_regulations/ibr_locations.html.
(c) The additive may be used as follows:
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Maximum Levels in Food (as
Category of Food Served)
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Soy beverages 50 International Units (IU)/100
grams (g)
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Soy beverage products 89 IU/100 g
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Soy-based butter substitute spreads 330 IU/100 g
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Soy-based cheese substitutes and soy- 270 IU/100 g
based cheese substitute products
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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
