Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2, 13540-13542 [2014-05060]
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations
Commission is adjusting this penalty
from $11,000 to $12,100.13
In addition, the FTC is adjusting civil
penalties under section 814(a) of the
Energy Independence and Security Act
of 2007 (‘‘EISA’’) 14 The CPI–U has
increased from 208.352 in June 2007 to
233.504 in June 2013, or 12.1%.
Applying this percentage increase and
the FCPIAA’s ten percent cap on initial
adjustments, this penalty will increase
from $1,000,000 to $1,100,000.
To reflect these adjustments, the FTC
is amending Commission Rule 1.98 by
modifying paragraphs (b) and (f)–(l),
adding new paragraphs (n)–(o), and
redesignating current paragraph (n) as
paragraph (p). These changes take effect
on April 10, 2014.
Procedural Requirements
Under the Administrative Procedure
Act (‘‘APA’’), a final rule may be issued
without public notice and comment if
an agency finds good cause that notice
and comment are impractical,
unnecessary, or contrary to the public
interest. 5 U.S.C. 553(b)(3)(B). Because
the Commission must adjust its civil
penalties according to a statutory
formula, the Commission finds that
good cause exists to forego public notice
and comment under the APA. Id.
Because these adjustments are
mandated by statute and do not involve
the exercise of Commission discretion
or any policy judgments, public notice
and comment is unnecessary. For this
reason, the requirements of the
Regulatory Flexibility Act (‘‘RFA’’) also
do not apply.15 Finally, this rule does
not contain any collection of
information requirements as defined by
the Paperwork Reduction Act of 1995 as
amended. 44 U.S.C. 3501 et seq.
List of Subjects for 16 CFR Part 1
Administrative practice and
procedure, Penalties, Trade practices.
For the reasons set forth in the
preamble, the Federal Trade
Commission amends Title 16, chapter I,
subchapter A, of the Code of Federal
Regulations, as follows:
PART 1—GENERAL PROCEDURES
Subpart L—[Amended]
1. The authority citation for subpart L
continues to read as follows:
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■
13 28 U.S.C.2461 note (citing Pub. L. 104–134,
section 31001(s)(2), 110 Stat. 1321, 1373 (1996)).
14 The Commission determined in 2009 that its
civil penalty authority under EISA was too recent
to warrant adjustment for inflation. 74 FR at 858.
15 A regulatory flexibility analysis under the RFA
is required only when an agency must publish a
notice of proposed rulemaking for comment. See 5
U.S.C. 603.
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16:00 Mar 10, 2014
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Authority: 28 U.S.C. 2461 note.
■
2. Revise § 1.98 to read as follows:
§ 1.98 Adjustment of civil monetary
penalty amounts.
This section makes inflation
adjustments in the dollar amounts of
civil monetary penalties provided by
law within the Commission’s
jurisdiction. The following civil penalty
amounts apply to violations occurring
after April 10, 2014.
(a) Section 7A(g)(1) of the Clayton
Act, 15 U.S.C. 18a(g)(1)—$16,000;
(b) Section 11(l) of the Clayton Act, 15
U.S.C. 21(l)—$8,500;
(c) Section 5(l) of the FTC Act, 15
U.S.C. 45(l)—$16,000;
(d) Section 5(m)(1)(A) of the FTC Act,
15 U.S.C. 45(m)(1)(A)—$16,000;
(e) Section 5(m)(1)(B) of the FTC Act,
15 U.S.C. 45(m)(1)(B)—$16,000;
(f) Section 10 of the FTC Act, 15
U.S.C. 50—$210;
(g) Section 5 of the Webb-Pomerene
(Export Trade) Act, 15 U.S.C. 65—$210;
(h) Section 6(b) of the Wool Products
Labeling Act, 15 U.SC. 68d(b)—$210;
(i) Section 3(e) of the Fur Products
Labeling Act, 15 U.S.C. 69a(e)—$210;
(j) Section 8(d)(2) of the Fur Products
Labeling Act, 15 U.S.C. 69f(d)(2)—$210;
(k) Section 333(a) of the Energy Policy
and Conservation Act, 42 U.S.C.
6303(a)—$210;
(l) Sections 525(a) and (b) of the
Energy Policy and Conservation Act, 42
U.S.C. 6395(a) and (b), respectively—
$8,500 and $16,000, respectively;
(m) Section 621(a)(2) of the Fair
Credit Reporting Act, 15 U.S.C.
1681s(a)(2)—$3,500;
(n) Section 1115(a) of the Medicare
Prescription Drug Improvement and
Modernization Act of 2003, Public Law
108–173, 21 U.S.C. 355 note—$12,100;
(o) Section 814(a) of the Energy
Independence and Security Act of 2007,
42 U.S.C. 17304—$1,100,000; and
(p) Civil monetary penalties
authorized by reference to the Federal
Trade Commission Act under any other
provision of law within the jurisdiction
of the Commission—refer to the
amounts set forth in paragraphs (c), (d),
(e) and (f) of this section, as applicable.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2014–05266 Filed 3–10–14; 8:45 am]
BILLING CODE 6750–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA–2009–F–0570]
Food Additives Permitted for Direct
Addition to Food for Human
Consumption; Vitamin D2 Bakers Yeast
AGENCY:
Food and Drug Administration,
HHS.
Final rule; response to
objections.
ACTION:
The Food and Drug
Administration (FDA or we) is
responding to objections that we have
received on the final rule that amended
the food additive regulations
authorizing the use of vitamin D2 bakers
yeast as a source of vitamin D2 and as
a leavening agent in yeast-leavened
baked products at levels not to exceed
400 International Units (IU) of vitamin
D2 per 100 grams (g) in the finished
food. After reviewing the objections to
the final rule, FDA has concluded that
they do not provide a basis for
amending or revoking the regulation.
DATES: Effective date confirmed: August
29, 2012.
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–
3835, 240–402–1071.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Introduction
In the Federal Register of December
17, 2009 (74 FR 66979), FDA published
a notice announcing the filing of a food
additive petition (FAP 9A4779)
submitted by Lallemand, Inc., c/o
Dennis T. Gordon, 117 N. Welcome
Slough Rd., Puget Island, Cathlamet,
WA 98612. The petition proposed to
amend the food additive regulations in
part 172, Food Additives Permitted for
Direct Addition to Food for Human
Consumption (21 CFR part 172), to
provide for the safe use of vitamin D2
bakers yeast as a dual purpose nutrient
supplement and leavening agent or
dough relaxer in yeast-containing baked
products at levels not to exceed 400 IU
of vitamin D2 per 100 g in the finished
food. The specific foods identified in
the petition were yeast-leavened baked
goods and baking mixes, and yeastleavened baked snack foods. After the
notice was published, Lallemand
amended the petition to exclude the
proposed use of the additive as a dough
relaxer.
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations
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In response to FAP 9A4779, we issued
a final rule in the Federal Register on
August 29, 2012 (77 FR 52228),
authorizing the safe use of vitamin D2
bakers yeast as a source of vitamin D2
and as a leavening agent in yeastleavened baked products at levels not to
exceed 400 IU of vitamin D2 per 100 g
in the finished food. This regulation is
codified at § 172.381. We based our
decision on data contained in the
petition and in our files. The preamble
to the final rule (77 FR 52228 at 52231)
stated that objections to the final rule
and requests for a hearing were due
within 30 days of the publication date
(i.e., by September 28, 2012).
II. Objections and Requests for a
Hearing
Section 409(f)(1) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 348(f)(1)) provides that, within
30 days after publication of an order
relating to a food additive regulation,
any person adversely affected by such
order may file objections, ‘‘specifying
with particularity the provisions of the
order deemed objectionable, stating
reasonable grounds therefor, and
requesting a public hearing upon such
objections.’’
Under § 171.110 (21 CFR 171.110),
objections and requests for a hearing are
governed by part 12 (21 CFR part 12) of
FDA’s regulations. Under § 12.22(a),
each objection must meet the following
conditions: (1) Must be submitted on or
before the 30th day after the date of
publication of the final rule; (2) must be
separately numbered; (3) must specify
with particularity the provision of the
regulation or proposed order objected
to; (4) must specifically state each
objection on which a hearing is
requested; failure to request a hearing
on an objection constitutes a waiver of
the right to a hearing on that objection;
and (5) must include a detailed
description and analysis of the factual
information to be presented in support
of the objection if a hearing is requested;
failure to include a description and
analysis for an objection constitutes a
waiver of the right to a hearing on that
objection.
Following publication of the final rule
authorizing the use of vitamin D2 bakers
yeast as a source of vitamin D2 and as
a leavening agent in yeast-leavened
baked products at levels not to exceed
400 IU of vitamin D2 per 100 g in the
finished food, we received a letter from
AB Mauri North America (AB Mauri)
(letter to Docket No. FDA–2009–F–0570,
September 26, 2012) containing two
objections. The letter from AB Mauri
did not request a hearing on either
objection. Therefore, AB Mauri has
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waived its right to a hearing on those
objections (see § 12.22(a)(4)). The only
remaining question under § 12.24(a) is
whether AB Mauri’s objections, and the
information submitted in support of the
objections, establish that the regulation
authorizing the use of vitamin D2 bakers
yeast should be modified or revoked. As
discussed in detail in section III, we
have concluded that AB Mauri has not
established a basis for modification or
revocation of the regulation authorizing
the use of vitamin D2 bakers yeast.
III. Analysis of Objections
The first objection raised by AB Mauri
contends that the regulation authorizing
the use of vitamin D2 bakers yeast in
food (§ 172.381) is based on the
incorrect assumptions that: (1) vitamin
D2 bakers yeast can be produced in such
a way that the vitamin D2 levels in the
yeast itself can be accurately controlled
and declared; and (2) vitamin D2 bakers
yeast can be used by food manufacturers
in a way that allows them to control the
level of vitamin D2 in the finished
product and accurately declare its level
on the labeling of the finished food
product. AB Mauri asserts that these
assumptions may result in vitamin D2
levels in finished products that exceed
the maximum level specified in the
regulation and declaration of inaccurate
vitamin D2 levels on finished product
nutrition labels.
In support of their claim, AB Mauri
presents vitamin D2 levels from a
limited number of samples of
Lallemand’s commercially available
vitamin D2 bakers yeast that AB Mauri
had analyzed by an independent
laboratory. According to AB Mauri, the
results of the independent analysis
demonstrate that the actual amount of
vitamin D2 in bakers yeast varies, and
does not necessarily reflect the level of
vitamin D2 that Lallemand claims on its
Web site is ‘‘typical’’ for the product.
AB Mauri also provides theoretical
ranges of vitamin D2 levels that could
result in batches of the same size
product, depending on the level and
type of vitamin D2 bakers yeast used.
According to AB Mauri, using different
levels and types of vitamin D2 bakers
yeast result in different levels of vitamin
D2 in batches of equal size.
However, AB Mauri did not provide
the manufacturer’s certificates of
analysis so that the vitamin D2 levels of
the analyzed samples could be verified.
Additionally, AB Mauri did not identify
the analytical method used in the
analyses of vitamin D2 bakers yeast and
did not provide information on the
samples that were analyzed (e.g., lot
numbers, number of samples and
replicates analyzed, age of samples,
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13541
sample storage conditions, or solid
content of the yeast cream samples).
Therefore, the information provided by
AB Mauri is not sufficient to
demonstrate that there was a difference
in the analyzed vitamin D2 levels and
the vitamin D2 levels which Lallemand
claims is typical for the product.
The information provided by AB
Mauri also does not provide sufficient
evidence showing levels of vitamin D2
in finished baked products made with
vitamin D2 bakers yeast exceed the
maximum permitted level since the
levels of vitamin D2 in the finished
baked products are based on
hypothetical percentages of yeast used.
Therefore, this objection does not
provide a basis for FDA to reconsider its
decision to issue the final rule on
vitamin D2 bakers yeast.
Our review of the petition explicitly
considered variability of vitamin D2 in
ultraviolet light-treated bakers yeast.
The petitioner provided analytical data
of vitamin D2 levels from production
lots of vitamin D2 bakers yeast,
including the certificates of analysis for
the products analyzed. Results
demonstrated that vitamin D2 levels
were at least equal to 80 percent of the
value for vitamin D2 declared on the
label of the vitamin D2 bakers yeast
product (see 21 CFR 101.9(g)(4)(ii)).
Additionally, certificates of analysis,
which include vitamin D2 levels in the
product, are provided with each product
sold, thus allowing bakers to calculate
the amount of vitamin D2 that each
finished product will contain. Based on
these data and other information
provided in the petition, we concluded
that there are adequate controls in place
to ensure that vitamin D2 bakers yeast
may be used in conformance with the
provisions in the regulation.
Section 409 of the FD&C Act requires
that a regulation authorizing the use of
a food additive must prescribe, with
respect to the proposed uses of the
additive, the conditions under which
the additive may be safely used. Section
172.381, as established in the final rule,
does not include a requirement to label
finished food with the level of vitamin
D2 contained in the finished food.
However, to ensure that the level of
vitamin D2 in the finished food does not
exceed the maximum level specified in
the regulation, § 172.381(d) states that
the label or labeling of the food additive
container must bear, in addition to the
other information required by the FD&C
Act, adequate directions for use to
provide a final product that complies
with the limitations prescribed in
§ 172.381(c) (under which the additive
may be used in yeast-leavened baked
goods and baking mixes and yeast-
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Rules and Regulations
leavened baked snack foods at levels not
to exceed 400 IU of vitamin D2 per 100
g in the finished food). The labeling
requirement in § 172.381(d) ensures that
when vitamin D2 bakers yeast is used to
make products, the manufacturer will
have the information necessary to use
the additive in conformance with the
provisions of the regulation.
The second objection from AB Mauri
asserts that if FDA is going to approve
vitamin D2 supplementation in baked
products at higher levels than are
currently permitted by the regulations,
it should do so in a way that permits
better control of vitamin D levels in
finished products by considering the
use of vitamin D3 instead. AB Mauri
questions whether vitamin D2 is as
effective for humans as vitamin D3 at
similar levels, and cites two peerreviewed journal articles to support this
claim.
Our evaluation of the petition was
based solely on the safety of the
proposed use of vitamin D2 bakers yeast
in yeast-containing baked goods.
Therefore, expanding the scope of the
final rule to provide for the safe use of
vitamin D3 is beyond the scope of the
petition submitted by Lallemand. If AB
Mauri is interested in obtaining
approval for the expanded use of
vitamin D3 in food, they may do so by
petitioning FDA for this use in
accordance with section 409(b) of the
FD&C Act.
IV. Summary and Conclusions
Section 409 of the FD&C Act requires
that a food additive be shown to be safe
prior to marketing. Under 21 CFR
170.3(i), a food additive is ‘‘safe’’ if
there is a reasonable certainty in the
minds of competent scientists that the
substance is not harmful under the
intended conditions of use. In the final
rule authorizing the use of vitamin D2
bakers yeast, we concluded that the data
presented by the petitioner to establish
safety of the additive demonstrate that
vitamin D2 bakers yeast is safe for its
intended use in yeast-leavened baked
products at levels not to exceed 400 IU
of vitamin D2 per 100 g in the finished
food.
The petitioner has the burden to
demonstrate the safety of the additive to
gain FDA approval. Once we make a
finding of safety, the burden shifts to an
objector, who must come forward with
evidence that calls into question our
conclusion (see section 409(f)(1) of the
FD&C Act). After evaluating the
objections from AB Mauri, we have
concluded that the objections do not
provide any basis for us to reconsider
our decision to issue the final rule
authorizing the use of vitamin D2 bakers
yeast as a dual purpose nutrient
supplement and leavening agent in
yeast-containing baked products at
levels not to exceed 400 IU of vitamin
D2 per 100 g in the finished food.
Accordingly, we are not making any
changes in response to the objections.
Dated: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–05060 Filed 3–10–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for 110 approved new
animal drug applications (NADAs) and
14 approved abbreviated new animal
drug applications (ANADAs) for new
animal drug for use in animal feed from
Pfizer, Inc., including its several
subsidiaries and divisions, to Zoetis,
Inc.
SUMMARY:
DATES:
This rule is effective March 11,
2014.
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855; 240–276–8300,
steven.vaughn@fda.hhs.gov.
Pfizer,
Inc., 235 E. 42d St., New York, NY
10017, and its wholly owned
subsidiaries Alpharma, LLC; Fort Dodge
Animal Health, Division of Wyeth; Fort
Dodge Animal Health, Division of
Wyeth Holdings Corp.; and its division,
Pharmacia & Upjohn Co., have informed
FDA that they have transferred
ownership of, and all rights and interest
in, the 110 approved NADAs and 14
approved ANADAs in Table 1 to Zoetis,
Inc., 333 Portage St., Kalamazoo, MI
4900.
SUPPLEMENTARY INFORMATION:
21 CFR Part 558
[Docket No. FDA–2014–N–0002]
New Animal Drugs; Change of Sponsor
AGENCY:
Food and Drug Administration,
HHS.
TABLE 1—NADAS AND ANADAS TRANSFERRED FROM PFIZER, INC., TO ZOETIS, INC.
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File No.
007–616
011–116
012–375
012–680
013–747
033–950
034–085
034–254
035–688
035–805
036–361
039–077
039–402
039–417
040–209
041–647
041–648
041–649
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Product name
HISTOSTAT 50 (nitarsone) Type A Medicated Article.
ZOAMIX (zoalene) Type A Medicated Article.
ALBAMIX (novobiocin) Type A Medicated Article.
PHARMASTATIN 20 (nystatin) Type A Medicated Article.
Zoalene 90 Medicated Coccidiostat.
Sulfamerazine In Fish Grade.
LINCOMIX (lincomycin) Type A Medicated Article.
MGA (melengestrol acetate) Type A Medicated Article.
AUREOMIX Granular 500 (pen G, CTC, sulfamethazine) Type A Medicated Article.
AUREO S 700 Granular (CTC and sulfamethazine) Type A Medicated Article.
Amprolium and ethopabate/CTC (chlortetracycline)/sodium sulfate.
CSP (chlortetracycline, sulfathiazole, and penicillin G procaine) 250 and 500 Type A Medicated Articles.
MGA 500 (melengestrol acetate) Liquid Type A Medicated Article.
DECCOX (decoquinate) Type A Medicated Article.
ROFENAID 40 (sulfadimethoxine and ormetoprim) Type A Medicated Article.
AUREOMIX S 700–A (CTC and sulfamethazine) Type A Medicated Article.
AUREOMIX S 700–D (CTC and sulfamethazine) Type A Medicated Article.
AUREOMIX S 700–G (CTC and sulfamethazine) Type A Medicated Article.
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]]>Agencies
[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Rules and Regulations]
[Pages 13540-13542]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05060]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2009-F-0570]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D2 Bakers Yeast
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; response to objections.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is responding to
objections that we have received on the final rule that amended the
food additive regulations authorizing the use of vitamin D2
bakers yeast as a source of vitamin D2 and as a leavening
agent in yeast-leavened baked products at levels not to exceed 400
International Units (IU) of vitamin D2 per 100 grams (g) in
the finished food. After reviewing the objections to the final rule,
FDA has concluded that they do not provide a basis for amending or
revoking the regulation.
DATES: Effective date confirmed: August 29, 2012.
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 20740-3835, 240-402-1071.
SUPPLEMENTARY INFORMATION:
I. Introduction
In the Federal Register of December 17, 2009 (74 FR 66979), FDA
published a notice announcing the filing of a food additive petition
(FAP 9A4779) submitted by Lallemand, Inc., c/o Dennis T. Gordon, 117 N.
Welcome Slough Rd., Puget Island, Cathlamet, WA 98612. The petition
proposed to amend the food additive regulations in part 172, Food
Additives Permitted for Direct Addition to Food for Human Consumption
(21 CFR part 172), to provide for the safe use of vitamin D2
bakers yeast as a dual purpose nutrient supplement and leavening agent
or dough relaxer in yeast-containing baked products at levels not to
exceed 400 IU of vitamin D2 per 100 g in the finished food.
The specific foods identified in the petition were yeast-leavened baked
goods and baking mixes, and yeast-leavened baked snack foods. After the
notice was published, Lallemand amended the petition to exclude the
proposed use of the additive as a dough relaxer.
[[Page 13541]]
In response to FAP 9A4779, we issued a final rule in the Federal
Register on August 29, 2012 (77 FR 52228), authorizing the safe use of
vitamin D2 bakers yeast as a source of vitamin D2
and as a leavening agent in yeast-leavened baked products at levels not
to exceed 400 IU of vitamin D2 per 100 g in the finished
food. This regulation is codified at Sec. 172.381. We based our
decision on data contained in the petition and in our files. The
preamble to the final rule (77 FR 52228 at 52231) stated that
objections to the final rule and requests for a hearing were due within
30 days of the publication date (i.e., by September 28, 2012).
II. Objections and Requests for a Hearing
Section 409(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(f)(1)) provides that, within 30 days after
publication of an order relating to a food additive regulation, any
person adversely affected by such order may file objections,
``specifying with particularity the provisions of the order deemed
objectionable, stating reasonable grounds therefor, and requesting a
public hearing upon such objections.''
Under Sec. 171.110 (21 CFR 171.110), objections and requests for a
hearing are governed by part 12 (21 CFR part 12) of FDA's regulations.
Under Sec. 12.22(a), each objection must meet the following
conditions: (1) Must be submitted on or before the 30th day after the
date of publication of the final rule; (2) must be separately numbered;
(3) must specify with particularity the provision of the regulation or
proposed order objected to; (4) must specifically state each objection
on which a hearing is requested; failure to request a hearing on an
objection constitutes a waiver of the right to a hearing on that
objection; and (5) must include a detailed description and analysis of
the factual information to be presented in support of the objection if
a hearing is requested; failure to include a description and analysis
for an objection constitutes a waiver of the right to a hearing on that
objection.
Following publication of the final rule authorizing the use of
vitamin D2 bakers yeast as a source of vitamin D2
and as a leavening agent in yeast-leavened baked products at levels not
to exceed 400 IU of vitamin D2 per 100 g in the finished
food, we received a letter from AB Mauri North America (AB Mauri)
(letter to Docket No. FDA-2009-F-0570, September 26, 2012) containing
two objections. The letter from AB Mauri did not request a hearing on
either objection. Therefore, AB Mauri has waived its right to a hearing
on those objections (see Sec. 12.22(a)(4)). The only remaining
question under Sec. 12.24(a) is whether AB Mauri's objections, and the
information submitted in support of the objections, establish that the
regulation authorizing the use of vitamin D2 bakers yeast
should be modified or revoked. As discussed in detail in section III,
we have concluded that AB Mauri has not established a basis for
modification or revocation of the regulation authorizing the use of
vitamin D2 bakers yeast.
III. Analysis of Objections
The first objection raised by AB Mauri contends that the regulation
authorizing the use of vitamin D2 bakers yeast in food
(Sec. 172.381) is based on the incorrect assumptions that: (1) vitamin
D2 bakers yeast can be produced in such a way that the
vitamin D2 levels in the yeast itself can be accurately
controlled and declared; and (2) vitamin D2 bakers yeast can
be used by food manufacturers in a way that allows them to control the
level of vitamin D2 in the finished product and accurately
declare its level on the labeling of the finished food product. AB
Mauri asserts that these assumptions may result in vitamin
D2 levels in finished products that exceed the maximum level
specified in the regulation and declaration of inaccurate vitamin
D2 levels on finished product nutrition labels.
In support of their claim, AB Mauri presents vitamin D2
levels from a limited number of samples of Lallemand's commercially
available vitamin D2 bakers yeast that AB Mauri had analyzed
by an independent laboratory. According to AB Mauri, the results of the
independent analysis demonstrate that the actual amount of vitamin
D2 in bakers yeast varies, and does not necessarily reflect
the level of vitamin D2 that Lallemand claims on its Web
site is ``typical'' for the product. AB Mauri also provides theoretical
ranges of vitamin D2 levels that could result in batches of
the same size product, depending on the level and type of vitamin
D2 bakers yeast used. According to AB Mauri, using different
levels and types of vitamin D2 bakers yeast result in
different levels of vitamin D2 in batches of equal size.
However, AB Mauri did not provide the manufacturer's certificates
of analysis so that the vitamin D2 levels of the analyzed
samples could be verified. Additionally, AB Mauri did not identify the
analytical method used in the analyses of vitamin D2 bakers
yeast and did not provide information on the samples that were analyzed
(e.g., lot numbers, number of samples and replicates analyzed, age of
samples, sample storage conditions, or solid content of the yeast cream
samples). Therefore, the information provided by AB Mauri is not
sufficient to demonstrate that there was a difference in the analyzed
vitamin D2 levels and the vitamin D2 levels which
Lallemand claims is typical for the product.'
The information provided by AB Mauri also does not provide
sufficient evidence showing levels of vitamin D2 in finished
baked products made with vitamin D2 bakers yeast exceed the
maximum permitted level since the levels of vitamin D2 in
the finished baked products are based on hypothetical percentages of
yeast used. Therefore, this objection does not provide a basis for FDA
to reconsider its decision to issue the final rule on vitamin
D2 bakers yeast.
Our review of the petition explicitly considered variability of
vitamin D2 in ultraviolet light-treated bakers yeast. The
petitioner provided analytical data of vitamin D2 levels
from production lots of vitamin D2 bakers yeast, including
the certificates of analysis for the products analyzed. Results
demonstrated that vitamin D2 levels were at least equal to
80 percent of the value for vitamin D2 declared on the label
of the vitamin D2 bakers yeast product (see 21 CFR
101.9(g)(4)(ii)). Additionally, certificates of analysis, which include
vitamin D2 levels in the product, are provided with each
product sold, thus allowing bakers to calculate the amount of vitamin
D2 that each finished product will contain. Based on these
data and other information provided in the petition, we concluded that
there are adequate controls in place to ensure that vitamin
D2 bakers yeast may be used in conformance with the
provisions in the regulation.
Section 409 of the FD&C Act requires that a regulation authorizing
the use of a food additive must prescribe, with respect to the proposed
uses of the additive, the conditions under which the additive may be
safely used. Section 172.381, as established in the final rule, does
not include a requirement to label finished food with the level of
vitamin D2 contained in the finished food. However, to
ensure that the level of vitamin D2 in the finished food
does not exceed the maximum level specified in the regulation, Sec.
172.381(d) states that the label or labeling of the food additive
container must bear, in addition to the other information required by
the FD&C Act, adequate directions for use to provide a final product
that complies with the limitations prescribed in Sec. 172.381(c)
(under which the additive may be used in yeast-leavened baked goods and
baking mixes and yeast-
[[Page 13542]]
leavened baked snack foods at levels not to exceed 400 IU of vitamin
D2 per 100 g in the finished food). The labeling requirement
in Sec. 172.381(d) ensures that when vitamin D2 bakers
yeast is used to make products, the manufacturer will have the
information necessary to use the additive in conformance with the
provisions of the regulation.
The second objection from AB Mauri asserts that if FDA is going to
approve vitamin D2 supplementation in baked products at
higher levels than are currently permitted by the regulations, it
should do so in a way that permits better control of vitamin D levels
in finished products by considering the use of vitamin D3
instead. AB Mauri questions whether vitamin D2 is as
effective for humans as vitamin D3 at similar levels, and
cites two peer-reviewed journal articles to support this claim.
Our evaluation of the petition was based solely on the safety of
the proposed use of vitamin D2 bakers yeast in yeast-
containing baked goods. Therefore, expanding the scope of the final
rule to provide for the safe use of vitamin D3 is beyond the
scope of the petition submitted by Lallemand. If AB Mauri is interested
in obtaining approval for the expanded use of vitamin D3 in
food, they may do so by petitioning FDA for this use in accordance with
section 409(b) of the FD&C Act.
IV. Summary and Conclusions
Section 409 of the FD&C Act requires that a food additive be shown
to be safe prior to marketing. Under 21 CFR 170.3(i), a food additive
is ``safe'' if there is a reasonable certainty in the minds of
competent scientists that the substance is not harmful under the
intended conditions of use. In the final rule authorizing the use of
vitamin D2 bakers yeast, we concluded that the data
presented by the petitioner to establish safety of the additive
demonstrate that vitamin D2 bakers yeast is safe for its
intended use in yeast-leavened baked products at levels not to exceed
400 IU of vitamin D2 per 100 g in the finished food.
The petitioner has the burden to demonstrate the safety of the
additive to gain FDA approval. Once we make a finding of safety, the
burden shifts to an objector, who must come forward with evidence that
calls into question our conclusion (see section 409(f)(1) of the FD&C
Act). After evaluating the objections from AB Mauri, we have concluded
that the objections do not provide any basis for us to reconsider our
decision to issue the final rule authorizing the use of vitamin
D2 bakers yeast as a dual purpose nutrient supplement and
leavening agent in yeast-containing baked products at levels not to
exceed 400 IU of vitamin D2 per 100 g in the finished food.
Accordingly, we are not making any changes in response to the
objections.
Dated: March 4, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05060 Filed 3-10-14; 8:45 am]
BILLING CODE 4160-01-P
