[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Rules and Regulations]
[Pages 13540-13542]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-05060]
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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.
ACTION: Final rule; response to objections.
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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