[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