Document ID: FDA-2018-F-3230-0002
Agency: fda
Document Type: Rule
Title: Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D2 Mushroom Powder
Posted Date: 2020-07-13T04:00Z

[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Rules and Regulations]
[Pages 41916-41920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13822]

[[Page 41916]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2018-F-3230]

Food Additives Permitted for Direct Addition to Food for Human 
Consumption; Vitamin D2 Mushroom Powder

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending the 
food additive regulations to provide for the safe use of vitamin 
D2 mushroom powder as a nutrient supplement in specific food 
categories. This action is in response to a petition filed by Oakshire 
Naturals, LP.

DATES: This rule is effective July 13, 2020. See section VII for 
further information on the filing of objections. Submit either 
electronic or written objections and requests for a hearing on the 
final rule by August 12, 2020.

ADDRESSES: You may submit objections and requests for a hearing as 
follows. Please note that late, untimely filed objections will not be 
considered. Electronic objections must be submitted on or before August 
12, 2020. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of August 12, 
2020. Objections received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or 
the delivery service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Objections submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your objection will be 
made public, you are solely responsible for ensuring that your 
objection does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your objection, that information will be 
posted on https://www.regulations.gov.
     If you want to submit an objection with confidential 
information that you do not wish to be made available to the public, 
submit the objection as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Dockets 
Management Staff, FDA will post your objection, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-F-3230 for ``Food Additives Permitted for Direct Addition to 
Food for Human Consumption; Vitamin D2 Mushroom Powder.'' 
Received objections, those filed in a timely manner (see ADDRESSES), 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with 
confidential information that you do not wish to be made publicly 
available, submit your objections only as a written/paper submission. 
You should submit two copies total. One copy will include the 
information you claim to be confidential with a heading or cover note 
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We 
will review this copy, including the claimed confidential information, 
in our consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper 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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Lauren VieBrock, Center for Food 
Safety and Applied Nutrition (HFS-255), Food and Drug Administration, 
5001 Campus Dr., College Park, MD 20740-3835, 301-796-7454.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 18, 2018 (83 FR 47118), we 
announced that we filed a food additive petition (FAP 8A4821) submitted 
by Oakshire Naturals LP (Oakshire), 295 Thompson Road, P.O. Box 388, 
Kennett Square, PA 19348. The petition proposes that we amend our 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 mushroom powder, produced by 
exposing homogenized edible mushrooms to ultraviolet (UV) light, as a 
nutrient supplement in: (1) Foods to which vitamin D2, 
vitamin D3, and vitamin D2 bakers yeast are 
currently allowed to be added under Sec. Sec.  184.1950, 172.379, 
172.380, and 172.381 (21 CFR 184.1950, 172.379, 172.380, and 172.381) 
(excluding cheese and cheese products, foods represented for use as a 
sole source of nutrition for enteral feeding, infant formula, milk and 
milk products, and margarine); (2) fruit smoothies; (3) vegetable 
juices; (4) extruded vegetable snacks; (5) soups and soup mixes (except 
for those containing meat or poultry that are subject to regulation by 
the U.S. Department of Agriculture under the Federal Meat Inspection 
Act or the Poultry Products Inspection Act); and (6) plant protein 
products as defined in 21 CFR 170.3(n)(33).
    Vitamin D is essential for human health. The major function of 
vitamin D is the maintenance of blood serum concentrations of calcium 
and

[[Page 41917]]

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. Excessive intake of vitamin D elevates blood plasma calcium 
levels by increased intestinal absorption or mobilization from the bone 
that can lead to vascular and tissue calcification, with subsequent 
damage to the heart, blood vessels, and kidneys (Ref. 1).
    To ensure that vitamin D is not added to the U.S. food supply at 
levels that could raise safety concerns, we affirmed vitamin D as 
generally recognized as safe (GRAS) with specific limitations as listed 
in Sec.  184.1950. Under Sec.  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 
requires a food additive regulation.
    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 vitamin D2, vitamin D3, or 
both. Vitamin D is affirmed as GRAS under Sec.  184.1950 for use in 
food as a nutrient supplement. In accordance with 21 CFR 184.1(b)(2), 
and as specified in Sec.  184.1950(c)(1), vitamins D2 and 
D3 may be used in food as the sole source of added vitamin D 
only within the following specific limitations:

------------------------------------------------------------------------
                                             Maximum levels in food (as
             Category of food                          served)
------------------------------------------------------------------------
Breakfast cereals.........................  350 international units (IU)/
                                             100 grams (g).
Grain products and pasta..................  90 IU/100 g.
Milk......................................  42 IU/100 g.
Milk products.............................  89 IU/100 g.
------------------------------------------------------------------------

    Additionally, under Sec.  184.1950(c)(2) and (3), vitamin D is 
affirmed as GRAS for use in infant formulas and margarine, 
respectively. Under Sec.  172.379, vitamin D2 is an approved 
food additive for use as a nutrient supplement in edible plant-based 
beverages intended as milk alternatives, edible plant-based yogurt 
alternatives, soy beverage products, soy-based butter substitute 
spreads, and soy-based cheese substitutes and soy-based cheese 
substitute products. Under Sec.  172.380, vitamin D3 is an 
approved food additive for use as a nutrient supplement in certain 
calcium-fortified fruit juices and fruit juice drinks; soy-protein 
based meal replacement beverages; meal replacement bars and other-type 
bars represented for special dietary use in reducing or maintaining 
body weight; some cheese and cheese products; meal replacement 
beverages not intended for special dietary use in reducing or 
maintaining body weight; foods represented as a sole source of 
nutrition for enteral feeding; and some milk. Under Sec.  172.381, 
vitamin D2 bakers yeast may be used in foods as a source of 
vitamin D2 and as a leavening agent in yeast-leavened baked 
goods and baking mixes and yeast-leavened baked snack foods.
    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 
mushroom powder that is produced by exposing a mushroom homogenate to 
UV light, resulting in increased conversion of endogenous ergosterol to 
ergocalciferol. Under section 402(a)(7) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), sources of irradiation, such as UV light, must 
be used in accordance with a regulation or exemption in effect pursuant 
to section 409 of the FD&C Act.
    To support their petition, Oakshire submitted dietary exposure 
estimates of vitamin D from the proposed uses of vitamin D2 
mushroom powder, as well as from naturally occurring dietary sources of 
vitamin D, uses in accordance with our approved food additive 
regulations (Sec. Sec.  172.379, 172.380, and 172.381) and our GRAS 
affirmation regulation (Sec.  184.1950), and from dietary supplements. 
Oakshire compared their dietary exposure estimates to the Tolerable 
Upper Intake Level (UL) for vitamin D established by the Institute of 
Medicine (IOM) of the National Academies. Oakshire also submitted a 
number of publications pertaining to human clinical studies on vitamin 
D. Oakshire included analyses to determine the presence of lumisterol, 
tachysterol, and vitamin D4 that are formed as a result of 
the UV treatment of the mushroom homogenate. Based on this information, 
Oakshire concluded that the proposed uses of vitamin D2 
mushroom powder are safe.

II. Evaluation of Safety

    To establish with reasonable certainty that a food additive is not 
harmful under its intended conditions of use, we consider the projected 
human dietary intake of the additive, the additive's toxicological 
data, and other relevant information (such as published literature) 
available to us. We compare an individual's estimated daily intake 
(EDI) of the additive from all food sources, including dietary 
supplements, 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. We use the EDI 
for the 90th percentile consumer of a food additive as a measure of 
high chronic dietary intake.

A. UV Light Treatment Used To Produce Vitamin D2 Mushroom 
Powder

    To support the safety of UV treatment to produce vitamin 
D2 mushroom powder, Oakshire provided information on the 
effects of UV light on biological molecules, the safety of UV light for 
treatment of food, and studies evaluating the bioavailability and 
safety of vitamin D from the consumption of vitamin D2 
mushroom powder (Ref. 1). Oakshire describes the source of UV radiation 
as a medium pressure mercury vapor lamp emitting broad-spectrum light 
(at wavelengths of 250-600 nm), with major intensity peaks in the UVB 
(280-315 nm) and UVA ranges (315-400 nm). Oakshire also analyzed 
extracts of mushroom powders from both UV-treated and untreated 
mushroom homogenate and identified the substances present in the 
mushroom powders. Oakshire identified tachysterol (a photoisomer 
resulting from UV light treatment of the vitamin D2 
precursor, previtamin D2) and lumisterol (typically formed 
from UV light treatment of previtamin D2) as present in the 
mushroom powders derived from UV-treated mushroom homogenate. Oakshire 
discussed the safety of these substances and we agree that the presence 
of small amounts of tachysterol and lumisterol do not pose a 
toxicological concern (Ref. 1).
    Agaricus bisporus mushrooms, which Oakshire uses to produce its 
vitamin D2 mushroom powder, also contain low levels of 
22,23-dihydroergosterol. When treated with UV light, 22,23-
dihydroergosterol forms vitamin D4 ((5Z,7E)-(3S)-9,10-seco-
5,7,10(19)-ergostatrien-3-ol). Oakshire analyzed powders from UV-
treated mushroom homogenate and found it to contain vitamin 
D4 at levels approximately 10 percent of vitamin 
D2 levels. Studies have shown that vitamin D4 
that is structurally similar to vitamin D3 has significantly 
less biological potency than vitamin D3 (Ref. 1). We 
included the contribution of vitamin D4 in the dietary 
exposure estimate for vitamin D2 mushroom powder by 
presuming that vitamin D4 was present at a level of 10 
percent of vitamin D2 levels in the vitamin D2 
mushroom powder, and that

[[Page 41918]]

vitamin D4 had equivalent potency to vitamin D2 
(Ref. 2). Oakshire discussed the safety of vitamin D4, and 
we agree that the presence of vitamin D4 in Vitamin 
D2 mushroom powder does not pose a toxicological concern 
(Ref. 1).

B. Acceptable Intake Level for Vitamin D

    The IOM considers the UL as the highest daily intake level of a 
nutrient that poses no risk of adverse effects with chronic consumption 
of the nutrient (Ref. 3). The UL is determined using a risk assessment 
model developed specifically for nutrients. 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 substances: No-observed-adverse-effect level, 
lowest-observed-effect level, and application of an uncertainty factor 
(Ref. 3).
    In 2011, the Standing Committee on the Scientific Evaluation of 
Dietary Reference Intakes of the Food and Nutrition Board at the IOM 
conducted an extensive review of relevant published scientific 
literature on vitamin D to update the nutrient's dietary reference 
intakes and ULs. Based on this information, the IOM revised the ULs for 
vitamin D and developed a report on their findings (Ref. 3). The IOM 
established the following ULs:
     1,000 IU per person per day (IU/p/d) for infants 0 months 
to 6 months of age;
     1,500 IU/p/d for infants 6 months to 12 months of age;
     2,500 IU/p/d for children 1 year to 3 years of age;
     3,000 IU/p/d for children 4 years to 8 years of age; and
     4,000 IU/p/d for children 9 years to 18 years of age and 
adults.
    We considered the ULs established by the IOM relative to the intake 
estimates as the primary basis for assessing the safety of the 
petitioned uses of vitamin D2 mushroom powder. We also 
reviewed published studies on the safety of vitamin D submitted in the 
petition, as well as other relevant published studies available to us 
(Ref. 1).

C. Estimated Daily Intake for Vitamin D

    Oakshire provided mean and 90th percentile vitamin D exposure 
estimates for consumers of foods from the: (1) Proposed food uses of 
vitamin D2 mushroom powder; (2) current food uses of vitamin 
D (including authorized uses as a food ingredient, naturally occurring 
sources of vitamin D, and dietary supplements); and (3) combined 
current and proposed food uses. Oakshire provided exposure estimates 
for the overall U.S. population (including infants under 1 year of age) 
and fourteen population subgroups (Ref. 2).
    The exposure estimates provided by Oakshire are appropriate. 
However, they did not employ the conservative assumptions that we 
typically use in pre-market exposure estimates. For pre-market exposure 
estimates, we conservatively assume that all foods for which the use of 
the additive is approved will contain the additive at the maximum level 
permitted. In the case of vitamin D exposure estimates presented in the 
most recent food additive approval for a new use of vitamin D (FAP 
3A4801, 81 FR 46578, July 18, 2016), we also included exposure to the 
vitamin D metabolite 25-hydroxyvitamin D (25(OH)D). For these reasons, 
we calculated our own exposure estimate for vitamin D2 
mushroom powder, as well as a cumulative exposure estimate for vitamin 
D from all background sources (approved food uses, dietary supplements, 
and naturally occurring sources, including 25(OH)D) and the petitioned 
uses for vitamin D2 mushroom powder (Ref. 2).
    For the overall U.S. population 1 year of age and older, we 
estimated the cumulative exposure at the 90th percentile from all food 
sources of vitamin D, including the proposed uses and background 
sources, to be 2,240 IU/p/d. We estimated the cumulative exposure for 
infants 0 to 6 months of age and infants 6 to 12 months of age to be 
948 IU/p/d and 960 IU/p/d, respectively, for the 90th percentile 
consumer (Ref. 2).

D. Safety of the Petitioned Uses of Vitamin D2 Mushroom 
Powder

    We reviewed and evaluated the information submitted by Oakshire 
regarding the safety of vitamin D2 mushroom powder, 
including the safety of using UV light treatment to produce it, and 
conclude that the use of vitamin D2 mushroom powder does not 
pose a safety concern (see section II.A). We also reviewed and 
evaluated the information submitted by Oakshire regarding the safety of 
dietary intake of vitamin D2 from the proposed uses of the 
vitamin D2 mushroom powder. Oakshire submitted reports of 
scientific studies published since our last evaluation of published 
scientific data in support of safety of the use of vitamin D and 
issuance of the final rule amending our food additive regulations to 
allow certain uses of vitamins D2 and D3 (81 FR 
46578). Oakshire concluded that these studies support a conclusion that 
the proposed uses of vitamin D2 mushroom powder are safe.
    We reviewed the studies submitted by Oakshire, as well as other 
relevant published studies available to us since our previous 
evaluations of food additive petitions for fortifying a variety of 
foods with vitamin D (81 FR 46578, July 18, 2016; 79 FR 46993, August 
12, 2014; 77 FR 52228, August 29, 2012; 74 FR 11019, March 16, 2009; 70 
FR 69435, November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, 
June 22, 2005; 68 FR 9000, February 27, 2003). These studies did not 
raise any safety concerns regarding the current or proposed uses of 
vitamin D. The most recent food additive petition for a new use of 
vitamin D resulted in our amendment of the food additive regulations in 
Sec. Sec.  172.379 and 172.380 to allow for the safe use of vitamin 
D2 as a nutrient supplement in edible plant-based beverages 
intended for use as milk alternatives and in edible plant-based yogurt 
alternatives, and of vitamin D3 as a nutrient supplement in 
milk (81 FR 46578). The earlier food additive petitions also resulted 
in amendments of the food additive regulations to allow for the safe 
use of vitamin D as a nutrient supplement in certain foods.
    We considered the ULs established by the IOM relative to the intake 
estimates as the primary basis for assessing the safety of the 
petitioned uses of vitamin D. Depending on the age group, the IOM UL 
for vitamin D for the U.S. population 1 year of age and older ranges 
from 2,500 IU/p/d to 4,000 IU/p/d (Ref. 3). The estimated dietary 
exposure to vitamin D from all food sources, including the proposed 
uses, at the 90th percentile for the U.S. population 1 year of age and 
older is estimated to be 2,240 IU/p/d, which is below the lowest IOM UL 
of 2,500 IU/p/d in the range of ULs for the overall U.S. population 1 
year of age and older. Estimated exposure to vitamin D from all food 
sources, including the proposed uses, for infants 0 months to 6 months 
of age at the 90th percentile is 948 IU/p/d; for infants 6 months to 12 
months of age, estimated exposure to vitamin D is 960 IU/p/d. Both of 
these estimates are below the IOM UL of 1,000 IU/p/d for infants 0 
months to 6 months of age and 1,500 IU/p/d for infants 6 months to 12 
months of age. Because the 90th percentile cumulative EDI of vitamin D 
from all food sources of vitamin D, including the proposed uses and 
background sources, for each population group is less than the 
corresponding IOM UL for that population group, we conclude that 
dietary intake of vitamin D2 mushroom powder from the 
proposed uses is safe (Ref. 1).

[[Page 41919]]

III. Conclusion

    Based on all data relevant to vitamin D2 mushroom powder 
we reviewed, we conclude that there is a reasonable certainty that no 
harm will result from the uses of vitamin D2 mushroom 
powder, produced using UV light treatment, as a source of vitamin 
D2 in: (1) Foods to which vitamin D2, vitamin 
D3, and vitamin D2 bakers yeast are allowed under 
Sec. Sec.  184.1950, 172.379, 172.380, and 172.381 (excluding cheese 
and cheese products, foods represented for use as a sole source of 
nutrition for enteral feeding, infant formula, milk and milk products, 
and margarine); (2) fruit smoothies; (3) vegetable juices; (4) extruded 
vegetable snacks; (5) soups and soup mixes (except for those containing 
meat or poultry that are subject to regulation by the U.S. Department 
of Agriculture under the Federal Meat Inspection Act or the Poultry 
Products Inspection Act); and (6) plant protein products as defined in 
21 CFR 170.3(n)(33). Thus, we are amending our food additive 
regulations as set forth in this document.

IV. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), the petition 
and the documents that we considered and relied upon in reaching our 
decision to approve the petition will be made available for public 
disclosure (see ADDRESSES). As provided in Sec.  171.1(h), we will 
delete from the documents any materials that are not available for 
public disclosure.

V. Analysis of Environmental Impacts

    As stated in the September 18, 2018 Federal Register notification 
of petition for FAP 8A4821 (83 FR 47118), the petitioners claimed a 
categorical exclusion from preparing an environmental assessment or 
environmental impact statement under Sec.  25.32(k) (21 CFR 25.32(k)) 
because vitamin D2 mushroom powder is intended to remain in 
food through ingestion by consumers and is not intended to replace 
macronutrients in food. We further stated that if FDA determines a 
categorical exclusion applies, neither an environmental assessment nor 
an environmental impact statement is required. We have not received any 
new information or comments regarding this claim of categorical 
exclusion. We have considered the petitioner's claim of categorical 
exclusion and have determined that this action is categorically 
excluded under Sec.  25.32(k). Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. 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.

VII. Objections

    If you will be adversely affected by one or more provisions of this 
regulation, you may file with the Dockets Management Staff (see 
ADDRESSES) either electronic or written objections. You must separately 
number each objection, and within each numbered objection you must 
specify with particularity the provision(s) to which you object, and 
the grounds for your objection. Within each numbered objection, you 
must specifically state whether you are requesting a hearing on the 
particular provision that you specify in that numbered objection. If 
you do not request a hearing for any particular objection, you waive 
the right to a hearing on that objection. If you request a hearing, 
your objection must include a detailed description and analysis of the 
specific factual information you intend to present in support of the 
objection in the event that a hearing is held. If you do not include 
such a description and analysis for any particular objection, you waive 
the right to a hearing on the objection.
    Any objections received in response to the regulation may be seen 
in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday, and will be posted to the docket at https://www.regulations.gov.

VIII. Section 301(ll) of the FD&C Act

    Our review of this petition was limited to section 409 of the FD&C 
Act (21 U.S.C. 348). This final rule is not a statement regarding 
compliance with other sections of the FD&C Act. For example, section 
301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction 
or delivery for introduction into interstate commerce of any food that 
contains a drug approved under section 505 of the FD&C 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) to (4) of the FD&C Act applies. In our review of 
this petition, FDA did not consider whether section 301(ll) of the FD&C 
Act 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) of the FD&C Act. 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) of the FD&C Act 
applies.

IX. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

1. FDA Memorandum from A. Khan, Toxicology Review Branch, Division of 
Food Ingredients, to L. VieBrock, Regulatory Review Branch, Division of 
Food Ingredients, March 18, 2020.*
2. FDA Memorandum from D. Folmer, Safety Assurance Team, Division of 
Science and Technology, to L. VieBrock, Regulatory Review Branch, 
Division of Food Ingredients, March 18, 2020.*
3. Committee to Review Dietary Reference Intakes for Vitamin D and 
Calcium, Food and Nutrition Board, Institute of Medicine, ``Dietary 
Reference Intakes for Calcium and Vitamin D,'' National Academies 
Press, Washington, DC, 2011. Available at https://www.nap.edu/read/13050/chapter/1 (accessed November 11, 2019).

List of Subjects in 21 CFR Part 172

    Food additives, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
172 is amended as follows:

[[Page 41920]]

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR 
HUMAN CONSUMPTION

0
1. The authority citation for part 172 continues to read as follows:

    Authority:  21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Add Sec.  172.382 to subpart D to read as follows:

Sec.  172.382  Vitamin D2 mushroom powder.

    Vitamin D2 mushroom powder may be used safely in foods 
as a source of vitamin D2 in accordance with the following 
prescribed conditions:
    (a) Vitamin D2 mushroom powder is the substance produced 
by exposing an aqueous homogenate of edible cultivars of Agaricus 
bisporus mushrooms to ultraviolet (UV) light, resulting in the 
photochemical conversion of endogenous ergosterol in the mushrooms to 
vitamin D2 (also known as ergocalciferol or [9,10-
Seco(5Z,7E,22E)-5,7,10(19),22- ergostatetraen-3-ol]).
    (b) The total dose of UV light applied to the mushroom homogenate 
shall not exceed 12 Joules/square centimeter (J/cm\2\).
    (c) Vitamin D2 mushroom powder meets the following 
specifications:
    (1) Moisture, not more than 10 percent.
    (2) Negative for Salmonella, Staphylococcus aureus, and Listeria 
monocytogenes, and any other recognized microbial pathogen or any 
harmful microbial toxin.
    (3) Standard plate count, not more than 5,000 colony forming units 
per gram (CFU/g).
    (4) Yeasts and molds, not more than 100 CFU/g.
    (5) Lead, not more than 0.5 milligrams per kilogram (mg/kg).
    (6) Arsenic, not more than 0.3 mg/kg.
    (d) To assure safe use of the additive, the label or labeling of 
the food additive container shall bear, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, 
adequate directions for use to provide a final product that complies 
with the limitations prescribed in paragraph (f) of this section.
    (e) Labels of manufactured food products containing the additive 
shall bear, in the ingredient statement, the name of the additive 
``vitamin D2 mushroom powder,'' in the proper order of 
decreasing predominance in the finished food.
    (f) Vitamin D2 mushroom powder may be used as a source 
of vitamin D2 in food as follows:

                        Table 1 to Paragraph (f)
------------------------------------------------------------------------
                                                Maximum level of vitamin
               Category of food                            D2
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Breakfast cereals............................  350 IU/100 g.
Edible plant-based beverages marketed as milk  84 IU/100 g.
 alternatives.
Edible plant-based products marketed as        89 IU/100 g.
 yogurt alternatives.
Extruded vegetable snacks....................  80 IU/28 g.
Fruit smoothies..............................  100 IU/240 mL.
100% fruit juices that are fortified with      100 IU/240 mL.
 greater than or equal to 330 mg of calcium
 per 240 mL, excluding fruit juices that are
 specially formulated or processed for
 infants.
Fruit juice drinks that are fortified with     100 IU/240 mL.
 greater than or equal to 100 mg of calcium
 per 240 mL, excluding fruit juice drinks
 that are specially formulated or processed
 for infants.
Grain products and pastas....................  90 IU/100 g.
Meal replacement bars or other-type bars that  100 IU/40 g.
 are represented for special dietary use in
 reducing or maintaining body weight.
Meal replacement beverages that are not        500 IU/240 mL.
 intended for special dietary use in reducing
 or maintaining body weight and that are
 represented for use such that the total
 amount of Vitamin D provided by the product
 does not exceed 1,000 IU per day.
Plant protein products.......................  80 IU/85 g.
Soups and soup mixes, except for soup and      100 IU/245 mL.
 soup mixes containing meat or poultry that
 are subject to regulation by the U.S.
 Department of Agriculture under the Federal
 Meat Inspection Act or the Poultry Products
 Inspection Act.
Soy-based spreads marketed as butter           330 IU/100 g.
 alternatives.
Soy-based products marketed as cheese and      270 IU/100 g.
 cheese-product alternatives.
Soy beverage products........................  89 IU/100 g.
Soy-protein based meal replacement beverages   140 IU/240 mL.
 (powder or liquid) that are represented for
 special dietary use in reducing or
 maintaining body weight.
Vegetable juices.............................  100 IU/240 mL.
Yeast-leavened baked goods and baking mixes    400 IU/100 g.
 and yeast-leavened baked snack foods.
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    Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13822 Filed 7-10-20; 8:45 am]
BILLING CODE 4164-01-P