[Federal Register Volume 85, Number 134 (Monday, July 13, 2020)]
[Rules and Regulations]
[Pages 41916-41920]
[FR Doc No: 2020-13822]

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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.

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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,<PHONE_NUMBER>.

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,<PHONE_NUMBER>.

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

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

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).

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:

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
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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


[Federal Register Volume 82, Number 71 (Friday, April 14, 2017)]
[Proposed Rules]
[Pages 17945-17947]
[FR Doc No: 2017-07477]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0164; Directorate Identifier 2017-NE-06-AD]
RIN 2120-AA64

Airworthiness Directives; General Electric Company Turbofan
Engines

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain General Electric Company (GE) CF34-8 model turbofan engines.
This proposed AD was prompted by analysis that resulted in the
reduction of the life of the affected fan blades. This proposed AD
would require inspections of the affected fan blades until their
removal. We are proposing this AD to correct the unsafe condition on
these products.

DATES: We must receive comments on this proposed AD by May 30, 2017.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact General
Electric Company, GE-Aviation, Room 285, 1 Neumann Way, Cincinnati, OH
45215, phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
You may view this service information at the FAA, Engine & Propeller
Directorate, 1200 District Avenue, Burlington, MA. For information on
the availability of this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2017-
0164; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Martin Adler, Aerospace Engineer,
Engine Certification Office, FAA, Engine & Propeller Directorate, 1200
District Avenue, Burlington, MA 01803; phone:<PHONE_NUMBER>; fax: 781-
238-7199; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this NPRM. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2017-0164;
Directorate Identifier 2017-NE-06-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this NPRM. We will
consider all comments received by the closing date and may amend this
NPRM because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this NPRM.

Discussion

    We learned that GE has determined, based on analysis, that the
stresses in the pinholes in the affected fan blade could result in
crack initiation at pinhole surfaces beyond 19,000, 19,500, or 25,000
cyles-since-new (CSN), depending on the engine model on which the blade
is installed. GE, therefore, has initiated a program of initial and
repetitive eddy current inspections (ECIs) and removal of this fan
blade before it reaches 41,000 CSN. GE also provided an option to
repair the blade which allows for an additional 28,000 cycles before it
must be removed. This condition, if not corrected, could result in
failure of the fan blade, uncontained blade release, damage to the
engine, and damage to the airplane.

Related Service Information Under 1 CFR Part 51

    We reviewed GE Alert Service Bulletins (ASBs) CF34-8C SB 72-A0137
R05, dated June 15, 2016; and CF34-8E SB 72-A0060 R05, dated June 15,
2016. These ASBs provide the procedures necessary for calculating the
adjusted CSN for the initial inspection. This service information is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

Other Related Service Information

    We reviewed GE ASB CF34-8E SB 72-A0115 R03, issued on December 9,
2016, and GE ASB CF34-8C SB 72-A0225 R03, issued on December 9, 2016.
The ASB's describe procedures for repairing fan blade, part number (P/
N) 4114T15P02, to P/N 4114T31G01 with the installation of a bushing in
the pinholes.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require initial and repetitive ECIs of the
affected fan blade. This proposed AD would also require removal or
repair of the affected fan blade at a reduced life. A fan blade

that has been repaired is eligible for an additional 28,000 cycles in
service before it must be removed.

Differences Between This Proposed AD and the Service Information

    The determination in this proposed AD of CSN, when CSN is not
known, is simpler and clearer than the method indicated in the service
information. The service information has several options that may lead
to confusion among operators in making this determination.

Costs of Compliance

    We estimate that this proposed AD affects 1,986 engines installed
on airplanes of U.S. registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Initial ECI Inspection................  4 work-hours x $85 per                $0            $340        $675,240
                                         hour = $340.
Replacement of fan blade (prorated      0 work-hours x $85 per             5,460           5,460      10,843,560
 annual cost).                           hour = $0.
----------------------------------------------------------------------------------------------------------------

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that it justifies making a regulatory distinction, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

General Electric Company: Docket No. FAA-2017-0164; Directorate
Identifier 2017-NE-06-AD.

(a) Comments Due Date

    We must receive comments by May 30, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to General Electric Company (GE) CF34-8C1, CF34-
8C5, CF34-8C5A1, CF34-8C5B1, CF34-8C5A2, CF34-8C5A3, CF34-8E2, CF34-
8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E5A2, CF34-8E6 and CF34-8E6A1
engines, including engines marked on the engine data plate as CF34-
8C5B1/B, CF34-8C5/B, CF34-8C5A1/B, CF34-8C5A2/B, CF34-8C5/M, CF34-
8C5A1/M, CF34-8C5A2/M, CF34-8C5A3/B, or CF34-8C5B1/M, with a fan
blade, part number (P/N) 4114T15P02 or P/N 4114T31G01, installed.

(d) Subject

    Joint Aircraft System Component (JASC) Code 7230, Turbine Engine
Compressor Section.

(e) Unsafe Condition

    This AD was prompted by analysis that resulted in the reduction
of the life of the affected fan blades. We are issuing this AD to
prevent failure of the fan blade, uncontained blade release, damage
to the engine, and damage to the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Eddy Current Inspections (ECIs)

    (1) For CF34-8C1, CF34-8C5B1, CF34-8C5B1/B and CF34-8E2 engines
with fan blade, P/N 4114T15P02, installed:
    (i) Perform an initial ECI of the fan blade pinhole prior to the
fan blade accumulating 25,000 cycles-since-new (CSN); and
    (ii) Repeat this inspection within every 3,000 cycles
thereafter.
    (2) For CF34-8C5, CF34-8C5/B, CF34-8C5A1, CF34-8C5A1/B, CF34-
8C5A2, CF34-8C5A2/B, CF34-8E2A1, CF34-8E5, CF34-8E5A1, CF34-8E6 and
CF34-8E6A1 engines with fan blade, P/N 4114T15P02, installed:
    (i) Perform an initial ECI of the fan blade pinhole prior to the
fan blade accumulating 19,500 CSN; and
    (ii) Repeat this inspection within every 3,000 cycles
thereafter, until the fan blade has accumulated 25,000 CSN, then
repeat the inspection every 1,500 cycles thereafter.
    (3) For CF34-8C5/M, CF34-8C5A1/M, CF34-8C5A2/M, CF34-8C5A3,
CF34-8C5A3/B, CF34-8C5B1/M, and CF34-8E5A2 engines with fan blade,
P/N 4114T15P02, installed:
    (i) Perform an initial ECI of the fan blade pinhole prior to the
fan blade accumulating 19,000 CSN; and
    (ii) Repeat this inspection within every 3,000 cycles
thereafter, until the fan blade has accumulated 25,000 CSN, then
repeat the inspection every 1,500 cycles thereafter.
    (4) For any affected engine with a fan blade, P/N 4114T15P02,
installed where the CSN of the fan blade is unknown on the effective
date of this AD:

    (i) Assume the blade has accumulated 25,000 CSN on the effective
date of this AD; and
    (ii) Inspect the blade prior to installation or within 500
cycles after the effective date of this AD, whichever is earlier.
    (5) If a fan blade is moved from one affected engine model to
another affected model after the initial ECI:
    (i) Perform an additional ECI of the blade prior to installation
in the new model; and
    (ii) Repeat this inspection based on the intervals of the new
engine installation, as specified in paragraph (g) of this AD.
    (6) If a fan blade, P/N 4114T15P02, has been used on more than
one engine model prior to the initial ECI, use Appendix A of GE
Alert Service Bulletin (ASB) CF34-8C SB 72-A0137 R05, dated June 15,
2016, or Appendix A of GE ASB CF34-8E SB 72-A0060 R05, dated June
15, 2016, to calculate the new cycle limit for the initial
inspection of that fan blade.

(h) Fan Blade Removal

    (1) For any affected engine with a fan blade, P/N 4114T15P02,
installed, remove the blade from service or repair to P/N 4114T31G01
prior to the blade accumulating 41,000 CSN.
    (2) For any affected engine with a fan blade, P/N 4114T31G01,
installed, remove the blade from service prior to the blade
accumulating 28,000 cycles since installation of the pinhole
bushing.

(i) Alternative Methods of Compliance (AMOCs)

    The Manager, Engine Certification Office, FAA, may approve AMOCs
for this AD. Use the procedures found in 14 CFR 39.19 to make your
request. You may email your request to<EMAIL_ADDRESS>
(j) Related Information

    (1) For more information about this AD, contact Martin Adler,
Aerospace Engineer, Engine Certification Office, FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA 01803;
phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>    (2) GE ASBs: CF34-8C SB 72-A0137 R05, dated June 15, 2016; CF34-
8E SB 72-A0060 R05, dated June 15, 2016; CF34-8E SB 72A0115 R03,
issued December 9, 2016; and CF34-8C ASB 72-A0225 R03, issued
December 9, 2016; can be obtained from GE using the contact
information in paragraph (j)(3) of this AD.
    (3) For service information identified in this proposed AD,
contact General Electric Company, GE-Aviation, Room 285, 1 Neumann
Way, Cincinnati, OH 45215, phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (4) You may view this service information at the FAA, Engine &
Propeller Directorate, 1200 District Avenue, Burlington, MA. For
information on the availability of this material at the FAA, call
781-238-7125.

    Issued in Burlington, Massachusetts, on April 5, 2017.
Carlos A. Pestana,
Acting Manager, Engine & Propeller Directorate, Aircraft Certification
Service.
[FR Doc. 2017-07477 Filed 4-13-17; 8:45 am]
 BILLING CODE 4910-13-P