83 FR 47118 - Oakshire Naturals LP; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 181 (September 18, 2018)

Page Range		47118-47119
FR Document		2018-20217

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Oakshire Naturals LP, proposing that the food additive regulations be amended to provide for the safe use of vitamin D<INF>2</INF> mushroom powder as a nutrient supplement in specific food categories.

Federal Register, Volume 83 Issue 181 (Tuesday, September 18, 2018)

[Federal Register Volume 83, Number 181 (Tuesday, September 18, 2018)]
[Proposed Rules]
[Pages 47118-47119]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20217]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

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


Oakshire Naturals LP; Filing of Food Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Oakshire Naturals LP, 
proposing that the food additive regulations be amended to provide for 
the safe use of vitamin D2 mushroom powder as a nutrient 
supplement in specific food categories.

DATES: The food additive petition was filed on July 16, 2018.

ADDRESSES: For access to the docket to read background documents or 
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.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1071.

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5))), we are giving notice 
that we have filed a food additive petition (FAP 8A4821), submitted by 
Oakshire Naturals LP, 295 Thompson Road, P.O. Box 388, Kennett Square, 
PA 19348. The petition proposes to amend the 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 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 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).
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(k) because the substance is intended to 
remain in food through ingestion by consumers and is not intended to 
replace macronutrients in food. In addition, the petitioner has stated 
that, to their knowledge, no extraordinary circumstances exist. If

[[Page 47119]]

FDA determines a categorical exclusion applies, neither an 
environmental assessment nor an environmental impact statement is 
required. If FDA determines a categorical exclusion does not apply, we 
will request an environmental assessment and make it available for 
public inspection.

    Dated: September 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20217 Filed 9-17-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 181 / Tuesday, September 18, 2018 / Proposed Rules 47119

FDA determines a categorical exclusion product to the market dominant or Commission may exempt the market test
applies, neither an environmental competitive product list.1 The proposed from the $10 million revenue limitation
assessment nor an environmental rules reflect lessons learned through the if certain requirements are met. 39
impact statement is required. If FDA Commission’s experiences with the U.S.C. 3641(e)(2). If the Commission
determines a categorical exclusion does existing regulations and current practice grants an exemption, total revenues
not apply, we will request an before the Commission. The proposed anticipated, or in fact received by, the
environmental assessment and make it rules appear after the signature of this Postal Service from a market test may
available for public inspection. order in Attachment A. not exceed $50 million in any year. Id.
Dated: September 12, 2018. II. Proposed Amendments These amounts must be adjusted
Leslie Kux,
annually by the change in the Consumer
Section 3641 of title 39 of the United Price Index for such year, as determined
Associate Commissioner for Policy. States Code authorizes the Postal under the regulations of the
[FR Doc. 2018–20217 Filed 9–17–18; 8:45 am] Service to conduct market tests of Commission. 39 U.S.C. 3641(g). Existing
BILLING CODE 4164–01–P experimental products. In accordance § 3035.15(a) uses the Consumer Price
with its specific authority to regulate Index—All Urban Customers (CPI–U
market tests under 39 U.S.C. 3641 and index), as specified by §§ 3010.21(a) and
POSTAL REGULATORY COMMISSION its general authority under 39 U.S.C. 3010.22(a) of this chapter, to calculate
503 to promulgate regulations and these amounts.
39 CFR Part 3035 establish procedures, the Commission
Existing § 3035.15(d) explains the
[Docket No. RM2018–12; Order No. 4822] codified existing 39 CFR part 3035 to
method for calculating the $10 million
establish procedures for conducting
revenue limitation on a fiscal year basis,
Market Tests market tests of experimental products.2
as adjusted for the change in the CPI–
The Commission establishes this
AGENCY: Postal Regulatory Commission. U index ($10 Million Adjusted
proceeding to consider amendments to
ACTION: Notice of proposed rulemaking. Limitation). Calculating the $10 Million
the existing market test regulations.
The proposed amendments are Adjusted Limitation involves three
SUMMARY: The Commission is proposing discussed below. The first set of steps. First, a simple average CPI–U
revisions to its rules governing market amendments intend to revise the index was calculated for Fiscal Year
tests of experimental products. This method for calculating applicable 2008 by summing the monthly CPI–U
document informs the public of the revenue limitations for market tests values from October 2007 through
docket’s initiation, invites public appearing in existing §§ 3035.15 and September 2008 and dividing the sum
comment, and takes other 3035.16 to be consistent with the by 12. 39 CFR 3035.15(d); see 39 U.S.C.
administrative steps. current level of precision used in 3641(g). The result is a Base Average of
DATES: Comments are due on or before calculating the annual limitation on the 214.5. 39 CFR 3035.15(d). Second, a
October 18, 2018. percentage change in rates for market second simple average CPI–U index is
ADDRESSES: Submit comments dominant products (price cap). The calculated for each subsequent fiscal
electronically via the Commission’s second set of proposed amendments aim year by summing the 12 monthly CPI–
Filing Online system at http:// to clarify the process under existing U values for the previous fiscal year and
www.prc.gov. Those who cannot submit § 3035.18 for adding a non-experimental dividing the sum by 12 to obtain a
comments electronically should contact product or price category based on an Recent Average. Id. Third, the revenue
the person identified in the FOR FURTHER experimental product to the market limitation for the current fiscal year is
INFORMATION CONTACT section by dominant or competitive product list calculated by multiplying $10 million
telephone for advice on filing and to emphasize the necessity of by the Recent Average divided by the
alternatives. receiving specific detailed information Base Average of 214.5. Id. The result is
in those instances. the $10 Million Adjusted Limitation,
FOR FURTHER INFORMATION CONTACT: rounded to the nearest dollar. Id.
David A. Trissell, General Counsel, at A. Market Test Revenue Limitations Existing § 3035.16(c) sets forth
202–789–6820. corresponding steps for calculating the
Unless the Commission grants an
SUPPLEMENTARY INFORMATION: exemption, total revenues anticipated or $50 million revenue limitation, as
Table of Contents in fact received by the Postal Service adjusted for the change in the CPI–U
from an experimental product must not index ($50 Million Adjusted
I. Introduction exceed $10 million in any year. 39 Limitation).
II. Proposed Amendments U.S.C. 3641(e)(1). Upon written Under existing §§ 3035.15 and
III. Section-by-Section Analysis application of the Postal Service, the 3035.16, the Base Average for both the
IV. Administrative Actions $10 Million and $50 Million Adjusted
V. Ordering Paragraphs 1 Product lists categorize postal products as either Limitations is calculated using one
market dominant or competitive. 39 CFR 3020.1(b). decimal place (214.5). In Order No. 303,
I. Introduction Each experimental product during a market test is
identified on the applicable product list under the
the Commission amended the price cap
Pursuant to 39 U.S.C. 503 and 3641, organizational group heading ‘‘Market Tests’’ in rules appearing in §§ 3010.21 and
this order establishes a rulemaking accordance with 39 U.S.C. 3641(b)(3) and existing 3010.22 of this chapter to calculate the
docket that proposes amendments to the §§ 3020.4(b)(2)(ii)(D) and 3020.4(b)(3)(ii)(D) of this CPI–U price cap using three decimal
daltland on DSKBBV9HB2PROD with PROPOSALS

Commission’s regulations governing chapter. The intent of existing § 3035.18 and the
revisions proposed in this order apply only to a
places instead of one.3 The Commission
market tests of experimental products request to offer a proposed product or price
appearing in existing 39 CFR part 3035. category in non-experimental status, that is— 3 Docket No. RM2009–8, Order Amending the Cap

The proposed amendments would subject to the applicable requirements of 39 U.S.C. Calculation in the System of Ratemaking,
revise regulations concerning market 3622, 3633, or 3642, and the applicable regulations September 22, 2009, at 1–2 (Order No. 303); see
promulgated thereunder. Docket No. RM2009–8, Notice of Proposed
test revenue limitations and requests to 2 See Docket No. RM2013–5, Order Adopting Rulemaking to Amend the Cap Calculation in the
add a non-experimental product or price Final Rules for Market Tests of Experimental System of Ratemaking, July 10, 2009 (Order No.
category based on an experimental Products, August 28, 2014 (Order No. 2173). 246).

VerDate Sep<11>2014 16:57 Sep 17, 2018 Jkt 244001 PO 00000 Frm 00019 Fmt 4702 Sfmt 4702 E:\FR\FM\18SEP1.SGM 18SEP1

Document Created: 2018-09-18 01:18:19
Document Modified: 2018-09-18 01:18:19

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Notification of petition.
Dates		The food additive petition was filed on July 16, 2018.
Contact		Judith Kidwell, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1071.
FR Citation		83 FR 47118

83 FR 47118 - Oakshire Naturals LP; Filing of Food Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 181 (September 18, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration