Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3, 47557-47560 [2018-20375]
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Federal Register / Vol. 83, No. 183 / Thursday, September 20, 2018 / Rules and Regulations
4. In appendix H to part 25, section
H25.4, add new paragraph (a)(5) to read
as follows:
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Appendix H to Part 25—Instructions for
Continued Airworthiness
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H25.4 Airworthiness Limitations section.
(a) * * *
(5) Each mandatory replacement time,
inspection interval, and related inspection
and test procedure, and each critical design
configuration control limitation for each
lightning protection feature approved under
§ 25.954.
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Issued under authority provided by 49
U.S.C. 106(f), 44701(a), and 44703 in
Washington, DC, on September 6, 2018.
Carl Burleson,
Acting Deputy Administrator.
[FR Doc. 2018–20174 Filed 9–19–18; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA–2017–F–3717]
Food Additives Permitted for Direct
Addition to Food for Human
Consumption; Vitamin D3
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or we) is
amending the food additive regulation
for vitamin D3 to replace the current
Reference Daily Intake (RDI) percentage
values of calcium in 100 percent fruit
juices and fruit juice drinks with
absolute values and to update the
reference for vitamin D3 specifications.
We are taking this action in response to
a food additive petition filed by the
Juice Products Association.
DATES: This rule is effective September
20, 2018. Submit either electronic or
written objections and requests for a
hearing on the final rule by October 22,
2018. The Director of the Federal
Register approves the incorporation by
reference of certain publications listed
in the rule as of September 20, 2018. See
the ADDRESSES section and the
OBJECTIONS section IX of this
document for further information on
filing objections.
ADDRESSES: You may submit objections
and requests for a hearing as follows.
Please note that late, untimely filed
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SUMMARY:
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objections will not be considered.
Electronic objections must be submitted
on or before October 22, 2018. The
https://www.regulations.gov electronic
filing system will accept objections until
midnight Eastern Time at the end of
October 22, 2018. 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–
2017–F–3717 for ‘‘Food Additives
Permitted for Direct Addition to Food
for Human Consumption; Vitamin D3
Final Rule.’’ Received objections, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
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47557
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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.
FOR FURTHER INFORMATION CONTACT:
Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5001 Campus
Dr., College Park, MD 20740–3835, 240–
402–1071.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 26,
2017 (82 FR 34615), amended August
22, 2017 (82 FR 39711), we announced
that we filed a food additive petition
(FAP 7A4818) submitted on behalf of
the Juice Products Association by Hogan
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Lovells US LLP, Columbia Square, 555
Thirteenth Street NW, Washington, DC
20004. The petition proposed to amend
the food additive regulations in
§ 172.380 (21 CFR 172.380), Vitamin D3,
to replace the currently specified
minimum RDI percentage values of
calcium in calcium-fortified 100 percent
fruit juices and fruit juice drinks with
absolute values. Specifically,
§ 172.380(c)(1) currently provides for
the use of vitamin D3 at a level not to
exceed 100 International Units (IU) per
240 milliliters (mL) in 100 percent fruit
juices that are fortified with greater than
or equal to 33 percent of the RDI of
calcium per 240 mL, excluding fruit
juices that are specifically formulated or
processed for infants. In addition,
§ 172.380(c)(2) provides for the use of
up to 100 IU of vitamin D3 per 240 mL
in fruit juice drinks that are fortified
with greater than or equal to 10 percent
of the RDI of calcium per 240 mL,
excluding fruit juice drinks that are
specifically formulated or processed for
infants. The petitioner proposed to
replace the RDI percentage values of
calcium in 100 percent fruit juices and
fruit juice drinks in these regulations
with the absolute values of added
calcium of 330 milligrams (mg) and 100
mg per 240 mL, respectively. The
petitioner also requested that we update
the reference for specifications for
vitamin D3 in § 172.380(b) from the 9th
edition of the Food Chemicals Codex
(FCC 9) to the 10th edition (FCC 10).
II. Evaluation of Petition
Section 409(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 348(i)) states that we shall, by
regulation, establish the procedure for
amending or repealing a food additive
regulation, and that this procedure shall
conform to the procedure provided in
section 409 of the FD&C Act. Our
regulations specific to administrative
actions for food additives provide that
the Commissioner of Food and Drugs,
on his own initiative or on the petition
of any interested person, may propose
the issuance of a regulation amending or
repealing a regulation pertaining to a
food additive (§ 171.130(a) (21 CFR
171.130(a))). The regulations further
provide that any such petition must
include an assertion of facts, supported
by data, showing that new information
exists with respect to the food additive
or that new uses have been developed
or old uses abandoned, that new data
are available as to toxicity of the
chemical, or that experience with the
existing regulation or exemption may
justify its amendment or repeal. New
data submitted as a food additive
petition must be furnished in the form
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specified in 21 CFR 171.1 and 171.100
for submitting such petitions
(§ 171.130(b)).
In the Federal Register of February
27, 2003 (68 FR 9000), we issued the
regulations at § 172.380(c)(1) and (2)
permitting the use of vitamin D3 in
calcium fortified 100 percent fruit juices
and fruit juice drinks. We took that
action in response to a food additive
petition (FAP 2A4734) from the Minute
Maid Co. (Minute Maid). Minute Maid
petitioned for vitamin D3 to be allowed
to be added to calcium-fortified 100
percent fruit juices and fruit juice drinks
so that the calcium and vitamin D levels
are comparable to the levels in milk.
When we issued these regulations in
2003, the RDI for calcium was 1,000 mg;
however, in the Federal Register of May
27, 2016 (81 FR 33742), we issued a
final rule which, among other things,
redefined the RDI of calcium for adults
and children 4 years of age and older to
1,300 mg (21 CFR 101.9(c)(8)(iv)).
Because of the change in the RDI for
calcium, the minimum level of added
calcium in 100 percent fruit juice that
may be fortified with vitamin D3
increased from 330 mg to 430 mg and
in fruit juice drinks from 100 mg to 130
mg.
The Juice Products Association stated
that the proposed revision of § 172.380
to specify absolute values of calcium on
a mg/mL basis rather than a percentage
of RDI is needed to maintain the relative
parity between fortified 100 percent
fruit juices and fruit juice drinks and
many dairy products. Without this
change, the petitioner stated that 100
percent fruit juices with vitamin D3
would have higher calcium levels than
milk. The petitioner also stated that the
higher levels of calcium resulting from
the redefined RDI for calcium present
formulation challenges and may
adversely impact the taste of the juice or
juice drink, which could deter
consumers from selecting calcium and
vitamin D fortified juices. Therefore, the
petitioner proposed that § 172.380 be
amended to express the allowable added
calcium levels on a mg basis consistent
with the calcium levels before the
revision of the RDI for calcium. In doing
so, the allowable levels of calcium and
vitamin D in 100 percent fruit juices and
juice drinks would again be comparable
to the levels in milk.
Because the petitioner sought to
revise the existing regulation to restore
the amount of calcium fortification
required to levels on par with milk,
without introducing new uses for
vitamin D3 or changing the levels of
vitamin D3 and calcium that were
considered when the regulations were
established, there is no increase in
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dietary exposure to vitamin D3 or to
calcium. Therefore, we have determined
that there are no safety concerns as a
result of the proposed amendment.
Additionally, the current regulation
for the use of vitamin D3 in food
(§ 172.380) indicates that the additive
must meet the specifications in the 9th
edition of the Food Chemicals Codex
(FCC 9). The petitioner requested that
we update the specifications for vitamin
D3 in § 172.380 by replacing the existing
FCC 9 reference with the 10th edition of
the Food Chemicals Codex (FCC 10), the
most recent edition at the time the
petition was submitted. The
specifications for vitamin D3 in FCC 10
are identical to those in FCC 9.
However, since we received the
petition, FCC has been updated to the
11th edition (FCC 11). The
specifications for vitamin D3 in FCC 11
are identical to those in FCC 10.
Therefore, we are amending § 172.380
by adopting the specifications for
vitamin D3 in FCC 11 in place of FCC
9, because FCC 11 is the most current
version.
III. Incorporation by Reference
FDA is incorporating by reference the
monograph from Food Chemicals
Codex, 11th ed., 2018, pp. 1243–1244
(vitamin D3), which is approved by the
Director of the Office of the Federal
Register. You may purchase a copy of
the material from the United States
Pharmacopeial Convention, 12601
Twinbrook Pkwy., Rockville, MD 20852,
1–800–227–8772, https://www.usp.org/.
Copies also may be examined at FDA’s
Main Library, 10903 New Hampshire
Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993, 301–796–2039.
The FCC monograph establishes the
standard for purity and identity for
vitamin D3. The monograph provides
specifications and analytical
methodologies used to identify the
substance and establish acceptable
purity criteria. To ensure that only food
grade vitamin D3 is used in foods listed
in § 172.380, the additive must meet the
specifications and identity in the FCC
monograph.
IV. Conclusion
Based on data and information in the
petition, we conclude that amending the
food additive regulations in the
regulation for vitamin D3 to replace the
current RDI percentage values of
calcium in 100 percent fruit juices and
fruit juice drinks with absolute values is
safe and appropriate. Thus, the RDI
percentage values of calcium in 100
percent fruit juices and fruit juice drinks
in these regulations are replaced with
the absolute values of added calcium of
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330 mg and 100 mg per 240 mL,
respectively. Consequently, we are
amending the food additive regulations
as set forth in this document.
Additionally, the current regulation
for the use of vitamin D3 in food
(§ 172.380) indicates that the additive
must meet the specifications in FCC 9.
The more current version is FCC 11,
which contains specifications for
vitamin D3 that are identical to those in
FCC 9. We are amending § 172.380 by
adopting the specifications for vitamin
D3 in FCC 11 in place of FCC 9.
V. Public Disclosure
In accordance with § 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 FOR
FURTHER INFORMATION CONTACT). As
provided in § 171.1(h), we will delete
from the documents any materials that
are not available for public disclosure.
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VI. Analysis of Environmental Impact
We previously considered the
environmental effects of this rule, as
stated in the July 26, 2017, Federal
Register notice of filing (82 FR 34615).
We stated in the notice of filing that we
had determined, under 21 CFR 25.30(i),
that this action ‘‘is of a type that does
not individually or cumulatively have a
significant effect on the human
environment because the amendments
are administrative in nature’’ such that
neither an environmental assessment
nor an environmental impact statement
is required. Upon further consideration,
we determined that FAP 7A4818 is not
solely administrative in nature as this
revision has the potential to lead to
manufacturing changes. Consequently,
the action being requested is neither a
correction nor technical change and the
original categorical exclusion (21 CFR
25.30(i)) is not appropriate. Therefore,
we have determined under 21 CFR
25.32(k) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment because the added vitamin
D3 and calcium will remain in the fruit
juice and fruit juice drinks through
ingestion by consumers and neither
food additive is intended to replace
macronutrients. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VII. Paperwork Reduction Act of 1995
This final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
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under the Paperwork Reduction Act of
1995 is not required.
VIII. Section 301(ll) of the Federal
Food, Drug, and Cosmetic Act
Our review of this petition was
limited to section 409 of the FD&C Act.
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, we 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. 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 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.
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47559
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.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by
reference, 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
1. The authority citation for part 172
continues to read as follows:
■
Authority: 21 U.S.C. 321, 341, 342, 348,
371, 379e.
2. Amend § 172.380 by revising
paragraphs (b) and (c)(1) through (2) to
read as follows:
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§ 172.380
Vitamin D3.
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(b) Vitamin D3 meets the
specifications of ‘‘Vitamin D3,’’, Food
Chemicals Codex, 11th ed., copyright
2018, pp. 1243–1244, which is
incorporated by reference. The Director
of the Office of the Federal Register
approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and
1 CFR part 51. You may obtain copies
from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy.,
Rockville, MD 20852 (internet address
https://www.usp.org). Copies may be
examined at the Food and Drug
Administration’s Main Library, 10903
New Hampshire Ave., Bldg. 2, Third
Floor, Silver Spring, MD 20993, 301–
796–2039, or at the National Archives
and Records Administration (NARA).
For information on the availability of
this material at NARA, call 202–741–
6030, or go to: https://www.archives.gov/
federal-register/cfr/ibr-locations.html.
(c) * * *
(1) At levels not to exceed 100
International Units (IU) per 240
milliliters (mL) in 100 percent fruit
juices (as defined under § 170.3(n)(35)
of this chapter) that are fortified with
greater than or equal to 330 milligrams
(mg) of calcium per 240 mL, excluding
fruit juices that are specially formulated
or processed for infants.
(2) At levels not to exceed 100 IU per
240 mL in fruit juice drinks (as defined
under § 170.3(n)(35) of this chapter) that
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I. Table of Abbreviations
are fortified with greater than or equal
to 100 mg of calcium per 240 mL,
excluding fruit juice drinks that are
specially formulated or processed for
infants.
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CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
OMB Office of Management and Budget
NPRM Notice of proposed rulemaking
(Advance, Supplemental)
§ Section
U.S.C. United States Code
FL Florida
FDOT Florida Department of
Transportation
AICW Atlantic Intracoastal Waterway
Dated: September 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–20375 Filed 9–19–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 117
[Docket No. USCG–2017–0273]
RIN 1625–AA09
Drawbridge Operation Regulation;
Atlantic Intracoastal Waterway, Palm
Beach, FL
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
The Coast Guard is modifying
the operating schedule that governs the
operation of the Flagler Memorial (SR
A1A) Bridge, mile 1021.8, the Royal
Park (SR 704) Bridge, mile 1022.6, and
the Southern Boulevard (SR 700/80)
Bridge, mile 1024.7, across the Atlantic
Intracoastal Waterway, at West Palm
Beach, Florida. This modification
allows the Flagler Memorial, Royal Park
and Southern Boulevard Bridges to
operate on alternative schedules when
the President of the United States,
members of the First Family, or other
persons under the protection of the
Secret Service visit Mar-a-Lago. The
modifications are necessary to
accommodate the increase in vehicular
traffic when the presidential motorcade
is in transit.
DATES: This rule is effective on
September 20, 2018.
ADDRESSES: To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov. Type USCG–
2017–0273 in the ‘‘SEARCH’’ box and
click ‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rulemaking.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email CWO4 Robert Wooten, Coast
Guard Sector Miami, FL, Waterways
Management Division, telephone 305–
535–4311, email robert.a.wooten@
uscg.mil.
SUPPLEMENTARY INFORMATION:
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II. Background Information and
Regulatory History
On August 17, 2017, the Coast Guard
published a notice of deviation from
drawbridge regulation with request for
comments in the Federal Register (82
FR 39019) to test proposed changes.
Three comments were received. Due to
delays in processing this proposed
regulatory change, on March 6, 2018,
the Coast Guard published a notice of
deviation from regulations with request
for comments extension in the Federal
Register (82 FR 9431) to allow for
additional time for the public to
comment. One comment was received.
On May 21, 2018, the Coast Guard
published a notice of proposed
rulemaking (NPRM) entitled Drawbridge
Operation Regulation; Atlantic
Intracoastal Waterway, Palm Beach, FL
in the Federal Register (83 FR 23398).
No comments were received. Due to
delays in processing this regulatory
change, on June 25, 2018, the Coast
Guard published a notice of deviation
from regulations with request for
comments extension in the Federal
Register (83 FR 29438) to allow
additional time for public comment and
to evaluate the changes to the operating
schedules with the establishment of the
Presidential Security Zone (82 FR
17295). No comments were received.
We are issuing rule under 5 U.S.C.
553(d)(3), the Coast Guard finds that
good cause exists for making this rule
effective in less than 30 days after
publication in the Federal Register. The
notice of deviation published in the
Federal Register (83 FR 29438) expires
on August 29, 2018 and this rule must
be in effect immediately thereafter.
III. Legal Authority and Need for Rule
The Coast Guard is issuing this rule
under authority 33 U.S.C. 499. The
Flagler Memorial (SR A1A) Bridge, mile
1021.8, across the AICW (Lake Worth
Lagoon) at West Palm Beach, Florida is
a double-leaf bascule bridge that has a
vertical clearance of 22 feet at mean
high water in the closed position. The
Royal Park (SR 704) Bridge, mile 1022.6,
across the AICW (Lake Worth Lagoon) at
West Palm Beach, Florida is a double-
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leaf bascule bridge that has a vertical
clearance of 21 feet at mean high water
in the closed position. The Southern
Boulevard (SR 700/80) Bridge, mile
1024.7, across the AICW (Lake Worth
Lagoon) at West Palm Beach, Florida is
under construction, a temporary lift
bridge is in place that has a vertical
clearance of 14 feet at mean high water
in the closed position and a 65 foot
vertical clearance in the open position.
The existing regulations are published
in 33 CFR 117.261(u), Flagler Memorial
Bridge, § 117.261(v) Royal Park Bridge,
and § 117.261(w) Southern Boulevard
Bridge.
The bridge owner, Florida Department
of Transportation, requested changes to
the drawbridge operating schedules to
better facilitate orderly vehicle traffic
flow across the Flagler Memorial, Royal
Park and Southern Boulevard bridges
when the President of the United States,
members of the First Family, or other
persons under the protection of the
Secret Service visit Mar-a-Lago. The
increase in traffic congestion occurs
when the Presidential Security Zone (82
FR 17295) is enforced which closes the
Southern Boulevard Bridge when the
presidential motorcade is in transit.
This action requires through traffic to
use the Flagler Memorial and Royal Park
Bridges.
IV. Discussion of Comments, Changes
and the Final Rule
As noted above, we received four
comments total on the two notices of
deviation published on August 17, 2017
and March 6, 2018, respectively. Of the
four comments received, one was a
political statement with no relevance on
the proposed regulation. Three of the
four comments received were in favor of
the regulation. Two of the comments in
favor of the regulation suggested the
changes be made permanent regardless
of presidential visits. The Coast Guard
has considered this recommendation,
however, making the modified operating
schedule permanent would place an
unreasonable burden on navigation and
potentially have a negative impact on
safe navigation. The modified schedule
is only in effect when uninterrupted
transit of dignitaries are crossing the
Southern Boulevard Bridge. While
vessels may have to wait up to an hour,
it is only during the weekdays and for
a short period.
V. Regulatory Analyses
We developed this rule after
considering numerous statutes and
Executive Orders related to rulemaking.
Below we summarize our analyses
based on a number of these statutes and
E:\FR\FM\20SER1.SGM
20SER1
]]>Agencies
[Federal Register Volume 83, Number 183 (Thursday, September 20, 2018)]
[Rules and Regulations]
[Pages 47557-47560]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-20375]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2017-F-3717]
Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D3
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
food additive regulation for vitamin D3 to replace the
current Reference Daily Intake (RDI) percentage values of calcium in
100 percent fruit juices and fruit juice drinks with absolute values
and to update the reference for vitamin D3 specifications.
We are taking this action in response to a food additive petition filed
by the Juice Products Association.
DATES: This rule is effective September 20, 2018. Submit either
electronic or written objections and requests for a hearing on the
final rule by October 22, 2018. The Director of the Federal Register
approves the incorporation by reference of certain publications listed
in the rule as of September 20, 2018. See the ADDRESSES section and the
OBJECTIONS section IX of this document for further information on
filing objections.
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
October 22, 2018. The https://www.regulations.gov electronic filing
system will accept objections until midnight Eastern Time at the end of
October 22, 2018. 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-2017-F-3717 for ``Food Additives Permitted for Direct Addition to
Food for Human Consumption; Vitamin D3 Final Rule.''
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Judith Kidwell, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5001
Campus Dr., College Park, MD 20740-3835, 240-402-1071.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of July 26, 2017 (82 FR 34615), amended
August 22, 2017 (82 FR 39711), we announced that we filed a food
additive petition (FAP 7A4818) submitted on behalf of the Juice
Products Association by Hogan
[[Page 47558]]
Lovells US LLP, Columbia Square, 555 Thirteenth Street NW, Washington,
DC 20004. The petition proposed to amend the food additive regulations
in Sec. 172.380 (21 CFR 172.380), Vitamin D3, to replace
the currently specified minimum RDI percentage values of calcium in
calcium-fortified 100 percent fruit juices and fruit juice drinks with
absolute values. Specifically, Sec. 172.380(c)(1) currently provides
for the use of vitamin D3 at a level not to exceed 100
International Units (IU) per 240 milliliters (mL) in 100 percent fruit
juices that are fortified with greater than or equal to 33 percent of
the RDI of calcium per 240 mL, excluding fruit juices that are
specifically formulated or processed for infants. In addition, Sec.
172.380(c)(2) provides for the use of up to 100 IU of vitamin
D3 per 240 mL in fruit juice drinks that are fortified with
greater than or equal to 10 percent of the RDI of calcium per 240 mL,
excluding fruit juice drinks that are specifically formulated or
processed for infants. The petitioner proposed to replace the RDI
percentage values of calcium in 100 percent fruit juices and fruit
juice drinks in these regulations with the absolute values of added
calcium of 330 milligrams (mg) and 100 mg per 240 mL, respectively. The
petitioner also requested that we update the reference for
specifications for vitamin D3 in Sec. 172.380(b) from the
9th edition of the Food Chemicals Codex (FCC 9) to the 10th edition
(FCC 10).
II. Evaluation of Petition
Section 409(i) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 348(i)) states that we shall, by regulation, establish
the procedure for amending or repealing a food additive regulation, and
that this procedure shall conform to the procedure provided in section
409 of the FD&C Act. Our regulations specific to administrative actions
for food additives provide that the Commissioner of Food and Drugs, on
his own initiative or on the petition of any interested person, may
propose the issuance of a regulation amending or repealing a regulation
pertaining to a food additive (Sec. 171.130(a) (21 CFR 171.130(a))).
The regulations further provide that any such petition must include an
assertion of facts, supported by data, showing that new information
exists with respect to the food additive or that new uses have been
developed or old uses abandoned, that new data are available as to
toxicity of the chemical, or that experience with the existing
regulation or exemption may justify its amendment or repeal. New data
submitted as a food additive petition must be furnished in the form
specified in 21 CFR 171.1 and 171.100 for submitting such petitions
(Sec. 171.130(b)).
In the Federal Register of February 27, 2003 (68 FR 9000), we
issued the regulations at Sec. 172.380(c)(1) and (2) permitting the
use of vitamin D3 in calcium fortified 100 percent fruit
juices and fruit juice drinks. We took that action in response to a
food additive petition (FAP 2A4734) from the Minute Maid Co. (Minute
Maid). Minute Maid petitioned for vitamin D3 to be allowed
to be added to calcium-fortified 100 percent fruit juices and fruit
juice drinks so that the calcium and vitamin D levels are comparable to
the levels in milk. When we issued these regulations in 2003, the RDI
for calcium was 1,000 mg; however, in the Federal Register of May 27,
2016 (81 FR 33742), we issued a final rule which, among other things,
redefined the RDI of calcium for adults and children 4 years of age and
older to 1,300 mg (21 CFR 101.9(c)(8)(iv)). Because of the change in
the RDI for calcium, the minimum level of added calcium in 100 percent
fruit juice that may be fortified with vitamin D3 increased
from 330 mg to 430 mg and in fruit juice drinks from 100 mg to 130 mg.
The Juice Products Association stated that the proposed revision of
Sec. 172.380 to specify absolute values of calcium on a mg/mL basis
rather than a percentage of RDI is needed to maintain the relative
parity between fortified 100 percent fruit juices and fruit juice
drinks and many dairy products. Without this change, the petitioner
stated that 100 percent fruit juices with vitamin D3 would
have higher calcium levels than milk. The petitioner also stated that
the higher levels of calcium resulting from the redefined RDI for
calcium present formulation challenges and may adversely impact the
taste of the juice or juice drink, which could deter consumers from
selecting calcium and vitamin D fortified juices. Therefore, the
petitioner proposed that Sec. 172.380 be amended to express the
allowable added calcium levels on a mg basis consistent with the
calcium levels before the revision of the RDI for calcium. In doing so,
the allowable levels of calcium and vitamin D in 100 percent fruit
juices and juice drinks would again be comparable to the levels in
milk.
Because the petitioner sought to revise the existing regulation to
restore the amount of calcium fortification required to levels on par
with milk, without introducing new uses for vitamin D3 or
changing the levels of vitamin D3 and calcium that were
considered when the regulations were established, there is no increase
in dietary exposure to vitamin D3 or to calcium. Therefore,
we have determined that there are no safety concerns as a result of the
proposed amendment.
Additionally, the current regulation for the use of vitamin
D3 in food (Sec. 172.380) indicates that the additive must
meet the specifications in the 9th edition of the Food Chemicals Codex
(FCC 9). The petitioner requested that we update the specifications for
vitamin D3 in Sec. 172.380 by replacing the existing FCC 9
reference with the 10th edition of the Food Chemicals Codex (FCC 10),
the most recent edition at the time the petition was submitted. The
specifications for vitamin D3 in FCC 10 are identical to
those in FCC 9. However, since we received the petition, FCC has been
updated to the 11th edition (FCC 11). The specifications for vitamin
D3 in FCC 11 are identical to those in FCC 10. Therefore, we
are amending Sec. 172.380 by adopting the specifications for vitamin
D3 in FCC 11 in place of FCC 9, because FCC 11 is the most
current version.
III. Incorporation by Reference
FDA is incorporating by reference the monograph from Food Chemicals
Codex, 11th ed., 2018, pp. 1243-1244 (vitamin D3), which is
approved by the Director of the Office of the Federal Register. You may
purchase a copy of the material from the United States Pharmacopeial
Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772,
https://www.usp.org/. Copies also may be examined at FDA's Main Library,
10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD
20993, 301-796-2039.
The FCC monograph establishes the standard for purity and identity
for vitamin D3. The monograph provides specifications and
analytical methodologies used to identify the substance and establish
acceptable purity criteria. To ensure that only food grade vitamin
D3 is used in foods listed in Sec. 172.380, the additive
must meet the specifications and identity in the FCC monograph.
IV. Conclusion
Based on data and information in the petition, we conclude that
amending the food additive regulations in the regulation for vitamin
D3 to replace the current RDI percentage values of calcium
in 100 percent fruit juices and fruit juice drinks with absolute values
is safe and appropriate. Thus, the RDI percentage values of calcium in
100 percent fruit juices and fruit juice drinks in these regulations
are replaced with the absolute values of added calcium of
[[Page 47559]]
330 mg and 100 mg per 240 mL, respectively. Consequently, we are
amending the food additive regulations as set forth in this document.
Additionally, the current regulation for the use of vitamin
D3 in food (Sec. 172.380) indicates that the additive must
meet the specifications in FCC 9. The more current version is FCC 11,
which contains specifications for vitamin D3 that are
identical to those in FCC 9. We are amending Sec. 172.380 by adopting
the specifications for vitamin D3 in FCC 11 in place of FCC
9.
V. 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 FOR FURTHER INFORMATION CONTACT). As provided in Sec.
171.1(h), we will delete from the documents any materials that are not
available for public disclosure.
VI. Analysis of Environmental Impact
We previously considered the environmental effects of this rule, as
stated in the July 26, 2017, Federal Register notice of filing (82 FR
34615). We stated in the notice of filing that we had determined, under
21 CFR 25.30(i), that this action ``is of a type that does not
individually or cumulatively have a significant effect on the human
environment because the amendments are administrative in nature'' such
that neither an environmental assessment nor an environmental impact
statement is required. Upon further consideration, we determined that
FAP 7A4818 is not solely administrative in nature as this revision has
the potential to lead to manufacturing changes. Consequently, the
action being requested is neither a correction nor technical change and
the original categorical exclusion (21 CFR 25.30(i)) is not
appropriate. Therefore, we have determined under 21 CFR 25.32(k) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment because the added
vitamin D3 and calcium will remain in the fruit juice and
fruit juice drinks through ingestion by consumers and neither food
additive is intended to replace macronutrients. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VII. 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.
VIII. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act
Our review of this petition was limited to section 409 of the FD&C
Act. 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, we 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. 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 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.
List of Subjects in 21 CFR Part 172
Food additives, Incorporation by reference, 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. Amend Sec. 172.380 by revising paragraphs (b) and (c)(1) through
(2) to read as follows:
Sec. 172.380 Vitamin D3.
* * * * *
(b) Vitamin D3 meets the specifications of ``Vitamin
D3,'', Food Chemicals Codex, 11th ed., copyright 2018, pp.
1243-1244, which is incorporated by reference. The Director of the
Office of the Federal Register approves this incorporation by reference
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain
copies from the United States Pharmacopeial Convention, 12601 Twinbrook
Pkwy., Rockville, MD 20852 (internet address https://www.usp.org).
Copies may be examined at the Food and Drug Administration's Main
Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring,
MD 20993, 301-796-2039, or at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
(c) * * *
(1) At levels not to exceed 100 International Units (IU) per 240
milliliters (mL) in 100 percent fruit juices (as defined under Sec.
170.3(n)(35) of this chapter) that are fortified with greater than or
equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit
juices that are specially formulated or processed for infants.
(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks
(as defined under Sec. 170.3(n)(35) of this chapter) that
[[Page 47560]]
are fortified with greater than or equal to 100 mg of calcium per 240
mL, excluding fruit juice drinks that are specially formulated or
processed for infants.
* * * * *
Dated: September 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20375 Filed 9-19-18; 8:45 am]
BILLING CODE 4164-01-P
