Food Additives Permitted in Feed and Drinking Water of Animals; 25-Hydroxyvitamin D3, 49485-49487 [2018-21396]
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Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Rules and Regulations
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
Issued in College Park, Georgia, on
September 24, 2018.
Ryan W. Almasy,
Manager, Operations Support Group, Eastern
Service Center, Air Traffic Organization.
1. The authority citation for part 71
continues to read as follows:
[FR Doc. 2018–21316 Filed 10–1–18; 8:45 am]
■
BILLING CODE 4910–13–P
Authority: 49 U.S.C. 106(f), 106(g); 40103,
40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR,
1959–1963 Comp., p. 389.
§ 71.1
[Amended]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.11C,
Airspace Designations and Reporting
Points, dated August 13, 2018, and
effective September 15, 2018, is
amended as follows:
■
Paragraph 6002
Airspace.
Class E Surface Area
*
*
*
*
ASO TN E2
21 CFR Part 573
[Docket Nos. FDA–2013–F–1540 and FDA–
2014–F–0296]
Food Additives Permitted in Feed and
Drinking Water of Animals; 25Hydroxyvitamin D3
AGENCY:
ACTION:
Knoxville, TN [Amended]
Paragraph 6005 Class E Airspace Areas
Extending Upward from 700 feet or More
Above the Surface of the Earth.
*
*
ASO TN E5
*
*
Knoxville, TN [Amended]
McGhee-Tyson Airport, TN
(Lat. 35°48′34″ N, long. 83°59′43″ W)
Gatlinburg-Pigeon Forge Airport, TN
(Lat. 35°51′28″ N, long. 83°31′43″ W)
Knoxville Downtown Island Airport, TN
(Lat. 35°57′50″ N, long. 83°52′25″ W)
That airspace extending upward from 700
feet above the surface within a 15.4-mile
radius of McGhee-Tyson Airport, and within
a 13-mile radius of Gatlinburg-Pigeon Forge
Airport, and from the 080° bearing from
Gatlinburg-Pigeon Forge Airport clockwise to
the 210° bearing extending from the 13-mile
radius southeast to the 33-mile radius
centered on Gatlinburg-Pigeon Forge Airport,
and within an 8-mile radius of Knoxville
Downtown Island Airport.
amozie on DSK3GDR082PROD with RULES
ASO TN E5
Madisonville, TN [New]
Monroe County Airport, TN,
(Lat. 35°32′43″ N, long. 84°22′49″ W)
That airspace extending upward from 700
feet above the surface within an 8.5-mile
radius of Monroe County Airport.
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16:20 Oct 01, 2018
Jkt 247001
Final rule.
The Food and Drug
Administration (FDA, we, or the
Agency) is amending the regulations for
food additives permitted in feed and
drinking water of animals to provide for
the safe use of 25-hydroxyvitamin D3 as
a source of vitamin D3 activity for layer
and breeder chickens and turkeys. This
action is in response to two food
additive petitions filed by DSM
Nutritional Products.
DATES: This rule is effective October 2,
2018. See section V of this document for
further information on the filing of
objections. Submit either electronic or
written objections and requests for a
hearing on the final rule by November
1, 2018.
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 November 1, 2018. The
https://www.regulations.gov electronic
filing system will accept comments
until 11:59 p.m. Eastern Time at the end
of November 1, 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.
SUMMARY:
Knoxville Downtown Island Airport, TN
(Lat. 35°57′50″ N, long. 83°52′25″ W)
University of Tennessee Medical Center
Heliport, TN
(Lat. 35°56′30″ N, long. 83°56′38″ W)
Within a 4.5-mile radius of Knoxville
Downtown Island Airport, excluding that
airspace within a 1.0-mile radius of
University of Tennessee Medical Center
Heliport.
*
Food and Drug Administration,
HHS.
*
Electronic Submissions
Submit electronic objections in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting objections.
Objections submitted electronically,
PO 00000
Frm 00027
Fmt 4700
Sfmt 4700
49485
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–
2013–F–1540 (for submissions related to
FAP 2277) or FDA–2014–F–0296 (for
submissions related to FAP 2279) for
‘‘Food Additives Permitted in Feed and
Drinking Water of Animals; 25hydroxyvitamin D3.’’ 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 in 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.’’ The Agency will
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Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Rules and Regulations
review this copy, including the claimed
confidential information, in its
consideration of objections. 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 objections 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 objections
received, go to https://
www.regulations.gov and insert the
appropriate 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:
Carissa Doody, Center for Veterinary
Medicine, Food and Drug
Administration, 7519 Standish Pl.
(HFV–228), Rockville, MD 20855, 240–
402–6283, carissa.doody@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
amozie on DSK3GDR082PROD with RULES
In documents published in the
Federal Register of December 23, 2013
(78 FR 77384) and March 26, 2014 (79
FR 16698), FDA announced that we had
filed two food additive petitions (animal
use) (FAPs 2277 and 2279) submitted by
DSM Nutritional Products, 45
Waterview Blvd., Parsippany, NJ 07054.
The petitions proposed that the
regulations for food additives permitted
in feed and drinking water of animals be
amended to provide for the safe use of
25-hydroxyvitamin D3 as a source of
vitamin D3 activity for layer and breeder
chickens (FAP 2277) and turkeys (FAP
2279).
II. Conclusion
FDA concludes that the data establish
the safety and utility of 25hydroxyvitamin D3 as a source of
vitamin D3 activity for layer and breeder
chickens and turkeys and that the food
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16:20 Oct 01, 2018
Jkt 247001
additive regulations should be amended
as set forth in this document. This is not
a significant regulatory action subject to
Executive Order 12866.
In accordance with § 571.1(h) (21 CFR
571.1(h)), the petitions and documents
we considered and relied upon in
reaching our decision to approve the
petitions will be made available for
public disclosure (see FOR FURTHER
INFORMATION CONTACT). As provided in
§ 571.1(h), we will delete from the
documents any materials that are not
available for public disclosure.
IV. Analysis of Environmental Impact
The Agency has determined under 21
CFR 25.32(r) that this action is of a type
that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
V. Objections and Hearing Requests
Any person who will be adversely
affected by this regulation may file with
the Dockets Management Staff (see
ADDRESSES) either electronic or written
objections. Each objection shall be
separately numbered, and each
numbered objection shall specify with
particularity the provision of the
regulation to which objection is made
and the grounds for the objection. Each
numbered objection on which a hearing
is requested shall specifically so state.
Failure to request a hearing for any
particular objection shall constitute a
waiver of the right to a hearing on that
objection. Each numbered objection for
which a hearing is requested shall
include a detailed description and
analysis of the specific factual
information intended to be presented in
support of the objection in the event
that a hearing is held. Failure to include
such a description and analysis for any
particular objection shall constitute a
waiver of the right to a hearing on the
objection.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 573 is
amended as follows:
PART 573—FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
1. The authority citation for part 573
continues to read as follows:
■
Frm 00028
Fmt 4700
2. Add § 573.550 to subpart B to read
as follows:
§ 573.550
III. Public Disclosure
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Authority: 21 U.S.C. 321, 342, 348.
■
Sfmt 4700
25-hydroxyvitamin D3
The food additive, 25-hydroxyvitamin
D3, may be safely used in accordance
with the following prescribed
conditions:
(a) The additive is used or intended
for use as a source of vitamin D3 activity
in animal feed or drinking water in
accordance with good manufacturing
and feeding practices as follows:
(1) In feed or drinking water of layer
and breeder chickens not to exceed 69
parts per billion (ppb) in feed or 34.5
ppb in drinking water.
(2) In feed or drinking water of
turkeys not to exceed:
(i) 92 ppb in feed; or
(ii) In drinking water, 25 ppb for
turkeys up to 3 weeks of age, 36 ppb for
turkeys from 4 to 11 weeks of age, or 45
ppb for turkeys over 11 weeks of age.
(b) The additive consists of not less
than 94 percent 25-hydroxyvitamin D3
(9,10-secocholesta-5,7,10(19)-triene-3b,
25-diol).
(c) The additive meets the following
specifications:
(1) Not more than 1 percent of any
individual sterol.
(2) Not more than 5 percent water.
(3) Not more than 20 parts per million
(ppm) lead.
(4) Not more than 20 ppm aluminum.
(5) Not more than 1.0 percent solvents
and non-detectable levels of 2′, 4′, 5′, 7′
tetraiodofluorescin.
(6) Not more than 1 ppb 1, 25dihydroxycholecalciferol.
(d) To assure safe use of the additive,
in addition to the other information
required by the Federal Food, Drug, and
Cosmetic Act, the label and labeling
shall contain:
(1) The name of the additive.
(2) A statement to indicate the
maximum use level of 25hydroxyvitamin D3 must not exceed 69
ppb in feed or 34.5 ppb in drinking
water for layer and breeder chickens.
(3) A statement to indicate for turkeys
the maximum use level of 25hydroxyvitamin D3 must not exceed 92
ppb in feed; or in drinking water, 25
ppb for turkeys up to 3 weeks of age, 36
ppb for turkeys from 4 to 11 weeks of
age, or 45 ppb for turkeys over 11 weeks
of age.
(4) Adequate use directions to ensure
that 25-hydroxyvitamin D3 (and all
premixes) is uniformly blended
throughout the feed or drinking water.
(5) An expiration date on all premix
labeling.
(6) A statement on all premix labeling
(feed and drinking water forms) that 25-
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Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Rules and Regulations
hydroxyvitamin D3 cannot be used
simultaneously in both feed and water.
Dated: September 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–21396 Filed 10–1–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Part 658
[FHWA Docket No. FHWA–2018–0035]
RIN 2125–AF81
Truck Size and Weight
Federal Highway
Administration (FHWA), U. S.
Department of Transportation (DOT).
ACTION: Final rule; technical correction.
AGENCY:
This rule makes a technical
correction to the regulations that govern
Longer Combination Vehicles (LCV) for
the Commonwealth of Pennsylvania and
the State of Ohio. The amendments
contained herein make no substantive
changes to FHWA regulations, policies,
or procedures.
DATES: This rule is effective November
1, 2018.
FOR FURTHER INFORMATION CONTACT: John
Berg, Truck Size and Weight Program
Manager, Office of Freight Management
and Operations, (202) 740–4602; or
William Winne, Office of the Chief
Counsel, (202) 366–1397. Both are
located at 1200 New Jersey Avenue SE,
Washington, DC 20590. Office hours for
FHWA are from 8:00 a.m. to 4:30 p.m.,
e.t., Monday through Friday, except
Federal holidays.
SUPPLEMENTARY INFORMATION:
SUMMARY:
amozie on DSK3GDR082PROD with RULES
Electronic Access
An electronic copy of this document
may be downloaded by accessing the
Office of the Federal Register’s home
page at: https://www.archives.gov or the
Government Publishing Office’s web
page at: https://www.gpoaccess.gov/nara.
Background
This rulemaking makes technical
corrections to the regulations in
appendix C of 23 CFR part 658 that
govern length and weight of trailers in
Pennsylvania and Ohio. The regulations
on LCV’s were frozen as of July 1, 1991,
in accordance with Section 1023 of the
Intermodal Surface Transportation
Efficiency Act (ISTEA).1
1 Public Law 105–240, 105 Stat. 1914, 1951 (Dec.
18, 1991) (codified at 23 U.S.C. 127(d)).
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16:20 Oct 01, 2018
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A procedure to ‘‘review and correct’’
the accuracy of the list mandated in 23
U.S.C. 127(d)(3)(D) is provided under 23
U.S.C. 127(d)(3)(E), and implemented
under 23 CFR 658.23(f). This provision
requires the FHWA Administrator to
review petitions to correct any errors in
Appendix C. The Commonwealth of
Pennsylvania and State of Ohio have
petitioned the Federal Highway
Administrator to make corrections to
items they found to be incorrect in
accordance with 23 CFR 658.23(f), and
certified those provisions were in effect
as of July 1, 1991.
The Pennsylvania Department of
Transportation petitioned FHWA
seeking to invoke the ‘‘grandfather’’
provisions of 23 U.S.C. 127(a)(4) to
allow the operation on the Pennsylvania
Turnpike of vehicles or loads with
weight limitations exceeding the
Federal maximums mandated in 23
U.S.C. 127(a). Pennsylvania’s claim to
grandfather rights is based on State
statute or enforceable regulation
authorizing weight limitations
exceeding the Federal maximum in
existence on or before July 1, 1956. The
Commonwealth seeks to correct a
reporting mistake under 23 U.S.C.
127(d)(3)(A) regarding the actual lawful
operation on the Turnpike of LCVs up
to 100,000 pounds and no longer than
28 1⁄2 feet for each trailer on or before,
June 1, 1991. These provisions will be
added to Appendix C and bring it into
conformance with the Pennsylvania
statutes of that time.
The Ohio Department of
Transportation (ODOT) petitioned
FHWA seeking to invoke the
‘‘grandfather’’ provisions of 23 U.S.C.
127(a)(4) to reflect that triple-trailers can
operate on any ‘‘turnpike project’’ as
defined in Ohio Revised Code (ORC)
section 5537.01 and permitted by the
Ohio Turnpike and Infrastructure
Commission under the program
authorized in ORC 5537.16 (The Ohio
Turnpike Act of 1949 and as amended
and effective prior to June 1, 1991). In
addition, under ORC 4513.34, ODOT
and local authorities are authorized to
issue special permits for oversized
vehicles (effective prior to June 1, 1991).
These provisions will be added to
Appendix C and bring it into
conformance with the Ohio’s statutes of
that time.
Rulemaking Analyses and Notice
Under the Administrative Procedure
Act (5 U.S.C. 553(b)), an agency may
waive the normal notice and comment
requirements if it finds, for good cause,
that they are impracticable,
unnecessary, or contrary to the public
interest. The FHWA finds that notice
PO 00000
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49487
and comment for this rule is
unnecessary and contrary to the public
interest because it will have no
substantive impact and is technical in
nature. The amendments to the rule are
based upon the explicit language of
statutes that were enacted subsequent to
the promulgation of the rule. The
FHWA does not anticipate receiving
meaningful comments. States, local
governments, motor carriers, and other
transportation stakeholders rely upon
the regulations corrected by this action.
These corrections will reduce confusion
for these entities and should not be
unnecessarily delayed. Accordingly, for
the reasons listed above, the agencies
find good cause under 5 U.S.C.
553(b)(3)(B) to waive notice and
opportunity for comment.
Executive Order 12866 (Regulatory
Planning and Review), Executive Order
13563 (Improving Regulation and
Regulatory Review), Executive Order
13771 (Reducing Regulations and
Controlling Regulatory Costs), and DOT
Regulatory Policies and Procedures
The FHWA has determined that this
action is not a significant regulatory
action within the meaning of Executive
Order (E.O.) 12866 or significant within
the meaning of DOT regulatory policies
and procedures. This action complies
with E.O.s 12866 and 13563 to improve
regulation. It is anticipated that the
economic impact of this rulemaking will
be minimal. This rule only makes minor
corrections that will not in any way
alter the regulatory effect of 23 CFR part
658. Thus, this final rule will not
adversely affect, in a material way, any
sector of the economy. In addition, these
changes will not interfere with any
action taken or planned by another
agency and will not materially alter the
budgetary impact of any entitlements,
grants, user fees, or loan programs. This
action complies with E.O.s 12866,
13563, and 13771 to improve regulation.
This rule is not an Executive Order
13771 regulatory action because this
rule is not significant under Executive
Order 12866.
Regulatory Flexibility Act
In compliance with the Regulatory
Flexibility Act (Pub. L. 96–354, 5 U.S.C.
601–612) FHWA has evaluated the
effects of this action on small entities
and has determined that the action will
not have a significant economic impact
on a substantial number of small
entities. This final rule will not make
any substantive changes to our
regulations or in the way that our
regulations affect small entities; it
merely corrects technical errors. For this
reason, FHWA certifies that this action
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]]>Agencies
[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Rules and Regulations]
[Pages 49485-49487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21396]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket Nos. FDA-2013-F-1540 and FDA-2014-F-0296]
Food Additives Permitted in Feed and Drinking Water of Animals;
25-Hydroxyvitamin D3
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, or the Agency) is
amending the regulations for food additives permitted in feed and
drinking water of animals to provide for the safe use of 25-
hydroxyvitamin D3 as a source of vitamin D3
activity for layer and breeder chickens and turkeys. This action is in
response to two food additive petitions filed by DSM Nutritional
Products.
DATES: This rule is effective October 2, 2018. See section V of this
document for further information on the filing of objections. Submit
either electronic or written objections and requests for a hearing on
the final rule by November 1, 2018.
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
November 1, 2018. The https://www.regulations.gov electronic filing
system will accept comments until 11:59 p.m. Eastern Time at the end of
November 1, 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 objections. 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-2013-F-1540 (for submissions related to FAP 2277) or FDA-2014-F-
0296 (for submissions related to FAP 2279) for ``Food Additives
Permitted in Feed and Drinking Water of Animals; 25-hydroxyvitamin
D3.'' 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 in 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.'' The
Agency will
[[Page 49486]]
review this copy, including the claimed confidential information, in
its consideration of objections. 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 objections 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 objections received, go to https://www.regulations.gov and insert the appropriate 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: Carissa Doody, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-228),
Rockville, MD 20855, 240-402-6283, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In documents published in the Federal Register of December 23, 2013
(78 FR 77384) and March 26, 2014 (79 FR 16698), FDA announced that we
had filed two food additive petitions (animal use) (FAPs 2277 and 2279)
submitted by DSM Nutritional Products, 45 Waterview Blvd., Parsippany,
NJ 07054. The petitions proposed that the regulations for food
additives permitted in feed and drinking water of animals be amended to
provide for the safe use of 25-hydroxyvitamin D3 as a source
of vitamin D3 activity for layer and breeder chickens (FAP
2277) and turkeys (FAP 2279).
II. Conclusion
FDA concludes that the data establish the safety and utility of 25-
hydroxyvitamin D3 as a source of vitamin D3
activity for layer and breeder chickens and turkeys and that the food
additive regulations should be amended as set forth in this document.
This is not a significant regulatory action subject to Executive Order
12866.
III. Public Disclosure
In accordance with Sec. 571.1(h) (21 CFR 571.1(h)), the petitions
and documents we considered and relied upon in reaching our decision to
approve the petitions will be made available for public disclosure (see
FOR FURTHER INFORMATION CONTACT). As provided in Sec. 571.1(h), we
will delete from the documents any materials that are not available for
public disclosure.
IV. Analysis of Environmental Impact
The Agency has determined under 21 CFR 25.32(r) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
V. Objections and Hearing Requests
Any person who will be adversely affected by this regulation may
file with the Dockets Management Staff (see ADDRESSES) either
electronic or written objections. Each objection shall be separately
numbered, and each numbered objection shall specify with particularity
the provision of the regulation to which objection is made and the
grounds for the objection. Each numbered objection on which a hearing
is requested shall specifically so state. Failure to request a hearing
for any particular objection shall constitute a waiver of the right to
a hearing on that objection. Each numbered objection for which a
hearing is requested shall include a detailed description and analysis
of the specific factual information intended to be presented in support
of the objection in the event that a hearing is held. Failure to
include such a description and analysis for any particular objection
shall constitute a waiver of the right to a hearing on the objection.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
573 is amended as follows:
PART 573--FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF
ANIMALS
0
1. The authority citation for part 573 continues to read as follows:
Authority: 21 U.S.C. 321, 342, 348.
0
2. Add Sec. 573.550 to subpart B to read as follows:
Sec. 573.550 25-hydroxyvitamin D3
The food additive, 25-hydroxyvitamin D3, may be safely
used in accordance with the following prescribed conditions:
(a) The additive is used or intended for use as a source of vitamin
D3 activity in animal feed or drinking water in accordance
with good manufacturing and feeding practices as follows:
(1) In feed or drinking water of layer and breeder chickens not to
exceed 69 parts per billion (ppb) in feed or 34.5 ppb in drinking
water.
(2) In feed or drinking water of turkeys not to exceed:
(i) 92 ppb in feed; or
(ii) In drinking water, 25 ppb for turkeys up to 3 weeks of age, 36
ppb for turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over
11 weeks of age.
(b) The additive consists of not less than 94 percent 25-
hydroxyvitamin D3 (9,10-secocholesta-5,7,10(19)-triene-
3[beta], 25-diol).
(c) The additive meets the following specifications:
(1) Not more than 1 percent of any individual sterol.
(2) Not more than 5 percent water.
(3) Not more than 20 parts per million (ppm) lead.
(4) Not more than 20 ppm aluminum.
(5) Not more than 1.0 percent solvents and non-detectable levels of
2', 4', 5', 7' tetraiodofluorescin.
(6) Not more than 1 ppb 1, 25-dihydroxycholecalciferol.
(d) To assure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act, the
label and labeling shall contain:
(1) The name of the additive.
(2) A statement to indicate the maximum use level of 25-
hydroxyvitamin D3 must not exceed 69 ppb in feed or 34.5 ppb
in drinking water for layer and breeder chickens.
(3) A statement to indicate for turkeys the maximum use level of
25-hydroxyvitamin D3 must not exceed 92 ppb in feed; or in
drinking water, 25 ppb for turkeys up to 3 weeks of age, 36 ppb for
turkeys from 4 to 11 weeks of age, or 45 ppb for turkeys over 11 weeks
of age.
(4) Adequate use directions to ensure that 25-hydroxyvitamin
D3 (and all premixes) is uniformly blended throughout the
feed or drinking water.
(5) An expiration date on all premix labeling.
(6) A statement on all premix labeling (feed and drinking water
forms) that 25-
[[Page 49487]]
hydroxyvitamin D3 cannot be used simultaneously in both feed
and water.
Dated: September 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21396 Filed 10-1-18; 8:45 am]
BILLING CODE 4164-01-P
