[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]
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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.
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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