Document ID: FDA-2013-F-1540-0002
Agency: fda
Document Type: Rule
Title: Food Additives Permitted in Feed and Drinking Water of Animals; 25-
Hydroxyvitamin D3
Posted Date: 2018-10-02T04:00Z

[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