[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Rules and Regulations]
[Pages 19934-19935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09636]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-1509]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Marine Microalgae

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 dried marine 
microalgae as a source of docosahexaenoic acid (DHA) for use in 
complete, dry foods for adult dogs. This action is in response to a 
food additive petition filed by DSM Nutritional Products.

DATES: This rule is effective May 7, 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 June 6, 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 June 
6, 2018. The https://www.regulations.gov electronic filing system will 
accept comments until midnight Eastern Time at the end of June 6, 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-2014-F-1509 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Marine Microalgae.'' 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 review this copy, including the claimed confidential 
information, in its consideration of objections. The second copy, which 
will have the claimed confidential information redacted/

[[Page 19935]]

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 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: Chelsea Trull, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224), 
Rockville, MD 20855, 240-402-6729, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of October 16, 2014 
(79 FR 62090), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2288) submitted by DSM Nutritional Products, 45 
Waterview Blvd., Parsippany, NJ 07054. The petition proposed that the 
regulations for food additives permitted in feed and drinking water of 
animals be amended to provide for the safe use of Schizochytrium sp. 
dried marine microalgae as a source of DHA for use in complete, dry 
foods for adult dogs.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
Schizochytrium sp. dried marine microalgae as a source of DHA for use 
in complete, dry foods for adult dogs 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 petition 
and documents we considered and relied upon in reaching our decision to 
approve the petition will be made available for inspection at the 
Center for Veterinary Medicine by appointment with the information 
contact person (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 before making the documents 
available for inspection.

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.  573.615 to subpart B to read as follows:


Sec.  573.615  Marine microalgae.

    The food additive, marine microalgae, may be safely used as a 
source of docosahexaenoic acid (DHA) and other omega-3 fatty acids in 
accordance with the following prescribed conditions:
    (a) The additive is dried whole cells of nonviable, nontoxigenic, 
nonpathogenic Schizochytrium sp. algae grown as a pure culture.
    (b) The additive is used in complete, dry adult maintenance food 
for dogs in accordance with good manufacturing and feeding practices 
not to exceed 16.5 pounds per ton (7.5 kilograms (kg) per 1000 kg) of 
complete, dry, adult maintenance dog food.
    (c) The additive consists of not less than 17.0 percent 
(4Z,7Z,10Z,13Z,16Z,19Z)-docosa-4,7,10,13,16,19-hexaenoic acid 
(docosahexaenoic acid or DHA).
    (d) The additive meets the following specifications:
    (1) Not less than 40 percent crude fat;
    (2) Not more than 12 percent ash;
    (3) Not more than 8 percent unsaponifiable matter;
    (4) Not more than 5 percent insoluble impurities;
    (5) Not more than 5 percent free fatty acids; and
    (6) Not more than 6 percent water.
    (e) To ensure the safe use of the additive, in addition to other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and 
complete feed, shall contain the name of the additive, marine 
microalgae.
    (2) The label and labeling of the additive and any feed premix 
shall also contain:
    (i) A statement to indicate that the maximum use level of the 
additive shall not exceed 16.5 pounds per ton (7.5 kg per 1000 kg) of 
complete, dry, adult maintenance dog food.
    (ii) Adequate directions for use.

    Dated: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09636 Filed 5-4-18; 8:45 am]
 BILLING CODE 4164-01-P


