Document ID: FDA-2015-F-2712-0003
Agency: fda
Document Type: Rule
Title: Food Additives Permitted in Feed and Drinking Water of Animals;
Selenomethionine Hyd
Posted Date: 2019-03-06T05:00Z

[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Rules and Regulations]
[Pages 7991-7993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03909]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2015-F-2712]

Food Additives Permitted in Feed and Drinking Water of Animals; 
Selenomethionine Hydroxy Analogue

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 
selenomethionine hydroxy analogue as a source of selenium in feed for 
chickens, turkeys, and swine, as well as to provide for the safe use of 
silicon dioxide as a carrier for selenomethionine hydroxy analogue. 
This action is in response to a food additive petition filed by Adisseo 
France S.A.S.

DATES: This rule is effective March 6, 2019. 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 April 5, 2019.

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 April 
5, 2019. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of April 5, 
2019. Objections received by mail/hand delivery/courier (for written/
paper submissions) will be considered timely if they are postmarked or 
the

[[Page 7992]]

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-2015-F-2712 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Selenomethionine Hydroxy Analogue.'' 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/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, chelsea.trull@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    In documents published in the Federal Register of August 13, 2015 
(80 FR 48471), and October 30, 2018 (83 FR 54526), FDA announced that 
we had filed a food additive petition (animal use) (FAP 2291) submitted 
by Adisseo France S.A.S., Immeuble Antony Parc II, 10 Place du 
G[eacute]n[eacute]ral de Gaulle, 92160 Antony, France. 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 
selenomethionine hydroxy analogue as a source of selenium in feed for 
chickens, turkeys, swine, dairy cattle, and beef cattle and the safe 
use of silicon dioxide as a carrier for selenomethionine hydroxy 
analogue at a level not to exceed 95 percent of the selenomethionine 
hydroxy analogue in its packaged form. Subsequently, the intended use 
of selenomethionine hydroxy analogue was limited to chickens, turkeys, 
and swine.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
selenomethionine hydroxy analogue as a source of selenium in feed for 
chickens, turkeys, and swine, as well as silicon dioxide as a carrier 
for selenomethionine hydroxy analogue 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 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

[[Page 7993]]

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. Amend Sec.  573.920 by:
0
a. Revising paragraph (b) and paragraph (c) introductory text,
0
b. Adding new paragraphs (c)(4) and (5);
0
c. Removing paragraph (d);
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d. Redesignating paragraphs (e) through (h) as paragraphs (d) through 
(g);
0
e. Revising newly redesignated paragraph (g)(4); and
0
f. Adding new paragraph (h).
    The revisions and additions read as follows:

Sec.  573.920   Selenium.

* * * * *
    (b) The food additive selenium is a nutrient administered in animal 
feed as sodium selenite or sodium selenate as provided in paragraph (c) 
of this section, as a controlled-release sodium selenite bolus as 
provided in paragraph (f) of this section, as selenium yeast as 
provided in paragraph (g) of this section, or as selenomethionine 
hydroxy analogue as provided in paragraph (h) of this section.
    (c) Selenium, as sodium selenite or sodium selenate, is added to 
feed as follows:
* * * * *
    (4) The additive, as sodium selenite or sodium selenate, shall be 
incorporated into feed as follows:
    (i) It shall be incorporated into each ton of complete feed by 
adding no less than 1 pound of a premix containing no more than 272.4 
milligrams of added selenium per pound.
    (ii) It shall be incorporated into each ton of salt-mineral mixture 
for sheep or beef cattle from a premix containing no more than 4.5 
grams of added selenium per pound.
    (5) Usage of the additive must conform to the requirements of 
paragraphs (d) and (e) of this section.
* * * * *
    (g) * * *
    (4) Usage of this additive must conform to the requirements of 
paragraphs (d) and (e) of this section.
    (h) Selenomethionine hydroxy analogue [R,S-2-hydroxy-4-
methylselenobutanoic acid (CAS 873660-49-2)] is manufactured by the 
reaction of elemental selenium with methyllithium to form a 
methylseleno salt, which is then reacted with R,S-2-
hydroxybutyrolactone to form a salt of 2-hydroxy-4-methylselenobutanoic 
acid. After acidification and purification, the additive consists of 
not less than 39.5 percent total selenium by weight with a 
selenomethionine hydroxy analogue content of not less than 98 percent 
of total selenium. The total organic selenium content of the additive 
is not less than 99 percent of total selenium.
    (1) The selenomethionine hydroxy analogue meets the following 
specifications:
    (i) Arsenic, not more than 2 parts per million (ppm);
    (ii) Cadmium, not more than 1 ppm;
    (iii) Lead, not more than 1 ppm; and
    (iv) Mercury, not more than 1 ppm.
    (2) Selenium, as selenomethionine hydroxy analogue, is added to 
complete feed for chickens, turkeys, and swine at a level not to exceed 
0.3 ppm.
    (3) To ensure safe use of the additive, in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act, the 
label and labeling of selenomethionine hydroxy analogue in its packaged 
form shall contain:
    (i) The name, selenomethionine hydroxy analogue;
    (ii) Minimum and maximum guarantees for a total selenium content of 
not less than 2.08 percent (weight/weight) and not more than 2.24 
percent;
    (iii) Minimum guarantee for selenomethionine hydroxy analogue 
content of not less than 5.2 percent;
    (iv) The following statement, ``Storage Conditions: 
Selenomethionine hydroxy analogue must be stored in a closed package at 
temperatures not higher than 20 [deg]C (68 [deg]F).''; and
    (v) An expiration date not to exceed 1 year from the date of 
manufacture.
    (4) The additive, as selenomethionine hydroxy analogue, shall be 
incorporated into each ton of complete feed by adding no less than 1 
pound of a premix containing no more than 272.4 milligrams of added 
selenium per pound.
    (5) Usage of this additive must conform to the requirements of 
paragraphs (d) and (e) of this section.

0
3. Amend Sec.  573.940 by adding an entry for ``Selenomethionine 
hydroxy analogue'' to the end of the table in paragraph (d) to read as 
follows:

Sec.  573.940  Silicon dioxide.

* * * * *
    (d) * * *

------------------------------------------------------------------------
                                                             Limitations
                       Feed component                         (percent)
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                                * * * * *
Selenomethionine hydroxy analogue..........................           95
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* * * * *

    Dated: February 28, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03909 Filed 3-5-19; 8:45 am]
 BILLING CODE 4164-01-P