Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue, 7991-7993 [2019-03909]
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Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Rules and Regulations
are an ‘‘agency’s reading of a statute’’
that do not ‘‘intend to create new rights
or duties, but only remind affected
parties of existing duties.’’ 16
28. This final rule is an interpretive
rule because it modifies the
Commission’s regulations to conform to
the Water Infrastructure Act. It does not
create new rights or duties. Rather, it
reminds affected parties of existing
duties required by the Water
Infrastructure Act, with which the
Commission and non-agency entities
have complied since the Act’s
enactment.
Document Availability
29. In addition to publishing the full
text of this document in the Federal
Register, the Commission provides all
interested persons an opportunity to
view and/or print the contents of this
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FERC’s Home Page (https://
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Reference Room during normal business
hours (8:30 a.m. to 5:00 p.m. Eastern
time) at 888 First Street NE, Room 2A,
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30. From FERC’s Home Page on the
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printing, and/or downloading. To access
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Effective Date and Congressional
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32. These regulations are effective
April 5, 2019. The Commission has
determined, with the concurrence of the
Administrator of the Office of
Information and Regulatory Affairs of
OMB, that this rule is not a ‘‘major rule’’
as defined in section 351 of the Small
Business Regulatory Enforcement
Fairness Act of 1996.
2012), https://www.sba.gov/sites/default/files/
rfaguide_0512_0.pdf.
16 Orengo Caraballo v. Reich, 11 F.3d 186, 195
(D.C. Cir. 1993).
VerDate Sep<11>2014
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List of Subjects
7991
PART 11—ANNUAL CHARGES UNDER
PART I OF THE FEDERAL POWER ACT
18 CFR Part 4
Administrative practice and
procedure, Electric power, Reporting
and recordkeeping requirements.
18 CFR Part 11
Dams, Electric power, Indians-lands,
Public lands, Reporting and
recordkeeping requirements.
By the Commission.
Issued: February 22, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
7. The authority citation for part 11 is
revised to read:
■
Authority: 16 U.S.C. 791a–825r; 42 U.S.C.
7101–7352.
§ 11.1
[Amended]
8. In § 11.1(c)(5), remove ‘‘, but in no
case longer than four years after the
issuance date of the license or
exemption’’.
■
[FR Doc. 2019–03742 Filed 3–5–19; 8:45 am]
BILLING CODE 6717–01–P
In consideration of the foregoing, the
Commission is amending parts 4 and 11,
chapter I, title 18, Code of Federal
Regulations, as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 4—LICENSES, PERMITS,
EXEMPTIONS, AND DETERMINATION
OF PROJECT COSTS
Food and Drug Administration
■
1. The authority citation for part 4 is
revised to read:
[Docket No. FDA–2015–F–2712]
Authority: 16 U.S.C. 791a–825r; 42 U.S.C.
7101–7352.
Food Additives Permitted in Feed and
Drinking Water of Animals;
Selenomethionine Hydroxy Analogue
§ 4.30
[Amended]
AGENCY:
2. In § 4.30(b)(26)(ii), remove the
number ‘‘5’’ and add in its place the
number ‘‘40’’.
■
§ 4.81
3. In § 4.81(a)(5), remove the number
‘‘36’’ and add in its place the number
‘‘48’’.
■ 4. In § 4.82, remove ‘‘five’’ and add in
its place ‘‘eight’’ in paragraphs (a) and
(c) and add paragraph (d) to read as
follows:
Amendments.
*
*
*
*
*
(d) At the end of the extension period
granted under paragraph (a) of this
section, the Commission may issue an
additional permit to the permittee if the
Commission determines that there are
extraordinary circumstances that
warrant the issuance of the additional
permit.
§ 4.400
[Amended]
5. In § 4.400, remove ‘‘by the
Hydropower Regulatory Efficiency Act
of 2013’’.
■
§ 4.401
[Amended]
6. In § 4.401:
a. In paragraph (a)(3), remove ‘‘the
date of enactment of the Hydropower
Regulatory Efficiency Act,’’.
■ b. In paragraph (b), remove ‘‘by
section 4 of the Hydropower Regulatory
Efficiency Act of 2013’’.
■
■
PO 00000
Frm 00013
Fmt 4700
Food and Drug Administration,
HHS.
ACTION:
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 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.
SUMMARY:
[Amended]
■
§ 4.82
21 CFR Part 573
Sfmt 4700
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
ADDRESSES:
E:\FR\FM\06MRR1.SGM
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7992
Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Rules and Regulations
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
VerDate Sep<11>2014
18:28 Mar 05, 2019
Jkt 247001
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/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
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 Ge´ne´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
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
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 § 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
§ 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
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Federal Register / Vol. 84, No. 44 / Wednesday, March 6, 2019 / Rules and Regulations
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:
■
Authority: 21 U.S.C. 321, 342, 348.
2. Amend § 573.920 by:
a. Revising paragraph (b) and
paragraph (c) introductory text,
■ b. Adding new paragraphs (c)(4) and
(5);
■ c. Removing paragraph (d);
■ d. Redesignating paragraphs (e)
through (h) as paragraphs (d) through
(g);
■ e. Revising newly redesignated
paragraph (g)(4); and
■ f. Adding new paragraph (h).
The revisions and additions read as
follows:
■
■
§ 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.
*
*
*
*
*
VerDate Sep<11>2014
18:28 Mar 05, 2019
Jkt 247001
(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-4methylselenobutanoic 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–2hydroxybutyrolactone 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 °C (68 °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.
■ 3. Amend § 573.940 by adding an
entry for ‘‘Selenomethionine hydroxy
analogue’’ to the end of the table in
paragraph (d) to read as follows:
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Frm 00015
Fmt 4700
Sfmt 4700
§ 573.940
*
Silicon dioxide.
*
*
(d) * * *
*
*
Limitations
(percent)
Feed component
*
*
*
*
Selenomethionine hydroxy analogue .......................................
*
*
*
*
*
95
*
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 884
[Docket No. FDA–2019–N–0138]
Medical Devices; Obstetrical and
Gynecological Devices; Classification
of the Software Application for
Contraception
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA or we) is
classifying the software application for
contraception into class II (special
controls). The special controls that
apply to the device type are identified
in this order and will be part of the
codified language for the software
application for contraception’s
classification. We are taking this action
because we have determined that
classifying the device into class II
(special controls) will provide a
reasonable assurance of safety and
effectiveness of the device. We believe
this action will also enhance patients’
access to beneficial innovative devices,
in part by reducing regulatory burdens.
SUMMARY:
This order is effective March 6,
2019. The classification was applicable
on August 10, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Paige Brown, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G627, Silver Spring,
MD 20993–0002, 301–796–6417,
Paige.Brown@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\06MRR1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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);
0
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)
------------------------------------------------------------------------
* * * * *
Selenomethionine hydroxy analogue.......................... 95
------------------------------------------------------------------------
* * * * *
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
