Food Additives Permitted in Feed and Drinking Water of Animals; Ammonium Formate and Formic Acid, 52207-52209 [2017-24366]
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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations
resources officer, or an equivalent
official of the recipient falsely attested
that the information on the application
was true;
(3) The employer was ineligible to
receive an award pursuant to § 1011.120
of this part; or
(4) The employer violated the display
restrictions at § 1011.405 of this part.
(c) If VETS decides to deny or revoke
an award, it will provide the employer
with notice of the decision. An
employer may request reconsideration
of VETS’ decision to deny or revoke an
award pursuant to § 1011.500 of this
part.
Subpart D—Fees and Caps
§ 1011.300 What are the application fees
for the HIRE Vets Medallion Award?
asabaliauskas on DSKBBXCHB2PROD with RULES
(a) The Act requires the Secretary of
Labor to establish a fee sufficient to
cover the costs associated with carrying
out the HIRE Vets Medallion Program.
(b) Table 1 to § 1011.300 sets forth the
fees an employer must pay to apply for
the HIRE Vets Medallion Award. VETS
will adjust the fees periodically
according to the Implicit Price Deflator
for Gross Domestic Product published
by the U.S. Department of Commerce
and notify potential applicants of the
adjusted fees.
(1) If a significant adjustment is
needed to arrive at a new fee for any
reason other than inflation, then a
proposed rule containing the new fees
will be published in the Federal
Register for comment.
(2) VETS will round the fee to the
nearest dollar.
Subpart E—Design and Display
§ 1011.400 What does a successful
applicant receive?
(a) The award will be in the form of
a certificate and will state the year for
which it was awarded.
(b) VETS will also provide a digital
image of the medallion for recipients to
use, including as part of an
advertisement, solicitation, business
activity, or product.
§ 1011.405 What are the restrictions on
display and use of the HIRE Vets Medallion
Award?
It is unlawful for any employer to
publicly display a HIRE Vets Medallion
Award, in connection with, or as a part
of, any advertisement, solicitation,
business activity, or product—
(a) For the purpose of conveying, or
in a manner reasonably calculated to
convey, a false impression that the
employer received the award through
the HIRE Vets Medallion Program, if
such employer did not receive such
award through the HIRE Vets Medallion
Program; or
(b) For the purpose of conveying, or
in a manner reasonably calculated to
convey, a false impression that the
employer received the award through
the HIRE Vets Medallion Program for a
year for which such employer did not
receive such award.
Subpart F—Requests for
Reconsideration
(a) An applicant may file a request for
reconsideration of VETS’ decision to
TABLE 1 TO § 1011.300
deny or revoke a HIRE Vets Medallion
Award or of VETS’ decision as to the
Application Fees
level of award by mailing a request for
Small Employer Fee .............
$90.00 reconsideration to the following address
Medium Employer Fee .........
190.00 no later than 15 business days after the
Large Employer Fee .............
495.00 date of VETS’ notice of its decision.
Requests for reconsideration must be
sent to: HIRE Vets Medallion Program,
(c) All applicants must submit the
DOL VETS, 200 Constitution Ave. NW.,
appropriate application processing fee
for each application submitted. This fee Room S1325, Washington, DC 20210.
(b) Requests for reconsideration
is based on the fees provided in table 1
pursuant to paragraph (a) of this section
to § 1011.300. Payment of this fee must
be made electronically through the U.S. must contain the following:
(1) The employer name and
Treasury pay.gov system or an
identification number;
equivalent.
(2) The reason for the request; and
(d) Once a fee is paid, it is
(3) An explanation, accompanied by
nonrefundable, even if the employer
any necessary documentation to support
withdraws the application or does not
that explanation, of why VETS’ decision
receive a HIRE Vets Medallion Award.
was incorrect.
§ 1011.305 May VETS set a limit on how
(c) VETS may request from the
many applications will be accepted in a
employer filing such request any
year?
additional evidence or explanation it
Yes, VETS may set a limit on how
finds necessary for reconsideration.
many applications will be accepted in
(d) Within 30 business days after the
any given year.
later of the receipt of the request or the
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17:36 Nov 09, 2017
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receipt of any additional evidence or
explanation requested, VETS will issue
a determination about whether to grant
or deny the request.
(e) No additional Department of Labor
review is available.
Subpart G—Record Retention
§ 1011.600 What are the record retention
requirements for the HIRE Vets Medallion
Award?
Applicants must retain a record of all
information used to support an
application for the HIRE Vets Medallion
Award for 2 years from the date of
application.
Signed at Washington, DC, this 1st day of
November 2017.
J.S. Shellenberger,
Deputy Assistant Secretary for the Veterans’
Employment and Training Service.
[FR Doc. 2017–24214 Filed 11–9–17; 8:45 am]
BILLING CODE 4510–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA–2014–F–0988]
Food Additives Permitted in Feed and
Drinking Water of Animals; Ammonium
Formate and Formic Acid
AGENCY:
§ 1011.500 What is the process to request
reconsideration of a denial or revocation?
52207
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA, we, the Agency)
is amending food additive regulations
for food additives permitted in feed and
drinking water of animals to provide for
the safe use of formic acid and
ammonium formate. This action is in
response to a food additive petition filed
by BASF Corp for Feed Grade Sodium
Formate (FAP 2286), which also
proposed to amend the animal food
additive regulations for formic acid and
ammonium formate to limit formic acid
and formate salts from all added
sources.
SUMMARY:
This rule is effective November
13, 2017. Submit either written or
electronic objections and requests for a
hearing by December 13, 2017. See
section V of this document for
information on the filing of objections.
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
DATES:
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52208
Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations
on or before December 13, 2017. The
https://www.regulations.gov electronic
filing system will accept objections until
midnight Eastern Time at the end of
December 13, 2017. 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.
asabaliauskas on DSKBBXCHB2PROD with RULES
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–0988 for ‘‘Food Additives
Permitted in Feed and Drinking Water
of Animals; Ammonium Formate and
Formic Acid.’’ 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
VerDate Sep<11>2014
17:36 Nov 09, 2017
Jkt 244001
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/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.,
Rockville, MD 20855, 240–402–6729,
chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the
Federal Register of July 25, 2014 (79 FR
43325), FDA announced that we had
filed a food additive petition (animal
use) (FAP 2286) submitted by BASF
Corp., 100 Park Ave., Florham Park, NJ
07932. The petition proposed that the
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regulations for food additives permitted
in feed and drinking water of animals be
amended to provide for the safe use of
feed grade sodium formate as a feed
acidifying agent in complete swine
feeds. The notice of petition provided
for a 30-day comment period on the
petitioner’s request for categorical
exclusion from preparing an
environmental assessment or
environmental impact statement.
In addition, the petition proposed that
the animal food additive regulations for
formic acid and ammonium formate be
amended to limit formic acid and
formate salts from all added sources to
1.2 percent of complete feeds. This
element of the petition was not
described in the July 2014 notice of
petition for FAP 2286, but was later
described in a September 30, 2016,
notice of petition (81 FR 67260).
II. Conclusion
FDA became concerned about the
safety of higher levels of formic acid and
formate salts in complete feeds when
multiple sources of formic acid and its
salts are used in combination. FDA
concludes that the data establish the
safety of formic acid and ammonium
formate for use as a feed acidifying
agent in complete feeds, that formic acid
and formate salts should be limited to
1.2 percent on complete feed, and that
the food additive regulations should be
amended as set forth in this document.
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
E:\FR\FM\13NOR1.SGM
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Federal Register / Vol. 82, No. 217 / Monday, November 13, 2017 / Rules and Regulations
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.
Any objections received in response
to the regulation may be seen in the
office of the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to
the docket at https://
www.regulations.gov.
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. In § 573.170, redesignate
paragraphs (c) and (d) as paragraphs (d)
and (e), add new paragraph (c) and
paragraph (d)(3) to newly redesignated
paragraph (d), and revise newly
redesignated paragraph (e) introductory
text to read as follows:
■
§ 573.170
asabaliauskas on DSKBBXCHB2PROD with RULES
*
*
*
*
(c) To ensure safe use of the additive,
formic acid and formate salts from all
added sources cannot exceed 1.2
percent of complete feed when multiple
sources of formic acid and its salts are
used in combination.
*
*
*
*
*
(d) * * *
(3) Cautions for use including this
statement: Caution: Follow label
directions. Formic acid and formate
salts from all added sources cannot
exceed 1.2 percent of complete feed
when multiple sources of formic acid
and its salts are used in combination.
(e) To ensure safe use of the additive,
in addition to the other information
VerDate Sep<11>2014
17:36 Nov 09, 2017
Jkt 244001
§ 573.480
Formic acid.
*
*
*
*
*
(b) * * *
(3) To ensure safe use of the additive,
formic acid and formate salts from all
added sources cannot exceed 1.2
percent of complete feed when multiple
sources of formic acid and its salts are
used in combination.
(4) * * *
(iii) Cautions for use including this
statement: Caution: Follow label
directions. Formic acid and formate
salts from all added sources cannot
exceed 1.2 percent of complete feed
when multiple sources of formic acid
and its salts are used in combination.
(5) To ensure safe use of the additive,
in addition to the other information
required by the Federal Food, Drug, and
Cosmetic Act and paragraph (b)(4) of
this section, the label and labeling shall
contain:
*
*
*
*
*
Dated: November 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–24366 Filed 11–9–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
Ammonium formate.
*
required by the Federal Food, Drug, and
Cosmetic Act and paragraph (d) of this
section, the label and labeling shall
contain:
*
*
*
*
*
■ 3. In § 573.480, redesignate
paragraphs (b)(3) and (4) as paragraphs
(b)(4) and (5), add new paragraph (b)(3)
and paragraph (b)(4)(iii) to newly
redesignated paragraph (b)(4), and
revise newly redesignated paragraph
(b)(5) introductory text to read as
follows:
31 CFR Part 543
ˆ
Removal of Cote d’Ivoire Sanctions
Regulations
Office of Foreign Assets
Control, Treasury.
ACTION: Final rule.
AGENCY:
The Department of the
Treasury’s Office of Foreign Assets
Control (OFAC) is removing from the
ˆ
Code of Federal Regulations the Cote
d’Ivoire Sanctions Regulations as a
result of the termination of the national
emergency on which the regulations
were based.
DATES: Effective: November 13, 2017.
SUMMARY:
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Fmt 4700
Sfmt 4700
52209
The
Department of the Treasury’s Office of
Foreign Assets Control: Assistant
Director for Licensing, tel.: 202/622–
2480, Assistant Director for Regulatory
Affairs, tel.: 202/622–4855, Assistant
Director for Sanctions Compliance &
Evaluation, tel.: 202/622–2490, or the
Department of the Treasury’s Office of
the Chief Counsel (Foreign Assets
Control), Office of the General Counsel,
tel.: 202/622–2410.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Electronic and Facsimile Availability
This document and additional
information concerning OFAC are
available from OFAC’s Web site
(www.treasury.gov/ofac).
Background
On February 7, 2006, the President
issued Executive Order 13396,
‘‘Blocking Property of Certain Persons
ˆ
Contributing to the Conflict in Cote
d’Ivoire’’ (E.O. 13396), in which the
President declared a national emergency
to deal with the unusual and
extraordinary threat to the national
security and foreign policy of the United
States posed by the situation in or in
ˆ
relation to Cote d’Ivoire. That situation,
which had been addressed by the
United Nations Security Council in
Resolution 1572 of November 15, 2004,
and subsequent resolutions, had
resulted in the massacre of large
numbers of civilians, widespread
human rights abuses, significant
political violence and unrest, and
attacks against international
peacekeeping forces leading to fatalities.
E.O. 13396 blocked all property and
interests in property of the persons
listed in the Annex to E.O. 13396 and
any person determined to meet one or
more of the criteria set out in E.O.
13396.
On April 13, 2009, OFAC issued the
Persons Contributing to the Conflict in
ˆ
Cote d’Ivoire Sanctions Regulations, 31
CFR part 543 (the ‘‘Regulations’’), as a
final rule to implement E.O. 13396 (74
FR 16763, April 13, 2009). On July 21,
2009, OFAC issued an amendment to
the Regulations to change the heading of
ˆ
the Regulations to the Cote d’Ivoire
Sanctions Regulations (74 FR 35802,
July 21, 2009). OFAC also amended the
Regulations on February 8, 2012, to add
a definition of a term used in the
Regulations (77 FR 6463, Feb. 8, 2012).
On September 14, 2016, the President
issued Executive Order 13739,
‘‘Termination of Emergency With
Respect to the Situation in or in
ˆ
Relation to Cote d’Ivoire’’ (E.O. 13739).
In E.O. 13739, the President found that
the situation that gave rise to the
E:\FR\FM\13NOR1.SGM
13NOR1
]]>Agencies
[Federal Register Volume 82, Number 217 (Monday, November 13, 2017)]
[Rules and Regulations]
[Pages 52207-52209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24366]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 573
[Docket No. FDA-2014-F-0988]
Food Additives Permitted in Feed and Drinking Water of Animals;
Ammonium Formate and Formic Acid
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, we, the Agency) is
amending food additive regulations for food additives permitted in feed
and drinking water of animals to provide for the safe use of formic
acid and ammonium formate. This action is in response to a food
additive petition filed by BASF Corp for Feed Grade Sodium Formate (FAP
2286), which also proposed to amend the animal food additive
regulations for formic acid and ammonium formate to limit formic acid
and formate salts from all added sources.
DATES: This rule is effective November 13, 2017. Submit either written
or electronic objections and requests for a hearing by December 13,
2017. See section V of this document for information on the filing of
objections.
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
[[Page 52208]]
on or before December 13, 2017. The https://www.regulations.gov
electronic filing system will accept objections until midnight Eastern
Time at the end of December 13, 2017. 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-0988 for ``Food Additives Permitted in Feed and Drinking
Water of Animals; Ammonium Formate and Formic Acid.'' 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., Rockville,
MD 20855, 240-402-6729, chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In a document published in the Federal Register of July 25, 2014
(79 FR 43325), FDA announced that we had filed a food additive petition
(animal use) (FAP 2286) submitted by BASF Corp., 100 Park Ave., Florham
Park, NJ 07932. 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 feed grade sodium formate as a feed
acidifying agent in complete swine feeds. The notice of petition
provided for a 30-day comment period on the petitioner's request for
categorical exclusion from preparing an environmental assessment or
environmental impact statement.
In addition, the petition proposed that the animal food additive
regulations for formic acid and ammonium formate be amended to limit
formic acid and formate salts from all added sources to 1.2 percent of
complete feeds. This element of the petition was not described in the
July 2014 notice of petition for FAP 2286, but was later described in a
September 30, 2016, notice of petition (81 FR 67260).
II. Conclusion
FDA became concerned about the safety of higher levels of formic
acid and formate salts in complete feeds when multiple sources of
formic acid and its salts are used in combination. FDA concludes that
the data establish the safety of formic acid and ammonium formate for
use as a feed acidifying agent in complete feeds, that formic acid and
formate salts should be limited to 1.2 percent on complete feed, and
that the food additive regulations should be amended as set forth in
this document.
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
[[Page 52209]]
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.
Any objections received in response to the regulation may be seen
in the office of the Dockets Management Staff between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at
https://www.regulations.gov.
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. In Sec. 573.170, redesignate paragraphs (c) and (d) as paragraphs
(d) and (e), add new paragraph (c) and paragraph (d)(3) to newly
redesignated paragraph (d), and revise newly redesignated paragraph (e)
introductory text to read as follows:
Sec. 573.170 Ammonium formate.
* * * * *
(c) To ensure safe use of the additive, formic acid and formate
salts from all added sources cannot exceed 1.2 percent of complete feed
when multiple sources of formic acid and its salts are used in
combination.
* * * * *
(d) * * *
(3) Cautions for use including this statement: Caution: Follow
label directions. Formic acid and formate salts from all added sources
cannot exceed 1.2 percent of complete feed when multiple sources of
formic acid and its salts are used in combination.
(e) To ensure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act and
paragraph (d) of this section, the label and labeling shall contain:
* * * * *
0
3. In Sec. 573.480, redesignate paragraphs (b)(3) and (4) as
paragraphs (b)(4) and (5), add new paragraph (b)(3) and paragraph
(b)(4)(iii) to newly redesignated paragraph (b)(4), and revise newly
redesignated paragraph (b)(5) introductory text to read as follows:
Sec. 573.480 Formic acid.
* * * * *
(b) * * *
(3) To ensure safe use of the additive, formic acid and formate
salts from all added sources cannot exceed 1.2 percent of complete feed
when multiple sources of formic acid and its salts are used in
combination.
(4) * * *
(iii) Cautions for use including this statement: Caution: Follow
label directions. Formic acid and formate salts from all added sources
cannot exceed 1.2 percent of complete feed when multiple sources of
formic acid and its salts are used in combination.
(5) To ensure safe use of the additive, in addition to the other
information required by the Federal Food, Drug, and Cosmetic Act and
paragraph (b)(4) of this section, the label and labeling shall contain:
* * * * *
Dated: November 3, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24366 Filed 11-9-17; 8:45 am]
BILLING CODE 4164-01-P
