Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate, 14565-14567 [2020-04988]

Download as PDF Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Rules and Regulations of the local flight standards district office/ certificate holding district office. jbell on DSKJLSW7X2PROD with RULES (j) Related Information For more information about this AD, contact Myles Jalalian, Aerospace Engineer, Systems and Equipment Section, FAA, Atlanta ACO Branch, 1701 Columbia Avenue, College Park, GA 30337; phone: 404–474–5572; fax: 404–474–5606; email: Myles.Jalalian@faa.gov. (k) Material Incorporated by Reference (1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51. (2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise. (i) Gulfstream GVII–G500 Airplane Flight Manual, GAC–AC–GVII–G500–OPS–0001, Revision 5, dated March 3, 2020. (A) Step 3., ‘‘Wind Conditions,’’ of Section 01–02–10, ‘‘Runway, Slope and Wind Conditions,’’ of Chapter 01, ‘‘LIMITATIONS.’’ (B) Step 15., ‘‘Approach Speed,’’ of Section 01–03–40, ‘‘Airspeed Limitations,’’ of Chapter 01, ‘‘LIMITATIONS.’’ (C) Section 01–27–10, ‘‘Normal Control Laws,’’ of Chapter 01, ‘‘LIMITATIONS.’’ (D) Step 5., Section 01–34–40, ‘‘Takeoff and Landing Data (TOLD),’’ of Chapter 01, ‘‘LIMITATIONS.’’ (E) ‘‘WARNING,’’ preceding Step 4. of Section 02–05–50, ‘‘Landing,’’ of Chapter 02, ‘‘NORMAL OPERATIONS.’’ (F) Step 11., ‘‘Landing,’’ of Section 03–12– 10, ‘‘Zero Flaps or Partial Flaps Landings,’’ of Chapter 03, ‘‘ABNORMAL PROCEDURES.’’ (G) Step 8., ‘‘Final Approach Fix,’’ of Section 04–08–40, ‘‘One Engine Inoperative Landing Procedure,’’ of Chapter 04, ‘‘EMERGENCY PROCEDURES.’’ (H) Step 1, ‘‘Introduction,’’ of Section 05– 11–10, ‘‘Threshold Speeds,’’ of Chapter 05, ‘‘PERFORMANCE FAA BASELINE.’’ (I) Step 1, ‘‘Introduction,’’ of Section 5A– 11–10, ‘‘Threshold Speeds,’’ of Chapter 5A, ‘‘PERFORMANCE (ASC 022).’’ (ii) Gulfstream GVII–G600 Airplane Flight Manual, GAC–AC–GVII–G600–OPS–0001, Revision 3, dated March 3, 2020. (A) Step 3., ‘‘Wind Conditions,’’ of Section 01–02–10, ‘‘Runway, Slope and Wind Conditions,’’ of Chapter 01, ‘‘LIMITATIONS.’’ (B) Step 15., ‘‘Approach Speed,’’ of Section 01–03–40, ‘‘Airspeed Limitations,’’ of Chapter 01, ‘‘LIMITATIONS.’’ (C) Section 01–27–10, ‘‘Normal Control Laws,’’ of Chapter 01, ‘‘LIMITATIONS.’’ (D) Steps 3. and 4., Section 01–34–40, ‘‘Takeoff and Landing Data (TOLD),’’ of Chapter 01, ‘‘LIMITATIONS.’’ (E) ‘‘WARNING,’’ preceding Step 4. of Section 02–05–50, ‘‘Landing,’’ of Chapter 02, ‘‘NORMAL OPERATIONS.’’ (F) Step 11., ‘‘Landing,’’ of Section 03–12– 10, ‘‘Zero Flaps or Partial Flaps Landings,’’ of Chapter 03, ‘‘ABNORMAL PROCEDURES.’’ (G) Step 8., ‘‘Final Approach Fix,’’ of Section 04–08–40, ‘‘One Engine Inoperative VerDate Sep<11>2014 16:21 Mar 12, 2020 Jkt 250001 Landing Procedure,’’ of Chapter 04, ‘‘EMERGENCY PROCEDURES.’’ (H) Step 1, ‘‘Introduction,’’ of Section 05– 11–10, ‘‘Threshold Speeds,’’ of Chapter 05, ‘‘PERFORMANCE.’’ (I) Step 1, ‘‘Introduction,’’ of Section 05– 11–20, ‘‘Tire Speed and BKE Limited Maximum Landing Weight,’’ of Chapter 05, ‘‘PERFORMANCE.’’ (3) For service information identified in this AD, contact Gulfstream Aerospace Corporation, Technical Publications Dept., P.O. Box 2206, Savannah, GA 31402–2206; telephone 800–810–4853; fax 912–965–3520; email pubs@gulfstream.com; internet https:// www.gulfstream.com/customer-support. (4) You may view this service information at the FAA, Policy and Innovation Division, 901 Locust, Kansas City, Missouri 64106. For information on the availability of this material at the FAA, call 816–329–4148. (5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, email fedreg.legal@nara.gov, or go to https:// www.archives.gov/federal-register/cfr/ibrlocations.html. Issued on March 6, 2020. Lance T. Gant, Director, Compliance & Airworthiness Division, Aircraft Certification Service. [FR Doc. 2020–05242 Filed 3–11–20; 11:15 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA–2018–F–3347] Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate AGENCY: 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 chromium propionate as a source of supplemental chromium in horse feed. This action is in response to a food additive petition filed by Kemin Industries, Inc. DATES: This rule is effective March 13, 2020. 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 13, 2020. SUMMARY: PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 14565 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 13, 2020. The https:// www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 13, 2020. 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. ADDRESSES: 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– 2018–F–3347 for ‘‘Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate.’’ Received objections, those filed in a E:\FR\FM\13MRR1.SGM 13MRR1 jbell on DSKJLSW7X2PROD with RULES 14566 Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Rules and Regulations 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.govinfo.gov/content/pkg/FR-201509-18/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 Cerrito, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV–224), Rockville, MD 20855, 240– 402–6729, Chelsea.Cerrito@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background In a document published in the Federal Register of October 2, 2018 (83 FR 49508), FDA announced that we had VerDate Sep<11>2014 16:21 Mar 12, 2020 Jkt 250001 filed a food additive petition (animal use) (FAP 2306) submitted by Kemin Industries, Inc., 1900 Scott Ave., Des Moines, IA 50317. 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 chromium propionate as a source of supplemental chromium in horse feed. II. Conclusion FDA concludes that the data establish the safety and utility of chromium propionate as a source of supplemental chromium in horse 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 carefully considered the potential environmental impact of this action and has concluded that the action will not have a significant impact on the human environment and that an environmental impact statement is not required. FDA’s finding of no significant impact and the evidence supporting that finding, contained in an environmental assessment, may be seen in the Dockets Management Staff (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. 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 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 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 1. The authority citation for part 573 continues to read as follows: ■ Authority: 21 U.S.C. 321, 342, 348. 2. In § 573.304, revise paragraphs (b), (c), (d)(3), and (e)(2)(ii) to read as follows: ■ § 573.304 Chromium propionate. * * * * * (b) The additive is added to feed as follows: (1) In complete feed for broiler chickens at a level not to exceed 0.2 milligrams (mg) of chromium from chromium propionate per kilogram feed. (2) In feed for horses at a level not to exceed an intake of 4 mg of chromium from chromium propionate per horse per day. (c) The additive meets the following specifications: (1) Total chromium content, 8 to 10 percent. (2) Hexavalent chromium content, less than 2 parts per million (ppm). (3) Arsenic, less than 1 ppm. (4) Cadmium, less than 1 ppm. (5) Lead, less than 0.5 ppm. (6) Mercury, less than 0.5 ppm. (7) Viscosity, not more than 2,000 centipoise. (d) * * * (3) Chromium from all sources of supplemental chromium cannot exceed: (i) A level of 0.2 ppm in complete feed for broiler chickens. (ii) An intake of 4 mg per horse per day. (e) * * * (2) * * * (ii) Adequate directions for use and cautions for use including these statements: ‘‘Caution: Follow label directions’’ and consistent with the directions for use, the following: (A) For feed for broiler chickens, ‘‘Chromium from all sources of supplemental chromium cannot exceed 0.2 parts per million of the complete feed for broiler chickens.’’ (B) For feed for horses, ‘‘Chromium from all sources of supplemental E:\FR\FM\13MRR1.SGM 13MRR1 Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Rules and Regulations chromium cannot exceed 4 milligrams per horse per day.’’ Dated: March 6, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–04988 Filed 3–12–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE TREASURY Internal Revenue Service II. Notice of Proposed Rulemaking 26 CFR Part 300 On October 13, 2016, the Treasury Department and the IRS published in the Federal Register (81 FR 70654) a notice of proposed rulemaking (REG– 108934–16) relating to the user fees charged for processing offers in compromise under section 7122 and § 301.7122–1. The notice of proposed rulemaking proposed to increase the fee under 26 CFR 300.3 for processing an offer in compromise from $186 to $300, effective for offers in compromise submitted on or after February 27, 2017. Under the notice of proposed rulemaking, offers based on doubt as to liability and offers from low-income taxpayers, as defined in § 300.3(b)(1)(ii), would continue to be excepted from a user fee. As explained in the notice of proposed rulemaking, the proposed user fee (even after the increase) was substantially less than the full cost to the IRS of providing this service and the OMB has granted an exception to the full-cost requirement. [TD 9894] RIN 1545–BN38 User Fees for Offers in Compromise Internal Revenue Service (IRS), Treasury. ACTION: Final regulation. AGENCY: This document contains the final regulations that provide user fees for offers in compromise. The final regulations affect taxpayers who wish to pay their Federal tax liabilities through offers in compromise. DATES: Effective date: These regulations are effective on April 27, 2020. Applicability date: These regulations apply to offers in compromise submitted on or after April 27, 2020. FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Jordan L. Thomas at (202) 317–5437; concerning cost methodology, Michael Weber, at (202) 803–9738 (not toll-free numbers). SUPPLEMENTARY INFORMATION: SUMMARY: Background This document contains amendments to the User Fee Regulations under 26 CFR part 300 regarding user fees charged for processing offers in compromise submitted in accordance with section 7122 of the Internal Revenue Code (Code) and § 301.7122–1 of the Procedure and Administration Regulations. I. Authority To Charge User Fees jbell on DSKJLSW7X2PROD with RULES agencies to impose user fees for services that confer a special benefit to identifiable recipients beyond those accruing to the general public. The agency must calculate the full cost of providing those benefits, and, in general, the amount of a user fee should recover the full cost of providing the service, unless the Office of Management and Budget (OMB) grants an exception under the OMB Circular. The Independent Offices Appropriations Act of 1952 (IOAA), which is codified at 31 U.S.C. 9701, authorizes Federal agencies, including the IRS, to prescribe regulations establishing user fees for services provided by the agency. Regulations prescribing user fees are subject to the policies of the President, which are currently set forth in the Office of Management and Budget Circular A–25 (OMB Circular), 58 FR 38142 (July 15, 1993). The OMB Circular allows VerDate Sep<11>2014 16:21 Mar 12, 2020 Jkt 250001 III. The Taxpayer First Act Section 1102 of the Taxpayer First Act, Public Law 116–25, 133 Stat. 981, 986 (2019), which was enacted on July 1, 2019, added paragraph (3) to section 7122(c). Section 7122(c)(3) exempts certain low-income taxpayers from payment of the offer in compromise user fee otherwise required in connection with the submission of an offer in compromise. These low-income taxpayers are individuals with adjusted gross income, as determined for the most recent taxable year for which such information is available, which does not exceed 250 percent of the applicable poverty level (as determined by the Secretary of the Treasury or his delegate). Section 1102(b) of the Taxpayer First Act provides that section 7122(c)(3) ‘‘shall apply to offers-incompromise submitted after the date of the enactment of this Act,’’ that is, offers in compromise submitted after July 1, 2019. PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 14567 Summary of Comments and Explanation of Revisions I. Overview In response to the notice of proposed rulemaking, four comments were received. One comment requested a public hearing, which was held on December 16, 2016. At the hearing, the Treasury Department and the IRS received testimony from two speakers from one organization who shared the allotted speaking time. After careful consideration of the comments and hearing testimony, the Treasury Department and the IRS have made some modifications to the proposed regulations, including nonsubstantive editorial changes to the text of § 300.3(b)(2)(ii). Specifically, in response to the comments and testimony received, the final regulations provide a more limited increase of the user fee under § 300.3 for processing an offer in compromise from $186 to $205, a 10 percent increase. This more limited increase is effective for offers in compromise submitted on or after April 27, 2020. The $205 user fee remains substantially less than the full cost to the IRS of providing this service. As required by the IOAA and the OMB Circular, the IRS will continue to biennially review the user fee, and the Treasury Department and the IRS will adjust and increase the fee as appropriate. The final regulations also continue to except offers based on doubt as to liability from a user fee, and expand the definition of low-income taxpayer consistent with section 7122(c)(3) to help reduce the burden on taxpayers. This Treasury Decision adopts the proposed regulations, as modified. II. First Comment The first comment suggested that the user fee for processing an offer in compromise should either remain at $186 or be lowered. In support of this recommendation, the comment stated that ‘‘[t]he service that the IRS provides does not make a large enough financial dent to justify hurting those who need this service with larger fees.’’ As noted more fully in the notice of proposed rulemaking, the full cost to the IRS for an offer in compromise in 2016 was $2,450. As required by the IOAA and the OMB Circular, the IRS recently completed its 2019 biennial review of the offer in compromise program and determined that the full cost of an offer in compromise was $2,374. When an offer in compromise is accepted, the user fee is either applied against the amount to be paid under the offer or refunded to the taxpayer if the E:\FR\FM\13MRR1.SGM 13MRR1

Agencies

[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Rules and Regulations]
[Pages 14565-14567]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04988]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2018-F-3347]


Food Additives Permitted in Feed and Drinking Water of Animals; 
Chromium Propionate

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 chromium 
propionate as a source of supplemental chromium in horse feed. This 
action is in response to a food additive petition filed by Kemin 
Industries, Inc.

DATES: This rule is effective March 13, 2020. 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 13, 2020.

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 
13, 2020. The https://www.regulations.gov electronic filing system will 
accept comments until 11:59 p.m. Eastern Time at the end of April 13, 
2020. 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-2018-F-3347 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Chromium Propionate.'' Received objections, those 
filed in a

[[Page 14566]]

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.govinfo.gov/content/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 Cerrito, 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 2, 2018 
(83 FR 49508), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2306) submitted by Kemin Industries, Inc., 1900 Scott 
Ave., Des Moines, IA 50317. 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 chromium propionate as a source 
of supplemental chromium in horse feed.

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
chromium propionate as a source of supplemental chromium in horse 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 carefully considered the potential environmental 
impact of this action and has concluded that the action will not have a 
significant impact on the human environment and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact and the evidence supporting that finding, contained in an 
environmental assessment, may be seen in the Dockets Management Staff 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

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. In Sec.  573.304, revise paragraphs (b), (c), (d)(3), and (e)(2)(ii) 
to read as follows:


Sec.  573.304  Chromium propionate.

* * * * *
    (b) The additive is added to feed as follows:
    (1) In complete feed for broiler chickens at a level not to exceed 
0.2 milligrams (mg) of chromium from chromium propionate per kilogram 
feed.
    (2) In feed for horses at a level not to exceed an intake of 4 mg 
of chromium from chromium propionate per horse per day.
    (c) The additive meets the following specifications:
    (1) Total chromium content, 8 to 10 percent.
    (2) Hexavalent chromium content, less than 2 parts per million 
(ppm).
    (3) Arsenic, less than 1 ppm.
    (4) Cadmium, less than 1 ppm.
    (5) Lead, less than 0.5 ppm.
    (6) Mercury, less than 0.5 ppm.
    (7) Viscosity, not more than 2,000 centipoise.
    (d) * * *
    (3) Chromium from all sources of supplemental chromium cannot 
exceed:
    (i) A level of 0.2 ppm in complete feed for broiler chickens.
    (ii) An intake of 4 mg per horse per day.
    (e) * * *
    (2) * * *
    (ii) Adequate directions for use and cautions for use including 
these statements: ``Caution: Follow label directions'' and consistent 
with the directions for use, the following:
    (A) For feed for broiler chickens, ``Chromium from all sources of 
supplemental chromium cannot exceed 0.2 parts per million of the 
complete feed for broiler chickens.''
    (B) For feed for horses, ``Chromium from all sources of 
supplemental

[[Page 14567]]

chromium cannot exceed 4 milligrams per horse per day.''

    Dated: March 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04988 Filed 3-12-20; 8:45 am]
 BILLING CODE 4164-01-P


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