Document ID: FDA-2018-F-3347-0004
Agency: fda
Document Type: Rule
Title: Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate
Posted Date: 2020-03-13T04:00Z

[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, 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 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