[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Rules and Regulations]
[Pages 35610-35611]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13082]



[[Page 35610]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

[Docket No. FDA-2014-F-0232]


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 chromium in broiler chicken feed. This action 
is in response to a food additive petition filed by Kemin Industries, 
Inc.

DATES: This rule is effective June 3, 2016. Submit either written or 
electronic objections and requests for a hearing by July 5, 2016. See 
section V of this document for information on the filing of objections.

ADDRESSES: You may submit comments or written objections and a request 
for a hearing as follows:

Electronic Submissions

    Submit electronic comments/objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments/objections 
submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because 
your comment/objection will be made public, you are solely responsible 
for ensuring that your comment/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 comments/objection, that information will be posted on 
http://www.regulations.gov.
     If you want to submit a comment/objection with 
confidential information that you do not wish to be made available to 
the public, submit the comment/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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments/objections submitted to the 
Division of Dockets Management, FDA will post your comment, 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-0232 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; Chromium Propionate.'' Received comments/objections 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment/objection 
with confidential information that you do not wish to be made publicly 
available, submit your comments/objections only as a written/paper 
submission. You should submit two copies 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 comments. The second copy, which 
will have the claimed confidential information redacted/blacked out, 
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets 
Management. 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 comments 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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, [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of March 10, 2014 (79 
FR 13263), FDA announced that we had filed a food additive petition 
(animal use) (FAP 2282) submitted by Kemin Industries, Inc., 2100 Maury 
St., Des Moines, IA 50317. The petition proposed to amend the food 
additive regulations to provide for the safe use of chromium propionate 
as a source of chromium in broiler chicken feed. The notice of petition 
was subsequently corrected to indicate the submission of an 
environmental assessment by the petitioner (79 FR 38478, July 8, 2014).

II. Conclusion

    FDA concludes that the data establish the safety and utility of 
chromium propionate for use as proposed 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 Division of Dockets 
Management (see ADDRESSES)

[[Page 35611]]

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 Division of Dockets Management (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.
    It is only necessary to send one set of documents. Identify 
documents with the docket number found in brackets in the heading of 
this document. Any objections received in response to the regulation 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://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 and 
redelegated to the Center for Veterinary Medicine, 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. Add Sec.  573.304 to read as follows:


Sec.  573.304  Chromium Propionate.

    The food additive chromium propionate may be safely used in animal 
feed as a source of supplemental chromium in accordance with the 
following prescribed conditions:
    (a) The additive is manufactured by the reaction of a chromium salt 
with propionic acid, at an appropriate stoichiometric ratio, to produce 
triaqua-(mu3-oxo) hexakis (mu2-propionato-O,O') 
trichromium propionate with the empirical formula, 
[Cr3(O)(CH3CH2CO2)6
(H2O)3]CH3CH2CO2.

    (b) The additive shall be incorporated at a level not to exceed 0.2 
milligrams of chromium from chromium propionate per kilogram feed in 
broiler chicken complete feed.
    (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.
    (3) Arsenic, less than 1 part per million.
    (4) Cadmium, less than 1 part per million.
    (5) Lead, less than 0.5 part per million.
    (6) Mercury, less than 0.5 part per million.
    (7) Viscosity, not more than 2,000 centipoise.
    (d) The additive shall be incorporated into feed as follows:
    (1) It shall be incorporated into each ton of complete feed by 
adding no less than one pound of a premix containing no more than 181.4 
milligrams of added chromium from chromium propionate per pound.
    (2) The premix manufacturer shall follow good manufacturing 
practices in the production of chromium propionate premixes. Inventory, 
production, and distribution records must provide a complete and 
accurate history of product production.
    (3) Chromium from all sources of supplemental chromium cannot 
exceed 0.2 parts per million of the complete feed.
    (e) To assure safe use of the additive in addition to the other 
information required by the Federal Food, Drug, and Cosmetic Act:
    (1) The label and labeling of the additive, any feed premix, and 
complete feed shall contain the name of the additive.
    (2) The label and labeling of the additive and any feed premix 
shall also contain:
    (i) A guarantee for added chromium content.
    (ii) Adequate directions for use and cautions for use including 
this statement: Caution: Follow label directions. Chromium from all 
sources of supplemental chromium cannot exceed 0.2 parts per million of 
the complete feed.

    Dated: May 26, 2016.
Tracey Forfa,
Acting Director, Center for Veterinary Medicine.
[FR Doc. 2016-13082 Filed 6-2-16; 8:45 am]
BILLING CODE 4164-01-P