81_FR_35717 81 FR 35610 - Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate

81 FR 35610 - Food Additives Permitted in Feed and Drinking Water of Animals; Chromium Propionate

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 107 (June 3, 2016)

Page Range35610-35611
FR Document2016-13082

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.

Federal Register, Volume 81 Issue 107 (Friday, June 3, 2016) 
[Federal Register Volume 81, Number 107 (Friday, June 3, 2016)]
[Rules and Regulations]
[Pages 35610-35611]
From the Federal Register Online  [www.thefederalregister.org]
[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, chelsea.trull@fda.hhs.gov.

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

35610 Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Rules and Regulations DEPARTMENT OF HEALTH AND (see ‘‘Written/Paper Submissions’’ and regulatoryinformation/dockets/ HUMAN SERVICES ‘‘Instructions’’). default.htm. Docket: For access to the docket to Food and Drug Administration Written/Paper Submissions read background documents or the Submit written/paper submissions as electronic and written/paper comments 21 CFR Part 573 follows: received, go to http:// • Mail/Hand delivery/Courier (for www.regulations.gov and insert the [Docket No. FDA–2014–F–0232] docket number, found in brackets in the written/paper submissions): Division of Dockets Management (HFA–305), Food heading of this document, into the Food Additives Permitted in Feed and and Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts Drinking Water of Animals; Chromium Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Division of Dockets Propionate Management, 5630 Fishers Lane, rm. • For written/paper comments/ AGENCY: Food and Drug Administration, objections submitted to the Division of 1061, Rockville, MD 20852. HHS. Dockets Management, FDA will post FOR FURTHER INFORMATION CONTACT: ACTION: Final rule. your comment, as well as any Chelsea Trull, Center for Veterinary attachments, except for information Medicine, Food and Drug SUMMARY: The Food and Drug submitted, marked and identified, as Administration, 7519 Standish Pl., Administration (FDA, we, or the confidential, if submitted as detailed in Rockville, MD 20855, 240–402–6729, Agency) is amending the regulations for ‘‘Instructions.’’ chelsea.trull@fda.hhs.gov. food additives permitted in feed and Instructions: All submissions received SUPPLEMENTARY INFORMATION: drinking water of animals to provide for must include the Docket No. FDA– the safe use of chromium propionate as I. Background 2014–F–0232 for ‘‘Food Additives a source of chromium in broiler chicken Permitted in Feed and Drinking Water In a notice published in the Federal feed. This action is in response to a food of Animals; Chromium Propionate.’’ Register of March 10, 2014 (79 FR additive petition filed by Kemin Received comments/objections will be 13263), FDA announced that we had Industries, Inc. placed in the docket and, except for filed a food additive petition (animal DATES: This rule is effective June 3, those submitted as ‘‘Confidential use) (FAP 2282) submitted by Kemin 2016. Submit either written or Submissions,’’ publicly viewable at Industries, Inc., 2100 Maury St., Des electronic objections and requests for a http://www.regulations.gov or at the Moines, IA 50317. The petition hearing by July 5, 2016. See section V Division of Dockets Management proposed to amend the food additive of this document for information on the between 9 a.m. and 4 p.m., Monday regulations to provide for the safe use of filing of objections. through Friday. chromium propionate as a source of • Confidential Submissions—To chromium in broiler chicken feed. The ADDRESSES: You may submit comments submit a comment/objection with notice of petition was subsequently or written objections and a request for confidential information that you do not corrected to indicate the submission of a hearing as follows: wish to be made publicly available, an environmental assessment by the Electronic Submissions submit your comments/objections only petitioner (79 FR 38478, July 8, 2014). Submit electronic comments/ as a written/paper submission. You II. Conclusion objections in the following way: should submit two copies total. One FDA concludes that the data establish • Federal eRulemaking Portal: http:// copy will include the information you the safety and utility of chromium www.regulations.gov. Follow the claim to be confidential with a heading propionate for use as proposed and that instructions for submitting comments. or cover note that states ‘‘THIS the food additive regulations should be Comments/objections submitted DOCUMENT CONTAINS amended as set forth in this document. electronically, including attachments, to CONFIDENTIAL INFORMATION.’’ The http://www.regulations.gov will be Agency will review this copy, including III. Public Disclosure posted to the docket unchanged. the claimed confidential information, in In accordance with § 571.1(h) (21 CFR Because your comment/objection will its consideration of comments. The 571.1(h)), the petition and documents be made public, you are solely second copy, which will have the we considered and relied upon in responsible for ensuring that your claimed confidential information reaching our decision to approve the comment/objection does not include redacted/blacked out, will be available petition will be made available for any confidential information that you or for public viewing and posted on http:// public disclosure (see FOR FURTHER a third party may not wish to be posted, www.regulations.gov. Submit both INFORMATION CONTACT). As provided in such as medical information, your or copies to the Division of Dockets § 571.1(h), we will delete from the anyone else’s Social Security number, or Management. If you do not wish your documents any materials that are not confidential business information, such name and contact information to be available for public disclosure. as a manufacturing process. Please note made publicly available, you can that if you include your name, contact provide this information on the cover IV. Analysis of Environmental Impact information, or other information that sheet and not in the body of your The Agency has carefully considered identifies you in the body of your comments and you must identify this the potential environmental impact of comments/objection, that information information as ‘‘confidential.’’ Any this action and has concluded that the will be posted on http:// information marked as ‘‘confidential’’ action will not have a significant impact mstockstill on DSK3G9T082PROD with RULES www.regulations.gov. will not be disclosed except in on the human environment and that an • If you want to submit a comment/ accordance with 21 CFR 10.20 and other environmental impact statement is not objection with confidential information applicable disclosure law. For more required. FDA’s finding of no significant that you do not wish to be made information about FDA’s posting of impact and the evidence supporting that available to the public, submit the comments to public dockets, see 80 FR finding, contained in an environmental comment/objection as a written/paper 56469, September 18, 2015, or access assessment, may be seen in the Division submission and in the manner detailed the information at: http://www.fda.gov/ of Dockets Management (see ADDRESSES) VerDate Sep<11>2014 21:04 Jun 02, 2016 Jkt 238001 PO 00000 Frm 00030 Fmt 4700 Sfmt 4700 E:\FR\FM\03JNR1.SGM 03JNR1

Federal Register / Vol. 81, No. 107 / Friday, June 3, 2016 / Rules and Regulations 35611 between 9 a.m. and 4 p.m., Monday stoichiometric ratio, to produce triaqua- Dated: May 26, 2016. through Friday. (mu3-oxo) hexakis (mu2-propionato- Tracey Forfa, O,O′) trichromium propionate with the Acting Director, Center for Veterinary V. Objections and Hearing Requests empirical formula, Medicine. Any person who will be adversely [Cr3(O)(CH3CH2CO2)6(H2O)3] [FR Doc. 2016–13082 Filed 6–2–16; 8:45 am] affected by this regulation may file with CH3CH2CO2. BILLING CODE 4164–01–P the Division of Dockets Management (b) The additive shall be incorporated (see ADDRESSES) either electronic or at a level not to exceed 0.2 milligrams written objections. Each objection shall of chromium from chromium DEPARTMENT OF STATE be separately numbered, and each propionate per kilogram feed in broiler numbered objection shall specify with chicken complete feed. 22 CFR Parts 120, 123, 124, 125, and particularity the provision of the (c) The additive meets the following 126 regulation to which objection is made specifications: and the grounds for the objection. Each [Public Notice: 9487] (1) Total chromium content, 8 to 10 numbered objection on which a hearing RIN 1400–AD70 percent. is requested shall specifically so state. Failure to request a hearing for any (2) Hexavalent chromium content, International Traffic in Arms: Revisions particular objection shall constitute a less than 2 parts per million. to Definition of Export and Related waiver of the right to a hearing on that (3) Arsenic, less than 1 part per Definitions objection. Each numbered objection for million. AGENCY: Department of State. which a hearing is requested shall (4) Cadmium, less than 1 part per include a detailed description and million. ACTION: Interim final rule. analysis of the specific factual (5) Lead, less than 0.5 part per SUMMARY: As part of the President’s information intended to be presented in million. Export Control Reform (ECR) initiative, support of the objection in the event (6) Mercury, less than 0.5 part per the Department of State amends the that a hearing is held. Failure to include million. International Traffic in Arms such a description and analysis for any (7) Viscosity, not more than 2,000 Regulations (ITAR) to update the particular objection shall constitute a centipoise. definitions of ‘‘export,’’ and ‘‘reexport or waiver of the right to a hearing on the (d) The additive shall be incorporated retransfer’’ in order to continue the objection. into feed as follows: process of harmonizing the definitions It is only necessary to send one set of with the corresponding terms in the (1) It shall be incorporated into each documents. Identify documents with the Export Administration Regulations ton of complete feed by adding no less docket number found in brackets in the (EAR), to the extent appropriate. than one pound of a premix containing heading of this document. Any Additionally, the Department creates no more than 181.4 milligrams of added objections received in response to the definitions of ‘‘release’’ and ‘‘retransfer’’ chromium from chromium propionate regulation may be seen in the Division in order to clarify and support the per pound. of Dockets Management between 9 a.m. interpretation of the revised definitions and 4 p.m., Monday through Friday, and (2) The premix manufacturer shall follow good manufacturing practices in that are in this rulemaking. The will be posted to the docket at http:// Department creates new sections of the www.regulations.gov. the production of chromium propionate premixes. Inventory, production, and ITAR detailing the scope of licenses, List of Subjects in 21 CFR Part 573 distribution records must provide a unauthorized releases of controlled complete and accurate history of information and revises the section on Animal feeds, Food additives. ‘‘exports’’ of technical data to U.S. product production. Therefore, under the Federal Food, persons abroad. Finally, the Department Drug, and Cosmetic Act and under (3) Chromium from all sources of consolidates regulatory provisions on authority delegated to the Commissioner supplemental chromium cannot exceed the treatment of foreign dual and third of Food and Drugs and redelegated to 0.2 parts per million of the complete country national employees within one the Center for Veterinary Medicine, 21 feed. exemption. CFR part 573 is amended as follows: (e) To assure safe use of the additive DATES: The rule is effective on in addition to the other information September 1, 2016. The Department of PART 573—FOOD ADDITIVES required by the Federal Food, Drug, and State will accept comments on this PERMITTED IN FEED AND DRINKING Cosmetic Act: interim final rule until July 5, 2016. WATER OF ANIMALS (1) The label and labeling of the ADDRESSES: Interested parties may additive, any feed premix, and complete ■ 1. The authority citation for part 573 submit comments within 30 days of the feed shall contain the name of the continues to read as follows: date of publication by one of the additive. following methods: Authority: 21 U.S.C. 321, 342, 348. (2) The label and labeling of the • Email: DDTCPublicComments@ additive and any feed premix shall also state.gov with the subject line, ‘‘ITAR ■ 2. Add § 573.304 to read as follows: contain: Amendment—Final Revisions to § 573.304 Chromium Propionate. (i) A guarantee for added chromium Definitions.’’ The food additive chromium content. • Internet: At www.regulations.gov, mstockstill on DSK3G9T082PROD with RULES propionate may be safely used in animal (ii) Adequate directions for use and search for this notice by using this rule’s feed as a source of supplemental cautions for use including this RIN (1400–AD70). chromium in accordance with the statement: Caution: Follow label Comments received after that date following prescribed conditions: directions. Chromium from all sources may be considered, but consideration (a) The additive is manufactured by of supplemental chromium cannot cannot be assured. Those submitting the reaction of a chromium salt with exceed 0.2 parts per million of the comments should not include any propionic acid, at an appropriate complete feed. personally identifying information they VerDate Sep<11>2014 21:04 Jun 02, 2016 Jkt 238001 PO 00000 Frm 00031 Fmt 4700 Sfmt 4700 E:\FR\FM\03JNR1.SGM 03JNR1


Document Created: 2018-02-08 07:29:47
Document Modified: 2018-02-08 07:29:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis 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.
ContactChelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]
FR Citation81 FR 35610 
CFR AssociatedAnimal Feeds and Food Additives
2024 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR