Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use), 49508-49509 [2018-21395]

Download as PDF 49508 Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Proposed Rules That airspace extending upward from 700 feet above the surface within a 6.3-mile radius of Leitchfield-Grayson County Airport. Issued in College Park, Georgia, on September 24, 2018. Ryan W. Almasy, Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization. [FR Doc. 2018–21318 Filed 10–1–18; 8:45 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] Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use) AGENCY: Food and Drug Administration, HHS. Notification; petition for rulemaking. ACTION: The Food and Drug Administration (FDA) is announcing that Kemin Industries, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of chromium propionate as a source of supplemental chromium in horse feed. DATES: Submit either electronic or written comments on the petitioner’s environmental assessment by November 1, 2018. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 1, 2018. Comments 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. SUMMARY: amozie on DSK3GDR082PROD with PROPOSALS1 Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your VerDate Sep<11>2014 16:46 Oct 01, 2018 Jkt 247001 comment 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 comment, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment 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 comments submitted to the Dockets Management Staff, 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– 2018–F–3347 for ‘‘Food Additives Permitted in Feed and Drinking Water of Animals; chromium propionate.’’ Received comments, 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 a comment with confidential information that you do not wish to be made publicly available, submit your comment 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 https://www.regulations.gov. Submit both copies to the Dockets Management PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 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 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: 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 comments 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: Under the Federal Food, Drug, and Cosmetic Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a food additive petition (FAP 2306) has been filed by Kemin Industries, Inc., 1900 Scott Ave., Des Moines, IA 50317. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of chromium propionate (21 CFR 573.304) as a source of supplemental chromium in horse feed. The potential environmental impact of this action is being reviewed. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), the Agency is placing the environmental assessment (EA) submitted with the petition that is the subject of this notice on public display at the Dockets Management Staff for public review and comment (see DATES and ADDRESSES). FDA will also place on public display any amendments to, or comments on, the petitioner’s EA without further announcement in the Federal Register. If, based on its review, the Agency finds that an environmental impact statement is not required and this petition results in a regulation, the E:\FR\FM\02OCP1.SGM 02OCP1 Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Proposed Rules notice of availability of the Agency’s finding of no significant impact and the evidence supporting that finding will be published with the regulation in the Federal Register in accordance with 21 CFR 25.51(b). Dated: September 26, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018–21395 Filed 10–1–18; 8:45 am] BILLING CODE 4164–01–P ENVIRONMENTAL PROTECTION AGENCY FOR FURTHER INFORMATION CONTACT: Stephanie Doolan, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551–7719, or by email at Doolan.Stephanie@epa.gov. 40 CFR Parts 52 and 70 [EPA–R07–OAR–2018–0642; FRL–9983– 78—Region 7] Air Plan Approval; Iowa; State Implementation Plan and Operating Permits Program SUPPLEMENTARY INFORMATION: Throughout this document ‘‘we,’’ ‘‘us,’’ and ‘‘our’’ refer to EPA. This section provides additional information by addressing the following: Environmental Protection Agency (EPA). ACTION: Proposed rule. AGENCY: The Environmental Protection Agency (EPA) is proposing to approve revisions to the Iowa State Implementation Plan (SIP) and the Operating Permits Program. The revisions include updating definitions, clarifying permit rule exemptions and permit-by-rule regulations, revising methods and procedures for performance test/stack test and continuous monitoring systems, and updating the Prevention of Significant Deterioration (PSD) regulations and Operating Permits Program. In addition, the State has removed its rules that implement the Clean Air Interstate Rule (CAIR) and revised their acid rain rules. These revisions will not impact air quality and will ensure consistency between the state and Federally approved rules. DATES: Comments must be received on or before November 1, 2018. ADDRESSES: Submit your comments, identified by Docket ID No. EPA–R07– OAR–2018–0642 to https:// www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the amozie on DSK3GDR082PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:46 Oct 01, 2018 Jkt 247001 official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www2.epa.gov/dockets/ commenting-epa-dockets. I. What is being addressed in this document? II. What SIP revisions are being proposed by EPA? III. What Operating Permit Plan revisions are being proposed by EPA? IV. Have the requirements for approval of a SIP and the Operating Permits Program revisions been met? V. What actions are proposed? VI. Incorporation by Reference VII. Statutory and Executive Order Reviews I. What is being addressed in this document? EPA is proposing to approve a submission from the State of Iowa to revise the Iowa SIP and the Operating Permits Program. The revisions to the Iowa SIP revise the definition for EPA reference method and volatile organic compounds (VOCs), clarifies permit rule exemptions and the State’s permit-byrule regulation, and revises methods and procedures for performance test/ stack test and continuous monitoring systems. In addition, the State has removed its rules that implement the CAIR. The State has also revised their Prevention of Significant Deterioration (PSD) regulations to incorporate the most recent Federal requirements. Iowa has also revised their Operating Permits Program by revising the definition for EPA Reference Method, clarifying insignificant activities as applied to internal combustion engines, revising forms used to submit emission inventories and due dates as well as revising the public participation rules. In addition, the State revised their acid rain rules to include the most recent EPA Reference Method. PO 00000 Frm 00012 Fmt 4702 Sfmt 4702 49509 EPA is not acting on Chapter 25.2— Continuous emission monitoring under the acid rain program, as these provisions are not approved in the operating permits program. EPA is also not acting on the New Source Performance Standards, emission standards for hazardous air pollutants, emission standards for hazardous air pollutants for source categories, and emission guidelines that were submitted in this SIP revision. These will be addressed separately. II. What SIP revisions are being proposed by EPA? EPA is proposing the following revisions to the Iowa SIP: Chapter 20—Scope of TitleDefinitions: The State revised the definition of ‘‘EPA reference method,’’ to adopt the most current EPA methods for measuring air pollutant emissions (stack testing and continuous monitoring). EPA revised the reference methods in 40 CFR parts 51, 60, 61 and 63 on August 30, 2016. These updates will ensure that state reference methods are equivalent to Federal reference methods and are no more stringent than Federal methods. The State revised the definition of ‘‘volatile organic compounds’’ (VOC) to reflect changes made to the Federal definition of VOC on August 1, 2016. EPA finalized a regulation on August 1, 2016, to exclude the compound 1,1,2,2tetrafluoro-1-(2,2,2-trifluoroethoxy) Ethane (HFE–347pcf2) from the Federal definition because this compound makes a negligible contribution to tropospheric ozone formation. This revision to the VOC definition ensures consistency with the Federal definition. Chapter 22—Controlling Pollution: The State made three revisions under Chapter 22, ‘‘Permits required for new or existing stationary sources,’’ subrule 22.1(2), ‘‘Permitting exemptions.’’ The revisions to permitting exemptions do not relieve the owner or operator of any source from any obligation to comply with any other applicable requirements. The introductory paragraph to 22.1(2) ‘‘i’’, ‘‘Initiation of construction, installation, reconstruction, or alteration (modification) to equipment,’’ now cross-refers to subrule 31.3(1) in the Iowa SIP as the previous reference no longer exists. Subrule 31.3(1) refers to definitions for nonattainment new source review requirements for areas designated nonattainment on or after May 18, 1998. Subparagraph 22.1(2) ‘‘r’’, applies to the exemption for an internal combustion engine with a brake horsepower rating of less than 400 measured at the shaft. The added E:\FR\FM\02OCP1.SGM 02OCP1

Agencies

[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)]
[Proposed Rules]
[Pages 49508-49509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21395]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 573

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


Kemin Industries, Inc.; Filing of Food Additive Petition (Animal 
Use)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; petition for rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Kemin Industries, Inc., has filed a petition proposing that the food 
additive regulations be amended to provide for the safe use of chromium 
propionate as a source of supplemental chromium in horse feed.

DATES: Submit either electronic or written comments on the petitioner's 
environmental assessment by November 1, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 1, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 1, 2018. Comments 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 comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
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 comment, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment 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 comments submitted to the Dockets 
Management Staff, 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-2018-F-3347 for ``Food Additives Permitted in Feed and Drinking 
Water of Animals; chromium propionate.'' Received comments, 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 a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comment 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 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 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: 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 comments 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, [email protected].

SUPPLEMENTARY INFORMATION: Under the Federal Food, Drug, and Cosmetic 
Act (section 409(b)(5) (21 U.S.C. 348(b)(5)), notice is given that a 
food additive petition (FAP 2306) has been filed by Kemin Industries, 
Inc., 1900 Scott Ave., Des Moines, IA 50317. The petition proposes to 
amend Title 21 of the Code of Federal Regulations (CFR) in part 573 
Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR 
part 573) to provide for the safe use of chromium propionate (21 CFR 
573.304) as a source of supplemental chromium in horse feed.
    The potential environmental impact of this action is being 
reviewed. To encourage public participation consistent with regulations 
issued under the National Environmental Policy Act (40 CFR 1501.4(b)), 
the Agency is placing the environmental assessment (EA) submitted with 
the petition that is the subject of this notice on public display at 
the Dockets Management Staff for public review and comment (see DATES 
and ADDRESSES). FDA will also place on public display any amendments 
to, or comments on, the petitioner's EA without further announcement in 
the Federal Register.
    If, based on its review, the Agency finds that an environmental 
impact statement is not required and this petition results in a 
regulation, the

[[Page 49509]]

notice of availability of the Agency's finding of no significant impact 
and the evidence supporting that finding will be published with the 
regulation in the Federal Register in accordance with 21 CFR 25.51(b).

    Dated: September 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21395 Filed 10-1-18; 8:45 am]
 BILLING CODE 4164-01-P
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