83 FR 49508 - Kemin Industries, Inc.; Filing of Food Additive Petition (Animal Use)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 191 (October 2, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 191 (October 2, 2018)
| Page Range | 49508-49509 | |
| FR Document | 2018-21395 |
[Federal Register Volume 83, Number 191 (Tuesday, October 2, 2018)] [Proposed Rules] [Pages 49508-49509] From the Federal Register Online [www.thefederalregister.org] [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.thefederalregister.org/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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That airspace extending upward from 700 comment does not include any Staff. If you do not wish your name and
feet above the surface within a 6.3-mile confidential information that you or a contact information to be made publicly
radius of Leitchfield-Grayson County Airport. third party may not wish to be posted, available, you can provide this
Issued in College Park, Georgia, on such as medical information, your or information on the cover sheet and not
September 24, 2018. anyone else’s Social Security number, or in the body of your comments and you
Ryan W. Almasy, confidential business information, such must identify this information as
Manager, Operations Support Group, Eastern as a manufacturing process. Please note ‘‘confidential.’’ Any information marked
Service Center, Air Traffic Organization. that if you include your name, contact as ‘‘confidential’’ will not be disclosed
[FR Doc. 2018–21318 Filed 10–1–18; 8:45 am]
information, or other information that except in accordance with 21 CFR 10.20
identifies you in the body of your and other applicable disclosure law. For
BILLING CODE 4910–13–P
comment, that information will be more information about FDA’s posting
posted on https://www.regulations.gov. of comments to public dockets, see 80
• If you want to submit a comment FR 56469, September 18, 2015, or access
DEPARTMENT OF HEALTH AND with confidential information that you the information at: https://www.gpo.gov/
HUMAN SERVICES do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a 23389.pdf.
Food and Drug Administration
written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
21 CFR Part 573
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments
[Docket No. FDA–2018–F–3347] received, go to https://
Written/Paper Submissions
www.regulations.gov and insert the
Kemin Industries, Inc.; Filing of Food Submit written/paper submissions as docket number, found in brackets in the
Additive Petition (Animal Use) follows: heading of this document, into the
• Mail/Hand delivery/Courier (for
AGENCY: Food and Drug Administration, ‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets
HHS. and/or go to the Dockets Management
Management Staff (HFA–305), Food and
ACTION:Notification; petition for Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers
rulemaking. Rockville, MD 20852.
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT:
SUMMARY: The Food and Drug submitted to the Dockets Management Chelsea Trull, Center for Veterinary
Administration (FDA) is announcing Staff, FDA will post your comment, as Medicine, Food and Drug
that Kemin Industries, Inc., has filed a well as any attachments, except for Administration, 7519 Standish Pl.,
petition proposing that the food additive information submitted, marked and Rockville, MD 20855, 240–402–6729,
regulations be amended to provide for identified, as confidential, if submitted chelsea.trull@fda.hhs.gov.
the safe use of chromium propionate as as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
a source of supplemental chromium in Instructions: All submissions received Federal Food, Drug, and Cosmetic Act
horse feed. must include the Docket No. FDA– (section 409(b)(5) (21 U.S.C. 348(b)(5)),
DATES: Submit either electronic or 2018–F–3347 for ‘‘Food Additives notice is given that a food additive
written comments on the petitioner’s Permitted in Feed and Drinking Water petition (FAP 2306) has been filed by
environmental assessment by November of Animals; chromium propionate.’’ Kemin Industries, Inc., 1900 Scott Ave.,
1, 2018. Received comments, those filed in a Des Moines, IA 50317. The petition
ADDRESSES: You may submit comments timely manner (see ADDRESSES), will be proposes to amend Title 21 of the Code
as follows. Please note that late, placed in the docket and, except for of Federal Regulations (CFR) in part 573
untimely filed comments will not be those submitted as ‘‘Confidential Food Additives Permitted in Feed and
considered. Electronic comments must Submissions,’’ publicly viewable at Drinking Water of Animals (21 CFR part
be submitted on or before November 1, https://www.regulations.gov or at the 573) to provide for the safe use of
2018. The https://www.regulations.gov Dockets Management Staff between 9 chromium propionate (21 CFR 573.304)
electronic filing system will accept a.m. and 4 p.m., Monday through as a source of supplemental chromium
comments until midnight Eastern Time Friday. in horse feed.
at the end of November 1, 2018. • Confidential Submissions—To The potential environmental impact
Comments received by mail/hand submit a comment with confidential of this action is being reviewed. To
delivery/courier (for written/paper information that you do not wish to be encourage public participation
submissions) will be considered timely made publicly available, submit your consistent with regulations issued under
if they are postmarked or the delivery comment only as a written/paper the National Environmental Policy Act
service acceptance receipt is on or submission. You should submit two (40 CFR 1501.4(b)), the Agency is
before that date. copies total. One copy will include the placing the environmental assessment
information you claim to be confidential (EA) submitted with the petition that is
Electronic Submissions with a heading or cover note that states the subject of this notice on public
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS display at the Dockets Management Staff
following way: CONFIDENTIAL INFORMATION.’’ The for public review and comment (see
• Federal eRulemaking Portal: Agency will review this copy, including DATES and ADDRESSES). FDA will also
amozie on DSK3GDR082PROD with PROPOSALS1
https://www.regulations.gov. Follow the the claimed confidential information, in place on public display any
instructions for submitting comments. its consideration of comments. The amendments to, or comments on, the
Comments submitted electronically, second copy, which will have the petitioner’s EA without further
including attachments, to https:// claimed confidential information announcement in the Federal Register.
www.regulations.gov will be posted to redacted/blacked out, will be available If, based on its review, the Agency
the docket unchanged. Because your for public viewing and posted on finds that an environmental impact
comment will be made public, you are https://www.regulations.gov. Submit statement is not required and this
solely responsible for ensuring that your both copies to the Dockets Management petition results in a regulation, the
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![Federal Register / Vol. 83, No. 191 / Tuesday, October 2, 2018 / Proposed Rules 49509
notice of availability of the Agency’s official comment and should include EPA is not acting on Chapter 25.2—
finding of no significant impact and the discussion of all points you wish to Continuous emission monitoring under
evidence supporting that finding will be make. The EPA will generally not the acid rain program, as these
published with the regulation in the consider comments or comment provisions are not approved in the
Federal Register in accordance with 21 contents located outside of the primary operating permits program. EPA is also
CFR 25.51(b). submission (i.e., on the web, cloud, or not acting on the New Source
Dated: September 26, 2018. other file sharing system). For Performance Standards, emission
additional submission methods, the full standards for hazardous air pollutants,
Leslie Kux,
EPA public comment policy, emission standards for hazardous air
Associate Commissioner for Policy.
information about CBI or multimedia pollutants for source categories, and
[FR Doc. 2018–21395 Filed 10–1–18; 8:45 am] emission guidelines that were submitted
submissions, and general guidance on
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making effective comments, please visit in this SIP revision. These will be
https://www2.epa.gov/dockets/ addressed separately.
commenting-epa-dockets. II. What SIP revisions are being
ENVIRONMENTAL PROTECTION
AGENCY FOR FURTHER INFORMATION CONTACT: proposed by EPA?
Stephanie Doolan, Environmental EPA is proposing the following
40 CFR Parts 52 and 70 Protection Agency, Air Planning and revisions to the Iowa SIP:
Development Branch, 11201 Renner Chapter 20—Scope of Title-
[EPA–R07–OAR–2018–0642; FRL–9983–
Boulevard, Lenexa, Kansas 66219 at Definitions: The State revised the
78—Region 7]
(913) 551–7719, or by email at definition of ‘‘EPA reference method,’’
Air Plan Approval; Iowa; State Doolan.Stephanie@epa.gov. to adopt the most current EPA methods
Implementation Plan and Operating SUPPLEMENTARY INFORMATION: for measuring air pollutant emissions
Permits Program Throughout this document ‘‘we,’’ ‘‘us,’’ (stack testing and continuous
and ‘‘our’’ refer to EPA. This section monitoring). EPA revised the reference
AGENCY: Environmental Protection methods in 40 CFR parts 51, 60, 61 and
Agency (EPA). provides additional information by
addressing the following: 63 on August 30, 2016. These updates
ACTION: Proposed rule. will ensure that state reference methods
I. What is being addressed in this document?
SUMMARY: The Environmental Protection are equivalent to Federal reference
II. What SIP revisions are being proposed by
Agency (EPA) is proposing to approve EPA? methods and are no more stringent than
revisions to the Iowa State III. What Operating Permit Plan revisions are Federal methods.
being proposed by EPA? The State revised the definition of
Implementation Plan (SIP) and the
IV. Have the requirements for approval of a ‘‘volatile organic compounds’’ (VOC) to
Operating Permits Program. The
SIP and the Operating Permits Program reflect changes made to the Federal
revisions include updating definitions, revisions been met? definition of VOC on August 1, 2016.
clarifying permit rule exemptions and V. What actions are proposed? EPA finalized a regulation on August 1,
permit-by-rule regulations, revising VI. Incorporation by Reference 2016, to exclude the compound 1,1,2,2-
methods and procedures for VII. Statutory and Executive Order Reviews tetrafluoro-1-(2,2,2-trifluoroethoxy)
performance test/stack test and
I. What is being addressed in this Ethane (HFE–347pcf2) from the Federal
continuous monitoring systems, and
document? definition because this compound
updating the Prevention of Significant
makes a negligible contribution to
Deterioration (PSD) regulations and EPA is proposing to approve a tropospheric ozone formation. This
Operating Permits Program. In addition, submission from the State of Iowa to revision to the VOC definition ensures
the State has removed its rules that revise the Iowa SIP and the Operating consistency with the Federal definition.
implement the Clean Air Interstate Rule Permits Program. The revisions to the Chapter 22—Controlling Pollution:
(CAIR) and revised their acid rain rules. Iowa SIP revise the definition for EPA The State made three revisions under
These revisions will not impact air reference method and volatile organic Chapter 22, ‘‘Permits required for new
quality and will ensure consistency compounds (VOCs), clarifies permit rule or existing stationary sources,’’ subrule
between the state and Federally exemptions and the State’s permit-by- 22.1(2), ‘‘Permitting exemptions.’’ The
approved rules. rule regulation, and revises methods revisions to permitting exemptions do
DATES: Comments must be received on and procedures for performance test/ not relieve the owner or operator of any
or before November 1, 2018. stack test and continuous monitoring source from any obligation to comply
ADDRESSES: Submit your comments, systems. In addition, the State has with any other applicable requirements.
identified by Docket ID No. EPA–R07– removed its rules that implement the The introductory paragraph to 22.1(2)
OAR–2018–0642 to https:// CAIR. The State has also revised their ‘‘i’’, ‘‘Initiation of construction,
www.regulations.gov. Follow the online Prevention of Significant Deterioration installation, reconstruction, or alteration
instructions for submitting comments. (PSD) regulations to incorporate the (modification) to equipment,’’ now
Once submitted, comments cannot be most recent Federal requirements. Iowa cross-refers to subrule 31.3(1) in the
edited or removed from Regulations.gov. has also revised their Operating Permits Iowa SIP as the previous reference no
The EPA may publish any comment Program by revising the definition for longer exists. Subrule 31.3(1) refers to
received to its public docket. Do not EPA Reference Method, clarifying definitions for nonattainment new
amozie on DSK3GDR082PROD with PROPOSALS1
submit electronically any information insignificant activities as applied to source review requirements for areas
you consider to be Confidential internal combustion engines, revising designated nonattainment on or after
Business Information (CBI) or other forms used to submit emission May 18, 1998.
information whose disclosure is inventories and due dates as well as Subparagraph 22.1(2) ‘‘r’’, applies to
restricted by statute. Multimedia revising the public participation rules. the exemption for an internal
submissions (audio, video, etc.) must be In addition, the State revised their acid combustion engine with a brake
accompanied by a written comment. rain rules to include the most recent horsepower rating of less than 400
The written comment is considered the EPA Reference Method. measured at the shaft. The added
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Document Created: 2018-10-02 01:19:21
Document Modified: 2018-10-02 01:19:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Notification; petition for rulemaking. | |
| Dates | Submit either electronic or written comments on the petitioner's environmental assessment by November 1, 2018. | |
| Contact | Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected] | |
| FR Citation | 83 FR 49508 |
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