82 FR 44129 - Akzo Nobel Surface Chemistry AB; Filing of Food Additive Petition (Animal Use)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 182 (September 21, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 182 (September 21, 2017)
| Page Range | 44129-44130 | |
| FR Document | 2017-20049 |
[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)] [Proposed Rules] [Pages 44129-44130] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20049] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2017-F-4375] Akzo Nobel Surface Chemistry AB; 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 or the Agency) is announcing that Akzo Nobel Surface Chemistry AB has filed a petition [[Page 44130]] proposing that the food additive regulations be amended to provide for the safe use of glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. DATES: Submit either electronic or written comments on the petitioner's environmental assessment by October 23, 2017. 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 October 23, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 23, 2017. 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-2017-F-4375 for ``Food Additives Permitted in Feed and Drinking Water of Animals; glyceryl polyethylene glycol (200) ricinoleate.'' 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 2296) has been filed by Akzo Nobel Surface Chemistry AB, Stenungsunds fabriker, 444 85 Stenungsund, Sweden. 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 glyceryl polyethylene glycol (200) ricinoleate as an emulsifier in animal food that does not include food for cats, dogs, vitamin premixes, or aquaculture. 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, at the Dockets Management Staff, and at https://www.regulations.gov, 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 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 14, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20049 Filed 9-20-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Proposed Rules 44129
environmental assessment by October of Animals; glyceryl polyethylene glycol Akzo Nobel Surface Chemistry AB,
23, 2017. (15) ricinoleate.’’ Received comments, Stenungsunds fabriker, 444 85
ADDRESSES: You may submit comments those filed in a timely manner (see Stenungsund, Sweden. The petition
as follows: Please note that late, ADDRESSES), will be placed in the docket proposes to amend Title 21 of the Code
untimely filed comments will not be and, except for those submitted as of Federal Regulations (CFR) in part 573
considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly Food Additives Permitted in Feed and
be submitted on or before October 23, viewable at https://www.regulations.gov Drinking Water of Animals (21 CFR part
2017. The https://www.regulations.gov or at the Dockets Management Staff 573) to provide for the safe use of
electronic filing system will accept between 9 a.m. and 4 p.m., Monday glyceryl polyethylene glycol (15)
comments until midnight Eastern Time through Friday. ricinoleate as an emulsifier in animal
at the end of October 23, 2017. • Confidential Submissions—To food that does not include food for cats,
Comments received by mail/hand submit a comment with confidential dogs, vitamin premixes, or aquaculture.
delivery/courier (for written/paper information that you do not wish to be The potential environmental impact
submissions) will be considered timely made publicly available, submit your of this action is being reviewed. To
if they are postmarked or the delivery comment only as a written/paper encourage public participation
service acceptance receipt is on or submission. You should submit two consistent with regulations issued under
before that date. copies total. One copy will include the the National Environmental Policy Act
information you claim to be confidential (40 CFR 1501.4(b)), the Agency is
Electronic Submissions placing the environmental assessment
with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS (EA) submitted with the petition that is
following way: CONFIDENTIAL INFORMATION.’’ The the subject of this notice on public
• Federal eRulemaking Portal: Agency will review this copy, including display at the Dockets Management Staff
https://www.regulations.gov. Follow the the claimed confidential information, in (see DATES and ADDRESSES) for public
instructions for submitting comments. its consideration of comments. The review and comment.
Comments submitted electronically, second copy, which will have the FDA will also place on public display,
including attachments, to https:// claimed confidential information at the Dockets Management Staff, and at
www.regulations.gov will be posted to redacted/blacked out, will be available https://www.regulations.gov, any
the docket unchanged. Because your for public viewing and posted on amendments to, or comments on, the
comment will be made public, you are https://www.regulations.gov. Submit petitioner’s EA without further
solely responsible for ensuring that your both copies to the Dockets Management announcement in the Federal Register.
comment does not include any Staff. If you do not wish your name and If, based on its review, the Agency
confidential information that you or a contact information to be made publicly finds that an environmental impact
third party may not wish to be posted, available, you can provide this statement is not required, and this
such as medical information, your or information on the cover sheet and not petition results in a regulation, the
anyone else’s Social Security number, or in the body of your comments and you notice of availability of the Agency’s
confidential business information, such must identify this information as finding of no significant impact and the
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked evidence supporting that finding will be
that if you include your name, contact as ‘‘confidential’’ will not be disclosed published with the regulation in the
information, or other information that except in accordance with 21 CFR 10.20 Federal Register in accordance with 21
identifies you in the body of your and other applicable disclosure law. For CFR 25.51(b).
comment, that information will be more information about FDA’s posting Dated: September 14, 2017.
posted on https://www.regulations.gov. of comments to public dockets, see 80 Anna K. Abram,
• If you want to submit a comment FR 56469, September 18, 2015, or access Deputy Commissioner for Policy, Planning,
with confidential information that you the information at: https://www.gpo.gov/ Legislation, and Analysis.
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- [FR Doc. 2017–20062 Filed 9–20–17; 8:45 am]
public, submit the comment as a 23389.pdf. BILLING CODE 4164–01–P
written/paper submission and in the Docket: For access to the docket to
manner detailed (see ‘‘Written/Paper read background documents or the
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments DEPARTMENT OF HEALTH AND
Written/Paper Submissions received, go to https:// HUMAN SERVICES
www.regulations.gov and insert the
Submit written/paper submissions as Food and Drug Administration
docket number, found in brackets in the
follows:
heading of this document, into the
• Mail/Hand delivery/Courier (for 21 CFR Part 573
‘‘Search’’ box and follow the prompts
written/paper submissions): Dockets
and/or go to the Dockets Management [Docket No. FDA–2017–F–4375]
Management Staff (HFA–305), Food and
Staff, 5630 Fishers Lane, Rm. 1061,
Drug Administration, 5630 Fishers
Rockville, MD 20852. Akzo Nobel Surface Chemistry AB;
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT: Filing of Food Additive Petition
submitted to the Dockets Management Chelsea Trull, Center for Veterinary (Animal Use)
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
Staff, FDA will post your comment, as Medicine, Food and Drug AGENCY: Food and Drug Administration,
well as any attachments, except for Administration, 7519 Standish Pl., HHS.
information submitted, marked and Rockville, MD 20855, 240–402–6729,
ACTION:Notification; petition for
identified, as confidential, if submitted Chelsea.trull@fda.hhs.gov.
rulemaking.
as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: Under the
Instructions: All submissions received Federal Food, Drug, and Cosmetic Act SUMMARY: The Food and Drug
must include the Docket No. FDA– (section 409(b)(5) (21 U.S.C. 348(b)(5)), Administration (FDA or the Agency) is
2017–N–5476 for ‘‘Food Additives notice is given that a food additive announcing that Akzo Nobel Surface
Permitted in Feed and Drinking Water petition (FAP 2297) has been filed by Chemistry AB has filed a petition
VerDate Sep<11>2014 17:10 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 E:\FR\FM\21SEP1.SGM 21SEP1](https://thefederalregister.org/doc/82_FR_44311/page/1.svg)
![44130 Federal Register / Vol. 82, No. 182 / Thursday, September 21, 2017 / Proposed Rules
proposing that the food additive Staff, FDA will post your comment, as Medicine, Food and Drug
regulations be amended to provide for well as any attachments, except for Administration, 7519 Standish Pl.,
the safe use of glyceryl polyethylene information submitted, marked and Rockville, MD 20855, 240–402–6729,
glycol (200) ricinoleate as an emulsifier identified, as confidential, if submitted Chelsea.trull@fda.hhs.gov.
in animal food that does not include as detailed in ‘‘Instructions.’’
food for cats, dogs, vitamin premixes, or Instructions: All submissions received SUPPLEMENTARY INFORMATION: Under the
aquaculture. must include the Docket No. FDA– Federal Food, Drug, and Cosmetic Act
DATES: Submit either electronic or 2017–F–4375 for ‘‘Food Additives (section 409(b)(5) (21 U.S.C. 348(b)(5)),
written comments on the petitioner’s Permitted in Feed and Drinking Water notice is given that a food additive
environmental assessment by October of Animals; glyceryl polyethylene glycol petition (FAP 2296) has been filed by
23, 2017. (200) ricinoleate.’’ Received comments, Akzo Nobel Surface Chemistry AB,
ADDRESSES: You may submit comments those filed in a timely manner (see Stenungsunds fabriker, 444 85
as follows: Please note that late, ADDRESSES), will be placed in the docket Stenungsund, Sweden. The petition
untimely filed comments will not be and, except for those submitted as proposes to amend Title 21 of the Code
considered. Electronic comments must ‘‘Confidential Submissions,’’ publicly of Federal Regulations (CFR) in part 573
be submitted on or before October 23, viewable at https://www.regulations.gov Food Additives Permitted in Feed and
2017. The https://www.regulations.gov or at the Dockets Management Staff Drinking Water of Animals (21 CFR part
electronic filing system will accept between 9 a.m. and 4 p.m., Monday 573) to provide for the safe use of
comments until midnight Eastern Time through Friday. glyceryl polyethylene glycol (200)
at the end of October 23, 2017. • Confidential Submissions—To ricinoleate as an emulsifier in animal
Comments received by mail/hand submit a comment with confidential food that does not include food for cats,
delivery/courier (for written/paper information that you do not wish to be dogs, vitamin premixes, or aquaculture.
submissions) will be considered timely made publicly available, submit your
if they are postmarked or the delivery comment only as a written/paper The potential environmental impact
service acceptance receipt is on or submission. You should submit two of this action is being reviewed. To
before that date. copies total. One copy will include the encourage public participation
information you claim to be confidential consistent with regulations issued under
Electronic Submissions the National Environmental Policy Act
with a heading or cover note that states
Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS (40 CFR 1501.4(b)), the Agency is
following way: CONFIDENTIAL INFORMATION.’’ The placing the environmental assessment
• Federal eRulemaking Portal: https:// Agency will review this copy, including (EA) submitted with the petition that is
www.regulations.gov. Follow the the claimed confidential information, in the subject of this notice on public
instructions for submitting comments. its consideration of comments. The display at the Dockets Management Staff
Comments submitted electronically, second copy, which will have the for public review and comment (see
including attachments, to https:// claimed confidential information DATES and ADDRESSES).
www.regulations.gov will be posted to redacted/blacked out, will be available
the docket unchanged. Because your FDA will also place on public display,
for public viewing and posted on at the Dockets Management Staff, and at
comment will be made public, you are https://www.regulations.gov. Submit
solely responsible for ensuring that your both copies to the Dockets Management https://www.regulations.gov, any
comment does not include any amendments to, or comments on, the
Staff. If you do not wish your name and
confidential information that you or a petitioner’s EA without further
contact information to be made publicly
third party may not wish to be posted, available, you can provide this announcement in the Federal Register.
such as medical information, your or information on the cover sheet and not If, based on its review, the Agency
anyone else’s Social Security number, or in the body of your comments and you finds that an environmental impact
confidential business information, such must identify this information as statement is not required, and this
as a manufacturing process. Please note ‘‘confidential.’’ Any information marked petition results in a regulation, the
that if you include your name, contact as ‘‘confidential’’ will not be disclosed notice of availability of the Agency’s
information, or other information that except in accordance with 21 CFR 10.20 finding of no significant impact and the
identifies you in the body of your and other applicable disclosure law. For evidence supporting that finding will be
comment, that information will be more information about FDA’s posting published with the regulation in the
posted on https://www.regulations.gov. of comments to public dockets, see 80
• If you want to submit a comment Federal Register in accordance with 21
FR 56469, September 18, 2015, or access CFR 25.51(b).
with confidential information that you the information at: https://www.gpo.gov/
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- Dated: September 14, 2017.
public, submit the comment as a 23389.pdf. Anna K. Abram,
written/paper submission and in the Docket: For access to the docket to Deputy Commissioner for Policy, Planning,
manner detailed (see ‘‘Written/Paper read background documents or the Legislation, and Analysis.
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments [FR Doc. 2017–20049 Filed 9–20–17; 8:45 am]
Written/Paper Submissions received, go to https://
asabaliauskas on DSKBBXCHB2PROD with PROPOSALS
BILLING CODE 4164–01–P
Submit written/paper submissions as www.regulations.gov and insert the
follows: docket number, found in brackets in the
• Mail/Hand delivery/Courier (for heading of this document, into the
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts;
Management Staff (HFA–305), Food and and/or go to the Dockets Management
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
• For written/paper comments FOR FURTHER INFORMATION CONTACT:
submitted to the Dockets Management Chelsea Trull, Center for Veterinary
VerDate Sep<11>2014 17:10 Sep 20, 2017 Jkt 241001 PO 00000 Frm 00007 Fmt 4702 Sfmt 9990 E:\FR\FM\21SEP1.SGM 21SEP1](https://thefederalregister.org/doc/82_FR_44311/page/2.svg)
Document Created: 2018-10-24 14:34:14
Document Modified: 2018-10-24 14:34:14
| 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 October 23, 2017. | |
| Contact | Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected] | |
| FR Citation | 82 FR 44129 |
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