81 FR 86268 - Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 230 (November 30, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 230 (November 30, 2016)
| Page Range | 86268-86270 | |
| FR Document | 2016-28754 |
[Federal Register Volume 81, Number 230 (Wednesday, November 30, 2016)] [Rules and Regulations] [Pages 86268-86270] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28754] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 573 [Docket No. FDA-2015-F-2337] Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid AGENCY: Food and Drug Administration, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. This action is in response to a food additive petition filed by Alzchem AG. DATES: This rule is effective November 30, 2016. Submit either written or electronic objections and requests for a hearing by December 30, 2016. See section V of this document for information on the filing of objections. ADDRESSES: You may submit objections and requests for a hearing as follows: Electronic Submissions Submit electronic objections in the following way:Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your 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 objection, that information will be posted on http://www.regulations.gov. If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). [[Page 86269]] 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 objections submitted to the Division of Dockets Management, FDA will post your objection, 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-2015-F-2337 for ``Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid.'' Received 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 an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies in 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 objections. 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 objections 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 objections received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected]. SUPPLEMENTARY INFORMATION: I. Background In a document published in the Federal Register of July 16, 2015 (80 FR 42069), FDA announced that we had filed a food additive petition (animal use) (FAP 2292) submitted by Alzchem AG, Chemiepark Trostberg, Dr.-Albert-Frank-Str. 32, 83308, Trostberg, Germany. The petition proposed that the regulations for food additives permitted in feed and drinking water of animals be amended to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. The notice of petition provided for a 30-day comment period on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement. II. Conclusion FDA concludes that the data establish the safety and utility of guanidinoacetic acid for use as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds 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 before making the documents available for inspection. IV. Analysis of Environmental Impact The Agency has determined under 21 CFR 25.32(r) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. 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. 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. 573.496 to read as follows: Sec. 573.496 Guanidinoacetic acid. The food additive, guanidinoacetic acid, may be safely used in broiler chicken and turkey feeds in accordance with the following prescribed conditions: (a) The additive is manufactured by reacting glycine with cyanamide in an aqueous solution. [[Page 86270]] (b) The additive is used or intended for use to spare arginine and as a precursor of creatine in broiler chicken and turkey feeds at levels not to exceed 0.12 percent of the complete feed. (c) The additive consists of not less than 97 percent guanidinoacetic acid [N-(aminoiminomethyl)-glycine] (CAS 352-97-6) by weight. (d) The additive meets the following specifications: (1) Dicyandiamide not to exceed 0.5 percent; (2) Cyanamide not to exceed 0.01 percent; (3) Melamine not to exceed 15 parts per million (ppm); (4) Sum of ammeline, ammelide, and cyanuric acid not to exceed 35 ppm; and (5) Water not to exceed 1 percent. (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 statement to indicate that the maximum use level of guanidinoacetic acid must not exceed 0.12 percent of the complete feed for broiler chickens and turkeys; and (ii) Adequate directions for use. Dated: November 22, 2016. Tracey H. Forfa, Deputy Director, Center for Veterinary Medicine. [FR Doc. 2016-28754 Filed 11-29-16; 8:45 am] BILLING CODE 4164-01-P
![86268 Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Rules and Regulations
§ 1026.3(b) exemption at consummation the creditor in real property, or in DEPARTMENT OF HEALTH AND
in year one is refinanced in year ten and personal property used or expected to HUMAN SERVICES
that the new loan amount is less than be used as the consumer’s principal
the threshold amount in effect in year dwelling. If, on July 20, 2011, an open- Food and Drug Administration
ten. In these circumstances, the creditor end account is exempt under § 1026.3(b)
must comply with all of the applicable based on a firm commitment to extend 21 CFR Part 573
requirements of this part with respect to credit in excess of $25,000, the account
the year ten transaction if the original remains exempt under § 1026.3(b)(2) [Docket No. FDA–2015–F–2337]
loan is satisfied and replaced by the until December 31, 2011 (unless the
new loan, which is not exempt under Food Additives Permitted in Feed and
firm commitment is reduced to $25,000
§ 1026.3(b). See also comment 3(b)–6. Drinking Water of Animals;
6. Addition of a security interest in or less). If the firm commitment is
Guanidinoacetic Acid
real property or a dwelling after account increased on or before December 31,
opening or consummation. i. Open-end 2011 to an amount in excess of $50,000, AGENCY: Food and Drug Administration,
credit. For open-end accounts, if after the account remains exempt under HHS.
account opening a security interest is § 1026.3(b)(1) regardless of subsequent ACTION: Final rule.
taken in real property, or in personal increases in the threshold amount as a
property used or expected to be used as result of increases in the CPI–W. If the SUMMARY: The Food and Drug
the consumer’s principal dwelling, a firm commitment is not increased on or Administration (FDA, we, the Agency)
previously exempt account ceases to be before December 31, 2011 to an amount is amending the regulations for food
exempt under § 1026.3(b) and the in excess of $50,000, the account ceases additives permitted in feed and drinking
creditor must begin to comply with all to be exempt under § 1026.3(b) based on water of animals to provide for the safe
of the applicable requirements of this a firm commitment to extend credit. For use of guanidinoacetic acid as a
part within a reasonable period of time. example: substance that spares arginine and
See comment 3(b)–4.ii. If a security serves as a precursor of creatine in
i. Assume that, on July 20, 2011, the broiler chicken and turkey feeds. This
interest is taken in the consumer’s
principal dwelling, the creditor must account is exempt under § 1026.3(b) action is in response to a food additive
also give the consumer the right to based on the creditor’s firm petition filed by Alzchem AG.
rescind the security interest consistent commitment to extend $30,000 in
DATES: This rule is effective November
with § 1026.15. credit. On November 1, 2011, the
30, 2016. Submit either written or
ii. Closed-end credit. For closed-end creditor increases the firm commitment
electronic objections and requests for a
loans, if after consummation a security on the account to $55,000. In these
hearing by December 30, 2016. See
interest is taken in real property, or in circumstances, the account remains section V of this document for
personal property used or expected to exempt under § 1026.3(b)(1) regardless information on the filing of objections.
be used as the consumer’s principal of subsequent increases in the threshold
dwelling, an exempt loan remains ADDRESSES: You may submit objections
amount as a result of increases in the
exempt under § 1026.3(b). However, the and requests for a hearing as follows:
CPI–W.
addition of a security interest in the Electronic Submissions
ii. Same facts as paragraph i above
consumer’s principal dwelling is a
except, on November 1, 2011, the Submit electronic objections in the
transaction for purposes of § 1026.23,
and the creditor must give the consumer creditor increases the firm commitment following way:
the right to rescind the security interest on the account to $40,000. In these • Federal eRulemaking Portal: http://
consistent with that section. See circumstances, the account ceases to be www.regulations.gov. Follow the
§ 1026.23(a)(1) and its commentary. In exempt under § 1026.3(b)(2) after instructions for submitting comments.
contrast, if a closed-end loan that is December 31, 2011, and the creditor Objections submitted electronically,
exempt under § 1026.3(b) is satisfied must begin to comply with the including attachments, to http://
and replaced by a loan that is secured applicable requirements of this part. www.regulations.gov will be posted to
by real property, or by personal property * * * * * the docket unchanged. Because your
used or expected to be used as the objection will be made public, you are
By order of the Board of Governors of the solely responsible for ensuring that your
consumer’s principal dwelling, the new
Federal Reserve System, November 17, 2016. objection does not include any
loan is not exempt under § 1026.3(b),
and the creditor must comply with all Robert deV. Frierson, confidential information that you or a
of the applicable requirements of this Secretary of the Board. third party may not wish to be posted,
part. See comment 3(b)–5. Dated: November 7, 2016. such as medical information, your or
7. Application to extensions secured anyone else’s Social Security number, or
Richard Cordray,
by mobile homes. Because a mobile confidential business information, such
Director, Bureau of Consumer Financial as a manufacturing process. Please note
home can be a dwelling under
Protection. that if you include your name, contact
§ 1026.2(a)(19), the exemption in
[FR Doc. 2016–28718 Filed 11–29–16; 8:45 am] information, or other information that
§ 1026.3(b) does not apply to a credit
extension secured by a mobile home BILLING CODE 6210–01–4810–AM–P identifies you in the body of your
that is used or expected to be used as objection, that information will be
the principal dwelling of the consumer. posted on http://www.regulations.gov.
sradovich on DSK3GMQ082PROD with RULES
See comment 3(b)–6. • If you want to submit an objection
8. Transition rule for open-end with confidential information that you
accounts exempt prior to July 21, 2011. do not wish to be made available to the
Section 1026.3(b)(2) applies only to public, submit the objection as a
open-end accounts opened prior to July written/paper submission and in the
21, 2011. Section 1026.3(b)(2) does not manner detailed (see ‘‘Written/Paper
apply if a security interest is taken by Submissions’’ and ‘‘Instructions’’).
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![86270 Federal Register / Vol. 81, No. 230 / Wednesday, November 30, 2016 / Rules and Regulations
(b) The additive is used or intended DATES: These regulations are effective Subpart A—Procedures for Disclosure
for use to spare arginine and as a December 27, 2016. of Records Under the Freedom of
precursor of creatine in broiler chicken ADDRESSES: Questions or comments on Information Act
and turkey feeds at levels not to exceed this action are welcome. Mail or deliver
0.12 percent of the complete feed. This subpart sets forth the procedural
written comments to: Michael Elston, rules applicable to the submission and
(c) The additive consists of not less Associate General Counsel and Chief
than 97 percent guanidinoacetic acid processing of FOIA requests, including
Ethics & Compliance Officer, 475 how and to whom a request should be
[N-(aminoiminomethyl)-glycine] (CAS L’Enfant Plaza SW., Room 6000,
352–97–6) by weight. submitted, the responsibility for and the
Washington, DC 20260–1135. timing of a response, the nature and
(d) The additive meets the following
specifications: FOR FURTHER INFORMATION CONTACT: content of the response, the treatment of
(1) Dicyandiamide not to exceed 0.5 Natalie A. Bonanno, Chief Counsel, confidential commercial information
percent; Federal Compliance, obtained from a submitter outside the
(2) Cyanamide not to exceed 0.01 natalie.a.bonanno@usps.gov, (202) 268– Postal Service that may be protected
percent; 2944. from disclosure, the procedure for
(3) Melamine not to exceed 15 parts SUPPLEMENTARY INFORMATION: The Postal making an administrative appeal of the
per million (ppm); Service is amending 39 CFR part 265 to Postal Service’s response to a request,
(4) Sum of ammeline, ammelide, and implement changes to the procedures and the fees that may apply to
cyanuric acid not to exceed 35 ppm; and for the disclosure of records and for processing a request. This subpart is
(5) Water not to exceed 1 percent. engaging in dispute resolution under the designed to carry forward the
(e) To assure safe use of the additive Freedom of Information Act (FOIA), 5 substantive content of former §§ 265.1–
in addition to the other information U.S.C. 552, as required by the FOIA 265.5 and §§ 265.7–265.9 in a more
required by the Federal Food, Drug, and Improvement Act of 2016 (FOIAIA), accessible and useful format.
Cosmetic Act: Public Law 114–185 (June 30, 2016),
(1) The label and labeling of the 265.1 General Provisions
130 Stat. 538. Under section 3 of the
additive, any feed premix, and complete FOIA Improvement Act (130 Stat. 544) This section has been retitled and
feed shall contain the name of the agencies are required to make such revised to present a concise and
additive. changes not later than 180 days after its accessible overview of the policies and
(2) The label and labeling of the date of enactment. functions implemented by this subpart.
additive and any feed premix shall also The Postal Service has accordingly
contain: prepared a revision of 39 CFR part 265 265.2 Proactive Disclosure of Postal
(i) A statement to indicate that the Service Records
to implement the amendments to the
maximum use level of guanidinoacetic
FOIA contained in section 2 of the This section has been retitled and
acid must not exceed 0.12 percent of the
FOIAIA. These amendments relate to revised to ensure the continued
complete feed for broiler chickens and
such matters as the availability of availability of those records that must be
turkeys; and
certain records for public inspection in made publicly available, or are
(ii) Adequate directions for use.
an electronic format; the assessment of appropriate for public disclosure, and to
Dated: November 22, 2016. fees related to voluminous record provide for the posting and indexing of
Tracey H. Forfa, requests; modifications to the records in an electronic format as
Deputy Director, Center for Veterinary exemptions from disclosure for certain required under the FOIAIA.
Medicine. records described in 5 U.S.C. 552(b);
[FR Doc. 2016–28754 Filed 11–29–16; 8:45 am] and addressing the role of the Office of 265.3 Procedure for Submitting a FOIA
BILLING CODE 4164–01–P Government Information Services Request
(OGIS).
This section has been retitled and
In addition, the Postal Service is
revised to explain the organization and
POSTAL SERVICE restructuring its FOIA response
functions of the Postal Service’s FOIA
procedures, without substantive change
39 CFR Part 265 Requester Service Centers (RSCs), as
to their underlying policy, with the
well as the procedures to be followed in
objective of enhancing their usefulness
Production or Disclosure of Material or submitting a FOIA request.
and comprehensibility. In this regard,
Information 39 CFR part 265 has been retitled and 265.4 Responsibility for Responding to
AGENCY: Postal Service. subdivided into three subparts, dealing Requests
ACTION: Final rule.
separately with (1) the generally
applicable procedures for the disclosure This section has been retitled and
SUMMARY: The Postal Service is of records under FOIA; (2) special rules revised to clarify the functional
amending its regulations concerning applicable to the disclosure of records responsibilities of the RSCs in
compliance with the Freedom of in compliance with subpoenas and responding to FOIA requests.
Information Act (FOIA) to implement other court orders, in response to 265.5 Timing of Responses to Requests
the changes to the procedures for the requests for records or testimony in
disclosure of records and for engaging in other legal proceedings, or pursuant to This section has been retitled and
dispute resolution required by the FOIA requests directed to the Postal revised to set out the timeframe
sradovich on DSK3GMQ082PROD with RULES
Improvement Act of 2016. As part of Inspection Service; and (3) the rules applicable to the processing of requests,
this process, the Postal Service is also concerning the availability of specific including special provisions for the
restructuring the regulations setting categories of records that are not subject multitrack processing of simple or
forth its FOIA procedures, without to mandatory disclosure in whole or in complex requests, expedited processing
substantive change, to make them easier part. where appropriate, the extension of time
for members of the public to understand As reorganized and amended, 39 CFR in unusual circumstances, and
and use. part 265 is structured as follows: aggregation of requests.
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Document Created: 2016-11-30 02:17:48
Document Modified: 2016-11-30 02:17:48
| 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 | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This rule is effective November 30, 2016. Submit either written or electronic objections and requests for a hearing by December 30, 2016. See section V of this document for information on the filing of objections. | |
| Contact | Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729, [email protected] | |
| FR Citation | 81 FR 86268 | |
| CFR Associated | Animal Feeds and Food Additives |
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