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Food and Drug Administration, HHS.
Final rule.
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 supplemental chromium in horse feed. This action is in response to a food additive petition filed by Kemin Industries, Inc.
This rule is effective March 13, 2020. See section V of this document for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by April 13, 2020.
You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before April 13, 2020. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 13, 2020. Objections 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.
Submit electronic objections in the following way:
Submit written/paper submissions as follows:
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 objections, those filed in a ( printed page 14566) 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.
Docket: For access to the docket to read background documents or the electronic and written/paper objections 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.
Chelsea Cerrito, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl. (HFV-224), Rockville, MD 20855, 240-402-6729, Chelsea.Cerrito@fda.hhs.gov.
In a document published in the Federal Register of October 2, 2018 (83 FR 49508), FDA announced that we had filed a food additive petition (animal use) (FAP 2306) submitted by Kemin Industries, Inc., 1900 Scott Ave., Des Moines, IA 50317. 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 chromium propionate as a source of supplemental chromium in horse feed.
FDA concludes that the data establish the safety and utility of chromium propionate as a source of supplemental chromium in horse feed and that the food additive regulations should be amended as set forth in this document.
In accordance with § 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 § 571.1(h), we will delete from the documents any materials that are not available for public disclosure.
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 Dockets Management Staff (see ADDRESSES ) between 9 a.m. and 4 p.m., Monday through Friday.
Any person who will be adversely affected by this regulation may file with the Dockets Management Staff (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.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 573 is amended as follows:
1. The authority citation for part 573 continues to read as follows:
2. In § 573.304, revise paragraphs (b), (c), (d)(3), and (e)(2)(ii) to read as follows:
(b) The additive is added to feed as follows:
(1) In complete feed for broiler chickens at a level not to exceed 0.2 milligrams (mg) of chromium from chromium propionate per kilogram feed.
(2) In feed for horses at a level not to exceed an intake of 4 mg of chromium from chromium propionate per horse per day.
(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 (ppm).
(3) Arsenic, less than 1 ppm.
(4) Cadmium, less than 1 ppm.
(5) Lead, less than 0.5 ppm.
(6) Mercury, less than 0.5 ppm.
(7) Viscosity, not more than 2,000 centipoise.
(d) * * *
(3) Chromium from all sources of supplemental chromium cannot exceed:
(i) A level of 0.2 ppm in complete feed for broiler chickens.
(ii) An intake of 4 mg per horse per day.
(e) * * *
(2) * * *
(ii) Adequate directions for use and cautions for use including these statements: “Caution: Follow label directions” and consistent with the directions for use, the following:
(A) For feed for broiler chickens, “Chromium from all sources of supplemental chromium cannot exceed 0.2 parts per million of the complete feed for broiler chickens.”
(B) For feed for horses, “Chromium from all sources of supplemental ( printed page 14567) chromium cannot exceed 4 milligrams per horse per day.”
Dated: March 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04988 Filed 3-12-20; 8:45 am]
BILLING CODE 4164-01-P
4 comments have been received at Regulations.gov.
Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them.