Listing of Color Additives Exempt From Certification; Myoglobin

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 73</CFR> <DEPDOC>[Docket No. FDA-2022-C-0098]</DEPDOC> <SUBJECT>Listing of Color Additives Exempt From Certification; Myoglobin</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final amendment; order. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products. We are taking this action in response to a color additive petition (CAP) submitted by Motif FoodWorks, Inc. (Motif FoodWorks or petitioner). </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This order is effective February 19, 2025. See section X for further information on the filing of objections. Either electronic or written objections and requests for a hearing on the order must be submitted by February 18, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. The <E T="03">https://www.regulations.gov</E> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of February 18, 2025. Objections received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. <HD SOURCE="HD2">Electronic Submissions</HD> Submit electronic objections in the following way: • <E T="03">Federal eRulemaking Portal:</E> <E T="03">https://www.regulations.gov.</E> Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to <E T="03">https://www.regulations.gov</E> 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 <E T="03">https://www.regulations.gov.</E> • 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”). <HD SOURCE="HD2">Written/Paper Submissions</HD> Submit written/paper submissions as follows: • <E T="03">Mail/Hand Delivery/Courier (for written/paper submissions):</E> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper objections submitted to the Dockets Management Staff, 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.” <E T="03">Instructions:</E> All submissions received must include the Docket No. FDA-2022-C-0098 for “Listing of Color Additives Exempt From Certification; Myoglobin.” Received objections, those filed in a timely manner (see <E T="02">ADDRESSES</E> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <E T="03">https://www.regulations.gov</E> or with the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. • 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 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 <E T="03">https://www.regulations.gov.</E> 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: <E T="03">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.</E> <E T="03">Docket:</E> For access to the docket to read background documents or the electronic and written/paper comments received, go to <E T="03">https://www.regulations.gov</E> 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, 240-402-7500. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> Ellen Anderson, Office of Pre-market Additive Safety, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1309 or Keronica Richardson, Office of Policy, Regulations, and Information, Human Foods Program, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1262. </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Introduction</HD> In a document published in the <E T="04">Federal Register</E> of February 14, 2022 (87 FR 8222), we announced that FDA filed a color additive petition (CAP 2C0322) submitted by Motif FoodWorks, Inc., 27 Drydock Ave., 2nd Floor, Boston, MA 02210. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73), “Listing of Color Additives Exempt from Certification” to provide for the safe use of myoglobin as a color additive in ground meat and ground poultry analogue products where the amount of myoglobin protein does not exceed 2 percent by weight of the uncooked analogue product. The petition used the terms “analogue” and “alternative” interchangeably to describe the type of food products in which the color additive is intended for use. This order will use the phrase “ground meat and ground poultry analogue products,” which refers to plant-based ground meat- and poultry-like food products, such as patties, sausages, links, and nuggets, subject to FDA regulation. (The petitioned use of this color additive does not include use in cell-cultured meat and poultry products under regulatory authority of the United States Department of Agriculture.) The petition described myoglobin protein as the characterizing coloring component of a stabilized liquid mixture that imparts a red to pink coloration in uncooked ground meat and ground poultry analogue products to give an appearance similar to raw meat and poultry. The petition referred to the color additive as “myoglobin” or “myoglobin preparation.” For the purposes of this order, we refer to “myoglobin preparation” as the stabilized liquid mixture that contains myoglobin protein and note that “myoglobin” and “myoglobin preparation” are used interchangeably to refer to this color additive. We are establishing “myoglobin” as the common or usual name for this color additive. <HD SOURCE="HD1">II. Background </HD> The color additive that is the subject of this petition is the stabilized product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, <E T="03">Komagataella phaffii</E> ( <E T="03">K. phaffii</E> ), genetically engineered to express myoglobin protein, the principal coloring component. Although the organism is referred to as <E T="03">Pichia pastoris</E> ( <E T="03">P. pastoris</E> ) throughout the petition, we note that the nomenclature for <E T="03">P. pastoris</E> was reassigned based on genetic typing to <E T="03">Komagataella phaffii.</E> (Ref. 1). We are referring to the organism hereafter as <E T="03">K. phaffii</E> to reflect the current taxonomic identity. The color additive is manufactured by the following steps: (1) construction of the <E T="03">K. phaffii</E> production strain that is genetically engineered to express a synthetic myoglobin gene from <E T="03">Bos taurus;</E> (2) expression of myoglobin protein via submerged fed-batch fermentation by the <E T="03">K. phaffii</E> production strain; (3) disruption of the <E T="03">K. phaffii</E> cells by mechanical shearing to release myoglobin protein and removal of the <E T="03">K. phaffii</E> cells by washing, lysing, centrifugation, and microfiltration; (4) ultrafiltration to concentrate the myoglobin protein; and (5) stabilization of the expressed protein as a liquid preparation. The gene that is inserted into the <E T="03">K. phaffii</E> is generated by DNA synthesis and is not obtained directly from the DNA of <E T="03">Bos taurus.</E> The amino acid sequence of the expressed myoglobin protein is identical to bovine myoglobin protein that has a history of being safely consumed. Based on information in the petition, the myoglobin preparation has a moisture content of ≥92.5 percent, a myoglobin protein content of ≥3 percent, and may contain stabilizers, preser ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 31k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━