83_FR_64284 83 FR 64045 - Impossible Foods, Inc.; Filing of Color Additive Petition

83 FR 64045 - Impossible Foods, Inc.; Filing of Color Additive Petition

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 239 (December 13, 2018)

Page Range64045-64046
FR Document2018-26949

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Impossible Foods, Inc., proposing that the color additive regulations be amended to provide for the safe use of soy leghemoglobin as a color additive in plant-based, non-animal derived ground beef analogue products.

Federal Register, Volume 83 Issue 239 (Thursday, December 13, 2018) 
[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Proposed Rules]
[Pages 64045-64046]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26949]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-4464]


Impossible Foods, Inc.; Filing of Color Additive Petition

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of petition.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that we have filed a petition, submitted by Impossible Foods, Inc., 
proposing that the color additive regulations be amended to provide for 
the safe use of soy leghemoglobin as a color additive in plant-based, 
non-animal derived ground beef analogue products.

DATES: The color additive petition was filed on November 5, 2018.

ADDRESSES: For access to the docket to read background documents or 
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: Ellen Anderson, Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-1309.

SUPPLEMENTARY INFORMATION: Under section 721(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice 
that we have filed a color additive petition (CAP

[[Page 64046]]

9C0314), submitted by Impossible Foods, Inc., c/o Exponent, Inc., 1150 
Connecticut Avenue NW, Suite 1100, Washington, DC 20036. The petition 
proposes 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 soy leghemoglobin as a color additive in 
plant-based, non-animal derived ground beef analogue products.
    The petitioner has claimed that this action is categorically 
excluded under 21 CFR 25.32(k) because soy leghemoglobin would be added 
directly to food and is intended to remain in food through ingestion by 
consumers and is not intended to replace macronutrients in food. In 
addition, the petitioner has stated that, to their knowledge, no 
extraordinary circumstances exist. If FDA determines a categorical 
exclusion applies, neither an environmental assessment nor an 
environmental impact statement is required. If FDA determines a 
categorical exclusion does not apply, we will request an environmental 
assessment and make it available for public inspection.

    Dated: December 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26949 Filed 12-12-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Proposed Rules 64045 Section B, including an explanation of enable the Bureau to assess potential information regarding the BCFP Product why the application was denied.95 risks to consumers posed by the Sandbox, the terms of such disclosure Public disclosure of any other described aspect of the product or will be included in the Terms and information regarding admission to the service. Similarly, subsection II.D.5 Conditions document specified in BCFP Product Sandbox is governed by requires recipients to report information Section II.D. The Bureau intends to draft applicable law, including the Dodd- about the effects of offering or providing the document in a manner such that Frank Act,96 the Freedom of Information the described aspects of the product or confidential information is not Act (FOIA),97 and the Bureau’s rule on service on complaint patterns, default disclosed. Consistent with applicable Disclosure of Records and Information rates, or similar metrics that will enable law and its own rules, the Bureau will (Disclosure Rule).98 The Disclosure Rule to the Bureau to determine if doing so not seek to publicly disclose any generally prohibits the Bureau from is causing material, tangible harm to information or data that would conflict disclosing confidential information,99 consumers. The other data and with consumers’ privacy interests. and defines confidential information to information the recipient(s) will provide Dated: December 6, 2018. include confidential supervisory pursuant to subsection II.D.6 will information and Bureau information Mick Mulvaney, likewise be used by the Bureau to that may be exempt from disclosure monitor for risks to consumers. Acting Director, Bureau of Consumer under the FOIA 100—including trade Financial Protection. Therefore, the Bureau expects that much secrets and confidential commercial or of the information submitted that is [FR Doc. 2018–26873 Filed 12–12–18; 8:45 am] financial information that is privileged responsive to subsections II.B.3, II.B.4, BILLING CODE 4810–AM–P or confidential.101 The Disclosure Rule II.B.6, and II.B.8, and the referenced defines confidential supervisory portions of subsection II.D, may information to include any information constitute confidential supervisory DEPARTMENT OF HEALTH AND provided to the Bureau by a financial information, since it is obtained for the HUMAN SERVICES institution to enable the Bureau to purpose of monitoring for risks to monitor for risks to consumers in the consumers. Additionally, the Bureau Food and Drug Administration offering or provision of consumer expects that much of the information or financial products or services.102 data submitted responsive to 21 CFR Part 73 Relatedly, the Disclosure Rule defines subsections II.B.2, II.B.8, and II.D.6 will [Docket No. FDA–2018–C–4464] business information as commercial or constitute business information. The financial information obtained by the Bureau expects that it may also Impossible Foods, Inc.; Filing of Color Bureau from a submitter that may be constitute confidential supervisory Additive Petition protected from disclosure under information, since understanding the Exemption 4 of FOIA, and generally nature of the described aspects of the AGENCY: Food and Drug Administration, provides that such business information product or service is essential for the HHS. shall not be disclosed pursuant to a Bureau to monitor for risks to ACTION: Notification of petition. FOIA request except in accordance with consumers.105 106 section 1070.20 of the rule.103 Disclosure of information or data SUMMARY: The Food and Drug The Bureau anticipates that much of provided to the Bureau under the Policy Administration (FDA or we) is the information submitted by applicants to other Federal and State agencies is announcing that we have filed a in their applications, and by recipients governed by applicable law, including petition, submitted by Impossible during their participation in the BCFP the Dodd-Frank Act 107 and the Bureau’s Foods, Inc., proposing that the color Product Sandbox pursuant to the Terms Disclosure Rule, and subject to Bureau additive regulations be amended to and Conditions document, will qualify Bulletin 12–01.108 This includes provide for the safe use of soy as confidential information, which may disclosure consistent with Memoranda leghemoglobin as a color additive in include confidential supervisory of Understanding (MOUs) the Bureau plant-based, non-animal derived ground information, and/or business has with other Federal and State beef analogue products. information, under the Disclosure agencies. For example, under certain DATES: The color additive petition was Rule.104 In particular, the information MOUs with other Federal agencies, the filed on November 5, 2018. requested under subsections II.B.3, Bureau has agreed to provide CSI to ADDRESSES: For access to the docket to II.B.4, II.B.6, and II.B.8 is designed to those agencies. read background documents or To the extent the Bureau wishes to comments received, go to https:// 95 Upon request, and to the extent permitted by publicly disclose non-confidential www.regulations.gov and insert the law, the Bureau does not intend to release identifying information from published denials, and docket number found in brackets in the 105 To the extent an applicant or recipient submits intends to redact such information from the denials heading of this document into the published on its website. The Bureau intends to information in connection with any of the identified subsections that is not actually ‘‘Search’’ box and follow the prompts, publish denials only after the applicant is given an opportunity to request reconsideration of the responsive to these subsections, such information and/or go to the Dockets Management denial. may be subject to disclosure. Staff, 5630 Fishers Lane, Rm. 1061, 106 The Bureau notes that the preceding 96 See, e.g., 12 U.S.C. 5512(c)(8). Rockville, MD 20852. 97 5 U.S.C. 552. protections from public disclosure must be balanced against the Bureau’s potential need to FOR FURTHER INFORMATION CONTACT: 98 12 CFR part 1070. 99 12 CFR 1070.41. publicly disclose submitted data in some form—as Ellen Anderson, Center for Food Safety amozie on DSK3GDR082PROD with PROPOSALS1 permitted by applicable law and/or consent of and Applied Nutrition, Food and Drug 100 12 CFR 1070.2(f). recipients—if it decides to revise relevant 101 5 U.S.C. 552(b)(4). regulatory provisions through notice-and-comment Administration, 5001 Campus Dr., 102 12 CFR 1070.2(i)(1)(iv). rulemaking based, in part, on such data—as College Park, MD 20740, 240–402–1309. 103 12 CFR 1070.20(a), (b). provided in Section E. SUPPLEMENTARY INFORMATION: Under 104 To the extent associated communications 107 See, e.g., 15 U.S.C. 5512(c)(6); 5514(b)(3); section 721(d)(1) of the Federal Food, include the same information, that information 5515(b)(2); 5516(c)(2); 5516(d)(2). would have the same status. But other information 108 Available at: https:// Drug, and Cosmetic Act (21 U.S.C. in associated communications may be subject to files.consumerfinance.gov/f/2012/01/GC_bulletin_ 379e(d)(1)), we are giving notice that we disclosure. 12-01.pdf. have filed a color additive petition (CAP VerDate Sep<11>2014 16:36 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 E:\FR\FM\13DEP1.SGM 13DEP1

64046 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Proposed Rules 9C0314), submitted by Impossible Office of Management, Office of the Regulatory Findings Foods, Inc., c/o Exponent, Inc., 1150 Legal Adviser, (202) 647–2318. Administrative Procedure Act Connecticut Avenue NW, Suite 1100, SUPPLEMENTARY INFORMATION: This Department is publishing this Washington, DC 20036. The petition proposes to amend the color additive Background document as a proposed rule with a 60- regulations in part 73 (21 CFR part 73), day comment period. ‘‘Listing of Color Additives Exempt The Department published its rules Regulatory Flexibility Act/Executive From Certification,’’ to provide for the implementing section 508 of the Order 13272: Consideration of Small safe use of soy leghemoglobin as a color Rehabilitation Act of 1973, 29 U.S.C. Entities in Agency Rulemaking additive in plant-based, non-animal 794d (section 508), in 2016. 81 FR derived ground beef analogue products. 32645. The Department certifies that this rule The petitioner has claimed that this will not have a significant economic Section 508 authorizes the Access action is categorically excluded under impact on a substantial number of small Board to establish standards for 21 CFR 25.32(k) because soy entities (small businesses, small technical and functional performance leghemoglobin would be added directly nonprofit organizations and small criteria to ensure that information to food and is intended to remain in governmental jurisdictions). technologies are accessible and usable food through ingestion by consumers Unfunded Mandates Reform Act of 1995 by persons with disabilities. In January and is not intended to replace of 2017, the Access Board published a Section 202 of the Unfunded macronutrients in food. In addition, the ‘‘refresh’’ of its existing standards and Mandates Reform Act of 1995, 2 U.S.C. petitioner has stated that, to their guidelines, which updated accessibility 1532, generally requires agencies to knowledge, no extraordinary circumstances exist. If FDA determines requirements for information and prepare a statement before proposing a categorical exclusion applies, neither communication technology (ICT) any rule that may result in an annual an environmental assessment nor an covered by section 508 of the expenditure of $100 million or more by environmental impact statement is Rehabilitation Act or section 255 of the State, local, or tribal governments, or by required. If FDA determines a Communications Act. The rule jointly the private sector. This rule will not categorical exclusion does not apply, we updated and reorganized the section 508 result in any such expenditure, nor will will request an environmental standards and section 255 guidelines to it significantly or uniquely affect small assessment and make it available for advance accessibility, facilitate governments. public inspection. compliance, and harmonize the requirements with other standards in Small Business Regulatory Enforcement Dated: December 7, 2018. Fairness Act of 1996 United States and abroad. 82 FR 5832. Leslie Kux, Federal agencies, however, need only This rule is not a major rule as Associate Commissioner for Policy. comply with the revised 508 standards defined by 5 U.S.C. 804. With this [FR Doc. 2018–26949 Filed 12–12–18; 8:45 am] (codified at 38 CFR 1194.1 and rulemaking, the Department is making BILLING CODE 4164–01–P appendices A, C, and D), whereas the changes to terminology to align its rules revised section 255 guidelines apply with those of the Access Board. The exclusively to telecommunications Department is aware of no monetary DEPARTMENT OF STATE equipment manufacturers. effect on the economy that would result from this rulemaking, nor will there be 22 CFR Part 147 Why is the Department promulgating any increase in costs or prices; or any this rule? effect on competition, employment, [Public Notice: 10458] In its ‘‘refresh’’, the Access Board, investment, productivity, innovation, or RIN 1400–AE35 among other things, reorganized the the ability of United States-based Information and Communication section 508 standards and updated companies to compete with foreign- Technology terminology, such as replacing based companies in domestic and references to ‘‘electronic and import markets. AGENCY: State Department. information technology’’ with Executive Order 12866: Regulatory ACTION: Proposed rule. ‘‘information and communication Planning and Review SUMMARY: The Department of State (the technology’’. The title of the standards The Department of State does not Department) updates and revises the was also changed from ‘‘Electronic and consider this rule to be a ‘‘significant rules that implement Section 508 of the Information Technology Accessibility regulatory action’’ under Executive Rehabilitation Act of 1973, consistent Standards’’, to ‘‘Information and Order 12866, section 3(f). The with a recent update to accessibility Communication Technology Standards Department of State has reviewed this standards from the U.S. Access Board. and Guidelines’’. rule to ensure its consistency with the DATES: The Department will accept The amendments to part 147 regulatory philosophy and principles set comments until February 11, 2019. proposed in this notice are intended to forth in Executive Order 12866. The ADDRESSES: You may submit comments align the Department’s regulations with Department has determined that the by the method: the Access Board’s revised section 508 benefits of this regulation, i.e., aligning • Internet: At www.Regulations.gov, standards. The Department also its regulation with the standards amozie on DSK3GDR082PROD with PROPOSALS1 you can search for the document using proposes adding one new provision promulgated by the Access Board, the Docket Number: DOS–2018–0029 or (§ 147.9), which provides a prohibition outweigh any costs. using the notice’s RIN 1400–AE35. against intimidation or retaliation • Email: kottmyeram@state.gov— against anyone who files a complaint, Executive Orders 12372: Alice Kottmyer, Attorney-Adviser, furnishes information, or engages in Intergovernmental Review of Federal Department of State. other lawful activities in furtherance of Programs and 13132: Federalism FOR FURTHER INFORMATION CONTACT: section 508, part 147, or other This regulation will not have Alice Kottmyer, Attorney Adviser, regulations that implement section 508. substantial direct effects on the States, VerDate Sep<11>2014 16:36 Dec 12, 2018 Jkt 247001 PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 E:\FR\FM\13DEP1.SGM 13DEP1


Document Created: 2018-12-13 01:15:52
Document Modified: 2018-12-13 01:15:52
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotification of petition.
DatesThe color additive petition was filed on November 5, 2018.
ContactEllen Anderson, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1309.
FR Citation83 FR 64045 
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