Impossible Foods, Inc.; Filing of Color Additive Petition, 64045-64046 [2018-26949]

Download as PDF Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Proposed Rules amozie on DSK3GDR082PROD with PROPOSALS1 Section B, including an explanation of why the application was denied.95 Public disclosure of any other information regarding admission to the BCFP Product Sandbox is governed by applicable law, including the DoddFrank Act,96 the Freedom of Information Act (FOIA),97 and the Bureau’s rule on Disclosure of Records and Information (Disclosure Rule).98 The Disclosure Rule generally prohibits the Bureau from disclosing confidential information,99 and defines confidential information to include confidential supervisory information and Bureau information that may be exempt from disclosure under the FOIA 100—including trade secrets and confidential commercial or financial information that is privileged or confidential.101 The Disclosure Rule defines confidential supervisory information to include any information provided to the Bureau by a financial institution to enable the Bureau to monitor for risks to consumers in the offering or provision of consumer financial products or services.102 Relatedly, the Disclosure Rule defines business information as commercial or financial information obtained by the Bureau from a submitter that may be protected from disclosure under Exemption 4 of FOIA, and generally provides that such business information shall not be disclosed pursuant to a FOIA request except in accordance with section 1070.20 of the rule.103 The Bureau anticipates that much of the information submitted by applicants in their applications, and by recipients during their participation in the BCFP Product Sandbox pursuant to the Terms and Conditions document, will qualify as confidential information, which may include confidential supervisory information, and/or business information, under the Disclosure Rule.104 In particular, the information requested under subsections II.B.3, II.B.4, II.B.6, and II.B.8 is designed to 95 Upon request, and to the extent permitted by law, the Bureau does not intend to release identifying information from published denials, and intends to redact such information from the denials published on its website. The Bureau intends to publish denials only after the applicant is given an opportunity to request reconsideration of the denial. 96 See, e.g., 12 U.S.C. 5512(c)(8). 97 5 U.S.C. 552. 98 12 CFR part 1070. 99 12 CFR 1070.41. 100 12 CFR 1070.2(f). 101 5 U.S.C. 552(b)(4). 102 12 CFR 1070.2(i)(1)(iv). 103 12 CFR 1070.20(a), (b). 104 To the extent associated communications include the same information, that information would have the same status. But other information in associated communications may be subject to disclosure. VerDate Sep<11>2014 16:36 Dec 12, 2018 Jkt 247001 enable the Bureau to assess potential risks to consumers posed by the described aspect of the product or service. Similarly, subsection II.D.5 requires recipients to report information about the effects of offering or providing the described aspects of the product or service on complaint patterns, default rates, or similar metrics that will enable to the Bureau to determine if doing so is causing material, tangible harm to consumers. The other data and information the recipient(s) will provide pursuant to subsection II.D.6 will likewise be used by the Bureau to monitor for risks to consumers. Therefore, the Bureau expects that much of the information submitted that is responsive to subsections II.B.3, II.B.4, II.B.6, and II.B.8, and the referenced portions of subsection II.D, may constitute confidential supervisory information, since it is obtained for the purpose of monitoring for risks to consumers. Additionally, the Bureau expects that much of the information or data submitted responsive to subsections II.B.2, II.B.8, and II.D.6 will constitute business information. The Bureau expects that it may also constitute confidential supervisory information, since understanding the nature of the described aspects of the product or service is essential for the Bureau to monitor for risks to consumers.105 106 Disclosure of information or data provided to the Bureau under the Policy to other Federal and State agencies is governed by applicable law, including the Dodd-Frank Act 107 and the Bureau’s Disclosure Rule, and subject to Bureau Bulletin 12–01.108 This includes disclosure consistent with Memoranda of Understanding (MOUs) the Bureau has with other Federal and State agencies. For example, under certain MOUs with other Federal agencies, the Bureau has agreed to provide CSI to those agencies. To the extent the Bureau wishes to publicly disclose non-confidential 105 To the extent an applicant or recipient submits information in connection with any of the identified subsections that is not actually responsive to these subsections, such information may be subject to disclosure. 106 The Bureau notes that the preceding protections from public disclosure must be balanced against the Bureau’s potential need to publicly disclose submitted data in some form—as permitted by applicable law and/or consent of recipients—if it decides to revise relevant regulatory provisions through notice-and-comment rulemaking based, in part, on such data—as provided in Section E. 107 See, e.g., 15 U.S.C. 5512(c)(6); 5514(b)(3); 5515(b)(2); 5516(c)(2); 5516(d)(2). 108 Available at: https:// files.consumerfinance.gov/f/2012/01/GC_bulletin_ 12-01.pdf. PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 64045 information regarding the BCFP Product Sandbox, the terms of such disclosure will be included in the Terms and Conditions document specified in Section II.D. The Bureau intends to draft the document in a manner such that confidential information is not disclosed. Consistent with applicable law and its own rules, the Bureau will not seek to publicly disclose any information or data that would conflict with consumers’ privacy interests. Dated: December 6, 2018. Mick Mulvaney, Acting Director, Bureau of Consumer Financial Protection. [FR Doc. 2018–26873 Filed 12–12–18; 8:45 am] BILLING CODE 4810–AM–P 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. 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 SUMMARY: E:\FR\FM\13DEP1.SGM 13DEP1 64046 Federal Register / Vol. 83, No. 239 / Thursday, December 13, 2018 / Proposed Rules 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 DEPARTMENT OF STATE [Public Notice: 10458] RIN 1400–AE35 Information and Communication Technology State Department. Proposed rule. AGENCY: The Department of State (the Department) updates and revises the rules that implement Section 508 of the Rehabilitation Act of 1973, consistent with a recent update to accessibility standards from the U.S. Access Board. DATES: The Department will accept comments until February 11, 2019. ADDRESSES: You may submit comments by the method: • Internet: At www.Regulations.gov, you can search for the document using the Docket Number: DOS–2018–0029 or using the notice’s RIN 1400–AE35. • Email: kottmyeram@state.gov— Alice Kottmyer, Attorney-Adviser, Department of State. FOR FURTHER INFORMATION CONTACT: Alice Kottmyer, Attorney Adviser, amozie on DSK3GDR082PROD with PROPOSALS1 SUMMARY: VerDate Sep<11>2014 16:36 Dec 12, 2018 Regulatory Findings SUPPLEMENTARY INFORMATION: This Department is publishing this document as a proposed rule with a 60day comment period. Background The Department published its rules implementing section 508 of the Rehabilitation Act of 1973, 29 U.S.C. 794d (section 508), in 2016. 81 FR 32645. Section 508 authorizes the Access Board to establish standards for technical and functional performance criteria to ensure that information technologies are accessible and usable by persons with disabilities. In January of 2017, the Access Board published a ‘‘refresh’’ of its existing standards and guidelines, which updated accessibility requirements for information and communication technology (ICT) covered by section 508 of the Rehabilitation Act or section 255 of the Communications Act. The rule jointly updated and reorganized the section 508 standards and section 255 guidelines to advance accessibility, facilitate compliance, and harmonize the requirements with other standards in United States and abroad. 82 FR 5832. Federal agencies, however, need only comply with the revised 508 standards (codified at 38 CFR 1194.1 and appendices A, C, and D), whereas the revised section 255 guidelines apply exclusively to telecommunications equipment manufacturers. Why is the Department promulgating this rule? 22 CFR Part 147 ACTION: Office of Management, Office of the Legal Adviser, (202) 647–2318. Jkt 247001 In its ‘‘refresh’’, the Access Board, among other things, reorganized the section 508 standards and updated terminology, such as replacing references to ‘‘electronic and information technology’’ with ‘‘information and communication technology’’. The title of the standards was also changed from ‘‘Electronic and Information Technology Accessibility Standards’’, to ‘‘Information and Communication Technology Standards and Guidelines’’. The amendments to part 147 proposed in this notice are intended to align the Department’s regulations with the Access Board’s revised section 508 standards. The Department also proposes adding one new provision (§ 147.9), which provides a prohibition against intimidation or retaliation against anyone who files a complaint, furnishes information, or engages in other lawful activities in furtherance of section 508, part 147, or other regulations that implement section 508. PO 00000 Frm 00011 Fmt 4702 Sfmt 4702 Administrative Procedure Act Regulatory Flexibility Act/Executive Order 13272: Consideration of Small Entities in Agency Rulemaking The Department certifies that this rule will not have a significant economic impact on a substantial number of small entities (small businesses, small nonprofit organizations and small governmental jurisdictions). Unfunded Mandates Reform Act of 1995 Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1532, generally requires agencies to prepare a statement before proposing any rule that may result in an annual expenditure of $100 million or more by State, local, or tribal governments, or by the private sector. This rule will not result in any such expenditure, nor will it significantly or uniquely affect small governments. Small Business Regulatory Enforcement Fairness Act of 1996 This rule is not a major rule as defined by 5 U.S.C. 804. With this rulemaking, the Department is making changes to terminology to align its rules with those of the Access Board. The Department is aware of no monetary effect on the economy that would result from this rulemaking, nor will there be any increase in costs or prices; or any effect on competition, employment, investment, productivity, innovation, or the ability of United States-based companies to compete with foreignbased companies in domestic and import markets. Executive Order 12866: Regulatory Planning and Review The Department of State does not consider this rule to be a ‘‘significant regulatory action’’ under Executive Order 12866, section 3(f). The Department of State has reviewed this rule to ensure its consistency with the regulatory philosophy and principles set forth in Executive Order 12866. The Department has determined that the benefits of this regulation, i.e., aligning its regulation with the standards promulgated by the Access Board, outweigh any costs. Executive Orders 12372: Intergovernmental Review of Federal Programs and 13132: Federalism This regulation will not have substantial direct effects on the States, E:\FR\FM\13DEP1.SGM 13DEP1

Agencies

[Federal Register Volume 83, Number 239 (Thursday, December 13, 2018)]
[Proposed Rules]
[Pages 64045-64046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

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