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Federal Register / Vol. 86, No. 168 / Thursday, September 2, 2021 / Rules and Regulations environmental impact statement is required. We did not receive any new information or comments regarding this claim of categorical exclusion. We considered the petitioners claim of categorical exclusion and determined that this action is categorically excluded under 25.32k. Therefore, neither an environmental assessment nor an environmental impact statement is required.
VIII. Paperwork Reduction Act of 1995
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

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IX. Section 301ll of the FD&C Act Our review of this petition was limited to section 721 of the FD&C Act.
This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301ll of the FD&C Act 21
U.S.C. 331ll prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act 21 U.S.C.
355, a biological product licensed under section 351 of the Public Health Service Act 42 U.S.C. 262, or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301ll1 to 4 of the FD&C Act applies. In our review of this petition, we did not consider whether section 301ll of the FD&C Act or any of its exemptions apply to food containing this color additive.
Accordingly, this final rule should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301ll of the FD&C Act.
Furthermore, this language is included in all color additive final rules that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301ll of the FD&C Act applies.
X. Objections This rule is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff see ADDRESSES either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify
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with particularity the provisions to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register.
XI. References The following references marked with an asterisk are on display at the Dockets Management Staff see ADDRESSES and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https
www.regulations.gov. References without asterisks are not on public display at https www.regulations.gov because they have copyright restriction.
Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff. FDA
has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time.
1. Wu, X., G. R. Beecher, J. M. Holden, et al., Concentrations of Anthocyanins in Common Foods in the United States and Estimation of Normal Consumption. Journal of Agricultural and Food Chemistry, 54:
40694075, 2006.
2. Memorandum from B. Petigara Harp, Color Technology Branch, Division of Color Certification and Technology, Office of Cosmetics and Colors, Center for Food Safety and Applied Nutrition CFSAN, FDA, to S.
DiFranco, Division of Food Ingredients DFI, Office of Food Additive Safety OFAS, CFSAN, FDA, June 4, 2021.
3. Lee, S. M., M. L. Papathakis, HM. C.
Feng, et al., Multipesticide Residue Method for Fruits and Vegetables: California Department of Food and Agriculture.
Fresenius Journal of Analytical Chemistry, 339, 376383, 1991.

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4. Memorandum from D. Doell, Chemistry Review Team, DFI, OFAS, CFSAN, FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 7, 2021.
5. Memorandum of Teleconference from S. DiFranco, Regulatory Review Team, DFI, OFAS, CFSAN, FDA, to the file, April 7, 2020.
6. EFSA, Scientific Opinion on the Reevaluation of Anthocyanins E163 as a Food Additive. EFSA Journal, 114: 3145, 2013.
7. NTP, Toxicology and Carcinogenesis Studies of Quercetin CAS No. 117395 in F344 Rats Feed Studies. NTP Technical Report Series, No. 409, 1992.
8. Hard, G. C., J. C. Seeley, L. J. Betz, et al., Re-evaluation of the Kidney Tumors and Renal Histopathology Occurring in a 2-Year Rat Carcinogenicity Bioassay of Quercetin.
Food and Chemical Toxicology, 45: 600608, 2007.
9. Memorandum from Y. Zang, Toxicology Review Team, DFI, OFAS, CFSAN, FDA, to S. DiFranco, DFI, OFAS, CFSAN, FDA, June 9, 2021.
10. Memorandum from S. Mog and S.
Francke to Y. Zang. Pathology Consultation Review on Renal Neoplasms in Male F344
rats from National Toxicology Program Technical Report NTP TR 409 on Quercetin in F344/N Rats feed studies, October 31, 2019.
11. USDA. Table 1a. Flavonoids from Food and Beverages: Mean Intake standard error per Individuals, by Gender and Age, in the United States, What We Eat in America.
NHANES 20072010, 2016.
12. Goodman R. E., M. Ebisawa, F. Ferreira, et al., AllergenOnline: A Peer-reviewed, Curated Allergen Database to Assess Novel Food Proteins for Potential Cross-reactivity.
Molecular Nutrition and Food Research, 605:11831198, 2016.

List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Foods, Medical devices.
Therefore, 21 CFR part 73 is amended as follows:
PART 73LISTING OF COLOR
ADDITIVES EXEMPT FROM
CERTIFICATION
1. The authority citation for part 73
continues to read as follows:

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e.

2. Add 73.69 to subpart A to read as follows:

73.69

Butterfly pea flower extract.

a Identity. 1 The color additive butterfly pea flower extract is a dark blue liquid prepared by the aqueous extraction of dried butterfly pea flowers from Clitoria ternatea. The extract is further processed by ultrafiltration to remove residues of plant products, followed by concentration and pasteurization. Citric acid may be used to control the pH. The color additive
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02SER1