FSIS accredits non-Federal analytical laboratories under its Accredited Laboratory Program (ALP). Under this voluntary program, FSIS accredits laboratories to conduct analyses of official meat and poultry samples for food chemistry (moisture, protein, fat, and salt), specific chemical residues, and classes of chemical residues. In response to the meat and poultry industries' need for more rapid analytical results as food testing expanded, and because of limitations in FSIS laboratory capacity at the time of this need, these programs were established to accredit non-Federal laboratories for certain tests of both meat and poultry products.

The ALP monitors each non-Federal laboratory currently accredited under the program to ensure that these laboratories are operating at a level of quality that produces reliable results that can be used to support decisions in establishments' food safety systems. The Proficiency Testing (PT) program administered by the ALP supports this effort. Monitoring is achieved by evaluating PT results for acceptable analytical performance and assessing quality assurance through on-site reviews of each laboratory's management system and facility assets.

On December 14, 2020, FSIS proposed changes to its ALP regulations (85 FR 80668). Specifically, FSIS proposed to change the statistical method it uses to evaluate laboratory PT sample results to the z score approach for those accreditations that are currently evaluated by Cumulative Summation (CUSUM). FSIS also proposed to accredit non-Federal laboratories for microbiological indicator organisms and pathogen testing, in response to industry interest. This second change will allow ALP-accredited laboratories to support statistical process control testing. FSIS intends to announce additional criteria for submitting test results in a future Federal Register document. Additionally, FSIS proposed to make various minor edits and changes to the regulations for the sake of clarity and to incorporate all sample types under the jurisdiction of FSIS ( e.g., to include egg products), as appropriate for the associated analyte, and to improve program flexibility.

The comment period ended on February 12, 2021. After reviewing comments, FSIS is finalizing the rule as proposed.

FSIS received seven comments on the proposed rule. Commenters included representatives from laboratories, an association of laboratory scientists, a State Department of Agriculture, a nationwide laboratory network, and a trade association. Four of the seven commenters expressed overall support for the proposed rule. Some commenters raised questions and made suggestions, and two of the commenters expressed concern with making International Organization for Standardization (ISO) 17025 accreditation a prerequisite to participation in the program, a possibility upon which FSIS requested comment in the proposal. No commenter expressed broad opposition to the proposal, as a whole, for updating the statistical PT scoring and expanding the program to include accreditations for microbiological indicator organisms and pathogen testing.

The following is a discussion of the relevant issues raised in the comments.

Comments: All commenters generally agreed with the proposed change from CUSUM to z scores. One commenter from a State Department of Agriculture asked at which point a lab would be considered on probation under the new statistical analysis using z scores; how grading will be applied; and whether a z score will be determined per event.

Response: Per 9 CFR 439.20 and ISO 13528, the PT scoring changes will be applied per event. The ALP will also monitor laboratory performance over time. After adopting the proposed changes, probation imposed for performance issues will be administered the same way it has with CUSUMs, but assessment will rely instead on unacceptable z scores and monitoring for persistent bias. Unacceptable z scores are greater than 3 and less than −3. FSIS intends to determine probation for PT performance issues as follows.

• A laboratory will be placed on probation for having two z scores that exceed the action level of | z | ≥ 3.0 for the same analyte or class of analytes within six consecutive PT events.

• A laboratory may be placed on probation for having a persistent bias of an analyte or class of analytes compared to the accepted values of ALP PT samples. As a general practice under ISO 13528, FSIS intends that the ALP will use control charts to monitor for this aspect of performance. Bias occurs once eight or more consecutive values fall above or below the center or mean line. Under the ALP, FSIS reserves the right to consider other factors (such as magnitude or significance) when determining the impact of bias.

Comments: Two commenters stated that ALP data should be managed through a website portal or other similar option. One commenter representing an association of scientists strongly supported the FSIS vision of utilizing the ALP to allow regulated establishments to voluntarily submit test results to FSIS. Another commenter representing a nationwide laboratory network suggested that accredited laboratories should maintain complete records of all aspects of the testing process and that the records should be securely maintained in an electronic format that is adequately backed up. In addition, the commenter recommended that key components of ALP data should be clearly defined to assure proper data interpretation and that definitions used by ISO13528:2015(E) should be consistent with USDA to assure uniformity.

Response: FSIS intends to develop a web-based platform for ALP test result submissions to FSIS. FSIS will announce the availability of the web-based platform in a future Constituent Update. Per 9 CFR 439.20, the FSIS ALP regulations require a secure management system that is adequate for tracking samples and related analyses and test results. The ALP does allow, but does not require, electronic records, and it does require that records be secure. Test result definitions used by the ALP are consistent with ISO 13528:2015(E). Any electronic system for submitting test results to FSIS will have to be compatible with FSIS data management systems.

Comment s: One commenter representing a laboratory did not see the benefit of adding pathogens and indicator organism constituents to the ALP. Five commenters recommended that FSIS expand the ALP offerings to include such items as pH in meat, beta-agonists in beef/pork muscle/organs, Campylobacter in chicken, Salmonella in meat products, Listeria spp. in swabs/sponges, Listeria monocytogenes in meat products, Escherichia coli in carcass swabs, Enterobacter in swabs/sponges, Shiga toxin-producing Escherichia coli in meat products, generic Escherichia coli, total coliform, Aerobic Plate Count, and drug residues in animal products, including antibiotics and pesticides. Other commenters recommended the ALP include microbiology qualitative and quantitative testing and requested that FSIS revisit approved analytes in the ALP on a systematic basis.

Response: Per 9 CFR 439.1 and 439.10, FSIS will consider all requests for accredited matrix and analyte pairs for the ALP that are within FSIS's jurisdiction. FSIS will also consider qualitative and quantitative testing for chemical and microbiological components under the ALP. Finally, FSIS will routinely examine the ALP offerings when appropriate.

Comments: Two commenters representing laboratories did not support making ISO 17025 accreditation a prerequisite to participating in the ALP and stated such a requirement could cause an undue burden on smaller laboratories wishing to join the ALP. Two commenters representing a laboratory association and a laboratory network supported making ISO 17025 accreditation a prerequisite to participating in the ALP but also stated that the requirement may be unnecessary. One of these commenters suggested that laboratories not accredited to ISO 17025 should operate under a robust quality management system or “ISO-like” environment. One commenter representing a laboratory network supported the rule and stated that ISO 17025 accreditation should be a prerequisite to membership in the ALP.

Response: This final rule expands the ALP in a way that is inclusive for all interested laboratories and establishments that can successfully meet the program requirements and, per 9 CFR 439.20, the ALP will require participating laboratories to have a management system in place that includes traceability, document control, and secure record retention. Laboratories may choose whether to be accredited to the ISO 17025 standard; however, FSIS will not require ISO 17025 accreditation under the ALP. Laboratories seeking ALP accreditation without ISO 17025 accreditation are often very small and conduct meat and poultry analyses only. In these cases, the ALP accreditation provides value by affirming that the lab can do independent PT analysis with those PT samples made by and coming from the ALP.

Comments: Three commenters responded that if a laboratory is accredited to ISO 17025, the FSIS ALP audit should be streamlined to account for this and offer fee discounts. One commenter representing a network of laboratories responded that the ALP proficiency testing program should be accredited to the ISO 17043 standard if it is to attract members from the governmental sector. One commenter representing an association of laboratories stated that a reduction in fees would be welcomed by laboratories interested in the ALP, but the best way to incentivize laboratories to become ALP members is to expand the scope of testing. The commenter pointed out that most laboratories providing services to meat and poultry companies are focused on supporting their clients' food safety programs. The commenter stated that laboratories' clients view their being an FSIS ALP laboratory as positive, which is beneficial to the laboratory.

Response: FSIS will continue to accept the management systems of laboratories that are accredited to ISO 17025 by an International Laboratory Accreditation Cooperation recognized accrediting body as meeting ALP requirements. The laboratories must be in good standing with their ISO accreditation for the ALP to accept the management systems. The ALP performs onsite reviews of participating laboratories to ensure they are following management system requirements, as well as the technical and method requirements for participation in the program. FSIS estimates that the ALP review for ISO 17025 accredited laboratories will be reduced by a range of 0.5 to 1 hour. The ALP has been ISO 17043 accredited as a proficiency testing provider since 2015. The ALP has also been ISO 17034 accredited as a reference material producer since 2017. Both accreditations are kept current. Because comments have been supportive of expanding the ALP offerings, FSIS intends to develop new offerings from the ALP. The new offerings may be found on the ALP website as they are developed and available.

Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This final rule has been designated as a “non-significant” regulatory action under section 3(f) of E.O. 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget under E.O. 12866.

There were approximately 55 food chemistry laboratories participating in the ALP in 2012. Since then, participation has declined to 34 laboratories in 2021. Of those laboratories, 25 were accredited for food chemistry, 13 for chemical residue chlorinated pesticides analysis, and 4 for chemical residue PCBs analysis (some laboratories have multiple accreditations). 1 Participation in the ALP will likely be bolstered by expanding the ALP to include additional analytes, such as indicator organisms and foodborne pathogens. In addition, switching from the CUSUM PT sample scoring system currently used by the ALP to z score -based statistics should simplify the accreditation process for both the laboratories and FSIS. The program generally facilitates industry testing to verify that food is safe and properly labeled.

Although the final rule does not change the current accreditation fee structure, 2 it will reduce the number of samples non-Federal food chemistry laboratories will have to analyze to attain and maintain food chemistry accreditation. Based on industry data, non-ALP laboratories charge approximately $108  3 per sample. Current criteria for obtaining accreditation (9 CFR 439.10(d)(2)(i)) require that laboratories analyze a set of 36 samples (9 CFR 439.1(k) “Initial accreditation check sample”) for food chemistry to obtain initial accreditation or to remove probationary status in food chemistry. The estimated cost for analyzing the sample set (also known as qualification set) is approximately $3,888 (36 × $108 = $3,888). This number of samples is not necessary to statistically evaluate laboratory performance for admittance to the program. Under this final rule, FSIS removed the requirement for the set of 36 samples. This will permit the ALP to offer laboratories smaller sets for food chemistry accreditation. The smaller qualification sets will reduce costs for laboratories and still be large enough to evaluate laboratory performance. FSIS experts provided an estimated cost of analysis of approximately $1,512 when using 14 samples per set (14 × $108 = $1,512), a reduction of $2,376 ($3,888−$1,512 = $2,376) per qualification set for food chemistry. This analysis assumes that between 1 and 6 establishments will have to complete qualification sets in any given year. 4 Based on this assumption the annual savings ranges from $2,376 (1 × $2,376) to $14,256 (6 × $2,376), with a mid-point of $8,316 (3.5 × $2,376).

Additionally, the changes to the accreditation process (9 CFR 439.10(d)(4)(ii)) are also expected to reduce industry costs. Current criteria state that if a laboratory's second set of qualification samples do not meet the criteria for obtaining accreditation, laboratories must submit a new application, all fees, and all documentation of corrective action required for accreditation. FSIS will no longer require food chemistry laboratories to reapply and pay the fees again before receiving the third qualification sample set. Instead, fees will be paid after the third set or if the initial accreditation process is not completed within eleven months (per 9 CFR 439.10(c)). This is expected to reduce an applicable laboratory's accreditation cost by between $2,100 and $5,000.

The FSIS Administrator (Administrator) has made a determination that this final rule will not have a significant economic impact on a substantial number of small entities in the United States, as defined by the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). First, this rule's impact is limited to a small number of entities and participation in the program is voluntary. Second, while the changes are expected to reduce accreditation costs, these cost savings are not anticipated to be significant and will apply to accredited laboratories regardless of size.

FSIS has reviewed this rule under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) and has determined that there is no new information collection related to this final rule. FSIS collects information for the ALP under Office of Management and Budget (OMB) approval numbers 0583-0082 and 0583-0163.

FSIS and USDA are committed to achieving the purposes of the E-Government Act (44 U.S.C. 3601, et seq. ) by, among other things, promoting the use of the internet and other information technologies and providing increased opportunities for citizen access to Government information and services.

This rule has been reviewed in accordance with the requirements of Executive Order 13175, Consultation and Coordination with Indian Tribal Governments. The review reveals that this regulation will not have substantial and direct effects on Tribal governments and will not have significant Tribal implications.

Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this Federal Register publication on-line through the FSIS web page located at: https://www.fsis.usda.gov/federal-register.

FSIS will also announce and provide a link to this Federal Register publication through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to our constituents and stakeholders. The Constituent Update is available on the FSIS web page. Through the web page, FSIS can provide information to a much broader, more diverse audience. In addition, FSIS offers an email subscription service which provides automatic and customized access to selected food safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves and have the option to password protect their accounts.

In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.

Persons with disabilities who require alternative means of communication for program information ( e.g., Braille, large print, audiotape, American Sign Language, etc.) should contact the responsible FSIS or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or contact USDA through the Federal Relay Service at (800) 877-8339. Additionally, program information may be made available in languages other than English.

To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and at any USDA office or write a letter addressed to USDA and provide in the letter all of the information requested in the form. To request a copy of the complaint form, call (866) 632-9992.

Submit your completed form or letter to USDA by: (1) mail: U.S. Department of Agriculture, Office of the Assistant Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) email: program.intake@usda.gov.

USDA is an equal opportunity provider, employer, and lender.

For the reasons discussed in the preamble, FSIS revises 9 CFR part 439 to read as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would modify the Class D and Class E airspace at Camarillo Airport, Camarillo, CA, to support VFR and IFR operations at the airport.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register for FAA-2021-0244 (87 FR 34595; June 7, 2022) to modify the Class E airspace designated as an extension to a Class D or Class E surface area, establish Class E airspace beginning at 700 feet above the surface, remove the Camarillo VOR/DME from the airspace's legal description, and make administrative changes to the Class D and Class E legal descriptions at Camarillo Airport, Camarillo, CA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received. Class D, Class E4, and Class E5 airspace designations are published in paragraphs 5000, 6004, and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

This document amends FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending 14 CFR part 71 by modifying the Class E airspace, designated as an extension to a Class D or Class E surface area. This airspace area is east of the airport and is reduced to properly contain IFR aircraft descending below 1,000 feet above the surface. This action also removes the Camarillo VOR/DME navigational aid (NAVAID) from the airspace's legal description. The NAVAID is not required to define the airspace and removal of the NAVAID simplifies the airspace's description.

Additionally, this action establishes Class E airspace extending upward from 700 feet above the surface. This airspace is designed to contain arriving IFR aircraft descending below 1,500 feet above the surface and departing IFR aircraft until they reach 1,200 feet above the surface. Lastly, this action also makes several administrative modifications to the Class D and Class E airspace's legal descriptions. To match the FAA database, the geographic coordinates in the third line of the Class E4 airspace's text header are modified to read lat. “34°12′50″ N, long. 119°05′40″ W.” Also, since Camarillo Airport's Class D airspace abuts the Class D areas for Point Mugu Naval Air Station and Oxnard Airports, the geographic coordinates at Camarillo Airport's Class D are updated to more accurately define the common borders of the Class D areas, which do not represent a change to the current boundaries. The Class D and Class E4 legal descriptions are updated to read “Notice to Air Missions” in place of “Notice to Airmen,” to match the FAA's current definition of the acronym “NOTAM.” Finally, the term “Airport/Facility Directory” in the last sentence of the Class D and Class E4 airspace descriptions is updated to read “Chart Supplement.”

Class D, E4, and E5 airspace designations are published in paragraphs 5000, 6004, and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11. FAA Order JO 7400.11 is published annually and becomes effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial, and unlikely to result in adverse or negative comments. It therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory policies and procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority, as it would modify the Class D and Class E airspace at Oxnard Airport, Oxnard, CA, to support VFR and IFR operations at the airport.

The FAA published a notice of proposed rulemaking (NPRM) in the Federal Register for FAA-2021-0243 (87 FR 21056; April 11, 2022) to remove the Class E airspace designated as an extension to a Class D or Class E surface area, establish Class E airspace beginning at 700 feet above the surface, and make administrative changes to the Class D legal description. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D, Class E4, and Class E5 airspace designations are published in paragraphs 5000, 6004, and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

This document amends FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

The FAA is amending 14 CFR part 71 by removing the Class E airspace, designated as an extension to a Class D or Class E surface area. This airspace is west of the airport and is no longer required to contain IFR arrivals descending below 1,000 feet above the surface.

This action also establishes Class E airspace extending upward from 700 feet above the surface to contain arriving IFR aircraft descending below 1,500 feet above the surface, and departing IFR aircraft until they reach 1,200 feet above the surface.

Finally, the FAA is making several administrative modifications to the Class D legal description. The current description requires modification to replace the use of the phrases “Notice to Airmen” and “Airport/Facility Directive.” These phrases should read “Notice to Air Missions” and “Chart Supplement” respectively, in the Oxnard Class D airspace legal description. Additionally, the Oxnard Airport's Class D airspace abuts the Class D areas of Point Mugu Naval Air Station Airport and Camarillo Airport. The geographic coordinates in the Oxnard Airport Class D legal description are updated to more accurately define the common borders of the three Class D surface areas, which does not represent a change to the current boundaries.

Class D, E4, and E5 airspace designations are published in paragraphs 5000, 6004, and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

FAA Order JO 7400.11 is published annually and becomes effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial, and unlikely to result in adverse or negative comments. It therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory policies and procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, Environmental Impacts: Policies and Procedures, paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

In consideration of the foregoing, the FAA amends 14 CFR part 71 as follows:

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class D airspace at Fort Worth Spinks Airport, Fort Worth, TX, and the Class E airspace extending upward from 700 feet above the surface at Granbury Regional Airport, Granbury, TX, contained within the Dallas-Fort Worth, TX, airspace legal description, to support instrument flight operations at these airports.

The FAA published a notice of proposed rulemaking in the Federal Register (86 FR 68571; December 3, 2021) for Docket No. FAA-2021-1047 to amend the Class D airspace at Fort Worth, TX, and the Class E airspace at Dallas-Fort Worth, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class D and E airspace designations are published in paragraphs 5000 and 6005, respectively, of FAA Order JO 7400.11F, dated August 10, 2021, and effective September 15, 2021, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in FAA Order JO 7400.11.

This document amends FAA Order JO 7400.11F, Airspace Designations and Reporting Points, dated August 10, 2021, and effective September 15, 2021. FAA Order JO 7400.11F is publicly available as listed in the ADDRESSES section of this document. FAA Order JO 7400.11F lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

Subsequent to publication of the NPRM, the FAA updated the term “Notice to Airmen” to “Notice to Air Missions.” As this is an administrative change and does not impact the proposed airspace, this change has been incorporated into the Fort Worth Spinks Airport, Fort Worth, TX, airspace legal description.

This amendment to 14 CFR part 71:

Amends the Class D airspace at Fort Worth Spinks Airport, Fort Worth, TX, by updating the geographic coordinates of the airport to coincide with the FAA's aeronautical database; and updates the outdated term “Notice to Airmen” to “Notice to Air Missions;”

And amends the Class E airspace extending upward from 700 feet above the surface within an 8.8-mile (increased from a 6.3-mile) radius of Granbury Regional Airport, Granbury, TX, contained within the Dallas-Fort Worth, TX, airspace legal description; and updates the geographic coordinates of Fort Worth Spinks Airport, Fort Worth, TX, also contained within the Dallas-Fort Worth, TX airspace legal description, to coincide with the FAA's aeronautical database.

This action is necessary due to an airspace review due to the cancellation of the instrument procedures and implementation of new instrument procedures at Granbury Regional Airport.

FAA Order JO 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5.a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.

The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, Takeoff Minimums or ODPs, but instead refer to their graphic depiction on charts printed by publishers or aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP, Takeoff Minimums and ODP listed on FAA form documents is unnecessary. This amendment provides the affected CFR sections and specifies the typed of SIAPS, Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure, and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for Part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.

The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.

Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:

This rule amends 14 CFR part 97 by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (NFDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the Federal Register expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained on FAA form documents is unnecessary. This amendment provides the affected CFR sections, and specifies the SIAPs and Takeoff Minimums and ODPs with their applicable effective dates. This amendment also identifies the airport and its location, the procedure and the amendment number.

The material incorporated by reference is publicly available as listed in the ADDRESSES section.

The material incorporated by reference describes SIAPs, Takeoff Minimums and ODPs as identified in the amendatory language for Part 97 of this final rule.

This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and Takeoff Minimums and ODP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP and Takeoff Minimums and ODP as modified by FDC permanent NOTAMs.

The SIAPs and Takeoff Minimums and ODPs, as modified by FDC permanent NOTAM, and contained in this amendment are based on criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts.

The circumstances that created the need for these SIAP and Takeoff Minimums and ODP amendments require making them effective in less than 30 days.

Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making these SIAPs effective in less than 30 days.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, pursuant to the authority delegated to me, Title 14, CFR part 97, (is amended by amending Standard Instrument Approach Procedures and Takeoff Minimums and ODPs, effective at 0901 UTC on the dates specified, as follows:

The Entity List (supplement No. 4 to part 744 of the EAR (15 CFR parts 730-774)) identifies entities for which there is reasonable cause to believe, based on specific and articulable facts, that the entities have been involved, are involved, or pose a significant risk of being or becoming involved in activities contrary to the national security or foreign policy interests of the United States, pursuant to § 744.11(b). The EAR imposes additional license requirements on, and limits the availability of, most license exceptions for exports, reexports, and transfers (in-country) to listed entities. The license review policy for each listed entity is identified in the “License Review Policy” column on the Entity List, and the impact on the availability of license exceptions is described in the relevant Federal Register document that added the entity to the Entity List. The Bureau of Industry and Security (BIS) places entities on the Entity List pursuant to part 744 (Control Policy: End-User and End-Use Based) and part 746 (Embargoes and Other Special Controls) of the EAR.

The End-User Review Committee (ERC), composed of representatives of the Departments of Commerce (Chair), State, Defense, Energy and, where appropriate, the Treasury, makes all decisions regarding additions to, removals from, or other modifications to the Entity List. The ERC makes all decisions to add an entry to the Entity List by majority vote and makes all decisions to remove or modify an entry by unanimous vote. This rule implements the ERC's decisions to add seven entities to the Entity List on the basis of § 744.11(b). Paragraphs (b)(1) through (5) of § 744.11 include an illustrative list of activities that could be contrary to the national security or foreign policy interests of the United States.

The ERC determined to add China Aerospace Science and Technology Corporation (CASC) 9th Academy 771 Research Institute, China Aerospace Science and Technology Corporation (CASC) 9th Academy 772 Research Institute, China Academy of Space Technology 502 Research Institute, China Academy of Space Technology 513 Research Institute, China Electronics Technology Group Corporation 43 Research Institute, China Electronics Technology Group Corporation 58 Research Institute, and Zhuhai Orbita Control Systems to the Entity List for acquiring and attempting to acquire U.S.-origin items in support of China's military modernization efforts. This activity is contrary to national security and foreign policy interests under § 744.11(b) of the EAR. For these seven entities added to the Entity List, BIS imposes a license requirement for all items subject to the EAR. For these seven entities, BIS will review license applications under a presumption of denial.

For the reasons described above, this final rule adds the following seven entities under seven entries to the Entity List and includes, where appropriate, aliases:

• China Aerospace Science and Technology Corporation (CASC) 9th Academy 771 Research Institute,

• China Aerospace Science and Technology Corporation (CASC) 9th Academy 772 Research Institute,

• China Academy of Space Technology 502 Research Institute,

• China Academy of Space Technology 513 Research Institute,

• China Electronics Technology Group Corporation 43 Research Institute,

• China Electronics Technology Group Corporation 58 Research Institute, and

• Zhuhai Orbita Control Systems

This final rule also makes typographical corrections to two existing entities on the Entity List. Beijing Tianhua and Tenfine Ltd. are revised by correcting “Haidain” to “Haidian” in their addresses.

For the changes being made in this final rule, shipments of items removed from eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR) as a result of this regulatory action that were en route aboard a carrier to a port of export, reexport, or transfer (in-country), on August 24, 2022, pursuant to actual orders for export, reexport, or transfer (in-country) to or within a foreign destination, may proceed to that destination under the previous eligibility for a License Exception or export, reexport, or transfer (in-country) without a license (NLR).

On August 13, 2018, the President signed into law the John S. McCain National Defense Authorization Act for Fiscal Year 2019, which included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-4852). ECRA provides the legal basis for BIS's principal authorities and serves as the authority under which BIS issues this rule.

1. This rule has been determined to be not significant for purposes of Executive Order 12866.

2. Notwithstanding any other provision of law, no person is required to respond to or be subject to a penalty for failure to comply with a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This regulation involves collections previously approved by OMB under control number 0694-0088, Simplified Network Application Processing System, which includes, among other things, license applications and commodity classifications, and carries a burden estimate of 29.4 minutes for a manual or electronic submission for a total burden estimate of 33,133 hours. Total burden hours associated with the PRA and OMB control number 0694-0088 are not expected to increase as a result of this rule.

3. This rule does not contain policies with federalism implications as that term is defined in Executive Order 13132.

4. Pursuant to section 1762 of the Export Control Reform Act of 2018, this action is exempt from the Administrative Procedure Act (5 U.S.C. 553) requirements for notice of proposed rulemaking, opportunity for public participation, and delay in effective date.

5. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule by 5 U.S.C. 553, or by any other law, the analytical requirements of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq., are not applicable. Accordingly, no regulatory flexibility analysis is required and none has been prepared.

Accordingly, part 744 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:

TTB authorizes the use of certain wine treating materials and processes under the authority of chapter 51 of the Internal Revenue Code of 1986, as amended (IRC), 26 U.S.C. chapter 51. Specifically, certain provisions of the IRC apply to the production of “natural wine,” which is defined at 26 U.S.C. 5381 as the product of the juice or must of sound, ripe grapes or other sound, ripe fruit, made with such cellar treatment as authorized under the IRC at 26 U.S.C. 5382. Section 5382(a) of the IRC (26 U.S.C. 5382(a)) provides that proper cellar treatment of natural wine constitutes those practices and procedures in the United States, of using various methods and materials to correct or stabilize the wine, or the fruit juice from which it is made, so as to produce a finished product acceptable in good commercial practice as prescribed by regulation. Section 5382(c) authorizes the Secretary of the Treasury (Secretary) to prescribe, by regulation, limitations on the preparation and use of methods and materials for clarifying, stabilizing, preserving, fermenting, and correcting wine and juice. In addition, section 5387(a) of the IRC (26 U.S.C. 5387(a)), which authorizes the production of agricultural wine from agricultural products other than the juice of fruit, provides that such agricultural wine must be made in accordance with good commercial practice as prescribed by regulation and may be cellar treated in accordance with sections 5382(a) and (c) of the IRC.

TTB administers chapter 51 of the IRC and its implementing regulations pursuant to section 1111(d) of the Homeland Security Act of 2002, as codified at 6 U.S.C. 531(d). The Secretary has delegated certain administrative and enforcement authorities to TTB through Treasury Order 120-01.

The regulations promulgated under these authorities are set forth in part 24 of title 27 of the Code of Federal Regulations (27 CFR part 24). The TTB regulations at 27 CFR 24.246 list materials authorized for the treatment of wine and juice; 27 CFR 24.247 lists materials authorized for the treatment of distilling material used in the production of wine; and 27 CFR 24.248 lists processes authorized for the treatment of wine, juice, and distilling material. The materials and processes listed in these regulatory sections are approved as being consistent with good commercial practice in the production, cellar treatment, or finishing of wine, and where applicable in the treatment of juice and distilling material, within limitations provided.

Industry members wanting to use a treating material or process not specifically authorized in part 24 may request authorization to do so. TTB may administratively approve the use of treating materials and processes not listed in the regulations, either as an experiment under 27 CFR 24.249 or for continual use (acceptable in good commercial practice) under 27 CFR 24.250. Applicants for such approvals must submit to TTB a request describing the material or process and the purpose, manner, and extent to which the material or process is to be used; certain samples and test results; and any other relevant information, as described in the regulations. If the request is for the approval of a material, the applicant must also submit documentary evidence of the U.S. Food and Drug Administration (FDA) approval of the material for its intended purpose in the amounts, along with the recommended minimum and maximum amounts of the material, if any. Consistent with §§ 24.246, 24.247, and 24.248, TTB may approve the use of treating materials and processes that are determined to be acceptable in good commercial practice. In Notice No. 164, TTB explained that it considers good commercial practice to include addressing the reasonable technological or practical need to enhance the keeping, stability, or other qualities of the wine, and achieving the winemaker's desired effect but not creating an erroneous impression about the character and composition of the wine.

When TTB approves the continued commercial use of a treating material or process under § 24.250, it provides public notice of such approval on its website at https://www.ttb.gov/wine/treating-materials. The listing of such administrative approvals on the TTB website affords all industry members the opportunity to use an administratively approved wine treating material or process pending future rulemaking.

For several reasons, TTB conducts rulemaking to consider adding to or amending the materials and processes authorized in the regulations for treating wine, juice, and distilling material listed in §§ 24.246 through 24.248. One reason is that when TTB administratively approves wine treatments or processes for continued commercial use under § 24.250, TTB is making an initial determination that the treatment is consistent with “good commercial practice.” The subsequent rulemaking process allows industry members and other members of the public an opportunity to publicly comment on, and specifically to confirm or refute, the initial determination that the use of a material or process is consistent with good commercial practice. TTB can then determine whether to add the material or process to its regulations.

Administrative approval of a wine treatment under § 24.250 does not guarantee acceptance in foreign markets of any wine so treated. Therefore, conducting rulemaking to add wine treating materials and processes to the regulations may also result in acceptance of the treated wines in certain foreign jurisdictions. For example, under Article 4.2 of the 2006 Agreement between the United States of America and the European Community on Trade in Wine (Wine Agreement), the United States and the European Union agreed not to restrict “on the basis of either wine-making practices or product specifications, the importation, marketing or sale of wine originating in the territory of the other Party that is produced using wine-making practices that are authorized under laws, regulations and requirements of the other Party . . . and published or communicated to it by that other Party.” Article 5.1 of the Wine Agreement also contains provisions to authorize new or modified wine-making practices if a party to the Wine Agreement provides public notice and specific notice to the other party, and provides a reasonable opportunity for comment and to have those comments considered. Through the rulemaking process, TTB provides such public notice and opportunity to comment on wine treating materials and processes that had been administratively approved. As a result, incorporation of the treating materials and processes in the regulations provides domestic winemakers with greater flexibility in producing wines for sale in foreign markets.

TTB also consults with the U.S. Food and Drug Administration (FDA) on whether alcohol beverages are adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act), including whether a substance added to an alcohol beverage is an unapproved food additive. Alcohol beverages are considered “food” under the FD&C Act. A substance added to food is a food additive unless it is otherwise excluded from the definition of a food additive under the FD&C Act. For example, the use of a substance in food that is generally recognized as safe by qualified experts (GRAS) is excluded from the definition of a food additive under the FD&C Act. See 21 U.S.C. 321(s), 21 CFR 170.30. The use of a food additive in food must be authorized by FDA either through a food additive regulation in 21 CFR or an effective food contact notification (FCN). 1 FDA has listed certain GRAS uses in its regulations. In addition, FDA has a voluntary notification procedure by which any person may notify FDA of a conclusion that a use of a substance is GRAS. FDA evaluates whether the notice provides a sufficient basis for a GRAS conclusion (which results in a “no questions” response) or whether FDA believes there is an insufficient basis for a GRAS conclusion (which results in an “insufficient basis” response). 2 For the purpose of this rulemaking, TTB is using the term “consistent with the food additive requirements under the FD&C Act” to refer to: (1) Authorized food additive uses; (2) uses that are GRAS under FDA's regulations, that are the subject of a “no questions” letter from FDA in response to a GRAS notice or that are subject to an opinion letter from FDA stating that the use is GRAS or otherwise permissible; or (3) uses that are otherwise excluded from regulation as a food additive.

On November 22, 2016, TTB published in the Federal Register (81 FR 83752) a notice of proposed rulemaking, Notice No. 164, proposing to amend its regulations to incorporate 15 wine and juice treating materials and the combined use of two existing wine treatment processes it had administratively approved. TTB also proposed some clarifying and editorial changes. In response to requests by commenters, TTB reopened the comment period for 90 days and then subsequently extended it for another 90 days. The comment period finally closed on April 9, 2018. TTB received 33 comments from major trade organizations, suppliers of wine treating materials and processes, winemakers, the public, and the European Union. The comments generally support the treating materials and processes proposed in Notice No. 164. Notice No. 164 and the comments received may be viewed in their entirety in Docket No. TTB-2016-0010 at the Regulations.gov website ( www.regulations.gov ). The primary proposals, comments received, and TTB responses to those comments are discussed in the following sections of this document. The clarifying and editorial changes to the regulations are described in detail in Notice No. 164, and unless subject of comments received, are incorporated in the final regulations below and not further discussed here.

On March 5, 2015, the Wine Institute, a wine industry trade association, petitioned TTB to amend §§ 24.246 and 24.247 to replace many of the numerical limits for wine treating materials and processes with a usage standard of “good manufacturing practice.” Wine Institute noted in its petition that the current provisions generally limit the authorized usage of a material to the particular use of the material by the industry member who originally petitioned for its use. It also submitted a comment to Notice No. 164 and reiterated its request for “a default limit of good manufacturing practice (GMP) for those [treating] materials unless otherwise dictated by health concerns.”

TTB agrees that the current process, as described above, results in TTB's authorizing materials at specific usage levels reflecting the parameters detailed in requests by winemakers, and therefore reflects winemakers' actual use, or expressed interest in use, and TTB's evaluation of wine or juice to which the materials and processes have been applied, rather than potential use. This reflects TTB's longstanding application of “good commercial practice” as that term is described above. TTB intends to publish separate rulemaking to obtain public comment on the broader approach proposed in the Wine Institute's petition. TTB is not addressing the entirety of the petition in this rulemaking as it would entail many more amendments to the relevant regulations than were proposed in Notice No. 164. In this final rule, TTB is addressing the proposals regarding materials and processes that already had been the subject of notice and comment under Notice No. 164.

TTB received 33 comments in response to Notice No. 164, of which 3 were requests for extension of the comment period (Wine Institute (2 requests), and David Douglas). The remainder were comments submitted by or on behalf of: Six members of the public (Alice Feiring, Dr. Robert Kreisher (2 comments), Heather Nenow, Coleman Reardon, and Samantha Hunter); 13 wine industry members (vineyards and/or wineries) (Adelsheim Vineyard, Bear Creek Winery; Clover Hill Winery, Deerfield Ranch, Domaine Serene, Don Sebastiani and Sons, E&J Gallo Winery, Firestone Vineyard, Halter Ranch Vineyard, South Coast Winery Resort and Spa, Toni Stockhausen, Wine by Joe, WX Brands); 2 trade organizations (Enzyme Technical Association and Wine Institute); 4 companies that produce wine treating materials or processes (Beverage Supply Group, Erbslöh Geisenheim (2 comments), ConeTech, and Laffort USA); 1 industry consultant (Richard Gahagan); and the European Union (2 comments).

Eleven of the commenters submitted essentially the same letter containing no substantive differences (Adelsheim Vineyard, Bear Creek Winery, Deerfield Ranch Winery, Domaine Serene, Don and Sons, Firestone Winery, Halter Ranch Vineyard, Laffort, South Coast Winery Resort and Spa, Wine by Joe, and WX Brands). These comments will be referred as the “11 form letter comments” for ease of reference.

The 11 form letter comments expressed support for amending the regulations to incorporate the proposed additional wine treating materials, stating that these additions would positively affect their ability to export their wine and allow them to continue to grow their business in export markets by offering wines with better stability and quality. They also provided specific support for certain of the materials, and their comments are included in the comment discussion for each of these materials below. They further noted that the materials they addressed in their comment are used in multiple countries, including all countries following the International Organization of Vine and Wine (OIV), in good commercial practice at dose rates like those suggested by TTB in Notice No. 164.

The Wine Institute also expressed general agreement that the administratively approved wine and juice treating materials and processes proposed for authorization in Notice No. 164 “have accumulated sufficient analytical data and should be added to §§ 24.246 and 24.248 as appropriate.”

One commenter, Alice Feiring, expressed discontent with the number of authorized wine and juice treating materials for wine, stating that they “interfere with the taste and liveliness of the wine.” The commenter asserted that “none of these additives—other than sulfite addition . . . —are evaluated for their health impact and allergen potential,” and that “tannins and enzymes are the primary materials that trigger allergic reactions.” The commenter pointed to the proposal in Notice No. 164 to add polyvinylpyrrolidone (PVP) to the list of authorized wine and juice treating materials in § 24.246 and raised concerns regarding the safety of its use, which TTB addresses in the discussion of PVP later in this document. The commenter further suggested that TTB consider requiring the labeling of ingredients in wine.

TTB Response. As discussed in Notice No. 164, all proposed wine and juice treating materials authorized for use under § 24.246 must have documentary evidence from the FDA that the material is consistent with the food additive requirements under the FD&C Act for its intended purpose in the amounts proposed for the particular treatment contemplated. Therefore, TTB disagrees with the assertion that the wine and juice treating materials currently authorized in § 24.246 and proposed in Notice No. 164 for addition to the authorized list are not evaluated for their impact on health, and TTB notes that the table in § 24.246 includes references to the relevant FDA regulations and advisory opinions for each material. Further, TTB consulted with FDA on the proposed amendments in Notice No. 164 prior to its publication, and the materials proposed in Notice No. 164 have been found to be consistent with the FD&C Act.

Concerning the labeling of ingredients in wine, TTB is separately considering rulemaking regarding ingredient labeling, as noted in Treasury's February 2022 report on “Competition in the Markets for Beer, Wine, and Spirits,”  3 issued in response to Executive Order 14036, “Promoting Competition in the American Economy.”

Below is a summary of the actions TTB is taking in this final rule, including a discussion of, and response to, comments received regarding the wine treating materials that were the subject of TTB proposals in Notice No. 164.

TTB proposed to include in § 24.246(b) a general, clarifying statement that approved materials may be used in a blend or otherwise in combination with other approved materials, provided that each material is used for its specified use and in accordance with any limitation specified for that use.

Comments. In its comment, Wine Institute agreed that approved wine treating materials may be blended or used in combination provided that each material is used in accordance with the individual limitations and allowable uses for that material.

The 11 commenters who submitted the form letter did not directly address the proposed language pertaining to blends; however, they did comment on the use of blends for yeast nutrients. These commenters stated in part that yeast nutrient blends mitigate the risk of sluggish or stuck fermentation.

TTB Response. TTB agrees that blends of authorized wine treating materials, including yeast nutrients, are consistent with good commercial practice, provided that the use of each material conforms to the conditions specified for that material (that is, the reason or purpose for its use and the references and limitations that apply to its use). Accordingly, TTB is finalizing the proposal on blends in § 24.246.

In Notice No. 164, TTB proposed to add six “yeast nutrients” to the list of approved treating materials and expand the approved use of a seventh that already appears on the list. Specifically, TTB proposed to add biotin, folic acid, inositol, magnesium sulfate, niacin, and pyridoxine hydrochloride to the list of authorized wine and juice treating materials in § 24.246, and to expand the current permitted use of calcium pantothenate in that section. The inclusion of these yeast nutrients was in response to a petition and to industry member requests. The specific proposals, comments, and final action are described below.

As described in Notice No. 164, TTB and its predecessor agencies have recognized the need to supply yeast with appropriate nutrients to facilitate fermentation of juice to wine and to prevent “stuck fermentation” (fermentation that has halted before completion due to, among other things, high sugar levels or nutrient deficiencies). In both the current and proposed regulations, TTB has referred to these nutrients as “yeast nutrients.”

Comments. The 11 submitters of the form letter, as well as Wine Institute and Richard Gahagan, addressed the use of the term “yeast nutrients.” The 11 form letter submitters requested that TTB omit the word “yeast” or conversely include the word “bacteria” in the heading used in the regulations. Wine Institute stated their belief that the term “yeast nutrients” is “misleading” and expressed a concern that “[t]he use of the word `nutrient' suggests there is some nutritive value to humans, which is not the case.” Instead of “yeast nutrients”, Wine Institute suggested TTB use the term “Fermentation Aids”, noting that “yeast nutrients” serve no purpose after completion of fermentation. Rather, they “are for the sole purpose of creating and maintaining a robust environment for yeast and/or malolactic bacteria during the fermentation process.”

Mr. Gahagan also opposed the use of the term “yeast nutrients” and suggested that a more appropriate heading would be “fermentation aids” or “fermentation adjuncts.” Mr. Gahagan points out that “yeast cell walls/membranes”, which are authorized for use in § 24.246 and proposed under the heading “yeast nutrients” in Notice No. 164, “are not yeast nutrients.” Mr. Gahagan cited scientific literature in support of his argument.

TTB Response. TTB agrees with the comments and is replacing the term “yeast nutrients” with the term “fermentation aids” in the regulations, where applicable. TTB is using the term “yeast nutrients” and “fermentation aid” as synonyms throughout the rest of this document, as the former reflects the terminology used in the proposal.

In Notice No. 164, TTB proposed to add biotin (vitamin B7), folic acid, inositol (myo-inositol), magnesium sulfate, niacin (vitamin B3), and pyridoxine hydrochloride (vitamin B6) to the list of authorized materials in § 24.246 for use as yeast nutrients. TTB had previously administratively approved all six materials but had not yet included them in the list of authorized materials in § 24.246. The proposed use limitations for each material were as follows:

• Biotin: 25 parts per billion (ppb).

• Folic acid: 100 ppb.

• Inositol (myo-inositol): 2 parts per million (ppm).

• Magnesium sulfate: 15 ppm.

• Niacin (vitamin B3): 1 ppm.

• Pyridoxine hydrochloride (vitamin B6): 150 ppb.

Additionally, TTB proposed to expand the authorized use of calcium pantothenate (vitamin B5) from use solely as a yeast nutrient in apple wine to use as a yeast nutrient in all juice and wine. The use limitation of 0.1 pound of calcium pantothenate per 25,000 gallons (0.48 ppm) would remain unchanged.

Comments. The Wine Institute and the 11 form letter comments supported including all six administratively approved materials as authorized materials in § 24.246, as well as approving calcium pantothenate for use in all juices and wines. While the 11 form letter comments supported the use of the materials at the usage rates proposed in Notice No. 164, Wine Institute requested that the usage rate for the materials be “good manufacturing practice.”

Additionally, Richard Gahagan supported the addition of magnesium sulfate to the list of authorized wine and juice treating materials in § 24.246 but concludes that the “qualitative limits” proposed in Notice No. 164 “may not be adequate in all cases.” Mr. Gahagan referenced scientific articles for his assertion that the proposed use level for magnesium sulfate “is not adequate” and recommended a use rate not to exceed 200 ppm (200 mg/L).

Mr. Gahagan also expressed his concern that the use rates for the proposed yeast nutrients in Notice No. 164 consist “essentially of the Gusmer commercial product”, which in his opinion, “would limit the United States wine industry to the use of only the Gusmer product, or products that contain no more of any one of the materials contained in Gusmer's product.” He argued that “commercial fermentation aid products would be excluded, severely limiting the choices of available fermentation aides [sic] to domestic winemakers.” Mr. Gahagan referred to the proposed yeast nutrients with use rates (“quantitative limitations”) and the fact that the use rates were proposed by the petitioner. Mr. Gahagan asserted that the FDA advisory opinion of August 29, 2016, referenced in Notice No. 164, states that the proposed yeast nutrients can be used in accordance with “good manufacturing practice.” He further pointed to www.ttb.gov where the list of administratively approved yeast nutrients are listed and noted that as a use rate for the listed yeast nutrients, the website reads “the amount used must not exceed that of good commercial practice” and includes a reference to the appropriate FDA regulation followed by the acronym GRAS, for “Generally Recognized As Safe.” He further stated that “[t]he limitations on all the fermentation aids should be good commercial practice or GRAS, rather than quantitative limits.”

TTB Response. TTB is finalizing the proposals for all seven materials, including the proposed use rates. TTB believes that additional public comment is needed to authorize a usage rate other than what was proposed in Notice No. 164 for any of the yeast nutrients, since the proposed rule did not include the prospect of different usage rates. However, TTB is considering the request to consider the yeast nutrient usage rate at “good manufacturing practice” for separate rulemaking in which TTB intends to address Wine Institute's petition, described above, to authorize usage rates of “good manufacturing practice” more broadly.

With respect to Mr. Gahagan's comment about the proposed use rate limits, under the regulatory provisions of §§ 24.249 and 24.250, TTB reviews and approves or denies proposed wine treating materials based on the information provided by the industry member who submitted the request. TTB does not have reason or resources to test experimentally treated wine containing a new wine treating material at a use rate greater than that which is being requested. In the case of the yeast nutrients that were administratively approved subsequent to the Gusmer petition, TTB proposed in Notice No. 164 to limit the amount of usage to the amounts provided in the Gusmer petition because TTB believes it is important to place limitations on the use of vitamins and minerals as nutrients for yeast growth. This belief is consistent with FDA's fortification policy in 21 CFR 104.20, as discussed in Notice No. 164. The FDA advisory opinion cited in the proposed regulations and referred to by Mr. Gahagan does not state that vitamins and minerals used in the production of wine are limited only by good manufacturing practice. Rather, in their advisory opinion, FDA referred to its regulations in which certain vitamins and minerals may be used in accordance with good manufacturing practice  4 if they are used in accordance with the intended purpose as stated by the regulations.

As noted in Notice No. 164, many of the yeast nutrients are vitamins and minerals that are authorized for use in food, and FDA has informed TTB that FDA regulations for certain vitamins ( e.g., folic acid and inositol) would not authorize their use in alcohol beverages as nutrients. Therefore, a cross-reference to the FDA regulations is not appropriate for yeast nutrients. Notice No. 164 further states that FDA has stated to TTB that the proposed vitamins and minerals could be used for the purpose of providing nutrients to the yeast, where the levels of the vitamins and minerals remaining in the wine would be of a de minimis level, and not to fortify the wine. In the interim, TTB is placing limitations on these substances to permit their use as nutrients for yeast growth but not as a source of nutrients in the finished wine.

TTB notes that among the 11 submitters of the form letter is Laffort U.S.A., a supplier of wine treating materials. Laffort U.S.A. wrote that they support the addition of yeast nutrients proposed by TTB “at the levels recommended by TTB.” This support indicates that Laffort U.S.A. is not concerned that the proposed use rates for yeast nutrients would exclude any of their products from the market. Another supplier of wine treating materials (including yeast nutrients), Beverage Supply Group, commented on Notice No. 164, and while they did not specifically express support for the proposed use rates of the proposed yeast nutrients, they did not expressly voice concern that the proposed use rates are insufficient and possibly exclude their products from the marketplace.

In Notice No. 164, TTB proposed to amend its regulations in § 24.246 to identify, for the purpose of clarifying and stabilizing wine, a maximum use rate of 8 pounds of acacia per 1,000 gallons (0.96 grams per liter (g/L)) of wine. Acacia (gum arabic) is listed in § 24.246 as authorized for such purposes, but currently subject to the limitation that its use not exceed 2 pounds per 1,000 gallons (0.24 g/L) of wine. TTB explained in Notice No. 164 that TTB had administratively approved several requests from industry members for use rates up to 16 pounds per 1,000 gallons of wine, but was proposing a use rate of 8 pounds per 1,000 gallons of wine as it believed that rate was consistent with the maximum rate authorized in FDA regulations at 21 CFR 184.1330. Based on that, TTB noted that any administrative approvals authorizing use rates greater than 8 pounds per 1,000 gallons of wine would be revoked.

Comments. The 11 submitters of the form letter indicated that acacia is necessary for the stabilization of coloring matter and potassium bitartrates as well as to clarify wine. They also stated that the dose rate recommended by TTB in the proposed rule is appropriate for good commercial practice. In its comment, the Wine Institute welcomed the proposal to increase the allowable level for acacia when used for its intended purpose of clarifying and stabilizing wine.

TTB Response. The regulations finalized through this rulemaking authorize the use of acacia for clarifying and stabilizing wine at a use rate of 16 pounds per 1,000 gallons of wine (1.9 g/L), or 0.19 percent, which is within the 1 percent use rate limitation set forth in the FDA regulations for these purposes. In Notice No. 164, TTB had erroneously calculated that 8 pounds per 1,000 gallons of wine was the maximum allowable within the FDA limitations. As a result, instead of 8 pounds per 1,000 gallons of wine, TTB is amending its regulations to correspond to the administrative approvals of 16 pounds per 1,000 gallons of wine, as discussed in Notice No. 164, as TTB believes this limit is consistent with good commercial practice for clarifying and stabilizing wine.

With regard to the comment that refers to acacia's use for stabilization of “coloring matter,” TTB notes that the stabilization of anthocyanins for color is consistent with how TTB interprets “stabilization” under § 24.246.

TTB proposed to add bakers yeast mannoprotein, at a use rate of 50-400 milligram per liter (mg/L) of wine, to the list of approved wine and juice treating materials contained in § 24.246, for the purpose of stabilizing wine from the precipitation of potassium bitartrate crystals. TTB had already administratively approved the use of bakers yeast mannoprotein for this purpose and with that limit.

Comments. The 11 commenters who submitted the form letter stated their support of TTB's proposal to add bakers yeast mannoprotein to the list of authorized treating materials contained in § 24.246 to stabilize wine from the precipitation of potassium bitartrate crystals. The commenters noted that bakers yeast mannoprotein is an efficient alternative for the stabilization of red wines and that it is appropriate for good commercial practice at the dose rates proposed by TTB.

The Wine Institute suggested GMP as the appropriate limit for bakers yeast mannoprotein, without a numerical limit, but stated that, if numerical limits are to be required, the proposed limit is “too low.” The Wine Institute stated that “a quick review of recommended usage rates . . . by Suppliers of this material to the Industry suggest usage rates up to 1500 mg/L as a more appropriate limit.”

The European Union (EU), in its comment, informed TTB that the EU does not have a fixed limit for bakers yeast mannoproteins, “which means that their use is based on the best manufacturing practice criteria.” They further state that the proposed limit for bakers yeast mannoproteins “may be insufficient for tartaric stabilization thus creating a possible barrier to trade.”

TTB Response. TTB received no additional comments from industry members regarding the usage rates, and has not received requests from industry members for approval to use bakers yeast mannoprotein at a rate higher than 400 mg/L. TTB notes that the proposed use for bakers yeast mannoprotein in TTB Notice No. 164 (not to exceed 400 mg/L) is consistent with the use rate considered by FDA in GRAS Notice No. GRN 000284. TTB does not approve the use of a material at a rate greater than that which FDA has determined is consistent with the food additive requirements under the FD&C Act. Considering this and the rulemaking record before it, TTB does not believe there is an adequate basis for establishing a limit different from that proposed in Notice No. 164, but will consider the comments of the European Union and the Wine Institute as suggestions for further broader rulemaking relating to GMP. This rulemaking finalizes the proposed use of bakers yeast mannoprotein to stabilize wine from the precipitation of potassium bitartrate crystals at an amount not to exceed 400 mg/L.

TTB proposed in Notice No. 164 to add beta-glucanase derived from Trichoderma harzianum, at a use rate not to exceed 30 parts per million (ppm) of wine, as an approved treating material in § 24.246 for the purpose of clarifying and filtering wine. Trichoderma harzianum had been administratively approved prior to the proposed rulemaking. Beta-glucanase derived from Trichoderma longibrachiatum is currently listed in § 24.246 as approved for use for clarifying and filtering wine at a rate not to exceed 3 grams per hectoliter of wine (30 ppm), and in Notice No. 164 TTB also solicited comments on whether Beta-glucanase derived from Trichoderma longibrachiatum is still relevant and should be retained as an authorized treatment.

Comments. The form letter submitted by 11 commenters specifically addressed beta-glucanase, as did comments from the Wine Institute, the Enzyme Technical Association, and an individual commenter. The 11 submitters of the form letter stated that the use rate of beta-glucanase proposed in Notice No. 164 is appropriate for good commercial practice to filter wine, whether the enzymatic activity is derived from Trichoderma harzianum or Trichoderma longibrachiatum. They also proposed that beta-glucanase should be authorized for use in juice prior to fermentation. In support of this, the commenters wrote that mold growth, specifically from Botrytis cinera, on grapes increase the content of glucans in the resultant wine. The commenters claimed that the glucans “can render the wine difficult or impossible to filter using available filter media.” Adding beta-glucanase to the juice or wine “will allow the reduction of glucan levels and improved filterability.” The commenters noted that unfiltered wines “can potentially have negative flavor profiles due to instabilities.”

Wine Institute recommended using GMP as a use rate for beta-glucanase. In the absence of GMP, Wine Institute recommended a use rate of 80 mg/L based on a review it performed of usage rates recommended by suppliers of this material to the industry. Wine Institute also noted TTB's comment in Notice No. 164 about the agency inadvertently stating that the amount of beta-glucanase derived from Trichoderma harzianum used must not exceed 300 ppm, and suggested that industry members are currently using beta-glucanase at higher use levels than 30 ppm because suppliers recommend a level higher than 30 ppm and because TTB administratively approved usage up to 300 ppm. As a result, Wine Institute argued that reducing the authorized use rate of beta-glucanase from an amount not to exceed 300 ppm to an amount not to exceed 30 ppm may cause difficulty to winemakers and impact the quality of resulting wines. With regard to beta-glucanase derived from Trichoderma longibrachiatum, Wine Institute supported retaining its authorized use.

The Enzyme Technical Association supported the addition of Trichoderma harzianum as a source of beta-glucanase. However, the association recommended TTB align the use rate of beta-glucanase derived from Trichoderma harzianum and that derived from Trichoderma longibrachiatum, and that the usage rate limitation for both should be “good manufacturing practice.” The association indicated that the proposed use rate limit of 30 ppm for beta-glucanase derived from Trichoderma harzianum is insufficient. It expressed its position that the FDA GRAS Notice No. GRN 000149, which TTB cites for its support of a 30 ppm limitation on beta-glucanase derived from Trichoderma harzianum, actually supports a higher use rate. Enzyme Technical Association argued that the range provided in GRAS Notice No. GRN 000149 “was not set as a maximum use” and stated that “what was not discussed in the FDA No Questions Letter is the wide safety margin of the beta-glucanase enzyme preparation that was included in the notifier's original submission.” It further stated that “[A] wide safety margin suggests that the enzyme preparation can be used well outside the range of 30 ppm with no toxic effects.” Enzyme Technical Association “agrees that beta-glucanase enzymatic activity derived from Trichoderma longibrachiatum (also known as T. reesei ) is still relevant for and used in wine treatments.”

In its second comment submitted in response to Notice No. 164, Erbslöh Geisenheim suggested that TTB add the microorganism species Penicillium funiculosum (synonym: Talaromyces versatilis ) as a third source besides Trichoderma longibrachiatum and Trichoderma harzianum for the entry “Enzymatic activity, intended for clarifying and filtering wine.” It noted that FDA already considers Penicillium funiculosum as GRAS for “use in various food applications in the US.” It also stated that both the International Oenological Codex and the European Commission recognize Penicillium funiculosum as a wine treating material.

TTB Response. After considering the comments, TTB is finalizing regulations that remove any specific use rate limitation other than that set forth in the FDA regulations at 21 CFR 184.1250. In effect, this implements the limitation that has applied during the time TTB had inadvertently authorized 300 ppm rather than 30 ppm, as described above, as use of the material above the 30 ppm rate would still have been subject to any limit set forth in FDA regulation. Similarly, TTB is also finalizing its proposal in Notice No. 164, to add to the regulations authorization for beta-glucanase derived from Trichoderma harzianum as an approved treating material in § 24.246 for the purpose of clarifying and filtering wine, with the only use rate limitation specified by a reference to FDA GRAS Notice No. GRN 000149. TTB has confirmed with FDA that a limitation of “good manufacturing practice” would be consistent with both 21 CFR 184.1250 and GRAS Notice No. GRN 000149, and that additional advisory opinions specifying that would be unnecessary. With regard to the use of the materials in juice, TTB is authorizing the use of both beta-glucanase derived from Trichoderma harzianum and beta-glucanase derived from Trichoderma longibrachiatum in juice, which is consistent with GRAS Notice No. GRN 000149 and 21 CFR 184.1250, 5 respectively.

With respect to the use of Penicillium funiculosum, TTB notes that it has not received any requests from winemakers to use this microorganism as a source of beta-glucanase for clarifying or filtering wine. Therefore, TTB has not had the opportunity to analyze wine treated with Penicillium funiculosum and cannot add it to its list of approved wine treating materials at this time. However, TTB would consider requests from individual industry members under §§ 24.249 and 24.250 for use of Penicillium funiculosum as a wine treating material.

In Notice No. 164, TTB proposed to authorize chitosan for the removal of spoilage organisms from wine at a usage rate not to exceed 10 grams per 100 liters (or 10g/hL) of wine.

Comments. The 11 submitters of the form letter agreed with TTB's proposal that chitosan should be authorized for use in the treatment of wine to remove spoilage organisms such as Brettanomyces from wine. They stated that the “unchecked growth of Brettanomysces [sic] organisms in wine can lead to highly negative flavor profiles” and that chitosan is “an efficient and effective treatment to destroy these spoilage organisms.” Further, submitters of the form letter confirmed that chitosan is consistent with good commercial practice at the levels proposed by TTB.

In its comment, Wine Institute welcomed the proposed addition of chitosan to the list of allowable treating materials but suggested that GMP is a more appropriate usage limit.

In his comment, Richard Gahagan supported the inclusion of chitosan but stated that the limitation should be “GRAS, or if TTB decides on a quantitative limit, 100 g/hL would be consistent with the OIV limitation.” Mr. Gahagan's comment regarding the authorized use of chitosan with OIV limitations was consistent with that of the EU, which stated that the TTB proposed use rate of 10 g/hL for chitosan is “10 times lower than the EU limit,” and indicated that the use rate proposed by TTB for chitosan “could create a trade barrier.” (TTB notes that OIV's use rate for chitosan was raised in 2015, to a rate not to exceed 500 g/hL of wine.)

TTB Response. Since TTB's publication of Notice No. 164, TTB has received numerous requests to experiment with chitosan at levels greater than 10 g/hL of wine. The most recent requests for experimentation sought to use chitosan at a rate of no more than 500 g/hL. TTB approved the experimentation of those requests because in GRAS Notice No. GRN 000397, FDA had “no questions” with regard to the stated intended use rate of 10 to 500 g/hL of wine. After the evaluation of numerous samples of wine experimentally treated with chitosan at rates exceeding 10 g/hL and including 500 g/hL, TTB administratively approved an increased use rate of chitosan not to exceed 500 g/hL of wine in 2021.

After considering comments from Wine Institute, the EU, and Mr. Gahagan supporting an increased level of chitosan, the use range specified in GRAS Notice No. 000397, and TTB's experience with recent administrative approvals, TTB is amending § 24.246 to include chitosan from Aspergillus niger, with a use rate not to exceed 500 g/hL of wine, for use in removing spoilage organisms, such as Brettanomyces, from wine.

Tartaric acid is currently listed in § 24.246 as a material authorized for the treatment of wine and juice for the purpose of correcting natural acid deficiencies in grape juice or wine and to reduce the pH of grape juice or wine. In Notice No. 164, TTB proposed to amend the entry for “tartaric acid” in the table at the end of § 24.246 to indicate that tartaric acid may be manufactured by either the method specified in 21 CFR 184.1099 (which allows for L(+) tartaric acid obtained as a byproduct of wine production) or the method specified for L(+) tartaric acid in GRAS Notice No. GRN 000187 (which allows L(+) tartaric acid manufactured using an enzyme from immobilized Rhodococcus ruber cells). TTB also proposed to add the citation for the FDA GRAS notice in the “Specific limitation” column.

Comments. In its comment, the EU stated that it and the OIV both authorize the use of L(+) tartaric acid with limits of 2.5g/L and 4g/L, respectively. The EU argued that “[t]hese limits are justified by the assessment made by JECFA fixing the acceptable daily intake (ADI) is between 0 and 30mg/kg of body weight.” Accordingly, the EU does not believe that GMP is an appropriate use rate for L(+) tartaric acid. The EU further stated that an excess of L(+) tartaric may “modify the natural and essential characteristics of the wine”, resulting in a possible breach of the Article 80(3)(d) of Regulation No. 1380/2013, which states that oenological practices shall “allow the preservation of the natural and essential characteristics of the wine and not cause a substantial change in the composition of the product.”

In her comment, Toni Stockhausen argued that “synthetically derived L(+) Tartaric Acid, or L(+) Tartaric Acid (alternate method) per FDA GRAS notice GRN 000187 . . . should not be considered Good Manufacturing Practice for use in winemaking in the USA.” In support of this, Ms. Stockhausen stated: (1) That FDA GRAS Notice No. GRN 000187 for L(+) tartaric acid “does not comment on the source of the maleic acid or on the safety of potentially unconverted maleic acid or other contaminants unique to the alternate production method;” (2) “Despite GRN 000187, issued in 2006, in 10 years the FDA has not updated the list of direct food substances affirmed as generally regarded as safe;” and, (3) “For the purposes of exportation, jurisdictions including the European Union have confirmed or amended their food safety regulations to specify the source of Tartaric Acid as wine or grape derived, including the most recent European Pharmacopeia (9th Edition, effective January 1, 2017).”

In its comment, Wine Institute stated that it understands that “synthetic (L(+)) tartaric acid, which was administratively approved by TTB,” is not currently being used for the production of wine within the United States.

TTB Response. TTB is finalizing in this rulemaking document the proposal in Notice No. 164 to include in the TTB regulations a reference to tartaric acid manufactured using an enzyme from immobilized Rhodococcus ruber cells (as described in FDA GRAS Notice No. GRN 000187) to correct natural acid deficiencies in grape juice/wine and to reduce the pH of grape juice/wine. TTB believes that this form of tartaric acid is the form commenters refer to as “synthetic.” The regulatory text uses the spelling “L-(+)-tartaric acid,” as TTB understands that this is the scientifically preferred spelling for the material, rather than the “L(+) tartaric acid” spelling used in the proposed rule document.

In response to the comments submitted by the EU and Wine Institute, TTB notes that with regard to the use rates for tartaric acid, the current regulations refer to TTB regulations at 27 CFR 24.182 and 24.192 that provide additional detail about its use, and to FDA regulations in 21 CFR 184.1099. The uses prescribed in the TTB regulations do not authorize a use rate that would “modify the natural and essential characteristics of the wine.” TTB did not propose to change the limitations on the use of tartaric acid, and is not changing those limits at this time. However, TTB will consider including the more limited use rates in any subsequent rulemaking for additional comment.

In her comment, Ms. Stockhausen claimed that the EU only allows tartaric acid derived from wine or grapes. TTB notes that in its comments on the proposal in Notice No. 186, the EU only addressed its belief that GMP was not an appropriate use rate for L(+) tartaric acid. The EU did not distinguish between L(+) tartaric acid derived from wine or grapes and L(+) tartaric acid manufactured using Rhodococcus ruber cells. Therefore, TTB does not believe that the EU objects to TTB's proposal to allow the alternate method of producing L(+) tartaric acid.

In response to Ms. Stockhausen's comments regarding GRAS Notice No. GRN 000187, the FDA has stated to TTB that GRAS Notice No. GRN 000187 does not specifically state the source of maleic acid, and that maleic acid may be an impurity in the starting material ( i.e., maleic anhydride), or it can be a byproduct of the reaction of maleic anhydride and hydrogen peroxide that is used to produce tartaric acid. GRAS Notice No. GRN 000187 does specify that the content of maleic acid in the final tartaric acid must be less than or equal to 0.05 percent. FDA also noted that the GRAS Notice process is an alternative to GRAS affirmation petitions, and that the FDA regulations do not provide a comprehensive list of GRAS substances.

TTB proposed to add polyvinylpyrrolidone (PVP)/polyvinylimidazole (PVI) polymer (terpolymer of 1-vinylimidazole, 1-vinylpyrrolidone, and 1,2-divinylimidazolidinone; CAS 87865-40-5  6 ) to remove heavy metal ions and sulfides from wine to the list of authorized wine and juice treating materials in § 24.246.

Comments. In their comment, the 11 submitters of the form letter expressed support for the proposal in Notice No. 164 to add polyvinylpyrrolidone (PVP)/polyvinylimadazole (PVI) polymer to the list of authorized wine and juice treating materials in § 24.246 to remove heavy metal ions and sulfides from wine at a level not to exceed 80 grams per 100 liters of wine. They stated that PVP/PVI polymer would “provide the US wineries with an effective tool to eliminate these metals”, and further stated that the “current US regulations provide unfair trade advantage for non-US wine producers in both domestic and international markets.”

The 11 commenters of the form letter also recommended that the approval of PVP/PVI be extended to use in juice and must. They argued that this will give wineries the ability to “remove excessive copper (from vineyard treatments) before starting fermentation or the early stages.” They also stated that adoption of this recommendation “would align the US regulation with other countries.”

One commenter, Alice Feiring, raised concerns regarding the safety of PVP. She described PVP as a material that should not be authorized for use in the production of wine, stating that it “is classified as `expected to be toxic or harmful,' by the Environment Canada Domestic Substance List.”

TTB Response. TTB is finalizing the use of PVP/PVI polymer as proposed in TTB Notice No. 164, for use at a level not to exceed 80 grams per 100 liters of wine to remove heavy metal ions and sulfides from wine. TTB did not propose the use of PVP/PVI in juice and has not had the opportunity to analyze juice treated with PVP/PVI. Accordingly, TTB is not including such authorization in its regulations at this time, but will consider for future action.

With regards to the comment regarding the Canadian classification of PVP, TTB notes that under the Canada Food and Drug Regulations (see C.R.C., c 807 B.02.100(b)(xii)(D)), PVP may be used in the production of wine “in an amount that does not exceed 2 parts per million in the finished product.”

In Notice No. 164, TTB proposed to add potato protein isolates, at a use rate of 500 ppm or 50 grams per 100 liters (50 g/hL) of wine, as a fining agent, to the list of approved treating materials contained in § 24.246.

Comments. In their form letter, 11 commenters supported the addition of potato protein isolate to the list of authorized treating materials in § 24.246 and stated that “potato protein isolate is an effective fining agent for both juice and wine to remove phenolic components effecting [sic] astringency and bitterness, as well as to aid in settling juice and wine . . .” at the use rate of 500 ppm (50 g/hL), which is the proposed use rate in wine, not juice. These commenters suggested that TTB authorize the use of potato protein isolate in the use of juice because “it is equally effective in application.” They also stated that in its first additional correspondence to GRAS Notice No. GRN 000447, the FDA considered the use of potato proteins in wine-must, which the commenters noted is “considered as `grape juice' prior to fermentation.” According to the commenters, “Many winemakers choose to use fining products on juice in preference to wine as the process is more efficient and ha[s] less impact on resulting wine flavor.”

In its comment, the Wine Institute indicated its support of the addition of potato protein isolates to the list of authorized treating materials contained in § 24.246. It also recommended the use rate of good manufacturing practice for the use of potato protein isolates as a “clarification” material.

Erbslöh Geisenheim indicated its support of the addition of potato protein isolates to the list of authorized treating materials contained in § 24.246, noting that proteins from plant origins, including potatoes, have been authorized by the International Oenological Codex as a wine and juice treating material. It further stated, “Vegetable based fining agents have become increasingly important for the production of beverages that are suitable for a vegetarian or vegan diet.”

TTB Response. TTB is finalizing the proposal to authorize fractionated potato protein isolate for use at a rate of 500 ppm or 50 grams per 100 liters (50 g/hL) of wine, as a fining agent. TTB believes the use of fractionated potato protein isolate in juice should be subject to public comment, and plans to include such use among other proposals in a separate rulemaking.

TTB proposed to add sodium carboxymethyl cellulose (CMC) to the list of authorized wine and juice treating materials in § 24.246 at a level not to exceed 0.8 percent of the wine, to stabilize wine from tartrate precipitation.

Comments. In their form letter, 11 commenters supported TTB's proposal in Notice No. 164 to add CMC to the list of authorized wine and juice treating materials contained in § 24.246. These commenters stated that the 0.8 percent use rate proposed by TTB is appropriate for good commercial practice. They also stated that CMC “is one of many tools the wine industry can use to stabilize wines, depending on unique wine chemistry and consumer preferences.”

Wine Institute supported the addition of CMC to the list of authorized wine and juice treating materials; however, they recommended a use rate of GMP. Wine Institute recommended that if TTB does not adopt GMP, it should decrease the authorized amount of CMC from proposed 0.8% (8,000 mg/L) to 0.1% (1,000 mg/L), which according to Wine Institute, is the standard in international markets. It is Wine Institute's belief that the use of CMC at the maximum proposed level of 8,000 mg/L “could create quality issues in wines.”

TTB response. As noted in Notice No. 164, FDA regulations at 21 CFR 182.1745 state that CMC is GRAS when used in accordance with good manufacturing practice. In light of this and the concern expressed in the Wine Institute's comment, this final rule amends the proposal to remove a specific use rate other than that contained in the reference to the FDA's regulations in 21 CFR 182.1745.

TTB proposed to amend the regulations in § 24.248, which set forth certain processes that TTB has approved as being consistent with good commercial practice for use by proprietors in the production, cellar treatment, or finishing of wine, juice, and distilling materials, within the limitations of that section. A discussion of the specific proposals, comments received, and TTB responses follows.

TTB proposed to expand the authorized use of nanofiltration and ultrafiltration in § 24.248 (Processes authorized for the treatment of wine, juice, and distilling material) to include dealcoholization (reduction of the alcohol content). Currently, nanofiltration is authorized to reduce the level of volatile acidity in wine when used with ion exchange. Ultrafiltration is authorized for use to remove proteinaceous material from wine; to reduce harsh tannic material from white wine produced from white skinned grapes; to remove color from blanc de noir wine; and to separate red wine into high color and low color wine fractions for blending purposes. Because both nanofiltration and ultrafiltration are capable of reducing alcohol content in wine, the proposed liberalization will provide industry members with more tools to reduce the alcohol content of wine.

Comments. In its comment, Wine Institute agreed with the proposal in Notice No. 164 to group nanofiltration, ultrafiltration, and reverse osmosis under the general category of “cross flow filtration” and welcomed the expansion of authorized uses for this category to include reduction of alcohol content.

In his comment, Dr. Robert Kreisher disagreed with TTB's proposal to expand the authorized uses of nanofiltration and ultrafiltration to include dealcoholization. Dr. Kreisher indicated that TTB considered nanofiltration for purposes of alcohol reduction in 2007 and found that such a process is not consistent with good commercial practice because “nanofiltration permeate contained too great a quantity of volatile esters and fixed acids.” Dr. Kreisher further stated that ultrafiltration has the same problems as nanofiltration, at a greater magnitude. If authorized, Dr. Kreisher advised TTB that it should be made clear that nanofiltration, ultrafiltration, and reverse osmosis may only be used in combination with distillation.

TTB Response. This rulemaking finalizes TTB's proposal in Notice No. 164 to expand the use of nanofiltration and ultrafiltration to include dealcoholization (reduction of alcohol).

In 2007, TTB reviewed a petition for the use of nanofiltration and ultrafiltration for purposes of removing off-flavors in wine. It did not review the processes for the purpose of alcohol reduction. However, TTB reviewed nanofiltration and ultrafiltration for purposes of alcohol reduction in 2013 and found that on a preliminary basis nanofiltration and ultrafiltration were acceptable for alcohol reduction pending future rulemaking.

In Notice No. 164, TTB proposed amending § 24.248 to state that nanofiltration, ultrafiltration, and reverse osmosis must be conducted on distilled spirits plant premises when used to remove ethyl alcohol (dealcoholization). The proposed amendment also provided a specific exemption to this rule for reverse osmosis and nanofiltration if ethyl alcohol is only temporarily created within a closed system. In this rulemaking document, TTB is adopting these amendments as final.

TTB proposed to amend the table of authorized processes in § 24.248 by revising the listings for reverse osmosis and osmotic transport to state that each process can be used in combination with the other to reduce the ethyl alcohol content of wine. These processes, whether used separately or in combination, must take place on distilled spirits plant premises.

Comment. Wine Institute expressed its support of the proposal and also requested that TTB expand the authorized use of osmotic transport to include removal of off flavors, indicating that this would maintain consistency between reverse osmosis and osmotic transport.

TTB Response. TTB is finalizing the proposal as set forth in Notice No. 164 to amend § 24.248 to allow reverse osmosis and osmotic transport to be used in combination with the other. TTB is not expanding the authorized use of osmotic transport to remove off flavors at this time, and intends to include that proposal in separate rulemaking as TTB believes that additional public comment is needed. TTB would consider individual industry member requests under §§ 24.249 and 24.250 for use of osmotic transport to remove off flavors from wine.

In Notice No. 164, TTB proposed amending § 24.248 to allow the use of ultrafiltration to separate red grape juice into high and low color fractions for blending purposes, and to separate white grape juice that had darkened due to oxidation during storage into high and low color fractions for blending purposes. TTB had previously administratively approved the use of ultrafiltration to separate red grape juice into low and high color fractions, and the proposed amendment would amend the table at § 24.248 accordingly. However, TTB had not administratively approved the use of ultrafiltration to separate high and low colored fractions of discolored white grape juice, so, in Notice No. 164, TTB did invite comments on whether this practice constitutes good commercial practice.

Comments. In its comment, Wine Institute welcomed TTB's proposal to authorize the use of ultrafiltration to separate red grape juice into low and high color fractions. Wine Institute also made two recommendations for the “Reference or limitation” column for ultrafiltration in § 24.248. The first recommendation was to change the phrase “greater than 500 and less than 25,000 molecular weight” to “not less than 500 and not greater than 25,000” molecular weight. This change, which Wine Institute implied would be an “edit”, would have the effect of including molecular weights of “500” and “25,000” as opposed to excluding them, which is what the current regulatory language does. Wine Institute's second recommendation was to allow transmembrane pressure up to 500 psi rather than limit the transmembrane pressure to less than 200 psi. Wine Institute stated that “limiting the transmembrane pressure to 200 psi incorporates obsolete technology into the regulation” and allowing transmembrane pressure up to 500 psi will “allow use of recent improvements in technology that allow more effective use of Ultrafiltration . . . without altering vinous character.”

TTB Response. TTB is finalizing in this rulemaking its proposal to expand the use of ultrafiltration to separate red grape juice into low and high color fractions. TTB does not consider the language change suggested by Wine Institute to be an editorial change, because the change would effectively allow the inclusion of molecular weights of 500 and 25,000, which are currently not permitted and were not proposed to be allowed in Notice No. 164. TTB also did not propose in Notice No. 164 an increase to the transmembrane pressure from less than 200 psi to 500 psi. TTB believes further notice and comment on these proposed substantive changes is needed. TTB would consider requests from industry members under §§ 24.249 and 24.250 to use membranes that are selected for weights outside what is currently authorized and to increase the authorized limit on transmembrane pressure for ultrafiltration.

TTB proposed a new 27 CFR 24.185 to maintain in one location all regulatory provisions pertaining to the treatment of wine with wood. Section 24.185(a) clarifies TTB's current policy that natural wine may be treated by contact with any wood that is consistent with the food additive requirements under the FD&C Act and that wood may be toasted, but not charred. Toasted wood refers to wood that has been heated but has not undergone combustion (that is, has not been burned or blackened).

Proposed § 24.185(b) states TTB's position on the use of wood essences and extracts in the production of wine. In the proposal, wood preparations made with an alcohol solution stronger than 24 percent alcohol by volume would be considered “essences” and must be used in accordance with § 24.85. Wood essences and extracts must be consistent with the food additive requirements of the FD&C Act for that purpose and could only be used in “other wines” in accordance with § 24.218.

TTB also proposed to remove the last sentence from § 24.225 (“Wooden storage tanks used for the addition of spirits may be used for the baking of wine”) and include it in the new § 24.185. Additionally, the proposal would remove the reference to oak chips from § 24.246 and include it in the new § 24.185.

Comment. In response to the proposals related to the use of wood to treat natural wine, Wine Institute expressed concern with the language in proposed § 24.185(a) “that would not allow the use of charred barrels in winemaking.” Wine Institute pointed to the standard of identity in TTB regulations for “Bourbon whisky”, which requires use of charred new oak containers (see 27 CFR 5.22(b)(1)(i)) and to the longstanding use of bourbon barrels by both winemakers and brewers and requested “equal regulatory treatment with respect to barrel requirements across all alcohol types and sectors.”

Wine Institute also noted that TTB did not propose language indicating how it will determine whether wood has been charred. Wine Institute noted that the proposed regulation would allow “toasting”, which does not include “undergoing combustion.” Wine Institute refuted this by arguing that “during the toasting process, minor blisters may occur on the wood, which can be significantly darker in color than the rest of the wood and thus suggests—inaccurately—that combustion has occurred.” For this reason Wine Institute believed that a color test would be “insufficient to determine if combustion, and thus charring, has occurred” and asked TTB to clarify how it would “identify improperly `charred' wood containers.”

TTB response. TTB notes that, in part, the proposed change in Notice No. 164 regarding the treatment of wine with wood stems from current § 24.246, which authorizes the use of uncharred and untreated oak chips or particles to smooth wine. TTB proposed to liberalize the current restriction on the treatment of wine with wood by authorizing the use of any wood that is consistent with the food additive requirements under the FD&C Act (not just oak) and to allow wood that has been toasted to be used for the purpose of smoothing wine. It was not TTB's intent to indicate that used distilled spirits barrels that were charred prior to use for storage of distilled spirits could not be used to store wine. TTB has considered Wine Institute's comment and has determined that the proposed language in § 24.185 may cause confusion. TTB has also determined that the restriction on charred wood as a treatment for wine is no longer necessary because one concern with charred wood was that it may, depending on the amount of charring, remove color from wine. However, TTB regulations have for many decades authorized the use of activated carbon to remove color from wine. Accordingly, TTB is finalizing new § 24.185 as proposed, with the exception that charred wood that is consistent with the requirements under the FD&C Act may be used to treat natural wine. Also, if charred wood is used to treat wine, it cannot remove color from the wine. TTB is retaining the restriction that the wood must not be otherwise treated.

TTB proposed to amend § 24.225, which sets forth rules under which proprietors of a bonded wine premises may withdraw and receive spirits without payment of tax from the bonded premises of a distilled spirits plant and add the spirits to natural wine on bonded wine premises. The proposals included amendments to:

• Incorporate the terms of section 5373(a) of the IRC related to standards for the production of wine spirits (that is, spirits distilled from fresh or dried fruit, or the wine or wine residue therefrom), to clarify that natural wine or special natural wine to which sugar has been added after fermentation may not be refermented to develop alcohol from the added sugar and then used to produce wine spirits;

• Specify that wine spirits derived from special natural wine (that is, a wine produced from a base of natural wine and to which natural flavorings are added) may be used only in the production of a special natural wine if those spirits retain any flavor characteristics of the special natural wine; and

• Specify that spirits derived from authorized alcohol reduction treatments may be used as wine spirits, if such spirits are distilled at a rate of 100 degrees proof or more (rather than the general IRC standard of 140 degrees proof or more), and if the spirits conform to the other terms of section 5373(a) of the IRC.

TTB also proposed the following non-substantive technical amendments:

• Moving the sentence allowing the use of wooden storage tanks used for the addition of spirits for the baking of wine to a new § 24.185 that is related solely to the use of wood to treat natural wine; and

• Reorganizing the entire § 24.225 to improve readability and clarity.

Comment. Wine Institute agreed with the proposals set out in Notice No. 164 for § 24.225 and welcomed the “use of clarifying and simplified language to amend the regulation.” Wine Institute believed that TTB's proposal of allowing the byproducts of alcohol reduction to be used as wine spirits if they are 100 degrees proof or more “will provide a useful opportunity for the by-products of the alcohol reduction process.” Wine Institute also stated that it “welcomes the clarifying language concerning wine spirits produced from special natural wine.”

TTB Response. TTB is finalizing all the amendments to § 24.225 as proposed in Notice No. 164. However, TTB is lowering the degrees of proof for which spirits byproducts of alcohol reduction processing deemed as wine spirits may be distilled from the proposed “100 degrees of proof or more” to “not less than 90 degrees proof.” As discussed in the preamble of Notice No. 164, section 5373(a) of the IRC sets a general standard of 140 degrees of proof or above for wine spirits used in wine production but also provides exceptions for other wine spirits “if regulations so provide.” The IRC allows for regulations to provide for distillation at less than 140 degrees of proof, and TTB did not receive any comments objecting to its original proposal of “100 degrees of proof or more.” TTB has previously authorized experiments for the use of the byproduct of spinning cone column at 90 degrees of proof for use as wine spirits. Because of its experience with the experimental use of lower-proof byproducts of alcohol reduction methods, and because TTB believes the use of such byproducts are consistent with the intent of the IRC, TTB is incorporating the 90 degrees of proof rate into its regulations to provide winemakers greater flexibility in their winemaking processes.

TTB proposed to add what would have been a new 27 CFR 24.251, to provide for the correction of standard wine when the wine becomes other than standard wine due to accidental water additions in excess of the authorized levels provided for in 27 CFR part 24, subparts F and L. The proposed text set forth the authority and standards to allow for removal of accidental additions of water of not more than 10 percent of the original volume of the wine without the need to first seek TTB approval. The proposal also stated that the appropriate TTB officer could approve other removals of accidentally added water upon application by a proprietor and sets forth the requirements for submitting an application to TTB. It also specified that, in evaluating any request under this section, TTB may consider as a factor whether the proprietor has demonstrated good commercial practices, taking into account the proprietor's prior history of accidental additions of water to wine and of compliance with other regulations in part 24.

Comment: In its comment, the Wine Institute expressed its support for the proposal to allow for removal of accidental additions of water of not more than 10 percent of the original volume of the wine without the need to first seek TTB approval. It also agreed with “the conditions of usage of reverse osmosis and distillation as outlined” in the proposed regulations for the purpose of removing accidentally added water. However, Wine Institute pointed out that the regulations were proposed for “new” § 24.251, which already exists.

Additionally, Wine Institute expressed its support for language in proposed § 24.186(a), which provides that wine shall remain “standard wine” if water is accidentally added to standard wine in an amount that does not exceed 1 percent of the total volume of the wine, and the proprietor need not take any action to correct the wine. Wine Institute also suggested amending § 24.186(b), which allows for the correction of accidental water additions, to allow “the addition of grape juice concentrate to correct an accidental dilution of grape wine.” Wine Institute argued that since grape juice and grape juice concentrate is authorized to be added to standard wine (see 27 CFR 24.186), TTB should authorize the addition of grape juice and grape juice concentrate to wine that has been accidentally diluted with water. Wine Institute expressed its belief that water accidentally added can be completely or partially accounted for by an appropriate amount of juice concentrate because water is necessary to reconstitute juice concentrate back to original Brix. It argued that this approach eliminates the need for processing (such as reverse osmosis) that, according to Wine Institute, is expensive and can potentially impact the quality of the wine. Wine Institute further suggested that the process proposed in § 24.251 be used on a portion of the wine if concentrate does not fully account for the accidental water addition.

Clover Hill Winery expressed concern that the authority of removing accidentally added water from wine under the standards as proposed could be abused by winemakers to fortify wines by distilling “slightly past the original concentration.” With no record of this distillation, Clover Hill Winery stated “there would be no red flags at the regulatory agencies and customers would be none the wiser.”

In its comment, the EU quoted the EU-US agreement  7 on wine in article 3, which provides that “the term wine shall cover beverages which contain no added water beyond technical necessity.” As stated in their comment, the “EU considers adding water intentionally to wine products as fraud.” They further noted, “[I]n EU, any addition of water for facilitating the solution or dispersion of oenological products must be reported in a register held by the producer.” It is for these reasons that the EU recommended that “any accidental addition of water should be reported to the competent authority and duly recorded even if it is in the context of its subsequent removal.” The EU further commented that “the blending of a watered wine with a non-watered wine is not considered by EU as an acceptable solution to reduce the proportion of added water within the limit of 1 percent, this limit being accepted only in the context of the addition of water for facilitating solution or dispersion of oenological products.” They also corrected a statement made in Notice No. 164 by stating that “concentration techniques including reverse osmosis are allowed in EU for the enrichment of musts used to produce any category of wine under the conditions referred to in Annex VIII(I)(B)(1)(b) to regulation (EU) No 1308/2017.”

TTB Response. In Notice No. 164, TTB referenced having received requests to allow wine to be salvaged by blending the accidentally diluted wine with standard wine to reduce the level of unauthorized water addition to less than 1 percent of the volume of the blended wine. TTB also stated that it has not approved these requests because, in accordance with § 24.218, the accidental addition of water renders the wine an “other than standard wine.” Further, § 24.218 provides that other than standard wine must be segregated from standard wine, thus generally prohibiting the blending of other than standard wine with standard wine.

TTB proposed in new § 24.186 to permit the blending of other than standard wine with standard wine to reduce the amount of accidentally added water to 1 percent or less of the total volume of the blended wine. The intent was that the resulting wine would be considered to be standard wine.

In response to the comment received by the EU, TTB has reconsidered this proposal and is removing it from § 24.186 in this final rulemaking document. Accordingly, this final rule will not allow for the “salvage” of wine by blending the accidentally diluted wine (other than standard wine) with a standard wine. However, in response to the Wine Institute's suggestion of allowing the addition of juice concentrate to wine that has been diluted with water, TTB has added language to proposed § 24.251 (which is redesignated as § 24.252 in this document) that authorizes the salvage of wine that has been diluted with water by adding concentrate under certain conditions.

TTB is codifying these provisions in a new section, § 24.252. TTB originally proposed them in § 24.251. However, that section was added by a rulemaking subsequent to the publication of Notice No. 164. TTB notes that the provisions in § 24.252 only apply to wine that contains water in excess of the limits provided for standard wine in part 24 that was “accidentally added,” not “intentionally.” TTB also notes that the recordkeeping requirements in § 24.252 provide that the industry member retain records that document the accidental addition of water, the use of any treatment or process to remove the water from the wine, and the fact that only the amount of water that was accidentally added to the wine was removed as a result of the treatment or process. Because the regulations already address these matters, TTB does not believe that there is a need to amend the proposed regulations to further clarify that the water must be “accidentally” added in order to take advantage of the provisions of § 24.252, nor does TTB believe that additional recordkeeping requirements are necessary.

In response to Clover Hill Winery's comment, TTB notes that in general, wine spirits are authorized to be added to standard wine (see 27 CFR part 24, subpart K). It is unclear to TTB what is meant by “distill slightly past the point of concentration.” Currently, there are no labeling requirements in 27 CFR part 24 that require an industry member to indicate on the label of their product that it contains wine spirits. In fact, such practices are generally prohibited for wines that are required to be covered by a Certificate of Label Approval (COLA) under TTB's regulations in 27 CFR part 4.

Labeling concerns aside, the issue at hand is that alcohol that was removed from the permeate stream resulting from reverse osmosis is distilled and returned to the wine. As provided in the proposed regulations, the wine must be returned to its original condition by removing an amount of water equal to the amount that was accidentally added to the wine. “Returned to its original condition” includes alcohol content. TTB is adding clarifying language to the provisions of § 24.252 to address this issue.

In addition to the changes discussed previously, TTB Notice No. 164 included the following proposed regulatory amendments.

TTB proposed numerous technical and clarifying changes to § 24.246. First, TTB proposed to amend the heading in paragraph (a) of § 24.246 to read “Wine and juice” rather than just “Wine.” TTB also proposed a number of technical changes to the table in § 24.246. A significant portion of these technical changes involve revising the measurement references specified for the limitation on use of the authorized wine treating materials by making the notation of units of measurement consistent throughout the chart, supplying closing parentheses where they were absent, and removing decimal points followed only by zeroes. In addition, where units were only in U.S. Common (English) units or SI (International Standard, or metric) units, TTB proposed adding the other unit of measure for reference purposes, where appropriate. Other technical changes in the proposed rule include: (1) Adding a footnote reference after each use of ppm and ppb in the chart to address parts per million and parts per billion, respectively; (2) including a definition of the word “stabilize” at the end of the chart; (3) adding a third column to the table in § 24.246 titled “FDA reference” to provide references to relevant FDA regulations in title 21 of the CFR, FDA GRAS Notices, and FDA advisory opinions; and (4) updating references to FDA opinions.

Comments. Wine Institute submitted the only comment specifically referencing the technical amendments to § 24.246. In its comment, Wine Institute expressed its support of TTB's proposal of “expressing units first in U.S. common units and then in SI units” for the specified limitations of use in the list of authorized wine and juice treating materials listed in § 24.246. Wine Institute “appreciates the fact that the limits are expressed using both conventions”, and suggested “that a common SI unit form, i.e. mg/L or g/L, be expressed wherever possible.” Wine Institute argues that “mg/L or g/L” is a “more correct from a scientific perspective than `ppm' or `ppb.' ” Wine Institute also stated that “in some instances, limits are expressed in grams per hectoliter or similar; use of mg/L would be more consistent and more useful and relevant to the Industry.”

TTB Response. TTB is amending its regulations to add the appropriate SI unit to the specified limitations of use in the list of authorized wine and juice treating materials listed in § 24.246. TTB notes that many of the limitations in the table in § 24.246 include both common and SI units. Adding the actual SI units to the remaining limitations in the table, in addition to the footnote regarding the relationship between ppm or ppb and the common SI units, would not change the substance of the limitations and would be useful to industry members and provide consistency within the table.

In the entry for activated carbon in § 24.246, TTB proposed to amend one of the entries in the “Materials and use” column for clarity by revising the phrase “remove color in wine and/or juice” to read “remove color from wine and/or juice.”

Comments. Although Wine Institute stated that the simplified proposed language for activated carbon would assist in clarification, it was uncertain as to why a limit on the use of activated carbon is necessary, provided that the wine retains its vinous character after the decoloring process is complete. Instead, Wine Institute suggested GMP as an appropriate limit under the belief that “[t]he need to limit color removal is unnecessary.”

TTB Response. TTB is finalizing its proposal for the entry for activated carbon in § 24.246, and notes that Notice No. 164 did not include a specific proposal to change the use rate of activated carbon. TTB intends to seek comment on the Wine Institute recommendation in separate rulemaking. As a result, TTB is not adopting the recommendation at this time, but will consider requests from individual industry members under §§ 24.249 and 24.250 to use different levels of activated carbon to remove color from juice and/or wine as needed.

TTB proposed to revise the name of the material to “Ammonium phosphate/diammonium phosphate ( mono and di basic)” and place the entry under a new entry for “Yeast nutrients” in the table in § 24.246. (TTB also proposed a conforming change revising the name of the material in § 24.247.)

Comments. Wine Institute expressed its belief that the current use rate of ammonium phosphate “is insufficient in certain circumstances.” Wine Institute stated “[a]n addition of 8lbs. DAP per 1000 gallons of juice results in an addition of approximately 200 mg/L of Nitrogen to the juice.” Wine Institute referred to scientific articles (Butzke et al. (U.C. Davis, 1998))  8 that suggested “[i]n juices with high Brix levels, . . . as much as 350 mg/L of Nitrogen will be required for a healthy fermentation, thus it is possible that if the high Brix juice is naturally deficient in Nitrogen, then an addition of 8lbs/1000 gallons may be insufficient.”

In her comment, Heather Nenow expressed her concern that the current authorized use rate of ammonium/diammonium phosphate at 8 pounds per 1000 gallons of wine is insufficient to finish fermentation with grapes grown in certain regions of the country. Ms. Nenow referred to uncited studies that indicate yeast-assimilable nitrogen of 250 to 350 ppm is required to finish fermentation. According to Ms. Nenow, 1 pound of diammonium phosphate added to juice provides 22 ppm of yeast-assimilable nitrogen. With a limit of 8 pounds per 1000 gallons for addition of diammonium phosphate, the maximum increase of yeast-assimilable nitrogen the winemaker can add is 176 ppm, which is well below the 250-to-350 ppm of yeast-assimilable nitrogen that Ms. Nenow indicated is necessary to complete fermentation. She recommended a use rate for diammonium phosphate of 15 pounds per 1000 gallons of wine.

TTB Response. TTB is revising the name of the material to “Ammonium phosphate/diammonium phosphate ( mono and di basic)” and adding it to the new entry “Fermentation aid” in the table in § 24.246 (as noted above, for clarity, TTB is replacing the term “Yeast nutrients” with the term “Fermentation aids” in the regulations). TTB notes that it has not yet received requests from winemakers to use ammonium phosphate at levels higher than proposed. TTB plans to include this recommendation in separate rulemaking in relation to Wine Institute's recommendation of GMP.

In the “Specific limitation” column, TTB proposed to remove the references to FDA's GRAS opinions. The opinions were from 1960 and 1961, and copies were no longer available from either TTB or FDA.

Comments. The 11 submitters of the form letter stated that casein, which is currently authorized for use to clarify wine under § 24.246, should also be authorized for use in grape juice. They argued that the use of casein in juice is as effective as its use in wine. They further stated that “[m]any winemakers choose to use fining products on juice in preference to wine as the process is more efficient and ha[s] less impact on resultant wine flavor.”

TTB Response. TTB notes that it has not received applications from winemakers submitted under § 24.250 for the approval of the use of casein as a clarifying agent for juice. As a result, TTB did not propose to extend its authorized use to include juice in Notice No. 164. TTB believes that additional notice and opportunity for comment is necessary, and plans to include this recommendation in separate rulemaking. Thus, TTB is not authorizing the use of casein in grape juice in the production of wine at this time, but will consider requests from individual industry members under §§ 24.249 and 24.250 for the use of casein as a treatment material for grape juice.

TTB also proposed to make the following technical changes to the current entries in the table in § 24.246:

• Albumen. In the “Specific limitation” column, TTB proposed to revise the words “of solution” in the second sentence to read “of wine.”

• Calcium carbonate. In the “Materials and use” column, TTB proposed to add the abbreviation “CaCO 3 ” to the material name, to revise the phrase “and juice” to read “or juice” in the first use entry, and to revise the phrase “A fining agent” to read “As a fining agent” in the second use entry.

• Citric acid. In the “Materials and use” column, TTB proposed revising the phrase “deficiencies in wine” to read “deficiencies in juice and wine.”

• Copper sulfate. In the “Specific limitation” column, TTB proposed to revise the phrase “sulfate added (calculated as copper)” to read “sulfate (calculated as copper) added to wine.”

• Dimethyl dicarbonate. For purposes of clarity, in the “Materials and use” column, TTB proposed to add the abbreviation “(DMDC)” after the material name and also proposed to remove the phrases “dealcoholized wine” and “low alcohol wine” from the entry to reduce redundancy.

• Ferrocyanide. TTB proposed to remove “ferrocyanide” from the list of authorized wine treating materials because TTB believes that ferrocyanide compounds are no longer available on the United States market and no longer being used by the U.S. wine industry.

• Milk products. Because milk products are currently approved for use as fining agents in all wines, TTB proposed to remove the phrase “Fining agent for grape wine or sherry.” TTB believes this phrase may cause confusion because under the standards of identity in § 4.21(a), sherry is a grape wine.

• Oxygen and compressed air. In the “Materials and use” column, TTB replaced the words “May be used in juice and wine” with the words “Various uses in juice and wine.”

• Polyvinylpolypyrrolidone (PVPP). In the “Materials and use” column, TTB proposed removing the phrase “black wine” because this term for a very dark red wine is no longer commonly used by industry members; the material will still be allowed in red wines, which covers so-called “black wines.”

• Sorbic acid and potassium salt of sorbic acid. In the “Materials and use” column, TTB proposed adding the words “potassium sorbate” in parentheses immediately after the material name because “potassium salt of sorbic acid” is commonly referred to as “potassium sorbate.”

• Sulfur dioxide. TTB proposed to correct the entry for sulfur dioxide to include its use in juice.

• Thiamine hydrochloride. TTB proposed to move the material thiamine hydrochloride under a new heading, “Yeast nutrients.”

Comments. In its comment, Wine Institute agreed with the proposed clarifying changes for albumen, ammonium phosphate (mono- and di basic), calcium carbonate, casein, citric acid, copper sulfate, dimethyl dicarbonate, ferrocyanide compounds, milk products, oxygen and compressed air, polyvinylpolypyrrolidone (PVPP), sorbic acid, sulfur dioxide, and thiamine hydrochloride.

TTB Response. This rule will finalize the technical changes to albumen, calcium carbonate, citric acid, copper sulfate, dimethyl dicarbonate, ferrocyanide compounds, milk products, oxygen and compressed air, polyvinylpolypyrrolidone (PVPP), sorbic acid, sulfur dioxide, and thiamine hydrochloride as proposed in Notice No. 164.

TTB proposed a technical amendment to clarify the requirements in § 24.250 for applications for use of new wine treating materials or processes. The amendment would require evidence that the proposed material is “consistent with the food additive requirements under the FD&C Act for its intended purpose in the amounts proposed for the particular treatment contemplated.” TTB believes the proposed language is clearer than the current language which requires proof of FDA “approval of the material.” TTB received no comments specifically related to this proposed amendment. Therefore, TTB is adopting the amendment as proposed in Notice No. 164 as final.

In Notice No. 164, TTB invited public comments on a number of additional potential changes to part 24. Most of these issues had been raised in petitions for rulemaking or arose in connection with wine treatment approval requests under § 24.249 or § 24.250. The issues in question, and the specific points on which TTB requested public comments, are outlined below.

In 2008, Oak Tannin Technologies submitted a petition to amend the TTB regulations to allow “alcoholic oak extracts for use in natural wines as a stabilizing, enriching and integrating agent.” The petitioner stated that use of such extracts in wine is approved by the South African Wine and Spirit Board. However, TTB and its predecessor agencies' longstanding policy has been to treat such materials as essences or extracts, which, under § 24.85, may be used only in the production of formula wines  9 except agricultural wine. 10

In Notice No. 164, TTB sought comments regarding the use of an alcoholic oak extract in the production of natural wines, in particular, as a material for use as a wine stabilizer, but also for any other purpose that is consistent with good commercial practice. TTB also advised that a manufacturer of alcoholic oak extract must contact FDA and go through the FDA pre-market review process.

Comment. In its comment, Clover Hill Winery indicated its support for the use of alcoholic oak extract in the production of standard wines because it “may be beneficial to smaller wineries.” However, they also expressed concern that the authorized use of alcoholic oak extract in standard wine would detract “from the individuals who take time to age in barrels or with oak substitutes.” To resolve this concern and dispel possible consumer confusion, Clover Hill Winery offered a “middle ground” suggestion, which would include a statement on the label indicating whether or not wine was aged in oak or with alcoholic oak.

TTB Response. TTB appreciates Clover Hill Winery's comment and will take it into consideration in any future decisions regarding the use of alcoholic oak extract. TTB notes that as of the date of this document, the use of alcoholic oak extract as a stabilizing, enriching, and integrating agent has not gone through the FDA pre-market review processes. Therefore, TTB is not amending its regulations to allow the use of alcoholic oak extract at this time.

In 2007, Hyman, Philips, & McNamara, P.C. petitioned TTB to amend §§ 24.182 and 24.246 to allow use of lactic acid in juice, must, and wine prior to fermentation. Lactic acid is most commonly found in dairy products and is a common component in both plant and animal metabolic processes. Under § 24.246, lactic acid is currently authorized for use in grape wine to correct natural acid deficiencies. In the table in § 24.246, the entry in the “Reference or limitation” column for lactic acid simply provides a citation to 27 CFR 24.182 and 24.192. Section 24.192 refers back to the limitations on the use of acid, among other things, prescribed in § 24.182. The regulations in § 24.182 state that acids of the kinds occurring in grapes or other fruit (including berries) may be added within the limitations of § 24.246 to juice or wine in order to correct natural deficiencies. Section 24.182 also states that, after fermentation is completed, citric acid, fumaric acid, malic acid, lactic acid, or tartaric acid, or a combination of two or more of these acids, may be added to correct natural deficiencies. The petitioner noted that lactic acid is currently allowed by § 24.246 for treatment of wine after fermentation and provided evidence that certain other countries allow the addition of lactic acid before fermentation. Further, the petitioner noted that lactic acid is less expensive and more reliably available than tartaric acid.

In Notice No. 164, TTB did not propose any changes to the regulations concerning the use of lactic acid. However, TTB invited comments regarding whether or not the use of lactic acid prior to fermentation is good commercial practice in the production of natural wine.

Comments. Wine Institute noted that L(+) tartaric acid, malic acid, citric acid, and lactic acid are commonly grouped together in the regulations of other wine producing countries as allowed for acidification purposes. Wine Institute thus suggested that the limitation on use of lactic acid be expanded to allow its use in both juice and wine.

TTB Response. TTB's understanding of Wine Institute's comment is that it was responding to the request for comment in support of allowing the use of lactic acid for use prior to fermentation of natural wine. TTB believes that the Wine Institute's suggestion would benefit from additional public comment and plans to include it in a separate rulemaking document. TTB would also consider requests from individual industry members under §§ 24.249 and 24.250 for the use of lactic acid in juice prior to fermentation.

Section 24.248 currently provides for the use of reverse osmosis to reduce the ethyl alcohol content of wine and to remove off flavors in wine. In 2014, Constellation Wines U.S. Inc. (Constellation) submitted a petition to TTB requesting an expansion of the authorized uses of reverse osmosis in § 24.248 to include: (1) improving the phenol and flavor character of wine; and (2) reducing the water content in standard wine. In Notice No. 164, TTB invited comments on whether the use of reverse osmosis to reduce the water content of wine, improve the phenol and flavor character of wine, or to improve the sensory quality of the wine would be acceptable in good commercial practice. TTB did not, however, propose any amendments to add these uses to the list of authorized uses for reverse osmosis.

TTB stated that if commenters believed that the use of reverse osmosis for these purposes is consistent with good commercial practice, their comments should explain their position in detail, as well as provide guidelines/standards concerning how much water (maximum percentage) may be removed. If commenters believed that the use of reverse osmosis for these purposes is not consistent with good commercial practice, their comments should explain their position in detail.

Comments. In its comment, Wine Institute expressed strong support for the use of reverse osmosis as described in Notice No. 164. It stated that this process “is consistent with good commercial practice” and suggested that it be added to the list of allowable uses for reverse osmosis. Wine Institute stated that the practice of using reverse osmosis to improve the phenol flavor and character of wine and reduce the water content of wine “is allowed in other wine producing countries such as Australia and New Zealand,” and argued that “the lack of ability in the U.S. to use the technology in the proposed manner places the U.S. Industry at a significant competitive disadvantage.” Wine Institute further stated “Australia and New Zealand do not set limits on the amount of water that can be removed.” Rather than setting a numerical use rate on the reverse osmosis for the proposed uses, Wine Institute stressed its desire to base a use rate/limitation on the resultant wine needing to retain vinous character.

In his comment, Coleman Reardon also expressed support for the use of reverse osmosis as requested by Constellation. Mr. Reardon argued that the concentration of standard wine via reverse osmosis would result in wine producers using more grapes in the production of wine, which would benefit grape growers. He also stated that “[i]ncluding less water in the production of wine would also inherently increase the flavor of wine's other ingredients and characteristics.” Mr. Reardon further argued that the U.S. is at an international disadvantage by not allowing the proposed use of reverse osmosis because such practice is authorized in some other countries.

In his second comment to Notice No. 164, Dr. Robert Kreisher opposed the proposed use of reverse osmosis and disagreed with Constellation's assertion that wine resulting from reverse osmosis to improve the phenol flavor and character of wine and reduce the water content “is considered to be standard wine but with reduced levels of alcohol and water.” Dr. Kreisher stated that Constellation's assertion was incorrect because, under current regulation, the concentration of wine via reverse osmosis is not authorized and, therefore, such a practice does not result in a standard wine.

Dr. Kreisher also argued that Constellation's statement that concentration of wine via reverse osmosis will result in “reduced levels of alcohol and water” is inaccurate. Dr. Kreisher indicated that concentration of wine cannot result in both a reduction of alcohol and water. He stated that reverse osmosis passes water (through a membrane) preferentially to alcohol and thus reduces water content, while concentrating (increasing) alcohol in the wine. Therefore, the alcohol in the retentate, i.e , “wine”, is increased.

Dr. Kreisher also refuted Constellation's assertion “that many foreign countries permit the use of reverse osmosis as an acceptable winemaking practice to concentrate phenols and flavors in wine and in grape must” and that “[t]he expanded use of reverse osmosis would provide winemakers with better ability to regulate the alcohol content of wines.” He argued that the alcohol content of wine would only be regulated upward when reverse osmosis is used and further indicated that the claim that foreign countries authorize such practices is incorrect.

Finally, Dr. Kreisher argued that the prohibition on the concentration of wine to improve phenolic flavor and character and to reduce the water content does not subject anyone to unfair competition because wine produced with the use of such practices “may not be sold in any major market, including the U.S.” Dr. Kreisher stated “[t]his isn't unfair, it's parity.”

In her comment, Alice Feiring opposed the proposed use of reverse osmosis, stating that such a practice would be used “to cover up sloppy and unclean winemaking.”

TTB Response. TTB has decided not to set out regulations pertaining to this issue in this rulemaking. However, TTB will consider seeking additional comment in separate rulemaking.

In Notice No. 164, TTB discussed an industry member's request to use ultrafiltration to separate white grape juice that had darkened due to oxidation during storage into high and low color fractions for blending purposes. The low color fraction would be blended with white wine, and the high color fraction would be blended with red wine. TTB sought comment on whether the use of ultrafiltration to separate discolored wine for blending would be acceptable in good commercial practice. In its request for comment, TTB stated that a comment should explain in detail the commenter's position as to why the use of ultrafiltration in this manner is or is not acceptable in good commercial practice.

Comments. In its comment, E&J Gallo Winery (Gallo) acknowledged that TTB's request for comments on this matter was in response to a request the agency received from Gallo. Gallo responded that “ultrafiltration should be permitted to be used for both discolored white grape juice and discolored white wine.” In support of its position, Gallo noted that “unprocessed discolored white grape juice and/or discolored white wine can currently be blended with red grape juice and/or red grape wine without any limitations.” It further argued that “[u]sing a processing step to separate white juice into color fractions should not alter where it can subsequently be used as is currently allowed today.”

In his second comment in response to Notice No. 164, Dr. Robert Kreisher expressed support for extending the authorized use of ultrafiltration to separate discolored white wine. He further argued that the use of ultrafiltration gives winemakers greater control over the wine they produce.

TTB Response. Because TTB did not receive any negative comments in its request for comments, the agency is authorizing the use of ultrafiltration to separate white grape juice into low and high color fractions.

In 2007, TTB received a petition from Gusmer Enterprises Inc. (Gusmer) requesting approval of eight vitamins and minerals for use as yeast nutrients in the production of wine—cobalamin (vitamin B12), iodine (potassium iodide), iron, manganese sulfate, nickel, potassium chloride, riboflavin (Vitamin B2), and zinc sulfate. Prior to the publication of Notice No. 164, TTB had not administratively approved these vitamins and minerals under § 24.250. In Notice No. 164, TTB sought comments supporting or rejecting the argument that the use of these vitamins and minerals as yeast nutrients in the production of wine is consistent with good commercial practice.

Comments. In response to TTB's request for comment on the eight vitamins and minerals, Wine Institute said that it has “no position on whether any of the other materials identified in the Gusmer Enterprises, Inc. petition should be approved as authorized wine treatment materials.”

In its comment, Beverage Supply Group stated support for Gusmer's petition, specifically the use of zinc sulfate and manganese sulfate as yeast nutrients. Beverage Supply Group expressed their belief that the use of zinc sulfate and manganese sulfate is consistent with good commercial practice and also provided scientific data that they believe supports allowing the use of these two materials as yeast nutrients.

TTB Response. TTB did not receive comments supporting the addition of cobalamin (vitamin B12), iodine (potassium iodide), iron, nickel, potassium chloride, and riboflavin (vitamin B2), to the list of authorized wine and juice treating materials in § 24.246. TTB also has not had an opportunity to analyze wine or juice treated with these substances. Accordingly, TTB does not believe it has enough information to add these vitamins and nutrients to the list of authorized wine and juice treating materials at this time. However, TTB would consider requests from individual industry members under the procedures of §§ 24.249 and 24.250 for use of any of these materials to aid in the fermentation of wine.

Comment. In her comment, Samantha Hunter asked TTB to “highlight” flower and botanical wines to “preserve historical methodologies and treatments in [w]inemaking.” Ms. Hunter further suggested that TTB add “flowers or botanicals” to the definition of “essences.” She also suggested that TTB amend its regulations pertaining to “other wine” to allow wine to be made “by blending wines or co-fermenting flowers with fruits or, juice.”

TTB Response. TTB notes that wine made with flowers, such as dandelions, are considered “agricultural wines” under its regulations in 27 CFR part 24, subpart I. Wine derived from flowers may be blended with wine made from fruit; TTB considers this type of wine to be an “other than standard wine.” TTB will propose clarifying language to resolve this issue in future rulemaking. With regard to adding flowers and botanicals to the regulations pertaining to essences, TTB will consider this issue for future rulemaking.

Comments. In their form letter, 11 commenters notified TTB that the type of malolactic bacteria authorized by § 24.246 ( Leuconostoc oenos ) for use in wine is no longer current. The commenters cited a scientific article which proposes assigning Leuconostoc oenos to a new genus, Oenococcus oeni. The 11 commenters, who are mostly winemakers, stated that Oenococcus oeni “was adopted by the wine industry and the U.S. regulations should be updated to reflect that.” The 11 commenters also expressed concern over competing with wines produced in other countries because those producers are authorized to use other types of malolactic bacteria, such as those belonging to Leuconostoc, Lactobacillus, and Pediococcus genus. They believed that this creates an unfair trade advantage for wines produced in other countries and stated that “[a]ligning the designation of the authorized bacteria with current OIV standards as outlined in document OIV-Oeno 328-2009, Oeno 494-2012 ( https://www.oiv.int/public/medias/4054/e-coei-1-balact.pdf ) would provide U.S. wine producers with relative competitive equality in all trade markets.”

In his comment, Richard Gahagan stated that he does not believe that malolactic fermentation should be limited to Leuconostoc oenos. He stated that “taxonomists have reclassified this organism to Oenococcus oeni (Dicks, Dellaglio and Collins (1995).” He also stated that researchers from University of California Davis isolated three genera of lactic acid bacteria ( Lactobacillus, Leuconostoc, and Pediococcus ) from California wine (references to scientific articles were provided).

TTB Response. TTB is amending its regulations to add the name Oenococcus oeni as a synonym for Leuconostoc oenos. TTB has considered these comments and notes that the agency received several requests in the past to experiment with a different type of malolactic bacteria than that which is authorized for use in § 24.246, namely, Lactobacillus plantarum. In the responses to these previous requests, TTB stated that although the use of Leuconostic oenos as a stabilizing agent in wine is considered GRAS by FDA, the Bureau has been unable to ascertain that Lactobacillus plantarum is likewise considered GRAS by FDA. Therefore, TTB did not approve commercial use of Lactobacillus plantarum. In 2021, FDA did evaluate Lactobacillus plantarum in GRAS Notice No. GRN 000953, but only for use in “conventional foods, such as yogurt and other dairy products, soy products, chewing gum, and confectionary snacks.” Alcohol beverages were not among the uses evaluated. As a result, TTB is still not approving commercial use of Lactobacillus plantarum in wine.

TTB has not received requests to experiment with malolactic bacteria belonging to the genera Leuconostoc, Lactobacillus, or Pediococcus. Further, because these types of malolactic bacteria were not discussed in the proposed rule, the public has not had the opportunity to review a proposal on this matter. Accordingly, TTB is not incorporating the commenters' recommendations in this final rule but plans to include them in future rulemaking.

Comments. The 11 submitters of the form letter, in addition to the Wine Institute and Erbslöh Geisenheim (in its first comment), all commented that they support the addition of pea protein to the list of authorized wine and juice treating materials in § 24.246 as a source of plant protein. It is TTB's understanding that pea protein is intended to be used as a clarifying material. The 11 submitters of the form letter stated that: “Current US regulations provide unfair trade advantage for non-US wine producers in both domestic and international markets.” The Wine Institute's comment agreed with this assertion. The 11 commenters further argued that pea protein should be in the list of authorized treating materials because TTB has received “multiple” submissions from wineries requesting experimentation under § 24.246.

TTB Response. Since the publication of Notice No. 164, TTB has administratively approved the use of pea protein as a fining agent and to remove off flavors from wine and juice. Because TTB did not propose pea protein for such uses in Notice No. 164, the public has not had sufficient opportunity to comment. TTB is not adding pea protein to the list of approved treating materials in § 24.246 at this time but will include it in a future rulemaking document.

Comment. In its comment, the Wine Institute suggested that TTB consider the addition of potassium polyaspartate to the list of approved materials. It stated that “potassium polyaspartate has recently been approved for use in winemaking in the European Union as a tartrate stabilization tool, similar to CMC.”

TTB Response. TTB understands that the potassium polyaspartate that the Wine Institute is recommending for addition to the authorized list of wine treating materials is “potassium polyaspartate A-5D K/SD.” Since the publication of Notice No. 164, the FDA has evaluated potassium polyaspartate for use as a wine stabilizer (see GRAS Notice No. GRN 000770) and TTB has administratively approved its use to stabilize wine by preventing tartrate crystal precipitation. However, because Notice No. 164 did not include a proposal to add this material to the authorized list of wine treating materials, TTB believes the public needs an opportunity to comment. TTB plans to include potassium polyaspartate in a separate rulemaking document.

Comment. In its comment, ConeTech argued that the “Reference or limitation” column for spinning cone column in § 24.248 should be amended to allow for addition of the original water that was removed via spinning cone column back to the wine, with the resulting wine being considered standard wine. ConeTech supplied arguments in its comments for the addition of this proposal to the final rule.

TTB Response. TTB administratively approved the process proposed by ConeTech subsequent to the publication of Notice No. 164. Because TTB has not aired this proposal for public comment, it is not incorporated in this final rule, but TTB plans to include it in a separate rulemaking document.

Comment. In its comment, Clover Hill Winery recommended that TTB authorize the use of spinning cone column for purposes of alcohol reduction on winery premises rather than requiring it be used on a distilled spirits plant premises.

TTB Response. Spinning cone column is considered to be a distillation process. In general, statutory requirements require that distillation processes take place on distilled spirits plant premises. Therefore, TTB is not authorizing the use of spinning cone column on winery premises.

Comment. In its comment, Wine Institute suggested that TTB authorize the use of thin-film evaporation to separate juice into low Brix and high Brix fractions. It claims that such an authorization “would conform the allowable use of Thin-film evaporation to the allowable use of thermal gradient processing.”

TTB Response. Because TTB did not air this proposal for public comment in Notice No. 164, it is not incorporated in this final rule, but TTB plans to include it in a separate rulemaking document.

It has been determined that this rule is not a significant regulatory action for purposes of Executive Order 12866. Therefore, a regulatory assessment is not required.

Pursuant to the requirements of the Regulatory Flexibility Act (5 U.S.C. chapter 6), TTB certifies that these final regulations will not have an economic impact on a substantial number of small entities. This final rule provides for the voluntary use of additional wine and juice treating materials and processes in the production of wine. This authorization does not impose any required change to current winemaking practices, nor does it impose additional compliance burden on small businesses. TTB authorizes new wine treating materials and processes by evaluating proprietors' requests to experiment with such materials and processes, such requests being made via application to TTB. This rule allows for certain treatments, under limited circumstances, without the submission of an application to TTB. TTB estimates that the regulation will reduce the number of respondents by approximately 10 applicants per year, thus slightly reducing the overall burden of the information collection.

In addition, TTB currently requires wineries to maintain usual and customary business records. Included in these records are those records that evidence the details and results of experiments approved by TTB under § 24.249. This recordkeeping requirement remains unchanged by this rule as wineries subject to part 24 still will be required to maintain those usual and customary records.

Pursuant to section 7805(f) of the IRC (26 U.S.C. 7805(f)), the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on their impact on small business, and no comments were received.

Regulations in this document contain current collections of information that have been previously reviewed and approved by the Office of Management and Budget (OMB) in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507) and assigned control numbers 1513-0057, titled “Letterhead Applications and Notices Related to Wine (TTB REC 5120/2),” and 1513-0115, titled, “Usual and Customary Business Records Relating to Wine (TTB REC 5120/1).” Any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by OMB.

In conjunction with Notice No. 164, TTB submitted revisions to OMB control numbers 1513-0057 to OMB for review. That revision accounted for the anticipated reduction in the number of respondents as a result of the proposal to no longer require proprietors to submit an application to TTB prior to correcting accidentally diluted wine. The proposal was included in Notice No. 164 and is adopted as final in this document. The revision and its connection to the proposed regulatory amendments are described in detail in Notice No. 164, which also solicited comments regarding the information collection revision. TTB received no comments in response to the revision, which OMB has now approved.

TTB finds good cause under 5 U.S.C. 553(d)(3) to dispense with the effective date limitation in 5 U.S.C. 553(d)(3). A 30-day delayed effective date is unnecessary because the regulatory changes in this final rule that authorize the use of wine treating materials are optional, and making the changes effective immediately upon publication will give wineries the option of using these newly-approved materials and processes as soon as possible.

For the reasons discussed above in the preamble, TTB amends 27 CFR part 24 as follows:

Title IV of the Surface Mining Control and Reclamation Act of 1977 (SMCRA) created the AML Fund, which is funded primarily by a reclamation fee (also known as the AML fee) assessed on each ton of coal produced in the United States and that, among other things, provides funding to eligible States and Tribes for the reclamation of coal mining sites abandoned or left in an inadequate reclamation status as of August 3, 1977. As originally enacted, section 402(a) of SMCRA set the reclamation fee at 35 cents per ton (or 10 percent of the value of the coal, whichever was less) for coal other than lignite produced by surface mining methods, 15 cents per ton (or 10 percent of the value of the coal, whichever was less) for coal other than lignite produced from underground mines, and 10 cents per ton (or 2 percent of the value of the coal, whichever was less) for lignite. Section 402(b) of SMCRA first authorized collection of reclamation fees for 15 years following the date of SMCRA's enactment (August 3, 1977). Subsequently, the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, 104 Stat. 1388, section 6003(a)) extended our fee collection authority through September 30, 1995, followed by the Energy Policy Act of 1992 (Pub. L. 102-486, 106 Stat. 2776, 3056, section 19143(b)(1) of Title XIX), which extended our fee collection authority through September 30, 2004. A series of short interim extensions in appropriations and other acts further extended our fee collection authority through September 30, 2007.

The Surface Mining Control and Reclamation Act Amendments of 2006 (the 2006 amendments) were signed into law on December 20, 2006, as part of the Tax Relief and Health Care Act of 2006 (Pub. L. 109-432, 120 Stat. 2922). The 2006 amendments extended our fee collection authority under section 402(b) through September 30, 2021, and reduced the reclamation fee rates in section 402(a) by 10 percent for the period from October 1, 2007, through September 30, 2012, and an additional 10 percent from the original levels for the period from October 1, 2012, through September 30, 2021. Therefore, the fee rates from October 1, 2012, through September 30, 2021, required coal mine operators to pay 28 cents per ton (or 10 percent of the value of the coal, whichever was less) for coal other than lignite produced by surface mining methods, 12 cents per ton (or 10 percent of the value of the coal, whichever was less) for coal other than lignite produced from underground mines, and 8 cents per ton (or 2 percent of the value of the coal, whichever was less) for lignite. OSMRE notified operators in writing of the change in fee rates resulting from the 2006 amendments in January and September 2007. 73 FR 67576, 67578. On November 14, 2008, the Department promulgated final regulations at 30 CFR parts 870 and 872 to codify these changes and other revisions made by the 2006 amendments (73 FR 67576).

The 2021 amendments, signed into law on November 15, 2021, as part of the Infrastructure Investment and Jobs Act (Pub. L. 117-58, 135 Stat. 429), commonly known as the Bipartisan Infrastructure Law (BIL), extended our fee collection authority under section 402(b) through September 30, 2034, and reduced reclamation fee rates in section 402(a) by 20 percent from the prior rates. Therefore, for the calendar quarter beginning October 1, 2021, the current rates require operators to pay 22.4 cents per ton (or 10 percent of the value of the coal, whichever is less) for coal other than lignite produced by surface mining methods, 9.6 cents per ton (or 10 percent of the value of the coal, whichever is less) for coal other than lignite produced from underground mines, and 6.4 cents per ton (or 2 percent of the value of the coal, whichever is less) for lignite.

In addition, the 2021 amendments extended the current annual AML grant distributions to both uncertified and certified States and Tribes. (A State or Tribe “certifies” under section 411(a) of SMCRA (30 U.S.C. 1240a) when it has completed all known coal AML priorities.) Specifically, the 2021 amendments revised section 401(f)(2) of SMCRA to extend the annual grant distributions from the AML Fund to eligible uncertified States and Tribes by 13 years. The extension of our fee collection authority in section 402(b) also effectively extended the AML grant distributions from general Treasury funds ( i.e., certified in lieu funds) to certified States and Tribes by 13 years, as provided in sections 402(i)(2) and 411(h)(2) of SMCRA (30 U.S.C. 1232(i)(2) and 1240a(h)(2)).

While we consider the 2021 amendments to be self-executing, some of our regulations were inconsistent with these provisions. To provide consistency between our regulations and the 2021 amendments and to clarify that fee collections continue without interruption at the reduced rates and that annual AML grant distributions to eligible States and Tribes based on fee collections continue using the formula described in sections 401(f) and 402(i)(2) of SMCRA, we published an interim final rule, effective upon publication, that revised 30 CFR parts 870 and 872 to reflect the reduction in reclamation fee rates and the extension of our fee collection authority and annual AML grant distributions (87 FR 2341 (January 14, 2022)). We are finalizing that rule in this document.

The interim final rule revised the Department's regulations to be consistent with the 2021 amendments, which extend our statutory authority to collect reclamation fees for an additional 13 years, reduce reclamation fee rates, and extend the dates when annual grant funding will be available to eligible States and Tribes. Similar to the proposed rule for the 2006 SMCRA amendments, the interim final rule retained certain expired fee rates at 30 CFR 870.13 for historical purposes and for use in future audits of production from the years in which those rates applied. See 73 FR 35214, 35219 (June 20, 2008). The interim final rule also made a clarifying change to the introductory text of 30 CFR 872.27(a)(2) by removing reference to Federal fiscal years 2007 through 2022.

Summary. OSMRE received two comments on the interim final rule, neither of which was specific to the rule language. One commenter recommended that “taxpayers not fund reclamation costs or fees” and suggested that other individuals benefiting from a mine should be responsible for reclamation. Another commenter similarly recommended that “no tax dollars be used to reclaim damages done by any private, or commercial enterprise on public lands” and suggested additional enforcement measures for tax crimes.

Response. Pursuant to SMCRA, all current coal mine operators are required to pay a reclamation fee on every ton of coal produced in the United States. These fees are deposited into the AML Fund and primarily used to provide grants to eligible States and Tribes for the reclamation of lands and waters that were mined for coal and abandoned or left in an inadequate reclamation status before August 3, 1977. These lands are characterized as “abandoned” because they were unreclaimed or inadequately reclaimed before the enactment of SMCRA, which was the first Federal law that required coal mine operators to restore lands and waters affected by mining practices. In addition, before States and Tribes can use AML moneys to reclaim a specific property, that State or Tribe must first make a determination that “there is no continuing reclamation responsibility [for that property] under State or other Federal laws.” Furthermore, if the property to be reclaimed is owned by someone who consented to, participated in, or exercised control over the mining operation that necessitated the reclamation, that property may be subject to a lien if there is a significant increase in the property value subsequent to reclamation. Thus, SMCRA ensures that no Federal funds will be used for reclamation of abandoned mine lands unless there is no continuing reclamation responsibility for those lands under State or Federal laws, and, even if there is no continuing reclamation responsibility, a property owner who consented to, participated in, or exercised control over the mining operation that necessitated the reclamation may not profit from the federally funded reclamation project. The 2021 amendments did not alter these requirements and safeguards, they only extended our authority to collect reclamation fees, reduced reclamation fee rates by 20 percent, and extended annual AML grant distributions. Likewise, the interim final rule and this final rule simply revise the regulations to be consistent with the 2021 amendments and do not alter the requirement that the coal industry internalize the cost of AML reclamation.

For the reasons discussed above and as provided in the interim final rule, OSMRE is adopting as final the interim final rule with two revisions to correct grammatical errors. Section 870.13(b) of the interim final rule incorrectly expressed the acronym for British Thermal Units as “Btu's” rather than “Btus.” This rule corrects those grammatical errors in the regulations by replacing “Btu's” with “Btus.” This rule also corrects two additional grammatical errors in 30 CFR 870.13(a) by replacing “Btu's” with “Btus.”

The Administrative Procedure Act (APA) generally requires that a final rule must be published in the Federal Register no less than 30 days before its effective date except for (1) substantive rules, which grant or recognize an exemption or relieve a restriction; (2) interpretive rules and statements of policy; or (3) as otherwise provided by the agency for good cause. 5 U.S.C. 553(d). As described below, OSMRE finds good cause to publish this rule with an immediate effective date.

The APA's legislative history indicates that the purpose of the 30-day publication requirement is to “afford persons affected a reasonable time to prepare for the effective date of a rule or rules or to take any other action which the issuance of the rules may prompt.” S. Rep. No. 79-752, at 201 (1945). However, the final rule merely revises the regulations to be consistent with the requirements of the BIL, which President Biden signed into law on November 15, 2021; thus, coal mine operators have had more than six months to prepare for the extension of our fee collection authority and commensurate reduction in reclamation fee rates, well in excess of the traditional 30-day requirement. Furthermore, the BIL did not create any new requirements with which coal mine operators must comply; both the requirement that coal mine operators pay a reclamation fee and our authority to collect the fee have existed since August 3, 1977, when SMCRA was enacted. Consequently, any impact on coal mine operators from the extension of our fee collection authority or the reduction in fee rates should be minimal. Finally, it is in the public interest for the final rule to be effective immediately because it revises out-of-date regulations to conform with the changes made by the 2021 amendments. These changes provide clarity and avoid the confusion that might otherwise result from stale regulatory provisions that are inconsistent with current law. The concurrent extension of our fee collection authority and reduction in reclamation fee rates, if not clearly understood by coal mine operators, could result in delayed payment of reclamation fees, which could subject operators to late payment penalties and potentially affect annual AML grant distributions to States and Tribes (30 U.S.C. 1231(f) and 1232(i)(2)) or estimated interest payments to the United Mine Workers of America (UMWA) Health and Retirement Funds' health care plans (30 U.S.C. 1232(h)). Conversely, confusion over reclamation fee rates could also result in overpayments based on the previous, higher reclamation fee rate, which may require OSMRE to process refunds and reduce administrative efficiency. For these reasons, we are availing ourselves of the good cause exemption at 5 U.S.C. 553(d)(3).

In addition, pursuant to 5 U.S.C. 553(b)(3)(B), an agency may waive the prior notice and public comment requirements if it finds, for good cause, that the requirements are impracticable, unnecessary, or contrary to the public interest. We are availing ourselves of the good cause exemption at 5 U.S.C. 553(b)(3)(B) to correct two grammatical errors in 30 CFR 870.13(a) that were the result of an earlier rulemaking and unaffected by the interim final rule. This is a ministerial action that will have no substantive impact on regulated entities or the public. For that reason, we do not anticipate receiving meaningful comments on a proposal to correct these grammatical errors and find good cause to forgo notice and an opportunity for public comment.

Pursuant to the Congressional Review Act, 5 U.S.C. 801 et seq., the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) has determined that this rulemaking is not a major rulemaking, as defined by 5 U.S.C. 804(2), because this rulemaking has not resulted in, and is unlikely to result in: (1) an annual effect on the economy of $100,000,000 or more; (2) a major increase in costs or prices for consumers, individual industries, Federal, State, or local government, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

As noted above, this rulemaking implements the 2021 amendments to SMCRA, which extended our fee collection authority for an additional 13 years, reduced reclamation fee rates by 20 percent, and extended annual AML grant distributions. Although OSMRE typically collects more than $100 million in reclamation fees annually and distributes over $100 million in annual AML grants to eligible States and Tribes, the reduction in fee collections resulting from the 20 percent reduction in reclamation fee rates is anticipated to be less than $100 million a year when compared to the fees collected and grants distributed in the fiscal years since fiscal year 2013, when the fee rate last changed. And because the 2021 amendments are self-executing, any effects come not from requirements imposed by this rule but rather from the extension of our traditional AML grant program and fee collection authority, and concurrent reduction in reclamation fee rates by Congress. As a result, this rule is not considered a major rulemaking.

Executive Order 12866 provides that OIRA will review all significant rules before they are issued. Because this final rule merely reflects the 2021 amendments to SMCRA, which extended our fee collection authority for an additional 13 years, reduced reclamation fee rates by 20 percent, and extended annual AML grant distributions, OIRA has concluded that this rulemaking is not a significant regulatory action under Executive Order 12866. Pursuant to Executive Order 12866, an action is a “significant regulatory action” if it is likely to result in a rule that may: (1) have an annual effect on the economy of $100 million or more or have a material adverse effect on the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or interfere with planned or actual action taken by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues that are the result of legal mandates, the President's priorities, or the principles set forth in the Executive order.

Although the reclamation fees collected and AML grants distributed typically exceed $100 million annually, this final rule is implementing only the 2021 amendments' continuation of an existing program mandated by Congress for an additional 13 years and is therefore not a change with a significant monetary impact. In addition, because the administrative and procedural provisions of this rule would reflect an annual impact of less than $100 million, it is not significant under Executive Order 12866. Furthermore, as OSMRE has collected reclamation fees and distributed annual AML grants for more than four decades, the agency is not aware of any inconsistencies with other agency actions or novel legal or policy issues that could arise as a result of the reauthorization of the reclamation fee and the extension of AML grants.

Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. Executive Order 13563 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements, to the extent permitted by statute.

The Regulatory Flexibility Act (RFA), which requires an agency to prepare a regulatory flexibility analysis for all rules, unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities, applies only where an agency is required to publish a general notice of proposed rulemaking for any proposed rule. See 5 U.S.C. 601(2), 603(a), and 604(a). As OSMRE was not required to publish a notice of proposed rulemaking associated with the interim final rule or this final rule, the RFA does not apply.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. As explained in section III.A. above, this rule:

(a) will not have an annual effect on the economy of $100 million or more;

(b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and

(c) will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of United States-based enterprises to compete with foreign-based enterprises.

The Unfunded Mandates Reform Act of 1995 (UMRA) requires that, before promulgating any general notice of proposed rulemaking that is likely to result in promulgation of any rule that may result in the expenditure by a State, Tribal, or local government, in the aggregate, or by the private sector of $100 million, adjusted annually for inflation, in any 1 year, an agency must prepare a written statement that assesses the effects on State, Tribal, and local governments and the private sector. See 2 U.S.C. 1532(a). However, the UMRA does not apply to final rules for which a general notice of proposed rulemaking was not published. As OSMRE was not required to publish a notice of proposed rulemaking for the interim final rule or this final rule, the UMRA does not apply.

This rule does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.

Under the criteria in section 1 of Executive Order 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.

This rule complies with the requirements of Executive Order 12988. Specifically, this rule:

(a) meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and

(b) meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.

The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy; Departmental Manual Part 512, Chapters 4 and 5; and Executive Order 13175 and have determined that it has no substantial direct effects on federally-recognized Tribes or Alaska Native Claims Settlement Act (ANCSA) Corporations, and that consultation under the Department's Tribal consultation policy is not required. OSMRE has conducted informal listening sessions with eligible Tribes to provide an overview of the BIL as it relates to the AML program. OSMRE is committed to communication and coordination and will continue engagement strategies as needed to keep Tribes informed of the requirements of the program.

In accordance with the requirements of the Paperwork Reduction Act (PRA), OSMRE may not conduct or sponsor, and you are not required to respond to, a collection of information unless it displays a currently valid OMB control number. OSMRE has reviewed this final rule and determined that it does not introduce any new or revised collections of information under the PRA. Therefore, no submission to OMB is required.

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because this rule is covered by a categorical exclusion. This rule is excluded from the requirement to prepare a detailed statement because it is a regulation of both an administrative and financial nature. See 43 CFR 46.210(i). In addition, any environmental effects resulting from this rulemaking as a whole are too broad, speculative, and conjectural because the nature of AML problems vary, occur in numerous locations throughout the country, and will be reclaimed at different times, and because each project completed with these funds is subject to NEPA review closer to the time that the project is undertaken. Id. We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.

This rule is not a significant energy action as defined in Executive Order 13211. A Statement of Energy Effects is not required.

We are required by Executive Orders 12866 (section 1(b)(12)), 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

(a) be logically organized;

(b) use the active voice to address readers directly;

(c) use common, everyday words and clear language rather than jargon;

(d) be divided into short sections and sentences; and

(e) use lists and tables wherever possible.

If you believe that we have not met these requirements in issuing this final rule, please contact the individual listed in the FOR FURTHER INFORMATION CONTACT section. Your comments should be as specific as possible in order to help us determine whether any future revisions to the rule are necessary. For example, you should identify the numbers of the sections or paragraphs that you find unclear, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

In developing this rule, we did not conduct or use a study, experiment, or survey requiring peer review under the Data Quality Act (Pub. L. 106-554).

Section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 3701 note et seq. ) directs Federal agencies to use voluntary consensus standards when implementing regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. This final rule is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with SMCRA, and the requirements would not be applicable to this final rulemaking.

Executive Order 13045 requires that environmental and related rules separately evaluate the potential impact to children. However, Executive Order 13045 is inapplicable to this rulemaking because this is not a substantive rulemaking and a notice of proposed rulemaking was neither required nor prepared. See section 2-202 and 5-501 of Executive Order 13045.

The action taken herein is pursuant to an existing delegation of authority.

For the reasons given in the preamble, the Department of the Interior adopts the interim rule amending 30 CFR parts 870 and 872, which was published at 87 FR 2341 on January 14, 2022, as final with the following changes:

The Coast Guard will enforce the special local regulations in 33 CFR 100.1101 for the location identified in Item No. 16 in table 1 to § 100.1101, from 7:30 a.m. until 11:30 a.m. on September 17, 2022, for the Swim for Special Operations Forces in San Diego Bay, CA. This action is being taken to provide for the safety of life on the navigable waterways during the event. Our regulation for recurring marine events in the San Diego Captain of the Port Zone, § 100.1101, Item No. 16 in table 1 to § 100.1101, specifies the location of the regulated area for the Swim for Special Operations Forces, which encompasses portions of San Diego Bay. Under the provisions of § 100.1101, persons and vessels are prohibited from entering into, transiting through, or anchoring within this regulated area unless authorized by the Captain of the Port, or his designated representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.

In addition to this document in the Federal Register , the Coast Guard will provide the maritime community with advance notification of this enforcement period via the Local Notice to Mariners and marine information broadcasts.

On August 16, 2022, the Coast Guard created a rulemaking that created a temporary safety zone. The safety zone was effective August 16, 2022, to August 18, 2022. A copy of the rulemaking that ended on August 18, 2022, is available in the docket USCG-2022-0600. However, additional time is needed to maintain safe navigation around response equipment and responders while additional damage assessments and salvage operations occurs, and, as a result, the Coast Guard is establishing through temporary regulations a safety zone that will be in effect through August 29, 2022. The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because immediate action is needed to respond to the safety hazards associated with the emergency response measures in product recovery of a sunken vessel. It is impracticable to publish an NPRM and hold a reasonable comment period for this rulemaking due to the emergent nature of the ongoing response and product recovery operations.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because immediate action is needed to respond to the safety hazards associated with the emergency response and salvage operations.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231). The Captain of the Port Sector Puget Sound (COTP) has determined that potential hazards associated with the emergency response and recovery operations will be a safety concern for anyone within a 1000-yard radius of Sunset Point, San Juan Island, WA. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the emergency response is ongoing and during the pollution mitigation measures and product recovery of the sunken vessel.

This rule establishes a temporary safety zone that will is subject to enforcement from August 18, 2022, at 10 p.m. through August 29, 2022, at 10 p.m. The safety zone will cover all navigable waters within 1000-yard radius of Sunset Point, San Juan Island, WA. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the emergency response of the sunken vessel are ongoing. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The safety zone may be suspended early at the discretion of COTP Sector Puget Sound.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).

This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Vessel traffic will be able to safely transit around this safety zone which would impact a small designated area of Sunset Point on San Juan Island for a total of no more than 11 days and operations may be suspended early at the discretion of the COTP Sector Pudget Sound. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting no more than 11 days that will prohibit entry within 1000 yards of Sunset Point while vessels, equipment, and personnel are being used in the emergency response and removal of a sunken vessel. It is categorically excluded from further review under paragraph L60[c] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The Coast Guard will enforce the safety zone in table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 for the Delaware River Waterfront Corporation fireworks display from 8:15 p.m. through 9 p.m. on September 3, 2022. This action is necessary to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after the fireworks display. Our regulation for safety zones of fireworks displays in the Fifth Coast Guard District, table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 specifies the location of the regulated area as all waters of Delaware River, adjacent to Penn's Landing, Philadelphia, PA, within a 500-yard radius of the fireworks barge position. The approximate position for the fireworks barge is latitude 39°56′52″ N, longitude 075°08′09″ W. During the enforcement period, as reflected in § 165.506(d), vessels may not enter, remain in, or transit through the safety zone unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on-scene.

In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide notification of this enforcement period via broadcast notice to mariners.

The Coast Guard will enforce the safety zone in table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 for the Rivers Casino Philadelphia fireworks display from 8:45 p.m. through 9:45 p.m. on September 4, 2022. This action is necessary to ensure safety of life on the navigable waters of the United States immediately prior to, during, and immediately after the fireworks display. Our regulation for safety zones of fireworks displays in the Fifth Coast Guard District, table 1 to paragraph (h)(1) to 33 CFR 165.506, entry 10 specifies the location of the regulated area as all waters of Delaware River, adjacent to Penn's Landing, Philadelphia, PA, within a 500-yard radius of the fireworks barge position. The approximate position for the fireworks barge is latitude 39°57′39″ N, longitude 075°07′45″ W. During the enforcement period, as reflected in § 165.506(d), vessels may not enter, remain in, or transit through the safety zone unless authorized by the Captain of the Port or designated Coast Guard patrol personnel on-scene.

In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide notification of this enforcement period via broadcast notice to mariners.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

You may access a frequently updated electronic version of 40 CFR part 180 through the Office of the Federal Register's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2022-0273 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 24, 2022. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b), although EPA strongly encourages those interested in submitting objections or a hearing request to submit objections and hearing requests electronically. See Order Urging Electronic Service and Filing (April 10, 2020), https://www.epa.gov/sites/production/files/2020-05/documents/2020-04-10_-_order_urging_electronic_service_and_filing.pdf. At this time, because of the COVID-19 pandemic, the judges and staff of the Office of Administrative Law Judges are working remotely and not able to accept filings or correspondence by courier, personal delivery, or commercial delivery, and the ability to receive filings or correspondence by U.S. Mail is similarly limited. When submitting documents to the U.S. EPA Office of Administrative Law Judges (OALJ), a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_upload.nsf.

Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions during this time that the Agency continues to maximize telework due to the pandemic; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. If it is impossible for a person to submit documents electronically or receive service electronically, e.g., the person does not have any access to a computer, the person shall so advise OALJ by contacting the Hearing Clerk at (202) 564-6281. If a person is without access to a computer and must file documents by U.S. Mail, the person shall notify the Hearing Clerk every time it files a document in such a manner. The address for mailing documents is U.S. Environmental Protection Agency, Office of Administrative Law Judges, Mail Code 1900R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2022-0273, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

In the Federal Register of April 28, 2022 (87 FR 25178) (FRL-9410-12-OCSPP), EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance exemption petition (PP 1F8953) by Danstar Ferment Ag/LALLEMAND PLANT CARE, Postsrasse 20, CH-6300 Zug, Switzerland (c/o Amy Plato Roberts, P.O. Box 990, Hailey, ID 83333). The petition requested that 40 CFR part 180.1120 be amended by establishing an exemption from the requirement of a tolerance for residues of Streptomyces sp. strain K61 in or on all food commodities. That notice referenced a summary of the petition prepared by the petitioner Danstar Ferment Ag/LALLEMAND PLANT CARE and is available in the docket via https://www.regulations.gov. Two comments were received on the notice of filing. EPA's response to these comments is discussed in Unit V.B.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement of a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .” Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.”

EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. If EPA is able to determine that a tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for Streptomyces sp. strain K61 including exposure resulting from the exemption established by this action. A full explanation of the data upon which EPA relied and its risk assessment based on those data can be found in the Streptomyces Strain K61 Registration Review Final Decision available in docket EPA-HQ-OPP-2009-0509, Streptomyces Strain K61 Biopesticides Registration Action Document available in docket EPA-HQ-OPP-2009-0509, Review of Petition to Amend an Existing Tolerance Exemption for Streptomyces sp. Strain K61 and in the document entitled “Risk Assessment for a FIFRA Section 3 Registration of Streptomyces sp. Strain K61 Technical, Containing 100% of the Currently Registered Active Ingredient Streptomyces sp. Strain K61” (a.k.a. Streptomyces sp. strain K61 Risk Assessment). Streptomyces sp. strain K61 Risk Assessment, as well as other relevant information, is available in the docket for this action as described under ADDRESSES .

Streptomyces strain K61 is a naturally occurring microbe found in soils throughout the world, and there are no known reports of any deleterious effects associated with its consumption. Additionally, the acute toxicity data on file with the Agency confirm its lack of acute toxicity. There is also no evidence of adverse effects from oral exposure to this microbial agent. Data on file with the Agency confirm the lack of oral toxicity/pathogenicity of Streptomyces strain K61. For the full discussion of the Toxicological Profile of Streptomyces sp. strain K61, see the Streptomyces Strain K61 Registration Review Final Decision and, the Streptomyces Strain K61 Biopesticides Registration Action Document, both available in docket EPA-HQ-OPP-2009-0509.

1. Dietary exposure from food, feed uses, and drinking water. Streptomyces sp. strain K61 is found in soils throughout the world. Dietary exposure to Streptomyces strain K61 is expected to be minimal. As the mode of action of Streptomyces strain K61 is through root colonization, the majority of applications are to seeds and soil. Certain foliar applications are permitted for the purposes of suppressing Botrytis infection and promoting growth; however, direct applications to crops are highly diluted and residues are not expected to persist.

Exposure to Streptomyces strain K61 via drinking water when the pesticide is used is not likely to be greater than current/existing exposures. Although Streptomyces strain K61 is found naturally, it does not thrive in aquatic environments. There are no aquatic use sites for the pesticide, so exposure in drinking water is not expected.

2. From non-dietary exposure. There are no residential uses for Streptomyces strain K61. Non-occupational exposures are not expected; in the event of accidental exposure, no non-occupational risks are anticipated.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance or exemption, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” EPA has not found that Streptomyces sp. strain K61 shares a common mechanism of toxicity with any other substances, and it does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed Streptomyces sp. strain K61 does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticides/cumulative.

FFDCA Section 408(b)(2)(C) provides that EPA shall retain an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA safety factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor. Based on the low toxicity of Streptomyces sp. strain K61 in the available studies, EPA has concluded that there are no toxicological endpoints of concern for the U.S. population, including infants and children, and therefore conducted a qualitative assessment of Streptomyces sp. strain K61. As part of its qualitative assessment, the Agency did not use safety factors for assessing risk, and no additional safety factor is needed for assessing risk to infants and children.

Based on the available data and information, the EPA has concluded that a qualitative aggregate risk assessment is appropriate to support the pesticidal use of Streptomyces sp. strain K61, and that risks of concern are not anticipated from aggregate exposure to the substance. This conclusion is based on the low toxicity of the active ingredient.

A full explanation of why the Agency is relying on prior 2011 Streptomyces sp. strain K61 registration review risk assessments for addressing the amendment to the exemption of a tolerance can be found within the Review of Petition to Amend an Existing Tolerance Exemption for Streptomyces sp. Strain K61 document. This document, as well as other relevant information, are available in the docket for this action as described under ADDRESSES .

Based on the Agency's assessment, EPA concludes that there is reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Streptomyces sp. strain K61.

An analytical method is not required for Streptomyces sp. strain K61 because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

One comment was received in response to the notice of filing. The comment discusses potential risk to humans and nontarget organisms from the use of products containing this active ingredient. Consistent with FFDCA section 408(b)(2)(D), EPA reviews the available scientific data and other relevant information and considers their validity, completeness, and reliability, as well as the relationship of this information to human risk. EPA also considers available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. EPA relied on a variety of data and information to conclude that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Streptomyces sp. strain K61.

Therefore, the existing tolerance exemption for Streptomyces sp. strain K61 is amended by establishing an exemption from the requirement of a tolerance for residues of Streptomyces sp. strain K61 in or on all food commodities when used in accordance with label directions and good agricultural practices.

This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to EPA. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) do not apply.

This action directly regulates growers, food processors, food handlers, and food retailers, not States or Tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or Tribal Governments, on the relationship between the National Government and the States or Tribal Governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian Tribes. Thus, EPA has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (2 U.S.C. 1501 et seq. ).

This action does not involve any technical standards that would require EPA's consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (15 U.S.C. 272 note).

Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq. ), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:

The provisions in 6 U.S.C. 232 reaffirm that, except for the law enforcement and related security functions that were transferred to the U.S. Department of Homeland Security (DHS) under the Homeland Security Act of 2002 (available at https://www.dhs.gov/sites/default/files/publications/hr_5005_enr.pdf ), Public Law 107-296, 116 Stat. 2135 (the Act), discussed in greater detail below, the GSA Administrator retains the authority to operate, maintain, and protect buildings and grounds owned or occupied by the Federal Government and under the jurisdiction, custody, or control of the Administrator (GSA-controlled facilities). This final rule amends in its entirety 41 CFR part 102-81, Security, last published in the Federal Register on November 8, 2005 (70 FR 67856), in light of changes to law, Executive orders, and facility security standards. This regulation is applicable to all GSA-controlled facilities, including those owned and leased by the Federal Government under GSA authority and those delegated under GSA authority.

Six months after the bombing of the Alfred P. Murrah Federal Building, President William Clinton issued Executive Order (E.O.) 12977: Interagency Security Committee, creating the Interagency Security Committee (ISC) within the Executive Branch (60 FR 54411, Oct. 19, 1995). The ISC, which consists of 66 Federal departments and agencies, has a mandate to enhance the quality and effectiveness of physical security in, and the protection of, nonmilitary Federal facilities, and to provide a permanent body to address continuing governmentwide security issues for these facilities. Pursuant to E.O. 12977, the ISC prepares guidance for the Facility Security Committees (FSC), which are responsible for addressing and implementing facility-specific security issues at each multi-occupant nonmilitary Federal facility.

In response to the terrorist attacks on September 11, 2001, Congress enacted the Act to enhance the protection of the assets and critical infrastructure of the United States. The Act established DHS and transferred the Federal Protective Service (FPS) from GSA to DHS. FPS was established as a component of GSA in January 1971. Historically, FPS serves as the security organization responsible for conducting investigations to protect GSA-controlled facilities, enforce Federal laws to protect persons and property, and make arrests without a warrant for any offense committed on Federal property in the presence of the arresting officer or for any felony that the arresting officer has reasonable grounds to believe the person to be arrested has committed or is committing. Section 1706 of the Act, codified at 40 U.S.C. 1315, transferred FPS's specific security and law enforcement functions and authorities to the Secretary of Homeland Security.

Section 422 of the Act references 6 U.S.C. 232, which reaffirms the authority of the Administrator of General Services to operate, maintain, and protect GSA-controlled facilities.

Following enactment of the Act, President George Bush issued E.O. 13286: Amendment of Executive Orders, and Other Actions, in Connection With the Transfer of Certain Functions to the Secretary of Homeland Security, which, among other things, transferred responsibility for chairing the ISC from the Administrator of General Services to the Secretary of Homeland Security (68 FR 10619, March 5, 2003).

In August 2004, President George Bush issued Homeland Security Presidential Directive 12 (HSPD-12) (available at https://www.dhs.gov/homeland-security-presidential-directive-12 ), which requires, to the maximum extent practicable, the use of identification by Federal employees and contractors that meets the standard promulgated by the Secretary of Commerce ( e.g., Federal Information Processing Standard Publication 201) to gain physical access to federally controlled facilities.

On December 15, 2020, the Office of Personnel Management issued the memorandum, “Credentialing Standards Procedures for Issuing Personal Identity Verification Cards under HSPD-12 and New Requirement for Suspension or Revocation of Eligibility for Personal Identity Verification Credentials” (available at https://www.opm.gov/suitability/suitability-executive-agent/policy/cred-standards.pdf ), which set forth credentialing standards procedures for Executive Branch departments and agencies to use when making eligibility determinations to issue personal identity verification credentials to Federal employees and contractors for access to federally controlled facilities or information systems, or both.

HSPD-12 was followed by the REAL ID Act of 2005, Public Law 109-13, 119 Stat. 302 (the REAL ID Act), which establishes minimum security standards for license issuance and production and prohibits Federal agencies from accepting for certain purposes driver's licenses and identification cards from States not meeting the REAL ID Act's minimum standards. Accessing Federal facilities, entering nuclear power plants and boarding federally regulated commercial aircraft are within the purview of the Real ID Act.

In June 2006, GSA and DHS signed a Memorandum of Agreement (MOA) outlining the responsibilities of each agency with regard to facility security. According to the MOA, FPS is required to conduct facility security assessments of GSA buildings in accordance with ISC standards. The resulting facility security assessment report should include recommended countermeasures for identified vulnerabilities. In addition, the MOA clarified that both agencies are responsible for the implementation of approved countermeasures, with FPS responsible for security equipment and GSA responsible for facility security fixtures. This 2006 MOA was superseded by an MOA executed by DHS and GSA as of September 27, 2018.

In February 2013, Presidential Policy Directive 21: Critical Infrastructure Security and Resilience (available at https://obamawhitehouse.archives.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil ) required the Secretary of Homeland Security to conduct comprehensive assessments of the vulnerabilities of the Nation's critical infrastructure. This directive designated both GSA and DHS as the responsible agencies for providing institutional knowledge and specialized expertise in support of security programs and activities for Government buildings.

In August 2013, the ISC issued the initial The Risk Management Process for Federal Facilities (the RMP Standard), a standard to define the criteria and processes to determine the facility security level (FSL) and provide a single source of physical security countermeasures for nonmilitary Federal facilities. The ISC updated the standard in November 2016 and again in March 2021. See, The Risk Management Process for Federal Facilities: An Interagency Security Committee Standard (2021 Edition) https://www.cisa.gov/publication/risk-management-process.

The following terms used in this final rule have the same definition as ascribed to them in the RMP Standard:

• Baseline Level of Protection,

• Facility Security Assessment,

• Facility Security Committee,

• Facility Security Level,

• Risk,

• Risk Mitigation,

• Level of Protection,

• Level of Risk, and

• Vulnerability.

Some notable provisions of the RMP Standard are described below:

(a) According to the RMP Standard, buildings with two or more Federal tenants with funding authority will have an FSC. FSCs are responsible for addressing building-specific security issues and approving the implementation of recommended countermeasures and practices. FSCs include representatives of all Federal occupant agencies in the building, as well as FPS and GSA. However, FPS and GSA do not have voting rights unless they are occupants in the building. If the FSC approves a countermeasure, each Federal occupant agency in the building is responsible for funding its pro rata share of the cost. According to the RMP Standard, in a building with only one Federal occupant agency, the sole agency with funding authority is the decision-maker for the building's security. Therefore, these types of buildings do not require an FSC.

(b) The RMP Standard requires FPS to conduct facility security assessments to identify vulnerabilities and recommend countermeasures. FSCs use a building's facility security assessment report to—

1. Evaluate security risk;

2. Implement countermeasures to mitigate risk; and

3. Allocate security resources effectively.

For example, a facility security assessment report might include a recommendation to install cameras and relocate a loading dock. Upon deliberation, the FSC might decide only to install the cameras. FPS, in consultation with the FSC, helps determine a facility's security level, which determines the baseline level of protection. FSLs range from Level 1 (lowest risk) to Level 5 (highest risk), and dictate the frequency of the facility security assessments for that building. The FSL is based on five factors: mission criticality, symbolism, facility population, facility size, and threat to occupant agencies. In addition, intangibles (such as short duration occupancy) can be used to adjust the security level.

Occupant agencies or FSCs use the facility security assessment reports prepared by FPS to inform their deliberations regarding recommended risk mitigation countermeasures and other security-related actions. GSA will facilitate the implementation of the countermeasures or other actions after occupant agency or FSC approval and commitment of each occupant agency to pay its pro rata share of the cost.

GSA is changing this section to describe more accurately the scope and coverage of the regulation. The regulation uses the phrase “under the jurisdiction, custody, or control of GSA,” which is consistent with the terminology that appears in 6 U.S.C. 232, to describe the buildings and grounds owned or occupied by the Federal Government that are covered by this part. This phrase replaces and clarifies the phrase “operating under, or subject to, the authorities of the Administrator of General Services,” which was used in the previous version. The definitions of “Federal facility” and “Federal grounds” are included to clarify any confusion in the scope.

GSA is changing this section to clarify that, under E.O. 12977, the ISC is responsible for setting policies and recommendations that govern physical security at nonmilitary Federal facilities and buildings. The ISC issues standards, such as the ISC Risk Management Process Standard (2021 Edition), which is the current RMP Standard. ISC policies do not supersede other laws, regulations, and Executive orders that are intended to protect unique assets.

GSA is adding this section to clarify the governing authorities that pertain to this regulation.

GSA is eliminating in its entirety the previous § 102-81.20 because the RMP Standard supersedes all previous guidance contained in the Department of Justice's report entitled “Vulnerability Assessment of Federal Facilities” (June 28, 1995). GSA is adding the replacement provision to clarify that Federal agencies are required to follow this regulation in nonmilitary Federal facilities and grounds under the jurisdiction, custody, or control of GSA, including those facilities and grounds that have been delegated by the Administrator of General Services. Federal agencies must cooperate and comply with ISC policies and recommendations for nonmilitary facilities, except where the Director of National Intelligence determines that compliance would jeopardize intelligence sources and methods or the Secretary of Energy determines that compliance would conflict with the authorities of the Secretary of Energy over Restricted Data and Special Nuclear Material under, among others, sections 141, 145, 146, 147, and 161 of the Atomic Energy Act of 1954, as amended, the Department of Energy Organization Act, or any other statute.

GSA is eliminating in its entirety the previous § 102-81.25 because the RMP Standard supersedes all previous guidance contained in the Department of Justice's report entitled “Vulnerability Assessment of Federal Facilities” (June 28, 1995). GSA is adding the replacement provision to clarify that Federal agencies are responsible for meeting physical security standards at nonmilitary facilities in accordance with ISC standards, policies, and recommendations. An occupant agency, if it is the only Federal occupant agency in the building, or the FSC, as applicable, uses the facility security assessment reports they receive from FPS to inform deliberations regarding recommended countermeasures and other security-related actions, such as the documentation of risk acceptance. GSA will facilitate the implementation of the countermeasures or other actions after occupant agency or FSC approval, as applicable, and commitment of each occupant agency to pay its pro rata share of the cost.

GSA is eliminating in its entirety the previous § 102-81.30 because the requirements are addressed in section 231 of Public Law 101-647, now codified at 34 U.S.C. 20351. GSA is adding the replacement provision to be consistent with the RMP Standard. This section now describes physical security considerations associated with existing nonmilitary facilities.

GSA is adding this section to be consistent with the RMP Standard. This section describes physical security considerations associated with nonmilitary leased facilities and new construction.

In the proposed rule published in the Federal Register at 85 FR 12489 on March 3, 2020, GSA provided the public a 60-day comment period, which ended on May 4, 2020. GSA did not receive any comments from the public.

E.O.s 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is a significant regulatory action and, therefore, was subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993.

This rule is not a major rule under 5 U.S.C. 804(2). Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (codified at 5 U.S.C. 801-808), also known as the Congressional Review Act or CRA, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. GSA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. A major rule under the CRA cannot take effect until 60 days after it is published in the Federal Register . The Office of Management and Budget's Office of Information and Regulatory Affairs has determined that this is not a “major rule” as defined by 5 U.S.C. 804(2).

This final rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601 et seq., because it applies to agency management or personnel.

Therefore, an Initial Regulatory Flexibility Analysis has not been performed. GSA invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.

GSA will also consider comments from small entities concerning the existing regulations in subparts affected by the rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (FMR Case 2018-102-2) in correspondence.

The Paperwork Reduction Act does not apply because the changes to the FMR do not impose recordkeeping or information collection requirements, or the collection of information from offerors, contractors or members of the public, that require the approval of the Office of Management and Budget under 44 U.S.C. 3501 et seq.

GSA determined there is no impact or cost associated with this final rule for either large or small businesses.

GSA determined a series of compliance activities for the establishment, training, and operations of future FSCs; initial determination of future FSLs; and future facility risk assessments.

Prior to determining the FSL of a facility, all prospective members of the facility's FSC must successfully complete a series of mandatory training outlined within the ISC's RMP Standard. 1 GSA consulted with ISC subject matter experts (SME) to determine the duration of each training and the average labor category of the FSC members. In addition, GSA consulted with the ISC and GSA Public Buildings Service (PBS) SMEs to determine the number of new facilities for both GSA and GSA-delegated authority agencies entering the portfolio requiring an FSC within the purview of the analysis. ISC SMEs also estimated the number of hours per FSL to determine the initial FSL and conduct a risk assessment at the appropriate juncture of the lease in accordance with the RMP Standard.

GSA identified five training courses required to be completed by FSC members prior to joining the committee. ISC staff estimated it will take an FSC member no more than two hours to complete and review each training. The trainings are the following:

• IS-1170: Introduction to the Interagency Security Committee and Risk Management Process Training

• IS-1171: Introduction to Interagency Security Committee Publications Training

• IS-1172: Interagency Security Committee Risk Management Process: Facility Security Level Determination Training

• IS-1173: Interagency Security Committee Risk Management Process: Levels of Protection and Application of the Design Basis Threat Report

• IS-1174: Interagency Security Committee Risk Management Process: Facility Security Committees.

GSA, in consultation with PBS SMEs, determined 263  2 new facilities are procured each year requiring an FSC to be established after reviewing GSA portfolio historical trends. 3 GSA applied an annual 1% reduction of the portfolio to the analysis in accordance with current portfolio acquisition and disposition trends. 4

GSA, in consultation with PBS and ISC SMEs, determined the average FSC is composed of four members. For the analysis, GSA assumed an average of two agencies per facility. 5 The FSC consists of a chair and voting member representing the agencies. GSA and FPS are included as non-voting members, unless they are occupants in the building, in which case they would have a vote. Historically, agencies nominate a senior official or the most senior official of the facility to the FSC. 6 Following consultation with PBS and ISC SMEs, GSA assumes the senior official to be the equivalent of a GS-15 at an hourly rate of $94.76. GSA estimated the duration of the activities required to operate an FSC to be four hours; one hour for each quarter.

Based on the analysis resulting from GSA's consultations, GSA estimated the cost to the Government for the training of each FSC member per course on a yearly basis to be $1,993,750 (2 hours × 1,052 FSC members × $94.76 [GS-15 rate]).

GSA determined 130 FSL 1  7 facilities, 115 FSL 2 facilities, 14 FSL 3 facilities, 3 FSL 4 facilities, and 1 FSL 5 facility  8 will be acquired and introduced to the portfolio on a yearly basis.

GSA estimated the cost to the Government for the operations of an FSC chairperson for an FSL 1 facility on a yearly basis to be $49,275 (4 hours × 130 facilities × $94.76 [GS-15 rate]). 9

GSA estimated the cost to the Government for the operations of an FSC chairperson for an FSL 2 facility on a yearly basis to be $43,590 (4 hours × 115 facilities × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC chairperson for an FSL 3 facility on a yearly basis to be $5,307 (4 hours × 14 facilities × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC chairperson for an FSL 4 facility on a yearly basis to be $1,137 (4 hours × 3 facilities × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC chairperson for an FSL 5 facility on a yearly basis to be $379 (4 hours × 1 facilities × $94.76 [GS-15 rate]). 10

GSA estimated the cost to the Government for the operations of an FSC voting member for an FSL 1 facility on a yearly basis to be $49,275 (4 hours × 130 facilities × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC voting member for an FSL 2 facility on a yearly basis to be $43,590 (4 hours × 115 facilities × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC voting member for an FSL 3 facility on a yearly basis to be $5,307 (4 hours × 14 facilities × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC voting member for an FSL 4 facility on a yearly basis to be $1,137 (4 hours × 3 facilities × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC voting member for an FSL 5 facility on a yearly basis to be $379 (4 hours × 1 facility × $94.76 [GS-15 rate]). 11

GSA estimated the cost to the Government for the operations of the two FSC non-voting members  12 for an FSL 1 facility on a yearly basis to be $98,550 (4 hours × 260 non-voting members × $94.76 [GS-15 rate]). 13

GSA estimated the cost to the Government for the operations of an FSC non-voting member for an FSL 2 facility on a yearly basis to be $87,179 (4 hours × 230 non-voting members × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC non-voting member for an FSL 3 facility on a yearly basis to be $10,163 (4 hours × 28 non-voting members × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC non-voting member for an FSL 4 facility on a yearly basis to be $2,274 (4 hours × 6 non-voting members × $94.76 [GS-15 rate]).

GSA estimated the cost to the Government for the operations of an FSC non-voting member for an FSL 5 facility on a yearly basis to be $758 (4 hours × 2 non-voting members × $94.76 [GS-15 rate]). 14

GSA consulted ISC staff to determine the duration per year for single tenant facilities to operate their facility and determined the duration to be 1/4 of the time spent by an FSC member. 15 In addition, GSA estimated 360 single tenant facilities per year to be added to the portfolio. 16

GSA estimated the cost to the Government for the operation of single tenant facilities on a yearly basis to be $34,114 (1 hour × 360 facilities × $94.76 [GS-15 rate]).

GSA consulted with ISC staff to determine the duration of an FSL determination based on the FSL of a facility and the average rate of the individuals performing the assessment. 17 18 Following consultation with ISC SMEs, GSA assumes the rate to be the equivalent of a GS-12 at an hourly rate of $57.33. Again, GSA used a 3/4 reduction of time in the analysis for single agency FSL determinations.

GSA estimated the cost to the Government for the FSL determination for new FSL 1 facilities on a yearly basis to be $149,058 (20 hours × 130 facilities × $57.33 [GS-12 rate]).

GSA estimated the cost to the Government for the FSL determination for new FSL 2 facilities on a yearly basis to be $263,718 (40 hours × 115 facilities × $57.33 [GS-12 rate]).

GSA estimated the cost to the Government for the FSL determination for new FSL 3 facilities on a yearly basis to be $48,157 (60 hours × 14 facilities × $57.33 [GS-12 rate]).

GSA estimated the cost to the Government for the FSL determination for new FSL 4 facilities on a yearly basis to be $13,759 (80 hours × 3 facilities × $57.33 [GS-12 rate]).

GSA estimated the cost to the Government for the FSL determination for new FSL 5 facilities on a yearly basis to be $5,733 (100 hours × 1 facility × $57.33 [GS-12 rate]). 19

This document announces that OMB approved the information collection requirement in 47 CFR 64.1200(n)(1) on July 20, 2022. The rule was modified in the Gateway Provider Report and Order, FCC 22-97 adopted on May 19, 2022 and released on May 20, 2022. The Commission publishes this document as an announcement of the compliance date of the rule. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Cathy Williams, Federal Communications Commission, Room 3.317, 45 L Street NE, Washington, DC 20554. Please include the OMB Control Number, 3060-1303, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

This document also modifies § 64.1200(p) of the Commission's rules, which advised that compliance was not required until OMB approval was obtained.

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received final OMB approval on July 20, 2022, for the information collection requirement contained in the modification to 47 CFR 64.1200(n)(1).

Under 5 CFR part 1320.5(b), an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number for the information collection requirement in 47 CFR 64.1200(n)(1) is 3060-1303.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-1303.

OMB Approval Date: July 20, 2022.

OMB Expiration Date: January 31, 2023.

Title: Advanced Methods to Target and Eliminate Unlawful Robocalls, Sixth Report and Order, CG Docket No. 17-59, Call Authentication Trust Anchor, Fifth Report and Order, WC Docket No. 17-97, FCC 22-37.

Form Number: N/A.

Respondents: Business or other for-profit entities, not-for-profit institutions, and state, local or tribal governments.

Number of Respondents and Responses: 6,493 respondents; 311,664 responses.

Estimated Time per Response: .25 hours.

Frequency of Response: On occasion reporting requirement.

Obligation to Respond: Required to obtain or retain benefits. The statutory authority for this information collection is contained in sections 4(i), 4(j), 201, 202, 217, 227, 227b, 251(e), 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 201, 202, 217, 227, 227b, 251(e), 303(r), and 403.

Total Annual Burden: 77,916 hours.

Total Annual Cost: No cost.

Needs and Uses: The Commission adopted a new information collection associated with the Advanced Methods to Target and Eliminate Unlawful Robocalls Sixth Report and Order and Call Authentication Trust Anchor Fifth Report and Order (“Gateway Provider Report and Order”). Unwanted and illegal robocalls have long been the Federal Communication Commission's (“Commission”) top source of consumer complaints and one of the Commission's top consumer protection priorities. Foreign-originated robocalls represent a significant portion of illegal robocalls, and gateway providers serve as a critical choke-point for reducing the number of illegal robocalls received by American consumers. In the Gateway Provider Report and Order, the Commission took steps to prevent these foreign-originated illegal robocalls from reaching consumers and to help track these calls back to the source. Along with further extension of the Commission's caller ID authentication requirements and Robocall Mitigation Database filing requirements, the Commission adopted several robocall mitigation requirements, including a requirement for gateway providers to respond to traceback within 24 hours, mandatory blocking requirements, a “know your upstream provider” requirement, and a general mitigation requirement.

This document also modifies § 64.1200(p) of the Commission's rules, which advised that compliance was not required until OMB approval was obtained.

The Federal Communications Commission amends 47 CFR part 64 as follows:

The Board's regulations at 49 CFR 1002.3(a) provide for an annual update of the Board's entire user-fee schedule. Fees are generally revised based on the cost study formula set forth at 49 CFR 1002.3(d), which looks to changes in salary costs, publication costs, and Board overhead cost factors. Applying that formula, 84 of the Board's 135 fees will increase and 51 fees will remain at their current levels.

Additional information is contained in the Board's decision. To obtain a free copy of the full decision, visit the Board's website at www.stb.gov or call (202) 245-0245. Assistance for the hearing impaired is available through Federal Information Relay Service (FIRS): (800) 877-8339.

For the reasons set forth in the preamble, title 49, chapter X, part 1002, of the Code of Federal Regulations is amended as follows:

On September 30, 2021, we published a proposed rule (86 FR 54145) to remove Braken Bat Cave meshweaver from the Federal List of Endangered and Threatened Wildlife ( i.e., to delist the species). Please refer to that proposed rule for a detailed description of previous Federal actions concerning this species. The proposed rule and supplemental documents are provided at https://www.regulations.gov under Docket No. FWS-R2-ES-2021-0054.

In accordance with our policy, “Notice of Interagency Cooperative Policy for Peer Review in Endangered Species Act Activities,” which was published on July 1, 1994 (59 FR 34270) and our August 22, 2016, Director's Memorandum “Peer Review Process,” we sought the expert review of our September 30, 2021, proposed rule to delist the Braken Bat Cave meshweaver (86 FR 54145). We sent the proposed rule to three independent peer reviewers and received two responses. We also sent the rule to one partner reviewer and received a response. The purpose of such review is to ensure that our decisions are based on scientifically sound data, assumptions, and analysis.

In preparing this final rule, we reviewed and fully considered comments on our September 30, 2021, proposed rule (86 FR 54145). We did not receive substantial additional information during the comment period, and therefore we did not make any changes from the proposed rule in this final rule.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an endangered species or a threatened species. On July 5, 2022, the U.S. District Court for the Northern District of California vacated regulations that the Service (jointly with the National Marine Fisheries Service) had promulgated in 2019 ( Center for Biological Diversity v. Haaland, No. 4:19-cv-05206-JST, Doc. 168 ( CBD v. Haaland ). As a result of that vacatur, regulations that were in effect before those 2019 regulations now govern listing and critical habitat decisions. Our analysis for this decision applied those pre-2019 regulations. However, given that litigation remains regarding the court's vacatur of those 2019 regulations, we also undertook an analysis of whether the decision would be different if we were to apply the 2019 regulations. We concluded that the decision would have been the same if we had applied the 2019 regulations. The analysis based on the 2019 regulations is included in the decision file for this decision.

The Braken Bat Cave meshweaver is a small, troglobitic (cave-dwelling) spider that inhabits caves and mesocaverns (humanly impassable voids in karst limestone) in Bexar County, Texas. Because the Braken Bat Cave meshweaver is restricted to the subterranean environment, individuals exhibit morphological adaptations to that environment, such as elongated appendages and loss or reduction of eyes and pigment (Service 2011b, p. 2).

Habitat for the Braken Bat Cave meshweaver includes karst-forming rock containing subterranean spaces (caves and connected mesocaverns) with stable temperatures, high humidities (near saturation), and suitable substrates (for example, spaces between and underneath rocks for foraging and sheltering) that are free of contaminants (Service 2011b, p. 2). Although the Braken Bat Cave meshweaver spends its entire life underground, its ecosystem is dependent on the overlying surface habitat (Service 2011b, p. 2). Examples of nutrient sources include leaf litter that has fallen or washed in, animal droppings, and animal carcasses. Individuals require surface and subsurface sources (such as plants and their roots, fruits, and leaves, and animal ( e.g., cave cricket) eggs, feces, and carcasses) that provide nutrient input into the karst ecosystem (Service 2011a, p. 6).

The Braken Bat Cave meshweaver is known from only two caves in the Culebra Anticline karst fauna region. One is located on private property, and the other occurs on a highway right-of-way. The species was first collected in 1980 and 1983 in Braken Bat Cave, but the cave itself was not initially described until 1988 (Reddell 1993, p. 38). The cave entrance was filled during construction of a home in 1990. Without excavation, it is difficult to determine what effect this incident had on the Braken Bat Cave meshweaver; however, there may still be some nutrient input, from a reported small side passage. The remaining location was discovered in 2012, during construction of State Highway 151 in San Antonio, Texas. Originally a void with no entrance, that feature was capped with concrete and the soil and vegetation above it was restored to the extent possible.

Threats to the Braken Bat Cave meshweaver and its habitat include destruction and/or deterioration of habitat by construction; filling of caves and karst features; increase of impermeable cover; contamination from septic effluent, sewer leaks, run-off, pesticides, and other sources; predation by and competition with nonnative fire ants; and vandalism (65 FR 81419; December 26, 2000).

Spider taxonomy generally relies largely on genitalic differences in adult specimens to delimit species (Paquin and Hedin 2004, p. 3240; Paquin et al. 2008, p. 139; Paquin and Dupérré 2009, p. 5). Delimiting troglobitic Cicurina species in particular is difficult not only because of the inaccessibility of their habitat for gathering adequate samples (Moseley 2009, pp. 47-48), but because most collections return immature specimens (Gertsch 1992, p. 80; Cokendolpher 2004, p. 15; Paquin and Hedin, 2004, p. 3240; Paquin et al. 2008, p. 140; Paquin and Dupérré 2009, p. 5). In addition, the few adults that are collected are disproportionately female (Cokendolpher 2004, pp. 14, 15, 17-18; Paquin and Dupérré 2009, p. 5). As females of troglobitic Cicurina exhibit variability in genitalic characters within and between caves, this makes it difficult to determine whether an individual represents a distinct species or intraspecific variation based on morphology alone (Cokendolpher 2004, pp. 30-32; Paquin and Duperre 2009, pp. 5-6; Paquin et al. 2008, pp. 140, 143, 147; Paquin and Dupérré 2009, pp. 4-6, 63-64).

The Braken Bat Cave meshweaver and Madla Cave meshweaver were originally described in 1992, from single female specimens found in Braken Bat Cave and Madla's Cave, respectively (Gertsch 1992, pp. 109, 111). These species were two of only four cave-dwelling spiders of the genus Cicurina described from Bexar County at the time (Gertsch 1992, p. 98) and were differentiated based on their geographic location and specific morphological characters of the females (Gertsch 1992, pp. 84, 109, 111; Cokendolpher 2004, pp. 26, 43, 52).

Various genetic data were combined to address species delimitation questions in troglobitic Cicurina species, including the Braken Bat Cave meshweaver (Hedin et al. 2018, entire). Analysis of the evolutionary history of the species using genetics (phylogenomics) revealed two lines of ancestry, both of which are eyeless and correspond to groups previously described based on female morphology and troglobitic (cave-dwelling) adaptations, specifically the shape of the female sperm storage organ and the ratio of leg length to body length (Hedin et al. 2018, pp. 55, 61, 63-64; Cokendolpher 2004, p. 18; Paquin and Dupérré 2009, p. 9). Although the type specimen for the Braken Bat Cave meshweaver was not included in the genetics portion of the study because DNA could not be collected due to age, newly discovered specimens from the same geographic region with similar morphology to the Braken Bat Cave meshweaver placed it in the Madla Cave meshweaver clade genetically (Hedin et al. 2018, pp. 56-57; Hedin et al. 2018, p. 67).

Therefore, based on similarity of morphologic characteristics and mitochondrial and nuclear DNA results, Braken Bat Cave meshweaver was synonomized under Madla Cave meshweaver (Hedin et al. 2018, p. 68). This synonomy was accepted by the World Spider Catalog (World Spider Catalog 2019). Please refer to the Bexar County Karst Invertebrates Recovery Plan (2011), the Bexar County Karst Invertebrates 5-year Review (2011), and the Madla Cave Meshweaver 5-year Review (2019) for more information.

In the September 30, 2021, proposed rule (86 FR 54145), we requested that all interested parties submit written comments on or before November 29, 2021. We also contacted appropriate State agencies and scientific experts and invited them to comment on the proposed rule. A newspaper notice inviting general public comment was published in the San Antonio Express-News' legal notices section on October 14, 2021. Although we invited requests for a public hearing in the rule, we did not receive any requests for a public hearing.

In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review actions under the Act, we sought the expert opinions of three specialists with expertise in the biology, habitat, and threats to the Braken Bat Cave meshweaver. We received responses from two experts. Both peer reviewers agreed that the Braken Bat Cave meshweaver should be delisted because it is no longer a taxonomically valid species and should be synonymized with the Madla Cave meshweaver. They did not provide any additional substantial information that would result in a change from the proposed rule.

We received one comment from Texas Parks and Wildlife Department that supported our determination to delist the Braken Bat Cave meshweaver. The agency did not provide any further substantive information.

We received four public comments during the comment period in response to the proposed rule. We reviewed all comments we received during the public comment period for substantive issues and new information regarding the proposed rule. None of the comments we received included new information concerning the proposed delisting of the Braken Bat Cave meshweaver. Two commenters supported our proposal to delist the Braken Bat Cave meshweaver, and the other two comments did not address or provide any information concerning the Braken Bat Cave meshweaver's delisting. We did not receive any comments opposing the proposed rule. Because all of the public comments we received did not provide any new or substantial information or pose questions to be addressed, they do not warrant an explicit response in this rule.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for listing species on, reclassifying species on, or removing species from the Federal Lists of Endangered and Threatened Wildlife and Plants. The Act defines “species” as including any species or subspecies of fish or wildlife or plants, and any distinct population segment of vertebrate fish or wildlife that interbreeds when mature (16 U.S.C. 1532(16)). Our regulations at 50 CFR 424.11 identify three reasons why we might determine that a listed species is neither an endangered species nor a threatened species: (1) The species is extinct; (2) the species has recovered; or (3) the original data or interpretations of the data used at the time the species was classified were in error. Here, we have determined that the Braken Bat Cave meshweaver was listed based on data or interpretations of data that were in error; therefore, we are delisting it. Consideration of the Recovery Criteria for the Braken Bat Cave meshweaver is not appropriate because it was delisted based on a previous taxonomic classification error. Both the Braken Bat Cave meshweaver and the Madla Cave meshweaver are covered under the Bexar County Karst Invertebrates Recovery Plan (Service 2011, entire); the Braken Bat Cave meshweaver will now be addressed under that recovery plan as the Madla Cave meshweaver (16 U.S.C. 1533(g)(1)).

This final rule revises 50 CFR 17.11(h) by removing the Braken Bat Cave meshweaver from the Federal List of Endangered and Threatened Wildlife. However, because the Braken Bat Cave meshweaver has been synonymized under the Madla Cave meshweaver, its status, and thus its protections under the Act, remain the same because the Madla Cave meshweaver is listed as endangered, wherever it is found, under the Act. The additional Braken Bat Cave meshweaver localities were included in the Madla Cave meshweaver 5-year review and did not change the endangered status of the Madla Cave meshweaver species (Service 2019, p. 17).

Unit 15, the area surrounding Braken Bat Cave, was designated as critical habitat for Braken Bat Cave meshweaver in 2012 (77 FR 8450; February 14, 2012). Because Braken Bat Cave meshweaver has designated critical habitat, this rule also amends 50 CFR 17.95(g) to remove the Braken Bat Cave meshweaver's designated critical habitat. This area has not yet been evaluated to determine if it is essential to the conservation of the Madla Cave meshweaver. Should we evaluate it in the future and determine that it is essential for the conservation of the Madla Cave meshweaver, proposing this unit as critical habitat for Madla Cave meshweaver would be completed in a subsequent rulemaking. Unit 15, however, is also critical habitat for an endangered beetle with no common name, Rhadine infernalis. Therefore, Unit 15 will retain the protections of the Act as designated critical habitat for R. infernalis.

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ), need not be prepared in connection with determining a species' listing status under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We do not expect any Tribes to be affected by this delisting because there are no Tribal lands in or near the range of the Braken Bat Cave meshweaver. Additionally, we did not receive any comments from any Tribes or Tribal members on the proposed rule (86 FR 54145; September 30, 2021).

A complete list of references cited in this rulemaking is available on the internet at https://www.regulations.gov and upon request from the Austin Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Austin Ecological Services Field Office.

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

On June 9, 1993, we listed Adiantum vivesii as an endangered species (58 FR 32308), due primarily to its limited distribution and low numbers of individuals.

We completed two 5-year reviews for Adiantum vivesii, the first on June 10, 2008 (see the announcement initiating the review at 70 FR 53807, September 12, 2005), and the second on September 25, 2018 (see the announcement initiating the review at 82 FR 29916, June 30, 2017). Both 5-year reviews recommended delisting due to the entity not meeting the Act's definition of a species; they found that the original data used at the time the entity was classified was in error. Peer reviewer comments received on the 5-year status review (2008) were part of our thorough review of the best available scientific and commercial data used to make our determination.

On July 30, 2021, we proposed to delist Adiantum vivesii because it is not a listable entity under the Act; our proposal further explained that the original data used at the time the species was classified were in error (86 FR 40996). In that document, we requested information and comments from the public and peer reviewers on our proposal to delist Adiantum vivesii.

There are no changes in this final rule from our proposed rule (86 FR 40996; July 30, 2021) based on the comments we received and that are summarized below under Summary of Comments and Recommendations.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for determining whether a species is an endangered species or a threatened species. On July 5, 2022, the U.S. District Court for the Northern District of California vacated regulations that the Service (jointly with the National Marine Fisheries Service) had promulgated in 2019 ( Center for Biological Diversity v. Haaland, No. 4:19-cv-05206-JST, Doc. 168 ( CBD v. Haaland ). As a result of that vacatur, regulations that were in effect before those 2019 regulations now govern listing and critical habitat decisions. Our analysis for this decision applied those pre-2019 regulations. However, given that litigation remains regarding the court's vacatur of those 2019 regulations, we also undertook an analysis of whether the decision would be different if we were to apply the 2019 regulations. We concluded that the decision would have been the same if we had applied the 2019 regulations. The analysis based on the 2019 regulations is included in the decision file for this decision.

The following discussion contains information that was presented in the proposed rule to delist Adiantum vivesii (86 FR 40996; July 30, 2021). A thorough discussion of the species' description, habitat, and life history is also found in that proposed rule.

Adiantum vivesii was found growing in colonies (clusters) where the rhizome (rootstock or underground stem) spreads horizontally. The fronds (leaves) are distichous (arranged in one plane) and erect-spreading with broad and irregular lance-oblong blades. The blades have two or three alternate or occasionally subopposite pinnae (segment of leaf), with a larger terminal pinna. The terminal pinnae are stalked often somewhat inequilateral with approximately 10 to 13 pairs of alternate, narrowly oblong-falcate pinnules (smaller segments of a leaf), shaped unequally cuneate at the base. The irregularly branched stalks are lustrous purple-black with hairlike scales. The rachis (axis of a fern leaf) and costae (central vein of a leaf) are more densely covered with hairlike scales than the stipe. The outer sterile margins of the pinna are irregularly serrulate (serrated teeth), and the tissue is dull green on both sides. Five elliptic to linear sori (sacks of spores) are borne along the basal half of the acroscopic (facing the apex) margin. The sori are also close or contiguous, but remain distinct, and the indusium flap (tissue covering the sori) is gray-brown and turgid, with an erose (irregular) margin (Proctor 1989, p. 140; USFWS 1995, pp. 1-2).

Adiantum vivesii was found in the limestone or karst region of northwestern Puerto Rico. This region is underlain by limestone rocks of the Oligocene or Miocene age. Topography varies throughout the karst region, from extremely rugged to gentle rolling hills. Canyons, sinkholes, and subterranean rivers, as well as these rolling hills, are the most common features of the region. Soils in the limestone hills are shallow, well-drained, alkaline, and interspersed between limestone outcrops (Lugo et al. 2001, pp. 13-26; USFWS 1995, pp. 6-7). Adiantum vivesii occurs within the semi-evergreen seasonal forests of the subtropical moist forest life zone (Ewel and Whitmore 1973, p. 20). This life zone, which covers 58 percent of the total area of Puerto Rico and the U.S. Virgin Islands, is delineated by a mean annual rainfall of between 1,000 to 1,100 millimeters (mm) (40 to 44 inches (in)) and about 2,000 to 2,200 mm (80 to 88 in) and a mean temperature between about 18 and 24 degrees Centigrade (64.4 and 75.2 degrees Fahrenheit) (Ewel and Whitmore 1973, p. 20). Adiantum vivesii occurs in a deeply shaded hollow at the base of a privately owned limestone hill in the municipality of Quebradillas (USFWS 1995, p. 7).

When the species was listed in 1993, it was known from only one population, which was estimated at 1,000 plants or growing apices by Proctor (1991, p. 5). The population was later documented in 2000 at the same location occurring in an area of 21 meters (m) by 10 m (68.9 feet (ft) by 32.8 ft) by Sepúlveda-Orengo (2000, p. 21). In the vicinity of this area, eight other species of the genus Adiantum were found ( A. cristatum, A. fragile, A. latifolium, A. melanoleucum, A. pulverulentum, A. tenerum, A. tetraphyllum, and A. wilsonii ). The fern Adiantum tetraphyllum was growing intermixed within the area occupied by Adiantum vivesii (Sepúlveda-Orengo 2000, p. 22). Surveys conducted in 2017 at the type locality (the location where the specimen was first identified) were unable to identify material that morphologically matched the original type specimen (despite similarities), nor any clonal stand of Adiantum vivesii material as it had been described there in 1991 and 2000 (Possley et al. 2020, p. 6). These results suggest that Adiantum vivesii is extirpated from the only known location.

Adiantum vivesii was believed to be a fern of the family Pteridaceae. It was described by Dr. George R. Proctor in 1985, from specimens collected by Miguel Vives and William Estremera at San Antonio Ward in the municipality of Quebradillas (Proctor 1989, p. 140). Non-genetic research on Adiantum vivesii after it was described as a species suggested this fern is a single sterile hybrid plant, rather than a population of individuals of a species (Sepúlveda-Orengo 2000, entire). Excavations at different points throughout the entire “population” of Adiantum vivesii found rhizome, or underground stem, connections between most of the apparent individual ferns (Sepúlveda-Orengo 2000, p. 21). Plantings of two 10-centimeter (4-inch) rhizome segments (planted in pots using the same soil from the colony location) of Adiantum vivesii grew into healthy plants within about 3 months (Sepúlveda-Orengo 2000, p. 21). Production of sporangia (structures from which the reproductive gametophytes arise) was observed throughout the year, but actual gametophytes (structures containing sperm and eggs, or gametes) were not observed. The lack of gamete production but growth of fronds from rhizome segments suggests that the Adiantum vivesii “population” consists of only one individual with rhizome proliferations (below-ground stems).

A morphometric analysis of Adiantum vivesii and the co-occurring species, Adiantum tetraphyllum, was conducted on 21 vegetative characters and one spore character (Sepúlveda-Orengo 2000, p. 22). In conjunction with the morphometric analysis, the following studies of Adiantum vivesii and Adiantum tetraphyllum were conducted: chromosome counts; light microscopy observations of fresh or dried pinnules, sori, and sporangia; and scanning electron microscopy (SEM) of rhizomes, fertile pinnules, and spores. The morphometric analysis showed significant differences between Adiantum vivesii and Adiantum tetraphyllum for 16 of the vegetative characters as well as spore size, revealing that Adiantum vivesii is morphologically different. Based on the results, the morphological features that best distinguish Adiantum vivesii from Adiantum tetraphyllum are the number of lateral pinnae and the number of pinnules on each lateral pinna, which are fewer in Adiantum vivesii. Although there are morphological differences, chromosome number in each taxon appears to be similar (Sepúlveda-Orengo 2000, p. 23), indicating Adiantum vivesii is not a polyploid (possesses more than two sets of chromosomes), a common cause of sterility in plants.

Based on spore observations in the light microscopy and SEM studies, Adiantum vivesii appears to be a sterile hybrid (Sepúlveda-Orengo 2000, p. 31). The greater variation in spore size in Adiantum vivesii observed in these studies was mainly produced by spore abortion. These observations of sori containing abortive sporangia and spores suggested Adiantum vivesii is indeed a hybrid (Sepúlveda-Orengo 2000, p. 29). Further, the forms of the spores of Adiantum vivesii are different from Adiantum tetraphyllum because of the collapse of the exospore (outer layer of the spore membrane) that is associated with the absence of the protoplast (plant cell with no cell wall). Mature spores of Adiantum vivesii are more compactly constructed than those of Adiantum tetraphyllum, with the sporangia appearing as more or less globular objects tightly grouped together, which is consistent with the sorus (spore-producing structure) of a hybrid (Sepúlveda-Orengo 2000, p. 28).

Based on the initial taxonomic analysis discussed above, Adiantum vivesii does not appear to be a distinct species (Sepúlveda-Orengo 2000, entire). This analysis showed that sporangia and spores were produced throughout the year, but signs of sexual reproduction as gametophytes or small plants were not observed. The plant instead reproduces vegetatively (asexually), and the entire colony seems to be the result of vegetative reproduction via rhizomes from a single, sterile individual (Sepúlveda-Orengo 2000, pp. 26-31).

More recently, the Fairchild Tropical Botanical Garden (Fairchild) has collaborated with the Service on the assessment of endangered ferns including Adiantum vivesii (Possley and Lange, 2016 and 2017, p. 4; Possley et al. 2020, pp. 5-11). In 2017, fieldwork was conducted to assess the colony of Adiantum vivesii and collect material for genetic analyses. Fairchild engaged Dr. Emily Sessa from the University of Florida (UF) to assist on a genetic study to validate whether Adiantum vivesii is a hybrid as indicated by Sepúlveda-Orengo (2000, p. 29).

Leaf material for DNA extraction was collected in the field in Puerto Rico in February 2017, and from herbarium specimens, including the isotype (duplicate or very similar type specimen) for Adiantum vivesii. A total of 27 specimens from the genus Adiantum were sampled from the field and herbarium specimens (all material of Adiantum vivesii was from herbarium specimens): 5 identified as A. latifolium, 2 as A. obliquum, 3 as A. petiolatum, 4 as A. pyramidale, 5 as A. tetraphyllum, 4 as A. vivesii, and 4 unidentified Adiantum individuals (Possley et al. 2020, p. 6).

The analysis found that five samples, including the Adiantum vivesii isotype, had sequence variants that fell in different groups, which indicate their hybrid origin (Possley et al. 2020, p. 10). The genetic sequencing further indicates that Adiantum vivesii is of hybrid origin with Adiantum petiolatum as one parent and the other parent likely being Adiantum tetraphyllum (Possley et al. 2020, p. 10).

The Act and supporting regulations define a species as any species or subspecies of fish, wildlife, or plant, and any distinct population segment of any vertebrate species that interbreeds when mature, but do not further define the terms “species” or “subspecies” used in this definition. Rather, per 50 CFR 424.11(a), the Service shall rely on standard taxonomic distinctions and the biological expertise of the Department of the Interior (Department) and the scientific community in determining whether a particular taxon or population is a species for the purposes of the Act. The standard biological definition of a “species” is a group of organisms that are capable of interbreeding when mature. The application of this definition becomes more complicated with plant species, as many can exhibit asexual reproduction (NRC 1995, p. 50). For this reason, we consulted with experts to assist in determining the appropriate treatment for this entity (Riibe 2020, pers. comm.; Sessa 2020, pers. comm).

Based upon expert input, here we are considering a species to be a distinct unit with a natural evolutionary trajectory, meaning that it has the ability to establish a lineage that could be lost to extinction (NRC 1995, p. 54; Riibe 2020, pers. comm.; Sessa 2020, pers. comm.). In the case of Adiantum vivesii, it was determined to be a sterile hybrid by Sepúlveda-Orengo (2000, entire), indicating that Adiantum vivesii is unable to sexually reproduce and is unlikely to perpetuate into the future. This research also demonstrated that the only known population was comprised of clonal individuals resulting from rhizome proliferations, some of which eventually fragmented.

Despite the extensive botanical research and inventories in Puerto Rico by the late Dr. George Proctor (former authority on ferns across the Caribbean) and other experts, Adiantum vivesii remains only known from the type locality. Additionally, during the latest field surveys at the type locality (2017), the Fairchild team was unable to locate material that morphologically matched the type specimen (despite similarities), nor any clonal stand of Adiantum material as described by Proctor and Sepúlveda-Orengo (Possley et al. 2020, p. 6). The team collected a variety of morphotypes from the type locality for genetic sequencing at the University of Florida; however, none of the material was a genetic match to Adiantum vivesii. These results suggest that Adiantum vivesii is extirpated from the only known location. Recent research has confirmed that Adiantum vivesii is a sterile hybrid that does not have the capacity to establish a lineage that could be lost to extinction (Possley et al. 2020, pp. 6-10). Consequently, we have determined that Adiantum vivesii does not qualify as a listable entity under the Act; the original data used at the time the entity was classified were in error; and thus Adiantum vivesii should be delisted.

In the proposed rule published in the Federal Register on July 30, 2021 (86 FR 40996), we requested that all interested parties submit written comments on our proposal to delist Adiantum vivesii by September 28, 2021. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. Newspaper notices in both Spanish and English inviting general public comment were published in El Nuevo Día on July 31, 2021. We did not receive any requests for a public hearing nor any substantive information during the comment period.

In addition, in accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing actions under the Act, we solicited expert opinion from eight knowledgeable individuals with scientific expertise that included knowledge of ferns and plant taxonomy. The selected experts were asked to help us identify any oversights, omissions, and inconsistencies; provide advice on reasonableness of judgments made from the scientific evidence; help us ensure that scientific uncertainties are identified and characterized; provide advice on the overall strengths and limitations of the scientific data used in the document; and inform us of any scientific information that we did not use. We received no responses from any of the peer reviewers.

During the comment period, we received four comments from the public on the proposal to delist Adiantum vivesii. We did not receive any comments from the Commonwealth of Puerto Rico or Federal agencies. All comments are posted at https://www.regulations.gov under Docket No. FWS-R4-ES-2020-0125.

Some public commenters did not state whether or not they support the delisting; others did not support delisting, but did not provide any evidence that Adiantum vivesii was actually a listable entity. Commentors mostly supported keeping Adiantum vivesii on the List in order to preserve its habitat even though it does not qualify as a listable entity and the original data used at the time the entity was classified were in error. One commentor further stated that the entity's midvein, which makes the leaf asymmetric, and its low number of pinnae give Adiantum vivesii unique morphological features. We acknowledge that Adiantum vivesii has unique morphological features; however, this fact, in and of itself, does not indicate that the entity is listable under the Act or that the original data used at the time the entity was classified were valid. The Act and supporting regulations define a species as any species or subspecies of fish, wildlife, or plant, and any distinct population segment of any vertebrate species that interbreeds when mature. Because the Act did not further define “species,” in our proposed rule, we considered a species to be a distinct unit with a natural evolutionary trajectory, meaning that it has the ability to establish a lineage that could be lost to extinction (NRC 1995, p. 54; Riibe 2020, pers. comm.; Sessa 2020, pers. comm.). As Adiantum vivesii is a sterile hybrid that does not have the capacity to establish a lineage that could be lost to extinction, we have determined that the entity does not qualify as a listable entity under the Act and the original data used at the time the entity was classified were in error. None of the commenters provided information to dispute this.

Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations (50 CFR part 424) set forth the procedures for adding species to, removing species from, or reclassifying species on the Lists of Endangered and Threatened Wildlife and Plants. Our regulations at 50 CFR 424.11 identify three reasons why we might determine that a listed species is neither an endangered species nor a threatened species: (1) The species is extinct; (2) the species has recovered, or (3) the original data used at the time the species was classified were in error.

Under section 3 of the Act and our implementing regulations at 50 CFR 424.02, a “species” includes any subspecies of fish or wildlife or plant, and any distinct population segment of any species of vertebrate species which interbreeds when mature. As such, a species under the Act may include any taxonomically defined species of fish, wildlife, or plant; any taxonomically defined subspecies of fish, wildlife, or plant; or any distinct population segment of any vertebrate species as determined by us per our Policy Regarding the Recognition of District Vertebrate Population Segments Under the Endangered Species Act (61 FR 4722; February 7, 1996).

Our implementing regulations provide further guidance on determining whether a particular taxon or population is a species or subspecies for the purposes of the Act; under 50 CFR 424.11(a), the Service shall rely on standard taxonomic distinctions and the biological expertise of the Department and the scientific community in determining whether a particular taxon or population is a species for the purposes of the Act. For listing determinations, section 4(b)(1)(A) of the Act mandates that we use the best scientific and commercial data available for each species under consideration. Given the wide range of taxa and the multitude of situations and types of data that apply to species under review, the application of a single set of criteria that would be applicable to all taxa is not practical or useful. In addition, because of the wide variation in the kinds of available data for a given circumstance, we do not assign a priority or weight to any particular type of data, but must consider it in the context of all the available data for a given species.

To determine what constitutes a listable entity under the Act, we evaluate and consider all available types of data, which may or may not include genetic information, to determine whether a taxon is a distinguishable species or subspecies. As a matter of practice, and in accordance with our regulations, in deciding which alternative taxonomic interpretations to recognize, the Service rely on the professional judgment available within the Service and the scientific community to evaluate the most recent taxonomic studies and other relevant information available for the subject species. Therefore, we continue to make listing decisions based solely on the best scientific and commercial data available for each species under consideration on a case-by-case basis.

In making our determination whether Adiantum vivesii is a listable entity, we considered all available data that may inform the taxonomy of Adiantum vivesii, such as ecology, morphology, and genetics, as well as expert opinion (Riibe 2020, pers. comm.; Sessa 2020, pers. comm). Here, we considered the ability of an entity to establish a lineage that could be lost to extinction in our determination of whether the species constitutes a listable entity.

After a review of all information available, we determined to remove Adiantum vivesii from the List of Endangered and Threatened Plants at 50 CFR 17.12. Since the time of listing, additional studies have shown that Adiantum vivesii is not a distinct species, but rather a sterile hybrid with rhizome proliferations that lacks the ability to establish a lineage that could be lost to extinction. As a result, we have determined that Adiantum vivesii was listed based on data or interpretations of data that were in error and that the entity is not a listable entity under the Act; therefore, we are delisting it.

Our review of the best available scientific and commercial information available indicates that Adiantum vivesii is not a valid taxonomic entity and that original data for classification of Adiantum vivesii when it was listed was in error. Therefore, we are removing Adiantum vivesii from the List of Endangered and Threatened Plants. Adiantum vivesii does not require a post-delisting monitoring plan because the requirements for a monitoring plan do not apply to species that are delisted for not meeting the statutory definition of a species because the original data for classification were in error.

This rule revises 50 CFR 17.12(h) by removing Adiantum vivesii from the Federal List of Endangered and Threatened Plants. On the effective date of this rule (see DATES , above), the prohibitions and conservation measures provided by the Act, particularly through sections 7 and 9, will no longer apply to Adiantum vivesii. Federal agencies will no longer be required to consult with the Service under section 7 of the Act in the event that activities they authorize, fund, or carry out may affect Adiantum vivesii. There is no critical habitat designated for Adiantum vivesii, so there will be no effect to 50 CFR 17.96.

We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq. ), need not be prepared in connection with determining a species' listing status under the Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination with Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that Tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to Tribes. We have determined that there are no Tribal lands that may be affected by this rulemaking.

A complete list of all references cited in this rule is available at https://www.regulations.gov at Docket No. FWS-R4-ES-2020-0125, or upon request from the Caribbean Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT ).

The primary authors of this rule are the staff members of the Fish and Wildlife Service's Species Assessment Team and the Caribbean Ecological Services Field Office.

Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as follows:

NMFS manages the groundfish fishery in the BSAI according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2022 Kamchatka flounder ITAC in the BSAI is 9,214 metric tons (mt) as established by the final 2022 and 2023 harvest specifications for groundfish in the BSAI (87 FR 11626, March 2, 2022) and inseason action (87 FR 43220, July 20, 2022). In accordance with § 679.20(d)(1)(i), the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that the 2022 Kamchatka flounder ITAC in the BSAI will soon be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 8,214 mt, and is setting aside the remaining 1,000 mt as incidental catch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Kamchatka flounder in the BSAI.

While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b), and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of Kamchatka flounder in the BSAI. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 18, 2022.

The Assistant Administrator for Fisheries, NOAA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.