83752 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

Issued in College Park, Georgia, on obtain copies of the petition and stabilizing, preserving, fermenting, and November 7, 2016. supporting materials. correcting wine and juice. • Ryan W. Almasy, FOR FURTHER INFORMATION CONTACT: Kara Section 5387(a) of the IRC (26 Manager, Operations Support Group, Eastern Fontaine, Regulations and Rulings U.S.C. 5387(a)), which authorizes the Service Center, Air Traffic Organization. Division, Alcohol and Tobacco Tax and production of agricultural wine, classed [FR Doc. 2016–27859 Filed 11–21–16; 8:45 am] Trade Bureau, 1310 G Street NW., Box as ‘‘standard agricultural wine,’’ from BILLING CODE 4910–13–P 12, Washington, DC 20005; phone 202– agricultural products other than the 453–1039, ext. 103. juice of fruit. Such agricultural wine must be made in accordance with good SUPPLEMENTARY INFORMATION: commercial practice as prescribed by DEPARTMENT OF THE TREASURY Background regulation and may be cellar treated in accordance with sections 5382(a) and (c) Alcohol and Tobacco Tax and Trade TTB Authority Bureau of the IRC. Also, section 5387(b) Chapter 51 of the Internal Revenue prohibits the addition of wine spirits, 27 CFR Part 24 Code of 1986, as amended (IRC), 26 coloring material or herbs, or other U.S.C. chapter 51, contains provisions flavoring material (except hops in the [Docket No. TTB–2016–0010; Notice No. concerning the taxation and production case of honey wine) to agricultural 164] of distilled spirits, wines, and beer. The wine, as well as the blending together of RIN 1513–AB61 Alcohol and Tobacco Tax and Trade wines from different agricultural Bureau (TTB) has been delegated commodities. Wine Treating Materials and Related authority to promulgate regulations The regulations promulgated under Regulations pertaining to wine under Chapter 51 of the IRC regarding the production of the IRC. The statutory provisions of the wine are set forth in part 24 of title 27 AGENCY: Alcohol and Tobacco Tax and IRC related to the distilled spirits and of the Code of Federal Regulations (27 Trade Bureau. wine regulations that TTB promulgates CFR part 24) and include, but are not ACTION: Notice of proposed rulemaking. include, but are not limited to, the limited to, the following provisions: • following: 27 CFR 24.10, which contains the SUMMARY: The Alcohol and Tobacco Tax • Section 5002(a)(4) of the IRC (26 definitions of certain terms used in 27 and Trade Bureau (TTB) is proposing to CFR part 24. U.S.C. 5002(a)(4)), which defines the • amend its regulations pertaining to the term ‘‘distiller,’’ in pertinent part, as 27 CFR 24.225, which sets forth production of wine and in particular in including any person who ‘‘(A) rules under which proprietors of a regard to the permissible treatments that produces distilled spirits from any bonded wine premises may withdraw may be applied to wine and to juice source or substance’’ or ‘‘(C) by any and receive spirits without payment of from which wine is made. These process separates alcoholic spirits from tax from the bonded premises of a proposed amendments are in response any fermented substance * * *.’’ distilled spirits plant and add the spirits to natural wine on bonded wine to requests from wine industry members • Section 5171(a) of the IRC (26 premises. to authorize certain wine treating U.S.C. 5171(a)), which requires that • 27 CFR 24.246, which includes a materials and processes not currently operations ‘‘as a distiller’’ only be table that lists the materials authorized authorized by TTB regulations. TTB conducted on the bonded premises of a for the treatment of wine and juice. invites comments on the proposed distilled spirits plant by a person who regulatory changes described in this • 27 CFR 24.247, which includes a is qualified under subchapter B of table that lists materials authorized for document, as well as on other wine chapter 51 of the IRC. treatment issues for which regulatory the treatment of distilling material. • Section 5373 of the IRC (26 U.S.C. • amendments are not proposed in this 27 CFR 24.248, which includes a 5373), which authorizes the document. table that lists processes authorized for promulgation of regulations regarding the treatment of wine, juice, and DATES: Comments must be received by the type of wine spirits that may be used distilling materials. January 23, 2017. in wine production. TTB administers chapter 51 of the IRC ADDRESSES: Please send your comments • Section 5381 of the IRC (26 U.S.C. and its implementing regulations on this document to one of the 5381), which provides that natural wine pursuant to section 1111(d) of the following addresses: is the product of the juice or must of Homeland Security Act of 2002, as • https://www.regulations.gov (via the sound, ripe grapes or other sound, ripe codified at 6 U.S.C. 531(d). The online comment form for this document fruit, made with such cellar treatment as Secretary has delegated various as posted within Docket No. TTB–2016– may be authorized under section 5382. authorities through Treasury 0010 at Regulations.gov, the Federal e- • Section 5382(a) of the IRC (26 Department Order 120–01, dated rulemaking portal); U.S.C. 5382(a)), which provides that December 10, 2013 (superseding • U.S. Mail: Director, Regulations and proper cellar treatment of natural wine Treasury Order 120–01 dated January Rulings Division, Alcohol and Tobacco constitutes those practices and 24, 2003), to the TTB Administrator to Tax and Trade Bureau, 1310 G Street procedures in the United States, of perform the functions and duties in the NW., Box 12, Washington, DC 20005; or using various methods and materials to administration and enforcement of these • Hand delivery/courier in lieu of correct or stabilize the wine, or the fruit laws. mail: Alcohol and Tobacco Tax and juice from which it is made, so as to In addition, TTB consults with the Trade Bureau, 1310 G Street NW., Suite produce a finished product acceptable U.S. Food and Drug Administration 400, Washington, DC 20005. in good commercial practice as (FDA) on whether alcohol beverages are See the Public Participation section of prescribed by regulation. Section adulterated under the Federal Food, this document for specific instructions 5382(c) also authorizes the Drug, and Cosmetic Act (FD&C Act), and requirements for submitting promulgation of regulations setting forth including whether a substance added to comments, and for information on how limitations on the preparation and use an alcohol beverage is an unapproved to request a public hearing or view or of methods and materials for clarifying, food additive. Alcohol beverages are

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00035 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83753

considered ‘‘food’’ under the FD&C Act. of ‘‘agricultural wine,’’ ‘‘amelioration,’’ • Yeast nutrients: For the purposes of A substance added to food is a food and ‘‘special natural wine’’ reflect this document, vitamins and minerals additive unless it is otherwise excluded language used in statutory provisions at that aid in the fermentation of juice to from the definition of a food additive sections 5387, 5383, and 5386, wine by acting as food for yeast. under the FD&C Act. For example, the respectively. The definition of ‘‘brix’’ is TTB Administrative Approvals of Wine use of a substance in food that is derived, in part, from statutory and Juice Treatments generally recognized as safe by qualified provisions at sections 5382 and 5393. experts (GRAS) is excluded from the Definitions of industry member and Industry members who wish to definition of a food additive under the yeast nutrients also are provided, experiment with, or commercially use, a FD&C Act. The use of a food additive in although these terms are not specifically treating material or process not food must be authorized by FDA either defined in statutory provisions or specifically authorized in 27 CFR part through a food additive regulation or an elsewhere in the regulations. 24 must file an application with TTB effective food contact notification • Agricultural wine: Wine made from requesting authorization to use the new (FCN). FDA has listed certain GRAS suitable agricultural products other than material or process. TTB may approve uses in its regulations. In addition, FDA the juice of grapes, berries, or other such requests as experiments under 27 has a voluntary notification procedure fruits. CFR 24.249 or allow for the continual by which any person may notify FDA of • Amelioration: The addition to juice use of the new material or process under a conclusion that a use of a substance or natural wine before, during, or after 27 CFR 24.250. Standards regarding approval of the is GRAS. FDA evaluates whether the fermentation, of either water or pure dry experimental use of a new treating notice provides a sufficient basis for a sugar, or a combination of water and material or process are set forth in GRAS conclusion (which results in a sugar to adjust the acid level. § 24.249. The provisions covering ‘‘no questions’’ response) or whether • Brix: The quantity of dissolved FDA believes there is an insufficient applications for commercial use of a solids expressed as grams of sucrose in new material or process are contained in basis for a GRAS conclusion (which 100 grams of solution at 68 degrees F results in an ‘‘insufficient basis’’ § 24.250. Consistent with §§ 24.246 and (20 degrees C.) (Percent by weight of 24.248, TTB may approve the use of response). For the purpose of this sugar). (The definition of ‘‘Brix’’ in rulemaking, we use the term ‘‘consistent wine treating materials and processes § 24.10 incorrectly refers to 60 degrees that are determined to be acceptable in with the food additive requirements F rather than 68, which is the equivalent under the FD&C Act’’ to refer to: (1) good commercial practice. In general, of 20 degrees C; TTB is proposing to good commercial practice includes Authorized food additive uses; (2) uses correct this typographical error in this that are GRAS under FDA’s regulations, addressing the reasonable technological document.) or practical need to enhance the that are the subject of a ‘‘no questions’’ • Essences: Preparations of natural letter from FDA in response to a GRAS keeping, stability, or other qualities of constituents extracted from fruit, herbs, the wine, and achieving the notice, or that are subject to an opinion berries, etc. letter from FDA stating that the use is winemaker’s desired effect without • Industry member: For the purposes GRAS or otherwise permissible; or (3) creating an erroneous impression about of this document, a proprietor of a uses that are otherwise excluded from the character and composition of the bonded wine premises. wine. regulation as a food additive. • Based on TTB’s experience in Natural wine: The product of the If TTB believes that it would be administering the statutory and juice or must of sound, ripe grapes or appropriate to approve the request, regulatory provisions mentioned above, other sound, ripe fruit (including whether as an experiment under TTB is proposing in this document a berries) made with any cellar treatment § 24.249 or for continued commercial number of amendments to the TTB authorized by 27 CFR part 24, subparts use under § 24.250, it will send a letter regulations and inviting comments from F and L, and containing not more than to the industry member authorizing use the public on these proposed regulatory 21 percent by weight (21 degrees Brix of the material or process and setting dealcoholized wine) of total solids. forth the conditions for that use. Also, changes. In addition, TTB is outlining in • this document a number of other issues Special natural wine: A product when TTB approves the continued that are not the subject of proposed produced from a base of natural wine commercial use of a wine treatment regulatory changes. TTB invites (including heavy bodied blending wine) material or process under § 24.250, it comments from the public on those to which natural flavorings are added, will provide public notice of such issues to assist TTB in determining and made pursuant to an approved approval on its Web site at https:// whether any of those issues warrant formula in accordance with 27 CFR part www.ttb.gov/wine/wine_treating_ specific regulatory changes. 24, subpart H. In subpart H, § 24.195 materials.shtml. The listing of additionally explains that, among other administrative approvals on the TTB Terms Used in This Document things, natural flavorings are added in Web site affords all industry members TTB is providing the following quantities or proportions such that the the opportunity to use an definitions to assist in the resulting product derives character and administratively approved wine treating comprehension of this final rule. The flavor distinctive from the base wine material or process pending future definitions of agricultural wine, and distinguishable from other natural rulemaking. amelioration, brix, natural wine, wine. TTB conducts rulemaking to consider standard wine, and wine spirits come • Standard wine: Natural wine, adding to or amending the materials and from § 24.10, the definition of essences specially sweetened natural wine, processes authorized in the regulations is derived from 27 CFR 24.85, and the special natural wine, and standard for treating wine, juice, and distilling definition of special natural wine is agricultural wine, produced in material listed in §§ 24.246 through derived from 27 CFR 24.10 and 24.195. accordance with 27 CFR part 24, 24.248 for several reasons. First, when The definitions of ‘‘natural wine’’ and subparts F, H, and I. TTB administratively approves wine ‘‘standard wine’’ are consistent with • Wine spirits: Brandy or wine spirits treatments for continued commercial statutory provisions at sections 5381 authorized under 26 U.S.C. 5373 for use use under § 24.250, TTB makes an and 5392, respectively. The definitions in wine production. initial determination that such material

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00036 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83754 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

or process is consistent with ‘‘good provides a reasonable opportunity for 19 proposed vitamins and minerals. commercial practice.’’ Administrative comment and to have those comments Four materials identified by the approval provides a more expeditious considered. For new wine treatments petitioner, selenium, boron, process than rulemaking for industry administratively approved in the United molybdenum, and chromium, are not members to obtain approval to use new States, TTB provides such public notice included in this proposal because no materials and processes. On the other and opportunity to comment through information was provided to hand, the rulemaking process allows the regulatory rulemaking process. demonstrate that their uses would be industry members and the public an TTB’s most recent amendment of consistent with the food additive opportunity to comment on, and §§ 24.246 through 24.248 to reflect requirements under the FD&C Act. specifically to confirm or refute, TTB’s treating material and process approvals Of the remaining 15 vitamins and initial determination that the use of a was published as Treasury Decision minerals proposed as yeast nutrients for material or process is consistent with (T.D.) TTB–61 in the Federal Register the production of wine by the good commercial practice. TTB believes (72 FR 51707) on September 11, 2007. petitioner, seven have been that input from industry members, the Since that time, TTB has received and administratively approved by TTB for users and potential users of these approved a number of applications for continued commercial use as yeast treatments commercially, should be experimental or commercial uses. These nutrients under § 24.250 in response to obtained before making a final include the 15 wine and juice treating industry member requests which were determination concerning the materials and the combined use of two received by TTB subsequent to TTB’s acceptability of the treatment in good existing wine treatment processes, receipt of the Gusmer petition. TTB is commercial practice. discussed below, on which TTB proposing, in this document, to amend Similarly, TTB might not approve a believes it has accumulated enough the regulations to add six of these request for administrative approval of a analytical data or other information to vitamins and minerals to the list of wine treatment because the Bureau is propose adding them to the list of approved treating materials and expand reluctant to approve the use of that approved materials and processes in the the approved use of a seventh that particular wine treatment without input TTB regulations at §§ 24.246 and already appears on the list. Specifically, from industry members and the public 24.248. TTB is proposing to add biotin, folic concerning the treatment’s acceptability TTB is soliciting comments from all acid, inositol, magnesium sulfate, in good commercial practice. After interested persons on TTB’s position niacin, and pyridoxine hydrochloride to obtaining information and comments that, based on the information set forth the list of authorized wine and juice through rulemaking, TTB may below, the use of each of these materials treating materials in § 24.246, and to determine that the wine treatment is or processes is consistent with good expand the current permitted use of consistent with good commercial commercial practice. calcium pantothenate in that section, as practice and approve the use of such described later in this document. treatment. As discussed below, through Yeast Nutrients For each of these seven yeast this document, TTB is seeking Seven of the administrative approvals nutrients TTB is proposing to limit the comments on the approval of the use of mentioned above authorize the use of amount of usage to the amounts several proposed treatments that have additional yeast nutrients in the provided in the Gusmer petition. While not been administratively approved by treatment of wine. TTB and its many of these yeast nutrients are the Bureau. predecessor agencies have recognized vitamins that are authorized for use in In addition, administrative approval the need to supply yeast with food, in the recent past FDA has advised of a wine treatment under § 24.250 does appropriate nutrients to facilitate TTB that the fortification of ‘‘alcoholic not guarantee acceptance in foreign healthy fermentation and to prevent beverages’’ with nutrients is not markets of any wine so treated, and ‘‘stuck fermentation’’ (fermentation that consistent with FDA’s fortification conducting rulemaking and adding wine has halted before completion due to, policy in 21 CFR 104.20 or the Dietary treating materials and processes to among other things, high sugar levels or Guidelines for Americans. In addition, §§ 24.246 through 24.248 results in nutrient deficiencies). The following FDA has informed TTB that FDA acceptance of the treated wines in yeast nutrients are currently listed in regulations for certain vitamins (e.g., certain foreign jurisdictions. For § 24.246 as authorized wine and juice folic acid and inositol) would not example, under Article 4.2 of the 2006 treating materials: authorize their use in alcohol beverages Agreement between the United States of • Ammonium phosphate; as nutrients. Nonetheless, FDA has America and the European Community • Calcium pantothenate (for apple stated to TTB that these vitamins could on Trade in Wine (Wine Agreement), wine); be used for the purpose of providing the United States and the European • Soy flour (defatted); nutrients to the yeast, and not to fortify Union agreed not to restrict ‘‘on the • Thiamine hydrochloride; the wine, where the levels of the basis of either wine-making practices or • Yeast, autolyzed; and vitamin remaining in the wine would be product specifications, the importation, • Yeast, cell wall/membrane of of a de minimis level. For these reasons, marketing or sale of wine originating in autolyzed yeast. TTB believes it is important to place the territory of the other Party that is In 2007, TTB received a petition from limitations on the use of these produced using wine-making practices Gusmer Enterprises Inc. (Gusmer) to substances that permit their use as that are authorized under laws, amend § 24.246 to allow the use of 19 nutrients for yeast growth but not as regulations and requirements of the vitamins and minerals as yeast nutrients food additives for human consumption. other Party listed in Annex I and in the production of wine. Gusmer For reasons discussed below in the published or communicated to it by that provided the names, descriptions, section titled ‘‘Other Issues for Public other Party.’’ Article 5.1 of the Wine functional roles for yeast metabolism, Comment and Possible Regulatory Agreement also contains provisions to conditions of use, and suggested Action,’’ TTB is not proposing in this authorize new or modified wine-making maximum amounts for the proposed document to add the eight vitamins and practices if a party to the Wine vitamins and minerals. The petitioner minerals that TTB has not approved Agreement provides public notice and also provided documentation on the administratively under § 24.250 to the specific notice to the other Party, and regulatory status of the uses of 15 of the list of authorized wine and juice treating

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83755

materials in § 24.246. However, TTB is 1984 (T.D. ATF–182, 49 FR 37522). list of approved wine and juice treating seeking comments on whether these Acacia also has a long record of use at materials contained in § 24.246. eight additional vitamins and minerals the level prescribed in the regulation. TTB administratively approved the should be approved as authorized wine While the increased amounts use of bakers yeast mannoprotein to treating materials. specified in those requests ranged as stabilize wine from the precipitation of potassium bitartrate crystals, in Proposed Regulatory Amendments high as 25 pounds of acacia per 1,000 gallons of wine, 16 pounds per 1,000 response to a number of requests from Wine Treating Materials gallons was the highest level that TTB industry members. In response to GRAS Notice No. GRN 000284, the FDA stated General Comment on Yeast Nutrients approved. In those reviews and approvals, TTB referenced FDA’s that it had no questions regarding the The six new yeast nutrients that TTB regulation (21 CFR 184.1330) for the use notifier’s conclusion that bakers yeast is proposing for the first time, based on of acacia at a rate greater than the mannoprotein is GRAS for use as a the Gusmer petition described above, amount listed in § 24.246, and TTB stabilizing agent in wines at levels and the six yeast nutrients already reviewed and considered relevant ranging from 50–400 milligrams per liter authorized for use by regulation, as submitted data required under (mg/L), to prevent tartaric acid listed in § 24.246 (including calcium § 24.250(b). TTB notes that some of the precipitation. In its administrative pantothenate), have been grouped requests to use higher amounts of acacia approval, TTB restricted the use of together in the proposed § 24.246 table also requested approval for an bakers yeast mannoprotein to 50–400 below under the heading ‘‘Yeast additional purpose, that is, to improve mg/L. nutrients.’’ This format is similar to the ‘‘mouthfeel’’; however, TTB’s authority Beta-glucanase having an enzyme one that currently exists for ‘‘Enzymatic under 26 U.S.C. 5382 to authorize wine activity derived from Trichoderma activity.’’ TTB is also broadening the treating materials only extends to harzianum: TTB is proposing to add use of those yeast nutrients that are correcting or stabilizing the wine or the beta-glucanase, at a use rate of 30 parts currently listed in § 24.246 to allow for fruit juice from which it is made. As per million (ppm) of wine, to the list of their use in all juice and wine. approved wine and juice treating reflected in its implementing materials contained in § 24.246. TTB Blends and Other Combinations of regulations in § 24.246, TTB policy is to administratively approved the use of Approved Treating Materials allow for wine treating materials that beta-glucanase having an enzyme filter, clarify, or purify wine or juice as TTB notes that, while the table in activity derived from Trichoderma materials that correct or stabilize wine. § 24.246 includes some references to harzianum. Several industry members Accordingly, TTB did not approve the approved materials used in combination requested approval to treat wine with an use of acacia for the purpose of (see, for example, the entry for enzymatic blend consisting of pectinase improving the ‘‘mouthfeel’’ of wine. potassium carbonate), there is no and beta-glucanase having an enzyme general statement to the effect that one TTB’s administrative approvals activity derived from Trichoderma or more approved materials may be used authorized the use of acacia in the harzianum. Pectinase is an approved as a blend or otherwise in combination treatment of wine at a level of 16 wine treating material listed with with another. TTB believes that such pounds per 1,000 gallons of wine, carbohydrase in § 24.246. While beta- combined uses should be permitted, which is equivalent to a maximum glucanase is also approved as a wine provided that the use of each material usage level of 2 percent. Subsequent to treating material listed with cellulose in conforms to the conditions specified for those administrative approvals, TTB § 24.246, that approval is limited to that material (that is, the reason or learned that although the FDA beta-glucanase having an enzyme purpose for its use and the references regulation cited for acacia gum in activity derived from Trichoderma and limitations that apply to its use). § 24.246 (§ 184.1330) is the correct longibrachiatum. In response to GRAS TTB is proposing, in this document, to citation, the beverage category listed in Notice No. GRN 000149, FDA stated that amend § 24.246 accordingly. This the table of FDA’s regulation does not it had no questions concerning the revision appears in proposed cover TTB’s intended use in wine. This notifier’s conclusion that the beta- § 24.246(b), with the current § 24.246(b) is because the FDA regulation further glucanase enzyme preparation derived moved to the proposed § 24.246(c). cites the food category definition in 21 from Trichoderma harzianum is GRAS CFR 170.3(n)(3), which does not cover at the minimum levels necessary to Specific Wine Treating Materials use in wine. Accordingly, the correct achieve the desired effect, typically Acacia (gum arabic): TTB is category from the table in § 184.1330 is ranging from 1 to 3 grams per hectoliter proposing to authorize a maximum use ‘‘all other food categories.’’ This of wine (10–30 ppm). In its rate of 8 pounds of acacia per 1,000 category has a limit of one percent administrative approval posted on gallons (1.92 grams per Liter (g/L)) of acacia gum (rather than 2 percent); the https://www.ttb.gov/wine/ wine in the list of authorized wine and functional effects for this category wine_treating_materials.shtml in 2010, juice treating materials in § 24.246. match TTB’s uses as clarifying and TTB inadvertently stated that the Acacia is currently listed in § 24.246 as stabilizing wine. TTB is correcting this amount of beta-glucanase derived from an authorized treating material to clarify mistake in this rulemaking by proposing Trichoderma harzianum used must not and stabilize wine, subject to a to increase the maximum use rate of exceed 300 ppm. TTB is correcting this limitation that its use shall not exceed acacia gum in wine to 8 pounds per mistake in this rulemaking by aligning 2 pounds per 1,000 gallons (0.24 g/L) of 1,000 gallons of wine. TTB’s earlier the proposed use rate with the rate wine. TTB has administratively administrative approvals authorizing stated in GRAS Notice No. GRN 000149. approved several requests from industry the use of acacia at levels greater than Accordingly, TTB is proposing to members to use acacia to treat wine at 8 pounds per 1,000 gallons of wine are amend the table in § 24.246 by adding levels exceeding the current maximum. revoked. to the entry on ‘‘Enzymatic activity: The current limitation in § 24.246 was Bakers yeast mannoprotein: TTB is Cellulase (beta-glucanase)’’ a second based on earlier evaluations of treated proposing to add bakers yeast source, Trichoderma harzianum, stating wine and was adopted through a public mannoprotein, at a use rate of 50–400 that its use must not exceed 30 ppm, rulemaking procedure on September 24, milligram per liter (mg/L) of wine, to the and by referencing GRAS Notice No.

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00038 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83756 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

GRN 000149. TTB is soliciting between 10 and 500 grams per hectoliter the current reference in § 24.246 is to comments on this proposed addition, (100 liters). In its administrative the FDA regulation at 21 CFR 184.1099, the limitation of 30 ppm, and also on approvals, TTB restricted the use of which specifies that tartaric acid with whether beta-glucanase enzymatic chitosan from Aspergillus niger to an the L configuration is obtained as a activity derived from Trichoderma amount not to exceed 10 grams per 100 byproduct of wine manufacturing. longibrachiatum is still relevant for liters of wine. In response to GRAS Notice No. GRN wine treatments. Folic acid: TTB is proposing to add 000187 for L(+) tartaric acid (alternative Biotin: TTB is proposing the addition folic acid to the list of authorized wine method) prepared using an enzyme from of biotin to the list of authorized wine and juice treating materials in § 24.246 immobilized Rhodococcus ruber cells, and juice treating materials in § 24.246 for use as a yeast nutrient at a use rate FDA stated that it had no questions as a yeast nutrient at a use rate not to not to exceed 100 ppb. TTB regarding the notifiers’ conclusion that exceed 25 parts per billion (ppb). TTB administratively approved an industry the substance is GRAS for use as an administratively approved an industry member’s request to use folic acid as a alternative source of L(+) tartaric acid in member’s request to use biotin as a yeast yeast nutrient in the production of wine. food at levels not to exceed current good nutrient in the production of wine. FDA FDA has stated to TTB in an informal manufacturing practices for use as a has stated to TTB in an informal opinion, that folic acid can be used for firming agent, a flavor enhancer, a opinion that biotin can be used for the the purpose of providing nutrients to flavoring agent, a humectant, and a pH purpose of providing nutrients to yeast, the yeast, and not to fortify the wine, control agent, as described in 21 CFR and not to fortify the wine, where the where the levels of folic acid remaining 184.1099. The FDA also noted that the levels of biotin remaining in the wine in the wine would be of a de minimis material is chemically identical to the would be of a de minimis level. The level. In TTB’s administrative approval, tartaric acid affirmed as GRAS in 21 Gusmer petition proposed a maximum TTB limited the use of folic acid to that CFR 184.1099. use rate for biotin of 25 ppb. which is consistent with good Based on the FDA response to the Calcium pantothenate (vitamin B5): commercial practice and did not GRAS notice and TTB’s analysis of wine TTB is proposing to amend § 24.246 to provide a specific use limit. The Gusmer treated with L(+) tartaric acid, TTB is expand the current authorized use of petition proposed a maximum use rate proposing to amend the entry for calcium pantothenate from use as a of 100 ppb for folic acid when used as ‘‘tartaric acid’’ in the table at the end of yeast nutrient in just apple wine to use a yeast nutrient in the production of § 24.246 to indicate that ‘‘tartaric acid’’ as a yeast nutrient in all wine. TTB wine. Such a use rate will ensure that may be manufactured by either the administratively approved an industry any folic acid remaining in the wine method specified in 21 CFR 184.1099 or member’s request to use calcium would be of a de minimis level. the method specified in GRAS Notice pantothenate as a yeast nutrient in the Inositol (myo-inositol): TTB is No. GRN 000187, and to add the citation production of wine. FDA has stated to proposing to add inositol to the list of to the FDA GRAS notice in the ‘‘Specific TTB in an informal opinion that authorized wine and juice treating limitation’’ column. calcium pantothenate can be used for materials in § 24.246 to be used as a Magnesium sulfate: TTB is proposing the purpose of providing nutrients to yeast nutrient at a use rate not to exceed to add magnesium sulfate to the list of yeast, and not to fortify the wine, where 2 ppm. TTB administratively approved authorized wine and juice treating the levels of calcium pantothenate an industry member’s request to use materials in § 24.246 to be used as a remaining in the wine would be of a de inositol as a yeast nutrient in the yeast nutrient at a use rate not to exceed minimis level. TTB’s administrative production of wine. FDA has stated to 15 ppm. TTB administratively approved approval restricted its use to that which TTB in an informal opinion that inositol an industry member’s request to use is consistent with good commercial could be used for the purpose of magnesium sulfate as a yeast nutrient in practice. TTB is proposing to apply the providing nutrients to the yeast, and not the production of wine. FDA has stated same use limit as is provided for the use to fortify the wine, where the levels of to TTB in an informal opinion that of calcium pantothenate in apple wine, inositol remaining in the wine would be magnesium sulfate can be used for the that is, a use rate of 0.1 pound of of a de minimis level. In TTB’s purpose of providing nutrients to yeast, calcium pantothenate per 25,000 gallons administrative approval, TTB restricted and not to fortify the wine, where the (1.5 ppm), and to allow for the use of the use of inositol to that which is levels of magnesium sulfate remaining calcium pantothenate for all juice and consistent with good commercial in the wine would be of a de minimis wine by removing the current apple practice and did not provide a specific level. In TTB’s administrative approval, wine limitation specified in § 24.246. use limit. The Gusmer petition proposed TTB restricted the use of magnesium Chitosan: TTB is proposing to add a maximum use rate of 2 ppm for sulfate as a yeast nutrient to that which chitosan from Aspergillus niger, at a use inositol when used as a yeast nutrient is consistent with good commercial rate not to exceed 10 grams per 100 in the production of wine. The practice and did not provide a specific liters of wine, to the list of approved maximum use rate of 2 ppm will ensure use limit. The Gusmer petition proposed wine and juice treating materials that any inositol remaining in the wine a maximum use rate of 15 ppm for contained in § 24.246. TTB would be of a de minimis level. magnesium sulfate when used as a yeast administratively approved several L(+) tartaric acid: TTB nutrient in the production of wine. industry member requests to use administratively approved several Niacin (vitamin B3): TTB is proposing chitosan from Aspergillus niger to industry member requests to use L(+) to add niacin to the list of authorized remove spoilage organisms, such as tartaric acid, prepared using an enzyme wine and juice treating materials in Brettanomyces, from wine. In its from immobilized Rhodococcus ruber § 24.246 to be used as a yeast nutrient response to GRAS Notice No. GRN cells, to correct natural acid deficiencies at a use rate not to exceed 1 ppm. TTB 000397, FDA stated that it had no and to reduce pH when ameliorating administratively approved an industry questions regarding the notifier’s material is used in the production of member’s request to use niacin as a conclusion that chitosan from grape wine. Tartaric acid is currently yeast nutrient in the production of wine. Aspergillus niger is GRAS for use as a listed in § 24.246 as a material FDA has stated to TTB in an informal secondary direct food ingredient in authorized for the treatment of wine and opinion that niacin can be used for the alcoholic beverage production at levels juice for these same purposes; however, purpose of providing nutrients to yeast,

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00039 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83757

and not to fortify the wine, where the applications.’’ The amount must not materials in § 24.246, to be used to levels of niacin remaining in the wine exceed 80 grams per 100 liters of wine. stabilize wine from tartrate precipitation would be of a de minimis level. In Based on FDA FCN No. 320, TTB’s at a level not to exceed 0.8 percent of TTB’s administrative approval, TTB experience with the use of sulfide and the wine. TTB administratively restricted the use of niacin as a yeast metal reducing matrix sheets (which approved several industry member nutrient to that which is consistent with contain PVI and are approved wine requests to use sodium carboxymethyl good commercial practice and did not treating processes listed in § 24.248), cellulose to stabilize wine by preventing provide a specific use limit. The Gusmer and TTB’s analysis of wine treated with tartrate precipitation. FDA regulations at petition proposed a maximum use rate the PVP/PVI copolymer, TTB is 21 CFR 182.1745 state that sodium of 1 ppm for niacin when used as a proposing to amend the table at the end carboxymethyl cellulose is GRAS when yeast nutrient in the production of wine. of § 24.246 by adding the PVP/PVI used in accordance with good Polyvinyl-pyrrolidone (PVP)/ copolymer as described by FDA FCN manufacturing practice. In TTB’s polyvinylimadazole (PVI) polymer: In No. 320 for use at a level not to exceed administrative approval, TTB restricted 2005, TTB began administratively 80 grams per 100 liters of wine to the use of sodium carboxymethyl approving industry member requests to remove heavy metal ions and sulfides cellulose to stabilize wine by preventing use a polyvinyl-pyrrolidone (PVP) and from wine. tartrate precipitation to an amount not polyvinylimadazole (PVI) copolymer Potato protein isolates: TTB is to exceed 0.8 percent of the wine. (PVP/PVI) as a wine treating material to proposing to add potato protein isolates, at a use rate of 500 ppm or 50 grams per Processes for the Treatment of Wine, be used for clarifying and stabilizing Juice, and Distilling Material alcohol beverages. PVP had once been 100 liters (50 g/hL) of wine, as a fining TTB is proposing to amend the listed as an authorized wine treating agent, to the list of approved wine and juice treating materials contained in regulations in § 24.248, which set forth material in ATF regulations at 27 CFR § 24.246. TTB administratively certain processes that TTB has approved 240.1051, Materials Authorized for approved an industry member’s request as being consistent with good Treatment of Wine. Specifically, it was to use potato protein isolates as a fining commercial practice for use by authorized as a clarifying agent for agent for wine. In response to GRAS proprietors in the production, cellar wine. After a 1990 recodification of 27 Notice No. GRN 000447, FDA stated that treatment, or finishing of wine, juice, CFR part 240, ATF rescinded its it had no questions regarding the and distilling materials, within the approval of PVP as a wine treating notifier’s conclusion that potato protein limitations of that section. Please note material because it was no longer in use isolates are GRAS for various technical that industry members are responsible by wine producers. See T.D. ATF–299 effects in a variety of foods that include for ensuring that any component used in (55 FR 24974). However, in the past alcoholic beverages at levels ranging an approved process, including several years TTB has received a from 0.01 to 15 percent. In its materials in contact with wine or juice, number of requests to use the PVP/PVI administrative approval, TTB restricted is used in a way that is consistent with copolymer as an authorized wine the use of potato protein isolates to an any applicable FDA regulations, treating material. The PVP/PVI amount not to exceed 500 ppm or 50 g/ including FDA food contact regulations. copolymer binds heavy metal ions and hL of wine for the purpose of fining Cross Flow Filtration sulfides present in juice and wine, after wine. The proposed limitation is which the bound materials and the PVI/ consistent with that of other countries. TTB is proposing to expand the PVP can be removed from the liquid Pyridoxine hydrochloride (vitamin authorized uses of nanofiltration and during filtration. B6): TTB is proposing to add pyridoxine ultrafiltration in § 24.248 to include On July 5, 2003, FDA allowed BASF hydrochloride to the list of authorized dealcoholization (reduction of the Corporation’s Food Contact Substance wine and juice treating materials in alcohol content). Currently, (FCS) Notification for their PVP/PVI § 24.246 to be used as a yeast nutrient nanofiltration is authorized to reduce copolymer to become effective (FCN No. at a use rate not to exceed 150 ppb. TTB the level of volatile acidity in wine 320). Under section 409(h)(2)(C) of the administratively approved an industry when used with ion exchange. FD&C Act (21 U.S.C. 348 (h)(2)(C)) a member’s request to use pyridoxine Ultrafiltration is authorized for use to food contact notification (FCN) is only hydrochloride as a yeast nutrient in the remove proteinaceous material from effective for the manufacturer or production of wine. FDA has stated to wine; to reduce harsh tannic material supplier identified in the notification. TTB in an informal opinion that from white wine produced from white Persons who market a FCS based on an pyridoxine hydrochloride can be used skinned grapes; to remove pink color effective notification must be able to for the purpose of providing nutrients to from blanc de noir wine; and to separate demonstrate that the notification is yeast, and not to fortify the wine, where red wine into high color and low color effective for their food contact the levels of pyridoxine hydrochloride wine fractions for blending purposes. substance. All persons who purchase a remaining in the wine would be of a de Ultrafiltration has also been food contact substance manufactured or minimis level. In its administrative administratively approved to separate supplied by a manufacturer or supplier approval, TTB restricted the use of red juice into low color and high color identified in an effective notification pyridoxine hydrochloride as a yeast fractions. (The administrative approval may rely on that notification to legally nutrient to that which is consistent with for ultrafiltration is discussed later in market or use the food contact substance good commercial practice and did not this document.) for the use that is the subject of the provide a specific use limit. The Gusmer Both nanofiltration and ultrafiltration notification, consistent with any petition proposed a maximum use rate are capable of reducing alcohol content limitations in that notification. of 150 ppb for pyridoxine hydrochloride in wine, and this proposed According to FDA FCN No. 320, the when used as a yeast nutrient in the liberalization will provide industry blend ‘‘is intended to be added directly production of wine. members with more tools to reduce the to alcoholic beverages during the Sodium carboxymethyl cellulose: TTB alcohol content of wine. However, as maturation process . . . is to be is proposing to add sodium required with those processes for completely removed by filtration . . . carboxymethyl cellulose to the list of dealcoholization currently authorized in and is limited to single use authorized wine and juice treating § 24.248 (reverse osmosis, osmotic

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00040 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83758 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

transport, and spinning cone column), skinned grapes; to remove pink color paragraph (a), covering withdrawal of ultrafiltration and nanofiltration, when from blanc de noir wine; and to separate spirits, paragraph (b), covering used to reduce the alcohol content of red wine into low color and high color production and use of wine spirits, and wine, must take place on distilled wine fractions for blending purposes. paragraph (c), covering spirits other spirits plant premises. TTB also is Since ultrafiltration is currently than wine spirits, and by otherwise proposing to place nanofiltration, authorized under § 24.248 to separate revising the text, in order to accomplish ultrafiltration, and reverse osmosis red wine into low color and high color the following: under the umbrella term ‘‘cross flow fractions for blending, TTB • To incorporate the terms of section filtration.’’ In cross flow filtration, the administratively approved use of 5373(a) of the IRC related to standards wine is passed across the filter ultrafiltration to separate red grape juice for the production of wine spirits, membrane (tangentially) at positive into low and high color fractions and is including that portion of section 5373(a) pressure relative to the permeate side. A proposing to amend the table at the end that reads, ‘‘where, in the production of proportion of the wine which is smaller of § 24.248 accordingly. TTB did not natural wine or special natural wine, than the membrane pore size passes administratively approve the use of sugar has been used, the wine or the through the membrane as permeate or ultrafiltration to separate high and low residuum thereof may not be used if the filtrate; everything else is retained on colored fractions of discolored white unfermented sugars therein have been the feed side of the membrane as grape juice, but as discussed under the refermented.’’ The proposed text retentate. TTB is adding this definition heading ‘‘Other Issues for Public clarifies and simplifies this statutory of ‘‘cross flow filtration’’ as a footnote to Comment and Possible Regulatory language without changing the meaning the table at the end of § 24.248. Action’’ in this document, invites or intent, which TTB believes is to comments on whether this practice prevent the production of wine spirits Reverse Osmosis in Combination With constitutes good commercial practice. by refermenting wine to develop alcohol Osmotic Transport from sugar added to the wine after TTB administratively approved Use of Wood To Treat Natural Wine fermentation. several requests to use reverse osmosis Section 24.246 currently authorizes • To allow the use of lower-proof in combination with osmotic transport the use of uncharred and untreated oak spirits in wine production in certain to reduce the ethyl alcohol content in chips or particles to smooth wine. TTB’s circumstances. Section 5373(a) of the wine. Reverse osmosis and osmotic predecessor agency had a longstanding IRC sets a general standard of 140 transport are both separately listed in policy allowing the use of ‘‘toasted’’ degrees of proof or above for wine § 24.248 as approved wine treatment wood as a wine treating material, and spirits used in wine production but also processes to reduce the ethyl alcohol TTB has issued several private letter provides for two exceptions to this rule: content of wine. Under this combined rulings allowing this use. In addition, (1) Distillation may be at less than 140 process, the wine to be treated is wooden storage tanks used for the degrees of proof if regulations so separated by reverse osmosis into two addition of spirits to wine may be used provide; and (2) commercial brandy portions called permeate and for the baking of wine under § 24.225. aged in wood for not less than 2 years, concentrate streams. The alcohol rich TTB is proposing a new 27 CFR and barreled at not less than 100 degrees permeate is then degassed, warmed, and 24.185 to clarify TTB’s policy on the of proof, is deemed to be wine spirits for pumped along one side of a completely treatment of wine with wood contact. purposes of section 5373(a). TTB hydrophobic microporous osmotic Section 24.185(a) would clarify that believes that allowing the byproducts of transport membrane, which is used to natural wine may be treated by contact alcohol reduction to be used as wine separate out the alcohol. The with any wood that is consistent with spirits if they are 100 degrees of proof dealcoholized permeate is then the food additive requirements under or more is consistent with the intent of recombined with the wine from which the FD&C Act and that wood may be the statute. TTB notes that these alcohol it was extracted, thus lowering the toasted, but not charred. Toasted wood reduction treatments, which are listed alcohol content of the wine. refers to wood that has been heated but in § 24.248, must be performed at a TTB is proposing to amend the table has not undergone combustion (that is, qualified distilled spirits plant because at the end of § 24.248 by revising the hasn’t been burned or blackened). TTB they result in a spirits byproduct. Thus, listings for reverse osmosis and osmotic is authorizing the use of toasted wood when the wine subjected to alcohol transport to state that each process can in this proposal. Section 24.185(b) reduction is natural wine or special be used in combination with the other would state TTB’s position on the use natural wine (and is subject to the other to reduce the ethyl alcohol content of of wood essences and extracts in the conditions of section 5373(a) and wine. These processes, whether used production of wine. § 24.225), the alcohol-containing separately or in combination, must take TTB is also proposing to remove the byproduct would still constitute wine place on distilled spirits plant premises. last sentence from § 24.225 (‘‘Wooden spirits even though the spirits may not storage tanks used for the addition of have been distilled at or above 140 Ultrafiltration spirits may be used for the baking of degrees of proof. Accordingly, TTB is In two separate requests, an industry wine’’) and include it in the new proposing, in revised § 24.225, to allow member requested to use ultrafiltration § 24.185, and to remove the reference to spirits derived from authorized alcohol to separate red grape juice into high and oak chips from § 24.246 and include it reduction treatments to be used as wine low color fractions for blending in new § 24.185, in an effort to maintain spirits if the spirits were distilled at 100 purposes, and to separate white grape in one location all regulatory provisions degrees of proof or more and if the juice that had darkened due to oxidation pertaining to the treatment of wine with spirits conform to the other terms of during storage into high and low color wood. section 5373(a) as reflected in the fractions for blending purposes. As revised regulatory text. described above, ultrafiltration is Wine Spirits/Revision of § 24.225 • To clarify the status of wine spirits authorized for use under § 24.248 to TTB is proposing to amend § 24.225 derived from special natural wine. This remove proteinaceous material from by removing the last sentence as source of spirits was codified in section wine; to reduce harsh tannic material described above, by revising the section 5373(a) of the IRC, which also from white wine produced from white heading, and by dividing the text into authorized the Secretary of the Treasury

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00041 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83759

to impose conditions on the use of • Return the wine to its original standard and other than standard wine special natural wine to make wine condition; generally is not permitted under TTB’s spirits. TTB is proposing to specify in • Transfer the wine to and from the regulations. the revised text that wine spirits derived distilled spirits plant for treatment in While TTB has not previously from special natural wine may only be bond; approved these requests, TTB notes that used in the production of special • Not remove more water than was current § 24.246 permits the addition to natural wine when such wine spirits accidentally added; wine of a limited amount of water with contain a distinctive flavor from the • Not alter the vinous character of the a wine treating material without ingredients used in the originating wine; and affecting the classification of the wine as • special natural wine. Keep the usual and customary a standard wine. Accordingly, TTB Within the proposed new paragraph records of the processing. believes that the regulations should be (b) text, subparagraphs (1) through (3) TTB believes that proprietors should changed to recognize that the accidental primarily reflect the terms of section have the authority to remove small addition of water to a standard wine 5373(a) of the IRC that TTB believes amounts of accidentally added water that represents 1 percent or less of the should be reflected in the regulatory text from wine using reverse osmosis and total volume of the wine does not render as discussed above, and subparagraph distillation without first seeking TTB the wine other than standard. TTB also (4) primarily reflects the existing approval. Proposed § 24.251 sets forth believes that blending wine should be § 24.225 text. authority and standards to allow for permitted to reduce the accidentally removal of accidental additions of water added water to 1 percent or less of the Accidental Water Additions of not more than 10 percent of the total volume of the blended wine, and original volume of the wine without the TTB is proposing to add a new 27 the resultant blended wine should be need to first seek TTB approval. CFR 24.251, to provide for the considered standard wine. Accordingly, Proposed § 24.251 also allows the correction of standard wine when the TTB has incorporated these two appropriate TTB officer to approve other wine becomes other than standard wine provisions into a new section, proposed removals of accidentally added water due to accidental water additions in § 24.186, with a reference to a new upon application by a proprietor and excess of the authorized levels provided § 24.251, regarding accidental additions sets forth the requirements for for in 27 CFR part 24, subparts F and L. of water to wine. Accidental water additions can occur submitting an application to TTB. It also during production of wine at various specifies that, in evaluating any request Other Proposed Regulatory stages, for example during filtration under this section, the appropriate TTB Amendments when water is accidentally left in a tank officer may consider as a factor whether In addition to the changes discussed that is later filled with wine. TTB has the proprietor has demonstrated good above, this document includes the received requests from industry commercial practices, taking into following proposed regulatory members who wish to be allowed to account the proprietor’s prior history of amendments: take corrective action regarding these accidental dilutions of water to wine water additions. To correct wine that and of compliance with other Definitions has been diluted with water is referred regulations in part 24. As a consequence of the proposed to within TTB as ‘‘to salvage.’’ TTB has also received requests to changes to § 24.225(a), discussed above, The most common way to salvage allow wine to be salvaged by blending TTB is proposing to revise the definition wine is to remove the water accidentally the accidentally diluted wine with of ‘‘wine spirits’’ in § 24.10 to include added to the wine through the use of standard wine to reduce the level of a reference to that regulatory provision. reverse osmosis, in combination with unauthorized water addition to less than distillation. The reverse osmosis creates 1 percent of the volume of the blended Wood Essences a colorless and flavorless permeate, wine. The requesters have asserted that, TTB is proposing to amend § 24.85, essentially consisting of alcohol and since § 24.246 provides that when a which concerns essences, by adding the water. The permeate is distilled to wine or juice treating material is used term ‘‘wood’’ as an additional example create a high ethanol fraction and a low and water is added to facilitate the of a source material for essences used in ethanol fraction. The high ethanol solution or dispersal of the material, the the production of formula wine. (The fraction is returned to the wine and the volume of water added may not exceed TTB regulations at 27 CFR 24.10 define low ethanol fraction is discarded. 1 percent of the juice or wine, reduction formula wine as special natural wine, Through the use of reverse osmosis and of the accidentally added water to less agricultural wine, and other than distillation, the industry member than 1 percent by blending wines meets standard wine (except for distilling removes the accidentally added water the intent of the regulations. TTB has material and vinegar stock) produced on and raises the alcohol by volume of the not approved these requests because the bonded wine permises under an wine back to its level before the accidental addition of water renders the approval formula.) TTB believes that it accidental water addition, without wine an ‘‘other than standard’’ wine, is appropriate to add wood to this affecting the vinous character of the and such wine cannot be blended with provision to reflect a longstanding wine. standard wine. Also, TTB’s authority to policy that an extract of wood made TTB has approved the use of reverse approve experimental or new wine using any solvent but wine should be osmosis and distillation to remove water treatments under §§ 24.249 and 24.250 treated as an essence or flavoring from wine under TTB’s authority in does not extend to blending of wine, material. § 24.249. In those reviews, TTB which is not a wine treatment or considered how the accidental water process. Additionally, wine diluted List of Authorized Wine and Juice addition occurred, the ratio of water to with water in excess of that permitted Treating Materials wine, and whether or not the requesting in part 24 renders the wine ‘‘other than TTB is proposing to amend the industry member has submitted similar standard’’ (see 27 CFR 24.218). Section heading in paragraph (a) of § 24.246 to requests in the past. TTB applied the 24.218 provides that other than standard read ‘‘Wine and juice’’ rather than just following conditions to those approvals. wine must be segregated from standard ‘‘Wine.’’ This is a clarifying change. The industry member must: wine, and accordingly the blending of TTB is also proposing numerous

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00042 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83760 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

technical and clarifying changes to the carbon, albumen (egg white), casein, conforming change revising the name of table in § 24.246. A significant portion potassium salt of casein, gelatin, the material in § 24.247.) of these technical changes involves potassium bi-tartrate, silica gel • Calcium carbonate: TTB is adding revising the measurement references (colloidal silicon dioxide), and tannin. the abbreviation ‘‘CaCO3’’ and, in the specified for the limitation on use of the FDA also provided TTB with an ‘‘Materials and use’’ column, TTB is authorized wine treating materials by advisory opinion dated August 29, 2016, replacing the word ‘‘and’’ with the word making the notation of units of regarding the use of current and ‘‘or’’ in the first use entry and replacing measurement consistent throughout the proposed yeast nutrients. With regard to the word ‘‘A’’ with the words ‘‘As a’’ in chart, supplying closing parentheses current yeast nutrients, FDA indicated the second use entry. • where they were absent, and removing that the use of yeast nutrients as a Casein, potassium salt of casein: In decimal points followed only by zeroes. treatment for wine is not listed in its the ‘‘Specific limitation’’ column, TTB In addition, where units are only in U.S. regulations or GRAS notices. FDA did, is referring only to the citation ‘‘27 CFR Common (English) units or SI however, state: ‘‘We have evaluated the 24.243’’ and removing references to (International Standard, or metric) units, FDA’s GRAS opinions. list of yeast nutrients * * * along with • TTB is adding the other unit of measure their proposed limitations for use prior Citric acid: In the ‘‘Materials and for reference purposes, where to and during juice fermentations for use’’ column, TTB is adding the words appropriate. Since the majority of the wine production, taking into ‘‘certain juice or’’ after the word ‘‘in’’ in units are expressed in U.S. Common consideration: (1) Their likely the first use entry. The limitations on units first and then in SI units, TTB is consumption by yeasts and bacteria [is] what types of juice or wine may be proposing to continue with that likely to be largely consumed during treated with citric acid may be found in convention. TTB is including a footnote fermentations and (2) their likely the regulations cited in the ‘‘Specific limitation’’ column. reference after each use of ppm and ppb presence in finished wine products at • in the chart to indicate parts per million levels that would not exceed those in Copper sulfate: In the ‘‘Specific and parts per billion, respectively. TTB unprocessed grape juice. We conclude limitation’’ column, TTB is removing is also including a definition of the that [the] increase in human dietary the word ‘‘added’’ after the word word ‘‘stabilize’’ at the end of the chart exposure to the substances resulting ‘‘sulfate’’ and adding the words ‘‘added and footnoting every appearance of the from their addition to wine juice is de to wine’’ after the first parenthetical. • Dimethyl dicarbonate: For purposes word ‘‘stabilize’’ with a ‘‘1’’ in the table. minimis with respect to human of clarity, TTB is adding the TTB is also adding a third column to the nutrition, [and that] they are safe under abbreviation ‘‘(DMDC)’’ after the table in § 24.246 titled ‘‘FDA reference’’. the conditions of their intended use. material name ‘‘Dimethyl dicarbonate’’ This new column contains references to Such levels would be far below any and removing the phrases relevant FDA regulations in title 21 of level that would result in a safety ‘‘dealcoholized wine,’’ and ‘‘low alcohol the CFR, FDA GRAS notifications, and concern for any of these substances. wine,’’ from the entry to reduce FDA advisory opinions. These Thus, we would not consider this very redundancy. references have been moved to this new low level exposure to be significant and • Ferrocyanide: TTB believes that column wherever such a reference we would not question a conclusion ferrocyanide compounds are no longer appears in the table. The ‘‘FDA that these uses of substances added to available on the United States market reference’’ column provides a limit or wine as yeast nutrients would be and no longer being used by the U.S. reference where there is no ‘‘Specific GRAS.’’ Accordingly, TTB is updating wine industry. Accordingly, TTB is limit’’ listed for a wine treating material. the FDA reference for calcium removing ‘‘ferrocyanide’’ from the list of FDA recently provided TTB with a panthothenate, soy flour, thiamine, authorized wine treating materials. new advisory opinion dated September yeast autolyzed, and yeast cell wall/ • Milk products: With the publication 8, 2016, updating their acceptance of membranes of autolyzed yeast. of T.D. ATF–350 (58 FR 52222) in the TTB’s approval for certain materials as Due to the large number of proposed Federal Register on October 7, 1993, wine and juice treating materials. This changes to § 24.246, this document ATF approved the use of milk products new advisory opinion was necessary presents those changes as a revision of as a fining agent in white grape wine or because in some cases, TTB’s current the entire section. Finally, TTB is sherry. With the publication of T.D. listing of FDA’s acceptance of the proposing to make the following other TTB–17 (69 FR 67639) in the Federal material as a wine treating material was changes to the current entries in the Register on November 19, 2004, TTB not entirely accurate because those table: extended this approval to all wines. The • references were not specific to the use Activated carbon: One of the entries listing in § 24.246 for the use of milk of wine. In other cases, references to old in the ‘‘Materials and use’’ column products, revised in 2004, reads, advisory opinions were subsequently currently refers to removing color in ‘‘Fining agent for grape wine or sherry.’’ revoked by FDA rulemaking. TTB is wine and/or juice from which the wine TTB believes this phrase may cause replacing the current FDA references in was produced. TTB is proposing to refer confusion because under the standards § 24.246 with an updated reference to an instead to removing color from wine of identity in § 4.21(a) sherry is a grape advisory opinion in which FDA stated and/or juice, for clarity. wine. Accordingly, TTB is amending the ‘‘We have evaluated the list of • Albumen: In the ‘‘Specific first listed use in the ‘‘Materials and substances * * * along with their limitation’’ column, TTB is adding the use’’ column for this entry to read: proposed limitations for use in wine words ‘‘of brine’’ in the second sentence ‘‘Fining agent for grape wine.’’ and juice treatment and conclude that after the word ‘‘Usage’’ and removing • Oxygen and compressed air: In the they are safe under the conditions of the words ‘‘of solution.’’ ‘‘Materials and use’’ column, TTB is their intended use. We would not • Ammonium phosphate (mono- and replacing the words ‘‘May be used in question a conclusion that these uses of di basic): TTB is revising the name of juice and wine’’ with the words substances added to wine would be the material to include ‘‘diammonium ‘‘Various uses in juice and wine.’’ generally recognized as safe (GRAS).’’ phosphate’’ and including it on the list • Polyvinyl-polypry-rolidone (PVPP): Accordingly, TTB is updating the FDA of yeast nutrients in the table in In the ‘‘Materials and use’’ column, TTB reference for: Acetaldehyde, activated § 24.246. (TTB is also making a is making a technical change by

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00043 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83761

removing the phrase ‘‘black wine.’’ In from the original text in that it is not comments regarding the use of an the ‘‘Specific limitation’’ column, TTB requiring documentary evidence that alcoholic oak extract in the production is replacing the two asterisk footnote the FDA has ‘‘approved’’ the use of the of natural wines, in particular, as a references with a reference to footnote proposed material. This editorial change material for use as a wine stabilizer, but ‘‘3’’ after the abbreviation ‘‘AOAC.’’ is consistent with similar changes in also for any other purpose that is • Sorbic acid and potassium salt of §§ 24.246 and 24.248. consistent with good commercial sorbic acid: In the ‘‘Materials and use’’ Other Issues for Public Comment and practice. TTB also advises that a column, TTB is adding the words manufacturer of alcoholic oak extract ‘‘potassium sorbate’’ in parentheses Possible Regulatory Action must contact FDA and go through the before the colon. In addition to the comments TTB is • Sulfur dioxide: Sulfur dioxide was soliciting on the proposed regulatory FDA pre-market review processes. added to the list of approved materials changes contained in this document, as Lactic Acid with the issuance of T.D. Internal discussed above, TTB is inviting public Revenue Service (IRS)–6475 (25 FR comments on a number of other In 2007, Hyman, Philips, & 6184) in 1960. At that time, the stated regulatory issues to assist TTB in McNamara, P.C. petitioned TTB to use of sulfur dioxide was to sterilize and determining whether it would be amend 27 CFR 24.182 and 24.246 to preserve wine. The list of authorized appropriate to incorporate additional allow use of lactic acid in juice, must, treating materials in 1960 was codified changes to part 24 in a final rule. Most and wine prior to fermentation. Lactic in 26 CFR 240.1051 and was titled of these issues were raised in petitions acid is most commonly found in dairy ‘‘Materials authorized for treatment of for rulemaking or arose in connection products and is a common component wine.’’ with wine treatment approval requests in both plant and animal metabolic Through the publication of T.D. ATF– under §§ 24.249 or 24.250, and in each processes. Under § 24.246, lactic acid is 182 (49 FR 37510) in 1984, ATF retitled case, TTB determined that more currently authorized for use in grape the list of authorized wine treating information would be required before a wine to correct natural acid materials as ‘‘Materials authorized for decision could be taken on whether, and deficiencies. In the table in § 24.246, the treatment of wine and juice.’’ In T.D. if so how, appropriate regulatory ATF–182, the comment discussion changes should be proposed. The issues entry in the ‘‘Reference or limitation’’ refers to the use of sulfur dioxide in in question, and the specific points on column for lactic acid simply provides wine as ‘‘necessary, common to, and which TTB is requesting public a citation to 27 CFR 24.182 and 24.192. historically documented in comments, are outlined below. Section 24.192 then refers back to the winemaking,’’ and it is further referred TTB requests comments and, where limitations on the use of acid, among to in the use of juice for purposes of appropriate, evidence supporting the other things, prescribed in § 24.182. The winemaking twice on page 37513, under position that the particular wine regulations in § 24.182 state that acids of the subheading Antimicrobial Agents. treatment is consistent with good the kinds occurring in grapes or other Sulfur dioxide is GRAS in the FDA commercial practice. If applicable, use fruit (including berries) may be added regulations at 21 CFR 182.3862 as a rates should be recommended, and the within the limitations of § 24.246 to chemical preservative. Section 182.3862 rationale as to why those use rates are juice or wine in order to correct natural states that sulfur dioxide cannot be recommended should be stated in any deficiencies. Section 24.182 also states applied to fruit that is intended to be comments. that, after fermentation is completed, served or sold raw to consumers. Juice Alcoholic Oak Extract citric acid, fumaric acid, malic acid, to be used in the production of wine is lactic acid, or tartaric acid, or a In 2008, Oak Tannin Technologies not fruit to be served or sold raw to combination of two or more of these submitted a petition to amend the consumers; thus, the use of sulfur acids, may be added to correct natural dioxide in juice that will be used in the regulations to allow ‘‘alcoholic oak extracts for use in natural wines as a deficiencies. The petitioner noted that production of wine is GRAS. Further, 27 lactic acid is currently allowed by CFR 24.176 authorizes the use of stabilizing, enriching and integrating § 24.246 for treatment of wine after sterilizing agents in juice. Accordingly, agent.’’ The petitioner stated that use of fermentation and provided evidence TTB is correcting the entry for sulfur such extracts in wine is approved by the that lactic acid may be added before dioxide to include its use in juice. South African Wine and Spirit Board. • Thiamine hydrochloride: As noted However, TTB understands that South fermentation in certain other countries. above, the yeast nutrient Thiamine Africa passed legislation that actually Further, the petitioner noted that lactic hydrochloride will be re-organized and prohibits the use of such extracts in acid is less expensive and more reliably grouped under the heading, ‘‘Yeast natural wines. In addition, TTB and its available than tartaric acid. nutrients’’ with the other yeast predecessor agencies’ longstanding TTB is not proposing any changes to nutrients. policy has been to treat such materials the regulations concerning the use of • Shall vs. must: Finally, to promote as essences or extracts, which, under lactic acid in this document; however, the use of plain language, TTB is also § 24.85, may be used only in the TTB invites comments regarding proposing to change ‘‘shall’’ to ‘‘must’’ production of formula wines except whether or not the use of lactic acid wherever the former appears in the agricultural wine. prior to fermentation is good As noted earlier in this document, affected regulations. commercial practice in the production TTB is proposing to amend TTB approves the use of wine treating § 24.250(a)(4) to require that an industry materials for, among other things, the of natural wine. Comments should member must provide documentary stabilization, clarification, and filtration address whether or not lactic acid evidence from the FDA showing that the of natural wine based on the materials’ should be authorized for use prior to the proposed material is consistent with the acceptance in good commercial practice. fermentation of natural wine and food additive requirements under the In order to assist TTB in determining provide detailed evidence supporting FD&C Act for its intended purpose in whether it would be appropriate to the stated position. the amounts proposed for the particular propose a specific regulatory change in treatment contemplated. This differs response to this petition, TTB is inviting

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00044 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83762 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

Reverse Osmosis To Enhance the Phenol cold and wet regions and that wine storage into high and low color fractions Flavor and Characteristics of Wine and produced with the use of reverse for blending purposes. The low color To Reduce the Water Content of osmosis in the EU must be labeled as fraction would be blended with white Standard Wine ‘‘table wine.’’ TTB’s counterparts in wine, and the high color fraction would Section 24.248 currently provides for Australia indicate that while authorized, be blended with red wine. the use of reverse osmosis to reduce the reverse osmosis is not a process Ultrafiltration is authorized for use ethyl alcohol content of wine and to officially recognized in the Australia under § 24.248 to separate red wine into remove off flavors in wine. However, in New Zealand Food Standards Code, and low color and high color wine fractions 2014, Constellation Wines U.S. Inc. is not used frequently. TTB understands for blending purposes; but the that South Africa authorizes the use of submitted a petition to TTB requesting regulations do not provide for the use of reverse osmosis on juice but not wine. an expansion of the authorized uses of ultrafiltration to separate white wine. TTB has not received other requests reverse osmosis in § 24.248 to include TTB believes it should provide the from industry members to use reverse public with the opportunity to comment (1) improving the phenol and flavor osmosis to improve the phenol and character of wine, and (2) reducing the before it makes a decision on whether flavor character of wine. However, TTB the use of ultrafiltration to separate water content in standard wine. The did receive a request to use reverse petition included the following discolored wine for blending as osmosis to improve the ‘‘sensory described above would be acceptable in arguments in support of this change: quality’’ of finished wines and to • Reverse osmosis can effectively good commercial practice. If you wish evaluate the potential sensory benefit of to submit a comment on this matter, eliminate the weak and watery character water content reduction compared to of the retentate (which, as a product of your comment should explain in detail the resultant loss of volume. your position as to why the use of the reverse osmosis process, is TTB has received and approved considered to be standard wine but with ultrafiltration in this manner is or is not industry member requests to use reverse acceptable in good commercial practice. reduced levels of alcohol and water), osmosis in combination with distillation resulting in a wine with improved to reduce the water content of wine only Yeast Nutrients (Gusmer Petition) phenol and flavor characteristics. for the purpose of salvage, discussed • The following list of vitamins and The present situation puts U.S. above, rather than as a winemaking minerals were proposed in the Gusmer winemakers at a competitive process to improve the character of the petition as yeast nutrients in the disadvantage in the global marketplace wine. In salvage, the removal of water production of wine but have not been in two ways. First, the petitioner asserts returns the wine to its previous administratively approved by TTB that many foreign countries permit the condition and, as a condition of pursuant to § 24.250: Cobalamin use of reverse osmosis as an acceptable approval, TTB strictly limited the (vitamin B12), iodine (potassium winemaking practice to concentrate amount of water to be removed to no iodide), iron, manganese sulfate, nickel, phenols and flavors in wine and in more than the amount that had been potassium chloride, riboflavin (Vitamin grape must. Exported U.S. wines, which accidentally added to the wine. cannot be produced in this way under TTB believes that it should provide B2), and zinc sulfate. With the the current regulations, would not the public the opportunity to comment exception of riboflavin, TTB has not reflect these characteristics in those before it makes a decision on whether received requests under §§ 24.249 or foreign markets. Second, under the the removal of water from wine to 24.250 to use these vitamins and terms of section 5382 of the IRC, most improve the characteristics of the wine minerals as yeast nutrients in the imported wines that were subjected to would be acceptable in good production of wine. TTB did not such a process would be allowed to commercial practice. To assist TTB in administratively approve the use of compete in the U.S. market against deciding whether to adopt any specific riboflavin as a yeast nutrient because domestic wines to which that process regulatory change in this regard, TTB is the evidence submitted with the request may not be applied. inviting comments on whether the use was not sufficient to conclude that the • Reverse osmosis benefits grape of reverse osmosis to reduce the water use of riboflavin as a yeast nutrient is growers, winemakers, and consumers. content of wine, improve the phenol consistent with good commercial The expanded use of reverse osmosis and flavor character of wine, or to practice. Gusmer provided information would allow grape growers to sell more improve the sensory quality of the wine on the FDA regulatory status, functional grapes, particularly those of marginal would be acceptable in good roles, and use rates for the following quality, to winemakers who could commercial practice. vitamins and minerals as yeast produce better quality standard wine If you believe that the use of reverse nutrients. TTB is interested in receiving with such grapes. Winemakers would be osmosis for these purposes is consistent comments supporting or rejecting the able to produce better quality wine at with good commercial practice, your argument that the use of these vitamins lower costs, and consumers would be comments should explain your position and minerals as yeast nutrients in the able to purchase better quality wine at in detail, as well as provide guidelines/ production of wine is consistent with lower prices. standards concerning how much water good commercial practice. Unless • The expanded use of reverse (maximum percentage) may be removed. otherwise noted, the information that osmosis would provide winemakers If you believe that the use of reverse follows was supplied by Gusmer. • with better ability to regulate the osmosis for these purposes is not Cobalamin (vitamin B12): alcohol content of wines. consistent with good commercial Cobalamin is used to promote growth of TTB notes that the byproduct of practice, your comments should explain yeast, and Gusmer proposed that reverse osmosis (the retentate) is only your position in detail. cobalamin be used at a rate not to considered to be standard wine if the exceed 15 ppb. wine that was processed with reverse Ultrafiltration • Iodine (potassium iodide): Iodine is osmosis was standard wine. TTB As previously discussed, an industry required for yeast growth and understands that the European Union member requested to use ultrafiltration fermentation, and Gusmer proposed that (EU) only authorizes the use of reverse to separate white grape juice that had iodine be used at a rate not to exceed osmosis to remove water from wine in darkened due to oxidation during 10 ppb.

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00045 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83763

• Iron: Iron is a catalyst for oxidation commercial practice, previous approvals please submit your entity’s comment on reactions, and Gusmer proposed that authorizing the higher amount of that letterhead. iron be used at a rate not to exceed 2 wine or juice treating material will be You may also write to the ppm. rescinded on the effective date of the Administrator before the comment • Manganese sulfate: Manganese final rule. Wines produced using closing date to ask for a public hearing. sulfate is a pale pink, odorless powder treatments pursuant to an The Administrator reserves the right to that is freely soluble in water and administrative approval that has been determine whether to hold a public insoluble in alcohol. Gusmer proposed rescinded based upon this rulemaking hearing. that manganese sulfate be used at a rate may nevertheless be labeled as if the Confidentiality not to exceed 100 ppb. materials or processes were authorized, • Nickel: Nickel is a catalyst for provided such treatments were used All submitted comments and hydrogenation, and Gusmer proposed prior to the date of rescission. attachments are part of the public record that nickel be used at a rate not to and subject to disclosure. Do not exceed 5 ppm. Submitting Comments enclose any material in your comments • Potassium chloride: Potassium You may submit comments on the that you consider to be confidential or chloride is a salt that disassociates into proposals described in this document by that is inappropriate for public ions that are necessary for phosphate using one of the following three disclosure. uptake by yeast. Gusmer proposed that methods: Public Disclosure potassium chloride be used at a rate not • Federal e-Rulemaking Portal: You On the Federal e-rulemaking portal, to exceed 100 ppm. may send comments via the online Regulations.gov, TTB will post, and the • Riboflavin (vitamin B2): Riboflavin comment form linked to this document public may view, copies of this is used as a coenzyme in oxidation/ in Docket No. TTB–2016–0010 on document, selected supporting reduction reactions, and Gusmer ‘‘Regulations.gov,’’ the Federal e- materials, and any electronic or mailed proposed riboflavin be used at a rate not rulemaking portal, at https:// comments TTB receives about this to exceed 600 ppb. www.regulations.gov. Direct links to the proposal. A direct link to the • Zinc sulfate: Zinc sulfate increases comment form and docket are available Regulations.gov docket containing this alcohol tolerance, and Gusmer proposed under Notice No. 164 on the TTB Web document and the posted comments on zinc sulfate be used at a rate not to site at https://www.ttb.gov/wine/wine- it is available on the TTB Web site at exceed 1.5 ppm. rulemaking.shtml. Supplemental files https://www.ttb.gov/wine/wine- may be attached to comments submitted Public Participation rulemaking.shtml under Notice No. 164. via Regulations.gov. For information on You may also reach the docket Comments Sought how to use Regulations.gov, click on the containing this document and the site’s Help tab. TTB requests comments from the posted comments received on it through • U.S. Mail: You may send comments public and all interested parties. TTB is the Regulations.gov search page at via postal mail to the Director, particularly interested in comments that https://www.regulations.gov. address the question of whether a Regulations and Rulings Division, All posted comments will display the particular material, process, or practice Alcohol and Tobacco Tax and Trade commenter’s name, organization (if addressed in this document is Bureau, 1310 G Street NW., Box 12, any), city, and State, and, in the case of consistent with good commercial Washington, DC 20005. • mailed comments, all address practice. Please support your comment Hand Delivery/Courier: You may information, including email addresses. with specific information about the hand-carry your comments or have them TTB may omit voluminous attachments material, process, or practice in hand-carried to the Alcohol and or material that TTB considers question. Tobacco Tax and Trade Bureau, 1310 G unsuitable for posting. After TTB analyzes any comments Street NW., Suite 400, Washington, DC You and other members of the public received in response to the regulatory 20005. may view copies of this document, all amendments TTB has proposed in this Please submit your comments by the supporting materials, and any electronic document, we plan to issue a final rule. closing date shown above in this or mailed comments TTB receives about If TTB receives comments and evidence document. Your comments must these proposals by appointment at the that persuade it that the use of a reference Notice No. 164 and include TTB Information Resource Center, 1310 particular wine treating material or your name and mailing address. Your G Street NW., Washington, DC 20005. process is not consistent with good comments also must be made in You may also obtain copies at 20 cents commercial practice, TTB will not English, be legible, and be written in per 8.5- x 11-inch page. Contact TTB’s include it in the final rule. As a result, language acceptable for public information specialist at the above and as stated in previously issued disclosure. TTB does not acknowledge address or by telephone at 202–453– administrative approvals, if TTB has receipt of comments, and TTB considers 2270 to schedule an appointment or to determined that the use of a wine or all comments as originals. request copies of comments or other juice treating material or process is not In your comment, please clearly state materials. consistent with good commercial if you are commenting for yourself or on practice, previous approvals of that behalf of an association, business, or Regulatory Flexibility Act wine or juice treating material or other entity. If you are commenting on Pursuant to the requirements of the process will be rescinded by operation behalf of an entity, your comment must Regulatory Flexibility Act (5 U.S.C. of law on the effective date of the final include the entity’s name, as well as chapter 6), TTB certifies that these rule. your name and position title. If you proposed regulations, if adopted, would Additionally, if TTB has determined comment via Regulations.gov, please not have a significant economic impact that the authorized amount of a wine or enter the entity’s name in the on a substantial number of small juice treating material should be ‘‘Organization’’ blank of the online entities. This proposed rule provides for decreased because its current authorized comment form. If you comment via the voluntary use of additional wine amount is not consistent with good postal mail or hand delivery/courier, and juice treating materials and

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00046 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83764 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

processes in the production of wine. proprietors’ requests to experiment with TTB does not believe that there is a This authorization does not impose any such materials and processes under change in the burden for this required change to current winemaking § 24.249. Section 24.249 states, in part, recordkeeping requirement, even for practices, nor does it impose additional that such requests must be made in the those wineries that are exempted from compliance burden on small businesses. form of an application filed with TTB. submitting a letterhead request under TTB authorizes new wine treating Under this authorization, TTB has § 24.251 because still they will be materials and processes by evaluating approved proprietors’ requests to take required to maintain the currently proprietors’ requests to experiment with corrective action when water has been required usual and customary business such materials and processes, such accidentally added to wine in amounts records. requests being made via letterhead exceeding those authorized for the Comments on this collection of application to TTB. This rule, if production of standard wine under 27 information should be sent to OMB to adopted, would allow for certain CFR part 24. In this notice, TTB is Office of Management and Budget, treatments, under limited proposing to add a new § 24.251 to Attention: Desk Officer for the circumstances, without the submission provide for the correction of Department of the Treasury, Office of of a letterhead application to TTB. TTB accidentally diluted wine under certain Information and Regulatory Affairs, estimates that the proposed regulation circumstances without the submission Washington, DC 20503; or email to will reduce the number of respondents of a letterhead application to TTB. TTB [email protected]. A copy by approximately 10 applicants per estimates that the proposed regulation also should be sent to the Alcohol and year, thus slightly reducing the overall will reduce the number of respondents Tobacco Tax and Trade Bureau by any burden of the information collection. by approximately 10 applicants per year of the methods previously described. In addition, TTB currently requires and, therefore, will slightly reduce the Comments on the information collection wineries to maintain usual and information collection’s overall burden. should be submitted not later than customary business records. Included in TTB estimates that, as a result of the January 23, 2017. these records are those records that proposed amendments, the new annual evidence the details and results of burden for control number 1513–0057 Executive Order 12866 experiments approved by TTB under will be as follows: Certain TTB regulations issued under § 24.249. This recordkeeping • Estimated total annual reporting the IRC, including this one, are exempt requirement remains unchanged by this and/or recordkeeping burden: 820 from the requirements of Executive proposal as wineries subject to this part hours. Order 12866, as supplemented and • still will be required to maintain those Estimated average annual burden reaffirmed by Executive Order 13563. usual and customary records. This hours per respondent: 0.5 hours (30 Therefore, a regulatory impact proposal has a neutral effect on the minutes). assessment is not required. current recordkeeping requirements. • Estimated number of respondents: Because this proposed rule will not 1,640. Drafting Information • have a significant economic impact on Estimated annual frequency of Kara Fontaine of the Regulations and a substantial number of small entities no respondents: 1. Rulings Division, Alcohol and Tobacco Comments on this collection of regulatory flexibility analysis is Tax and Trade Bureau drafted this information should be sent to OMB to required. Pursuant to 26 U.S.C. 7805(f), document. TTB will submit the proposed Office of Management and Budget, regulations to the Chief Counsel for Attention: Desk Officer for the List of Subjects in 27 CFR Part 24 Advocacy of the Small Business Department of the Treasury, Office of Administrative practice and Administration for comment on the Information and Regulatory Affairs, procedure, Claims, Electronic fund impact of the proposed regulations on Washington, DC 20503; or email to _ transfers, Excise taxes, Exports, Food small businesses. OIRA [email protected]. A copy additives, Fruit juices, Labeling, also should be sent to the Alcohol and Paperwork Reduction Act Liquors, Packaging and containers, Tobacco Tax and Trade Bureau by any Reporting and recordkeeping Two collections of information of the methods previously described. requirements, Research, Scientific approved by the Office of Management Comments on the information collection equipment, Spices and flavoring, Surety and Budget (OMB) would be affected by should be submitted not later than bonds, Vinegar, Warehouses, Wine. the adoption of the proposed regulatory January 23, 2017. changes described in this document. Amendments to the Regulations OMB Control Number 1513–0115 These collections of information, For the reasons discussed in the Under TTB’s authority in 26 U.S.C. approved in accordance with the preamble, TTB proposes to amend 27 5367, 5369, 5370, and 5555, TTB Paperwork Reduction Act of 1995 (44 CFR part 24 as follows. U.S.C. 3507), are assigned control requires wineries to maintain usual and numbers 1513–0057, titled, ‘‘Letterhead customary business records. Included in PART 24—WINE Applications and Notices Relating to these records are those evidencing the Wine (TTB REC 5120/2),’’ and 1513– details and results of experiments ■ 1. The authority citation for 27 CFR 0115, titled ‘‘Usual and Customary approved by TTB under § 24.249. The part 24 continues to read as follows: Business Records Relating to Wine (TTB proposed regulations contained in this Authority: 5 U.S.C. 552(a); 26 U.S.C. 5001, REC 5120/1).’’ An agency may not document provide for a recordkeeping 5008, 5041, 5042, 5044, 5061, 5062, 5121, conduct or sponsor, and a person is not requirement in new § 24.251 when wine 5122–5124, 5173, 5206, 5214, 5215, 5351, required to respond to, a collection of is corrected for accidental water 5353, 5354, 5356, 5357, 5361, 5362, 5364– information unless it displays a valid dilutions. The recordkeeping 5373, 5381–5388, 5391, 5392, 5511, 5551, control number assigned by OMB. requirement in this proposed section is 5552, 5661, 5662, 5684, 6065, 6091, 6109, already accounted for under OMB 6301, 6302, 6311, 6651, 6676, 7302, 7342, OMB Control Number 1513–0057 Control Number 1513–0115 because 7502, 7503, 7606, 7805, 7851; 31 U.S.C. 9301, TTB authorizes new wine treating such requests currently are treated as 9303, 9304, 9306. materials and processes by evaluating experiments under § 24.249. Therefore, ■ 2. Section 24.10 is amended by:

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00047 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83765

■ a. Removing the number ‘‘60’’ in the § 24.186 Accidental additions of water. (i) Commercial brandy aged in wood definition of ‘‘Brix’’ and adding, in its (a) Accidental additions of water for a period of not less than 2 years, and place, the number ‘‘68’’; and totaling 1 percent or less of the volume barreled at not less than 100 degrees of ■ b. Revising the definition of ‘‘Wine of standard wine. When in the proof, shall be deemed wine spirits for spirits’’ to read as follows: production, storage, treatment, or purposes of this section; and finishing of standard wine water is (ii) Spirits byproducts of alcohol § 24.10 Meaning of terms. accidentally added to a standard wine reduction processing authorized under * * * * * in an amount that does not exceed 1 § 24.248 that are produced at a distilled spirits plant and distilled, if necessary, Wine spirits. Brandy or wine spirits percent of the total volume of the wine, at not less than 100 degrees of proof authorized under 26 U.S.C. 5373 and such wine shall remain standard wine shall be deemed wine spirits for § 24.225 of this part for use in wine and the proprietor need not take any purposes of this section. production. action to correct the wine. (b) Correction of accidental additions (3) Addition of sugar after § 24.85 [Amended] of water. When in the production, fermentation. When, in the production of natural wine or special natural wine, ■ 3. In § 24.85, the first sentence is storage, treatment, or finishing of standard wine water is accidentally sugar has been added after fermentation, amended by adding the word ‘‘wood,’’ the wine may not be refermented to after the word ‘‘berries.’’ added to a standard wine in an amount that exceeds 1 percent of the volume of develop alcohol from such added sugar ■ 4. Section 24.185 is added to read as the wine, such wine may be corrected and then used in the production of wine follows: by either: spirits. (4) Addition of wine spirits to natural § 24.185 Use of wood to treat natural wine. (1) Blending the diluted wine with a quantity of wine of the same kind so wine. (a) Treatment by contact. Natural that the amount of water accidentally (i) Wine spirits produced in the wine may be treated by contact with any added does not exceed 1 percent of the United States may be added to natural wood that is consistent with the food total volume of the blended wine; or wine on bonded wine premises if both additive requirements under the Federal (2) Removal of the accidentally added the wine and the spirits are produced Food, Drug, and Cosmetic Act for food water from the wine in accordance with from the same kind of fruit. (ii) In the case of natural still wine, contact (see 21 CFR part 7). The wood § 24.251. may be in the form of barrels, staves, wine spirits may be added in any State (Sec. 201, Pub. L. 85–859, 72 Stat. 1383– only to wine produced by fermentation chips, particles, or storage tanks that 1384, as amended (26 U.S.C. 5382)) were used for the addition of wine on bonded wine premises located spirits if the tanks are used for the ■ 6. Section 24.225 is revised to read as within the same State. baking of wine. The wood may be follows: (iii) If wine has been ameliorated, wine spirits may be added (whether or toasted (that is, heated to low, medium, § 24.225 Production and use of spirits. or high temperature without undergoing not wine spirits were previously added) (a) Withdrawal of spirits. The combustion), but not charred, and the only if the wine contains not more than proprietor of a bonded wine premises wood must not be otherwise treated. 14 percent of alcohol by volume derived may withdraw and receive wine spirits from fermentation. (b) Use of wood essences and extracts. without payment of tax from the bonded (c) Spirits other than wine spirits. A proprietor may make or purchase for premises of a distilled spirits plant for Spirits other than wine spirits may be blending purposes wine that has been use as provided in this section. received, stored, and used on bonded heavily treated with wood; however, (b) Production and use of wine spirits. wine premises only for the production wood preparations made with an (1) In general. The only products of nonbeverage wine and nonbeverage alcohol solution stronger than 24 considered to be wine spirits authorized wine products. percent alcohol by volume are essences for use in wine production under this (Sec. 201, Pub. L. 85–859, 72 Stat. 1381– and must be used in accordance with section are brandy or wine spirits 1384, as amended, and sec. 455, Pub. L. 98– § 24.85. If any solvent other than alcohol produced in a distilled spirits plant 369, (26 U.S.C. 5214, 5362, 5373, 5382, 5383, or water is used to make a wood extract, (with or without the use of water to 5386)) the resulting extract must be consistent facilitate extraction and distillation) ■ 7. Section 24.246 is revised to read as with the food additive requirements exclusively from: follows: under the Federal Food, Drug, and (i) Fresh or dried fruit, or their Cosmetic Act for that purpose and may residues; § 24.246 Materials authorized for the be used only in ‘‘other wine’’ in (ii) Natural wine or wine residues treatment of wine and juice. accordance with § 24.218. This from fresh or dried fruit, including (a) Wine and juice. Materials used in paragraph applies to liquid extracts and spirits byproducts of authorized wine the process of filtering, clarifying, or essences and to the extracts and treatments to reduce alcohol; or purifying wine may remove cloudiness, essences in powder form or dissolved in (iii) Special natural wine. If wine precipitation, and undesirable odors water after the solvent has been spirits produced from special natural and flavors, but the addition of any evaporated. wine contain any flavor characteristics substance foreign to wine that changes (c) Use of wooden storage tanks. of the special natural wine, those wine the character of the wine, or the Wooden storage tanks used for the spirits may be used only in the abstraction of ingredients so as to addition of spirits may be used for the production of a special natural wine. change the character of the wine, if not baking of wine. (2) Distillation proof requirements. consistent with good commercial The proof of wine spirits at distillation practice, is not permitted on bonded (Sec. 201, Pub. L. 85–859, 72 Stat. 1383– 1384, 1386, as amended (26 U.S.C. 5382, must not be reduced by the addition of wine premises. The materials listed in 5386)) water. In addition, a product is not this section are approved as being considered to be wine spirits if it is consistent with good commercial ■ 5. Section 24.186 is added to read as distilled at less than 140 degrees of practice in the production, cellar follows: proof except in the following cases: treatment, or finishing of wine and,

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00048 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83766 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

where applicable, in the treatment of (2) Where water is added to facilitate that each material is used for its juice, within the ‘‘Specific TTB the solution or dispersal of a material, specified use and in accordance with limitation’’ of this section and subject to the volume of water added, whether the any limitation specified for that use. If the following conditions: material is used singly or in a proprietor uses several lots that (1) If the FDA informs TTB that a combination with other water-based contain the same material, it is the specified use or limitation of any treating materials, may not total more proprietor’s responsibility to ensure that material listed in this section is than 1 percent of the volume of the the cumulative amount of the material inconsistent with the food additive treated wine or juice, or of both the does not exceed the limitation specified requirements under the Federal Food, wine and the juice, from which the wine in this section for that material. Drug, and Cosmetic Act, the appropriate is produced. TTB officer may cancel or amend the (b) Use in combination or in multiple (c) Formula wine. In addition to the approval for use of the material in the lots. Subject to the conditions specified materials listed in this section, other treatment of wine and juice in the in paragraph (a) of this section, a materials may be used in formula wine production, cellar treatment, or proprietor may use the materials listed if approved for such use. finishing of wine; and in this section in combination, provided

MATERIALS AUTHORIZED FOR TREATMENT OF WINE AND JUICE

Specific TTB limitation Materials and use (if applicable) FDA reference

Acacia (gum arabic): To clarify and stabilize 1 The amount used must not exceed 8 pounds 21 CFR 184.1330. wine. per 1000 gallons (1.92 g/L) of wine. Acetaldehyde: For color stabilization of juice The amount used must not exceed 300 ppm,2 FDA advisory opinion dated September 8, prior to concentration. and the finished concentrate must have no 2016. detectable level of the material. Activated carbon: To assist precipitation during fer- 27 CFR 24.176...... FDA advisory opinion dated September 8, mentation. 2016. To clarify and purify wine ...... The amount used to clarify and purify wine FDA advisory opinion dated January 26, must be included in the total amount of acti- 1979. vated carbon used to remove excessive color in wine. 27 CFR 24.241 and 24.242. To remove color from wine and/or The amount used to treat the wine, including FDA advisory opinion dated January 26, juice from which wine is produced. the juice from which the wine was pro- 1979. duced, must not exceed 25 pounds per 1000 gallons (3 g/L). If the amount nec- essary exceeds this limit, a notice is re- quired pursuant to 27 CFR 24.242. Albumen (egg white): Fining agent for wine ...... May be prepared in a light brine 1 ounce FDA advisory opinion dated September 8, (28.35 grams) potassium chloride, 2 pounds 2016. (907.2 grams) egg white, 1 gallon (3.785 L) of water. Usage of brine not to exceed 1.5 gallons per 1,000 gallons (1.5 milliliters per liter) of wine. Alumino-silicates (hydrated) e.g., Bentonite None ...... 21 CFR 182.2727, 182.2729, 184.1155 and (Wyoming clay) and Kaolin: To clarify and 186.1256. stabilize 1 wine or juice. FDA advisory opinion dated July 26, 1985. Ascorbic acid iso-ascorbic acid (erythorbic May be added to grapes, other fruit (including 21 CFR 182.3013 and 182.3041. acid): To prevent oxidation of color and flavor berries), and other primary wine making components of juice or wine. materials, or to the juice of such materials, or to the wine, within limitations which do not alter the class or type of the wine. Bakers Yeast Mannoprotein: To stabilize 1 wine The amount used must not exceed 3.3 GRAS Notice No. GRN 284. from the precipitation of potassium bitartrate pounds per 1000 gallons (400 mg/L) of crystals. wine. Calcium carbonate (CaCO3) (with or without calcium salts of tartaric and malic acids): To reduce the excess natural acids in The natural or fixed acids must not be re- 21 CFR 184.1069, 184.1099, and 184.1191. high acid wine, or in juice prior to or duced below 40 pounds per 1000 gallons (5 during fermentation. g/L). As a fining agent for cold stabilization The amount used must not exceed 30 pounds per 1000 gallons (3.59 g/L) of wine. Calcium sulfate (gypsum): To lower pH in sher- The sulfate content of the finished wine must 21 CFR 184.1230. ry wine. not exceed 1.67 pounds per 1000 gallons (0.2 g/L), expressed as potassium sulfate. 27 CFR 24.214. Carbon dioxide (including food grade dry ice): See 27 CFR 24.245 ...... 21 CFR 184.1240. To stabilize 1 and preserve wine. Casein, potassium salt of casein: To clarify See 27 CFR 24.243...... FDA advisory opinion dated September 8, wine. 2016. Chitosan from Aspergillus niger: To remove The amount used must not exceed 0.8 GRAS Notice No. GRN 000397. spoilage organisms such as Brettanomyces pounds per 1000 gallons (10 g/hL) of wine. from wine.

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00049 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83767

MATERIALS AUTHORIZED FOR TREATMENT OF WINE AND JUICE—Continued

Specific TTB limitation Materials and use (if applicable) FDA reference

Citric acid: To correct natural acid deficiencies in See 27 CFR 24.182 and 24.192 ...... 21 CFR 184.1033. certain juice or wine. To stabilize 1 wine other than citrus The amount of citric acid must not exceed 5.8 21 CFR 184.1033. wine. pounds per 1000 gallons (0.7 g/L). 27 CFR 24.244. Copper sulfate: To remove hydrogen sulfide The quantity of copper sulfate (calculated as 21 CFR 184.1261. and/or mercaptans from wine. copper) added to wine must not exceed 6 ppm.2 The residual level of copper in the finished wine must not exceed 0.5 ppm 2. Defoaming agents (polyoxyethylene 40 mono- Defoaming agents which are 100 percent ac- 21 CFR 173.340 and 184.1505. stearate, silicon dioxide, dimethylpoly-silox- tive may be used in amounts not exceeding ane, sorbitan monostearate, glyceryl mono- 0.15 pounds per 1000 gallons (18 mg/L) of oleate and glyceryl dioleate): To control wine. Defoaming agents which are 30 per- foaming, fermentation adjunct. cent active may be used in amounts not ex- ceeding 0.5 pounds per 1000 gallons (60 mg/L) of wine. Silicon dioxide must be com- pletely removed by filtration. The amount of silicon remaining in the wine must not ex- ceed 10 ppm 2. Dimethyl dicarbonate (DMDC): To sterilize and DMDC may be added to wine in a cumulative Must meet the conditions prescribed by FDA stabilize 1 wine. amount not to exceed 200 ppm 2. in 21 CFR 172.133. Enzymatic activity: Various enzymes and uses, The enzyme preparation used must be pre- as shown below: pared from nontoxic and nonpathogenic microorganisms in accordance with good manufacturing practice and be consistent with FDA’s regulations. Carbohydrase (alpha-Amylase): To The amylase enzyme activity must be derived FDA advisory opinion of August 18, 1983. convert starches to fermentable car- from: bohydrates. Aspergillus niger, Aspergillus oryzae, Ba- cillus subtilis, or barley malt; or. from Rhizopus oryzae: or ...... 21 CFR 173.130. from Bacillus licheniformis ...... 21 CFR 184.1027. Carbohydrase (beta-Amylase): To The amylase enzyme must be derived from FDA advisory opinion dated August 18, 1983. convert starches to fermentable car- barley malt. bohydrates. Carbohydrase (Glucoamylase, The amylase enzyme activity must be derived FDA advisory opinion dated August 18, 1983. Amylogluco-sidase): To convert from Aspergillus niger, Aspergillus oryzae, starches to fermentable carbo- or. hydrates. from Rhizopus oryzae, ...... 21 CFR 173.130. or from Rhizopus niveus ...... 21 CFR 173.110. Carbohydrase (pectinase, cellulase, The enzyme activity must be derived from As- FDA advisory opinion dated December 19, hemicellulase): To facilitate separa- pergillus aculeatus. 1996. tion of juice from the fruit. Catalase: To clarify and stabilize 1 The enzyme activity must be derived from As- FDA advisory opinion dated August 18, 1983. wine. pergillus niger or bovine liver. Cellulase: To clarify and stabilize 1 The enzyme activity must be derived from As- FDA advisory opinion dated August 18, 1983. wine and facilitate separation of the pergillus niger. juice from the fruit. Cellulase (beta-glucanase): To clarify The enzyme activity must be derived from For beta-gucanase derived from Trichoderma and filter wine. Trichoderma longibrachiatum or longibrachiatum, 21 CFR 184.1250. Trichoderma harzianum. The amount used For beta-glucanase derived from Trichoderma must not exceed 30 ppm 2. harzianum, GRAS Notice No. GRN 149. Glucose oxidase: To clarify and stabilize 1 wine The enzyme activity must be derived from As- FDA advisory opinion of August 18, 1983. pergillus niger. Lysozyme: To stabilize 1 wines from malolactic The amount used must not exceed 500 ppm.2 FDA advisory opinion dated December 15, acid bacterial degradation. 1993. Pectinase: To clarify and stabilize 1 wine and to The enzyme activity used must be derived FDA advisory opinion dated August 18, 1983. facilitate separation of juice from the fruit. from Aspergillus niger. Protease (general): To reduce or to remove The enzyme activity must be derived from: FDA advisory opinion dated August 18, 1983. heat labile proteins. Aspergillus niger or Bacillus subtilis or from;. Bacillus licheniformis ...... 21 CFR 184.1027. Protease (Bromelin): To reduce or re- The enzyme activity must be derived from FDA advisory opinion dated August 18, 1983. move heat labile proteins. Ananus comosus or Ananus bracteatus (L). Protease (Ficin): To reduce or remove The enzyme activity must be derived from FDA advisory opinion dated August 18, 1983. heat labile proteins. Ficus spp. Protease (Papain): To reduce or re- The enzyme activity must be derived from 21 CFR 184.1585. move heat labile proteins. Carica papaya (L).

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00050 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83768 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

MATERIALS AUTHORIZED FOR TREATMENT OF WINE AND JUICE—Continued

Specific TTB limitation Materials and use (if applicable) FDA reference

Protease (Pepsin): To reduce or re- The enzyme activity must be derived from FDA advisory opinion dated August 18, 1983. move heat labile proteins. porcine or bovine stomachs. Protease (Trypsin): To reduce or re- The enzyme activity must be derived from FDA advisory opinion dated August 18, 1983. move heat labile proteins. porcine or bovine pancreas. Urease: To reduce levels of naturally The enzyme activity must be derived from 21 CFR 184.1924. occurring urea in wine to help pre- Lactobacillus fermentum. Use is limited to vent the formation of ethyl carba- not more than 200 ppm 2 and must be fil- mate. tered prior to final packaging. Ethyl maltol: To stabilize 1 wine ...... Use authorized at a maximum level of 100 FDA advisory opinion dated December 1, ppm 2 in all standard wines except natural 1986. wine produced from Vitis vinifera grapes. Ferrous sulfate: To clarify and stabilize 1 wine .. The amount used must not exceed 3 ounces 21 CFR 184.1315. per 1000 gallons (0.022 g/L) of wine. Fumaric acid: To correct natural acid deficiencies in The fumaric acid content of the finished wine 21 CFR 172.350. grape wine. must not exceed 25 pounds per 1000 gal- lons (3 g/L). 27 CFR 24.182 and 24.192. To stabilize 1 wine ...... The fumaric acid content of the finished wine 21 CFR 172.350. must not exceed 25 pounds per 1000 gal- lons (3 g/L). 27 CFR 24.244. Gelatin (food grade): To clarify juice or wine .... None ...... FDA advisory opinion dated September 8, 2016. Granular cork: To smooth wine ...... The amount used must not exceed 10 pounds FDA advisory opinion dated February 25, per 1000 gallons of wine (1.2 g/L). 1985. Isinglass: To clarify wine ...... None ...... FDA advisory opinion dated February 25, 1985. Lactic acid: To correct natural acid deficiencies 27 CFR 24.182 and 24.192 ...... 21 CFR 184.1061. in grape wine. Malic acid: To correct natural acid deficiencies 27 CFR 24.182, 24.192 ...... 21 CFR 184.1069. in juice or wine. Malo-lactic bacteria: To stabilize 1 grape wine .. Malo-lactic bacteria of the type Leuconostoc FDA advisory opinion dated February 25, oenos may be used in treating wine. 1985. Maltol: To stabilize 1 wine ...... Use authorized at a maximum level of 2 FDA advisory opinion dated December 1, pounds per 1000 gallons (250 mg/L) in all 1986. standard wine except natural wine produced from Vitis vinifera grapes. Milk products (pasteurized whole, skim, or half- and-half): Fining agent for grape wine ...... The amount used must not exceed 2 parts of milk products per 1,000 parts (0.2 percent V/V) of wine. To remove off flavors in wine ...... The amount used must not exceed 10 parts of milk products per 1,000 parts (1 percent V/ V) of wine. Nitrogen gas: To maintain pressure during fil- None ...... 21 CFR 184.1540. tering and bottling or canning of wine and to prevent oxidation of wine. Oxygen and compressed air: Various uses in None. juice and wine. Polyvinyl-polypyr-rolidone (PVPP): To clarify The amount used to treat the wine, including 21 CFR 173.50. and stabilize 1 wine and to remove color from the juice from which the wine was pro- red wine or juice. duced, must not exceed 60 pounds per 1000 gallons (7.19 g/L) and must be re- moved during filtration. PVPP may be used in a continuous or batch process. The fin- ished wine must retain vinous character and must have color of not less than 0.6 Lovibond in a one-half inch cell or not more than 95 percent transmittance per AOAC Method 11.003–11.004 (14th Ed.) 3. Polyvinyl-pyrrolidone (PVP)/polyvinylimadazole The amount used to treat the wine must not 21 CFR 173.55 and FDA FCN No. 320. (PVI) polymer: To remove heavy metal ions exceed 6.7 pounds per 1000 gallons (80 g/ and sulfides from wine. hL) of wine. Potassium bitartrate: To stabilize 1 grape wine The amount used must not exceed 35 pounds FDA advisory opinion dated September 8, per 1000 gallons (4.19 g/L) of grape wine. 2016. Potassium carbonate and/or potassium bicar- The natural or fixed acids must not be re- 21 CFR 184.1619 and 184.1613. bonate: To reduce excess natural acidity in duced below 0.668 ounces per gallon (5 g/ wine and in juice prior to or during fermenta- L). tion.

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00051 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83769

MATERIALS AUTHORIZED FOR TREATMENT OF WINE AND JUICE—Continued

Specific TTB limitation Materials and use (if applicable) FDA reference

Potassium citrate: pH control agent and The amount of potassium citrate must not ex- 21 CFR 184.1625. sequestrant in the treatment of citrus wines. ceed 25 pounds per 1000 gallons (3 g/L) of finished wine. 27 CFR 24.182. Potassium meta-bisulfite: To sterilize and pre- The sulfur dioxide content of the finished wine 21 CFR 182.3637. serve wine. must not exceed the limitations prescribed in 27 CFR 4.22. Potato protein isolate: Fining agent for wine ..... Use must not exceed 500 ppm 2 (50 g/hL) of GRAS Notice No. GRN 000447. wine. Silica gel (colloidal silicon dioxide): To clarify Use must not exceed the equivalent of 20 FDA advisory opinion dated September 8, wine or juice. pounds colloidal silicon dioxide at a 30 per- 2016. cent concentration per 1000 gallons (2.4 g/ L) of wine. Silicon dioxide must be com- pletely removed by filtration. Sodium carboxymethyl cellulose: To stabilize 1 The amount used must not exceed 0.8% of 21 CFR 182.1745. wine by preventing tartrate precipitation. the wine. Sorbic acid and potassium salt of sorbic acid The finished wine must not contain more than 21 CFR 182.3089 and 182.3640. (potassium sorbate): To sterilize and pre- 300 ppm 2 of sorbic acid. serve wine; to inhibit mold growth and sec- ondary fermentation. Sulfur dioxide: To sterilize and to preserve wine The sulfur dioxide content of the finished wine 21 CFR 182.3862. or juice. must not exceed the limitations prescribed in 27 CFR 4.22(b)(1). Tannin: To adjust tannin content in apple juice The residual amount of tannin must not ex- FDA advisory opinion dated September 8, or in apple wine. ceed 24 pounds per 1000 gallons (3 g/L), 2016. calculated as gallic acid equivalents (GAE). Total tannin must not be increased by more than 150 ppm 2 by the addition of tannic acid (polygalloylglucose). To clarify, or adjust tannin content of, The residual amount of tannin, calculated in FDA advisory opinion dated September 8, juice or wine (other than apple). GAE, must not exceed 6.4 GAE per 1000 2016. gallons of wine (800 mg/L) in white wine and 24 pounds per 1000 gallons (3 g/L) in red wine. Only tannin which does not impart color may be used in the cellar treatment of juice or wine. Total tannin must not be in- creased by more than 150 ppm 2 by the ad- dition of tannic acid (poly-galloylglucose). Tartaric acid (L(+) tartaric acid): To correct natural acid deficiencies in Use as prescribed in 27 CFR 24.182 and 21 CFR 184.1099 and grape juice or wine and to reduce 24.192. GRAS Notice No. GRN 000187. the pH of grape juice or wine where ameliorating material is used in the production of grape wine. Yeast nutrients: To facilitate fermentation of juice and wine Ammonium phosphate/diammonium The amount used must not exceed 8 pounds FDA advisory opinion dated August 29, 2016. phosphate (mono- and di basic). per 1000 gallons (0.96 g/L). Biotin ...... The amount used must not exceed 25 ppb 4 .. FDA advisory opinion dated August 29, 2016. Calcium pantothenate (vitamin B5) ..... The amount used must not exceed 1.5 ppm 2 FDA advisory opinion dated August 29, 2016. Folic acid (folate) ...... The amount used must not exceed 100 ppb 4 FDA advisory opinion dated August 29, 2016. Inositol (myo-inositol) ...... The amount used must not exceed 2 ppm 2 ... FDA advisory opinion dated August 29, 2016. Magnesium sulfate ...... The amount used must not exceed 15 ppm 2 FDA advisory opinion dated August 29, 2016. Niacin (vitamin B3) ...... The amount used must not exceed 1 ppm 2 ... FDA advisory opinion dated August 29, 2016. Pyridoxine hydrochloride (vitamin B6) The amount used must not exceed 150 ppb 4 FDA advisory opinion dated August 29, 2016. Soy flour (defatted) ...... The amount used must not exceed 2 pounds FDA advisory opinion dated August 29, 2016. per 1000 gallons (0.24 g/L) of wine. Thiamine hydrochloride ...... The amount used must not exceed 0.005 FDA advisory opinion dated August 29, 2016. pounds per 1000 gallons (0.6 mg/L) of wine or juice. Yeast, autolyzed ...... None ...... FDA advisory opinion dated August 29, 2016. Yeast, cell wall/membranes of The amount used must not exceed 3 pounds FDA advisory opinion dated August 29, 2016. autolyzed yeast. per 1000 gallons (0.36 g/L) of wine or juice. 1 To stabilize—To prevent or to retard unwanted alteration of chemical and/or physical properties. 2 Parts per million—1 ppm = 0.128 ounces per 1000 gallons = 1 mg/L = 1000 ppb. 3 Official Methods of Analysis of AOAC INTERNATIONAL, Volumes I & II, AOAC INTERNATIONAL, 481 North Frederick Avenue, Suite 500, Gaithersburg, MD 20877–2417. 4 Parts per billion—1ppb = 0.000128 ounces per 1000 gallons = 1 mg/1000L.

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00052 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS 83770 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules

* * * * * § 24.247 Materials authorized for the informs TTB that a specified use or ■ 8. Section 24.247 is amended by: treatment of distilling material. limitation of any material listed in this ■ a. Revising the introductory text; The materials listed in this section as section is inconsistent with the food well as the materials listed in § 24.246 ■ b. Revising the entry in the table for additive requirements under the Federal are approved as being acceptable in Food, Drug, and Cosmetic Act, the ‘‘Ammonium phosphate (mono- and di good commercial practice for use by basic’’; and appropriate TTB officer may cancel or proprietors in the treatment of distilling amend the approval for use of the ■ c. Removing the footnote at the end of material within the limitations specified material in the treatment of distilling the table. in this section. If, however, the U.S. material. The revisions read as follows: Food and Drug Administration (FDA)

Materials Use Reference or limitation

Ammonium phosphate/diammonium phosphate Yeast nutrient in distilling material ...... The amount used shall not exceed 10 pounds (mono-and di basic). per 1000 gallons (1.2 g/L). 21 CFR 184.1141a and 184.1141b.

*******

* * * * * ■ e. Removing footnote 1 at the end of general limitations of this section. If, ■ 9. Section 24.248 is amended by: the table and adding new footnotes 1 however, the U.S. Food and Drug ■ a. Revising the introductory text; and 2. Administration (FDA) informs TTB that ■ b. Removing the entries for The additions and revisions to the a specified use or limitation of any ‘‘Nanofiltration,’’ ‘‘Reverse osmosis,’’ table and its footnotes read as follows: material listed in this section is and ‘‘Ultrafiltration’’; inconsistent with the food additive ■ c. Adding an entry for ‘‘Cross flow § 24.248 Processes authorized for the filtration’’, including subentries for treatment of wine, juice, and distilling requirements under the Federal Food, ‘‘Nanofiltration’’, ‘‘Reverse osmosis’’, material. Drug, and Cosmetic Act, the appropriate and ‘‘Ultrafiltration’’, at the top of the The processes listed in this section TTB officer may cancel or amend the table; are approved as being consistent with approval for use of the process in the ■ d. Revising the entries for ‘‘Osmotic good commercial practice for use by production, cellar treatment, or transport’’, ‘‘Spinning cone column’’, proprietors in the production, cellar finishing of wine, juice, and distilling and ‘‘Thin-film evaporation under treatment, or finishing of wine, juice, material. reduced pressure’’; and and distilling material, within the

PROCESSES AUTHORIZED FOR THE TREATMENT OF WINE, JUICE, AND DISTILLING MATERIAL

Process Use Reference or limitation

Cross flow filtration ...... Various processes and uses. 1 Nanofiltration 2 To reduce the level of volatile acidity in wine This process must use permeable membranes (used with ion exchange), to reduce the which are selective for molecules not great- ethyl alcohol content of wine. er than 150 molecular weight with transmembrane pressures of 250 psi or less. Reverse osmosis 2 ...... To reduce the ethyl alcohol content of wine Permeable membranes that are selective for and to remove off flavors in wine. molecules not greater than 500 molecular weight with transmembrane pressures of 200 pounds per square inch (psi) and great- er. The addition of water other than that originally present prior to processing will render standard wine ‘‘other than standard.’’ Use must not alter the vinous character of the wine. May be used in combination with osmotic transport. Ultrafiltration 2 ...... To remove proteinaceous material from wine; Permeable membranes that are selective for to reduce harsh tannic material from white molecules greater than 500 and not less wine produced from white skinned grapes; than 25,000 molecular weight with to remove pink color from blanc de noir transmembrane pressures less than 200 psi. wine; to separate red juice and wine into Shall not alter vinous character. low color and high color fractions for blend- ing purposes, to reduce the ethyl alcohol content of wine.

******* Osmotic transport 2 ...... For alcohol reduction ...... (1) Use must not alter the vinous character of the wine. (2) None of the stripping solution may migrate into the wine. (3) May be used in combination with reverse osmosis.

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00053 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Proposed Rules 83771

PROCESSES AUTHORIZED FOR THE TREATMENT OF WINE, JUICE, AND DISTILLING MATERIAL—Continued

Process Use Reference or limitation

******* Spinning cone column 2 ...... To reduce the ethyl alcohol content of wine Use shall not alter vinous character. For and to remove off flavors in wine. standard wine, the same amount of essence must be added back to any lot of wine as was originally removed.

******* Thin film evaporation under reduced To separate wine into a low alcohol wine frac- Use shall not alter vinous character. Water preasure 2. tion and into a higher alcohol distillate. separated with alcohol during processing may be recovered by refluxing in a closed continuous system and returned to the wine. The addition of water other than that origi- nally present in the wine prior to processing, will render standard wine other than stand- ard wine. 1 In cross-flow filtration, the wine is passed across the filter membrane (tangentially) at positive pressure relative to the permeate side. A pro- portion of the wine which is smaller than the membrane pore size passes through the membrane as permeate or filtrate; everything else is re- tained on the feed side of the membrane as retentate. 2 When used to remove ethyl alcohol (dealcoholization), this process must be done on distilled spirits plant premises. However, reverse osmo- sis and nanofilitration, under certain limited conditions, may be used on bonded winery premises if ethyl alcohol is only temporarily created within a closed system.

* * * * * (b) Removal of accidentally added accidentally added to the wine was ■ 10. Paragraph (b) of § 24.250 is water with TTB approval. If a proprietor removed as a result of the treatment or amended to read as follows: accidentally adds water to standard process. wine and the accidentally added water § 24.250 Application for use of new (Sec. 201, Pub. L. 85–859, 72 Stat. 1383– treating material or process. represents more than 10 percent of the 1384, as amended (26 U.S.C. 5382)) original volume of the wine, then the (b) Documentary evidence from the proprietor must request permission from Signed: June 16, 2016. U.S. Food and Drug Administration that TTB prior to treating the wine. A John J. Manfreda, the material is consistent with the food proprietor may submit an application Administrator. additive requirements under the Federal requesting permission to treat the wine Approved: October 25, 2016. Food, Drug, and Cosmetic Act for its to remove the water and return the wine Timothy E. Skud, intended purpose in the amounts to its original condition. The removal of proposed for the particular treatment Deputy Assistant Secretary. (Tax, Trade, and water may not be conducted until the Tariff Policy). contemplated; appropriate TTB officer has approved [FR Doc. 2016–27581 Filed 11–21–16; 8:45 am] * * * * * the request. The application, which is to BILLING CODE 4810–31–P ■ 11. Section 24.251 is added to read as be submitted to the appropriate TTB follows: officer, must be in writing, must provide § 24.251 Salvaging accidentally diluted evidence of the exact amount of water ENVIRONMENTAL PROTECTION wine. accidentally added to the wine and an AGENCY (a) Removal of accidentally added explanation of how the water was water without prior TTB approval. If a accidentally added, and must specify 40 CFR Part 52 proprietor accidentally adds to standard the method the proprietor will use to remove the water from the wine. In [EPA–R06–OAR–2016–0206; FRL–9954–83– wine water in excess of limitations Region 6] specified in subparts F and L of this approving any request under this part, the accidentally diluted wine may section, the appropriate TTB officer may Approval and Promulgation of be returned to its original condition require the proprietor to take steps to Implementation Plans; Louisiana; through the use of reverse osmosis and prevent future accidental additions of Revisions to the New Source Review distillation without prior application to water to wine. In evaluating any request State Implementation Plan; Air Permit TTB provided that: under this section, the appropriate TTB Procedure Revisions (1) The accidentally added water officer may consider as a factor whether represents no more than 10 percent of the proprietor has demonstrated good AGENCY: Environmental Protection the original volume of the wine; commercial practices, taking into Agency (EPA). (2) The wine is returned to its original account the proprietor’s prior history of ACTION: Proposed rule. condition by removing an amount of accidental addition of water to wine and water equal to the amount that was of compliance with other regulations in SUMMARY: The Environmental Protection accidentally added to the wine; part 24. Agency (EPA) is proposing to partially (3) The vinous character of the wine (c) Records. The proprietor must, with approve and partially disapprove is not altered; respect to removals of water from wine severable portions of four revisions to (4) The proprietor transfers the wine authorized under this section, maintain the Louisiana New Source Review in bond to a distilled spirits plant for records that document the accidental (NSR) State Implementation Plan (SIP) treatment; and addition of water, the use of any submitted by the Louisiana Department (5) Records are maintained in treatment or process to remove the of Environmental Quality (LDEQ). accordance with paragraph (c) of this water from the wine, and the fact that Specifically, we are proposing to section. only the amount of water that was partially approve and partially

VerDate Sep<11>2014 16:39 Nov 21, 2016 Jkt 241001 PO 00000 Frm 00054 Fmt 4702 Sfmt 4702 E:\FR\FM\22NOP1.SGM 22NOP1 sradovich on DSK3GMQ082PROD with PROPOSALS