# [Amended]
**AGENCY:**
Bureau of Alcohol, Tobacco and Firearms (ATF), Department of the Treasury.
**ACTION:**
Final Rule (Treasury decision).
**SUMMARY:**
This final rule amends the regulations in 27 CFR Parts 19 and 21 by updating the information relating to the formulation of completely denatured alcohol (CDA), specially denatured alcohol (SDA), and specially denatured rum (SDR); the denaturants authorized for use in the manufacturing of these formulations; and the specifications for these denaturants. The updates include removing the proprietary brand name “BITREX” listed with the denaturant denatonium benzoate, incorporating an ATF ruling that approves the use of two substitute denaturants, and making other amendments to provide clarity.
**DATES:**
This rule is effective on March 1, 2001.
**FOR FURTHER INFORMATION CONTACT:**
Lisa M. Gesser, Regulations Division, Bureau of Alcohol, Tobacco and Firearms, 650 Massachusetts Avenue NW., Washington, DC 20226, (202-927-9347) or e-mail at [email protected].
**SUPPLEMENTARY INFORMATION:**
**Background**
27 CFR Part 21 contains listings of information relating to the formulation of CDA, SDA, and SDR, to the specifications for denaturants and to the denaturants authorized for use in the formulation of CDA, SDA, and SDR. ATF is authorized under § 5242 of the Internal Revenue Code of 1986 to prescribe the character and quantity of approved denaturing materials. Pursuant to § 21.91, ATF may authorize substitutions or variations from the specified list of denaturants upon application filed with ATF by the denaturer. This final rule amends Part 21 by incorporating additional denaturants that have been approved pursuant to such applications. Additionally, this final rule incorporates several technical corrections.
**Substitute Denaturants**
ATF Ruling 94-4 approved the use of heptane as a substitute denaturant for toluene in SDA Formula No. 2-B (SDA 2-B) and alpha terpineol as a substitute denaturant in SDA Formula No. 38-B (SDA 38-B).
Heptane is currently approved as a substitute denaturant for rubber hydrocarbon solvent in SDA 28-A. This ruling allows for the use of heptane as a substitute, on an equal (1:1) basis, for any one of the denaturants (toluene, benzene or rubber hydrocarbon solvent) in SDA 2-B.
Alpha terpineol, having similar specifications to those of pine oil, N.F., an approved denaturant for SDA 38-B, is now approved for use as a substitute denaturant in SDA 38-B.
**Removal of a Proprietary Name**
This final rule removes the proprietary brand name “BITREX” each place it appears in parts 19 and 21. The use of the proprietary brand name “BITREX” in conjunction with the approved denaturant denatonium benzoate, N.F. may be mistakenly considered a product endorsement by ATF over all over proprietary names.
**Other Changes**
27 CFR 21.6 and 21.141 are amended to correctly cite referenced information.
**Notice of Proposed Rulemaking**
On July 31, 1996, ATF published a notice of proposed rulemaking (Notice No. 832, 61 FR 39929-39931) to solicit public comment on regulations to update the information provided in parts 19 and 21 relating to the formulation of CDA, SDA, and SDR; the denaturants authorized for use in the manufacturing of these formulations; and the specifications for these denaturants. The comment period closed on September 30, 1996.
**Comments on the NPRM**
ATF did not receive any comments in response to Notice 832, therefore, most of the amendments proposed in Notice No. 832 have been adopted in this final rule.
**Paperwork Reduction Act**
The provisions of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this final rule because there are no new reporting or recordkeeping requirements.
**Regulatory Flexibility Act**
It is hereby certified that this final rule will not have a significant economic impact on a substantial number of small entities. The regulations provide industry members with the most current listings of denaturants, denatured alcohol and rum formulations and their specifications. The regulations will not increase recordkeeping or reporting requirements. Accordingly, a regulatory flexibility analysis is not required because this final rule will not have a significant economic impact on a substantial number of small entities. Pursuant to section 7805(f) of the Internal Revenue Code, the NPRM preceding this regulation was submitted to the Chief Counsel for Advocacy of the Small Business Administration, for comment on its impact on small business. The Chief Counsel for Advocacy did not submit any comments.
**Executive Order 12866**
It has been determined that this final rule is not a significant regulatory action as defined by Executive Order 12866. Therefore, a regulatory assessment is not required.
**Drafting Information**
The principal author of this document is Lisa M. Gesser, Regulations Division, Bureau of Alcohol, Tobacco and Firearms.
**List of Subjects**
Administrative practice and procedure, Alcohol and alcoholic beverages, Authority delegations (Government agencies), Chemicals, Claims, Customs duties and inspection, Electronic fund transfers, Excise taxes, Exports, Gasohol, Imports, Labeling, Liquors, Packaging and containers, Puerto Rico, Reporting and recordkeeping requirements, Research, Security measures, Spices and flavorings, Stills, Surety bonds, Transportation, Vinegar, Virgin Islands, Warehouses, Wine.
Alcohol and alcoholic beverages, Authority delegation, Chemicals, Gasohol.
**Authority and Issuance**
**27 CFR Part 19**
Accordingly, ATF is amending chapter I of title 27 of the Code of Federal Regulations as follows:
**PART 19—DISTILLED SPIRITS PLANTS**
*Paragraph 1.* The authority citation for Part 19 continues to read as follows:
**Authority:**
19 U.S.C. 81c, 1311; 26 U.S.C. 5001, 5002, 5004-5006, 5008, 5010, 5041, 5061, 5062, 5066, 5081, 5101, 5111-5113, 5142, 5143, 5146, 5171-5173, 5175, 5176, 5178-5181, 5201-5204, 5206, 5207, 5211-5215, 5221-5223, 5231, 5232, 5235, 5236, 5241-5243, 5271, 5273, 5301, 5311-5313, 5362, 5370, 5373, 5501-5505, 5551-5555, 5559, 5561, 5562, 5601, 5612, 5682, 6001, 6065, 6109, 6302, 6311, 6676, 6806, 7011, 7510, 7805; 31 U.S.C. 9301, 9303, 9304, 9306.
**27 CFR Part 19**
§ 19.460
*Par. 2.* Amend § 19.460(a) by removing the word “(BITREX)”.
**27 CFR Part 19**
§ 19.1005
*Par. 3.* Amend § 19.1005(c)(2) by removing the word “(Bitrex)”.
**27 CFR Part 19**
**PART 21—FORMULAS FOR DENATURED ALCOHOL AND RUM**
*Par. 4.* The authority citation for Part 21 continues to read as follows:
**Authority:**
5 U.S.C. 552(a); 26 U.S.C. 5242, 7805.
**27 CFR Part 21**
§ 21.32
*Par. 5.* Amend § 21.32(a) by removing the word “(BITREX)”.
**27 CFR Part 21**
*Par. 6.* Revise § 21.33(a) to read as follows:
§ 21.33
(a) Formula. To every 100 gallons of alcohol add:
One-half gallon of benzene, 1/2 gallon of rubber hydrocarbon solvent, 1/2 gallon of toluene, or 1/2 gallon of heptane.
**27 CFR Part 21**
§ 21.65
*Par. 7.* Amend § 21.65(a) by adding the words “Alpha terpineol” to the top of the list of substances.
**27 CFR Part 21**
§ 21.76
*Par. 8.* Amend § 21.76(a) by removing the word “(BITREX)”.
**27 CFR Part 21**
§ 21.91
*Par. 9.* Amend the second sentence of § 21.91 by removing the word “of” where it appears for the second time and adding the word “or” in its place.
**27 CFR Part 21**
§§ 21.95 through 21.132
*Par. 10.* Redesignate § 21.95 through § 21.132 as § 21.96 through § 21.133.
**27 CFR Part 21**
*Par. 11.* Add a new § 21.95 to read as follows:
§ 21.95
(a) Boiling point at 752mm 218.8-219.4°C.
(b) Density at 15° 0.9386.
(c) Refractive index at 20° 1.4831.
**27 CFR Part 21**
§ 21.141
*Par. 12.* Amend § 21.141 by adding “40-B” to the end of the list in the column entitled “Formulas authorized” for the entry “External pharmaceuticals, miscellaneous, U.S.P. or N.F.”, “Code No. 249.”
**27 CFR Part 21**
§ 21.151
*Par. 13.* Amend § 21.151 as follows:
a. Add the words “Alpha Terpineol * * * S.D.A. 38-B” directly after the words “Almond oil, bitter, N.F.X. * * * S.D.A. 38-B”;
b. Remove the word “(BITREX)” from the reference to “Denatonium benzoate, N.F. S.D.A. 1, 40-B”; and
c. Add “2-B” between “S.D.A.” and “28-A” across from “Heptane.”
Signed: January 4, 2001.
Bradley A. Buckles,
Director.
Approved: February 1, 2001.
Timothy E. Skud,
Acting Deputy Assistant Secretary, (Regulatory, Tariff and Trade Enforcement).