Hand Sanitizer Guidance Extension Act of 2020

II 116TH CONGRESS 2D SESSION S. 3938 To extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus public health emergency, and for other purposes. IN THE SENATE OF THE UNITED STATES JUNE 11, 2020 Mr. THUNE (for himself, Mr. BRAUN, Mr. GRASSLEY, Mr. ROUNDS, and Ms. ERNST) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To extend Federal guidance concerning the use of certain alcohol-based hand sanitizer during the coronavirus pub- lic health emergency, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Hand Sanitizer Guid- 4 ance Extension Act of 2020’’. 5 SEC. 2. FEDERAL GUIDANCE ON HAND SANITIZER. 6 (a) EXTENSION OF FEDERAL GUIDANCE.—The Food 7 and Drug Administration guidance entitled ‘‘Guidance for 8 Industry: Temporary Policy for Preparation of Certain Al- 9 VerDate Sep 11 2014 04:35 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S3938.IS S3938 pbinns on DSKJLVW7X2PROD with BILLS 2 •S 3938 IS cohol-Based Hand Sanitizer Products During the Public 1 Health Emergency (COVID–19)’’, initially released on 2 March 23, 2020, and updated on April 15, 2020, and on 3 June 1, 2020, shall remain in effect until the date that 4 is 2 years after the date of enactment of this Act. 5 (b) EFFECT OF EXTENSION.—During the 2-year pe- 6 riod described in subsection (a), the Food and Drug Ad- 7 ministration shall permit the production, sale, and use of 8 hand sanitizer, consistent with the guidance described in 9 subsection (a), provided that such hand sanitizer is manu- 10 factured using only the following ingredients in the prepa- 11 ration of the product: 12 (1)(A) Subject to subsection (c), alcohol (eth- 13 anol) that is not less than 94.9 percent ethanol by 14 volume; or 15 (B) United States Pharmacopeia grade iso- 16 propyl alcohol. 17 (2) United States Pharmacopeia grade or Food 18 Chemical Codex grade glycerin (glycerol). 19 (3) Hydrogen peroxide. 20 (4) Sterile water meeting United States Phar- 21 macopeia specifications for purified water. 22 (c) ETHANOL PRODUCED IN CERTAIN FACILITIES.— 23 Ethanol produced in facilities normally producing fuel or 24 VerDate Sep 11 2014 04:35 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3938.IS S3938 pbinns on DSKJLVW7X2PROD with BILLS 3 •S 3938 IS technical ethanol may be used as described in subsection 1 (b)(1)(A) only if such ethanol— 2 (1) meets United States Pharmacopeia or Food 3 Chemical Codex grade requirements; 4 (2) has been screened for any other potentially 5 harmful impurities not specified in the United States 6 Pharmacopeia or Food Chemical Codex require- 7 ments; or 8 (3) has otherwise been approved for use by the 9 Food and Drug Administration. 10 (d) AUTOMATIC EXTENSION.—The effective period of 11 the guidance described in subsection (a) shall automati- 12 cally be extended for 1 additional year if the Secretary 13 of Health and Human Services determines that a public 14 health emergency exists at the time that the 2-year period 15 described in subsection (a) expires. 16 (e) EXEMPTION.—If the Commissioner of Food and 17 Drugs determines that a public health emergency requires 18 that the requirement for the use of denatured alcohol be 19 reduced, or requires a waiver of any other requirement 20 with respect to hand sanitizer under the guidance, the 21 Commissioner of Food and Drugs may waive or reduce 22 such requirement, as applicable. 23 Æ VerDate Sep 11 2014 04:35 Jun 25, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6301 E:\BILLS\S3938.IS S3938 pbinns on DSKJLVW7X2PROD with BILLS