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S. 578: FASTER Act of 2021


The text of the bill below is as of Mar 12, 2021 (Preprint (Suspension)).


II




                                                                       117TH CONGRESS
                                                                          1ST SESSION
                                                                                                                 S. 578
                                                                       To improve the health and safety of Americans living with food allergies
                                                                           and related disorders, including potentially life-threatening anaphylaxis,
                                                                           food protein-induced enterocolitis syndrome, and eosinophilic gastro-
                                                                           intestinal diseases, and for other purposes.




                                                                                   IN THE SENATE OF THE UNITED STATES
                                                                                                      MARCH 3, 2021
                                                                       Mr. SCOTT of South Carolina (for himself, Mr. MURPHY, Ms. COLLINS, Mrs.
                                                                           GILLIBRAND, Mr. TILLIS, Mr. BLUMENTHAL, Ms. BALDWIN, Mr. MAR-
                                                                           SHALL, and Mr. WARNOCK) introduced the following bill; which was read
                                                                           twice, considered, read the third time, and passed




                                                                                                                 A BILL
                                                                       To improve the health and safety of Americans living with
                                                                          food allergies and related disorders, including potentially
                                                                          life-threatening anaphylaxis, food protein-induced
                                                                          enterocolitis syndrome, and eosinophilic gastrointestinal
                                                                          diseases, and for other purposes.

                                                                         1              Be it enacted by the Senate and House of Representa-
                                                                         2 tives of the United States of America in Congress assembled,
                                                                         3     SECTION 1. SHORT TITLE.

                                                                         4              This Act may be cited as the ‘‘Food Allergy Safety,
kjohnson on DSK79L0C42PROD with BILLS




                                                                         5 Treatment, Education, and Research Act of 2021’’ or the
                                                                         6 ‘‘FASTER Act of 2021’’.


                                        VerDate Sep 11 2014   00:44 Mar 04, 2021   Jkt 019200   PO 00000   Frm 00001   Fmt 6652   Sfmt 6201   E:\BILLS\S578.CPS   S578

2 1 SEC. 2. FOOD ALLERGY SAFETY. 2 (a) IN GENERAL.—Section 201(qq)(1) of the Federal 3 Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is 4 amended by striking ‘‘and soybeans’’ and inserting ‘‘soy- 5 beans, and sesame’’. 6 (b) EFFECTIVE DATE.—The amendment made by 7 subsection (a) shall apply to any food that is introduced 8 or delivered for introduction into interstate commerce on 9 or after January 1, 2023. 10 SEC. 3. REPORT TO CONGRESS. 11 (a) REPORT.—Not later than 18 months after the 12 date of enactment of this Act, the Secretary of Health and 13 Human Services (referred to in this section as the ‘‘Sec- 14 retary’’) shall submit to the Committee on Health, Edu- 15 cation, Labor, and Pensions of the Senate and the Com- 16 mittee on Energy and Commerce of the House of Rep- 17 resentatives a report that includes— 18 (1) descriptions of ongoing Federal activities re- 19 lated to— 20 (A) the surveillance and collection of data 21 on the prevalence of food allergies and severity 22 of allergic reactions for specific food or food in- 23 gredients, including the identification of any 24 gaps in such activities; kjohnson on DSK79L0C42PROD with BILLS 25 (B) the development of effective food al- 26 lergy diagnostics; •S 578 CPS VerDate Sep 11 2014 00:44 Mar 04, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S578.CPS S578
3 1 (C) the prevention of the onset of food al- 2 lergies; 3 (D) the reduction of risks related to living 4 with food allergies; and 5 (E) the development of new therapeutics to 6 prevent, treat, cure, and manage food allergies; 7 and 8 (2) specific recommendations and strategies to 9 expand, enhance, or improve activities described in 10 paragraph (1), including— 11 (A) strategies to improve the accuracy of 12 food allergy prevalence data by expanding and 13 intensifying current collection methods, includ- 14 ing support for research that includes the iden- 15 tification of biomarkers and tests to validate 16 survey data and the investigation of the use of 17 identified biomarkers and tests in national sur- 18 veys; 19 (B) strategies to overcome gaps in surveil- 20 lance and data collection activities related to 21 food allergies and specific food allergens; and 22 (C) recommendations for the development 23 and implementation of a regulatory process and 24 framework that would allow for the timely, kjohnson on DSK79L0C42PROD with BILLS 25 transparent, and evidence-based modification of •S 578 CPS VerDate Sep 11 2014 00:44 Mar 04, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S578.CPS S578
4 1 the definition of ‘‘major food allergen’’ included 2 in section 201(qq) of the Federal Food, Drug 3 and Cosmetic Act (21 U.S.C. 321(qq)), includ- 4 ing with respect to— 5 (i) the scientific criteria for defining a 6 food or food ingredient as a ‘‘major food 7 allergen’’ pursuant to such process, includ- 8 ing recommendations pertaining to evi- 9 dence of the prevalence and severity of al- 10 lergic reactions to a food or food ingredient 11 that would be required in order to establish 12 that such food or food ingredient is an al- 13 lergen of public health concern appropriate 14 for such process; and 15 (ii) opportunities for stakeholder en- 16 gagement and comment, as appropriate, in 17 considering any such modification to such 18 definition. 19 (b) PUBLICATION.—The Secretary shall make the re- 20 port under subsection (a) available on the internet website 21 of the Department of Health and Human Services. Æ kjohnson on DSK79L0C42PROD with BILLS •S 578 CPS VerDate Sep 11 2014 00:44 Mar 04, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\S578.CPS S578