FASTER Act of 2021

I 117TH CONGRESS 1ST SESSION H. R. 1202 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 HOUSE OF REPRESENTATIVES FEBRUARY 22, 2021 Ms. MATSUI (for herself, Mr. MCHENRY, Mrs. LURIA, and Mr. GONZALEZ of Ohio) introduced the following bill; which was referred to the Committee on Energy and Commerce 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. 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 ‘‘Food Allergy Safety, 4 Treatment, Education, and Research Act of 2021’’ or the 5 ‘‘FASTER Act of 2021’’. 6 VerDate Sep 11 2014 22:19 Mar 13, 2021 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H1202.IH H1202 khammond on DSKJM1Z7X2PROD with BILLS 2 •HR 1202 IH SEC. 2. FOOD ALLERGY SAFETY. 1 (a) IN GENERAL.—Section 201(qq)(1) of the Federal 2 Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is 3 amended by striking ‘‘and soybeans’’ and inserting ‘‘soy- 4 beans, and sesame’’. 5 (b) EFFECTIVE DATE.—The amendment made by 6 subsection (a) shall apply to any food that is introduced 7 or delivered for introduction into interstate commerce on 8 or after January 1, 2023. 9 SEC. 3. REPORT TO CONGRESS. 10 (a) REPORT.—Not later than 18 months after the 11 date of enactment of this Act, the Secretary of Health and 12 Human Services (referred to in this section as the ‘‘Sec- 13 retary’’) shall submit to the Committee on Health, Edu- 14 cation, Labor, and Pensions of the Senate and the Com- 15 mittee on Energy and Commerce of the House of Rep- 16 resentatives a report that includes— 17 (1) descriptions of ongoing Federal activities re- 18 lated to— 19 (A) the surveillance and collection of data 20 on the prevalence of food allergies and severity 21 of allergic reactions for specific food or food in- 22 gredients, including the identification of any 23 gaps in such activities; 24 (B) the development of effective food al- 25 lergy diagnostics; 26 VerDate Sep 11 2014 22:19 Mar 13, 2021 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H1202.IH H1202 khammond on DSKJM1Z7X2PROD with BILLS 3 •HR 1202 IH (C) the prevention of the onset of food al- 1 lergies; 2 (D) the reduction of risks related to living 3 with food allergies; and 4 (E) the development of new therapeutics to 5 prevent, treat, cure, and manage food allergies; 6 and 7 (2) specific recommendations and strategies to 8 expand, enhance, or improve activities described in 9 paragraph (1), including— 10 (A) strategies to improve the accuracy of 11 food allergy prevalence data by expanding and 12 intensifying current collection methods, includ- 13 ing support for research that includes the iden- 14 tification of biomarkers and tests to validate 15 survey data and the investigation of the use of 16 identified biomarkers and tests in national sur- 17 veys; 18 (B) strategies to overcome gaps in surveil- 19 lance and data collection activities related to 20 food allergies and specific food allergens; and 21 (C) recommendations for the development 22 and implementation of a regulatory process and 23 framework that would allow for the timely, 24 transparent, and evidence-based modification of 25 VerDate Sep 11 2014 22:19 Mar 13, 2021 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1202.IH H1202 khammond on DSKJM1Z7X2PROD with BILLS 4 •HR 1202 IH the definition of ‘‘major food allergen’’ included 1 in section 201(qq) of the Federal Food, Drug 2 and Cosmetic Act (21 U.S.C. 321(qq)), includ- 3 ing with respect to— 4 (i) the scientific criteria for defining a 5 food or food ingredient as a ‘‘major food 6 allergen’’ pursuant to such process, includ- 7 ing recommendations pertaining to evi- 8 dence of the prevalence and severity of al- 9 lergic reactions to a food or food ingredient 10 that would be required in order to establish 11 that such food or food ingredient is an al- 12 lergen of public health concern appropriate 13 for such process; and 14 (ii) opportunities for stakeholder en- 15 gagement and comment, as appropriate, in 16 considering any such modification to such 17 definition. 18 (b) PUBLICATION.—The Secretary shall make the re- 19 port under subsection (a) available on the internet website 20 of the Department of Health and Human Services. 21 Æ VerDate Sep 11 2014 22:19 Mar 13, 2021 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6301 E:\BILLS\H1202.IH H1202 khammond on DSKJM1Z7X2PROD with BILLS