The publication is reproduced in full below:
FOOD ALLERGY SAFETY, TREATMENT, EDUCATION, AND RESEARCH ACT OF 2021
Mr. PALLONE. Mr. Speaker, I move to suspend the rules and pass the bill (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 gastrointestinal diseases, and for other purposes.
The Clerk read the title of the bill.
The text of the bill is as follows:
S. 578
Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food Allergy Safety, Treatment, Education, and Research Act of 2021'' or the
``FASTER Act of 2021''.
SEC. 2. FOOD ALLERGY SAFETY.
(a) In General.--Section 201(qq)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(qq)(1)) is amended by striking ``and soybeans'' and inserting ``soybeans, and sesame''.
(b) Effective Date.--The amendment made by subsection (a) shall apply to any food that is introduced or delivered for introduction into interstate commerce on or after January 1, 2023.
SEC. 3. REPORT TO CONGRESS.
(a) Report.--Not later than 18 months after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the ``Secretary'') shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes--
(1) descriptions of ongoing Federal activities related to--
(A) the surveillance and collection of data on the prevalence of food allergies and severity of allergic reactions for specific food or food ingredients, including the identification of any gaps in such activities;
(B) the development of effective food allergy diagnostics;
(C) the prevention of the onset of food allergies;
(D) the reduction of risks related to living with food allergies; and
(E) the development of new therapeutics to prevent, treat, cure, and manage food allergies; and
(2) specific recommendations and strategies to expand, enhance, or improve activities described in paragraph (1), including--
(A) strategies to improve the accuracy of food allergy prevalence data by expanding and intensifying current collection methods, including support for research that includes the identification of biomarkers and tests to validate survey data and the investigation of the use of identified biomarkers and tests in national surveys;
(B) strategies to overcome gaps in surveillance and data collection activities related to food allergies and specific food allergens; and
(C) recommendations for the development and implementation of a regulatory process and framework that would allow for the timely, transparent, and evidence-based modification of the definition of ``major food allergen'' included in section 201(qq) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(qq)), including with respect to--
(i) the scientific criteria for defining a food or food ingredient as a ``major food allergen'' pursuant to such process, including recommendations pertaining to evidence of the prevalence and severity of allergic reactions to a food or food ingredient that would be required in order to establish that such food or food ingredient is an allergen of public health concern appropriate for such process; and
(ii) opportunities for stakeholder engagement and comment, as appropriate, in considering any such modification to such definition.
(b) Publication.--The Secretary shall make the report under subsection (a) available on the internet website of the Department of Health and Human Services.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from New Jersey (Mr. Pallone) and the gentlewoman from Washington (Mrs. Rodgers) each will control 20 minutes.
The Chair recognizes the gentleman from New Jersey.
General Leave
Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members may have 5 legislative days in which to revise and extend their remarks and include extraneous material on S. 578.
The SPEAKER pro tempore. Is there objection to the request of the gentleman from New Jersey?
There was no objection.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of the Food Allergy Safety, Treatment, Education, and Research Act, also known as the FASTER Act.
An estimated 32 million Americans, including approximately one in every 13 children, are affected by food allergies. These allergies can pose significant risks, particularly when inaccurate food labels fail to warn consumers about the presence of some of these allergens.
Under current law, eight allergens are considered major food allergens. These allergens include milk, eggs, shellfish, tree nuts, wheat, peanuts, and soybeans. Due to their status as major food allergens, manufacturers must clearly state the presence of any of these ingredients on labels.
Notably missing from this list of allergens is sesame. Sesame is considered an allergen of growing concern. While its prevalence has more than doubled over the last decade, it is not required to be listed as an allergen on food packaging. In fact, in some cases, a food may contain sesame, but the ingredient won't be listed at all on the labels, instead being referred to through nonspecific terms such as
``spices'' or words that may not be easily recognized by consumers as containing sesame, such as tahini.
While many may not recognize the significance of a simple ingredients label, for many families, a lack of clarity on ingredients could mean life or death for those who are allergic to sesame. Clearly, this information should be prominently featured on all packaged food labels.
This is an issue we have been working on for quite some time. I previously introduced a bill several years ago that would list sesame as a major food allergen, and although the Food and Drug Administration opened a docket to solicit feedback about sesame labeling, the agency has not been able to require the listing of sesame due to overly long regulatory processes.
So today, Mr. Speaker, we are bypassing these regulatory delays and taking action. The appropriately-named FASTER Act would quickly move this process along by recognizing sesame as a major food allergen and requiring its listing on new food labels after a phase-in process.
The bill will also require FDA to report recommendations on how we can make additional improvements to protect individuals with food allergies, including ways to add additional major food allergens.
So I want to thank Representative Matsui for her tireless work on this bill. She is the prime sponsor. We came so close to getting this over the finish line in the last Congress, and I am glad that today we are sending this bill to President Biden for his signature. I am proud to support the legislation. I encourage all Members to vote for it.
Mr. Speaker, I reserve the balance of my time.
Mrs. RODGERS of Washington. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of S. 578, the Food Allergy Safety, Treatment, Education, and Research Act. This legislation is bipartisan, a companion of H.R. 1202, that was led by Representatives McHenry, Gonzalez, and Matsui.
S. 578 will designate sesame as a major food allergen. This means that, with the enactment of this legislation, manufacturers would have to list this ingredient on the food packaging label of products containing sesame.
Recent studies indicate that sesame allergies are of growing concern in the United States, with a prevalence rate on par with allergies to soy and fish, which are both listed as major allergens under the Federal Food, Drug, and Cosmetic Act.
This commonsense legislation will provide consumers with the information they need to protect themselves and their families from certain dangerous and life-threatening allergic reactions.
Mr. Speaker, I urge my colleagues to support this legislation, and I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield such time as she may consume to the gentlewoman from California (Ms. Matsui) who is the House sponsor of the legislation.
Ms. MATSUI. Mr. Speaker, I rise today in support of two of my bills being considered under suspension today, the FASTER Act and the TRANSPLANT Act.
The Food Allergy Safety, Treatment, Education, and Research Act, FASTER--which wasn't as fast as I wanted it to be, but this act will help to improve the safety of more than 32 million Americans, including 5.6 million children, living with potentially life-threatening food allergies.
Under current law, mandatory labeling is required for major food allergens recognized by the FDA like milk, eggs, and peanuts.
My grandson, Robby, has a peanut allergy, and for families like mine, accurate food ingredient labels are vital to making safe and healthy choices. The time we have spent reading the labels and having discussions about whether he can go to a birthday party or not, or go to camp or not, and having friends over, it was just heartbreaking. We need to have those labels be clear.
Critically, the FASTER Act extends these labeling protections to nearly 1.6 million Americans allergic to sesame by requiring sesame to be included as an ingredient on a packaged food label.
The bill also expands the research necessary to find new treatments and is an important step in the right direction to finding an eventual cure for food allergies.
Today is a testament to the hard work of thousands of grassroots advocates who sent emails, made calls, and visited Members of Congress and staff to build support and make sesame the ninth allergen to be labeled under law.
The outpouring of support was incredible. The FASTER Act will truly make a difference for those living with potentially life-threatening food allergies, and we are proud that it can now be sent to President Biden's desk.
{time} 1245
I also rise today in support of H.R. 941, the TRANSPLANT Act, my legislation to reauthorize the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory for another 5 years.
Every 3 minutes, someone is diagnosed with blood cancer. For patients and families facing these fatal diseases, a bone marrow or cord blood transplant may be the best treatment or only potential for a cure.
Congress has long recognized the need to coordinate lifesaving transplants between patients and unrelated donors at the national level and has shown strong bipartisan support over the years for the program.
We must continue to encourage donors and give these patients with otherwise fatal blood cancers a second chance at life. That is why I joined with Representative Bilirakis to introduce the TRANSPLANT Act.
This past year, there has been a new sense of urgency for this timely reauthorization. We have seen how Be The Match's status, as the designated operator of the national program, has helped bone marrow couriers continue to facilitate transplants during the pandemic.
We must act swiftly to preserve this critical designation and ensure patients with otherwise fatal blood cancers continue to have access to transplants, both during and after the current public health crisis.
I urge my colleagues to support this legislation today so we may further prevent any lapse in funding. I support both bills.
Mrs. RODGERS of Washington. Mr. Speaker, I yield 3 minutes to the gentleman from North Carolina (Mr. McHenry), one of the leaders of this legislation and the leader of the Financial Services Committee.
Mr. McHENRY. Mr. Speaker, I thank Mrs. Rodgers, my classmate and a member of the Energy and Commerce Committee for yielding. It is an amazing thing to be with you here today, and it is an amazing thing to be here today to talk about this important bill.
As the lead Republican cosponsor of the House companion to S. 578, I rise in support of the FASTER Act.
Millions of Americans suffer from life-threatening food allergies. More than 1.5 million Americans are allergic to sesame, in particular, yet there is no current requirement to include the ingredient on product labels. This legislation would declare it the ninth major allergen to be recognized by the U.S. Food and Drug Administration and update laws to require the labeling of sesame.
This bill would also require the Secretary of Health and Human Services to regularly review promising food allergy treatments and research. This is a major bipartisan priority. These efforts will help slow this rapidly growing disease and ultimately find and fund a cure.
Finally, the FASTER Act establishes a scientific process and framework for establishing additional allergens covered by the Federal Food, Drug, and Cosmetic Act.
I am proud to serve as cofounder and co-chair of the newly formed Congressional Food Allergy Research Caucus, along with Congresswoman Doris Matsui. We recognize there is more we can do to help those 32 million Americans, including many who are children who suffer from food allergies.
We can and we should do more to increase funding into research, therapies, and treatments for food allergies. Sending this legislation to the President's desk would be a major first step to achieving our goal of improving treatment opportunities.
I urge my colleagues on both sides of the aisle to vote ``yes'' on this bill.
Mr. PALLONE. Mr. Speaker, I urge my colleagues to support this bill, S. 578, the FASTER Act, and I yield back the balance of my time.
Mrs. RODGERS of Washington. Mr. Speaker, I have no additional speakers, and I yield back the balance of my time.
The SPEAKER pro tempore. The question is on the motion offered by the gentleman from New Jersey (Mr. Pallone) that the House suspend the rules and pass the bill, S. 578.
The question was taken.
The SPEAKER pro tempore. In the opinion of the Chair, two-thirds being in the affirmative, the ayes have it.
Mr. BISHOP of North Carolina. Mr. Speaker, on that I demand the yeas and nays.
The SPEAKER pro tempore. Pursuant to section 3(s) of House Resolution 8, the yeas and nays are ordered.
Pursuant to clause 8 of rule XX, further proceedings on this motion are postponed.
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SOURCE: Congressional Record Vol. 167, No. 64
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