[Congressional Record Volume 148, Number 123 (Wednesday, September 25, 2002)]
[Senate]
[Pages S9231-S9233]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. Kennedy (for himself, Mr. Gregg, Mrs. Clinton, Mr. 
        Roberts, Mr. Dodd, Mr. Frist, Mr. Jeffords, Ms. Collins, and 
        Mr. Torricelli):
  S. 3001. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
establish labeling requirements regarding allergenic substances in 
food, and for other purposes; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. KENNEDY. Mr. President, I am pleased today to join my colleagues 
Senator Gregg, Senator Clinton, Senator Roberts, Senator Dodd, Senator 
Frist and others in introducing legislation to improve the labeling of 
allergens in food.
  American families deserve to feel confident that the food they eat is 
safe. The Food Allergen Labeling and Consumer Protection Act will allow 
the seven million Americans with food allergies to identify more easily 
a product's ingredients, avoid foods that may harm them, and stay 
healthy. One hundred fifty Americans die each year from ingesting 
allergenic foods, and this legislation will greatly reduce that number.
  The Food Allergen Labeling and Consumer Protection Act will require 
that food ingredient statements on food packages identify in common 
language when an ingredient, including a flavoring, coloring, or other 
additive, is itself, or is derived from, one of the eight main food 
allergens.
  The Food Allergen Labeling and Consumer Protection Act will require 
the Food and Drug Administration to provide for ``gluten-free'' 
labeling on foods, to help people with celiac disease avoid the glutens 
that cause their disease. It will require FDA to report to Congress 
about how manufacturers can minimize cross-contact with food allergens 
between foods produced in the same facility or on the same production 
line, and about when manufacturers should use ``may contain'' or other 
advisory language in food labeling.
  The Food Allergen Labeling and Consumer Protection Act will also 
require the Centers for Disease Control and Prevention to track deaths 
related to food allergies, and it will direct the National Institutes 
of Health to develop a plan for research activities concerning food 
allergies.
  I urge my colleagues in the Senate to support this legislation that 
will do so much to improve the lives of those with food allergies and 
celiac disease. I ask unanimous consent that the text of the bill be 
printed in the Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 3001

       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 Allergen Labeling and 
     Consumer Protection Act''.

     SEC. 2. FINDINGS.

       Congress finds that--
       (1) it is estimated that--
       (A) approximately 2 percent of adults and about 5 percent 
     of infants and young children in the United States suffer 
     from food allergies; and
       (B) each year, roughly 30,000 individuals require emergency 
     room treatment and 150 individuals die because of allergic 
     reactions to food;
       (2)(A) Eight major foods or food groups--milk, eggs, fish, 
     Crustacean shellfish, tree nuts, peanuts, wheat, and 
     soybeans--account for 90 percent of food allergies;
       (B) at present, there is no cure for food allergies; and
       (C) a food allergic consumer must avoid the food to which 
     the consumer is allergic;
       (3)(A) in a review of randomly selected manufacturers of 
     baked goods, ice cream, and candy in Minnesota and Wisconsin 
     in 1999, the Food and Drug Administration found that 25 
     percent of sampled foods failed to list peanuts or eggs as 
     ingredients on the food labels; and
       (B) nationally, the number of recalls because of unlabeled 
     allergens rose to 121 in 2000 from about 35 a decade earlier;
       (4) a recent study shows that many parents of children with 
     a food allergy were unable correctly to identify in each of 
     several food labels the ingredients derived from major food 
     allergens;
       (5)(A) current regulations of the Food and Drug 
     Administration require that ingredients in foods be listed by 
     their ``common or usual name'';
       (B) in some cases, the common or usual name of an 
     ingredient may be unfamiliar to consumers, and many consumers 
     may not realize the ingredient is derived from, or contains, 
     a major food allergen; and
       (C) current regulations of the Food and Drug Administration 
     exempt spices, flavorings, and certain colorings and 
     additives from ingredient labeling requirements that would 
     allow consumers to avoid those to which they are allergic; 
     and
       (6)(A) celiac disease is an immune-mediated disease that 
     causes damage to the gastrointestinal tract, central nervous 
     system, and other organs;
       (B) the current recommended treatment is avoidance of 
     glutens in foods that are associated with celiac disease; and
       (C) a multicenter, multiyear study estimated that the 
     prevalence of celiac disease in the United States is 0.5 to 1 
     percent of the general population.

     SEC. 3. FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING 
                   ALLERGENIC SUBSTANCES.

       (a) In General.--Section 403 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 343) is amended by adding at the end 
     the following:
       ``(t)(1) If it is not a raw agricultural commodity and it 
     is, or it intentionally bears or contains, a major food 
     allergen, unless either--
       ``(A) `Contains', which statement is followed by the name 
     of the food source as described in section 201(ll)(1) from 
     which the major food allergen is derived, follows immediately 
     after or is adjacent to (in a type size no smaller than the 
     type size used in the list of ingredients) the list of 
     ingredients required under subsections (g) and (i); or
       ``(B) the common or usual name of the major food allergen 
     in the list of ingredients required under sections (g) and 
     (i) is followed in parentheses by the name of the food source 
     as described in section 201(ll)(1) from which the major food 
     allergen is derived, except that the name of the food source 
     is not required when--
       ``(i) the common or usual name of the ingredient is the 
     term used to describe a major food allergen in section 
     201(ll)(1), or
       ``(ii) the name of the food source as described in section 
     201(ll)(1) has appeared previously in the ingredient list; 
     and

       ``Provided all major food allergens are labeled in a 
     consistent manner either as specified in clause (A) or as 
     specified in clause (B).
       ``(2) The information required under this subsection may 
     appear in labeling other than the label only if the Secretary 
     finds that such other labeling is sufficient to protect the 
     public health. A finding by the Secretary under this 
     subparagraph is effective upon publication in the Federal 
     Register as a notice (including any change in an earlier 
     finding under this subparagraph).
       ``(3) Notwithstanding subsection (g), (i), or (k), or any 
     other law, a spice, flavoring,

[[Page S9232]]

     coloring, or incidental additive that is, or that 
     intentionally bears or contains, a major food allergen shall 
     be subject to the labeling requirements of this subsection.
       ``(4) The Secretary may by regulation modify the 
     requirements of subparagraph (A) or (B) of paragraph (1), or 
     eliminate either the requirement of subparagraph (A) or the 
     requirement of subparagraph (B), if the Secretary determines 
     that the modification or elimination of the requirement is 
     necessary to protect the public health.
       ``(u) Notwithstanding subsection (g), (i), or (k), or any 
     other law, a spice, flavoring, coloring, or incidental 
     additive that is, or that intentionally bears or contains, a 
     food allergen (other than a major food allergen), as 
     determined by the Secretary by regulation, shall be disclosed 
     in a manner specified by the Secretary by regulation.''.
       (b) Effect on Other Authority.--This section does not alter 
     the authority of the Secretary of Health and Human Services 
     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
     et seq.) to require the labeling of other food allergens.
       (c) Conforming Amendment.--Section 201 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 321) is amended by adding 
     at the end the following:
       ``(ll) The term `major food allergen' means any of the 
     following:
       ``(1) Milk, egg, fish, Crustacean shellfish, tree nuts, 
     wheat, peanuts, and soybeans.
       ``(2) A proteinaceous substance derived from a food 
     specified in paragraph (1) (unless the Secretary determines 
     that the substance does not cause an allergic response that 
     poses a risk to human health).''.
       (d) Effective Date.--A food that is labeled on or after 
     January 1, 2006, and that is, or that intentionally bears or 
     contains, a major food allergen (as defined in the amendment 
     made by subsection (c)) shall be labeled in compliance with 
     the requirements of the amendment made by subsection (a).

     SEC. 4. REPORT ON FOOD ALLERGENS.

       Not later than June 30, 2004, the Secretary of Health and 
     Human Services 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--
       (1)(A) analyzes--
       (i) the ways in which foods, during manufacturing and 
     processing, can be unintentionally contaminated with major 
     food allergens, including contamination caused by the use by 
     manufacturers of the same production line to produce both 
     products for which major food allergens are intentional 
     ingredients and products for which major food allergens are 
     not intentional ingredients; and
       (ii) the ways in which foods produced on dedicated 
     production lines might nonetheless become unintentionally 
     contaminated with major food allergens; and
       (B) estimates how common those practices are in the food 
     industry, with breakdowns by food type as appropriate;
       (2) recommends methods that can be used to reduce or 
     eliminate cross-contact of foods with the major food 
     allergens;
       (3) describes--
       (A) the various types of advisory labeling (such as use of 
     the words ``may contain'') used by food producers;
       (B) the conditions of manufacture of food that are 
     associated with the various types of advisory labeling; and
       (C) the extent to which advisory labels are being used on 
     food products;
       (4) determines how consumers with food allergies or the 
     caretakers of consumers would prefer information about the 
     risk of cross-contact be communicated on food labels by using 
     appropriate survey mechanisms; and
       (5) identifies the circumstances, if any, under which 
     advisory labeling could appropriately be used.

     SEC. 5. INSPECTIONS RELATING TO FOOD ALLERGENS.

       (a) In General.--The Secretary of Health and Human Services 
     shall give priority to increasing the number of inspections 
     under section 704 of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 374) of facilities in which foods are 
     manufactured, processed, packed, or held--
       (1) to ensure that the foods comply with practices to 
     reduce or eliminate cross-contact of a food with major food 
     allergen residues that are not intentional ingredients of the 
     food; and
       (2) to ensure that major food allergens are properly 
     labeled on foods.
       (b) Report.--On October 1, 2003, and biennially thereafter, 
     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--
       (1) states the number of inspections conducted in the 
     previous year and the numbers of facilities and food labels 
     that were found to be in compliance or out of compliance;
       (2) describes the nature of the violations found;
       (3) includes the number of voluntary recalls, and their 
     classifications, requested by the Secretary of foods with 
     undeclared major food allergens;
       (4) assesses the extent of use of advisory language found 
     and the appropriateness of that use; and
       (5) assesses the extent to which the Secretary and the food 
     industry have effectively addressed cross-contact issues.

     SEC. 6. LABELING OF GLUTENS AND CELIAC DISEASE.

       (a) Contract With Institute of Medicine.--The Secretary of 
     Health and Human Services (in this section, the 
     ``Secretary'') shall enter into a contract with the Institute 
     of Medicine for--
       (1) the conduct of a review of the science relating to--
       (A) the glutens in food that are associated with celiac 
     disease;
       (B) the means of preventing and treating celiac disease; 
     and
       (C) the methodologies for detecting such glutens in foods; 
     and
       (2) the submission to the Secretary, the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, not later than 2 years after the date of 
     enactment of this Act, of a report concerning the review 
     conducted under paragraph (1).
       (b) Requirements of Expertise.--The Institute of Medicine 
     shall conduct the review under subsection (a)(1) and make the 
     report under subsection (a)(2) in conjunction with experts in 
     celiac disease, including experts in the pathogenesis, 
     epidemiology, and biochemistry of celiac disease, the 
     sensitivity to, and tolerance of, the glutens in food that 
     are associated with celiac disease, and the clinical aspects 
     of celiac disease, including prevention and treatment.
       (c) Gluten Labeling.--Considering the review conducted 
     under paragraph (a)(1), the Secretary shall, not later than 4 
     years after the date of enactment of this Act, issue a 
     proposed rule to define, and permit use of, the term 
     ``gluten-free'' on the labeling of foods. Not later than 6 
     years after the date of enactment of this Act, the Secretary 
     shall issue a final rule to define, and permit use of, the 
     term ``gluten-free'' on the labeling of foods.
       (d) Report.--Not later than 2 years after submission to the 
     Secretary of the report under subsection (a)(2), 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 
     assesses whether additional requirements for the labeling of 
     gluten are warranted and necessary to better inform 
     individuals with celiac disease, and if other labeling is 
     warranted and necessary, identifies the types of such 
     labeling.

     SEC. 7. DATA ON FOOD-RELATED ALLERGIC RESPONSES.

       (a) Study.--Not later than one year after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services (in this section referred to as the ``Secretary''), 
     in consultation with consumers, providers, State governments, 
     and other relevant parties, shall complete a study for the 
     purposes of--
       (1) determining whether existing systems for the reporting, 
     collection and analysis of national data accurately capture 
     information on--
       (A) the prevalence of food allergies;
       (B) the incidence of clinically significant or serious 
     adverse events related to food allergies; and
       (C) the use of different modes of treatment for and 
     prevention of allergic responses to foods; and
       (2) identifying new or alternative systems or enhancements 
     to existing systems (including by educating physicians and 
     other health care providers), for the reporting collection 
     and analysis of national data on--
       (A) the prevalence of food allergies;
       (B) the incidence of clinically significant or serious 
     adverse events related to food allergies; and
       (C) the use of different modes of treatment for and 
     prevention of allergic responses to foods.
       (b) Improvement and Publication of Data.--On completion of, 
     and consistent with the findings of, the study conducted 
     under subsection (a), the Secretary, acting through the 
     Director of the Centers for Disease Control and Prevention 
     and in consultation with the Commissioner of Foods and Drugs, 
     shall improve the collection of, and publish as it becomes 
     available, national data on--
       (1) the prevalence of food allergies;
       (2) the incidence of clinically significant or serious 
     adverse events related to food allergies; and
       (3) the use of different modes of treatment for and 
     prevention of allergic responses to foods.
       (c) Report to Congress.--Not later than 30 months after the 
     date of the enactment of this Act, the Secretary shall submit 
     to the Congress a report on the progress made with respect to 
     subsections (a) and (b).
       (d) Authorization of Appropriations.--For the purpose of 
     carrying out this section, there are authorized to be 
     appropriated such sums as may be necessary.

     SEC. 8. FOOD ALLERGIES RESEARCH.

       (a) In General.--The Secretary of Health and Human 
     Services, through the National Institutes of Health, shall 
     convene a panel of nationally recognized experts to review 
     current basic and clinical research efforts related to food 
     allergies. The panel shall develop a plan for expanding, 
     intensifying, and coordinating research activities concerning 
     food allergies.
       (b) Report to Congress.--Not later than 1 year after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services shall submit a plan under subsection (a) to 
     the Committee on Energy and Commerce in the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions in the Senate.

[[Page S9233]]

     SEC. 9. FOOD ALLERGENS IN THE FOOD CODE.

       The Secretary of Health and Human Services shall, in the 
     Conference for Food Protection, as part of its cooperative 
     activities between the States under section 311 of the Public 
     Health Service Act (42 U.S.C. 243), pursue revision of the 
     Food Code to provide guidelines for preparing allergen-free 
     foods in food establishments, including in restaurants, 
     grocery store delicatessens and bakeries, and elementary and 
     secondary school cafeterias. The Secretary shall consider 
     public and private guidelines and recommendations for 
     preparing allergen-free foods in pursuing this revision.

     SEC. 10. RECOMMENDATIONS REGARDING RESPONDING TO FOOD-RELATED 
                   ALLERGIC RESPONSES.

       The Secretary of Health and Human Services shall, in 
     providing technical assistance relating to trauma care and 
     emergency medical services to State and local agencies under 
     section 1202(b)(3) of the Public Health Service Act (42 
     U.S.C. 300d-2(b)(3)), include technical assistance relating 
     to the use of different modes of treatment for and prevention 
     of allergic responses to foods.
                                 ______