[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 3001 Introduced in Senate (IS)]







107th CONGRESS
  2d Session
                                S. 3001

To amend the Federal Food, Drug, and Cosmetic Act to establish labeling 
  requirements regarding allergenic substances in food, and for other 
                               purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 25, 2002

  Mr. Kennedy (for himself, Mr. Gregg, Mrs. Clinton, Mr. Roberts, Mr. 
    Dodd, Mr. Frist, Mr. Jeffords, Ms. Collins, and Mr. Torricelli) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to establish labeling 
  requirements regarding allergenic substances in food, and for other 
                               purposes.

    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, 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.

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.
                                 <all>