[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3684 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 3684

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


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            December 8, 2003

 Mrs. Lowey (for herself, Mr. Greenwood, Mr. LaTourette, Ms. Woolsey, 
Mr. Serrano, Mr. Pallone, Mr. Hoeffel, Ms. Slaughter, Mr. Hinchey, Ms. 
  Norton, Ms. DeLauro, Mr. George Miller of California, Mr. Brown of 
Ohio, Ms. Roybal-Allard, and Mr. Waxman) introduced the following bill; 
       which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to establish labeling 
 requirements with respect to allergenic substances in foods, 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 of 2003''.

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 the foods 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 to correctly identify in each of 
        several food labels the ingredients derived from major food 
        allergens;
            (5)(A) ingredients in foods must 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) in other cases, the ingredients may be declared as a 
        class, including spices, flavorings, and certain colorings, or 
        are exempt from the ingredient labeling requirements, such as 
        incidental additives; 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:
    ``(w)(1) If it is not a raw agricultural commodity and it is, or it 
contains an ingredient that bears or contains, a major food allergen, 
unless either--
            ``(A) the word `Contains', followed by the name of the food 
        source from which the major food allergen is derived, is 
        printed immediately after or is adjacent to the list of 
        ingredients (in a type size no smaller than the type size used 
        in 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 subsections (g) and 
        (i) is followed in parentheses by the name of the food source 
        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 
                uses the name of the food source from which the major 
                food allergen is derived; or
                    ``(ii) the name of the food source from which the 
                major food allergen is derived appears elsewhere in the 
                ingredient list, unless the name of the food source 
                appears elsewhere in the ingredient list only in the 
                common or usual name of foods that are food ingredients 
                that are not major food allergens under section 
                201(qq)(2)(A) or (B).
    ``(2) As used in this subsection, the term `name of the food source 
from which the major food allergen is derived' means the name described 
in section 201(qq)(1); provided that in the case of a tree nut, fish, 
or Crustacean shellfish, the term `name of the food source from which 
the major food allergen is derived' means the name of the specific type 
of nut or species of fish or Crustacean shellfish.
    ``(3) The information required under this subsection may appear in 
labeling in lieu of appearing on 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 paragraph (including any change in 
an earlier finding under this paragraph) is effective upon publication 
in the Federal Register as a notice.
    ``(4) Notwithstanding subsection (g), (i), or (k), or any other 
law, a flavoring, coloring, or incidental additive that is, or that 
bears or contains, a major food allergen shall be subject to the 
labeling requirements of this subsection.
    ``(5) 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 requirements of subparagraph (B) 
of paragraph (1), if the Secretary determines that the modification or 
elimination of the requirement of subparagraph (A) or the requirements 
of subparagraph (B) is necessary to protect the public health.
    ``(6)(A) Any person may petition the Secretary to exempt a food 
ingredient described in section 201(qq)(2) from the allergen labeling 
requirements of this subsection.
    ``(B) The Secretary shall approve or deny such petition within 180 
days of receipt of the petition or the petition shall be deemed denied, 
unless an extension of time is mutually agreed upon by the Secretary 
and the petitioner.
    ``(C) The burden shall be on the petitioner to provide scientific 
evidence (including the analytical method used to produce the evidence) 
that demonstrates that such food ingredient, as derived by the method 
specified in the petition, does not cause an allergic response that 
poses a risk to human health.
    ``(D) A determination regarding a petition under this paragraph 
shall constitute final agency action.
    ``(E) The Secretary shall promptly post to a public site all 
petitions received under this paragraph within 14 days of receipt and 
the Secretary shall promptly post the Secretary's response to each.
    ``(7)(A) A person need not file a petition under paragraph (6) to 
exempt a food ingredient described in section 201(qq)(2) from the 
allergen labeling requirements of this subsection, if the person files 
with the Secretary a notification containing--
            ``(i) scientific evidence (including the analytical method 
        used) that demonstrates that the food ingredient (as derived by 
        the method specified in the notification, where applicable) 
        does not contain allergenic protein; or
            ``(ii) a determination by the Secretary that the ingredient 
        does not cause an allergic response that poses a risk to human 
        health under a premarket approval or notification program under 
        section 409.
    ``(B) The food ingredient may be introduced or delivered for 
introduction into interstate commerce as a food ingredient that is not 
a major food allergen 90 days after the date of receipt of the 
notification by the Secretary, unless the Secretary determines within 
the 90-day period that the notification does not meet the requirements 
of this paragraph, or there is insufficient scientific evidence to 
determine that the food ingredient does not contain allergenic protein 
or does not cause an allergenic response that poses a risk to human 
health.
    ``(C) The Secretary shall promptly post to a public site a list of 
all notifications received under this subparagraph within 14 days of 
receipt and promptly post any objections thereto by the Secretary.
    ``(x) Notwithstanding subsection (g), (i), or (k), or any other 
law, a spice, flavoring, coloring, or incidental additive that is, or 
that 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.--The amendments made by this section 
that require a label or labeling for major food allergens do 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 
a label or labeling for other food allergens.
    (c) Conforming Amendments.--
            (1) Section 201 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 321) (as amended by section 2(b)) is amended by 
        adding at the end the following:
    ``(qq) The term `major food allergen' means any of the following:
            ``(1) Milk, egg, fish (e.g., bass, flounder, or cod), 
        Crustacean shellfish (e.g., crab, lobster, or shrimp), tree 
        nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and 
        soybeans.
            ``(2) A food ingredient that contains protein derived from 
        a food specified in paragraph (1), except the following:
                    ``(A) Any highly refined oil derived from a food 
                specified in paragraph (1) and any ingredient derived 
                from such highly refined oil.
                    ``(B) A food ingredient that is exempt under 
                paragraph (6) or (7) of section 403(w).''.
            (2) Section 403A(a)(2) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 343-1(a)(2)) is amended by striking 
``or 403(i)(2)'' and inserting ``403(i)(2), 403(w), or 403(x)''.
    (d) Effective Date.--The amendments made by this section shall 
apply to any food that is labeled on or after January 1, 2006.

SEC. 4. REPORT ON FOOD ALLERGENS.

    Not later than 18 months after the date of enactment of this Act, 
the Secretary of Health and Human Services (in this section referred to 
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--
            (1)(A) analyzes--
                    (i) the ways in which foods, during manufacturing 
                and processing, are 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 are unintentionally contaminated with 
                major food allergens; and
            (B) estimates how common the practices described in 
        subparagraph (A) are in the food industry, with breakdowns by 
        food type as appropriate;
            (2) advises whether good manufacturing practices or other 
        methods 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 
                labeling that uses 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) describes how consumers with food allergies or the 
        caretakers of consumers would prefer that information about the 
        risk of cross-contact be communicated on food labels as 
        determined by using appropriate survey mechanisms;
            (5) states the number of inspections of food manufacturing 
        and processing facilities conducted in the previous 2 years and 
        describes--
                    (A) the number of facilities and food labels that 
                were found to be in compliance or out of compliance 
                with respect to cross-contact of foods with residues of 
                major food allergens and the proper labeling of major 
                food allergens;
                    (B) the nature of the violations found; and
                    (C) the number of voluntary recalls, and their 
                classifications, of foods containing undeclared major 
                food allergens; and
            (6) assesses the extent to which the Secretary and the food 
        industry have effectively addressed cross-contact issues.

SEC. 5. INSPECTIONS RELATING TO FOOD ALLERGENS.

    The Secretary of Health and Human Services shall conduct 
inspections consistent with the authority 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 entities operating the facilities 
        comply with practices to reduce or eliminate cross-contact of a 
        food with residues of major food allergens that are not 
        intentional ingredients of the food; and
            (2) to ensure that major food allergens are properly 
        labeled on foods.

SEC. 6. GLUTEN LABELING.

    Not later than 2 years after the date of enactment of this Act, the 
Secretary of Health and Human Services, in consultation with 
appropriate experts and stakeholders, shall issue a proposed rule to 
define, and permit use of, the term ``gluten-free'' on the labeling of 
foods. Not later than 4 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.

SEC. 7. IMPROVEMENT AND PUBLICATION OF DATA ON FOOD-RELATED ALLERGIC 
              RESPONSES.

    (a) In General.--The Secretary of Health and Human Services, acting 
through the Director of the Centers for Disease Control and Prevention 
and in consultation with the Commissioner of Food and Drugs, shall 
improve (including by educating physicians and other health care 
providers) 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.
    (b) 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, acting 
through the Director of the National Institutes of Health, shall 
convene an ad hoc panel of nationally recognized experts in allergy and 
immunology to review current basic and clinical research efforts 
related to food allergies.
    (b) Recommendations.--Not later than 1 year after the date of 
enactment of this Act, the panel shall make recommendations to the 
Secretary for enhancing and coordinating research activities concerning 
food allergies, which the Secretary shall make public.

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 efforts to encourage 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 guidelines and recommendations developed by 
public and private entities for public and private food establishments 
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.
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