[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 2499 Reported in Senate (RS)]






                                                       Calendar No. 739
107th CONGRESS
  2d Session
                                S. 2499

                          [Report No. 107-322]

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

                              May 9, 2002

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

                            October 17, 2002

               Reported by Mr. Kennedy, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in Italic]

_______________________________________________________________________

                                 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,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Food Allergen Consumer 
Protection Act''.</DELETED>

<DELETED>SEC. 2. FINDINGS.</DELETED>

<DELETED>    The Congress finds as follows:</DELETED>
        <DELETED>    (1) Approximately 7,000,000 Americans suffer from 
        food allergies. Every year roughly 30,000 people receive 
        emergency room treatment due to the ingestion of allergenic 
        foods, and an estimated 150 Americans die from anaphylactic 
        shock caused by a food allergy.</DELETED>
        <DELETED>    (2) Eight major foods--milk, egg, fish, Crustacea, 
        tree nuts, wheat, peanuts, and soybeans--cause 90 percent of 
        allergic reactions. At present, there is no cure for food 
        allergies. A food allergic consumer depends on a product's 
        label to obtain accurate and reliable ingredient information so 
        as to avoid food allergens.</DELETED>
        <DELETED>    (3) Current Food and Drug Administration 
        regulations exempt spices, flavorings, and certain colorings 
        and additives from ingredient labeling requirements that would 
        allow consumers to avoid those to which they are allergic. Such 
        unlabeled food allergens may pose a serious health threat to 
        those susceptible to food allergies.</DELETED>
        <DELETED>    (4) A recent Food and Drug Administration study 
        found that 25 percent of bakery products, ice creams, and 
        candies that were inspected failed to list peanuts and eggs, 
        which can cause potentially fatal allergic reactions. The 
        mislabeling of foods puts those with a food allergy at constant 
        risk.</DELETED>
        <DELETED>    (5) In that study, the Food and Drug 
        Administration found that only slightly more than half of 
        inspected manufacturers checked their products to ensure that 
        all ingredients were accurately reflected on the labels. 
        Furthermore, the number of recalls because of unlabeled 
        allergens rose to 121 in 2000 from about 35 a decade earlier. 
        In part, mislabeling occurs because potentially fatal allergens 
        are introduced into the manufacturing process when production 
        lines and cooking utensils are shared or used to produce 
        multiple products.</DELETED>
        <DELETED>    (6) Individuals who have food allergies may 
        outgrow their allergy if they strictly avoid consuming the 
        allergen. However, some scientists believe that because low 
        levels of allergens are unintentionally present in foods, those 
        with an allergy are unable to keep from being repeatedly 
        exposed to the very foods they are allergic to. Good 
        manufacturing practices can minimize the unintentional presence 
        of food allergens. In addition, when good manufacturing 
        practices cannot eliminate the potential for cross-
        contamination, an advisory label on the product can provide 
        additional consumer protection.</DELETED>
        <DELETED>    (7) The Food and Drug Administration is the 
        Nation's principal consumer protection agency, charged with 
        protecting and promoting public health through premarket and 
        postmarket regulation of food. The agency must have both the 
        necessary authority to ensure that foods are properly labeled 
        and produced using good manufacturing practices and the ability 
        to penalize manufacturers who violate our food safety 
        laws.</DELETED>
        <DELETED>    (8) Americans deserve to have confidence in the 
        safety and labeling of the food on their tables.</DELETED>

<DELETED>SEC. 3. FOOD LABELING; REQUIREMENT OF INFORMATION REGARDING 
              ALLERGENIC SUBSTANCES.</DELETED>

<DELETED>    (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:</DELETED>
<DELETED>    ``(t)(1) If it is not a raw agricultural commodity and it 
is, or it intentionally bears or contains, a known food allergen, 
unless its label bears, in bold face type, the common or usual name of 
the known food allergen and the common or usual name of the food source 
described in subparagraph (3)(A) from which the known food allergen is 
derived, except that the name of the food source is not required when 
the common or usual name of the known food allergen plainly identifies 
the food source.</DELETED>
<DELETED>    ``(2) The information required under this paragraph 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).</DELETED>
<DELETED>    ``(3) For purposes of this Act, the term `known food 
allergen' means any of the following:</DELETED>
        <DELETED>    ``(A) Milk, egg, fish, Crustacea, tree nuts, 
        wheat, peanuts, and soybeans.</DELETED>
        <DELETED>    ``(B) A proteinaceous substance derived from a 
        food specified in clause (A), unless the Secretary determines 
        that the substance does not cause an allergic response that 
        poses a risk to human health.</DELETED>
        <DELETED>    ``(C) Other grains containing gluten (rye, barley, 
        oats, and triticale).</DELETED>
        <DELETED>    ``(D) In addition, any food that the Secretary by 
        regulation determines causes an allergic or other adverse 
        response that poses a risk to human health.</DELETED>
<DELETED>    ``(4) Notwithstanding paragraph (g), (i), or (k), or any 
other law, the labeling requirement under this paragraph applies to 
spices, flavorings, colorings, or incidental additives that are, or 
that bear or contain, a known food allergen.</DELETED>
<DELETED>    ``(u) If it is a raw agricultural commodity that is, or 
bears or contains, a known food allergen, unless it has a label or 
other labeling that bears in bold face type the common or usual name of 
the known food allergen and the Secretary has found that the label or 
other labeling is sufficient to protect the public health. A finding by 
the Secretary under this paragraph is effective upon publication in the 
Federal Register as a notice (including any change in an earlier 
finding under this paragraph).</DELETED>
<DELETED>    ``(w) If the labeling required under paragraphs (g), (i), 
(k), (t), (u), or (v)--</DELETED>
        <DELETED>    ``(1) does not use a single, easy-to-read type 
        style that is black on a white background, using upper and 
        lower case letters and with no letters touching;</DELETED>
        <DELETED>    ``(2) does not use at least 8 point type with at 
        least one point leading (i.e., space between two lines of 
        text), provided the total surface area of the food package 
        available to bear labeling exceeds 12 square inches; 
        or</DELETED>
        <DELETED>    ``(3) does not comply with regulations issued by 
        the Secretary to make it easy for consumers to read and use 
        such labeling by requiring a format that is comparable to the 
        format required for the disclosure of nutrition information in 
        the food label under section 101.9(d)(1) of title 21, Code of 
        Federal Regulations.''.</DELETED>
<DELETED>    (b) Civil Penalties.--Section 303(g)(2) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 333(g)(2)) is amended--
</DELETED>
        <DELETED>    (1) in subparagraph (A), by striking ``section 
        402(a)(2)(B) shall be subject'' and inserting the following: 
        ``section 402(a)(2)(B) or regulations under this chapter to 
        minimize the unintended presence of allergens in food, or that 
        is misbranded within the meaning of section 403(t), 403(u), 
        403(v), or 403(w), shall be subject''; and</DELETED>
        <DELETED>    (2) in subparagraph (B), by inserting ``or 
        misbranded'' after ``adulterated'' each place such term 
        appears.</DELETED>
<DELETED>    (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:</DELETED>
<DELETED>    ``(ll) The term `known food allergen' has the meaning 
given such term in section 403(t)(3).''.</DELETED>
<DELETED>  (d) Effective Date.--The amendments made by this section 
take effect upon the expiration of the 180-day period beginning on the 
date of the enactment of this Act.</DELETED>

<DELETED>SEC. 4. UNINTENTIONAL PRESENCE OF KNOWN FOOD 
              ALLERGENS.</DELETED>

<DELETED>    (a) Food Labeling of Such Food Allergens.--Section 403 of 
the Federal Food, Drug, and Cosmetic Act, as amended by section 3(a) of 
this Act, is amended by inserting after paragraph (u) the 
following:</DELETED>
<DELETED>    ``(v) If the presence of a known food allergen in the food 
is unintentional and its labeling bears a statement that the food may 
bear or contain the known food allergen, or any similar statement, 
unless the statement is made in compliance with regulations issued by 
the Secretary to provide for advisory labeling of the known food 
allergen.''.</DELETED>
<DELETED>    (b) Effective Date.--The amendment made by subsection (a) 
takes effect upon the expiration of the four-year period beginning on 
the date of the enactment of this Act, except with respect to the 
authority of the Secretary of Health and Human Services to engage in 
rulemaking in accordance with section 5.</DELETED>

<DELETED>SEC. 5. REGULATIONS.</DELETED>

<DELETED>    (a) In General.--</DELETED>
        <DELETED>    (1) Regulations.--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'') shall issue a proposed rule under sections 402, 
        403, and 701(a) of the Federal Food, Drug, and Cosmetic Act to 
        implement the amendments made by this Act. Not later than two 
        years after such date of enactment, the Secretary shall 
        promulgate a final rule under such sections.</DELETED>
        <DELETED>    (2) Effective date.--The final rule promulgated 
        under paragraph (1) takes effect upon the expiration of the 
        four-year period beginning on the date of the enactment of this 
        Act. If a final rule under such paragraph has not been 
        promulgated as of the expiration of such period, then upon such 
        expiration the proposed rule under such paragraph takes effect 
        as if the proposed rule were a final rule.</DELETED>
<DELETED>    (b) Unintentional Presence of Known Food Allergens.--
</DELETED>
        <DELETED>    (1) Good manufacturing practices; records.--
        Regulations under subsection (a) shall require the use of good 
        manufacturing practices to minimize, to the extent practicable, 
        the unintentional presence of allergens in food. Such 
        regulations shall include appropriate record keeping and record 
        inspection requirements.</DELETED>
        <DELETED>    (2) Advisory labeling.--In the regulations under 
        subsection (a), the Secretary shall authorize the use of 
        advisory labeling for a known food allergen when the Secretary 
        has determined that good manufacturing practices required under 
        the regulations will not eliminate the unintentional presence 
        of the known food allergen and its presence in the food poses a 
        risk to human health, and the regulations shall otherwise 
        prohibit the use of such labeling.</DELETED>
<DELETED>    (c) Ingredient Labeling Generally.--In regulations under 
subsection (a), the Secretary shall prescribe a format for labeling, as 
provided for under section 403(w)(3) of the Federal, Food, Drug, and 
Cosmetic Act.</DELETED>
<DELETED>    (d) Review by Office of Management and Budget.--If the 
Office of Management and Budget (in this section referred to as 
``OMB'') is to review proposed or final rules under this Act, OMB shall 
complete its review in 10 working days, after which the rule shall be 
published immediately in the Federal Register. If OMB fails to complete 
its review of either the proposed rule or the final rule in 10 working 
days, the Secretary shall provide the rule to the Office of the Federal 
Register, which shall publish the rule, and it shall have full effect 
(subject to applicable effective dates specified in this Act) without 
review by OMB. If the Secretary does not complete the proposed or final 
rule so as to provide OMB with 10 working days to review the rule and 
have it published in the Federal Register within the time frames for 
publication of the rule specified in this section, the rule shall be 
published without review by OMB.</DELETED>

<DELETED>SEC. 6. FOOD LABELING; INCLUSION OF TELEPHONE 
              NUMBER.</DELETED>

<DELETED>    (a) In General.--Section 403(e) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 343(e)) is amended--</DELETED>
        <DELETED>    (1) by striking ``and (2)'' and inserting the 
        following: ``(2) in the case of a manufacturer, packer, or 
        distributor whose annual gross sales made or business done in 
        sales to consumers equals or exceeds $500,000, a toll-free 
        telephone number (staffed during reasonable business hours) for 
        the manufacturer, packer, or distributor (including one to 
        accommodate telecommunications devices for deaf persons, 
        commonly known as TDDs); or in the case of a manufacturer, 
        packer, or distributor whose annual gross sales made or 
        business done in sales are less than $500,000, the mailing 
        address or the address of the Internet site for the 
        manufacturer, packer, or distributor; and (3)''; and</DELETED>
        <DELETED>    (2) by striking ``clause (2)'' and inserting 
        ``clause (3)''.</DELETED>
<DELETED>    (b) Effective Date.--The amendments made by subsection (a) 
take effect upon the expiration of the 180-day period beginning on the 
date of the enactment of this Act.</DELETED>

<DELETED>SEC. 7. DATA ON FOOD-RELATED ALLERGIC RESPONSES.</DELETED>

<DELETED>    (a) In General.--Consistent with the findings of the study 
conducted under subsection (b), the Secretary of Health and Human 
Services (in this section referred to as 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 (beginning 18 months after the date of 
the enactment of this Act) annually publish, national data on--
</DELETED>
        <DELETED>    (1) the prevalence of food allergies, 
        and</DELETED>
        <DELETED>    (2) the incidence of deaths, injuries, including 
        anaphylactic shock, hospitalizations, and physician visits, and 
        the utilization of drugs, associated with allergic responses to 
        foods.</DELETED>
<DELETED>    (b) Study.--Not later than one year after the date of the 
enactment of this Act, the Secretary, in consultation with consumers, 
providers, State governments, and other relevant parties, shall 
complete a study for the purposes of--</DELETED>
        <DELETED>    (1) determining whether existing systems for the 
        reporting, collection and analysis of national data accurately 
        capture information on the subjects specified in subsection 
        (a); and</DELETED>
        <DELETED>    (2) identifying new or alternative systems, or 
        enhancements to existing systems, for the reporting collection 
        and analysis of national data necessary to fulfill the purpose 
        of subsection (a).</DELETED>
<DELETED>    (c) Public and Provider Education.--The Secretary shall, 
directly or through contracts with public or private entities, educate 
physicians and other health providers to improve the reporting, 
collection, and analysis of data on the subjects specified in 
subsection (a).</DELETED>
<DELETED>    (d) Child Fatality Review Teams.--Insofar as is 
practicable, activities developed or expanded under this section shall 
include utilization of child fatality review teams in identifying and 
assessing child deaths associated with allergic responses to 
foods.</DELETED>
<DELETED>    (e) Reports to Congress.--Not later than 18 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) through (d).</DELETED>
<DELETED>    (f) Authorization of Appropriations.--For the purpose of 
carrying out this section, there are authorized to be appropriated 
$10,000,000 for fiscal year 2003, and such sums as may be necessary for 
each subsequent fiscal year.</DELETED>
<DELETED>    (g) Effective Date.--This section takes effect on the date 
of the enactment of this Act.</DELETED>

<DELETED>SEC. 8. FOOD ALLERGIES RESEARCH.</DELETED>

<DELETED>    (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, including recommendations for expenditures, for 
expanding, intensifying, and coordinating research activities 
concerning food allergies.</DELETED>
<DELETED>    (b) Report to Congress.--Not later than 180 days after the 
date of the 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.</DELETED>
<DELETED>    (c) Effective Date.--This section takes effect on the date 
of the enactment of this Act.</DELETED>

<DELETED>SEC. 9. CERTAIN FEDERAL RECOMMENDATIONS REGARDING AVOIDING AND 
              RESPONDING TO FOOD-RELATED ALLERGIC RESPONSES.</DELETED>

<DELETED>    The Secretary of Health and Human Services shall carry out 
the following:</DELETED>
        <DELETED>    (1) Develop and appropriately disseminate 
        recommendations on--</DELETED>
                <DELETED>    (A) training emergency medical technicians 
                with respect to administering epinephrine auto-injector 
                devices; and</DELETED>
                <DELETED>    (B) the need for emergency vehicles to 
                maintain supplies of such devices.</DELETED>
        <DELETED>    (2) Activities to increase the awareness by the 
        restaurant industry of public or private guidelines and 
        recommendations for training in preparing allergen-free foods, 
        including the Food Allergy and Anaphylaxis Network and Food 
        Allergy Initiative's document entitled ``Food Allergy Training 
        Guide for Restaurants and Good Services''.</DELETED>
        <DELETED>    (3) With respect to food prepared for students by 
        elementary and secondary schools, develop and appropriately 
        disseminate recommendations for the preparation of allergen-
        free foods, with priority given to the issue of life-
        threatening food allergies.</DELETED>

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) 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) spices, flavorings, and certain colorings and 
        incidental additives are exempt 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 
                uses 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) appears elsewhere 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 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 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 Amendments.--
            (1) 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 (e.g. bass, flounder, or tuna), 
        Crustacean shellfish (e.g. crab, lobster, or shrimp), tree nuts 
        (e.g. almonds, pecans, or walnuts), 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).''.
            (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(t), or 
        403(u)''.
    (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 good manufacturing practices or other 
        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) Reports.--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 2 years 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, 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.




                                                       Calendar No. 739

107th CONGRESS

  2d Session

                                S. 2499

                          [Report No. 107-322]

_______________________________________________________________________

                                 A BILL

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

_______________________________________________________________________

                            October 17, 2002

                       Reported with an amendment