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







107th CONGRESS
  2d Session
                                S. 2499

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 and Mrs. Clinton) 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 Consumer Protection 
Act''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (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.
            (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.
            (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.
            (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.
            (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.
            (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.
            (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.
            (8) Americans deserve to have confidence in the safety and 
        labeling of the food on their tables.

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 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.
    ``(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).
    ``(3) For purposes of this Act, the term `known food allergen' 
means any of the following:
            ``(A) Milk, egg, fish, Crustacea, tree nuts, wheat, 
        peanuts, and soybeans.
            ``(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.
            ``(C) Other grains containing gluten (rye, barley, oats, 
        and triticale).
            ``(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.
    ``(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.
    ``(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).
    ``(w) If the labeling required under paragraphs (g), (i), (k), (t), 
(u), or (v)--
            ``(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;
            ``(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
            ``(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.''.
    (b) Civil Penalties.--Section 303(g)(2) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 333(g)(2)) is amended--
            (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
            (2) in subparagraph (B), by inserting ``or misbranded'' 
        after ``adulterated'' each place such term appears.
    (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 `known food allergen' has the meaning given such 
term in section 403(t)(3).''.
  (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.

SEC. 4. UNINTENTIONAL PRESENCE OF KNOWN FOOD ALLERGENS.

    (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:
    ``(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.''.
    (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.

SEC. 5. REGULATIONS.

    (a) In General.--
            (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.
            (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.
    (b) Unintentional Presence of Known Food Allergens.--
            (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.
            (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.
    (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.
    (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.

SEC. 6. FOOD LABELING; INCLUSION OF TELEPHONE NUMBER.

    (a) In General.--Section 403(e) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 343(e)) is amended--
            (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
            (2) by striking ``clause (2)'' and inserting ``clause 
        (3)''.
    (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.

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

    (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--
            (1) the prevalence of food allergies, and
            (2) the incidence of deaths, injuries, including 
        anaphylactic shock, hospitalizations, and physician visits, and 
        the utilization of drugs, associated with allergic responses to 
        foods.
    (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--
            (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
            (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).
    (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).
    (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.
    (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).
    (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.
    (g) Effective Date.--This section takes effect on the date of the 
enactment of this Act.

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, including recommendations for expenditures, for expanding, 
intensifying, and coordinating research activities concerning food 
allergies.
    (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.
    (c) Effective Date.--This section takes effect on the date of the 
enactment of this Act.

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

    The Secretary of Health and Human Services shall carry out the 
following:
            (1) Develop and appropriately disseminate recommendations 
        on--
                    (A) training emergency medical technicians with 
                respect to administering epinephrine auto-injector 
                devices; and
                    (B) the need for emergency vehicles to maintain 
                supplies of such devices.
            (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''.
            (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.
                                 <all>