[Congressional Record Volume 148, Number 58 (Thursday, May 9, 2002)]
[Senate]
[Pages S4163-S4165]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. KENNEDY (for himself and Mrs. Clinton):
  S. 2499. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
establish labeling requirements regarding allergenic substances in 
food, and for other purposes; to the Committee on Health, Education, 
Labor, and Pensions.
  Mr. KENNEDY. Mr. President, I am pleased today to join my colleagues 
Senator Clinton and Congresswoman Nita Lowey in introducing legislation 
to improve the labeling of allergens in food.
  American families deserve to feel confident about the safety of the 
food on their tables. The Food Allergen Consumer Protection Act will 
allow the seven million Americans with food allergies to identify more 
easily a product's ingredients, avoid foods that may harm them, and 
stay healthy. We anticipate that this legislation will reduce the 
number, currently estimated to be 150 yearly, of Americans who die due 
to the ingestion of allergenic foods.
  The Food Allergen Consumer Production Act will require that food 
ingredient statements on food packages identify in common language when 
an ingredient, including a flavoring, coloring, or other additive, is 
itself, or is derived from, one of the eight main food allergens, or 
from grains containing gluten. This legislation will also make the 
ingredient label on foods easier to read, and require it to include a 
working telephone number, including one for telecommunication devices 
for deaf persons.

[[Page S4164]]

  The Food Allergen Consumer Protection Act will require food 
manufacturers to minimize cross-contamination with food allergens 
between foods produced in the same facility or on the same production 
line. It will require the use of ``may contain'' or other advisory 
language in food labeling when steps to reduce such cross-contamination 
will not eliminate it. This legislation also preserves the Food and 
Drug Administration's current authority to regulate the safety of 
certain products that are bioengineered to contain proteins that cause 
allergic reactions.
  The Food Allergen Consumer Protection Act will also require the 
Centers for Disease Control and Prevention to track deaths related to 
food allergies, and it will direct the National Institutes of Health to 
develop a plan for research activities concerning food allergies.
  I urge my colleagues in the Senate to support this legislation that 
will do so much to improve the lives of those with food allergies. I 
ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the bill was ordered to be printed in the 
Record, as follows:

                                S. 2499

       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

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     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.
                                 ______