Food Allergen Labeling and Consumer Protection Act of 2003

        [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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