1513-0121 Falcpa

PUBLIC LAW 108–282—AUG. 2, 2004

118 STAT. 905

(T) Section 108(b)(3) of Public Law 90–399 is amended
by striking ‘‘section 201(w) as added by this Act’’ and
inserting ‘‘section 201(v)’’.
(6) REGULATIONS.—On the date of enactment of this Act,
the Secretary of Health and Human Services shall implement
sections 571 and 573 of the Federal Food, Drug, and Cosmetic
Act and subsequently publish implementing regulations. Not
later than 12 months after the date of enactment of this Act,
the Secretary shall issue proposed regulations to implement
section 573 of the Federal Food, Drug, and Cosmetic Act (as
added by this Act), and not later than 24 months after the
date of enactment of this Act, the Secretary shall issue final
regulations implementing section 573 of the Federal Food,
Drug, and Cosmetic Act. Not later than 18 months after the
date of enactment of this Act, the Secretary shall issue proposed
regulations to implement section 572 of the Federal Food, Drug,
and Cosmetic Act (as added by this Act), and not later than
36 months after the date of enactment of this Act, the Secretary
shall issue final regulations implementing section 572 of the
Federal Food, Drug, and Cosmetic Act. Not later than 30
months after the date of enactment of this Act, the Secretary
shall issue proposed regulations to implement section 571 of
the Federal Food, Drug, and Cosmetic Act (as added by this
Act), and not later than 42 months after the date of enactment
of this Act, the Secretary shall issue final regulations implementing section 571 of the Federal Food, Drug, and Cosmetic
Act. These timeframes shall be extended by 12 months for
each fiscal year, in which the funds authorized to be appropriated under subsection (i) are not in fact appropriated.
(7) OFFICE.—The Secretary of Health and Human Services
shall establish within the Center for Veterinary Medicine (of
the Food and Drug Administration), an Office of Minor Use
and Minor Species Animal Drug Development that reports
directly to the Director of the Center for Veterinary Medicine.
This office shall be responsible for overseeing the development
and legal marketing of new animal drugs for minor uses and
minor species. There is authorized to be appropriated to carry
out this subsection $1,200,000 for fiscal year 2004 and such
sums as may be necessary for each fiscal year thereafter.
(8) AUTHORIZATION OF APPROPRIATIONS.—There is authorized to be appropriated to carry out section 573(b) of the Federal
Food, Drug, and Cosmetic Act (as added by this section)
$1,000,000 for the fiscal year following publication of final
implementing regulations, $2,000,000 for the subsequent fiscal
year, and such sums as may be necessary for each fiscal year
thereafter.

TITLE II—FOOD ALLERGEN LABELING
AND CONSUMER PROTECTION
SEC. 201. SHORT TITLE.

21 USC 360b
note.
Effective date.
Deadlines.
Publication.
21 USC 360ccc
note.

Government
organization.
21 USC 393 note.

Appropriation
authorization.

Food Allergen
Labeling and
Consumer
Protection Act of
2004.
21 USC 301 note.

This title may be cited as the ‘‘Food Allergen Labeling and
Consumer Protection Act of 2004’’.
SEC. 202. FINDINGS.

21 USC 343 note.

Congress finds that—

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118 STAT. 906

PUBLIC LAW 108–282—AUG. 2, 2004
(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. 203. FOOD
LABELING;
REQUIREMENT
OF
REGARDING ALLERGENIC SUBSTANCES.

INFORMATION

(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

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PUBLIC LAW 108–282—AUG. 2, 2004

118 STAT. 907

‘‘(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 that appears elsewhere in the ingredient list appears as part of the name
of a food ingredient that is not a major food allergen
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.

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Federal Register,
publication.

Public
information.
Deadline.

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118 STAT. 908

Deadlines.

Public
information.
Deadline.

21 USC 343 note.

Applicability.
21 USC 321 note.

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PUBLIC LAW 108–282—AUG. 2, 2004

‘‘(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 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 102(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.

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PUBLIC LAW 108–282—AUG. 2, 2004

118 STAT. 909

SEC. 204. 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. 205. INSPECTIONS RELATING TO FOOD ALLERGENS.

21 USC 374a.

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

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118 STAT. 910

PUBLIC LAW 108–282—AUG. 2, 2004
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.

Deadlines.
Regulations.
21 USC 343 note.

SEC. 206. GLUTEN LABELING.

42 USC 242r.

SEC. 207. IMPROVEMENT AND PUBLICATION OF DATA ON FOODRELATED ALLERGIC RESPONSES.

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.

(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.
42 USC 243 note.

SEC. 208. FOOD ALLERGIES RESEARCH.

Government
organization.

(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.

Deadline.
Public
information.

SEC. 209. 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.

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PUBLIC LAW 108–282—AUG. 2, 2004

118 STAT. 911

SEC. 210. RECOMMENDATIONS REGARDING RESPONDING TO FOODRELATED ALLERGIC RESPONSES.

42 USC 300d–2
note.

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.
Approved August 2, 2004.

LEGISLATIVE HISTORY—S. 741:
HOUSE REPORTS: No. 108–608 (Comm. on Energy and Commerce).
SENATE REPORTS: No. 108–226 (Comm. on Health, Education, Labor, and Pensions).
CONGRESSIONAL RECORD, Vol. 150 (2004):
Mar. 8, considered and passed Senate.
July 20, considered and passed House.

Æ

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