[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[S. 741 Enrolled Bill (ENR)]
S.741
One Hundred Eighth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Tuesday,
the twentieth day of January, two thousand and four
An Act
To amend the Federal Food, Drug, and Cosmetic Act with regard to new
animal drugs, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,

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This title may be cited as the ``Minor Use and Minor Species Animal
Health Act of 2004''.

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TITLE I

-MINOR USE AND MINOR SPECIES HEALTH

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This title may be cited as the ``Food Allergen Labeling and
Consumer Protection Act of 2004''.

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TITLE II

-FOOD ALLERGEN LABELING AND CONSUMER PROTECTION

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.

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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 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.
``(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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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.

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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.

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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.

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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.

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(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.

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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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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.
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.

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Minor Use and Minor Species Animal Health Act of 2004 — S. 741

Other Sections

TITLE I

TITLE II

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