I
107TH CONGRESS
2D SESSION
H. R. 4704
To amend the Federal Food, Drug, and Cosmetic Act to establish labeling
requirements regarding allergenic substances in food, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MAY 9, 2002
Mrs. LOWEY (for herself, Mrs. JONES of Ohio, Ms. MCKINNEY, Mr. KILDEE,
Mr. FRANK, Mr. KUCINICH, Mrs. MINK of Hawaii, Ms. RIVERS, Mr.
OWENS, Mr. RANGEL, Mr. NADLER, Ms. LEE, Ms. VELA´ZQUEZ, Mrs.
MORELLA, and Mr. ISRAEL) introduced the following bill; which was re-
ferred to the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
establish labeling requirements regarding allergenic sub-
stances in food, and for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ‘‘Food Allergen Con-
sumer 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 peo-
ple receive emergency room treatment due to the in-
gestion 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 soy-
beans—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 ob-
tain accurate and reliable ingredient information so
as to avoid food allergens.
(3) Current Food and Drug Administration reg-
ulations exempt spices, flavorings, and certain color-
ings and additives from ingredient labeling require-
ments that would allow consumers to avoid those to
which they are allergic. Such unlabeled food aller-
gens may pose a serious health threat to those sus-
ceptible 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 Adminis-
tration found that only slightly more than half of in-
spected manufacturers checked their products to en-
sure that all ingredients were accurately reflected on
the labels. Furthermore, the number of recalls be-
cause of unlabeled allergens rose to 121 in 2000
from about 35 a decade earlier. In part, mislabeling
occurs because potentially fatal allergens are intro-
duced into the manufacturing process when produc-
tion lines and cooking utensils are shared or used to
produce multiple products.
(6) Individuals who have food allergies may out-
grow 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 al-
lergens. In addition, when good manufacturing prac-
tices cannot eliminate the potential for cross-con-
tamination, 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 au-
thority 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 com-
mon 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 Fed-
eral Register as a notice (including any change in an ear-
lier 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 de-
termines that the substance does not cause an aller-
gic response that poses a risk to human health.
‘‘(C) Other grains containing gluten (rye, bar-
ley, 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 para-
graph 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 publica-
tion 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 sec-
tion 101.9(d)(1) of title 21, Code of Federal Regula-
tions.’’.
(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 fol-
lowing: ‘‘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 mis-
branded’’ 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 pe-
riod beginning on the date of the enactment of this Act.
SEC. 4. UNINTENTIONAL PRESENCE OF KNOWN FOOD AL-
LERGENS.
(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 Sec-
retary of Health and Human Services (in this sec-
tion 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 im-
plement 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 promul-
gated under paragraph (1) takes effect upon the ex-
piration 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 ex-
piration 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 in-
spection requirements.
(2) ADVISORY LABELING.—In the regulations
under subsection (a), the Secretary shall authorize
the use of advisory labeling for a known food aller-
gen when the Secretary has determined that good
manufacturing practices required under the regula-
tions 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 regula-
tions 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 re-
view in 10 working days, after which the rule shall be pub-
lished 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 re-
view by OMB. If the Secretary does not complete the pro-
posed or final rule so as to provide OMB with 10 working
days to review the rule and have it published in the Fed-
eral 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 NUM-
BER.
(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 fol-
lowing: ‘‘(2) in the case of a manufacturer, packer,
or distributor whose annual gross sales made or
business done in sales to consumers equals or ex-
ceeds $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 an-
nual gross sales made or business done in sales are
less than $500,000, the mailing address or the ad-
dress 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 con-
sultation 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 pub-
lish, 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 Sec-
retary shall, directly or through contracts with public or
private entities, educate physicians and other health pro-
viders 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 ex-
perts to review current basic and clinical research efforts
related to food allergies. The panel shall develop a plan,
including recommendations for expenditures, for expand-
ing, intensifying, and coordinating research activities con-
cerning 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 REGARD-
ING 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 rec-
ommendations 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 aller-
gen-free foods, including the Food Allergy and Ana-
phylaxis Network and Food Allergy Initiative’s docu-
ment entitled ‘‘Food Allergy Training Guide for Res-
taurants 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.
Æ