S 2499 RS
Mr. KENNEDY (for himself, Mrs. CLINTON, and Mr. TORRICELLI) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions
Reported by Mr. KENNEDY, with an amendment
SECTION 1. SHORT TITLE. [<-Struck
out]
This Act may be cited as the `Food Allergen
Consumer Protection Act'. [<-Struck out]
SEC. 2. FINDINGS. [<-Struck out]
The Congress finds as follows: [<-Struck
out]
(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.
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(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.
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(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.
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(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. [<-Struck out]
(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.
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(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. [<-Struck out]
(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.
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(8) Americans deserve to have confidence in the
safety and labeling of the food on their tables. [<-Struck
out]
SEC. 3. FOOD LABELING; REQUIREMENT OF INFORMATION
REGARDING ALLERGENIC SUBSTANCES. [<-Struck out]
(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: [<-Struck out]
`(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.
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`(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). [<-Struck out]
`(3) For purposes of this Act, the term `known
food allergen' means any of the following: [<-Struck out]
`(A) Milk, egg, fish, Crustacea, tree nuts,
wheat, peanuts, and soybeans. [<-Struck out]
`(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. [<-Struck out]
`(C) Other grains containing gluten (rye,
barley, oats, and triticale). [<-Struck out]
`(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. [<-Struck out]
`(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. [<-Struck out]
`(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 [<-Struck out][Struck out->] 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).
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`(w) If the labeling required under paragraphs
(g), (i), (k), (t), (u), or (v)-- [<-Struck out]
`(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; [<-Struck out]
`(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 [<-Struck out]
`(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.'. [<-Struck
out]
(b) CIVIL PENALTIES- Section 303(g)(2) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333(g)(2)) is amended--
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(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
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(2) in subparagraph (B), by inserting `or
misbranded' after `adulterated' each place such term appears.
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(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: [<-Struck out]
`(ll) The term `known food allergen' has the
meaning given such term in section 403(t)(3).'. [<-Struck out]
(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. [<-Struck out]
SEC. 4. UNINTENTIONAL PRESENCE OF KNOWN FOOD
ALLERGENS. [<-Struck out]
(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:
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`(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.'.
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(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. [<-Struck out]
SEC. 5. REGULATIONS. [<-Struck out]
(a) IN GENERAL- [<-Struck out]
(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. [<-Struck out]
(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 takes
effect as if the proposed rule were a final rule. [<-Struck
out]
(b) UNINTENTIONAL PRESENCE OF KNOWN FOOD
ALLERGENS- [<-Struck out]
(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. [<-Struck out]
(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. [<-Struck out]
(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. [<-Struck out]
(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. [<-Struck out]
SEC. 6. FOOD LABELING; INCLUSION OF TELEPHONE
NUMBER. [<-Struck out]
(a) IN GENERAL- Section 403(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 343(e)) is amended--
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(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 [<-Struck
out]
(2) by striking `clause (2)' and inserting
`clause (3)'. [<-Struck out]
(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. [<-Struck out]
SEC. 7. DATA ON FOOD-RELATED ALLERGIC RESPONSES.
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(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-- [<-Struck out]
(1) the prevalence of food allergies, and
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(2) the incidence of deaths, injuries, including
anaphylactic shock, hospitalizations, and physician visits, and the
utilization of drugs, associated with allergic responses to foods.
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(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-- [<-Struck out]
(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
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(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).
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(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).
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(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. [<-Struck
out]
(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). [<-Struck out]
(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. [<-Struck out]
(g) EFFECTIVE DATE- This section takes effect on
the date of the enactment of this Act. [<-Struck out]
SEC. 8. FOOD ALLERGIES RESEARCH. [<-Struck
out]
(a) IN GENERAL- The Secretary of Health and Human
Services, through the National Institutes of Health, shall convene a panel of
nationally recognized experts to review current basic and clinical research
efforts related to food allergies. The panel shall develop a plan, including
recommendations for expenditures, for expanding, intensifying, and
coordinating research activities concerning food allergies.
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(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. [<-Struck out]
(c) EFFECTIVE DATE- This section takes effect on
the date of the enactment of this Act. [<-Struck out]
SEC. 9. CERTAIN FEDERAL RECOMMENDATIONS REGARDING
AVOIDING AND RESPONDING TO FOOD-RELATED ALLERGIC RESPONSES. [<-Struck
out]
The Secretary of Health and Human Services shall
carry out the following: [<-Struck out]
(1) Develop and appropriately disseminate
recommendations on-- [<-Struck out]
(A) training emergency medical technicians
with respect to administering epinephrine auto-injector devices; and
[<-Struck out]
(B) the need for emergency vehicles to
maintain supplies of such devices. [<-Struck out]
(2) Activities to increase the awareness by the
restaurant industry of public or private guidelines and recommendations for
training in preparing allergen-free foods, including the Food Allergy and
Anaphylaxis Network and Food Allergy Initiative's document entitled `Food
Allergy Training Guide for Restaurants and Good Services'.
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(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. [<-Struck
out]
Calendar No. 739
To amend the Federal Food, Drug, and Cosmetic Act to establish labeling requirements regarding allergenic substances in food, and for other purposes.
END