HR 5747 IH
107th CONGRESS
2d Session
H. R. 5747
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
NOVEMBER 14, 2002
Mrs. LOWEY (for herself, Mr. WAXMAN, Mr. BROWN of Ohio, Ms. DELAURO, Mr.
SMITH of Washington, Ms. LEE, Mr. HOLT, Mr. HINCHEY, Mr. DEFAZIO, Ms.
ROYBAL-ALLARD, Mr. LANGEVIN, Ms. RIVERS, Mr. LEVIN, Ms. NORTON, Mr. PRICE of
North Carolina, Mr. NADLER, Mr. FROST, Mr. PALLONE, Mr. ROTHMAN, Mr. RANGEL, and
Mr. GEORGE MILLER of California) 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 regarding allergenic substances in food, 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'.
SEC. 2. FINDINGS.
(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 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 correctly to 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) spices, flavorings, and certain colorings and incidental additives
are exempt from ingredient labeling requirements that would allow consumers
to avoid those to which they are allergic; 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:
`(t)(1) If it is not a raw agricultural commodity and it is, or it
intentionally bears or contains, a major food allergen, unless either--
`(A) `Contains', which statement is followed by the name of the food
source as described in section 201(ll)(1) from which the major food allergen
is derived, follows immediately after or is adjacent to (in a type size no
smaller than the type size used in the list of ingredients) 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 sections (g) and (i) is followed in parentheses
by the name of the food source as described in section 201(ll)(1) 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 term used to
describe a major food allergen in section 201(ll)(1), or
`(ii) the name of the food source as described in section 201(ll)(1)
appears elsewhere in the ingredient list; and
Provided all major food allergens are labeled in a consistent manner
either as specified in clause (A) or as specified in clause (B).
`(2) 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 subparagraph is effective upon publication in the Federal
Register as a notice (including any change in an earlier finding under this
subparagraph).
`(3) Notwithstanding subsection (g), (i), or (k), or any other law, a
spice, flavoring, coloring, or incidental additive that is, or that
intentionally bears or contains, a major food allergen shall be subject to the
labeling requirements of this subsection.
`(4) 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 requirement of subparagraph (B), if the Secretary
determines that the modification or elimination of the requirement is
necessary to protect the public health.
`(u) Notwithstanding subsection (g), (i), or (k), or any other law, a
spice, flavoring, coloring, or incidental additive that is, or that
intentionally 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- This section does 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 the labeling of other food
allergens.
(c) CONFORMING AMENDMENTS-
(1) 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 `major food allergen' means any of the following:
`(1) Milk, egg, fish (e.g. bass, flounder, or tuna), Crustacean
shellfish (e.g. crab, lobster, or shrimp), tree nuts (e.g. almonds, pecans,
or walnuts), wheat, peanuts, and soybeans.
`(2) A proteinaceous substance derived from a food specified in
paragraph (1) (unless the Secretary determines that the substance does not
cause an allergic response that poses a risk to human health).'.
(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(t), or 403(u)'.
(d) EFFECTIVE DATE- A food that is labeled on or after January 1, 2006,
and that is, or that intentionally bears or contains, a major food allergen
(as defined in the amendment made by subsection (c)) shall be labeled in
compliance with the requirements of the amendment made by subsection (a).
SEC. 4. REPORT ON FOOD ALLERGENS.
Not later than June 30, 2004, the Secretary of Health and Human Services
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--
(i) the ways in which foods, during manufacturing and processing, can
be 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
might nonetheless become unintentionally contaminated with major food
allergens; and
(B) estimates how common those practices are in the food industry, with
breakdowns by food type as appropriate;
(2) recommends good manufacturing practices or other methods that can be
used to reduce or eliminate cross-contact of foods with the major food
allergens;
(A) the various types of advisory labeling (such as use of 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) determines how consumers with food allergies or the caretakers of
consumers would prefer information about the risk of cross-contact be
communicated on food labels by using appropriate survey mechanisms;
and
(5) identifies the circumstances, if any, under which advisory labeling
could appropriately be used.
SEC. 5. INSPECTIONS RELATING TO FOOD ALLERGENS.
(a) IN GENERAL- The Secretary of Health and Human Services shall give
priority to increasing the number of inspections 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 foods comply with practices to reduce or
eliminate cross-contact of a food with major food allergen residues that are
not intentional ingredients of the food; and
(2) to ensure that major food allergens are properly labeled on
foods.
(b) REPORTS- On October 1, 2003, and biennially thereafter, 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) states the number of inspections conducted in the previous 2 years
and the numbers of facilities and food labels that were found to be in
compliance or out of compliance;
(2) describes the nature of the violations found;
(3) includes the number of voluntary recalls, and their classifications,
of foods with undeclared major food allergens;
(4) assesses the extent of use of advisory language found and the
appropriateness of that use; and
(5) assesses the extent to which the Secretary and the food industry
have effectively addressed cross-contact issues.
SEC. 6. LABELING OF GLUTENS AND CELIAC DISEASE.
(a) CONTRACT WITH INSTITUTE OF MEDICINE- The Secretary of Health and Human
Services (in this section, the `Secretary') shall enter into a contract with
the Institute of Medicine for--
(1) the conduct of a review of the science relating to--
(A) the glutens in food that are associated with celiac
disease;
(B) the means of preventing and treating celiac disease; and
(C) the methodologies for detecting such glutens in foods;
and
(2) the submission to the Secretary, the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy and Commerce
of the House of Representatives, not later than 2 years after the date of
enactment of this Act, of a report concerning the review conducted under
paragraph (1).
(b) REQUIREMENTS OF EXPERTISE- The Institute of Medicine shall conduct the
review under subsection (a)(1) and make the report under subsection (a)(2) in
conjunction with experts in celiac disease, including experts in the
pathogenesis, epidemiology, and biochemistry of celiac disease, the
sensitivity to, and tolerance of, the glutens in food that are associated with
celiac disease, and the clinical aspects of celiac disease, including
prevention and treatment.
(c) GLUTEN LABELING- Considering the review conducted under paragraph
(a)(1), the Secretary shall, not later than 4 years after the date of
enactment of this Act, issue a proposed rule to define, and permit use of, the
term `gluten-free' on the labeling of foods. Not later than 6 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.
(d) REPORT- Not later than 2 years after submission to the Secretary of
the report under subsection (a)(2), 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
assesses whether additional requirements for the labeling of gluten are
warranted and necessary to better inform individuals with celiac disease, and
if other labeling is warranted and necessary, identifies the types of such
labeling.
SEC. 7. DATA ON FOOD-RELATED ALLERGIC RESPONSES.
(a) STUDY- 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'), 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--
(A) the prevalence of food allergies;
(B) the incidence of clinically significant or serious adverse events
related to food allergies; and
(C) the use of different modes of treatment for and prevention of
allergic responses to foods; and
(2) identifying new or alternative systems or enhancements to existing
systems (including by educating physicians and other health care providers),
for the reporting collection and analysis of national data on--
(A) the prevalence of food allergies;
(B) the incidence of clinically significant or serious adverse events
related to food allergies; and
(C) the use of different modes of treatment for and prevention of
allergic responses to foods.
(b) IMPROVEMENT AND PUBLICATION OF DATA- On completion of, and consistent
with the findings of, the study conducted under subsection (a), 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 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.
(c) REPORT TO CONGRESS- Not later than 30 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) and (b).
(d) 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, 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 for expanding, intensifying, and
coordinating research activities concerning food allergies.
(b) REPORT TO CONGRESS- Not later than 1 year after the date of 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.
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 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 public and private guidelines and recommendations
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.
END