Minor Use and Minor Species Animal Health Act of 2003
PL 108-282 (S.741), enacted 08/02/2004

118 STAT. 891
PUBLIC LAW 108–282—AUG. 2, 2004
Public Law 108–282
108th Congress
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,
TITLE I—MINOR USE AND MINOR
SPECIES HEALTH
SECTION 101. SHORT TITLE.
This title may be cited as the ‘‘Minor Use and Minor Species
Animal Health Act of 2004’’.
SEC. 102. MINOR USE AND MINOR SPECIES ANIMAL HEALTH.
(a) FINDINGS.—Congress makes the following findings:
(1) There is a severe shortage of approved new animal
drugs for use in minor species.
(2) There is a severe shortage of approved new animal
drugs for treating animal diseases and conditions that occur
infrequently or in limited geographic areas.
(3) Because of the small market shares, low-profit margins
involved, and capital investment required, it is generally not
economically feasible for new animal drug applicants to pursue
approvals for these species, diseases, and conditions.
(4) Because the populations for which such new animal
drugs are intended may be small and conditions of animal
management may vary widely, it is often difficult to design
and conduct studies to establish drug safety and effectiveness
under traditional new animal drug approval processes.
(5) It is in the public interest and in the interest of animal
welfare to provide for special procedures to allow the lawful
use and marketing of certain new animal drugs for minor
species and minor uses that take into account these special
circumstances and that ensure that such drugs do not endanger
animal or public health.
(6) Exclusive marketing rights for clinical testing expenses
have helped encourage the development of ‘‘orphan’’ drugs for
human use, and comparable incentives should encourage the
development of new animal drugs for minor species and minor
uses.
(b) AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT.—
21 USC 360ccc
note.
21 USC 301 note.
Minor Use and
Minor Species
Animal Health
Act of 2004.
Aug. 2, 2004
[S. 741]
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118 STAT. 892
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(1) DEFINITIONS.—Section 201 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 321) is amended by adding at
the end the following:
‘‘(nn) The term ‘major species’ means cattle, horses, swine,
chickens, turkeys, dogs, and cats, except that the Secretary may
add species to this definition by regulation.
‘‘(oo) The term ‘minor species’ means animals other than
humans that are not major species.
‘‘(pp) The term ‘minor use’ means the intended use of a drug
in a major species for an indication that occurs infrequently and
in only a small number of animals or in limited geographical areas
and in only a small number of animals annually.’’.
(2) THREE-YEAR EXCLUSIVITY FOR MINOR USE AND MINOR
SPECIES APPROVALS.—Section 512(c)(2)(F) (ii), (iii), and (v) of
the Federal Food, Drug, and Cosmetic Act is amended by
striking ‘‘(other than bioequivalence or residue studies)’’ and
inserting ‘‘(other than bioequivalence studies or residue deple-
tion studies, except residue depletion studies for minor uses
or minor species)’’ every place it appears.
(3) SCOPE OF REVIEW FOR MINOR USE AND MINOR SPECIES
APPLICATIONS.—Section 512(d) of the Federal Food, Drug, and
Cosmetic Act is amended by adding at the end the following
new paragraph:
‘‘(5) In reviewing an application that proposes a change
to add an intended use for a minor use or a minor species
to an approved new animal drug application, the Secretary
shall reevaluate only the relevant information in the approved
application to determine whether the application for the minor
use or minor species can be approved. A decision to approve
the application for the minor use or minor species is not,
implicitly or explicitly, a reaffirmation of the approval of the
original application.’’.
(4) MINOR USE AND MINOR SPECIES NEW ANIMAL DRUGS.—
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by adding at the end the
following:
‘‘Subchapter F—New Animal Drugs for Minor Use and Minor
Species
‘‘SEC. 571. CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS FOR
MINOR USE AND MINOR SPECIES.
‘‘(a)(1) Except as provided in paragraph (3) of this section,
any person may file with the Secretary an application for conditional
approval of a new animal drug intended for a minor use or a
minor species. Such an application may not be a supplement to
an application approved under section 512. Such application must
comply in all respects with the provisions of section 512 of this
Act except sections 512(a)(4), 512(b)(2), 512(c)(1), 512(c)(2), 512(c)(3),
512(d)(1), 512(e), 512(h), and 512(n) unless otherwise stated in
this section, and any additional provisions of this section. New
animal drugs are subject to application of the same safety standards
that would be applied to such drugs under section 512(d) (including,
for antimicrobial new animal drugs, with respect to antimicrobial
resistance).
‘‘(2) The applicant shall submit to the Secretary as part of
an application for the conditional approval of a new animal drug—
21 USC 360ccc.
21 USC 360b.
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118 STAT. 893
PUBLIC LAW 108–282—AUG. 2, 2004
‘‘(A) all information necessary to meet the requirements
of section 512(b)(1) except section 512(b)(1)(A);
‘‘(B) full reports of investigations which have been made
to show whether or not such drug is safe under section 512(d)
(including, for an antimicrobial new animal drug, with respect
to antimicrobial resistance) and there is a reasonable expecta-
tion of effectiveness for use;
‘‘(C) data for establishing a conditional dose;
‘‘(D) projections of expected need and the justification for
that expectation based on the best information available;
‘‘(E) information regarding the quantity of drug expected
to be distributed on an annual basis to meet the expected
need; and
‘‘(F) a commitment that the applicant will conduct addi-
tional investigations to meet the requirements for the full dem-
onstration of effectiveness under section 512(d)(1)(E) within
5 years.
‘‘(3) A person may not file an application under paragraph
(1) if—
‘‘(A) the application seeks conditional approval of a new
animal drug that is contained in, or is a product of, a transgenic
animal.
‘‘(B) the person has previously filed an application for condi-
tional approval under paragraph (1) for the same drug in the
same dosage form for the same intended use whether or not
subsequently conditionally approved by the Secretary under
subsection (b), or
‘‘(C) the person obtained the application, or data or other
information contained therein, directly or indirectly from the
person who filed for conditional approval under paragraph (1)
for the same drug in the same dosage form for the same
intended use whether or not subsequently conditionally
approved by the Secretary under subsection (b).
‘‘(b) Within 180 days after the filing of an application pursuant
to subsection (a), or such additional period as may be agreed upon
by the Secretary and the applicant, the Secretary shall either—
‘‘(1) issue an order, effective for one year, conditionally
approving the application if the Secretary finds that none of
the grounds for denying conditional approval, specified in sub-
section (c) of this section applies and publish a Federal Register
notice of the conditional approval, or
‘‘(2) give the applicant notice of an opportunity for an
informal hearing on the question whether such application
can be conditionally approved.
‘‘(c) If the Secretary finds, after giving the applicant notice
and an opportunity for an informal hearing, that—
‘‘(1) any of the provisions of section 512(d)(1) (A) through
(D) or (F) through (I) are applicable;
‘‘(2) the information submitted to the Secretary as part
of the application and any other information before the Sec-
retary with respect to such drug, is insufficient to show that
there is a reasonable expectation that the drug will have the
effect it purports or is represented to have under the conditions
of use prescribed, recommended, or suggested in the proposed
labeling thereof; or
‘‘(3) another person has received approval under section
512 for the same drug in the same dosage form for the same
Federal Register,
publication.
Deadline.
Reports.
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118 STAT. 894
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intended use, and that person is able to assure the availability
of sufficient quantities of the drug to meet the needs for which
the drug is intended;
the Secretary shall issue an order refusing to conditionally approve
the application. If, after such notice and opportunity for an informal
hearing, the Secretary finds that paragraphs (1) through (3) do
not apply, the Secretary shall issue an order conditionally approving
the application effective for one year and publish a Federal Register
notice of the conditional approval. Any order issued under this
subsection refusing to conditionally approve an application shall
state the findings upon which it is based.
‘‘(d) A conditional approval under this section is effective for
a 1-year period and is thereafter renewable by the Secretary
annually for up to 4 additional 1-year terms. A conditional approval
shall be in effect for no more than 5 years from the date of approval
under subsection (b)(1) or (c) of this section unless extended as
provided for in subsection (h) of this section. The following shall
also apply:
‘‘(1) No later than 90 days from the end of the 1-year
period for which the original or renewed conditional approval
is effective, the applicant may submit a request to renew a
conditional approval for an additional 1-year term.
‘‘(2) A conditional approval shall be deemed renewed at
the end of the 1-year period, or at the end of a 90-day extension
that the Secretary may, at the Secretary’s discretion, grant
by letter in order to complete review of the renewal request,
unless the Secretary determines before the expiration of the
1-year period or the 90-day extension that—
‘‘(A) the applicant failed to submit a timely renewal
request;
‘‘(B) the request fails to contain sufficient information
to show that—
‘‘(i) the applicant is making sufficient progress
toward meeting approval requirements under section
512(d)(1)(E), and is likely to be able to fulfill those
requirements and obtain an approval under section
512 before the expiration of the 5-year maximum term
of the conditional approval;
‘‘(ii) the quantity of the drug that has been distrib-
uted is consistent with the conditionally approved
intended use and conditions of use, unless there is
adequate explanation that ensures that the drug is
only used for its intended purpose; or
‘‘(iii) the same drug in the same dosage form for
the same intended use has not received approval under
section 512, or if such a drug has been approved,
that the holder of the approved application is unable
to assure the availability of sufficient quantities of
the drug to meet the needs for which the drug is
intended; or
‘‘(C) any of the provisions of section 512(e)(1) (A)
through (B) or (D) through (F) are applicable.
‘‘(3) If the Secretary determines before the end of the 1-
year period or the 90-day extension, if granted, that a condi-
tional approval should not be renewed, the Secretary shall
issue an order refusing to renew the conditional approval, and
such conditional approval shall be deemed withdrawn and no
Deadline.
Applicability.
Federal Register,
publication.
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118 STAT. 895
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longer in effect. The Secretary shall thereafter provide an oppor-
tunity for an informal hearing to the applicant on the issue
whether the conditional approval shall be reinstated.
‘‘(e)(1) The Secretary shall issue an order withdrawing condi-
tional approval of an application filed pursuant to subsection (a)
if the Secretary finds that another person has received approval
under section 512 for the same drug in the same dosage form
for the same intended use and that person is able to assure the
availability of sufficient quantities of the drug to meet the needs
for which the drug is intended.
‘‘(2) The Secretary shall, after due notice and opportunity for
an informal hearing to the applicant, issue an order withdrawing
conditional approval of an application filed pursuant to subsection
(a) if the Secretary finds that—
‘‘(A) any of the provisions of section 512(e)(1) (A) through
(B) or (D) through (F) are applicable; or
‘‘(B) on the basis of new information before the Secretary
with respect to such drug, evaluated together with the evidence
available to the Secretary when the application was condi-
tionally approved, that there is not a reasonable expectation
that such drug will have the effect it purports or is represented
to have under the conditions of use prescribed, recommended,
or suggested in the labeling thereof.
‘‘(3) The Secretary may also, after due notice and opportunity
for an informal hearing to the applicant, issue an order withdrawing
conditional approval of an application filed pursuant to subsection
(a) if the Secretary finds that any of the provisions of section
512(e)(2) are applicable.
‘‘(f)(1) The label and labeling of a new animal drug with a
conditional approval under this section shall—
‘‘(A) bear the statement, ‘conditionally approved by FDA
pending a full demonstration of effectiveness under application
number’; and
‘‘(B) contain such other information as prescribed by the
Secretary.
‘‘(2) An intended use that is the subject of a conditional approval
under this section shall not be included in the same product label
with any intended use approved under section 512.
‘‘(g) A conditionally approved new animal drug application may
not be amended or supplemented to add indications for use.
‘‘(h) 180 days prior to the termination date established under
subsection (d) of this section, an applicant shall have submitted
all the information necessary to support a complete new animal
drug application in accordance with section 512(b)(1) or the condi-
tional approval issued under this section is no longer in effect.
Following review of this information, the Secretary shall either—
‘‘(1) issue an order approving the application under section
512(c) if the Secretary finds that none of the grounds for
denying approval specified in section 512(d)(1) applies, or
‘‘(2) give the applicant an opportunity for a hearing before
the Secretary under section 512(d) on the question whether
such application can be approved.
Upon issuance of an order approving the application, product
labeling and administrative records of approval shall be modified
accordingly. If the Secretary has not issued an order under section
512(c) approving such application prior to the termination date
established under subsection (d) of this section, the conditional
Records.
Deadline.
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118 STAT. 896
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approval issued under this section is no longer in effect unless
the Secretary grants an extension of an additional 180-day period
so that the Secretary can complete review of the application. The
decision to grant an extension is committed to the discretion of
the Secretary and not subject to judicial review.
‘‘(i) The decision of the Secretary under subsection (c), (d),
or (e) of this section refusing or withdrawing conditional approval
of an application shall constitute final agency action subject to
judicial review.
‘‘(j) In this section and section 572, the term ‘transgenic animal’
means an animal whose genome contains a nucleotide sequence
that has been intentionally modified in vitro, and the progeny
of such an animal; Provided that the term ‘transgenic animal’
does not include an animal of which the nucleotide sequence of
the genome has been modified solely by selective breeding.
‘‘SEC. 572. INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL
DRUGS FOR MINOR SPECIES.
‘‘(a)(1) The Secretary shall establish an index limited to—
‘‘(A) new animal drugs intended for use in a minor species
for which there is a reasonable certainty that the animal or
edible products from the animal will not be consumed by
humans or food-producing animals; and
‘‘(B) new animal drugs intended for use only in a hatchery,
tank, pond, or other similar contained man-made structure
in an early, non-food life stage of a food-producing minor spe-
cies, where safety for humans is demonstrated in accordance
with the standard of section 512(d) (including, for an anti-
microbial new animal drug, with respect to antimicrobial resist-
ance).
‘‘(2) The index shall not include a new animal drug that is
contained in or a product of a transgenic animal.
‘‘(b) Any person intending to file a request under this section
shall be entitled to one or more conferences to discuss the require-
ments for indexing a new animal drug.
‘‘(c)(1) Any person may submit a request to the Secretary for
a determination whether a new animal drug may be eligible for
inclusion in the index. Such a request shall include—
‘‘(A) information regarding the need for the new animal
drug, the species for which the new animal drug is intended,
the proposed intended use and conditions of use, and antici-
pated annual distribution;
‘‘(B) information to support the conclusion that the proposed
use meets the conditions of subparagraph (A) or (B) of sub-
section (a)(1) of this section;
‘‘(C) information regarding the components and composition
of the new animal drug;
‘‘(D) a description of the methods used in, and the facilities
and controls used for, the manufacture, processing, and packing
of such new animal drug;
‘‘(E) an environmental assessment that meets the require-
ments of the National Environmental Policy Act of 1969, as
amended, and as defined in 21 CFR Part 25, as it appears
on the date of enactment of this provision and amended there-
after or information to support a categorical exclusion from
the requirement to prepare an environmental assessment;
21 USC 360ccc–1.
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118 STAT. 897
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‘‘(F) information sufficient to support the conclusion that
the proposed use of the new animal drug is safe under section
512(d) with respect to individuals exposed to the new animal
drug through its manufacture or use; and
‘‘(G) such other information as the Secretary may deem
necessary to make this eligibility determination.
‘‘(2) Within 90 days after the submission of a request for a
determination of eligibility for indexing based on subsection (a)(1)(A)
of this section, or 180 days for a request submitted based on
subsection (a)(1)(B) of this section, the Secretary shall grant or
deny the request, and notify the person who requested such deter-
mination of the Secretary’s decision. The Secretary shall grant
the request if the Secretary finds that—
‘‘(A) the same drug in the same dosage form for the same
intended use is not approved or conditionally approved;
‘‘(B) the proposed use of the drug meets the conditions
of subparagraph (A) or (B) of subsection (a)(1), as appropriate;
‘‘(C) the person requesting the determination has estab-
lished appropriate specifications for the manufacture and con-
trol of the new animal drug and has demonstrated an under-
standing of the requirements of current good manufacturing
practices;
‘‘(D) the new animal drug will not significantly affect the
human environment; and
‘‘(E) the new animal drug is safe with respect to individuals
exposed to the new animal drug through its manufacture or
use.
If the Secretary denies the request, the Secretary shall thereafter
provide due notice and an opportunity for an informal conference.
A decision of the Secretary to deny an eligibility request following
an informal conference shall constitute final agency action subject
to judicial review.
‘‘(d)(1) With respect to a new animal drug for which the Sec-
retary has made a determination of eligibility under subsection
(c), the person who made such a request may ask that the Secretary
add the new animal drug to the index established under subsection
(a). The request for addition to the index shall include—
‘‘(A) a copy of the Secretary’s determination of eligibility
issued under subsection (c);
‘‘(B) a written report that meets the requirements in sub-
section (d)(2) of this section;
‘‘(C) a proposed index entry;
‘‘(D) facsimile labeling;
‘‘(E) anticipated annual distribution of the new animal
drug;
‘‘(F) a written commitment to manufacture the new animal
drug and animal feeds bearing or containing such new animal
drug according to current good manufacturing practices;
‘‘(G) a written commitment to label, distribute, and promote
the new animal drug only in accordance with the index entry;
‘‘(H) upon specific request of the Secretary, information
submitted to the expert panel described in paragraph (3); and
‘‘(I) any additional requirements that the Secretary may
prescribe by general regulation or specific order.
‘‘(2) The report required in paragraph (1) shall—
‘‘(A) be authored by a qualified expert panel;
Reports.
Records.
Deadline.
Notification.
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‘‘(B) include an evaluation of all available target animal
safety and effectiveness information, including anecdotal
information;
‘‘(C) state the expert panel’s opinion regarding whether
the benefits of using the new animal drug for the proposed
use in a minor species outweigh its risks to the target animal,
taking into account the harm being caused by the absence
of an approved or conditionally approved new animal drug
for the minor species in question;
‘‘(D) include information from which labeling can be writ-
ten; and
‘‘(E) include a recommendation regarding whether the new
animal drug should be limited to use under the professional
supervision of a licensed veterinarian.
‘‘(3) A qualified expert panel, as used in this section, is a
panel that—
‘‘(A) is composed of experts qualified by scientific training
and experience to evaluate the target animal safety and
effectiveness of the new animal drug under consideration;
‘‘(B) operates external to FDA; and
‘‘(C) is not subject to the Federal Advisory Committee Act,
5 U.S.C. App. 2.
The Secretary shall define the criteria for selection of a qualified
expert panel and the procedures for the operation of the panel
by regulation.
‘‘(4) Within 180 days after the receipt of a request for listing
a new animal drug in the index, the Secretary shall grant or
deny the request. The Secretary shall grant the request if the
request for indexing continues to meet the eligibility criteria in
subsection (a) and the Secretary finds, on the basis of the report
of the qualified expert panel and other information available to
the Secretary, that the benefits of using the new animal drug
for the proposed use in a minor species outweigh its risks to
the target animal, taking into account the harm caused by the
absence of an approved or conditionally-approved new animal drug
for the minor species in question. If the Secretary denies the
request, the Secretary shall thereafter provide due notice and the
opportunity for an informal conference. The decision of the Secretary
following an informal conference shall constitute final agency action
subject to judicial review.
‘‘(e)(1) The index established under subsection (a) shall include
the following information for each listed drug—
‘‘(A) the name and address of the person who holds the
index listing;
‘‘(B) the name of the drug and the intended use and condi-
tions of use for which it is being indexed;
‘‘(C) product labeling; and
‘‘(D) conditions and any limitations that the Secretary
deems necessary regarding use of the drug.
‘‘(2) The Secretary shall publish the index, and revise it periodi-
cally.
‘‘(3) The Secretary may establish by regulation a process for
reporting changes in the conditions of manufacturing or labeling
of indexed products.
‘‘(f)(1) If the Secretary finds, after due notice to the person
who requested the index listing and an opportunity for an informal
conference, that—
Publication.
Deadline.
Regulations.
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‘‘(A) the expert panel failed to meet the requirements as
set forth by the Secretary by regulation;
‘‘(B) on the basis of new information before the Secretary,
evaluated together with the evidence available to the Secretary
when the new animal drug was listed in the index, the benefits
of using the new animal drug for the indexed use do not
outweigh its risks to the target animal;
‘‘(C) the conditions of subsection (c)(2) of this section are
no longer satisfied;
‘‘(D) the manufacture of the new animal drug is not in
accordance with current good manufacturing practices;
‘‘(E) the labeling, distribution, or promotion of the new
animal drug is not in accordance with the index entry;
‘‘(F) the conditions and limitations of use associated with
the index listing have not been followed; or
‘‘(G) the request for indexing contains any untrue statement
of material fact,
the Secretary shall remove the new animal drug from the index.
The decision of the Secretary following an informal conference shall
constitute final agency action subject to judicial review.
‘‘(2) If the Secretary finds that there is a reasonable probability
that the use of the drug would present a risk to the health of
humans or other animals, the Secretary may—
‘‘(A) suspend the listing of such drug immediately;
‘‘(B) give the person listed in the index prompt notice
of the Secretary’s action; and
‘‘(C) afford that person the opportunity for an informal
conference.
The decision of the Secretary following an informal conference shall
constitute final agency action subject to judicial review.
‘‘(g) For purposes of indexing new animal drugs under this
section, to the extent consistent with the public health, the Sec-
retary shall promulgate regulations for exempting from the oper-
ation of section 512 minor species new animal drugs and animal
feeds bearing or containing new animal drugs intended solely for
investigational use by experts qualified by scientific training and
experience to investigate the safety and effectiveness of minor spe-
cies animal drugs. Such regulations may, at the discretion of the
Secretary, among other conditions relating to the protection of
the public health, provide for conditioning such exemption upon
the establishment and maintenance of such records, and the making
of such reports to the Secretary, by the manufacturer or the sponsor
of the investigation of such article, of data (including but not limited
to analytical reports by investigators) obtained as a result of such
investigational use of such article, as the Secretary finds will enable
the Secretary to evaluate the safety and effectiveness of such article
in the event of the filing of a request for an index listing pursuant
to this section.
‘‘(h) The labeling of a new animal drug that is the subject
of an index listing shall state, prominently and conspicuously—
‘‘(1) ‘NOT APPROVED BY FDA.—Legally marketed as an FDA
indexed product. Extra-label use is prohibited.’;
‘‘(2) except in the case of new animal drugs indexed for
use in an early life stage of a food-producing animal, ‘This
product is not to be used in animals intended for use as food
for humans or other animals.’; and
Regulations.
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‘‘(3) such other information as may be prescribed by the
Secretary in the index listing.
‘‘(i)(1) In the case of any new animal drug for which an index
listing pursuant to subsection (a) is in effect, the person who has
an index listing shall establish and maintain such records, and
make such reports to the Secretary, of data relating to experience,
and other data or information, received or otherwise obtained by
such person with respect to such drug, or with respect to animal
feeds bearing or containing such drug, as the Secretary may by
general regulation, or by order with respect to such listing, prescribe
on the basis of a finding that such records and reports are necessary
in order to enable the Secretary to determine, or facilitate a deter-
mination, whether there is or may be ground for invoking subsection
(f). Such regulation or order shall provide, where the Secretary
deems it to be appropriate, for the examination, upon request,
by the persons to whom such regulation or order is applicable,
of similar information received or otherwise obtained by the Sec-
retary.
‘‘(2) Every person required under this subsection to maintain
records, and every person in charge or custody thereof, shall, upon
request of an officer or employee designated by the Secretary,
permit such officer or employee at all reasonable times to have
access to and copy and verify such records.
‘‘(j)(1) Safety and effectiveness data and information which
has been submitted in support of a request for a new animal
drug to be indexed under this section and which has not been
previously disclosed to the public shall be made available to the
public, upon request, unless extraordinary circumstances are
shown—
‘‘(A) if no work is being or will be undertaken to have
the drug indexed in accordance with the request,
‘‘(B) if the Secretary has determined that such drug cannot
be indexed and all legal appeals have been exhausted,
‘‘(C) if the indexing of such drug is terminated and all
legal appeals have been exhausted, or
‘‘(D) if the Secretary has determined that such drug is
not a new animal drug.
‘‘(2) Any request for data and information pursuant to para-
graph (1) shall include a verified statement by the person making
the request that any data or information received under such para-
graph shall not be disclosed by such person to any other person—
‘‘(A) for the purpose of, or as part of a plan, scheme,
or device for, obtaining the right to make, use, or market,
or making, using, or marketing, outside the United States,
the drug identified in the request for indexing; and
‘‘(B) without obtaining from any person to whom the data
and information are disclosed an identical verified statement,
a copy of which is to be provided by such person to the Sec-
retary, which meets the requirements of this paragraph.
‘‘SEC. 573. DESIGNATED NEW ANIMAL DRUGS FOR MINOR USE OR
MINOR SPECIES.
‘‘(a) DESIGNATION.—
‘‘(1) The manufacturer or the sponsor of a new animal
drug for a minor use or use in a minor species may request
that the Secretary declare that drug a ‘designated new animal
drug’. A request for designation of a new animal drug shall
21 USC 360ccc–2.
Records.
Reports.
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118 STAT. 901
PUBLIC LAW 108–282—AUG. 2, 2004
be made before the submission of an application under section
512(b) or section 571 for the new animal drug.
‘‘(2) The Secretary may declare a new animal drug a ‘des-
ignated new animal drug’ if—
‘‘(A) it is intended for a minor use or use in a minor
species; and
‘‘(B) the same drug in the same dosage form for the
same intended use is not approved under section 512 or
571 or designated under this section at the time the request
is made.
‘‘(3) Regarding the termination of a designation—
‘‘(A) the sponsor of a new animal drug shall notify
the Secretary of any decision to discontinue active pursuit
of approval under section 512 or 571 of an application
for a designated new animal drug. The Secretary shall
terminate the designation upon such notification;
‘‘(B) the Secretary may also terminate designation if
the Secretary independently determines that the sponsor
is not actively pursuing approval under section 512 or
571 with due diligence;
‘‘(C) the sponsor of an approved designated new animal
drug shall notify the Secretary of any discontinuance of
the manufacture of such new animal drug at least one
year before discontinuance. The Secretary shall terminate
the designation upon such notification; and
‘‘(D) the designation shall terminate upon the expira-
tion of any applicable exclusivity period under subsection
(c).
‘‘(4) Notice respecting the designation or termination of
designation of a new animal drug shall be made available
to the public.
‘‘(b) GRANTS AND CONTRACTS FOR DEVELOPMENT OF DESIGNATED
NEW ANIMAL DRUGS.—
‘‘(1) The Secretary may make grants to and enter into
contracts with public and private entities and individuals to
assist in defraying the costs of qualified safety and effectiveness
testing expenses and manufacturing expenses incurred in
connection with the development of designated new animal
drugs.
‘‘(2) For purposes of paragraph (1) of this section—
‘‘(A) The term ‘qualified safety and effectiveness
testing’ means testing—
‘‘(i) which occurs after the date such new animal
drug is designated under this section and before the
date on which an application with respect to such
drug is submitted under section 512; and
‘‘(ii) which is carried out under an investigational
exemption under section 512(j).
‘‘(B) 
The 
term 
‘manufacturing 
expenses’ 
means
expenses incurred in developing processes and procedures
associated with manufacture of the designated new animal
drug which occur after the new animal drug is designated
under this section and before the date on which an applica-
tion with respect to such new animal drug is submitted
under section 512 or 571.
‘‘(c) EXCLUSIVITY FOR DESIGNATED NEW ANIMAL DRUGS.—
Notifications.
Terminations.
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118 STAT. 902
PUBLIC LAW 108–282—AUG. 2, 2004
‘‘(1) Except as provided in subsection (c)(2), if the Secretary
approves or conditionally approves an application for a des-
ignated new animal drug, the Secretary may not approve or
conditionally approve another application submitted for such
new animal drug with the same intended use as the designated
new animal drug for another applicant before the expiration
of seven years from the date of approval or conditional approval
of the application.
‘‘(2) If an application filed pursuant to section 512 or section
571 is approved for a designated new animal drug, the Sec-
retary may, during the 7-year exclusivity period beginning on
the date of the application approval or conditional approval,
approve or conditionally approve another application under sec-
tion 512 or section 571 for such drug for such minor use
or minor species for another applicant if—
‘‘(A) the Secretary finds, after providing the holder
of such an approved application notice and opportunity
for the submission of views, that in the granted exclusivity
period the holder of the approved application cannot assure
the availability of sufficient quantities of the drug to meet
the needs for which the drug was designated; or
‘‘(B) such holder provides written consent to the Sec-
retary for the approval or conditional approval of other
applications before the expiration of such exclusivity
period.’’.
(5) CONFORMING AMENDMENTS.—
(A) Section 201(u) of the Federal Food, Drug, and Cos-
metic Act is amended by striking ‘‘512’’ and inserting ‘‘512,
571’’.
(B) Section 201(v) of the Federal Food, Drug, and Cos-
metic Act is amended by inserting the following after para-
graph (2): ‘‘Provided that any drug intended for minor
use or use in a minor species that is not the subject
of a final regulation published by the Secretary through
notice and comment rulemaking finding that the criteria
of paragraphs (1) and (2) have not been met (or that the
exception to the criterion in paragraph (1) has been met)
is a new animal drug.’’.
(C) Section 301(e) of the Federal Food, Drug, and Cos-
metic Act is amended by striking ‘‘512(a)(4)(C), 512(j), (l)
or (m)’’ and inserting ‘‘512(a)(4)(C), 512 (j), (l) or (m), 572(i).’’
(D) Section 301(j) of the Federal Food, Drug, and Cos-
metic Act is amended by striking ‘‘520’’ and inserting ‘‘520,
571, 572, 573.’’
(E) Section 502 of the Federal Food, Drug, and Cos-
metic Act is amended by adding at the end the following
new subsection:
‘‘(w) If it is a new animal drug—
‘‘(1) that is conditionally approved under section 571 and
its labeling does not conform with the approved application
or section 571(f), or that is not conditionally approved under
section 571 and its label bears the statement set forth in
section 571(f)(1)(A); or
‘‘(2) that is indexed under section 572 and its labeling
does not conform with the index listing under section 572(e)
or 572(h), or that has not been indexed under section 572
and its label bears the statement set forth in section 572(h).’’.
21 USC 351.
21 USC 331.
21 USC 321.
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118 STAT. 903
PUBLIC LAW 108–282—AUG. 2, 2004
(F) Section 503(f) of the Federal Food, Drug, and Cos-
metic Act is amended—
(i) in paragraph (1)(A)(ii) by striking ‘‘512’’ and
inserting ‘‘512, a conditionally-approved application
under section 571, or an index listing under section
572’’; and
(ii) in paragraph (3) by striking ‘‘section 512’’ and
inserting ‘‘section 512, 571, or 572’’.
(G) Section 504(a)(1) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ‘‘512(b)’’ and inserting
‘‘512(b), a conditionally-approved application filed pursuant
to section 571, or an index listing pursuant to section
572’’.
(H) Sections 504(a)(2)(B) and 504(b) of the Federal
Food, Drug, and Cosmetic Act are amended by striking
‘‘512(i)’’ each place it appears and inserting ‘‘512(i), or
the index listing pursuant to section 572(e)’’.
(I) Section 512(a) of the Federal Food, Drug, and Cos-
metic Act is amended by striking paragraphs (1) and (2)
and inserting the following:
‘‘(1) A new animal drug shall, with respect to any particular
use or intended use of such drug, be deemed unsafe for purposes
of section 501(a)(5) and section 402(a)(2)(C)(ii) unless—
‘‘(A) there is in effect an approval of an application filed
pursuant to subsection (b) with respect to such use or intended
use of such drug, and such drug, its labeling, and such use
conform to such approved application;
‘‘(B) there is in effect a conditional approval of an applica-
tion filed pursuant to section 571 with respect to such use
or intended use of such drug, and such drug, its labeling,
and such use conform to such conditionally approved applica-
tion; or
‘‘(C) there is in effect an index listing pursuant to section
572 with respect to such use or intended use of such drug
in a minor species, and such drug, its labeling, and such use
conform to such index listing.
A new animal drug shall also be deemed unsafe for such purposes
in the event of removal from the establishment of a manufacturer,
packer, or distributor of such drug for use in the manufacture
of animal feed in any State unless at the time of such removal
such manufacturer, packer, or distributor has an unrevoked written
statement from the consignee of such drug, or notice from the
Secretary, to the effect that, with respect to the use of such drug
in animal feed, such consignee (i) holds a license issued under
subsection (m) and has in its possession current approved labeling
for such drug in animal feed; or (ii) will, if the consignee is not
a user of the drug, ship such drug only to a holder of a license
issued under subsection (m).
‘‘(2) An animal feed bearing or containing a new animal drug
shall, with respect to any particular use or intended use of such
animal feed be deemed unsafe for purposes of section 501(a)(6)
unless—
‘‘(A) there is in effect—
‘‘(i) an approval of an application filed pursuant to
subsection (b) with respect to such drug, as used in such
animal feed, and such animal feed and its labeling, distribu-
tion, holding, and use conform to such approved application;
21 USC 360b.
21 USC 354.
21 USC 353.
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118 STAT. 904
PUBLIC LAW 108–282—AUG. 2, 2004
‘‘(ii) a conditional approval of an application filed
pursuant to section 571 with respect to such drug, as
used in such animal feed, and such animal feed and its
labeling, distribution, holding, and use conform to such
conditionally approved application; or
‘‘(iii) an index listing pursuant to section 572 with
respect to such drug, as used in such animal feed, and
such animal feed and its labeling, distribution, holding,
and use conform to such index listing; and
‘‘(B) such animal feed is manufactured at a site for which
there is in effect a license issued pursuant to subsection (m)(1)
to manufacture such animal feed.’’.
(J) Section 512(b)(3) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ‘‘under paragraph
(1) or a request for an investigational exemption under
subsection (j)’’ and inserting ‘‘under paragraph (1), section
571, or a request for an investigational exemption under
subsection (j)’’.
(K) Section 512(d)(4) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ‘‘have previously been
separately approved’’ and inserting ‘‘have previously been
separately approved pursuant to an application submitted
under section 512(b)(1)’’.
(L) Section 512(f) of the Federal Food, Drug, and Cos-
metic Act is amended by striking ‘‘subsection (d), (e), or
(m)’’ and inserting ‘‘subsection (d), (e), or (m), or section
571 (c), (d), or (e)’’.
(M) Section 512(g) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ‘‘this section’’ and
inserting ‘‘this section, or section 571’’.
(N) Section 512(i) of the Federal Food, Drug, and Cos-
metic Act is amended by striking ‘‘subsection (b)’’ and
inserting ‘‘subsection (b) or section 571’’ and by inserting
‘‘or upon failure to renew a conditional approval under
section 571’’ after ‘‘or upon its suspension’’.
(O) Section 512(l)(1) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ‘‘subsection (b)’’ and
inserting ‘‘subsection (b) or section 571’’.
(P) Section 512(m)(1)(C) of the Federal Food, Drug,
and Cosmetic Act is amended by striking ‘‘applicable regu-
lations published pursuant to subsection (i)’’ and inserting
‘‘applicable regulations published pursuant to subsection
(i) or for indexed new animal drugs in accordance with
the index listing published pursuant to section 572(e)(2)
and the labeling requirements set forth in section 572(h)’’.
(Q) Section 512(m)(3) of the Federal Food, Drug, and
Cosmetic Act is amended by inserting ‘‘or an index listing
pursuant to section 572(e)’’ after ‘‘subsection (i)’’ each place
it appears.
(R) Section 512(p)(1) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ‘‘subsection (b)(1)’’
and inserting ‘‘subsection (b)(1) or section 571(a)’’.
(S) Section 512(p)(2) of the Federal Food, Drug, and
Cosmetic Act is amended by striking ‘‘subsection (b)(1)’’
and inserting ‘‘subsection (b)(1) or section 571(a)’’.
21 USC 360b.
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118 STAT. 905
PUBLIC LAW 108–282—AUG. 2, 2004
(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 imple-
menting 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 appro-
priated 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 author-
ized 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.
This title may be cited as the ‘‘Food Allergen Labeling and
Consumer Protection Act of 2004’’.
SEC. 202. FINDINGS.
Congress finds that—
21 USC 343 note.
21 USC 301 note.
Food Allergen
Labeling and
Consumer
Protection Act of
2004.
Appropriation
authorization.
Government
organization.
21 USC 393 note.
Effective date.
Deadlines.
Publication.
21 USC 360ccc
note.
21 USC 360b
note.
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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 emer-
gency 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 manu-
facturers 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 ingre-
dient 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 
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:
‘‘(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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118 STAT. 907
PUBLIC LAW 108–282—AUG. 2, 2004
‘‘(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 else-
where 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 subpara-
graph (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 evi-
dence) 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.
Public
information.
Deadline.
Federal Register,
publication.
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118 STAT. 908
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 Cos-
metic 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.
Applicability.
21 USC 321 note.
21 USC 343 note.
Public
information.
Deadline.
Deadlines.
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118 STAT. 909
PUBLIC LAW 108–282—AUG. 2, 2004
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 Representa-
tives 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 aller-
gens and the proper labeling of major food allergens;
(B) the nature of the violations found; and
(C) the number of voluntary recalls, and their classi-
fications, of foods containing undeclared major food aller-
gens; 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.
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
21 USC 374a.
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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.
SEC. 206. GLUTEN LABELING.
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.
SEC. 207. IMPROVEMENT AND PUBLICATION OF DATA ON FOOD-
RELATED 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 preven-
tion 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.
SEC. 208. FOOD ALLERGIES RESEARCH.
(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.
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 deli-
catessens and bakeries, and elementary and secondary school cafe-
terias. The Secretary shall consider guidelines and recommenda-
tions developed by public and private entities for public and private
food establishments for preparing allergen-free foods in pursuing
this revision.
Deadline.
Public
information.
Government
organization.
42 USC 243 note.
42 USC 242r.
Deadlines.
Regulations.
21 USC 343 note.
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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 Pen-
sions).
CONGRESSIONAL RECORD, Vol. 150 (2004):
Mar. 8, considered and passed Senate.
July 20, considered and passed House.
SEC. 210. 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 treat-
ment for and prevention of allergic responses to foods.
Approved August 2, 2004.
42 USC 300d–2
note.
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