[Congressional Record Volume 150, Number 101 (Tuesday, July 20, 2004)]
[House]
[Pages H6093-H6101]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
MINOR USE AND MINOR SPECIES ANIMAL HEALTH ACT OF 2004
Mr. PICKERING. Mr. Speaker, I move to suspend the rules and pass the
Senate bill (S. 741) to amend the Federal Food, Drug, and Cosmetic Act
with regard to new animal drugs, and for other purposes.
The Clerk read as follows:
S. 741
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.--
(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
depletion 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--
``(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 expectation 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
additional investigations to meet the requirements for the
full demonstration 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
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), 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--
[[Page H6094]]
``(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
subsection (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
Secretary 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
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 distributed
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
conditional 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 longer in effect. The Secretary shall
thereafter provide an opportunity 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
conditional 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
conditionally 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 conditional 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 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
species, where safety for humans is demonstrated in
accordance with the standard of section 512(d) (including,
for an antimicrobial new animal drug, with respect to
antimicrobial resistance).
``(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 requirements 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
anticipated annual distribution;
``(B) information to support the conclusion that the
proposed use meets the conditions of subparagraph (A) or (B)
of subsection (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
requirements 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 thereafter or information
[[Page H6095]]
to support a categorical exclusion from the requirement to
prepare an environmental assessment;
``(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 determination 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
established appropriate specifications for the manufacture
and control of the new animal drug and has demonstrated an
understanding 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
Secretary 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
subsection (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;
``(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
written; 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
conditions 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
periodically.
``(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--
``(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
Secretary shall promulgate regulations for exempting from the
operation 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 species 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
``(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 determination, 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
Secretary.
[[Page H6096]]
``(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
paragraph (1) shall include a verified statement by the
person making the request that any data or information
received under such paragraph 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 Secretary, 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
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
`designated 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 expiration
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 application with
respect to such new animal drug is submitted under section
512 or 571.
``(c) Exclusivity for Designated New Animal Drugs.--
``(1) Except as provided in subsection (c)(2), if the
Secretary approves or conditionally approves an application
for a designated 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
Secretary 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 section 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 Secretary
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 Cosmetic
Act is amended by striking ``512'' and inserting ``512,
571''.
(B) Section 201(v) of the Federal Food, Drug, and Cosmetic
Act is amended by inserting the following after paragraph
(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 Cosmetic
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 Cosmetic
Act is amended by striking ``520'' and inserting ``520, 571,
572, 573.''
(E) Section 502 of the Federal Food, Drug, and Cosmetic 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).''.
(F) Section 503(f) of the Federal Food, Drug, and Cosmetic
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 Cosmetic
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
application 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
application; 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--
[[Page H6097]]
``(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,
distribution, holding, and use conform to such approved
application;
``(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 Cosmetic
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 Cosmetic
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 regulations
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)''.
(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 implementing
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
appropriated 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 authorized
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--
(1) it is estimated that--
(A) approximately 2 percent of adults and about 5 percent
of infants and young children in the United States suffer
from food allergies; and
(B) each year, roughly 30,000 individuals require emergency
room treatment and 150 individuals die because of allergic
reactions to food;
(2)(A) eight major foods or food groups--milk, eggs, fish,
Crustacean shellfish, tree nuts, peanuts, wheat, and
soybeans--account for 90 percent of food allergies;
(B) at present, there is no cure for food allergies; and
(C) a food allergic consumer must avoid the food to which
the consumer is allergic;
(3)(A) in a review of the foods of randomly selected
manufacturers of baked goods, ice cream, and candy in
Minnesota and Wisconsin in 1999, the Food and Drug
Administration found that 25 percent of sampled foods failed
to list peanuts or eggs as ingredients on the food labels;
and
(B) nationally, the number of recalls because of unlabeled
allergens rose to 121 in 2000 from about 35 a decade earlier;
(4) a recent study shows that many parents of children with
a food allergy were unable to correctly identify in each of
several food labels the ingredients derived from major food
allergens;
(5)(A) ingredients in foods must be listed by their
``common or usual name'';
(B) in some cases, the common or usual name of an
ingredient may be unfamiliar to consumers, and many consumers
may not realize the ingredient is derived from, or contains,
a major food allergen; and
(C) in other cases, the ingredients may be declared as a
class, including spices, flavorings, and certain colorings,
or are exempt from the ingredient labeling requirements, such
as incidental additives; and
(6)(A) celiac disease is an immune-mediated disease that
causes damage to the gastrointestinal tract, central nervous
system, and other organs;
(B) the current recommended treatment is avoidance of
glutens in foods that are associated with celiac disease; and
(C) a multicenter, multiyear study estimated that the
prevalence of celiac disease in the United States is 0.5 to 1
percent of the general population.
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
``(B) the common or usual name of the major food allergen
in the list of ingredients required under subsections (g) and
(i) is followed in parentheses by the name of the food
source from which the major food allergen is derived,
except that the name of the food source is not required
when--
``(i) the common or usual name of the ingredient uses the
name of the food source from which the major food allergen is
derived; or
``(ii) the name of the food source from which the major
food allergen is derived appears elsewhere in the ingredient
list, unless the name of the food source that appears
elsewhere in the ingredient list appears as part of the name
of a food ingredient that is not a major food allergen under
section 201(qq)(2)(A) or (B).
``(2) As used in this subsection, the term `name of the
food source from which the major food allergen is derived'
means the name described in section 201(qq)(1); provided that
in the case of a tree nut, fish, or Crustacean shellfish, the
term `name of the food source from which the major food
allergen is derived' means the name of the specific type of
nut or species of fish or Crustacean shellfish.
``(3) The information required under this subsection may
appear in labeling in lieu of appearing on the label only if
the Secretary finds that such other labeling is sufficient to
protect the public health. A finding by the Secretary under
this paragraph (including any change in an earlier finding
under this paragraph) is effective upon publication in the
Federal Register as a notice.
``(4) Notwithstanding subsection (g), (i), or (k), or any
other law, a flavoring, coloring,
[[Page H6098]]
or incidental additive that is, or that bears or contains, a
major food allergen shall be subject to the labeling
requirements of this subsection.
``(5) The Secretary may by regulation modify the
requirements of subparagraph (A) or (B) of paragraph (1), or
eliminate either the requirement of subparagraph (A) or the
requirements of subparagraph (B) of paragraph (1), if the
Secretary determines that the modification or elimination of
the requirement of subparagraph (A) or the requirements of
subparagraph (B) is necessary to protect the public health.
``(6)(A) Any person may petition the Secretary to exempt a
food ingredient described in section 201(qq)(2) from the
allergen labeling requirements of this subsection.
``(B) The Secretary shall approve or deny such petition
within 180 days of receipt of the petition or the petition
shall be deemed denied, unless an extension of time is
mutually agreed upon by the Secretary and the petitioner.
``(C) The burden shall be on the petitioner to provide
scientific evidence (including the analytical method used to
produce the evidence) that demonstrates that such food
ingredient, as derived by the method specified in the
petition, does not cause an allergic response that poses a
risk to human health.
``(D) A determination regarding a petition under this
paragraph shall constitute final agency action.
``(E) The Secretary shall promptly post to a public site
all petitions received under this paragraph within 14 days of
receipt and the Secretary shall promptly post the Secretary's
response to each.
``(7)(A) A person need not file a petition under paragraph
(6) to exempt a food ingredient described in section
201(qq)(2) from the allergen labeling requirements of this
subsection, if the person files with the Secretary a
notification containing--
``(i) scientific evidence (including the analytical method
used) that demonstrates that the food ingredient (as derived
by the method specified in the notification, where
applicable) does not contain allergenic protein; or
``(ii) a determination by the Secretary that the ingredient
does not cause an allergic response that poses a risk to
human health under a premarket approval or notification
program under section 409.
``(B) The food ingredient may be introduced or delivered
for introduction into interstate commerce as a food
ingredient that is not a major food allergen 90 days after
the date of receipt of the notification by the Secretary,
unless the Secretary determines within the 90-day period that
the notification does not meet the requirements of this
paragraph, or there is insufficient scientific evidence to
determine that the food ingredient does not contain
allergenic protein or does not cause an allergenic response
that poses a risk to human health.
``(C) The Secretary shall promptly post to a public site
all notifications received under this subparagraph within 14
days of receipt and promptly post any objections thereto by
the Secretary.
``(x) Notwithstanding subsection (g), (i), or (k), or any
other law, a spice, flavoring, coloring, or incidental
additive that is, or that bears or contains, a food allergen
(other than a major food allergen), as determined by the
Secretary by regulation, shall be disclosed in a manner
specified by the Secretary by regulation.''.
(b) Effect on Other Authority.--The amendments made by this
section that require a label or labeling for major food
allergens do not alter the authority of the Secretary of
Health and Human Services under the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 301 et seq.) to require a label or
labeling for other food allergens.
(c) Conforming Amendments.--
(1) Section 201 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321) (as amended by section 102(b)) is amended by
adding at the end the following:
``(qq) The term `major food allergen' means any of the
following:
``(1) Milk, egg, fish (e.g., bass, flounder, or cod),
Crustacean shellfish (e.g., crab, lobster, or shrimp), tree
nuts (e.g., almonds, pecans, or walnuts), wheat, peanuts, and
soybeans.
``(2) A food ingredient that contains protein derived from
a food specified in paragraph (1), except the following:
``(A) Any highly refined oil derived from a food specified
in paragraph (1) and any ingredient derived from such highly
refined oil.
``(B) A food ingredient that is exempt under paragraph (6)
or (7) of section 403(w).''.
(2) Section 403A(a)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 343-1(a)(2)) is amended by striking
``or 403(i)(2)'' and inserting ``403(i)(2), 403(w), or
403(x)''.
(d) Effective Date.--The amendments made by this section
shall apply to any food that is labeled on or after January
1, 2006.
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 Representatives a report that--
(1)(A) analyzes--
(i) the ways in which foods, during manufacturing and
processing, are unintentionally contaminated with major food
allergens, including contamination caused by the use by
manufacturers of the same production line to produce both
products for which major food allergens are intentional
ingredients and products for which major food allergens are
not intentional ingredients; and
(ii) the ways in which foods produced on dedicated
production lines are unintentionally contaminated with major
food allergens; and
(B) estimates how common the practices described in
subparagraph (A) are in the food industry, with breakdowns by
food type as appropriate;
(2) advises whether good manufacturing practices or other
methods can be used to reduce or eliminate cross-contact of
foods with the major food allergens;
(3) describes--
(A) the various types of advisory labeling (such as
labeling that uses the words ``may contain'') used by food
producers;
(B) the conditions of manufacture of food that are
associated with the various types of advisory labeling; and
(C) the extent to which advisory labels are being used on
food products;
(4) describes how consumers with food allergies or the
caretakers of consumers would prefer that information about
the risk of cross-contact be communicated on food labels as
determined by using appropriate survey mechanisms;
(5) states the number of inspections of food manufacturing
and processing facilities conducted in the previous 2 years
and describes--
(A) the number of facilities and food labels that were
found to be in compliance or out of compliance with respect
to cross-contact of foods with residues of major food
allergens and the proper labeling of major food allergens;
(B) the nature of the violations found; and
(C) the number of voluntary recalls, and their
classifications, of foods containing undeclared major food
allergens; and
(6) assesses the extent to which the Secretary and the food
industry have effectively addressed cross-contact issues.
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 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
prevention of allergic responses to foods.
(b) Authorization of Appropriations.--For the purpose of
carrying out this section, there are authorized to be
appropriated such sums as may be necessary.
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 delicatessens and
bakeries, and elementary and secondary school cafeterias. The
Secretary shall consider guidelines and recommendations
developed by public and private entities for public and
private food establishments for preparing allergen-free foods
in pursuing this revision.
[[Page H6099]]
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 treatment for and prevention
of allergic responses to foods.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Mississippi (Mr. Pickering) and the gentlewoman from New York (Mrs.
Lowey) each will control 20 minutes.
The Chair recognizes the gentleman from Mississippi (Mr. Pickering).
General Leave
Mr. PICKERING. Mr. Speaker, I ask unanimous consent that all Members
may have 5 legislative days within which to revise and extend their
remarks and include extraneous material on S. 741.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Mississippi?
There was no objection.
Mr. PICKERING. Mr. Speaker, I yield myself such time as I may
consume.
Mr. Speaker, I rise today to highlight a problem faced by livestock
and food animal producers, animal and pet owners, zoo and wildlife
biologists, and animals themselves, as well as to present a policy
remedy that can lead to a solution for this often unnoticed threat.
We face a severe shortage of approved animal drugs for use in minor
animal species. These include sheep, goats, game birds, ranched deer,
rabbits and all fish and shellfish. A similar shortage of
pharmaceutical medicines exist for major animal species for diseases
that occur infrequently or which only occur in limited geographic
areas. These species include horses, cattle, dogs, cats, swine, and
others. Millions of animals go either untreated for illnesses or
treatment is delayed, due to the lack of availability of these minor
use drugs. This produces not only unnecessary animal suffering, but
could also pose a serious threat to human health, while undermining our
agricultural industry.
An unhealthy animal left untreated can spread disease through an
entire stock of its fellow species, resulting in severe economic losses
and hardships to our farmers and ranchers. Ultimately, these costs are
passed on to consumer food costs.
One example that is reported in my home State of Mississippi is the
catfish industry, the fifth largest agricultural sector in my home
State. Every year, they lose approximately $60 million attributable to
minor diseases for which drugs are not available to treat aquaculture
and catfish. In this industry alone, we have approximately 800
different species, yet the industry has only six drugs approved for use
in treating aquaculture diseases. It creates tremendous economic
hardship and animal suffering within the industry.
Restricted market opportunity, low profit margin, and the requirement
of massive capital investment prevents the economic feasibility of drug
manufacturers in pursuing research, development, and government
approval for medicines used in minor species and infrequent conditions
and diseases.
As a sponsor of this bill, or one similar to the one we introduced in
the House, it is an honor today to resolve this issue with the passage
of S. 741, the Minor Use and Minor Species Act, or affectionately
referred to as the MUMS Act. This legislation will allow companies the
opportunity to develop and approve minor use drugs which are of vital
interest to a large number of animal industries. Our legislation
incorporates the major proposals of the FDA's Center for Veterinary
Medicine to increase the availability of drugs for minor animal species
and rare diseases in major species.
The Animal Drug Availability Act of 1996 required the Food and Drug
Administration to provide Congress with a report describing
administrative and legislative proposals to improve and enhance the
animal drug approval process for minor uses and minor species of new
animal drugs. This report by FDA delivered to Congress in December of
1998 laid out nine proposals. Tonight, eight of these FDA proposals
require statutory changes, and this bill before us reflects those
changes called for in the report. Today's MUMS Act creates incentives
for animal drug manufacturers to invest in product development and
obtain FDA marketing approvals. Furthermore, it creates a program very
similar to the successful Human Orphan Drug Program that over the past
20 years has dramatically increased the availability of drugs to treat
rare human diseases.
Mr. Speaker, besides providing benefits to livestock producers and
animal owners, this measure will develop incentives in sanctioning
programs for the pharmaceutical industry, while maintaining and
ensuring public human health. This measure is supported by the Food and
Drug Administration, the American Farm Bureau, the Animal Health
Institute, the American Veterinary Medical Association, and virtually
every organization representing all genres of minor animal species.
This is vital legislation which will fill a great need in the animal
health world.
S. 741 will alleviate much animal suffering. It will promote the
health and well-being of minor animal species, while increasing and
protecting human health. It benefits pets and provides the emotional
security of the pets and their owners. It will provide greater health
security to various endangered species of aquatic species, and it will
reduce economic hardships and risks to farmers and ranchers.
This is a commonsense piece of legislation which will benefit
millions of Americans, from our farmers to our pet owners. I call on
all of my colleagues in the House to support S. 741, and I take
personal privilege to thank my staff who have worked on this, John
Rounsaville and Cade King. They have worked hard and worked effectively
to bring this bill to passage in the House, to passage in the Senate,
and to the President's signature soon.
Mr. Speaker, I reserve the balance of my time.
Mrs. LOWEY. Mr. Speaker, I yield myself such time as I may consume.
I rise in support of S. 741, the Minor Use and Minor Species Animal
Health Act of 2004. The bill, known as MUMS, will make an important
contribution to animal health.
This legislation is very similar to H.R. 2079 sponsored by the
gentleman from Louisiana (Mr. John) and the gentleman from Mississippi
(Mr. Pickering); and although we are taking up the Senate bill, they,
along with my colleague, the gentleman from Ohio (Mr. Brown), deserve
credit for leadership on this issue.
The bill is supported by the MUMS Coalition and the Keep Antibiotics
Working Coalition. The MUMS coalition includes the American Farm Bureau
Federation, the American Veterinary Medical Association, the Animal
Health Institute, the National Fisheries Institute, and many other
organizations. The Keep Antibiotics Working Coalition includes the
Union of Concerned Scientists, Environmental Defense, and the Center
For Science in the Public Interest. In sum, the proverbial delicate
balance has been found.
Mr. Speaker, I am also greatly pleased that MUMS includes the Food
Allergen Labeling and Consumer Protection Act, Title II of S. 741. I
authored the food allergy bill 4 years ago; and since the bill's
inception, everyone, from food-allergic consumers to members of the
food industry, has rallied behind the bill.
However, we would not be here today without the backing of the
gentleman from Michigan (Ranking Member Dingell), the gentleman from
Texas (Chairman Barton), the gentleman from Florida (Mr. Bilirakis),
the gentleman from Ohio (Mr. Brown), Secretary Thompson, and
Commissioner Crawford. I am truly grateful to them for their
involvement and support.
I also owe the gentleman from Pennsylvania (Mr. Greenwood) and
Senators Kennedy and Gregg special thanks for being my partners in this
effort. We spent a few years and many hours hashing out the bill before
us, committed to crafting a noncontroversial, bipartisan product. And I
believe we accomplished our goal.
Yesterday, I was surprised to learn that my good friend, the
gentleman from Pennsylvania (Mr. Greenwood), will be retiring at the
end of the year. While I am disappointed to be losing such a tremendous
colleague, one I have worked with on so many issues of importance for
so many years, I know that the gentleman from Pennsylvania (Mr.
Greenwood) will continue to lead
[[Page H6100]]
and be a strong advocate for great causes. Good luck in all your future
endeavors. And please know, Jim, that your fair, bipartisan manner will
be missed.
Mr. Speaker, the 11 million Americans with food allergies face a
daily struggle. Because there is no cure for allergies, the only way to
stay healthy is to avoid certain foods. But maintaining an allergen-
free diet is incredibly difficult. Food ingredient statements use
scientific jargon commonly used by only those wearing lab coats, not
average citizens.
{time} 1915
Take, for example, a recent study which found that fewer than one in
ten parents restricting milk from their allergic children's diet were
actually able to correctly recognize terms for milk on a label.
Statistics like this make you think if adults cannot easily determine
terms like whey, casein, lactose, how can you expect food-allergic
children to remember so many complicated terms? The answer is, we
cannot and we should not.
Today up to 200 allergic reactions to foods result in death each
year, and 30,000 require life-saving emergency treatments. Moreover,
within just the last five years, the number of children with a peanut
allergy has doubled. If we do not take action to improve food labels,
the number of deaths and incidents will rise.
Navigating insufficient labels is much more than an irritation for
the millions with food allergies. It is a matter of life and death.
Unfortunately, the situation is the same for those with celiac disease,
a lifelong digestive disorder that damages the small intestine and
interferes with absorption of nutrients from food. Although celiac
sufferers do not go into anaphylactic shock if they consume gluten, the
consequences of leaving the disease undiagnosed or untreated can be
just as grave and deadly, potentially leading to additional autoimmune
disorders, infertility, osteoporosis or cancer.
With no treatment for this disease, the only alternative is to follow
a strict gluten-free diet, which means not eating wheat, rye or barley.
However, it is a regimen difficult to adhere to, because food
ingredient statements are written more for scientists than consumers.
The bill before us provides a common-sense solution for those with
food allergies and celiac disease. It will require that food ingredient
statements list in everyday language the eight major food allergens:
milk, egg, peanuts, tree nuts, fish, crustacean shellfish, soy and
wheat. It will also give those with celiac disease the green light to
consume foods without hesitation by establishing and setting guidelines
for the use of the term ``gluten-free.''
Simply put, the Food Allergen Labeling and Consumer Protection Act
requires minimal but life-saving changes to food ingredient statements.
Upon its implementation, millions of Americans will finally be able to
let out a collective sigh of relief, something we can all be proud of.
Before I close, I hope the Speaker and my colleagues will indulge me
for just a moment. This bill has been a work in progress for 4-plus
years. There are many people who worked diligently behind the scenes to
craft it and secure its implementation. I would be remiss if I did not
personally thank some key staffers, including John Ford, Ed Walz, Ryan
Long, Alan Eisenberg, David Dorsey and Kate Winkler.
Additionally, we would not be standing here without the expertise of
Tina Harper, Bob Lake and Felicia Satchell from the Food and Drug
Administration.
The Food Allergy Initiative, American Celiac Task Force, Food Allergy
and Anaphylaxis Network and so many others also deserve thanks for
their continued dedicated advocacy.
I urge my colleagues to support S. 741 so that those with food
allergies and celiac disease will have the dietary information they
need at their fingerprints.
Mr. Speaker, I yield back the balance of my time.
Mr. PICKERING. Mr. Speaker, I yield myself such time as I may
consume.
I want to commend the gentlewoman from New York for all of her hard
and good and effective work and that of her staff. It is a great
accomplishment after a long path to get to this place, both on the
allergens and on the MUMS. I am glad that we could find a coalition
that could make something during a difficult Congress actually pass,
and we will send this to the President. It will be signed, and we can
celebrate soon.
So I thank the gentlewoman for her good and hard work and the
gentleman from Pennsylvania (Mr. Greenwood) and the gentleman from
Texas (Mr. Barton) and the gentleman from Michigan (Mr. Upton) and many
from the committee. Again, my staff, Cade King and John Rounsaville, I
wish that they could be here with us tonight to celebrate.
Mr. SHUSTER. Mr. Speaker, I rise today in strong support of S. 741,
the Minor Use and Minor Species Animal Health Act. This legislation
contains provisions that will better the lives and ease some of the
frustrations for the more than 7 million Americans that suffer from
food allergies every day.
I have had the unfortunate experience to learn more about the trials
and tribulations of food allergen sufferers when one of the members of
my staff, Christy Farmer, was diagnosed with Celiac Disease earlier
this year. Celiac Disease is an immune-mediated disease that causes
damage to the gastrointestinal tract and is triggered by the
consumption of gluten. Gluten is the protein part of wheat, rye,
barley, oats, and other related grains, which are found in many of the
foods that people eat on a day-to-day basis. The only treatment for
Celiac Disease is adherence to a strict lifelong, gluten-free diet. In
order to comply with this, individuals must carefully read all food
labels, which can often be inaccurate and extremely confusing. Many
times, food products may contain a derivative of a known food allergen,
however the food label does not make that clear. This can lead to
people unknowingly consuming exactly what they have been trying so hard
to avoid. This painstaking process of carefully examining every food
label and determining the exact ingredient of each product can be
extremely frustrating and difficult for individuals.
This legislation will help tremendously in taking some of the
guesswork out of reading food labels. Manufacturers in the food
industry must now include the commonly accepted names of the eight most
common allergens--milk, eggs, fish, crustacea, tree nuts, wheat,
peanuts, and soybeans. Food allergen sufferers will now be able to scan
food labels with greater ease and many incidents of accidental
ingestion can be avoided.
Having a food allergy, especially to something that is found in so
many different foods, can add a level of complication to a person's
life that can be difficult to imagine. Christy was required to undergo
a total lifestyle change due to her gluten sensitivity. Spontaneously
stopping at a restaurant for dinner is no longer possible, traveling
not knowing in advance what foods will be available is no longer an
option, and giving up your favorite foods is not as easy as it sounds.
I am pleased that this legislation will help ease some of the
frustrations and make adhering to an allergy-free diet a little easier
for the millions of Americans that suffer from food allergies. I
strongly urge my colleagues in joining me to support S. 741.
Mr. DINGELL. Mr. Speaker, I rise in support of S. 741, the ``Minor
Use and Minor Species Animal Health Act of 2004.'' The bill known as
``MUMS'' will make an important contribution to animal health. This
legislation is very similar to H.R. 2079 sponsored by Reps. John and
Pickering, and although we are taking up the Senate bill, they, along
with my colleague Sherrod Brown, deserve credit for leadership on this
issue.
The bill is supported by the MUMS Coalition and the Keep Antibiotics
Working Coalition. The MUMS Coalition includes the American Farm Bureau
Federation, the American Veterinary Medical Association, the Animal
Health Institute, the National Fisheries Institute, and many other
organizations. The Keep Antibiotics Working Coalition includes the
Union of Concerned Scientists, Environmental Defense, and the Center
for Science in the Public Interest. In sum, the proverbial ``delicate
balance'' has been found.
I also note that the MUMS bill contains a specific provision on food
allergens. I want to acknowledge the hard work in the House on the
issue by the gentlelady from New York, Mrs. Lowey. Eight food allergens
cause over ninety percent of serious allergic reactions from food. This
legislation will require that food labels bear the name of any of these
allergens if they are in the food and are not already noted on the
ingredient label.
S. 741 is a good bill and I urge my colleagues to support this
legislation.
Mr. RADANOVICH. Mr. Speaker, upon reading S. 741, there appears to be
some confusion over the application of the allergen labeling
requirements. It is my understanding
[[Page H6101]]
that the requirements contained in this bill only apply to food subject
to regulation by the Food and Drug Administration (FDA). I would like
to clarify that wine and other alcoholic beverages are regulated by the
Alcohol and Tobacco Tax and Trade Bureau. Subject to a Memorandum of
Understanding with the FDA, the Tax and Trade Bureau has primary
jurisdiction over the production and labeling of most wine and other
alcoholic beverages.
In this regard, the Tax and Trade Bureau is sensitive to the issue of
allergens in alcoholic beverages. For example, wine with levels of
sulfites over 10 parts per million has been required to state
``Contains Sulfites'' since 1987. The Tax and Trade Bureau works
closely with the FDA in determining whether such labeling is
appropriate.
Because of the manner in which wine and other alcoholic beverages are
produced, there are significant questions whether substances that Tax
and Trade Bureau allows to be used in the production of wine would have
any allergenic effect. In this connection, other countries have
implemented or are considering additional regulation of allergens in
their food supply. Due to the potential impact of this on the
international wine trade, research specifically directed to the
allergenic effect of certain substances used in production of wine in
being conducted in Australia and elsewhere. In light of this research,
the industry section of the World Wine Trade Group (WWTG) (an
intergovernmental organization which seeks to facilitate trade in wine
among its members, including the U.S., Canada, Australia, New Zealand,
and Chile), submitted the following statement to their Governments:
Allergen Labeling for Wine
Several countries, including WWTG members countries, have
introduced or are considering the introduction of labeling
for potential allergens including, inter alia, fish, milk and
egg products. The WWTG industry group recommends that any
such labeling must be based on sound science.
To date the scientific community has no evidence on the
allergenic affects of these products in wine. Australia is
currently undertaking extensive research in this area.
Therefore, the WWTG industry group urges the WWTG governments
to take full account of the scientific findings, expected
within 12 months, in formulating or revising their labeling
regulations in this area.
I anticipate that the Tax and Trade Bureau, in consultation with the
FDA, will take the results of this international research into account
in determining whether additional regulations requiring allergen
labeling would be appropriate for wine and other alcoholic beverages.
Among other things, the Tax and Trade Bureau should evaluate whether
any such regulation would create an inadvertent international trade
barrier. In this regard, I would like to work with the Chairman and
Ranking Member, as well as the author of this bill, to ensure there are
no unintended consequences resulting from this legislation.
Mr. PICKERING. Mr. Speaker, I have no further requests for time, and
I yield back the balance of my time.
The SPEAKER pro tempore (Mr. Hensarling). The question is on the
motion offered by the gentleman from Mississippi (Mr. Pickering) that
the House suspend the rules and pass the Senate bill, S. 741.
The question was taken; and (two-thirds having voted in favor
thereof) the rules were suspended and the Senate bill was passed.
A motion to reconsider was laid on the table.
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