I
104TH CONGRESS
2D SESSION
H. R. 3200
To amend the Federal Food, Drug, and Cosmetic Act to increase access
to nutritional information about foods, to increase the availability of
safe food products, and for other purposes.
IN THE HOUSE OF REPRESENTATIVES
MARCH 29, 1996
Mr. KLUG (for himself, Mr. GREENWOOD, Mr. TOWNS, Mr. BILIRAKIS, Mr.
RICHARDSON, Mr. BURR, Mr. HALL of Texas, Mr. BARTON of Texas, Mr.
GORDON, Mr. UPTON, Mr. BREWSTER, Mr. BILBRAY, Mr. PAYNE of Vir-
ginia, Mr. COBURN, Mr. DOOLEY of California, Mr. GANSKE, Mr.
MCHALE, Mr. OXLEY, Mr. HOLDEN, Mr. FIELDS of Texas, Mr. PAXON,
Mr. WHITFIELD, Mr. SCHAEFER, Mr. TAUZIN, Mr. FOX of Pennsylvania,
Mr. CAMPBELL, Mr. MCINTOSH, Mr. COX of California, Mr. DREIER, Mr.
HEINEMAN, Mr. FUNDERBURK, Mr. WELDON of Florida, Mr. SHAYS, Mr.
HASTERT, Mr. NORWOOD, Mr. FRAZER, Mr. STEARNS, Mr. FRISA, Mr.
RAMSTAD, Mr. MARTINI, and Ms. DUNN of Washington) introduced the
following bill; which was referred to the Committee on Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
increase access to nutritional information about foods,
to increase the availability of safe food products, and
for other purposes.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE; TABLE OF CON-
TENTS.
(a) SHORT TITLE.—This Act may be cited as the
‘‘Food Amendments and the Animal Drug Availability Act
of 1996’’.
(b) REFERENCE.—Whenever in this Act (other than
in section 111) an amendment or repeal is expressed in
terms of an amendment to, or repeal of, a section or other
provision, the reference shall be considered to be made to
a section or other provision of the Federal Food, Drug,
and Cosmetic Act.
(c) TABLE OF CONTENTS.—The table of contents is
as follows:
Sec. 1. Short title; reference; table of contents.
TITLE I—FOOD AMENDMENTS
Sec. 101. FDA mission and annual report.
Sec. 102. Access to disease prevention information.
Sec. 103. Access to nutrient descriptor information.
Sec. 104. Special labeling to protect public health.
Sec. 105. Accredited person review.
Sec. 106. Accredited persons.
Sec. 107. Improving the delaney clause.
Sec. 108. National uniformity.
Sec. 109. Harmonization.
Sec. 110. Informal agency statements.
Sec. 111. Colored margarine.
TITLE II—ANIMAL DRUGS
Sec. 201. Evidence of effectiveness for animal drugs.
Sec. 202. Timeframe for approval for animal drugs.
Sec. 203. Dispute resolution.
Sec. 204. Limitation on residues.
Sec. 205. Veterinary feed directives.
TITLE I—FOOD AMENDMENTS
SEC. 101. FDA MISSION AND ANNUAL REPORT.
(a) MISSION.—Section 903 (21 U.S.C. 393) is
amended by redesignating subsections (b) and (c) as sub-
sections (c) and (d), respectively, and by adding after sub-
section (a) the following:
‘‘(b) MISSION.—The Food and Drug Administration
shall protect the public health and safety and promptly
and efficiently review and approve clinical research and
marketing of products in a manner that does not unduly
impede innovation or product availability. The Food and
Drug Administration shall participate with other countries
to reduce the burden of regulation, harmonize regulatory
requirements, and achieve appropriate reciprocal arrange-
ments.’’
(b) ANNUAL REPORT.—Section 903 (21 U.S.C. 393),
as amended by subsection (a), is amended by adding at
the end the following:
‘‘(e) ANNUAL REPORT.—The Secretary shall, simul-
taneously with the submission each year of the budget for
the Food and Drug Administration, submit to the Com-
mittee on Commerce of the House of Representatives and
the Committee on Labor and Human Resources of the
Senate an annual report which shall—
‘‘(1) review the performance of the Food and
Drug Administration in meeting its mission and the
development of Food and Drug Administration poli-
cies to implement such mission;
‘‘(2) review the performance of the Food and
Drug Administration in meeting its own perform-
ance standards, including its own outcome measure-
ments and statutory deadlines for the approval of
products or for other purposes contained in this Act;
‘‘(3) describe the staffing and resources of the
Food and Drug Administration and list those per-
sons and organizations accredited to review petitions
under sections 403(r), 409, and 721 and applica-
tions under section 512;
‘‘(4) describe the goals, activities, and accom-
plishments of the Food and Drug Administration in
bilateral and multinational meetings that addressed
methods and approaches to reduce the burden of
regulation, harmonize regulation, and to seek appro-
priate reciprocal arrangements, list each such meet-
ing, and list pending issues specifying those that are
not consistent with or are contrary to the provisions
of this Act; and
‘‘(5) compare the performance of the Food and
Drug Administration in approving innovative prod-
ucts with that of the most successful agencies per-
forming similar functions in other countries and
compare the resources used by such agencies.’’.
SEC. 102. ACCESS TO DISEASE PREVENTION INFORMATION.
Section 403(r)(3) (21 U.S.C. 343(r)(3)) is amend-
ed—
(1) in clause (B)(i), by adding at the end ‘‘Sig-
nificant scientific agreement does not require con-
sensus or unanimity.’’; and
(2) by adding at the end the following:
‘‘(C) Information in materials prepared or distributed
by a Federal health agency or by the National Academy
of Sciences or its component organizations shall be deemed
to comply with clauses (A)(i) and (B).’’.
SEC. 103. ACCESS TO NUTRIENT DESCRIPTOR INFORMA-
TION.
Section 403(r)(2)(A)(i) (21 U.S.C. 343(r)(2)(A)(i))
is amended by adding at the end the following: ‘‘or terms
which are synonyms of such defined terms and are not
false or misleading’’.
SEC. 
104. 
SPECIAL 
LABELING 
TO 
PROTECT 
PUBLIC
HEALTH.
Section 403 (21 U.S.C. 343) is amended by adding
at the end the following: