109TH CONGRESS 
2D SESSION 
H. R. 4167
AN ACT 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide for uniform food safety warning notification re-
quirements, 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. 
This Act may be cited as the ‘‘National Uniformity 
for Food Act of 2005’’. 
SEC. 2. NATIONAL UNIFORMITY FOR FOOD. 
(a) NATIONAL UNIFORMITY.—Section 403A of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343–
1) is amended—
(1) in subsection (a)(4), by striking ‘‘or’’ at the 
end; 
(2) in subsection (a)(5), by striking the period 
and inserting ‘‘, or’’; 
(3) in subsection (a), by inserting after para-
graph (5) the following: 
‘‘(6) any requirement for a food described in 
section 402(a)(1), 402(a)(2), 402(a)(6), 402(a)(7), 
402(c), 404, 406, 409, 512, or 721(a), that is not 
identical to the requirement of such section.’’; and 
(4) by adding at the end the following: 
‘‘(c)(1) For purposes of subsection (a)(6) and section 
403B, the term ‘identical’ means that the language under 
the laws of a State or a political subdivision of a State 
is substantially the same language as the comparable pro-
vision under this Act and that any differences in language 
do not result in the imposition of materially different re-
quirements. For purposes of subsection (a)(6), the term 
‘any requirement for a food’ does not refer to provisions
of this Act that relate to procedures for Federal action 
under this Act. 
‘‘(2) For purposes of subsection (a)(6), a State or 
political subdivision of a State may enforce a State law 
that contains a requirement that is identical to a require-
ment in a section of Federal law referred to in subsection 
(a)(6) if—
‘‘(A) the Secretary has promulgated a regula-
tion or adopted a final guidance relating to the re-
quirement and the State applies the State require-
ment in a manner that conforms to the regulation 
or guidance; or 
‘‘(B) the Secretary has not promulgated a regu-
lation or adopted a final guidance relating to the re-
quirement, except that if the Secretary has consid-
ered a proposal for a regulation or final guidance re-
lating to the requirement and has, after soliciting 
public comment, made a determination not to pro-
mulgate such regulation or adopt such guidance, 
which determination is published in the Federal 
Register, the State may not enforce any require-
ments in State law that are policies rejected by the 
Secretary through such determination.’’.
(b) UNIFORMITY IN FOOD SAFETY WARNING NOTI-
FICATION REQUIREMENTS.—Chapter IV of such Act (21 
U.S.C. 341 et seq.) is amended—
(1) by redesignating sections 403B and 403C 
as sections 403C and 403D, respectively; and 
(2) by inserting after section 403A the fol-
lowing new section: 
‘‘SEC. 403B. UNIFORMITY IN FOOD SAFETY WARNING NOTI-
FICATION REQUIREMENTS. 
‘‘(a) UNIFORMITY REQUIREMENT.—
‘‘(1) IN GENERAL.—Except as provided in sub-
sections (c) and (d), no State or political subdivision 
of a State may, directly or indirectly, establish or 
continue in effect under any authority any notifica-
tion requirement for a food that provides for a warn-
ing concerning the safety of the food, or any compo-
nent or package of the food, unless such a notifica-
tion requirement has been prescribed under the au-
thority of this Act and the State or political subdivi-
sion notification requirement is identical to the noti-
fication requirement prescribed under the authority 
of this Act. 
‘‘(2) DEFINITIONS.—For purposes of paragraph 
(1)—
‘‘(A) the term ‘notification requirement’ in-
cludes any mandatory disclosure requirement 
relating to the dissemination of information 
about a food by a manufacturer or distributor 
of a food in any manner, such as through a 
label, labeling, poster, public notice, advertising, 
or any other means of communication, except 
as provided in paragraph (3); 
‘‘(B) the term ‘warning’, used with respect 
to a food, means any statement, vignette, or 
other representation that indicates, directly or 
by implication, that the food presents or may 
present a hazard to health or safety; and 
‘‘(C) a reference to a notification require-
ment that provides for a warning shall not be 
construed to refer to any requirement or prohi-
bition relating to food safety that does not in-
volve a notification requirement. 
‘‘(3) CONSTRUCTION.—Nothing in this section 
shall be construed to prohibit a State from con-
ducting the State’s notification, disclosure, or other 
dissemination of information, or to prohibit any ac-
tion taken relating to a mandatory recall, civil ad-
ministrative order, embargo, detention order, or 
court proceeding involving food adulteration under a
State statutory requirement identical to a food adul-
teration requirement under this Act. 
‘‘(b) REVIEW
OF
EXISTING
STATE
REQUIRE-
MENTS.—
‘‘(1) EXISTING STATE REQUIREMENTS; DEFER-
RAL.—Any requirement that—
‘‘(A)(i) is a State notification requirement 
that expressly applies to a specified food or food 
component and that provides for a warning de-
scribed in subsection (a) that does not meet the 
uniformity requirement specified in subsection 
(a); or 
‘‘(ii) is a State food safety requirement de-
scribed in section 403A(6) that does not meet 
the uniformity requirement specified in that 
paragraph; and 
‘‘(B) is in effect on the date of enactment 
of the National Uniformity for Food Act of 
2005, shall remain in effect for 180 days after 
that date of enactment. 
‘‘(2) STATE
PETITIONS.—With respect to a 
State notification or food safety requirement that is 
described in paragraph (1), the State may petition 
the Secretary for an exemption or a national stand-
ard under subsection (c). If a State submits such a
petition within 180 days after the date of enactment 
of the National Uniformity for Food Act of 2005, 
the notification or food safety requirement shall re-
main in effect in accordance with subparagraph (C) 
of paragraph (3), and the time periods and provi-
sions specified in subparagraphs (A) and (B) of such 
paragraph shall apply in lieu of the time periods and 
provisions specified in subsection (c)(3) (but not the 
time periods and provisions specified in subsection 
(d)(2)). 
‘‘(3) ACTION ON PETITIONS.—
‘‘(A) PUBLICATION.—Not later than 270 
days after the date of enactment of the Na-
tional Uniformity for Food Act of 2005, the 
Secretary shall publish a notice in the Federal 
Register concerning any petition submitted 
under paragraph (2) and shall provide 180 days 
for public comment on the petition. 
‘‘(B) TIME PERIODS.—Not later than 360 
days after the end of the period for public com-
ment, the Secretary shall take final agency ac-
tion on the petition. 
‘‘(C) ACTION.—
‘‘(i) IN GENERAL.—With respect to a 
State that submits to the Secretary a peti-
tion in accordance with paragraph (2), the 
notification or food safety requirement in-
volved shall remain in effect during the pe-
riod beginning on the date of enactment of 
the National Uniformity for Food Act of 
2005 and ending on the applicable date 
under subclause (I) or (II), as follows: 
‘‘(I) If the petition is denied by 
the Secretary, the date of such denial. 
‘‘(II) If the petition is approved 
by the Secretary, the effective date of 
the final rule that is promulgated 
under subsection (c) to provide an ex-
emption or national standard pursu-
ant to the petition, except that there 
is no applicable ending date under 
this subparagraph for a provision of 
State law that is part of such State 
requirement in any case in which the 
final rule does not establish any con-
dition regarding such provision of law. 
‘‘(ii) NONCOMPLIANCE OF SECRETARY 
REGARDING TIMEFRAMES.—
‘‘(I) 
JUDICIAL
REVIEW.—The 
failure of the Secretary to comply
with any requirement of subparagraph 
(A) or (B) shall constitute final agen-
cy action for purposes of judicial re-
view. If the court conducting the re-
view determines that the Secretary 
has failed to comply with the require-
ment, the court shall order the Sec-
retary to comply within a period de-
termined to be appropriate by the 
court. 
‘‘(II) STATUS
OF
STATE
RE-
QUIREMENT.—With respect to a State 
that submits to the Secretary a peti-
tion in accordance with paragraph (2), 
if the Secretary fails to take final 
agency action on the petition within 
the period that applies under subpara-
graph (B), the notification or food 
safety requirement involved remains 
in effect in accordance with clause (i). 
‘‘(c) EXEMPTIONS AND NATIONAL STANDARDS.—
‘‘(1) EXEMPTIONS.—Any State may petition 
the Secretary to provide by regulation an exemption 
from section 403A(a)(6) or subsection (a), for a re-
quirement of the State or a political subdivision of
the State. The Secretary may provide such an ex-
emption, under such conditions as the Secretary may 
impose, for such a requirement that—
‘‘(A) protects an important public interest 
that would otherwise be unprotected, in the ab-
sence of the exemption; 
‘‘(B) would not cause any food to be in 
violation of any applicable requirement or prohi-
bition under Federal law; and 
‘‘(C) would not unduly burden interstate 
commerce, balancing the importance of the pub-
lic interest of the State or political subdivision 
against the impact on interstate commerce. 
‘‘(2) NATIONAL STANDARDS.—Any State may 
petition the Secretary to establish by regulation a 
national standard respecting any requirement under 
this Act or the Fair Packaging and Labeling Act 
(15 U.S.C. 1451 et seq.) relating to the regulation 
of a food. 
‘‘(3) ACTION ON PETITIONS.—
‘‘(A) PUBLICATION.—Not later than 30 
days after receipt of any petition under para-
graph (1) or (2), the Secretary shall publish 
such petition in the Federal Register for public
comment during a period specified by the Sec-
retary. 
‘‘(B) TIME
PERIODS
FOR
ACTION.—Not 
later than 60 days after the end of the period 
for public comment, the Secretary shall take 
final agency action on the petition or shall in-
form the petitioner, in writing, the reasons that 
taking the final agency action is not possible, 
the date by which the final agency action will 
be taken, and the final agency action that will 
be taken or is likely to be taken. In every case, 
the Secretary shall take final agency action on 
the petition not later than 120 days after the 
end of the period for public comment. 
‘‘(C) EXPEDITED
CONSIDERATION.—The 
Secretary shall expedite the consideration of 
any petition under paragraphs (1) or (2) that 
involves a request for a notification requirement 
for a food that provides a warning where the 
health effect to be addressed by the warning re-
lates to cancer or reproductive or birth defects 
or is intended to provide information that will 
allow parents or guardians to understand, mon-
itor, or limit a child’s exposure to cancer-caus-
ing agents or reproductive or developmental 
toxins. 
‘‘(4) JUDICIAL
REVIEW.—The failure of the 
Secretary to comply with any requirement of this 
subsection shall constitute final agency action for 
purposes of judicial review. If the court conducting 
the review determines that the Secretary has failed 
to comply with the requirement, the court shall 
order the Secretary to comply within a period deter-
mined to be appropriate by the court. 
‘‘(d) IMMINENT HAZARD AUTHORITY.—
‘‘(1) IN GENERAL.—A State may establish a re-
quirement that would otherwise violate section 
403A(a)(6) or subsection (a), if—
‘‘(A) the requirement is needed to address 
an imminent hazard to health that is likely to 
result in serious adverse health consequences or 
death; 
‘‘(B) the State has notified the Secretary 
about the matter involved and the Secretary 
has not initiated enforcement action with re-
spect to the matter; 
‘‘(C) a petition is submitted by the State 
under subsection (c) for an exemption or na-
tional standard relating to the requirement not