‘‘(t) No provision of this section or section 409 shall
be construed to require on a food a separate disclosure
of—
‘‘(1) a method of production, or
‘‘(2) an ingredient other than in the statement
of ingredients,
unless such disclosure is necessary to protect the public
health.’’.
SEC. 105. ACCREDITED PERSON REVIEW.
(a) HEALTH CLAIMS.—Section 403(r)(4)(A) (21
U.S.C. 343(r)(4)(A)) is amended by inserting at the end
of the first sentence in subclauses (i), (ii), and (iii) the
following: ‘‘or may file such a petition with a person au-
thorized to review it under section 712’’.
(b) 
ACCREDITED
PERSON
REVIEW.—Section
403(r)(4) (21 U.S.C. 434(r)(4)) is amended by adding at
the end the following:
‘‘(D)(i) In reviewing a petition submitted under
clause (A) to an accredited person such a person shall de-
termine if the petition meets the requirements for peti-
tions to the Secretary. The review of such a petition shall
be conducted under the standards and requirements of
this Act that are applicable to the review of petitions to
the Secretary. After a period of 120 days after such a peti-
tion is submitted, the accredited person shall submit a re-
port of its review of such petition to the Secretary and
include its recommendations. Such recommendations to
the Secretary shall specify—
‘‘(I) in the case of a petition under subclause
(i), whether the claim with respect to which the peti-
tion was made should be approved or denied;
‘‘(II) in the case of a petition under subclause
(ii), whether such claim may use the terms specified
in the petition, and
‘‘(III) in the case of a petition under subclause
(iii), whether such claim may be made in a brand
name, and
shall state the basis for the recommendation.
‘‘(ii) The recommendation of an accredited person to
approve or deny a petition submitted to such person shall
be deemed to be the decision of the Secretary unless the
Secretary finds that such recommendation is contrary to
the findings required in this Act. If the Secretary makes
such a finding, the Secretary shall provide a detailed ex-
planation of the basis of the finding.’’.
(c) FOOD ADDITIVES.—Section 409 (21 U.S.C. 348)
is amended—
(1) by inserting at the end of subsection (b)(1)
the following: ‘‘Any person may submit such a peti-
tion to a person accredited under section 712.’’;
(2) by inserting at the end of subsection (c)(2)
the following: ‘‘This paragraph shall apply to a peti-
tion submitted to an accredited person under sub-
section (b)(1).’’; and
(3) by adding at the end of subsection (c) the
following:
‘‘(6)(A) An accredited person shall review a petition
submitted to it under subsection (b)(1) to determine
whether there is reasonable assurance that the food addi-
tive with respect to which the petition was submitted may
be safely used under the proposed conditions of use. The
review of such a petition shall be conducted under the
standards and requirements of this Act that are applicable
to the review of petitions to the Secretary. After expiration
of the period prescribed by paragraph (2), the accredited
person shall submit a report of its review of such petition
to the Secretary and include its recommendations. Such
recommendations to the Secretary shall specify whether
a petition should be approved or denied and shall state
the basis for the recommendation.
‘‘(B) The recommendation of an accredited person to
approve or deny a petition submitted to such person shall
be deemed to be the decision of the Secretary unless the
Secretary finds that there is a reasonable probability it
is not safe. If the Secretary makes such a finding, the
Secretary shall provide a detailed explanation of the basis
of the finding.’’.
(d) COLOR ADDITIVES.—Section 721 (21 U.S.C
379e) is amended by adding at the end the following:
‘‘(g) PETITION TO ACCREDITED PERSON.—(1) Any
person may submit a petition to a person accredited under
section 712 for the issuance of a regulation under sub-
section (b) or (c) or for the issuance of an exemption
under subsection (f).
‘‘(2) In reviewing a petition submitted under para-
graph (1) to an accredited person, such a person shall de-
termine if the petition meets the requirements for the issu-
ance of a regulation under subsection (b) or (c) or for the
issuance of an exemption under subsection (f). The review
of such a petition shall be conducted under the standards
and requirements of this Act that are applicable to the
review of petitions to the Secretary for the issuance of
such a regulation or exemption. After a period of 120 days
after such a petition is submitted, the accredited person
shall submit a report of its review of such petition to the
Secretary and include its recommendations. Such rec-
ommendations to the Secretary shall specify if such a reg-
ulation or exemption should be issued and shall state the
basis for its recommendation.
‘‘(3) The recommendation of an accredited person to
approve or deny a petition submitted to such person shall
be deemed to be the decision of the Secretary unless the
Secretary finds that there is a reasonable probability it
is not safe. If the Secretary makes such a finding, the
Secretary shall provide a detailed explanation of the basis
of the finding.’’.
SEC. 106. ACCREDITED PERSONS.
(a) AMENDMENT.—Subchapter A of chapter VII is
amended by adding at the end the following:
‘‘SEC. 712. ACCREDITED PERSONS.
‘‘(a) IN GENERAL.—The Secretary shall, within 180
days of the date of the enactment of this section, by regu-
lation establish procedures for the accreditation of third
parties for the purposes of—
‘‘(1) reviewing petitions under sections 403(r),
409, and 721(g), an application under section 512,
providing written reviews to the Secretary for the
Secretary’s consideration, and making recommenda-
tions on whether or not such petitions or application
should be approved; and
‘‘(2) conducting good manufacturing practice
inspections to determine the conformance of a facil-
ity with regulations promulgated under section 402.
‘‘(b) ACCREDITATION.—
‘‘(1) PROGRAMS.—The Secretary shall provide
for such accreditation through programs adminis-
tered by government agencies or by other qualified
organizations.
‘‘(2) IMPLEMENTATION.—The Secretary may
designate one or more qualified non-government or-
ganizations to implement such programs. Such orga-
nizations shall implement such programs from fees
charged to applicants for accreditation.
‘‘(3) QUALIFICATIONS.—An accredited person
shall meet the following requirements:
‘‘(A) Such person shall be an independent
organization which is not owned or controlled
by manufacturer, supplier or vendor of food or
animal drugs and which has no organizational,
material, or financial affiliation with such a
manufacturer, supplier, or vendor.
‘‘(B) Such person shall be a legally con-
stituted entity permitted to conduct the activi-
ties for which it seeks accreditation.
‘‘(C) Such person shall not engage in the
design, manufacture, promotion, or sale of food
or animal drugs.
‘‘(D) Such person shall be operated in ac-
cordance with generally accepted professional
and ethical business practices and shall agree in
writing that as a minimum it will—
‘‘(i) certify that reported information
accurately reflects data reviewed;
‘‘(ii) limit work to that for which com-
petence and capacity are available;
‘‘(iii) 
treat 
information 
received,
records, reports, and recommendations as
proprietary information; and
‘‘(iv) promptly respond and attempt to
resolve complaints regarding its activities
for which it is accredited.’’.
(b) CONFORMING AMENDMENT.—Section 301 (21
U.S.C. 321) is amended by redesignating the second para-
graph (u) as paragraph (v) and by adding after that para-
graph the following:
‘‘(w) in the case of a drug, device, or food—
‘‘(A) the submission of a report or rec-
ommendation by a person accredited under section
712 that is false or misleading in any material re-
spect;
‘‘(B) the disclosure by a person accredited
under section 712 of confidential commercial infor-
mation or any trade secret without the express writ-
ten consent of the person who submitted such infor-
mation or secret to such person; or
‘‘(C) the receipt by a person accredited under
section 712 of a bribe in any form or the doing of
any corrupt act by such person associated with a re-
sponsibility delegated to such person under this
Act.’’.
SEC. 107. IMPROVING THE DELANEY CLAUSE.
(a) FOOD ADDITIVES.—
(1) AMENDMENT.—Section 409(c)(3)(A) (21
U.S.C. 348(c)(3)(A)) is amended by striking all
after ‘‘substance’’ and inserting ‘‘that presents a
negligible or de minimus risk’’.
(2) REGULATIONS.— The Secretary shall, with-
in 180 days of the date of the enactment of this Act,
issue a proposed regulation to establish criteria to
determine a negligible or insignificant risk for pur-
poses of section 409(c)(3)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 348(c)(3)(A)).
Such proposed regulation shall become final unless
the Secretary issues a final regulation before 18
months after such date of enactment.
(b) ANIMAL DRUGS.—
(1) AMENDMENT.—Section 512(d)(1)(I) (21
U.S.C 360b(d)(1)(I)) is amended by striking every-
thing after ‘‘if’’ and inserting ‘‘if such drug presents
a negligible or insignificant risk to humans or ani-
mals.’’.
(2) REGULATIONS.— The Secretary shall, with-
in 180 days of the date of the enactment of this Act,
issue a proposed regulation to establish criteria to
determine a negligible or insignificant risk for pur-
poses of section 512(d)(1)(I) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360b(d)(1)(I)).
Such proposed regulation shall become final unless
the Secretary issues a final regulation before 18
months after such date of enactment.
(c) COLOR ADDITIVE.—
(1) AMENDMENT.—Section 721(b)(5)(B) (21
U.S.C 379e(b)(5)(B)) is amended by striking all
after ‘‘with respect to the use of a color additive’’
and inserting ‘‘if such color additive presents a neg-
ligible or insignificant risk to humans or animals.’’.
(2) REGULATIONS.— The Secretary shall, with-
in 180 days of the date of the enactment of this Act,
issue a proposed regulation to establish criteria to
determine a negligible or insignificant risk for pur-
poses of section 721(b)(5)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379e(b)(5)(B)).
Such proposed regulation shall become final unless
the Secretary issues a final regulation before 18
months after such date of enactment.
SEC. 108. NATIONAL UNIFORMITY.
Chapter VII is amended by adding at the end the
following:
‘‘SUBCHAPTER D—NATIONAL UNIFORMITY
‘‘SEC. 741. (a)(1) Except as provided in paragraph
(2) or subsections (b) and (c), no State or political subdivi-
sion of a State may, directly or indirectly, establish or con-
tinue in effect under any authority any requirement (in-
cluding a prohibition) for a—
‘‘(A) food for human use,
‘‘(B) a drug (including a biological product), or
‘‘(C) a cosmetic,
which is of the type authorized or required under the adul-
teration, misbranding, or new drug provisions of this Act
or any regulation to implement such provisions if such
State or political subdivision requirement is not identical
to a requirement imposed under this Act.
‘‘(2) Paragraph (1) does not apply to a State or polit-
ical subdivision requirement relating to the practice of
pharmacy or the dispensing of a drug for human use only
upon prescription of a practitioner licensed by law to ad-
minister such drug.
‘‘(b)(1) Except as provided in subsection (c), no State
or political subdivision of a State may, directly or indi-
rectly, establish or continue in effect under any authority
any notification requirement for a food, drug, or cosmetic
that provides—
‘‘(A) for disclosure of the constituents, source,
or method of production or processing of the food,
drug, or cosmetic, or
‘‘(B) for a warning concerning the safety of the
food, drug, or cosmetic or any component or package
thereof,
unless such notification requirement has been prescribed
under the authority of this Act and the State or political
subdivision notification requirement is identical to the no-
tification requirement prescribed under the authority of
this Act.
‘‘(2) For purposes of paragraph (1)—
‘‘(A) the term ‘warning’ with respect to a food,
drug, or cosmetic means any statement, vignette, or
other representation which indicates, directly or by
implication, that the food, drug, or cosmetic presents
or may present a hazard to human health or safety;
and
‘‘(B) the term ‘notification requirement’ in-
cludes any requirement relating to the dissemination
of information about a food, drug, or cosmetic in
any manner, such as labels, labeling, posters, public
notices, advertising, or any other means of commu-
nication.
‘‘(c) Upon application of a State, the Secretary may
by regulation, after notice and opportunity for written and
oral presentation of views, exempt from subsection (a) or
(b), under such conditions as the Secretary may impose,
a State requirement which—
‘‘(1) is justified by compelling and unique local
conditions;
‘‘(2) protects an important public interest that
would otherwise by unprotected;
‘‘(3) would not cause any food, drug, or cos-
metic to be in violation of any applicable require-
ment or prohibition under Federal law; and
‘‘(4) would not unduly burden interstate com-
merce.’’.
SEC. 109. HARMONIZATION.
Section 803 (21 U.S.C. 383) is amended by adding
at the end the following:
‘‘(c)(1) The Secretary shall regularly and continu-
ously participate in meetings with other countries to dis-
cuss methods and approaches to reduce the burden of reg-
ulation, harmonize regulatory requirements, and seek ap-
propriate reciprocal arrangements. The Secretary shall,
within 180 days of the date of enactment of this sub-
section, make public a plan that establishes a framework
for achieving mutual recognition of good manufacturing
practices.
‘‘(2) The Secretary shall report to the Committee on
Commerce of the House of Representatives and the Com-
mittee on Labor and Human Resources of the Senate at
least 60 days before executing any bilateral or multilateral
agreement under paragraph (1).’’.
SEC. 110. INFORMAL AGENCY STATEMENTS.
Section 701 (21 U.S.C. 371) is amended by adding
at the end the following:
‘‘(h)(1) The Secretary shall not rely upon informal
agency statements, including guidance documents, policy
statements, points to consider documents, or any other
statements that have not been promulgated in accordance
with the rulemaking requirements of chapter V of title 5,
United States Code, to require any action be taken to sat-
isfy a requirement of this Act.
‘‘(2) The Secretary shall publish notice in the Federal
Register of the availability to the public of each type of
statement identified in paragraph (1). Additionally, the
Secretary shall undertake to make available all such state-
ments by electronic or other similar means.’’.
SEC. 111. COLORED MARGARINE.
(a) SECTION 301(m).—Paragraph (m) of section 301
(21 U.S.C. 321) is repealed.
(b) SECTION 407.—Section 407 (21 U.S.C. 347) is
repealed.
(c) ACT OF MARCH 16, 1950.—Sections 3(a) and 6
of the Act of March 16, 1950 (21 U.S.C. 347a, 347b)
are repealed.
(d) FEDERAL TRADE COMMISSION ACT.—Section 15
of the Federal Trade Commission Act (15 U.S.C. 55) is
amended—
(1) in subsection (a), by striking ‘‘(a)(1)’’ and
inserting ‘‘(a)’’ and by striking paragraph (2); and
(2) by striking subsection (f).
TITLE II—ANIMAL DRUGS
SEC. 201. EVIDENCE OF EFFECTIVENESS FOR ANIMAL
DRUGS.
(a) ORIGINAL APPLICATIONS.—Section 512(d) (21
U.S.C. 360b(d)) is amended by striking paragraph (3) and
by adding at the end the following:
‘‘(4)(A) As used in this subsection and subsections
(c)(2)(F)(iii) and (e)(1)(C), the term ‘substantial evi-
dence’ means evidence from 1 or more scientifically sound
studies, including as appropriate in vitro studies, studies
in laboratory animals (including a target species),
bioequivalence studies, and any studies voluntarily under-
taken by or for the applicant, that taken together provide
reasonable assurance that the drug will have the claimed
or intended effect of the drug.
‘‘(B) For purposes of subparagraph (A), a study shall
be considered to be scientifically sound if the study is de-
signed and conducted in a manner that is consistent with
generally recognized scientific procedures and principles.’’.
(b) 
SUPPLEMENTAL
APPLICATIONS.—Section
512(c)(2)(F)(iii) (21 U.S.C. 360b(c)(2)(F)(iii)) is amend-
ed—
(1) by striking ‘‘reports of new clinical or field
investigations (other than bioequivalence or residue
studies) and’’ and inserting ‘‘substantial evidence (as
defined in subsection (d)(4)) of the effectiveness of
the drug involved, any studies of animal safety, or’’;
and
(2) by striking ‘‘essential to’’ and inserting ‘‘,
required for’’.
(c) MINOR SPECIES AND USES.—Section 512(d)(1)
(21 U.S.C. 360b(d)(1)) is amended by adding at the end
the following new sentence: ‘‘Subparagraph (E) shall not
apply to a claim for use of the drug described in subpara-
graph (E) in a minor species, or for a minor use of the
drug, as the terms ‘minor species’ and ‘minor use’ are de-
fined in regulations issued by the Secretary, if there is
an application filed under subsection (b) for the drug, and
the application is approved, prior to the submission of the
claim.’’.
(d) COMBINATION
DRUGS.—Section 512(d) (21
U.S.C. 360b(d)) is amended by inserting before paragraph
(4) (as added by subsection (a)) the following new para-
graph:
‘‘(3) In a case in which a new animal drug contains
more than 1 active ingredient, or the labeling of the drug
prescribes, recommends, or suggests use of the drug in
combination with another animal drug, and the active in-
gredients or drugs in the combination have been sepa-
rately approved for particular uses and species prior to
the approval of the application for the same uses and spe-
cies in combination (or, in the absence of such approvals,
after evaluating the safety and efficacy of the combination
itself), the Secretary may only consider with respect to the
combination whether any of the active ingredients or any
of the drugs in the combination, respectively, at the long-
est withdrawal time of any of the active ingredients or
drugs in the combination, respectively, is above its safe
concentration, i.e. exceeds its established tolerance (as
measured by its marker residue), or interferes with the
methods of analysis for another of the active ingredients
or drugs in the combination, respectively.’’.
(e) 
WITHDRAWAL
OF
APPROVAL.—Section
512(e)(1)(C) (21 U.S.C. 360b(e)(1)(C)) is amended by in-
serting after ‘‘substantial evidence’’ the following: ‘‘(as de-
fined in subsection (d)(4))’’.
(f) IMPLEMENTATION.—
(1) IN
GENERAL.—Not later than 6 months
after the date of enactment of this Act, the Sec-
retary shall issue proposed regulations implementing
the amendments made by this section. Not later
than 18 months after the date of enactment of this
Act, the Secretary shall issue final regulations imple-
menting the amendments.
(2) CONTENTS.—In issuing regulations imple-
menting the amendments made by this section, and
in taking an action to review an application for ap-
proval of a new animal drug under section 512 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b), or a request for an investigational ex-
emption for a new animal drug under subsection (j)
of such section, that is pending or has been submit-
ted prior to the effective date of the regulations, the
Secretary shall—
(A) further define the term ‘‘substantial
evidence’’, as defined in subsection (d)(4) of
such section, in a manner that encourages the
submission of applications for production drugs
that conserve food resources, of applications for
veterinary prescription drugs whose use is de-
signed to rely on the experience and training of
practitioners in establishing effective doses for
such drugs, and of supplemental applications,
including applications seeking approval for uses
of animal drugs in minor species, for minor
uses of such drugs, and for permitted unlabeled
uses of such drugs;
(B) take into account the proposals con-
tained in the citizen petition (FDA Docket No.
91P–0434/CP) jointly submitted by the Amer-
ican Veterinary Medical Association and the
Animal Health Institute, dated October 21,
1991;
(C)(i) provide for the opportunity for a
conference prior to the submission of an appli-
cation for approval of a new animal drug under
such section, and prior to the submission of a
request for an investigational exemption under
subsection (j) of such section, to make a deci-
sion establishing a submission or an investiga-
tional requirement (which decision shall bind
the Secretary and the applicant or requester
unless the Secretary by order determines that a
documented scientific requirement essential to
the determination of safety or effectiveness of
the animal drug involved has appeared after the
conference); and
(ii) not later than 10 days after each such
conference, by written order, provide a scientific
justification specific to the animal drug and in-
tended uses under consideration for requiring
studies of types other than the types of studies
specified in subsection (d)(4) of such section, as
being essential to provide substantial evidence
of effectiveness for the intended uses of the
drug.
SEC. 202. TIMEFRAME FOR APPROVAL FOR ANIMAL DRUGS.
The first sentence of section 512(c)(1) (21 U.S.C.
360b(c)(1)) is amended by striking ‘‘one hundred and
eighty’’ and inserting ‘‘90’’.
SEC. 203. DISPUTE RESOLUTION.
Section 
512(c)(1) 
(21 
U.S.C. 
360b(c)(1)) 
is
amended—
(1) in the first sentence—
(A) by redesignating subparagraphs (A)
and (B) as clauses (i) and (ii), respectively; and
(B) by inserting ‘‘(A)’’ after ‘‘(1)’’;