to the investigations, including data that does not support 
the claim of safety for use.’’. 
(2) NOTICES; PUBLIC AVAILABILITY OF INFOR-
MATION.—Section 409(b)(5) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)) is 
amended— 
(A) by striking ‘‘(5)’’ and inserting 
‘‘(5)(A)’’; and 
(B) by adding at the end the following sub-
paragraphs: 
‘‘(B) In the case of a genetic food additive: 
‘‘(i) Promptly after providing the notice under 
subparagraph (A), the Secretary shall make avail-
able to the public all reports and data described in 
paragraph (2)(E) that are contained in the petition 
involved, and all other information in the petition to 
the extent that the information is relevant to a de-
termination of the safety for use of the additive. 
‘‘(ii) Such notice shall state whether any infor-
mation in the petition is not being made available to 
the public because the Secretary has made a deter-
mination that the information does not relate to the 
safety for use of the additive. Any person may peti-
tion the Secretary for a reconsideration of such a de-
termination. 
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‘‘(C) In the case of genetic food additives: 
‘‘(i) The Secretary shall maintain and make 
available to the public through telecommunications a 
list of petitions that are pending under this sub-
section and a list of petitions for which regulations 
under subsection (c)(1)(A) have been established. 
Such list shall include information on the additives 
involved, including the source of the additives, and 
including any information received by the Secretary 
pursuant to clause (ii). 
‘‘(ii) If a regulation is in effect under sub-
section (c)(1)(A) for a genetic food additive, any 
person who manufactures such additive for commer-
cial use shall submit to the Secretary a notification 
of any knowledge of data that relate to the adverse 
health effects of the additive, when knowledge is ac-
quired by the person after the date on which the 
regulation took effect. If the manufacturer is in pos-
session of the data, the notification shall include the 
data. The Secretary shall by regulation establish the 
scope of the responsibilities of manufacturers under 
this clause, including such limits on the responsibil-
ities as the Secretary determines to be appropriate.’’. 
(3) EFFECTIVE DATE OF REGULATION REGARD-
ING
SAFE
USE; OPPORTUNITY
FOR
PUBLIC
COM-
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MENT.—Section 409(c)(2) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 348(c)(2)) is 
amended— 
(A) by striking ‘‘(2)’’ and inserting 
‘‘(2)(A)’’; and 
(B) by adding at the end the following sub-
paragraph: 
‘‘(B)(i) In the case of a genetic food additive, an 
order under paragraph (1)(A) may not be issued regarding 
the petition involved before the expiration of the applicable 
period under clause (ii). During such period, and con-
tinuing until an order under paragraph (1) is issued, the 
Secretary shall provide interested persons an opportunity 
to submit to the Secretary comments on the petition. In 
publishing such notice, the Secretary shall inform the pub-
lic of such opportunity. 
‘‘(ii) For purposes of clause (i), the applicable period 
under this clause regarding a petition is the 30-day period 
beginning on the date on which the Secretary has under 
subparagraph (B)(i) of subsection (b)(5) made informa-
tion available to the public regarding the petition, except 
that, if under subparagraph (B)(ii) of such subsection the 
Secretary finds in favor of a person who files for reconsid-
eration (relating to a determination by the Secretary that 
information does not relate to safety), such 30-day period 
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is extended by an additional period of 30-days. For pur-
poses of the preceding sentence, a discrete 30-day exten-
sion applies to each such reconsideration for which the 
Secretary finds in favor of the person filing for reconsider-
ation.’’. 
(4) CONSIDERATION OF CERTAIN FACTORS.— 
Section 409(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 348(c)) is amended by adding 
at the end the following paragraph: 
‘‘(6) In the case of a genetic food additive, the factors 
considered by the Secretary regarding safety for use shall 
include (but not be limited to) the results of the following 
analyses: 
‘‘(A) Allergenicity effects resulting from the 
added proteins, including proteins not found in the 
food supply. 
‘‘(B) Pleiotropic effects. The Secretary shall re-
quire tests to determine the potential for such ef-
fects (using molecular characterization, biochemical 
characterization, mRNA profiling, or other tech-
niques, or as appropriate, combinations of such tech-
niques). 
‘‘(C) Appearance of new toxins or increased lev-
els of existing toxins. 
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‘‘(D) Changes in the functional characteristics 
of food. 
‘‘(E) Changes in the levels of important nutri-
ents. 
‘‘(F) Changes in the levels of anti-nutrients.’’. 
(5) CERTAIN
TESTS.—Section 409(c) of the 
Federal Food, Drug, and Cosmetic Act, as amended 
by paragraph (4), is amended by adding at the end 
the following paragraph: 
‘‘(7) In the case of genetic food additives: 
‘‘(A) If a genetic food additive is a protein from 
a commonly or severely allergenic food, the Sec-
retary may not establish a regulation under para-
graph (1)(A) if the petition under subsection (b)(1) 
fails to include full reports of investigations that 
used serum or skin tests (or other advanced tech-
niques) on a sensitive population to determine 
whether such additive is commonly or severely aller-
genic. 
‘‘(B)(i) If a genetic food additive is a protein 
that has not undergone the investigations described 
in subparagraph (A), the Secretary may not estab-
lish a regulation under paragraph (1)(A) if the peti-
tion under subsection (b)(1) fails to include full re-
ports of investigations that used the best available 
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biochemical and physiological protocols to evaluate 
whether it is likely that the protein involved is an al-
lergen. 
‘‘(ii) For purposes of clause (i), the Secretary 
shall by regulation determine the best available bio-
chemical and physiological protocols. In carrying out 
rulemaking under the preceding sentence, the Sec-
retary shall consult with the Director of the Na-
tional Institutes of Health.’’. 
(6) PROHIBITED ADDITIVES.—Section 409(c) of 
the Federal Food, Drug, and Cosmetic Act, as 
amended by paragraph (5), is amended by adding at 
the end the following paragraph: 
‘‘(8) In the case of a genetic food additive, the Sec-
retary may not establish a regulation under paragraph 
(1)(A) if— 
‘‘(A) the additive is a protein and a report of 
an investigation finds that the additive is likely to be 
commonly or severely allergenic; 
‘‘(B) the additive is a protein and a report of 
an investigation that uses a protocol described in 
paragraph (7)(B) fails to find with reasonable cer-
tainty that the additive is unlikely to be an allergen; 
or 
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