HR 1108 RFS 
‘‘(B) consult with other Federal agencies 
concerned with standard setting and other na-
tionally or internationally recognized standard- 
setting entities; and 
‘‘(C) 
invite 
appropriate 
participation, 
through joint or other conferences, workshops, 
or other means, by informed persons represent-
ative of scientific, professional, industry, agri-
cultural, or consumer organizations who in the 
Secretary’s judgment can make a significant 
contribution. 
‘‘(b) CONSIDERATIONS BY SECRETARY.— 
‘‘(1) TECHNICAL
ACHIEVABILITY.—The Sec-
retary shall consider information submitted in con-
nection with a proposed standard regarding the tech-
nical achievability of compliance with such standard. 
‘‘(2) OTHER CONSIDERATIONS.—The Secretary 
shall consider all other information submitted in 
connection with a proposed standard, including in-
formation concerning the countervailing effects of 
the tobacco product standard on the health of ado-
lescent tobacco users, adult tobacco users, or non-
tobacco users, such as the creation of a significant 
demand for contraband or other tobacco products 
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that do not meet the requirements of this chapter 
and the significance of such demand. 
‘‘(c) PROPOSED STANDARDS.— 
‘‘(1) IN GENERAL.—The Secretary shall publish 
in the Federal Register a notice of proposed rule-
making for the establishment, amendment, or rev-
ocation of any tobacco product standard. 
‘‘(2) REQUIREMENTS OF NOTICE.—A notice of 
proposed rulemaking for the establishment or 
amendment of a tobacco product standard for a to-
bacco product shall— 
‘‘(A) set forth a finding with supporting 
justification that the tobacco product standard 
is appropriate for the protection of the public 
health; 
‘‘(B) invite interested persons to submit a 
draft or proposed tobacco product standard for 
consideration by the Secretary; 
‘‘(C) invite interested persons to submit 
comments on structuring the standard so that 
it does not advantage foreign-grown tobacco 
over domestically grown tobacco; and 
‘‘(D) invite the Secretary of Agriculture to 
provide any information or analysis which the 
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Secretary of Agriculture believes is relevant to 
the proposed tobacco product standard. 
‘‘(3) FINDING.—A notice of proposed rule-
making for the revocation of a tobacco product 
standard shall set forth a finding with supporting 
justification that the tobacco product standard is no 
longer appropriate for the protection of the public 
health. 
‘‘(4) COMMENT.—The Secretary shall provide 
for a comment period of not less than 60 days. 
‘‘(d) PROMULGATION.— 
‘‘(1) IN GENERAL.—After the expiration of the 
period for comment on a notice of proposed rule-
making published under subsection (c) respecting a 
tobacco product standard and after consideration of 
comments submitted under subsections (b) and (c) 
and any report from the Tobacco Products Scientific 
Advisory Committee, if the Secretary determines 
that the standard would be appropriate for the pro-
tection of the public health, the Secretary shall— 
‘‘(A) promulgate a regulation establishing 
a tobacco product standard and publish in the 
Federal Register findings on the matters re-
ferred to in subsection (c); or 
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‘‘(B) publish a notice terminating the pro-
ceeding for the development of the standard to-
gether with the reasons for such termination. 
‘‘(2) EFFECTIVE
DATE.—A regulation estab-
lishing a tobacco product standard shall set forth 
the date or dates upon which the standard shall take 
effect, but no such regulation may take effect before 
1 year after the date of its publication unless the 
Secretary determines that an earlier effective date is 
necessary for the protection of the public health. 
Such date or dates shall be established so as to min-
imize, consistent with the public health, economic 
loss to, and disruption or dislocation of, domestic 
and international trade. In establishing such effec-
tive date or dates, the Secretary shall consider infor-
mation submitted in connection with a proposed 
product standard by interested parties, including 
manufacturers and tobacco growers, regarding the 
technical achievability of compliance with the stand-
ard, and including information concerning the exist-
ence of patents that make it impossible to comply in 
the timeframe envisioned in the proposed standard. 
If the Secretary determines, based on the Sec-
retary’s evaluation of submitted comments, that a 
product standard can be met only by manufacturers 
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requiring substantial changes to the methods of 
farming the domestically grown tobacco used by the 
manufacturer, the effective date of that product 
standard shall be not less than 2 years after the 
date of publication of the final regulation estab-
lishing the standard. 
‘‘(3) LIMITATION ON POWER GRANTED TO THE 
FOOD AND DRUG ADMINISTRATION.—Because of the 
importance of a decision of the Secretary to issue a 
regulation— 
‘‘(A) banning all cigarettes, all smokeless 
tobacco products, all little cigars, all cigars 
other than little cigars, all pipe tobacco, or all 
roll-your-own tobacco products; or 
‘‘(B) requiring the reduction of nicotine 
yields of a tobacco product to zero, 
the Secretary is prohibited from taking such actions 
under this Act. 
‘‘(4) AMENDMENT; REVOCATION.— 
‘‘(A) AUTHORITY.—The Secretary, upon 
the Secretary’s own initiative or upon petition 
of an interested person, may by a regulation, 
promulgated in accordance with the require-
ments of subsection (c) and paragraph (2), 
amend or revoke a tobacco product standard. 
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