change between a retailer and a consumer 
in order to protect individuals who have not 
attained the minimum age established by 
applicable law for the purchase of such 
products. 
‘‘(B) RELATION TO OTHER AUTHORITY.— 
Nothing in this paragraph limits the authority 
of the Secretary to take additional actions under 
the other paragraphs of this subsection. 
‘‘(e) GOOD MANUFACTURING PRACTICE REQUIRE-
MENTS.— 
‘‘(1) METHODS, FACILITIES, AND CONTROLS TO 
CONFORM.— 
‘‘(A) IN GENERAL.—In applying manufac-
turing restrictions to tobacco, the Secretary shall, 
in accordance with subparagraph (B), prescribe 
regulations (which may differ based on the type 
of tobacco product involved) requiring that the 
methods used in, and the facilities and controls 
used for, the manufacture, preproduction design 
validation (including a process to assess the per-
formance of a tobacco product), packing, and 
storage of a tobacco product conform to current 
good manufacturing practice, or hazard analysis 
and critical control point methodology, as pre-
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scribed in such regulations to assure that the 
public health is protected and that the tobacco 
product is in compliance with this chapter. Such 
regulations may provide for the testing of raw 
tobacco for pesticide chemical residues regardless 
of whether a tolerance for such chemical residues 
has been established. 
‘‘(B) 
REQUIREMENTS.—The 
Secretary 
shall— 
‘‘(i) before promulgating any regula-
tion under subparagraph (A), afford the To-
bacco Products Scientific Advisory Com-
mittee an opportunity to submit rec-
ommendations with respect to the regulation 
proposed to be promulgated; 
‘‘(ii) before promulgating any regula-
tion under subparagraph (A), afford oppor-
tunity for an oral hearing; 
‘‘(iii) provide the Tobacco Products 
Scientific Advisory Committee a reasonable 
time to make its recommendation with re-
spect to proposed regulations under sub-
paragraph (A); 
‘‘(iv) in establishing the effective date 
of a regulation promulgated under this sub-
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section, take into account the differences in 
the manner in which the different types of 
tobacco products have historically been pro-
duced, the financial resources of the dif-
ferent tobacco product manufacturers, and 
the state of their existing manufacturing fa-
cilities, and shall provide for a reasonable 
period of time for such manufacturers to 
conform to good manufacturing practices; 
and 
‘‘(v) not require any small tobacco 
product manufacturer to comply with a reg-
ulation under subparagraph (A) for at least 
4 years following the effective date estab-
lished by the Secretary for such regulation. 
‘‘(2) EXEMPTIONS; VARIANCES.— 
‘‘(A) PETITION.—Any person subject to any 
requirement prescribed under paragraph (1) 
may petition the Secretary for a permanent or 
temporary exemption or variance from such re-
quirement. Such a petition shall be submitted to 
the Secretary in such form and manner as the 
Secretary shall prescribe and shall— 
‘‘(i) in the case of a petition for an ex-
emption from a requirement, set forth the 
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basis for the petitioner’s determination that 
compliance with the requirement is not re-
quired to assure that the tobacco product 
will be in compliance with this chapter; 
‘‘(ii) in the case of a petition for a 
variance from a requirement, set forth the 
methods proposed to be used in, and the fa-
cilities and controls proposed to be used for, 
the manufacture, packing, and storage of 
the tobacco product in lieu of the methods, 
facilities, and controls prescribed by the re-
quirement; and 
‘‘(iii) contain such other information 
as the Secretary shall prescribe. 
‘‘(B) REFERRAL TO THE TOBACCO PROD-
UCTS
SCIENTIFIC
ADVISORY
COMMITTEE.—The 
Secretary may refer to the Tobacco Products Sci-
entific Advisory Committee any petition sub-
mitted under subparagraph (A). The Tobacco 
Products Scientific Advisory Committee shall re-
port its recommendations to the Secretary with 
respect to a petition referred to it within 60 days 
after the date of the petition’s referral. Within 60 
days after— 
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‘‘(i) the date the petition was sub-
mitted to the Secretary under subparagraph 
(A); or 
‘‘(ii) the day after the petition was re-
ferred to the Tobacco Products Scientific 
Advisory Committee, 
whichever occurs later, the Secretary shall by 
order either deny the petition or approve it. 
‘‘(C) APPROVAL.—The Secretary may ap-
prove— 
‘‘(i) a petition for an exemption for a 
tobacco product from a requirement if the 
Secretary determines that compliance with 
such requirement is not required to assure 
that the tobacco product will be in compli-
ance with this chapter; and 
‘‘(ii) a petition for a variance for a to-
bacco product from a requirement if the 
Secretary determines that the methods to be 
used in, and the facilities and controls to be 
used for, the manufacture, packing, and 
storage of the tobacco product in lieu of the 
methods, facilities, and controls prescribed 
by the requirement are sufficient to assure 
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that the tobacco product will be in compli-
ance with this chapter. 
‘‘(D) CONDITIONS.—An order of the Sec-
retary approving a petition for a variance shall 
prescribe such conditions respecting the methods 
used in, and the facilities and controls used for, 
the manufacture, packing, and storage of the to-
bacco product to be granted the variance under 
the petition as may be necessary to assure that 
the tobacco product will be in compliance with 
this chapter. 
‘‘(E) HEARING.—After the issuance of an 
order under subparagraph (B) respecting a peti-
tion, the petitioner shall have an opportunity for 
an informal hearing on such order. 
‘‘(3) COMPLIANCE.—Compliance with require-
ments under this subsection shall not be required be-
fore the end of the 3-year period following the date of 
enactment of the Family Smoking Prevention and To-
bacco Control Act. 
‘‘(f) RESEARCH AND DEVELOPMENT.—The Secretary 
may enter into contracts for research, testing, and dem-
onstrations respecting tobacco products and may obtain to-
bacco products for research, testing, and demonstration pur-
poses. 
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