123STA T . 1 798PUBLIC LA W 111 – 31 —J U NE 22 , 2 0 09 ‘ ‘ (i i )befor e p ro mulgat i n gan y regulation un d er s ubparagrap h ( A ) , afford opportunity for an oral hearing
‘‘(iii) pro v ide the T oba c co P roducts S cientific Advisory C ommittee a reasonable time to ma k e its recommendation w ith respect to proposed regulations under subparagraph (A); ‘‘(iv) in establishing the effective date of a regula - tion promulgated under this subsection, take into account the differences in the manner in which the different types of tobacco products have historically been produced, the financial resources of the different tobacco product manufacturers, and the state of their e x isting manufacturing facilities, and shall provide for a reasonable period of time for such manufacturers to conform to good manufacturing practices; and ‘‘(v) not re q uire any small tobacco product manu- facturer to comply with a regulation under subpara- graph (A) for at least 4 years following the effective date established by the Secretary for such regulation . ‘‘( 2 ) EXEMPTIONS
VAR IAN C ES. — ‘‘(A) PETITION.—Any person sub j ect to any requirement prescribed under paragraph ( 1 ) may petition the Secretary for a permanent or temporary exemption or variance from such requirement. 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 exemption from a requirement, set forth the basis for the peti- tioner ’ s determination that compliance with the requirement is not required 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 facilities 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 requirement; and ‘‘(iii) contain such other information as the Sec- retary shall prescribe. ‘‘( B ) R E F ERRA L TOT H ETO B ACCO PRO DU CTS SCIENTIFIC ADVISOR Y COMMITTEE.—The Secretary may refer to the Tobacco Products Scientific Advisory Committee any peti- tion submitted under subparagraph (A). The Tobacco Prod- ucts Scientific Advisory Committee shall report its rec- ommendations to the Secretary with respect to a petition referred to it within 60 days after the date of the petition’s referral. W ithin 60 days after— ‘‘(i) the date the petition was submitted to the Secretary under subparagraph (A); or ‘‘(ii) the day after the petition was referred 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 approve— ‘‘(i) a petition for an exemption for a tobacco product from a requirement if the Secretary determines Reports.D e adlin e. C o m plian c e date. H earin g s.
