Marketing Orders for Virginia Slims 120'S Menthol Gold Pack Box

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FINDING OF NO SIGNIFICANT IMPACT Marketing Orders for Virginia Slims 120’s Menthol Gold Pack Box Manufactured by Philip Morris USA Inc. The Center for Tobacco Products of the Food and Drug Administration (FDA) has carefully considered the potential environmental impacts of this action and has concluded that this action will not have significant effects on the quality of the human environment. Therefore, an environmental impact statement is not required. Philip Morris USA Inc. wishes to introduce one new combusted, filtered cigarette into interstate commerce for commercial distribution in the United States and submitted to FDA one substantial equivalence report to obtain a marketing order under the provisions of sections 910 and 905(j) of the Federal Food, Drug, and Cosmetic Act. The Agency prepared the environmental assessment (EA), dated December 12, 2019, in accordance with the Council on Environmental Quality's regulations (40 CFR Part 1500) implementing the National Environmental Policy Act (NEPA) and FDA’s NEPA regulations (21 CFR 25.40) to support the finding of no significant impact. The evidence supporting this finding is contained in the attached EA, which is available to the public upon request. The EA evaluates potential environmental effects due to manufacturing, use, and disposal of the new product. No increased or new types of environmental impacts due to manufacturing are anticipated. The Agency does not foresee use of the new product would result in new or different environmental impacts. The Agency believes that the disposal of the new product is the same as the disposal conditions of other combusted, filtered cigarettes that are currently marketed in the United States. Therefore, the Agency does not foresee adverse impacts to the environment due to the proposed action as a result of manufacturing, use, and disposal of the new product. Digitally signed by Hans M. Rosenfeldt -S Date: 2019.12.13 09:16:38 -05'00' Approved by For Kimberly Benson, PhD Director Division of Nonclinical Science Office of Science Center for Tobacco Products U.S. Food and Drug Administration .

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