; and (iv) experience with the ingredient or non-functional constituent in products that are distributed in the United States or in other countries, if such experience is well-documented and has resulted in substantial human exposure to the ingredient or non-functional constituent over time. (i) Coal-Tar Hair Dye Coal-tar hair dye shall be subject to the conditions of section 601(a) unless the Food and Drug Administration has issued a final determination for a coal-tar hair dye ingredient under subsection (d)(4)(C). . 103. Good manufacturing practices for cosmetics (a) In general Chapter VI of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 361 et seq.), as amended by section 102, is further amended by adding at the end the following: 608. Good manufacturing practices for cosmetics (a) In general The Food and Drug Administration shall review national and international standards for cosmetic good manufacturing practices that are in existence on the date of enactment of the Personal Care Products Safety Act and shall develop and implement, through regulations, standards consistent, to the extent the Food and Drug Administration determines practicable and appropriate, with such national and international standards for cosmetic good manufacturing practices to ensure that requirements of this chapter with respect to the manufacture of cosmetic products are in harmony. (b) Consultation The standards under subsection (a) shall include simplified good manufacturing practices for small businesses that take into account the size and scope of the business, developed in consultation with the Small Business Administration. (c) Timeframe The Food and Drug Administration shall publish a proposed rule described in subsection (a) not later than 18 months after the date of enactment of the Personal Care Products Safety Act and shall publish a final such rule not later than 3 years after such date of enactment. . (b) Effective date for cosmetic manufacturers (1) Large businesses For businesses of a size greater than the Small