Document 5bdNZrw7enMMm7zw5X6GR8VOD

Re: Asbestos Particles in Food and Drugs Establishing limits for asbestos in talc used in the manufacture of food and drug items is realistic and a way to obviate the effect of environmental contaminate levels. In addition to the proposed rule-making, a provision should be made to include medical devices manufactured with the aid of talc. Even though Section 501 (aj of The Act is referenced under 133.6, (.i) and 501 (a) includes devices, there is not a straight-forward mechanism outlined to include medical devices. You cannot include medical devices under Part 133 since this section is for drugs. Therefore, it will be difficult to include devices under this proposal even though those items should be covered in the proposed rule-making. qT J