Consumer Product Safety Commission February 2011 – Federal Register Recent Federal Regulation Documents

It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e).\1\ Published below is a provisionally-accepted Settlement Agreement with Ms. Bubbles, Inc., containing a civil penalty of $40,000.00.

The Consumer Product Safety Commission (``CPSC,'' ``Commission,'' or ``we'') is proposing to amend its child-resistant packaging requirements to exempt powder formulations of two oral prescription drugs, colesevelam hydrochloride and sevelamer carbonate. Colesevelam hydrochloride, currently marketed as Welchol[supreg], is available in a new powder formulation and is indicated to reduce elevated LDL cholesterol levels and improve glycemic control in adults with type 2 diabetes mellitus. Sevelamer carbonate, currently marketed as Renvela[supreg], is available as a new powder formulation and is indicated for the control of elevated serum phosphorus in chronic kidney disease patients on dialysis. The proposed rule would exempt these prescription drug products on the basis that child-resistant packaging is not needed to protect young children from serious injury or illness from powder formulations of colesevelam hydrochloride and sevelamer carbonate because the products are not acutely toxic, lack adverse human experience associated with acute ingestion, and in powder form, are not likely to be ingested in large quantities by children under 5 years of age.

The Consumer Product Safety Commission (``CPSC,'' ``Commission,'' or ``we'') is announcing its decision to stay enforcement of the testing of youth all-terrain vehicles (``ATVs'') by third party conformity assessment bodies, subject to conditions, until November 27, 2011.