The Environmental Protection Agency is proposing significant new use rules (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for the chemical substances rutile, tin zinc, calcium-doped (CAS No. 389623--01--2) and rutile, tin zinc, sodium-doped (CAS No. 389623--07--8), which were the subject of premanufacture notices and TSCA section 5(e) consent orders issued by EPA and are used as colorants for polymers and industrial coatings. The proposed SNURs on these substances, which are based on and consistent with the provisions of the underlying consent orders, would designate as a significant new use the absence of the protective measures required in the consent orders. This action would require persons who intend to manufacture, import, or process either of the chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity, allowing EPA to evaluate the intended use and, if necessary, prohibit or limit the activity before it occurs. Comments are due by approximately January 27, 2012.
The Environmental Protection Agency is proposing significant new use rules (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for 17 chemical substances1 which were the subject of premanufacture notices (PMNs). Fifteen of these chemical substances are subject to TSCA section 5(e) consent orders issued by EPA. This action would require persons who intend to manufacture, import, or process any of these 17 chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification would provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs.
On December 22, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
U.S. Customs and Border Protection has issued CSMS message #11-000318 notifying Food and Drug Administration filers located within the San Diego area to send all routine FDA-related mail correspondence to: 2320 Paseo de las Americas, Suite 200, San Diego, CA 92154. Filers should not use the address: 9777 via de la Amistad, RM131, San Diego, CA 92154.
The Food and Drug Administration announced on December 21, 2011 the creation of the Food Safety Preventive Controls Alliance (FSPCA) to develop training and guidelines for industry on the upcoming hazard analysis and preventive controls requirements for food and feed facilities, which are mandated by the Food Safety Modernization Act.
On December 21, 2011, the Food and Drug Administration issued a warning to consumers not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks. King International recalled the ShoulderFlex Massager on Aug. 31, 2011. However, during a recent compliance audit, FDA found that the company had gone out of business and not followed through with recall procedures.
On December 21, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On December 20, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration is seeking comments and information that will assist it in its deliberations about ways to help individuals with celiac disease avoid the presence of gluten in drug products. In particular, FDA is interested in information on ingredients present in human drug products marketed in the U.S. that are currently derived from wheat, barley, or rye. Comments are due by February 21, 2012.
U.S. Customs and Border Protection has issued a CSMS message announcing that the Food and Drug Administration has created two new Affirmation of Compliance (AofC) codes - KIT and DDM - to address shipments of kits containing finished devices imported into the U.S.