On December 27, 2011, the Food and Drug Administration announced a recall by U.B.C Food Distributors of “Baraka Apricot Candies” manufactured by Baraka Co. in Lebanon due to undeclared Sulfites/Preservatives.
On December 27, 2011, the Environmental Protection Agency sent to the Office of Management and Budget a proposed rule entitled, "CBI: PMN Amendments Claiming Chemical and Microorganism Identity as Confidential in Data From Health and Safety Studies Submitted Under TSCA Prior to the Commencement of Manufacture." EPA states it is developing proposed amendments to its new chemical and microorganism premanufacture regulations with respect to the information submitted to the EPA under the Toxic Substances Control Act (TSCA).
The Food and Drug Administration has submitted to the Office of Management and Budget a proposed rule required by the Food Safety Modernization Act (FSMA) that would establish and publish science-based minimum standards for the safe production and harvesting of those types of fruits and vegetables, including specific mixes or categories of fruits and vegetables, that are raw agricultural commodities, at risk of contamination and serious adverse health consequences or death.
The Food and Drug Administration sent a Warning Letter dated December 20, 2011 to Four Star Import and Distribution, Inc. of Brooklyn, NY as there was no evidence during inspection that the importer's Munia Churi Dry Fish and Noya Boyal Dry Fish from Bangladesh were processed using procedures equivalent to the seafood Hazard Analysis and Critical Control Point (HACCP) regulations in 21 CFR Part 123, nor did the importer in its initial response provide a time frame for corrective action or provide related supporting documentation. Without such evidence, FDA states these products appear to be adulterated and may be denied admission, placed on the "detention without physical examination" list, seized, or the firm enjoined from further violations of the law. The importer has 15 days to respond to the December 20 letter.
On December 28, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The Environmental Protection Agency is proposing a significant new use rule (SNUR) under section 5(a)(2) of the Toxic Substances Control Act for the chemical substance identified as phenol, 2,4-dimethyl-6-(1-methylpentadecyl)- (CAS No. 134701-20-5), which is used as an antioxidant. This action would require persons who intend to manufacture, import, or process the substance for an activity that is designated as a significant new use by this proposed "SNUR" 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. 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 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 27, 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 23, 2011, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: