The Food and Drug Administration is announcing a public meeting on May 14, 2012 to provide information and receive comments on the International Conference on Harmonization (ICH) as well as the upcoming ICH Steering Committee meeting in Fukuoka, Japan scheduled for June 2 through 7, 2012.
The Environmental Protection Agency has issued a proposed rule to amend the National Volatile Organic Compound Emission Standards for the Aerosol Coatings final rule, which is a rule that established national reactivity-based emission standards for the aerosol coatings category (aerosol spray paints) under the Clean Air Act. This proposed rule would add three compounds: dimethyl carbonate, benzotrifluoride, and hexamethyldisiloxane and their associated reactivity factors to the aerosol coatings table of reactivity factors, based on petitions received from regulated entities. This action would also revise two other tables in the final rule, and correct a typographical error in a test method reference. Comments must be received by April 23, 2012. If anyone contacts the EPA requesting to speak at a public hearing concerning the proposed regulation by March 19, EPA will hold a public hearing on March 26, 2012.
The Food and Drug Administration issued its weekly Enforcement Report for March 7, 2012 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration has issued a March 1, 2012 version of its chart listing the sample-by-sample results of its testing of imported orange juice products that may be contaminated with the fungicide carbendazim. The chart lists the (1) sample number, (2) collection date, (3) declared country of origin, (4) type of product, (5) sample result for carbendazim, (6) action, and (7) date of action. For example, the first entry is for imported sample number 733701 and states that the orange juice concentrate was collected on January 9, 2012, the declared country of origin was Brazil, that 8-10 ppb of carbendazim was found, and that the shipment was refused entry on February 27. FDA chart (dated 03/01/12) listing its import samplings by number, product, and carbendazim levels is available here.
The Food and Drug Administration is announcing a public meeting on May 15, 2012 to provide information and receive comments on the International Cooperation on Cosmetics Regulations (ICCR) as well as the upcoming ICCR meetings in Rockville, MD. The purpose of this meeting is to solicit public input prior to the next ICCR Steering Committee and expert working group meetings in Rockville, MD on July 10-13, 2012. ICCR is a voluntary international group of cosmetics regulatory authorities from the U.S., Japan, the European Union, and Canada. These regulatory authority members will enter into constructive dialog with their relevant cosmetics industry trade associations.
On March 1, 2012, the Food and Drug Administration issued a weekly update to the trade on its sampling of imported orange juice products that may be contaminated with the fungicide carbendazim. This update, as well as those from prior weeks, is in the form of an "add on" to a February 2 addendum to a letter to the Juice Products Association. FDA is no longer sampling imported juice from domestic manufacturers.
On March 7, 2012, 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 announcing the availability of a guidance entitled "Guidance for Industry: Testing for Salmonella Species in Human Foods and Direct-Human-Contact Animal Foods." The document provides guidance to firms that manufacture, process, pack, or hold human foods (except shell eggs) or direct-human-contact animal foods intended for distribution to consumers, institutions, or food processors. The guidance addresses testing procedures for Salmonella species (spp.) in human foods (except shell eggs) and direct-human-contact animal foods, and the interpretation of test results, when the presence of Salmonella spp. in the food may render the food injurious to human health. Comments may be submitted on this guidance at any time.
On March 6, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 5, 2012, the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: