On April 12, 2011, the Consumer Product Safety Commission announced that My Michelle has voluntarily recalled about 90,000 girls tops and dresses with attached jewelry and decorative trim that contains high levels of lead. The apparel is sized small to extra large and 7 to 16, and was manufactured in Vietnam.

The Food and Drug Administration has posted the transcript from the March 29, 2011 public meeting on the import safety provisions of the Food Safety Modernization Act. FDA has also posted archived webcasts of the event and a reminder that it is seeking comment until April 29 on the import provisions of the FSMA which FDA will consider in its implementation.

The Consumer Product Safety Commission published notice of the following voluntary recall on April 12, 2011:

The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled “Safety Labeling Changes - Implementation of Section 505(o)(4) of the Federal Food, Drug, and Cosmetic Act.” This draft guidance for certain drugs and biologic products provides information on the implementation of new provisions, including a description of the types of safety labeling changes that ordinarily might be required under the new legislation; how FDA plans to determine what constitutes new safety information; the procedures involved in requiring safety labeling changes, and enforcement of the requirements for safety labeling changes. Comments are due by July 12, 2011.

The Food and Drug Administration is announcing a public meeting on April 20, 2011 in Silver Spring, MD to provide interested persons an opportunity to discuss implementation of the preventive controls for facilities provisions of the recently enacted Food Safety Modernization Act (FSMA). FDA will also be seeking public comment to inform its rulemakings and guidance documents on the issue.

The Food and Drug Administration is responding to objections and is denying requests that it received for a hearing on the final rule that amended the food additive regulations to provide for the safe use of ionizing radiation for the reduction of Salmonella in fresh shell eggs. After reviewing objections, FDA has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking or modifying the amendment to the regulation.

On April 4, 2011, a Consumer Product Safety Commission official provided an update on Consumer Product Safety Commission activities at the National Customs Brokers and Forwarders Association of America (NCBFAA) Annual Conference. He discussed CPSC detention notices, the agency’s increased focus on imports, and the Consumer Product Safety Improvement Act of 2008’s (CPSIA’s) expansion of penalties and prohibited acts for consumer products.

On April 11, 2011, the Food and Drug Administration posted revised versions of the following Import Alerts on the detention without physical examination of:

On April 7, 2011, the Center for Environmental Health testified before a subcommittee of the House Energy and Commerce Committee that the Consumer Product Safety Improvement Act of 2008 is working, particularly its limits on lead in children's products. CEH pointed to a study it conducted on more than 1200 toys and other children’s products which it chose based on their tendency to have lead. CEH found that 96% of these riskier products were compliant with federal lead limits. It believes that the greater marketplace has even higher lead compliance rates. CEH says that since the CPSIA was enacted, lead hazards in children's products have been reduced by a factor of approximately three.

On April 11, 2011, the Food and Drug Administration updated its question and answer document on what it is doing to ensure the safety of products imported from Japan to add a link to a webpage on FDA standards for radionuclides in food and to reorder other cited documents. The Q&A continues to state that all milk and milk products and vegetables and fruits produced or manufactured from the four Japanese prefectures of Fukushima, Ibaraki, Tochigi and Gunma will be detained upon entry into the U.S. They will not be allowed to enter the U.S. food supply, unless shown to be free from radionuclide contamination, with the exception of the specific products restricted by the Government of Japan. Those products will be refused admission into the US. (See ITT's Online Archives or 04/05/11, 03/30/11, 03/28/11, 03/22/11 and 03/24/11 news, 11040529, 11032813, 11032813, 11032225, and 11032438, for previous BP summaries of the Q&A and FDA's import alert on the topic.)