Friday, December 20, 2013

NEWS!!!....The ChemDAQ Blog has moved

The ChemDAQ Blog has moved to

Visit our new location and find all the old blog articles and some new ones as well.

Thursday, December 5, 2013

Industry News: ASP to Pay $1.2 M to FDA for Unsupported Shelflife of Biological Indicators

The FDA issued a News Release on 12/4/13 saying that it had reached a$1.25 million settlement with Advanced Sterilization Products and company executives for distributing adulterated and misbranded devices.

 ... The settlement requires ASP to pay $1.2 million, company President Bernard J. Zovighian to pay $30,000, and company Vice President of Quality and Regulatory Compliance Richard J. Alberti to pay $20,000.

This action was taken after the FDA learned that the company knew that it did not have sufficient data to support the shelf life stated on the label of its Sterrad Cyclesure 24 Biological Indicators, but continued to ship the product to customers with inaccurate expiration dates. Sterrad Cyclesure 24 Biological Indicators are used to monitor and confirm the effectiveness of the sterilization process in ASP’s Sterrad sterilizers.

“Accurate expiration dates are critical to ensuring product integrity,” said Steve Silverman, director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “ASP’s actions violated the law and put patients at unnecessary risk for infection. ...”

During an inspection in June 2012, FDA learned that ASP had study data indicating that the effectiveness of the biological indicators had not been established for the entire 15-month shelf life indicated in the product labeling. ASP issued voluntary recalls of affected product in July 2012. ...

ASP has addressed the shelf-life issues relating to the recalled product by reducing the labeled shelf-life. ...

Wednesday, December 4, 2013

OSHA Publishes Regulatory Agenda for Fall 2013

The Office of Information and Regulatory Affairs has published a unified regulatory agenda for federal government departments and agencies. The Department of Labor's regulatory agenda is on a linked page, including OSHA. There are two items of interest to readers of this blog.:
The first is the Review/Lookback of OSHA Chemical Standards (Pre-rule stage), 1218-AC74. This blog has frequently commented on the need to update the OSHA PELs and OSHA itself is well aware of the problem, and writes:
The majority of OSHA's Permissible Exposure Limits (PELs) were adopted in 1971, ... and only a few have been successfully updated since that time. There is widespread agreement among industry, labor, and professional occupational safety and health organizations that occupational safety and health organizations that OSHA's PELs are outdated and need revising in order to take into account newer scientific data that indicates that significant occupational health risks exist at levels below OSHA's current PELs. ... Recently, OSHA sought input through a stakeholder meeting and web forum to discuss various approaches that might be used to address its outdated PELs. As part of the Department's Regulatory Review and Lookback Efforts, OSHA is developing a Request for Information (RFI) seeking input from the public to help the Agency identify effective ways to address occupational exposure to chemicals.
It is still early days in the process and the wheels of government turn slowly, especially in a small agency like OSHA with limited resources and a large workplace to protect. Essentially the same proposal was made in  in the Fall of 2011 and again in the spring of 2013 with little progress so far; but we remain hopeful that OSHA will be able to issue modern standards in the not too distant future.

The second item is the Occupational Injury and Illness Recording and Reporting Requirements--NAICS Update and Reporting Revisions (Final rule stage). 1218-AC50 which has already been discussed in this blog.