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

The ChemDAQ Blog has moved to http://www.chemdaq.com/blog/

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

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. ... 

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.

NIOSH Solicits Comments on New Classification of Carcinogens

NIOSH has published a draft document titled Current Intelligence Bulletin: Update of NIOSH Carcinogen Classification and Target Risk Level Policy for Chemical Hazards in the Workplace and and has published a notice in the Federal Register. soliciting comments.

There have been several criticisms of NIOSH's current system for classifying carcinogens. The current method is described in 29 CFR 1999 "Identification, Classification and Regulations of Potential Occupational Carcinogens."

One of the objections is the term "Potential Occupational Carcinogen" which makes it sound as if the dangers of carcinogens such as benzene, ethylene oxide etc. are only 'Potential Carcinogens' and not the more definitive 'Known Carcinogens'.

Another criticism is that unlike other organizations such as the National Toxicology Program (NTP), the International Agency for Research on Cancer (IARC) and the Environmental Protection Agency (EPA) the current NIOSH carcinogen policy does not classify compounds based on the weight of the scientific evidence. The new proposals would bring NIOSH into line with these other organizations and avoid duplication of effort.

NIOSH will also continue to provide quantitative assessment of cancer risk but will modify the way it estimates its recommended exposure limits (RELs). The RELs will continue to be health-based but unlike before, NIOSH will no longer 'specifically consider technical 10 achievability (i.e., ability to control exposures) in establishing RELs.' Instead, the RELs include a note saying whether existing controls are available or effective, and suggest alternative methods to reduce worker exposure.

Comments must be submitted to NIOSH by February 13, 2014.

Blame Health and Safety!

Everyone knows that Health and Safety of important in the workplace and this blog often discusses serious issues related to health and safety. The Health and Safety Executive (HSE) is the UK's occupational safety agency, similar to the US OSHA.The HSE has collected a number of cases where individuals have cited Health and Safety regulations in situations that may not strictly apply. A few of the more humorous  2013 cases are copied below.

• The Chef at a carvery restaurant refused to serve the customer some skin off the turkey on the grounds of health and safety. The Chef said it was a 'choking hazard'.
•  A member of staff in a café refused to put sauce on the enquirers' ice cream due to health and safety reasons.
• The enquirer visited a racecourse as a spectator. While she was there, a steward confiscated her parasol because it posed a health and safety risk. She was told that someone could use it as a weapon.
• The enquirer and a friend went to a restaurant in a Department store and decided to share a baguette between them. When they asked for the baguette to be cut in half to share the assistant told them they were no longer able to do that because the store had taken away all the knives on health and safety grounds.
• During children's swimming lessons, the local swimming pool has banned spectating parents from reading e-readers, for child protection and health and safety reasons
• The school had planned to run a sports day for 3-4 year old pupils in the morning – followed by activities for older pupils in the afternoon. The morning event was postponed due to dew on the grass.
• The enquirer visited a department store restaurant with friends for breakfast and were told they couldn't have fried eggs because of 'health and safety issues'. Puzzled at this remark they enquired further. They were told it was because someone in another store had left a pan on the heat whilst frying eggs causing a fire, therefore the decision was made to stop supplying fried eggs in all store restaurants.
• The enquirer wanted to purchase filleted trout in her local supermarket. None was available pre-packed so they asked the assistant on the fresh fish counter if he could fillet some from a whole fish. He agreed but then his supervisor intervened saying that this wasn't possible on the grounds of health and safety because the fish are too slippery. The enquirer noted that on the supermarket website, it states "just ask if you'd like your fish skinned or filleted".
• A custard pie fight at a local event has been cancelled because the event organisers could not get insurance on the basis that the activity is too dangerous.
  
  

Some of these cases may be the result of people blaming health and safety laws in order to get their own way; others may be an over reaction to past accident and some may be the result of poor education, i.e. people learning about the regulations third or fourth hand; by which time they have become greatly embellished.

Therefore, if one does not want to end up on a list like the one above, is always important to ensure that both the employer and the employees have an accurate understanding of the health and safety laws and to apply common sense.

There are many more cases on the HSE website, including the HSE's commentary on each one.