October 15, 2014 – Safety News

PHMSA Administrator Leaves Agency

Cynthia Quarterman, administrator of the Pipeline and Hazardous Materials Safety Administration, left the agency on October 3, after serving in the position since 2009. Deputy Administrator Timothy P. Butters was named the acting administrator until a successor is found.

PHMSA regulates the safety of transportation of hazardous materials in commerce by all modes. In response to a number of rail accidents involving crude oil transport, the agency recently proposed a controversial new rule relating to rail tank car standards and the operation of trains carrying crude oil and other flammable liquids. PHMSA is also preparing a major rulemaking proposal to incorporate hundreds of longstanding special permits into the Hazardous Materials Regulations.

PHMSA Extends Deadline on Reverse Logistics Proposal

The Pipeline and Hazardous Materials Safety Administration has extended the deadline for comments for an additional 30 days on its proposal to provide an exception from the Hazardous Materials Regulations for materials that are transported in “reverse logistics.” 79 Fed. Reg. 57494 (September 25, 2014). In this rulemaking, PHMSA also proposed to identify the hazardous materials authorized, and the packaging, hazard communication and training requirements applicable to reverse logistics shipments. The deadline for comments on the proposed rule is now November 10, 2014.

New FDA Medical Gas Compliance Publication

In 2012, Congress directed the FDA to work with industry to decide if more appropriate regulations were needed for medical gases. In May 2013, CGA and GAWDA sent the agency a letter listing the many necessary changes to improve the Current Good Manufacturing Practices (CGMPs) for designated medical gases. These changes are needed to assure public safety and, in many cases, to recognize the existing enforcement discretion of the agency. We have also met with FDA leadership three times over the past nine months to encourage the agency to update the regulations for medical gases. The FDA may not be able to make the changes that are needed for medical gases in a timely manner. Nevertheless, our industry needs to have clear regulatory information in order to assure compliance with CGMP. CGA, with GAWDA’s support, has published an outstanding Position Statement PS-42 Appropriate and Effective Regulations For Medical Gases within 21 CFR Parts 201, 205 and 210/211. CGA PS-42 lists the current regulations that are inappropriate for medical gases, details the necessary modifications and provides the clear rationale for each regulation. We highly encourage you to obtain PS-42. It is free to GAWDA members who participate in the GAWDA/CGA Safety Program. A copy of our industry’s position has been provided to the FDA.

Here are some Action Steps you can take:

  • Review CGA PS-42 to assure that your operations are consistent with industry standard CGMPs.
  • Use this document during FDA inspections to help clarify for the inspector how to apply ambiguous regulations to medical gases.
  • Advise GAWDA Medical Gas Consultant Tom Badstubner if you receive any FDA violations while following this industry position statement. We will support your efforts to comply with these CGMP standards and to have consistent interpretation of CGMP for all members.

If you have any questions about CGA PS-42, contact Tom Badstubner at tom@asteriskllc.com or by phone at 1-508-883-0927.

Top 10 OSHA Workplace Safety Violations in 2014

The U.S. Department of Labor’s Occupational Safety and Health Administration has announced the Top 10 most frequently cited workplace safety violations for fiscal year 2014…

  1. Fall protection (1926.501) – 6,143
  2. Hazard Communication (1910.1200) – 5,161
  3. Scaffolding (1926.451) – 4,029
  4. Respiratory Protection (1910.134) – 3,223
  5. Lockout/Tagout (1910.147) – 2,704
  6. Powered Industrial Trucks (1910.178) – 2,662
  7. Electrical – Wiring Methods (1910.305) – 2,490
  8. Ladders (1926.1053) – 2,448
  9. Machine Guarding (1910.212) – 2,200
  10. Electrical – General Requirements (1910.303) – 2,056