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Safety

No Retreat From Reform

March 24, 2014 | A version of this story appeared in Volume 92, Issue 12

Jan. 20, page 25: FDA has sent more than a “handful” of warning letters to Indian drug manufacturers in the past three years. Although C&EN could not obtain an exact figure, the agency tells C&EN that in the 12 months ending Sept. 30, 2013, seven of 26 warning letters sent to foreign drug producers went to Indian firms.

Feb. 24, page 6: A story about a visit to India by FDA Commissioner Margaret A. Hamburg incorrectly quoted Helena Champion, head of the consulting firm Drug Quality Assurance, as saying the European Medicines Agency put 19 Indian companies on a noncompliance list. In fact, she said EMA has posted 30 noncompliance reports involving Indian companies since January 2010.

“Retreat on Refinery Reform,” the article on the Chemical Safety & Hazard Investigation Board’s (CSB) meeting in Richmond, Calif., mischaracterizes the position of the United Steelworkers, the union representing workers in a majority of U.S. refineries (C&EN, Jan. 27, page 6).

We are very much in favor of the “safety case” approach to the regulation of high-hazard facilities. However, its proper implementation requires significantly increased staffing and expertise in the agencies adopting it. It also requires a defined and protected role for refinery workers, who are in the best position to point out flaws in and noncompliance with safety cases submitted by refinery management.

The two board members who voted against the immediate adoption of the safety case recommendation asked for more study of these issues. They were right to do so. Such study is essential to the successful adoption of a safety case system. In the meantime, the safety case debate should not distract us from needed improvements in the OSHA Process Safety Management standard and EPA Risk Management Program.

The United Steelworkers Union has never advocated a retreat on refinery reform. Nor has CSB. U.S. refineries collectively experience a fire, explosion, or serious release at a rate exceeding one a week. These events kill and injure our members every year; many have the potential to affect thousands in the surrounding community. Whatever their differences in approach, we know that the three CSB members, and the CSB staff, all share our passionate commitment to true and effective reform.

Michael Wright
Director of Health, Safety & Environment
United Steelworkers
Pittsburgh

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