InterviewRegs put US chemicals at disadvantage

25 June 2008 19:53  [Source: ICIS news]

By Joseph Chang

NEW YORK (ICIS news)--Small to medium-size chemical companies in the US are facing a big disadvantage competing globally because of unfair regulations, the president of the Synthetic Organic Chemical Manufacturers Association (SOCMA) said on Wednesday.

“All we’re asking for is a level playing field,” said SOCMA president Joseph Acker.

“One of the greatest areas where this is a problem is with the FDA [US Food and Drug Administration] and the lack of inspections of offshore API [active pharmaceutical ingredient] manufacturers.”

While US API producers are subject to FDA inspections at their facilities every 2.7 years on average, few Chinese producers that export pharmaceutical fine chemicals to the US are ever inspected, said Acker.

“Out of something like 3,000 API manufacturing facilities in China, 30 have been inspected by the FDA,” he said. “That’s not fair. This is a major competitive issue for US manufacturers, and is also a safety issue for US consumers.”

SOCMA submitted proposed legislation to Representative John Dingell’s (Democrat- Michigan) House committee on Energy and Commerce two weeks ago, to address the issue, said Acker.

“The idea that the FDA is going to inspect every facility in China is not realistic. But there are different ways to do it,” said Acker.

One proposed solution is to have overseas API manufacturers pay registration fees if they want to sell product into the US, he said. Those fees would then pay for inspections.

SOCMA aims to get its proposals into the FDA Globalization Act of 2008, said Gregory Minchak, manager, public relations and communications at SOCMA.

“It looks like the committee will get to the process of moving the legislation forward in 2009,” he said.

Other regulations or proposed regulations impacting the competitiveness of small to medium-size companies in the US include the EU’s Reach (Registration, Evaluation and Authorisation of Chemicals), US site security, and proposed cap-and-trade legislation to reduce greenhouse gas emissions (GHGs), said Acker.

“These regulations put disproportionate burdens on small companies - they don’t always have the resources to deal with them,” Acker said. “The margins at smaller companies tend to be a lot thinner and product volumes smaller.”

“They look at something like Reach that’s going to cost them a pile of money, that has the potential of costing them any proprietary information, and many of them have said they just won’t register,” said Acker.

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Author: Joseph Chang
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