US chems concerned by changes to protection for confidential data

22 March 2011 20:00  [Source: ICIS news]

BALTIMORE, Maryland (ICIS)--Broad changes to federal environmental rules that shelter confidential business information (CBI) could have profound and perverse effects on industry investments and innovation, a top chemical sector official warned on Tuesday.

Christina Franz, director of regulatory affairs at the American Chemistry Council (ACC), urged Environmental Protection Agency (EPA) officials to use discretion and balance in revising regulations that under current law allow manufacturers to retain confidentiality of chemical compositions and other trade secrets when submitting reports.

The agency is reviewing requirements and protections under the Toxic Substances Control Act (TSCA) for confidential business information and seeks to reduce the circumstances under which a company can make a CBI claim.

The EPA was revising the TSCA provisions for confidentiality in anticipation of a major reform of TSCA by Congress. But, as that reform effort was thought to take as long as two or more years, the agency said it also wanted to revise qualifications for proprietary business information for current enforcement practices.

A final revised CBI rule is expected from the agency within a few months.

Speaking to some 400 chemical sector executives at the annual GlobalChem regulatory conference, Franz said that EPA should exercise caution in revising the rules because if companies are forced to disclose formulations, “they could have significant economic value for a company’s competitors”.

If EPA is not careful, Franz said, “there would be a perverse outcome without appropriate balance struck between transparency and protection of legitimate confidential business information for chemical identities”.

If those CBI disclosures were mandated without balance between the public’s access to safety and health information and companies’ proprietary data, Franz said that there would be little or no protection for formulations in commerce.

“If confidential business information cannot be protected in commerce,” she said, “there is no point in any company making an investment in innovation in the first place.”

She noted that language put in the TSCA statute by Congress in 1976 specifically cautions regulators against doing harm to industry’s business interests.

“Congress recognised the importance of chemistry to the US economy,” she said, quoting TSCA Section 2(b) that “...Authority over chemical substances and mixtures ... [should] not impede unduly or create unnecessary economic barriers to technological innovation”.

In addition, she noted, in TSCA Section 2(c) it was the intent of Congress that the EPA administrator should carry out regulation of the statute in “a reasonable and prudent manner” and “shall consider the environmental, economic and social impact of any action under TSCA”.

Under an existing voluntary effort, EPA has asked US chemical companies to review product registration filings over the last 30 years or more to determine if previous CBI claims were no longer necessary or valid, so that the chemical compositions of those earlier products may now be disclosed to the public.

The agency also has asked chemical producers filing new product registrations to limit their confidentiality claims to only those circumstances where they are absolutely necessary to protect a formulation.

Franz said she was working with environmental groups and EPA officials to see if sufficiently descriptive generic names could be used instead of exact chemicals and formulations to satisfy TSCA’s right-to-know objectives while protecting competitive commercial interests of industry.

So far, she said, EPA has “frowned on the idea”.

GlobalChem is cosponsored by ACC and the Society of Chemical Manufacturers and Affiliates (SOCMA). The conference runs through Wednesday.

Paul Hodges studies key influencers shaping the chemical industry in Chemicals and the Economy

By: Joe Kamalick
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