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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA), which involve chemical safety and reporting requirements is drawing criticism from the chemical industry.
Legislative efforts to modernize provisions in the Toxic Substances Control Act of 1976 (TSCA) that involve chemical safety and reporting requirements is drawing criticism from the chemical industry. The Society of Chemical Manufacturers and Affiliates (SOCMA) raised concerns over one bill, the Toxic Chemicals Safety Act of 2010 (HR 5820), in a Congressional hearing last week. SOCMA is the US trade association representing custom and batch manufacturers, including contract manufacturers of active pharmaceutical ingredients and intermediates.
TSCA provides the US Environmental Protection Agency with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA, including food, drugs, cosmetics, and pesticides. Although there is general agreement between business groups and environmental groups that TSCA needs to be modernized, there is debate over specific legislative proposals.
In testimony before the US House Subcommittee on Commerce, Trade, and Consumer Protection, Beth D. Bosley, president of Boron Specialties (Valencia, PA) and representing SOCMA, said the recently introduced legislation, the Toxic Chemicals Safety Act of 2010, poses “overwhelming challenges for batch, custom, and specialty chemical manufacturers,” according to a SOCMA press release. Although Bosley noted some improvements in the bill, including the requirement for varied and tiered testing, she expressed concern over the economic impact of the bill.
“It is more important than ever that we maintain our competitive edge as innovators,” Bosley stated. “The US chemical industry’s competitiveness has continued to decrease substantially in recent years due to competition from countries, like China and India, with lower resource costs, lower wage standards, and a less burdensome regulatory environment.”
SOCMA highlighted several major concerns with the legislation. First, it said that the bill applies “inappropriate safety standards” by regulating industrial chemicals similar to standards used to regulate drugs and foods, which would create market barriers for low-risk chemicals. SOCMA also objects to new chemical and use requirements, which it contends involve an “unnecessary” increase in testing and reporting, thereby discouraging research and development and the introduction of new chemicals or new applications of existing chemicals into the market.
The association also objects to the inclusion of mixtures in reporting requirements, citing that it would increase the level of reporting for chemical mixtures that do not have an identified risk. SOCMA also says that the disclosure requirements do not adequately protect confidential business information and that the bill does not provide for state preemption, thereby causing a potential disruption in interstate commerce.
SOCMA said it “looks forward to continuing its efforts to promote recommendations for a pragmatic approach to TSCA reform with members of Congress,” according to the organization's press release.