SOCMA Raises Concern over TSCA Reform - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

SOCMA Raises Concern over TSCA Reform


ePT--the Electronic Newsletter of Pharmaceutical Technology

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.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
How does your company apply quality-by-design (QbD) principles to manufacturing processes?
To all processes for both new and legacy products
To all process for new products only
To select process for new products only
To select processes for both new and legacy products
Do not use QbD
To all processes for both new and legacy products
20%
To all process for new products only
13%
To select process for new products only
24%
To select processes for both new and legacy products
20%
Do not use QbD
22%
View Results
UPCOMING CONFERENCES

Programs for Investigational and Pre-Launch Drugs
Philadelphia, PA
July 17-18, 2013
Request Brochure

Strategic Pipeline Planning & Portfolio Valuation
Philadelphia, PA
August 13-14, 2013
Request Brochure

MES 2013 - Forum on Manufacturing Execution Systems
Philadelphia, PA
August 14-15, 2013
Request Brochure

Mobile Innovation for the Life Sciences Industry
Philadelphia, PA
August 20-21, 2013
Request Brochure

See All Conferences >>

Eric Langer Outsourcing Outlook Eric LangerOutsourcing's Modest Role as a Cost-Containment Strategy
Patricia Van Arnum Ingredients Insider Patricia Van ArnumIntellectual Property Battles in Solid-State Chemistry
Nathan Jessop Industry Insider Nathan Jessop Campaign Against Counterfeit Drugs Continues
Lynn Torbeck Statistical Solutions Lynn D. TorbeckCompositing Samples and the Risk to Product Quality
 More
Inadequate Access to Medicines Puts EU at Risk
FDA Offers Insight on QbD for Modified-Release Products
Global Biosimilars Market to Reach $2.445 Billion in 2013
Adapting to Change
AstraZeneca and Exco InTouch Collaborate to Augment Current COPD Pathways
FindPharma Custom Search
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here