DEA List I Chemical Requirement Changes - GBL and Phosphorus
Monday 19 July 2010 at 3:25 pm
Gamma-Butyrolactone (DEA Code Number 2011) - On June 29th, the Drug Enforcement Administration (DEA) issued a final rule regarding mixtures containing gamma-butyrolactone (GBL). This regulation makes GBL chemical mixtures, in concentrations greater than 70 percent, subject to List I chemical regulatory requirements of the CSA, except if exempted through an existing categorical exemption. DEA is taking this action because there is a serious threat to the public safety associated with the ease by which GBL is chemically converted to the schedule I controlled substance gamma-hydroxybutyric acid (GHB). The DEA regulations provide for an application process by which manufacturers may obtain exemptions for those GBL chemical mixtures that are not automatically exempt under the concentration criteria. This rulemaking becomes effective July 29, 2010. Entities seeking registration must apply on or before July 29, 2010 to continue their business pending final action by DEA on their application.
Phosphorus / Hypophosphorous acid and its salts (DEA Code Numbers 6795/6796/6797) - On June 26th the DEA issued a proposed rule, which would establish exemption thresholds for chemical mixtures containing red phosphorus, white phosphorus (also known as yellow phosphorus) or hypophosphorous acid and its salts. The DEA is proposing that chemical mixtures containing red phosphorus in a concentration of 80 percent or less and mixtures containing hypophosphorous acid and its salts (hypophosphite salts) in a concentration of 30 percent and less, shall qualify for automatic exemption. The DEA is not proposing automatic exemption for chemical mixtures containing white phosphorus. Unless otherwise exempted, all material containing white phosphorus shall become subject to regulatory controls regardless of concentration. The agency is accepting written comments up until August 24, 2010.
On April 15, 2010 U.S. Senator Frank R. Lautenberg (D-NJ) announced legislation to overhaul the "Toxic Substances Control Act of 1976" (TSCA). The proposed legislation is intended to provide the Environmental Protection Agency (EPA) with sufficient information to gauge the safety of chemicals. Rather than the current system, which places the burden of judging a chemical's risk solely on the EPA (using risk assessments based on models and analogous substances in the absence of data), manufacturers would be required to prepare a minimum data set. The EPA would request additional information on a case-by-case basis. The burden of proof would rest with the manufacturers. The EPA would also prioritize chemicals based on risk and act accordingly on those materials posing the greatest harm to the public and environment. The act would give the EPA the ability to act faster on those substances that the agency already knows are dangerous. The act will also promote the development of "greener" chemistries with an expedited review process for those materials which meet this criteria. Finally, the act would create greater transparency by creating open access to the chemical information collected.
On March 9, 2010 the Department of Transportation's (DOT) Pipeline and Hazardous Materials Safety Administratio (PHMSA), in consultation with the Transportation Security Administration (TSA) of the Department of Homeland Security (DHS), is modifying current security plan requirements applicable to the commercial transportation of hazardous materials by air, rail, vessel, and highway. Based on an evaluation of the security threats associated with specific types and quantities of hazardous materials, the final rule narrows the list of materials subject to security plan requirements and reduces associated regulatory costs and paperwork burden. The final rule also clarifies certain requirements related to security planning, training, and documentation. This final rule is effective October 1, 2010. Voluntary compliance with all the amendments in this final rule is authorized as of April 8, 2010.
In 2009 the Chinese Ministry of Environmental Protection (MEP) proposed changes to the notification of new chemical substances. The new regulation has been dubed China REACh, since it introduces a tiered system of testing and notification akin to the European REACh system. The legislative amendments are intended to only affect new chemicals after the adoption date...not chemicals already listed on the Inventory of the Existing Chemical Substances in China (IECSC). The law is expected to come into force in October 2010.
2010 will be a year filled with regulatory challenges in chemical compliance both in the US and elsewhere. Most notibly, re-registration work will accelerate and will be required for the EU under its new REACh chemical notificaiton system. Additionally, there are anticipated changes to TSCA in the US and with the implementation of the GHS hazard communication requirements globally.
Selected dates for the 2010 calendar year of regulatory importance are listed. This list is periodically updated and should not be viewed as all inclusive.