2012 Regulatory Calendar
Monday 23 January 2012 at 12:00 am
Selected dates for the 2012 calendar year of regulatory importance are listed. This list is periodically updated and should not be viewed as all inclusive.
Important changes for 2012 include
- Chemical Data Reporting under the EPA's Toxic Substances Control Act (TSCA),
- Submissions under TSCA must use the Central Data Exchange (ePMN electronic submissions) starting in April, and
- The finalization and alignment of US OSHA's new Hazard Communication Standard with the Global Harmonized System of Classification and Labeling of Chemicals (GHS). The date for the final rule should occur in the first half of 2012.
On August 16th, EPA amended the Toxic Substances Control Act (TSCA) section 8(a) Inventory Update Reporting (IUR) rule and changing its name to the Chemical Data Reporting (CDR) rule. The CDR enables EPA to collect and publish information on the manufacturing, processing, and use of commercial chemical substances and mixtures on the TSCA Chemical Substance Inventory (TSCA Inventory). This includes current information on chemical substance production volumes, manufacturing sites, and how the chemical substances are used. Manufacturers and importers of commercial chemical substances may be required to report, depending on site volumes. For 2012, the submission period will be from February 1 through June 30, 2012. This final rule is effective September 15, 2011.
The 12th Edition of the Report on Carcinogens (RoC) was released on June 10th. There are six new listings and two revised listings. Of the six newly listed substances, Aristolochic Acids are listed as known to be human carcinogens, and Captafol, Cobalt Tungsten Carbide: Powders and Hard Metals, o-Nitrotoluene, Riddelliine and Styrene are listed as reasonably anticipated to be human carcinogens. Formaldehyde, which was first listed in the Second Annual Report on Carcinogens in 1981 as reasonably anticipated to be a human carcinogen, is now listed as known to be a human carcinogen. Certain Glass Wool Fibers (Inhalable) was first listed as Glass Wool (Respirable Size) in the Seventh Annual Report on Carcinogens (1994) as reasonably anticipated to be a human carcinogen; although the classification remains the same, the review of Glass Wool Fibers has resulted in a change in the scope of the listing.
On June 2nd, the Drug Enforcement Administration (DEA) issued a final rule regarding chemical mixtures containing red phosphorus or hypophosphorous acid and its salts (List I substances). The rule specifies composition limits for mixtures which will automatically be exempt from Controlled Substances Act. 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. DEA is not implementing automatic exemption for any concentration of chemical mixtures containing white phosphorus (also known as yellow phosphorus).
In January the Korean Ministry of the Environment drafted the "Act on the Registration and Evaluation of Chemicals". The Act will amend the current Toxic Chemicals Control Act (TCCA) and is intended to introduce a regulatory structure similar to the European Union's REACh legislation. The overall goals of this Act are to secure more than 80% of the relavent hazard information on chemicals and reduce the use of toxic (carcinogenic) materials by 32% by 2020. Some new requirements would be introduced through the Act. These include the prioritization of chemicals (based on hazards), authorization of chemicals, restriction/prohibition of chemicals, introduction of an Only Representative, annual notification of existing chemicals, pre-registration of priority chemicals (0.5 ton threshold), joint submissions and data sharing. While it is unclear when the Act will be approved, it is anticipated to enter into force 2 years after its publication.
In 2009 Taiwan's Council of Labor Affairs (CLA) declared their intent to establish a national chemical inventory. The new law will strengthen Taiwan's EPA and their Toxic Chemical Control Act, which was originally promulgated in November 1986. The strategy of establishing a chemical inventory is meant to stengthen their management of new and existing chemicals through risk assessment. As a result, actions may be taken on chemicals based on the assessment of the hazards, exposure scenarios and risks of chemical substances.