ChemOne Compliance News

DEA List I Chemical Requirement Changes - GBL and Phosphorus

2010-07-19T15:30:00-00:00

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.

Proposed TSCA Reform - Safe Chemicals Act

2010-07-19T15:29:00-00:00

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.

The full bill can be read here.

EPA Develops Chemical Action Plans

2010-03-23T13:08:00-00:00

Based on an initial list of "chemicals of concern" that the EPA proposed in September of 2009, the EPA have posted the first four action plans on phthalates, long-chain perfluorinated chemicals (PFCs), polybrominated diphenyl ethers (PBDEs) in products and short-chain chlorinated paraffins. The action plans outline the concerns that each chemical may present and identify specific steps the Agency intends to take to address these concerns, including, for the first time, utilizing TSCA Sec. 5(b)(4) authority to list chemicals that pose a concern, Section 6 actions to limit chemicals, Section 4 test rules and Design for the Environment efforts.

EPA is finalizing the two remaining action plans from the initial list - BPA and benzidine dyes. Utilizing the criteria outlined above, EPA is today making public the following list of chemicals for upcoming action plan development. EPA anticipates making the next set of action plans available in late Spring. These will include NP/NPE (nonylphenol/nonylphenol ethoxylate), HBCD (hexabromocyclododecane), Siloxanes and Diisocyanates. It is anticipated that the EPA will release new action plans every four months.

DOT Modifies HazMat Security Plan Requirements

2010-03-23T12:50:00-00:00

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.

Chemical Registration Changes Anticipated in China

2010-02-04T00:45:00-00:00

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.

If adopted, the most significant aspects to China REACh will include the following:

Reduced regulatory requirements (Simplified Notification) for substanced manufactured or imported at less than 1 metric ton per year. This will also include low-volume intermediates for export, low concern polymers and substances for scientific research and product development purposes (100-kg threshold).

Tiered testing and notification at thresholds of manufacturing or importation of 1, 10, 100, and 1,000 tons

Only Chinese-based entities may conduct the notification and testing of substances (e.g. registration agents and testing laboratories must be based in China).

Companies will be required to report their activities and keep volume records after receiving the registration certificate (e.g. a first time activity report will be due to the Chemical Registration Center within 30 days of the first manufacture or import for each company supplied).

A registration package will need to include the notification application form, a testing report for all physicochemicical properties, as well as toxicitiy and ecotoxicity test results, an environmental assessment, classification/labeling categories and a Chinese MSDS.

Polymer Exemption to Exclude Certain Perfluorinated Polymers

2010-02-01T18:28:00-00:00

On January 27, 2010 the US Environmental Protection Agency (EPA) issued a final rule amending the Polymer Exemption rule to exclude certain perfluoroalkyl moieties consisting of CF3- or longer chain lengths. The rule will become effective on February 26, 2010 and will affect polymers that contain any one or more of the following:

Perfluoroalkyl sulfonates (PFAS),
perfluoroalkyl carboxylates (PFAC),
fluorotelomers, or
perfluoroalkyl moieties that are covalently bound to either a carbon or sulfur atom where the carbon or sulfur atom is an integral part of the polymer molecule (affected polymers).

As of the effective date of the rule, any entity which manufactures or imports these types of materials will no longer be able to do so under the exemption and must complete the usual Premanufacturing Notice (PMN) requirements (or other exemption such as the Low Volume Exemption - LVE). Currently manufactured or imported affected polymers, or polymers previously manufactured or imported but are not currently in active commerce may continue until January 27, 2012 as long as they are in full compliance with the 1995 polymer exemption rule. After that date, manufacture of these polymers will no longer be authorized under the polymer exemption rule, and continued manufacture or import must be authorized under a different TSCA section. This change is necessary because, based on current information, EPA can no longer conclude that these polymers "will not present an unreasonable risk to human health or the environment" under the terms of the polymer exemption rule.

EPA Changes CBI Allowances for TSCA 8(e) Notices

2010-07-19T16:01:00-00:00

On January 21, 2010 the Environmental Protection Agency (EPA) issued a notice through the Federal Register regarding CBI (Confidential Business Information) claims for information submitted under Section 8(e) of the Toxic Substances Control Act (TSCA). It is the EPA's intention going forward to reject certain confidentiality claims, specifically the chemical identity, where the substance is already non-confidentially listed on the TSCA inventory. Section 8(e) submissions relate to new data and studies, which show substantial risk of existing materials to people's health and the environment. In the past the information had been posted with the identity masked, if CBI was claimed; this will no longer be the case. The intention of this change in policy is to make chemical information more transparent and readily available to the public.

UPDATE: On May 27, 2010, the EPA outlined plans to generally deny Confidential Business Information (CBI) claims for the identity of chemicals in health and safety studies filed under the Toxic Substances Control Act (TSCA), unless the chemical identity explicitly contains process information or discloses mixture information that is expressly protected under TSCA. The EPA expects to begin reviews of confidentiality claims — both newly submitted and existing claims — in accordance with this guidance on August 25, 2010.

Final Rule Issued for TSCA eReporting

2010-01-06T14:32:00-00:00

On January 6, 2010, the EPA issued a final rule to amend the Toxic Substances Control Act (TSCA) section 5 reporting regulations. The amendments establish electronic reporting requirements for TSCA section 5 submissions. The final rule is effective as of April 6, 2010 and will establish requirements for using EPA's Central Data Exchange (CDX) to electronically submit premanufacture notices (PMNs) and other TSCA section 5 notices. EPA is also amending TSCA section 5 user fee regulations by adding a new User Fee Payment Identity Number field to the PMN form, to enable the Agency to match more easily a particular user fee with its notice submission. Lastly, EPA is amending the PMN form by removing the Agent signature block field and thus the requirement for designated agents to sign the form.

EPA is issuing these amendments to require manufacturers (including importers) and processors of TSCA chemical substances to use the Internet, through EPA's CDX, to submit TSCA section 5 notices and related documents to the Agency. These include PMNs, Significant New Use Notices (SNUNs), Test Market Exemption Applications (TMEAs), Low Volume Exemption notices (LVEs), Low Exposure/Low Release Exemption (LoRex) notices, biotechnology notices for genetically modified microorganisms, Notices of Commencement of Manufacture or Import (NOCs) and other support documents (e.g., correspondence, requests for suspensions of the notice review period, amendments, and test data).

The requirement of CDX reporting will take place in 3 phases over a 2-year period. During the first year following the effective date of this final rule, the Agency will allow submissions via CDX, optical disc (CD or DVD), and paper. Regardless of the method of submission, EPA will require that all submissions be generated using the new electronic-PMN (e-PMN) software. One year after the effective date of this final rule, paper submissions will no longer be accepted for any new notices and support documents (including NOCs), though optical discs may continue to be used. Two years after the effective date of this final rule, optical discs will no longer be accepted, and all submitters must submit the notices and support documents via CDX.

EPA is also amending the TSCA section 5 User Fee regulations at 40 CFR 700.45 to add a new User Fee Payment Identity Number field to the PMN form. This new field will enable the Agency to more easily match a particular user fee with its notice submission. The second new information element on the amended PMN form will be optional and consist simply of the e-mail address for the Authorized Official (AO) submitting the notice listed on the "Submitter Identification" section on page 3 of the PMN form. EPA is also removing the required Agent signature block field on page 2 of the form.

New Year...New and Continued Regulatory Challenges

2010-01-04T20:53:00-00:00

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.

REACh: Re-registration of pre-registered chemicals under the EU's new REACh notification system must be registered by December 1, 2010 for those chemicals manufactured or imported into the EU at volumes of 1000 metric tons or more. Also included in this are chemicals deemed to be carcinogenic, mutagenic or reproductively toxic (CMR) at 100 metric tons or more per year and environmentally toxic substances at 1 metric ton or more. This is the first deadline for re-registrations under the new law. Keep in mind that SIEF's (Substance Information Exchange Forums) are formed between companies which intend to re-register the same substance. It is the company's responsibility to determine when and if a SIEF should be formed. There can be only one Lead Registrant and one "joint submission dossier" for a given substance.

TSCA: The chemical registration system in the US, known as the Toxic Substances Control Act (TSCA), will likely see some changes in 2010. Administrator Lisa P. Jackson is committed to to strengthen and reform chemical management in the US. The agency is finally recognizing that the 1976 law is both outdated and in need of reform. A few actions that may be noticed during the year involve using existing tools to legislate and control chemicals of concern, possibly "re-setting" the TSCA inventory and the rolling out of a new electronic notification system for TSCA notices. There may also be a push to totally re-write TSCA, possibly in a similar fashion to the EU's REACh...but it's still anyone's guess as to how this will all play out.

GHS: The implementation of the UN's Global Harmonized System of Classification and Labeling (GHS) will finally come into being in the European Union and likely to also become legislated in the US and Canada. US OSHA will be holding informal public hearings regarding changes to the hazard communication standard during the first 2 quarters of 2010 and Canada's WHMIS anticipates regulation changes during the year. Implementation status in other countries can be found at http://www.unece.org/trans/danger/publi/ghs/implementation_e.html.

Of course, the landscape for chemical compliance is an ever-changing one and there will likely be more significant changes as the year progresses.

EPA to Establish Chemicals of Concern List

2010-01-04T19:16:00-00:00

The EPA announced on December 30th, that it intends to establish a list of chemicals of concern. This is just one action being taken to strengthen and reform chemical management in the US. The initial set of chemicals includes phthalates, short-chain chlorinated paraffins, polybrominated diphenyl ethers (PBDEs) and perfluorinated chemicals, including PFOA. Steps will be taken under the authority of Secion 6 of TSCA. This is the first time EPA has used TSCA’s authority to list chemicals that “may present an unreasonable risk of injury to health and the environment.” More information on EPA’s legislative reform principles and a fact sheet on the complete set of actions on the four chemicals: http://www.epa.gov/oppt/existingchemicals/index.html.