Critical Path Services, LLC

3070 McCann Farm Drive
Suite 112
Garnet Valley, PA 19060
PHONE: 610.558.3001
FAX: 610.558.6025

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Thursday
Mar132014

Update on the Implementation of GHS in North America: U.S., Canada, and Mexico

As GHS is implemented across the globe, it is important to remember two things:  first, not all countries are at the same point in the implementation process and second, not all countries are implementing the same version of GHS.  Even those countries who do implement the same version are able to customize GHS to fit their individual needs and preferences. 

Within North America, the United States, Canada and Mexico are all at different places in their implementation of GHS.  The U.S. published the revised Hazard Communication Standard in 2012 with implementation to be completed by June 1, 2015.  Canada’s regulations to address GHS are currently in draft form and are expected to be published by June 2015, with implementation expected to begin in July 2015.  And finally, Mexico’s GHS standard (NMX-R-SCFI-2011) was published in June 2011, but the standard is  currently not mandatory.

There are some similarities within GHS in North America.  For example, the U.S., Canada and Mexico are all implementing UN GHS Revision 3.  Canada wants to synchronize implementation with the U.S. to the greatest extent possible and that has resulted in Canada and the U.S. being alike in their approach to the implementation.  Both countries decided against the inclusion of the same building blocks:  Acute Toxicity, Category 5; Skin Corrosion/Irritation, Category 3; Aspiration Hazard, Category 2; Hazardous to the Aquatic Environment, Acute and Chronic – all categories.  Additionally, Canada is expected to include the same additional hazards not documented in the Purple Book as the U.S. did.  These include combustible dust, simple asphyxiants and pyrophoric gases.  Mexico’s approach was to implement all of the Revision 3 hazard classes and categories in the Purple Book, as is.

Critical Path Services (CPS) and knoell will continue to follow the ever-changing scope of GHS both in North America and worldwide so that we will be able to continue providing our clients with solutions to help them meet their regulatory needs.

Tuesday
Feb042014

CPS Attends AAPS Crystal City-V Conference on the FDA Draft Guidance on Bioanalytical Methods Validation

Dr. Larry Mallis, CPS Laboratory Director, attended a 3-day workshop of the American Association of Pharmaceutical Scientists (AAPS) focused on FDA’s recently revised draft guidance on quantitative bioanalytical methods validation, and the implementation of that guidance. The workshop was held to provide a platform for open discussion between industry and the FDA around these topics.

Originally published in 2001, the guidance was revised to demonstrate advances in methods for bioanalytical validation. Since that time, AAPS, in conjunction with the FDA, has held multiple workshops and events that have informed changes made in the new draft guidance. The draft guidance includes new sections, including discussions of endogenous compounds, incurred sample reanalysis, biomarker assays, use of diagnostic kits and new technologies, system suitability, and report formats for tabular data listings. Other text has been updated, such as the sections on chromatography and ligand-binding assays.

One of the significant changes to the guidance is the percent of incurred samples to be reanalyzed (ISR).  Previous confusion around this point has led the agency to suggest that a flat 7% of incurred samples be chosen for reanalysis.  This was hotly debated due largely in part to the fact that the EMA guidance document (released in 2012) indicated 10% ISR up to 1000 samples, and 5% for sample sets greater than 5%.

AAPS will produce white papers discussing consensus outcomes of the discussions during the presentations related to each section of the new draft guidance.  Once these white papers are made available, CPS will provide them as links on our website.

CPS is committed to staying informed of changes to this and other important guidance relating to methods validation. Our full-service, GLP-compliant laboratory can meet trace level detection limits, work within complicated matrices, and achieve quick turn-around times.

Thursday
Jan092014

The Need for Data: Three Perspectives on TSCA Reform

At the recent Chemical Watch Summit, attendees had the opportunity to listen to numerous perspectives on TSCA reform, a topic that has attracted significant attention in recent months. Of particular note were presentations from the federal government, a prominent NGO, and a leading manufacturer of downstream consumer products. One of the underlying themes of the discussion was the need for good data on more chemicals.

Richard Denison of the Environmental Defense Fund provided background on TSCA, and in so doing emphasized the need for reform. He began with a thorough overview of changes that have occurred since TSCA was passed in 1976. In short, global chemical production has increased dramatically (25 fold) from 1970 to 2010. We now have a better understanding of how to screen and assess chemicals, yet the regulatory framework for evaluating them lags behind. Under TSCA, EPA has the responsibility to assess chemicals, although they lack the authority to obtain the necessary information in an efficient way. As a result, EPA has only regulated five of the over 60,000 chemicals that were grandfathered in under TSCA, and the Agency has required testing on less than 300. There is a general lack of use and exposure data, and even hazard data are very limited in their availability. Under TSCA, no data generally means no action, and there is a need for a new legislation that enacts a regulatory framework moving us “from assuming safety if there is no evidence of harm, to requiring evidence of safety before entering the market.” To make this paradigm shift, good data on numerous chemicals are needed. 

Jeff Morris of the US EPA spoke about the Agency’s increased attention to existing chemicals, but also noted that there are many chemicals for which we have very little data. Critical to EPA’s Existing Chemicals Program is development of 21st century approaches for screening and prioritizing chemicals. EPA is also making an effort to obtain data through collaboration with international governments, such as Canada, on specific groups of chemicals such as nanomaterials. When asked whether EPA plans to approach the European Chemical Agency about a comprehensive data sharing plan, their response was that collaboration is best done on a case-by-case basis.

Julie Froelicher of Proctor and Gamble represented the downstream industry perspective. She described the pressure that industry  receives from numerous stakeholders (e.g., consumers, retailers, states, federal government) for access to data on chemicals. While industry understands these requests, they must be careful in what they disclose. Retailers such as Walmart and Target are developing sustainable product standards and even offer incentive programs for disclosing ingredients. However, transmittal of otherwise proprietary information can create a conflict for industry because some of these large retailers offer their own competing brands. Yet processing companies such as Proctor and Gamble recognize that they are in a unique position to provide use and exposure information to EPA, and this information may not be available to the manufacturers and importers who have been traditionally responsible for providing data. To this end, the Consumer Specialty Products Association (CSPA) is designing a project with EPA in which companies will report use information for select TSCA Work Plan chemicals, and EPA will evaluate this information for further prioritization of remaining Work Plan chemicals.

Critical Path Services is committed to staying abreast of regulatory changes in the US and worldwide. Follow our blog for updates on TSCA and other key US regulations.

Thursday
Jan022014

Pesticide Registration in the United States

Pesticides can be harmful to humans and pests if they are not used according to label instructions.  The information given on the label is the result of extensive testing and a lengthy registration process.  In the United States, the label acts as the license for a company to sell that product.

The Federal, Insecticide, Fungicide, Rodenticide, Act (FIFRA) is the primary federal law that governs how the EPA oversees pesticide use in the US.  FIFRA identifies a pesticide in Section 2 as, “Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest; any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant; and any nitrogen stabilizer.”

To register a pesticide, an application form must be completed and fees according to PRIA (Pesticide Registration Improvement Renewal Act) must be paid.  Next, a registration package must be assembled that consists of studies covering the following data requirements:  physical chemistry, mammalian and eco- toxicology, analytical methods, residue, and environmental fate.  The quality of study data must be good and follow GLP (Good Laboratory Practices) where necessary.  Reports must follow PR Notice 2011-3, which describes both the recommended and required procedures for electronic and paper FIFIRA submissions.

The registration package also contains information on the pesticide use, including the application concentration and rate.  It provides information on how the pesticide will be used, where it can be applied, and the types of personnel protective equipment that are required. This information also appears on the pesticide label.  

Important to note is that pesticide registrations in the US are use-specific. This means that companies may need to submit multiple registrations for the same product if it has multiple uses. However, the same data can often be used to support multiple registrations for different uses in the US, or for registrations outside of the US. Critical Path Services has expertise in identifying registration requirements and the data needed to fulfill these requirements in regulatory jurisdictions around the globe. As a knoell company, we specialize in worldwide registration of agrochemicals.

Wednesday
Dec112013

GHS Concerns in Asia

Asia is increasingly a major player in the industrial chemicals industry, and the regulatory landscape is very complex.  For example, the United Nation’s Globally Harmonized System of Classification and Labeling of Chemicals (GHS) is a voluntary regulatory framework, and Asian countries are adopting it piecemeal and on their own timeframe.  As such, a number of concerns have surfaced for companies wishing to do business in this region.  Simply identifying the specific chemicals that are subject to GHS is often challenging.  Taiwan, for example, requires mandatory compliance only for certain chemicals: those specified by the three lists of the Council of Labour Affairs (CLA), the toxic chemical substances of EPA, and their mixtures.  Likewise, the scope of obligatory SDS and labeling in Japan is limited to some 1,500 substances published in the NITE website; all others are subject only to “reasonable efforts.”

Countries have also adopted varying revisions of GHS.  China, Taiwan, and Indonesia have adopted Revision 4 in recent legislation, while Thailand and Malaysia have implemented Revision 3.  Interestingly, Japan has adopted Revision 2 for classification and Revision 4 for Safety Data Sheets (SDSs) and labeling.  These regulatory discrepancies can be challenging in application.  More recent revisions of GHS specify additional hazard categories with added hazard criteria and cut-off values, generating inconsistencies between countries.  In addition, countries have also added their own non-GHS regulatory requirements to SDSs and labels.  China, for example, requires all labels of imported chemicals to include a local 24 hour emergency telephone number, much to the chagrin of industry.  Language-specific SDS and label requirements should also be verified, with countries such as Taiwan, Thailand, Malaysia, and Indonesia requiring Chinese, Thai, and Bahasa Malaysian or Bahasa Indonesian, respectively.

Even after a country determines which revision of GHS to adopt and which chemicals it will regulate, implementation timeframes differ across borders.  Many Asian countries have chosen to implement GHS in phases.  Thailand, for example, made GHS implementation mandatory for substances on March 13, 2013 and will make mixtures mandatory on March 13, 2017.  Similarly, Malaysia has a transition period of one year for substances and three years for mixtures.  The Philippines is taking a different approach in establishing a four‑step transition period that is tentatively spaced over seven years and involves chemical groups stipulated by several different inventories.

As GHS becomes more ubiquitous worldwide, Critical Path Services (CPS) and knoell are committed to understanding the resulting complex regulatory landscape.  We send regulatory specialists to conferences around the world to consult with experts and ensure that our regulatory strategies remain current.  Our goal is to provide our clients with flexible solutions that meet their diverse and constantly fluctuating regulatory needs.

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