TSCA and TSCA Reform

The Toxic Substances Control Act (TSCA) was passed in 1971 as one of the nation’s early chemical control regulations. Prior to 1970, federal regulations of harmful chemicals were very limited. These regulations tended to be specific to one exposure medium (e.g., air, water), and they intervened only after contamination had occurred. TSCA was passed in response to a need for a comprehensive regulatory framework for industrial chemicals. When TSCA was passed, there were upwards of 60,000 industrial chemicals in commerce in the United States. Currently, there are over 84,000 industrial chemicals on the TSCA inventory.

Under TSCA, the US Environmental Protection Agency (EPA) is authorized to screen chemicals, require reporting or testing on chemicals, ban manufacturing or importing of chemicals, and track new chemicals. However, in the 35 years since TSCA was passed, EPA has required testing on less than 300 substances. EPA has only attempted to ban nine chemicals, and was unsuccessful in its attempt to ban one of them (asbestos). For this and numerous other reasons, TSCA has undergone significant criticism in recent years, making clear the need for TSCA reform. 

Among the primary criticisms of TSCA are the complex and burdensome requirements that EPA must meet to require testing of chemicals. There is also little transparency regarding how EPA determines and prioritizes chemicals of concern, assesses the safety of these chemicals, and decides when risk assessment and/or management is needed. In addition, confidential business information (CBI) claims limit the public’s access to substantial amounts of risk-related information.

In response to criticisms of TSCA, EPA published principles of TSCA reform in 2009. The principles emphasized the need for sound science, risk-based criteria for reviewing chemicals, manufacturers to supply safety information, consideration of sensitive subpopulations in assessments, consideration of cost and substitutes in assessments, prioritization, incorporation of green chemistry, and sustained funding for EPA to conduct assessments. Also in 2009, EPA released an Enhanced Chemical Management Program. EPA then expanded on this effort in the Existing Chemicals Program, which was published in 2012. The 2012 Program described a two-step prioritization process for identifying chemicals for expedited review. From 1000 candidates, 83 chemicals were selected. As of May 2013, 30 have been listed for assessment and five draft assessments have been published.

In April 2013, the US Government Accountability Office (GAO) published a report in which they evaluated EPA’s efforts to strengthen chemicals management. Their findings were mixed. On a positive note, EPA has increased efforts to obtain toxicological and exposure data. However, it may take years to obtain the data using the vehicles in place, and it is not clear that this review process will result ultimately in risk reduction. GAO also found that EPA has missed some opportunities to obtain data submitted by companies to foreign governments. For example, EPA could take further action to report toxicity and exposure data submitted to the European Chemicals Agency under the REACH regulation. 

Also in April 2013, the Safe Chemicals Act was reintroduced in identical form to an act with the same name that was introduced (but not passed) in 2011. Among other things, the Safe Chemicals Act would shift the burden of safety to chemical companies and give EPA full authority to require data beyond a minimum data set. The Act has been co-sponsored by Democrats and Republicans in the Senate.

CPS risk assessor, Elizabeth Dederick, PhD, will present on TSCA and TSCA reform at a workshop in Germany hosted by Knoell. Details on the workshop are available here: http://www.knoell.com/en/event/workshop-asia-north-america-2013.

CPS attends SCHC Spring Meeting

Critical Path Services, LLC recently attended the Society for Chemical Hazard Communication (SCHC) spring meeting in Austin, Texas. Professional development courses and presentations were made on issues related to hazard communication around the world.

One important topic covered in this meeting included implementation issues with U.S. OSHA HazCom 2012 and in particular, the training requirements employers must provide by December 1, 2013. Topics such as important subjects to address, how to develop a curriculum, and how to ensure that all employees are properly trained to understand the new workplace labeling system, the new safety data sheets (SDS), and how employees can obtain and use the appropriate hazard information were discussed. Maureen Ruskin, the Office Director of the Office of Chemical Hazards within OSHA, spoke about how the new labels and SDSs must be consistent and in compliance with the international harmonization system known as the Globally Harmonized System of Classification and Labelling of Chemicals (GHS). New labels and SDSs are required to be provided by suppliers by June 1, 2015 and employers have until June 1, 2016 to make adjustments to their workplace programs.

With the increasing global adoption of GHS, SDSs are becoming more streamlined. However, various countries have unique minimum requirements and additional national and/or regional requirements. If a company wants to market a product in a country where GHS has been adopted, the company’s labels and SDSs must be in compliance with that country’s specific GHS requirements. Speakers covered the information required in each of the 16 sections of the SDS for the EU, US, Japan, Korea, and Brazil.

Other topics discussed include the dis-harmonization within the transportation sector of the US and UN Model regulations, the Safer Consumer Products (SCP) regulations proposed by the California Department of Toxic Substances Control (DTSC), Mexico and Brazil regulatory updates, current amendments to Taiwan’s Chemical Substances Control Act (TCSCA), and NFPA combustible dust standard updates. The SCHC meeting was a great opportunity for Critical Path Services, LLC to learn about new and developing issues related to hazard communication that may be of interest to existing and potential clients.

HazCom 2012 – What you should know

In the United States, the OSHA Hazard Communication Standard (HCS) requires chemical manufacturers, importers, suppliers, and distributors to evaluate chemical hazards and prepare labels and safety data sheets (SDSs) to convey these hazards to workers. All employers with hazardous chemicals in their workplaces are required to have a hazard communication program, including workplace labels on containers, immediate and easy access to SDSs, and employee training. In 2012, OSHA adopted a revised HCS, also referred to as HazCom 2012, that is designed to advance the concept that employees also have a ‘right-to-understand’ workplace hazards.

The new standard covers over 43 million workers who produce or handle hazardous chemicals in more than five million workplaces across the country. The modification is expected to prevent over 500 workplace injuries and illnesses and 43 fatalities annually. Once implemented, the new rule will:

• Enhance worker comprehension of hazards, especially for low and limited-literacy workers;
• Reduce confusion in the workplace;
• Facilitate safety training;
• Result in safer handling and use of chemicals;
• Provide workers quicker and more efficient access to information on the safety data sheets;
• Result in cost savings to American businesses of more than $475 million in productivity  improvements, fewer safety data sheet and label updates and simpler new hazard communication training; and
• Reduce trade barriers by harmonizing with systems around the world.

The revised standard requires a common approach to hazard determination and communication that results in better quality and consistent hazard classification across the workplace, making it easier for workers to understand the properties of the materials they handle. HazCom 2012 requires that all manufacturers, importers, and distributors revise product labels and SDSs by June 2015. Employers are also required to train workers by December 1, 2013 on the new labels elements and safety data sheets format to facilitate recognition and understanding.

Product stewardship experts and toxicologists at CPS are currently helping companies implement the new HazCom 2012 standard.

Genetically Modified Crops: Status and Regulations

Genetically modified (GM) soybean was first commercialized in 1996. Since then, GM crop acreage has increased 100-fold worldwide, according to a special issue of the international journal, Nature. The magazine lists a number of traits that have been implemented successfully by biotechnology, including tolerance to abiotic stress such as drought in corn, disease and insect resistance, tolerance to herbicides, and modification of nutritional qualities, among others. The International Service for the Acquisition of Agri-Biotech Applications, or ISAAA, recently presented a report showing that 20 developing countries accounted for 52% of the GM crops in 2012, with the remaining being grown in eight industrialized countries, including Spain, the US, Canada, and Australia. The US is the lead grower, with a 90% adoption rate of GM corn, soybean, cotton, and other crops.

Herbicide resistance, notably resistance to glyphosate, known by the trade name, Round-up®, was the first commercially-viable trait introduced. The benefit to the farmer is the ability to adopt a no-till system, which saves costs and reduces loss of topsoil. The next major trait that has been widely adopted is resistance to lepidopteran insects through the use of the CryIA gene from Bacillus thuringiensis, hence the name, BT. BT cotton is resistant to the cotton bollworm (Helicoverpa zea), which gives farmers the advantage of not having to use expensive and potentially environmentally-damaging pesticides. The same gene in corn gives resistance to European corn borer (Ostrinia nubilalis).

Before a GM crop can be planted commercially in the US, it must first past inspection by the Animal Health and Plant Inspection Service, or APHIS. APHIS is primarily concerned with whether an introduced crop, by biotechnology or importation, will become a pest. APHIS lists approximately 140 crops that have passed regulation status. Industries hold the majority of the permits, but also publically funded entities such as USDA-ARS and University of Florida hold permits on GM crops. Testing of a new crop can take 5 to 10 years. Crops are evaluated for stability of phenotype, environmental effects, and vulnerability to pests and disease.

Any new agricultural food crop, whether bred through biotechnology or traditional means, must pass FDA regulation, which evaluates the characteristics of the food. According to guidance issued by the FDA (see FDA.gov, statement of policy – Foods derived from New Plant Varieties), known toxicants, nutrients, and allergenicity of the crop must be screened. This applies to foods destined for both animal and human consumption. Although the testing is carried out by the developer, the FDA’s Biotechnology Evaluation Team evaluates safety and compliance with the law. The FDA lists a total of 95 consultations on GM crops.

Finally, a plant that expresses a pesticide, such as the CryIA gene in BT corn, must pass EPA’s regulation of pesticidal substances (Federal Register Volume 66, Number 139, 2001). These biopesticides undergo the same rigorous inspection as any other pesticide. Toxicology and digestibility tests were conducted on the protein product of the CryIA gene when it was first introduced in corn, and the endotoxin was found to be non-toxic for mammalian consumption.

Critical Path Services, LLC (CPS), recently presented a poster on a method for testing allergen proteins in soybean. CPS’s GLP compliant laboratory partners with a number of crop protection companies to test their genetically modified foods for alterations in known metabolites and proteins.

The Mid-Atlantic Chromatography Group Collaboration at PITTCON

Critical Path Services, LLC will be attending the Mid-Atlantic Chromatography Group Collaboration (MACGC) at PITTCON, March 19, 2013, from 5:30-8:30 pm EST.  The MACGC consists of the Chromatography Forum of Delaware Valley (CFDV), the Washington Chromatography Discussion Group (WCDG), and North Jersey Chromatography Group (NJCG).  These groups collectively are planning the largest PITTCON collaboration of its kind. Join us for appetizers and cocktails to celebrate and foster fellowship of chromatographers from around the country. The event is taking place at The Union League, which is Philadelphia's most auspicious and culturally rich club, created in 1862 to aid the northern civil war effort. Admission by ticket only!  RSVP at: http://wcdg.squarespace.com/pittcon-2013/

*Business casual attire, defined as a collared shirt and pressed slacks for men and comparable attire for women (per the dress code of The Union League).

Contact sales@criticalpathservices.com for information on how CPS can assist you with your chromatography needs.