The Cardno ChemRisk View
Keller and Heckman LLP and Cardno ChemRisk present a webinar series on the changes to the Toxic Substances Control Act (TSCA) resulting from the June 22, 2016 passage of the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Next Week’s Topic: PMN Review and Review Period Issues
Section 5 of TSCA has changed! Before a new substance is allowed onto the market EPA must now make "an affirmative finding of safety" under a new risk-based safety standard. EPA must also consider “conditions of use,” and “potentially exposed or susceptible subpopulations," but not cost, availability of alternatives, or other non-risk factors. Since the changes in the law, many new substances will be cleared only after issuance of section 5(e) orders, which may impose restrictions on manufacture / import volume, water release, and occupational safety and health practices. As before, the Agency will make conservative assumptions in predicting toxicity and exposure, necessitating a more strategic approach to PMN management and chemical risk assessment including identification of existing data and more accurate descriptions of applications and uses, and filling data gaps using read-across approaches or development of new toxicological data. Topics will include:
· Changes to the New Chemical Review Process
· The New Standard of Review
· New Data Requirements
· More Surprises to Come
· What Manufacturers Should Do
Registration for this program is complimentary, but required. Click here to register today.
Date: October 12, 2016
Time: 1:00 PM ET
Duration: 30 Minutes
Hosts: Keller and Heckman with Cardno ChemRisk
The TSCA 30/30 webinar will be presented by the Keller and Heckman LLP's TSCA attorneys and Cardno ChemRisk Scientists. Keller and Heckman LLP's TSCA Chemical Control Practice Group is the leading TSCA and Chemical Control legal firm with offices around the world, Serving Business Through Law and Science®. Cardno ChemRisk is a scientific consulting firm that is respected worldwide for its risk assessment experience, technical capabilities, industry leadership and pioneering spirit.
Part 3: Five Reasons Why Computer Modeling is an Essential Tool for Manufacturers, Importers and Distributors of Composite Wood Products
This posting is last of a three-part series on formaldehyde emissions from hardwood plywood (HWPW), medium-density fiberboard (MDF) and particleboard (PB), collectively called composite wood products. Starting in the summer of 2017, manufacturers, distributors and importers of composite wood products will be subject to the new Emission Standards for Composite Wood Products posted as a pre-publication final rule on July 27, 2016 as Title VI of the Toxic Substance and Control Act (TSCA). The emission standards will mandate that wood products within the scope of the rule comply with emission test requirements conducted under prescribed conditions. The emission standard is consistent with and modeled after a similar existing regulation previously promulgated by California Air Resources Board (CARB) as an Airborne Toxic Control Measure (ATCM).
There are five important reasons why companies in the composite wood product supply chain should consider exposure modeling as part of their regulatory compliance and due diligence strategy.
#1: Understand the contribution of emissions from your product to overall air quality
Computational models can help manufacturers, distributors and retailers assess the specific contribution of their product to indoor air quality in the environment for which the product is intended, which is likely less than what would be predicted by the controlled emissions tests that will be required by U.S. EPA. Under real-world conditions, formaldehyde emissions from consumer products are affected by aging of the material, interactions between materials, and attenuation of airborne concentration through loss of formaldehyde to adsorptive surfaces. Exposure models are an invaluable tool that can be used to understand how the introduction of a new product into a residence or workplace will affect air quality.
#2: Evaluate the effect of environmental factors on your product
Environmental factors such as temperature, humidity, and fresh air turnover can alter how emissions from composite wood products affect indoor air quality. Exposure modeling can be very useful for understanding how a specific product may respond to changes in the environment. For example, modeling can be used to predict the impact of a range of plausible and worst case scenario conditions. This knowledge can be very useful for responding to customer complaints, or in the preparation of product quality assessments.
#3: Assess emissions over the lifetime of a product
The controlled emissions tests used to comply with voluntary or regulatory standards do not consider the decrease in formaldehyde emissions that occur as the product ages with time. Exposure models provide useful information on the contribution of a product to indoor air formaldehyde concentrations over the lifetime of the product, not just when it is newly installed. This information can be very useful for understanding the length of time a product is likely to affect indoor air concentrations, or in the assessment of lifetime exposure.
#4: Interpret air concentration measurements that may have been collected by others
Indoor air measurements can be commissioned by building owners or consumers to support a complaint or product defect claim. Alternatively, products may be removed by the owner and submitted for analysis in a laboratory. Room measurements or product samples collected by building owners are difficult to interpret because formaldehyde is used as a resin or preservative in a wide variety of consumer products, occurs naturally in wood, and is a component of ambient outdoor air. A single air sample collected in a room captures all sources formaldehyde, and is not specific to a product of concern.
It is noteworthy that low emitting formaldehyde sources can capture formaldehyde from other sources, and subsequently reemit formaldehyde that was not present in the original product. Both indoor air measurements and tests of used products are impacted by these other sources. Exposure modeling can be a useful tool for understanding how a specific product may have contributed to a measured indoor air concentration. Similarly, modeling can be used to understand whether a sample of a used product may have been impacted by environmental formaldehyde.
#5: Develop an action plan to address non-compliant products
The existing CARB and newly finalized U.S. EPA emissions standards have many steps in place to prevent non-compliant products from entering the chain of commerce. The possibility exists, however, that a non-compliant product will be sold to consumers and subject to a customer complaint or regulatory compliance action. In these cases, exposure modeling is a very valuable tool for assessing whether a non-compliant product will have a meaningful impact on air quality. Additionally, a model can be used to evaluate the duration of time the product would remain non-compliant before aging processes sufficiently reduce the airborne concentration. These factors may impact risk mitigation plans in the event a product is determined to be non-compliant in one of the various stages of the supply chain.
How Cardno ChemRisk Can Assist with Questions about Formaldehyde