- A more formalized process that now includes chemical assessments that are risk-based, and prohibits the consideration of cost, or other non-risk factors;
- The requirement for EPA to contemplate the “reasonably foreseen conditions of use” for a substance, in addition to evaluating the current and future uses;
- Replacing risk modeling techniques with requirements that chemical manufacturers provide hard data (or reliable analog data) to be used by EPA to evaluate chemical risk; and
- The requirement for a formal risk assessment if EPA decides insufficient data exists on a new or existing chemical.
Evaluating Chemical Risk
- Organization: LCSA required the EPA to establish a Chemical Inventory reset, which lists “Active” chemicals that have been manufactured in the United States or imported.
- Prioritization: EPA then established a risk-based screening process for prioritizing chemicals. This determines which chemicals receive prioritization, identifying them as either a high-priority or low-priority substance. The priority list ensures that the most significant chemicals (based on hazards, use, and exposure risk) take precedence.
- Risk Evaluations: A high-priority designation for a substance triggers the risk evaluation process. The risk evaluation must be completed within three and a half years, and use best available science. The initial ten high-priority evaluations were conducted for the following substances: 1,4 Dioxane; 1-Bromopropane; Asbestos; Carbon Tetrachloride; HBCD; Methylene Chloride; N-Methyl pyrolidone; Pigment Violet 29; Trichloroethylene; and Tetrachloroethylene.
- Risk Management: Based on the required risk-based safety reviews of new chemicals, EPA must prohibit or restrict the manufacture, use, distribution, or disposal of any new substance if the chemical will not likely meet the safety standard. EPA can request additional information, if necessary, to make a safety determination.
LCSA Fees & Implementation
Time to Take Action
- Assess all anticipated new chemicals. Consider filing an exemption, but if you must file a PMN or SNUN, make sure to provide as much health and environmental data as possible, including necessary analog data.
- Review all of your products carefully. Identify all substances manufactured, imported or processed from June 2006 to June 2016, confirm your products are on the TSCA Inventory, confirm duplicative substances that are being submitted by another manufacturer or group, and confirm that suppliers are going to submit notices for their products that you use.
- Focus on risk evaluations. Review the EPA scoping documents for the first ten high-priority chemical substances and determine how your products may be impacted.
- Engage EPA/OPPT. Communicate with OPPT directly to discuss your substances and the LCSA policy framework, and actively engage with industry associations and stakeholder groups to navigate the new rule.
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