Chemical and biotechnological compliance (TSCA) - USA
The Toxic Substances Control Act of 1976 (TSCA) grants EPA authority to collect data on chemicals used to evaluate, assess, mitigate and control risks that might be posed by their manufacture, processing and use. TSCA provides a variety of control methods to prevent chemicals and microorganisms from posing unreasonable risks, including reporting, recordkeeping and testing requirements and restrictions related to chemical and microbial substances and mixtures.
TSG assists clients in all aspects of TSCA compliance, including the notification of new chemicals and microorganisms, TSCA compliance audits, and training, reporting and record keeping.
Understanding the TSCA requirements
The Toxic Substances Control Act (TSCA) gives the Environmental Protection Agency (EPA) the authority to regulate new and existing chemicals. Although initially passed in 1976, the Act was amended in 2016 to include updated provisions that require the EPA to evaluate existing chemicals in a timely fashion, outline new risk-based safety standards, increase public transparency on chemical substances and differentiate chemical risk evaluations based on whether they present a high or low risk. As a result, there are deadlines for manufacturers and importers of chemical substances to meet in 2019 and beyond.
Different sections of TSCA provide EPA with various authorities, a few of which are listed below:
- Section 5: Require pre-manufacture notification for "new chemical substances" before manufacture/import
- Section 4: Testing of chemicals by manufacturers, importers, and processors where risks or exposures of concern are found
- Section 5: Issue Significant New Use Rules (SNURs) when it identifies a significant new use that could result in exposures to, or releases of, a substance of concern
- Section 8(b): Maintain the TSCA Inventory
- Sections 13 and 12(b) respectively: Require importers and exporters of chemicals, to comply with certification reporting and/or other requirements
- Section 8(a): Require manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce in large quantities
- Section 8(e): Require that any person who manufactures (including imports), processes, or distributes in commerce a chemical substance or mixture and who obtains information which reasonably supports the conclusion that such substance or mixture presents a substantial risk of injury to health or the environment to immediately inform EPA, except where EPA has been adequately informed of such information
EPA also regulates the use of intergeneric organisms – ‘‘new’’ microorganisms formed by deliberate combinations of genetic material from organisms classified in different taxonomic genera. Intergeneric microorganisms require notification under Section 5 of TSCA:
- Section 5: Require Microbial Commercial Activity Notice (MCAN) for commercial purposes of intergeneric microorganisms before manufacturer/import
- Section 5: To recognize the needs of researchers, TSCA Experimental Release Application (TERA) must be submitted prior to initiating field trials which provides a high measure of flexibility and a shorter review period
TSG can help
We can help with all aspects of chemical compliance under TSCA including:
- Preparing TSCA compliance manuals
- Preparing Premanufacture Notices (PMN)
- Assisting with consent order negotiations
- Preparing Significant New Use Notices (SNUN)
- Making polymer exemption determinations
- Preparing Low Volume Exemption applications (LVE)
- Providing chemical import/export advice
- Assisting with chemical data reporting (CDR)
- Performing TSCA compliance audits and training
- Preparing TSCA inventory NOA Form B
- Preparing Microbial Commercial Activity Notices (MCAN)
- Preparing TSCA Environmental Release Application (TERA)
- Assisting with Confidential Business Information (CBI) substantiation
- Assisting with microbial characterization for MCAN and TERA
- Assisting with genetic manipulation data per requirements
- Assisting with production process and determine the Quality Control (QC) check points
- Determining if client qualifies for Tier I and Tier II exemptions
- Determining whether client qualifies for biotechnological Test Market Exemption Applications (TMEAs)
TSG provides companies with high-quality regulatory and scientific consulting services. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG's team of experts is deadline-focused, responsive and committed to professionalism. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.
TSG has a team of scientists, regulatory and environmental compliance consultants who manage all aspects of TSCA compliance. The TSCA team is led by Saadia Eltayeb who has over 20 years of experience preparing and submitting premanufacture notices (PMNs), Low Volume Exemptions (LVEs), polymer exemption determinations and consent order negotiations under Section 5 of TSCA and NSNs under CEPA. She also routinely audits chemical facilities to ensure compliance and provides import and export guidance. The team also includes Om Singh Senior Scientific Consultant, who has over 20 years of scientific research experience in Molecular Biology and Microbiology, assisting industries for TERA and MCAN submissions.
I am writing to express my gratitude for the work Dr Eltayeb performed on a PMN for our company and a foreign vendor partner. This PMN was accepted with no 5e consent order or SNUR in an EPA review that took less than 4 months. I appreciate the technical rigor, hard work, and good communication skills Dr Eltayeb brought to our multicontinental and multicultural team.