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TSCA Premanufacture Notification (PMN) and other Section 5 Support
Note: Effective April 12, 2011, all PMN and Section 5 Notices are required to be submitted electronically via EPA's eTSCA ecryption software. Click Here to learn more
The Toxic Substances Control Act (TSCA) requires the notification of any “new” chemical substances
being imported into or manufactured in the United States for the first time. Any company intending to
manufacture or import a new chemical substance must give USEPA’s Office of Chemical Safety and
Pollution Prevention 90-day notification under TSCA § 5. EPA will review the intended use of a new
chemical substance and evaluate any hazards associated with its use and, if necessary, regulate a new
chemical substance. toXcel can compile all information concerning chemical identity, use profile,
manufacture/import volume, and exposure potential to human health and the environment into the required
documentation to complete a new chemical’s Premanufacture Notification.
toXcel can help you determine whether the chemical you intend to manufacture or import is indeed a
new chemical substance and what, if any, exclusions or exemptions may apply to a chemical substance
or its use. toXcel can be your source for the preparation of PMNs and other TSCA § 5 Notices and
can coordinate submission of documents and materials to EPA and track their progress during Agency
review. We are prepared and ready for upcoming technological advances with EPA’s submission process
for PMNs and continue to stay abreast of any changes in the TSCA regulation.
toXcel is an experienced and reliable source of scientific and regulatory support for manufacturers and
distributors. Examples of toXcel’s in-house technical support capability include cost-effective assessment
of toxicology data and selection of appropriate data sets for regulatory utilization, conduct of risk
assessments, development of bridging, justification for “cluster” grouping and waiver arguments, management
of new data generation projects, document preparation, submission coordination, and collaboration/
communication with EPA personnel.
Areas of Scientific Expertise include:
- Toxicology (including acute, subacute, mutagenicity, chronic and carcinogenicity, developmental
and reproductive toxicity, and other special studies)
- Structure Activity Relationships (SAR), bridging, and waiver argument development
- Exposure Modeling (occupational, user, dietary) and Risk Assessment
- Environmental Fate
- Ecotoxicity
toXcel has decades of experience in regulatory affairs and has prepared
full Premanufacture Notifications for an array of industrial chemicals.
Let us help you!
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