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Toxic Substances Control Act (TSCA) Services
3E Company provides support for the complex and time-consuming tasks associated with regulatory compliance for the Toxic Substances Control Act (TSCA). Outsourcing this process to a team of experienced regulatory professionals that is actively involved and engaged in these activities on a daily basis can be a highly efficient and effective way to address the challenges associated with ensuring compliance with chemical control laws.
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TSCA services can be performed as either a defined project or on a scheduled, on-going basis and range from fully outsourcing TSCA compliance to project-based, function-specific areas.
Support You Need, When You Need It
3E`s team of TSCA Compliance professionals can perform the following:
- Regulatory Tracking - Monitor EPA activity, federal register notices, final rules, enforcement activities to review and direct compliance measures
- Spearhead TSCA Compliance - Interface with the client`s management team, regulatory personnel and others to direct TSCA Compliance program
- TSCA Section 5 - New Chemical Substance Compliance Support, Premanufacture Notice (PMN) requirements (Low volume exemption (LVE)), Notice of Commencement (NOCs), bona fide letters
- Consulting with client
- Consulting with EPA - PNCs
- Review of test data and other supporting documentation
- Collaboration with customer chemists and regulatory personnel, industrial hygiene and other professionals
- Completion of Form 7710-25
- QC Proof of submission
- Duplication of supporting documents
- Sanitization of PMN
- Support Registrant Role in Submission of Notification
- Guidance on Fee Filing (3E will advise on process)
- Notice of commencement
- Significant New Use Rules (SNUR)
- Interpret and compliance program
- Significant New Use Notice (SNUN)
- Notify EPA 90 days before activity
- Chemical Data Reporting (CDR)
- Review inventory update report requirements 2012 – 2016 as per most recent amendment
- Review current mechanisms for tracking volumes and other required information of imported and manufactured products and materials at substance level
- If required information is not currently tracked, recommendations will be made on the best way to do so
- Complete report for signature and submission
- TSCA 8b Status Reviews and Certifications
- TSCA 8c and 8e Review and Submission
- Import Certifications - TSCA Stamp and FIFRA Notice of Arrival of Pesticides
- Review incoming shipments for TSCA Import Status
- Provide proper TSCA Import Certification paperwork for all shipments coming into US from overseas
- If necessary, file FIFRA Notice of Arrival of Pesticides forms with EPA
- TSCA 12(b) Export Notification Support
- Review raw materials and mixtures for presence of substances subject to TSCA 12(b)
- File any necessary Export Notifications with EPA
- Exemptions Assessments and Certifications: R&D, Polymer, LoRex
- CAS RN Number Application
- CAS Inventory Expert Services Purchase Order
- Complete required documentation
- Global Inventory Status of New Ingredients and Finished Goods
- Training at all levels
- On–site self assessments and audit preparedness