TSCA Implementation and Compliance Guide

In order to facilitate the appropriate application of, and compliance to, Toxic Substance Control Act (TSCA) regulations, this Implementation and Compliance Guide has been developed.

TSCA regulations are extremely complex and compliance can be a significant challenge for those laboratories at Duke engaged in activities subject to TSCA jurisdiction. Under some circumstances, the record keeping, notifications, reporting and other TSCA-required practices can represent a significant administrative burden. Unlike hazardous waste handling and most other environmental laws, TSCA compliance activities are focused on specific laboratory operating practices. For this reason, compliance responsibility rests almost entirely with the laboratory. The following Implementation and Compliance strategy is recommended.

Step 1: Determine TSCA applicability to your laboratory

Use the TSCA Applicability Determination Decision Tree and complete the Targeted Chemical Reporting Survey.  The five TSCA applicability questions at the end of the survey will determine your TSCA compliance requirements.  If your Laboratory answers “yes” to any of the questions, an email follow up will be sent from OESO EP informing you of the steps your laboratory must take to be in compliance with the TSCA regulations. Laboratory operations should be monitored on an on-going basis for any changes that could affect your TSCA applicability. The Targeted Chemical Reporting Survey should be resubmitted whenever such changes take place or at least once a year. A copy of TSCA applicability questions will be automatically forwarded to the OESO EP TSCA Contact.

Step 2: Identify a “TSCA Coordinator” for your laboratory

This person may be the lab manager or another technically qualified individual that will manage the lab TSCA requirements to ensure compliance. A lab person who is knowledgeable in the following areas should act as TSCA Coordinator:

• How chemicals are procured and transferred (e.g. direct purchase, import from foreign countries, etc.)
• The type and approximate quantity of chemicals used in laboratory;
• The nature of the research and operations conducted in lab;
• Grant and funding applications and contracts.

See TSCA Roles and Responsibilities for additional information.

Step 3: Establish a TSCA compliance file

TSCA is primarily an administrative, records-intensive program. Your TSCA files will be the first stop during an inspector’s visit. Your file should contain the following documents:

• TSCA Applicability Determination Form
• Import certifications
• Export notifications
• Inter-facility shipping records
• Significant adverse effect log
• Substantial risk reports

Step 4: Develop a process for ongoing review of TSCA applicability/compliance

Ensure that a process is in-place to conduct (at a minimum) annual applicability determination and completion of the Self-Assessment Checklist.