Toxic Substance Control Act for Laboratories: Compliance Essentials to Avoid Costly Penalties

Transcription

1 Toxic Substance Control Act for Laboratories: Compliance Essentials to Avoid Costly Penalties Presented by: Stan Abramson Arent Fox Anne Sefried BIOVIA Sponsored By: Thursday, November 11, :00 p.m. to 3:00 p.m. Eastern 1:00 p.m. to 2:00 p.m. Central 12:00 p.m. to 1:00 p.m. Mountain 11:00 a.m. to 12:00 p.m. Pacific This webinar qualifies for Continuance of Certification (COC) credit. CSPs will earn COC points for attending this webinar. For further instruction on COC credit reporting, please visit BLR and HR Hero Business & Legal Resources and HR Hero. All rights reserved. These materials may not be reproduced in part or in whole by any process without written permission.

2 Toxic Substance Control Act for Laboratories: Compliance Essentials to Avoid Costly Penalties Sponsored by Agenda TSCA Background TSCA Scope New Chemical Review Pre-Manufacture Notices (PMN) Significant New Use Rules (SNURs) EPA Inspections Reporting & Recordkeeping Compliance Challenges & Solutions Q&A

3 Toxic Substances Control Act (TSCA) Enacted October 12, 1976 Administered by U.S. EPA Authority for cradle to grave control Gap Filler Risk/benefit standard Scope of TSCA TSCA applies to: Chemical substances Mixtures Manufacturing (including import) Processing Use

4 Scope of TSCA Exclusions Pesticides Foods Drugs Cosmetics Tobacco Regulated nuclear material Firearms Scope of TSCA 1. Chemical Control - Premarket Review of New Chemicals (Section 5) - Regulation of New and Existing Chemicals (Section 6) 2. Information Gathering - Chemical Testing by Industry (Section 4) - Recordkeeping and Reporting of Existing Information (Section 8)

5 New Chemical Review TSCA Inventory - New v. Existing Chemicals Pre-manufacture (PMN) Review - All available health and environmental data submitted to EPA - No prescribed data set as in EU - 90-day review (extendable to 180 days by EPA) New Chemical Review Listing New Chemicals No action by EPA 90 (180) days expires Submit NOC to EPA TSCA Inventory Existing chemical

6 New Chemical Review New Chemical Controls Section 5(e) Additional information needed Control or prohibit manufacture, processing, distribution, use or disposal Administrative order - Unilateral order - Negotiated consent order Court injunction Significant New Use Rules (SNURS) SNURs bind all manufacturers and importers - 5(e) orders bind submitters only Notice and comment rulemaking required Manufacturer or processor must submit Significant New Use Notice (SNUN) at least 90 days prior to engaging in the new use

7 Exemptions From PMN and SNUR Requirements Substances produced solely in small quantities for R&D - Exemption is for R&D on the new chemical itself, NOT for use of the new chemical in R&D Test marketing Further exemptions on application and by rule Chemical Regulation Hazardous Chemical Substances and Mixtures Section 6 Rules - Control or prohibit manufacture, processing, distribution, use or disposal - Asbestos/PCBs Expedited regulatory actions Limitations on regulatory actions Statutory mandates New and existing chemicals

8 Information Gathering Section 4 Test Rules New and existing chemicals Mixtures Unreasonable risk standard ITC designations Notice and comment rulemaking Enforceable consent agreements Conducted by manufacturers and processors Reporting and Recordkeeping Existing information on chemicals/mixtures Records/reports on structure, uses, amounts, environment/health effects, exposure, disposal Section 8(a) rules Records of Significant Adverse Reactions Section 8(c) Reporting of Health and Safety Studie Section 8(d) rules Notice of Substantial Risk Section 8(e)

9 Reporting and Recordkeeping Chemical Data Reporting (CDR) - Formerly Inventory Update Reporting (IUR) - Required every four years Next CDR due June 1 Sept. 30, Generally, must report on manufacture or import of 25,000# or more per site in any year for past four years EPA Inspections What to Expect - Interview facility employees - Review records and reports - Observe operations - Take photographs - Collect samples

10 EPA Inspections TSCA inspections may be part of or follow other inspections for chemicals subject to: - EPCRA Extremely Hazardous Substance (EHS) reporting (302 notification, 304 release, 311 MSDS, 312 Tier I or II inventory form) - OSH Act Hazard Communication Standard - EPCRA 313 Toxic Release Inventory (TRI) Reporting - CERCLA Hazardous Substance Release Reporting - CAA Sec 112(r) Accidental Release Prevention EPA Inspections How to Prepare -Review records - Organize files - Notify corporate counsel EPA Red Flags - Other compliance issues (state and federal) - Anonymous reports - Missing records - Discrepancies in submissions

11 EPA Penalties Avoid penalties with chemical safety compliance and accurate records - Rigorous internal compliance programs including internal audits and training - Environmental Management Systems - Safe Chemical Practices - Corrective Action - Use of EPA Audit Policy Chemical Compliance Challenges Regulatory Compliance is Difficult! EHS Today reports that there have been a 30-40% increase in regulations concerning site safety and compliance that affect R&D organizations in general, and the lab specifically The number of regulatory audits will increase as a result The cost of noncompliance is high: managers are being held criminally and fiscally liable as well as the organization

12 Chemical Compliance Challenges Regulatory Compliance is Difficult! Different frequency, due dates Different formats Different chemicals of interest Chemical Compliance Challenges Chemical Inventory Management is Difficult!

13 Chemical Compliance Challenges Chemical Inventory Management is Difficult! Receiving SDS Management Accurate Reporting Hazard Identification Ensuring Proper Storage Disposal Location Management Monitoring Quantity Levels Efficient Re-order Chemical Compliance Challenges Chemical Inventory Management is Difficult! Multiple points of chemical receipt Incomplete data tracked Lack of central inventory system Inconsistent process for updates Over-ordering chemicals over stocking Materials expiring before use waste Time lost searching for inventory Lack of management involvement Disconnect between the lab and EHS

14 Chemical Compliance Challenges Goals Logistics Efficiently managing incoming, outgoing, and onsite materials Compliance Provide real-time, accurate reporting for internal and external needs Risk Management Increase safety by reducing hazardous situations Chemical Compliance Challenges Goals

15 Chemical Compliance Challenges Best Practices Use Of f the Shelf Webbased Solutio n d Implement Centralize Receiving Get the Right People Involved Barcode All Inventory Adopt Simple Workflows Incorporate Safety and Compliance BIOVIA CISPro Industry-Leading Chemical Inventory Management System Real-time barcode system Manage chemicals, biologicals, supplies and more Track inventory receipt to disposal Easy to use, intuitive user interface Location, owner, expiration date monitoring Product-specific SDS management Regulatory association and reporting notifications

16 Summary Accurate chemical inventory management is the basis for accurate hazardous materials reporting and compliance. Successful compliance is knowing how regulations affect the organization, how to address those regulations, and streamlining chemical and hazardous materials workflows to ensure the accurate chemical inventory data and site safety. Learn More Please send me: [ ] Receive link to on-demand version of the webinar [ ] Download link to BIOVIA s Best Practices for Chemical Inventory Management white paper [ ] Request BIOVIA CISPro web demo [ ] Contact me [ ] All of the above

17 Toxic Substance Control Act (TSCA) for Laboratories Compliance Essentials to Avoid Costly Penalties Q&A Disclaimers *This webinar is designed to provide accurate and authoritative information about the subject matter covered. It is sold with the understanding that the publisher is not engaged in rendering legal, accounting, or other professional services. *This webinar provides general information only and does not constitute legal advice. No attorney-client relationship has been created. If legal advice or other expert assistance is required, the services of a competent professional should be sought. We recommend that you consult with qualified local counsel familiar with your specific situation before taking any action.

18 Stan Abramson Stan Abramson is a partner in the Arent Fox Washington, DC office, where he co-chairs the life sciences group. Stan s practice is focused on biotechnology, food safety, pesticide law, and environmental law, with emphasis on product counseling and regulation. He represents clients in federal and state enforcement proceedings, defends challenges to pesticides and other chemical and biological products, develops corporate compliance and product stewardship programs, and conducts environmental audits and due diligence reviews. Anne Sefried Anne Sefried is a Field Applications Engineer for BIOVIA.Anne Sefried leverages her application expertise at BIOVIA to assist organizations in optimizing their chemical inventory management activities. Anne graduated from Chapman University with a B.S. in Computer Information Systems.

19 Dassault Systemès BIOVIA provides a scientific collaborative environment for advanced biological, chemical and materials experiences. BIOVIA enterprise systems for modeling/simulation, laboratory and quality management enable innovation for science-based industries. The BIOVIA experience sets new software standards for life science and process-based enterprises, enabling them to discover, design, deploy and deliver innovative, sustainable and competitive products of higher quality to consumers globally. The BIOVIA CISPro chemical inventory system is a high-performance system for tracking chemicals and other laboratory supplies. BIOVIA CISPro helps drive safe chemical handling, storage and management, thereby eliminating potential problems caused by chemical safety deficiencies. For more information, visit