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Thursday, November 11, 2014 2:00 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

Presented by:

Stan Abramson Arent Fox

Anne Sefried BIOVIA

Toxic Substance Control Act for Laboratories: Compliance

Essentials to Avoid Costly Penalties

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

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

Scope of TSCA

• Pesticides• Foods• Drugs• Cosmetics• Tobacco• Regulated nuclear material• Firearms

Exclusions

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)

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

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

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

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)

Reporting and Recordkeeping

• Chemical Data Reporting (CDR)- Formerly Inventory Update Reporting (IUR)- Required every four years

• Next CDR due June 1 – Sept. 30, 2016- 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

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

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

• 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

Regulatory Compliance is Difficult!

Chemical Compliance Challenges

Different frequency, due datesDifferent formatsDifferent chemicals of interest

Regulatory Compliance is Difficult!

Chemical Compliance Challenges

Chemical Inventory Management is Difficult!

Chemical Compliance Challenges

Receiving

Hazard Identification

Location Management

MonitoringQuantity Levels

Ensuring Proper Storage

SDS Management

Accurate Reporting

Disposal

Efficient Re-order

Chemical Inventory Management is Difficult!

Chemical Compliance Challenges

Multiple points of chemical receiptIncomplete data trackedLack of central inventory systemInconsistent process for updatesOver-ordering chemicals – over stockingMaterials expiring before use – wasteTime lost searching for inventoryLack of management involvementDisconnect between the lab and EHS

Chemical Inventory Management is Difficult!

Chemical Compliance Challenges

Goals

Logistics

Efficiently managing incoming, outgoing, and on-

site materials

ComplianceProvide

real-time, accurate reporting

for internal

and external needs

Risk Management

Increase safety by reducing

hazardous situations

Chemical Compliance Challenges

Goals

Chemical Compliance Challenges

Use‘Off the

Shelf’ Web-based

Solution

Implement

Centralized

Receiving

Get the Right People

Involved

Barcode All Inventory

Adopt Simple

Workflows

Incorporate Safety

and Compliance

Best Practices

Chemical Compliance Challenges

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 datemonitoring

• Product-specific SDS management

• Regulatory association and reporting

• Email notifications

BIOVIA CISPro

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

Toxic Substance Control Act (TSCA)for Laboratories

Compliance Essentials to Avoid Costly Penalties

Q&Awww.arentfox.com

www.accelrys.com/CISPro

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.

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 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.

Stan Abramson

Anne Sefried

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 www.accelrys.com/cispro.