Hazard material information management and regulatory compliance

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Courtesy of Courtesy of 3E Company

Prior to the 1970s, legislative acts addressing hazardous chemicals were few in number and specific to a handful of topics. The Refuse Act of 1899 was often ignored and rarely enforced, and the Atomic Energy Act of 1954 was exclusive to radioactive material. When it came to workplace and community safety involving the handling, storage, disposal, and transportation of hazardous materials, companies were left to do the right thing.

The early '70s witnessed an environmental awakening. Primary drivers for new legislation and mandated agency oversight reacted to major incidents negatively impacting the environment and public health. High levels of toxic substances in waterways were the catalyst for The Clean Water Act (CWA), as were smog and alarming levels of air pollution for The Clean Air Act (CAA).

The late '70s through the early '90s saw a transition from a reactive to a proactive and preventive approach with a focus on workplace safety, the environment, and public health. This transition began with the passage of sweeping environmental health and safety (EH&S) legislation (e.g., OSHA's HazCom Standard and TSCA) and the creation of new regulatory enforcement agencies. This was followed by additional amendments and reauthorizations (CERCLA, SARA) that broadened federal authority, assigned liability for existing environmental issues, established a trust (funded by taxes on the chemical manufacturing industry) to clean up abandoned sites, and set regulatory restrictions and requirements for the management of hazardous waste and chemical inventories.

This transition helped bring an end to the practice of moving forward with the relatively uncontrolled and unrestricted production, use, transportation, and disposal of hazardous substances unless or until a significant negative impact resulted. The foundation of today's corporate EH&S compliance strategies has been built on the proactive, pre-emptive analytical approaches evident in such initiatives as Responsible Care and BAT and the Precautionary Principle, which have elevated chemical compliance from a necessary burden to a cornerstone of corporate policy.

Compliance Today
Managing compliance today goes far beyond conforming to EH&S laws. In addition to adhering to international, federal, state, and local regulations, compliance practice today includes three progressive approaches that are broadly accepted and implemented.

  • Corporate Social Responsibility (CSR): Assumption of responsibility for the impact of corporate activities upon employees, customers, community, and the environment. This is often carried out in the context of voluntary improvement commitments and performance reporting.
  • Industry best practices: Techniques or methodology that, through experience and research, has proven to reliably lead to a desired result. A commitment to use and share best practices is a commitment to applying all of the knowledge and technology at one's disposal to ensure safety and compliance.
  • Supply chain strategies: Compliance responsibilities are stretching beyond the confines of organizational walls. Qualification of upstream suppliers to ensure comprehensive conformance to federal laws, global mandates, and accepted standards has become embedded in procurement practices.

Finally, recent legislation requires the designation of responsible C-Level officers who now sign, under penalty of civil litigation and/or criminal prosecution, that all business activities and the results of those activities are compliant.

Life Cycle Compliance
This approach, which covers hazardous substances and material from cradle to grave, is widely accepted as an industry best practice. It defragments the operational disciplines and requirements of R&D, manufacturing, transport, use, and disposal. What were once separate silos of expertise, technology, data, and applicable regulations can be effectively integrated into a single managed system.

The breadth of global chemical regulation can be overwhelming. To manage the life cycle of hazardous materials effectively, companies should:

  • Develop a comprehensive program to meet the needs and objectives of all affected parties
  • Account for multiple data sources
  • Implement a data-driven, solution-oriented Environmental Management Information System (EMIS)

Affected parties include internal operations and disciplines (product stewardship, industrial hygiene, procurement, environmental, production, safety, shipping, etc.) that are dependent on an integrated system to provide immediate access to data and analytics to achieve compliance and assist in decision making. Other internal entities (sales, marketing, risk management, quality assurance) also are affected. The role of downstream users (customers and consumers) is expanding as their requests for chemical life cycle data increase.

Data sources include the Material Safety Data Sheet (MSDS), which has evolved into a comprehensive clearinghouse for EH&S information that extends far beyond workplace safety. Critical product information not directly listed on the MSDS must be sourced. Classification data specific to storage, regulatory reporting, transport, and disposal may not be included or may be insufficient to complete decision-making. Substance-level data is required for upstream processes. Integrated regulatory content enables the identification of regulated materials and the associated regulatory impact. Policy mandates specific to CSR must be accounted for, as well.

Implementation of an EMIS transitions internal compliance from a scattered, incomplete, outdated, incongruent set of practices and information to a current, accurate, and consistent data and decision-making source. Integrated and synchronized systems ensure that when change occurs, methods are in place to update all other affected systems and data. Multi-platform solutions -- not uncommon in today's enterprise-level compliance programs -- require a single source of data to ensure consistency of practice.

Benefits of EH&S Outsourcing
Managing the information associated with EH&S compliance is complex, time-consuming, resource-draining, technically challenging, and often expensive. Accessing critical supplier data; maintaining up-to-date and site-specific inventories of regulated materials; and managing spills and releases, waste, and regulatory reporting are formidable ongoing tasks.

These obligations are not optional, often being mandated by government agencies and insurance companies. Outsourcing the acquisition and management of this information, integrating technology where possible, and obtaining access to technical and regulatory expertise comprise a proven successful strategy to achieve compliance objectives for small, mid-size, and large organizations alike.

Life Cycle Management (LCM) Benefits
There are several benefits to properly managing the product life cycle, including:

  • Consistency of process with regard to data and document management site-to-site/department-to-department and all aspects of EH&S compliance management
  • Ensuring leverageable data that supports corporate EH&S objectives, internal operations, external data requirements, regulatory compliance, and workplace and community safety
  • Significant cost control and reduction because effective LCM eliminates duplicate sources of information and increases efficiencies across the supply chain
  • Improved product stewardship with the ability to react to and manage the impact of regulatory changes and support customers with required and requested product information
  • Efficient change management to leverage a single change to all affected users and track changes to regulations, formulations, processes, protocols, etc.
  • Improved quality through automation and error proofing, which results in more accurate and current data and simplifies process documentation
  • Reduced impact of the human capital shortage by reducing dependence on tribal knowledge and allowing EH&S professionals to focus on technical, compliance, and regulatory issues versus data and document management

Getting Started
First, define and document your EH&S information management requirements. Then identify stakeholder, power user, and end user roles in the information management chain. Second, evaluate your data and systems options. Is the current framework sufficiently robust to achieve EH&S requirements and objectives?

It also may be beneficial to build a high-level transition map from as-is to the LCM model. This information can be communicated during a stakeholder summit to gain acceptance and support for the desired approach and prioritize objectives. Finally, once buy-in is achieved, the path is laid to develop an implementation strategy.

Keep Pace with Changes
Both domestically and globally, the regulatory landscape is increasingly more complex and data-driven. With the phased acceptance of Globally Harmonized System (GHS) document, classification, and labeling standards, the next few years could see significant and sweeping changes.

Well-managed tools and processes enabling access to critical information that spans the entire product life cycle are keys to keeping pace with the ever-changing face of EH&S information management.

About the Author

Kami Blake is a Solutions Engineer with 3E Company. In this role, she provides technical expertise to assess regulatory requirements, information management technology, and analysis of existing hazmat programs to develop compliance solutions. Blake launched her career in 1982 in the United States Marine Corps and is a two-time Navy Achievement Medal recipient for small systems implementation and training. Prior to joining 3E in 2002, she served in Quality Assurance, Supply Chain Management and Process Engineering roles in the biotech and medical device manufacturing industries. She can be reached at info@3ECompany.com or 800-360-3220.

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