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Biotechnology Labs: Reasons to Change
Table of Contents
Background and Overview
Operations
Reasons to Change
P2 Opportunities
Where To Go for P2 Help
Acknowledgements
Complete List of Links

Why is pollution prevention important in biotech research and manufacturing? Both are highly regulated, and use their fair share of solvents, hazardous or toxic chemicals, water, and other products of environmental concern. (Some typical research lab inputs and outputs are discussed in the Operations Section of this hub.) Every step taken to minimize use of these materials and natural resources aids in reducing operating expenses, improving environmental compliance, improving worker safety, and reducing environmental impacts.

Reasons to adopt pollution prevention are discussed under individual areas below.

Chemical Use

The industry uses many different chemicals, solvents, and materials, including biological specimens, to research and develop new products. The Chemical Strategies Partnership estimates that conventional chemical management methods can cost up to $1 for every $1 of chemical purchased [1]. Hazardous wastes generated costs more than $2 per pound to manage, according to the PPRC Measurement Project.

Minimizing use of chemicals reduces purchase, management, inventory, and disposal costs. Chemical reduction helps with environmental compliance, risk and liability reduction, and meeting good laboratory practice standards. Also of high importance is minimizing staff exposure to hazardous and toxic materials, including solvents and formaldehyde, an anticipated carcinogen. And, reduced chemical use translates to smaller quantities of emissions and effluents, and related costs to treat or perform pollution abatement.

Energy Use

Energy requirements are typically high in labs due to ventilation requirements for work stations and storage areas. Installing low-flow fume hoods and high-efficiency fans, along with other energy conservation measures will reduce energy costs and greenhouse gases from fuel combustion to produce energy.

Water Use

Water-related costs result from obtaining water for facility and lab uses, producing or purchasing various grades of purified water (in large-scale volumes for manufacturing), and treatment and disposal of wastewater. More water-efficient equipment and processes, along with recycling and reclamation, reduce cost and environmental impact.

Water is becoming scarcer in many areas - so water conservation makes a biotech manufacturing facility more desirable in a community.

Compliance (in the U.S.)

The industry is highly regulated due to the unique nature of lab work. Pollution prevention helps comply with environmental regulations. Some of the potentially applicable federal requirements are listed below, exclusive of additional state or local statutes.

  • Clean Air Act Amendments, Section 112, addressing hazardous air pollutants and spill prevention and control
  • Clean Air Act Amendments per 40 CFR 68 for chemical accident prevention
  • Clean Air Act Amendments, addressing ozone depleting substances, and air pollution episode planning
  • New Source Performance Standards (NSPS), per 40 CFR 60
  • National Emission Standards for Hazardous Air Pollutants (NESHAP) per 40 CFR 61
  • Clean Water Act - National Pretreatment Standards and Effluent Guidelines per 40 CFR 403
  • National Pollutant Discharge Elimination System (NPDES) for surface water discharges per 40 CFR 122
  • Resource Conservation and Recovery Act (RCRA) Subtitle C per 40 CFR 260-279 for hazardous waste management, storage, and disposal
  • Resource Conservation and Recovery Act (RCRA) Subtitle D per 40 CFR 257-258 for sound management of solid waste
  • Occupational Safety and Health Administration (OSHA) per 29 CFR 1910 for chemical hygiene plans, chemical hazards, permissible exposures, ventilation requirements, and the bloodborne pathogen standard. National Institute for Occupational Safety and Health (NIOSH) standards may also apply;
  • Department of Transportation requirements for packaging and shipping
  • Nuclear Regulatory Commission (NRC) per 10 CFR 19, 20, 30, 31, and 40
  • FDA's Good Laboratory Practices requirements per 21 CFR 58
  • Emergency Planning and Community Right-to-Know Act (EPCRA) per 40 CFR 370 and 372, including Toxic Release Inventory reporting requirements. (See list of TRI reportable chemicals and hazard information).
  • Toxic Substances Control Act (TSCA) per 40 CFR 700-725
  • TSCA's Good Laboratory Practice Standard per 40 CFR 792
  • FDA's Good Manufacturing Practices regulations 21 CFR 210 addressing manufacturing, processing, packing, or holding of drugs
  • FDA's Good Manufacturing Practices regulations 21 CFR 211 addressing practices for finished pharmaceuticals

States or local jurisdictions may enforce supplemental or additional regulations, especially for biomedical (infectious) waste and mixed infectious/hazardous waste.

Global Requirements

New laws resulting from enactment of the United Nations Stockholm Convention (Persistent Organic Pollutants (POPs) Protocol) in May 2004, have led to significant new activity in the assessment of Persistent, Bioaccumulative, Toxic substances (PBT). Canada's Persistent, Bioaccumulative & Toxics (PBT) program is categorizing thousands of commercial substances regulates and authorizes other instruments to prevent or control the use and/or release of several of these substances within Canada. The REACH (Registration, Evaluation and Authorisation of Chemicals) effort in the European Union will expand this effort, as will the integration of PBT evaluation into reviews of new substances in the US, Japan, Australia, and other POPs Protocol signatories. It may become increasingly important to minimize use of PBTs in exported pharmaceutical products, and to minimize use of any such products during production.

Solid and Hazardous Waste

In general, reducing wastes demonstrates leadership, cuts costs in disposal, raw materials, and operations, and improves worker safety. Minimizing solid waste and maximizing reuse and recycling also conserves resources and reduces landfill loading. Reducing hazardous waste quantities can lessen permitting requirements and reduce regulatory burdens, cut cost and future liability. For more incentives to reduce waste, see the Washington Department of Ecology's webpage What are the Economic Incentives for Pollution Prevention.

Public Relations and Marketing

Employing the best environmental practices is important for maintaining a good image with the public and stakeholders, as well as attracting new customers and maintaining competitiveness.

Sources:
[1] Claussen, J. Chemical Strategies Partnership. [Presentation] Undated. Chemical Management Services: A New Strategy for Pollution Prevention.


 

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Hub Last Updated: 1/16/2014