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Pollution Prevention Master Plan and Statement of Commitments
Introduction
Roche Colorado Corporation (RCC) is a manufacturer of pharmaceuticals, pharmaceutical intermediates and fine chemicals. Roche Colorado is a member of the Chemical Manufacturer's Association (CMA), and as such subscribes to Responsible Care® is an industry-based initiative to ensure that member companies take actions with respect to community concerns, environmental impacts, employee health and safety, and product stewardship beyond those required by regulation. CMA requires annual reporting of progress against Responsible Care® requirements. CMA also administers a management system verification program whereby CMA and community verifiers evaluate a member company's compliance with Responsible Care® principles.
Pollution prevention is a specific area targeted by Responsible Care®. As such, Roche Colorado has prioritized the environmental impacts of its operations and addressed such impacts through technical improvements and community dialogue. In consultation with the City of Boulder and community representatives, Roche Colorado retained a third party pollution prevention expert to review the site's past, present and future pollution prevention achievements and plans. Much of this document is based upon recommendations received in the final report from the third-party audit.
In response to suggestions from the third party audit and requests from stakeholders in our community, Roche Colorado has prepared this Master Plan and Statement of Commitments. It begins with an introduction to Responsible Care® and further details the Pollution Prevention Code under this program. Because Responsible Care'is the primary basis of Roche Colorado's pollution prevention program, background information on this initiative is included. Business strategies and significant company initiatives are discussed in relationship to Responsible Care®. This document closes with sections on pollution prevention goals, specific air emission reductions, training, and communication.
Specific pollution prevention projects and numerical objectives will change from year to year. In addition to this Pollution Prevention Master Plan and Statement of Commitments, Roche Colorado will establish specific objectives annually and will share them with the City of Boulder (see Communication section).
Responsible Care® Summary
The Guiding Principles of Responsible Care®, listed below, serve as goal statements for Roche Colorado's entire pollution prevention program.
Guiding Principles of Responsible Care®
- To recognize and respond to community concerns about chemicals and our operations;
- To develop and produce chemicals that can be manufactured, transported, used and disposed of safely.
- To make health, safety and environmental considerations a priority in our planning for all existing and new products and processes;
- To report promptly to officials, employees, customers and the public, information on chemical-related health or environmental hazards and to recommend protective measures;
- To operate our plants and facilities in a manner that protects the environment and the health and safety of our employees and the public;
- To extend knowledge by conducting or supporting research on the health, safety, and environmental effects of our products, processes, and waste materials;
- To promote the principles and practices of Responsible Care® by sharing experiences and offering assistance to others who produce, handle, use, transport, or dispose of chemicals;
- To work with others to resolve problems created by past handling and disposal of hazardous substances;
- To participate with government and others in creating responsible laws, regulations and standards to safeguard the community, workplace and environment.
The Chemical Manufacturer's Association (CMA) has developed six Codes of Management Practices to act as specific direction to member companies addressing the above Principles. The Pollution Prevention Code, quoted below, describes member commitments surrounding the minimization of waste and environmental impact. Each Code is then supported by a list of Management Practices by which to implement the Code. Roche Colorado is committed to continuous improvement with respect to its chemical releases to the environment. To help accomplish this goal, Roche Colorado is committed to operating its facility with the fourteen Management Practices in place as discussed in the Pollution Prevention Code. (See attached Appendix 1 for a listing of these fourteen Management Practices.)
Pollution Prevention Code Of Management Practices: Purpose
"This Code is designed to achieve ongoing reductions in the amount of all contaminants and pollutants released to the air, water, and land from member company facilities. These reductions are intended to respond to public concerns about the existence of such releases, and to further increase the margin of safety for public health and the environment.
"The Code is also designed to achieve ongoing reductions in the amount of wastes generated at facilities. These reductions are intended to help relieve the burden on industry and society of managing such wastes in future years.
"In implementing the Code, each company should strive for annual reductions, recognizing that production rates, new operations, and other factors may result in increases. Despite these fluctuations, however, the goal is to establish a long-term, substantial downward trend in the amount of wastes generated and contaminants and pollutants released. Quantitative reduction goals will be established for giving priority to those pollutants, contaminants and wastes of highest health and environmental concern.
"This code also includes practices that address the broader waste management issues beyond source reduction and other waste and release reduction efforts. Each member company must manage remaining wastes and releases in a manner that protects the environment and the health and safety of employees and the public."
Overview of Facility Operations
Roche Colorado manufactures pharmaceutical intermediates, bulk pharmaceutical chemicals and fine chemicals. All products are bulk, and most are shipped to other sites within the Hoffmann-La Roche family of manufacturing locations for either final chemical transformations or formulation. Four small volume organic chemical products are delivered to outside customers for use in their processes. Key pharmaceutical products manufactured at Roche Colorado include intermediates of Naprosyn (naproxen), intermediates of Invirase (saquinavir), intermediates of Viracept (nelfinavir) and finished Cytovene (ganciclovir). Naprosyn is an anti-inflammatory specifically targeted at arthritis patients. It is also the active ingredient in the over-the-counter medication ALEVE®. Invirase and Viracept are both used in the treatment of HIV positive and AIDS patients. Cytovene (also called Cymevene) is used to prevent blindness in AIDS, organ transplant, and other immune deficient patients. The Boulder site also manufactures several small, laboratory scale products used for a range of illnesses, including endometriosis and osteoporosis, and other specialty chemicals for outside customers. Roche Colorado continues to evaluate new processes for production at the Boulder site as research makes more innovative and successful drug treatments possible.
Also located on the Roche Colorado site, the Boulder Technology Center conducts pharmaceutical research and development for Hoffmann-La Roche. Second generation processes are developed and tested in Tech Center laboratories and the pilot plant to increase product yield and decrease wastes and cost.
Pharmaceutical manufacturing includes the use of organic chemicals as chemical "building blocks" for pharmaceuticals and as solvents in which to conduct the chemical reactions. Some quantities of the chemical "building blocks" react to form impurities that are removed during the manufacturing operations as wastes. These wastes can leave the Roche Colorado site in one of three ways; 1) as a small constituent in aqueous waste (biologically treated at Roche Colorado under City of Boulder-issued wastewater discharge permit and then discharged to the City's wastewater treatment facility), 2) as a solid waste (shipped to a licensed hazardous waste facility for disposal, when appropriate) or 3) dissolved in organic liquid waste (shipped to a licensed hazardous waste facility for disposal). The solvents used to conduct the chemical reactions can also become wastes, despite the fact that the majority of solvent used in manufacturing is recycled. The majority of organic liquid wastes from the Boulder site are incinerated and the energy is recovered. Because of the tendency of organic solvents to evaporate more readily than water, some losses to air are experienced when these solvents are in use.
Roche Colorado faces some challenges unique to the pharmaceutical industry in attempting to maximize its pollution prevention opportunities. Over eighty percent of the products produced on site are filed with and regulated by the Food and Drug Administration (FDA). Detailed manufacturing procedures for approved products must be filed, including the type and quantities of raw materials and solvents used to make the product. It is the position of the FDA that any process change could impact the quality of the product, thus all changes must meet with the approval of the FDA's Good Manufacturing Procedures. Furthermore, the FDA views changes in process materials as substantial changes. These process changes are subject to lengthy review by the FDA. Historically, FDA has not prioritized substitution of less hazardous materials, sticking instead with priorities around improved product quality, labeling, etc. While acceptance of material substitutions is improving, alternative materials and procedures that satisfy pollution prevention objectives must adequately demonstrate acceptable product quality before FDA approval of the change is possible.
Solvents at times cannot be returned to high enough quality standards to be used again and meet pharmaceutical product quality standards. These solvent and by-product mixtures are disposed of as hazardous waste. As mentioned above, the unrecoverable wastes are shipped to a hazardous waste facility for recycle or for incineration with energy recovery. Those treatment, storage, and disposal facilities (TSDF's) which accept wastes from Roche Colorado go through an auditing process before receiving any shipments from RCC. Members of the Environmental Team or other officials visit the facility to ensure it operates according to the standards set by regulatory agencies and by Roche Colorado policies.
Most production related aqueous waste streams enter the Roche Colorado biological treatment system. For processes where solvents and water are used together, aqueous streams can include some solvent as a small constituent. The levels of organics and solids are reduced by the treatment system before being released to the city's water treatment facility. Aqueous waste streams that contain higher levels of metals or other constituents not easily treated are sent to a TSDF for incineration. Any stormwater that comes in contact with production areas is managed according to Roche Colorado's stormwater permit from the Colorado Department of Public Health and Environment. The Stormwater Management Plan (SWMP) for the site defines practices to maintain and improve the quality of stormwater being discharged from the site, such as the maintenance of containment dikes, periodic inspections, and water quality testing.
Related Business Strategies
Roche Colorado is a subsidiary of Hoffmann-La Roche, the international pharmaceutical firm. Roche Colorado's work in small-scale manufacturing has earned it recognition worldwide and is the site of first choice for Hoffmann-La Roche in this area of pharmaceutical manufacturing. These types of processes use significantly less chemicals to make the annual quantity needed and, intrinsically, are low-polluting. Continuing to incorporate more pharmaceutical production of this type is a business strategy for Roche Colorado.
Additionally, the staff at the Boulder Technology Center is familiar with pollution prevention techniques and incorporates these into their research and development of second generation products. They are especially committed to eliminating the use of methylene chloride and other chlorinated solvents. The Tech Center's accomplishments with Ganciclovir in particular are very impressive from a pollution prevention standpoint.
Based in large part on these business strategies, plus our Responsible Care commitments, Roche Colorado began participation in the Governor's Pollution Prevention Challenge in 1995. Roche Colorado made commitments in the areas of air emissions and hazardous waste reduction, targeting both specific chemicals and total numbers. (See Appendix 2).
The Agreement signed between Roche Colorado, the City of Boulder, and BREATHE during 1995 commits Roche Colorado to end-of-pipe technology for controlling air emissions, to an expanded leak detection and repair program, and to providing ongoing information to the other two parties to the Agreement. RCC is committed to honoring these agreements. The Emissions Control System (ECS) project began routine operation in March 1999. We received full funding of $20,000,000 from Hoffmann-La Roche for this project.
Finally, Roche Colorado has pursued a variety of initiatives to better communicate with the public concerning pollution prevention issues. Roche Colorado was the first CMA member in Colorado, and one of the first nationally, to organize a community advisory panel (CAP). The CAP serves as an important interface between the community and Roche Colorado, providing Roche Colorado with a vehicle for understanding community concerns and an avenue for educating the public. As an additional tool for communicating with the public, Roche Colorado is developing a web site that will feature information concerning pollution prevention issues.
To summarize, Roche Colorado a) is an ethical and adequately funded corporation, b) focuses pollution prevention through, in part, process development and small-scale manufacturing, and c) is committed to ongoing communication with the community.
Pollution Control and Waste Disposal Costs
All spending at Roche Colorado is either classified as expense or capital cost. Capital costs are dollars spent that result in a physical asset with a value above a certain dollar level and a useful life of eight years or greater. Physical assets that the company acquires as a result of capital spending are depreciated over a schedule appropriate to the anticipated useful life. All other spending is classified as expense.
Expense spending covering pollution control, waste disposal and environmental regulatory compliance totals approximately four million dollars annually at Roche Colorado. This figure includes the salaries of individuals dedicated both to operating pollution control equipment (such as the ECS and on-site wastewater treatment plant) and individuals responsible for regulatory compliance, supplies, equipment upkeep, and waste disposal fees. These costs are collected in environmentally related departmental budgets, then allocated as appropriate to the products made at the site.
Although cost information is currently available in very detailed categories, Roche Colorado's third-party audit recommended moving to a more direct costing model, basing the cost of individual products partially on their specific waste volumes. We support this recommendation and are moving to expand our current system. The cost allocation for hazardous waste disposal, which constitutes the single largest environmental expense, has already been refined. The product allocations are reviewed and updated annually.
In addition to expenses, each year Roche Colorado also spends capital investment dollars in the areas of pollution control. Notably, total dollars spent in support of the Emissions Control System will reach approximately $20,000,000 by the completion of the project.
Pollution Prevention Goals: Continuous Improvement
This section of this Master Plan speaks to pollution prevention goals in general. Roche Colorado is committed to a goal of continuous improvement in waste trends and pollution prevention efforts. The company sets both long and short-term goals and continually tracks progress toward those goals. The following section specifically targets air emissions, which have encompassed Roche Colorado's primary pollution prevention objectives since 1989 and which have historically been the focus of community concerns.
Currently, work assignments are documented and progress tracked within each department relative to the site's overall goals. Pollution prevention objectives are established jointly by members of the Environmental Department, the Pollution Prevention Team, and the manufacturing technical staff. Progress is tracked and documented by members of the Pollution Prevention Team.
In addition, employees can make formal suggestions on how to address specific pollution prevention opportunities. These are collected and passed on to the appropriate reviewers by Roche Colorado's Suggestion Committee. Employees who submit environmentally related suggestions receive a specific monetary award. They also receive a portion of any return on investment resulting from the suggestion. This program allows an additional avenue and an incentive for every employee to impact pollution prevention.
During 1995, Governor Romer issued a Pollution Prevention Challenge to industry in the state, targeting particular media and chemicals. Roche Colorado committed to reductions in air emissions and hazardous waste, targeting acetone and methylene chloride specifically. The commitments were made from a base year of 1993, with improvements due in 1996, 1998 and 2000 (see Appendix 4). All goals related to acetone and methylene chloride have been achieved. Roche Colorado is still striving to achieve its goals relative to bulk hazardous waste volumes.
One of the recommendations of the third-party pollution prevention audit conducted during October 1995, was to commission a Pollution Prevention Team to provide a "clearing house" for goals, to track progress against those goals, and to act as the multi-disciplinary driving force behind pollution prevention at Roche Colorado. Such a team has been commissioned and meets regularly. This group establishes specific objectives on an annual basis, makes recommendations to Roche Colorado management, and tracks progress relative to these objectives.
Specific Air Emission Reduction Topics
An analysis conducted in the late 1980s by Roche Colorado identified air pollution as the company's highest environmental improvement priority. Hazardous air pollutant (HAP) emissions are of keen interest to members of the community.
With the installation of the new ECS mentioned above, Roche Colorado expects HAP emissions from the site will drop dramatically. Emissions due to ECS downtime and from fugitive sources and storage tanks will represent significant fractions of the smaller total site emissions. Lack of sufficient information concerning causes of downtime of the ECS or site-specific fugitive emission calculation methodologies, however, makes it impossible to commit to a particular annual HAP level at this time. Each year's pollution prevention goals will include reduction goals for all wastes, including HAP emissions, based on the current product mix and process conditions.
Minimizing the emissions of chlorinated solvents continues to be a major focus at Roche Colorado. This is a two-step objective. The first step is to continue previously successful process development efforts in this area, such as those that eliminated methylene chloride from use in Ganciclovir. Process development efforts at Roche Colorado for future products or processes will give the elimination of methylene chloride as a solvent a high priority. The second step, for remaining products using chlorinated solvents, is heightened air pollution control procedures/equipment. Any processes operating at Roche Colorado will be controlled with technology that exceeds the control efficiency of standard condensers before entering the ECS. Specifically, technology will be implemented to increase the source reduction of methylene chloride streams entering the ECS by at least 75% over what it is currently in place.
Both the discontinued use of methylene chloride, where possible, and the source reduction planned prior to the environmental control system, will exceed the requirements of the Maximum Achievable Control Technology regulation (MACT) or any other anticipated regulatory requirements for the pharmaceutical industry.
Odors emitted from production, whether they are from hazardous chemicals or not, present an unwanted release of chemicals to the environment. As processes are reviewed on an annual basis, a member of the Environmental Department evaluates the potential for odors and other releases to the air. Procedure adjustments or additions are made to minimize the release of all chemicals to the air. Should an odor be detected on or off the site, employees respond immediately to determine the source of the odor through a detailed procedure. An individual certified by the State of Colorado helps to review the complaint and measures the odor according to the criteria outlined in Colorado Regulation No. 2. If the report came from an individual off the site, we offer that person a tour of the facility to see if they can identify the odor on site. It is not unusual to determine through our investigation that the odor source is somewhere other than Roche Colorado. If the odor can be traced to production, that process is examined to ensure that procedures are being properly followed and that operations are occurring normally. Any control equipment is checked to ensure good working order. If the problem can not be immediately corrected, the causative operations are shut down.
Since 1995, Roche Colorado has been phasing in a broad leak detection and repair (LDAR) program. This effort monitors and ensures expeditious repair of fugitive emissions sources. "Fugitives" are air emissions resulting from imperfectly sealed equipment and piping in volatile organic chemical (VOC) service. Inadequate sealing can cause minor leaks ranging from visible liquid drips to undetectable small vapor leaks. The Clean Air Act requires an LDAR program for pharmaceutical processing equipment coming in contact with methylene chloride or carbon tetrachloride. Since Roche Colorado does not currently have any large scale processes using either of these solvents, an LDAR program is not required by regulations at this site. However, Roche Colorado, in response to requests from City of Boulder staff and citizens, has maintained an LDAR program to include equipment in and outside all plants which come in contact with VOCs. With the ECS in operation, fugitive emissions will represent a much more significant portion of the site's total emissions. The LDAR program is another way that emission sources from the site will be continuously improved.
Implementation Methods
Multiple implementation methods have been used in the past at Roche Colorado to reduce pollution. Specifically, process development to eliminate particular chemical use, implementation of additional control technologies, modified operating procedures and training are the techniques used most frequently at Roche Colorado. Particular projects use these and other techniques to address those processes that are already in place, depending upon what is appropriate for that project's objective.
Training
Responsible Care® training is conducted annually for all employees at Roche Colorado. Pollution prevention training overview is a part of this annual training. Additional training is conducted for specific job functions at the company, which could have a significant impact in this area. The Pollution Prevention Team takes part in determining what levels of training are appropriate to which job functions.
Communication
Progress reporting on pollution prevention is done annually to Roche Colorado's employees, Roche Colorado's Community Advisory Panel, and staff members of the Boulder County Health Department and the City of Boulder Environmental Affairs Division. The report follows the format outlined by City of Boulder Environmental Affairs Division staff, and additionally includes other elements listed here:
- Accomplishments vs. objectives for the prior year
- Plans for the current year
- Status of Management Practices under Responsible Care' Pollution Prevention Code
- Significant changes in environmental permits and reporting
- Summary of waste data for each media
- Pollution prevention control expenditures
- Methylene chloride use, emissions to air
- Other topics determined to be of concern to the community
The written report may be followed by a face-to-face meeting upon request to clarify points contained in the report. The report will not contain confidential business information when presented to groups outside Roche Colorado.
As a part of its commitment to Responsible Care, Roche Colorado has participated in CMA's voluntary Management System Verification (MSV) program. CMA implemented this evaluation process as a means for member companies to receive knowledgeable and professional external evaluation of Responsible Care' systems and activities. Two technical MSV verifiers and three community representatives selected by the CAP conducted the verification. The scope of the MSV included all of the six Responsible Care codes and management practices in place, including Pollution Prevention. Although not a requirement of the program, Roche Colorado will share the final report with the City of Boulder and the public as a way to expand the dialogue on Responsible Care with the community.
Roche Colorado also is committed to communication with other companies, both within the Boulder community and without, regarding pollution prevention issues. Participation in Responsible Care, the Governor's Pollution Prevention Challenge, the City of Boulder Pollution Prevention Program, and other more informal groups offers many benchmarking opportunities that are helpful to all involved. Roche Colorado, as part of its commitment to the community, has mentored local companies that use chemicals to assist them in developing safe and environmentally-friendly business practices.
Roche Colorado will continue to seek these and other opportunities to expand its pollution prevention activities and to communicate both its challenges and its successes.
Appendixes
Appendix available by contacting Roche Colorado.
APPENDIX 1
Pollution Prevention Code of Management Practices - Responsible Care®
APPENDIX 2
Governor's Pollution Prevention Challenge - Goals and Commitments
