How can industry use a multi-media standard, such as ISO 14000, to demonstrate they achieve performance above and beyond compliance with regulatory standards for product and processes?
As stated above, CSPA believes that a more holistic approach to certifying a company as “green” is preferred to product specific certification. As you know the ISO 14000 standard is a documentation standard for a company’s Environmental Health and Safety procedures and practices. It takes a management system approach to integrating environmental factors into business operations.
However, due to the technical requirements (i.e. audits, computer systems needed, documentation requirements, etc) of ISO 14000 CSPA believes that this certification can be a serious market barrier to small and medium size companies. DTSC must provide for equitable and flexible “green” certifications that do not serve as economic barriers to companies to enter markets.
CSPA supports a holistic recognition of a company for its environmental business practices that considers factors such as manufacturing, distribution, toxicity, and disposal or recycling. However, we believe that such recognition must not be a barrier to small and medium-sized companies who are looking to compete in this market. Examples of more equitable systems to review a company’s positive environmental impacts might be the Dow Jones Sustainability Index or the FTSE Group’s FTSE4Good Index.
There are a number of domestic and international government-based and third-party certification programs focusing the environmental attributes of individual products, such as EPA’s Energy Star program and the EcoLogo program, respectively. There are industry based environmental stewardship programs such as the American Chemistry Council's Responsible Care, which includes evaluations of chemical products and their uses to assure that they deliver their intended benefits while protecting public health and the environment; in addition, it includes a management system (Responsible Care Management System) for plant operation certified by third-party auditors similar to ISO 9001 and 14001. There are similar programs for companies specific to their efforts on climate change such as EPA’s Climate Leaders program which is an industry-government partnership that works with companies to develop comprehensive climate change strategies. A similar type of program could be used to rate across-the-board environmental performance. The State of California could devote its resources to developing such a program or partner with an existing program which has goals consistent with the Green Chemistry Initiative.
The State of California should consider and use data from all scientific evaluations that are conducted according to internationally recognized scientific principles. The State’s decision-making should be test method neutral, allowing different approaches as long as they are scientifically sound and validated according to international procedures.
There are a number of internationally recognized conventions for evaluating the quality of data in the context of chemicals management programs. For example, the OECD's Manual for Investigation of HPV Chemicals addresses the issue within the context of the high production volume (HPV) chemical program under the OECD’s chemical safety program.
Paraphrasing from the manual: consideration of all available existing information on a chemical is important because, if it is judged to be of sufficient quality, there is no need for additional testing, resulting in savings in resources, such as time, costs and laboratory animals.
The manual goes on to state: “The process of determining the quality of existing data takes into consideration three aspects - adequacy, reliability and relevance of the available information to describe a given SIDS element. These terms were defined by Klimisch et al. (Klimisch, H.J., Andreae, E., and Tillmann, U. 1997. A systematic approach for evaluating the quality of experimental and ecotoxicological data. Reg.Tox. and Pharm. 25:1-5) along the following lines:
Reliability - evaluating the inherent quality of a test report or publication relating to preferably standardised methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings;
Relevance - covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterisation; and
Adequacy - defining the usefulness of data for hazard/risk assessment purposes. When there is more than one study for each SIDS element, the greatest weight is attached to the study that is the most reliable and relevant. Robust study summaries are prepared for the highest quality or “key” studies.”
More over, the OECD Manual is compatible and synergistic with similar programs in the U.S. (EPA HPV), Europe (REACH), Canada (CMP) and Japan (Japan HPV program). The State of California should use a similar approach when considering scientific data for decision-making in order to create synergy between the California program and these other programs.
Environmental Management Systems (EMS) like ISO 14000 establish tools, resources, management support and review/evaluation processes that are necessary to reliably ensure regulatory compliance. To a large degree, these are the same elements necessary to address the emerging and evolving environmental issues that are not yet encoded in regulations, but are of strong concern to customers, environmental groups and stakeholders. Identifying and addressing these issues in a proactive manner, not waiting until they become compliance issues is what “performance above and beyond compliance” is all about.
If an EMS system is NOT in place, it can be difficult to develop the support and methods needed to address these issues (since “compliance issues” tend to take precedence), or to document and demonstrate that such efforts DO exist within a company. If an EMS system IS in place, it is relatively simple to treat such issues as “regulations” and use much of the same management system.
Instead of “compliance”, the goal is “risk reduction”. Instead of assessment against a regulatory list, a “watch list” may be used, created by a regulatory agency (considering future regulations), a scientific advisory group, or by the company itself. Instead of non-conformance penalties being driven by external regulatory consequences, internal “sunset” provisions (solve the problem or obsolete the product) and dates may be established.
To be useful for evaluation of such issues, resources that provide formulation and composition data for products and components must generally be complete. Including only “hazardous” or “intended” or “>0.1%” components is not useful if the emerging issue involves an issue not currently considered a hazard, or involves a known hazard now being found to have effects at much lower levels than currently regulated, or if it is being triggered by a contaminant. The alternative may be an extensive questionnaire process for suppliers or formulators, but this must be repeated and updated each time a new issue is identified or the threshold for an existing issue is lowered. This may cause the EMS to trigger upgrading current resources or developing new ones.
An EMS system may currently address waste and exposure concerns arising from internal product manufacture or preparation processes, but it might not address those same issues for materials that are obtained from other companies. Increasingly, there is pressure to consider the entire corporate “footprint” regarding an issue, which includes upstream and sometimes downstream contributions. Addressing these can also require the need of new data collection and evaluation resources, and can affect supplier qualification processes and “product use” recommendations. This may require EMS modification, but the “continuous improvement” element of such systems usually supports this.
A major barrier can be the lack of clear definition of the issue. Lists of “CAS numbers” or other identifiers are rarely available, or if available may not be comprehensive, since the necessary data is rarely available. “Watch lists” for the same issue supplied by different sources can be very different. The more generic the list of items triggering the issue, the more difficult it is to evaluate and comply with. This is also a problem with many regulations, but is often worse with emerging and evolving issues. An individual company may not have internal resources capable of refining such a list. This can ruin the effectiveness of even an excellent EMS, and is a major area in which regulatory and scientific agencies can provide assistance. They may have the ability to apply in-depth knowledge of an issue, evaluate available data, and apply analog or QSAR approaches to generate a “recommended watch list”, (ideally a list of CAS numbers) that does NOT need to carry any regulatory weight but could be used by industry as a common starting point for evaluating the impact of an issue. Industry can then suggest additions or identify listed items that may have unexpected impact if regulated in the future, without each company having to develop its own version of the “watch list”.
It would be best first to define the desired outcome, and then decide whether third-party accreditation is useful. Many government and third-party certification programs focus on the environmental attributes of products and encourage performance beyond regulatory standards. California may want to devote its limited resources to partner with existing programs that have common goals with the Green Chemistry Initiative.
Established third party certifications like these are becoming more common and acceptable for demonstrating high level EHS compliance programs. These may be used to at least put the company in a tier above typical companies and possibly below the tier of OSHA VPP and EPA Performance Track, although several companies with the latter may also have the former. As with the successful San Diego CUPA "EPIC" project, a reasonable result of being part of this tier of companies would be a reduction of the frequency and duration of regulatory inspections, thus resulting in a savings to the government of time and energy spent on already compliant sectors. The time and energy saved here would naturally have a better return on investment if redirected to the least compliant sectors.
An environmental management system (EMS), including those based on the ISO 14001 standard, is a continual cycle of planning, implementing, reviewing and improving the processes and actions that an organization undertakes to meet its business and environmental goals.
While an important feature of an EMS is to promote continuous environmental improvement by setting and tracking specific measurable goals, ISO 14001 does not establish absolute requirements for environmental performance beyond commitment to compliance and continual improvement. It does, however, require that an organization establish, measure and improve on environmental objectives and targets.
The U.S. Environmental Protection Agency’s National Environmental Performance Track program requires eligible facilities to have an EMS, set and report publicly on environmental goals that go beyond compliance, have a strong compliance history, a record of continuous improvement, and conduct outreach to their communities. Having an EMS allows Performance Track facilities to systematically evaluate, identify and set goals in their significant environmental aspect areas. Performance Track facilities also receive periodic independent assessments of their EMSs.
Performance Track goals cover a wide range of beyond-compliance environmental improvements and can include green chemistry-related improvements, such as: using materials with fewer hazardous or toxic components and making products that produce less waste over their lifetimes and less waste when disposed. The Agency can also create “challenge” goals to address high priority Agency or state environmental goals. U.S. EPA would be interested in partnering with DTSC on how Performance Track facilities can support DTSC’s priorities.
EMSs, alone, provide many benefits. An EMS helps an organization systematically manage its environmental "footprint", including both regulatory responsibilities and beyond-compliance impacts, including those associated with its activities, products, and services. An EMS can streamline operations, save the organization money, help meet business goals, reduce risks, and engage employees in improving environmental performance.
In order to demonstrate progress in beyond-compliance performance under an EMS, a transparent, public reporting process would be needed. U.S. EPA’s Performance Track program provides one model of reporting, and alternative models could also be implemented.
Twenty-two states have created performance-based environmental programs that are similarly designed to demonstrate beyond compliance achievements. Another four states are developing programs. We would welcome the opportunity to work in partnership with DTSC on a program that uses a multimedia standard, like ISO 14001, and allows facilities to demonstrate beyond-compliance achievements.
Any approach that is used should be evaluated prior to use to ensure it does not just create another beaurocratic boondogle.The primary differences in economy drivers in US, EU and Asia must be considered before any approach is taken. Asia has a lower labor cost, and EU has a higher welfare support level, compared to the US, These places love beaurocracy. Here in the US we need to keep our manufacturing lean as far as costs, so we can continue manufacturing here instead of just becoming a client nation.Also, while European fashions are among the best in the world, the same may not be said for their approaches to science. It is the US that has by far the best science base in the world, and our EPA was certainly the first formal government institution to include the environment in business considerations. So before we adopt EU regulations into our own regs, we need to keep all this in mind, rather than lapping them like they are French wines.
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As stated above, CSPA believes that a more holistic approach to certifying a company as “green” is preferred to product specific certification. As you know the ISO 14000 standard is a documentation standard for a company’s Environmental Health and Safety procedures and practices. It takes a management system approach to integrating environmental factors into business operations.
However, due to the technical requirements (i.e. audits, computer systems needed, documentation requirements, etc) of ISO 14000 CSPA believes that this certification can be a serious market barrier to small and medium size companies. DTSC must provide for equitable and flexible “green” certifications that do not serve as economic barriers to companies to enter markets.
CSPA supports a holistic recognition of a company for its environmental business practices that considers factors such as manufacturing, distribution, toxicity, and disposal or recycling. However, we believe that such recognition must not be a barrier to small and medium-sized companies who are looking to compete in this market. Examples of more equitable systems to review a company’s positive environmental impacts might be the Dow Jones Sustainability Index or the FTSE Group’s FTSE4Good Index.
There are a number of domestic and international government-based and third-party certification programs focusing the environmental attributes of individual products, such as EPA’s Energy Star program and the EcoLogo program, respectively. There are industry based environmental stewardship programs such as the American Chemistry Council's Responsible Care, which includes evaluations of chemical products and their uses to assure that they deliver their intended benefits while protecting public health and the environment; in addition, it includes a management system (Responsible Care Management System) for plant operation certified by third-party auditors similar to ISO 9001 and 14001. There are similar programs for companies specific to their efforts on climate change such as EPA’s Climate Leaders program which is an industry-government partnership that works with companies to develop comprehensive climate change strategies. A similar type of program could be used to rate across-the-board environmental performance. The State of California could devote its resources to developing such a program or partner with an existing program which has goals consistent with the Green Chemistry Initiative.
The State of California should consider and use data from all scientific evaluations that are conducted according to internationally recognized scientific principles. The State’s decision-making should be test method neutral, allowing different approaches as long as they are scientifically sound and validated according to international procedures.
There are a number of internationally recognized conventions for evaluating the quality of data in the context of chemicals management programs. For example, the OECD's Manual for Investigation of HPV Chemicals addresses the issue within the context of the high production volume (HPV) chemical program under the OECD’s chemical safety program.
Paraphrasing from the manual: consideration of all available existing information on a chemical is important because, if it is judged to be of sufficient quality, there is no need for additional testing, resulting in savings in resources, such as time, costs and laboratory animals.
The manual goes on to state:
“The process of determining the quality of existing data takes into consideration three aspects - adequacy, reliability and relevance of the available information to describe a given SIDS element. These terms were defined by Klimisch et al. (Klimisch, H.J., Andreae, E., and Tillmann, U. 1997. A systematic approach for evaluating the quality of experimental and ecotoxicological data. Reg.Tox. and Pharm. 25:1-5) along the following lines:
Reliability - evaluating the inherent quality of a test report or publication relating to preferably standardised methodology and the way the experimental procedure and results are described to give evidence of the clarity and plausibility of the findings;
Relevance - covering the extent to which data and tests are appropriate for a particular hazard identification or risk characterisation; and
Adequacy - defining the usefulness of data for hazard/risk assessment purposes. When there is more than one study for each SIDS element, the greatest weight is attached to the study that is the most reliable and relevant. Robust study summaries are prepared for the highest quality or “key” studies.”
More over, the OECD Manual is compatible and synergistic with similar programs in the U.S. (EPA HPV), Europe (REACH), Canada (CMP) and Japan (Japan HPV program). The State of California should use a similar approach when considering scientific data for decision-making in order to create synergy between the California program and these other programs.
Environmental Management Systems (EMS) like ISO 14000 establish tools, resources, management support and review/evaluation processes that are necessary to reliably ensure regulatory compliance. To a large degree, these are the same elements necessary to address the emerging and evolving environmental issues that are not yet encoded in regulations, but are of strong concern to customers, environmental groups and stakeholders. Identifying and addressing these issues in a proactive manner, not waiting until they become compliance issues is what “performance above and beyond compliance” is all about.
If an EMS system is NOT in place, it can be difficult to develop the support and methods needed to address these issues (since “compliance issues” tend to take precedence), or to document and demonstrate that such efforts DO exist within a company. If an EMS system IS in place, it is relatively simple to treat such issues as “regulations” and use much of the same management system.
Instead of “compliance”, the goal is “risk reduction”. Instead of assessment against a regulatory list, a “watch list” may be used, created by a regulatory agency (considering future regulations), a scientific advisory group, or by the company itself. Instead of non-conformance penalties being driven by external regulatory consequences, internal “sunset” provisions (solve the problem or obsolete the product) and dates may be established.
To be useful for evaluation of such issues, resources that provide formulation and composition data for products and components must generally be complete. Including only “hazardous” or “intended” or “>0.1%” components is not useful if the emerging issue involves an issue not currently considered a hazard, or involves a known hazard now being found to have effects at much lower levels than currently regulated, or if it is being triggered by a contaminant. The alternative may be an extensive questionnaire process for suppliers or formulators, but this must be repeated and updated each time a new issue is identified or the threshold for an existing issue is lowered. This may cause the EMS to trigger upgrading current resources or developing new ones.
An EMS system may currently address waste and exposure concerns arising from internal product manufacture or preparation processes, but it might not address those same issues for materials that are obtained from other companies. Increasingly, there is pressure to consider the entire corporate “footprint” regarding an issue, which includes upstream and sometimes downstream contributions. Addressing these can also require the need of new data collection and evaluation resources, and can affect supplier qualification processes and “product use” recommendations. This may require EMS modification, but the “continuous improvement” element of such systems usually supports this.
A major barrier can be the lack of clear definition of the issue. Lists of “CAS numbers” or other identifiers are rarely available, or if available may not be comprehensive, since the necessary data is rarely available. “Watch lists” for the same issue supplied by different sources can be very different. The more generic the list of items triggering the issue, the more difficult it is to evaluate and comply with. This is also a problem with many regulations, but is often worse with emerging and evolving issues. An individual company may not have internal resources capable of refining such a list. This can ruin the effectiveness of even an excellent EMS, and is a major area in which regulatory and scientific agencies can provide assistance. They may have the ability to apply in-depth knowledge of an issue, evaluate available data, and apply analog or QSAR approaches to generate a “recommended watch list”, (ideally a list of CAS numbers) that does NOT need to carry any regulatory weight but could be used by industry as a common starting point for evaluating the impact of an issue. Industry can then suggest additions or identify listed items that may have unexpected impact if regulated in the future, without each company having to develop its own version of the “watch list”.
It would be best first to define the desired outcome, and then decide whether third-party accreditation is useful. Many government and third-party certification programs focus on the environmental attributes of products and encourage performance beyond regulatory standards. California may want to devote its limited resources to partner with existing programs that have common goals with the Green Chemistry Initiative.
Established third party certifications like these are becoming more common and acceptable for demonstrating high level EHS compliance programs. These may be used to at least put the company in a tier above typical companies and possibly below the tier of OSHA VPP and EPA Performance Track, although several companies with the latter may also have the former. As with the successful San Diego CUPA "EPIC" project, a reasonable result of being part of this tier of companies would be a reduction of the frequency and duration of regulatory inspections, thus resulting in a savings to the government of time and energy spent on already compliant sectors. The time and energy saved here would naturally have a better return on investment if redirected to the least compliant sectors.
An environmental management system (EMS), including those based on the ISO 14001 standard, is a continual cycle of planning, implementing, reviewing and improving the processes and actions that an organization undertakes to meet its business and environmental goals.
While an important feature of an EMS is to promote continuous environmental improvement by setting and tracking specific measurable goals, ISO 14001 does not establish absolute requirements for environmental performance beyond commitment to compliance and continual improvement. It does, however, require that an organization establish, measure and improve on environmental objectives and targets.
The U.S. Environmental Protection Agency’s National Environmental Performance Track program requires eligible facilities to have an EMS, set and report publicly on environmental goals that go beyond compliance, have a strong compliance history, a record of continuous improvement, and conduct outreach to their communities. Having an EMS allows Performance Track facilities to systematically evaluate, identify and set goals in their significant environmental aspect areas. Performance Track facilities also receive periodic independent assessments of their EMSs.
Performance Track goals cover a wide range of beyond-compliance environmental improvements and can include green chemistry-related improvements, such as: using materials with fewer hazardous or toxic components and making products that produce less waste over their lifetimes and less waste when disposed. The Agency can also create “challenge” goals to address high priority Agency or state environmental goals. U.S. EPA would be interested in partnering with DTSC on how Performance Track facilities can support DTSC’s priorities.
EMSs, alone, provide many benefits. An EMS helps an organization systematically manage its environmental "footprint", including both regulatory responsibilities and beyond-compliance impacts, including those associated with its activities, products, and services. An EMS can streamline operations, save the organization money, help meet business goals, reduce risks, and engage employees in improving environmental performance.
In order to demonstrate progress in beyond-compliance performance under an EMS, a transparent, public reporting process would be needed. U.S. EPA’s Performance Track program provides one model of reporting, and alternative models could also be implemented.
Twenty-two states have created performance-based environmental programs that are similarly designed to demonstrate beyond compliance achievements. Another four states are developing programs. We would welcome the opportunity to work in partnership with DTSC on a program that uses a multimedia standard, like ISO 14001, and allows facilities to demonstrate beyond-compliance achievements.
Any approach that is used should be evaluated prior to use to ensure it does not just create another beaurocratic boondogle.The primary differences in economy drivers in US, EU and Asia must be considered before any approach is taken. Asia has a lower labor cost, and EU has a higher welfare support level, compared to the US, These places love beaurocracy. Here in the US we need to keep our manufacturing lean as far as costs, so we can continue manufacturing here instead of just becoming a client nation.Also, while European fashions are among the best in the world, the same may not be said for their approaches to science. It is the US that has by far the best science base in the world, and our EPA was certainly the first formal government institution to include the environment in business considerations. So before we adopt EU regulations into our own regs, we need to keep all this in mind, rather than lapping them like they are French wines.