As stated in CSPA’s comments on Phase-1 of the Green Chemistry Initiative, CSPA supports appropriate use-restrictions for chemical ingredients when scientific safety-based assessments indicate that they cannot be used safely in a consumer product or use application. CSPA and our members believe that every responsible company should be performing these types of safety-based assessments.
However, before any use-restriction is established, an analysis must be done to determine whether the particular chemical use poses an unreasonable risk. In other words, the State of California should not ban all uses of a chemical unless all uses pose unreasonable risks. Establishing that a mere hazard exists, however, should be insufficient to justify a ban if the product has performance qualities that are valuable and if exposures from particular applications pose no unreasonable risk to human health or the environment. Additionally, with any use-restriction DTSC must provide for the creation of deminimus limits or no-significant-risk-limits that take into consideration naturally occurring trace levels of chemicals that can be found in all chemical substances. Finally, within any use-restriction process DTSC must ensure that alternatives to a banned chemical are commercially and technologically feasible, and that the alternatives do not pose unreasonable risks to human health or the environment.
Before any action can be taken to establish chemical use-restrictions for specific product applications, CSPA asserts that all proposed restriction decisions must be based on sound scientific evidence that has been endorsed by a reputable government agency or panel. CSPA believes that it is of the utmost importance that data used for chemical restrictions be peer-reviewed by credible scientists and approved by a government agency such as the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, the Consumer Product Safety Commission, or similar agencies.
Finally, it is absolutely crucial that any use-restriction be subject to a transparent public process. Without, a transparent review process, CSPA believes that any restriction would create significant legal challenges and would not provide for appropriate due process.
The State of California should evaluate the environmental and human safety of chemicals in commerce in California within the context of its current mandates. This might include an evaluation of the hazards, uses and exposures (environmental and human health) of chemicals. Based on this evaluation, it might be appropriate to develop a risk management strategy for chemicals which have unacceptable risks associated with their uses. Such a strategy could include a wide range of mitigation measures but use-specific restrictions should be limited to situations where there are no other options for mitigation of unacceptable risks. Some mitigation measures the State might make (presuming the appropriate authority exists) might include product labeling regarding use or disposal, personal protective equipment required for use of a particular product, specifications for particular packaging, restriction on the maximum concentration permitted in a product, or restriction on the form of a product (e.g., aerosol, liquid, solid) that a chemical may be permitted to be used in. Such mitigation measures need to be supported by scientific analysis demonstrating that they will have the effect of reducing the adverse impact of concern.
-Well, since nearly every chemical is going to be hazardous, it’d be easiest to line them up in CAS number order and use every number from the MEGA Millions each draw and ban six chemicals each time. That would knock out 48 chemicals a month. You could use the SuperLOTTO Plus too and knock out 96 chemicals a month! That’s only 1,152 chemicals a year though. But if you multiply each number by the MEGA number, you’d double the banned chemicals. Or…. You get the idea. -Since you haven’t defined what makes something “hazardous” it’s hard to use that, but you could pick one or more of the classification criteria and again, line up the chemicals according to level of hazard. But that would mean weighting different factors like cancer against birth defects against poisons and since so many chemicals allegedly have no good data, you might as well use an arbitrary system like the lotteries. - Or you can go in reverse: Ban everything unless it has received the UC Berkeley Green Chemical Seal. Companies would send in a package of data (that is also undefined and going to be variable as new and exotic health and environmental effects and test methods are developed) and maybe a wad of money and hope that UCB gives them the green thumbs up. If a product doesn’t have a valid UCBGC Seal, it can’t be sold in California. Since it will take awhile to process applications, you can phase this in and use the #1 tax system on everything.
Seriously, there are very few chemical uses that should be banned and those only when backed by solid scientific support of unreasonable risk and where suitable, safer alternatives exist. But even those are not as simple as you would think. E.g., intentional use of lead in toys should be banned, but what about unintended and variable contamination? Lead solder is considered bad, but failures in electrical equipment using alternate solders are increasingly happening. What if that happens in your phone while calling 911?
Where an authoritative, independent body performs a sound risk assessment through a transparent process and determines that the weight of the scientific evidence shows that the risk of a particular use of a chemical is unreasonable, that use may need to be managed or even banned. However, arbitrary, across the board bans do not make sense when they are not based on the actual risk (hazard and exposure). The same chemical in different applications and products may not have the same risk associated with it.
Naturally occurring trace levels of chemicals in chemical substances must have a de minimus limit, or a no-significant-risk limit. Alternatives to a “banned” chemical must be commercially and technologically feasible and, at the same time, must not pose unreasonable risks to human health or the environment.
It is essential that any data used be robust and peer-reviewed by credible experts. In addition, transparency and due process must be a fundamental element of any use-restriction process.
A chemical ban should only be considered if a chemical represents a clear, conclusive and significant danger to human health or the environment due to either uncontrollable exposure or unacceptable risk. The overall societal value vs risk/detriment must be a critical factor in the decision. Even then, the ban should allow for specific uses if the risk can be minimized sufficiently.
Banning of chemicals should have an extremely high bar, and then only executed if there are less hazardous marketplace alternatives or their use places individuals at risk of great immediate personal harm. Even a highly toxic chemical that is stable may be desirable if it can substitute for another chemical that is both highly toxic AND reactive. A science based risk analysis could be used to generate point values or hazard levels (some of these are already existent and should be used rather than reinvented at great expense). If chemical contamination is a problem (e.g. certain toys from China) than the specific contaminated item from the specific manufacturer should be not only banned but also recalled until it can be shown to be safe (similar to contaminated medicines or other products). It should be noted that in the biologics industry, any change in manufacturing process, including use of intermediary chemicals, is subject to review and approval by the FDA. If a chemical necessary to the manufacturing process is banned, the resulting changes in process could have many consequences, up to and including a requirement for additional clinical trials.
NO specific information about a chemical should create a "ban" on such a chemical by the state of California. Restrictions on use, transport and disposal are more reasonable and avoid sweeping, politically-based power grabs by interest groups and lawmakers.
Bans of chemicals in California should be triggered by their potential to harm human health and/or the environment. Consequently the state should establish a regulatory program that will provide it with comprehensive data by which to accurately assess both chemicals currently on the market and new chemicals, and will enable it to restrict, phase out, and ban the use of chemicals based on the presence of specified hazard traits or by the absence of required information.
As an essential element of such a regulatory program, chemical manufacturers and commercial users of chemicals must be required to demonstrate to the government the reasonable safety of their products in order for those products to remain on or be introduced into the market. Chemicals should not be presumed safe with government bearing the responsibility to demonstrate that a chemical has negatively impacted human health and/or the environment in order for it to be regulated. Such a structure undermines producer responsibility, motivates manufacturers and commercial users to resist generating public information about the safety of their products, and makes it unreasonably difficult for government to take steps necessary to protect the public and the environment.
Manufacturers should be required to provide publicly available safety data about a specified set of hazard traits in order for chemicals to remain on or be introduced into the market. They should also be required to demonstrate a reasonable certainty that their chemicals do not exhibit any of these hazard traits, or any other significant hazard traits that may become known, on the basis of data that is required by the state or that is obtained as a result of a request for additional information by the state or other governing entity. Where the state determines that a manufacturer has failed to make this showing, either because of the quality of the scientific data they provide or by failing to provide required data, chemicals should not be permitted to remain on or be introduced into the market.
California should set a legal standard for whether a chemical is permitted to enter or remain on the market that is focused on whether the chemical presents an intrinsic hazard, and not on risk assessment or on balancing safety with economic or other countervailing considerations. Specifically, a structure like that of the Toxic Substances Control Act, which permits use of monetized cost benefit analysis in which economic factors are weighed against human health or the environment, should not be part of any regulatory program under which the state seeks to better manage chemical hazards. In other words, the intrinsic value of human and environmental health should take precedence over financial considerations when deciding on whether chemicals can be used. While such a principle can and should stand alone, we also believe, as discussed in the previous section, that consideration of cost must include “external” financial impacts on our communities, workforce, and environment, which has not been done traditionally. When these factors are included, we believe that even the economic considerations will support prioritizing health and safety
In determining whether manufacturers have demonstrated the safety of their products, the state should ensure that manufacturers:
1) Account for the importance of low doses; the significance of background exposures, synergistic effects, and the timing of exposures during the life cycle; and the effects of cumulative exposures, and differences in genetic responses to chemical exposure. 2) Evaluate the hazards to the most vulnerable populations, the most susceptible life stages, the most sensitive environmental factors, and the most fragile ecosystems. Vulnerable populations include pregnant women or women who may become pregnant, infants and children, the elderly, people with compromised immune systems, communities that bear an unequal burden of chemical exposure such as workers and fence-line communities.
Additionally, the state should ensure that manufacturers consider the different uses of their chemicals and safer alternatives to their chemicals for these various uses. We recognize that there may be circumstances in which chemicals have important uses for which there is currently no safer chemical or non-chemical alternative. The state may want to create provisions for manufacturers to apply for exemptions in such circumstances. In such cases, the burden should be on the manufacturer to demonstrate why a specific use should be exempted and to demonstrate how they will reasonably ensure that there are no health or environmental impacts as a result of the exemption, including at the end of life of their products and through product or chemical disposal. Furthermore, any exemption should be re-evaluated at least every three years and be accompanied by a rigorous program to search for safer alternatives.
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8 Comments
Reader Comments (8)
As stated in CSPA’s comments on Phase-1 of the Green Chemistry Initiative, CSPA supports appropriate use-restrictions for chemical ingredients when scientific safety-based assessments indicate that they cannot be used safely in a consumer product or use application. CSPA and our members believe that every responsible company should be performing these types of safety-based assessments.
However, before any use-restriction is established, an analysis must be done to determine whether the particular chemical use poses an unreasonable risk. In other words, the State of California should not ban all uses of a chemical unless all uses pose unreasonable risks. Establishing that a mere hazard exists, however, should be insufficient to justify a ban if the product has performance qualities that are valuable and if exposures from particular applications pose no unreasonable risk to human health or the environment. Additionally, with any use-restriction DTSC must provide for the creation of deminimus limits or no-significant-risk-limits that take into consideration naturally occurring trace levels of chemicals that can be found in all chemical substances. Finally, within any use-restriction process DTSC must ensure that alternatives to a banned chemical are commercially and technologically feasible, and that the alternatives do not pose unreasonable risks to human health or the environment.
Before any action can be taken to establish chemical use-restrictions for specific product applications, CSPA asserts that all proposed restriction decisions must be based on sound scientific evidence that has been endorsed by a reputable government agency or panel. CSPA believes that it is of the utmost importance that data used for chemical restrictions be peer-reviewed by credible scientists and approved by a government agency such as the U.S. Food and Drug Administration, the U.S. Environmental Protection Agency, the Consumer Product Safety Commission, or similar agencies.
Finally, it is absolutely crucial that any use-restriction be subject to a transparent public process. Without, a transparent review process, CSPA believes that any restriction would create significant legal challenges and would not provide for appropriate due process.
The State of California should evaluate the environmental and human safety of chemicals in commerce in California within the context of its current mandates. This might include an evaluation of the hazards, uses and exposures (environmental and human health) of chemicals. Based on this evaluation, it might be appropriate to develop a risk management strategy for chemicals which have unacceptable risks associated with their uses. Such a strategy could include a wide range of mitigation measures but use-specific restrictions should be limited to situations where there are no other options for mitigation of unacceptable risks. Some mitigation measures the State might make (presuming the appropriate authority exists) might include product labeling regarding use or disposal, personal protective equipment required for use of a particular product, specifications for particular packaging, restriction on the maximum concentration permitted in a product, or restriction on the form of a product (e.g., aerosol, liquid, solid) that a chemical may be permitted to be used in. Such mitigation measures need to be supported by scientific analysis demonstrating that they will have the effect of reducing the adverse impact of concern.
-Well, since nearly every chemical is going to be hazardous, it’d be easiest to line them up in CAS number order and use every number from the MEGA Millions each draw and ban six chemicals each time. That would knock out 48 chemicals a month. You could use the SuperLOTTO Plus too and knock out 96 chemicals a month! That’s only 1,152 chemicals a year though. But if you multiply each number by the MEGA number, you’d double the banned chemicals. Or…. You get the idea.
-Since you haven’t defined what makes something “hazardous” it’s hard to use that, but you could pick one or more of the classification criteria and again, line up the chemicals according to level of hazard. But that would mean weighting different factors like cancer against birth defects against poisons and since so many chemicals allegedly have no good data, you might as well use an arbitrary system like the lotteries.
- Or you can go in reverse: Ban everything unless it has received the UC Berkeley Green Chemical Seal. Companies would send in a package of data (that is also undefined and going to be variable as new and exotic health and environmental effects and test methods are developed) and maybe a wad of money and hope that UCB gives them the green thumbs up. If a product doesn’t have a valid UCBGC Seal, it can’t be sold in California. Since it will take awhile to process applications, you can phase this in and use the #1 tax system on everything.
Seriously, there are very few chemical uses that should be banned and those only when backed by solid scientific support of unreasonable risk and where suitable, safer alternatives exist. But even those are not as simple as you would think. E.g., intentional use of lead in toys should be banned, but what about unintended and variable contamination? Lead solder is considered bad, but failures in electrical equipment using alternate solders are increasingly happening. What if that happens in your phone while calling 911?
Where an authoritative, independent body performs a sound risk assessment through a transparent process and determines that the weight of the scientific evidence shows that the risk of a particular use of a chemical is unreasonable, that use may need to be managed or even banned. However, arbitrary, across the board bans do not make sense when they are not based on the actual risk (hazard and exposure). The same chemical in different applications and products may not have the same risk associated with it.
Naturally occurring trace levels of chemicals in chemical substances must have a de minimus limit, or a no-significant-risk limit. Alternatives to a “banned” chemical must be commercially and technologically feasible and, at the same time, must not pose unreasonable risks to human health or the environment.
It is essential that any data used be robust and peer-reviewed by credible experts. In addition, transparency and due process must be a fundamental element of any use-restriction process.
A chemical ban should only be considered if a chemical represents a clear, conclusive and significant danger to human health or the environment due to either uncontrollable exposure or unacceptable risk. The overall societal value vs risk/detriment must be a critical factor in the decision. Even then, the ban should allow for specific uses if the risk can be minimized sufficiently.
Banning of chemicals should have an extremely high bar, and then only executed if there are less hazardous marketplace alternatives or their use places individuals at risk of great immediate personal harm. Even a highly toxic chemical that is stable may be desirable if it can substitute for another chemical that is both highly toxic AND reactive. A science based risk analysis could be used to generate point values or hazard levels (some of these are already existent and should be used rather than reinvented at great expense). If chemical contamination is a problem (e.g. certain toys from China) than the specific contaminated item from the specific manufacturer should be not only banned but also recalled until it can be shown to be safe (similar to contaminated medicines or other products). It should be noted that in the biologics industry, any change in manufacturing process, including use of intermediary chemicals, is subject to review and approval by the FDA. If a chemical necessary to the manufacturing process is banned, the resulting changes in process could have many consequences, up to and including a requirement for additional clinical trials.
NO specific information about a chemical should create a "ban" on such a chemical by the state of California. Restrictions on use, transport and disposal are more reasonable and avoid sweeping, politically-based power grabs by interest groups and lawmakers.
Bans of chemicals in California should be triggered by their potential to harm human health and/or the environment. Consequently the state should establish a regulatory program that will provide it with comprehensive data by which to accurately assess both chemicals currently on the market and new chemicals, and will enable it to restrict, phase out, and ban the use of chemicals based on the presence of specified hazard traits or by the absence of required information.
As an essential element of such a regulatory program, chemical manufacturers and commercial users of chemicals must be required to demonstrate to the government the reasonable safety of their products in order for those products to remain on or be introduced into the market. Chemicals should not be presumed safe with government bearing the responsibility to demonstrate that a chemical has negatively impacted human health and/or the environment in order for it to be regulated. Such a structure undermines producer responsibility, motivates manufacturers and commercial users to resist generating public information about the safety of their products, and makes it unreasonably difficult for government to take steps necessary to protect the public and the environment.
Manufacturers should be required to provide publicly available safety data about a specified set of hazard traits in order for chemicals to remain on or be introduced into the market. They should also be required to demonstrate a reasonable certainty that their chemicals do not exhibit any of these hazard traits, or any other significant hazard traits that may become known, on the basis of data that is required by the state or that is obtained as a result of a request for additional information by the state or other governing entity. Where the state determines that a manufacturer has failed to make this showing, either because of the quality of the scientific data they provide or by failing to provide required data, chemicals should not be permitted to remain on or be introduced into the market.
California should set a legal standard for whether a chemical is permitted to enter or remain on the market that is focused on whether the chemical presents an intrinsic hazard, and not on risk assessment or on balancing safety with economic or other countervailing considerations. Specifically, a structure like that of the Toxic Substances Control Act, which permits use of monetized cost benefit analysis in which economic factors are weighed against human health or the environment, should not be part of any regulatory program under which the state seeks to better manage chemical hazards. In other words, the intrinsic value of human and environmental health should take precedence over financial considerations when deciding on whether chemicals can be used. While such a principle can and should stand alone, we also believe, as discussed in the previous section, that consideration of cost must include “external” financial impacts on our communities, workforce, and environment, which has not been done traditionally. When these factors are included, we believe that even the economic considerations will support prioritizing health and safety
In determining whether manufacturers have demonstrated the safety of their products, the state should ensure that manufacturers:
1) Account for the importance of low doses; the significance of background exposures, synergistic effects, and the timing of exposures during the life cycle; and the effects of cumulative exposures, and differences in genetic responses to chemical exposure.
2) Evaluate the hazards to the most vulnerable populations, the most susceptible life stages, the most sensitive environmental factors, and the most fragile ecosystems. Vulnerable populations include pregnant women or women who may become pregnant, infants and children, the elderly, people with compromised immune systems, communities that bear an unequal burden of chemical exposure such as workers and fence-line communities.
Additionally, the state should ensure that manufacturers consider the different uses of their chemicals and safer alternatives to their chemicals for these various uses. We recognize that there may be circumstances in which chemicals have important uses for which there is currently no safer chemical or non-chemical alternative. The state may want to create provisions for manufacturers to apply for exemptions in such circumstances. In such cases, the burden should be on the manufacturer to demonstrate why a specific use should be exempted and to demonstrate how they will reasonably ensure that there are no health or environmental impacts as a result of the exemption, including at the end of life of their products and through product or chemical disposal. Furthermore, any exemption should be re-evaluated at least every three years and be accompanied by a rigorous program to search for safer alternatives.