Unfortunately, the " burden of proof paradigm" is identical to TSCA, which has crippled the federal program since passage in 1976.
I got this list of comments from the Env Working Grp's review of the Green Chem initiative:
From EWG:
"* The initial list of “chemicals of concern” to be regulated covers reproductive toxicity and carcinogens named in California’s Proposition 65 list, which is known to be incomplete; chemicals considered to be mutagenic by the European Union; and those considered by the U.S. Environmental Protection Agency to be persistent, bioaccumulative and toxic. But state officials haven’t said when they might expand the list to include such worrisome substances as endocrine disruptors OR neurotoxic chemicals."
Proposition 65 requires the Governor to publish, at least annually,a list of chemicals known to the state to cause cancer or reproductive toxicity.
Here is what Prop 65 is concerned with:
from section 25249.8. List Of Chemicals Known to Cause Cancer Or Reproductive Toxicity
"A chemical is known to the state to cause cancer or reproductive toxicity within the meaning of this chapter if in the opinion of the state's qualified experts it has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity, or if a body considered to be authoritative by such experts has formally identified it as causing cancer or reproductive toxicity, or if an agency of the state or federal government has formally required it to be labeled or identified as causing cancer or reproductive toxicity."
Again, from EWG:
* State regulators propose to give a thumbs up to a “chemical of concern” as long as there are fewer than 1,000 parts per million of it in almost any product. Yet scientists around the world are finding that human health can be harmed by exposure to some chemicals in the parts-per-billion range – a million times lower than the state’s proposed safety threshold.
This is a serious issue. As they mention, endocrine disruptor, neurotoxins, and other classes of toxicants can have serious impacts on human health and ecological receptors at very low concentrations- parts per billion and parts per trillion (we're talking something on the order of teaspoon of chemical in a pond or lake) in some cases. In the environmental cleanup industry, there are cleanup goals for contaminated sites set at these lower levels. These cleanup goals are based on risk assessments that determine what the concentration of the contaminant needs to be for the risks to be "acceptable" (pollution resulting in 1 in a million excess cases of cancer is acceptable under current regulations). Therefore, how much impact will a Green Chemistry regulation have if it does not decrease the environmental burden of these most toxic chemicals.
* The entire regulatory process will take far too long – many years, very likely. A major goal of the initiative was to enable the state to take quick action on potential problems.
This is a problem throughout the regulatory sector. Streamlining regulatory processes does not seem to be a priority for the individuals in regulatory positions. There is good reason for this, as civil servants are charged to act on behalf of the general public, which is traditionally a convoluted and carefully considered process. However, with respect to the mounting environmental issues (global climate change, ocean pollution, freshwater resource depletion, forest destruction, top soil erosion, etc), the regulatory response times are not producing the needed results within time frames required to curb the impacts. I fear this is true of burgeoning global climate change legislation and is probably true of this regulation as well.
What appears to be absent from discussions, is the recognition that the interests of individual parties have diminished importance when considering the greater implications of environmental destruction as a whole. This realization can only be achieved if the fundamentals are resolved within the regulatory system. I believe we (most of us) have moved past the fundamentals (is global climate change real, for example) and are truly engaged in seeking solutions. However, a population of nay-sayers in United States, combined with disproportionate media representation, continually robs the momentum. Inertia is not on our side.
At the root of this issue is the NOTW phenomenon within our culture. The notion that our terrestrial environment is not of consequence because "He will provide", seems to be pervasive. How can a plea for environmental compassion be effective if the recipient does not believe the natural worth protecting? This point of view has been particularly problematic in recent years with the erosion of the First Amendment. In addition to this, certain political movements that hold economic growth (regardless of costs) as their ultimate goal have sought to systematically disassemble the institutions that have been the guardians of collectively owned natural resources.
Regardless, government is not responding to the times in an effective way. This is due to these systemic issues with the institutions and principals that make up regulatory agencies. Much of the problem comes on the backs of years of the new brand of conservative politics. Department heads have been installed throughout state and federal agencies who have long-standing interests (by way of direct profit) in the destruction of environmental regulation. Additionally, there is a culture apathy that has overcome these institutions. Some have gotten so bad that they might as well be "waiting-rooms" for retirement. For younger people entering public service, the institutions structure and hierarchy feel rigid, archaic, and cumbersome to navigate. This is particularly true in California, where budgetary issues seem to always land on the backs of state employees, who are asked to sacrifice for the effects of poor leadership. The current state budget is perhaps worse than anyone had imagined possible and is a direct result of poor regulatory leadership during the good economic times of the not-so-distant past. State employees are being asked to make so many concessions, that those with desirable skills, motivation, and the ability to change will be leaving civil service. On a practical level (i.e. support a family) the calculation done when one enters a civil service career is something like the following: Civil service = lower income (about 2/3 of equivalent private sector position) + better benefits + more security. However, just one glance at the current and candidates for future governor of California proposals for "fixing" the budget will show you how these benefits are rapidly eroding and the security is gone. This trend has been in-place for years. Cost of living increases, raises, promotions, salary scale changes etc have been scuttled long ago in the name of "fiscal responsibility". There are serious consequences as there is little ability for regulatory agencies to attract and retain top candidates. Furthermore, as they have been so thoroughly de-valued in our culture regulatory agencies may not have the ability to be relevant.
But I digress..
next comment from EWG:
* Manufacturers would be responsible for assessing their own products or paying consultants to do so, an inherent conflict of interest. Theoretically, the state could review those analyses, but a cash-strapped agency will lack the resources to analyze most chemicals and products. There’s also no place for independent scientists, medical experts and other members of the public to question these industry assessments. Industry claims of “confidential business information” – trade secrets – could veil the identity of much of the information in the analyses. The public would have to trust that these so-called “black boxes” contained accurate information.
This is the burden of proof issue. The Toxic Substance Control Act of 1976 relies on industry to characterize their own products and report toxic effects and analyses to the government. This issue alone has resulted in a failure to protect the population and environment from the effects of toxic chemicals. Less than 1% of chemicals in the market place have had comprehensive toxicological profiles completed. Some believe this is the driving factor behind the increased rates of cancer, autism spectrum disorders, declines of amphibian populations world-wide, as well as many other diseases of environmental origin. There is a lot vocal action currently calling for the reform of this aspect TSCA. An unbiased entity should be reviewing these chemicals.
* The proposed rules would not allow any public participation in the state’s decisions about how, exactly, certain substances would be regulated. If officials chose to take no action on a particular toxic chemical, consumers would have no real recourse for voicing objections and concerns."
This is (if true) a major failure, as the role of government is to act on behalf of the public and "stakeholder" participation is an essential ingredient to all successful regulatory initiatives. Moreover, if this aspect is not included, the process with be riddled with accusations of acting on behalf of industry (common conception) and litigation will surely slow the process significantly.
There are probably legal jurisdiction issues with an out-right ban, by this is regulatory NIMBY, no?
Additionally, would egregious chemicals stilll be used in manufacturing processes here locally, so long as their are predominately for export?
Proposition 65 requires the Governor to publish, at least annually,a list of chemicals known to the state to cause cancer or reproductive toxicity.
Here is what Prop 65 is concerned with:
from section 25249.8. List Of Chemicals Known to Cause Cancer Or Reproductive Toxicity
"A chemical is known to the state to cause cancer or reproductive toxicity within the meaning of this chapter if in the opinion of the state's qualified experts it has been clearly shown through scientifically valid testing according to generally accepted principles to cause cancer or reproductive toxicity, or if a body considered to be authoritative by such experts has formally identified it as causing cancer or reproductive toxicity, or if an agency of the state or federal government has formally required it to be labeled or identified as causing cancer or reproductive toxicity."
Again, from EWG:
* State regulators propose to give a thumbs up to a “chemical of concern” as long as there are fewer than 1,000 parts per million of it in almost any product. Yet scientists around the world are finding that human health can be harmed by exposure to some chemicals in the parts-per-billion range – a million times lower than the state’s proposed safety threshold.
This is a serious issue. As they mention, endocrine disruptor, neurotoxins, and other classes of toxicants can have serious impacts on human health and ecological receptors at very low concentrations- parts per billion and parts per trillion (we're talking something on the order of teaspoon of chemical in a pond or lake) in some cases. In the environmental cleanup industry, there are cleanup goals for contaminated sites set at these lower levels. These cleanup goals are based on risk assessments that determine what the concentration of the contaminant needs to be for the risks to be "acceptable" (pollution resulting in 1 in a million excess cases of cancer is acceptable under current regulations). Therefore, how much impact will a Green Chemistry regulation have if it does not decrease the environmental burden of these most toxic chemicals.
* The entire regulatory process will take far too long – many years, very likely. A major goal of the initiative was to enable the state to take quick action on potential problems.
This is a problem throughout the regulatory sector. Streamlining regulatory processes does not seem to be a priority for the individuals in regulatory positions. There is good reason for this, as civil servants are charged to act on behalf of the general public, which is traditionally a convoluted and carefully considered process. However, with respect to the mounting environmental issues (global climate change, ocean pollution, freshwater resource depletion, forest destruction, top soil erosion, etc), the regulatory response times are not producing the needed results within time frames required to curb the impacts. I fear this is true of burgeoning global climate change legislation and is probably true of this regulation as well.
What appears to be absent from discussions, is the recognition that the interests of individual parties have diminished importance when considering the greater implications of environmental destruction as a whole. This realization can only be achieved if the fundamentals are resolved within the regulatory system. I believe we (most of us) have moved past the fundamentals (is global climate change real, for example) and are truly engaged in seeking solutions. However, a population of nay-sayers in United States, combined with disproportionate media representation, continually robs the momentum. Inertia is not on our side.
At the root of this issue is the NOTW phenomenon within our culture. The notion that our terrestrial environment is not of consequence because "He will provide", seems to be pervasive. How can a plea for environmental compassion be effective if the recipient does not believe the natural worth protecting? This point of view has been particularly problematic in recent years with the erosion of the First Amendment. In addition to this, certain political movements that hold economic growth (regardless of costs) as their ultimate goal have sought to systematically disassemble the institutions that have been the guardians of collectively owned natural resources.
Regardless, government is not responding to the times in an effective way. This is due to these systemic issues with the institutions and principals that make up regulatory agencies. Much of the problem comes on the backs of years of the new brand of conservative politics. Department heads have been installed throughout state and federal agencies who have long-standing interests (by way of direct profit) in the destruction of environmental regulation. Additionally, there is a culture apathy that has overcome these institutions. Some have gotten so bad that they might as well be "waiting-rooms" for retirement. For younger people entering public service, the institutions structure and hierarchy feel rigid, archaic, and cumbersome to navigate. This is particularly true in California, where budgetary issues seem to always land on the backs of state employees, who are asked to sacrifice for the effects of poor leadership. The current state budget is perhaps worse than anyone had imagined possible and is a direct result of poor regulatory leadership during the good economic times of the not-so-distant past. State employees are being asked to make so many concessions, that those with desirable skills, motivation, and the ability to change will be leaving civil service. On a practical level (i.e. support a family) the calculation done when one enters a civil service career is something like the following: Civil service = lower income (about 2/3 of equivalent private sector position) + better benefits + more security. However, just one glance at the current and candidates for future governor of California proposals for "fixing" the budget will show you how these benefits are rapidly eroding and the security is gone. This trend has been in-place for years. Cost of living increases, raises, promotions, salary scale changes etc have been scuttled long ago in the name of "fiscal responsibility". There are serious consequences as there is little ability for regulatory agencies to attract and retain top candidates. Furthermore, as they have been so thoroughly de-valued in our culture regulatory agencies may not have the ability to be relevant.
But I digress..
next comment from EWG:
* Manufacturers would be responsible for assessing their own products or paying consultants to do so, an inherent conflict of interest. Theoretically, the state could review those analyses, but a cash-strapped agency will lack the resources to analyze most chemicals and products. There’s also no place for independent scientists, medical experts and other members of the public to question these industry assessments. Industry claims of “confidential business information” – trade secrets – could veil the identity of much of the information in the analyses. The public would have to trust that these so-called “black boxes” contained accurate information.
This is the burden of proof issue. The Toxic Substance Control Act of 1976 relies on industry to characterize their own products and report toxic effects and analyses to the government. This issue alone has resulted in a failure to protect the population and environment from the effects of toxic chemicals. Less than 1% of chemicals in the market place have had comprehensive toxicological profiles completed. Some believe this is the driving factor behind the increased rates of cancer, autism spectrum disorders, declines of amphibian populations world-wide, as well as many other diseases of environmental origin. There is a lot vocal action currently calling for the reform of this aspect TSCA. An unbiased entity should be reviewing these chemicals.
* The proposed rules would not allow any public participation in the state’s decisions about how, exactly, certain substances would be regulated. If officials chose to take no action on a particular toxic chemical, consumers would have no real recourse for voicing objections and concerns."
This is (if true) a major failure, as the role of government is to act on behalf of the public and "stakeholder" participation is an essential ingredient to all successful regulatory initiatives. Moreover, if this aspect is not included, the process with be riddled with accusations of acting on behalf of industry (common conception) and litigation will surely slow the process significantly.
I would add the following issue as well:
from 69301.3:
"This chapter does not apply to any consumer product manufactured in California solely for shipment and use outside of California. In establishing whether or not a product is manufactured solely for shipment and use outside of California, the burden of proof shall be on the manufacturer."
from 69301.3:
"This chapter does not apply to any consumer product manufactured in California solely for shipment and use outside of California. In establishing whether or not a product is manufactured solely for shipment and use outside of California, the burden of proof shall be on the manufacturer."
There are probably legal jurisdiction issues with an out-right ban, by this is regulatory NIMBY, no?
Additionally, would egregious chemicals stilll be used in manufacturing processes here locally, so long as their are predominately for export?
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