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   Unreasonable Risk - April/May 2010


The Networker
I. Editors Note - The Power of Telling All Nancy Myers
II. The Unreasonable Risk of Secret Ingredients
Joseph H. Guth


  I. Editor's Note   TOP
by Nancy Myers

In this issue, SEHN Legal Director Joe Guth presents a compelling, two-part argument for full disclosure of all pesticide ingredients.

If you have followed Joe's work you will recognize the first part of the argument. It is that the current state of the Earth, pushed beyond its assimilative capacity by the cumulative impact of human activity, calls for a new definition of "unreasonable risk" of harm to human health and the environment: All harmful impacts that can be avoided must now be considered "unreasonable."

Joe has presented this case in detail in a series of law review articles and elsewhere including a previous issue of the Networker. Applying the case to a specific issue, pesticides and their inert ingredients, shows precisely how that new goal works in policy.

The second part of the argument is that transparency is a powerful mechanism for protecting against unreasonable risk because it gives the public the power to decide whether they are willing to take a risk. Among other things, full disclosure can unleash market forces in a competition to create safer products. Does a mom want to buy a product with a possibly hazardous chemical in it for her 5-year-old? So the market must include the public, equipped with access to full information in order to help figure out what is safe and how to reduce the harm we do to ourselves and the environment. In this approach government does not have to be the decider. Its role is to make sure the information playing field is level.

Of course, these arguments apply to much more than pesticide inert ingredients—chemicals, climate change, industrial pollutants, food. "Unreasonable risk" is a term found in many of our environmental statutes. It needs to be reinterpreted in light of current circumstances.

Let's embed in all our policies the 21st Century goal of reducing harm wherever we can. Full disclosure of all kinds, including exposing the full cost of doing things the old (alas, the current) way, can speed that process. We collect that information in our True Cost Clearinghouse.



  II. The Unreasonable Risk of Secret Ingredients   TOP
by Joseph H. Guth

This is adapted from comments submitted on behalf of the Science & Environmental Health Network to the US Environmental Protection Agency on the EPA’s advance notice of proposed rulemaking setting forth several proposals for public disclosure of inert ingredient information. Complete comments with references are available here.

We support EPA's proposal to develop a comprehensive rule to mandate public disclosure of all inert ingredients in pesticides. "Inert ingredient" is defined by FIFRA (the Federal Insecticide, Fungicide, and Rodenticide Act) as any ingredient other than an "active" ingredient, regardless of whether the inert ingredient is chemically or biologically inert. EPA has concluded that consumers and users of pesticides should have broad access to information relating to all or most inert ingredients because that information would help them make informed choices. We agree.

According to EPA, public disclosure for all inert ingredients could be required if inert ingredients as a class are not entitled to confidential treatment under FIFRA section 10(b). There are two possible bases for such a determination:

1) EPA would determine that the ability of competitors or others to reverse engineer pesticides without undue cost renders information for inert ingredients ineligible for confidential treatment. We understand EPA to be considering a broad, programmatic determination that would apply to inert ingredients generally. We support this initiative and believe EPA may be able to determine that substantial information about inert ingredients, as a class of information, should not be entitled to confidential treatment. In the 1996 case NCAP v. Browner, the court found that even at that time there was "no genuine issue of material fact as to the economic feasibility of identifying the common names and CAS numbers of inert ingredients through 'reverse engineering.'"

2) FIFRA section 10(d)(1)(C) authorizes EPA to publicly disclose information relating to all inert ingredients if it "is necessary to protect against an unreasonable risk of injury to health or the environment." Our comments will focus on describing the basis for such a conclusion.

Nothing requires EPA to make this "unreasonable risk" determination solely on an ingredient-by-ingredient basis. EPA can determine that information relating to all inert ingredients must be disclosed to protect against unreasonable risks. Such a determination can be made based on two findings:

  • The problem of environmental degradation is rooted in excessive cumulative impacts, including impacts by pesticides and pesticide inert ingredients. This makes any and all avoidable use of potentially hazardous inert ingredients "unreasonable."
  • Public disclosure for all inert ingredients, not just those already known to be hazardous, is the best way to minimize environmental impacts, and therefore is required to reduce all "unreasonable" risks.

I. Because of the Rise of Cumulative Environmental Impacts, All Risks of Injury to Human Health and the Environment Should Be Avoided Wherever Possible

An essential question is: what is an "unreasonable risk" of injury to human health or the environment? FIFRA uses but does not define that term. That term is used in many environmental statutes and is rarely, if ever, specifically defined in any of them.

Historically, United States regulatory authorities have frequently determined whether chemical exposures are "reasonable" under federal environmental laws including TSCA (Toxic Substances Control Act) and FIFRA by using chemical-by-chemical risk assessments along with analyses of the costs and benefits of regulating exposures. A regulatory cost typically is deemed reasonable if the benefits of reducing a chemical exposure outweigh the costs. This is the approach generally taken by Executive Order 12,866, under which this advance notice of proposed rulemaking was reviewed.

The Obama Administration is in the process of reviewing Executive Order 12,866. We have filed extensive comments on behalf of 24 co-signers with the Obama Administration in connection with this review, in which we argued in detail that it is no longer appropriate to evaluate each incremental environmental impact on a cost-benefit basis. This decision-making method evaluates the costs and benefits of each particular environmental impact as though it were the only one. Since all impacts are permitted to continue unless they are calculated to be "unreasonable," this system intentionally permits, as the economy grows forever, the unlimited growth of cost-benefit-justified increments of environmental damage. No mechanism is built into the cost-benefit decision-making structure that can restrain the cumulative costs of numerous incremental impacts.

The central problem with this definition of "unreasonable risk" is that it ignores the critical and inescapable fact that there is a limit to the earth’s ability to tolerate environmental damage without jeopardizing the ecological systems human beings depend on to live. And there is no doubt that the growing cumulative impact of diverse environmental harms is now exceeding that limit.

A. Pesticides contribute to ecological degradation

Pesticides and inert ingredients are contributing factors in the widespread ecological degradation that is occurring today. Billions of pounds of pesticides are disseminated into the lands and waters of the United States every year. Numerous active ingredients are widespread in the bodily tissues of Americans, including certain fungicides, herbicides, carbamate insecticides, organochlorine pesticides, organophosphorus pesticides, and pyrethroid pesticides. Often between 50% and 99% of the formulations of these pesticides are comprised of inert ingredients, many of which are also virtually certain to be contaminating human tissues and the environment.

Pesticide active ingredients, which are intended to be toxic to living organisms, are capable of causing a wide variety of adverse impacts on human health and the environment, including cancer, adverse reproductive effects, neurotoxicity and other chronic effects, developmental toxicity, and ecological effects as well as persistence and the potential for bioaccumulation. These effects can be caused by very low doses and after long latency periods. Moreover, multiple pesticide ingredients have been demonstrated to cause synergistic effects that are greater than the impact expected if the effects of the individual ingredients were additive. In one recent report, mixtures of five commonly used pesticides in California frequently produced synergistic inhibition of acetylcholinesterase at environmentally relevant doses in juvenile coho salmon.

B. "Inert" does not mean "safe"

Inert ingredients are also capable of causing virtually the same wide variety of adverse effects. Hundreds of industrial chemicals that are used as inert ingredients are found on various government lists of hazardous chemicals. Inert ingredients can enhance the toxicity of pesticides to the nervous, cardiovascular, and hormone systems; increase the persistence and movement of pesticides in the environment; and enhance the toxic effects of pesticides on non-target plants, animals, and microorganisims in the environment.

EPA has identified about half of the 3–4,000 inert ingredients in use as having some hazard property that makes them at least moderately risky. But these known hazards are very likely to be just the tip of the iceberg. EPA has identified the lack of information available to users and consumers about inert ingredients as a problem. We agree that there is a profound lack of public information about the hazardous properties of inert ingredients. When pesticides are registered with the EPA, some toxicity tests are required. But most of these tests are performed only on the active ingredients. Only one-third to one-half of the required tests for human health effects, and even fewer for effects on wildlife, must be performed on the pesticide formulations (which would include the inert ingredients). This means that many potential long-term effects of the combinations of active and inert ingredients used in pesticide products are never assessed under FIFRA, including tests for cancer, reproductive harm, and genetic damage.

Many inert ingredients are industrial chemicals that may also be subject to other environmental laws, including the Toxic Substances Control Act. But the failure of TSCA to require the development of information about the toxicity of industrial chemicals is well documented. A recent report examining the toxicity information available from numerous public sources for nearly 10,000 industrial chemicals used in commerce, including inert pesticide ingredients, confirms the continued persistent and pervasive nature of the "data gap." The authors concluded that no information at all is available for one-third of the 10,000 chemicals, and detailed toxicology information (on a selected set of endpoints) is available for only one-quarter of them. And this does not begin to reflect our lack of understanding of the cumulative and synergistic effects of pesticide ingredients as mixtures comprising other chemicals and environmental agents, which is after all what humans and other living things are exposed to in the real world.

These data gaps are especially troubling because it is becoming very clear that many or even most industrial chemicals are likely to be hazardous. The European Commission, in developing a proposal for the European Union's REACH regulation, concluded in 2003 that 70% of the chemicals evaluated under its new chemicals program since 1981 were shown to have one or more dangerous properties. When it comes to inert pesticide ingredients, the most plausible starting assumption under today's understanding of the effects of chemicals on the environment must be that, if they were thoroughly studied, most would likely be found inherently hazardous.

C. One more harm in an overstressed world

But there is a larger context for evaluating the risks of inert ingredients. Pesticides contribute to the cumulative impact on the environment of myriad destructive human activities. This cumulative impact is the root cause of the mounting ecological degradation that is being widely and comprehensively reported by the world’s scientists.

For example, the larger context of the Coho salmon case cited above is that pesticide pollution of waterways contributes to the long-term habitat degradation that has brought wild salmon populations in the Western United States to the brink of extinction. While numerous factors are implicated in this decline in addition to pesticides, it is also true that none of these factors by themselves would decimate the fishery. The fishery has nearly been destroyed by the cumulative effect of numerous factors, a death by a thousand cuts, none of which taken alone would be fatal. Pesticides are one of many.

Pesticides are similarly contributing to cumulative environmental impacts causing numerous ecological and human health problems all around the U.S. and the world. In 2005 the Millennium Assessment, a comprehensive assessment of the global environment compiled by over 2,000 scientists from 95 countries, concluded that 60 percent of global ecosystem services are "being degraded or used unsustainably," including fresh water supplies, capture fisheries, air purification, water purification, and the regulation of natural hazards and pests. Excessive use of pesticides was reported to be contributing to this ecological damage, degrading the capacity of ecosystems to provide pest control in many agricultural areas. Pesticides were reported to be putting humans at risk of adverse health effects, including endocrine disruption and acute health impacts. The Millennium Assessment recommended reducing the use of pesticides through adoption of new government policies, development of economic incentives, and creation of new technologies.

In 2007, the United Nations Environment Programme published a report prepared by over 400 scientists and policy makers on current trends in environmental degradation. It identified many elements of the environment that are being degraded and concluded that we are now crossing thresholds of sudden, irreversible environmental changes. Among other environmental impacts, this report documented widespread contamination of many regions of the earth’s soils, oceans, and fresh waters by persistent toxic pesticides. It concluded that long-term exposure to pesticides can increase the risk of developmental and reproductive disorders, disrupt the immune and endocrine systems, and impair the function of the nervous system; is associated with the development of certain cancers; and poses elevated risks to children. The report recommended reduction in the use of pesticides and the development of safer pesticides.

There is today widespread agreement that international and U.S. legal systems are not containing the mounting cumulative human impacts on the environment. For the first time in human history we are approaching and have likely surpassed the biosphere's assimilative limits. The World Wildlife Fund and its collaborators have found that, by the 1980's, humanity's "Global Ecological Footprint" had reached the capacity of the biosphere to provide resources and absorb waste; that by 2003 it had overshot that capacity by 25 percent; and that it continues to grow every year. They concluded that humanity is now depleting reserves of ecological assets that accumulated on the Earth over long periods of time, and that we cannot do so much longer without damaging the Earth's ability to renew them. Other groups of scientists have similarly concluded that in the last several decades, humanity’s demands on the biosphere surpassed sustainable levels.

The Millennium Assessment summarized its scientists' current evaluation of the cumulative human impact on the ecological systems of the Earth in these stark but clear terms: "Human activity is putting such strain on the natural functions of Earth that the ability of the planet’s ecosystems to sustain future generations can no longer be taken for granted."

D. Reduce and contain

These scientific bodies have concluded that the only solution to the environmental problems we face is to contain and reduce our cumulative environmental impacts. It is in this context that the dissemination into the environment every year of billions of pounds of inert ingredients must be evaluated. Comprehensive scientific and government reports virtually always include pesticides as contributing factors in the cumulative human environmental footprint. Focused on responding to the problem of cumulative impacts, these reports consistently recommend a reduction in the use of hazardous pesticides and the development of policy tools to promote development of safer ones.

Disparities in environmental impacts are an additional acute environmental problem in the U.S. In studying this problem, the state of California has drawn a clear connection between environmental justice disparities and cumulative impacts. Between 1999 and 2001 California adopted three state laws requiring California Environmental Protection Agency (Cal/EPA) to address the problem of environmental justice. Under these laws, Cal/EPA must, among other things, conduct its programs, policies, and activities, and promote enforcement of all health and environmental statutes, so as to "ensure the fair treatment of people of all races, cultures, and income levels." As Cal/EPA has worked to comply with this mandate, a central issue has become the disparate cumulative impacts experienced by different populations within the state. For some communities such as farm worker communities, pesticide exposures are a major contributing factor to environmental justice disparities.

The critical ecological and environmental justice problems faced by the U.S. are caused at root by cumulative impacts, including from pesticides, that are exceeding the earth’s ability to tolerate damage. If this continues indefinitely, the only possible result is the eventual destruction of the earth’s ecological systems on which we depend. The implications for environmental decision-making are profound.

E. A new definition of "unreasonable harm"

The central assumption underlying the use of cost-benefit environmental decision-making, that endless growth of increments of damage is possible, is no longer valid. As is typical of threshold effects, once total environmental damage exceeds the earth's ecological limits, the total cost to humanity (the loss of the ecological systems we need to survive) far surpasses the total calculated cost of all the individual increments of damage. This means that it is no longer scientifically justifiable to determine the reasonableness of environmental impacts, including those caused by inert ingredient risks, to human health and the environment by attempting to evaluate the costs and benefits of each impact independently.

We need a new understanding of an "unreasonable" environmental impact that is based on the message from the scientific community about the full world that has come upon us: the growing cumulative impact of the human footprint is threatening the ecological integrity of the biosphere, which we need to survive and prosper. Environmental decision-makers should adopt as an overarching priority for implementing the nation's environmental laws the imperative of restraining the cumulative impact of our environmental damage to an ecologically sustainable scale. Viewed in this way, the goal of any environmental program, including one governing inert pesticide ingredients under FIFRA, must be to seek to eliminate all avoidable environmental impacts. It should seek permanently and in all cases to use fewer harmful pesticides and substitute safer alternatives.

All impacts that can be avoided should be considered "unreasonable."

II. Under EPA's Market-Driven Regulatory Approach, EPA Should Mandate Public Disclosure for All Inert Ingredients

EPA has proposed a market-based mandatory public disclosure requirement for all inert ingredients. We support this proposal. Applying market incentives to the entire universe of inert ingredients would more effectively reduce risks to human health and the environment than applying them only to those inert ingredients EPA determines are hazardous.

Over the last several decades, the field of information economics has demonstrated the crucial role of information in the proper operation of a market economy, and the serious economic consequences of "imperfect information" and "information asymmetries." Information transparency systems have emerged in the last several decades as a common regulatory tool in many diverse fields including nutritional labeling, campaign finance disclosure, and the Toxics Release Inventory under section 313 of EPCRA (Emergency Planning and Community Right-to-Know Act).

Transparency programs create a new set of incentives for market actors and must be carefully designed if they are to promote policy goals and avoid unintended consequences. The users and consumers of inert ingredients have differing goals and motivations, so it is critical to consider the incentives for each of them that would be created by EPA's proposed regulatory transparency program.

As a preliminary issue, EPA has raised the question of whether the disclosure programs it proposes should be voluntary or mandatory. We think the evidence is clear that there is virtually no possibility that a voluntary information disclosure program would work. In the case of pesticides, only a mandatory disclosure program can produce a level playing field for all market participants.

A. No safe harbors

We believe it is clear that application of a public disclosure requirement to all inert ingredients, rather than to hazardous ones only, would be more effective in reducing risks to human health and the environment. Public disclosure for only those ingredients determined to be hazardous would divide the universe of inert ingredients into two classes: those that are publicly disclosed and those that are not.

Consumers and users of pesticides who wish to avoid publicly disclosed hazardous inert ingredients would drive the market away from products containing them. This market force would give pesticide manufacturers and industrial users of pesticides substantial motivation to avoid using disclosed inert ingredients and to use non-disclosed alternatives instead. Industry may also be exposed to adverse publicity, tort liability, and regulatory action if it continues to use inert ingredients EPA determines to be hazardous. All of these motivating factors would ensure that the pesticide market would shift to inert ingredients whose public disclosure is not required. Indeed, EPA has reported that since it required labels to identify one set of about 50 hazardous inert ingredients, most of those ingredients have disappeared from pesticides.

Non-disclosed inert ingredients, on the other hand, would not be subject to market pressures influencing their use. They would not be subject to regulatory pressures. They would not be subject to liability concerns, adverse publicity, or any other incentives. They would simply be hidden from the public and the market. They would remain entrenched in the market, protected by the regulatory system from any scrutiny at all. Thus, a hazardous-ingredient-only disclosure program, though desirable as an interim step, would, if permanent, create a regulatory safe harbor for all non-disclosed inert ingredients.

B. No data gaps

Under a hazardous-only disclosure program, EPA must rely on an evidentiary test for concluding that an inert ingredient is hazardous. There will inevitably be some cases in which there is some evidence of hazard (such as early warnings of harm) that EPA will conclude is insufficient to meet that test. In such cases, those potentially hazardous ingredients would enjoy the same regulatory safe-harbor status as ingredients that are truly safe.

Once industry switches to non-disclosed inert ingredients, it will be motivated to perpetuate the non-disclosed status of those ingredients and resist providing any toxicity information about them. In other words, incentives would be created for industry to perpetuate data gaps.

In contrast, if public disclosure were required for all inert ingredients, data gaps would become a matter of public knowledge. The data gaps themselves are a problem that the market is capable of addressing, for consumers and users of inert ingredients can demand that the pesticide industry fill those gaps if they can be identified. Hence, public disclosure for all inert ingredients would help close rather than perpetuate data gaps.

C. No regrettable substitutions

Public disclosure for all inert ingredients would make "regrettable substitutions" less likely. Because of the pervasive data gaps on health and environmental effects of inert ingredients, it is very likely that at least some of the substitutions driven by a hazardous-ingredient-only disclosure program would turn out to be hazardous as well, and sometimes even worse for human health and the environment.

This problem of regrettable substitutions plagues virtually all piecemeal regulation of chemicals in the absence of a comprehensive program. As just one example, it is likely that EPCRA’s section 313 Toxics Release Inventory disclosure program for a specified list of chemicals has led industry to reduce use of TRI chemicals by, in at least some cases, switching to non-listed chemicals that are nevertheless hazardous, and this has reduced the effectiveness of that program's ability to achieve the policy goal of protecting public health.

One might hope for a substantial toxicity information requirement for all inert ingredients. This would provide a much greater basis for confidence that substitutes for hazardous inert ingredients would not themselves be hazardous. But in the absence of such a requirement, which is the unfortunate reality, eliminating inert ingredients EPA is able to determine are hazardous will not always mean a reduction in risk to human health and the environment.

The best and perhaps only way to minimize the occurrence of regrettable substitutions is to mandate public disclosure for all inert ingredients. This would give the market the best chance to replace hazardous inert ingredients with alternatives that are truly safer.

D. Maximize efficiencies

A transparency requirement for all inert ingredients would maximize the efficiencies offered by the information disclosure program. Requiring public disclosure for all inert ingredients involves a single regulatory decision by EPA. It would enlist the power of the market, including thousands of concerned market participants, to make rapid and efficient decisions about how best to use pesticides and which inert ingredients were safest. An informed market could make more efficient and particularized decisions than could EPA regarding use of pesticides under diverse circumstances. And it could move far faster than EPA ever could to accommodate new information.

In contrast, a transparency program directed only at hazardous inert ingredients would require EPA to rely on case-by-case determinations that particular inert ingredients present an unreasonable risk. This would put EPA in the position of making hazard determinations for thousands of inert ingredients, virtually in perpetuity. EPA would be required to grapple with the difficulties of interpreting new and emerging scientific toxicity data, the particular uses of each pesticide involved, and all the other controversial issues inherent in risk assessment and cost benefit analysis. Decisions would have to be revisited whenever significant new information emerged. Every decision to require public disclosure of additional inert ingredients would require new rulemaking. Every new rule could be challenged, either by industry or by public health advocates. Each decision would be subject to political influence.

We do not believe that EPA should put itself permanently in the position of being the "decider." A transparency program for all inert ingredients would make best use of the power of the market and be far simpler, more efficient, and more effective at reducing risks of inert ingredients than a more limited hazard-only disclosure program.

E. Compete for safety

Finally, disclosure of all ingredients would foster a market that competes on the basis of safety. EPA has expressed concern about potential negative effects on innovation in the pesticide market and has asked for comments on that issue. We urge EPA not to fall prey to this misplaced concern.

There are many reasons industry rationally does not wish to reveal that products contain an inert ingredient known to be hazardous or that might be if it were studied. These include subjecting products to potential adverse market forces provided by consumers and users of their products, adverse publicity, tort liability, and regulatory restrictions. These reasons, while very real, are difficult for any particular company to admit to, so that industry’s most common objection to public disclosure requirements is alleged effects on innovation and competition.

Inert pesticide ingredients, like industrial chemicals generally, currently compete solely on the basis of price and function. There is virtually no competition on the basis of safety and virtually no market incentive for innovation of safer products. That is precisely the market failure EPA has identified in its proposed rule. The only way to create a market in which inert ingredients compete also on the basis of safety is to require safety and ingredient information to be publicly disclosed. It is just as important for information to be disclosed for "safe" ingredients as "hazardous" ingredients because the safety determinations themselves should be subject to market scrutiny.

In the competitive market EPA should be seeking to create, competitors must be able to market their products as safer alternatives that the market desires. They will not be able to do this unless EPA requires disclosure of all inert ingredients, including those that are allegedly "safe" as well as those that are allegedly "hazardous." If EPA requires only disclosure of hazardous ingredients, then any company that develops a safer inert ingredient is likely to simply maintain its product within the non-disclosure safe harbor and will not be motivated to provide the public information that would be required to market its product as a safer alternative.

The current inert ingredient market contains products that are hazardous and yet are entrenched by the regulatory non-disclosure protections. Ingredient disclosure will certainly have an adverse effect on the manufacturers of those products and on all manufacturers who continue to market hazardous inert ingredients solely on the basis of price and function. But those companies are not the element of the pesticide industry that EPA should be concerned with. EPA should be promoting those elements of the industry that will develop safer alternatives that can compete on the basis of greater safety. Many of these companies and products do not yet exist, and yet EPA can bring them into existence with the right set of policies.

EPA has suggested the problem of competitors "free riding" on the research and development of innovators if disclosure is required. But EPA is also proposing that pesticides can be reverse engineered easily enough to warrant finding that pesticide formulations are not entitled to confidentiality. It seems likely that industry is quite capable of reverse-engineering competitors’ products, that ingredient information is much more widespread within industry than in the public domain, and that industry objections to its disclosure have more to do with non-competitive reasons (exposure to market forces, publicity, tort liability, and regulation) than with competition or free-riders.

Even if innovation of new inert ingredients would suffer under a disclosure requirement, that innovation would relate to attributes of products other than safety. Innovation on safety is not occurring precisely because of the market failure EPA has identified. EPA is authorized to determine, and should determine, that the benefits to society of promoting innovation of safer inert ingredients outweigh any other impacts there may be on some forms of innovation.

To conclude, a government-mandated information disclosure requirement applied to all inert ingredients would result in reduced use of potentially hazardous inert ingredients, motivate the search for safer alternatives to them, motivate closing of data gaps, minimize the occurrence of regrettable substitutions, and promote innovation of safer inert ingredients. While a hazardous-only disclosure requirement would be useful as an interim step to protect human health and the environment from known hazards, disclosure for all inert ingredients is preferable in the longer term. Under our current conditions of excessive cumulative environmental impacts, all avoidable use of potentially toxic inert ingredients is "unreasonable." It follows that public disclosure for all inert ingredients is "necessary to protect against an unreasonable risk of injury to human health or the environment."

Complete, referenced comments are available here.



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