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2 DTSC's Proposed Overall Approach
Pages 36-54

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From page 36...
... for its effort to improve the scientific structure of its regulatory system and increase the use of modern risk-analysis procedures and environmental models in this undertaking. Clearly DTSC devoted a substantial effort to the development of the proposed approach for classification of hazardous wastes, and made extensive use of many of the most up-to-date scientific procedures.
From page 37...
... However, they are all important to the development and implementation of regulations designed to protect human health and the environment. The committee recommends that DTSC consider using similarly defined set of criteria when revising and evaluating their proposed approach.
From page 38...
... The remaining chapters provide more detailed comments about specific elements of the proposed classification system. STATEMENT OF GOALS In any undertaking directed at protecting human health and the environment, it is important to clearly set forth, at the beginning of the regulatory process, the level of protection that is being sought and for whom.
From page 39...
... For risks from hazardous waste disposal all the following protection goals would be required: · Ninety-five percent of Catifornia's population will be protected from carcinogenic risks to a level of lo-6 or better (lifetime risk)
From page 40...
... DTSC's inclusion of acute toxicity measures in its classification scheme was confusing, as no goals involving acute effects were given in the DTSC documentation. It appears, however, that based on the proposed classification schematic (DTSC 1998a, p.
From page 41...
... . The analyses apply the i0-5 carcinogenic risk protection and the hazard index of I.0 to these most-exposed individuals without explicitly enunciating any health protection goals for them.
From page 42...
... The CalTOX mode} incorporates many of the appropriate factors for undertaking a good multimedia, multipathway risk assessment, and its components can be considered to approximate the state-of-the-art when correctly applied. A disadvantage of CalTOX is that it does not include exposure scenarios that are explicitly appropriate for ecological receptors.
From page 43...
... The disadvantage of regulating on a chemical-by-chemical basis is that people and ecological receptors are rarely exposed to individual chemicals; instead they are typically exposed to mixtures of chemicals. The proposed classification system does not address the additive or potential synergistic effects of exposure to multiple toxicants.
From page 44...
... The description of the acute exposure scenarios was extremely limited for oral and dermal exposures and non-existent for inhalation exposures, and the committee is unsure whether DTSC intended to protect separately against acute effects, or whether the acute toxicity part of the classification scheme was somehow also supposed to protect against chronic effects. The justification of the wildlife exposure scenarios was even weaker than that of the human exposure scenarios.
From page 45...
... VALID SCIENCE The committee is pleased that DTSC has incorporated a number of up-todate and valid scientific methods in developing its proposed regulations. These include not only the multimedia, multipathway risk assessments mentioned earlier, but also sophisticated modeling techniques and a statistical method for incorporating factors whose values vary for different members of a population.
From page 46...
... If, however, DTSC is attempting to use the acute toxicity measures for protection against chronic risks (and the acute toxicity approaches are currently all that are applied for anywastes that do not contain any of the 38 TTEC chemicals) , then the measures of toxicity used by DTSC are scientifically inappropriate.
From page 47...
... In one such case, DTSC used methodologies and data from EPA's proposed hazardous waste identification rule that were found to be inadequate by EPA's Scientific Advisory Board when subjected to peer review. If DTSC believes that it needs to make use of information or methodologies that have not yet undergone full peer review, it should thoroughly document these cases and, to the extent possible, subject them to peer review before releasing the proposal for public comment.
From page 48...
... Evidence of the inadequacy of DTSC's explanation of its approach lies in the fact that many of the public comments provided to the committee appear to be based on incorrect interpretations about what DTSC is proposing and why. The principal documentation failures, apart from missing elements, are the lack of logical order to the documents, the lack of a complete overview with adequate cross-referencing, and the lack of adequate copyediting for accuracy and clarity.
From page 49...
... The most serious documentation failures relate to the policy decisions that are necessarily a fundamental element of these analyses. These flaws range from what level of health and environmental protection is intended, to why twice the level of detection was established as the regulatory level when the risk level falls below the detection-level criterion.
From page 50...
... In addition, it is strongly recommended that the documentation include a table of contents, consistent pagination and cross-referencing, perhaps an index, and an introduction that summarizes the DTSC waste classification process in tote, and the layout of the documentation, with cross-references. FLEXIBILITY DTS C's proposal intends to establish a waste classification system that is more flexible than the one currently used.
From page 51...
... Perhaps DTSC can begin the process of including additional substances before issuing the final regulations because making frequent changes in regulations such as these is expensive and is likely to leave the public confused about what is being regulated and what is not. The committee is also concerned about how flexible the proposed regulations will be in dealing with special wastes and the particular characteristics of specific waste-management proposals.
From page 52...
... Variances are usually requested by waste generators or managers when they believe that the characteristics of their waste or its proposed management warrant a relaxation from the stringent regulatory requirements. However, these parties have no incentive to request a variance when the characteristics of the waste or its proposed management warrant a tightening of the requirements.
From page 53...
... 28) , DTSC presumes that all hazardous wastes will be disposed to a class I landfill, and all special wastes will be disposed to a class ~ landfill, or a class IT landed!
From page 54...
... · Establish, as discussed above, efficient processes for incorporating new information into the regulations and for allowing the regulations to be tailored to site- and waste-specific characteristics. This is particularly important if the regulations do, in fact, incorporate waste management requirements and are not solely a waste-classification scheme.


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