5 Colo. Code Regs. § 1002-31.30
The provisions of Colorado Revised Statutes (C.R.S.) Sections 25-8-202(1)(b), (2), and 25-8-204 provide the specific statutory authority for adoption of the attached regulatory amendment regarding a statewide surface water standard for diisopropylmethylphosphonate. In support of the regulatory amendment and in accordance with 24-4-103(4) C.R.S., the following statement of basis and purpose is provided.
The purpose of this hearing was to consider the adoption of statewide water quality standards for diisopropylmethylphosphonate (DIMP). DIMP is a liquid chemical, a by-product from the manufacture and detoxification of a nerve agent, Sarin or GB (isopropylmethanefluorophosphonate), produced by the U.S. Army (Army) at the Rocky Mountain Arsenal in the 1950s. This is an area on the Front Range of the Rocky Mountains, just north of Denver. The Army disposed of DIMP, along with other chemicals, primarily in surface impoundments at the Rocky Mountain Arsenal where it leached into the underlying soils and ground water. The Water Quality Control Commission has heard testimony indicating that DIMP contamination has been detected in the surface and ground water within and outside the boundaries of the Rocky Mountain Arsenal, although ground water contamination exists in the greatest concentrations and is the most prevalent.
The Commission has heard evidence demonstrating that a significant quantity of ground water in the vicinity of the Rocky Mountain Arsenal is contaminated with DIMP. DIMP has been detected in certain drinking water wells located up to 5 miles downgradient of the Rocky Mountain Arsenal. In addition, the evidence indicates that DIMP-contaminated ground water near the Rocky Mountain Arsenal discharges to certain irrigation ditches and affects First Creek, a tributary to the South Platte River. For approximately the last three years, the State has been providing bottled water for consumption and cooking to residents and businesses whose wells were found to contain DIMP, although it is uncertain how long funds will be available to continue this program.
The Commission was presented with, and considered, a voluminous amount of evidence in this rulemaking. The majority of the evidence addressed the risk associated with exposure to DIMP and the toxicity of the chemical. The Commission heard approximately twenty-five hours of oral testimony from more than twenty witnesses for the Colorado Department of Health, the Army, the Shell Oil Company (Shell), the Arsenal Action Alliance, and the Environmental Protection Agency (EPA), as well as comments by members of the public and commentary by an expert advisory panel of toxicologists. The Commission received and considered literally thousands of pages of written testimony and exhibits from parties and the expert advisory panel. A Regulatory Analysis was prepared by Water Quality Control Division staff in response to a request by one of the parties. The Commission devoted a significantly greater amount of time in hearing testimony and considering written submissions, compared to the majority of water quality standard-setting proceedings it undertakes. Moreover, this hearing addressed the adoption of a water quality standard for a single contaminant, whereas most hearings address multiple pollutants and multiple segments.
Because of the importance of this proceeding, prior to the hearing the Commission took the unprecedented step of requesting that the parties and the Department of Health fund an independent expert advisory panel to provide testimony to the Commission on toxicology issues relating to DIMP. The expert advisory panel, which consisted of three toxicologists who were qualified to discuss risk assessment, assisted the Commission in objectively understanding the large volume of evidence regarding the toxicity of DIMP. The expert advisory panel provided a background educational briefing to the Commission, reviewed the written record, prepared a report for the Commission generally discussing the toxicity information and the different positions of the parties, attended the hearing and asked questions of witnesses, made an oral presentation to the Commission, and responded to questions from the Commission. The Commission found the explanation and clarification of the large amount of evidence by the expert advisory panel very helpful. In accordance with an agreement between the Department of Health, Shell and the Army, and upon advice by the Attorney General's Office, the panel did not advocate or offer a recommendation as to whether a water quality standard for DIMP should be adopted, or, if so, at what level.
Prior to these proceedings, there were no enforceable federal or state standards for DIMP. In 1989, the EPA's Office of Drinking Water issued a lifetime Health Advisory, which is not an enforceable standard, of 600 ug/l (micrograms per liter, also expressed as parts per billion) for DIMP. The EPA Health Advisory is based on a 1980 study of beagle dogs exposed to DIMP over a period of ninety days.1
The Department of Health initiated these water quality proceedings by requesting that the Commission adopt a statewide standard for DIMP of 8 ug/l, based on its evaluation of the relevant toxicology studies and selection of the 1979 Aulerich mink study2 as the critical study upon which to base the water quality standard. In the Aulerich study, a significant number of female mink died over the course of their one year exposure to DIMP. Based on this and a more recent study with mink3 , the Department of Health is concerned about the public health threat associated with DIMP exposure, particularly long-term or lifetime exposure, and derived its proposed standard to protect against these possible effects. In deriving its proposed standard of 8 ug/l for DIMP, the Department of Health followed EPA risk assessment methodology published in EPA's Integrated Risk Information System (IRIS) guidance. The Department of Health presented witnesses and exhibits supporting its recommended standard for DIMP of 8 ug/l. The State's consultant, Dr. Edward Calabrese, recommended a more stringent standard of 0.36 ug/l based on the Aulerich study, but employed certain factors in deriving that recommendation which the Department of Health, based on its professional judgment and the IRIS guidance, chose not to incorporate in its derivation of the recommended standard.
The EPA provided a witness who explained the toxicological basis for that agency's DIMP Health Advisory, and also discussed other issues related to the toxicity of DIMP. The Army and Shell offered witnesses and exhibits supporting the EPA Health Advisory of 600 ug/l on a site-specific basis, although one witness for Shell supported a standard of 500 ug/l later in the proceedings.
The Arsenal Action Alliance provided testimony and exhibits supporting its recommendation that a DIMP standard of 0 ug/l be adopted by the Commission. This position was based largely on that entity's general policy concerns regarding toxins and pollutants in the environment, although it referenced as support Dr. Calabrese's 1990 report regarding DIMP toxicity. The Commission also heard considerable testimony from the public regarding the significant health concerns raised by the presence of DIMP in domestic water supplies.
Accordingly, the toxicological testimony supporting the various recommended standards primarily involved three studies, the 1980 Hart dog study lasting ninety days, the 1992 Bucci study with mink lasting ninety days, and the 1979 Aulerich mink study lasting one year. As the expert advisory panel acknowledged, interpreting the toxicological data from these and the other relevant DIMP studies in the risk assessment context involves professional judgment, and there were differing opinions among the various experts on behalf of the parties regarding the results of these studies.
One question that arose near the conclusion of this process was whether a transcript of the Commission's deliberations regarding the issues raised in this rulemaking proceeding should be made a part of the hearing record. The Commission has decided not to include the deliberations transcript in the record, because it believes that to do so may result in confusion regarding the basis for the Commission's ultimate determination. During deliberations it is typical for many perspectives to be offered and many options advanced and "tested" by individual Commission members. However, it is ultimately only this Statement of Basis, Specific Statutory Authority, and Purpose that accurately reflects the final views of the full Commission. It is this document that sets forth the basis for the Commission's decision, not some or all of the individual comments made during the deliberative process.
Following consideration of the extensive information briefly summarized above, the Commission has decided to establish a statewide interim surface water quality standard for DIMP at 8.0 ug/l, with an accompanying practical quantitation limit (PQL) of 1.0 ug/l. The ultimate basis for this decision is a policy judgment regarding what level of DIMP is protective of public health and the beneficial uses of water, in the face of credible but differing scientific interpretation of the information regarding the toxicity of DIMP.
The Commission has experienced considerable frustration in coming to the realization that the extensive information and data presented in the record does not lead to the identification of one scientifically "correct" value for the toxicity of DIMP upon which all experts can agree. EPA, which issued a lifetime Health Advisory for DIMP, has indicated that it has "low confidence" in the standard it recommends. Based upon the information provided by the parties, the public, and the Department of Health staff, and the explanations and clarifications of this scientific evidence provided by the expert advisory panel, it is the Commission's judgment that it is ultimately faced with a range of scientifically supportable interpretations of the evidence regarding the toxicity of DIMP. The Commission acknowledges that each of these interpretations carries with it a degree of uncertainty. In the face of this uncertainty, the Commission must exercise its policy judgment. Even a decision to adopt no standard for DIMP would entail substantial uncertainty - uncertainty as to whether public health and the beneficial uses of water would be adequately protected until better information might become available in the future.
Fully cognizant of the existing scientific uncertainty, the Commission has determined that there is a need for the adoption of a statewide surface water quality standard for DIMP at the level of 8 ug/l, in view of the evidence submitted regarding the presence of DIMP in some waters of the State as described above and the evidence regarding the toxicological risk posed by DIMP (as discussed briefly above, and further discussed in section II of this Statement of Basis and Purpose). This standard is derived from the results of the 1979 Aulerich study. The Commission is concerned by the death of female mink observed at each dose level in that study, and cannot ignore these results. The Commission believes that the statewide standard of 8 ug/l is necessary to protect public health and the beneficial uses of waters of the State at this time, and that the standard is based on sound scientific and technical evidence in the record.
The Army and Shell have stated their belief that the Commission's selection of an 8 ug/l standard is based upon a public policy choice that "was not supported by the weight of the scientific evidence." This assertion is a misleading characterization of the basis for the Commission's action. The Commission finds that there is substantial and sufficient scientific and technical evidence in the record to support this standard. The fact that other standards could also be defended from a scientific and technical standpoint based upon the information submitted does not mean that there is no such basis for the standard selected.
This Statement of Basis, Specific Statutory Authority, and Purpose does set forth "an evaluation of the scientific or technological rationale justifying the rule," as required by the State Administrative Procedure Act. § 24-4-103(4)(c). Indeed, in view of the importance of and controversy surrounding this determination, the Commission has taken pains to assure that this evaluation is substantially more extensive than that typically provided for the adoption of water quality standards. However, the Commission rejects the interpretation of the Administrative Procedure Act and Water Quality Control Act requirements implicit in the position advocated by the Army and Shell, which would appear to lead to the conclusion that whenever there is scientific disagreement or any remaining level of uncertainty regarding the appropriate standard to be adopted, the Commission is required to adopt the least stringent scientifically defensible standard. The Commission does not believe that this interpretation is mandated by law, and in fact believes that it would be contrary to the Commission's mission as set forth in the Water Quality Control Act.
The Commission previously considered the adoption of water quality standards for DIMP in January, 1991. The Commission eventually decided not to adopt any standards for DIMP as a result of that proceeding, in part based upon the representations of the Army that new DIMP toxicity studies then being conducted and scheduled for completion in 1992 would provide additional information that might address some of the uncertainty surrounding the interpretations of the studies completed prior to that time. It had been the Commission's hope that a new mink study of at least one year's duration, including at least one reproductive cycle for female mink, would be completed to essentially reassess the results of the 1979 Aulerich mink study, which was the focus of substantial debate in 1991 and again in this 1993 rulemaking hearing. Unfortunately, the additional studies conducted were not of a design or duration to provide this reassessment. Moreover, based upon the information presented in these proceedings it now appears unlikely that a new study of this scope, design and duration is likely to be completed in the foreseeable future. Therefore, the Commission believes that further delay or inaction on its part would be inappropriate. Accordingly, the Commission believes it must exercise its judgment based upon the information available now as presented in the 1993 rulemaking hearing, and adopt a standard to protect against the potential adverse health effects associated with DIMP exposure and to help ensure that DIMP does not become a more widespread threat to human health and the waters of the State.
This decision does not mean that the Commission is not open to reconsidering appropriate water quality standards for DIMP should additional relevant information become available in the future. Consistent with the Commission's practice for statewide standards for other organic chemicals, the DIMP standard is being adopted as an interim statewide standard. This standard is fully effective and enforceable once promulgated. However, the "interim" label recognizes the potential for future modifications should additional relevant information become available. In this regard, the Commission's statement concerning the adoption of interim statewide organic pollutant standards in 1989 applies here:
As new information becomes available and potential conflicts among the various numerical levels are resolved, it may be appropriate in specific instances in the future to adopt permanent standards either more or less stringent than the interim standards being established at this time. However, given the importance of controlling toxic pollutants in the environment, the Commission believes that it is necessary to move forward with the adoption of interim statewide standards at this time, and that the interim standards adopted are reasonable based on the best currently available information.
As briefly described above, the Water Quality Control Commission has heard and considered substantial testimony and scientific evidence regarding the toxicity of DIMP and the risk associated with DIMP exposure. The Commission believes that a statewide interim standard for DIMP of 8 ug/l is necessary and appropriate to protect the citizens of Colorado and the waters of the State, and is based on sound scientific evidence as presented by the Department of Health and the parties to the hearing. The Commission's determination follows EPA risk assessment methodology, as applied to the available information regarding DIMP toxicity. In summary form, the Commission's substantive basis for adopting the 8 ug/l statewide standard for DIMP in surface water is described below.
There are no studies of human exposure to DIMP that can be used in deriving a health-based drinking water standard. Of the most relevant animal studies regarding DIMP toxicity, the Commission has identified the 12 month mink study undertaken by Aulerich, as the critical animal study from which to derive a water quality standard. The Commission believes this is the critical study because none of the other species of animal used in other DIMP studies are proven to be of superior extrapolative relevance to humans; the 12 month mink study had the longest duration of all the animal studies; the 12 month study used a relatively large number of animals; and, the mink in the 12 month study proved to be the most sensitive of all the animals exposed to DIMP (exhibiting an increasing linear mortality relationship to their exposure to DIMP). This selection of the critical study comports with accepted risk assessment principles, including EPA's IRIS guidance.
The Commission recognizes the disagreement among scientific experts regarding the cause of death of mink in the 1979 Aulerich study and the issues surrounding background mortality for mink. However, the Commission agrees with the expert advisory panel's conclusion that the possibility that the mink deaths resulted from administration of DIMP could not be ruled out. The Aulerich 12 month mink study is the only study lasting one full year. Although experts debate over the significance of the results of the Aulerich study, the Commission recognizes that a dose-response relationship was exhibited during the study. This fact is troubling and cannot be ignored from a public health perspective, particularly because the end-point was mortality. No other studies to date have addressed female mink exposed before, during and through the reproductive cycle. The Commission also recognizes that adverse blood effects, among others, were observed in mink in the 90 day Bucci study, and that these effects were still increasing in severity when the study was completed at 90 days.
Given the Aulerich study's statistically significant mortality rate at the highest dose level, the statistically significant linear dose-response relationship across all doses, and the highly biologically significant end-point, the Commission believes it is an appropriate scientific and policy decision to base the DIMP standard of 8 ug/l on the information available currently to the Commission regarding mortality in female mink. The Commission recognizes that there was a difference of opinion among experts in the hearing regarding the relevance of the linear regression (trend) analysis of mortality across the different dose levels to select a Lowest Observed Adverse Effect Level. One member of the expert advisory panel commented that such trend analysis could result in more false positive conclusions compared to other relevant statistical tests. Recognizing this concern as well as the advantages of trend analysis, the difference of opinion among experts, and that the end-point was mortality in female mink, the Commission has chosen to use this potentially more conservative approach as part of its analysis.
The Commission recognizes there was considerable debate in the testimony regarding whether to incorporate in the statistical analysis of the 1979 Aulerich DIMP study the female mink deaths observed in the control group of a parallel 1979 study with dicyclopentadiene (DCPD). The expert advisory panel discussed the results of the DCPD study and noted that, because of atypical circumstances, they "should be factored in the overall analysis" of the results of the Aulerich DIMP study. The Commission has considered this information, as well as countervailing evidence presented that it is unorthodox to use data from a different study to statistically evaluate the results of the primary study that is being considered, and that statistical comparison using the concurrent control group from the primary study is the norm. There was evidence both supporting and challenging the notion that the two studies were sufficiently similar to allow their respective results to be commingled. There is considerable professional judgment involved in evaluating the available data in risk assessment, and the Commission is concerned by the direct linear increase in female mink mortality observed between the control group and the successive treatment groups in the 1979 Aulerich DIMP study. Considering the above, the Commission has decided to follow scientific convention and use only the data from the 1979 Aulerich DIMP study to evaluate the death of female mink in that study.
With the selection of the Aulerich study as the critical study, following accepted risk assessment guidance, the Commission derives the recommended standard as follows:
Based on the information available and evidence presented during these rulemaking proceedings, the Commission believes the statewide surface water standard for DIMP of 8 ug/l is necessary, scientifically justified and supported by the record. Also, as described above, the Commission has fully considered the relevant evidence regarding the risk associated with the pollutant, and the extent of such pollution to be tolerated as a goal, in deciding to adopt the standard for DIMP of 8 ug/l.
Based on evidence presented to the Commission in these proceedings, the Commission believes it is technically and economically feasible and practical to treat water contaminated with DIMP with granular activated carbon to achieve a DIMP effluent concentration in water of 8 ug/l or less. There is evidence in the record that other treatment technologies might also be practical and technically and economically feasible to achieve the adopted standard.
The Commission recognizes that the Army and Shell are currently undertaking ground water remediation at and near the Rocky Mountain Arsenal employing granular activated carbon; that their existing ground water treatment systems are treating ground water for DIMP prior to discharge and are capable of achieving the adopted DIMP standard of 8 ug/l; that the existing ground water treatment systems may have to be reconfigured or costs associated with those systems may be increased; and that, if adopted as an applicable or relevant and appropriate requirement under the federal Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) remediation process or applied as a standard pursuant to any other law, new or additional ground water treatment systems may be required of the Army and Shell in order to meet the adopted statewide surface water standard for DIMP, due to the hydrological connection between ground and surface water. The Commission recognizes that costs may be associated with meeting the adopted standard if DIMP is discovered in surface water elsewhere in the State. 8 It is the hope of the Commission that public health and the waters of the State can be protected in a cost-effective manner when the standards it adopts are applied in any regulatory or remedial context. However, the Commission finds that in general the costs associated with compliance with the adopted DIMP standard, wherever compliance may be required, will be counter-balanced by the public health and water quality benefits achieved.
As described in part above, in promulgating the statewide ground and surface water quality standards for DIMP, the Commission has considered the factors enumerated in Section 25-8-204(4), C.R.S. The Commission has considered evidence regarding the extent of DIMP contamination and the risk associated with DIMP exposure. The Commission is aware that DIMP is a non-naturally occurring pollutant and it is also a "continuous" pollutant in the ground water (versus "intermittent" or "seasonal") in the currently known affected area, which has resulted in detection of some impact on surface waters in the area. The Commission has also considered the technical evidence regarding treatment, and has concluded that treatment techniques to achieve the statewide standard of 8 ug/l are available, practical, and technically and economically feasible. As discussed above, the Commission recognizes the potential economic impacts associated with the adopted standard for DIMP, but believes these potential impacts will be counter-balanced by the public health and water quality benefits achieved. No evidence was submitted indicating that treatment for DIMP would have a significant impact on water quantity. Based on all the evidence presented, as summarized above, the Commission believes that there is a strong need for a statewide standard for DIMP of 8 ug/l at this time to support the beneficial uses of State waters, including drinking water, and that the standard adopted is appropriate and scientifically supported by the record.
Colorado Senate Bill 181, adopted in the 1989 legislative session and codified in part in Section 25-8-202(8)(a), C.R.S., includes provisions that apply when the Commission adopts "rules more stringent than corresponding enforceable federal requirements." In the 1989 revision to the Basic Standards and Methodologies for Surface Water 3.1.0 (5 CCR 1002-8), the Commission interpreted these provisions to be inapplicable to the rulemaking since there were no "corresponding enforceable federal requirements" that establish ambient surface water quality standards. Likewise, the provisions of C.R.S. Section 25-8-202(8)(a) are inapplicable to the proposed rulemaking on DIMP because, as stated above, there are no enforceable federal requirements for DIMP. Even if Section 25-8-202(8)(a) were applicable, the Commission finds that the standard adopted is based on sound scientific and technical evidence in the record.
In establishing a statewide standard for DIMP the Commission has determined that DIMP should be controlled on a statewide basis, wherever it is found in the waters of the State, within or outside the Rocky Mountain Arsenal. While the present known contaminated area is limited, the Commission recognizes that the ultimate clean-up and remediation actions for the Rocky Mountain Arsenal may not be finally determined, or may not be put in place, for many years. In establishing a statewide standard, the Commission also intends to ensure that future disposal and handling practices associated with the cleanup and remediation do not adversely affect surface or ground water resources anywhere in the State, and that new contamination problems associated with DIMP do not arise elsewhere in the future.
Much of the rationale for the Commission's 1989 adoption of statewide standards for organic chemicals applies with respect to DIMP (see, Section 3.1.22 ; revised in 1991, Section 3.1.23). The Commission believes that as a matter of policy all potential beneficial uses of water should be protected on a statewide basis from potential contamination from non-naturally occurring organic chemicals. This policy was reflected in the Commission's 1989 adoption of statewide standards for surface and ground water for approximately 55 organic chemicals. The current adoption of the DIMP standard is a consistent extension of this policy. As with the other organic chemicals, DIMP is a non-naturally occurring pollutant for which a statewide standard is appropriate. Unlike certain other potential pollutants, there is no need to take natural background levels for DIMP into account on a site-specific basis in adopting standards. DIMP is a "continuous" pollutant in the ground water at and near the Rocky Mountain Arsenal, with an estimated half-life of over 500 years, and this ground water is hydrologically connected to area surface water so the adoption of a statewide standard that applies at all times, and that protects future water supplies, is appropriate. As Water Quality Control Division staff testified, there are other statewide standards for chemicals that exist in limited areas of the State, such as chlorobenzene, for example.
The Commission also intends to set a statewide standard in order to protect any state waters that are not yet known to have DIMP contamination, if any are found to exist. The Commission intends that the standard should be applied uniformly wherever DIMP may be a concern in the State, currently or in the future, and that the standard is generally applicable and legally enforceable throughout the State pursuant to statute and associated regulations.
The parties to the hearing have expressed differing opinions regarding the Commission's intent on how its statewide water quality standards will be used as cleanup standards in other statutory programs. In a letter to the Commission, Shell appears to interpret Sections 3.11.5 (regarding statewide ground water standards) and 3.1.11(5) (regarding statewide surface water standards), 5 C.C.R. 1002-8, of the Commission's regulations to mean that the Commission "did not intend" for its standards to be applicable or relevant and appropriate requirements (ARARs) under CERCLA (i.e., cleanup standards) or to be enforced as cleanup standards under other statutes. Shell interprets those sections to mean that the Commission believes "it is in the discretion of other agencies" to apply or ignore the statewide standards as cleanup standards, and that the Commission intended to "specifically defer to the discretion of other agencies in setting cleanup levels at Superfund sites." This is an inaccurate expression of the Commission's intent. Instead, the Commission intends for its standards to be used as cleanup requirements, including at CERCLA sites, except in the limited circumstances where " a determination is made that such a variation is authorized pursuant to the applicable provisions" of those federal statutes [ § 3.11.5(C)(5)(a); § 3.1.11(5)].
These cited sections were added to the Commission's regulations in 1989 as simple clarifying statements to address potential conflicts between the Commission's statewide standards and other remediation requirements under the federal programs. The Commission is simply stating that it does not attempt to preempt a federal law, such as CERCLA, by mandating the use of its specific water quality standards as cleanup standards in instances where the federal program is authorized to use a different standard, more or less stringent, and where such programs dictate that the different standard be applied. See e.g., §3.1.22 . The Commission's regulations do not provide that any agency has open-ended discretion to choose to apply or disregard the Commission's standards as cleanup requirements. The Commission intends for its standards to be used as cleanup standards; the Commission understands that in certain federal programs, such as CERCLA, the federal agency can waive a state standard, but only if certain specific statutory requirements have been met. From the Commission's perspective, the standards cannot be waived based on the federal agency's mere discretion whether to use them or not.
The Commission has heard testimony from the Department of Health's Laboratory on its routine analytical capability and procedure for DIMP analysis, and has determined that the Practical Quantitation Limit (PQL) for DIMP should be set at 1.0 ug/l. The Commission credited the testimony that the Department of Health Laboratory has devised a reliable and effective methodology for analyzing DIMP. The Commission also considered the evidence that the Army has been reporting levels of DIMP above .392 ug/l since 1988, demonstrating that the Department of Health Laboratory's PQL could be reproduced by other laboratories. The basis for this PQL is consistent with that underlying PQLs for other statewide organic chemical standards. Because the adopted standard is higher than the PQL of 1.0 ug/l, this value should have little practical significance.
PARTIES TO THE RULEMAKING HEARING
5 CCR 1002-31.30