Suggested Changes to HR 2500 - `Reform of Superfund Act of 1995' ================= Letter =============== Date: March 12, 1997 Dear Senator or Representative: Subject: HR 2500 - `Reform of Superfund Act of 1995' The current CERCLA laws repeatedly require cost effective remediation of Superfund facilities and should have served to bring about unbiased, accurate risk assessment. Yet these laws have resulted in the current procedures for risk assessment which require the use of conservative data and models. These in turn lead to the costly remediation of facilities that are clearly not a significant risk to public health nor to the environment. While this is stated to be "best science", clearly it is not, as the data used intentionally lead to risk estimates that are conservative by a factor of 1,000 or more. Risk assessment that is this wide of the mark cannot be considered as best science nor can it lead to cost-effective remediation. This biased implementation of the CERCLA law has been justified as "a mandate from Congress to restore CERCLA facilities to an unquestionably safe level" and that "it cannot be changed unless the law is changed." If such a biased and long-standing implementation also is not to be read again into the current CERCLA reauthorization, then the new wording must be carefully crafted to preclude it. The present wording of Senate bill S8 is good but not impervious to distortion. It should be further strengthened to preclude the same biased interpretation of the risk assessment process as the previous CERCLA laws have permitted. I am suggesting a small but important strengthening of the wording in HR 2500 to preclude the continued implementation distortions that have occurred in the past and which have resulted in so many justifiable criticisms of CERCLA. Based on a knowledge of the science and from my intimate experience with CERCLA processes over the last seven years, I sincerely believe that these wording changes will be necessary to bring realism and cost-effectiveness into the remediation process. The current EPA administrative reforms to expedite the process, while desirable, will not effect the necessary fundamental changes to the risk assessment model. The attached suggested wording changes to HR 2500 are intended to do just that: to preclude the use of biased data in the risk assessment process and to present to the public and risk managers the best unbiased estimates that the science of risk assessment has to offer. Also attached (to the S.8 page for the use of the technically inclined) is a brief lay description of the assumptions of the current practices and the more realistic assumptions of the practices I believe Congress intends. The misconceptions of the "always safe error" assumption with limited funding are described. If it is required, I can supply more detailed background information and technical description. I would appreciate hearing if you can support all or any part of the suggested wording or would support other wording for the same purpose. Very respectfully yours, ___________________ Alfred A. Brooks 100 Wiltshire Drive Oak Ridge, TN 37830 Ph: (423) 482 1559 Attachments (1) ============= Attachment 1 ============================ Suggested Wording Changes to 104 HR2500 Base Document: HR 2500 Dated: October 18, 1995 as found on Internet: URL: http://thomas.loc.gov/cgi-bin/query/z?c104:H.R.2500: Note: The "^" has been substituted for "accent grave". The italicized notes describe the reason for each change. TITLE I -- REMEDY SELECTION AND COMMUNITY PARTICIPATION SEC. 101. OBJECTIVE AND UNBIASED RISK ASSESSMENT STANDARDS ^SEC. 127. National Risk Protocol Change [0] In ^(a) ^(1), after "environment" add ", and which recognizes the need to allocate limited resources in an optimal manner obtaining the maximal overall risk reduction across many sites for the available resources". Reason: This phrase is required to establish the fundamental difference between the current EPA model of unlimited resources and a new model of limited resources. The difference invalidates the EPA assumption of "always safe error" and requires a different approach to the many facets of the problem including data approximations. This concept is fundamental to risk assessment reform. Change [1] In ^(a) ^(3), after "epidemoiologic data, insert " occupational exposure data, ". Reason: Occupational exposure data is a valuable source of human exposure data at levels only slightly above safe levels for the general population. Change [2] After ^(b) ^(1) ^(F), add a new item: "^(G) establish a database of suitable unbiased distributions for the variables used in probabilistic risk assessment." Reason: The proper and efficient use of probabilistic modeling will be greatly facilitated by the existence of acceptable unbiased distribution functions. This data base will supplant the point value data bases now in use. Change [3] In ^(b) ^(2), change "of the exposure" to "of the risk". Reason: The exposure distribution function is not the same as the risk distribution function. The probabilistic model should include the variability of the reference dose for the population as well as those parameters that compose the exposure. Change [4] In ^(b) ^(2), after "probability distribution" add " of a substantive subpopulation of the exposed population". Reason: If a small subpopulation, e.g., only the most sensitive individuals, the results can be extremely biased and the purpose of the clause defeated. Change [5] In ^(c) ^(2),after "relevant, " insert "of occupational exposure data, ". Reason: This is to ensure that all applicable human data is considered. Change [6] In ^(c) ^(2),after "between" insert "human" Reason: This is to ensure that the review and assessment is related to the critical scenario values and that all human exposure values are included. Change [7] In ^(c) ^(2), after "physiology, " insert "variability of the sensitivity of test animals and human species to similar toxins, " Reason: The area of greatest conservative error is the extrapolation from the strain of the test animal to the human species. Change [8] In ^(c) ^(4), after "estimate" insert "and that population shall constitute a substantive fraction of the total exposed population". Reason: If a small subpopulation, e.g., only the most sensitive individuals, the results can be extremely biased and the purpose of the clause defeated. SEC. 102. REMEDY DELECTION ^SEC. 121. REMEDY SELECTION Change [9] ^(b) ^(1), after "means" add " and shall recognize the need to allocate limited resources in an optimal manner obtaining the maximal overall risk reduction across many sites for the available resources". Reason: This phrase is required to establish the fundamental difference between the current EPA model of unlimited resources and a new model of limited resources. The difference invalidates the EPA assumption of "always safe error" and requires a different approach to the many facets of the problem including data approximations. Change [10] in ^(b) ^(3), The changes required here need acceptance of the principle before wordsmithing starts. The principle is one of the setting the risk range based on the severity of the impact. For example, why should the risk level for a mild, reversible skin rash be set the same as for a terminal disease? Or, should human carcinogens (A), probable human carcinogens (B1 - limited human data) and probable human carcinogens (B2 - little or no evidence of human data) all have the same risk level? Should the risk level bear some relation to the background risk level for the disease? Should the risk level bear some relation to the detectable epidemiological risk level? My own opinion is that if the probabilistic model is truly unbiased the 90% is too small for a terminal disease and about right for a minor effect. Since this is a risk management decision, not a risk assessment decision, perhaps the best thing is to stipulate ranges and let the public/risk managers decide. Change [12] In ^(b) ^(4), change "of the exposure" to "of the risk". Reason: See change [3] Change [13] In ^(b) ^(4), between "most" and "plausible" insert "unbiased". Reason: "Plausible" by itself is to subjective. Change [14] In ^(f) ^(1), after "remedial alternatives" insert " covering a range of end state risk levels. Reason: The public needs an opportunity to judge the cost of risk reduction at various levels in making an informed acceptance decision. Change [15] In ^(f) ^(2), add at the end: " Cost-effectiveness evaluation shall consider the requirements of optimal allocation and that there are other sites and functions that must be implemented from the same limited resources." Reason: See change [0] SEC. 104. COMMUNITY ASSISTANCE GROUPS Change [16] In ^(g) ^(1), before "regular" insert "early and". Reason: If the public is does not participate at the start, much valuable assistance is lost and they also feel left with the option endorsing the existing plans. Change [17] In ^(g) ^(2), after "removal actions." insert a new sentence "The Community Assistance Group shall hold open meetings, shall solicit the opinion of the public and incorporate such opinion into their reports." Reason: Limiting the size of the group may prohibit the participation of late comers who can make valuable contributions. Change [18] In ^(g) ^(4), after ^(J), add a new item: "^(H) Members of the local community who have applicable technical training." Reason: These persons can aid the CAG members in the interpretation of the risk assessment and other technical data. The presence of such members keeps the system "honest". Change [19] In an appropriate location in HR 2500 add the following: "Any ATSDR health consultation or other report which comments on the safety of a proposed remediation alternative shall state the maximum contaminant level at which the remediation site would be safe." Reason: Currently, the ATSDR is administratively restricted to commenting if the proposal does or does not result in public safety. This restriction deprives the public of the ATSDR's independent professional opinion as to the safety of other possible remediation levels.