 
September 7, 2000
W-99-16 Arsenic Comments Clerk To Whom It May Concern: RE: Proposed rule for arsenic in drinking water, published in the Federal Register on June 22, 2000, vol. 65, number 121, at pp. 38887-38983. The Pima County Medical Society represents about 1,000 physicians in Pima County, Arizona. We are very concerned about the financial burden of proposed regulations as well as a detrimental impact on the general welfare of our community, including the need to assure a reliable water supply for our growing desert community. Our objections are summarized as follows: A. There is no scientifically valid rationale for reducing the permitted concentration of arsenic below current standards, especially by an enormous factor of 10 or more. B. The cost to our community would vastly exceed any measurable or even hypothetical benefit. C. The methods needed to meet the new requirements would imperil our community's water supply and infrastructure. D. Any conceivable benefit to especially vulnerable populations could be achieved by means that are far less disruptive and costly. For these reasons, the proposed regulations violate the statute. The Safe Drinking Water Act requires at §1412(a)(3) that the EPA set the maximum concentration at a level "at which no known or anticipated adverse effects on the health of persons occur and that allows an adequate margin of safety." However, if benefits at the feasible level would not justify the costs, EPA may propose and promulgate an MCL "that maximizes health risk reduction benefits at a cost that is justified by the benefits §1412(b)(6). A. There is no scientifically valid rationale for the proposed new standard. Arsenic is the 12th most common element in the earth's crust, and is unavoidably present in food and water, especially ground water. In trace quantities, it may actually be necessary for life. It is also a notorious poison, so that it is easy to inflame public fears. As with all substances (whether recognized as toxins or not), the dose determines the poison. Arsenic is also carcinogenic. Fortunately, at least some of the cancers due to this element have features that are quite characteristic so that the cause can be reliably identified. The EPA's public health policy that "the recommended concentration for maximum protection of human health is zero" is absurd because manifestly impossible to achieve. The best (or least) that can possibly be achieved is a concentration that is nondetectable by increasingly sophisticated chemical methods. Whether the least concentration achievable gives maximum protection of human health is speculative; conceivably, it deprives the organism of a necessary trace element. Moreover, the method used to achieve this level either introduces or removes other elements, and this process can also affect human health. The doctrinaire assertion that "less is better" is not necessarily true and is an unacceptable basis for public policy. Indeed, the NAS projected that 25 to 50 µg per day of arsenic may be essential; if a person drinks water with a concentration of 10 µg/L of arsenic, he would need to drink 5 liters daily to get 50 µg/day from the water. The EPA is not convinced that arsenic is essential; moreover, "the fact that arsenic occurs naturally in food [means that] consideration of essentiality is not necessary for public health considerations about water." The occurrence of arsenic in food does, however, mean that water standards determine only a portion of the total intake. Avoidance of food with the heaviest contamination might have an effect just as great as more stringent water standards. It is only much later in the document that some figures are given (p. 38949): an average intake in food of 4.5 µg/ day for 14-16 year old males to 12.5 µg/day for 60-65 year old males. Average intake in Taiwan is considerably higher, ranging from 15 - 211 µg/day, confounding the risk assessment from water on which the EPA relies. The EPA's risk estimates are routinely based on the linear no-threshold assumption, which is not supported by actual evidence and indeed is contradicted by vast amounts of evidence in the case of radioactive materials. The EPA's 1980 estimate of arsenic risk (2.2 ng/L increases cancer risk by 1 in 1 million (10-6) predicts that the 1942 standard of 50 µg/L would have been associated with a 2.5% increase in risk: easily observable if present, but not observed. The 10 µg/L standard would be predicted, on this basis, to increase cancer risk by 1 in 200, also easily observable and not observed: in a population of 1 million, there would be 5,000 arsenic-induced cancers. On p. 38894, the EPA refers to a recalculation that estimates the risk to be 1 in a million for 0.018 µg/L arsenic or 18 ng/L, without explicitly admitting that its earlier calculation was wrong, according to the recalculation, by a factor of nearly 10. The EPA cites no actual evidence validating the recalculation. On p. 38902, the EPA states that "with a straight-line extrapolation from the point of departure, the report estimated risk to be 1.0 to 1.5 x 10-3 at the current MCL of 50 ppb" (µg/L): another decrease in predicted risk by a factor of approximately 2. The point is that ALL of these inconsistent estimates are based on calculations and refuted by actual experience. The EPA has NO evidence of the actual cancer risk due to 50 µg/L of arsenic in drinking water, and the risk of 1 in 1,000 (1,000 in 1 million) is still manifestly too high, as that level should be readily observable. On p. 38896, the EPA discusses a 1998 research plan to answer many outstanding questions. No results of the research are presented. In the cited 1977 study in Taiwan, NO skin cancers were observed in persons exposed to up to 0.29 mg/L (290 µg/L) of inorganic arsenic. U.S. studies have NOT seen increases in cancer at the low levels of arsenic exposure in U.S. drinking water. The EPA admits, on p. 38092, that there are "important issues in projecting risk from the observed data range in the epidemiologic studies to lower environmental exposures experienced in U.S. drinking water," and that studies are ongoing. There is no urgency in implementing new regulations before studies are complete and subject to peer review. The EPA speculates that pregnant women and their babies, infants, lactating women, and children may be especially susceptible, on the basis that there are no data available to disprove this hypothesis. Even if these groups are more susceptible, the EPA has no actual knowledge of the level of risk at the current level of intake. In summary, there is no evidence that a single resident of Tucson will be spared an arsenic-induced cancer by the proposed new standard. For a zero benefit, the cost:benefit ratio would be infinite. B. The cost to our community would vastly exceed the benefit. As shown above, the benefits could be zero. The costs, however, are real and extremely onerous. It should be noted that the EPA has historically underestimated costs by very large factors. Once the error is discovered, it is too late to reverse the course. Independent assessments of costs, particularly by those who will have to bear them, should be required before any proposed regulations are imposed. In this instance, the American Water Works Association Research Foundation estimates that the cost of achieving a 10 µg/L standard to be $600 million per year with capital costs of $5 billion. For a 5 µg/L standards, costs would be $1.4 billion annually with a capital cost of $14 billion. A standard of 3 µg/L would cost $2.8 billion per year with a capital cost of $28 billion. In contrast, the EPA estimates that the 5 µg/L rule would only cost $374 million per year. This is nearly a four-fold discrepancy. Public policy that imposes unfunded mandates on Americans should not be based on inflated risks and under-stated costs. Note that the EPA considers $750 per year to be "affordable." The "median" U.S. family can by no means afford this large an increment in its annual water bill. This may be 2.5% of the "median family income," but it is a much larger fraction of the median family disposable, after-tax income. Families could be forced to choose between paying the water bill and obtaining routine medical care. This is the functional equivalent of a huge and regressive tax increase, an unfunded mandate that will fall most heavily on the poor. Costs could conceivably be much higher in areas with the highest natural arsenic levels. Few families would voluntarily pay this much, especially for a near-zero benefit calculated by a Monte Carlo analysis of a "what if" scenario of future risks derived from Taiwanese experience at much higher arsenic levels. The EPA has an elaborate "willingness to pay (WTP)" calculation, but of course actual willingness does not matter and cannot be determined when the regulations are imposed by fiat. That the EPA is attempting to distinguish the risk due to 3 µg/L from that due to 5 µg/L shows an extreme degree of straining at gnats, while attempting to force municipalities to swallow a camel. A microgram is one millionth of a gram. The difference is comparable to that of 3/5 of a teaspoon added to 1,000,000 liters of water versus 1 tsp added to the same quantity. If the EPA were to express the quantities in grams, the public would be better able to perceive the differences: 0.000003 gm vs 0.000005 gm (cf 0.00005 gm under the current standard). The difference in content is minuscule; the difference in expense to achieve it is monstrous. The public would also have a better grasp of the EPA's linear no-threshold methodology if expressed in terms such as the following: Taking 10 tablets of 0.25 mg of digoxin all at once might kill you. The EPA assumes that if ten people each take one tablet, there is the same probability that at least one of them will die. This is obviously not so. Since the EPA considers one "non-monetized benefit" to be customer peace of mind knowing that the water is treated for arsenic, it should be obligated to consider the contribution that it makes to this loss of peace of mind due to extrapolating a known risk to the (0,0) origin (in the total absence of data at low doses), and then multiplying a minuscule risk by a very large population. Because the EPA has specifically requested comments on its rationale for choosing 5 µg/L, we believe that choosing 5 instead of 50 is arbitrary and capricious. In addition, the proposed rule fails to consider that potential alternative water supplies may meet arsenic requirements but may be inferior in many other ways. The city of Tucson should have the freedom to develop the water supply that is optimum under the natural and economic constraints prevailing in our community. C. The methods needed to meet the new requirements would imperil our community's water supply and infrastructure. When the EPA asserts that a certain standard is "feasible," it fails to consider the situation of various municipalities. For Tucson-a community dependent on ground water, with high geological content of arsenic in rock-to achieve this level may be "feasible," but would require heavy use of wells in central Tucson, which urgently need to be closed for other reasons (such as subsidence). It is grossly inequitable for a central agency to require the same standards for all communities, when they will have very disparate impacts, and in some instances require tradeoffs that are highly disadvantageous to the overall well-being of the community. The EPA's unsubstantiated "belief" that average health benefits will accrue in the long term does not justify the arbitrary imposition of heavy costs on communities regardless of their individual circumstances. D. Any conceivable benefit to especially vulnerable populations could be achieved by means that are far less disruptive and costly. Although the EPA briefly mentions the possibility of supplying bottled water, this document does not adequately address this alternative. For some contaminants, such as cholera, the consumer could become extremely ill or die from drinking a glass of water. Thus, all water needs to be treated to remove dangerous microorganisms or other entities posing comparable dangers. With current technology, this can be readily accomplished at reasonable cost. For substances such as arsenic, however, the risk, if any, comes from constant, long-term exposure. It is thus appropriate to consider that only 2% of the water is actually ingested. The proposed rule would force communities to incur enormous costs to treat what immediately becomes waste water (for showering, flushing toilets, doing laundry, watering gardens, etc.). It would probably make much better economic sense to supply at-risk populations with bottled water for drinking and cooking, or a still or other purification apparatus for use in the kitchen. Municipalities or for that matter individuals should make their own assessments of the cost: benefit tradeoffs in increasing the quality of the water they ingest beyond the already very acceptable quality served by Tucson Water. The proposed rule claims to meet "environmental justice" requirements by convening a meeting of "stakeholders." Such a procedure falls far short of achieving such justice because it does not permit real individuals to decide whether they should have scarce cash extracted from them to pay unnecessarily high water bills in order to hypothetically reduce a risk that is already very low. In fact, the poor will be disproportionately burdened to alleviate a risk that may be of no concern to them (in comparison with other risks that could be ameliorated with the extra cash), for the benefit of more affluent persons to whom the risk of tiny concentrations of arsenic may be of greater importance. In summary, we believe that the proposed standards are too stringent and too inflexible. The proposed rule has fatal substantive and procedural flaws. It should be rejected on grounds of scientific defects and failures to comply with statutory requirements and executive orders concerning environmental justice and federalism (despite a pretext of compliance). Once ongoing studies are completed, the results should be subjected to open peer review by all interested persons. A better process for meeting the needs of individual communities must be developed. |