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Draft 2 Regulating Drinking W ater Quality in the United States The 1996 Safe Drinking Water Act Amendments established regulatory framework that more than any of the other current federal environmental statutes in the United States transparently considers the available science, public health benefit, and the cost of rule implementation. In keeping with the Pareto Principle, the Amendments did a few things, very well. First it set the stage for the rapid development of a list of regulations for which there was an ample body of evidence to begin the rulemaking process and secondly, it established very clear criteria and expectations for rulemakings. In the wake of the 1996 Amendments EPA has promulgated eleven regulations for the express purpose of improving the quality of water systems provide consumers. Those rules include: 1. Arsenic Rule 2. Radionuclides Rule 3. Filter Backwash Recycle Rule 4. Stage 1 Disinfectants and Disinfection Byproducts Rule 5. Stage 2 Disinfectants and Disinfection Byproducts Rule 6. Interim Enhanced Surface Water Treatment Rule 7. Long-Term 1 Enhanced Surface Water Treatment Rule 8. Long-Term 2 Enhanced Surface Water Treatment Rule 9. Ground Water Rule 10. Lead and Copper Rule Short-Term Revisions 11. Revised Total Coliform Rule Based on EPA estimates, these rules represent a total regulatory implementation burden of $2.8 billion each year. While the arsenic rule was specific to arsenic and the "enhanced" SWTRs were nominally to regulate Cryptosporidium, the SWTRs, FBRR, DBP rules, GWR, and Revised TCR establish more stringent performance criteria through treatment techniques that reduce risks from hundreds of pathogens and disinfection byproducts. Rule Stage 1 Disinfectants and Disinfection Byproducts Rule Interim Enhanced Surface Water Treatment Rule Lead and Copper Rule Minor Revisions* Radionuclides Rule Arsenic Rule Filter Backwash Recycle Rule Long-Term 1 Enhanced Surface Water Treatment Rule Lead and Copper Rule Minor Clarifications Year 1998 1998 1999 2000 2001 2001 2002 2004 Named Contaminants TTHM, HAA5, Bromate, Chlorate Cryptosporidium Lead, Copper radium-226, radium-228, gross alpha, beta particle and photon activity, uranium Arsenic Cryptosporidium Cryptosporidium Lead, Copper Annual Burden ($million, 2017)+ $728 $299 -- $220 $129 $7.2 $44.8 -- Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00094359-00001 Draft 2 Stage 2 Disinfectants and Disinfection 2006 TTHM, HAA5 $254 Byproducts Rule Long-Term 2 Enhanced Surface Water 2006 Cryptosporidium $150.5 Treatment Rule Ground Water Rule 2006 Fecal contamination (i.e., $62.3 bacteria, viruses, and Cryptosporidium) Lead and Copper Rule Short-Term 2007 Lead, Copper $6.3 Revisions Revised Total Coliform Rule 2012 E. coli $23.8 Note:* Burden, $926 million annually, reflects 1991 rule as implemented post-1999 revision. Note:+ EPA annual burden estimate adjusting to 2017 dollars based on ENR CCI. No other federal environmental statute managed by the U.S. Environmental Protection Agency has promulgated as many standards targeting the same regulated entities over this period. And this list is limited to the list of regulations that target delivered water quality. By comparison, under the Clean Air Act the list of new hazardous air pollutants has decreased by four contaminants since 1996, and only one new contaminant is being considered for listing.1 Under the Resource Conservation and Recovery Act, there were no new regulations to manage additional hazardous substances rather the focus has been on the applicability and application of the existing risk management targets.2,3 In 1996 - early 2018 timeframe EPA published 15 drinking water health advisories. A number of these advisories complement primary standards, but not all. While not strictly regulatory requirements, health advisories have implications. Most recently in 2015 and 2016, health advisories for microcystins, cylindrospermopsin, perfluorooctanoic acid, and perfluorooctanesulfonate, which are all identified as having semi-acute health effects for children at very low concentrations in water, have led to numerous water systems taking water supplies off-line, modifying treatment, expanding monitoring, and taking other steps. In 1998 the advisory for Methyl tertiary butyl ether and again in 2008 the advisory for perchlorate had similar impacts on the drinking water sector. Over this same period, EPA has promulgated five rulemakings to collect data to support regulatory decision-making. Occurrence data is already compiled for more than 80 contaminants and data is being gathered now for an additional 30 contaminants. Rule Information Collection Rule Unregulated Contaminant Monitoring Rule 1 Unregulated Contaminant Monitoring Rule 2 Unregulated Contaminant Monitoring Rule 3 Unregulated Contaminant Monitoring Rule 4 Year 1996 1999 2007 2012 2016 Number of Named Analytes 27 26 25 30 30 Estimated Burden (million $) $129 NA $44.4 $69.8 $97.2 1USE PA, Initial List of Hazardous Air Pollutants with Modifications, https://www.epa.gov/haps/initial-jisthazardous-air-poljutants-modifications#mods 2USEPA, Resource Conservation and Recovery Act Timeline, https://www.epa.gov/rcra/resource-conservation- r 4 . v -'v ' nu ! / 3ATSDR has developed or updated 164 minimal risk levels for use by RCRA and CERCLA program between 1996 and May 2018. https://www.atsdr.cdc.gov/nnrls/pdfs/atsdr mris.pdf one or more of which may be monitored and managed at individual clean-up sites. Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00094359-00002 Draft 2 Note: The ICR required sampling for 27 contaminants, as well as an extensive list of supporting analytes, ancillary data, and treatment studies from 500 large water systems. Note: NA, available historical information are not sufficient to prepare a complete estimate. With the data available from UCMR and the peer reviewed literature EPA has prepared three regulatory determination rulemakings. And, through those rulemakings identified 24 contaminants that were initially believed to be present at a level that might warrant regulations, none but perchlorate has warranted further warrant further action.4 EPA did issue guidance for Acanthamoeba particularly for contact Sens wearers. While perchlorate is the only contaminant for which EPA made a positive regulatory determination, the process established in the 1996; Amendments has not only focused the sector's attention on contaminants for which there is a scientific basis to consider regulation, not just with respect to the 80 contaminants investigated in the UCMR process, but also the more than 100 contaminants that are identified every five years through the contaminant candidate list process. The CCL process, which utilizes a protocol developed with the assistance of the National Academy of Sciences and the National Drinking Water Advisory Council evaluates the available information on occurrence and health effects for thousands of chemicals and hundreds of microbes. The current CCL4 includes 97 chemicals or chemical groups and 12 microbial contaminants. Contaminant Candidate List 4 Chemicals 1,1-Dichloroethane 1,1,1,2-Tetrachloroethane 1,2,3-Trichloropropane 1,3-Butadiene 1,4-Dioxane 17alpha-estradiol 1-Butanol 2-Methoxyethanol 2-Propen-l-o! 3-Hydroxycarbofuran 4,4'-Methylenedianiline Acephate Acetaldehyde Equilin Erythromycin Estradiol (17-beta estradiol) Estriol Estrone Ethinyl estradiol (17-alpha ethynyl estradiol) Ethoprop Ethylene glycol Ethylene oxide Ethylene thiourea Formaldehyde Germanium HCFC-22 Halon 1011 (bromochloromethane) o-Toluidine Oxirane, methyl Oxydemeton-methyl Oxyfluorfen Periluorooctanesulfonic acid (PFOS) Perfluorooctanoic add (PFOA) Permethrin Profen ofos Quinoline RDX (Hexahydro-l,3,5-trinitro1,3,5-triazine) sec-Butylbenzene Tebuconazole Tebufenozide Tellurium 4 Regulatory Determinations 3 (dimethoate, 1,3-dinitrobenzene, terbufos, and terbufos sulfone); Regulatory Determinations 2 (Boron, Dacthal mono-acid (MTP) degradate, Dacthal di-acid (TRA) degradate, l,l-Dich!oro-2,2bis(p-chlorophenyl) ethylene (DDE), 1,3-Dichioropropene (Telone), 2,4-Dinitrotoluene, 2,6-Dinitrotoluene, s-Ethyl propylthiocarbamate (EPTC), Fonofos, Terbacil, 1,1,2,2-Tetrachloroethane); Regulatory Determinations 1 {Acanthamoeba, Aldrin, Dieidrin, Hexachlorobutadiene, Manganese, Metribuzin, Naphthalene, Sodium, Sulfate) Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00094359-00003 Draft 2 Acetamide Acetochlor Acetochlor ethanesulfonic acid (ESA) Acetochlor oxanilic acid (OA) Acrolein Alachlor ethanesulfonic acid (ESA) Alachlor oxanilic acid (OA) alpha-Elexachlorocyclohexane Aniline Bensulide Benzyl chloride Butylated hydroxyanisole Captan Chlorate Chloromethane (Methyl chloride) Clethodim Cobalt Cumene hydroperoxide Cya notoxins Dicrotophos Dimethipin Diuron Equilenin Hexane Hydrazine Manganese Thiodicarb Thiophanate-methyl Toluene diisocyanate Mestranol Methamidophos Methanol Tribufos Triethylamine Triphenyltin hydroxide (TPTH) Methyl bromide (bromomethane) Methyl tert-butyl ether (MTBE) Metolachlor Metolachlor ethanesulfonic add (ESA) Metolachlor oxanilic acid (OA) Molybdenum Nitrobenzene Nitroglycerin N-Methyl-2-pyrrolidone Urethane Vanadium Vinclozolin Ziram Microbes Adenovirus Caliciviruses Campylobacter jejuni Enterovirus N-nitrosodiethylamine (NDEA) N-nitrosodimethylamine (NDMA) N-nitroso-di-n-propylamine (NDPA) N-Nitrosodiphenylamine N-nitrosopyrrolidine (NPYR) Nony!phenol2 Norethindrone (19Norethisterone) n-Propylbenzene Escherichia coli (0157) Helicobacter pylori Hepatitis A virus Legionella pneumophila Mycobacterium avium Naegleria fowleri Salmonella enterica Shigella sonne! Today more than ever, the concept of science-based regulatory policy is a topic of discussion. In crafting the 1996 SDWA, Congress described the fundamental decision criteria for sound rulemaking in a way that focuses public resources on the best risk reduction opportunities and does so based on the best available science. When evaluating whether to regulate, EPA must ask and answer three key questions: (1) is the contaminant likely to occur in drinking water, (2) is the contaminant likely to pose a risk to public health, and (3) is there a meaningful opportunity for risk reduction. And, EPA must not only answer these questions but substantiate the basis for the rulemaking (1) using best available science and (2) enumerating both quantifiable and nonquantifiable costs and benefits. When setting a regulatory standard benefit-cost and feasibility must be taken into account when considering regulatory alternatives. Beyond the water quality regulations, there have been federal regulations that establish standards for public notification, requirements for routine consumer confidence reports, and structure variances and Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00094359-00004 Draft 2 exemptions. In addition to federal requirements, state requirements also continue - back flow prevention, operator certification, water loss control, water supply plans, and other initiatives. While we most often focus on water systems when we think about SDWA implementation. Insufficient Resources for State Drinking Water Programs Threaten Public Health, a report prepared by the Association of State Drinking Water administrators illustrates that appropriately targeting regulatory activity is important, because available resources are limited and need to be focused where they provide the most public health protection. The last edition of this report in 2014 documented a yearly shortfall of at least $230 million between program needs and available resources available in state primacy agencies. There are opportunities for additional risk reduction in the drinking water sector. First and foremost is addressing pressing needs for infrastructure investment. With an estimated trillion dollar 20-year capital investment need to assure that the current water supply is reliable, it is danger that inadequate investment will ultimately lead to public health risk. We know that when funding is not adequate to support utility operations, shortcomings in ongoing maintenance can occur. Adequate ongoing attention to reservoirs, water treatment plants, and distribution system facilities are an essential aspect of managing infrastructure renewal costs, they contribute to maintaining the quality and reliability of water service. We saw in Flint, Ml that a failure to invest in facilities and personnel ultimately led to a crisis in water quality, a loss of public confidence, and potentially illness and death in the community. Sierra Club v. EPA 18cv3472 NDCA Tier 5 ED 002061 00094359-00005