sdwa newsletter, 2016 no. 1

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03 Drought Monitor Map INSIDE HDR’S SAFE DRINKING WATER ACT NEWSLETTER SDWA 02 UCMR 4 Proposal 07 Regulatory Update 11 Proposed Pharmaceutical Waste Rule 04 Harmful Algal Blooms and Algal Toxins 10 Hexavalent Chromium In California 06 Microbeads Decisive Action 2016 No. 1

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This issue of the SDWA Newsletter features articles on the proposed fourth Unregulated Contaminant Monitoring Rule (UCMR 4), concerns about harmful algal blooms and toxins, federal government action in regards to microbeads, hexavalent chromium compliance in California, and the proposed pharmaceutical waste rule.

TRANSCRIPT

Page 1: SDWA Newsletter, 2016 No. 1

03 Drought Monitor MapINSI

DE

HDR’S SAFE DRINKING WATER ACT NEWSLETTER

SDWA

02 UCMR 4 Proposal 07 Regulatory Update 11 Proposed Pharmaceutical Waste Rule04 Harmful Algal Blooms

and Algal Toxins

10 Hexavalent Chromium In California06 Microbeads Decisive

Action

2016No. 1

Page 2: SDWA Newsletter, 2016 No. 1

02

REGULATORY

By Sarah Clark, [email protected]

UCMR 4 Proposal

On December 11, 2015, the United States Environmental Protection Agency (EPA) published the proposed fourth Unregulated Contaminant Monitoring Rule (UCMR 4), which will require monitoring by all large community and non-transient non-community water systems (NTNCWSs) serving more than 10,000 people. The proposed UCMR 4 is another iteration of the rulemakings to fill the occurrence data gaps in the Contaminant Candidate Lists (CCLs). EPA estimates that the total average national cost of the rule will be $25.3 million per year from 2017 to 2021, with 80 percent of these costs attributed to laboratory and shipping expenses. Sampling is expected to take place between 2018 and 2020.

The proposed UCMR 4 analytes are listed in Table 1. Samples will be collected at the entry point to the distribution system, with the addition of sampling total microcystins at the source water intake concurrent with source water pH and temperature. While sampling of haloacetic acids (HAAs) will take place in the distribution system, sampling for total organic carbon and bromide will occur at a single source water intake concurrent with the HAAs sampling.

EPA held a public meeting on the proposed UCMR 4 on January 13, 2016, and comments were due to EPA in mid-February. Some of the questions raised during the comment period include:

• What should the timing be for monitoring cyanotoxins — June, July, August, or September when blooms are likely, or during each quarter?

• Where should samples be taken for cyanotoxin monitoring — raw water or finished water, or both? Should both samples be collected at the same time?

• What is the most appropriate analytical method for cyanotoxins?

• What parameters should be monitored along with the HAAs? Should the UCMR 4 monitoring be tied to the system’s regulatory schedule for disinfection byproduct (DBP) monitoring to facilitate analysis of the overall DBP production?

The final UCMR 4 is expected to be published in late 2016 or early 2017. UCMR 4 monitoring is scheduled to begin in January 2018. The proposed rule may be read at https://www.gpo.gov/fdsys/pkg/FR-2015-12-11/pdf/2015-30824.pdf.

Table 1. UCMR 4 Proposed Analytes

One Cyanotoxin Group using ELISA Standard Operating Procedure (Ohio EPA, 2015)

total microcystins

Seven Cyanotoxins using EPA Method 544 (SPE LC/MS/MS)

microcystin-LA microcystin-RR

microcystin-LF microcystin-YR

microcystin-LR Nodularin

microcystin-LY

Two Cyanotoxins using EPA Method 545 (LC/ECI-MS/MS)

anatoxin-a Cylindrospermopsin

Two Metals using EPA Method 200.8 (ICP-MS) or alternative SM or ASTM

Germanium Manganese

Nine Pesticides using EPA Method 525.3 (SPE GC/MS)

alpha-hexachlorocyclohexane Profenofos

chlorpyrifos Tebuconazole

Dimethipin total permethrin (cis- & trans-)

Ethoprop Tribufos

Oxyfluorfen

Three Brominated HAA Groups using EPA Method 552.3 (GC/ECD) or 557 (IC/ECI-MS/MS)

HAA5 HAA9

HAA6Br

Three Alcohols using EPA Method 541 (GC/MS)

1-butanol 2-propen-1-ol

2-methoxyethanol

Three Semivolatile Organic Chemicals (SVOCs) using EPA Method 530 (GC/MS)

butylated hydroxyanisole quinolone

o-toluidine

Page 3: SDWA Newsletter, 2016 No. 1

03

Drought Monitor MapWhile most of California is still in the Exceptional Drought category, significant heavy rains across the Pacific Coast in early March are expected to begin to reduce the drought condition. Weather projections for the second week in March favor above average precipitation in the western third and eastern half of the country.

Above-median temperatures are likely in the eastern two-thirds of the lower 48 States and southern Alaska, especially the eastern Great Lakes region and Ohio Valley. Below normal temperatures are predicted for the Southwest and western Alaska.

DROUGHT

Page 4: SDWA Newsletter, 2016 No. 1

04

PUBLIC HEALTH

By Phil Brandhuber, PhD [email protected]

On June 22, 2015, EPA published drinking water Health Advisories (HAs) for the algal toxins microcystin and cylindrospermopsin. In a related action on August 7, 2015, President Barack Obama signed into law the Drinking Water Protection Act (P.L.114-45). This law requires that EPA’s actions for controlling algal toxins in drinking water be reported to Congress. These events illustrate the growing concerns of regulators and public officials regarding the possible health effects of toxic compounds in water that can be produced by algal blooms.

HARMFUL ALGAL BLOOMS Rising levels of nutrients in drinking water sources have increased the frequency of algal blooms — the intense, rapid and excessive growth of single cell organisms in water. Frequently, algal blooms consist of photosynthetic cyanobacteria commonly called blue-green algae. Algal blooms can have a range of undesirable consequences for water bodies including unpleasant smells, discoloration, consumption of dissolved oxygen, blockage of sunlight, and production of algal toxins. Not all cyanobacteria produce toxins, but if toxins are present, the bloom is called a harmful algal bloom (HAB).

The consequences of HABs can be severe. Because of a 2014 HAB in Lake Erie, the City of Toledo, Ohio, was required to issue a two-day “Do Not Drink” order to its customers. This order was issued because of uncertainty regarding the risks associated with the levels of microcystin detected in the water. EPA continues to be

Other algal toxins, including anatoxin–a and saxitoxin, can also occur during cyanobacteria blooms. EPA did not establish HAs for these cyanotoxins.

Because of the dynamic nature of HABs, rapid and accurate quantification of algal toxin levels is desirable, particularly since some states have issued “Do Not Drink” orders based on their presence. The use of enzyme-linked immunosorbent assays (ELISA) can provide timely response. However, ELISA method’s Level of Quantitation (LOQ) is equal to the 10-day HA for

Green is Not Always Good — Concerns About Harmful Algal Blooms and Algal Toxins

Table 1. Ten Day Health Advisory Levels for Algal Toxins

CyanotoxinHealth Advisory (micrograms/L)

Bottle-fed and Children Younger than School-Age

School-Age Children and Adults

Microcystin 0.3 1.6

Cylindrospermopsin 0.7 3.0

concerned about vulnerability of surface water systems to HABs and algal toxins, estimating that 38 to 40 million people are served by water systems with lakes or reservoirs susceptible to HABs.

Algal toxins are a complicated and rapidly developing issue. There even remains disagreement on basic terminology. For this article the terms algal toxins and cyanotoxins are used interchangeably.

EPA SETS HEALTH ADVISORIES FOR ALGAL TOXINSHAs are non-regulatory, non-enforceable standards established by EPA to provide guidance to regulators concerning safe levels of contaminant exposure over a period of time. Each HA specifies an estimated contaminant concentration in drinking water that is not expected to cause adverse noncarcinogenic effects for the period of exposure. In the June 2015 action, EPA established age-sensitive HAs for microcystin and cylindrospermopsin. Table 1 summarizes EPA’s action.

Page 5: SDWA Newsletter, 2016 No. 1

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microcystin, so its suitability as a basis for regulatory action is questionable. ELISA is probably more suitable as a screening tool. Regulatory actions should be based on algal toxin measurement by slower but more reliable high-performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) methods.

Given the lack of an enforceable national regulation for algal toxins and the limitations on analytical techniques, it is up to state regulatory agencies to decide whether and how these HAs will be used for local regulation. Utilities need to be aware of the actions that their primacy agency is taking at the local level.

ALGAL TOXIN STRATEGIC PLAN AND FUTURE EPA ACTIONSIn mid-November 2015, EPA submitted the Algal Toxin Strategic Plan to Congress as required by P.L.114-45. The plan compiled EPA’s ongoing and future algal toxin research into six areas:

• Improved understanding of the health effects of algal toxins • Need for additional HAs • Improved understanding of causes of HABs • Improved analytics • Feasibility of treatment options • Actions to improve source water protection

Previously, EPA listed cyanotoxins on the Draft Fourth Contaminant Candidate List (CCL4) and on the proposed Fourth Unregulated Contaminant Monitoring Rule (UCMR 4). UCMR 4 will monitor the occurrence of anatoxin–a, microcystins, nodularin and cylindrospermopsin. Predicting if and when EPA would regulate cyanotoxins is difficult, but if EPA waits until the UCMR 4 monitoring is completed at the end of 2020, a proposed rule could take shape by 2023. However, EPA retains the authority to develop an “emergency regulation” sooner if it determines that circumstances (or Congressional pressure) warrant such an action.

INDUSTRY DEVELOPED GUIDANCEIn April 2015, American Water Works Association and the Water Research Foundation jointly released industry-developed guidance for utilities concerning cyanotoxins. The pamphlet, “A Water Utility Manager’s Guide to Cyanotoxins,” addresses cyanotoxin occurrence, source water management and treatment strategies. It provides a self-assessment tool for utilities to determine their potential for cyanotoxin events and tools to mitigate these events. This 18-page pamphlet is available free of charge at http://www.waterrf.org/PublicReportLibrary/4548a.pdf.

WHAT DOES THE FUTURE HOLD?The risks that algal toxins pose to utilities are becoming more apparent. Clearly, rising nutrient levels in surface drinking water sources are placing more utilities at risk for HABs. Future regulatory actions regarding algal toxins seem probable. Utilities should start assessing their risks associated with HABs and algal toxins.

PUBLIC HEALTH

Page 6: SDWA Newsletter, 2016 No. 1

06

WATER QUALITY

Over the last 5 to 10 years, there has been increasing concern about microbeads — the tiny polyethylene or polypropylene beads found commonly in facial scrubs, shampoos, soaps, deodorants and toothpaste. These beads provide abrasive, exfoliating or lubricating characteristics, as well as aesthetic qualities. Various types of fluorescent microbeads (aka “microspheres”) are also used in microscopy, biotechnology, electronics, manufacturing, flow visualization and ultraviolet disinfection validation processes.

The environmental and legislative focus has been primarily directed at the consumer personal care product varieties that are intended to be washed down the drain into public sewer and treatment systems. The trouble is that these non-biodegradable beads are not removed in most wastewater treatment plants; they are discharged more or less intact into the environment. Fish cannot distinguish the beads from food, so they are ingested. Some beads may be toxic, and it’s been observed that they can absorb other contaminants such as polychlorinated biphenyls (PCBs), thus increasing bio-accumulation in fish.

Around 2012, as more and more microbeads were being found in lakes, bays and oceans around the world, a Dutch public awareness campaign was launched by the North Sea Foundation. Designed for worldwide dissemination, the campaign spread to audiences of the United Nations Environment Programme and other interested agencies. In the United States, concern over plastic particle water pollution grew quickly, particularly in the Great Lakes region where

numerous investigations found microbeads in large numbers. As awareness increased, several major companies, including Procter & Gamble and Johnson & Johnson, committed to stop producing microbead products.

On the regulatory front, the Clean Water Act can address microbeads only in direct industrial discharges, not domestic wastes. Most of the applicable consumer products have not been subject to United States Food and Drug Administration approval for water quality and environmental impact. Microbeads have thus become sort of a water quality conundrum that water and wastewater industry professionals have been keeping an eye on, until now.

With surprising efficiency, the federal government has nipped this emerging water quality issue in the bud. On December 28, 2015, President Barack Obama signed the Microbead-Free Waters Act, which will ban consumer personal care products containing microbeads. The original bipartisan bill was presented by the House Energy and Commerce subcommittee in May 2014. Within a month, the State of Illinois enacted a ban on products containing rinse-away, non-biodegradable microbeads. Eight other states followed suit throughout 2014 and 2015, racing ahead of the federal legislation. In December, the Federal Microbead-Free Waters Act was approved by the House and then the Senate. The law only pertains to rinse-off personal care products, the manufacture of which will be banned beginning in January 2017.

By Matt McFadden, [email protected]

Microbeads: The Federal Government Takes Decisive Action on a Water Quality Issue

Page 7: SDWA Newsletter, 2016 No. 1

07

The regulatory development arena had a busy year in 2015 with a dozen regulatory actions (not all of them are regulations) being published by EPA and the Department of Health and Human Services (HHS).

CCL4. The first drinking water regulatory action in 2015 was the publication of the Draft Fourth Contaminant Candidate List (CCL4) on February 2 (80 FR 6076). The Draft CCL4 listed 100 chemicals or groups and 12 microbial contaminants. EPA asked for CCL4 nominations in May 2012 (77 FR 27057) and two of the nominated chemicals, nonylphenol and manganese, ended up on the Draft CCL4. EPA made a negative regulatory determination for manganese in 2003 (68 FR 42898) but added it back to the Draft CCL4 due to new health effects data that showed potential neurological effects. The rest of the Draft CCL4 consists of the remainders from CCL3, minus the one positive preliminary determination from CCL3 in 2014 (strontium); the four preliminary negative determinations (1,3-dinitrobenzene, dimethoate, terbufos, and terbufos sulfone), also in 2014; and an off-cycle positive determination in 2011 (perchlorate). Publication of the final CCL4 has slipped into early 2016.

LT2ESWTR. The second round of the Long Term 2 Enhanced Surface Water Treatment Rule (LT2ESWTR) monitoring has staggered start times, starting in 2015, similar to the first round of monitoring. Surface water systems and groundwater under the direct influence of surface water (GWUDI) systems serving more than 100,000 people started monitoring by April 1, 2015. Systems serving 50,000-99,999 people started monitoring by October 1, 2015. Two issues of note with the second round: the lack of a central EPA database for monitoring as the state primacy agencies are now collecting the monitoring data, and EPA’s recommendation (but not a requirement) that Method 1623.1 should be used for this monitoring.

Fluoride. On April 27, HHS released the final recommendation for community water fluoridation. This final action was substantially delayed, for reasons unknown, since the agency’s January 2011 proposal of 0.7 mg/L as the optimal fluoride level (76 FR 2383). EPA is in the process of reviewing both the primary and secondary standards for fluoride, but the timeline for completing that review is not clear.

Water Sector Cybersecurity Report. The final Critical Infrastructure Partnership Advisory Council (CIPAC) Water Sector Cybersecurity Strategy report was approved by the Water Sector Coordinating Council and Government Coordinating Council (WSCC/GCC) in May. This report was in response to Executive Order 13636, Improving Critical Infrastructure Cybersecurity,

issued February 2013, which included a requirement to review implementation guidance or supplemental materials necessary to support sector-specific approaches to the National Institute of Standards and Technology (NIST) Cybersecurity Framework. The guidance and use-case tool developed by the American Water Works Association (AWWA) to support the water sector’s voluntary application of the NIST Cybersecurity Framework is a central element of the final CIPAC report. This includes having AWWA lead development of a survey in 2016 to assess the sector’s progress in addressing cybersecurity risks.

Waters of the U.S. On May 27, EPA and the United States Army Corps of Engineers published the final Waters of the U.S. rule, which was supposed to clarify some jurisdictional issues. This rulemaking is extremely controversial, with lots of people and powerful organizations expressing serious reservations with the final rule. Litigation has resulted in this rule being stayed. Legislation has also been introduced to negate the final rule but has not moved in Congress. It’s unclear whether such a bill would be approved by Congress, and even if it did, whether the President would veto it.

Cyanotoxins. On June 15, EPA released health advisories (HAs) for two cyanotoxins. For children under school age (younger than 6), the 10-day HA levels are 0.3 μg/L for microcystin and 1.6 μg/L for cylindrospermopsin. For children 6 and older and adults, the 10-day HA levels are 0.7 μg/L for microcystin and 3.0 μg/L for cylindrospermopsin. EPA simultaneously released some relatively detailed monitoring, treatment and communications recommendations for water systems. Cyanotoxins (as a group) were listed on the Draft CCL4, and 10 cyanotoxins/groups were included in the proposed UCMR 4. See the extended discussion of cyanotoxins on page 4.

On August 7, President Barack Obama signed into law the Drinking Water Protection Act (P.L. 114-45) that amends the Safe Drinking Water Act (SDWA) with the intent to control harmful algal blooms in drinking water. The legislation required EPA to develop and submit a plan to Congress by November 5 to evaluate the risks to human health from harmful cyanotoxins and to recommend feasible treatment options to mitigate any adverse public health effects.

Given the focus in Congress and at EPA, regulations addressing cyanotoxins, either as a group or individually, are likely at some point in the future. Assuming EPA waits until the UCMR 4 monitoring is completed at the end of 2020, EPA could move the UCMR 4 cyanotoxins forward in the regulatory development process with the fourth round of regulatory determinations

By Alan Roberson, PE, AWWA, and Sarah Clark, PE, HDR [email protected]

Regulatory Update

REGULATORY

Page 8: SDWA Newsletter, 2016 No. 1

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REGULATORY

scheduled to be finalized in 2021. A proposed cyanotoxins rule could be proposed two years later in 2023, and the final rule approximately two years after the proposal in 2025. EPA Administrator has the authority to develop an “emergency regulation” if the circumstances warranted such action, such as several “Do Not Boil/Do Not Use” orders in a single year.

Lead and Copper Rule. A Lead and Copper Rule Working Group (LCRWG) under the National Drinking Water Advisory Council (NDWAC) met throughout 2014–2015 to develop recommendations for long-term LCR revisions. The final LCRWG report was released on August 24, and the report was approved by the full NDWAC at its fall meeting on November 18-20. The LCRWG process has been slow due to the breadth and depth of the issues being discussed, such as developing inventories of lead service line, lead service line replacement, optimized corrosion control, how in-home sampling might be revised, corrosivity of water for new/replaced copper plumbing, etc. After the recent NDWAC approval, EPA now has to assess how the recommendations could be incorporated into proposed revisions, and that assessment and development of rule language could take a year or more. Therefore, the proposed revisions are not likely to be published until early 2017, with a possible final rule in either late 2018 or 2019.

Legionella. The recent Legionellosis outbreak in New York City has resulted in a renewed focus on Legionella. EPA released a draft literature review on treatment options for Legionella in October and held a public meeting to solicit comments on November 9. Some water systems that serve large facilities, as well as state primacy agencies, have had to contend with Legionella outbreaks over the past few years. Therefore, some facilities have installed secondary disinfection systems for water quality issues within their premise plumbing, making these facilities public water systems that face all of the associated monitoring and operator certification requirements. EPA intends to have the literature review peer-reviewed in early 2016 and publish the final in spring 2016. AWWA is developing a communications guide for water systems on how to talk to building owners and operators that is scheduled for release sometime in 2016.

UCMR 4. On December 11, EPA published the proposed UCMR 4. The proposed UCMR 4 is another iteration of the rulemakings to fill the occurrence data gaps in CCLs. EPA held a public meeting on the proposed UCMR 4 on January 13, 2016, with comments due to EPA in mid-February 2016. The final UCMR 4 is anticipated to be published in late 2016 or early 2017. UCMR 4 monitoring is anticipated to start in January 2018. Details of UCMR 4 are presented on page 2.

Third Regulatory Determinations. On December 22, EPA released the Final Third Regulatory Determinations. In this notice, EPA decided not to regulate four contaminants — dimethoate, 1,3-dinitrobenzene, terbufos, and terbufos sulfone. EPA also decided to delay the final regulatory determination for strontium in order to collect more health effects, occurrence and treatment data. EPA will then determine whether regulating strontium in drinking water provides a meaningful opportunity for risk reduction as required by the SDWA. A strontium regulation would potentially impact many small groundwater systems, and depending on the MCL ultimately selected, the national compliance cost for a strontium regulation could be in the same ballpark as the revised arsenic regulation in 2001.

UPCOMING REGULATORY ACTIONSGiven what we know about EPA’s workload, we will likely see two major drinking water regulatory actions in 2016:

1. Final Fourth Contaminant Candidate List (CCL4); and 2. Third Six-Year Review of existing regulations.

Third Six-Year Review. The Third Six-Year Review is scheduled to be published in late 2016. Chlorate, nitrosamines and brominated haloacetic acids (due to their inclusion on the proposed UCMR 4) are now being evaluated as part of the review of the Microbial/Disinfection Byproducts (M/DBP) cluster of regulations. Any potential revisions to the M/DBP regulations could be significant due to the risk-balancing challenges, and some recent challenges with maintaining a “detectable” disinfection residual further complicate the risk balancing. At this point, it’s not clear whether or not chlorate might be regulated separately from the other DBPs.

The federal regulatory requirements for maintenance of a disinfectant residual date back to the 1989 Surface Water Treatment Rule (SWTR). The SWTR requirement states that “the residual disinfectant concentration … cannot be measured as undetectable in more than 5 percent of the samples each month.” Given the 2008 waterborne outbreak of Salmonella in Alamosa, Colorado, multiple Legionella pneumophila outbreaks in premise plumbing in a handful of cities, and Naegleria fowleri outbreaks in Louisiana in 2014, some states have moved forward with their own revisions to the disinfectant residual requirements. Over the past several years, roughly half of the states have set a higher numerical standard than the “detectable” residual in the federal standard, with many states setting a residual requirement of 0.2 mg/L in 95 percent of the samples.

Page 9: SDWA Newsletter, 2016 No. 1

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REGULATORY

Rule Proposal Final

Fourth Unregulated Contaminant Monitoring Rule (UCMR 4)

2015 2016/2017

Long-Term Revisions to the Lead and Copper Rule

2017 2018/2019

Perchlorate?? 2017?? 2019??

Carcinogenic Volatile Organic Compounds (cVOCs)??

2018?? 2020??

Cyanotoxins 2023 2025

AWWA hosted two workshops that included water systems, consulting engineers, state regulators and researchers to discuss whether the federal regulatory requirements for disinfectant residual needed to be revised as part of the Third Six-Year Review. These two workshops resulted in a letter to EPA’s Office of Groundwater and Drinking Water that listed some topics that EPA should consider as part of the Third Six-Year Review. There are still lots of research gaps surrounding disinfectant residuals, and it is not clear at this time whether or not EPA has adequate data or information to make an informed decision about how or if to potentially revise the federal disinfectant residual requirements.

Hexavalent chromium (Cr(VI)) will likely be discussed as part of the review of the total chromium regulation, and it is not clear whether EPA will choose to regulate Cr(VI) separately.

REGULATORY DELAYSWhile some might think EPA is not really doing anything since we have seen only one new final regulation in the last few years (the Revised Total Coliform Rule in 2013) and no new final regulations are on the horizon, the above actions from 2015 show that EPA has been very busy on the regulatory side. Several steps are necessary to bring new or revised national drinking water regulations to the finish line and use the best available, peer-reviewed science as required by the SDWA. The table at right shows the schedules for EPA’s future regulations (not just regulatory actions but actual regulations).

Projected Future Regulatory Schedule

Page 10: SDWA Newsletter, 2016 No. 1

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Bill Offers Path to Hexavalent Chromium Compliance for California UtilitiesBy Phil Brandhuber, [email protected]

On September 4, 2015, California Governor Jerry Brown signed Senate Bill 385 (SB 385) into law. This bill provides California utilities a realistic compliance period for meeting the maximum contaminant level (MCL) of 10 μg/L for hexavalent chromium (Cr(VI)). Prior to this action, California had established a first-in-the-nation MCL for Cr(VI) and remains the only state regulating this form of chromium. When promulgated in July 2014, the California Cr(VI) regulation gave utilities at most 18 months until they were considered out of compliance — an insufficient time for many utilities with Cr(VI) to complete sampling and institute treatment measures. Without making any changes to the MCL, SB 385 delays when a utility would be deemed out of compliance, as long as the utility meets the following conditions:

• Prepares and receives approval for a compliance plan from the relevant regulatory agency.

• Provides notice to customers at least twice per year regarding the progress being made in meeting the compliance plan.

• Institutes treatment at the earliest feasible date, but no later than January 1, 2020.

LEGISLATION

Cr6+

Page 11: SDWA Newsletter, 2016 No. 1

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REGULATORY

Proposed Pharmaceutical Waste RuleBy Sarah Clark, [email protected]

In late August 2015, EPA published a proposed rule under the Resource Conservation and Recovery Act (RCRA) that would improve hazardous waste pharmaceutical disposal practices for healthcare facilities, pharmacies and reverse distributors. The proposed Management Standards for Hazardous Waste Pharmaceuticals rule is expected to reduce the amount of pharmaceuticals entering waterways by banning healthcare facilities from flushing hazardous waste pharmaceuticals down the sink and toilet. This rule does not apply to pharmaceutical manufacturing, production facilities or other generators of hazardous waste pharmaceuticals.

A number of studies have documented the presence of various pharmaceutically active ingredients and metabolic byproducts in surface waters and groundwater in the United States. The pharmaceuticals entering the environment, through flushing or other means, are having a negative effect on aquatic ecosystems and on fish and animal populations. Impacts of pharmaceuticals on the environment have led EPA to propose the changes in the rule.

The rule proposes a tailored set of management standards specifically designed to reduce the complexity of the RCRA hazardous waste regulations for hazardous waste pharmaceuticals. It streamlines the collection and handling requirements for widely-dispersed hazardous wastes and facilitates their inclusion in the hazardous waste management system.

EPA expects that the ban on flushing hazardous waste pharmaceuticals will be finalized in 2016 and will be effective six months after promulgation. Authorized states will be required to adopt this rule and modify their RCRA programs in order to retain their authorized status.

More information about the Management Standards can be found at: http://www.epa.gov/hwgenerators/frequent-questions-about-management-standards-hazardous-waste-pharmaceuticals-proposed

Page 12: SDWA Newsletter, 2016 No. 1

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Sarah Clark, PE is the editor of SDWA. Please contact her with any comments or questions regarding this publication at 303.764.1560. To join, change an address or be removed from the SDWA mailing list, please send requests to [email protected].

14th Edition SDWA Wall Chart Our most recent SDWA Regulations Wall Chart, published February 2015, is available through our website: www.hdrinc.com/SDWA. The poster-sized chart provides an easy-to-use reference to all drinking water regulations including a detailed listing of contaminants and maximum contaminant levels, health effects and monitoring requirements. This 14th edition includes current information on the Revised Total Coliform Rule.

Waterscapes is another technical publication produced and distributed by HDR. It focuses on the latest innovations and technical issues facing the water, wastewater and water resources markets. You can view Waterscapes on our website at: www.hdrinc.com/waterscapes. If you would like to join our Waterscapes mailing list, please send an e-mail to [email protected].