Regulatory Flexibility Act Section 610 Review of the National Primary Drinking Water Regulations : Ground Water Rule
United States Environmental Protection Agency

Office of Water
April 1, 2016

Results of Section 610 Review of the Ground Water Rule

BACKGROU ND
On November 8, 2006 ( 71 FR 65573) , the EPA promulgated the N ationa l P rimary D rinking W ater R egulation s : G round W ater Rule as authorized by the Safe Drinking Water Act (SDWA). In this action, referred to as the Ground Water Rule (GWR), the EPA promulgate d sanitary survey, source water monitoring, treatment technique and compliance monitoring requirements. The GWR became effective on January 8, 2007.
Before the GWR was promulgated , the EPA developed a Regulatory Flexibility Analysis and took several steps to lessen the impacts on small entities. These s teps included: (1) s electing a targeted approach, requiring corrective action (e.g. , disinfection) only for high risk systems or sources that are vulnerable to contamination ; ( 2) a llowing s tate flexibility to make the GWR less burdensome by permitting Total Coliform Rule ( TCR ) source water repeat samples to satisfy GWR triggered sourc e water monitoring requirements ; ( 3) m inimizing burden by promulgating monitoring requirements based on syste m characteristics (risk) rather than on system size ; and ( 4) a llowing s tates to consider the characteristics of

an individual system when determining an appropriate corrective action.
Section 610 of the Regulatory Flexibility Act (RFA) requires federal age ncies to review regulations that have significant economic impact on a substantial number of small entities within 10 years of their adoption as final rules. Pursuant to this requirement , the EPA has reviewed this rule to determine if it should be continue d without change, or should be rescinded or amended to minimize adverse impacts on small entities. This review was announ ce d in the Regulatory Agenda , which was published in the Federal Register on December 15, 2015 (80 FR 78024). As part this review , the EPA considered and solicited comment on the following factors: (1) t he continued need for the rule; (2) the nature of complaints or comments received concerning the rule; (3) the complexity of the rule; (4) the extent to which the rule overlaps, duplicates , or conflicts with other f ederal, s tate, or local government rules; and (5) the degree to which technology, economic conditions, or other factors have changed in the area affected by the rule.

The EPA received three comment letters in response to the Dece mber 15, 2015 , Federal Register notice. One additional submission appeared to be a duplicate response. All the letters are available for public inspection in the rulemaking docket (docket number EPA

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- 0541 at www.regulations.gov ). The results of the EPA’ s Section 610 review of the Ground Water Rule are presented in this report.

Discussion of Factors R equired by Section 610 of the Regulatory Flexibility Act

1. Continued need for the rule.Two of the comment er s suggested there was a clear and continued need for the rule

. They identified

multiple GWR elements that remain key to providing safe drinking water, including targeted monitoring for bacteria. According to these two commenters, the GWR is benef icial because the r ule provides: 1) state flexibility to incorporate program activities to meet state

- specific needs; 2) source water monitoring to characterize well water quality ; and 3) regulatory authority to require correct ion of significant deficiencies.

The other comment er stated that the GWR has outlived its usefulness, despite a previou s initial beneficial effect. This commenter suggested that the GWR now only results in unnecessary bacteriological testing.

T he a gency believes that the GWR continues to provide essential protection

. For example, bacterial monitoring is a key element of a multi

- barrier approach for public health protection , especially for ground water that has not been disinfected

. The EPA concludes that such testing is necessary and appropriate . Hence, the a gency agrees with the viewpoint that there is a clear and continued need for the rule

. 2. Nature of complain t s or comments received concerning the rule.

There were two main issues for which comme nter s requested that the rule be amended to ease the burden on small systems. Both issues are associated with triggered monitoring when a total coliform is detected under the T CR or the Revised Total Coliform Rule (RTCR) 1

. The TCR/RTCR and GWR are designed to complement each other, and therefore reduce monitoring costs. Monitoring required under the TCR/RTCR is the trigger for some actions required under the GWR. For instance, s ource water GWR monitoring is required only if a TCR/RTCR sample is total colifo rm positive.

Two commenters report an apparent prevalence of routine tot al coliform positive occurrence. According to the commenters, t hese detections add cost because a positive sample requires additional source water samples. Both commenter s believe th at this single , unconfirmed occurrence is too sensitive a trigger; one commenter believes that a better choice is either a confirmed total coliform positive or an E. coli occurrence ; the other commenter suggests triggering only when a sample is E. coli positive

. During the GWR r ulemaking process, the EPA took public comment on the triggered monitoring provisions in the proposed r ule. Based on those comments, the EPA revised the proposed rule to reduce the cost to the regulated community prior to promul gating the final rule

. The EPA recognized that total coliform in undisinfected drinking water is an indicator of a potential contaminant pathway , but it is not in and of itself an indication of fecal contamination. As a result, under the GWR, total c olifor m occurrence results in additional sampling of the well(s) for fecal indicators (either E. coli, enterococci , or coliphage)

. The EPA recognizes that additional samples add burden, but the agency believes that the se ad ditional samples provide better informa tion , which is useful to protect the public health of consumers using undisinfected public water systems ( PWS s)

. A dditional samples help ascertain whether the total

1 The Revised Total Coliform Rule (RTCR) is a revision of the Total Coliform Rule . The RTCR became effective on April 1 5, 2013. Public water systems must begin compliance with the RTCR no later than April 1, 2016. The RTCR did not change the provisions for triggered source monitoring under the GWR.coliform occurrence is a resu lt of contaminant infiltration of the source water or whether there is some

bacteria l occurrence within the water distribution network

. If the source of contamination is infiltration, it is considered a more serious issue because the infiltrating groundwater can entrain fecal contaminants such as bacteria l and viral pathogens.

All commenters suggest that making change s to the GWR triggered monitoring target would better align the GWR with the RTCR. The RTCR was promulgated after the GWR. Because the RTCR shifted focus to E. coli and away from fecal colifor m, commenters suggest reducing total coliform monitoring in the GWR to reduce total burden and , in their opinions, better align the GWR with RTCR requirements

. The EPA notes that t he RTCR applies equally to all PWS s , both treated and untreated. The rule is designed to identify (and remediate) contaminant intrusion into distribution systems and contaminant occurrence. In contrast, the GWR triggered source water monitoring requirement applies only to untreated systems or to systems that do not provide 4

- log i nactivation of viruses

. Fecal indicator monitoring protects public health by identifying wells with potential contamin ant pathways and contamination occurrence

. Furthermore, many GWR systems are small with limited distribution systems . Because of these differing public health objectives and because the GWR and RTCR complement each other ’ s goals , the EPA does not believe that the recent RTCR changes necessitate GWR changes.

A second issue espoused by two commenter s is the burden on consecutive systems whe n a routine TCR/RTCR sample is total coliform positive. The GWR requires that all sources that serve the consecutive system must be tested for the presence of fecal indicators when a sample under the TCR/RTCR is total coliform positive

. These two commenter s state that it is significant burden to test each source. The EPA acknowledges the extra burden that result s when multiple source water samples must be tested. However, for these undisinfected systems, sampling all ground water sources identifies which , if any , of the sources show evidence of a contaminant pathway so that potential issues can be addressed

. This deductive approach generates actionable information that can be used to protect public health.
3. The complexity of the rule.

The EPA received comments that the GWR overlap s in part with the TCR /RTCR . I n particular, commenters noted perceived overlap in needing to coordinate and track significant deficiencies under the GWR and sanitary defects under the RTCR. Commenters believe that t he differin g schedules associated in addressing significant deficiencies and sanitary defects may pose a challenge to achieving compliance with both rules.

As discussed in the Public Comment and Response Document for the Revised Total Coliform Rule , 2 t he advisory c ommittee 3 specifically stated that “sanitary defects” are specific to the assessment and corrective action requirements of the RTCR and are not intended to be linked directly to “significant deficiencies” under the Interim Enhanced Surf ace Water Treatment Rule and the GWR, although some problems could meet either definition. The term “significant deficiency” is tied or associated with the eight elements of a sanitary survey. Accordingly, there are problems that are “sanitary defects” and are also “significa nt deficiencies” and vice versa. For instance, source water problems like those associated

2 US EPA. Public Comment and Response Document for the Revised Total Colifo rm Rule. EPA815

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- 014. December 2012.
3 EPA convened a Federal Advisory Committee to discuss the revisions to the Total Coliform Rule.with the well casing may fit the definition of both a “sanitary defect” and a “significant deficiency.”

Depending on when the problem was identified (i.e., during a sanitary survey or during an assessment triggered under RTCR) and on the nature of the problem, the state can set guidelines on how to characterize the problem and how systems can comply with both rules, if needed. Nothing in the RTCR is intended to limit the existing authorities of states under other regulations

. As discussed above, the TCR/RTCR and GWR are complementary rules and are designed to support each other. The EPA recognizes that there may be challenges in implementing both rules. The EPA tries t o address simultaneous compliance with the RTCR and with the requirements of other drinking water rules such as the GWR in the RTCR Assessments and Corrective Actions Guidance Manual

- Interim Final, 4 State Implementation Guidance

- Interim Final, 5 and A Guide for Small Public Water Systems. 6 S tates also have the flexibility and multiple authorities to address issues under the two rules. This allows states to use system

- specific knowledge to most effectively and expeditiously address issues.
One commenter stated the difficulty for s tate approval of UV for 4

- log virus inactivation. The
commenter suggested that there remains insufficient information for s tates to approve UV inactivation as an alternative to chlorine disinfection for 4

- log virus inactivation.

The EPA acknowledges the challenges for s tate s tasked with approval of UV (instead of chlorination) for 4

- log virus inactivation. T he UV validation process published in the Long Term 2 Enhanced Surface Water Rule UV Disinfection Guidance docu ment 7 is appropriate for demonstrating 4

- log virus inactivation for technolo gies with perform ance studies for adenovirus validation . However, the current guidance may not have the newest results and may require UV doses, hardware and energy burdens that may be too costly for small undisinfected ground water systems. The EPA continues to participate in UV work groups to find ways to verif y 4

- log virus inactivation using differing UV lamps in combination with a variety of virus targ ets, including adenovirus, hepatitis A and coxsackie A virus , which are especially resistant to UV inactivation . The UV workgroup continues to look at validation studies to reduce burden and to make UV available to smaller sy s tems.

4. The extent to which r ule overlaps, duplicates, or conflicts with other f eder al , s tate, or local government rules.

One commenter reiterated that the GWR dea d lines for correction of significant deficiencies are different from the RTCR deadlines for sanitary defects. This putativ e conflict is believed to complicate s tate management of the two rules. The EPA anticipates experience gained from implementing both rules provide s s tates with insight on more efficient ways to manage complementary components of both rules. Please see disc ussion above (item 3) about simultaneous rule compliance.

4 US EPA. Revised Total Coliform Rule Assessments and Corrective Actions Guidance Manual

– Interim Final. EPA 815

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- 006. September 2014.
5 US EPA. The Revised Total Coliform Rule (RTCR) State Implementation Guidance

– Interim Final. EPA 816

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- 004. December 2014.
6 US EPA. The Revised Total Coliform Rule, A Guide for Small Public Water Systems. EPA 815

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- 0 02. October 2015

. 7 US EPA. Ultraviolet Disinfection Guidance Manual for the Final Long Term 2 Enhanced Surface Water Treatment R ule. EPA 815

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- 007. November 2007.5. The degree to which technology, economic conditions, or other factors have changed in the area

affected by the r ule.
One commenter suggests that the newer technologies (membrane or UV) to achiev e 4

- log virus inactivation remain desirable but insufficiently demonstrated protective of public health. The EPA recognizes that continued information sharing with the states is key to state adoption and oversight of new technologies. The EPA continues to participate in workshops and to conduct research to bett er demonstrate the capability of the new technologies , especially the use of new lamps and vir us targets for UV. For membrane technologies , state oversight of performance remains challenging because membrane i n tegrity testing to show virus removal is impractical

. Because many membranes are not capable of virus removal, s tates are challenged by conflicting and incomplete information. The EPA believes that continued information sharing about membrane s a nd membrane integrity over time will assist state adoption and oversight procedures.

Conclusion
Most of the comments were aimed at suggesting that the a gency make clarifications in certain areas of the GWR to aid small entitie s in r ule compliance. After re vie w ing all the comments regarding this Regulatory Flexibility Act Section 610 Review, the a gency has concluded that revisions or amendments to minimize economic impacts on small entities from the Ground Water Rule are not warranted at this time.

The EPA c ontinues to view the Ground Water Rule component of the Nation Primary Drinking Water Regulations ( NPDWR ) as important to ensure and protect the health of consumers served by public drinking water systems and intends to continue to require compliance with this NPDWR. The a gency also bases its decision to not revise or amend the r ule at this time on the analysis conducted during the promulgation of the r ule . Among other things, the rule included elements which were specifically designed to minimize economic burden on small entities. Among the measures that the a gency took, at the time of r ule promulgation , to minimize imp acts on small entities are: (1) s electing a targeted approach, requiring corrective action (e.g. disinfection) only for high risk systems o r sources that are vulnerable to contamination ; (2) a llowing s tate flexibility to make the GWR less burdensome by permitting TCR source water repeat samples to satisfy GWR triggered source water monitoring requirements ; (3) m inimizing burden by promulgatin g monitoring requirements based on system characteristics (risk) rather than on system size ; and (4) a llowing s tates to consider the characteristics of the individual system when determining an appropriate corrective action. The EPA believes these

measures remain appropriate and minimize burden on small entities

.