The NPDES regulations at 40 CFR 122.44(d) require the development of water quality-based effluent limitations (WQBELs) as necessary to attain water quality standards.  Under §122.45(d), permit limits for continuous dischargers must include both short- and long-term WQBELs unless there is a specific finding of "impracticability." To derive the required short-term (maximum daily or average weekly) permit limits, EPA recommends that permitting authorities use the more stringent derivation values between the GM and STV. To derive the required long-term (average monthly) permit limits, EPA recommends that permitting authorities use the GM. Once established, pathogen limits for continuous dischargers are applied and enforced in a manner consistent with all other water quality parameters.

For non-continuous or episodic discharges, by comparison, 40 CFR 122.45(e) requires WQBELs to reflect the frequency of discharge; total mass; maximum discharge rate; and prohibition or limitation of specified pollutants by mass, concentration, or other measure.  Combined sewer overflows (CSOs) are a key example of these types of discharges.  As the paragraph below discusses, EPA's longstanding CSO Policy has recommended various approaches for addressing CSO discharges.  The statistical framework underlying EPA's revised water quality criteria recommendations recognizes that a certain number of excursions from the STV criteria value may be permissible.  Therefore, in permitting episodic discharges, such as CSOs, it may be appropriate for a permitting authority to authorize a limited number of discharge events that could exceed the STV as long as the permitting authority could demonstrate that the applicable criteria for primary contact uses (STV and geometric mean values) would be maintained in the stream.  (As mentioned above, CSOs are episodic discharges that pose particular challenges for water quality-based permitting due to the extreme variability in the volume and quality of overflows. For this reason the 1994 CSO Control Policy (also see section 402(q) of the CWA) provides for expression of WQBELs as performance standards based on average design conditions (e.g., a maximum number of overflow events per year or a minimum percentage capture of combined sewage). The CSO Policy also recommends WQS review and revision, as appropriate, to reflect the site-specific wet weather impacts of CSOs. This review should be coordinated with the development, implementation, and post-construction monitoring associated with an approved long-term CSO control plan. WQS review could involve a use attainability analysis (40 CFR 131.10(g)) and subsequent modification of a designated use -- for example, adoption of a partial or time-limited use for a defined period of time when primary contact recreation does not exist.

Detailed approaches for deriving WQBELs to meet WQS based on EPA's final 2012 RWQC will be further explained in the TSM.

Identification of Impaired and Threatened Waters Under §303(d) of the CWA and EPA's implementing regulations (40 CFR 130.7), states, territories, and authorized tribes (hereafter referred to as states) are required to develop lists of impaired and threatened waters that require Total Maximum Daily Loads (TMDLs). Impaired waters are those that do not meet any applicable WQS. EPA recommends that states consider as threatened those waters that are currently attaining WQS, but which are expected not to meet WQS by the next listing cycle (every two years). Consistent with EPA recommendation, many states consolidate their §303(d) and §305(b) reporting requirement into one "integrated" report.

For making these water quality attainment determinations, a State that adopts WQSs consistent with the 2012 RWQC, would evaluate all readily available data and information to determine whether a waterbody meets the WQS (i.e., whether the waterbody is in attainment).  A WQS that is consistent with EPA's recommended criteria would include both a GM and an STV, and all three components of a WQS (e.g., magnitude, duration, and frequency) for both the GM and the STV. Both the GM and the STV apply independently and would need to be evaluated to determine whether or not water quality in a given waterbody meets the WQS for primary contact recreation. The waterbody condition would need to be evaluated based on all existing and readily available data and information for the specified duration. EPA's regulations define "all existing and readily available water quality related data and information" at 40 CFR 130.7(b)(5).  EPA expects that water quality attainment determinations would include water quality monitoring data collected as part of a beach monitoring program, as well as information regarding beach closures and advisories.

3.6.3 Practical Considerations for Applying the Criteria

The number of samples is not an approvable element of a WQS, therefore states should not include a minimum sample size as part of their criteria submission.  The recommendations and information provided in this section can be used when identifying sampling frequency as part of a state's monitoring plan.

Typically, a larger dataset will more accurately characterize the water quality in a waterbody, resulting in more meaningful attainment determinations (Table 3 and Figure 5). Therefore, EPA is recommending that states conduct weekly sampling to calculate a GM over a 30 to 90 day period. This recommendation is consistent with global recommendations for recreational water management (WHO, 2003; E.U. 2007; MFE 2003). EPA's analysis indicates increasing the number of samples when calculating a GM from the typical monthly regime of 4 or 5 samples to the recommended 90 day basis of 12 to 15 samples will reduce waterbody misclassification from both Type I (false positive) and Type II (false negative) errors with respect to attainment status based on the computed GM (Table 3 and Figure 5). For example, compared to GMs based on four samples (logsd=0.7), the predicted level of waterbody misclassification for 15 samples is reduced by 50 percent for a simulated waterbody with GM of 30 cfu per 100 mL (from 34 percent to 17 percent) and 98 percent for a simulated waterbody with GM of 60 cfu per 100 mL (from 10 percent to 0.2 percent). Although waterbody misclassification can occur even with large datasets (e.g., 60 samples or more), the likelihood of waterbody misclassification is highest when the GM is based on a small number of samples (Figure 5).

Table 3. Sample size influences the likelihood of misclassification.[1]

                               Number of Samples                            Actual Geometric Mean[2]                          (cfu enterococci per 100 ml)                                                                               25                                       30                                       45                                       60                                        4                                      20.3%                                      34.6%                                      25.0%                                      10.0%                                        5                                      14.0%                                      31.0%                                      21.1%                                      4.0%                                       12                                      5.3%                                      22.0%                                      9.7%                                      0.2%                                       15                                      3.4%                                      17.4%                                      8.6%                                      0.2%

[1]Falsely being determined as above or below the limit (35 GM), when in fact the true GM is below (GM=25 and 30) or above (GM=45 and 60).  [2] Actual GM is the GM of a simulated waterbody (with logsd=0.7).

                                        Figure 5. Likelihood of misclassification as a function of sample size.  (Graphical representation of data in Table 3)

4.0 Recreational Water Quality Criteria

EPA evaluated the available data and determined that the designated use of recreation would be protected if the following criteria were adopted into State WQS:

      (a) Fresh water criteria          Magnitude: Culturable E. coli at a GM of 126 cfu per 100 mL and an STV of 235 cfu per 100 mL measured using EPA Method 1603, or any other equivalent method that measures culturable E. coli; culturable enterococci at a GM of 33 cfu per 100 mL and an STV of 61 cfu per 100 mL measured using EPA Method 1600 (U.S. EPA, 2002b), or any other equivalent method that measures culturable enterococci; or both of the above criteria. EPA believes that in order to be consistent with EPA's recommended criteria, the criteria in a State WQS need to include both the GM and STV.                    Duration: For calculating the GM and associated STV, EPA recommends a duration between 30 days and 90 days.  The duration for calculating the GM and associated STV should not exceed 90 days. The duration is a component of a water quality criterion, and as such, would need to be explicitly included in the State's WQS. Sampling of waterbodies should be representative of meteorological conditions (e.g., wet and dry weather). If a State is not sampling during or immediately after a rain event, the State should advise the public to the risks of primary contact recreation.                    Frequency: EPA recommends a frequency of zero exceedances of the GM and <= 25 percent exceedance of the STV, over the duration specified for calculating the GM and STV.  The frequency of exceedance is a component of a water quality criterion, and as such, would need to be explicitly included in State's WQS.

      (b) Marine criteria          Magnitude: Culturable enterococci at a GM of 35 cfu per 100 mL and an STV of 104 cfu per 100 mL measured using EPA Method 1600, or any other equivalent method that measures culturable enterococci. EPA believes that in order to be consistent with EPA's recommended criteria, the criteria in a State WQS need to include both the GM and STV.

         Duration: For calculating the GM and associated STV, EPA recommends a duration between 30 days and 90 days. The duration for calculating the GM and the associated STV should not exceed 90 days. The duration is a component of a water quality criterion, and as such, would need to be explicitly included in the State's WQS. Sampling of waterbodies should be representative of meteorological conditions (e.g., wet and dry weather). If a State is not sampling during or immediately after a rain event, the State should advise the public to the risks of primary contact recreation.

         Frequency: EPA recommends a frequency of zero exceedances of the GM and <= 25 percent exceedance of the STV, over the duration specified for calculating the GM and STV.  The frequency of exceedance is a component of a water quality criterion, and as such, would need to be explicitly included in State's WQS.           EPA has also developed a qPCR method to detect and quantify enterococci more rapidly than the culture method. Enterococci as measured by EPA Enterococcus qPCR method A has shown a strong relationship to GI illness in the recent EPA NEEAR epidemiological studies compared to other methods tested (Wade et al., 2008; U.S. EPA, 2010d). Introduction of EPA Enterococcus qPCR method A is anticipated also to provide increased public health protection by permitting timely notification to swimmers of levels of FIB that exceed the site-specific criteria value. While the fresh water Great Lakes and temperate marine water NEEAR studies resulted in minimal to no inhibition, it is EPA's goal to publish RWQC recommendations that can be recommended nationally.  Given the current state of knowledge regarding the performance of qPCR methods under varied waterbody conditions and the limited experience of its use in the field, EPA encourages a site-specific assessment of the method's performance before it is adopted into State WQS for implementation in beach monitoring programs.

For the purposes of beach monitoring, alternative site-specific criteria could be adopted into State standards measured by EPA's Enterococcus qPCR method A based on a site-specific performance characterization. This method is not recommended for NPDES permitting. A "site" may be a beach, a waterbody, or a particular watershed that is anticipated to have uniform qualities throughout. As States adopt water-quality standards for enterococci, as measured by EPA's Enterococcus qPCR method A, they will gain experience with the qPCR method and better understand how this method performs in their waters. Considerations for determining how qPCR could be used to develop site-specific criteria will be provided in additional TSM. For States interested in adopting a value for enterococci using EPA's Enterococcus qPCR method A into their WQS, EPA recommends a GM criterion of 475 CCE per 100 mL and an STV criterion of 1,000 CCE per 100 mL in freshwaters and marine waters based on its epidemiological study data.

Because this document only includes supplementary information about how States may adopt water-quality standards on a site-specific basis for enterococci as measured by qPCR, the 2012 RWQC recommendations are not "applicable" to that pathogen indicator (i.e., enterococci as measured by qPCR). Therefore, the inclusion of qPCR-related information in this document does not trigger the requirement in CWA §303(i) that States adopt water-quality standards "for all pathogens and pathogen indicators to which the new or revised WQC are applicable" for their coastal recreational waters. 5.0 Tools to Support States and Tribes in Managing Recreational Waters and for Considering Alternate Water Quality Criteria

EPA's implementing regulations for §303 of the CWA provide that "states must adopt those WQC that protect the designated use. Such criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use." (40 CFR §131.11(a)). EPA's regulations stated in 40 CFR §131.11(b)(1) provide that "In establishing criteria, States should (1) Establish numerical values based on (i) 304(a) Guidance; or (ii) 304(a) Guidance modified to reflect site-specific conditions; or (iii) Other scientifically defensible methods." WQS can be established for waterbodies, or a portion of a water body and therefore they could be established for a specific site, such as a waterbody adjacent to a beach or the entire water body that is  anticipated to have uniform qualities throughout. When EPA reviews State WQSs for approval or disapproval under the CWA, EPA must ensure that the WQC in the standard (regardless of whether they are "site-specific") are scientifically defensible and protective of the designated use.

The tools discussed in this section fall into two main categories: (1) tools that States can use to enhance public health protection when implementing state WQS for primary contact recreation; and (2) tools that can be used by States in the development of WQC that differs from EPA's recommended criteria ("alternate criteria"). Alternate criteria could be developed to reflect site-specific conditions, or they could be developed using different indicators and analytical methods.  State WQS that include alternate criteria would need to be scientifically defensible and protective of the use. These tools reflect currently available scientific information, can be utilized to assist in the assessment and management of recreational waters (see section 5.1), and have the potential to be used in the development of site-specific criteria (see section 5.2). Site-specific criteria are based in part on assumptions regarding the current state of a watershed such as current land uses, and should be revisited no less frequently than triennially to ensure the site-specific criteria remains protective of the primary contact recreation use. This section does not provide details on how to implement these tools. Additional, detailed information on these tools will be provided in TSM.

The tools discussed below (and the corresponding subsections) are (1) sanitary surveys (5.1.1); (2) predictive models (5.1.2); (3) epidemiological studies (5.2.1); (4) quantitative microbial risk assessment (QMRA) (5.2.2); and (5) approaches for developing criteria using alternative fecal indicators and/or methods (5.2.3).

5.1 Tools for Assessing and Managing Recreational Waters

EPA recognizes that advancements have been made since the publication of the 1986 criteria in the area of managing recreational waters. This section discusses tools that States can use to enhance public health protection. These tools can aid in the identification of days of poor water quality on a site-specific basis. Specifically, this section discusses the use of sanitary surveys as a tool for identifying sources of fecal contamination and identifying and prioritizing clean-up/remediation actions for a specific body of water and the use of predictive models for timely beach notification. EPA encourages the use of sanitary surveys and predictive models, specifically by beach managers, to better understand and potentially control sources of fecal contamination and pathogens. EPA also encourages the use of predictive models to supplement a sound monitoring program that has the potential to prevent human exposure on days of poor water quality. Together, the tools in this section have the potential to allow a State or locality to assess and communicate the risks associated with fecally contaminated recreational waters. These tools are not a part of the adopted WQSs and do not result in different numerical criteria value(s).

5.1.1 Sanitary Survey

Beach managers often use sanitary surveys to assess beaches for fecal contamination and to prioritize clean-up and remediation efforts. Beach sanitary surveys involve collecting information at the beach, as well as in the surrounding watershed. Information collected at the beach may include the following: proximity to septic systems, number of birds at the beach, slope of the beach, location and condition of bathrooms at beach facilities, and amount of algae on the beach. Information collected in the watershed may include the following: land use, location of storm water outfalls, surface water quality, and residential septic tank information.

Sanitary surveys are a "snapshot" of the conditions at a beach, which can change due to factors including those listed above. Sanitary surveys help State and local beach program managers and public health officials identify sources of beach water pollution, assess the magnitude of pollution, and designate priority locations for water testing. In conjunction with monitoring to determine whether a waterbody is meeting State WQS for recreation, they can use sanitary survey data (such as bacteria levels, source flow, turbidity, and rainfall) to develop models to predict bathing beach water quality using readily available data. Other information, such as source tracking and watershed information may be needed to effectively delineate sources within the watershed.

EPA has developed documents on sanitary surveys for the purpose of supplementing the 2012 RWQC recommendations. These documents are available on the website: http://water.epa.gov/type/oceb/beaches/sanitarysurvey_index.cfm, as well as in Great Lakes Beach Sanitary Survey User Manual (U.S. EPA, 2008). EPA plans to include detailed information on developing and using sanitary surveys in its upcoming beach guidance and other TSM (see Appendix D).

5.1.2 Predictive Models

EPA recognizes that, at some locations and under some conditions, implementation of a rapid enumeration methodology, such as the qPCR-based method described previously in this document, is not feasible or is unlikely to provide sufficiently timely information for making a same-day beach notification decision (for example, in locations where water samples cannot be transported to the appropriate laboratory facilities for analysis in a timely manner). EPA is therefore providing an approach that may supplement the current culture-based analytical results to facilitate same-day public health decisions. EPA encourages the use of predictive models in these situations to allow timely notification at beaches. Typically, States would use these and site-specific predictive models, such as statistical models, rainfall threshold levels, and notification protocols (U.S. EPA, 2010b, 2010c), to supplement monitoring using culture-based methods. The models would not themselves be a part of State' WQS.

Predictive models that are currently employed in areas such as the Great Lakes have proven to be effective.  These models draw on existing culture-based monitoring data bases, are inexpensive to use, and allow for a rapid, proactive beach management decisions (U.S. EPA, 2010b,c). They provide a means to supplement monitoring and support rapid notification.

EPA has conducted research and published a two-volume report to advance the use of predictive models (U.S. EPA, 2010b,c). Volume I summarizes the current uses of these predictive tools to provide model developers with the basic concepts for developing predictive tools for same-day beach notifications at coastal marine waters, the Great Lakes, and inland waters (U.S. EPA, 2010b). Volume II provides the results of research conducted by EPA on developing statistical models at research sites. It also presents Virtual Beach, a software package designed to build statistical multivariate linear regression predictive models (U.S. EPA, 2010c; see Appendix D). EPA is also expanding the Virtual Beach tool so that it will include other statistical approaches besides multiple linear regression. Techniques such as recursive partitioning (especially a technique called the Gradient Boosting Method [GBM] that involves usage of multiple decision trees) are promising. Artificial neural networks, binary logistic regression, and partial least-squares techniques also are being added. Beyond these improvements in Virtual Beach, other efforts such as linking watershed and statistical models, Cyterski's temporal synchronization approach to incorporate time lags, and process-based transformations are being pursued to improve predictive modeling efforts.

The types of predictive tools that can be used to make beach notification decisions fall into the following categories: statistical regression models, rainfall-based notifications, decision trees or notification protocols, deterministic models, and combinations of tools.

   * A statistical regression model is a general term for any type of statistical modeling approach used to predict beach water quality. A statistical correlation (for example, one established using multivariate linear regression techniques) is observed between FIB and environmental and water quality variables that are easier to measure than FIB. Typical variables include meteorological conditions (such as solar radiation, air temperature, precipitation, wind speed and direction, and dew point), water quality (such as turbidity, pH, conductivity/salinity, and ultraviolet [UV]/visible spectra), and hydrodynamic conditions (such as flows of nearby tributaries, magnitude and direction of water currents, wave height, and tidal stage).     * Rainfall-based notifications are based on a rain threshold level, which is a predictive tool that can be used when a connection exists between the concentration of FIB at a beach and the amount of rain received in nearby areas. That relationship can be quantified as the amount or intensity of rainfall (i.e., the threshold level) that is likely to cause an exceedance of the WQSs at a beach, and the length of time over which the standards will be exceeded.     * Decision trees or notification protocols are a series of questions that can also be used to consider factors such as rainfall to guide beach notifications. Such evaluations use water quality sampling, rainfall data, and other environmental factors that could influence FIB levels (such as proximity to pollution sources, wind direction, visual observations, or other information specific to the region or beach). This process is referred to as developing a notification protocol.     * Deterministic models use mathematical representations of the processes that affect bacteria densities to predict exceedances of WQSs. They include a range of simple to complex modeling techniques.

There are various considerations for developing each of these model types for beaches and each has its own set of challenges (Boehm et al., 2007). To be effective, these predictive models should be sufficiently calibrated to reflect site-specific conditions and account for inter-seasonal variations, if applicable. Predictive models are intended for use as a rapid beach notification tool only. They do not replace the need for a sound monitoring program, and the development of predictive models requires monitoring data both for establishing and maintaining statistical relevance. A State using a site-specific predictive model would still need to evaluate the waterbody in order to determine whether it meets the WQS for purposes of CWA §303(d) listing.

5.2 Tools for Use in Developing Alternative Criteria

As described above, EPA's regulations provide that "States must adopt those water quality criteria that protect the designated use.  Such criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use."  40 CFR 131.11(a).  EPA's regulations at 40 CFR §131.11(b)(1) provide that in establishing criteria, States should (1) establish numerical criteria based on (i) EPA's CWA §304(a) guidance; (ii) §304(a) guidance modified to reflect site-specific conditions or, (iii) other scientifically defensible methods. States could adopt site-specific modifications of a §304(a) criterion to reflect local environmental conditions and human exposure patterns.  A "site" may signify beach, a waterbody, or a particular watershed, that is anticipated to have uniform qualities throughout. Such site-specific criteria may be adopted into a state WQS as long as the resulting site-specific WQS are scientifically defensible and protective of the use. For example, alternative WQSs may involve the adoption of different numerical value(s) that are based on: (1) the results of an epidemiological study; (2) the results of a quantitative QMRA to account for different sources of FIB; or (3) a different FIB-method combination. To be used for CWA purposes, site-specific criteria would need to be adopted into State WQS and reviewed and approved under CWA §303(c).

EPA believes that the recommended 2012 RWQC, which are derived from and informed by the preponderance of epidemiological evidence in human fecal-impacted waters, would be protective of primary contact recreation. EPA recognizes, however, that the conditions studied in the temperate fresh waters and marine waters by the NEEAR studies (i.e., waters primarily impacted by secondary-treated and disinfected POTW effluent) may not be representative of all possible fecal contamination combinations that could impact recreational bodies of water in the United States. Therefore, this section describes the tools available to support States considering alternate WQS based on other data such as: (1) epidemiological studies, (2) QMRA, and (3) novel fecal indicators and analytical methods.

5.2.1 Epidemiological Studies

EPA's NEEAR epidemiological studies were conducted in water primarily impacted human fecal contamination, including temperate fresh water, temperate marine water, and tropical marine water sites, as well as one temperate marine water site that was impacted by urban runoff (Wade et al., 2006, 2008, 2010; U.S. EPA, 2010d). Statistically significant associations between water quality, as determined using Enterococcus measured by qPCR, and reported illness were observed in the temperate marine water and fresh water POTW-impacted beaches. No associations between FIB, enumerated with either culture-based or qPCR-based methods, and reported illness were observed at the beach impacted by urban runoff in Surfside, SC or at the tropical beach in Boquerón, PR.

Local and/or State agencies have conducted, or are considering conducting, epidemiological studies of health risks and water quality at recreational beach sites. For example, epidemiology studies of recreational water exposures have been conducted recently in Southern California (SCCWRP,personal communication, 2010), south Florida (Fleming, 2006; Sinigalliano, 2010), and Ohio (Marion et al., 2010). These studies could be used to confirm EPA's 2012 criteria or to develop site-specific criteria.

Several factors can influence the potential epidemiological relationship between indicator density and relative human health risk. Some of the potentially important factors include the source of fecal contamination, age of the fecal contamination, intensity of solar radiation that the fecal contamination is exposed to, water salinity, turbidity, dissolved organic matter, water temperature, and nutrient content. Numerous factors also affect the occurrence and distribution of FIB and the pathogens from the source of contamination to the receptor location that include, but are not limited to, the following: predation of bacteria by other organisms; differential interactions between microbes and sediment, including the release and resuspension of bacteria from sediments in the water column; and differential environmental effects on indicator organisms versus pathogens. For additional information, see Appendix B.

States or local agencies may choose to conduct epidemiological studies in their waterbodies and use the results from those studies to derive site-specific criteria. To derive scientifically defensible site-specific WQC for adoption into state standards, the epidemiological studies should be of similar quality and of comparable scientific rigor as EPA's NEEAR water studies. The epidemiological information underlying the recommended 2012 RWQC was produced using a study design called "prospective cohort." EPA is unsure at the current time how results from alternate epidemiological study designs can inform site-specific criteria. Significant differences in the study designs, data collection, and analysis methods, exposure, and health outcome measures pose a major challenge to the ability to quantitatively compare the illness rate and water quality relationships in epidemiological studies with significant design differences to the NEEAR studies.

Epidemiological studies are resource intensive and logistically difficult, although the results can provide the data necessary for a scientifically defensible basis to allow the adoption of WQS based on fecal indicator/methods that are not part of EPA's national §304(a) recommendations. First, site-specific epidemiological studies can take into account the characteristics of local waterbodies to support the derivation of a site-specific criteria value based on the fecal indicator/methods that are part of EPA's national §304(a) recommendations. Second, such studies may support the development and adoption of alternative criteria based on different health endpoints, such as respiratory illnesses, than EPA has used in its current recommendations (i.e., GI illnesses). Where the studies demonstrate a statistically significant correlation between levels of water quality measured using particular FIB(s) and adverse health outcomes, they may be scientifically defensible and as such, could be used to develop and adopt alternate criteria.

If a State wishes to develop alternative criteria using their own epidemiological studies, EPA recommends that the studies also be of the PC design, to facilitate the evaluation of the resultant alternative criteria. EPA's TSM will provide additional information on the use of epidemiological studies in development of site-specific criteria.

5.2.2 Quantitative Microbial Risk Assessment and Sanitary Characterization

If a particular waterbody is believed to be predominantly impacted by nonhuman sources, a site-specific criterion may be worth investigating. EPA's research indicates that understanding the predominant source of fecal contamination is critical for characterization of the human health risks associated with recreational water exposure. Various epidemiological investigations, including EPA's have documented human health effects in waters impacted by human fecal contamination. Additionally, QMRA studies have demonstrated that the potential human health risks from human and non-human fecal sources can be different due to the nature of the source, the type and number of pathogens from any given source, as well as, variations in the co-occurrence of pathogens and fecal indicators associated with different sources (Till and McBride, 2004, Roser et al, 2006, Schoen and Ashbolt, 2010, Soller et al., 2010b, Bambic et al, 2011). While human sources of fecal contamination pose similar health risks regardless of location, the differences in predicted human health risks from recreational water exposure to non-human fecal contamination are dependent on local characteristics that will vary from site-to-site.  EPA is not recommending nationally-applicable criteria values for recreational waters that account for non-human sources of fecal contamination due to this variability.  EPA's nationally applicable criteria values can be used for such waters. However, EPA is making available TSMs for QMRA to assist States in developing equivalent site-specific criteria to account for local scale, non-human sources.

Any alternative WQSs must be scientifically defensible and protective of the use. QMRA is one tool that has been identified as potentially useful for developing alternative criteria by enhancing the interpretation and application of new or existing epidemiological data (Boehm et al., 2009; Dorevitch et al., 2011).  Recreational water epidemiological studies describe the risks associated with exposure to fecal contamination as measured by FIB.  QMRA can supplement new or existing epidemiological results by characterizing various exposure scenarios, interpreting potential etiological drivers for the observed epidemiological results, and accounting for differences in risks posed by various types of fecal sources.  EPA is working to anchor the QMRA framework to existing epidemiological relationships as part of the TSMs.

QMRA applies risk-assessment principles (NRC, 1983) to approximate the consequences from exposure to selected infectious pathogens. To the greatest possible extent, the QMRA process includes the evaluation and consideration of quantitative information; qualitative information, however, is also used when appropriate (WHO, 1999). QMRA can be initiated for a variety of reasons, including, but not limited to, the following:

   * to assess the potential for human risk associated with exposure to a known pathogen;     * to determine critical points for control, such as watershed protection measures;    * to determine specific treatment processes to reduce, remove, or inactivate various pathogens;      * to predict the consequences of various management options for reducing risk;      * to determine appropriate criteria (regulatory) levels that will protect individuals and/or populations to a specified risk level or range    * to identify and prioritize research needs; and    * to assist in interpretation of epidemiological investigations.

QMRA methodologies have been applied to evaluate and manage pathogen risks for a range of scenarios, including from food, sludge/biosolids, drinking water, recycled water, and recreational waters. Moreover, risk assessment in general has been used extensively by EPA for decades to establish human health criteria for a wide range of pollutants in water and other media, and microbial risk assessment has been used to inform EPA's policy making for microbiological pollutants in drinking water and biosolids, and by other U.S. and international governmental agencies (e.g., U.S. Department of Agriculture [USDA], U.S. Food and Drug Administration, WHO) to protect public health from exposure to microbiological pollutants in food and water.

For recreational waters, QMRA incorporates a site-specific sanitary characterization and maybe used to determine if a particular waterbody/watershed is predominantly impacted by a source other than human fecal contamination and whether lower relative risk is associated with the contributing source(s) of fecal contamination in that waterbody or watershed (Soller et al., 2010a,b). Site characterization tools (similar to an enhanced sanitary survey) can provide detailed information on the source(s) of fecal contamination in a waterbody and whether the sources are human or nonhuman. EPA developed a QMRA-specific application of the sanitary survey, hereafter referred to as a site characterization, to capture information directly applicable for the conduct of a QMRA. This site-specific sanitary characterization process will be described in detail in the QMRA TSM.

Where sanitary site characterization work indicates that the predominant source is human, the 2012 RWQC recommendations are scientifically defensible and protective of primary contact recreation. Also, when sources are predominately nonhuman, EPA has concluded the 2012 RWQC would be scientifically defensible and protective of primary contact recreation.  Where the sources of fecal contamination are predominantly nonhuman or non fecal, QMRA is a tool that is less resource intensive and more broadly applicable than epidemiological studies.  Epidemiological studies have reported ambiguous results in scenarios impacted by nonhuman sources and are impractical in infrequently used waterbodies.  However, EPA's QMRA framework, anchored with the newer reported epidemiological relationships, will help facilitate the risk characterization on a site-specific basis.

EPA's recent QMRA research provides new information on fecal contamination from nonhuman sources which, under some circumstances, may be less risky to human health than contamination from human sources (Schoen and Ashbolt, 2010; Soller et al., 2010a,b; U.S. EPA, 2010a). For additional information and case studies of QMRA for recreational waters, see Appendix C. This research demonstrates that different pathogens are expected to cause illness in recreational waters impacted by different sources of fecal contamination. For example, in human-impacted recreational waters, human enteric viruses are expected to cause a large proportion of illnesses (Soller et al., 2010a). In recreational waters impacted by gulls and agricultural animals, such as cattle, pigs, and chickens, other pathogens (such as bacteria and protozoa) would be expected to be the etiologic agents that cause human illness (Roser et al., 2006, Soller et al., 2010b; Schoen and Ashbolt, 2010). Other research also supports the utility of QMRA, such as QMRA conducted for a tropical waterbody (Viau et al., 2011) and the use of QMRA to establish recreational WQC in New Zealand (MFE, 2003).

Moreover, the relative level of predicted human illness in recreational waters impacted by nonhuman sources can vary depending on whether the contamination is direct or via runoff due to a storm event (U.S. EPA, 2010a). For example, when considering a direct contamination scenario in which FIB was assumed to be present at the 1986 criteria levels, predicted GI illness risks associated with exposure to recreational waters impacted by fresh cattle feces were not substantially different from waters impacted by human sources (Soller et al., 2010b). Predicted illness levels in bodies of water that contain FIB at the 1986 criteria levels from land-applied fecal material from cattle (with microbial loading due to runoff from a storm event), however, were approximately 20 times lower than the risk associated with human-impacted water (U.S. EPA, 2010a). These results highlight the potential power of QMRA to inform site-specific criteria.

To derive site-specific criteria that are considered scientifically defensible and protective of the use, QMRA studies should follow accepted practices, rely on scientifically defensible data, and be well documented (Haas et al., 1999; Soller et al., 2004; Schoen and Ashbolt, 2010; MFE, 2003). EPA plans to provide additional guidance on conducting QMRA for the purpose of assessing differences in risk and for the possible derivation of site-specific criteria in a TSM.

5.2.3 Developing Alternative Criteria Based on Novel Indicators or New Analytical Methods, without Site-Specific Epidemiological Studies

EPA anticipates that scientific advancements will provide new technologies for quantifying fecal pathogens or fecal contamination indicators. These newer technologies may provide alternative ways to address methodological considerations, such as rapidity, sensitivity and specificity, and method performance in site-specific situations, but may not be appropriate for all CWA purposes. As new or alternative indicator and/or enumeration method combinations are developed, States may want to consider using them to develop WQC on a site-specific basis.  EPA would approve them if the resulting criteria are scientifically defensible and protective of the recreational use. One way such alternate criteria may be demonstrated to be scientifically defensible would be a consistent and predictable demonstration of the enumeration method performance for a proposed site-specific criterion.

Previously, EPA has used the relative performance of enumeration methods to describe a common level of water quality. For example, derivation of the 1986 criteria was fundamentally based on the comparison of enumeration methods for FC, enterococci, and E. coli. In that specific case, those comparisons were made among membrane filtration methods specific to each target organism. Another example of this occurred when EPA approved the use of the IDEXX-based methods for the detection of enterococci and E. coli. In this comparison, results from a membrane-filtration method were compared to another method that relied on substrate-utilization and MPN enumeration. Use of already available rapid methods, such as qPCR methods for E. coli, has been demonstrated (Lavender and Kinzelman, 2009), on a site-specific basis.

Examples of other reported methodologies for quantifying of FIB include the following: immunomagnetic separation/adenosine triphosphate (IMS/ATP), propidium monoazide (PMA) qPCR, reverse transcriptase (RT) PCR, covalently linked immunomagnetic separation/adenosine triphosphate (COV-IMS-ATP), and transcription mediated amplification (TMA-RNA)

Also, additional indicator organisms can be used with existing methodologies similar to those recommended by the 2012 RWQC. Examples of possible alternative indicators include but are not limited to, Bacteroidales, Clostridium perfringens, human enteric viruses, and coliphages. For example, in one case, Bacteroidales measured by qPCR were highly correlated with Enterococcus and E. coli when either traditional, cultivation dependent, or qPCR methods were used (WERF, 2011). Norovirus GI and GII have also shown to be predictors of the presence of other pathogens like Adenovirus, Giardia, and Cryptosporidium measured by qPCR (WERF, 2011). E. coli and Enterococcus measured by qPCR may also be a possible indicator and method in fresh water. For organism and enumeration methodology combinations that are different from the 2012 RWQC, EPA would review technical information on incorporating alternative indicator organisms and enumeration methods provided by the State.

To facilitate consideration, States could gather water quality data over a recreational season for both an EPA-approved method and the proposed alternative indicator-method combination. A robust relationship need not necessarily be established between EPA's recommendation and alternative indicator(s) for the whole range of indicator densities observed, as EPA's recent research highlights these difficulties and limitations (U.S. EPA, 2010e). It is, however, important that a consistent and predictable relationship exist between the enumeration methods and an established indicator-health relationship in the range of the criteria. A State WQS using a different indicator or analytical method would need to be scientifically defensible and protective of the primary contact recreational use. Information on demonstrating the relationship between two-indicator method combinations can be found in TSM.   References

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Xue, J., Zartarian, V., Moya, J., Freeman, N., Beamer, P., Black, K., Tulve, N., Shalat, S. 2007. Meta-Analysis of Children's Hand-to-Mouth Frequency Data for Estimating Nondietary Ingestion Exposure. Risk Analysis 27(2): 411-420.

Zmirou, N., Pena, L., Ledrans, M., Leterte, A. 2003. Risks Associated with the Microbiological Quality of Bodies of Fresh and Marine Water Used for Recreational Purposes: Summary Estimates Based on Published Epidemiological Studies. Archives of Environmental Health 58(11): 703-711.


[Federal Register Volume 84, Number 164 (Friday, August 23, 2019)]
[Notices]
[Pages 44296-44297]
[FR Doc No: 2019-18151]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2019-0369; FRL-9998-37]

Pesticide Product Registrations; Receipt of Applications for a
New Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has received applications to add a new site (hemp) to the
labeling of currently registered pesticide products that contain active
ingredients with established tolerance exemptions. Due to EPA's
expectation that these initial applications involving hemp may be of
significant interest to the public and to enhance transparency, EPA is
hereby providing notice of receipt and opportunity to comment, although
not required pursuant to the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA).

DATES: Comments must be received on or before September 23, 2019.

ADDRESSES: Submit your comments, identified by the EPA Registration
Number of interest as shown in the body of this document, by one of the
following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (BPPD) (7511P), main telephone number:
(703) 305-7090, email address<EMAIL_ADDRESS>or Michael
Goodis, Registration Division (RD) (7505P), main telephone number:
(703) 305-7090, email address<EMAIL_ADDRESS>The mailing address
for each contact person is: Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001. As part of the mailing address, include the contact person's
name, division, and mail code. The division to contact is listed at the
end of each application summary.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT for the division listed at the end of the
application summary of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in

accordance with procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low-income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, EPA
seeks information on any groups or segments of the population who, as a
result of their location, cultural practices, or other factors, may
have atypical or disproportionately high and adverse human health
impacts or environmental effects from exposure to the pesticides
discussed in this document, compared to the general population.

II. Registration Applications

    When the Agriculture Improvement Act of 2018 (2018 Farm Bill) was
signed into law on December 20, 2018, hemp, defined therein as the
plant Cannabis sativa L. and any part of that plant with a delta-9-
tetrahydrocannabinol concentration of not more than 0.3% on a dry
weight basis, was removed from the Controlled Substances Act.
Consequently, interest in hemp production has substantially increased
over the last several months and the availability of particular tools,
such as pesticides registered under FIFRA, will likely be essential to
supporting the success of this industry going forward.
    Because of these recent developments with regard to hemp, EPA has
received applications to add hemp as a new site to the labeling of some
currently registered pesticide products. These registered pesticide
products contain active ingredients for which EPA previously determined
the residues will be safe under any reasonably foreseeable
circumstances and, pursuant to the Federal Food, Drug, and Cosmetic Act
(FFDCA), established tolerance exemptions, as indicated below, for
those residues in or on all raw agricultural or food commodities. As
these initial applications that involve hemp may be of significant
interest to the public and to enhance transparency, EPA is hereby
providing notice of receipt and opportunity to comment on these
applications. Notice of receipt of these applications does not imply a
decision by EPA on these applications.
    FIFRA section 3(c)(4) requires EPA to ``publish in the Federal
Register [. . .] a notice of each application for registration of any
pesticide [. . .] if it would entail a changed use pattern.'' As
terrestrial outdoor and residential outdoor use patterns (40 CFR
158.100) were previously assessed and approved for the active
ingredients listed below and because hemp, as proposed for addition to
the labels of the products below, falls under these use patterns, EPA
does not consider the use patterns to be changed with these
applications. Thus, EPA is not statutorily required to provide an
opportunity to comment and is doing so here because of the potential
significant interest from the public in these initial applications and
in furtherance of being completely transparent about these
applications. For future pesticide registration applications that are
similar to these applications and that are expected to be submitted
with more regularity, EPA is not planning to notify the public of their
receipt.
    1. EPA Registration Number: 70310-5. Applicant: Agro Logistic
Systems, Inc., P.O. Box 5799, Diamond Bar, CA 91765. Active
ingredients: Azadirachtin and Neem Oil. Product type: Insecticide,
Miticide, Fungicide, and Nematicide. FFDCA clearances: 40 CFR 180.1119
and 40 CFR 180.1291. Contact: BPPD.
    2. EPA Registration Number: 70310-7. Applicant: Agro Logistic
Systems, Inc., P.O. Box 5799, Diamond Bar, CA 91765. Active
ingredients: Azadirachtin and Neem Oil. Product type: Insecticide,
Miticide, Fungicide, and Nematicide. FFDCA clearances: 40 CFR 180.1119
and 40 CFR 180.1291. Contact: BPPD.
    3. EPA Registration Number: 70310-8. Applicant: Agro Logistic
Systems, Inc., P.O. Box 5799, Diamond Bar, CA 91765. Active
ingredients: Azadirachtin and Neem Oil. Product type: Insecticide,
Miticide, Fungicide, and Nematicide. FFDCA clearances: 40 CFR 180.1119
and 40 CFR 180.1291. Contact: BPPD.
    4. EPA Registration Number: 70310-11. Applicant: Agro Logistic
Systems, Inc., P.O. Box 5799, Diamond Bar, CA 91765. Active ingredient:
Neem Oil. Product type: Insecticide, Miticide, and Fungicide. FFDCA
clearance: 40 CFR 180.1291. Contact: BPPD.
    5. EPA Registration Number: 84059-3. Applicant: Marrone Bio
Innovations, D/B/A Marrone Bio Innovations, Inc., 1540 Drew Ave.,
Davis, CA 95618. Active ingredient: Extract of Reynoutria
sachalinensis. Product type: Fungicide and Fungistat. FFDCA clearance:
40 CFR 180.1259. Contact: BPPD.
    6. EPA Registration Number: 84059-28. Applicant: Marrone Bio
Innovations, D/B/A Marrone Bio Innovations, Inc., 1540 Drew Ave.,
Davis, CA 95618. Active ingredient: Bacillus amyloliquefaciens strain
F727. Product type: Fungicide. FFDCA clearance: 40 CFR 180.1347.
Contact: BPPD.
    7. EPA Registration Number: 91865-1. Applicant: Hawthorne
Hydroponics LLC, D/B/A General Hydroponics, 2877 Giffen Ave., Santa
Rosa, CA 95407. Active ingredients: Soybean Oil, Garlic Oil, and
Capsicum Oleoresin Extract. Product type: Insecticide and Repellent.
FFDCA clearances: 40 CFR 180.950(c) and 40 CFR 180.1165. Contact: BPPD.
    8. EPA Registration Number: 91865-2. Applicant: Hawthorne
Hydroponics LLC, D/B/A General Hydroponics, 2877 Giffen Ave., Santa
Rosa, CA 95407. Active ingredient: Potassium Salts of Fatty Acids.
Product type: Insecticide, Fungicide, and Miticide. FFDCA clearance: 40
CFR 180.1068. Contact: RD.
    9. EPA Registration Number: 91865-3. Applicant: Hawthorne
Hydroponics LLC, D/B/A General Hydroponics, 2877 Giffen Ave., Santa
Rosa, CA 95407. Active ingredient: Bacillus amyloliquefaciens strain
D747. Product type: Fungicide and Bactericide. FFDCA clearance: 40 CFR
180.1308. Contact: BPPD.
    10. EPA Registration Number: 91865-4. Applicant: Hawthorne
Hydroponics LLC, D/B/A General Hydroponics, 2877 Giffen Ave., Santa
Rosa, CA 95407. Active ingredient: Azadirachtin. Product type: Insect
Growth Regulator and Repellent. FFDCA clearance: 40 CFR 180.1119.
Contact: BPPD.

    Authority: 7 U.S.C. 136 et seq.

    Dated: August 13, 2019.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of
Pesticide Programs.
[FR Doc. 2019-18151 Filed 8-22-19; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: June 9, 2010 (Volume 75, Number 110)]
[Rules and Regulations]
[Page 32663-32664]
[DOCID:fr09jn10-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2010-0406]

Drawbridge Operation Regulations; Newark Bay, NJ, Maintenance

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, First Coast Guard District, has issued a
temporary deviation from the regulation governing the operation of the
Lehigh Valley Bridge across Newark Bay, mile 4.3, at Newark, New
Jersey. This deviation allows the bridge to remain in the closed
position on seven nonconsecutive days to facilitate scheduled
maintenance.

DATES: This deviation is effective from 9 a.m. on June 14, 2010 through
2 p.m. on July 26, 2010.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2010-0406 and are available online
at http://www.regulations.gov, inserting USCG-2010-0406 in the
``Keyword'' and then clicking ``Search''. They are also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call Mr. Joe Arca, Project Officer, First Coast Guard District,
telephone<PHONE_NUMBER>. If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: The Lehigh Valley Bridge, across Newark Bay
at mile 4.3, at Newark, New Jersey, has a vertical clearance in the
closed position of 35 feet at mean high water and 39 feet at mean low
water. The drawbridge operation regulations are listed at 33 CFR
117.735.
    The owner of the bridge, Conrail, requested a temporary deviation
from the regulations to facilitate scheduled bridge maintenance, lift
cable replacement at the bridge.
    Under this temporary deviation the Lehigh Valley Bridge may remain
in the closed position on Mondays, June 14, 21, 28, July 5, 12, 19, and
26, 2010 between 9 a.m. and 2 p.m. to facilitate lift cable
replacement.
    Waterway users were advised of the requested bridge closures and
offered no objection.
    In accordance with 33 CFR 117.35(e), the bridge must return to its
regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: May 27, 2010.
Gary Kassof,
Bridge Program Manager, First Coast Guard District.
[FR Doc. 2010-13818 Filed 6-8-10; 8:45 am]
BILLING CODE 9110-04-P