Laws and Regulations

Regulatory Authority

• EPA– Water

• Safe Drinking Water Act• Clean Water Act

– Air• Currently No EPA Standards Set for Mold in Indoor Air• Homeland Security; “Biowatch Program”

– Biosolids• Section 405 (d) and (e) • 40 CFR 503

– Disinfectants• FIFRA• OPP

Regulatory Authority

• FDA– Food– Pharmaceutics– Title 21 of CFR

• USDA– FSIS

• Federal Meat, Poultry and Egg Products Inspection Acts

• Title 9 of CFR

– Homeland Security

Drinking Water Regulations

• National Primary Drinking Water Regulation– Legally enforceable standard– Limits levels of specific contaminants that can

adversely affect public health– Maximum Contaminant Level or Treatment Technique

• National Secondary Drinking Water Regulation– Nonenforceable guideline– Covers contaminants that may cause cosmetic or

aesthetic effects

Establishing Standards

Step 1Determining Contaminants

Step 2Establishing

Priorities

Step 3DevelopingRegulations

Selecting Contaminants for Regulation

Contaminant Contaminant Candidate Candidate

ListListUpdated Every Updated Every

5 Years5 Years(Currently 50 chemicals, (Currently 50 chemicals,

10 microbials)10 microbials)

Contaminant Contaminant Candidate Candidate

ListListUpdated Every Updated Every

5 Years5 Years(Currently 50 chemicals, (Currently 50 chemicals,

10 microbials)10 microbials)

Sound ScienceSound ScienceSound ScienceSound Science

Public InputPublic InputPublic InputPublic Input

Regulatory Regulatory Determination Determination on Five on Five Contaminants Contaminants Every 5 YearsEvery 5 Years

Regulatory Regulatory Determination Determination on Five on Five Contaminants Contaminants Every 5 YearsEvery 5 Years

Establishing Standards –Setting Priorities

Occurrence Data

Human Exposure

Health Risks

CCLHealth Effects

Studies

Regulation?

Unregulated ContaminantMonitoring Regulation

NationalContaminantOccurrence

Database

Monitoring Under SDWA

• Underground injection wells

• Public water systems– Finished water monitoring– PWS treatment process monitoring

Public Water System Monitoring

• Finished water monitoring– (MCLs and MRDLs)– Water receiving no treatment– Water with disinfection– Water receiving treatment and disinfection

• Raw water monitoring

• Water treatment process monitoring– Treatment techniques

Finished Water Monitoring Requirements Vary

• Source water type

• System type

• Contaminant group

• System size

• Sampling locations

How Often Must a System Monitor under SDWA?

• Bacteriological quality (coliform bacteria)– Ranges from daily to quarterly

• Turbidity– Ranges from daily or less to continuous

• Chemicals and radiologicals– Quarterly (less or more)

• Disinfectant residuals– Ranges from daily to monthly

• Disinfection byproducts (DBPs)– Ranges from 4 samples per quarter to 1 per quarter

Monitoring-General

• A system can remain on a monitoring schedule only if the sampling results support the schedule

• MCL exceedance?– Must begin quarterly sampling– Must continue until 4 consecutive quarterly

samples are below the MCL• NOTE: compliance determination based on annual

average

Unregulated Contaminant Monitoring Rule

• List of contaminants to monitor

• A schedule for sampling

• Analytical methods

• Reporting requirements– To regulatory agencies– To the public

SDWA

• Regulated Microbes– Cryptosporidium– Giardia– Legionella – Enteric Viruses

• Indicators– Total Coliforms– HPC– Turbidity

CCL

• CCL 2– Adenoviruses – Aeromonas hydrophila – Caliciviruses – Coxsackieviruses – Cyanobacteria (blue-green algae), other freshwater

algae, and their toxins – Echoviruses – Helicobacter pylori – Microsporidia (Enterocytozoon & Septata) – Mycobacterium avium intracellulare (MAC)

Total Coliform Rule

• Standard is 0 CFU/100ml

• Must not detect Coliforms in more than 5% of samples in a month (1 sample per month in<40 samples collected)

• If >5% of samples positive then must report to state and public– State within next business day– Public within 14 days (30days)

Total Coliform Rule

• If a sample positive then system must be retested for TC within 24 hours and analyzed for fecal coliforms and E.coli

• If positives in retest, then acute MCl violation and must rapidly report to state and public; issue BWA– State by end of next business day– Public within 72 hours (24 hours)

Total Coliform Rule

• Sampling is population dependent– <1000 people, once per month

• Exception for GW with SS free of defects

– 50,000 people, 60 times per month– 2.5 million people, 420 time per month

Groundwater Rule

• Periodic Sanitary Surveys

• Source Water Monitoring– Triggered: TCR violation in distribution system

• Within 24 of notification conduct fecal indicator test• 5 repeats if sample positive

– Assessment: At any time required by state to assess high risk systems

LT2 ESWTR

• 2 years of monthly sampling for Cryptosporidium (E.coli trigger)

• Also monitor turbidity

• All SW and GWUDI systems must sample

System Size and Type

Monitor For Frequency Duration

Filtered Systems > 10,000

Cryptosporidium

E. Coli

Turbidity

1 per month 24 months

Filtered Systems < 10,000

E. Coli* 2 per month 24 months

Cryptosporidium 1 per month

2 per month

24 months

12 months

*E. coli results may trigger Cryptosporidium monitoring. If annual mean E. coli > 10 / 100 ml when using lake / reservoir then must sample for crypto. If annual mean E. coli > 50 / 100 ml when using flowing stream, then must sample for crypto. (SWM GM table 1-1)

Aircraft DW Rule (proposed)

• Will require Coliform sampling – Frequency will depend on disinfection and flushing schedule

• Quarterly flushing, annual coliform• 1-3 times flushing/yr, quarterly coliform• <1 flushing/year, monthly coliform

• Positive detect disinfection w/in 72 hours OR 4 follow-up samples w/in 24 hours

• More than one positive Restrict public access w/in 24 hours; disinfect; followup samples; Notify

• Fecal coliform or E.coli positive Restrict public access w/in 24 hours; disinfect; followup samples; Notify

CWA

• Water– Fecal Coliforms– E.coli– Enterococci

• Biosolids– Helminth Ova– Salmonella– Enteric Viruses

US EPA Recreational Water Quality Criteria - Freshwater

• From a statistically sufficient number of samples (generally 5+ samples equally spaced over a 30-day period)

• Geometric mean bacterial densities not to exceed either:– E. coli 126 per 100 ml; or– enterococci 33 per 100 ml;

• no sample should exceed a one-sided confidence limit (C.L.) calculated using the following as guidance:– designated bathing beach 75% C.L.– moderate use for bathing 82% C.L– light use for bathing 90% C.L.– infrequent use for bathing 95% C.L.– based on a site-specific log standard deviation, or if site data are insufficient

to establish a log standard deviation, then using 0.4 as the log standard deviation for both indicators.

US EPA Recreational Water Quality Criteria - Marine Water

• From a statistically sufficient number of samples (generally 5+ samples equally spaced over a 30-day period)

• geom. mean enterococci densities not to exceed 35 per 100 ml;• no sample exceed a one-sided CL using the following guidance:• designated bathing beach 75% C.L.• moderate use for bathing 82% C.L.• light use for bathing 90% C. L.• infrequent use for bathing 95% C. L.• based on a site-specific log standard deviation, or if site data are

insufficient to establish a log standard deviation, then using 0.7 as the log standard deviation.

Problem- Creates Potential Conflict with NSSP

• NSSP protection still based on MPN enumerated fecal coliforms; only standard for regulation allowed

• Should take into account WQ when classifying waters, but situation can arise when water “safe” to eat shellfish but “unsafe to swim”, and vice-versa

Shellfish

• NSSP• Sanitary Surveys• Bacterial Monitoring

– Fecal Coliform Standard• Geometric mean of 14 MPN/100ml• Not more than 10% of samples with 49 MPN/100ml (3-tube

MPN)

– Total Coliform Standard• Geomentric mean of 70 MPN/100ml• Not more than 10% of samples with 330 MPN/100ml (3 tube

MPN)

Shellfish

• Sampling schemes– Adverse Pollution Condition (APC) (<10% samples

exceed 43 MPN)• Min. 5 samples per station per year• Min. 15 samples/station to calculate geometric mean (30 if

new station)• Sampling stations located adjacent to sources of pollution

– Systematic Random Sampling (SRS) (estimated 90th %tile not >)

• Scheduled in advance• Min. 6 samples per year per station• Min. 30 samples per station to determine geometric mean

and 90th percentile

Washington Freshwater StandardsCategory Bacteria Indicator

Extraordinary Primary Contact Recreation

Fecal coliform organism levels must not exceed a geometric mean value of 50 colonies/100 mL, with not more than 10 percent of all samples (or any single sample when less than ten sample points exist) obtained for calculating the geometric mean value exceeding 100 colonies/100 mL.

Primary Contact Recreation

Fecal coliform organism levels must not exceed a geometric mean value of 100 colonies /100 mL, with not more than 10 percent of all samples (or any single sample when less than ten sample points exist) obtained for calculating the geometric mean value exceeding 200 colonies /100 mL.

Secondary Contact Recreation

Fecal coliform organism levels must not exceed a geometric mean value of 200 colonies/100 mL, with not more than 10 percent of all samples (or any single sample when less than ten sample points exist) obtained for calculating the geometric mean value exceeding 400 colonies /100 mL

Washington Marine Water Standards

Category Bacteria Indicator

Primary Contact Recreation Fecal coliform organism levels must not exceed a

geometric mean value of 14 colonies/100 mL, with not more than 10 percent of all samples (or any single sample when less than ten sample points exist) obtained for calculating the geometric mean value exceeding 43 colonies /100 mL.

Secondary Contact Recreation Enterococci organism levels must not exceed a

geometric mean value of 70 colonies/100 mL, with not more than 10 percent of all samples (or any single sample when less than ten sample points exist) obtained for calculating the geometric mean value exceeding 208 colonies/100 mL.