Subchapter J. BOTTLED WATER AND VENDED WATER
SYSTEMS, RETAIL WATER FACILITIES AND BULK
WATER HAULING SYSTEMS
Sec.
109.1001. Scope.
109.1002. MCLs, MRDLs or treatment techniques.
109.1003. Monitoring requirements.
109.1004. Public notification.
109.1005. Permit requirements.
109.1006. Design and construction standards.
109.1007. Labeling requirements for bottled water systems, vended water systems and retail water facilities.
109.1008. System management responsibilities.
109.1009. System operational requirements.
Cross References This subchapter cited in 25 Pa. Code § 109.5 (relating to organization of chapter).
§ 109.1001. Scope.
This subchapter applies to bottled water systems, vended water systems, retail water facilities and bulk water hauling systems.
Source The provisions of this § 109.1001 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621.
§ 109.1002. MCLs, MRDLs or treatment techniques.
(a) Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall supply drinking water that complies with the MCLs, MRDLs and treatment technique requirements under § § 109.202 and 109.203 (relating to State MCLs, MRDLs and treatment technique requirements; and unregulated contaminants). Bottled water systems, vended water systems, retail water facilities and bulk water hauling systems using surface water or GUDI sources shall comply with the requirements in § 109.204 (relating to disinfection profiling and benchmarking). Bottled water systems, vended water systems, retail water facilities and bulk water hauling systems shall provide continuous disinfection for groundwater sources. Water for bottling labeled as mineral water under § 109.1007 (relating to labeling requirements for bottled water systems, vended water systems and retail water facilities) shall comply with the MCLs except that mineral water may exceed the MCL for total dissolved solids.
(b) Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall supply drinking water that contains no more than 0.005 mg/L of lead and no more than 1.0 mg/L copper.
(c) Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with the treatment technique requirements under Subchapter L (relating to long-term 2 enhanced surface water treatment rule).
(d) Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with Subchapter M (relating to additional requirements for groundwater sources). For the purpose of determining compliance with Subchapter M, bottled water and vended systems, retail water facilities and bulk water hauling systems using groundwater sources shall comply with standards pertaining to noncommunity groundwater systems.
Authority The provisions of this § 109.1002 amended under section 4 of the Pennsylvania Safe Drinking Water Act (35 P.S. § 721.4); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 109.1002 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended October 7, 1994, effective October 8, 1994, 24 Pa.B. 5175; amended July 20, 2001, effective July 21, 2001, 31 Pa.B. 3895; amended December 24, 2009, effective December 26, 2009, 39 Pa.B. 7279; amended April 27, 2018, effective April 28, 2018, 48 Pa.B. 2509. Immediately preceding text appears at serial pages (383489) to (383490).
Cross References This section cited in 25 Pa. Code § 109.1005 (relating to permit requirements); 25 Pa. Code § 109.1006 (relating to design and construction standards); and 25 Pa. Code § 109.1009 (relating to system operational requirements).
§ 109.1003. Monitoring requirements.
(a) General monitoring requirements. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall monitor for compliance with the MCLs, MRDLs and treatment techniques as follows, except that systems which have installed treatment to comply with a primary MCL shall conduct quarterly operational monitoring for the contaminant which the treatment is designed to remove:
(1) Bottled water systems, retail water facilities and bulk water hauling systems, for each entry point shall:
(i) Monitor weekly for the presence or absence of total coliform. For any total coliform positive routine or check sample, determine the presence or absence of E. coli. All analyses must be conducted in accordance with analytical techniques approved by the Department under § 109.304 (relating to analytical requirements). A system may forego E. coli testing on a total coliform-positive sample if the system assumes that any total coliform-positive sample is also E. coli-positive. A system which chooses to forego E. coli testing shall, under § 109.701(a)(3) (relating to reporting and recordkeeping), notify the Department within 1 hour after the water system learns of the violation or the situation, and shall provide public notice in accordance with § 109.1004 (relating to public notification).
(ii) Monitor for turbidity every 4 hours or continuously each day a surface water or GUDI source is in use.
(iii) Monitor for compliance with the MCLs for VOCs in accordance with § 109.301(5) beginning during the quarter that begins January 1, 1995, except that:
(A) Systems that obtain finished water from another permitted public water system are exempt from conducting monitoring for the VOCs if the public water system supplying the finished water performs the required monitoring at least annually and a copy of the analytical reports are received by the Department.
(B) For systems in existence prior to January 1, 1995, that obtain raw water from only protected groundwater sources, initial monitoring for compliance with the MCLs for VOCs established by the EPA under 40 CFR 141.61(a) (relating to MCLs for organic contaminants) on January 30, 1991, and July 17, 1992, will be reduced to one sample for entry points or systems which meet the following conditions:
(I) The VOC monitoring required by the Department between January 1, 1988, and December 31, 1994, has been conducted and no VOCs were detected.
(II) The first quarter of VOC monitoring required by this subparagraph has been conducted during the first quarter of 1995 with no detection of a VOC.
(C) Initial monitoring of new entry points associated with new sources which are permitted in accordance with § 109.1005 (relating to permit requirements) to begin operation after December 31, 1994, shall be conducted as follows:
(I) Entry points at which a VOC is detected during new source monitoring shall be monitored quarterly beginning the first quarter the entry points begin serving the public. Quarterly monitoring shall continue until reduced monitoring is granted in accordance with clause (D)(I).
(II) Entry points at which no VOC is detected during new source monitoring shall begin initial quarterly monitoring during the first calendar quarter of the year after the entry point begins serving the public.
(D) Repeat monitoring for entry points shall be conducted as follows:
(I) For an entry point at which a VOC is detected during initial monitoring or where a VOC is detected anytime at a level in excess of its MCL, compliance monitoring shall be repeated quarterly for the VOCs for which the EPA has established MCLs under 40 CFR 141.61(a), except for vinyl chloride as provided in § 109.301(5)(i). After analyses of four consecutive quarterly samples at an entry point, including initial quarterly monitoring samples, demonstrate that the VOC levels in each quarterly sample are less than the MCLs, the required compliance monitoring is reduced to one sample per year at that entry point for all 21 VOCs, except for vinyl chloride as provided in § 109.301(5)(i).
(II) For a groundwater or surface water entry point at which VOCs are not detected during the initial and subsequent repeat monitoring, repeat monitoring shall be one sample per year from that entry point.
(iv) Conduct initial and repeat monitoring for compliance with the MCLs for SOCs—pesticides and PCBs—in accordance with § 109.301(6) for four consecutive quarters beginning during the quarter that begins January 1, 1995, except that:
(A) Systems that obtain finished water from another permitted public water system are exempt from conducting compliance monitoring for the SOCs if one of the following applies:
(I) The public water system supplying the finished water performs the required monitoring annually and a copy of the analytical results are received by the Department.
(II) The public water system supplying the water has been granted a waiver from conducting the initial or repeat compliance monitoring, or both, for one or more SOCs under § 109.301(6)(v). This exemption from conducting compliance monitoring applies only to SOCs indicated in the waiver.
(B) Systems which are granted an initial monitoring waiver in accordance with § 109.301(6)(v) are exempt from conducting compliance monitoring for the SOCs indicated in the waiver.
(C) Initial monitoring of new entry points associated with new sources which are permitted in accordance with § 109.1005 to begin operation after December 31, 1994, shall be conducted as follows:
(I) Entry points at which an SOC is detected during new source monitoring shall be monitored quarterly beginning the first quarter the entry points begin serving the public. Quarterly monitoring shall continue until reduced monitoring is granted in accordance with clause (D)(I).
(II) Entry points at which no SOC is detected during new source monitoring and which begin operation before April 1, 1995, shall conduct initial quarterly monitoring beginning during the quarter beginning January 1, 1995.
(III) Entry points at which no SOC is detected during new source monitoring and which begin operation after March 31, 1995, shall conduct initial quarterly monitoring beginning during the first calendar quarter of the year after the entry point begins serving the public.
(D) Repeat monitoring for entry points shall be conducted as follows:
(I) For entry points at which an SOC is detected during initial monitoring or where an SOC is detected anytime in excess of its MCL, compliance monitoring shall be repeated quarterly for the detected SOC for which the EPA has an established MCL under 40 CFR 141.61(c). After analyses of four consecutive quarterly samples at an entry point, including initial quarterly monitoring samples, demonstrate that the SOC level in each quarterly sample is less than the MCL, the required compliance monitoring is reduced for each SOC below the MCL to one sample per year at that entry point.
(II) For a groundwater or surface water entry point at which SOCs are not detected during the initial and any subsequent repeat monitoring, repeat monitoring shall be one sample per year from that entry point.
(v) Beginning in 1995, monitor for the primary IOCs, including lead and copper annually, except that:
(A) Systems are granted a waiver from asbestos monitoring unless the Department determines that the system’s finished water is vulnerable to asbestos contamination by means of an asbestos cement pipe or the system’s source water is vulnerable to asbestos contamination.
(B) Systems that obtain finished water from another permitted public water system are exempt from conducting compliance monitoring for the IOCs, except lead, copper and asbestos if the supplying system has not optimized corrosion control, if the public water system supplying the finished water performs the required monitoring annually and a copy of the analytical results is received by the Department.
(C) Monitoring for compliance with the MCLs for nitrate and nitrite shall be conducted quarterly following a monitoring result which is equal to or greater than 50% of the MCL. After four consecutive quarterly samples, indicate nitrate and nitrite in each sample are less than 50% of the MCLs, required monitoring is reduced to one sample per year.
(vi) Conduct operational monitoring for fluoride at least once each day, if the system fluoridates its water.
(vii) Monitor for compliance with radiological MCLs once every 4 years.
(viii) TTHM and HAA5 Stage 1 DBP Rule. Beginning January 1, 2004, monitor annually for TTHM and HAA5 if the system uses a chemical disinfectant or oxidant, or obtains finished water from another public water system that uses a chemical disinfectant or oxidant to treat the water. Bottled water systems are not required to monitor for TTHM and HAA5 if the system does not use a chlorine-based disinfectant or oxidant and does not obtain finished water from another public water system that uses a chlorine-based disinfectant or oxidant to treat the water.
(A) Routine monitoring. Systems shall take at least one sample per year per entry point during the month of warmest water temperature. If the sample, or average of all samples, exceeds either a TTHM or HAA5 MCL, the system shall take at least one sample per quarter per entry point. The system shall return to the sampling frequency of one sample per year per entry point if, after at least 1 year of monitoring, the TTHM running annual average is no greater than 0.060 mg/L and the HAA5 running annual average is no greater than 0.045 mg/L.
(B) Reduced monitoring. Systems that use groundwater sources shall monitor for TTHM and HAA5 for at least 1 year prior to qualifying for reduced monitoring. The Department retains the right to require a system that meets the requirements of this clause to resume routine monitoring.
(I) Systems that use groundwater sources shall reduce monitoring to one sample per 3-year cycle per entry point if the annual TTHM average is no greater than 0.040 mg/L and the annual HAA5 average is no greater than 0.030 mg/L for 2 consecutive years or the annual TTHM average is no greater than 0.020 mg/L and the annual HAA5 average is no greater than 0.015 mg/L for 1 year. The sample shall be taken during the month of warmest water temperature. The 3-year cycle shall begin on January 1 following the quarter in which the system qualifies for reduced monitoring.
(II) Systems that use groundwater sources that qualify for reduced monitoring shall remain on reduced monitoring if the TTHM annual average is no greater than 0.060 mg/L and the HAA5 annual average is no greater than 0.045 mg/L. Systems that exceed these levels shall resume routine monitoring as prescribed in clause (A), except that systems that exceed either a TTHM or HAA5 MCL shall increase monitoring to at least one sample per quarter per entry point beginning in the quarter immediately following the quarter in which the system exceeds the TTHM or HAA5 MCL.
(ix) TTHM and HAA5 Stage 2 DBP Rule. Beginning October 1, 2013, monitor annually for TTHM and HAA5 if the system uses a chemical disinfectant or oxidant to treat the water, or obtains finished water from another public water system that uses a chemical disinfectant or oxidant to treat the water as follows:
(A) Routine monitoring. Systems shall take at least one dual sample set per year per entry point during the peak historical month except that systems meeting the conditions in subsection (d) or (e) shall monitor in accordance with § 109.301(12)(ii) (relating to general monitoring requirements).
(B) Increased monitoring. If any sample results exceed either a TTHM or HAA5 MCL, the system shall take at least one dual sample set per quarter (every 90 days) per entry point. The system shall return to the sampling frequency of one dual sample set per year per entry point if, after at least 1 year of monitoring, each TTHM sample result is no greater than 0.060 mg/L and each HAA5 sample result is no greater than 0.045 mg/L.
(C) Compliance determinations. Compliance with the TTHM and HAA5 MCLs is based on the LRAA.
(I) A system required to monitor quarterly shall calculate LRAAs for TTHM and HAA5 using monitoring results collected under this subparagraph and determine that each LRAA does not exceed the MCL. A system that fails to complete 4 consecutive quarters of monitoring shall calculate compliance with the MCL based on the average of the available data from the most recent 4 quarters. A system that takes more than one sample per quarter at a monitoring location shall average all samples taken in the quarter at that location to determine a quarterly average to be used in the LRAA calculation.
(II) A system required to monitor yearly or less frequently shall determine that each sample result is less than the MCL. If any single sample result exceeds the MCL, the system shall comply with the requirements of clause (B). If no sample result exceeds the MCL, the sample result for each monitoring location is considered the LRAA for that monitoring location.
(III) A system required to conduct quarterly monitoring shall make compliance calculations at the end of the 4th calendar quarter that follows the compliance date (or earlier if the LRAA calculated based on fewer than 4 quarters of data would cause the MCL to be exceeded regardless of the monitoring results of subsequent quarters) and at the end of each subsequent calendar quarter. A system required to conduct monitoring at a frequency that is less than quarterly shall make compliance calculations beginning with the first compliance sample taken after the compliance date.
(IV) A system is in violation of the MCL when the LRAA at any location exceeds the MCL for TTHM or HAA5, calculated as specified in subclause (I), or the LRAA calculated based on fewer than 4 quarters of data if the MCL would be exceeded regardless of the monitoring results of subsequent quarters. If a system fails to monitor, the system is in violation of the monitoring requirements for each quarter that a monitoring result would be used in calculating an LRAA.
(x) Beginning January 1, 2004, monitor daily for chlorite if the system uses chlorine dioxide for disinfection or oxidation. Systems shall take at least one daily sample at the entry point. If a daily sample exceeds the chlorite MCL, the system shall take three additional samples within 24 hours from the same lot, batch, machine, carrier vehicle or point of delivery. The chlorite MCL is based on the average of the required daily sample plus any additional samples.
(xi) Beginning April 28, 2018, a system using chlorine dioxide shall take one sample per day at each entry point. A violation of the chlorine dioxide MRDL occurs when any entry point sample result exceeds the chlorine dioxide MRDL.
(xii) Beginning January 1, 2004, monitor monthly for bromate if the system uses ozone for disinfection or oxidation.
(A) Routine monitoring. Systems shall take one sample per month for each entry point that uses ozone while the ozonation system is operating under normal conditions.
(B) Reduced monitoring.
(I) Until March 31, 2009, systems shall reduce monitoring for bromate from monthly to quarterly if the average source water bromide concentration is less than 0.05 mg/L based upon representative monthly bromide measurements for 1 year. Systems on reduced monitoring shall continue monthly source water bromide monitoring. If the running annual average source water bromide concentration, computed quarterly, is equal to or exceeds 0.05 mg/L, the system shall revert to routine monitoring as prescribed by clause (A).
(II) Beginning April 1, 2009, a system required to analyze for bromate may reduce monitoring from monthly to quarterly, if each sample result analyzed using methods specified in 40 CFR 141.132(b)(3)(ii)(B) (relating to monitoring requirements) is less than or equal to 0.0025 mg/L based on monthly measurements as prescribed in clause (A) for the most recent 12 months. Systems qualifying for reduced bromate monitoring under subclause (I) may remain on reduced monitoring as long as each sample result analyzed using methods specified in 40 CFR 141.132(b)(3)(ii)(B) from the previous 12 months is less than or equal to 0.0025 mg/L. If any sample result exceeds 0.0025 mg/L, the system shall resume routine monitoring as prescribed under clause (A).
(xiii) Beginning April 28, 2018, a system that provides filtration of surface water or GUDI sources shall comply with the following:
(A) Maintain a residual at the entry point as specified in § 109.202(c)(1)(ii) (relating to State MCLs, MRDLs and treatment technique requirements).
(B) Monitor residual disinfectant concentration at the entry point in accordance with § 109.301(1)(i)(C).
(C) Report the results in accordance with § 109.701(a)(2).
(xiv) Beginning April 28, 2018, a system that uses or obtains finished water from another permitted public water system using surface water or GUDI sources shall comply with the following requirements:
(A) As a minimum, a detectable residual disinfectant concentration of 0.20 mg/L measured as total chlorine, combined chlorine, chlorine dioxide or another level approved by the Department for systems using an alternate oxidizing disinfection treatment shall be maintained at the entry point as demonstrated by monitoring conducted under § 109.301(1) and (2) or (8)(v).
(B) Sampling points with nondetectable residual disinfectant concentrations which have heterotrophic plate count measurements of less than 500/ml are deemed to be in compliance with clause (A).
(C) When the requirements of clause (A) or (B) cannot be achieved, the supplier shall initiate an investigation under the Department’s direction to determine the cause, potential health risks and appropriate remedial measures.
(xv) Beginning January 1, 2024, monitor for compliance with the MCLs for PFAS established under § 109.202(a).
(A) Monitoring exemption. Systems that obtain finished water from another permitted public water system are exempt from conducting monitoring for PFAS if the public water system supplying the finished water performs the required monitoring at least annually and a copy of the analytical reports are received by the Department.
(B) Initial monitoring. Initial monitoring shall consist of 4 consecutive quarterly samples at each entry point. Systems that add new sources to new or existing entry points on or after January 1, 2024, shall conduct initial monitoring according to this clause. An entry point with one or more new sources shall be monitored for 4 consecutive quarters, beginning the first full quarter the entry point begins serving the public.
(C) Repeat monitoring. Repeat monitoring for entry points shall be conducted as follows:
(I) For an entry point at which a PFAS is detected during initial monitoring or where a PFAS is detected anytime at a level in excess of its MCL, compliance monitoring for the detected PFAS shall be conducted quarterly. After analyses of four consecutive quarterly samples at an entry point, including initial quarterly monitoring samples, demonstrate that the PFAS level in each quarterly sample is reliably and consistently below the MCL, the required compliance monitoring is reduced to one sample per year at that entry point for the detected PFAS.
(II) For an entry point at which a PFAS is not detected during the initial and subsequent repeat monitoring, repeat monitoring shall be one sample per year from that entry point.
(D) Confirmation samples. A confirmation sample shall be collected and analyzed for each of the PFAS detected in exceedance of its MCL during annual monitoring. The confirmation sample shall be collected within 2 weeks of notification from the accredited laboratory performing the analysis of the MCL exceedance.
(E) Repeat and performance monitoring for entry points with PFAS removal treatment. Compliance monitoring shall be conducted annually at entry points with PFAS treatment. Performance monitoring shall be conducted at least quarterly for the specific PFAS for which treatment is provided.
(F) Invalidation of PFAS samples.
(I) The Department may invalidate results of obvious sampling errors.
(II) A sample invalidated under this clause does not count towards meeting the minimum monitoring requirements of this subparagraph.
(G) Compliance determinations. Compliance with the PFAS MCLs shall be determined based on the analytical results obtained at each entry point. If one entry point is in violation of an MCL, the system is in violation of the MCL.
(I) For systems monitoring more than once per year, compliance with the MCL is determined by a running annual average of all samples taken at each entry point.
(II) If monitoring is conducted annually, the system is out of compliance if the level of a contaminant at any entry point is greater than the MCL. If a confirmation sample is collected as specified in clause (D), compliance is determined using the average of the two sample results.
(III) If any sample result will cause the running annual average to exceed the MCL at any entry point, the system is out of compliance with the MCL immediately.
(IV) If a system fails to collect the required number of samples, compliance with the MCL will be based on the total number of samples collected.
(V) If a sample result is less than the MRL, zero will be used to calculate compliance.
(2) Vended water systems shall monitor in accordance with paragraph (1) except that vended water systems qualifying for permit by rule under § 109.1005(b), for each entry point shall:
(i) Monitor monthly for microbiological contaminants.
(ii) Monitor annually for total dissolved solids, lead and cadmium.
(iii) Conduct special monitoring as required by the Department.
(iv) Beginning April 28, 2018, a system that obtains finished water from another permitted public water system using surface water or GUDI sources shall also monitor in accordance with paragraph (1)(xiv).
(b) Sampling requirements.
(1) For bottled water and vended water systems, retail water facilities and bulk water hauling systems, samples taken to determine compliance with subsection (a) shall be taken from each entry point.
(i) For bottled water systems, each entry point means each finished bottled water product. If multiple sources are used for a product and are not blended prior to bottling, the bottled water product for each source shall be considered a different product for monitoring purposes.
(ii) For bulk water hauling systems, retail water facilities and vended water systems, each entry point shall mean a point of delivery to the consumer from each carrier vehicle, machine or dispenser representative of each source.
(2) For the purpose of determining compliance with the monitoring and analytical requirements established under this subchapter, the Department will consider only those samples analyzed by a laboratory accredited by the Department, except that measurements of turbidity, fluoridation operation, residual disinfectant concentration, daily chlorite, temperature and pH may be performed by a person meeting the requirements of § 109.1008(c) (relating to system management responsibilities).
(3) Sampling and analysis shall be performed in accordance with analytical techniques adopted by the EPA under the Federal act or methods approved by the Department in accordance with § 109.304.
(4) Compliance monitoring samples for VOCs, as required under subsection (a)(1)(iii), shall be collected by a person properly trained by a laboratory certified by the Department to conduct VOC or vinyl chloride analysis.
(5) Compliance monitoring samples required under subsection (a)(1)(iii) may be composited in accordance with 40 CFR 141.24(g)(7) (relating to organic chemicals, sampling and analytical requirements) except:
(i) Samples from groundwater entry points may not be composited with samples from surface water entry points.
(ii) Samples from one type of bottled water product or vended water product may not be composited with samples from another type of bottled water product or vended water product.
(iii) Samples used in compositing shall be collected in duplicate.
(iv) If a VOC listed under 40 CFR 141.61(a) is detected at an entry point, samples from that entry point may not be composited for subsequent compliance or repeat monitoring requirements.
(v) Samples obtained from an entry point which contains water treated by a community water supplier or nontransient noncommunity water supplier to specifically meet an MCL for a VOC listed under 40 CFR 141.61(a) may not be composited with other entry point samples.
(6) [Reserved].
(c) Repeat monitoring for microbiological contaminants.
(1) If a sample collected in accordance with subsection (a)(1)(i) or (2)(i) is found to be total coliform-positive:
(i) The bottled water system shall collect a set of three additional samples (check) from the same lot or batch of the type of product.
(ii) The vended water, retail water facility or bulk water hauling systems shall collect a set of three additional samples (check) from the same entry point (machine, point of delivery or carrier vehicle).
(2) Samples shall be collected for analysis within 24 hours of being notified of the total coliform-positive sample. The Department may extend this 24-hour collection limit to a maximum of 72 hours if the system adequately demonstrates a logistical problem outside the system’s control in having the check samples analyzed within 30 hours of collection. A logistical problem outside the system’s control may include a coliform-positive result received over a holiday or weekend in which the services of a Department certified laboratory are not available within the prescribed sample holding time.
(3) At a minimum, the system shall collect one set of check samples for each total coliform-positive routine sample. If a check sample is total coliform-positive, the public water system shall collect additional check samples in the manner specified in this subsection. The system shall continue to collect check samples until either total coliforms are not detected in a set of check samples, or the system determines that an assessment has been triggered under § 109.202(c)(4).
(d) A bulk water hauling system that serves at least 25 of the same persons year around. A bulk water hauling system that is determined by the Department to serve at least 25 of the same persons year round shall also comply with the monitoring requirements for community water systems in accordance with § 109.301.
(e) A bulk water hauling system, vended water system or retail water facility that serves at least 25 of the same persons over 6 months per year. A bulk water hauling system, vended water system or retail water facility that is determined by the Department to serve at least 25 of the same persons over 6 months per year shall also comply with the monitoring requirements for nontransient noncommunity water systems in accordance with § 109.301.
(f) Additional monitoring requirements for surface water and GUDI sources. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with the monitoring requirements under Subchapter L (relating to long-term 2 enhanced surface water treatment rule).
(g) Additional monitoring requirements for groundwater sources. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with the monitoring requirements under Subchapter M (relating to additional requirements for groundwater sources).
(h) Compliance determinations. Compliance with MCLs, MRDLs and treatment techniques shall be determined in accordance with § § 109.202 and 109.301.
(i) Special monitoring requirements. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with § 109.302 (relating to special monitoring requirements).
Authority The provisions of this § 109.1003 amended under section 4 of the Pennsylvania Safe Drinking Water Act (35 P.S. § 721.4); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of this § 109.1003 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended October 7, 1994, effective October 8, 1994, 24 Pa.B. 5175; corrected June 2, 1995, effective February 4, 1995, 25 Pa.B. 2180; amended April 23, 1999, effective April 24, 1999, 29 Pa.B. 2231; amended July 20, 2001, effective July 21, 2001, 31 Pa.B. 3895; amended August 9, 2002, effective August 10, 2002, 32 Pa.B. 3894; amended August 13, 2004, effective August 14, 2004, 34 Pa.B. 4435; amended May 22, 2009, effective May 23, 2009, 39 Pa.B. 2661; corrected August 29, 2009, effective August 1, 2009, 39 Pa.B. 5119; amended December 24, 2009, effective December 26, 2009, 39 Pa.B. 7279; amended September 23, 2016, effective September 24, 2016, 46 Pa.B. 6005; amended April 27, 2018, effective April 28, 2018, 48 Pa.B. 2509; amended August 17, 2018, effective August 18, 2018, 48 Pa.B. 4974; amended January 13, 2023, effective January 14, 2023, 53 Pa.B. 333. Immediately preceding text appears at serial pages (393352) to (393361).
Cross References This section cited in 25 Pa. Code § 109.303 (relating to sampling requirements); and 25 Pa. Code § 109.1008 (relating to system management responsibilities).
§ 109.1004. Public notification.
(a) General public notification requirements. A bottled water supplier shall give public notification in accordance with this section. A bulk water hauler, vended water supplier or retail water supplier shall give public notification in accordance with Subchapter D (relating to public notification). For the purpose of establishing a bulk hauling, vended or retail water supplier’s responsibilities under Subchapter D, a bulk water supplier shall comply with the public notification requirements specified for a community water system and a vended or retail water supplier shall comply with the public notification requirements specified for a noncommunity water system.
(1) A bottled water supplier who knows that a primary MCL or an MRDL has been exceeded or treatment technique performance standard has been violated or has reason to believe that circumstances exist which may adversely affect the quality of drinking water, including, but not limited to, source contamination, spills, accidents, natural disasters or breakdowns in treatment, shall report the circumstances to the Department within 1 hour of discovery of the problem.
(2) If the Department determines, based upon information provided by the bottled water supplier or other information available to the Department, that the circumstances present an imminent hazard to the public health, the water supplier shall issue a water supply warning approved by the Department and, if applicable, initiate a program for product recall approved by the Department under this subsection. The water supplier shall be responsible for disseminating the notice in a manner designed to inform users who may be affected by the problem.
(i) Within 4 hours of the Department’s determination that an imminent hazard is present, the water supplier shall provide the notice to newspapers, radio and television media serving the affected public, or directly notify affected users in a manner approved by the Department. The water supplier shall also notify key public officials as designated in the system’s emergency response plan.
(ii) If the notice provided under subparagraph (i) does not ensure that the affected public is adequately notified, the Department may require the water supplier to further disseminate the notice in an appropriate manner which may include direct mailings, publication in newspapers or other paid advertising, or postings.
(iii) A water supply warning shall be followed by further notices designed to inform the public on a continuing basis as to the expected duration of the hazard, progress towards solving the problem, and measures that should be taken by users to reduce their risk. These notices shall be given at intervals and in a manner directed by the Department as long as the threat to public health continues.
(iv) The water supply warning shall continue until the Department is satisfied that no significant threat to the public health remains and approves a notice canceling the warning. The water supplier is responsible for disseminating the cancellation of the water supply warning in a manner similar to the issuance of the warning.
(b) Description and content of notice. Notice given under this section shall be written in a manner reasonably designed to fully inform the users of the system. When appropriate or as designated by the Department, additional notice in a foreign language shall be given.
(1) The notice shall be conspicuous and may not use technical language, small print or other methods which would frustrate the purpose of the notice.
(2) The notice shall disclose material facts regarding the subject, including the nature of the problem and, when appropriate, a clear statement that an MCL or MRDL has been violated and preventive measures that should be taken by the public.
(3) Notices shall include a balanced explanation of the significance or seriousness to the public health of the subject of the notice including potential adverse health effects, the population at risk, a clear explanation of steps taken by the supplier to correct the problem, necessity for seeking alternative supplies, guidance on safeguards and alternatives available to users, and the results of additional sampling. In addition, bottled water system and retail water facility notices shall describe a program for product recall, if applicable.
(4) The notice shall include the telephone number of the owner, operator or designee of the public water system as a source of additional information concerning the notice.
(5) In all notices, when providing the information on potential adverse health effects required by subsection (b)(3), the water supplier shall include language established by the EPA for the contaminant specified in 40 CFR Part 141, Subpart Q, Appendix B (relating to mandatory health effects language) and incorporated by reference, or language established by the Department by regulations or order. The health effects language for fluoride is not incorporated by reference. A public water system shall include the health effects language specified in § 109.411(d)(1) (relating to content of a public notice) in each public notice required for violation of the primary MCL of 2 mg/L for fluoride.
(c) Notice by the Department. If a water supplier fails to give notice to the public as required by this section, the Department may perform this notification on behalf of the supplier of water and may assess costs of notification on the responsible water supplier. Issuance of public notice by the Department under the section does not divest a public water supplier of legal responsibility for issuance of public notification otherwise required by the subchapter.
(d) CCR requirements. A bulk water supplier that is determined by the Department to serve at least 25 of the same persons year-round shall prepare and deliver a CCR to each bill-paying customer in accordance with § 109.416 (relating to CCR requirements).
Authority The provisions of this § 109.1004 amended under section 4 of the Pennsylvania Safe Drinking Water Act (35 P.S. § 721.4); and section 1920-A of The Administrative Code of 1929 (71 P.S. § 510-20).
Source The provisions of the § 109.1004 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended July 20, 2001, effective July 21, 2001, 31 Pa.B. 3895; amended August 9, 2002, effective August 10, 2002, 32 Pa.B. 3894; amended April 27, 2018, effective April 28, 2018, 48 Pa.B. 2509. Immediately preceding text appears at serial pages (383498) to (383500).
Cross References This section cited in 25 Pa. Code § 109.1003 (relating to monitoring requirements); 25 Pa. Code § 109.1008 (relating to system management responsibilities).
§ 109.1005. Permit requirements.
(a) General permit requirement. A person may not construct or operate a bottled water or vended water system, retail water facility or bulk water hauling system without first having obtained a public water system permit under subsection (b) or (e).
(b) Special permit by rule requirement for vended water systems.
(1) A person constructing and operating a vended water system shall obtain a separate and distinct permit under subsection (d) for each water vending machine owned by the same person unless the vended water system satisfies the conditions in this subsection. A separate and distinct permit by rule will be required for each Department region in which the water vending machines are located. The Department retains the right to require a vended water system that meets the requirements of this subsection to obtain a permit, if, in the judgment of the Department, the vended water system cannot be adequately regulated through the standardized specifications and conditions. A vended water system which is released from the obligation to obtain a permit shall comply with the other requirements of this subchapter, including design, construction and operation requirements.
(i) A vended water system in which all water vending machines are located in the same Department region.
(ii) A vended water system which has as its sole source of water, finished water from existing permitted community water systems and uses only NAMA approved water vending machines satisfies the permit requirement of the act.
(2) A vended water system covered under this subsection shall register with the Department on forms provided by the Department. Amendments to the registration shall be filed when a substantial modification is made to the system. Descriptions of modifications shall be filed within 30 days of operation of the modification.
(c) Special permit by rule requirement for bottled water systems. A person owning or operating a bottled water system in this Commonwealth permitted under this chapter shall obtain an amended permit before making substantial modifications to the processing and bottling facilities unless the bottled water system satisfies the conditions in paragraphs (1)—(5). The permit-by-rule does not apply to the collection facilities. The Department retains the right to require a bottled water system that meets the requirements of paragraphs (1)—(5) to obtain a permit, if, in the judgment of the Department, the bottled water system cannot be adequately regulated through the standardized specifications and conditions. A bottled water system which is released from the obligation to obtain a permit shall comply with the other requirements of this subchapter, including design, construction and operation requirements. The following are the conditions for a permit-by-rule:
(1) The bottled water system has as its sole source of water permitted groundwater sources which are not under the direct influence of surface water as determined through the Department’s Guidance for Surface Water Identification protocol or finished water from a Department approved community water system.
(2) The water quality of the sources does not exceed the Food and Drug Administration quality standards for primary (that is, health-related) chemical and radiological contaminants specified in 21 CFR 165.110 (relating to bottled water) as determined under sampling conducted under subsection (e)(4)(ii) and requires treatment no greater than disinfection to provide water of a quality that meets the primary MCLs established under Subchapter B (relating to MCLs, MRDLs or treatment technique requirements).
(3) Proof that the facilities meet the standards of the Food and Drug Administration in 21 CFR Parts 110, 129 and 165 (relating to current good manufacturing practice in manufacturing, packing, or holding human food; processing and bottling of bottled drinking water; and beverages) and the IBWA Model Bottled Water Code as determined by an onsite evaluation conducted by a Nationally recognized, independent, not-for-profit third-party organization such as NSF or other organization acceptable to the Department. The onsite evaluation shall be conducted annually. The proof shall consist of the report issued by the organization which shall be submitted to the Department within 30 days following the completion of the onsite evaluation. To be acceptable to the Department, the organization shall:
(i) Be accredited by ANSI as a third-party inspection/evaluation organization.
(ii) Have well developed, documented policies, procedures and contracts to support Department enforcement actions for meeting compliance objectives.
(4) A bottled water system intending to operate under this subsection shall submit written notification to the Department with documentation that the system complies with paragraphs (1)—(3).
(5) A bottled water system operating under this subsection shall file descriptions of substantial modifications made to the system to the Department within 30 days of operation of the modification. The description must include documentation that the modification meets the following requirements as applicable:
(i) Compliance with the product water-contact materials and treatment chemical additives toxicological requirements of § 109.606 (relating to chemicals, materials and equipment) or alternatively, the Food and Drug Administration standards in 21 CFR Part 129.
(ii) Validated treatment technologies for the reduction of contaminants. Validated treatment technologies are those that have been permitted by the Department under this chapter at the bottled water system operating under the permit by rule or certified to an applicable ANSI/NSF standard by NSF or other certification organization acceptable to the Department or verified under the EPA Environmental Technology Verification Program. To be acceptable to the Department, a certification organization other than NSF shall be accredited by ANSI as a third-party certification organization and meet the requirements under § 109.606(e) as applicable to the appropriate ANSI/NSF standard for the treatment technology.
(6) The Department will publish a notice in the Pennsylvania Bulletin of its determination that a bottled water system has complied with paragraphs (1)—(4) and is operating under the permit by rule. The Department will publish a notice in the Pennsylvania Bulletin of descriptions submitted under paragraph (5) of substantial modifications made by a bottled water system operating under the permit-by-rule.
(d) Permit amendments. A person may not substantially modify a bottled water or vended water system, retail water facility or bulk water hauling system operated under a public water system permit without obtaining a permit amendment from the Department or otherwise complying with subsection (f).
(e) Permit applications. An application for a public water system permit for a bottled water or vended water system, retail water facility or bulk water hauling system shall be submitted in writing on forms provided by the Department and shall be accompanied by plans, specifications, engineer’s report, water quality analyses and other data, information or documentation reasonably necessaryto enable the Department to determine compliance with the act and this chapter. The Department will make available to the applicant the Public Water Supply Manual, available from the Bureau of Safe Drinking Water, Post Office Box 8467, Harrisburg, Pennsylvania 17105-8467 which contains acceptable design standards and technical guidance. Water quality analyses shall be conducted by a laboratory certified under this chapter. An application for a public water system permit for a bottled water or vended water system, retail water facility or bulk water hauling system must include:
(1) The signature of the appropriate individual identified in § 109.503(a)(1)(i) (relating to public water system construction permits).
(2) Plans, specifications and engineer’s report or modules prepared by or under the supervision of a professional engineer registered to practice in this Commonwealth, or in the state in which the water system is located, except that manufacturer’s drawings and specifications for equipment or vending machines may be submitted in lieu of plans and specifications, as prescribed in this section, for the equipment or machines.
(3) The front cover or flyleaf of each set of drawings, and of each copy of the specifications and engineer’s report, except for manufacturer’s drawings and specifications, shall bear the signature and imprint of the seal of the registered professional engineer. Each drawing shall bear an imprint or a legible facsimile of the seal.
(4) Information describing new sources as follows:
(i) A comprehensive sanitary survey of the physical surroundings of each new source of raw water.
(ii) An evaluation of the quantity and quality of the raw water available from each new source. The evaluation shall include data for each primary and secondary contaminant and other contaminants the Department determines necessary to evaluate potability of the source. When a new source is finished water from another public water system, the most recent quality data if in compliance with the monitoring requirements of this chapter, obtained from the public water system supplying the finished water may be submitted.
(5) An erosion and sedimentation control plan which meets the requirements in Chapter 102 (relating to erosion and sediment control) when earthmoving activities are involved.
(6) In lieu of compliance with paragraphs (2)—(5), the Department may accept approval of an out-of-State systems’ source and facilities by the agency having jurisdiction over drinking water in that state if the supplier submits proof of the approval by the other State agency.
(7) In addition to the information required under paragraphs (1)—(6), an application for a bottled water system permit shall include:
(i) An analysis of the quality of the manufactured water for each bottled water product. The analysis shall include data for each primary and secondary contaminant under § 109.1002 (relating to MCLs, MRDLs or treatment techniques).
(ii) A copy of each label of identification to be affixed to each type of bottled water product and trade name distributed by the public water system.
(iii) Proof that the system is in compliance with the standards of the Food and Drug Administration contained in 21 CFR Part 129.
(A) For out-of-State bottled water systems, the proof shall consist of the report issued by a Nationally recognized organization which inspects bottled water systems for compliance with 21 CFR Part 129, such as NSF, or another organization, state or country which utilizes an inspection protocol as stringent as NSF’s protocol.
(B) For in-State bottled water systems, the proof shall consist of an inspection report issued by the Department.
(8) In addition to the information required under paragraphs (1)—(6), an application for a bulk water hauling system shall include:
(i) A detailed description of each water transportation tank, fill connection, outlet valve, hose, pump and other appurtenances including the manner in which they will be protected from contamination.
(ii) A description of the exact location where withdrawals will be made from each source of supply.
(9) In addition to the information required under paragraphs (1)—(6), an application for a vended water system shall include:
(i) A description of the exact location of each water vending machine.
(ii) A copy of the system’s operation and maintenance plan detailing machine maintenance schedules.
(iii) A copy of the NAMA certification for each type of machine, if a certification has been issued.
(10) In addition to the information required under paragraphs (1)—(6), an application for a retail water facility shall include:
(i) A copy of NSF certificates, when applicable, for system components.
(ii) A copy of product labels, when applicable.
(f) Permit amendment applications. A bottled water or vended water system, retail water facility or bulk water hauling system operating under a public water system permit shall obtain a permit amendment before making a substantial modification to the public water system.
(1) A water supplier shall submit an application for a major permit amendment in accordance with subsection (e), if the proposed modification constitutes a major change to the public water system.
(i) For bottled water systems and retail water facilities, typical modifications which may be considered major changes are proposed new sources, additions or deletions of treatment techniques or processes and new types of products.
(ii) For bulk water hauling systems typical modifications which may be considered major changes are proposed new sources, additions or deletions of treatment techniques or processes, pumping stations and storage reservoirs.
(iii) For vended water systems, typical modifications which may be considered major changes are proposed additions or deletions of treatment techniques or processes, new product lines or types of products and the addition to the system of machines not certified by NAMA. For new sources, the supplier shall obtain a separate and distinct permit in accordance with subsection (e) unless the system qualifies for a permit-by-rule under subsection (b).
(2) A water supplier shall submit a written request to the Department for a minor permit amendment if the proposed modification constitutes a relatively minor change to the public water system. A request for a permit amendment under this paragraph shall describe the proposed change in sufficient detail to allow the Department to adequately evaluate the proposal.
(i) For bottled water systems and retail water facilities, typical modifications which can generally be accomplished under this paragraph include:
(A) Changes in treatment chemicals.
(B) Construction of storage tanks designed to standard specifications.
(C) Installation of replacement equipment.
(D) Changes in legal status, such as transfers of ownership, incorporation or mergers.
(ii) For bulk water hauling systems, typical modifications which can generally be accomplished under this paragraph include:
(A) Changes in treatment chemicals.
(B) Replacement of tank or reservoir linings or similar materials in contact with the water supply.
(C) Additions and modifications to water carrier vehicles and standpipes designed to standard specifications.
(D) Transmission mains.
(E) Changes in legal status, such as transfers of ownership, incorporation or mergers.
(iii) For vended water systems, typical modifications which can generally be accomplished under this paragraph include changes in treatment chemicals, repair or replacement of machines, and the addition of new NAMA certified machines to a permitted vended water system.
(3) The Department determines whether a particular modification requires a permit amendment under subsection (f)(1) or a permit amendment under subsection (f)(2). The Department’s determination will include consideration of the magnitude and complexity of the proposed change and the compliance history of the public water system.
(g) Emergency permits. In emergency circumstances, the Department may issue permits for construction, operation or modification to a bottled water or bulk water hauling system, which the Department determines may be necessary to assure that potable drinking water is available to the public.
(1) Emergency permits shall be limited in duration and may be conditioned on additional monitoring, reporting and the implementation of appropriate emergency response measures. The Department may revoke an emergency permit if it finds the water system is not complying with drinking water standards or the terms or conditions of the permit. An authorization for construction, operation or modifications obtained under an emergency permit will not extend beyond the expiration of the emergency permit unless the public water system receives a permit or permit amendment under subsection (e) or (f) for the construction, operation or modification initiated during the emergency.
(2) State and Federal agencies conducting emergency response bulk water hauling operations need not obtain a permit under this subchapter, if a Department-approved source is utilized and adequate monitoring specified by the Department is conducted to assure compliance with the microbiological MCL specified in § 109.1002.
(h) Department’s review. Applications for public water system permits and permit amendments for bottled water and vended water systems, retail water facilities and bulk water hauling systems will be reviewed in accordance with the following procedures:
(1) Applications will be reviewed in accordance with accepted engineering practices. The approval of plans, specifications and engineer’s reports by the Department is limited to the sanitary features of design and other features of public health significance.
(2) The Department will not accept an application for review until the application is determined to be complete. A complete application is one which includes the information specified in this chapter and other information necessary for the Department to ensure compliance with this chapter.
(3) As a condition of receiving a public water system permit, a bottled water system shall comply with the standards of the Food and Drug Administration contained in 21 CFR Part 129. Evidence shall be presented demonstrating compliance with subsection (e)(7)(iii).
(4) In reviewing a permit application under this chapter, the Department may consider the following:
(i) Adherence to standards of the Department in Subchapter F (relating to design and construction standards) and § 109.1006 (relating to design and construction standards).
(ii) Compliance by the proposed project with applicable statutes administered by the Commonwealth, river basin commissions created by interstate compact or Federal environmental statutes or regulations.
(i) Permit fees. An application for a permit from the Department under this subchapter must be accompanied by a fee in the amount specified in Subchapter N (relating to drinking water fees).
Authority The provisions of this § 109.1005 amended under section 4(a) of the Pennsylvania Safe Drinking Water Act (35 P.S. § 721.4(a)); and section 1920-A(b) of The Administrative Code of 1929 (71 P.S. § 510-20(b)).
Source The provisions of this § 109.1005 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended October 7, 1994, effective October 8, 1994, 24 Pa.B. 5175; amended April 23, 1999, effective April 24, 1999, 29 Pa.B. 2231; amended July 20, 2001, effective July 21, 2001, 31 Pa.B. 3895; amended August 17, 2018, effective August 18, 2018, 48 Pa.B. 4974. Immediately preceding text appears at serial pages (391413) to (391420).
Cross References This section cited in 25 Pa. Code § 109.1003 (relating to monitoring requirements); 25 Pa. Code § 109.1306 (relating to information describing 4-log treatment and compliance monitoring); 25 Pa. Code § 109.1404 (relating to community and noncommunity water system permitting fees); and 25 Pa. Code § 109.1406 (relating to permitting fees for bottled water and vended water systems, retail water facilities and bulk water hauling systems).
§ 109.1006. Design and construction standards.
(a) Application of standards. Standards in this section apply to design and construction or modification of bottled water and vended water systems, retail water facilities and bulk water hauling systems regardless of whether a Department permit or permit amendment is required. The standards apply to new facilities and facility modifications unless otherwise specifically indicated.
(b) Acceptable design. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall be designed to provide an adequate quality of water to the public. The design shall ensure that the system will, upon completion, be capable of providing water that complies with the primary and secondary MCLs, MRDLs and treatment techniques established in § 109.1002 (relating to MCLs, MRDLs or treatment techniques). The Department may approve control techniques, such as nonremoval processes, which abate the problems associated with a secondary contaminant, and achieve the objective of the secondary MCL.
(1) Designs of bottled water and vended water systems, retail water facilities and bulk water hauling systems shall conform to accepted standards of engineering and design in the water supply, bottled water, retail water or bulk water hauling industry, as applicable.
(2) Designs of bottled water and vended water systems, retail water facilities and bulk water hauling systems shall be in accordance with Subchapter F (relating to design and construction standards) except that § 109.607 (relating to pressures) does not apply.
Source The provisions of this § 109.1006 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended July 20, 2001, effective July 21, 2001, 31 Pa.B. 3895. Immediately preceding text appears at serial pages (254843) to (254844).
Cross References This section cited in 25 Pa. Code § 109.1005 (relating to permit requirements).
§ 109.1007. Labeling requirements for bottled water systems, vended water systems and retail water facilities.
(a) General labeling requirements. Containers of bottled water distributed in this Commonwealth by bottled water systems, retail water facilities or, when appropriate, vended water systems, shall have labels which are designed to remain affixed to the container during use and which include the following information as required by this section. Labels with the following information on the caps of bottled water containers designed for reuse by the bottler are deemed to meet this requirement if the Department-issued identification number and the manufacture date, lot or batch number are on the bottle:
(1) The name and address of the water supplier together with the product trade name.
(2) The water source. When finished water is the source, the name of the public water system shall appear on the label.
(3) The Department identification number issued to the bottled or vended water system or retail water facility.
(4) The manufacture date, or a lot or batch number. The manufacturing date, or lot or batch number shall identify a specific set of primary containers or units of the same size, type and style, produced under conditions as nearly uniform as possible. A batch or lot may not extend for longer than 7 days.
(5) Labeling for mineral water shall include the words ‘‘mineral water.’’ Mineral water which exceeds the MCL for total dissolved solids shall include a statement on the label that the product exceeds the MCL for total dissolved solids.
(6) Labeling for artificially-fluoridated water shall include the words ‘‘fluoridated water.’’
(b) Corporate name and trade name. A bottled water system, vended water system or retail water facility whose corporate name contains the words ‘‘Spring,’’ ‘‘Well,’’ ‘‘Artesian,’’ ‘‘Mineral’’ or ‘‘Natural’’ or a derivative of those words, shall label each bottle with the trade name in typeface of at least equal size to the typeface of the corporate name.
(c) Special vending machine label. The name and address of the water supplier together with the Department identification number shall be provided in a conspicuous location on each machine. When water is prebottled from the water vending machine and made available on the shelf for sale, each container shall be labeled in accordance with subsections (a) and (b).
(d) Special retail water facility label. When water is prebottled from the retail water facility and made available on the shelf for sale, each container shall be labeled in accordance with subsections (a) and (b).
Authority The provisions of this § 109.1007 amended under section 4 of the Pennsylvania Safe Drinking Water Act (35 P S. § 721.4); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.S. § § 510-7 and 510-20).
Source The provisions of this § 109.1007 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended April 23, 1999, effective April 24, 1999, 29 Pa.B. 2231. Immediately preceding text appears at serial pages (207296) to (207297).
Cross References This section cited in 25 Pa. Code § 109.1002 (relating to MCLs, MRDLs or treatment techniques); and 25 Pa. Code § 109.1008 (relating to system management responsibilities).
§ 109.1008. System management responsibilities.
(a) Reporting and recordkeeping requirements for bottled water and vended water systems, retail water facilities and bulk water hauling systems. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with the reporting requirements in § 109.701(a) and (d) (relating to reporting and recordkeeping).
(1) In addition to the requirements in § 109.701(a) and (d), bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with the following requirements:
(i) Annual product monitoring as required under § 109.1003 (relating to monitoring requirements) shall be reported to the Department by December 31 of each year.
(ii) Each bottled water system shall, by December 31 of each year, submit to the Department proof that the system is in compliance with the standards of the Food and Drug Administration in 21 CFR Part 129 (relatingto processing and bottling of bottled drinking water) as required by § 109.1009(b) (relating to system operational requirements). Proof shall consist of the report issued by a Nationally-recognized organization which inspects bottled water systems for compliance with 21 CFR Part 129, such as NSF, or another organization, state or country which utilizes an inspection protocol as stringent as NSF’s protocols.
(iii) A monthly operational report shall be prepared on forms provided by the Department or in a form acceptable to the Department. The report shall be maintained on file by the operator for at least 2 years and submitted upon request of the Department. The report shall include at least the following:
(A) The water produced daily.
(B) The chemicals added daily.
(C) The physical and chemical determinations taken daily.
(D) The maintenance performed.
(E) The operational problems and how they have been corrected.
(iv) By March 31, an Annual Water Supply Report for the previous calendar year shall be submitted on forms provided by the Department or in a form acceptable to the Department. This report shall include at least the following:
(A) Information related to water produced or hauled for the year.
(B) A summary of sanitary surveys conducted by the water supplier, including, when applicable, updates to the operation and maintenance plan and cross-connection control program.
(C) Updates to the plan for product recall required under subsection (e).
(2) The bottled water, vended water, retail water or bulk water supplier shall retain on the premises of the public water system or at a convenient location near the premises all records in accordance with the schedule in § 109.701(d).
(3) For bottled water systems and, if applicable, vended water systems and retail water facilities, new or additional proprietary labels shall be reported to the Department in writing, along with copies of the labels, within 10 days following production or distribution of the new or additional label product. The new or additional proprietary labels may be submitted to the Department prior to the product production if the water supplier desires initial Department review. The new or additional proprietary labels shall comply with § 109.1007 (relating to labeling requirements for bottled water systems, vended water systems and retail water facilities).
(4) In addition to the requirements of this subsection, bottled water and vended water systems, retail water facilities and bulk water hauling systems using surface water or GUDI sources shall also comply with the reporting and recordkeeping requirements of Subchapter L (relating to long-term 2 enhanced surface water treatment rule).
(5) In addition to the requirements of this subsection, bottled water and vended water systems, retail water facilities and bulk water hauling systems using groundwater sources, including purchased groundwater, shall also comply with the reporting and recordkeeping requirements of Subchapter M (relating to additional requirements for groundwater sources).
(b) Operation and maintenance plan requirements. Bottled water, vended water, retail water and bulk water suppliers shall develop an operation and maintenance plan for each system. The operation and maintenance plan shall conform to the guidelines contained in Part III of the Department’s Public Water Supply Manual which is available from the Bureau of Safe Drinking Water, Post Office Box 8467, Harrisburg, Pennsylvania 17105-8467. The water supplier shall implement the operation and maintenance plan in accordance with this chapter, and if appropriate in accordance with accepted practices of the bottled water, vended water, retail water facility or bulk water hauling industry. The plan shall be reviewed and updated as necessary to reflect changes in the operation or maintenance of the water system. The plan shall be bound and placed in locations which are readily accessible to the water system’s personnel, and shall be presented upon request to the Department.
(c) Operator requirements. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall have competent personnel qualified to operate and maintain the system’s facilities.
(d) Annual system evaluation requirements. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall conduct an evaluation of the water system at least annually that includes the activities listed in paragraphs (1)—(4). A bottled water, vended water, bulk water hauling system or retail water facility obtaining finished water from a permitted public water system is not required to perform the activities in paragraphs (1) and (2) if the Department determines that there are no potential problems necessitating inspection and evaluation of the source.
(1) Watershed surveillance consisting of an inspection of portions of the drainage area necessary to identify and evaluate actual and probable sources of contamination.
(2) Evaluation of source construction and protection and, when appropriate, withdrawal and transmission facilities.
(3) Treatment facilities inspection consisting of an evaluation of the effectiveness of the operation and maintenance procedures and the condition and operability of permitted facilities.
(4) Evaluation of finished water storage facilities.
(e) Emergency response requirements.
(1) A bottled water, vended water, retail water or bulk water supplier who knows or has reason to believe that circumstances exist which may adversely affect the quality of drinking water supplied by the system, shall notify the Department immediately under § 109.1004 (relating to public notification).
(2) The bottled water, vended water, retail water or bulk water supplier shall develop a plan for product recall under emergency circumstances, and submit the plan to the Department for approval. The plan shall:
(i) Identify detailed procedures for implementing product recalls, including emergency communications and notifications.
(ii) Be kept on file in a readily accessible location by the bottled water, vended water, retail water or bulk water supplier.
(iii) Be reviewed and updated at least annually. A copy of the update shall be included in the annual water supply report to the Department under this section.
(f) Cross-connection control program. At the direction of the Department, the bottled water, vended water, retail water or bulk water supplier shall develop and implement a comprehensive control program for the elimination of existing cross-connections or the effective containment of sources of contamination, and prevention of future cross-connections. A description of the program, including the following information, shall be submitted to the Department for approval:
(1) A description of the methods and procedures to be used.
(2) An implementation schedule for the program.
(3) A description of the methods and devices which will be used to protect the water system.
(g) Level 1 and Level 2 assessments. Bottled water systems, vended water systems, retail water facilities and bulk water hauling systems shall comply with the requirements of § 109.705(b) (relating to system evaluations and assessments). Bottled water systems, vended water systems, retail water facilities and bulk water hauling systems may use a Nationally-recognized organization which inspects bottled water systems for compliance with 21 CFR Part 129, such as NSF, or another organization, state or country which utilizes an inspection protocol as stringent as NSF’s protocols to conduct the Level 2 assessment.
(h) Seasonal systems. A bottled water system, vended water system, retail water facility or bulk water hauling system that operates as a seasonal system shall comply with the requirements of § 109.715 (relating to seasonal systems).
(i) Significant deficiencies. Bottled water and vended water systems, retail water facilities and bulk water hauling systems shall comply with § 109.705(d) and (e).
(j) Stage 2 Disinfectants/Disinfection Byproducts Rule monitoring plan and operational evaluation levels. A bulk water hauling system, vended water system or retail water facility that is determined by the Department to meet the definition of a community or nontransient noncommunity public water system and that uses a chemical disinfectant or that obtains finished water from another public water system that uses a chemical disinfectant or oxidant shall comply with § 109.701(g)(2).
Authority The provisions of this § 109.1008 amended under section 4 of the Pennsylvania Safe Drinking Water Act (35 P.S. § 721.4); and sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.S. § § 510-7 and 510-20).
Source The provisions of this § 109.1008 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended April 23, 1999, effective April 24, 1999, 29 Pa.B. 2231; amended December 24, 2009, effective December 26, 2009, 39 Pa.B. 7279; amended September 23, 2016, effective September 24, 2016, 46 Pa.B. 6005; amended April 27, 2018, effective April 28, 2018, 48 Pa.B. 2509. Immediately preceding text appears at serial pages (383509) to (383512).
Cross References This section cited in 25 Pa. Code § 109.1003 (relating to monitoring requirements); and 25 Pa. Code § 109.1009 (relating to system operational requirements).
§ 109.1009. System operational requirements.
(a) General facilities operation. Facilities of bottled water and vended water systems, retail water facilities and bulk water hauling systems approved by written permit from the Department shall be operated in a manner consistent with the terms and conditions of the permit to achieve the level of treatment for which the facilities were designed.
(b) Special bottled water system requirements. Bottled water systems shall be operated in accordance with the standards of the Food and Drug Administration in 21 CFR Part 129 (relating to processing and bottling of bottled drinking water). Proof of this determination shall be submitted to the Department annually under § 109.1008(a)(1)(ii) (relating to system management responsibilities).
(c) Disinfectant residual requirements. A disinfectant residual acceptable to the Department shall be maintained at the entry point of the bottled water or vended water system, retail water facility or bulk water hauling system sufficient to assure compliance with the microbiological MCL specified in § 109.1002 (relating to MCLs, MRDLs or treatment techniques). The Department will determine the acceptable residual of the disinfectant considering factors such as type and form of disinfectant, temperature and pH of the water, and other characteristics of the water system.
(d) Disinfection of facilities following construction, modification or repair. After repairing, constructing or modifying a bottled water, vended water, retail water or bulk water hauling facility and before the facility is placed in service, it shall be properly cleaned and disinfected. Cleaning shall be in accordance with 21 CFR 129.80(c) and (d) (relating to processes and controls) and disinfection shall be with 50 ppm chlorine for 1 minute at 75°F or the equivalent.
(e) Dedicated equipment. Bottled water, vended water, retail water and bulk water may not be transported, stored or processed through equipment or lines used for any nonfood product. Bottled water, vended water, retail water and bulk water transported, stored or processed through equipment used for a food product other than water shall comply with the following cleaning and disinfection procedures:
(1) When foods other than milk or dairy products have been transported, stored, processed or bottled, each time before water is transported, stored, processed or bottled through the same lines or equipment, product contact surfaces shall be thoroughly cleaned and disinfected in accordance with subsection (d).
(2) When milk or other dairy products are transported, stored or processed or bottled through the same lines or equipment as bottled water, vended water, retail water and bulk water, the feed line used to convey water to the filler shall be dedicated to water only. Each time before water is transported, stored or processed or bottled, other product contact surfaces shall be disassembled and cleaned in accordance with subsection (d).
(f) Special operational requirements for bottled water systems and retail water facilities.
(1) Bottled water systems and retail water facilities using ozone as a final disinfectant shall maintain an ozone residual of 0.1—0.4 ppm in the bottle immediately after filling.
(2) When ozone is used as a disinfectant for bottled water or retail water, gaskets, o-rings and similar flexible material shall be made of silicone rubber, teflon or other ozone-resistant material. These flexible parts shall be replaced when they show evidence of surface deterioration.
(g) Special operational requirements for water vending machine systems.
(1) Each vending machine shall be cleaned, serviced and sanitized in accordance with the manufacturer’s service manuals, but at least once every 2 weeks. A record of all cleaning and maintenance operations for each machine shall be kept by the operator with a copy retained in the interior of the machine.
(2) A notice to consumers listing the industry’s recommendations for the care, cleaning and type of container suitable for use with the water vending machine shall be posted at each water vending machine.
(h) Special operational requirements for bulk water hauling systems.
(1) Transportation tanks or containers shall be sealed at all times except when being cleaned, filled or when water is being delivered.
(2) Hoses, pumps, connections and fittings shall be sanitized prior to delivering water using a disinfectant solution containing at least 50 ppm of chlorine at 75°F for 1 minute or the equivalent.
(3) Hoses, pumps, connections and fittings used for loading and delivering potable water shall be stored, capped or covered and used so as to be protected from contamination at all times.
(4) A record of cleaning and sanitizing activities conducted on the interior of the transportation tank or transfer equipment shall be maintained with the vehicle and shall be available to the Department upon request.
Source The provisions of this § 109.1009 adopted May 15, 1992, effective May 16, 1992, 22 Pa.B. 2621; amended July 20, 2001, effective July 21, 2001, 31 Pa.B. 3895. Immediately preceding text appears at serial pages (254848) to (254849) and (207301) to (207302).
Cross References This section cited in 25 Pa. Code § 109.1008 (relating to system management responsibilities).
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