(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 necessary to 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).