[Federal Register: June 20, 2008 (Volume 73, Number 120)]
[Proposed Rules]
[Page 35111]
[DOCID:fr20jn08-21]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2008-0392; FRL-8582-1]

Approval and Promulgation of Implementation Plans; State of
Missouri

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA proposes to approve a request to amend the Missouri State
Implementation Plan (SIP) to include revisions to the Kansas City
Solvent Metal Cleaning rule. The revisions to this rule include
consolidating exemptions in the applicability section, adding new
exemptions, adding definitions of new and previously undefined terms,
and clarifying rule language regarding operating procedure requirements
for spray gun cleaners and air-tight and airless cleaning systems. This
revision will ensure consistency between the state and the federally-
approved rules.

DATES: Comments on this proposed action must be received in writing by
July 21, 2008.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2008-0392 by mail to Amy Algoe-Eakin, Environmental Protection
Agency, Air Planning and Development Branch, 901 North 5th Street,
Kansas City, Kansas 66101. Comments may also be submitted
electronically or through hand delivery by following the detailed
instructions in the ADDRESSES section of the direct final rule located
in the rules section of this Federal Register.

FOR FURTHER INFORMATION CONTACT: Amy Algoe-Eakin at<PHONE_NUMBER>, or
by e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the final rules section of the Federal
Register, EPA is approving the state's SIP revision as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial revision amendment and anticipates no relevant adverse
comments to this action. A detailed rationale for the approval is set
forth in the direct final rule. If no relevant adverse comments are
received in response to this action, no further activity is
contemplated in relation to this action. If EPA receives relevant
adverse comments, the direct final rule will be withdrawn and all
public comments received will be addressed in a subsequent final rule
based on this proposed action. EPA will not institute a second comment
period on this action. Any parties interested in commenting on this
action should do so at this time. Please note that if EPA receives
adverse comment on part of this rule and if that part can be severed
from the remainder of the rule, EPA may adopt as final those parts of
the rule that are not the subject of an adverse comment. For additional
information, see the direct final rule which is located in the rules
section of this Federal Register.

    Dated: June 9, 2008.
John B. Askew,
Regional Administrator, Region 7.
[FR Doc. E8-13756 Filed 6-19-08; 8:45 am]

BILLING CODE 6560-50-P


switching coagulants (e.g., alum to ferric chloride), and switching
corrosion inhibitor products (e.g., orthophosphate to blended
phosphate). Long-term changes can include dose changes to existing
chemicals if the water system is planning long-term changes to its
finished water pH or residual inhibitor concentration. Long-term
treatment changes would not include chemical dose fluctuations
associated with daily raw water quality changes.
    (4) Any small water system applying for a monitoring waiver under
Sec.  141.86(g), or subject to a waiver granted pursuant to Sec.
141.86(g)(3), shall provide the following information to the State in
writing by the specified deadline:
    (i) By the start of the first applicable monitoring period in Sec.
141.86(d), any small water system applying for a monitoring waiver
shall provide the documentation required to demonstrate that it meets
the waiver criteria of Sec. Sec.  141.86(g)(1) and (2).
    (ii) No later than nine years after the monitoring previously
conducted pursuant to Sec.  141.86(g)(2) or Sec.  141.86(g)(4)(i), each
small water system desiring to maintain its monitoring waiver shall
provide the information required by Sec. Sec.  141.86(g)(4)(i) and
(ii).
    (iii) No later than 60 days after it becomes aware that it is no
longer free of lead-containing and/or copper-containing material, as
appropriate, each small water system with a monitoring waiver shall
provide written notification to the State, setting forth the
circumstances resulting in the lead-containing and/or copper-containing
materials being introduced into the water system and what corrective
action, if any, the water system plans to remove these materials.
    (iv) Reserved.
    (5) Each groundwater system that limits water quality parameter
monitoring to a subset of entry points under Sec.  141.87(c)(3) shall
provide, by the commencement of such monitoring, written correspondence
to the State that identifies the selected entry points and includes
information sufficient to demonstrate that the sites are representative
of water quality and treatment conditions throughout the water system.
    (b) Source water monitoring reporting requirements. (1) A water
system shall report the sampling results for all source water samples
collected in accordance with Sec.  141.88 within the first 10 days
following the end of each source water monitoring period (i.e.,
annually, per compliance period, per compliance cycle) specified in
Sec.  141.88.
    (2) With the exception of the first round of source water sampling
conducted pursuant to Sec.  141.88(b), the water system shall specify
any site which was not sampled during previous monitoring periods and
include an explanation of why the sampling point has changed.
    (c) Corrosion control treatment reporting requirements. By the
applicable dates under Sec.  141.81, water systems shall report the
following information:
    (1) For water systems demonstrating that they have already
optimized corrosion control, information required in Sec.  141.81(b)(2)
or (3).
    (2) For water systems required to reoptimize corrosion control,
their recommendation regarding optimal corrosion control treatment
under Sec.  141.82(a).
    (3) For water systems required to evaluate the effectiveness of
corrosion control treatments under Sec.  141.82(c), the information
required by that paragraph.
    (4) For water systems required to install optimal corrosion control
designated by the State under Sec.  141.82(d), a letter certifying that
the water system has completed installing that treatment.
    (d) Source water treatment reporting requirements. By the
applicable dates in Sec.  141.83, water systems shall provide the
following information to the State:
    (1) If required under Sec.  141.83(b)(1), their recommendation
regarding source water treatment;
    (2) For water systems required to install source water treatment
under Sec.  141.83(b)(2), a letter certifying that the water system has
completed installing the treatment designated by the State within 24
months after the State designated the treatment.
    (e) Lead service line inventory and replacement reporting
requirements. Water systems shall report the following information to
the State to demonstrate compliance with the requirements of Sec.
141.84:
    (1) No later than 12 months after the end of a monitoring period in
which a water system exceeds the lead action level in sampling referred
to in Sec.  141.84(f), the water system must submit written
documentation to the State of the material evaluation conducted as
required in Sec.  141.84(a), identify the initial number of lead
service lines in its distribution system at the time the water system
exceeds the lead action level, and provide the water system's schedule
for annually replacing at least 3 percent of the initial number of lead
service lines in its distribution system.
    (2) No later than 12 months after the end of a monitoring period in
which a water system exceeds the lead action level in sampling referred
to in Sec.  141.84(f), and every 12 months thereafter, the water system
shall certify to the State in writing that the water system has:
    (i) Replaced in the previous 12 months at least 3 percent of the
initial lead service lines (or a greater number of lines specified by
the State under Sec.  141.84(f)(10)) in its distribution system,
    (ii) Conducted consumer notification as specified in Sec.
141.84(e).
    (iii) Additionally, the water system must certify to the State that
it delivered public education materials to the affected consumers as
specified in Sec.  141.85(a) and the notification of lead service line
materials as specified in Sec.  141.85(e).
    (3) The annual letter submitted to the State under paragraph (e)(2)
of this section shall contain the following information:
    (i) The number of lead service lines scheduled to be replaced
during the previous year of the water system's replacement schedule;
    (ii) The location of each lead service line replaced, and total
number replaced during the previous year of the water system's
replacement schedule;
    (iii) The certification that the water system has notified the
resident(s) served by the lead service line at least 45 days prior to
the planned lead service line replacement or within 24 hours of an
emergency full or partial replacement;
    (iv) The certification that the water system delivered lead service
line

information materials in Sec.  141.85(e) to the affected consumers; and
    (v) The certification that results of samples collected between
three months and six months after the date of a full or partial lead
service line replacement were provided to the customer in accordance
with the timeframes in 141.85(d)(2). Mailed notices post-marked within
three business days of receiving the results shall be considered ``on
time.''
    (4) [Reserved].
    (5) No later than the compliance date of the rule, the water system
must submit to the State an inventory of lead service lines as required
in Sec.  141.84(a), and every 12 months thereafter, any water system
that has lead service lines must submit to the State an updated
inventory that includes the number of lead service lines remaining in
the distribution system as required in Sec.  141.84(a).
    (i) Any water system that contains a lead service line in their
distribution system must submit to the State, as specified in section
Sec.  141.84(b) a lead service line replacement plan at the same time
the lead service line inventory is submitted.
    (ii) Any water system that contains a lead service line in their
distribution system or a service line of unknown material must certify
to the State annually that it conducted consumer notification as
specified in Sec.  141.85(e).
    (iii) Any water system that contains a lead service line in their
distribution system or a service line of unknown material must certify
to the State annually that it delivered lead service line information
materials to the affected consumers as specified in Sec.  141.85(e).
    (6) No later than 12 months after the end of a monitoring period in
which a water system exceeds the lead trigger level but not the lead
action level in sampling referred to in Sec.  141.84(e) has replaced
lead service lines at the annual goal rate. In addition, every 12
months thereafter, the water system shall certify to the State in
writing that the water system has:
    (i) Replaced in the previous 12 months, at least enough of the
initial lead service lines to meet the annual goal-based rate set by
the State under Sec.  141.84(d)(1) in its distribution system;
    (ii) Conducted consumer notification as specified in Sec.
141.85(f);
    (iii) Additionally, the water system must certify to the State that
it delivered the notification of lead service line materials as
specified in Sec.  141.85(b); and
    (iv) A water system that does not meet its annual service line
replacement goal as required under Sec.  141.84(f) shall certify to the
State in writing that the water system has conducted customer outreach
as specified in Sec.  141.85(g).
    (f) Public education program reporting requirements. (1) Any water
system that is subject to the public education requirements in Sec.
141.85 shall, within 10 days after the end of each period in which the
water system is required to perform public education in accordance with
Sec.  141.85(b), send written documentation to the State that contains:
    (i) A demonstration that the water system has delivered the public
education materials that meet the content requirements in Sec.
141.85(a) and the delivery requirements in Sec.  141.85(b); and
    (ii) A list of all the newspapers, radio stations, television
stations, and facilities and organizations to which the system
delivered public education materials during the period in which the
system was required to perform public education tasks.
    (2) Unless required by the State, a water system that previously
has submitted the information required by paragraph (f)(1)(ii) of this
section need not resubmit the information required by paragraph
(f)(1)(ii) of this section, as long as there have been no changes in
the distribution list and the water system certifies that the public
education materials were distributed to the same list submitted
previously.
    (3) No later than three months following the end of the monitoring
period, each water system must mail a sample copy of the consumer
notification of tap results to the State along with a certification
that the notification has been distributed in a manner consistent with
the requirements of Sec.  141.85(d).
    (4) Annually on July 1, a demonstration that the water system
delivered annual notification to customers with a lead service line or
service line of unknown material in accordance with Sec.  141.85(e).
    (5) Annually on July 1, a demonstration that the water conducted an
outreach activity in accordance with Sec.  141.85(g) when failing to
meet the lead service line replacement goal as specified in Sec.
141.84(f).
    (g) Reporting of additional monitoring data. Any water system which
collects sampling data in addition to that required by this subpart
shall report the results to the State within the first 10 days
following the end of the applicable monitoring period under Sec. Sec.
141.86, 141.87 and 141.88 during which the samples are collected. This
includes the monitoring data pertaining to ``find and fix'' pursuant to
Sec. Sec.  141.86(h) and 141.87(g).
    (h) Reporting of 90th percentile lead and copper concentrations
where the State calculates a water system's 90th percentile
concentrations. A water system is not required to report the 90th
percentile lead and copper concentrations measured from among all lead
and copper tap water samples collected during each monitoring period,
as required by paragraph (a)(1)(iv) of this section if:
    (1) The State has previously notified the water system that it will
calculate the water system's 90th percentile lead and copper
concentrations, based on the lead and copper tap results submitted
pursuant to paragraph (h)(2)(i) of this section, and has specified a
date before the end of the applicable monitoring period by which the
water system must provide the results of lead and copper tap water
samples;
    (2) The water system has provided the following information to the
State by the date specified in paragraph (h)(1) of this section:
    (i) The results of all tap samples for lead and copper including
the location of each site and the criteria under Sec.  141.86(a)(3)
through (8) and/or (9), under which the site was selected for the water
system's sampling pool, pursuant to paragraph (a)(1)(i) of this
section; and
    (ii) An identification of sampling sites utilized during the
current monitoring period that were not sampled during previous
monitoring periods, and an explanation why sampling sites have changed;
and
    (3) The State has provided the results of the 90th percentile lead
and copper calculations, in writing, to the water system before the end
of the monitoring period.
    (i) Reporting requirements for a community water system's public
education and sampling in schools and child care facilities. (1) A
community water system shall send a report to the State by July 1 of
each year for the previous calendar year's activity. The report must
include the following:
    (i) Certification that it made a good faith effort to identify
schools and child care facilities in accordance with Sec.  141.92(a).
The good faith effort may include reviewing customer records and
requesting lists of schools and child care facilities from the primacy
agency or other licensing agency. A water system that certifies that no
schools or child care facilities are served by the water system is not
required to include information in paragraph (i)(1)(ii) through
(i)(1)(iii) of this section in the report.

    (ii) Certification that the water system has completed the
notification and sampling requirements of Sec. Sec.  141.86 and 141.92
at a minimum of 20 percent of schools and child care facilities;
    (A) The number of schools and child care facilities served by the
water system;
    (B) The number of schools and child care facilities sampled in the
calendar year;
    (C) The number of schools and child care facilities that have
refused sampling;
    (D) Information pertaining to attempts to gain entry for sampling
that were declined by the customer; and
    (iii) Certification that sampling results were provided to schools,
child care facilities, and local or State health departments.
    (iv) Certification of compliance with an alternative school and
childcare testing program at least as stringent paragraphs (a) through
(c) of Sec.  141.92, if applicable.
    (j) Small system compliance flexibility option using point-of-use
devices. Small water systems and non-transient, non-community water
systems shall report the results from the tap sampling required under
Sec.  141.93 and any corrective actions taken if the trigger level was
exceeded in that monitoring. Small water systems shall also provide
documentation to certify maintenance of the point-of-use devices if
requested by the State.
0
15. Add Sec.  141.92 to subpart I to read as follows:

Sec.  141.92   Monitoring for lead in schools and child care
facilities.

    All community water systems must conduct directed public education
to schools and child care facilities served by the water system,
including any facilities that are consecutive water systems if those
schools or child care facilities were constructed prior to January 1,
2014.
    (a) Public Education to schools and child care facilities. (1) By
the compliance date for the rule, each water system shall compile a
list of schools or licensed child care facilities served by the system.
The provisions of this section do not apply to a school or child care
facility that is a regulated as a public water system, including
consecutive public water systems.
    (2) Each water system shall contact schools or licensed child care
facilities identified by the system in paragraph (a) of this section to
provide:
    (i) Information about health risks from lead in drinking water on
at least an annual basis;
    (ii) Notification that the water system will be conducting sampling
for lead at the facility, including information about testing for lead
in schools and child care facilities (EPA's 3Ts for Reducing Lead in
Drinking Water Toolkit, EPA-815-B-18-007 or subsequent EPA guidance),
and;
    (iii) Instructions for identifying outlets for sampling and
preparing for a sampling event 30 days prior to the event.
    (3) The water system must include documentation in the proposed
reporting requirement in Sec.  141.90(i) if a school or child care
facility refuses entry or otherwise declines to participate in the
monitoring or education requirements of this section.
    (b) Monitoring for lead in schools and child care facilities. (1) A
water system shall collect five samples per school and two samples per
child care facility at outlets typically used for consumption. The
outlets shall not have point-of-use (POU) devices and shall consist of
the following locations:
    (i) For schools: Two drinking water fountains, one kitchen faucet
used for food or drink preparation, one classroom faucet, and one
nurse's office faucet, as available.
    (ii) For child care facilities: One drinking water fountain and one
of either a kitchen faucet used for preparation of food or drink or one
classroom faucet.
    (iii) If any facility has fewer than the required number of
outlets, the water system shall sample all outlets used for
consumption.
    (iv) If any facility does not contain the type of faucet listed
above, the water system shall collect a sample from another outlet
typically used for consumption as identified by the facility.
    (v) Samples shall be collected from the cold water tap subject to
the following additional requirements:
    (A) Each sample for lead shall be a first-draw sample;
    (B) The sample must be 250 ml in volume;
    (C) The water must have remained stationary in the plumbing system
of the sampling site (building) for at least 8 but no more than 18
hours;
    (D) Samples may be collected by either the customer, school or
child care facility, or the water system, and;
    (E) Samples shall be analyzed using acidification and the
corresponding analytical methods in Sec.  141.89.
    (2) [Reserved].
    (c) Frequency of sample collection at schools and child care
facilities. (1) A water system shall collect samples from at least 20
percent of schools served by the system and 20 percent of child care
facilities served by the system per year until all schools and child
care facilities identified under paragraph (a) of this section have
been sampled or have declined to participate.
    (2) A water system shall continue to collect samples from at least
20 percent of school and child care facilities in its distribution
system each year thereafter.
    (3) A water system shall conduct monitoring at all schools and
child care facilities at least once every five years.
    (4) The water system must include documentation in the report
required in Sec.  141.90(i) if a school or child care facility refuses
entry or otherwise declines to allow the system to conduct the
monitoring or education requirements of this section.
    (d) Alternative School Sampling Programs. (1) If Local or State law
or regulations require schools and childcare facilities to be tested,
by either the school or the water system, in a way that is at least as
stringent as paragraphs (a) through (c) of this section, the water
system may execute that program to comply with the requirements of this
section.
    (2) The water system must include documentation in the report
required in Sec.  141.90(i) if a school or child care facility refuses
entry or otherwise declines to allow the system to conduct the
monitoring or education requirements of this section.
    (e) Confirmation or revision of schools and child care facilities
in inventory. A water system shall either confirm that there have been
no changes to its list of schools and child care facilities served by
the system developed pursuant to Sec.  141.92(a), or submit a revised
list at least once every five years.
    (f) Notification of Results. A water system shall provide
analytical results as soon as practicable but no late than 30 days
after receipt of the results to:
    (1) The school or child care facility, along with information about
remedial options;
    (2) the local or State health department; and
    (3) the primacy agency.
0
16. Add Sec.  141.93 to subpart I to read as follows:

Sec.  141.93  Small Water System Compliance Flexibility

    The compliance alternatives described in this section apply to
small community water systems serving 10,000 or fewer persons or non-
transient non-community water systems.
    (a) A small community water system that exceeds the lead trigger
level but meets the lead and copper action levels must evaluate
compliance options in paragraphs (a)(1) through (3) of this section and
make a compliance option

recommendation to the State within six months of the end of the
monitoring period in which the exceedance occurred. A State must
approve the recommendation or designate an alternative from compliance
options in paragraphs (a)(1) through (3) of this section within six
months of the recommendation by the water system. If the water system
subsequently exceeds the lead action level it must implement the
approved option. Community water systems must select from the following
compliance options:
    (1) Lead Service Line Replacement. A water system shall implement a
full lead service line replacement program and replace its lead service
lines on a schedule approved by the State and shall complete
replacement of all lead service lines within 15 years, even if its 90th
percentile is below the action level in future monitoring periods.
    (2) Corrosion Control Treatment. A water system must install and
maintain corrosion control treatment in accordance with Sec.  141.82,
even if its 90th percentile is below the action level in future
monitoring periods. Any water system that has corrosion control
treatment installed must re-optimize as per Sec.  141.82(d).
    (3) Point-of-Use Devices. A water system must install, maintain,
and monitor POU devices in each household or building, even if its 90th
percentile is below the action level in future monitoring periods.
    (i) A community water system must install a minimum of one POU
device (at one tap) in every household or building in its distribution
system.
    (ii) The POU device must be certified by the American National
Standards Institute to reduce lead in drinking water, and
    (iii) The POU device must be maintained by the water system to
ensure continued effective filtration, including but not limited to
changing filter cartridges and resolving any operational issues.
    (iv) The community water system must monitor one-third of the POU
devices each year and all POU devices must be monitored within a three-
year cycle. First-draw tap samples collected under this section must be
taken after water passes through the POU device to assess its
performance. Samples should be one-liter in volume and have had a
minimum 6-hour stagnation time. All samples must be at or below the
lead trigger level. The system must document the problem and take
corrective action at any site where the sample result exceeds the lead
trigger level.
    (b) A non-transient non-community water system that exceeds the
lead trigger level but meets the lead and copper action levels must
evaluate compliance options in paragraphs (b)(1) through (4) of this
section and make a compliance option recommendation to the State within
six months of the end of the monitoring period in which the exceedance
occurred. A State must approve the recommendation or designate an
alternative from compliance options in paragraphs (b)(1) through (4) of
this section within six months of the recommendation by the water
system. If the water system subsequently exceeds the lead action level
it must implement the approved option. Non-transient non-community
water system must select from the following compliance options:
    (1) Lead Service Line Replacement. A water system shall implement a
full lead service line replacement program and replace its lead service
lines on a schedule approved by the State and shall complete
replacement of all lead service lines within 15 years, even if its 90th
percentile is at or below the action level in future monitoring
periods.
    (2) Corrosion Control Treatment. A water system must install and
maintain corrosion control treatment in accordance with Sec.  141.82,
even if its 90th percentile is below the action level in future
monitoring periods. Any water system that has corrosion control
treatment installed must re-optimize as per Sec.  141.82(e).
    (3) Point-of-Use Devices. A water system must install, maintain,
and monitor POU devices in each household or building, even if its 90th
percentile is at or below the action level in future monitoring
periods.
    (i) A non-transient non-community water system must provide a POU
device to every tap that is used for cooking and/or drinking.
    (ii) The POU device must be certified by the American National
Standards Institute to reduce lead in drinking water and:
    (iii) The POU device must be maintained by the water system to
ensure continued effective filtration, including but not limited to
changing filter cartridges and resolving any operational issues.
    (iv) The non-transient non-community water system must monitor one-
third of the POU devices each year and all POU devices must be
monitored within a three-year cycle. First-draw tap samples collected
under this section must be taken after water passes through the POU
device to assess its performance. Samples should be one-liter in volume
and have had a minimum 6-hour stagnation time. All samples must be at
or below the lead trigger level. The system must document the problem
and take corrective action at any site where the sample result exceeds
the lead trigger level.
    (4) Replacement of Lead-Bearing Plumbing. A water system must
replace all plumbing that is not lead free in accordance with Section
1417 of the Safe Drinking Water Act, as amended by the Reduction of
Lead in Drinking Water Act and any future amendments applicable at the
time of replacement, including a lead service line, even if its 90th
percentile is below the action level in future monitoring periods. A
water system must have control over all plumbing in its buildings. The
replacement of all lead-bearing plumbing must occur on a schedule
established by the State, not to exceed one year.
    (c) A small community water system that exceeds the lead action
level but meets the copper action level must evaluate according to
paragraphs (c)(1) through (3) of this section and make a compliance
option recommendation to the State within six months of the end of the
monitoring period in which the exceedance occurred. A State must
approve the recommendation or designate an alternative from compliance
options in paragraphs (c)(1) through (3) of this section within six
months of the recommendation by the water system. If the water system
subsequently exceeds the lead action level it must implement the
approved option. Community water systems must select from the following
compliance options:
    (1) Lead Service Line Replacement. A water system shall implement
full lead service line replacement program and replace its lead service
lines on a schedule approved by the State and shall complete
replacement of all lead service lines within 15 years, even if its 90th
percentile is below the action level in future monitoring periods.
    (2) Corrosion Control Treatment. A water system must install and
maintain corrosion control treatment in accordance with Sec.  141.82,
even if its 90th percentile is below the action level in future
monitoring periods.
    (3) Point-of-Use Devices. A water system must install, maintain,
and monitor POU devices in each household or building, even if its 90th
percentile is below the action level in future monitoring periods.
    (i) A community water system must install a minimum of one POU
device (at one tap) in every household or building in its distribution
system.
    (ii) The POU device must be certified by the American National
Standards

Institute to reduce lead in drinking water, and
    (iii) The POU device must be maintained by the water system to
ensure continued effective filtration, including but not limited to
changing filter cartridges and resolving any operational issues.
    (iv) The community water system must monitor one-third of the POU
devices each year and all POU devices must be monitored within a three-
year cycle. First-draw tap samples collected under this section must be
taken after water passes through the POU device to assess its
performance. Samples should be one-liter in volume and have had a
minimum 6-hour stagnation time. All samples must be at or below the
lead trigger level. The system must document the problem and take
corrective action at any site where the sample result exceeds the lead
trigger level.
    (d) A non-transient non-community water system that exceeds the
lead action level but does not exceed the copper action level must
evaluate (1) through (4) of this section and make a compliance
recommendation to the State from compliance options in paragraphs
(d)(1) through (4) of this section within six months of the end of the
monitoring period in which the exceedance occurred. A State must
approve the recommendation or designate an alternative within six
months of the recommendation by the water system. If the water system
subsequently exceeds the lead action level it must implement the
approved option. Non-transient non-community water systems must select
from the following compliance options:
    (1) Lead Service Line Replacement. A water system shall implement
full lead service line replacement program and replace its lead service
lines on a schedule approved by the State and shall complete
replacement of all lead service lines within 15 years, even if its 90th
percentile is at or below the action level in future monitoring
periods.
    (2) Corrosion Control Treatment. A water system must install and
maintain corrosion control treatment in accordance with Sec.  141.82,
even if its 90th percentile is at or below the action level in future
monitoring periods. Any water system that has corrosion control
treatment installed must re-optimize as per Sec.  141.82(e).
    (3) Point-of-Use Devices. A water system must install, maintain,
and monitor POU devices in each household or building, even if its 90th
percentile is at or below the action level in future monitoring
periods.
    (i) A non-transient non-community water system must provide a POU
device to every tap that is used for cooking and/or drinking.
    (ii) The POU device must be certified by the American National
Standards Institute to reduce lead in drinking water and:
    (iii) The POU device must be maintained by the water system to
ensure continued effective filtration, including but not limited to
changing filter cartridges and resolving any operational issues.
    (iv) The non-transient non-community water system must monitor one-
third of the POU devices each year and all POU devices must be
monitored within a three-year cycle. First-draw tap samples collected
under this section must be taken after water passes through the POU
device to assess its performance. Samples should be one-liter in volume
and have had a minimum 6-hour stagnation time. All samples must be
below the lead trigger level. The system must document the problem and
take corrective action at any site where the sample result exceeds the
lead trigger level.
    (4) Replacement of Lead-Bearing Plumbing. A water system must
replace all plumbing that is not lead free in accordance with section
1417 of the Safe Drinking Water Act as amended by the Reduction of Lead
in Drinking Water Act and any future amendments applicable at the time
of replacement, including a lead service line, even if its 90th
percentile is below the action level in future monitoring periods. A
water system must have control over all plumbing in its buildings. The
replacement of all lead-bearing plumbing must occur on a schedule
established by the State, not to exceed one year.
0
17. Amend Sec.  141.153 by revising paragraph (d)(4)(vi) to read as
follows:

Sec.  141.153  Content of the reports

* * * * *
    (d) * * *
    (4) * * *
    (vi) For lead and copper: The 90th percentile concentration of the
most recent round of sampling, the number of sampling sites exceeding
the action level, and the range of tap sampling results;
* * * * *
0
18. Amend Sec.  141.154 to revise paragraph (d)(1) to read as follows:

Sec.  141.154  Required additional health information.

* * * * *
    (d) * * *
    (1) A short informational statement about lead in drinking water
and its effects on children. The statement must include the following
information:
    If present, lead can cause serious health problems, especially for
pregnant women and young children. Lead in drinking water is primarily
from materials and components associated with service lines and home
plumbing. [NAME OF UTILITY] is responsible for providing high quality
drinking water, but cannot control the variety of materials used in
plumbing components. You share the responsibility for protecting
yourself and your family from the lead in your home plumbing. You can
take responsibility by identifying and removing lead materials within
your home plumbing and taking steps to reduce your family's risk.
Before drinking, flush your pipes for several minutes by running your
tap, taking a shower, doing laundry or a load of dishes. You can also
use a filter certified to remove lead from drinking water. If you are
concerned about lead in your water you may wish to have your water
tested, contact [NAME OF UTILITY and CONTACT INFORMATION]. Information
on lead in drinking water, testing methods, and steps you can take to
minimize exposure is available at http://www.epa.gov/safewater/lead.
* * * * *
0
19. Amend Appendix A to Subpart O of Part 141 by revising the entry for
lead to read as follows:

                                               Appendix A to Subpart O of Part 141--Regulated Contaminants
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  To convert for
      Contaminant        Traditional MCL in mg/L   CCR, multiply      MCL in CCR units          MCLG         Major sources in    Health effects language
                                                        by                                                    drinking water
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Lead...................  AL = .015..............            1000  AL = 15................               0  Corrosion of         Exposure to lead can
                                                                                household plumbing   cause serious health
                                                                                systems, Erosion     effects in all age
                                                                                of natural           groups. Infants and
                                                                                deposits.            children who drink
                                                                                water containing lead
                                                                                could have decreases in
                                                                                IQ and attention span
                                                                                and increases in
                                                                                learning and behavior
                                                                                problems. Lead exposure
                                                                                among women who are
                                                                                pregnant increases
                                                                                prenatal risks. Lead
                                                                                exposure among women
                                                                                who later become
                                                                                pregnant has similar
                                                                                risks if lead stored in
                                                                                the mother's bones is
                                                                                released during
                                                                                pregnancy. Recent
                                                                                science suggests that
                                                                                adults who drink water
                                                                                containing lead have
                                                                                increased risks of
                                                                                heart disease, high
                                                                                blood pressure, kidney
                                                                                or nervous system
                                                                                problems.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
20. Amend Sec.  141.201 by:
0
a. Adding entry (a)(3)(vi) in Table 1 to Sec.  141.201; and
0
b. Revising paragraph (c)(3).
    The additions read as follows.

Sec.  141.201  General public notification requirements.

* * * * *
    (a) * * *

  Table 1 to Sec.   141.201--Violation Categories and Other Situations
                        Requiring a Public Notice
------------------------------------------------------------------------

-------------------------------------------------------------------------
(3) Special public notices:

                              * * * * * * *
(vi) Exceedance of the lead action level.
------------------------------------------------------------------------

* * * * *
    (c) * * *
    (3) A copy of the notice must also be sent to the primacy agency
and the Administrator (as applicable) in accordance with the
requirements of Sec.  141.31(d).
0
21. In Sec.  141.202 amend paragraph (a) by adding entry (10) in Table
1 to Sec.  141.202, to read as follows:

Sec.  141.202  Tier 1 Public Notice--Form, manner and frequency of
notice.

    (a) * * *

  Table 1 to Sec.   141.202--Violation Categories and Other Situations
                    Requiring a Tier 1 Public Notice
------------------------------------------------------------------------

-------------------------------------------------------------------------

                              * * * * * * *
(10) Exceedance of the Action Level for lead as specified in Sec.
 141.80(c).
------------------------------------------------------------------------

* * * * *
0
22. Amend Appendix A to subpart Q by adding an entry for Violations of
National Primary Drinking Water Regulations (NPDWR) under ``C. Lead and
Copper Rule'' to read as follows:

     Appendix A to Subpart Q of Part 141--NPDWR Violations and Other Situations Requiring Public Notice \1\
----------------------------------------------------------------------------------------------------------------
                                                 MCL/MRDL/TT violations \2\      Monitoring & testing procedure
                                             ----------------------------------            violations
                 Contaminant                                                   ---------------------------------
                                               Tier of public      Citation      Tier of public
                                              notice required                   notice required      Citation
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
C. Lead and Copper Rule (Action Level for
 lead is 0.015 mg/L, for copper is 1.3 mg/L)

                                                  * * * * * * *
2. Exceedance of the Action Level for lead..                1        141.80(c)

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Violations and other situations not listed in the table (e.g., failure to prepare Consumer Confidence
  Reports), do not require notice unless determined by the primacy agency. Primacy agencies may, at their
  options, also require a more stringent public notice tier (e.g., Tier 1 instead of Tier 2 or Tier 2 instead of
  Tier 3) for specific violations and situations listed in this Appendix, as authorized under Sec.   141.202(a)
  and Sec.   141.203(a).
\2\ MCL--Maximum contaminant level, MRDL--Maximum residual disinfectant level, TT--Treatment technique.

* * * * *
0
23. Amend Appendix B to subpart Q by revising the entry for contaminant
``23. Lead'' to read as follows:

          Appendix B to Subpart Q of Part 141--Standard Health Effects Language for Public Notification
----------------------------------------------------------------------------------------------------------------
                                                                                Standard health effects
        Contaminant                MCLG \1\ mg/L               MCL \2\ mg/L              language for public
                                                                                notification
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                             D. Lead and Copper Rule
----------------------------------------------------------------------------------------------------------------
23. Lead..................  zero......................  TT \13\...................  Exposure to lead can cause
                                                                                serious health effects in
                                                                                all age groups. Infants and
                                                                                children who drink water
                                                                                containing lead could have
                                                                                decreases in IQ and
                                                                                attention span and
                                                                                increases in learning and
                                                                                behavior problems. Lead
                                                                                exposure among women who
                                                                                are pregnant increases
                                                                                prenatal risks. Lead
                                                                                exposure among women who
                                                                                later become pregnant has
                                                                                similar risks if lead
                                                                                stored in the mother's
                                                                                bones is released during
                                                                                pregnancy. Recent science
                                                                                suggests that adults who
                                                                                drink water containing lead
                                                                                have increased risks of
                                                                                heart disease, high blood
                                                                                pressure, kidney and
                                                                                nervous system problems.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ MCLG--Maximum contaminant level goal.
\2\ MCL--Maximum contaminant level.
 * * * * * * *
\13\ Action Level = 0.015 mg/L.

* * * * *

PART 142--NATIONAL PRIMARY DRINKING WATER REGULATIONS
IMPLEMENTATION

0
24. The authority citation for part 142 continues to read as follows:

    Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.

0
25. Amend Sec.  142.14 by revising paragraphs (d)(8)(iii) and
(d)(8)(vii) and adding paragraphs (d)(8)(xviii) through (xx) to read as
follows:

Sec.  142.14  Records kept by States.

* * * * *
    (d) * * *
    (8) * * *
    (iii) Section 141.82(d)--designations of optimal corrosion control
treatment and any simultaneous compliance considerations that factored
into the designation;
* * * * *
    (viii) Section 141.84(e)--determinations of lead service line
replacement goal rate as well as mandatory full lead service line
service line replacement rates below 3 percent;
* * * * *
    (xviii) Section 141.88--evaluation of water system source water or
treatment changes;
    (xix) Section 141.93--identification of small water systems and
non-transient non-community water systems utilizing the compliance
alternatives, and the compliance alternative selected by the water
system and the compliance option approved by the State;
    (xx) Section 141.84(a)--completed lead service line inventories and
annual updates to inventories.
* * * * *
0
26. Amend Sec.  142.15 by:
0
a. Revising paragraphs (b)(4)(i), (b)(4)(i)(A), (b)(4)(ii), and
(b)(4)(ii)(A) through (E) to read as follows; and removing paragraph
(b)(4)(iii).

Sec.  142.15  Reports by States.

* * * * *
    (b) * * *
    (4) * * *
    (i) States shall report the name and PWS identification number:
    (A) Each public water system which exceeded the lead and copper
action levels and the date upon which the exceedance occurred;
* * * * *
    (ii) States shall report the PWS identification number of each
public water system identified in paragraphs (c)(4)(iii)(A) through (F)
of this section.
    (A) For each public water system, regardless of size, all 90th
percentile lead levels calculated during each monitoring period
specified in Sec.  141.86 of this chapter, and the first and last day
of the monitoring period for which the 90th percentile lead level was
calculated;
    (B) For each public water system (regardless of size), the 90th
percentile copper level calculated during each monitoring period in
which the system exceeds the copper action level, and the first and
last day of each monitoring period in which an exceedance occurred;

    (C) For each public water system for which the State has designated
optimal water quality parameters under Sec.  141.82(f) of this chapter,
or which the State has deemed to have optimized corrosion control under
Sec.  141.81(b)(1) or (b)(3) of this chapter, the date of the
determination and the paragraph(s) under which the State made its
determination, the corrosion control treatment status of the water
system, and the water system's optimal water quality parameters;
    (D) For each public water system, the number of lead service lines
in its distribution system, including service lines of unknown
material;
    (E) For each public water system required to begin replacing lead
service lines after a lead trigger level or action level exceedance, as
specified in Sec.  141.84 of this chapter and the date each system must
begin replacement; and
* * * * *
0
27. Amend Sec.  142.16 by:
0
a. Adding paragraphs (d)(5) through (9); and
0
b. Revising paragraph (o)(2)(i)(B).
    The additions and revision to read as follows:

Sec.  142.16  Special primacy requirements.

* * * * *
    (d) * * *
    (5) Section 141.84--Establishing lead service line replacement goal
rates.
    (6) Section 141.84--Designating acceptable methods for determining
service line material for the lead service line inventory.
    (7) Section 141.92--Defining a school or childcare facility and
determining any existing State testing program is at least as stringent
as the Federal requirements.
    (8) Section 141.82--Verifying compliance with ``find-and-fix''
requirements.
    (9) Section 141.88--Reviewing any change in source water or
treatment and how this change may impact other National Primary
Drinking Water Regulations.
* * * * *
    (o)(2)(i)(B) Treatment, including corrosion control treatment and
water quality parameters as applicable,
* * * * *
0
28. Amend Sec.  142.19 redesignating paragraphs (b) through (f) as
paragraphs (c) through (g) and adding a new paragraph (b) to read as
follows:

Sec.  142.19  EPA review of State implementation of national primary
drinking water regulations for lead and copper.

* * * * *
    (b) Pursuant to the procedures in this section, the Regional
Administrator may review state determinations establishing a goal lead
service line replacement rate and may issue an order establishing
federal goal rate requirements for a public water system pursuant to
Sec.  141.84(b) where the Regional Administrator finds that an
alternative goal lead service line replacement rate is feasible.
* * * * *
[FR Doc. 2019-22705 Filed 11-12-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 77, Number 156 (Monday, August 13, 2012)]
[Notices]
[Pages 48159-48160]
[FR Doc No: 2012-19744]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0523]

Draft Guidance for Industry and Food and Drug Administration
Staff; Refuse To Accept Policy for 510(k)s; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance entitled ``Refuse to Accept Policy
for 510(k)s.'' The purpose of this document is to explain the
procedures and criteria FDA intends to use in determining whether a
premarket notification (510(k)) submission is administratively
complete, which determines whether it should be accepted for
substantive review. This guidance is applicable to 510(k)s reviewed in
the Center for Devices and Radiological Health (CDRH) and the Center
for Biologics Evaluation and Research (CBER). This draft guidance is
not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 27, 2012.

ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Refuse to Accept Policy for 510(k)s'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for

Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002;
or Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Geeta Pamidimukkala, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 1564, Silver Spring, MD 20993-0002,
301-796-6453; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

I. Background

    The purpose of the 510(k) acceptance review is to make a threshold
determination whether a submission is administratively complete, which
determines whether it should be accepted for substantive review to
reach a determination regarding substantial equivalence under section
513(i) of the FD&C Act, 21 U.S.C. 360c(i). To find a device
substantially equivalent under section 513(i) of the FD&C Act, FDA must
find that it has the same intended use as the predicate device, and
either: (1) Has the same technological characteristics as the predicate
device or (2) has different technological characteristics, as defined
at section 513(i)(1)(B), and the submission contains information,
including appropriate clinical or scientific data if necessary, that
demonstrates the device is as safe and effective as the predicate and
does not raise different questions of safety and effectiveness than the
predicate.
    The purpose of this document is to explain the procedures and
criteria FDA intends to use in determining whether a 510(k) submission
is administratively complete and should be accepted for substantive
review. This guidance document provides updated information to two
existing guidance documents entitled ``Center for Devices and
Radiological Health's Premarket Notification (510(k)) Refuse to Accept
Policy'' issued on June 30, 1993, and ``510(k) Refuse to Accept
Procedures, 510(k) Memorandum K94-1'' issued on May 20, 1994. Upon
issuance as a final guidance document, this guidance will replace those
documents.
    To further focus the Agency's review resources on complete
applications, which will provide a more efficient approach to ensuring
that safe and effective medical devices reach patients as quickly as
possible, we have modified the 1993 and 1994 guidances. For example, we
have modified the 510(k) refuse to accept policy to include an early
review against specific acceptance criteria and to inform the submitter
within the first 15 calendar days of receipt of the submission if the
submission is administratively complete, or if not, to identify the
missing element(s). In order to enhance the consistency of our
acceptance decisions and to help submitters better understand the types
of information FDA needs to conduct a substantive review, this
guidance, including the checklists included in the appendices,
clarifies the necessary elements and contents of a complete 510(k)
submission. These elements are applicable to all devices reviewed
through the 510(k) notification process in CDRH and CBER and have been
compiled into checklists for use by FDA review staff.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on the refuse
to accept policy for 510(k)s. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by using the Internet. A search capability for all CDRH guidance
documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm or http://www.regulations.gov.
    To receive ``Refuse to Accept Policy for 510(k)s,'' you may either
send an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document or send a fax request to<PHONE_NUMBER> to receive a
hard copy. Please use the document number 1793 to identify the guidance
you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 807, subpart E, have been
approved under OMB control number 0910-0120.

V. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 7, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-19744 Filed 8-10-12; 8:45 am]
BILLING CODE 4160-01-P