EPA-815-Z-Ol-OO^
Friday,
June 8, 2001
Part IV
Environmental
Protection Agency
40 CFR Parts 9, 141, and 142
National Primary Drinking Water; Filter
Backwash Recycling Rule; Final Rule
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Federal Register/Vol. 66, No. ill /Friday, June 8, 2001/Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9,141, and 142
[WH-FRL-6989-5]
R1N2040-AD17
National Primary Drinking Water
Regulations: Filter Backwash
Recycling Rule
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Final rule.
SUMMARY: In this document, EPA is
finalizing the Filter Backwash .Recycling
Rule (FBRR). The purpose of the FBRR
is to further protect public health by
requiring public water systems (PWSs),
where needed, to institute changes to
the return of recycle flows to a plant's
treatment process that may otherwise
compromise microbial control- Today's
final rule addresses a statutory
requirement of the 1996 Safe Drinking
Water Act (SDWA) Amendments to
promulgate a regulation which
"governs" the recycling of filter
backwash water within the treatment
process of PWSs.
DATES: This regulation is effective
August 7, 2001. As discussed in the
supplementary information section and
consistent with sections 1412(b)(lO) and
1445 of SDWA, regulated entities must
comply with this rule starting December
8, 2003. For judicial review purposes,
this final rule is promulgated as of 1
p.m. eastern time on June 8, 2001.
ADDRESSES: Public comments, the
comment/response document,
applicable Federal Register documents,
other major supporting documents, and
a copy of the index to the public docket
for this rulemaking are available for
review at EPA's Office of Water Docket:
Docket W-99-10 Final Filter Backwash
Recycling Rule, 401 M Street, SW., Rm.
EB57, Washington, DC 20460 from 9:00
a.m. to 4:00 p.m., Eastern Time, Monday
through Friday, excluding federal
holidays. For access to docket materials
or to schedule an appointment, please
call (202) 260-3027.
FOR FURTHER INFORMATION CONTACT: For
technical inquiries, contact Jeffery
Robichaud, Office of Ground Water and
Drinking Water (4607), U.S.
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460; telephone (202) 260-2568.
For general information, contact the Safe
Drinking Water Hotline, Telephone
(800) 426-4791. The Safe Drinking
Water Hotline is open Monday through
; Friday, excluding Federal holidays,
from 9:00 a.m. to 5:30 p.m. Eastern
Time.
SUPPLEMENTARY INFORMATION: Regulated
entities. Entities potentially regulated by
the FBRR are public water systems that
use surface water or ground water under
the direct influence of surface water
(GWUDI), practice conventional or
direct filtration, and recycle spent filter
backwash, thickener supernatant, or
liquids from dewatering processes.
Regulated categories and entities
include:
Category
Tribal or Federal Governments ......
Examples of regulated entities
Public Water Systems that use surface water or ground water under the direct in-
fluence of surface water.
Public Water Systems that use surface water or ground water under the direct in-
fluence of surface water.
This table is not intended to be
exhaustive, but rather provides a guide
for readers regarding entities likely to be
regulated by the FBRR. This table lists
the types of entities that EPA is now
aware could potentially be regulated by
this rule. Other types of entities not
listed in this table could also be
regulated. To determine whether your
facility is regulated by this action, you
should carefully examine the definition
of PWS in § 141.2 of title 40 of the Code
of Federal Regulations and § 141.76 of
today's final rule. If you have questions
regarding the applicability of the FBRR
to a particular entity, consult the person
listed in the preceding section entitled
FOR FURTHER INFORMATION CONTACT.
List of abbreviations/acronyms used
in this document:
AWWA American Water Works
Association
AWWSCo American Water Works
Service Company
°C Degrees Celsius
CCR Consumer Confidence Report
CFR Code of Federal Regulations
CPE Comprehensive Performance
Evaluation
DAF Dissolved Air Flotation
EPA Environmental Protection Agency
ESWTR Enhanced Surface Water
Treatment Rule
FBRR Filter Backwash Recycling Rule
FR Federal Register
gpm Gallons per Minute
GWUDI Ground Water Under the Direct
Influence of Surface Water
HRRCA Health Risk Reduction and
. Cost Analysis
ICR Information Collection Request
IESWTR Interim Enhanced Surface
Water Treatment Rule
IRFA Initial Regulatory Flexibility
Analysis
LTlESWTR Long Term 1 Enhanced
Surface Water Treatment Rule
MCLG Maximum Contaminant Level
Goal
NOW AC National Drinking Water
.Advisory Council
NPDWR National Primary Drinking
Water Regulation
NOD A Notice of Data Availability
NTTAA National Technology Transfer
and Advancement Act
OMB Office of Management and Budget
PBMS Performance-based Measurement
System
PRA Paperwork Reduction Act
PWS Public Water System
RFA Regulatory Flexibility Act
SAB Science Advisory Board
SBA Small Business Administration
SBAR Small Business Advocacy
Review
SBREFA Small Business Regulatory
Enforcement Fairness Act of 1996
SDWA Safe Drinking Water Act
SDWIS Safe Drinking Water
Information System
UMRA Unfunded Mandates Reform Act
Table of Contents
I. Summary .
A. Why is EPA Promulgating the Filter
Backwash Recycling Rule (FBRR)?
B. What are Filter Backwash Water, Sludge
Thickener Supernatant, and Liquids
from Dewatering Processes?
C. What is Cryptosporidium?
D. What are the Health Concerns
Associated with Cryptosporidium?
E. Does this Regulation Apply to My Water
System?
F. How will this Regulation Protect Public
Health?
II. Background
A. What is the Statutory Authority for the
FBRR?
B. What is the Regulatory History for the
FBRR?
C. How were Stakeholders Involved in the
Development of the FBRR?
D. What did the April 10, 2000 Proposal
Contain?
III. Discussion of Today's Filter Backwash
Recycling Rule Requirements
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A. Where does the FBRR Specify that
Recycle Must be Returned?
B. What Reporting does the FBRR Require
of Conventional Filtration Systems that
Recycle?
C. What Reporting does the FBRR Require
of Direct Filtration Systems that Recycle?
D. What is the Compliance Schedule for
the FBRR?
E. What Public Notification and Consumer
Confidence Report Requirements are
contained in the FBRR?
IV. State Implementation
A. What Special State Primacy
Requirements does the FBRR contain?
B. What State Information Collection,
Recordkeeping and Reporting
Requirements does the FBRR contain?
C. How Must a State Obtain Interim
Primacy for the FBRR?
V. Economic Analysis (Health Risk
Reduction and Cost Analysis)
A. What are the Costs of the FBRR?
B. What are the Household Costs of the
FBRR?
C. What are the Benefits of the FBRR?
D. What are the Incremental Costs and
Benefits of the FBRR?
E. Are there Benefits From the Reduction
of Co-Occurring Contaminants?
F. Is there Increased Risk From Other
Contaminants?
G. What are the Uncertainties in Risk,
Benefit and Cost Estimates for the FBRR?
H. What is the Benefit/Cost Determination
for the FBRR?
VI. Other Requirements
A. Regulatory Flexibility Act (RFA), as
amended by the Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA), 5 U.S.C. 601 et. seq
B. Paperwork Reduction Act
C. Unfunded Mandates Reform Act of 1995
D. National Technology Transfer and
Advancement Act
E. Executive Order 12S66: Regulatory
Planning and Review
F. Executive Order 12898: Environmental
Justice
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
H. Consultations With the Science
Advisory Board, National Drinking
Water Advisory Council, and the
Secretary of Health and Human Services
I. Executive Order 13132: Executive Orders
on Federalism
J. Executive Order 13175: Consultation and
Coordination With Indian Tribal
Governments
K. Likely Effect of Compliance With the
FBRR on the Technical, Financial, and
Managerial Capacity of Public Water
Systems
L. Plain Language
M. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
N. Congressional Review Act
VH. References
I. Summary
A. Why Is EPA Promulgating the Filter
Backwash Recycling Rule (FBRR)?
When a facility recycles filter
backwash water, it reintroduces
contaminants back into treatment
processes. Poor recycle practices can
degrade influent water quality and
impair treatment process performance.
The 1996 Amendments to the Safe
Drinking Water Act (SDWA) require
EPA to promulgate a regulation that
"governs" the recycle of filter backwash
water within a treatment plant (42
U.S.C. 300g-l(b)(14)). Today's final rule
addresses filter backwash water and two
additional recycle streams of concern,
sludge thickener supernatant and
liquids from dewatering processes. The
Agency believes that establishing such a
regulation will improve performance at
filtration plants by reducing the
opportunity for recycle practices to
adversely affect plant performance in a
way that would allow microbes such as
Cryptosporidium to pass through into
finished drinking water.
B. What Are Filter Backwash Water,
Sludge Thickener Supernatant, and
Liquids From Dewatering Processes?
Throughout today's final rule, when
the word recycle is used as a noun it
refers to the three recycle streams (filter
backwash water, sludge thickener
supernatant, and liquids from
dewatering processes) regulated under
the FBRR.
Filter backwashing is an integral part
of treatment plant operation. When
filters need to be cleaned, water must be
returned back up through the filtration
media with sufficient force to separate
particles from the filter media. The
resulting water which was pushed back
through the filter in the cleaning process
is referred to as filter backwash water or
spent filter backwash water. It contains
many of the particles that were trapped
in the filter during operation, including
coagulants, metals, and microbes such
as Cryptosporidium. Several studies
have documented a range of
Cryptosporidium oocysts concentrations
in spent filter backwash from non-
detects to over 15,000 oocysts/100 L,
(EE&T, 1999).
Sedimentation basins and clarifiers
are constructed to remove particles from
a treatment process through gravity
settling. When these units are employed
to treat recycled water, the "clear water"
that exits the units after particles have
been allowed to settle out is called
sludge thickener supernatant. While the
sludge at the bottom of sedimentation
basins and clarifiers contain the
majority of the Cryptosporidium oocysts
entering a unit, recent research has
documented a range of concentrations of
Cryptosporidium oocysts in thickener
supernatant from 82 to 420 oocysts/100
L (EE&T, 1999).
Finally, some filtration plants employ
dewatering processes to remove water
from waste solids in order to reduce the
solids volume to be disposed. This
"sludge" typically comes from
sedimentation basins and clarifiers and
contains only one to two percent solids.
The dewatering units press or centrifuge
the sludge, removing liquids from
solids, which increases the solids
volume up to 90 percent. The liquids
that are removed are referred to as
liquids from dewatering processes.
Since nearly all particles and solids are
removed in sludge or slurry form from
a treatment plant, the sludge or slurry
will contain a substantial amount of the
Cryptosporidium oocysts which have
entered the plant since the dewatering
unit was last cleaned. If this sludge or
slurry is dewatered, there exists
significant potential that the liquids
from dewatering may contain elevated
levels of Cryptosporidium oocysts.
Although the Agency is unaware of
specific effluent liquid oocyst data from
dewatering processes, influent slurries
(consisting of sedimentation basin
sludges) have been shown to contain a
range of Cryptosporidium oocyst
concentrations, even as high as 2,600
oocysts/100 L (EE&T, 1999).
It should be noted that process solids
recycle flows from softening and contact
clarification units are not covered by
today's final FBRR. However, if
softening systems or contact
clarification systems recycle any of the
three recycle flows covered by the FBRR
(filter backwash water, sludge thickener
supernatant, and liquids from
dewatering processes) then they must
meet the requirements of the FBRR for
these three recycle flows.
C. What Is Cryptosporidium?
Cryptosporidium is a protozoan
parasite found in humans, many other
mammals and also in birds, fish and
reptiles. It is common in the
environment and widely found in
surface water supplies (Rose, 1988;
LeChevallier and Norton, 1995;
Atherholt et al., 1998; EPA, 2000a). In
the infected animal, the parasite
multiplies in the gastrointestinal tract.
The animal then excretes oocysts of the
parasite in its feces. These oocysts are
tiny spore-like organisms 4 to 6 microns
in diameter (too small to be seen
without a microscope) which contain
the sporozoites (infective form). The
oocysts of Cryptosporidium are very
resistant to adverse factors in the
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environment and can survive dormant
for months in cool, dark, moist soil Or
for up to a year in clean water. When
ingested by another animal, they can
reproduce in the intestinal tract and
start a new cycle of cryptosporidiosis
illness. Cryptosporidiosis is primarily a
waterborne disease, but
cryptosporidiosis has also been
transmitted by consumption of
contaminated food, unhygienic diaper
changing practices (and other person-to-
person contact), and contact with young
farm animals.
Cryptosporidium oocysts are
relatively resistant at normal
temperatures and are not easily killed
by commonly used disinfectants. Oocyst
infectivity appears to persist under
normal temperatures, although oocysts
may lose infectivity if sufficiently .
cooled or heated (EPA, 2000a). For
example, Payer (1994) discovered that
cleaned oocysts in distilled water
heated to 72.4 °G for 1 minute and to
64.2 °C for two minutes were not
infective to mice. Payer and Nerad
(1996) found that cleaned oocysts in
distilled water cooled to -20 °C for
eight hours and 70 °C for 1 hour were
not infective to mice. However, oocysts
may remain viable after freezing (Payer
and Nerad, 1996). The oocysts are
relatively unaffected by chlorine and
chloramines in the concentrations that
are used for drinking water treatment.
They are also resistant to the effects of
60 percent alcohol and many
disinfectants commonly used in the ,
home or animal husbandry.
D. What Are the Health Concerns
Associated With Cryptosporidium?
When someone is infected with
Cryptosporidium, symptoms can
include watery diarrhea, stomach
cramps, nausea, loss of appetite, and a
mild fever. This disease is called
cryptosporidiosis and is a major cause
of reported waterborne disease
outbreaks from rivers, lakes, waterparks,
and swimming pools. The symptoms of
cryptosporidiosis begin an average of
seven days after infection. Persons with
a normal, healthy immune system can
expect their illness to last for two weeks
or less, with constant or intermittent
diarrhea. Even after symptoms cease, an
individual can still pass
Cryptosporidium in the stool for up to
two months and may be a source of "
infection for others. Cryptosporidiosis is
not treatable with antibiotics so
prevention of infection is critical.
People with weakened immune systems
(those with fflV/AIDS, on cancer
chemotherapy, or those who have
received organ transplants) may have
cryptosporidiosis for a longer period of
time, and it can be life-threatening.
Small children, pregnant women, or the
elderly infected with cryptosporidiosis
can quickly become severely
dehydrated.
E. Does This Regulation Apply to My
Water System?
Today's final rule applies to all public
water systems that:
• Use surface water or ground water
under the direct influence of surface
water (GWUDI); -
• Utilize direct or conventional
filtration processes; and
• Recycle spent filter backwash
water, sludge thickener supernatant, or
liquids from dewatering processes.
F. How Will This Regulation Protect
Public Health?
EPA has determined that the presence
of microbiological contaminants is a
health concern. If finished water
supplies contain microbiological
contaminants, disease outbreaks may
result. Of the 12 waterborne
cryptosporidiosis outbreaks that have
occurred at drinking water systems
since 1984, three (Carollton, GA, 1987;
Talent, OR, 1992; and Milwaukee, WI,
1993) were linked to contaminated
drinking water from water utilities
where waste stream recycle was
identified as a possible cause (Craun,
1998; EPA, 2000a). The largest of the
known outbreaks occurred in
Milwaukee and was responsible for over
400,000 illnesses and 50 deaths (Hoxie,
et al., 1997; MacKenzie et al., 1994);
other known outbreaks have occurred in
smaller communities and have involved
many fewer people.
The Surface Water Treatment Rule
(SWTR) and Interim Enhanced Surface
Water Treatment Rule (IESWTR) (63 PR
69478, December 16,1998) set
enforceable drinking water treatment
technique requirements to reduce the
risk of waterborne microbiological
disease-including Cryptosporidium from
surface water. Today's final rule
provides further necessary protection
against Cryptosporidium for systems
that practice recycle.
Today's rule ensures that the 2-log
:Cryptosporidium removal requirement
established in the IESWTR and
proposed in the Long Term 1 Enhanced
Surface Water Treatment Rule
(LT1ESWTR) (65 PR 19046, April 10,
- 2000) is not jeopardized by recycle
practices. The rule requires (with some
^exceptions) that recycle be returned
through the processes of a system's
existing conventional or direct filtration
(as defined in'§ 141.2 of the CFR) that '
the Agency has recognized capable of
achieving 2-log (99 percent)
Cryptosporidium removal. Today's rule
also ensures that systems and States will
have the recycle flow information
necessary to evaluate whether site-
specific recycle practices may adversely
affect the ability of systems to achieve
2-log Cryptosporidium removal. Surges
of recycle flow returned to the treatment
plant.may adversely affect treatment
systems by creating hydraulically
overloaded conditions (when plants
exceed design capacity or State-
approved operating capacity) that can
lower performance of individual units
within a treatment plant resulting in
lowered Cryptosporidium removal
efficiency.
n. Background
A. What Is the Statutory Authority for
the FBRR?
The Safe Drinking Water Act (SDWA
or the Act), as amended in 1986,
requires -EPA to publish a maximum
contaminant level goal (MCLG) for each
contaminant which, in the judgement of
EPA, "may have any adverse effect on
the health of persons and which is
known or anticipated to occur in public
water systems" (Section 1412(b)(3)(A)). '
MCLGs. are to be set at a level at which
"no known or anticipated adverse effect
on the health of persons occur and
which allows an adequate margin of
safety" (Section 1412(b)(4)).
The Act was again amended in
August 1996, resulting in the
renumbering and augmentation of
certain sections with additional
statutory language. New sections were
added establishing new drinking water
requirements. Section 1412(b)(l4)
requires EPA to promulgate a regulation
to govern the recycling of filter
backwash water within the treatment
process of a public water system. The
Amendments require EPA to promulgate
such a regulation no later than four
years after the date of the enactment of
the SDWA Amendments of 1996 unless
this type of recycling has been
addressed by EPA's Enhanced Surface
Water Treatment Rule prior to the
deadline.
B. What Is the Regulatory History for the
FBRR?
The practice of filter backwash
recycling has not previously been
addressed in drinking water rules
promulgated by the Agency. As noted
earlier, the 1996 Amendments to the
SDWA, required EPA to promulgate a
regulation governing the recycling of
filter backwash water. The Agency first
presented information regarding filter
backwash practices, data, and health
risks in the November 3,1997, Interim
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31089
Enhanced Surface Water Treatment Rule
Notice of Data Availability (NOD A) (62
FR 59486). In this NODA, EPA indicated
that while both the SWTR and
forthcoming IESWTR contained
treatment technique requirements
designed to address microbial pathogens
such as Cryptosporidium, neither the
SWTR or IESWTR addressed filter
backwash recycling practices. In the
NODA, EPA indicated that it did not
plan to include separate provisions for
regulating recycling of filter backwash
water in the IESWTR, but planned to
develop a regulation to address filter
backwash recycling in conjunction with
the Long Term 1 Enhanced Surface
Water Treatment Rule (LTlESWTR).
The proposed LTlESWTR and FBRR
were published on April 10, 2000 (65 „
FR 19046).
C. How Were Stakeholders Involved in
the Development of the FBRR?
The Agency initially conducted a
broad literature search to gather
research papers and information on the
occurrence of Cryptosporidium and
other materials in recycle flows. The
literature search also sought information
on how recycling practices may impact
plant efficiency. The Agency worked
with American Water Works
Association (AWWA), the American
Water Works Service Company
(AWWSCo.), and Cincinnati Water
Works to develop twelve issue papers
on commonly generated recycle flows.
These papers are found in the docket of
today's final rule (EE&T, 1999).
EPA began outreach efforts to develop
the FBRR in the summer of 1998. Two
public stakeholder meetings, announced
in the Federal Register, were held on
July 22-23,1998, in Lakewood,
Colorado, and on March 3-4,1999, in
Dallas, Texas. In addition, EPA held
several formal and informal meetings
with stakeholders, trade associations,
and environmental groups. Small entity
representatives also contributed
valuable input as part of the Small
Business Regulatory Enforcement
Fairness Act (SBREFA) panel process.
The FBRR SBREFA panel was initiated
in April of 1998 and officially convened
in August of 1998. The panel's
recommendations were incorporated
into today's final rule.
During rule development EPA
considered a range of different options.
In addition to those found in the
proposed rule, EPA also considered
mandatory treatment of recycle streams
and a ban on all recycle flows, but
ultimately did not select these options.
EPA determined that the rule would
apply to the three largest recycle flows
at treatment plants (spent filter
backwash, sludge thickener supernatant,
and liquids from dewatering processes),
which constitute 98 percent of recycle
flow at an average system.
In early June 1999, EPA mailed an
informal draft of the FBRR preamble to
approximately 100 stakeholders who
attended either of the public stakeholder
meetings. Members of trade associations
and the SBREFA panel also received the
draft preamble. EPA received valuable
comments and stakeholder input from
15 State representatives, trade
associations, environmental interest
groups, and individual stakeholders.
During the comment period for
today's rule, the Agency held a public
meeting in Washington, DC on April 14,
2000. Additionally, the proposed rule
was either presented or discussed in
nearly 50 meetings across the U.S. (EPA,
2000i). Finally, EPA requested
stakeholder comments by mailing
approximately 200 copies of the
proposed rule to stakeholders requesting
comment. EPA received 67 comments
from a variety of stakeholders including
States, municipalities, Tribes, elected
officials, consultants, trade groups, and
private industry. These comments were
reviewed and evaluated while
developing today's final rule. Responses
to all of the comments are found in
EPA's Response to Comment Document
for the FBRR (EPA, 2000J).
D. What Did the April 10, 2000 Proposal
Contain?
The April 10, 2000 proposal (65 FR
19046) contained the Filter Backwash
Recycling Rule provisions as well as the
LTlESWTR provisions. The proposed
rulemaking package was entitled, "The
Long Term 1 Enhanced Surface Water
Treatment and Filter Backwash Rule;
Proposed Rule" (EPA, 2000b). The
Agency intends to promulgate the
LTlESWTR in a future Federal Register
announcement, separate from today's
final rule. The FBRR provisions of the
proposal applied to all surface water
and GWUDI systems which recycle
regardless of population served. The
proposal included the following
requirements:
—Spent filter backwash water, sludge
thickener supernatant, and liquids
from dewatering processes were
required to be recycled prior to the
point of primary coagulant addition
unless the State specified an
alternative location;
—Conventional filtration systems with
20 or fewer filters that recycle spent
filter backwash water, sludge
thickener supernatant, or liquids from
dewatering processes without
treatment or equalization were
required to perform a one month, one-
time recycle self assessment. The
proposed self assessment required
hydraulic flow monitoring and certain
data to be reported to the State. Upon
review of these data, the State could
require that modifications be made to
the recycle practice in order to protect
Sublic health; and
irect filtration systems recycling to
the treatment process were required to
provide detailed recycle treatment
information to the State. Upon review
of this data, the State could require
that modifications be made to the
recycle practice in order to protect
public health.
These three requirements have been
modified in today's final FBRR as
described in the following section.
III. Discussion of Today's Filter
Backwash Recycle Rule Requirements
A. Where Does the FBRR Specify That
Recycle Must Be Returned?
1. What Does Today's Rule Require?
The Agency's goal is to address risks
associated with certain recycle practices
in the least burdensome, most effective,
and simplest means possible.
Accordingly, today's final rule requires
that recycled filter backwash water,
sludge thickener supernatant, and
liquids from dewatering processes must
be returned to a location such that all
processes of a system's conventional or
direct filtration, as defined in § 141.2,
are employed. Systems may apply to the
State if they want to recycle at an
alternate location.
2. What Was the Rationale and Basis for
the Proposed Requirement?
The Agency proposed that spent filter
backwash water, sludge thickener
supernatant, and liquids from
dewatering process be recycled prior to
the point,of primary coagulant addition
unless the State specified an alternative
location. In establishing this proposed
requirement, EPA had two goals in
mind. First, the Agency believes it is
important that recycle practices be
conducted in a manner that does not
upset the chemical treatment and
coagulation process vital to the
performance and contaminant removal
capability of a filtration plant. Second,
the Agency also believes treatment
plants must assure that
Cryptosporidium oocysts in recycled
water, as well as source water, receive
the full benefit of well-operated
treatment processes to achieve at least 2-
log Cryptosporidium removal.
As indicated in the proposal, close to
80 percent of the systems which recycle,
currently return recycle prior to the
rapid mix unit and coagulation stage of
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the treatment plant. Studies from many
researchers (Patania et al., 1995;
Edzwald and Kelly, 1998; Bellamy et al.,
1993; Conley, 1965; Robeck et al., 1964;
and Trussell et al., 1980) indicate that
proper coagulation is paramount to
optimal performance of treatment
plants. In fact, pilot scale work
performed by Dugan et al. (1999)
showed that coagulation has a
significant influence on the log removal
of Cryptosporidium.
The ability for conventional and
direct filtration plants to remove
Cryptosporidium under appropriate
coagulation conditions was
demonstrated through eight studies
(Patania et al., 1995; Nieminski and
Ongerth, 1995; Ongerth and Pecoraro,
1995; LeChevallier and Norton, 1992;
LeChevallier et al., 1991; Foundation for
Water Research, 1994; Kelly et al., 1995;
and West et al., 1994) that were
described in greater detail in the
proposal for today's final rule (EPA ,
2000b). These eight studies
demonstrated that conventional and
direct filtration plants which employed
coagulation, flocculation, sedimentation
(in conventional filtration only), and
filtration steps had the ability to achieve
at least 2-log removal of .
Cryptosporidium when meeting specific
turbidity limits. These studies formed
the basis for the Agency's development
of turbidity limits (0.3 NTU 95 percent
of the time and a 1 NTU maximum)
associated with the 2-log treatment
technique in the IESWTR and the
proposed LT1ESWTR. As noted earlier,
none of the studies evaluated the
practice of recycling on treatment
performance.
In order to minimize the impacts of
recycle on chemical treatment,
minimize hydraulic disruption within
the treatment processes due to recycle,
and provide the appropriate level of
treatment necessary to achieve at least
2-log removal of Cryptosporidium in
recycle flows, the Agency believed it
necessary to include as part of the
proposed FBRR, a specific recycle
return location requirement, while also
allowing systems the ability to establish
alternate"recycle locations as approved
by the State.
3. What Major Comments Were
Received on the Proposal?
Many commenters agreed with the
proposal and noted that requiring
recycle to be returned prior to the point
of primary coagulant addition was
appropriate. Several others noted that
recycle should be allowed concurrent
with the point of primary coagulant
addition. Still others, most notably
EPA's Science Advisory Board (SAB),
indicated that because of the site-
specific characteristics of recycle,
defining a single acceptable recycle
return location was inappropriate since,
in some circumstances, it could reduce
the performance of the treatment -
system. Finally, a few commenters
expressed concern regarding workload
implications for States if too many
requests for alternate recycle locations
are received.
4. What Was the Basis for Revising the
Proposal? .
After evaluating the data submitted by
commenters, EPA believes that the goal
of this rule can be achieved more
efficiently by slightly modifying the .
return location requirement. Rather than
requiring recycle to be returned to a
specific location, today's final rule
requires recycle flows to pass through
all processes of the system's
representative treatment as defined in
§ 141.2 in order for conventional and
direct filtration systems which recycle
to maintain 2-log Cryptosporidium
removal credit. For most systems, this
requirement would allow the return of
recycle concurrent with the point of
primary coagulant addition. Today's
final rule continues to allow States the
opportunity to approve alternative
recycle return locations for systems on
a system-specific basis. Conventional
filtration is defined in § 141.2 of the
Code of Federal Regulations as a series
of processes including coagulation,
flocculation, sedimentation, and
filtration resulting in substantial particle
removal. Direct filtration is defined in
§ 141.2 of the Code of Federal
Regulations as a series of processes
including coagulation and filtration but
excluding sedimentation resulting in
substantial particle removal. As noted
earlier, the ability for conventional and
direct filtration plants to remove
Cryptosporidium has been demonstrated
in many studies. These studies
demonstrated that conventional and
direct filtration plants which employed
coagulation, flocculation, sedimentation
(in conventional filtration only), and
filtration processes, had the ability to
achieve 2-log removal of
Cryptosporidium while meeting specific
turbidity limits. EPA firmly believes
these studies demonstrate a minimum of
2-log Cryptosporidium removal only
when water passes through all processes
of conventional or direct filtration
treatment. Some studies have shown
that when recycle is performed
properly, namely •when recycle is
returned through all processes of the
plant's existing treatment system and
normal plant operations are not
disrupted with hydraulic surges or
increased overall plant flow, the return
of recycle does not perceptively impair
plant treatment with respect to
Cryptosporidium or turbidity removal
(Levesque et al., 1999 and Cornwell and
MacPhee, 2001). Because continuing to
ensure at least 2-log Cryptosporidium
removal is the goal of this provision,
EPA believes it appropriate to require
that recycle be returned at least through
existing processes which the Agency
has determined to have the ability to
achieve 2-log Cryptosporidium removal,
instead of requiring that recycle be
returned to a discrete location.
The Agency continues to recognize
that some systems may be able to
achieve 2-log or higher Cryptosporidium
removal when recycling to other
locations within the treatment plant.
Therefore, the final rule continues to
include a provision that States may
approve alternate recycling locations for
systems on a case-by-case basis.
However, the Agency dropped an
explicit requirement in the proposal that
systems must apply to the State for
approval of the change in recycle
location before the system implements
it, as the Agency believes that such a
requirement is implicit in the regulatory
language for today's final rule, and
unnecessary as systems are unlikely to
make a change to their location without
approval from the State.
B. What Reporting Does the FBRR
Require of Conventional Filtration
Systems That Recycle?
1. What Does Today's Rule Require?
The Agency's goal is to address risks
associated with recycle practices in the
least burdensome, most effective, and
simplest means possible, Accordingly,
today's final rule requires that systems
that practice conventional filtration and
recycle spent filter backwash, sludge
thickener supernatant, or liquids from
dewatering processes, notify the State in
writing that they practice recycle. When
notifying the State, systems must also
provide the following information:
—A plant schematic showing the origin
of all recycle flows, the hydraulic
conveyance used to transport them,
and the location where they are
recycled back into the plant; and
—Typical recycle flow in gallons per
minute (gpm), highest observed plant
flow experienced in the previous year
(gpm), design flow for the treatment
plant (gpm), and the State-approved
operating capacity for the plant where
the State has made such
determinations.
Additionally, systems must collect
and maintain the following information
for review by the State, which may, after
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31091
evaluating the information, require a
system to modify their recycle location
or recycle practices:
(1) Copy of the recycle notification
and information submitted to the State;
(2) List of all recycle flows and the
frequency with which they are returned;
(3) Average and maximum backwash
flow rate through the filters and the
average and maximum duration of the
filter backwash process in minutes;
(4) Typical filter run length and a
written summary of how filter run
length is determined (headless,
turbidity, time etc.);
(5) The type of treatment provided for
the recycle flow; and
(6) Data on the physical dimensions of
the equalization and/or treatment units,
typical and maximum hydraulic loading
rates, type of treatment chemicals used
and average dose and frequency of use,
and frequency at which solids are
removed from treatment units where
such units are used.
These requirements are identical to
the requirements for direct filtration
systems that recycle, as described in
Section III.C. They are discussed in
separate preamble sections because in
the proposed rule, separate and distinct
requirements for the two types of
systems were proposed.
2. What Was the Rationale and Basis for
the Proposed Requirement?
The Agency proposed that
conventional filtration systems with
fewer than 20 filters that do not provide
treatment or equalization of their
recycle streams would be required to
develop a flow monitoring plan for
submittal and approval by the State,
conduct a month of flow monitoring,
and develop and submit a self-
assessment report to the State. The State
would then be required to make a
determination of whether modifications
to a system's recycle practice should be
required.
This component was designed to
assist States in addressing the potential
negative impact of hydraulic surge on
treatment performance. The first
component of today's final rule requires
that recycle flows proceed through all
steps of the treatment processes to
ensure 2-log removal of
Cryptosporidium. However, hydraulic
surge can still upset treatment
performance even when recycle is
treated by all necessary steps of a
treatment process (e.g., surges that cause
hydraulic flow to exceed design or
operating capacity).
Because of the high volume of water
and short duration of a filter backwash
recycle event (typically about 15
minutes long), a large volume of water
may surge through the treatment plant.
This hydraulic surge can potentially
overload treatment capability by
challenging the ability of each process
within a system including the filters.
Some studies have demonstrated
(Glasgow and Wheatley, 1998; McTigue
et al, 1998; and Myers et al., 2000) that
increasing loading rates through surges
to filters can have an adverse effect on
finished water quality. McTigue et al.,
reported that when filter loading rates in
a pilot plant were doubled from 2 gpm
to 4 gpm instantaneously,
Cryptosporidium counts in finished
water jumped from non detect to 18
oocysts/100 L. When filter loading rates
were doubled from 4 gpm to 8 gpm
instantaneously, Cryptosporidium
counts in finished water jumped from
non detect to 50 oocysts/lOOL, resulting
in a reduction in performance from 5-
log Cryptosporidium removal to 3.5-log
Cryptosporidium removal. Pilot work
completed by Myers et al., showed that
when hydraulic surges occurred,
particle counts increased. When
hydraulic flow was instantaneously
increased from 2 gpm to 3 gpm, particle
counts rose from 17 particles/mL to 27
particles/mL. When the flow was raised
from 2 gpm to 4 gpm, particle counts
rose from 17 particles/mL to 36
particles/mL. Many commenters to the
IESWTR noted that increased loading
rates to filters (in excess of approved
design rates) would contribute to poor
performance of filters (EPA, 19981).
Although hydraulic surging can have
a adverse effect, systems that practice
equalization or treatment of their
recycle streams can mitigate the effect
that recycle may have on the
performance of the treatment systems.
Limited data (Cornwell and Lee, 1996)
have shown that equalization of recycle
streams minimizes the risk of hydraulic
upset. Proper equalization can serve to
avoid abrupt changes in the flow rates
and the water quality. Several studies
have recommended maintaining recycle
flow at or below 10 percent of the plant
flow (Cornwell and Lee, 1994; McGuire,
1997; Pederson and Calhoun, 1995; and
Levesque et al., 1999).
Treatment reduces the number of ,
microbial constituents a recycle flow
may reintroduce into the primary
treatment process and therefore, reduce
the risk associated with passing oocysts
if hydraulic surges occur. Work by a
variety of individuals (Grubb and
Arnold, 1997; Levesque et al., 1999; and
Parker et al., 1999;) has demonstrated
the utility of treatment of recycle
streams prior to being returned to the
primary treatment plant. In addition, as
indicated previously, some studies have
shown that when recycle is performed
in accordance with.the requirements of
the FBRR, Cryptosporidium removal is
not impaired, even without separate
•treatment of recycle streams.
Given the variety and site-specific
nature of recycle practices throughout
the country, the Agency believed it
necessary to require conventional
filtration systems to notify States that
they practice recycle, and provide
information the State could utilize to
evaluate whether a treatment plant may
be susceptible to hydraulic disruptions
as a result of recycling.
In the proposal, the Agency attempted
to identify the subset of systems that
would be most susceptible to hydraulic
surges by only requiring that systems
without equalization or treatment
(referred to as "direct recycle") meet the
reporting requirements. The Agency
further limited the applicability of these
requirements (including a one-time
requirement to submit a recycle self-
assessment) to those direct recycle
systems that employ 20 or fewer filters
to meet production requirements during
a selected month, and recycle spent
filter backwash water, thickener
supernatant, and/or liquids from
dewatering process within the treatment
process. The self-assessment required
that a monitoring plan, one month of
hydraulic flow monitoring, and a self-
assessment report containing additional
recycle information be submitted to the
State. After reviewing the self-
assessment, the State would have been
required to make a determination
whether to require modifications to a
system's recycle practice in order to
protect public health and report the
determination to EPA. The self-
assessment was designed to provide the
State with adequate information to make
this determination.
3. What Major Comments Were
Received?
The Agency received many comments
on the Direct Recycle Reporting in the
proposed rule. The proposed rule only
applied to conventional filtration plants
which did not practice equalization or
treatment of recycle and which utilized
fewer than 20 filters to meet demand.
Many commenters believed that the
operational values used in the analysis
conducted by the Agency to arrive at a
20 filter cut-off did not accurately
represent the true range of values
witnessed throughout the country.
Similarly, many commenters noted that
excluding systems that treat or equalize
recycle flows was inappropriate because
of the lack of clearly defined, widely-
used parameters for the definitions of
equalization and treatment of recycle.
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The Agency also received significant
comment on the proposed hydraulic
flow monitoring associated with this
requirement. Many commenters
disagreed with the appropriateness of
hydraulic flow monitoring, citing a
range of problems with the process
including the amount of data which
would be collected, determining the
month in which monitoring should take
place, and the time of day monitoring
should take place. States noted that
submittal of self-assessment reports and
requirement for a State determination
would result in an increased burden,
and, that given resource limitations,
could be problematic.
4. What Was the Basis for Revising the
Proposal?
After evaluating the information
submitted by commenters, EPA believes
that the goal of this requirement can be
achieved more efficiently by slightly
modifying this requirement. Rather than
requiring only certain conventional
filtration systems to develop, obtain
State approval of, and implement a
hydraulic flow monitoring program, the
Agency believes that all conventional
filtration systems that practice recycle
can assemble existing information on
recycle flow volumes, treatment/
equalization and other parameters that
is adequate for States to evaluate
whether recycle modifications are
necessary. Some of the information
would be reported by all affected
systems to the State, which will
facilitate State identification of those
systems where recycle practices warrant
closer scrutiny. Additional information
would be maintained on-site by the
system and available to the State for
review.
Today's final rule now applies to all
conventional filtration systems that
recycle. In requiring only those systems
that did not provide treatment or
equalization of their recycle streams and
which utilized less than 20 filters to
comply with the proposed requirement,
the Agency was attempting to identify
the subset of systems where hydraulic
surge was a particular risk. Given the
wide variability among system
operations as noted by commenters, the
Agency believes it to be more protective
of public health to require all
conventional filtration systems to
comply.
The Agency has also modified flow
monitoring and the self-assessment
portions of the requirement in the
proposal. EPA established hydraulic
flow monitoring as a means for
developing information to evaluate
whether hydraulic surge may cause a
plant to exceed its operating capacity
and threaten treatment performance.
The self-assessment was intended to
serve as a vehicle for providing this
information and additional recycle data
to the State. The comments highlighted
the technical concerns and burden
associated with having systems conduct
the flow monitoring, develop the self-
assessment, and duplicate existing
information submitted to the State. EPA
believes this same goal can be achieved
more efficiently with a modified
approach. Today's final rule requires
systems to notify the State that they
practice recycle, and include, along
with a schematic of the system's recycle
process, four key pieces of information
(typical recycle flow (gpm), highest
observed plant flow experienced in the
previous year (gpm), design flow for the
treatment plant (gpm), and the State-
approved operating capacity for the
plant where the State has made such
determinations). This information will
be submitted to the State, so States may
evaluate whether recycle practices have
the potential to cause a hydraulic surge
that may cause a plant to exceed its
operating capacity. Systems will not be
required to perform flow monitoring,
but will still be required to collect
certain additional recycle data (as
described previously) and keep it on file
for State review during sanitary surveys,
other inspections (e.g., comprehensive
performance evaluations (CPEs)), or
other State activities, rather than submit
it in a special report to the State. An
ancillary benefit of this modification is
significantly reduced burden for
systems and States because of the
removal of the monitoring, associated
monitoring plan, and State approval
provisions.
C. What Reporting Does the FBRR
Require of Direct Filtration Systems
That Recycle?
1. What Does Today's Rule Require?
The Agency's goal is to address risks
associated with recycle practices in the
least burdensome, most effective, and
simplest means possible. Accordingly,
today's final rule requires that systems
that practice direct filtration and recycle
spent filter backwash, sludge thickener
supernatant, or liquids from dewatering
processes, notify the State in writing
that they practice recycle. When
notifying the State, systems must also
provide the following information:
—A plant schematic showing the origin
of all recycle flows, the hydraulic
conveyance used to transport them,
and the location where they are
recycled back into the plant; and
—Typical recycle flow (gpm), highest
observed plant flow experienced in
the previous year (gpm), design flow
for the treatment plant (gpm), and the
State-approved operating capacity for
the plant where the State has made
such determinations.
Additionally, systems must collect
and maintain the following information
for review by the State, which may, after
evaluating the information, require a
system to modify their recycle location
or recycle practices:
(l) Copy of the recycle notification
and information submitted to the State;
(2) List of all recycle flows and the
frequency with which they are returned;
(3) Average and maximum backwash
flow rate through the filters and the
average and maximum duration of the
filter backwash process in minutes;
(4) Typical filter run length and a
written summary of how filter run
length is determined (headloss,
turbidity, time etc.);
(5) The type of treatment provided for
the recycle flow; and
(6) Data on the physical dimensions of
the equalization and/or treatment units,
typical and maximum hydraulic loading
rates, type of treatment chemicals used
and average dose and frequency of use,
and frequency at which solids are
removed from treatment units where
such units are used.
These requirements are identical to
the requirements for conventional
filtration systems that recycle, as
described in Section III.B. They are
discussed in separate preamble sections
because in the proposed rule, separate
and distinct requirements for the two
types of systems were proposed.
2. What Was the Rationale and Basis for
the Proposed Requirement?
The Agency proposed that all direct
filtration systems that recycle submit a
report to the State that would include
information on recycle practices. The
State would then be required to make a
determination of whether modifications
to a system's recycle practice would be
required.
This component was designed to
assist States in addressing the potential
negative impact of hydraulic surge and
inadequate treatment on direct filtration
treatment performance. The first
component of today's final rule requires
that recycle flows be returned to an
appropriate place in the treatment
system to ensure that they are given
adequate treatment and achieve 2-log
removal of Cryptosporidium. However,
the practice of recycle can still upset
treatment performance if not performed
properly. Consequently, the Agency
developed the direct filtration system
requirements to address the following
two concerns.
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31093
First, as discussed with respect to
conventional filtration systems that
recycle, during the short duration of a
filter backwash recycle event (typically
about 15 minutes long), a large volume
of xvater may surge through lie
treatment plant. This surge can
potentially overload treatment
capability by challenging the ability of
each step within a system (e.g., surges
that cause hydraulic flow to exceed
design or operating capacity). Reduced
filter efficiency can lead to
Cryptosporidium oocysts passing
through to the finished water.
Second, treatment of recycle streams
is of utmost importance for direct
filtration systems. By definition, direct
filtration does not have a sedimentation
or solids removal step in the primary
treatment train. Any solids which enter
the process either are deposited on the
filter or travel through the filter. If the
recycle flow is not adequately treated
before being returned to the primary
treatment train, significant numbers of
the oocysts captured on a filter during
a filter run will be returned to the plant.
These oocysts are again loaded onto the
filters, increasing the risk that
disinfectant-resistant pathogens such as
Cryptosporidium can slip through
filtration, thereby posing a public health
risk.
Given the variety and site-specific
nature of recycle practices throughout
the country, the Agency believed it
necessary to require direct filtration
systems to notify States that they
practice recycle, and provide
information the State could utilize to
evaluate whether a treatment plant may
be susceptible to hydraulic disruptions
as a result of recycling, and whether the
existing recycle practices sufficiently
address potential health risks. This
information would allow States to focus
resources and prioritize systems where
recycle may be a concern.
3. What Major Comments Were
Received?
Many States commented that
information required to be submitted as
part of the proposed Direct Filtration
Reporting was in many cases
duplicative of information already
available to the State. States also noted
that submittal of direct filtration reports
would result in an increased burden,
and that given resource limitations this
could be problematic.
Additionally, several commenters,
including the EPA's Science Advisory
Board, noted that it would be unlikely
for a direct filtration system to continue
operations and recycle without
employing a solids removal step in the
recycle train. EPA agrees that this would
be true for systems that recycle on a
more or less continuous basis. EPA
based assumptions on data from an
AWWA Fax Survey (AWWA, 1998)
which indicated that eight percent of
direct filtration systems that recycled
used equalization but not treatment.
EPA believes that the Direct Filtration
Reporting requirement of today's final
rule will allow systems and States to
evaluate recycle practices and
determine whether existing recycle
practices sufficiently address potential
health risks.
4. What Was the Basis for Refining the
Proposal?
After evaluating the information
submitted by commenters, EPA believes
that the goal of this requirement can be
achieved more efficiently by slightly
modifying this requirement. Rather than
requiring direct filtration systems to
prepare and submit a report on the
adequacy of recycle flow treatment, the
Agency believes that these systems can
notify the State that they recycle and
submit some basic flow information.
The direct filtration systems would
assemble and maintain on-site
additional information on recycle flow
volumes and treatment/equalization and
other parameters that is adequate for
States to determine if recycle
modifications are necessary.
The final rule requires systems to
notify the State that they practice
recycle, and include, along with a
schematic of the systems recycle
process, four key pieces of information
(typical recycle flow (gpm), highest
observed plant flow experienced in the
previous year (gpm), design flow for the
treatment plant (gpm), and if applicable
the State-approved operating capacity
for the plant). This information will be
submitted to the State, so States may
evaluate whether .recycle practices have
the potential to cause a hydraulic surge
that may cause a plant to exceed its
operating capacity. Systems would still
be required to collect certain additional
recycle data (as described previously)
and keep it on file for State review
during sanitary surveys, other
inspections (e.g., CPEs), or other State
activities rather than submit it in a
special report to the State. An ancillary
benefit of this modification is
significantly reduced burden for
systems and States.
D. What Is the Compliance Schedule for
theFBRR?
1. What Does Today's Rule Require?
Section 1412(b)(10) of SDWA
provides that systems must comply with
new drinking water rules 36 months
after promulgation unless the
Administrator determines that an earlier
time is practicable. The Administrator
or an authorized State may extend the
compliance date by .an additional 24
months if capital improvements are
necessary.
The Agency developed the
requirements.of today's final FBRR to
provide flexibility for States and
systems to implement and comply with
the rule. Today's final rule requires that
systems must recycle spent filter
backwash water, thickener supernatant,
or liquids from dewatering processes
through the processes of a system's
existing conventional or direct filtration
system as defined in § 141.2 or an
alternate recycle location approved by
the State no later than June 8, 2004.
Systems that need to make capital
improvements to modify their recycle
location must complete activities by
June 8, 2006. The Agency believes that
granting an additional 24 months to the
compliance date is appropriate under
1412(b)(10). The Agency estimates that
as many as 400 systems are expected to
make changes to their recycle location
and will require additional time to
secure financing for their capital
improvements. These improvements
may include preliminary planning
activities, development of alternatives,
selection of consultants and contractors,
receipt of State approval and/or permits,
and finally installation of new piping,
pumps, processes, and instrumentation.
The reporting requirements of today's
final rule must be completed no later
than December 8, 2003. The schedule
for submitting the reporting contained
in today's final rule ;was slightly
modified from the proposal to maintain
a consistent order of activities and to
ensure that systems submit basic recycle
information to the State prior to the
compliance date for the recycle return
location requirement. These reporting
requirements were established pursuant
to the authority of Section 1445 of
SDWA to ensure that States have the
appropriate information from systems to
determine compliance with the recycle
return location requirement of today's
final rule.
2. What Major Comments Were
Received? ;
As discussed in the previous sections,
the Agency received significant
comment on all three proposed
provisions. Today's final rule includes
some modifications of the proposed
provisions, and the compliance
schedule has been adjusted accordingly.
One argument made by several
commenters was that EPA should not
require systems or States to undertake
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activities before three years from the
date a rule is promulgated because it
would result in "early implementation"
of the rule. EPA notes that the recycle
return location requirement of today's
final rule does not require compliance
until June 8, 2004, three years after
promulgation of the rule in the Federal
Register as required by Section
1412(b)(lO) of SDWA. Only minimal
reporting is required, pursuant to the
authority of Section 1445 of SDWA, at
two and a half years after promulgation
of today's final rule.
. Several commenters indicated that
guidance documents would play an
important role in implementing and
understanding the requirements of the
FBRR. In addition to an implementation
guidance manual, the.Agency is
currently developing additional
guidance to aid systems and States in
complying with the FBRR. EPA intends
to solicit input from a variety of
stakeholders during the development of
the guidance documents, and will
ensure that the documents undergo
significant technical review by industry
experts.
E. What Public Notification and
Consumer Confidence Report
Requirements Are Contained in the
FBRR?
Today's final rule modifies the Public
Notification (PN) requirements found in
Appendix A and B of subpart Q of Part
141 to include two public notification
requirements associated with the FBRR.
Today's final rule establishes public
notification of a Tier 2 treatment
technique violation for failure to comply
with the requirements of § 141.76(c) of
today's final rule. Additionally, the
FBRR establishes public notification of
a Tier 3 monitoring and testing violation
for failure to notify the .State and
include the appropriate information
collected as part of § 141.76[b) or failure
to collect and maintain recycle
information as part of § 141.76(d),
Today's rule does not specifically
modify the Consumer Confidence
Report (CCR) Requirements found in
subpart O of part 141. However,
consumer confidence reports must
contain any violations of treatment
techniques or requirements of NPDWRs
as specified in § 141.153(d)(6) and
§ 141.153(f). This includes any such
violations of the FBRR.
Updated CCR and PN appendices can
be found on the Agency's website at
http://www/epa.gov/safewater/
tables.html.
IV. State Implementation
A. What Special State Primacy
Requirements. Does the FBRR Contain?
Today's final rule contains one
special primacy requirement that a State
must meet in order to receive primacy
for the rule. A State's application must
contain a description of the proper rules
or other authority possessed by the State
to use Sanitary Surveys, comprehensive
performance evaluations (CPEs), other
inspections or other activities to
evaluate recycle data maintained by
systems, and require modifications to
recycle practices as necessary. The
Agency recognizes that there are
numerous mechanisms a State could use
to evaluate recycle practices including
Sanitary Surveys, CPEs, and other
inspection. However, a State must also
have the authority to require systems to
modify recycle practices after an
evaluation has been completed. The
proposed rule contained two additional
special primacy requirements, which
related to approval of recycle locations
other than prior to the point of primary
coagulant addition and to recycle self-
assessments. However, both of these
special primacy requirements were
related to recycle provisions that have
been modified as a result of comments
on the proposal. Resultant changes to
the recycle provisions have obviated the
need for these two special primacy
requirements, since recycle is no longer
required to be returned prior to the
point of primary coagulant addition and
recycle self-assessments have been
removed from the final rule.
B. What. State Information Collection,
Recordkeeping and Reporting
Requirements Does the FBRR Contain?
Today's final rule includes no specific
State information collection, reporting,
or recordkeeping requirements. The
proposal included State reporting
requirements; however changes to the
final FBRR provisions (as a result of
comments on the proposed rule) have
obviated the need for the State self-
assessment determination and direct
filtration determination reports since
these requirements are no longer
contained in the final rule. Furthermore,
the Agency decided to remove the State
reporting requirement associated with
the recycle return location as a result of
comments on the proposed rule.
However, today's rule modifies § 142.14
to require States to keep on file system-
specific decisions made under § 141.76
such as approval of alternate recycle
locations.
C. How Must a State Obtain Interim
Primacy for the FBRR?
To maintain primacy for the Public
Water Supply Supervision (PWSS)
program and to be eligible for interim
primacy enforcement authority Jor
future regulations, States must adopt
today's final rule. A State must submit
a request for approval of program
revisions that adopt the revised MCL or
treatment technique and implement
regulations within two years of
promulgation, unless EPA approves an
extension per § 142.12[b). Interim
primacy enforcement authority allows
States to implement and enforce
drinking •water regulations once State
regulations are effective and the State
has submitted a complete and final
primacy revision application. To obtain
interim primacy, a State must have
primacy with respect to each existing
NPDWR. Under interim primacy
enforcement authority, States are
effectively considered to have primacy
during the period that EPA is reviewing
their primacy revision application.
V. Economic Analysis (Health Risk
Reduction and Cost Analysis)
This section summarizes the Health
Risk Reduction and Cost Analysis in
support of the FBRR as required by
section 1412(b)(3)(C) of the 1996 SDWA.
In addition, under Executive Order
12866, Regulatory Planning and Review,
EPA must estimate the costs and
benefits of the FBRR. EPA has prepared
an estimate of the costs and benefits to
comply with the requirements of this
Executive Order and the SDWA Health
Risk Reduction and Cost Analysis
(USEPA, 2001). This final analysis will
be published on the Agency's web site,
at http://www.epa.gov/safewater. It can
also be found in the docket for this
rulemaking.
EPA has estimated the total
annualized cost for implementing the
FBRR and analyzed the total benefits
that result from the rule. Total annual
costs for the rule are estimated at either
$5.84 million or $7.2 million in 2000
dollars, depending on whether a three
percent or a seven percent discount rate
is used to annualize capital and start-up
costs. The cost estimate includes capital
costs for treatment changes and start-up
and annual labor costs for reporting
activities. More details, including tide
basis for these estimates and alternate
cost estimates using different cost of
capital assumptions are described later
in this section. The benefits associated
with the FBRR are discussed
qualitatively, but remain unquantified
because of data limitations.
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A. What Are the Costs of the FBRR?
In estimating the costs of today's final
rule, the Agency considered impacts on
public water systems and on States
(including territories and EPA
implementation in non-primacy States)
and Tribes. The FBRR will result in
increased costs to public water systems
for reading and understanding the rule,
reporting recycle practices to the State,
and capital improvements to recycle
return locations at up to 400 systems.
States will also face implementation
costs associated with reading and
understanding the rule, obtaining
primacy, and evaluating system's
recycle reports and recycle practices.
The recycle provisions apply to all
surface water and GWUDI systems that
recycle filter backwash, thickener
supernatant, or liquids from dewatering.
EPA estimates that the annualized cost
of today's final rule will be $5.84
million or S7.2 million (annualized
using a three percent or seven percent
discount rate respectively). Total capital
and associated O&M costs associated
ivith modifications to recycle locations
at an estimated 371 systems are S45.2
million, and represent S5.5 million or
$6.8 million annually (annualized over
20 years using a three percent or seven
percent discount rate, respectively). The
recycle return provision of today's final
rule accounts for 95 percent of total
annualized costs. Public Water System
expenditures for all provisions are
greater than 99 percent ($5.8 million at
a three percent discount rate or $6.7
million at a seven percent discount rate)
of total annualized costs; State
expenditures make up less than 1
percent (S0.07 million at a three percent
discount rate or $0.098 million at a
seven percent discount rate). The
national estimate of annual system costs
for the recycle provisions is based on
estimates of system-level costs for the
rule and estimates of the number of
systems expected to incur each type of
cost.
Although EPA has evaluated the cost
to drinking water systems and States of
all provisions of the rule, there are some
costs that the Agency was not able to
quantify such as indirect costs to
systems. These costs may result if States
require systems to make additional
changes to their recycle practice based
on the data collected under this rule.
Additionally, there are uncertainties
surrounding rule assumptions that may
affect the quantified cost estimates. For
example, EPA estimated the number of
systems that may be affected by this rule
based on survey information. If the
surveys underestimated the numbers of
systems required to change the return
location of their filter backwash, then
the cost of this requirement would be
underestimated. However, it is also
possible that the surveys overestimated
the number of systems required to make
changes and this would result in an
overestimation of rule costs.
B. What Are the Household Costs of the
FBRR?
The mean annual cost per household
is $0.19 and the total annual cost per
household is less than $1.70 for 99
percent of the 31.4 million households
potentially affected by today's final rule.
The remaining one percent of
households •will experience a range of
costs between $1.70 and approximately
$100 per year. Only 321 of the 31.4
million households potentially affected
by the FBRR (.00001 percent) are
expected to incur costs of approximately
$100 per year.
C. What Are the Benefits of the FBRR?
The primary benefits of today's final
rule come from reductions in the risk of
illness from microbial pathogens in
drinking water. In particular, FBRR
focuses on reducing the risk associated
with disinfection resistant pathogens,
such as Cryptosporidium.
Available literature research
demonstrates that increased hydraulic
loading or disruptive hydraulic
currents, such as may be experienced
when plants exceed State-approved
operating capacity or when recycle is
returned directly into the sedimentation
basin, can disrupt filter (Cleasby, 1963;
Glasgow and Wheatley, 1998; McTigue
etal., 1998) and sedimentation (Fulton,
1987; Logsdon, 1987; Cleasby, 1990)
performance. However, the literature
does not quantify the extent to which
performance can be lowered and, more
specifically, does not quantify the
decrease in Cryptosporidium removal
that may be experienced during direct
recycle events. Specifically, there is a
lack of treatment performance data to
accurately model the oocysts removal
achieved by individual full-scale
treatment processes and the impact
recycle may have on treatment unit
Cryptosporidium removal and resulting
finished water quality. However, as
indicated previously, some studies have
shown that when recycle is performed
in accordance with the requirements of
the FBRR, Cryptosporidium removal is
not impaired.
The goal of the FBRR is to reduce the
potential for oocysts getting into the
finished water and causing cases of
cryptosporidiosis. Other disinfection-
resistant pathogens may also be
removed more efficiently due to
implementation of these provisions.
Exposure to other pathogenic protozoa,
such as Giardia, or other emerging
microbial pathogens is likely to be
•reduced by the this rule as well.
In addition to preventing illnesses,
this rule is expected to have other non-
health related benefits. These benefits
result from avoiding non-health related
costs associated with waterborne
disease outbreaks. During an outbreak,
local governments and water systems
must issue warnings and alerts and may
need to provide an alternative source of
water. Systems also face negative
publicity and possibly legal costs.
Businesses have to supply their
customers and employees with
alternative sources of water and some,
especially restaurants, may even have to
temporarily close. Households also have
to either boil their water, purchase
water, or obtain water from another
source. The monetary costs associated
with an outbreak can be difficult to
quantify and will vary with respect to a
host of criteria. However, one study of
a Giardia outbreak in. Luzerne County,
Pennsylvania estimated these non-
health related outbreak costs to be quite
significant (Harrington et al., 1985). This
study estimated losses to individuals
due to actions taken to avoid the
contaminated water at between $19
million and $49 million, in 1984
dollars. ($31M-$81M in 2000$). Losses
due to averting actions for restaurants
and bars totaled $1 million and $0.6
million for schools and other
businesses, in 1984 dollars. The burden
for government agencies was $230,000
and the outbreak cost the water utility
an estimated $1.8 million, again in 1984
dollars.
D. What Are the Incremental Costs and
Benefits of the FBRR?
Analytical limitation in the estimation
of monetized benefits for the FBRR
prevented the Agency from
quantitatively describing the
incremental benefit of the various
regulatory alternatives considered for
this rulemaking. The RIA supporting the
final FBRR provides detailed
information on the incremental costs of
various rule components.
E. Are There Benefits From the
Reduction of Co-Occurring
Contaminants?
Improvements in recycle practices
may also reduce exposure to Giardia
lamblia and emerging disinfection
resistant pathogens, such as
microsporidia, Toxoplasma, and
Cyclospora. The frequency and extent
that FBRR would reduce risk from these
other contaminants has not been
quantitatively evaluated because the
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Agency lacked removal efficiency data
for these various technologies as well as
co-occurrence data.
F. Is There Increased Risk From Other
Contaminants?
The Agency has not identified any
increased risk from other contaminants
as a result of promulgating the FBRR.
G. What Are the Uncertainties in Risk,
Benefit and Cost Estimates for the
FBRR?
EPA has included a detailed
discussion of the possible sources of
uncertainty in risk, benefit and cost
estimates in the cost-benefit analysis. As
noted earlier, the risk and benefits have
been expressed qualitatively for this
rule, and associated sources of
uncertainty include occurrence of
Cryptosporidium oocysts in source
waters and finished waters, reduction of
Cryptosporidium oocysts due to
improved treatment, viability and
infectivity of Cryptosporidium oocysts,
and the characterization of risk.
Uncertainty associated with costs
include assumptions with respect to
changes a system might make to their
point of recycle, assumptions about
costs of labor, maintenance, and capital,
and the number of systems expected to
undertake certain activities. The Agency
believes that the qualitative risks and
benefits, and the quantitative costs have
been accurately portrayed. Discussions
and analysis of risks, benefits, and costs
indicate where uncertainty may be
introduced and to the extent possible,
the effect uncertainty may have on
analysis (EPA, 2001).
H. What Is the Benefit/Cost
Determination for the FBRR?
The Agency has determined that the
benefits of the FBRR justify their cost on
a qualitative basis. The FBRR will
reduce the potential for improper
recycle practices to upset treatment
plant performance during recycle
events. Today's rule will therefore help
prevent Cryptosporidium oocysts and
other contaminants from entering
finished drinking water supplies and
causing endemic illness or costly
waterborne disease outbreaks.
The Agency strongly believes that
returning Cryptosporidium to the
treatment process in recycle flows, if
performed improperly, can create
additional public health risk. Therefore,
the Agency is requiring that recycle
flows be returned to the point such that
all steps of a system's conventional or
direct filtration will be employed to
ensure that the system continues to
achieve at least a 2-log removal of
Cryptosporidium. As indicated
previously, some studies have shown
that when recycle is performed in
accordance with the requirements of the
FBRR, Cryptosporidium removal is not
impaired. Additionally, today's rule also
will aid States and systems by ensuring
that they have the requisite information
to evaluate whether a treatment plant
may be susceptible to hydraulic
disruptions as a result of recycling, and
whether the existing recycle practices
sufficiently addresses potential health
.risks.
VI. Other Requirements
A. Regulatory Flexibility Act (RFA), as
Amended by the Small Business
Regulatory Enforcement Fairness Act of
1996 (SBREFA), 5 U.S.C. 601 etseq,
The RFA generally requires an agency
to prepare a regulatory flexibility
analysis of any rule subject to notice
and comment rulemaking requirements
under the Administrative Procedure Act
or any other statute unless the agency
certifies that the rule will not have a
significant economic impact on a
substantial number of small entities.
Small entities include small businesses,
small organizations, and small
governmental jurisdictions.
The RFA provides default definitions
for each type of small entity. It also
authorizes an agency to use alternative
definitions for each category of small
entity, "which are appropriate to the
activities of the agency" after proposing
the alternative definition(s) in the
Federal Register and taking comment. 5
U.S.C. 601(3)-(5). In addition to the
above, to establish an alternative small
business definition, agencies must
consult with SBA's Chief Counsel for
Advocacy.
For purposes of assessing the impacts
of today's rule on small entities, EPA
considered small entities to be PWSs
serving fewer than 10,000 persons. This
is the cut-off level specified by Congress
in the 1996 Amendments to the Safe
Drinking Water Act for small system '
flexibility provisions. In accordance
with the RFA requirements, EPA
proposed using this alternative
definition in the Federal Register (63 FR
7620, February 13,1998), requested
comment, consulted with the Small
Business Administration (SBA), and
expressed its intention to use the
alternative definition for all future
drinking water regulations in the
Consumer Confidence Reports
regulation (63 FR 44511, August 19,
1998). EPA has thus used this
alternative definition in this final rule.
After considering the economic
impacts of today's final rule on small
entities, I certify that this action will not
have a significant economic impact on
a substantial number of small entities.
In accordance with section 603 of the
RFA, EPA prepared an initial regulatory
flexibility analysis, (IRFA) for the
proposed rule (see 65 FR 19046,19126-
27), and convened a Small Business
Advocacy Review (SBAR) Panel to
obtain advice and recommendations
from representatives of small entities
that would potentially be regulated by
the rule in accordance with section
609(b) of the RFA. A detailed discussion
of the Panel's advice and
recommendations is found in the Panel
Report found in the docket for today's
final rule (EPA, 1998k). A summary of
the Panel's recommendations is
presented in the proposal (65 FR 19046,
19127-19130).
EPA originally developed an IRFA
and convened an SBAR Panel because
one of the preliminary alternatives being
evaluated by the Agency was a ban on
the recycle of spent filter backwash.
. This preliminary alternative would have
resulted in substantial costs to all
conventional and direct filtration
systems that practiced recycle including
small entities. After development of the
IRFA and completion of the SBAR
Panel, the Agency determined that a ban
on recycle was not an appropriate
alternative and removed it from
consideration. The Agency re-evaluated
the economic effects on small entities
after publication of the April 10, 2000
FBRR proposal and was able to certify
that today's final rule will not have a
significant economic impact on a
substantial number of small entities.
Of the 3,840 small entities potentially
affected by the FBRR, 93 percent are
expected to incur average annualized
costs of less than $50. This equates to
approximately 0.001 percent of average
annual revenue. The remaining 7
percent (278 systems) are expected to
incur average annualized costs of
approximately $2,200, or 0.08 percent of
average annual revenue. The Agency
has included a detailed description of
this analysis in the Regulatory
Flexibility Screening Analysis prepared
for the final rule (USEPA, 2000f).
B. Paperwork Reduction Act
The Office of Management and Budget
has approved the information collection
requirements contained in this rule
under the provisions of the Paperwork
Reduction Act, 44 U.S.C. 3501 et seq.
and has assigned OMB control number
2040-0224. The information collected
as a result of this rule will allow the
States to determine appropriate
requirements for specific systems, in
some cases, and to evaluate compliance
with the rule. For the first three years
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31097
after the effective date of the FBRR, the
major information requirements are the
required notification to States by
systems that recycle, including a plant
schematic and flow information that
must accompany the notification. The
information collection requirements in
section 141.76, for systems, and section
142.14, for States, are mandatory. The
information collected is not
confidential.
The preliminary estimate of aggregate
annual average burden hours for the
first three years after the effective date
of the FBRR is 66,363. For systems these
hours consist of reading and
understanding the rule, mobilization
and planning, and preparation of the
State notifications. For States these
hours consist of reading and
understanding the rule, obtaining
primacy, mobilization and planning,
and staff training. The annual average
aggregate cost estimate over the first
three years is SO for capital, and SO for ,
operation and maintenance. The burden
hours per response annually is 8.4
hours. The frequency of response
(average responses per respondent) is
4.0 annually. The estimated number of
likely respondents is 1,986 (the product
of burden hours per response,
frequency, and respondents does not
total the annual average burden hours
due to rounding).
Burden means the total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information; processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
An Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA's regulations are listed
in 40 CFR part 9 and 48 CFR chapter 15.
The OMB control number(s) for the
information collection requirements in
this rule.will be listed in an amendment
to 40 CFR part 9 hi a subsequent
Federal Register document after OMB
approves the ICR.
C. Unfunded Mandates Reform Act of
1995
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Public
Law 104—4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State, local,
and Tribal governments and the private
sector. Under UMRA section 202, EPA
generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with "Federal mandates" that may
result in expenditures by State, local,
and Tribal governments, in the
aggregate, or to the private sector, of
$100 million or more in any one year.
Before promulgating an EPA rule, for
which a written statement is needed,
section 205 of the UMRA generally
requires EPA to identify and consider a
reasonable number of regulatory
alternatives and adopt the least costly,
most cost-effective or least burdensome
alternative that achieves the objectives
. of the rule. The provisions of section
205 do not apply when they are
inconsistent with applicable law.
Moreover, section 205 allows EPA to
adopt an alternative other than the least
costly, most cost effective or least
burdensome alternative if the
Administrator publishes with the final
rule an explanation why that alternative
was not adopted.
Before EPA establishes any regulatory
requirements that may significantly or
uniquely affect small governments,
including Tribal governments, it must
have developed, under section 203 of
the UMRA, a small government agency
plan. The plan must provide for
notifying potentially affected small
governments, enabling officials of
affected small governments to have
meaningful and timely input in the
development of EPA regulatory
proposals with significant Federal
intergovernmental mandates and
informing, educating, and advising
small governments on compliance with
the regulatory requirements.
EPA has determined that this rule
does not contain a Federal mandate that
may result in expenditures of $100
million or more for the State, local and
Tribal governments, in the aggregate, or'
the private sector in any one year. The
estimated annual cost of this rule is
$5.84 million at a three percent discount
or and $7.2 million at a seven percent
discount rate. Thus today's rule is not
subject to the requirements of sections
202 and 205 of the UMRA.
EPA has determined that this rule
contains no regulatory requirements that
might significantly or uniquely affect
small governments. Of the 1,574 small
government entities potentially affected
by the FBRR, 93 percent are expected to
incur average anriualized costs of less
than $50 dollars. This equates to
approximately 0.002 percent of average
annual revenue. The remaining 7
percent (114 systems) are only expected
to incur average annualized costs of
approximately $2,200 dollars or 0.09
percent of average annual revenue.
Thus, today's rule is not subject to the
requirements of section 203 of UMRA.
Nevertheless, EPA has tried to ensure
that State, local, and Tribal governments
had opportunities to provide comment.
EPA consulted with small governments
to address impacts of regulatory
requirements in the rule that might
significantly or uniquely affect small
governments. As discussed next, a
variety of stakeholders, including small
governments, were provided the
opportunity for timely-and meaningful
participation in the regulatory
development process. EPA used these
opportunities to notify potentially
affected small governments of regulatory
requirements being considered.
EPA began outreach efforts to develop
the FBRR in the summer of 1998. Two
public stakeholder meetings, which
were announced in the Federal
Register, were held on July 22-23,1998,
in Lakewood, Colorado, and on March
3-4,1999, 'in Dallas, Texas:
Stakeholders include representatives of
State, local and Tribal governments,
environmental groups and public and
private public water systems. In
addition to these meetings, EPA has
held several formal and informal
meetings with stakeholders including
the Association of State Drinking Water
Administrators. A summary of each
meeting and attendees is available in the
public docket for this rule. EPA also
convened a Small Business Advocacy
Review (SBAR) Panel in accordance
with the Regulatory Flexibility Act
(RFA), as amended by the Small
Business Regulatory Enforcement
Fairness Act (SBREFA) to address small
entity concerns including those of small
local governments. The SBAR Panel
allows small regulated entities to
provide input to EPA early in the
regulatory development process. In
early June 1999, EPA mailed an
informal draft of the FBRR preamble to
the approximately 100 stakeholders who
attended one of the public stakeholder
meetings. Members of trade associations
and the SBREFA Panel also received the
draft preamble. EPA received valuable
suggestions and stakeholder input from
15 State representatives, trade
associations, environmental interest
groups, and individual stakeholders.
The majority of concerns dealt with
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reducing burden on small systems and
maintaining flexibility.
To inform and involve Tribal
governments in the rulemaking process,
EPA presented the FBRR at three
venues: the 16th Annual Consumer
Conference of the National Indian
Health Board, the annual conference of
the National Tribal Environmental
Council, and the EPA/Inter Tribal
Council of Arizona, Inc. tribal
consultation meeting. Over 900
attendees representing Tribes from
across the country attended the National
Indian Health Board's Consumer
Conference and over 100 Tribes were
represented at the annual conference of
the National Tribal Environmental
Council. At the first two conferences, an
EPA representative conducted two
workshops on EPA's drinking water
program and upcoming regulations,
including the FBRR.
At the OGWDW/Inter Tribal Council
of Arizona meeting, representatives
from 15 Tribes participated. The
presentation materials and meeting
summary were sent to over 500 Tribes
and tribal organizations. Additionally,
EPA contacted each of the 12 Native
American Drinking Water State
Revolving Fund Advisors to invite
them, and representatives of their
organizations to the stakeholder
meetings described previously.
During the comment period for
today's final rule, the Agency held a
public meeting in Washington DC on
April 14, 2000 (EPA,2000d).
Additionally, the proposed rule was
either presented or discussed in nearly
50 meetings across the US. Finally, EPA
mailed approximately 200 copies of the
proposed rule to stakeholders requesting
comment. EPA received 67 comments
from a variety of stakeholders including
24 States, 21 municipalities, one Tribe,
one elected official, two consultants,
eight trade groups, and four private
industries.
In addition, EPA will educate, inform,
and advise small systems, including
those run by small governments, about
the FBRR requirements. The Agency is
developing plain-English guidance that
will explain what actions a small entity
must take to comply with the rule. Also,
the Agency has developed fact sheets
that concisely describe various aspects
and requirements of the FBRR. These
fact sheets are available by calling the
Safe Drinking Water Hotline at 800-
426-4791.
D. National Technology Transfer and
Advancement Act
As noted in the proposed rule, section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTAAJ, Public Law No. 104-113,
Section 12(d) (15 U.S.C. 272), directs
EPA to use voluntary consensus
standards in its regulatory activities
unless to do so would be inconsistent
with applicable law or otherwise
impractical. Voluntary consensus
standards are technical standards (e.g.,
materials specifications, test methods,
sampling procedures, and business
practices) that are developed or adopted
by voluntary consensus standards
bodies. The NTAA directs EPA to
provide Congress, through the Office of
Management and Budget, explanations
when the Agency decides not to use
available and applicable voluntary
consensus standards.
This action does not involve technical
standards. Therefore, EPA did not
consider the use of any voluntary
consensus standards. We did not receive
any comments identifying potentially-
applicable voluntary consensus
standards that we should consider using
either.
E. Executive Order 12866: Regulatory
Planning and Review
Under Executive Order 12866, (58 FR
51735 (October 4,1993) the Agency
must determine whether the regulatory
action is "significant" and therefore
subject to OMB review and the
requirements of the Executive Order.
The Order defines "significant
regulatory action" as one that is likely
to result in a rule that may:
1. Have an annual effect on the
economy of $100 million or more or
adversely affect in a material way the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or Tribal governments or
communities;
2. Create a serious inconsistency or
otherwise interfere with an action taken
or planned by another agency;
3. Materially alter the budgetary
impact of entitlements, grants, user fees,
or loan programs or the rights and
obligations of recipients thereof, or;
4. Raise novel legal or policy issues
arising out of legal mandates, the
President's priorities, or the principles
set forth in the Executive Order.
Pursuant to the terms of the Executive
Order 12866, it has been determined
that this rule is a "significant regulatory
action." As such, this action was
submitted to OMB for review. Changes
made in response to OMB suggestions or
recommendations have been
documented in the public record.
F. Executive Order 12898:
Environmental Justice
Executive Order 12898 establishes a
Federal policy for incorporating
environmental justice into Federal
agency missions by directing agencies to
identify and address disproportionately
high and adverse human health or
environmental effects of its programs,
policies, and activities on minority and
low-income populations. The Agency
has considered environmental justice
related issues concerning the potential
impacts of this action and consulted '
with minority and low-income
stakeholders.
On March 12,1998, the Agency held
a stakeholder meeting to address various
components of pending drinking water
regulations and how they may impact
sensitive sub-populations, minority
populations, and low-income
populations. Topics discussed included
treatment techniques, costs and benefits,
. data quality, health effects, and the
regulatory process. Participants
included national, State, Tribal,
municipal, and individual stakeholders.
EPA conducted the meetings by video
conference call between 11 cities. This
meeting was a continuation of
stakeholder meetings that started in '
1995 to obtain input on the Agency's
drinking water programs. The major
objectives for the March 12, 1998
meeting were:
—Solicit ideas from stakeholders on
known issues concerning current
drinking water regulatory efforts;
—Identify key issues of concern to
stakeholders, and;
—Receive suggestions from stakeholders
concerning ways to increase
representation of communities in EPA
regulatory efforts.
In addition, EPA developed a plain-
English guide specifically for this
meeting to assist stakeholders in
understanding the multiple and
sometimes complex issues surrounding
drinking water regulation.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
Executive Order 13045: "Protection of
Children from Environmental Health
Risks and Safety Risks" (62 FR 19885,
April 23,1997) applies to any rule that:
(1) Is determined to be economically
significant as defined under Executive
Order 12866, and; (2) concerns an
environmental health or safety risk that
EPA has reason to believe may have a
disproportionate effect on children. If
the regulatory action meets both criteria,
the Agency must evaluate the
environmental health or safety effects of
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31099
the planned rule on children and
explain why the planned regulation is
preferable to other potentially effective
and reasonably feasible alternatives
considered by the Agency.
While this final rule is not subject to
the Executive Order because it is not
economically significant as defined in
Executive Order 12866, we nonetheless
have reason to believe that the
environmental health or safety risk
addressed by this action may have a
disproportionate effect on children. As
a matter of EPA policy, we therefore
have assessed the environmental health
effects of Cryptosporidium on children.
The results of this assessment are
contained in cost-benefit analysis
supporting the FBRR (EPA, 2001). A
copy of the analysis and supporting
documents is available for public review
in the Office of Water docket at 401 M
St. SW., Washington, DC.
The risk of illness and death due to
cryptosporidiosis depends on several
factors, including age, nutrition,
exposure, genetic variability, disease
and immune status of the individual.
Mortality resulting from diarrhea shows
the greatest risk of mortality occurring
among the very young and elderly
(Gerba et al, 1996). For
Cryptosporidium, young children are a
vulnerable population subject to
infectious diarrhea (CDC 1994).
Cryptosporidiosis is prevalent
worldwide, and its occurrence is higher
in children than in adults (Payer and
Ungar, 1986).
Cryptosporidiosis appears to be more
prevalent in populations such as
infants, that may not have established
immunity against the disease and may
be in greater contact with
environmentally contaminated surfaces
(DuPont, et al., 1995). An infected child
may spread the disease to other children
or family members. Evidence of such
secondary transmission of
cryptosporidiosis from children to
household and other close contacts has
been found in a number of outbreak
investigations (Casemore, 1990; Cordell
et al., 1997; Frost et al., 1997). Chapell
et al., (1999) found that prior exposure
to Cryptosporidium through the
ingestion of a low oocyst dose provides
protection from infection and illness.
However, it is not known whether this
immunity is life-long or temporary. Data
also indicate that either mothers confer
short term immunity to their children or
that babies have reduced exposure to
Cryptosporidium, resulting in a
decreased incidence of infection during
the first year of life. For example, in a
survey of over 30,000 stool sample
analyses from different patients in the
United Kingdom, the 1-5 year age group
suffered a much higher infection rate
than individuals less than one year of
age. For children under one year of age,'
those older than six months of age
showed a higher rate of infection than
individuals aged fewer than six months
(Casemore, 1990).
EPA has not been able to quantify the
health effects for children as a result of
Cryptosporid/uin-contaminated drinking
water. However, the result of the FBRR
will be a reduction in the risk of illness
for the entire population, including
children. Because available evidence
indicates that children may be more
vulnerable to Cryptosporidiosis than the
rest of the population, the FBRR would,
therefore, result in greater risk reduction
for children than for the general
population.
H. Consultations With the Science
Advisory Board, National Drinking
Water Advisory Council, and the
Secretary of Health and Human Services
In accordance with section 1412 (d)
and (e) of the SDWA, the Agency
discussed or submitted possible FBRR
requirements to the Science Advisory
Board, National Drinking Water
Advisory Council (NDWAC), and to the
Secretary of Health and Human Services
and requested comment from the
Science Advisory Board (SAB) on the
FBRR.
On March 13th and 14th, 2000 in
Washington, DC, the Agency met with
the Science Advisory Bpard during
meetings open to the public where
several of the Agency's drinking water
rules were discussed. A copy of the
SAB's comments are found in the
docket (EPA, 2000n).
On May 10th, 2000 in San Francisco,
California, the Agency presented the
FBRR to NDWAC. A copy of the
materials presented to the NDWAC as
well as the charge presented to the
council are" found in the docket (EPA,
2000g). A copy of NDWAC's
recommendations are also found in the
docket (NDWAC, 2000).
EPA invited the Secretary of Health
and Human Services to the April 14th,
2000 informational meeting regarding
the proposed Long Term 1 Enhanced
Surface Water Treatment and Filter
Backwash Rule and consulted with the
Center for Disease Control (CDC) during
June 20, 2000 and October 10, 2000,
conference calls with the Center's
Working Group on Waterborne
Cryptosporidiosis. The meeting notes
for these calls are found in the docket
for today's rule (CDC, 2000b). CDC's role
as an Agency of the Department of
Health and Human Services is to
provide a system of health surveillance
to monitor and prevent outbreak of
diseases. With the assistance of States
and other partners; CDC guards against
international disease transmission,
maintains national health statistics,
provides immunization services and
supports research into disease and
injury prevention.,
Only SAB provided substantive
comments on the FBRR. SAB had
several recommendations including
recommending against requirements
that would alter the design of direct.
recycle systems and recommending
against requiring that washwater flows
be recycled ahead of the point of
coagulant addition. Today's final FBRR
is consistent with the recommendations
of the SAB.
/. Executive Order .13132: Executive
Orders on Federalism
Executive Order 13132, entitled
"Federalism" (64 FR 43255, August 10,
1999), requires EPA to develop an
accountable process to ensure
"meaningful and timely input by State
and local officials in the development of
regulatory policies that have federalism
implications." "Policies that have
federalism implications" is defined in
the Executive Order to include
regulations that have "substantial direct
effects on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government."
This final rule does not have
federalism implications. It will not have
substantial direct effects on the States,
on the relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132. Today's final
rule does not have a substantial direct
effect on local and State governments
because it is not expected to impose
substantial direct compliance costs. The
rule imposes annualized compliance
costs of approximately $3.78 or $4.64
million (at 3 percent and 7 percent
discount rates, respectively) per year for
local and State governments. Only $0.07
or $0.98 million (at 3 percent and 7
percent discount rates respectively,) of
these costs are attributable to States,
while $0.64 or $0.82 million (at 3
percent and 7 percent discount rates,
respectively) is attributable to
approximately 1,575 local governments
serving fewer than 10,000 persons and
the remaining $4.7 million or $5.8
million (at 3 percent and 7 percent
discount rates, respectively) is
attributable to approximately 980 local
governments serving 10,000 or more
persons. Furthermore, the rule does not
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have a substantial direct effect on the
relationship between the national
government and the States, or the
distribution of power and
responsibilities among the various
levels of government as specified in
Executive Order 13132 because the rule
does not change the current roles and
relationships of the Federal government,
State governments and local
governments in implementing drinking
water programs. Thus, Executive Order
13132 does not apply to this rule.
Although the Executive Order does not
apply to this rule, EPA did consult with
State and local officials in developing
this rule. In addition to our outreach
efforts described earlier, on May 30,
2000, the Agency held a meeting in
Washington, DC with ten
representatives of elected State and
local officials to discuss how new
Federal drinking water regulations
(FBRR, LTlESWTR, Ground Water Rule,
Radon Rule, Radionuclides Rule, and
Arsenic Rule) may affect State, county,
and local governments. Throughout the
consultation, stakeholders asked EPA
for clarification of basic concepts and
rule elements. EPA addressed these
issues throughout the consultation and
provided background and clarification
to promote better understanding of the
issues. For example, stakeholders asked
EPA to describe what Cryptosporidium
is and how individuals are diagnosed
with cryptosporidiosis. A detailed
summary of this consultation meeting
and the concerns raised is found in the
docket (EPA, 2000h). No significant
concerns were raised regarding the
FBRR.
/. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
On November 6, 2000, the President
issued Executive Order 13175 (65 FR
67249) entitled, "Consultation and
Coordination with Indian Tribal
Governments." Executive Order 13175
took effect on January 6, 2001, and
revokes Executive Order 13084 (Tribal
Consultation) as of that date. EPA
developed this final rule, however,
during the period when Executive Order
13084 was in effect; thus, EPA
addressed Tribal considerations under
Executive Order 13084.
Under Executive Order 13084, EPA
may not issue a regulation that is not
required by statute, that significantly or
uniquely affects the communities of
Indian Tribal governments, and that
imposes substantial direct compliance
costs on those communities, unless the
Federal government provides the funds
necessary to pay the direct compliance
costs incurred by the Tribal
governments or EPA consults with those
governments. If EPA complies by
consulting, Executive Order 13084
requires EPA to provide to the Office of
Management and Budget, in a separately
identified section of the preamble to the
rule, a description of the extent of EPA's
prior consultation with representatives
of affected Tribal governments, a
summary of the nature of their concerns,
and a statement supporting the need to
issue the regulation. In addition,
Executive Order 13084 requires EPA to
develop an effective process permitting
elected officials and other
representatives of Indian Tribal
governments "to provide meaningful
and timely input in the development of
regulatory policies on matters that
significantly or uniquely affect their
communities."
Today's rule does not significantly or
uniquely affect the communities of
Indian Tribal governments, nor will it
impose substantial direct compliance
costs on them. This rule will affect
fewer than 22 of the 987 (2 percent) total
tribal drinking water systems. Of these
22 systems, 20 are estimated to incur
annualized compliance costs of less
than $50 per year or 0.001 percent of
average annual revenue. The remaining
two systems are estimated to incur
annualized compliance costs of
approximately $2,200 per year or 0.08
percent of average annual revenue.
Accordingly, the requirements of
section 3(b) of Executive Order 13084
do not apply to this rule.
K. Likely Effect of Compliance With the
FBRR on the Technical, Financial, and
Managerial Capacity of Public Water
Systems
Section 1420(d)(3) of the SDWA as
amended requires that, in promulgating
a NPDWR, the Administrator must
include an analysis of the likely effect
of compliance with the regulation on
the technical, financial, and managerial
capacity of public water systems. This
analysis can be found in the FBRR cost-
benefit analysis (EPA, 2001).
Overall water system capacity is
defined in EPA guidance (EPA, 1998J) as
the ability to plan for, achieve, and
maintain compliance with applicable
drinking water standards. Capacity has
three components: technical,
managerial, and financial.
Technical capacity is the physical and
operational ability of a water system to
meet SDWA requirements. Technical
capacity refers to the physical
infrastructure of the water system,
including the adequacy of source water
and the adequacy of treatment, storage,
and distribution infrastructure. It also
refers to the ability of system personnel
to adequately operate and maintain the
system and to otherwise implement
requisite technical knowledge.
Managerial capacity is the ability of a
water system to conduct its affairs to
achieve and maintain compliance with
SDWA requirements. Managerial
capacity refers to the system's
institutional and administrative
capabilities. Financial capacity is a
water system's ability to acquire and
manage sufficient financial resources to
allow the system to achieve and
maintain compliance with SDWA
requirements. Technical, Managerial,
and Financial capacity can be assessed
through key issues and questions,
including:
Technical Capacity
Source water adequacy .
Infrastructure adequacy
Technical knowledge and implementation
Does the system have a reliable source of drinking water? Is the
source of generally good quality and adequately protected?
Can the system provide water that meets SDWA standards? What is
the condition of its infrastructure, including well(s) or source
water intakes, treatment, storage, and distribution? What is the in-
frastructure's life expectancy? Does the system have a capital im-
provement plan? '
Is the system's operator certified? Does the operator have sufficient
technical knowledge of applicable standards? Can the operator ef-
fectively implement this technical knowledge? Does the operator
understand the system's technical and operational characteristics?
Does the system have an effective operation and maintenance pro-
gram?
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31101
Managerial Capacity
Ownership accountability .
Staffing and organization ..
Effective external linkages
Are the system owner(s) clearly identified? Can they be held ac-
countable for the system? • - .
Are the system operator(s) and manager(s) clearly identified? Is the
system properly organized and staffed? Do personnel understand
the management aspects of regulatory requirements and system
operations? Do they have adequate expertise to manage water sys-
tem operations? Do personnel have the necessary licenses and cer-
tifications? • . '
Does the system interact well with customers, regulators, and other
entities? Is the system aware of available external resources, such
as technical and financial assistance?
Financial Capacity
Revenue sufficiency
Credit worthiness
Fiscal management and controls ,
Do revenues cover costs? Are water rates and charges adequate to
cover the cost of water? '
Is the system financially healthy? Does it have access to capital
through public or private sources?
Are adequate books and records maintained? Are appropriate budg-
eting, accounting, and financial planning methods used? Does the
system manage its revenues effectively?
Generally, systems affected by this
rule are not required to make significant
modifications to the treatment process
to meet FBRR requirements. Therefore,
most systems are not expected to
experience a significant impact on their
technical, financial, or managerial
capacity.
L. Plain Language
Executive Order 12866 requires each
agency to write its rules in plain
language. Readable regulations help the
public find requirements quickly and
understand them easily. They increase
compliance, strengthen enforcement,
and decrease mistakes, frustration,
phone calls, appeals, and distrust of
government. Of the several techniques
typically utilized for writing readably,
using a question and answer format, and
using the word, "you" for whoever must
comply, do the most to improve the look
and sound of a regulation. The preamble
for today's final rule uses the first
principle and was developed using a
plain language question and answer
format. Today's final rule language does
not use these principles since the rule
only modifies or adds to existing
regulatory language that is in the
previous regulatory language format.
However, EPA has made every effort to
write the rule in as clear, concise, and
unambiguous manner as possible.
M. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
Executive Order 13211, "Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use" (66 FR 28355 (May
22, 2001)), provides that agencies shall
prepare and submit to the Administrator
of the Office of Information and
Regulatory Affairs, Office of
Management and Budget, a Statement of
Energy Effects for certain actions
identified as "significant energy
actions." Section 4(b) of Executive
Order 13211 defines "significant energy
actions" as "any action by an agency
(normally published in the Federal
Register) that promulgates or is
expected to lead to the promulgation of
a final rule or regulation, including
notices of inquiry, advance notices of '
proposed rulemaking, and notices of
proposed rulemaking: (l)(i) That is a
significant regulatory action under
Executive Order 12866 or any successor
order, and (ii) is likely to have a
significant adverse effect on the supply,
distribution, or use of energy; or (2) that
is designated by the Administrator of
the Office of Information and Regulatory
Affairs as a significant energy action."
We have not prepared a Statement of
Energy Effects for this final rule because
this rule is not a significant energy
action, as defined in Executive Order
13211. While this rule is a significant
regulatory action under Executive Order
12866, it is not likely to have a
significant adverse effect on the supply,
distribution, or use of energy.
N'. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., as added by the Small
Business Regulatory Enforcement
Fairness Act of 1996, generally provides
that before a rule may take effect, the
agency promulgating the rule'must
submit a rule report, which includes a
copy of the rule, to each House of the
Congress and to the Comptroller General
of the United States. EPA will submit a
report containing this rule and other
required information to the U.S. Senate,
the U.S. House of Representatives, and
the Comptroller General of the United
States prior to publication of the rule in
the Federal Register. A major rule
cannot take effect until 60 days after it
is published in the Federal Register.
This action is not a "major rule" as
defined by 5 U.S.Q. 804(2). This rule
will be effective August 7, 2001.
VII. References
American Water Works Association. 1998.
Spent Filter Backwash Water Survey.
Atherholt, T., LeChevallier, M., Norton, W.,
and Rosen, J. 1998. Effect of rainfall on
Giardia and crypto. J.AWWA (90:9:66-80).
Bellamy, W., Cleasby, J., Lpgsdon, G., and
Allen, M. 1993. Assessing Treatment Plant
Performance. J. AWWA (85:12:34-38).
Bellamy, Bill and Carlson, Ken. 1998.
Assessing the Impact of Steady-State and
Surge Recycling on Process Performance.
Casemore, D. 1990. Epidemiological aspects
of human cryptospbridiosis. Epidemiol.
Infect. (104:1-28).
CDC 1994. Addressing Emerging Infectious
Disease Threats: A iPrevention Strategy for
the United States. Executive Summary. P.
1-3.
CDC 2000a. CDC Morbidity and Mortality
Weekly Report. Surveillance for
Waterborne-Disease Outbreaks—United
States, 1997-1198, v. 49, N. SS-4, May 26,
2000.
CDC 2000b. Notes from June 20, and October
10, 2000, CDC Working Group on
Waterborne Cryptosporidiosis
Teleconference. October 10, 2000.
Chappell, C., Okhuysen, P., Sterling, C.,
Wang, C., Jakubowski, W., and Dupont, H.
1999. Infectivity of Cryptosporidium
Parvum in Healthy Adults with Pre-
existing Anti-C. Parvum Serum
Immunoglobulin G. Am. J. Trop. Med. Hyg.
(60:1:157-164).
Cleasby, J., Williamson, M., and Baumarm, E.
1963. Effect of Filtration Rate Changes on
Filtered Water Quality. J. AWWA
(55:7:869-880).
-------
31102
Federal Register/ Vol. 66, No. Ill/Friday, June 8, 2001/Rules and Regulations
Cleasby, J, 1990. Filtration, Chapter 8, IN: (F.
Pontius, ed) Water Quality and Treatment.
AWWA, Denver, 57pp.
Conley, W. 1965. Integration of the
Clarification Process. Proceedings AWWA
Annual Conference.
Cordell, R., Thor, P., Addiss, D., Theurer, J.,
Lichterman, R., Ziliak, S., Juranek, D., and
Davis, J. 1997. Impact of a massive
waterborne cryptosporidiosis outbreak on
child care facilities in metropolitan
Milwaukee, Wisconsin. Pediatr Infect Dis J.
(16:639-44).
Cornwell, D. and M. Macphee, 2001. "Effects
of Spent Filter Backwash Recycle on
Cryptosporidium Removal." Journal of the
American Water Works Association:
93(04): 153-162.
Cornwell, D. and Lee, R. 1994. Waste Stream
Recycling: Its Effect on Water Quality. J.
AWWA (86:11:50-63).
Cornwell, D., and Lee, R. 1996. Treatment
Options for giardia, Cryptosporidium, and
Other Contaminants in Recycled Backwash
Water. Proposal to AWWARF. (Cited in
Cornwell 1997 as Cornwell and
LeChevallier 1996).
Cornwell, D. 1997. Treatment of Recycle and
Backwash Streams. Water Residuals and
Biosolids Management: WEF/AWWA,
llpp.
Craun, Gunther. 1998. Memorandum from G.
Craun to U.S. Environmental Protection
Agency (M. Negro), dated 10/26/98.
Waterborne outbreak data 1971-1996,
community and noncommunity water .
systems.
Dugan, N., Fox, K., Miltner, R., Lytle, D.,
Williams, D., Parrett, C., Feld, C., and
Owens, J. 1999. "Control of "
Cryptosporidium Oocysts by Steady-State
Conventional Treatment". Proceedings of
the U. S. Environmental Protection Agency
6th National Drinking Water and
Wastewater Treatment Technology
Transfer Workshop, Kansas City, MO
(August 2-4, 1999), 19 pp.
Dupont, H., Chappell, C., Sterling, C.,
Okhuysen, P., Rose, J., and Jakubowski, W.
1995. The Infectivity of Cryptosporidium
parvum in Healthy Volunteers. N. Engl. J.
Med. (332:13:855-859).
Edzwald, J., and Kelley, M. 1998. Control of
Cryptosporidium: From Reservoirs to
Clarifiers to Filters. Water Science and
Technology (37:2:1-8).
Environmental Engineering & Technology,
Inc. 1999. Background Papers on Potential
Recycle Streams in Drinking Water
Treatment Plants. AWWA, 73 pp.
EPA.1989a. Drinking Water; National
Primary Drinking Water Regulations; Total
Coliforms (including Fecal Coliforms and
E. Coli); Final Rule. 54 FR 27544, June 29,
1989.
EPA.1989b. National Primary Drinking Water
Regulations: Filtration, Disinfection;
Turbidity, Giardia lamblia, Viruses,
Legionella, and Heterotrophic Bacteria;
Final Rule (SWTR). 54 FR 27486, June 29, -
1989.
EPA/SAB 1990. Reducing Risk: Setting
Priorities and Strategies for Environmental
Protection. U.S. Environmental Protection
Agency Science Advisory Board (A—101),
Washington, DC. Report No. SAB-EC-90-
021 (September).
EPA.1991. Guidance Manual .for compliance
with the filtration and disinfection
requirements for public water systems
using surface water sources. Washington,
D.C., 574 pp. [Also published by AWWA].
EPA.1993. Methods for the Determination of
Inorganic Substances in Environmental
Samples. Environmental Monitoring
Systems Laboratory. Cincinnati, OH 45268.
August. 169 pp. 600 /R-93-100.
EPA.1994, January 10,1994 letter from Jim
Elder, Director, Office of Ground Water and
Drinking Water to John H. Sullivan, Deputy
Executive Director, AWWA, 5 pp.
EPA.1996. National Primary Drinking Water
Regulations; Monitoring Requirements for
Public Drinking Water Supplies; Final
Rule. 61 FR 24354, May 14,1996.
EPA.1997. National Primary Drinking Water
Regulations: Interim Enhanced Surface
Water Treatment Notice of Data
Availability. 62 FR 59486. EPA-815-Z-97-
001.
EPA.1998a. National Primary Drinking Water
Regulations: Interim Enhanced Surface
Water Treatment; Final Rule. 63 FR 69477,
December 16,1998. EPA 815-Z-98-009.
EPA.1998b. Cryptosporidium and Giardia
Occurrence Assessment for the Interim
Enhanced Surface Water Treatment Rule.
Prepared for the Office of Ground Water
and Drinking Water, Washington, DC by
Science Applications International
Corporation, McLean, VA, 185 pp.
EPA.1998C. National Primary Drinking Water
Regulations: Disinfectants and Disinfection
Byproducts; Final Rule. 63 FR 69389,
December 16, 1998.
EPA.1998d. Addendum to the Drinking
Water Criteria Document for Giardia.
Prepared for Office of Water, Office of
Science and Technology, U.S. EPA,
Washington, D.C., by ARCTECH, Inc.,
1999. Gunther F. Craun & Associates.
271PP.
EPA.1998e. Demographic Distribution of
Sensitive Population Groups. Final Report.
Prepared by SRA Technologies, Inc., Falls
Church, VA. Work Assignment No. B-ll/
22 (SRA 557-05/14: February 24).
EPA.1998f. National Primary Drinking Water .
Regulation: Consumer Confidence Reports;
Final Rule. 63 FR 44511, August 19,1998.
EPA.1998g. Revision of Existing Variance
and Exemption Regulations To Comply
With Requirements of the Safe Drinking
Water Act. 63 FR 43833, August 14,1998.
EPA.1998h. Announcement of the Drinking
Water Contaminant Candidate List; Notice.
63 FR 10273, March 2,1998.
EPA.1998i. Revisions to State Primacy
Requirements to Implement Safe Drinking
Water Act Amendments; Final Rule. 63
Federal Register 23362.
EPA.1998J. Guidance on Implementing the
Capacity Development Provisions of the
Safe Drinking Water Act Amendments of ,
1996. EPA Document Number: 816-R-98-
006.
EPA.1998k. Final Report of the SBREFA
Small Business Advocacy Review Panel on
EPA's Planned Proposed Rule: Filter
Backwash Recycling, 76 pp.
EPA.19981. Response to Comment Document
for the Interim Enhanced Surface Water
Treatment Rule.
EPA.1999a. Drinking Water Criteria
Document for Viruses: An Addendum.
Prepared for Health and Ecological Criteria
Division, Office of Science and Technology
by ISSI, Inc., Silver Spring, MD. Final Draft
265 pp. (EPA/822/R/98/042: January 15).
EPA.1999b. Drinking Water Criteria
Document for Enteroviruses and Hepatitis
A: An Addendum. Prepared for Health and
Ecological Criteria Division by Nena
Nwachuku, Office of Science and
Technology. Final Draft 173 pp. (EPA/822/
R/98/043: January 15).
EPA. 1999c. Regulatory Impact Analysis for
the Proposed Long Term 1 Enhanced
Surface Water Treatment and Filter
Backwash Rule. EPA 815-R-00-005. 222
pp.
EPA.1999d. Water Industry Baseline
Handbook, 462pp (First Edition: March 2,
1999).
EPA.1999e. Meeting Summary: Long Term 1
Enhanced Surface Water Treatment Rule
(LT1ESWTR) and Filter Backwash Recycle
Rule (FBR). Dallas, TX. March. 11 pp.
EPA.1999f. Stakeholder Meeting Summary:
Long Term 1 Enhanced Surface Water
Treatment Rule and Filter Backwash
Recycle Rule. Denver, CO. July. 67 pp.
EPA.2000a. Occurrence Assessment for the
Long Term 1 Enhanced Surface Water
Treatment and Filter Backwash Recycle
Rule, (EPA/815/R/00/019).
EPA.2000b. National Primary Drinking Water
Regulations: Long Term 1 Enhanced
Surface Water Treatment and filter
Backwash Rule; Proposed Rule. 65 FR
19046. April 10, 2000. (EPA/815/Z/00/01).
EPA.2000c. Regulatory Impact Analysis for
the Filter Backwash Recycle Rule, (EPA/
815/R/00/022).
EPA.2000d. Summary of the Proposed Long
Term 1 Enhanced Surface Water Treatment
and Filter Backwash Rule. April, 14, 2000.
EPA.2000e. Application of the Microbial
Framework to LT2ESWTR FACA Options,
M/DBP FACA Meeting, June 1, 2000.
EPA.2000f. Regulatory Flexibility Screening
Analysis for the Filter Backwash Recycling
Rule, September 26, 2000.
EPA.2000g. Proposed Long Term 1 Enhanced
Surface Water Treatment and Filter
Backwash Rule (LTlFBR) Issues for the
National Drinking Water Advisory Council.
April 20, 2000.
EPA.2000h. Meeting Summary, Government
Dialogue on EPA's Upcoming Drinking
Water Regulations, May 30, 2000.
EPA.2000i. Representative List of Meetings
Attended where Presentations were Made
or where Materials were Handed out
(LT1ESWTR and FBRR).
EPA.2000J. Response to Comment Document
for the Filter Backwash Recycle Rule.
EPA.2000k. Estimated Per Capita Water
Ingestion in the United States. Office of
Science and Technology. February, 2000.
EPA 20001, Long Term 1 Enhanced Surface
Water Treatment Rule Data Set from the
Round 1 Monitoring (1987-92) of the
„ Unregulated Contaminant Monitoring
Information System.
EPA.2000m. M/DBP FACA Meeting
Materials. June 1-2, 2000.
EPA. 2000n. SAB Commentary on EPA's
Draft Proposal for LTlESWTR and FBRR.
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31103
EPA-SAB-DWC-COM-00-004. May 23,
2000.
EPA 20000. National Primary Drinking Water
Regulation: Public Notification Rule; Final
Rule. 65 FR 25982, May 4, 2000.
EPA.2001. Regulatory Impact Analysis for the
Filter Backwash Recycle Rule. Payer, R.
and Ungar, B. 1986. Cryptosporidium spp.
and cryptosporidiosis. Microbial Review.
(50:4:458-483).
Payer, R. 1994. Effect of high temperature on
fnfectivity of Cryptosporidium parvum
oocysts in water. Appl. Environ. Microbiol.
60:2732-2735.
Payer, R., and T. Nerad. 1996. Effects of low
temperatures on viability of
Cryptosporidium parvum oocysts. Appl.
Environ. Microbiol. 62:1431-1433.
Foundation for Water Research. 1994.
Removal of Cryptosporidium oocysts by
water treatment processes. Foundation for
Water Research, Britain. April.
Frost, P., Craun, G., Calderon, R., and Hubfas,
S. 1997. So many oocysts, so few
outbreaks. J. AWWA (89:12:8-10).
Fulton, P. 1987. Upgrading Filtration to Meet
Pending Standards. Public Works (August:
68-72).
Gerba, C.P., J.B. Rose and C.N. Haas (1996).
Sensitive populations: who is at the
greatest risk? International )ournal of Food
Microbiology: 30(1-2), 10pp.
Glasgow, G. and Wheatley, A. 1998. The
Effect of Surges on the Performance of
Rapid Gravity Filtration. Wat. Sci. Tech.
(37:2:75-81).
Grubb, T. and Arnold, S. 1997. Filter
Backwash Reuse: Treatment by Dissolved
Air Floatation. Proceedings AWWA
Annual Conference, 15pp.
Harrington W., Krupnick, A.J., and W.O.
Spofford. "The Benefits of Preventing an
Outbreak of Giardiasis Due to Drinking
Water Contamination." EPA/Resources for
the Future Report.
Hoxie, N., Davis, J., Vergeront, J., Nashold, R.,
and Blair, K. 1997. Cryptosporidiosis-
associated mortality following a massive
waterborne outbreak in Milwaukee,
Wisconsin. Amer. J. Publ. Health
(87:12:2032-2035).
Kolley, M., Warrier, P., Brokaw, J., Barrett, K.
and Komisar, S. 1995. A Study of Two U.S.
Army Installation Drinking Water Sources
and Treatment Systems for the Removal of
Giardia and Cryptosporidium. Proceedings
AWWA Annual Conference.
LeChevallier, M., Norton, W., and Lee, R.
1991. Giardia and Cryptosporidium spp. in
filtered drinking water supplies. Appl.
Environ. Microbial. (57:9:2617-2621).
LeChevallier, M., and Norton, W. 1992.
Examining relationships between particle
counts and Giardia, Cryptosporidium and
turbidity. J. AWWA (84:120:54-60).
LeChevallier, M., and Norton, W. 1995.
Giardia and Cryptosporidium in raw and
finished water. J. AWWA (87:9:54-68).
Levesque, B.L., Tobiason, J., Parmenter, W.,
and J. Edzwald 1999. Filter Backwash
Recycle: Quality Characteristics and
Impacts on Treatment. Proceedings AWWA
Annual Conference.
Logdson, G. 1987. Evaluating Treatment
Plants forParticulate Contaminant
Removal. J. AWWA (79:9:82-92).
MacKenzie, W.R., N.J. Hoxie, M.E. Proctor,
M.S. Gradus, K.A. Blair, D.E. Peterson, J.J.
Kazmierczak, D.G. Addiss, K.R. Fox, J.B.
Rose, and J.P. Davis. 1994. A massive
outbreak in Milwaukee of Cryptosporidium
infection transmitted through the public
water supply. New England Jour. Med.
331(3):16l-167.
McGuire, M.J., Analysis of Fax Survey
Results. Prepared for American Water
Works Association, Government Affairs
Office, Washington, D.C. Jan. 26,1997.
McTigue, N., LeChevallier, M., Arora, H., and
Clancy, J. 1998. National Assessment of
Particle Removal by Filtration. AWWARF.
Denver, 256pp.
Myers, Tony, Skadsen, Janice and Sanford,
Larry. 2000. Coping with Filter Backwash
Recycle in Water Treatment. AWWA 2000
Annual Conference Proceedings-
Innovation for the New Millennium,
AWWA, Denver, llpg.
NDWAC, 2000. National Drinking Water
Advisory Council Meeting Minutes and
Recommendations, June 14, 2000.
Nieminski, E., and Ongerth, J. 1995.
Removing Giardia and Cryptosporidium by
Conventional Treatment and Direct
Filtration. J. AWWA (87:9:96-106).
Ongerth, J.. and Pecoraro, J. 1995. Removing
Cryptosporidium Using Multimedia Filters.
J. AWWA. (87:12: 83-89).
Parker, D.Y., Leonard, M.J., Barber, P., Bonic,
G., Jones W., and Leavell, K.L., 1999.
Microfiltration treatment of filter backwash
recycle water from a drinking water
treatment facility. Proceedings, AWWA
Water Quality Technology Conference.
Patania, N., Jacangelo,)., Cummings, L.,
Wilczak, A., Riley, K., and Oppenheimer,
J. 1995. Optimization of Filtration for Cyst
Removal. AWWARF. Denver, 178pp.
Pederson & Calhoun, 1995. Do You Recycle?
Results of AW WA's Recycle Practices
Survey. AWWA.
Robeck, G., Dostal, K., and Woodward, R.
1964. Studies of Modification in Water
Filtration. J. AWWA (56:2:198-213).
Rose, J.B., 1988, "Occurrence and
Significance of Cryptosporidium in water,
J. AWWA 80(2):53-58.
Trussell, R., Trussell, A., Lang, J., and Tate,
C. 1980. Recent Developments in Filtration
System Design. J. AWWA (72:12:705-710).
West, T., Danile, P., Meyerhofer, P., DeGraca,
A., Leonard, S., and Gerba, C. 1994.
Evaluation of Cryptosporidium Removal
through High-rate Filtration. Proceedings
AWWA Annual Conference, June. Pp 493-
504.
List of Subjects
40CFRPart9
Reporting and recordkeeping
requirements.
40CFRPartl41 •... .
Environmental protection, Chemicals,
Indians-lands, Intergovernmental
relations, Reporting and recordkeeping
requirements, Water supply.
40 CFR Part 142
Environmental protection,
Administrative practice and procedure,
Chemicals, Indians-lands, Reporting and
recordkeeping requirements, Water
supply.
Dated: May 23, 2001.
Christine Todd Whitman,
Administrator.
For the reasons set forth in the
preamble, title 40, chapter I of the Code
of Federal Regulations is amended as
follows:
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311,1313d, 1314,1318,
1321,1326-1330,1324,1344,1345 (d) and
(e), 1361; E.0.11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-1,
300J-2, 300J-3, 300J-4, 300J-9,1857 et seq.,
6901-992k, 7401-7671q, 7542, 9601-9657.
11023,11.048.
2. In § 9.1 the table is amended by
adding under the indicated heading the
new entry in numerical order to read as
follows: .
§ 9.1 OMB Approvals under the Paperwork
Reduction Act.
40 CFR citation
OMB control No.
National Primary Drinking Water
Regulations
141.76
2040-0224
PART 141—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
3. The authority citation for part 141
continues to read as follows:
Authority: 42 U.S.C. 300f, 300g-l, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300J-4,
300J-9, and 300J-11.
4. Subpart H is amended by adding
§ 141.76 to read as follows:
§141.76 Recycle Provisions.
(a) Applicability. All subpart H
systems that employ conventional
filtration or direct filtration treatment
and that recycle spent filter backwash
water, thickener supernatant, or liquids
from dewatering processes must meet
the requirements in paragraphs (b)
through (d) of this section.
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31104
Federal Register/Vol. 66, No. Ill/Friday, June 8, 2001/Rules and Regulations
(b) Reporting. A system must notify
the State in writing by Decemeber 8,
2003, if the system recycles spent filter
.backwash water, thickener supernatant,
or liquids from dewatering processes.
This notification must include, at a
minimum, the information specified in
paragraphs (b)(l) and (2) of this section.
(1) A plant schematic showing the
origin of all flows which are recycled
(including, but not limited to, spent
filter backwash water, thickener
supernatant, and liquids from
dewatering processes), the hydraulic
conveyance used to transport them, and
the location where they are re-
introduced back into the treatment
plant.
(2) Typical recycle flow in gallons per
minute (gpm), the highest observed
plant flow experienced in the previous
year (gpm), design flow for the
treatment plant (gpm), and State7
approved operating capacity for the
plant where the State has made such
determinations.
(c) Treatment technique requirement.
Any system that recycles spent filter
backwash water, thickener supernatant,
or liquids from dewatering processes
must return these flows through the
processes of a system's existing
conventional or direct filtration system
as defined in § 141.2 or at an alternate
location approved by the State by June
8, 2004. If capital improvements are
required to modify the recycle location
to meet this requirement, all capital
improvements must be completed no
later than June 8, 2006.
(d) Recordkeeping. The system must
collect and retain on file recycle flow
information specified in paragraphs
(d)(l) through (6) of this section for
review and evaluation by the State
beginning June 8, 2004.
(1) Copy of the recycle notification
and information submitted to the State
under paragraph (b) of this section.
(2) List of all recycle flows and the
frequency with which they are returned.
(3) Average and maximum backwash
flow rate through the filters and the
average and maximum duration of the
filter backwash process in minutes.
(4) Typical filter run length and a
written summary of how filter run
length is determined.
(5) The type of treatment provided for
the recycle flow. .
(6) Data on the physical dimensions of
the equalization and/or treatment units,
typical and maximum hydraulic loading
rates, type of treatment chemicals used
and average dose and frequency of use,
and frequency at which solids are
removed, if applicable.
5. Appendix A to Subpart Q of Part
141 is amended by adding a new entry
"8." in numerical order under LA. to
read as follows:
APPENDIX A TO SUBPART Q OF PART 141.—NPDWR VIOLATIONS AND OTHER SITUATIONS REQUIRING PUBLIC NOTICE 1
MCL/MRDUTT violations2
Contaminant
Monitoring and testing proce-
- dure violations
Tier of public
notice required
Citation
Tier of public
notice required
Citation
1. Violations of National Primary Drinking Water Regulations (NPDWR):3
A. Microbiological Contaminants
8. Filter Backwash Recycling Rule violations
2r
141.76
141.76
Appendix A—Endnotes
1. Violations and other situations not listed in this table (e.g., reporting violations and failure to prepare Consumer Confidence Reports), do not
require notice, unless otherwise determined by the primacy agency. Primacy agencies may, at their option, 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 § 141.202(a) and § 141.203(a).
2. MCL—Maximum contaminant level, MRDL—Maximum residual disinfectant level, TT—Treatment technique.
3. The term Violations of National Primary Drinking Water Regulations (NPDWR) is used here to include violations of MCL, MRDL, treatment
technique, monitoring, and testing procedure requirements.
6. Appendix B to Subpart Q of Part 141 is amended by revising B and entry "7." under B. -to read as follows:
APPENDIX B TO SUBPART Q OF PART 141. — STANDARD HEALTH EFFECTS LANGUAGE FOR PUBLIC NOTIFICATION
Standard health
Contaminant
MCLQi mg/L MCL 2 mg/L
notification
National Primary Drinking Water Regulations (NPDWR):
B. Surface Water Treatment Rule (SWTR), Interim Enhanced Surface Water Treatment
Rule (lESWTR) and Filter Backwash Recycling Rule (FBRR) violations:
7. Cryptosporidium (IESWTR/FBRR).
Appendix B—Endnotes
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Federal Register/Vol. 66, No. Ill/Friday, June 8. 2001/Rules and Regulations
31105
1. MCLG—Maximum contaminant level goal.
2. MCL—Maximum contaminant level.
PART 142—NATIONAL PRIMARY
DRINKING WATER REGULATIONS
IMPLEMENTATION
7. The authority citation for Part 142
continues to read as follows:
Authority: 42 U.S.C. 300f, SOOg-l, 300g-2,
300g-3,300g-4,300g-5,300g-6,300J-4,
300J-9, and 300J-11-
8. Section 142.14 is amended by
removing the word "and" at the end of
the paragraph (a)(4)(ii)(A)(7) and
revising paragraph (a)(4)(ii)(A)(S) and
adding paragraph (a)(4)(ii)(A)(9) to read
as follows:
§ 142.14 Records kept by States.
(a)* * *
(4)* * *
(ii)* * *
(A)* * *
(8) Section 141.75(b](2)(iv}—Any
decision to allow reduced reporting by
a filtered public water system; and
(9) Section 141.76—Any decisions
made to approve alternate recycle
locations, require modifications to
recycle return locations, or require
modifications to recycle practices.
*****
9. Section 142.16 is amended by
adding paragraph (i) to read as follows:
§ 142.16 Special primacy requirements.
***,**
(i) Requirements for States to adopt
40 CFR part 141, § 141.76 Recycle
Provisions. In addition to the general
primacy requirements enumerated
elsewhere in this part, including the
requirement that the State provisions
are no less stringent than the federal
requirements, an application for
approval of a State program revision
that adopts 40 CFR part 141, § 141.76
Recycle Provisions must contain the
information specified in this paragraph:
(1) State practices or procedures, (i)
Section 141.76(d) of this chapter—States
must have the proper rules and
authority to use Sanitary Surveys,
comprehensive performance evaluations
(CPEs), other inspections, or other
activities to evaluate recycle data
maintained by systems under
§ 141.76(d) of this chapter and require
modifications to recycle practices.
(ii) [Reserved]
(2) [Reserved] .
[FR Doc. 01-13776 Filed 6-7-01; 8:45 am]
BILLING CODE 6560-50-P
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