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National Primary Drinking Water;
Filter Backwash Recycling Rule; Final
Rule
[Federal Register: June 8, 2001 (Volume 66, Number 111)]
[Rules and Regulations]
[Page 31085-31105]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn01-13]
[[Page 31085]]
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Part IV
Environmental Protection Agency
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40 CFR Parts 9, 141, and 142
National Primary Drinking Water; Filter Backwash Recycling Rule; Final
Rule
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9, 141, and 142
[WH-FRL-6989-5]
RIN 2040-AD17
National Primary Drinking Water Regulations: Filter Backwash
Recycling Rule
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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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)(10) 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:
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Category Examples of regulated entities
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Industry............................... Public Water Systems that use
surface water or ground water
under the direct influence of
surface water.
State, Local, Tribal or Federal Public Water Systems that use
Governments. surface water or ground water
under the direct influence of
surface water.
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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 Sec. 141.2 of title 40 of the Code of Federal
Regulations and Sec. 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
deg.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
LT1ESWTR Long Term 1 Enhanced Surface Water Treatment Rule
MCLG Maximum Contaminant Level Goal
NDWAC National Drinking Water Advisory Council
NPDWR National Primary Drinking Water Regulation
NODA 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
[[Page 31087]]
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 12866: 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
VII. 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-
1(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, Fayer (1994) discovered that cleaned oocysts
in distilled water heated to 72.4 deg.C for 1 minute and to 64.2
deg.C for two minutes were not infective to mice. Fayer and Nerad
(1996) found that cleaned oocysts in distilled water cooled to -20
deg.C for eight hours and 70 deg.C for 1 hour were not infective to
mice. However, oocysts may remain viable after freezing (Fayer 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 HIV/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 FR 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 FR 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
Sec. 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.
II. 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)(14) 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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Enhanced Surface Water Treatment Rule Notice of Data Availability
(NODA) (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 (LT1ESWTR). The proposed LT1ESWTR 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 LT1ESWTR 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 LT1ESWTR 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 public health; and
--Direct 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 Sec. 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 Sec. 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
Sec. 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 Sec. 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
[[Page 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 (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 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/100L, 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, 1998l).
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.
[[Page 31092]]
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:
(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 (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.
[[Page 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 water may
surge through the 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 the FBRR?
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 Sec. 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
[[Page 31094]]
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)(10) 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 Sec. 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 Sec. 141.76(b) or failure to collect
and maintain recycle information as part of Sec. 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 Sec. 141.153(d)(6)
and Sec. 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 Sec. 142.14 to require States to keep on file
system-specific decisions made under Sec. 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
for 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
Sec. 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 the 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.
[[Page 31095]]
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 $7.2 million (annualized using a three percent or seven
percent discount rate respectively). Total capital and associated O&M
costs associated with modifications to recycle locations at an
estimated 371 systems are $45.2 million, and represent $5.5 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 ($0.07
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 et al., 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
[[Page 31096]]
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 et
seq.
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
[[Page 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 $0 for capital, and $0 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 in 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
annualized 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
[[Page 31098]]
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 (NTAA), 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
[[Page 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
(Fayer 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 Cryptosporidium-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 Board 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.
I. 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
[[Page 31100]]
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, LT1ESWTR, 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.
J. 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.................. Does the system have a reliable
source of drinking water? Is
the source of generally good
quality and adequately
protected?
Infrastructure adequacy................ 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
infrastructure's life
expectancy? Does the system
have a capital improvement
plan?
Technical knowledge and implementation. Is the system's operator
certified? Does the operator
have sufficient technical
knowledge of applicable
standards? Can the operator
effectively implement this
technical knowledge? Does the
operator understand the
system's technical and
operational characteristics?
Does the system have an
effective operation and
maintenance program?
------------------------------------------------------------------------
[[Page 31101]]
Managerial Capacity
------------------------------------------------------------------------
Ownership accountability............... Are the system owner(s) clearly
identified? Can they be held
accountable for the system?
Staffing and organization.............. 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 system
operations? Do personnel have
the necessary licenses and
certifications?
Effective external linkages............ 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.................... Do revenues cover costs? Are
water rates and charges
adequate to cover the cost of
water?
Credit worthiness...................... Is the system financially
healthy? Does it have access
to capital through public or
private sources?
Fiscal management and controls......... Are adequate books and records
maintained? Are appropriate
budgeting, 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: (1)(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.C.
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., Logsdon, 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
cryptosporidiosis. Epidemiol. Infect. (104:1-28).
CDC 1994. Addressing Emerging Infectious Disease Threats: A
Prevention 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 Baumann, E. 1963. Effect of
Filtration Rate Changes on Filtered Water Quality. J. AWWA
(55:7:869-880).
[[Page 31102]]
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, 11pp.
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-11/22 (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.1998l. 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 (LT1FBR) 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 2000l, 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 LT1ESWTR and
FBRR.
[[Page 31103]]
EPA-SAB-DWC-COM-00-004. May 23, 2000.
EPA 2000o. 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. Fayer, R. and Ungar, B. 1986. Cryptosporidium spp. and
cryptosporidiosis. Microbial Review. (50:4:458-483).
Fayer, R. 1994. Effect of high temperature on infectivity of
Cryptosporidium parvum oocysts in water. Appl. Environ. Microbiol.
60:2732-2735.
Fayer, 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, F., Craun, G., Calderon, R., and Hubbs, 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 Journal 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).
Kelley, 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 for Particulate
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):161-167.
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, 11pg.
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Minutes and Recommendations, June 14, 2000.
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Cryptosporidium by Conventional Treatment and Direct Filtration. J.
AWWA (87:9:96-106).
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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, J., Cummings, L., Wilczak, A., Riley, K.,
and Oppenheimer, J. 1995. Optimization of Filtration for Cyst
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Pederson & Calhoun, 1995. Do You Recycle? Results of AWWA's Recycle
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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
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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
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504.
List of Subjects
40 CFR Part 9
Reporting and recordkeeping requirements.
40 CFR Part 141
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.O. 11735, 38 FR 21243, 3 CFR, 1971-
1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-
1, 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, 11048.
2. In Sec. 9.1 the table is amended by adding under the indicated
heading the new entry in numerical order to read as follows:
Sec. 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-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.
4. Subpart H is amended by adding Sec. 141.76 to read as follows:
Sec. 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.
[[Page 31104]]
(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)(1) 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 State-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 Sec. 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)(1) 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 I.A. to read as follows:
Appendix A to Subpart Q of Part 141.--NPDWR Violations and Other Situations Requiring Public Notice \1\
----------------------------------------------------------------------------------------------------------------
MCL/MRDL/TT violations \2\ Monitoring and testing
------------------------------- procedure violations
Contaminant ------------------------------
Tier of public Citation Tier of public
notice required notice required Citation
----------------------------------------------------------------------------------------------------------------
1. Violations of National Primary Drinking Water
Regulations (NPDWR): \3\
A. Microbiological Contaminants
* * * * * *
*
8. Filter Backwash Recycling Rule violations.. 2 141.76 3 141.76
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
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 Sec. 141.202(a) and Sec. 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
effects language
Contaminant MCLG \1\ mg/L MCL \2\ mg/L for public
notification
----------------------------------------------------------------------------------------------------------------
National Primary Drinking Water Regulations (NPDWR):
* * * * * *
*
B. Surface Water Treatment Rule (SWTR), Interim Enhanced
Surface Water Treatment Rule (IESWTR) and Filter Backwash
Recycling Rule (FBRR) violations:
* * * * * *
*
7. Cryptosporidium (IESWTR/FBRR)........................
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
Appendix B--Endnotes
[[Page 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, 300g-1, 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)(8) and adding paragraph (a)(4)(ii)(A)(9) to read as
follows:
Sec. 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:
Sec. 142.16 Special primacy requirements.
* * * * *
(i) Requirements for States to adopt 40 CFR part 141, Sec. 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, Sec. 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 Sec. 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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