[Federal Register: June 8, 2001 (Volume 66, Number 111)]
[Rules and Regulations]               
[Page 31085-31105]

[[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.
------------------------------------------------------------------------

    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

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    A. Where does the FBRR Specify that Recycle Must be Returned?
    B. What Reporting does the FBRR Require of Conventional 
Filtration Systems that Recycle?
    C. What Reporting does the FBRR Require of Direct Filtration 
Systems that Recycle?
    D. What is the Compliance Schedule for the FBRR?
    E. What Public Notification and Consumer Confidence Report 
Requirements are contained in the FBRR?
IV. State Implementation
    A. What Special State Primacy Requirements does the FBRR 
contain?
    B. What State Information Collection, Recordkeeping and 
Reporting Requirements does the FBRR contain?
    C. How Must a State Obtain Interim Primacy for the FBRR?
V. Economic Analysis (Health Risk Reduction and Cost Analysis)
    A. What are the Costs of the FBRR?
    B. What are the Household Costs of the FBRR?
    C. What are the Benefits of the FBRR?
    D. What are the Incremental Costs and Benefits of the FBRR?
    E. Are there Benefits From the Reduction of Co-Occurring 
Contaminants?
    F. Is there Increased Risk From Other Contaminants?
    G. What are the Uncertainties in Risk, Benefit and Cost 
Estimates for the FBRR?
    H. What is the Benefit/Cost Determination for the FBRR?
VI. Other Requirements
    A. Regulatory Flexibility Act (RFA), as amended by the Small 
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 
U.S.C. 601 et. seq
    B. Paperwork Reduction Act
    C. Unfunded Mandates Reform Act of 1995
    D. National Technology Transfer and Advancement Act
    E. Executive Order 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

[[Page 31090]]

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.
NDWAC, 2000. National Drinking Water Advisory Council Meeting 
Minutes and Recommendations, June 14, 2000.
Nieminski, E., and Ongerth, J. 1995. Removing Giardia and 
Cryptosporidium by Conventional Treatment and Direct Filtration. J. 
AWWA (87:9:96-106).
Ongerth, J., and Pecoraro, J. 1995. Removing Cryptosporidium Using 
Multimedia Filters. J. AWWA. (87:12: 83-89).
Parker, D.Y., Leonard, M.J., Barber, P., Bonic, G., Jones W., and 
Leavell, K.L., 1999. Microfiltration treatment of filter backwash 
recycle water from a drinking water treatment facility. Proceedings, 
AWWA Water Quality Technology Conference.
Patania, N., Jacangelo, J., Cummings, L., Wilczak, A., Riley, K., 
and Oppenheimer, J. 1995. Optimization of Filtration for Cyst 
Removal. AWWARF. Denver, 178pp.
Pederson & Calhoun, 1995. Do You Recycle? Results of AWWA's Recycle 
Practices Survey. AWWA.
Robeck, G., Dostal, K., and Woodward, R. 1964. Studies of 
Modification in Water Filtration. J. AWWA (56:2:198-213).
Rose, J.B., 1988, ``Occurrence and Significance of Cryptosporidium 
in water, J. AWWA 80(2):53-58.
Trussell, R., Trussell, A., Lang, J., and Tate, C. 1980. Recent 
Developments in Filtration System Design. J. AWWA (72:12:705-710).
West, T., Danile, P., Meyerhofer, P., DeGraca, A., Leonard, S., and 
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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