Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70513 

(B) The report covering the period 

covering April 1 to June 30 shall be 

submitted by the following August 31. 

(C) The report for the period from July 

1 to September 30 shall be submitted by 

the following November 30. 

(D) The report for the quarterly 

compliance period from October 1 to 

December 31 shall be submitted by the 

following February 28. 

(vi) The report for the quarterly 

compliance period from April 1, 2010 to 

May 31, 2010 shall be submitted by 

August 31, 2010. 

(vii) The report for the last quarterly 

compliance period from June 1, 2010 to 

September 30, 2010 shall be submitted 

by November 30, 2010. 

* * * * * 

(3) All reports shall be submitted on 

forms and following procedures 

specified by the Administrator, shall 

include a statement that volumes 

reported to the Administrator under this 

section are in substantial agreement to 

volumes reported to the Internal 

Revenue Service (and if these volumes 

are not in substantial agreement, an 

explanation must be included) and shall 

be signed and certified by a responsible 

corporate officer of the reporting entity. 

* * * * * 

■ 16. Section 80.602 is amended by 

revising paragraphs (a)(2)(iii), (b) 

introductory text, (d), and (e), and 

adding paragraph (f) to read as follows: 

§ 80.602 What records must be kept by 

entities in the NRLM diesel fuel and diesel 

fuel additive production, importation, and 

distribution systems? 

(a) * * * 

(2) * * * 

(iii) The results of the tests for sulfur 

content (including, where applicable, 

the test results with and without 

application of the adjustment factor 

under § 80.580(d)), for cetane index or 

aromatics content, dye solvent red 164, 

marker solvent yellow 124 (as 

applicable), and the volume of product 

in the storage tank or container from 

which the sample was taken. 

* * * * * 

(b) Additional records to be kept by 

refiners and importers of NRLM diesel 

fuel. Beginning June 1, 2007, or June 1, 

2006, pursuant to the provisions of 

§ 80.535 or § 80.554(d), any refiner 

producing diesel fuel subject to a sulfur 

standard under § 80.510, § 80.513, 

§ 80.536, § 80.554, § 80.560, or § 80.561, 

for each of its refineries, and any 

importer importing such diesel fuel 

separately for each facility, shall keep 

records that include the following 

information for each batch of NRLM 

diesel fuel or heating oil produced or 

imported: 

* * * * * 

(d) Additional records that must be 

kept by mobile facilities. Any registered 

mobile facility must keep records of all 

contracts from any contracted 

components (e.g. tank truck, barge, 

marine tanker, rail car, etc.) of each of 

its registered mobile facilities. 

(e) Length of time records must be 

kept. The records required in this 

section shall be kept for five years from 

the date they were created, except that 

records relating to credit transfers shall 

be kept by the transferor for five years 

from the date the credits were 

transferred, and shall be kept by the 

transferee for five years from the date 

the credits were transferred, used or 

terminated, whichever is later. 

(f) Make records available to EPA. On 

request by EPA, the records required in 

this section must be made available to 

the Administrator or the Administrator’s 

representative. For records that are 

electronically generated or maintained, 

the equipment and software necessary 

to read the records shall be made 

available, or if requested by EPA, 

electronic records shall be converted to 

paper documents which shall be 

provided to the Administrator’s 

authorized representative. 

[FR Doc. 05–22807 Filed 11–21–05; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 146 

[FRL–7999–7] 

Underground Injection Control 

Program—Revision to the Federal 

Underground Injection Control 

Requirements for Class I Municipal 

Disposal Wells in Florida 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rule. 

SUMMARY: Today’s rule amends the 

current Federal Underground Injection 

Control (UIC) requirements by providing 

a regulatory alternative to owners and 

operators of Class I municipal disposal 

wells in specific areas of Florida that 

have caused or may cause movement of 

fluid into an Underground Source of 

Drinking Water (USDW). Because 

operation of Class I wells with fluid 

movement into a USDW is prohibited by 

Federal UIC regulations, this new rule 

offers owners and operators of 

municipal disposal wells in certain 

counties in Florida the ability to 

continue to operate their wells provided 

they meet additional wastewater 

treatment requirements. These new 

treatment requirements, which apply 

only to injection operations in certain 

counties of Florida, are designed to 

provide an equivalent level of 

protection to USDWs that is afforded by 

the no-fluid-movement standard. 

DATES: This regulation is effective 

December 22, 2005. For purposes of 

judicial review, this final rule is 

promulgated as of 1 p.m., Eastern time 

on December 6, 2005, as provided in 40 

CFR 23.7. 

ADDRESSES: The official public docket 

for this rule is located at the U.S. 

Environmental Protection Agency 

(EPA), Region 4 Library (9th Floor), Sam 

Nunn Atlanta Federal Center, 61 

Forsyth Street, SW., Atlanta, GA 30303–

8960. The docket is available for 

inspection from 8 a.m. to 3:30 p.m., 

Eastern time, Monday through Friday, 

excluding legal holidays. For 

information on how to access Docket 

materials, please call (404) 562–8190 

and refer to the Florida UIC docket. 

FOR FURTHER INFORMATION CONTACT: For 

technical inquiries, contact Nancy H. 

Marsh, Ground Water & UIC Section, 

U.S. EPA Region 4, 61 Forsyth Street, 

SW., Atlanta, GA 30303–8960 (phone: 

404–562–9450; E-mail: 

marsh.nancy@epa.gov) or Lee 

Whitehurst, Office of Ground Water and 

Drinking Water, U.S. EPA, EPA East, 

1200 Pennsylvania Avenue, 

NW.,Washington, DC 20460 (phone: 

202–564–3896; E-mail: 

whitehurst.lee@epa.gov). For general 

information, contact the Safe Drinking 

Water Hotline, at 800–426–4791. The 

Safe Drinking Water Hotline is open 

Monday through Friday, excluding legal 

holidays, from 9 a.m. to 5 p.m., Eastern 

time. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. General Information 

A. Who Are Regulated Entities? 

B. Abbreviations and Acronyms Used in 

the Preamble and Final Rule 

II. Background 

A. Why Is EPA Taking This Regulatory 

Action? 

B. Statutory and Regulatory Framework 

C. Requirements To Prevent Fluid 

Movement 

D. Domestic Wastewater Disposal in 

Florida Through Class I Wells 

E. July 7, 2000 Proposed Rule 

1. Option 1: Advanced Wastewater 

Treatment (AWT) with a Nonendangerment Demonstration. 

2. Option 2: In-depth Hydrogeologic 

Demonstration and Advanced Treatment, 

as Necessary 

70514 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

F. 2003 Relative Risk Assessment 

1. Relative Risk Assessment Question 1: 

What Level of Treatment and 

Disinfection Is Provided for the 

Management Options of Treated 

Wastewater in South Florida? 

2. Relative Risk Assessment Question 2: 

What Stressors Remain (After Treatment) 

That May Be a Concern for the 

Management Options of Treated 

Wastewater in South Florida? 

3. Relative Risk Assessment Question 3: 

What Exposure Pathways Are (or May 

Be) of Significance for the Management 

Options of Treated Wastewater in South 

Florida? 

4. Relative Risk Assessment Question 4: 

What Is the Overall Estimate of Risk for 

the Management Options of Treated 

Wastewater in South Florida? 

5. Relative Risk Assessment Question 5: 

What Are the Important Data or 

Knowledge Gaps for Deep Well 

Injection? 

G. May 5, 2003, Notice of Availability and 

Notice of Data Availability 

1. NODA Question 1: What Is the 

Appropriate Level of Wastewater 

Treatment Prior to Injection? 

2. NODA Question 2: Is it Feasible To 

Predict Movement of Fluids Through 

Hydrogeologic Demonstrations? 

3. NODA Question 3: Have Some Deep 

Wells Been Misclassified as Class I, 

When They Are Actually Class V? 

III. Summary of Public Comments 

A. Comments on the July 7, 2000, Proposed 

Rule 

1. Selection of Option 1, Option 2, or a 

Combination of Both 

2. Appropriate Level of Wastewater 

Treatment 

3. Need for Pretreatment 

4. Feasibility of Hydrogeologic 

Demonstrations to Predict Movement of 

Fluids 

5. Monitoring Requirements 

6. Rule Applicability 

7. Suitability of Florida Geology for 

Domestic Wastewater Disposal Through 

Class I Wells 

B. Comments on the Notice of Data 

Availability and the Relative Risk 

Assessment 

1. Appropriate Level of Wastewater 

Treatment Prior to Injection 

2. Feasibility of Hydrogeologic 

Demonstrations To Predict Movement of 

Fluids 

3. Class I or Class V 

IV. Explanation of Today’s Action 

A. Objectives and Approach 

B. Operating Requirements 

1. Selected Approach 

a. Rationale for Requiring Pretreatment of 

Wastewater 

b. Rationale for Requiring Secondary 

Treatment of Wastewater 

c. Rationale for Using Florida Definition of 

High-Level Disinfection 

d. Rationale for Not Requiring the Removal 

of Other Contaminants 

e. Rationale for Phasing In the New 

Treatment Over Time 

2. In-Depth Hydrogeologic Demonstrations 

C. Monitoring Requirements 

D. Rule Applicability 

1. How Will the New Rule Affect New 

Wells? 

2. What Florida Counties Are Covered by 

the Final Rule? 

E. Reclassification of Wells that Have 

Caused Fluid Movement 

V. Cost of the Rule 

VI. Statutory and Executive Order Reviews 

A. Executive Order 12866: Regulatory 

Planning and Review 

B. Paperwork Reduction Act 

C. Regulatory Flexibility Act 

D. Unfunded Mandates Reform Act 

E. Executive Order 13132: Federalism 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

G. Executive Order 13045: Protection of 

Children From Environmental Health & 

Safety Risks 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

I. National Technology Transfer 

Advancement Act 

J. Congressional Review Act 

I. General Information 

A. Who Are Regulated Entities? 

This regulation is limited in 

application to the owners and/or 

operators of existing Class I 

underground injection wells that inject 

domestic wastewater effluent in certain 

parts of Florida. It is limited 

geographically to wells in the following 

counties: Brevard, Broward, Charlotte, 

Collier, Flagler, Glades, Hendry, 

Highlands, Hillsborough, Indian River, 

Lee, Manatee, Martin, Miami-Dade, 

Monroe, Okeechobee, Orange, Osceola, 

Palm Beach, Pinellas, St. Johns, St. 

Lucie, Sarasota, and Volusia. These 

counties are included in this rule 

because they have the unique geologic 

conditions that are predominated by 

carbonate rocks. Such rocks commonly 

contain fractures, faults, and solution 

cavities that provide preferential paths 

for the movement of underground 

fluids. 

Class I injection wells are wells that 

inject fluids beneath the lowermost 

formation containing, within onequarter mile of a well bore, a USDW (40 

CFR 144.6(a)). Class I wells can be used 

to inject hazardous, industrial, or 

municipal wastes. Class I municipal 

disposal wells inject treated wastewater 

from publicly or privately owned and 

operated facilities that treat domestic 

wastewater (commonly referred to as 

sanitary wastewater or sewage), which 

is principally derived from dwellings, 

business buildings, and institutions. 

Treated wastewater from industrial 

facilities, often controlled through 

pretreatment standards, may also be 

found in this wastewater. Currently, 

Class I municipal disposal wells are 

located only in the State of Florida. 

Specific regulated categories and 

entities include: 

Category Examples of entities 

Municipalities and Local Government ...................................................... Class I municipal disposal wells disposing of domestic wastewater effluent in certain parts of Florida 

Private ....................................................................................................... Class I municipal disposal wells disposing of domestic wastewater effluent in certain parts of Florida. 

This table is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

regulated by this action. This table lists 

the types of entities that EPA is now 

aware could potentially be regulated by 

this action. Other types of entities not 

listed in the table could also be 

regulated. To determine whether your 

facility is regulated by this action, you 

should carefully examine the 

applicability criteria in 40 CFR 146.15 

of the rule. If you have questions 

regarding the applicability of this action 

to a particular entity, consult one of the 

persons listed in the preceding FOR

FURTHER INFORMATION CONTACT section. 

B. Abbreviations and Acronyms Used in 

the Preamble and Final Rule 

AWT Advanced Wastewater Treatment 

BOD Biochemical Oxygen Demand 

CFR Code of Federal Regulations 

EPA Environmental Protection Agency 

F.A.C. Florida Administrative Code 

FDEP Florida Department of Environmental 

Protection 

ICR Information Collection Request 

MGD Million Gallons per Day 

NDWAC National Drinking Water Advisory 

Council 

NOA Notice of Availability 

NODA Notice of Data Availability 

NTTAA National Technology Transfer and 

Advancement Act 

O&M Operations and Maintenance 

OMB Office of Management and Budget 

RCRA Resource Conservation and Recovery 

Act 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70515 

RFA Regulatory Flexibility Act 

SBREFA Small Business Regulatory 

Enforcement Fairness Act 

SDWA Safe Drinking Water Act 

TDS Total Dissolved Solids 

TSS Total Suspended Solids 

USDW Underground Source of Drinking 

Water 

UIC Underground Injection Control 

UMRA Unfunded Mandates Reform Act 

II. Background 

A. Why Is EPA Taking This Regulatory 

Action? 

In the early 1980’s EPA found that 

some Class I municipal wells in specific 

areas in Florida caused or may cause 

fluid movement into an Underground 

Source of Drinking Water (USDW). On 

July 7, 2000, EPA proposed a revision to 

the UIC regulations whereby continued 

injection would be allowed only if 

owners or operators met certain 

additional wastewater treatment 

requirements. EPA requested public 

comment on options for providing 

additional wastewater treatment at 

municipal disposal facilities in certain 

counties in Florida that have or may 

cause fluid movement. 

As part of EPA’s FY 2000 

appropriations bill, Congress asked EPA 

to conduct a relative risk assessment of 

deep well injection, ocean disposal, 

surface discharge, and aquifer recharge 

of treated effluent in South Florida. EPA 

published the Relative Risk Assessment 

of Management Options for Treated 

Wastewater in South Florida in April 

2003. In the Relative Risk Assessment, 

EPA reported that results from ground 

water monitoring around some Class I 

municipal disposal wells in Florida 

confirm that fluids have migrated out of 

the permitted injection zone and, in 

some cases, into USDWs. EPA also 

found that the full extent of USDWs 

contamination is not known because the 

fate and transport of pathogens 

contained in injected effluent is 

especially difficult to define even with 

the most sophisticated ground water 

modeling or monitoring. 

On May 5, 2003, EPA issued a Notice 

of Availability (NOA) announcing the 

availability of the Relative Risk 

Assessment and a Notice of Data 

Availability (NODA), requesting public 

comment on how the findings in the 

Relative Risk Assessment should inform 

this final rulemaking. 

Without today’s rule, the no-fluidmovement requirement would remain 

the only available approach for 

regulating Class I municipal disposal 

wells in Florida, regardless of the level 

of wastewater treatment prior to 

injection. Enforcing this approach 

would, in effect, require owners and 

operators to shut these wells down 

because wastewater isolation from 

USDWs cannot be ensured. Shutting 

down the injection wells would, in turn, 

force the municipal wastewater to be 

managed by other means, which could 

increase the risks to surface water and 

coastal ecosystems. 

As an alternative, EPA has chosen, for 

Class I municipal disposal wells in 

certain parts of Florida, another 

approach that it believes will be as 

effective as confinement in protecting 

USDWs from the contaminants in the 

wastewater. This alternate approach 

involves the rigorous control of the 

quality of the injected fluids. Under this 

approach, the movement of fluids into 

USDWs, whether known or suspected, 

should not endanger the USDWs 

because the quality of the wastewater 

has been treated to a level that is no 

longer a threat to USDWs. Today’s 

action shifts the endangerment 

protection strategy employed for Class I 

municipal disposal wells in certain 

parts of Florida from the no-fluidmovement standard to an alternate 

approach that relies on treatment of 

wastewater before it is injected. This 

shift, however, does not undercut the 

protection of USDWs or weaken the UIC 

Program requirements. Although facility 

owners and operators in the designated 

counties must meet new treatment 

requirements to continue injecting 

without violating the no-fluidmovement standard, they must also 

comply with all other applicable UIC 

requirements to ensure that their 

injection wells do not endanger USDWs. 

In the Relative Risk Assessment’s 

evaluation of injection practices in 

Florida, pathogens were identified as 

the contaminant in municipal 

wastewater that presents the greatest 

risk to USDWs. High-level disinfection 

of this municipal wastewater is an 

effective method for inactivating these 

pathogens. 

Therefore, in today’s rule, EPA 

amends the current Federal UIC 

regulations to allow owners and 

operators of Class I municipal disposal 

wells in specific areas of Florida to 

continue using their wells, even if they 

have caused or may have caused 

movement of fluid into a USDW, 

provided they meet new requirements to 

treat their municipal wastewater with 

pretreatment, secondary treatment, and 

high-level disinfection. 

B. Statutory and Regulatory Framework 

Class I underground injection wells 

are regulated under the authority of Part 

C of the Safe Drinking Water Act 

(‘‘SDWA’’ or ‘‘the Act’’) (42 U.S.C. 300h 

et seq.). The SDWA is designed to 

protect the quality of drinking water 

sources in the United States and 

prescribes that: 

Underground injection endangers drinking 

water sources if such injection may result in 

the presence in underground water which 

supplies or can reasonably be expected to 

supply any public water system of any 

contaminant, and if the presence of such 

contaminant may result in such system’s not 

complying with any national primary 

drinking water regulation or may otherwise 

adversely affect the health of persons. 

(Section 1421(d)(2) of the SDWA, 42 U.S.C. 

300h(d)(2).) 

Part C Protection of Underground 

Sources of Drinking Water of the Act 

specifically mandates the regulation of 

underground injection. The Agency has 

promulgated a series of UIC regulations 

under this authority at 40 CFR parts 144 

through 147. The chief goal of any 

Federally approved UIC Program 

(whether administered by the State or 

EPA) is the protection of USDWs. This 

includes not only those aquifers which 

are presently being used for drinking 

water, but also those which can 

reasonably be expected to be used in the 

future. EPA has established through its 

UIC regulations that underground 

aquifers with less than 10,000 mg/l total 

dissolved solids (TDS) and which 

contain a sufficient quantity of ground 

water to supply a public water system 

are USDWs. (40 CFR 144.3) 

Section 1421 of the Act requires EPA 

to propose and promulgate regulations 

specifying minimum requirements for 

effective State programs to prevent 

underground injection that endangers 

drinking water sources. EPA 

promulgated administrative and 

permitting regulations, now codified in 

40 CFR parts 144 and 146, on May 19, 

1980 (45 FR 33290), and technical 

requirements, in 40 CFR part 146, on 

June 24, 1980 (45 FR 42472). The 

regulations were subsequently amended 

on August 27, 1981 (46 FR 43156), 

February 3, 1982 (47 FR 4992), January 

21, 1983 (48 FR 2938), April 1, 1983 (48 

FR 14146), July 26, 1988 (53 FR 28118), 

December 3, 1993 (58 FR 63890), June 

10, 1994 (59 FR 29958), December 14, 

1994 (59 FR 64339), June 29, 1995 (60 

FR 33926), December 7, 1999 (64 FR 

68546), May 15, 2000 (65 FR 30886), 

and June 7, 2002 (67 FR 39584). Section 

1421(b)(3)(A) of the Act also provides 

that EPA’s UIC regulations shall ‘‘permit 

or provide for consideration of varying 

geologic, hydrological, or historical 

conditions in different States and in 

different areas within a State.’’

When EPA promulgated its UIC 

regulations, it defined five classes of 

injection wells in 40 CFR 144.6. Class I 

wells are defined as wells which inject 

70516 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

fluids beneath the lowermost formation 

containing, within one-quarter mile of 

the well bore, a USDW. Class I wells can 

be hazardous waste or other industrial 

or municipal disposal wells. (Hazardous 

waste injection must meet additional 

Resource Conservation and Recovery 

Act (RCRA) requirements. See 40 CFR 

part 148. Class I municipal disposal 

wells can be owned by public and 

private entities, as discussed above. 

Section 1422 of the Act provides that 

States may apply to EPA for national 

primary enforcement responsibility to 

administer the UIC program. Those 

States receiving such authority are 

referred to as ‘‘Primacy States.’’ Florida 

received national primary enforcement 

responsibility for the UIC program for 

Class I, III, IV, and V wells on March 9, 

1983. UIC regulations specific to 

Florida’s primacy program are 

established in 40 CFR part 147, Subpart 

K. For the remainder of this preamble, 

reference to the UIC Program ‘‘Director’’

means the Secretary of the Florida 

Department of Environmental Protection 

(FDEP). Currently, all UIC Programs in 

Indian Country for Florida are directly 

implemented by EPA. It is EPA’s intent 

that the provisions of this regulation 

apply to Class I municipal disposal 

wells in Indian Country within the 

counties identified in 40 CFR 146.15(f). 

At this time, there are no known Class 

I municipal disposal wells in Florida in 

Indian Country. 

C. Requirements To Prevent Fluid 

Movement 

When EPA promulgated its 

regulations for the UIC program, it 

established different requirements for 

each class of wells, based upon the uses 

and risks of various types of wells. All 

classes of wells are required to comply 

with 40 CFR 144.12(a) which states: 

No owner and/or operator shall construct, 

operate, maintain, convert, plug, abandon, or 

conduct any other injection activity in a 

manner that allows the movement of fluid 

containing any contaminant into 

underground sources of drinking water, if the 

presence of that contaminant may cause a 

violation of any primary drinking water 

regulation under 40 CFR part 142 or may 

otherwise adversely affect the health of 

persons. 

Then, for Class I, II, and III wells, 40 

CFR 144.12(b) more specifically 

provides that: 

If any water quality monitoring of an 

underground source of drinking water 

indicates the movement of any contaminant 

into the underground source of drinking 

water, except as authorized under 40 CFR 

part 146, the Director shall prescribe such 

additional requirements for construction, 

corrective action, operation, monitoring, or 

reporting (including closure of the injection 

well) as are necessary to prevent such 

movement. 

In contrast to subsection (a), which, 

for all classes of wells, prohibits fluid 

movement that may endanger USDWs, 

40 CFR 144.12(b) requires for Class I, II, 

and III wells that a State or Federal UIC 

Program Director, upon detection of 

contaminant movement into a USDW, 

prescribe requirements to prevent any 

such movement, regardless of whether 

the movement may endanger the USDW. 

In addition to 40 CFR 144.12(b), EPA 

established technical and other 

requirements for specific classes of 

wells in Parts 144 and 146 regulations. 

Parts 144 and 146 regulations address 

siting, construction, operation, and 

closure of wells. Parts 144.12(b) and the 

specific technical requirements of parts 

144 and 146 regulate the activities 

through which fluid movement may 

result and impose requirements 

designed to ensure that Class I, II, and 

III wells will not endanger USDWs by 

prohibiting movement of any fluid into 

the USDW. 

D. Domestic Wastewater Disposal in 

Florida Through Class I Wells 

Beginning more than 20 years ago, 

municipalities in Florida began to 

pursue the use of underground injection 

as an alternative to surface disposal of 

treated wastewater from domestic 

wastewater treatment facilities. 

Underground injection technology was 

employed to relieve stress to surface 

water environments because it was 

technologically feasible to inject large 

volumes of wastewater into deep 

permeable and transmissive formations. 

Through technical and monetary 

assistance, EPA supported construction 

of many of these facilities in an effort to 

safeguard surface waters. Through 

injection technology, domestic 

wastewater facilities have been able to 

dispose of large quantities of domestic 

effluent, with the resulting benefit of 

reducing impacts to surface ecosystems. 

Wells at facilities that inject domestic 

wastewater into wells below the 

lowermost USDW are considered to be 

Class I municipal disposal wells, and in 

Florida such wells inject into zones 

ranging from 650 to 3,500 feet below the 

land surface. 

The volumes of domestic wastewater 

permitted for injection at Class I 

municipal disposal well facilities 

presently range from one well with less 

than one million gallons per day (MGD) 

at the Gasparilla Island Water Utilities 

to 17 wells with about 110 MGD at 

Miami-Dade Water & Sewer Department, 

South District Wastewater Treatment 

Plant. Florida requires that domestic 

wastewater must, at a minimum, be 

treated to secondary wastewater 

treatment standards (see 40 CFR part 

133). At the time Florida permitted the 

currently operating Class I municipal 

disposal wells, characterization of the 

geology indicated that there was 

adequate confinement to isolate the 

injection fluids from any USDWs. 

Because it was thought there was 

adequate confinement, it was believed 

that injection fluids would never 

migrate upwards into the shallower 

geologic formations containing USDWs. 

The current injection and confining 

zones in peninsular Florida exist in 

what is known as the Floridan Aquifer 

System. This system is made up of 

carbonate rocks. The uppermost 

geologic formations of the Floridan 

Aquifer System, as well as formations 

above the Floridan Aquifer, are USDWs. 

The porosity and permeability 

variations of the carbonate rocks of 

peninsular Florida and the existence of 

fractures within the formation 

determine their confining ability. The 

porosity varies greatly, even within the 

same horizon or geological deposit of a 

particular time. Monitoring of injection 

operations over the past several years 

has indicated that some deep geologic 

zones provide less confinement between 

formations than was originally thought. 

It now appears, from recent well 

monitoring data, that upward fluid 

movement from some Class I municipal 

disposal operations occurs in Florida 

because the injection fluid from Class I 

municipal disposal wells has a lower 

density (lower TDS) than the native 

formation fluids. This tends to cause the 

less dense injection fluids to rise to the 

top of the injection zone preferentially 

through fractures that may exist within 

the formations and above the injection 

zone if migration pathways, such as 

fractures, exist. Movement of injected 

fluid into USDWs either has been 

confirmed or is suspected at eight 

facilities, as evidenced by levels of 

nitrates and ammonia, as well as 

significant changes in dissolved solids 

concentrations. (The preferential flow 

that leads to the movement of fluid with 

nitrates and ammonia can also lead to 

the presence of pathogens.) At an 

additional eight facilities, there is 

evidence of movement outside of the 

injection zone, though not into USDWs. 

E. July 7, 2000 Proposed Rule 

On July 7, 2000, EPA proposed 

revisions to the UIC regulations that 

would allow continued wastewater 

injection by existing Class I municipal 

disposal wells that have caused or may 

cause movement of contaminants into 

USDWs in specific areas of Florida (65 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70517 

FR 42234). Continued injection would 

be allowed only if owners or operators 

met certain additional requirements that 

provide adequate protection for USDWs. 

EPA co-proposed two primary options 

for the additional requirements: 

1. Option 1: Advanced Wastewater 

Treatment (AWT) With a NonEndangerment Demonstration 

The authorization to inject under 

Option 1 would have required that the 

owner and/or operator of a Class I 

municipal disposal well injecting 

domestic wastewater effluent treat the 

wastewater by advanced treatment 

methods and high-level disinfection and 

demonstrate that injection would not 

cause fluids that exceed the national 

primary drinking water regulations or 

other health-based standards to enter 

the USDW. The non-endangerment 

demonstration would focus on any 

contaminants that still exceed national 

drinking water regulations or other 

health-based standards after wastewater 

treatment. In the proposal, EPA solicited 

public comment on the appropriateness 

of this option, as well as the appropriate 

level of wastewater treatment, nutrient 

removal, and high-level disinfection 

that should be required if Option 1 is 

selected. The alternatives proposed 

were: 

Treatment to 10–24 mg/l biochemical 

oxygen demand (BOD) with 

disinfection; 

Treatment to 10–24 mg/l BOD with 

disinfection and nutrient removal; 

Treatment to <10 mg/l BOD with 

disinfection; 

Treatment to <10 mg/l BOD with 

disinfection and nutrient removal. 

2. Option 2: In-Depth Hydrogeologic 

Demonstration and Advanced 

Treatment, as Necessary 

The authorization to inject under 

Option 2 would have required that the 

owner and/or operator of a Class I 

municipal disposal well injecting 

domestic wastewater effluent provide a 

hydrogeologic demonstration that the 

injection operation would not cause the 

USDW to exceed national primary 

drinking water regulations or other 

health-based standards. EPA anticipated 

that this hydrogeologic demonstration 

would be an extensive evaluation, 

similar in detail to those required for a 

RCRA land ban no-migration petition, 

and consist of an analysis of the 

contaminants in wastewater prior to 

injection, include monitoring data from 

deep wells at the base of the USDW, and 

also include detailed hydrogeologic 

modeling of vertical and horizontal 

fluid transport in the injection zone and 

USDWs. If it was anticipated that the 

fluids may enter the USDW, the 

demonstration would have to show that 

the fluids would not cause the USDW to 

exceed primary drinking water 

regulations in 40 CFR part 141 or other 

health-based standards. Operators who 

could not successfully demonstrate that 

the injection operation meets these 

criteria would have been required to 

treat their injectate to address the 

contaminants of concern and satisfy 

additional requirements proposed to be 

added in a new 40 CFR 146.15(d). This 

second option also proposed a provision 

whereby all facilities qualifying for 

authorization to inject under this option 

would be required to install advanced 

wastewater treatment and high-level 

disinfection by 2015. 

EPA proposed to limit the 

applicability of the rule to existing Class 

I municipal disposal wells that have 

caused or may cause fluid movement 

into USDWs in specific counties and 

under certain geologic conditions in 

Florida. The proposed counties were: 

Brevard, Broward, Charlotte, Collier, 

Flagler, Glades, Hendry, Highlands, 

Hillsborough, Indian River, Lee, 

Manatee, Martin, Miami-Dade, Monroe, 

Okeechobee, Orange, Osceola, Palm 

Beach, Pinellas, St. Johns, St. Lucie, 

Sarasota, and Volusia. These counties 

were targeted in the proposal because 

they have the unique geologic 

conditions that are predominated by 

carbonate rocks discussed previously. 

The counties were selected using a map 

adapted from Florida Geological Survey 

map series 94 ‘‘Potential Subsurface 

Zones for Liquid-Waste Storage in 

Florida,’’ created by James A. Miller of 

the United States Geological Survey in 

1979. The proposed geological 

conditions were those where the 

injection and confining zones are both 

in the Floridan Aquifer, and no clastic 

confining unit separates the injection 

zone from the lowermost USDW. See 

United States Geological Survey’s Web 

site for specific information on Florida’s 

geology at http://www.usgs.gov or at 

http://www.dep.state.FL.us/geology/. 

EPA requested comment on a range of 

issues associated with this proposal, 

including the following: (1) Should the 

Agency select Option 1 or 2, or, if it 

would be more appropriate, select a 

combination of both options? (2) What 

is the appropriate level of wastewater 

treatment, if Option 1 were selected? (3) 

What is the need to require pretreatment 

as an additional condition of 

authorization under the rule, and is it 

necessary to extend the pretreatment 

standards presently required by the 

State to injection facilities with less 

than 5 MGD? (4) Are owners and 

operators able to provide the kind of 

hydrogeologic and other information 

necessary for a successful hydrogeologic 

demonstration under Option 2? (5) Is 

there a need for any additional 

monitoring requirements for the final 

rule? (6) Is it appropriate to make the 

rule applicable only to existing wells 

(not new wells) and only to the 

proposed list of counties? (7) Is the 

Florida geology suitable for domestic 

wastewater disposal through Class I 

injection wells? 

Following publication of the proposed 

rule, EPA held a series of public 

meetings during the comment period. 

These meetings provided an 

opportunity for interested parties to 

submit oral comments on the proposal. 

Two public meetings were held on 

August 22, 2000, in Tampa, Florida, and 

an additional two meetings were held 

on August 24, 2000, in West Palm 

Beach, Florida. 

The written comments submitted on 

the proposed rule and the oral 

comments provided during the public 

meetings mirror each other. EPA has 

carefully considered all of these 

comments and has responded to them in 

full in the comment response document 

for the proposal, which is part of the 

record for this final rule. These 

comments are also summarized in 

Section III.A and factored into the 

Agency’s final decisionmaking 

discussed in Section IV of today’s 

preamble. 

F. 2003 Relative Risk Assessment 

As noted previously, following the 

July 7, 2000, proposal, Congress 

included the following provision as part 

of EPA’s fiscal year 2000 appropriations 

bill: ‘‘Within available funds, the 

conferees direct EPA to conduct a 

relative risk assessment of deep well 

injection, ocean disposal, surface 

discharge, and aquifer recharge of 

treated effluent in South Florida, in 

close cooperation with the Florida 

Department of Environmental Protection 

and South Florida municipal water 

utilities.’’ Because this directive came at 

a time when EPA’s work on the July 7, 

2000, proposal was substantially 

complete, the Agency decided to 

proceed with the proposal and the 

relative risk assessment along separate 

but converging paths. EPA initiated and 

conducted the relative risk assessment 

with the intent of using relevant 

findings from the assessment to inform 

the final rulemaking. EPA published the 

Relative Risk Assessment of 

Management Options for Treated 

Wastewater in South Florida (EPA 816–

R–03–010) in April 2003. 

The methodology for the assessment 

involved a process of investigating the 

70518 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

four very different wastewater disposal 

options: deep well injection, aquifer 

recharge, discharge to ocean outfalls, 

and discharge to other (non-ocean) 

surface water bodies. Each option has its 

own specific stressors (hazards), 

exposure pathways, receptors, and 

potential effects. Parameters that are 

relevant to one particular disposal 

option are not necessarily relevant to 

the other three. Therefore, a strictly 

quantitative comparison between the 

four options was not possible. 

Instead, EPA conducted what is 

termed a relative risk assessment to both 

assess the risks associated with each 

disposal method and allow 

comparisons. Individual risk 

assessments were completed for each 

wastewater disposal option and the 

risks associated with each were 

characterized. The risks and risk factors 

identified for each specific disposal 

option were then evaluated and 

described. Overall comparisons and 

conclusions were then presented as 

relative risk assessment matrices. 

The Relative Risk Assessment 

addresses five key questions specifically 

related to deep well injection: (1) What 

level of treatment and disinfection is 

provided for deep well injection? (2) 

What stressors remain (after treatment) 

that may be a concern for deep well 

injection? (3) What exposure pathways 

are (or may be) of significance for deep 

well injection? (4) What is the overall 

estimate of risk for deep well injection? 

(5) What are the important data or 

knowledge gaps for deep well injection? 

The significant findings of the Relative 

Risk Assessment pertaining to deep well 

injection are contained in the report and 

are summarized below. (See the Relative 

Risk Assessment document for details 

on the other disposal options.) 

1. Relative Risk Assessment Question 1: 

What Level of Treatment and 

Disinfection Is Provided for the 

Management Options of Treated 

Wastewater in South Florida? 

All facilities that manage municipal 

wastewater by deep well injection in 

Florida are required by Florida law to 

provide at least secondary treatment of 

the wastewater prior to injection. In 

addition, utilities that employ deep well 

injection must maintain, as a 

contingency, disinfection capability, per 

F.A.C 62–500.540(1), but many do not 

disinfect treated effluent prior to 

injection. For example, treatment of 

wastewater that is injected by Class I 

municipal disposal wells in MiamiDade and Brevard Counties consists of 

secondary treatment with no 

disinfection, although backup 

disinfection capability is required. In 

contrast, in Pinellas County, wastewater 

is treated to more stringent reclaimed 

water standards before being discharged 

into Class I municipal disposal wells, 

because the Class I wells are used to 

dispose of reclaimed water during 

periods of wet weather. Reclaimed 

water standards, as specified by the 

State of Florida, include secondary 

treatment plus a variety of techniques to 

remove microorganisms, including 

filtration and high-level disinfection. 

Filtration before disinfection serves to 

increase the ability of the disinfection 

process to inactivate viruses and other 

pathogens. Filtration also serves as the 

primary means for removing protozoa, 

such as Cryptosporidium and Giardia. 

2. Relative Risk Assessment Question 2: 

What Stressors Remain (After 

Treatment) That May Be a Concern for 

the Management Options of Treated 

Wastewater in South Florida? 

‘‘Stressors’’ include chemical or 

biological agents that may cause adverse 

effects if exposure levels are high 

enough. The Relative Risk Assessment 

describes the human health and 

ecological health stressors that may be 

found in wastewater effluent after it has 

been treated and that may pose a risk. 

In cases where injectate has received 

secondary treatment only, 

microorganisms are generally not 

inactivated prior to deep well injection 

in Florida. When used, disinfection 

serves to inactivate bacteria and viruses, 

especially when the wastewater is 

sufficiently filtered prior to disinfection. 

Protozoan pathogens (e.g., 

Cryptosporidium and Giardia) may still 

be present if the wastewater is not 

filtered. Disinfection (or chlorination) 

byproducts such as trihalomethanes 

may also be present in some wastewater, 

although no data are available to suggest 

that such byproducts are a serious 

concern for deep well injection or any 

of the other wastewater management 

options studied. 

Nutrients (e.g., nitrogen and 

phosphorus) can potentially stimulate 

the production of algae, which can lead 

to adverse side effects such as 

eutrophication, should the stressors 

reach surface water. Nitrogen is the 

primary nutrient of concern for Class I 

injection, because of its mobility in 

ground water. 

3. Relative Risk Assessment Question 3: 

What Exposure Pathways Are (or May 

Be) of Significance for the Management 

Options of Treated Wastewater in South 

Florida? 

An ‘‘exposure pathway’’ is the course 

a stressor takes from a source of release 

to an exposed organism. It is defined by 

the different environmental media 

through which a stressor migrates (e.g., 

air, surface water, ground water) as well 

as the mechanism by which an organism 

is actually exposed (e.g., inhalation, 

drinking, topical contact). 

There are documented impacts to 

USDWs resulting from deep well 

injection in Florida, which raise 

concerns about potential human 

exposures via the drinking water 

pathway. Beginning in the late 1980s, 

ground water monitoring wells at 16 of 

the 42 municipal facilities that utilize 

Class I deep well injection in Florida 

began to detect the movement of fluid 

outside of the permitted injection zones. 

As previously mentioned, movement of 

contamination into USDWs either has 

been confirmed or is suspected at eight 

facilities. 

There is also the potential for 

contaminants released by deep well 

injection to migrate through the 

subsurface and discharge into marine 

and/or surface waters, where they could 

pose risk via other pathways if loadings 

were sufficiently large. However, the 

risk assessment concluded that it is 

unlikely that stressors would migrate 

from the deep injection zone to surface 

water. 

4. Relative Risk Assessment Question 4: 

What Is the Overall Estimate of Risk for 

the Management Options of Treated 

Wastewater in South Florida? 

Although the report does not quantify 

risks, it offers conclusions about the 

relative risks of the four wastewater 

management options studied and about 

the various factors that influence risks 

to human and ecological health. 

What Is the Human Health Risk? 

The human health risks associated 

with deep well injection (as well as the 

other three wastewater management 

options studied in the risk assessment) 

were found to be generally low. 

However, the degree of wastewater 

treatment, and in particular the level of 

disinfection and filtration of pathogenic 

microorganisms, is a major risk driver. 

There is greater potential risk associated 

with wastewater that is not filtered and 

then disinfected to inactivate bacteria 

and viruses, and not filtered to remove 

protozoan pathogens, such as 

Cryptosporidium and Giardia. This 

suggests higher relative risks for deep 

well injection operations that do not 

filter and disinfect wastewater and the 

risk is highest in situations where the 

injectate migrates through fractures, and 

solution cavities. The risk associated 

with microorganisms being released by 

deep well injection would be mitigated 

somewhat in situations where the 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70519 

injection is dominated by porous media 

flow, characterized by long travel times 

to current or potential drinking water 

sources and fine pore spaces capable of 

retaining microorganisms. 

Once microorganisms and other 

stressors are released to the 

environment, the level of risk they pose 

to human health depends largely on 

how likely they are to enter drinking 

water supplies. The Relative Risk 

Assessment suggests that deep well 

injection has a higher risk than the other 

wastewater management options 

because current UIC regulatory 

requirements for pathogen removal/ 

inactivation are less stringent. 

What Are the Ecological Health Risks? 

Overall, the risk to surface water 

ecosystems is low when treated 

wastewater is managed by deep well 

injection. The potential for damage may 

be higher where treated wastewater is 

released in proximity to surface water 

with previously impaired water quality, 

which is the case for many surface water 

bodies in Florida. Deep well injection 

could also pose a risk to marine ecology 

if contaminants can readily migrate and 

discharge to offshore waters. Although 

some uncertainty remains, the potential 

for this actually to happen in Florida 

and pose a real threat in the ocean is 

believed to be unlikely. Two potential 

ecological effects of particular concern, 

should surface or ocean waters be 

sufficiently contaminated, include 

harmful algal blooms and 

bioconcentration of toxic contaminants 

in the food web. Algal blooms can cause 

a variety of toxic symptoms (including 

death) in aquatic organisms as well as 

nontoxic adverse effects such as 

clogging of gills and smothering of coral 

reefs and sea grass beds. Food web 

bioconcentration of metals and other 

contaminants can also cause a variety of 

toxic effects. 

5. Relative Risk Assessment Question 5: 

What Are the Important Data or 

Knowledge Gaps for the Management 

Options of Treated Wastewater in South 

Florida? 

For all four wastewater management 

options that were considered in the 

Relative Risk Assessment, EPA found 

that there is a lack of definitive studies 

in Florida that use a physical or 

chemical tracer or indicator to identify 

the source and transport pathways of 

stressors detected in the environment. 

Without more definitive tracer studies 

for each wastewater management 

option, it is difficult to assess the 

potential effects of local conditions on 

the fate and transport of treated 

wastewater after being released into the 

environment. While results from ground 

water monitoring around some Class I 

municipal disposal wells in Florida 

confirm that fluids have migrated out of 

the permitted injection zone, the full 

areal extent of USDW contamination is 

not known. The unknown degree of 

migration is not only because of limited 

availability of monitoring data, but also 

because the location and connectivity of 

natural conduits for fluid flow (fractures 

and solution cavities in underground 

formations) are difficult to predict. In 

addition, the rates of microbial survival, 

inactivation, and transport are difficult 

to predict. Also uncertain are the rates 

of microbial straining or filtration by 

geological materials under different 

fluid flow scenarios, including porous 

media and conduit flow. The fate and 

transport of pathogens is especially 

difficult to verify for deep well 

injection, even with the most 

sophisticated modeling or with 

expensive monitoring, since the 

receiving formations are thousands of 

feet underground. 

G. May 5, 2003, Notice of Availability 

and Notice of Data Availability 

On May 5, 2003, EPA issued a Notice 

of Availability (NOA) (68 FR 23673) 

announcing the availability of the 

Relative Risk Assessment and a Notice 

of Data Availability (NODA) (68 FR 

23666), requesting public comment on 

how the Relative Risk Assessment 

informs this rulemaking. 

Following publication of the NOA 

and NODA, EPA held a series of public 

meetings on the Relative Risk 

Assessment. These meetings, held 

during the comment period, provided 

an opportunity for interested parties to 

submit oral comments on the Relative 

Risk Assessment. Two public meetings 

were held, one in West Palm Beach, 

Florida on June 24, 2003, and a second 

in Tampa, Florida on June 25, 2003. 

The comments provided at the 

meetings address the same issues as 

those submitted in writing. EPA has 

considered the comments provided in 

the meetings along with the written 

comments submitted during the 

comment period following publication 

of the NODA. The comment response 

document for the NODA, which is part 

of the record for this rule, summarizes 

all of these comments and provides 

EPA’s responses. These comments are 

also summarized in Section III.A and 

factored into the Agency’s final 

decisionmaking discussion in Section 

IV of today’s preamble. 

In the NODA, EPA summarized the 

findings of the Relative Risk 

Assessment, highlighting those that are 

most relevant findings to informing the 

final regulatory action, and requested 

comment on three issues: The 

appropriate level of wastewater 

treatment required for continued deep 

well injection; the feasibility of 

hydrogeological demonstrations for 

showing that injection will not cause 

fluids to enter USDWs; and whether 

some of the Class I municipal disposal 

wells in Florida are actually 

misclassified Class V wells. 

1. NODA Question 1: What Is the 

Appropriate Level of Wastewater 

Treatment Prior to Injection? 

In the NODA, EPA requested 

comment on an alternative option for 

defining the appropriate level of 

wastewater treatment required for 

continued injection in deep municipal 

disposal wells in Florida (instead of the 

four options included in the July 7, 

2000, proposal, as listed in Section II.D 

above). Based on comments received on 

the proposed rule related to wastewater 

treatment, as well as findings from the 

Relative Risk Assessment, the NODA 

solicited comments on prescribing 

wastewater treatment requirements that 

conform with relevant State 

requirements. Under this alternative, the 

Agency would simply adopt, in lieu of 

the standards considered in the 

proposal, the Florida standards in Rule 

62–610.460, F.A.C. (for waste treatment 

and disinfection applicable to reclaimed 

water that may come into contact with 

people) or the standards in Rule 62–

600.540(2), F.A.C. (for ground water 

disposal by underground injection in 

Class V wells) and Rule 62–600.440(5), 

F.A.C. (for design and operational 

criteria for high-level disinfection). 

Specifically, EPA would require 

wastewater treatment that results in 

injected water meeting, at a minimum, 

secondary treatment and high-level 

disinfection as defined in the Florida 

regulations. Also, filtration would be 

required for total suspended solids 

(TSS) control prior to disinfection, 

which would specify that the treated 

wastewater not contain more than 5.0 

mg/l of TSS before the application of the 

disinfectant. As discussed in the NODA, 

EPA believes that this treatment 

standard might offer some important 

advantages over the alternatives 

proposed on July 7, 2000. In particular, 

it might better address the risks 

associated with pathogens and it would 

be consistent with the standards already 

adopted and implemented in Florida for 

reclaimed water and wastewater 

disposed through Class V injection 

wells, which are part of domestic 

wastewater treatment systems. 

In the NODA, EPA asked commenters 

whether this standard for advanced 

70520 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

treatment and high-level disinfection 

should be specified in the final rule. 

EPA also requested that commenters 

describe the type of treatment that 

would be necessary to achieve the 

performance standards (i.e., national 

primary drinking water regulations and 

other health-based standards) and 

provide any information they have on 

the costs of this option. 

2. NODA Question 2: Is It Feasible To 

Predict Movement of Fluids Through 

Hydrogeologic Demonstrations? 

In the NODA, EPA requested 

comment on whether the findings from 

the Relative Risk Assessment regarding 

deep well injection suggest anything 

about the practicability and feasibility of 

the approach outlined under Option 2 

in the July 7, 2000, proposal. As 

summarized above, Option 2 would 

allow owners and operators to conduct 

hydrogeologic demonstrations to show 

that injection will not cause fluids that 

exceed any national primary drinking 

water regulations or other health-based 

standards to enter any USDW. 

Based on the added findings in the 

Relative Risk Assessment regarding the 

Florida geology, EPA posed several 

questions in the NODA related to the 

uncertainties of hydrogeologic 

demonstrations that would be required 

under Option 2. In particular, EPA 

asked whether facilities should be 

granted the opportunity to conduct the 

demonstrations; how the UIC Program 

Director should address anticipated 

technical difficulties in his/her review 

of a demonstration; and how a 

satisfactory hydrogeological 

demonstration would be conducted. 

3. NODA Question 3: Have Some Deep 

Wells Been Misclassified as Class I, 

When They Are Actually Class V? 

Given the extent of fluid movement 

documented at some sites, as well as 

information concerning the geology and 

the construction of some municipal 

disposal wells in Florida, it is possible 

that some wells may have been 

misclassified as Class I, when they are 

actually Class V. According to the 

Federal UIC regulations, Class I wells 

‘‘inject fluids beneath the lowermost 

formation containing, within one 

quarter mile of the well bore, an 

underground source of drinking water’’

(40 CFR 144.6(a)(2)). Class V wells are 

defined as wells that are not included in 

Class I, II, III, or IV. Typically, Class V 

wells release nonhazardous fluids into 

or above formations containing USDWs. 

Separate from the issue of how Class 

I and Class V wells are defined, the 

Federal Class I and Class V UIC 

programs differ in their basic approach 

to protecting USDWs. As previously 

described in Section II.B, the basic 

standard of protection in the Class I 

program is to ensure that there is no 

movement of any contaminant into 

USDWs. This standard is achieved 

through a Class I regulatory program 

that focuses on the development and 

enforcement of stringent permit 

requirements, including, but not limited 

to, criteria for well siting, construction, 

and operation and maintenance. A key 

component of the Class I program is 

ensuring that adequate confinement 

exists between the permitted injection 

zone and USDWs at a given site. 

Since most Class V wells release 

fluids either directly into or above 

USDWs, they by definition cause the 

movement of fluid, which may contain 

contaminants, into or above USDWs. 

Therefore, the basic standard of 

protection in the Class V program is to 

prevent any contaminants in the fluid 

from endangering USDWs. Protection 

efforts in the Class V program mainly 

focus on regulating and monitoring 

injectate quality to ensure that the 

movement of injected fluid will not 

contain any contaminants that may 

endanger USDWs. This standard is 

achieved through inventory and 

assessment requirements, additional 

reporting requirements, closure 

requirements, and other requirements 

(possibly including permitting 

requirements) believed by UIC Program 

staff to be necessary to protect drinking 

water supplies. 

Information collected for the Relative 

Risk Assessment raises a question as to 

whether certain Florida municipal 

disposal wells should have been 

classified as Class V at the time they 

were first permitted. In particular, all of 

the lithologic units of the upper 

Floridan Aquifer in Pinellas County and 

the lower Floridan Aquifer in MiamiDade consist of limestone and dolomite 

that have shown evidence of solution 

cavities and fractures. These natural 

conduits for fluid flow raise a question 

as to whether lithologic units in these 

aquifers are effective confining layers 

and whether the injection zones and 

overlying USDWs are in different and 

distinct formations, as they were 

believed to be when the wells were 

originally sited, constructed, and 

permitted as Class I wells. 

Based on this information, the NODA 

requested comment on whether the 

findings from the Relative Risk 

Assessment suggest that some Florida 

wells may have been misclassified as 

Class I wells. EPA also asked whether 

the findings suggest that some wells in 

Florida may, in fact, discharge directly 

to (and not below) formations 

containing a USDW, and if the findings 

suggest that this misclassification 

should be accepted for the entire group 

of Florida municipal disposal wells, or 

only a subset. 

III. Summary of Public Comments 

A. Comments on the July 7, 2000, 

Proposed Rule 

EPA received 1,181 comments in 

response to the proposed rule. The 

following sections summarize the more 

significant public comments on the 

seven main issues raised in the 

proposal. These comments are 

addressed in more detail in the 

comment response document available 

for review in the Florida UIC docket as 

well as in Section IV of today’s 

preamble. 

1. Selection of Option 1, Option 2, or a 

Combination of Both 

In the proposal, EPA solicited 

comment on whether to select Option 1 

(advanced wastewater treatment (AWT) 

with a non-endangerment 

demonstration), Option 2 (in-depth 

hydrogeologic demonstration and 

advanced treatment, as necessary), or a 

combination of both options. 

Commenters who favor Option 1 

explained that, although initially more 

costly, this option offers the advantage 

of allowing identification and avoidance 

of potential drinking water 

contamination, which would be more 

cost-effective than ground water 

remediation. One commenter offered 

that Option 1 should be required only 

if needed to meet the non-endangerment 

requirement. A commenter opposed to 

Option 1 said that even with AWT, the 

proposed requirements may not prevent 

violations of drinking water standards 

in USDWs. 

Those commenters favoring Option 2 

argued that it would be burdensome to 

require utilities to employ AWT 

immediately. They therefore suggested 

that AWT either should not be required 

at all or should be phased-in. One 

commenter opposing Option 2 said that 

facilities already perform analyses to 

demonstrate compliance, and 

geochemical modeling should be 

required only where actual data are not 

available. Another commenter opposing 

Option 2 said that it is unclear what 

geochemical modeling would 

accomplish. 

2. Appropriate Level of Wastewater 

Treatment 

In the proposed rule, EPA requested 

comment on which treatment 

alternative to specify in the final rule, if 

Option 1 were selected. Comments were 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70521 

solicited on the appropriate level of 

BOD treatment and the need for 

disinfection and nutrient removal. 

Commenters who favored higher 

levels of BOD treatment (to less than 10 

mg/l) asserted that these standards 

would protect the environment and can 

be met with available cost-effective 

technologies. Commenters opposed to 

requiring BOD treatment said that it is 

not possible to meet the disinfection 

requirement with BOD levels of 10 to 24 

mg/l, or that there is no technical basis 

for requiring those levels, since the 

treated wastewater is being discharged 

to an anaerobic environment without 

plant life. 

Commenters who supported nutrient 

removal requirements said that such 

treatment would have environmental 

benefits, including protecting wetlands 

and endangered species. Commenters 

who opposed nutrient removal 

explained that it could adversely impact 

water reuse programs. These 

commenters also opposed setting 

phosphorus limitations, saying that 

there are no human health benefits 

associated with phosphorus removal. 

Commenters who favored requiring 

AWT said that injected fluids can move 

into surficial aquifers or near shore 

surface waters, and AWT is thus needed 

to protect aquatic species. Commenters 

opposed to requiring AWT asserted that 

imposing health-based standards as 

discharge requirements is inconsistent 

with the SDWA and not supported by 

scientific data. These commenters 

added that injection provides effective 

source separation that has protected 

water supplies for many years and that 

requiring AWT would jeopardize the 

viability of this practice going forward. 

Other commenters thought that AWT is 

insufficient to prevent endangerment of 

USDWs. These commenters expressed 

concern that the proposal does not 

adequately protect USDWs from many 

of the substances that may be found in 

municipal wastewater. 

3. Need for Pretreatment 

EPA solicited public comment on the 

need for pretreatment as an additional 

condition of the authorization to inject, 

and on whether to extend the 

pretreatment requirements presently 

required by the State of Florida to 

injection facilities with flows of less 

than 5 MGD. 

Commenters advocating pretreatment 

requirements suggested that requiring 

industrial users to pretreat their 

wastewater would reduce the chance of 

contaminating USDWs and reduce the 

costs to municipal treatment works. 

Several commenters advocated 

extending pretreatment requirements to 

facilities with flows of less than 5 MGD. 

Commenters opposed to the 

pretreatment requirements cited 

concerns about the ineffectiveness of 

pretreatment programs to prevent fluid 

movement or protect public health. 

4. Feasibility of Hydrogeologic 

Demonstrations To Predict Movement of 

Fluids 

EPA solicited comment on the ability 

of injection well owners and operators 

to provide the kind of hydrogeologic 

and other information necessary for a 

successful hydrogeologic demonstration 

that their injectate will not cause a 

USDW to exceed any primary drinking 

water regulations or other health-based 

standards. 

Commenters opposed to the proposed 

hydrogeologic demonstrations asserted 

that they could not accurately reflect 

flow responses after prolonged 

injection, and that EPA should not rely 

on them to protect USDWs. These 

commenters cited limitations in 

available knowledge of the subsurface 

geology of Florida and the fate of 

contaminants. 

5. Monitoring Requirements 

EPA requested comments on the 

proposed monitoring requirements 

(which would include, at a minimum, 

effluent monitoring and an analysis of 

any such contaminants following 

injection), and asked whether any 

additional monitoring requirements 

should be included in the final rule. 

Some commenters challenged the 

proposed monitoring requirements, 

claiming that they are not adequate to 

prevent endangerment of ground water 

quality. Two commenters suggested a 

need to monitor for pathogens, viruses, 

and pharmaceuticals. Several 

commenters requested an increased 

monitoring frequency, believing that 

annual monitoring is insufficient to 

characterize the injected fluids. 

Many commenters requested that EPA 

clarify certain aspects of the proposed 

monitoring requirements, including 

what is meant by ‘‘other health-based 

standards.’’

6. Rule Applicability 

EPA requested comment on whether 

the rule should apply to existing wells 

only or also to new wells. Some 

commenters suggested that the rule 

apply to new and existing wells, as well 

as to replacement wells, and 

recommended that the rule apply in all 

counties where fluid migration could or 

does occur. Those commenters who 

opposed applying the rule to facilities 

that have not shown movement of fluid 

to USDWs expressed concern that such 

an approach would limit the future 

application of injection as a disposal 

technology. 

In the proposal, EPA also requested 

comment on whether any additional (or 

fewer) counties in Florida should be 

included within the scope of the rule. 

No comments requesting the addition or 

removal of any counties were received. 

7. Suitability of Florida Geology for 

Domestic Wastewater Disposal Through 

Class I Wells 

Commenters provided information 

and background on the geology of 

Florida, fluid migration, and the 

appropriateness of wastewater injection 

in Florida. 

Some commenters expressed concern 

about injection operations 

contaminating drinking water aquifers 

with a virus or pathogen, citing 

evidence that effluent is leaking into the 

Floridan Aquifer that is 

hydrogeologically connected to the 

Biscayne Aquifer, the sole source of 

Miami-Dade’s drinking water. These 

commenters said that there are many 

unknowns about the geology of Florida 

and that the behavior of injected fluids 

cannot be accurately predicted. 

Other commenters asserted that 

injection is a safe practice that has been 

taking place in Florida for decades 

without any documented adverse 

impacts to USDWs. They indicated that 

the injected fluid is ‘‘freshening’’ the 

highly saline receiving waters, and that 

the availability of injection as a disposal 

alternative has resulted in significant 

improvements to surface water quality 

in Florida. Some commenters added 

that, in the proposal, EPA did not 

adequately characterize the subsurface 

geology in Florida. Some commenters 

recognized that fluid movement is 

occurring, but support a rule that allows 

fluid movement if it is accompanied by 

a non-endangerment policy. These 

commenters added that a strict no 

movement policy would eliminate all 

injection and supply wells in the region. 

B. Comments on the Notice of Data 

Availability and the Relative Risk 

Assessment 

EPA received 203 comments in 

response to the NODA and its summary 

of the Relative Risk Assessment. The 

paragraphs below summarize the more 

significant comments on the three main 

issues raised in the NODA. The 

complete comment response document 

available for review in the Florida UIC 

docket addresses these comments in 

more detail. 

70522 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

1. Appropriate Level of Wastewater 

Treatment Prior to Injection 

In the NODA, EPA asked for comment 

regarding the level to which wastewater 

should be treated before it is injected 

into deep wells that have caused or may 

cause fluid movement into a USDW. 

Some commenters advocated requiring 

treatment to drinking water standards 

before injection, citing concerns about 

pathogens migrating to aquifers and the 

inability of modeling to identify all 

pathways by which contamination 

could occur. Some commenters also 

expressed concern about the potential 

migration of viruses, pathogenic 

bacteria, and protozoa. They asserted 

that data show that injected fluids are 

migrating and, without disinfection, 

pathogens may survive, especially 

where the travel times to USDWs are 

short. 

Some commenters advocated 

requiring denitrification as well. 

Commenters opposed to requiring 

advanced wastewater treatment said 

that current treatment requirements are 

adequate, and that the cost of requiring 

AWT all the time would be excessive. 

Some commenters cautioned against a 

‘‘one-size-fits-all’’ approach, and 

suggested including case-by-case 

treatment requirements in permits. They 

added that, at most facilities, drinking 

water standards are already met within 

the aquifer and that, given the salinity 

of the injection zone, any water from the 

USDW would require reverse osmosis 

treatment before it is usable for 

drinking. 

EPA also asked commenters whether 

treatment consistent with corresponding 

Florida requirements (i.e., treatment that 

meets the State’s secondary treatment 

and high-level disinfection standards) is 

appropriate. Some commenters 

advocated requiring AWT in accordance 

with Florida’s standards. Other 

commenters said that Florida sets 

differing standards based on the quality 

of the receiving waters, and that simply 

adopting the Florida standard would not 

resolve the issue where fluid migration 

is occurring. 

2. Feasibility of Hydrogeologic 

Demonstrations To Predict Movement of 

Fluids 

As previously described in Section 

II.F.2, the NODA requested comment on 

the practicality and feasibility of 

allowing facilities to conduct 

hydrogeologic demonstrations, given the 

inherent difficulties and uncertainties 

regarding the extent, location, and 

connectivity of possible natural 

conduits for flow identified in the 

Relative Risk Assessment. 

Commenters who advocated the use 

of hydrogeological demonstrations said 

that such demonstrations would provide 

utilities needed flexibility, given the 

hydrogeologic variability in Florida. 

They added that this approach would be 

in line with the intent of Congress and 

the SDWA. These commenters added 

that monitoring shows that 

contaminants are not moving into 

USDWs, and that the critical point to 

consider is whether the USDW is 

endangered (rather than just that fluids 

are moving into USDWs). 

Commenters who opposed allowing 

facilities to conduct hydrogeologic 

demonstrations said that monitoring 

programs cannot adequately 

characterize fluid movement in the 

subsurface, especially given the faulted 

and fractured geology of Florida. 

Other commenters agreed that 

hydrogeological demonstrations should 

be conducted to understand the geology 

of the injection zone, but said that 

treatment should be required as well. 

3. Class I or Class V 

EPA solicited comment on ways to 

address the fluid movement that has 

occurred, while preventing the 

endangerment of USDWs. Specifically, 

EPA asked for comment on whether 

wells with fluid movement should be 

reclassified as Class V wells, or whether 

Class I or Class V requirements specific 

to Florida should be promulgated. 

Commenters who advocated 

reclassifying the wells as Class V said 

that the injection and confining layers 

are sufficiently similar to be considered 

a single formation. These commenters 

were against ‘‘blanket’’ reclassification 

of the wells, however, saying that each 

well should be considered individually. 

Other commenters, who were against 

reclassifying the wells as Class V, cited 

concerns that doing so would lead to 

greater reliance on injection as a 

wastewater disposal method. They 

asserted that some injected fluid is 

migrating to and impacting coral reefs, 

the wells are in violation of SDWA 

requirements, and the level of treatment 

specified will not protect USDWs. These 

commenters expressed doubt whether, 

given the existence of natural conduits 

connecting subsurface layers, the upper 

layer is sufficiently confining injected 

wastewater. They added that two 

subsurface layers sharing certain 

characteristics do not constitute a single 

formation. 

IV. Explanation of Today’s Action 

This section describes today’s action. 

It also discusses how EPA considered 

information in the Relative Risk 

Assessment and the NODA, as well as 

public comments received on each of 

these documents. 

A. Objectives and Approach 

Under Section 1421 of the Act, UIC 

regulations must prevent underground 

injection that endangers drinking water 

sources. While EPA met this statutory 

requirement in the past by prohibiting 

fluid movement, the Act authorizes 

other approaches as well, such as the 

approach used in today’s rule, which 

requires treatment of wastewater prior 

to injection. The overriding objective of 

today’s action is to ensure the protection 

of USDWs, which is the chief goal of the 

Federal UIC Program. In so doing, it is 

important that the rule: (1) Not undercut 

or unnecessarily burden the Florida UIC 

Program as it pertains to Class I 

municipal disposal wells; and (2) not 

transfer potential problems to other 

programs or increase concerns 

associated with the management of 

treated municipal wastewater by other 

practices, including aquifer recharge, 

surface water discharge, and ocean 

disposal. 

In order to meet this last objective, 

EPA has concluded that it is important 

to maintain underground injection as a 

viable alternative for managing treated 

municipal wastewater in Florida. There 

are eight instances of known or 

suspected contamination of USDWs 

caused by Class I municipal disposal 

wells, but the Relative Risk Assessment 

has shown that the overall risks 

associated with such underground 

injection are low. The factors on which 

this determination of ‘‘low risk’’ was 

based include: The quality of the treated 

wastewater and the contaminants that 

are found in wastewater; the reduction 

in certain contaminants provided by 

secondary and, for some facilities, 

advanced treatment; the estimated time 

of travel for wastewater to move 

vertically to USDWs; and the 

anticipated reduction in contaminant 

concentration that occurs in the deep 

underground environment. 

In comparison, the other wastewater 

management options EPA assessed in 

the Relative Risk Assessment do not 

offer clear environmental advantages 

and are more expensive than 

underground injection. The Relative 

Risk Assessment found that the other 

wastewater management options each 

pose specific (yet low) risks to human 

health and the environment that do not 

necessarily make them preferable to 

underground injection. For example, 

disposal of secondary treated 

wastewater into surface water or the 

ocean, rather than deep injection, 

carries nutrients that feed algae blooms 

that, in turn, can deplete the oxygen 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70523 

necessary for plant life. Fish need plants 

for food to live. To limit these nutrients 

in critical surface water areas (such as 

Tampa Bay), municipalities are required 

to provide advanced wastewater 

treatment with nutrient removal, which 

is more expensive than underground 

injection, even when the effluent is 

treated by high-level disinfection. It is 

also important to note that, while ocean 

outfalls have not been prohibited by 

Florida statute or regulation, no new 

outfalls have been approved and 

constructed for more than 15 years. 

Therefore, it is questionable whether 

additional ocean disposal would even 

be an option, if injection were no longer 

allowed. 

In order to continue to allow 

underground injection, the question 

becomes how to allow it and, at the 

same time, ensure the protection of 

USDWs. There are two basic approaches 

within the UIC Program for doing this. 

The first approach, which is currently 

employed for all Class I, II, and III wells, 

is to ensure that injected fluids are 

confined and isolated from USDWs. 

This approach is based on the premise 

that the quality of the injected fluids is 

poor and the movement of such fluids 

into a USDW is likely to endanger its 

use. To implement this approach, the 

standard of protection for Class I, II, and 

III wells is to prevent any movement of 

fluid into a USDW, as summarized in 

Section II.B of this preamble. 

In the absence of today’s rule, the 

requirement for no fluid movement 

would remain the basic approach for 

regulating Class I municipal disposal 

wells and be the requirement that 

owner/operators would have to meet in 

order to remain in operation. Enforcing 

this approach would, in effect, require 

these wells to shut down, because 

isolation from USDWs cannot be 

ensured due to the Florida geology and 

available monitoring data at some sites 

as described above. Shutting down the 

injection wells would in turn force the 

municipal wastewater to be managed by 

other means, which would not provide 

any net environmental benefits, would 

increase the risks to surface water and 

coastal ecosystems, and would increase 

treatment and other costs to owners and 

operators of domestic wastewater 

treatment facilities. The Relative Risk 

Assessment found that the other 

wastewater management options, 

including underground injection, pose a 

low risk to human health and the 

environment. Shutting down the wells 

would result in a different, but not 

necessarily better, alternative. All of 

this, in EPA’s view, provides a 

compelling argument for an alternate 

approach. 

The alternate approach, which is used 

when adequate confinement between 

the permitted injection zone and 

USDWs cannot be assured, is the 

rigorous control of the quality of the 

injected fluids. Under this approach, 

movement of fluids into USDWs is 

known or suspected, but that movement 

should not endanger the USDWs 

because the quality of the injectate is 

not a concern. This is the basic 

approach employed by EPA and the 

States for Class V wells, most of which 

release fluids into or above USDWs. 

Today’s rule adopts a similar approach 

that relies on an appropriate level of 

wastewater treatment prior to injection 

in order to assure the protection of 

USDWs. While changing to this 

approach does represent a shift in the 

form of the controls employed for 

certain Class I municipal disposal wells 

in certain parts of Florida, it is not 

undercutting protection of USDWs, 

weakening the UIC Program 

requirements, or introducing a new 

standard. To the contrary, it is simply 

taking a standard approach long used in 

the UIC Program and applying it to this 

narrow category of Class I wells as a 

way to prevent endangerment where the 

existing regulations do not offer any 

flexibility. 

Today’s rule, therefore, provides a 

regulatory alternative to owners and 

operators of Class I municipal disposal 

wells in specific areas of Florida that 

have caused or may cause unauthorized 

movement of fluid into a USDW. 

Because operation of such wells is 

prohibited by existing Federal UIC 

regulations, the new rule offers owners 

and operators the ability to continue to 

operate their wells, provided they meet 

requirements to protect USDWs by 

treating their waste according to these 

requirements. 

B. Operating Requirements 

Today’s rule provides owners and 

operators of Class I municipal disposal 

wells in certain counties of Florida 

whose injection has caused or may 

cause the movement of fluids into a 

USDW the option to (1) develop and 

implement a pretreatment program that 

is no less stringent than the 

requirements of Chapter 62–625, F.A.C. 

or demonstrates that they have no 

significant industrial users as defined in 

Chapter 62–625, F.A.C., and (2) treat the 

injected wastewater using secondary 

treatment in a manner that is no less 

stringent than the requirements of 

Florida Rule 62–600.420(1)(d), and use 

high-level disinfection in a manner that 

is no less stringent than the 

requirements of Florida Rule 62–

600.440(5)(a)–(f). To continue injecting, 

owners and operators of facilities that 

have caused or may cause fluid 

movement into a USDW will have five 

years from the effective date of this rule 

to install the required treatment; these 

owners and operators have already been 

notified by the UIC Program Director 

that their injection wells have caused or 

may cause fluid movement into USDWs. 

If, at a later time, the Director 

determines that other Class I municipal 

disposal wells in the targeted areas of 

Florida have caused or may cause 

movement of fluids into USDWs, 

owners and operators of those wells will 

be so notified by the Director and will 

have five years from the date of that 

notification to install high-level 

disinfection. See new 40 CFR 

146.15(d)(2). During the time between 

such notification and the time highlevel disinfection becomes operational 

at these facilities, the Director has the 

authority to require additional operating 

requirements on a site-specific basis in 

order to protect USDWs. 

These new provisions comprise 

Option 1 from the July 7, 2000, 

proposed rule as refined by the 

alternative treatment standard proposed 

in the May 5, 2003, NODA. Option 1 of 

the proposed rule proposed additional 

treatment, beyond secondary treatment, 

in the form of four suboptions. All four 

suboptions proposed high-level 

disinfection with advanced treatment as 

defined by two levels of BOD reduction 

with and without nutrient removal. The 

alternative treatment level in the NODA, 

like all of the suboptions in the 

proposed rule, also called for high-level 

disinfection. However, the alternative 

treatment level in the NODA called for 

high-level disinfection as it is currently 

prescribed by the State, which includes 

a reduction in TSS levels to 5 ppm. This 

TSS level is substantially equivalent to 

the two suboptions in the proposed rule 

that called for high-level disinfection 

and advanced treatment defined by 

reduction in BOD to less than 10 ppm. 

In selecting this option for high-level 

disinfection, as first prescribed in 

Option 1 of the proposed rule and 

refined in the NODA, EPA agrees with 

commenters who recommended that 

EPA require additional or enhanced 

treatment because of concerns for 

insufficient confinement, as well as 

uncertainties regarding the areal extent 

of movement of injected wastewater in 

the subsurface. The selected approach, 

therefore, requires an additional or 

enhanced level of treatment that will 

provide an effluent quality that would 

not endanger USDWs. As discussed in 

the preceding section of this preamble, 

an approach that focuses on effluent 

70524 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

quality is a standard approach used in 

the Federal UIC program when adequate 

confinement cannot be assured. 

The final operating requirements, 

however, do not call for the nonendangerment demonstration that was 

included within Option 1 of the July 7, 

2000, proposal. As envisioned in the 

proposal, this non-endangerment 

demonstration would have focused on 

any contaminants that still exceed 

national drinking water regulations or 

other health-based standards after 

advanced wastewater treatment. 

However, the proposal did not 

rigorously define the level of advanced 

treatment that would be required, 

instead the proposal states that 

‘‘advanced treatment is any level of 

treatment in excess of secondary 

treatment’’ (65 FR 42239, July 7, 2000). 

At the same time, the four alternative 

treatment standards proposed as part of 

Option 1 provided numerical criteria for 

BOD removal, but did not provide any 

criteria or other specific details to define 

the required level of ‘‘disinfection.’’ By 

adopting the definition of ‘‘high-level 

disinfection’’ from the Florida 

regulations, today’s final rule imposes a 

specific and widely accepted standard 

for ensuring the removal of 

microorganisms, which the Relative 

Risk Assessment (completed after the 

proposal) now shows are the primary 

contaminants of concern. As a result, 

EPA does not believe that the final rule 

needs to require a non-endangerment 

demonstration focusing on 

contaminants after treatment. EPA is 

confident that the problem will be 

adequately solved by the treatment 

itself. Instead, the Florida UIC Program 

Director is left with the flexibility that 

he or she currently has to require such 

a demonstration, or any other measure 

deemed necessary, to protect USDWs on 

a case-by-case basis. 

The following subsections provide 

additional discussion of two key aspects 

of these final operating requirements. 

The first discusses the selected 

requirement for pretreatment, secondary 

treatment, and high-level disinfection, 

including the rationale for adopting the 

Florida standard; the rationale for not 

requiring the removal of BOD, nutrients, 

or other contaminants besides 

microorganisms; and the rationale for 

phasing in the new treatment over time. 

The second subsection elaborates on 

EPA’s rationale for not adopting the 

hydrogeologic demonstration approach 

discussed in the proposal and NODA. 

1. Selected Approach 

The following sections outline EPA’s 

rationale for the specific requirements 

in today’s rule, including requiring 

pretreatment, secondary treatment, and 

high-level disinfection, as well as the 

rationale for not requiring the removal 

of other contaminants and why the new 

treatment will be phased in over time. 

a. Rationale for Requiring 

Pretreatment of Wastewater. Today’s 

rule includes requirements for owners 

and operators of facilities that wish to 

be covered by the alternative 

endangerment standard to comply with 

existing pretreatment requirements for 

those facilities. EPA found that almost 

all (14 of the 16) facilities that have 

caused or may cause fluid movement 

into a USDW already have pretreatment 

programs in place, and the remaining 

two facilities have conducted surveys 

indicating that they are not handling 

waste streams from significant 

industrial users. EPA believes that 

existing pretreatment programs at the 

affected facilities are adequate and 

necessary to ensure that a variety of 

contaminants that might appear in 

wastewater do not endanger USDWs. 

EPA agrees with commenters who 

suggested that requiring industrial users 

to pretreat their wastewater would 

reduce the chance of contaminating 

USDWs and reduce the costs to 

municipal treatment works. EPA also 

agrees with several commenters who 

advocated extending pretreatment 

requirements to facilities with flows of 

less than 5 MGD. EPA disagrees with 

commenters who opposed the 

pretreatment requirements, and who 

cited concerns about the ineffectiveness 

of pretreatment programs to prevent 

fluid movement or protect public 

health. EPA believes that it is important 

for significant industrial users to 

pretreat their wastewater to remove 

those contaminants that would not be 

consistently removed by a municipal 

wastewater treatment facility before 

they are injected. 

Therefore, today’s rule requires that 

owners and operators develop and 

implement a pretreatment program that 

is no less stringent than the State’s 

requirements in Florida Rule 62–625, 

unless they have no significant 

industrial users as defined in that 

chapter, if they wish to avail themselves 

of the alternative endangerment 

standard. The State developed these 

pretreatment requirements to ensure 

that contaminants are prevented from 

endangering the public. EPA is adopting 

pretreatment provisions consistent with 

those requirements under the authority 

of the SDWA to prevent contaminants 

from endangering USDWs. 

b. Rationale for Requiring Secondary 

Treatment of Wastewater. Florida 

currently requires Class I municipal 

wastewater facilities to apply secondary 

treatment prior to injection, and this 

requirement will stay in place regardless 

of the addition of the high-level 

disinfection requirement. Applying 

secondary treatment, which requires 

BOD reduction to 25 ppm and TSS 

reduction to 30 ppm, is necessary for 

high-level disinfection to work. Without 

significant reduction in suspended 

solids that is first achieved by secondary 

treatment and is further addressed by 

filtration, the standards for compliance 

with the high-level disinfection 

standard of 5 ppm of total suspended 

solids in this rule could not be 

achieved. 

EPA’s July 2000 proposed rule 

assumed that domestic wastewater 

effluent injected into Class I municipal 

disposal wells would have been subject 

to secondary treatment. See new 40 CFR 

146.15(c)(3). Although some 

commenters expressed opposition to the 

options for advanced treatment 

proposed, no commenters expressed 

opposition to secondary treatment. 

Since the State already requires 

secondary treatment, and all Class I 

municipal well facilities provide 

secondary treatment, no facilities would 

need to upgrade their plants to meet this 

requirement. 

c. Rationale for Using the Florida 

Definition of High-Level Disinfection. 

The record supporting this rule—

including available monitoring data, the 

Relative Risk Assessment, and public 

comments—provides compelling 

evidence that additional wastewater 

treatment to remove pathogenic 

microorganisms is needed to ensure that 

continued Class I municipal disposal in 

certain parts of Florida does not 

endanger USDWs. EPA agrees with 

concerns expressed by many 

commenters that the quality of 

secondary-treated wastewater poses a 

threat to USDWs in certain parts of 

Florida in light of information that 

injected fluid at some sites is not being 

confined to the injection zone. In 

particular, pathogens may remain in 

wastewater following secondary 

treatment and can threaten USDWs if 

injected in certain parts of Florida. As 

found in the Relative Risk Assessment, 

the degree to which pathogenic 

microorganisms are removed by 

wastewater treatment is the main factor 

determining the risk associated with 

injection. 

The Relative Risk Assessment 

identified pathogens as being of concern 

not only because of their high 

concentration in secondary-treated 

wastewater, but also because of 

uncertainties associated with fluid 

movement and their fate within the 

subsurface of certain parts of Florida. 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70525 

EPA acknowledges, as noted by some 

commenters, that there will be some 

level of pathogen die-off in the deep 

subsurface and that a shallow confining 

system may serve as a barrier to the 

movement of contamination in some 

locations. However, EPA believes that 

there is incomplete information about 

the movement and fate of pathogens in 

the subsurface. This lack of information 

prevents EPA from concluding that 

pathogen die-off is sufficient to protect 

USDWs in the areas of Florida targeted 

by today’s rule. 

Based on these concerns, EPA has 

determined that owners and operators of 

Class I municipal disposal wells in 

specific areas of Florida must provide 

high-level disinfection if their injection 

has caused or may cause fluid 

movement into a USDW. EPA has 

decided to adopt Florida’s definition of 

high-level disinfection in today’s rule 

because it effectively addresses the risk 

of pathogens better than any of the other 

proposed alternatives. It also offers the 

important advantage of being consistent 

with the standards already adopted and 

implemented in Florida, thereby 

eliminating any confusion or disruption 

to existing programs. 

The specific definition of high-level 

disinfection, as detailed in Florida Rule 

62–600.440(5)(a)–(f), includes 

requirements to: (1) Reduce total 

suspended solids to 5.0 mg/l or less 

before the application of the disinfectant 

to maximize disinfection effectiveness 

which, (2) result in an effluent with 

fecal coliform values that are below 

detectable levels in 75 percent of the 

samples, and that are never above 25 

organisms per 100 ml in any one 

sample; and (3) where chlorine is used 

for disinfection, assure rapid and 

uniform mixing with a minimum dose 

of 1 mg/l of free chlorine for a minimum 

contact time of 15 minutes. EPA is 

confident that requiring high-level 

disinfection, defined in this way (no 

less stringent than Florida Rule 62–

600.440(5)(a)–(f)), will satisfactorily 

address the risk associated with 

microbial pathogens released by Class I 

injection wells in the targeted areas of 

Florida. Viruses and bacteria will be 

inactivated through high-level 

disinfection, the effectiveness of which 

is ensured by operational criteria (i.e., 

fecal coliform limits) and the 

requirement to filter the wastewater 

beforehand. Filtration is also the 

accepted method for the removal of 

protozoa (e.g., Cryptosporidium and 

Giardia). 

The State of Florida found, after 

significant public comment and 

evaluation by the State Department of 

Health, that high-level disinfection thus 

defined will significantly address 

pathogens and reduce the chance of 

waterborne disease. For this reason, the 

State allows wastewater that has been 

treated by high-level disinfection to be 

reclaimed for reuse purposes where the 

public has access, such as watering 

lawns and golf courses. In addition, 

Florida requires domestic wastewater 

systems to use high-level disinfection 

when they discharge effluent above or 

directly into USDWs using Class V wells 

or when they discharge to certain 

surface waters, such as Tampa Bay. It is 

important to note, however, that these 

standards for high-level disinfection are 

not equivalent to the standards that 

apply to drinking water. Florida 

requires that valves and outlets that use 

reclaimed water be painted purple and 

labeled with ‘‘Do Not Drink’’ warning 

signs. Reclaimed water and water 

injected into Class I wells that meet the 

standards of today’s rule will have the 

same water quality resulting from 

pretreatment, secondary treatment, 

filtration and high-level disinfection to 

ensure that they will not endanger 

USDWs. 

In contrast to the standards for highlevel disinfection, Florida also has 

standards for basic disinfection and 

intermediate disinfection, which EPA 

believes are not appropriate for today’s 

rule. The State requires basic 

disinfection for certain surface water 

discharge and offshore ocean disposal, 

or for reclaimed wastewater used for 

other purposes where the public will 

not be exposed, such as cooling water 

use. Basic disinfection does not limit 

the quantity of TSS in the effluent and 

requires half the chlorine dose of highlevel disinfection. Facilities that provide 

basic disinfection must be designed to 

result in a fecal coliform value of not 

more than 200 organisms per 100 ml. 

Facilities that use intermediate 

disinfection must be designed for rapid 

and uniform mixing of chlorine with a 

minimum dose of 1 mg/l free of chlorine 

for a minimum contact time of 15 

minutes, as with high-level disinfection. 

However, no TSS limitations are set, so 

the facilities avoid the expense of 

filtration. Facilities that provide 

intermediate disinfection must be 

designed to result in not more than 14 

fecal coliform values per 100 ml. In 

contrast, high-level disinfection 

treatment facilities are designed to 

result in zero fecal coliform values per 

100 ml. Intermediate disinfection is 

used in a few ‘‘middle-ground’’

instances where public access is 

restricted but could possibly occur; 

high-level disinfection is required 

where there is public access; and basic 

disinfection is allowed where public 

access is clearly restricted. One such 

instance is discharge to wetlands where 

public access is restricted. 

EPA is adopting the State’s standard 

for high-level disinfection rather than 

basic or intermediate disinfection 

because high-level disinfection is more 

appropriate for effluent injected into 

wells that have caused or may cause 

fluid movement into a USDW. Such a 

standard applied to effluent that moves 

into a USDW from below is consistent 

with standards the State applies to 

effluent that is released into or above 

USDWs by Class V wells. Florida’s 

definitions and standards for basic 

disinfection and intermediate 

disinfection were established by the 

State to apply to situations where 

wastewater would be isolated and not 

come in contact with humans. The State 

anticipated the possibility that humans 

could inadvertently come into contact 

with water that has achieved high-level 

disinfection despite warnings. The 

reclaimed wastewater is not intended 

for regular ingestion by the population 

and thus does not require that level of 

advanced treatment needed to meet 

drinking water standards prior to 

discharge. EPA believes that the 

injection scenario is similar to use of 

reclaimed water in that, because of the 

depths at which wastewater is injected, 

the possibility of inadvertent human 

ingestion prior to additional treatment is 

remote. 

However, the lack of control over the 

movement of fluids into USDWs in 

certain parts of Florida and the 

uncertainties about the location, 

concentration, and survivability of 

waterborne pathogens injected in those 

areas call for the degree of disinfection 

and filtration that is defined by highlevel disinfection. As noted above, 

without the filtration that goes with 

high-level disinfection, there is no 

assurance that the treatment would 

effectively remove pathogenic protozoa, 

such as Cryptosporidium and Giardia. 

d. Rationale for Not Requiring the 

Removal of Other Contaminants. 

Although pretreatment, secondary 

treatment, and high-level disinfection 

will remove many contaminants that 

may be present in municipal 

wastewater, EPA agrees with 

commenters who said that a large 

variety of contaminants, such as 

pharmaceutical products and 

disinfection byproducts, that may be 

present in treated municipal 

wastewater, may not be removed. 

Today’s final rule does not 

specifically require all affected facilities 

to install treatment to remove these 

other contaminants for four main 

reasons: (1) The Relative Risk 

70526 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

Assessment found that the only 

contaminants that posed a potential 

threat were pathogenic microorganisms; 

(2) Class I municipal disposal wells are 

precluded from injecting listed or 

characteristically hazardous waste 

streams; (3) Class I municipal disposal 

wells are allowed to inject only 

wastewater that has received a level of 

treatment, specified in individual 

permits, deemed necessary by the 

Director to prevent endangerment; and 

(4) many other contaminants are 

addressed through EPA’s existing 

pretreatment regulations (see Section 

IV.B.1.a, above) . If the Director finds 

that any other contaminants pose a 

threat to USDWs, that threat can be 

addressed on a site-specific basis under 

existing authorities. 

In the July 7, 2000, notice, EPA 

proposed four treatment alternatives 

that prescribed varying levels of BOD 

removal. This approach seemed 

reasonable because BOD, along with 

TSS, is a universal measure for defining 

levels of wastewater treatment and 

contaminant removal. In this sense, EPA 

does not agree with commenters who 

said that BOD cannot be used as a 

parameter for defining the level of 

treatment necessary to protect drinking 

water. However, the Agency does 

acknowledge, as several commenters 

pointed out, that a BOD standard would 

not necessarily achieve the objectives of 

today’s final rule. EPA believes that the 

State’s definition and standards for 

high-level disinfection which uses a 

standard for fecal coliform and a TSS 

limit, rather than a BOD limit, 

sufficiently defines the level of 

treatment that is necessary to protect 

USDWs. 

The July 7, 2000, notice also proposed 

nutrient (nitrogen and phosphorus) 

removal as an element of some of the 

treatment alternatives. However, EPA 

agrees with those commenters who said 

that nutrient removal may not be 

necessary based on two findings from 

the Relative Risk Assessment: (1) There 

is not strong evidence that Class I 

injection has caused or may cause 

exceedances of the nitrate MCL in 

USDWs; and (2) there is not strong 

evidence that nutrients released by 

Class I injection wells are migrating into 

surface waters. These findings do not 

necessarily mean that nutrients are 

never a potential concern, only that 

there is not sufficient evidence to 

compel a nutrient removal standard for 

all wells. Therefore, today’s rule does 

not require nutrient removal. However, 

the Director retains the flexibility and 

discretion under current authority to 

address nutrients on a case-by-case basis 

if necessary to protect USDWs. 

e. Rationale for Phasing In the New 

Treatment Over Time. EPA agrees with 

commenters who said that it will take 

time for facilities to install high-level 

disinfection systems. Therefore, the 

final rule requires owners and operators 

wishing to avail themselves of today’s 

final rule’s alternative endangerment 

standard to have high-level disinfection 

installed and operating within five years 

of the rule’s effective date, if they have 

already been notified by the Director 

that they have caused or may cause 

fluid movement, or within five years of 

the time they are so notified. EPA 

selected five years because it is 

consistent with the time that has been 

determined to be needed to install highlevel disinfection at Miami-Dade Water 

& Sewer Department, South District 

Wastewater Treatment Plant. In the 

meantime, the Director has the authority 

to require additional operating 

requirements on a site-specific basis to 

address any potential for endangerment 

until the additional treatment goes into 

operation. 

2. In-Depth Hydrogeologic 

Demonstrations 

Today’s rule does not provide the 

option for facility owners and operators 

to use a hydrogeologic demonstration to 

show that injection either will not cause 

fluids to enter USDWs, or if that cannot 

be shown, will not cause USDWs to 

exceed MCLs or other health-based 

standards (i.e., will not endanger 

USDWs). This approach was originally 

proposed as Option 2 and discussed 

further in the NODA. EPA has instead 

determined that, where injection has 

caused or may cause fluid movement 

into USDWs, pretreatment, secondary 

treatment, and high-level disinfection is 

the only effective alternative to the ‘‘nomovement’’ standard as a means of 

ensuring non-endangerment. 

EPA does not agree with commenters 

who support the use of hydrogeological 

demonstrations in lieu of wastewater 

treatment. EPA believes that existing 

compliance monitoring programs are 

not sufficient to protect against 

movement of contaminants into 

USDWs, nor do they provide sufficient 

early warning of contamination. To 

demonstrate that injected fluids are not 

migrating into and endangering a 

USDW, a facility would need to show 

the full areal extent of the fluids’

movement and its quality. However, as 

discussed in the NODA, ground water 

monitoring wells at most deep well 

facilities in Florida are only intended to 

provide some initial indication of fluid 

movement and are not capable of 

characterizing the full areal extent of 

fluid movement, especially where 

natural conduits for flow are present. 

Moreover, once any contamination is 

detected, it may be too late to prevent 

endangerment. 

There are at least two other problems 

with relying on monitoring for this 

purpose. First, deep monitoring wells 

are very costly to site, design, and 

construct. As stated in the NODA, it is 

unclear whether it would be practicable 

to provide a sufficient number of 

additional ground water monitoring 

wells to provide the information needed 

to demonstrate that injection has not 

caused fluid movement, or that USDWs 

are not being contaminated at sites 

where natural conduits for flow exist. 

Second, there is a potential that 

monitoring wells installed for this 

purpose could themselves create 

artificial conduits for fluid movement. 

Additional deep monitoring wells 

would have to perforate all shallow 

confining layers as they are installed, 

posing the risk of contamination along 

the well borehole to more shallow 

aquifers. 

EPA also does not believe that 

modeling can provide an adequate 

demonstration in the complex geology 

of Florida. For example, in the Relative 

Risk Assessment, EPA used numerical 

modeling to simulate the time of travel 

for fluid to move vertically from the 

injection zone to USDWs and the depth 

of hypothetical public water supply 

wells. This modeling used input 

parameter values for porous media flow 

(relatively slow movement through 

small pore spaces) and for preferential 

flow (rapid movement through larger 

fissures, cracks, fractures, voids, and 

channels). The Agency found that the 

time of travel estimated from the 

preferential flow model matches actual 

experience fairly closely at Miami-Dade 

and Pinellas Counties. However, the 

modeling only simulated time of travel 

and did not show the full extent of the 

movement of injectate from specific 

sites. A more in-depth modeling effort 

to show the extent of vertical and 

horizontal movement of the hundreds of 

millions of gallons a day would require 

information on the location and extent 

of fissures, cracks, voids, and channels 

which is impossible, using current 

technologies, to obtain with any 

certainty. Therefore, the Relative Risk 

Assessment showed that a credible 

hydrogeological demonstration that 

would need to rely on this type of more 

in-depth modeling does not appear 

feasible at this time. 

Finally, in the public comments, EPA 

did not receive answers to key questions 

that it posed in the NODA as to whether 

hydrogeological demonstrations were 

feasible (i.e., whether they would work 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70527 

or whether they were adequate for 

showing that there was no 

endangerment to USDWs). Commenters 

did not describe how the technical 

challenges and missing information 

regarding wastewater fate and transport 

could be overcome, or how the UIC 

Program Director might address these 

difficulties in his or her review and 

decisionmaking. With no new 

information on how to effectively use 

monitoring data or effectively simulate 

the location and extent of channels and 

solution cavities that are pervasive in 

Florida’s complex geology, a final rule 

allowing demonstrations would 

establish an expensive and burdensome 

approval process. The Agency questions 

(based on all of the evidence cited 

above) whether that process would yield 

credible demonstrations. Before 

adopting this approach, EPA would 

need extensive credible evidence that 

facilities can provide demonstrations 

that would show where all, or a 

significant volume, of the fluid is 

located and that it does not endanger 

drinking water sources. 

Given these uncertainties about the 

subsurface geology of Florida, the ability 

of ground water monitoring to identify 

and characterize the full extent of fluid 

movement, and the ability of models to 

predict the movement of fluids in the 

Florida subsurface, EPA has determined 

that relying on hydrogeologic 

demonstrations would not be 

sufficiently protective of USDWs. 

Today’s rule therefore takes the more 

conservative approach of requiring 

owners and operators in certain parts of 

Florida to treat their injected wastewater 

using pretreatment, secondary 

treatment, and high-level disinfection if 

they wish to avail themselves of the 

alternative endangerment standard. 

C. Monitoring Requirements 

Today’s rule does not add any new 

monitoring requirements to those that 

currently exist in the Federal 

regulations at 40 CFR 146.13. That 

section provides the Director with 

authority to require a site-specific 

monitoring program and periodic 

monitoring of ground water quality 

within the lowermost USDW and 

aquifer above the injection zone. The 

State’s monitoring requirements and the 

procedures for modifying those 

requirements also remain in effect. 

In the July 7, 2000, notice, EPA did 

not propose any changes to the 

monitoring requirements for Class I 

municipal disposal wells. EPA did, 

however, consider adding more specific 

requirements for effluent and ground 

water monitoring than currently 

contained in 40 CFR 146.13, and asked 

for comments on the appropriate level 

of monitoring. 

EPA agrees with comments on the 

proposal saying that deep ground-water 

monitoring does not, by itself, prevent 

endangerment, and thus is not 

prescribing new deep monitoring 

requirements as part of today’s rule. 

EPA believes that the threat of USDW 

contamination in the targeted areas of 

Florida is best addressed by requiring 

the wastewater to be treated with 

pretreatment, secondary treatment, and 

high-level disinfection before it is 

injected. Nevertheless, the Agency 

recognizes that effluent and ground 

water monitoring provides an indication 

of whether treatment is sufficient and 

working as it was designed and whether 

fluid movement is occurring. EPA 

believes that the current authority 

provided to the Director in 40 CFR 

146.13 for a site-specific monitoring 

program is sufficient and that 

appropriate monitoring requirements for 

effluent and ground water will be 

prescribed by the State in the facility 

permit. This provision allows the 

Director to require that certain 

parameters and contaminants be 

monitored and reported, some of which 

have specific health-based limits under 

the national primary drinking water 

regulations. The Director also has the 

authority to require other contaminants 

to be monitored in order to ‘‘protect the 

health of persons’’ even if a national 

primary drinking water regulation has 

not been promulgated. 

D. Rule Applicability 

1. How Will the New Rule Affect New 

Wells? 

EPA agrees with several public 

comments on the Agency’s proposal, to 

require any new Class I municipal 

disposal well constructed in one of the 

counties in Florida identified in today’s 

rule to meet the pretreatment, secondary 

treatment, and high-level disinfection 

standard being established for existing 

wells. To be clear, the standard applies 

to any new Class I municipal disposal 

well in the counties in Florida 

identified in today’s rule, not just new 

wells at facilities that (as determined 

and notified by the Director) have 

caused or may cause fluid movement, 

per new 40 CFR 146.16 in today’s rule. 

Contrary to other public comments, 

EPA does not believe that applying the 

rule to new wells will prohibit new 

facilities or wells from being 

constructed. EPA believes that new 

wells in the identified counties where 

there is a history of fluid movement can 

be constructed and operated to meet the 

new treatment standards as a way to 

ensure the protection of USDWs. 

2. What Florida Counties Are Covered 

by the Final Rule? 

As mentioned previously, EPA did 

not receive any public comments 

regarding the proposed list of Florida 

counties to be targeted by the rule. 

Therefore, the rule is being finalized to 

apply only to publically and privately 

owned facilities in those counties listed 

in the proposal, as follows: Brevard, 

Broward, Charlotte, Collier, Flagler, 

Glades, Hendry, Highlands, 

Hillsborough, Indian River, Lee, 

Manatee, Martin, Miami-Dade, Monroe, 

Okeechobee, Orange, Osceola, Palm 

Beach, Pinellas, St. Johns, St. Lucie, 

Sarasota, and Volusia. These counties 

are being targeted because they have the 

unique geologic conditions that are 

predominated by carbonate rocks, as 

discussed above. 

E. Reclassification of Wells That Have 

Caused Fluid Movement 

In today’s action, EPA is promulgating 

new Class I requirements. In the NODA, 

EPA asked for comment on whether, 

based on the findings of the Relative 

Risk Assessment, wells with fluid 

movement should be regulated as Class 

I, Class V, or under provisions for both 

Class I and Class V. 

Public comments on this issue were 

mixed. Some commenters were in favor 

of reclassifying the wells as Class V, 

saying that the injection zone and 

confining layers are sufficiently similar 

to be considered a single formation. 

Other commenters were against 

reclassifying the wells as Class V, citing 

concerns that doing so would lead to 

greater reliance on injection as a 

wastewater disposal method or that 

Class V standards would provide less 

protection. 

After considering these different 

approaches and public comments, EPA 

believes the best approach is to keep the 

wells as Class I and impose the new 

requirements as a condition for future 

injection. As previously discussed in 

Section IV A, this approach does 

represent a change in the criteria (i.e., 

currently ‘‘no fluid movement’’) that 

apply to certain Class I wells in certain 

counties in Florida, but it embraces the 

long-standing approach of controlling 

injectate quality as a way to ensure 

protection when fluid movement is 

known or suspected. Therefore, EPA 

believes that the rule is protective and 

entirely consistent with measures used 

in the Federal UIC Program, does not 

undermine the goals or integrity of the 

Class I program, and does not set a 

dangerous precedent for other Class I 

70528 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

wells found to be causing fluid 

movement. Reclassifying the wells as 

Class V would provide no greater 

protection than this rule but would 

introduce substantial confusion and 

new burdens to well owners and 

operators and regulators, who would 

have to develop and implement 

substantially revised UIC programs. 

V. Cost of the Rule 

In the absence of the availability of 

the regulatory alternative in today’s 

rule, owners and operators with wells 

that have caused or may cause fluid 

movement to a USDW would need to 

find a way to operate so that the injected 

fluid does not move into a USDW. 

However, that simply cannot be done if 

the movement is a function of a lack of 

sufficient confinement. Owners and 

operators would face having to close 

their wells and adopt other disposal 

alternatives. For the purpose of 

estimating the cost of the final rule, EPA 

assumes that operators would have to 

use surface disposal, because Florida 

has not approved new ocean disposal 

pipelines for many years in order to 

protect its coral reefs and beaches. 

The economic analysis supporting 

today’s rule compares the costs of 

compliance under the previous 

regulations (the baseline) with the costs 

of compliance under the new rule. The 

baseline scenario assumes that operators 

of affected wells would be required to 

abandon their injection wells and 

switch to surface disposal. Assumptions 

for estimating the cost of complying 

with today’s rule include the addition of 

treatment necessary at each affected 

facility to meet the high-level 

disinfection requirements of Florida 

Rule 62–600.440(5)(a)–(f). Of a total of 

42 Class I municipal disposal well 

facilities in Florida, EPA estimates that 

approximately 16 cause or may cause 

fluid movement into a USDW and 

therefore fall within the scope of this 

rule. EPA estimates costs only for those 

16 facilities. 

To develop the cost estimates, EPA 

used Version 3.0 of EPA’s W/W Costs 

Model, combined with a methodology 

recommended by the National Drinking 

Water Advisory Council (NDWAC). The 

W/W Costs Model generates capital and 

annual operations and maintenance 

(O&M) costs based on treatment 

technology, design and average daily 

flows, and chemical dose. 

EPA relied on information from 

Florida DEP to determine the number of 

wells that would likely be affected by 

the rule. The State reports that there has 

been confirmed fluid movement into 

USDWs from deep wells at three 

facilities. The State also reports that 

fluid has likely moved into USDWs 

from wells at another five facilities and 

that fluid has moved outside of the 

permitted injection zone into a nonUSDW at another eight facilities. 

EPA also used relevant information 

from domestic wastewater facility 

permits, compliance monitoring data, 

and information about the availability of 

high-level disinfection to determine the 

required treatment upgrades for each 

facility. At many of these facilities, 

high-level disinfection capacity is 

already in place; at the remainder, if 

movement into the USDW is likely, 

high-level disinfection will be necessary 

if the well is to avail itself of the 

authorization to inject provided by this 

rule, once these requirements are 

adopted by Florida as part of its UIC 

program and approved by EPA. For this 

reason, EPA has included all 16 of the 

wells with varying degrees of fluid 

movement or suspected movement in 

the economic assessment for the rule. 

The 16 facilities included in the cost 

assessment are for the purpose of 

estimating the cost of today’s rule. This 

rule does not specifically require any of 

these facilities to install additional 

treatment. The remaining wells in 

Florida with no fluid movement outside 

the injection zone may never have fluid 

movement detected in deep monitoring 

wells, or, over a period of years and 

decades, some will show fluid 

movement. Due to this level of 

uncertainty, EPA did not include them 

in the economic assessment for this 

rule. EPA does not believe that owners 

and operators will incur additional costs 

due to the pretreatment requirements of 

this rule, because the 16 facilities with 

varying degrees of fluid movement or 

suspected movement already have a 

pretreatment plan in place or have no 

significant industrial users. 

Based on the cost analysis, today’s 

rule is significantly less costly than the 

baseline requirements. The table below 

presents a summary of the total capital 

and annualized costs (at two discount 

rate scenarios—3 percent and 7 percent) 

for the baseline case and under today’s 

rule. The cost savings are calculated by 

subtracting costs for the injection 

requirements associated with today’s 

alternative approach from the baseline 

case. As the table shows, the costs for 

meeting the new requirements for 14 of 

16 existing facilities, that are not already 

required to install additional wastewater 

treatment, where there is some form of 

fluid movement or suspected movement 

is $27.7 million in capital costs and $7.2 

million annually (3 percent discount 

rate), including O&M, as compared to 

the baseline costs of $132.2 million in 

capital costs and $15.2 million annually 

(3 percent discount rate). At the 7 

percent discount rate, the annualized 

capital costs and O&M costs are $7.9 

million. Thus, today’s alternative 

represents a savings of $104.5 million in 

capital costs and $8.0 million annually 

at the 3 percent discount rate ($12.6 

million at the 7 percent discount rate). 

EPA’s complete cost estimation 

document is in the Florida UIC docket. 

Scenario 

Total cost 

(in millions) 

Average cost 

per facility—based on 14 facilities * 

(in millions) 

Capital 

costs 

Annualized costs 

(annualized capital + O&M) 

Capital 

costs 

Annualized costs 

(annualized 

capital + O&M) 

3% 7% 

3% 7% 

Baseline: Abandon injection wells and switch to 

surface disposal .................................................... $132.2 $15.2 $20.6 $9.4 $1.1 $1.5 

Today’s rule: Continue injecting after treating with 

high-level disinfection ............................................ 27.7 7.2 7.9 2.0 0.5 0.6 

Cost Savings ..................................................... 104.5 8.0 12.6 7.5 0.6 0.9 

Note: Numbers may not appear to add due to independent rounding. 

Costs are annualized over 20 years. 

* Two of the 16 affected facilities are under a consent order and are excluded from the cost analysis. 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70529 

EPA solicited comments on the cost 

estimation approach. A few commenters 

provided input on costs at specific 

affected facilities, and several general 

comments were offered on the cost 

analysis, including that it is overly 

simplistic, given the complexity of the 

rule. Many commenters believed the 

cost of the rule as proposed was too 

high. The comment response documents 

in the Florida UIC docket provide a 

more complete summary of and 

response to these comments on the cost 

analysis. 

VI. Statutory and Executive Order 

Reviews 

A. 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. 

It has been determined that this rule 

is not a ‘‘significant regulatory action’’

under the terms of Executive Order 

12866 and is therefore not subject to 

OMB review. 

One comment was submitted on this 

topic, stating that the proposed rule is 

a significant regulatory action. The 

commenter believes the rule will create 

a serious inconsistency or otherwise 

interfere with an action by another 

agency and will raise novel legal and 

policy issues. The commenter did not 

provide any specific information in 

support of the comment. EPA does not 

agree with this comment. Providing this 

alternative set of requirements for 

certain Class I wells in Florida does not 

create any inconsistency with the rest of 

the UIC program, nor does it raise novel 

issues triggering this Executive Order. 

Today’s alternative applies the Agency’s 

long-standing Class V endangerment test 

to a class of municipal disposal wells 

that are unique to Florida. That these 

wells are suspected of injecting below 

formations without adequate 

confinement makes application of the 

Class V standard both reasonable and 

appropriate. As noted in Section V 

above, the Agency estimates that 

implementing the selected option will 

result in a savings of $104.5 million in 

capital costs and $8.0 million annually. 

B. Paperwork Reduction Act 

The information collection 

requirements in this rule have been 

submitted for approval to Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act, 44 U.S.C. 

3501 et seq. The information collection 

requirements are not enforceable until 

OMB approves them. 

The ICR estimates monitoring, 

demonstration, reporting, and 

recordkeeping burdens and costs for 

Class I municipal disposal well 

operators in selected parts of Florida 

associated with today’s rule. Class I 

municipal disposal well operators must 

submit this information per § 144.51 of 

the CFR. Information regarding 

wastewater quality, treatment, and 

migration will be collected as outlined 

in the rule for review by the State of 

Florida as primacy agent. Under the 

rule, the Primacy State would be 

required to revise and resubmit a UIC 

program application for Class I wells. 

Information collected under SDWA 

and, by extension, this ICR is expected 

to be used by EPA and the State of 

Florida to help ensure the maintenance 

of clean, safe public drinking water 

supplies. 

Operators of injection wells may 

claim confidentiality, as provided in 

section 144.5, Confidentiality of 

Information. If confidentiality is 

requested, the information is treated in 

accordance with the provisions of 40 

CFR part 2, Public Information. 

Information collected under this ICR is 

intended for the Agency’s and/or State’s 

internal use and there are no plans to 

routinely release or publish any of the 

data. However, if no claim of 

confidentiality is made at the time of 

submission, the information can be 

made available to the public without 

further notice. 

EPA estimates that the average annual 

burden on Class I municipal disposal 

well operators (which includes public 

and private entities) and the State of 

Florida associated with this rule will be 

2,003 hours. This is based on an 

estimate that one State, Florida, will 

need to provide 6 responses each year 

at 88.4 hours per response. It is also 

estimated that each of the 16 Class I 

municipal disposal well operators will 

need to provide an average of 10.7 

responses each year at an average of 138 

hours per response. The labor burden is 

estimated for activities associated with 

reading and understanding the rule, 

performing and reviewing monitoring, 

and meeting primacy requirements. No 

respondents are expected to incur 

capital or O&M costs to complete 

information collection requirements. 

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 in 40 

CFR are listed in 40 CFR part 9. When 

this ICR is approved by OMB, the 

Agency will publish a technical 

amendment to 40 CFR part 9 in the 

Federal Register to display the OMB 

control number for the approved 

information collection requirements 

contained in the rule. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (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. 

For purposes of assessing the impacts 

of today’s action on small entities, a 

small entity is defined as: (1) A small 

business that is primarily engaged in 

waste management services as defined 

by NAICS code 562998 with annual 

revenue less than $6 million according 

70530 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

to Small Business Administration size 

standards; (2) a small governmental 

jurisdiction that is a government of a 

city, county, town, school district or 

special district with a population of less 

than 50,000; and (3) a small 

organization that is any not-for-profit 

enterprise which is independently 

owned and operated and is not 

dominant in its field. 

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 determining whether a rule has 

significant economic impact on a 

substantial number of small entities, the 

impact of concern is any significant 

adverse economic impact on small 

entities, since the primary purpose of 

the regulatory flexibility analyses is to 

identify and address regulatory 

alternatives ‘‘which minimize any 

significant economic impact of the rule 

on small entities.’’ 5 U.S.C. 603 and 604. 

Thus, an agency may certify that a rule 

will not have a significant economic 

impact on a substantial number of small 

entities if the rule relieves regulatory 

burden, or otherwise has a positive 

economic effect on all of the small 

entities subject to the rule. 

Of a total of 42 Class I municipal 

disposal well facilities in Florida, EPA 

estimates that approximately 16 cause 

or may cause fluid movement into a 

USDW and fall within the scope of this 

rule. As discussed in Section V, the 

economic impact of this action actually 

results in a cost savings to the Class I 

municipal disposal well facilities 

compared to the baseline, i.e., 

complying with existing UIC 

regulations. Because Class I municipal 

disposal well facilities that may avail 

themselves of the authorization to inject 

provided by this rule are only affected 

if they cause or may cause fluid 

movement prohibited by present law, 

EPA has determined that the effect on 

small entities will be positive to the 

extent they are impacted. If the entity 

chooses not to follow these new 

requirements, the legal status of its 

continued operations is not impacted by 

the rule. We have therefore concluded 

that today’s final rule either will have 

no effect on or, in the alternative, will 

relieve regulatory burden for all small 

entities. 

D. Unfunded Mandates Reform Act 

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 section 202 of the UMRA, 

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 to 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. 

Today’s rule contains no Federal 

mandate (under the provisions of Title 

II of the UMRA) for State, local, and 

Tribal governments or the private sector. 

Because the authorization to inject 

provided for by today’s rule is optional 

on applicants, the costs incurred by an 

entity in conjunction with such 

authorization to inject under the rule are 

discretionary, not mandated. The total 

cost impact, in comparison to other 

alternatives to provide effective 

wastewater disposal, is anticipated to be 

positive for those entities that choose to 

avail themselves of the option provided 

by this rule. This rule will reduce the 

burden imposed by the current 

regulations. 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. This rule is not 

targeted at small governments. It offers 

owners and operators of Class I 

municipal disposal wells in certain 

parts of Florida that inject domestic 

wastewater effluent an alternative 

method of compliance with the existing 

UIC rules, which prohibit fluid 

movement, without requiring the 

facilities to cease injection and abandon 

their existing Class I municipal disposal 

wells. This rule will provide them with 

a less burdensome alternative for 

compliance. Thus, today’s rule is not 

subject to the requirements of section 

203 of the UMRA. 

E. Executive Order 13132: 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’’ are 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 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. The rule allows 

for an optional alternate method for the 

State of Florida to use to ensure that no 

owner and/or operator would endanger 

a USDW by injection of domestic 

wastewater effluent into a Class I 

municipal disposal well. EPA is not 

requiring that an owner and/or operator 

use this authorization, but rather is 

providing options that owners and/or 

operators of existing Class I municipal 

disposal wells may wish to use in order 

to maintain their injection operations. 

Thus, the requirements of Section 6 of 

the Executive Order do not apply to this 

rule. Although Section 6 of Executive 

Order 13132 does not apply to this rule, 

EPA did consult with the Florida 

Department of Environmental Protection 

(FDEP) in developing this rule and 

FDEP agrees with EPA’s approach. 

Two public comments were submitted 

on this topic. Both comments suggest 

EPA should revise its determination 

under Executive Order 13132, and claim 

the rule imposes significant burdens 

and costly solutions on the State of 

Florida. One commenter suggested that 

EPA modify its final rule to allocate all 

permitting decisions solely to the State. 

Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 70531 

In response, today’s rule does not 

change the current process by which the 

State of Florida exercises its primacy 

over injection operations in the State. 

While the State would have to revise 

and resubmit a UIC program application 

for Class I wells if it wished to provide 

owners and operators of Class I 

municipal disposal wells in Florida 

with the optional authorization 

contained in this rule, it is anticipated 

that the Director will retain authority 

over Class I injection in Florida. In the 

spirit of Executive Order 13132, and 

consistent with EPA policy to promote 

communications between EPA and State 

and local governments, EPA solicited 

comment on the proposed rule from 

State officials. 

F. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175, entitled 

‘‘Consultation and Coordination with 

Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000), requires EPA 

to develop an accountable process to 

ensure ‘‘meaningful and timely input by 

Tribal officials in the development of 

regulatory policies that have Tribal 

implications.’’

This final rule does not have Tribal 

implications as specified in Executive 

Order 13175. At present, there are no 

Class I injection wells used for domestic 

wastewater effluent disposal in Florida 

that are owned or operated by an Indian 

Tribal community. The intent of this 

rule is to protect all USDWs from 

endangerment caused by Class I 

municipal disposal wells, including 

those on Tribal land. 

G. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

Executive Order 13045: ‘‘Protection of 

Children from Environmental Health 

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 

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. 

This final rule is not subject to 

Executive Order 13045 because it is not 

economically significant as defined in 

Executive Order 12866, and because the 

Agency does not have reason to believe 

the environmental health or safety risks 

addressed by this action present a 

disproportionate risk to children. The 

rule provides an optional authorization 

for certain Class I wells in Florida to 

inject domestic wastewater effluent in 

accordance with regulatory 

requirements designed to prevent 

endangerment of underground sources 

of drinking water. The criteria 

established in the rule safeguard these 

resources for all potential users, 

including but not limited to children. 

Three comments were received on 

this topic from environmental advocates 

and a citizen. All three suggest that the 

proposal has not adequately assessed 

potential risk to children’s health, or 

that contaminants in injected 

wastewater may have a disproportionate 

effect on vulnerable populations, 

including children. EPA disagrees that 

Class I municipal disposal of 

wastewater that has been subjected to 

pretreatment, secondary treatment, and 

high-level disinfection as a result of this 

rule will have a disproportionate impact 

on children or any other vulnerable 

population. By requiring pretreatment, 

secondary treatment, and high-level 

disinfection as a condition of future 

operation of the targeted injection wells, 

the rule is ensuring the protection of 

USDWs and the health of children who 

may rely on these USDWs as drinking 

water sources. 

H. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This rule is not subject to Executive 

Order 13211, ‘‘Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use’’ (66 FR 28355 (May 

22, 2001)) because it is not a significant 

regulatory action under Executive Order 

12866. 

I. 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 

(‘‘NTTAA’’), Public Law. No. 104–113, 

12(d), (15 U.S.C. 272 note) 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 [Underground 

Injection Control Program—Revision of 

Federal Underground Injection Control 

Requirements for Class I Municipal 

Disposal Wells in Florida Page 62 of 62.] 

technical standards (e.g., materials 

specifications, test methods, sampling 

procedures, and business practices) that 

are developed or adopted by voluntary 

consensus standards bodies. The 

NTTAA directs EPA to provide 

Congress, through OMB, explanations 

when the Agency decides not to use 

available and applicable voluntary 

consensus standards. This action does 

not involve technical standards. 

Therefore, EPA does not consider the 

use of any voluntary consensus 

standards. 

J. 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 on December 22, 2005. 

List of Subjects in 40 CFR Part 146 

Environmental protection, Hazardous 

waste, Indians-lands, Water supply. 

Dated: November 15, 2005. 

Stephen L. Johnson, 

Administrator. 

■ For the reasons set forth in the 

preamble, 40 CFR part 146 is amended 

as follows: 

PART 146—UNDERGROUND 

INJECTION CONTROL PROGRAM: 

CRITERIA AND STANDARDS 

■ 1. The authority citation for part 146 

continues to read as follows: 

Authority: Safe Drinking Water Act, 42 

U.S.C. 300f et seq.; Resource Conservation 

and Recovery Act, 42 U.S.C. 6901 et seq. 

Subpart B—Criteria and Standards 

Applicable to Class I Wells 

■ 2. Section 146.15 is added to Subpart 

B to read as follows: 

§ 146.15 Class I municipal disposal well 

alternative authorization in certain parts of 

Florida. 

(a) Existing Class I municipal disposal 

wells in specific geographic regions as 

defined in paragraph (f) of this section 

may continue to inject without violating 

the regulatory prohibitions in Parts 144 

and 146 of this chapter against the 

70532 Federal Register / Vol. 70, No. 224 / Tuesday, November 22, 2005 / Rules and Regulations 

movement of injection or formation 

fluids into a USDW, provided that such 

wells meet the requirements of this 

section, even if the Director determines 

they have caused or may cause fluid 

movement into a USDW. Nothing in this 

section excuses such Class I municipal 

disposal wells from meeting all other 

applicable State and Federal 

requirements including 40 CFR 

144.12(a). 

(b) For purposes of this section, an 

existing Class I municipal disposal well 

is defined as a well for which a 

complete UIC construction permit 

application was received by the Director 

on or before December 22, 2005. 

(c) For purposes of this section, the 

determination that a Class I municipal 

disposal well has caused or may cause 

movement of injection or formation 

fluids into a USDW may be made by the 

Director based on any relevant data 

available to him/her, including ground 

water monitoring data generated 

pursuant to regulatory requirements 

governing operation of Class I municipal 

disposal wells. 

(d) In order for a Class I municipal 

disposal well to qualify for 

authorization to inject pursuant to 

paragraph (a) of this section, the Owner/ 

Operator of that well shall: 

(1) Develop and implement a 

pretreatment program that is no less 

stringent than the requirements of 

Chapter 62–625, Florida Administrative 

Code, or have no significant industrial 

users as defined in that chapter. 

(2) Treat the injectate using secondary 

treatment in a manner that is no less 

stringent than the requirements of 

Florida Rule 62–600.420(1)(d), and 

using high-level disinfection in a 

manner that is no less stringent than the 

requirements of Florida Rule 62–

600.440(5)(a)–(f), within five years after 

notification by the Director that the well 

has caused or may cause fluid 

movement into a USDW. 

(e) Where the Director issued such 

notice for a well prior to December 22, 

2005, in order for that well to qualify for 

authorization to inject pursuant to 

paragraph (a) of this section, the Owner/ 

Operator shall: 

(1) Develop and implement a 

pretreatment program that is no less 

stringent than the requirements of 

Chapter 62–625, Florida Administrative 

Code, or have no significant industrial 

users as defined in that chapter; and 

(2) Treat the injectate using secondary 

treatment in a manner that is no less 

stringent than the requirements of 

Florida Rule 62–600.420(1)(d), and 

using high-level disinfection in a 

manner that is no less stringent than the 

requirements of Florida Rule 62–

600.440(5)(a)–(f), within five years after 

December 22, 2005. 

(f) Authorization to inject wastewater 

into existing Class I municipal disposal 

wells pursuant to this section is limited 

to Class I municipal disposal wells in 

Florida in the following counties: 

Brevard, Broward, Charlotte, Collier, 

Flagler, Glades, Hendry, Highlands, 

Hillsborough, Indian River, Lee, 

Manatee, Martin, Miami-Dade, Monroe, 

Okeechobee, Orange, Osceola, Palm 

Beach, Pinellas, St. Johns, St. Lucie, 

Sarasota, and Volusia. 

■ 3. Section 146.16 is added to Subpart 

B to read as follows: 

§ 146.16 Requirements for new Class I 

municipal wells in certain parts of Florida. 

Prior to commencing injection, any 

Class I municipal disposal well in one 

of the counties identified in § 146.15(f) 

that is not an existing Class I municipal 

disposal well as defined in § 146.15(b) 

of this section shall meet all of the 

requirements for existing wells seeking 

authorization to inject pursuant to 

§ 146.15. 

[FR Doc. 05–23088 Filed 11–21–05; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 418 

[CMS–1022–F] 

RIN 0938–AJ36 

Medicare Program; Hospice Care 

Amendments 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule revises existing 

regulations that govern coverage and 

payment for hospice care under the 

Medicare program. These revisions 

reflect the statutory changes required by 

the Balanced Budget Act of 1997 (BBA), 

the Medicare, Medicaid, and SCHIP 

Balanced Budget Refinement Act of 

1999 (BBRA), and the Medicare, 

Medicaid, and SCHIP Benefits 

Improvement and Protection Act of 

2000 (BIPA). Additionally, these 

revisions reflect current policy on the 

documentation needed to support a 

certification of terminal illness, 

admission to Medicare hospice, and a 

new requirement that allows for 

discharges from hospice for cause under 

very limited circumstances. 

This final rule does not address the 

requirement for hospice data collection, 

the changes to the limitation of liability 

rules, or the changes to the hospice 

conditions of participation that were 

included in the BBA. 

The intent of this final rule is to 

expand the hospice benefit periods, 

improve documentation requirements to 

support certification and recertification 

of terminal illness, provide guidance on 

hospice admission procedures, clarify 

hospice discharge procedures, update 

coverage and payment requirements, 

and address the changing needs of 

beneficiaries, suppliers, and the 

Medicare program. 

DATES: These regulations are effective 

on January 23, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Linda Smith, (410) 786–5650. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Hospice Care 

Hospice care means a comprehensive 

set of services described in 1861(dd)(1) 

of the Social Security Act (the Act), 

identified and coordinated by an 

interdisciplinary team to provide the 

physical, psychosocial, spiritual, and 

emotional needs of a terminally ill 

patient and family members or both as 

denoted in a specific patient plan of 

care. 

The emphasis of hospice care is on 

the control of pain and the furnishing of 

services that enable the beneficiary to 

remain at home as long as possible with 

minimal disruption to normal activities. 

A hospice uses an interdisciplinary 

approach to deliver medical, social, 

psychological, emotional, and spiritual 

services through the use of a broad 

spectrum of professional and other 

caregivers, with the goal of making the 

individual as physically and 

emotionally comfortable as possible. 

Counseling and respite services are 

available to the family of the hospice 

patient. Hospice programs consider both 

the patient and the family as the unit of 

care. 

B. Medicare Hospice Before the 

Balanced Budget Act of 1997 

The Balanced Budget Act of 1997 

changed and clarified numerous aspects 

of the Medicare hospice benefit 

including the length of available benefit 

periods, the amount of annual updates, 

how local payment rates are 

determined, the time frame for 

physician certification, and what is 

considered a covered Medicare hospice 

service. Section 1861(dd) of the Act 

provides for coverage of hospice care for 

terminally ill Medicare beneficiaries