Miami-Dade County v. United States Environmental Protection Agency

[PUBLISH]

IN THE UNITED STATES COURT OF APPEALS
FILED
FOR THE ELEVENTH CIRCUIT U.S. COURT OF APPEALS
________________________ ELEVENTH CIRCUIT
JUNE 6, 2008
No. 06-10551 THOMAS K. KAHN
CLERK
________________________

EPA No. 40 CFR 146

MIAMI-DADE COUNTY,
a political subdivision of the State of Florida,

Petitioner,

versus

THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
STEPHEN L. JOHNSON, Administrator,
U.S. Environmental Protection Agency,

Respondents,
________________________

No. 06-10574
________________________

EPA No. 40 CFR 146

CITY OF COOPER CITY, FLORIDA,
a municipal corporation,

Petitioner,

versus
THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
STEPHEN L. JOHNSON, Administrator,
U.S. Environmental Protection Agency,

Respondents,

________________________

No. 06-10575
________________________

EPA No. 40 CFR 146

CITY OF MIRAMAR, FLORIDA,
a municipal corporation,

Petitioner,

versus

THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
STEPHEN L. JOHNSON, Administrator,
U.S. Environmental Protection Agency,

Respondents,
________________________

No. 06-10576
________________________

EPA No. 40 CFR 146

CITY OF SUNRISE,
a Municipal Corporation,
E. CENTRAL REGIONAL WASTEWATER TREATMENT FACILITIES
OPERATION BOARD,
an Interlocal Entity Created pursuant to Section 163.01, et. seq., FLA. Stat.,

2
 Petitioners,

versus

THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
STEPHEN L. JOHNSON, Administrator,
U.S. Environmental Protection Agency,

Respondents,
________________________

No. 06-10579
________________________

EPA No. 40 CFR 146

SIERRA CLUB,

Petitioner,

versus

THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
STEPHEN L. JOHNSON, Administrator,
U.S. Environmental Protection Agency,

Respondents,
________________________

No. 06-10583
________________________

EPA No. 40 CFR 146

CITY OF MARGATE, FL,

Petitioner,

3
 versus

THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY,
STEPHEN L. JOHNSON, Administrator,
U.S. Environmental Protection Agency,

Respondents.

________________________

Petitions for Review of a Decision of the
Environmental Protection Agency
_________________________

(June 6, 2008)

Before BIRCH, PRYOR and KRAVITCH, Circuit Judges.

PER CURIAM:

Miami-Dade County (“the County”), City of Miramar, City of Margate, City

of Cooper City, City of Sunrise, East Central Regional Wastewater Treatment

Facilities Operation Board (collectively “Municipalities”), and the Sierra Club

petition for review of the Final Rule promulgated by the EPA amending the current

federal underground injection control (“UIC”) requirements for Class I municipal

disposal wells in Florida. 40 C.F.R. § 146.15, 146.16. The petitioners argue that

the Final Rule conflicts with the plain language of the authorizing statute, that the

EPA’s approach to UIC regulation in South Florida is arbitrary and capricious, and

4
that the EPA gave insufficient notice of certain terms of the Final Rule in violation

of the Administrative Procedure Act (“APA”). We DENY the petition.

I. BACKGROUND

A. Statutory History

In 1974, concerned that drinking water across the country contained unsafe

levels of a wide variety of contaminants, Congress passed the Safe Drinking Water

Act (“SDWA”). Part C of the act addresses the protection of underground sources

of drinking water (“USDW”) against contamination by underground injection of

effluent.1 42 U.S.C. §§ 300h to 300h-8. Under the SDWA, the EPA promulgates

regulations setting parameters for state UIC programs. 42 U.S.C. § 300h(b)(1).

State requirements must at least meet, but may also exceed EPA requirements for

protection. In protecting USDWs, § 1421(d)(2) of the SDWA states that:

[u]nderground 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.

1
A USDW is an aquifer, or portion thereof, that either (a)(1) “supplies any public water
system; or (2) . . . contains a sufficient quantity of ground water to supply a public water system;
and (i) [c]urrently supplies drinking water for human consumption; or (ii) [c]ontains fewer than
10,000 mg/l total dissolved solids; and (b) . . . is not an exempted aquifer.” 40 C.F.R. § 144.3.

5
Id. § 300h(d)(2).2 Additionally, EPA regulations “shall permit or provide for

consideration of varying geologic, hydrological, or historical conditions in

different States and in different areas within a State.” Id. § 300h(b)(3)(A).

B. Regulatory and Procedural History

The EPA has implemented Part C of the SDWA at 40 C.F.R. Parts 144-46.

In its initial UIC regulations, the EPA defined five classes of injection wells. See

40 C.F.R. §§ 144.6, 146.5. The County and Municipalities own and operate

municipal disposal wells, which inject treated domestic wastewater from a variety

of facilities. These constitute one type of Class I well, and this is the only class of

well at issue in this case.3

Regulatory requirements vary by well class. However, no injection well

may cause “the movement of fluid containing any contaminant into [USDWs], if

the presence of that contaminant may cause a violation of any primary drinking

water regulation . . . or may otherwise adversely affect the health of persons.” 40

C.F.R. § 144.12(a). Within this limitation, the EPA has recognized several

2
National “primary drinking water regulation[s]” specify the maximum contaminant
levels (“MCL”) for any contaminant in water “delivered to any user of a public water system.”
42 U.S.C. § 300f(1), (3).
3
Industrial, radioactive, and hazardous waste disposal wells also fall into Class I.
Injection wells operated in relation to oil and natural gas production and mineral extraction fall
into Classes II and III, respectively. Class IV includes shallow hazardous or radioactive waste
disposal wells. Finally, a variety of specific well types not covered by the other four classes
make up Class V. 40 C.F.R. §§ 144.6, 146.5.

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approaches for preventing the endangerment of USDWs by underground injection.

These include bans on certain types of wells and particular practices, waste

isolation, and waste treatment.

Currently applied to wells in Classes I, II, and III, the waste isolation

approach keeps injected wastewater from coming into contact with USDWs.

Under this “no fluid movement” or the “no migration” standard, any evidence

“indicat[ing] the [unauthorized] movement of any contaminant into [a USDW]”

requires “the Director [to] prescribe such additional requirements . . . as are

necessary to prevent such movement.” 40 C.F.R. § 144.12(b). This rule has

applied even in the absence of evidence that a USDW has actually been

endangered.

Because this no-fluid-movement standard “is operationally meaningful (i.e.,

it can be measured or otherwise determined) and because it can be achieved

through the use of available, good engineering practices,” the EPA has applied it to

wells in Classes I, II, and III since 1980. Consolidated Permit Regulations, 45 Fed.

Reg. 33,290, 33,330 (May 19, 1980) (to be codified at 40 C.F.R. pt. 122).

However, EPA regulations have also long recognized the viability of alternative

approaches. For instance, the regulations give the permitting authority discretion

to relieve existing or new Class II wells in existing injection fields of casing and

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cementing requirements as long as such wells comply with the casing and

cementing regulations extant at the time of drilling or when the field was submitted

to the state program for approval, and as long as any resulting “movement of fluids

into an underground source of drinking water [will not] create a significant risk to

the health of persons.” 40 C.F.R. § 146.22(c)(2), (d)(2). Also, under 40 C.F.R.

§ 144.82, Class V well operators have discretion to employ a wide range of

measures to prevent USDW endangerment – at base, they are prohibited only from

injection activities that will result in the presence of a contaminant of concern in a

USDW. See 40 C.F.R. § 144.82. As a result, many such wells “inject non-

hazardous fluids into and above USDWs.” Consolidated Permit Regulations, 45

Fed. Reg. at 33,330. The EPA recognizes that implementing § 1421(d) in this

manner is different from employing the no-fluid-movement approach, but views it

as no “more stringent or more inclusive.” Water Programs; Consolidated Permit

Regulations and Technical Criteria and Standards; State Underground Injection

Control Programs, 45 Fed. Reg. 42,472, 42,477 (June 24, 1980) (to be codified at

40 C.F.R. pts. 122 and 146).

(1) No-Fluid-Movement Standard & Florida Class I Municipal Disposal
Wells.

For more than 20 years, Florida municipalities have injected large quantities

of treated domestic effluent into deep underground caverns as an alternative to

8
surface disposal. The Florida Department of Environmental Protection (FDEP) has

administered the federally-approved UIC program that regulates Class I

underground injection wells in Florida since 1983. When the FDEP first began

issuing permits to Class I wells, it was thought that these cavernous formations

would adequately confine the wastewater, isolating it from USDWs. Revision to

the Federal Underground Injection Control (UIC) Requirements for Class I –

Municipal Wells in Florida, 65 Fed. Reg. 42,234, 42,235 (July 7, 2000) (proposed

rules to be codified at 40 C.F.R. pt. 146). Since then, however, groundwater

monitoring wells have detected unpermitted fluid movement that has, in some

cases, reached USDWs. Additional investigation has shown this fluid movement

to have resulted from a failure of the porous rock around the Floridan Aquifer

adequately to confine the effluent.4

4
The Upper Floridan Aquifer and the Biscayne Aquifer are the main water sources in
South Florida. Certified Extracts of Administrative Record, Vol. 2 (CE2) at 1192. The Floridan
Aquifer is quite large, underlying parts of Alabama, southeastern Georgia, southern South
Carolina, and all of Florida. CE2 at 1202. It is divided into the Upper and Lower Floridan
Aquifers, separated by a middle confining unit. CE2 at 1203. In southeastern Florida, the
Floridan is overlain by the surficial Biscayne Aquifer composed of relatively thin layers of sands
with some interbedded shell and limestone. CE2 at 1197; CE1 at 332. The Biscayne Aquifer,
which is fairly thick, provides most of the water for Southeast Florida. CE2 at 1192, 1196. The
surficial aquifers underlying Brevard and Pinellas counties (to the north and west) are much
thinner, as is their intermediate confining unit. CE2 at 1192, 1193; CE1 at 332.

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 (2) Alternative Treatment-Based Approach

a. Proposed Rule

Responding to the detection of this fluid movement and having held a

meeting with industry representatives, environmental groups, local governments

and other stakeholders, the EPA issued a proposed revision of its regulations on 7

July 2000. This revision would have allowed existing Class I wells in specific

areas in Florida to continue to inject if the owners or operators of those wells met

certain further treatment requirements. More specifically, the EPA proposed two

options that were to apply to all existing Class I municipal disposal wells that had

caused or might cause movement of contaminants into USDWs. Revision to UIC

Requirements, 65 Fed. Reg. 42,234.

Option 1 would have allowed the continued use of wells as long as the

facility in question provided advanced wastewater treatment, high-level

disinfection, and a non-endangerment demonstration to show that the injectate

would not cause a USDW to exceed any national primary drinking water

regulations or other health-based standards. Id. at 42,244. This demonstration

would have focused on any contaminants that still exceeded the relevant levels

after the specified level of advanced wastewater treatment. Id. at 42,239. It would

have required a well-owner to “identify any such contaminants” in the injectate and

10
“demonstrate that they would not cause similar exceedences” in the USDW at

issue. Id. The proposal explained that this demonstration requirement could have

been satisfied by something as simple as reference to existing “technical literature

describing die-off rates for viruses and other pathogens, or how metals bind in soils

compared to the results of ground water sampling and analysis pursuant to §

146.13.” Revision to UIC Requirements, 65 Fed. Reg at 42,240.

Option 2 would have required facilities to conduct an in-depth

hydrogeological demonstration that the injection operation would not cause fluids

that could migrate into a USDW to exceed any national primary drinking water

regulation or other health based standard. Id. at 42,239. The Option 2

demonstration, at a minimum, would have required “ground-water modeling,

geochemical analysis, and effluent and ground-water monitoring and analysis.” Id.

If the demonstration were unsuccessful, the facility in question would be required

to provide advanced treatment as necessary to ensure that injectate would not cause

any violation. Id. Option 2 also included a sunset provision which would have

required high-level disinfection and advanced wastewater treatment at those

facilities by 2015 regardless of any hydrogeological demonstration. Id. at 42,240.

The area in which the proposed revision applied included the following

counties: Brevard, Broward, Charlotte, Collier, Flagler, Glades, Hendry,

11
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 included because their underlying

geology is predominated by carbonate rocks – a geologic condition which

generally involves “fractures, faults, and solution cavities that provide preferential

pathways for the movement of underground fluids.” CE1 at 76; 65 Fed. Reg at

42,236-37.

In connection with this proposed rule, the EPA requested public comment as

to (1) whether it should select Option 1, Option 2, or a combination of the two, id.

at 42,240; (2) the most appropriate of four proposed levels of wastewater treatment

under Option 1, id. at 42,239; (3) the need to require pretreatment as an additional

condition under Option 2 “to address contaminants that might move through a

treatment system and enter into a USDW at concentrations of concern,” id. at

42,240; (4) whether owners and operators were able to provide the kind of

hydrogeological and other information necessary for a successful demonstration

under Option 2, id.; (5) whether there was a need for any additional monitoring

requirements for the Final Rule, id. at 42,239; (6) whether the “proposed rule

should apply to existing wells only, or . . . also . . . to new wells,” id. at 42,238; (7)

with regard to the sunset provision in Option 2, which of the four levels of

12
advanced wastewater treatment and nutrient removal proposed under Option 1

should be required, id. at 42,240; (8) the general need “to require pretreatment [by

industrial users] as an additional condition of authorization,” extending the

industrial pretreatment standards presently required by the FDEP, id. at 42,239;

and, finally, (9) comparing the various means of domestic wastewater disposal in

Florida, and considering the “effects . . . those methods have on Florida’s fragile

environment,” whether this proposal may result in the increased or decreased use

of reuse or other disposal practices such as ocean or other surface water disposal,

id. at 42,240.5 The EPA received just under 1200 comments and also held a series

of public meetings during the comment period.

b. Risk Assessment

The same year the proposed options were published, Congress directed the

EPA to study the relative risks of deep well injection, ocean disposal, surface

discharge, and aquifer recharge of treated effluent in South Florida. In April 2003,

the EPA published a Relative Risk Assessment (“Risk Assessment”). Therein the

EPA confirmed that effluent from some Florida Class I wells had migrated out of

the permitted injection zones and, in a few instances, into USDWs. CE1 at 413.

5
The EPA also solicited comment as to the assumptions used in its economic analysis of
the proposed rule, and as to the potential economic or environmental impact of either making no
change or choosing one of the proposed options.

13
The study also concluded that each alternative disposal method posed enough risk

to human health and the environment that none was clearly preferable to

underground injection. CE1 at 611-12.

The EPA issued a Notice of Data Availability (NODA) as to the Risk

Assessment and its underlying data on 5 May 2003 and requested public comment

as to the potential impact of the Risk Assessment on the July 2000 proposed

options. Underground Injection Control Program – Revision of Underground

Injection Control Requirements for Class I Municipal Wells in Florida; Notice of

Data Availability, 68 Fed. Reg. 23,666 (May 5, 2003) (proposed rules to be

codified at 40 C.F.R. pt. 146). Specifically, the EPA also asked for comments on

(1) “an alternative option for defining the appropriate level of wastewater treatment

required for continued injection” (the proposed rule had suggested 4 specific levels

of biochemical oxygen demand with disinfection, some also involving nutrient

removal)6; (2) the “practicability and feasibility” of Option 2 as proposed –

particularly as it incorporated an in-depth hydrogeological demonstration –

including any suggestions for viable alternatives to the sunset provision requiring

treatment by 2015; and (3) the possibility of reclassifying certain Class I wells as

6
The alternative would adopt the Florida standards applicable either (1) to reclaimed
water that might come into contact with people or (2) to Class V wells. Either would require
filtration for total suspended solids (TSS control) prior to disinfection. Underground Injection
Control Program – NODA, 68 Fed. Reg. at 23,672.

14
Class V wells, thereby requiring them to meet higher wastewater treatment

standards instead of changing the standards for all Class I wells. Id. at 23,672-73.

The EPA received a little over 200 additional comments in response to the Risk

Assessment NODA.

c. Final Rule

The EPA published a Final Rule revising its UIC regulations on 22

November 2005. According to this Rule, which took effect on 22 December 2005,

owners and operators of existing Class I municipal wells have a choice: (1) They

may continue to operate under the no-fluid-movement standard, assuming their

wells have not been deemed likely to cause fluid movement. If their effluent

reaches a USDW, they face the consequences under that standard as originally

promulgated. Underground Injection Control Program – Revision to the Federal

Underground Injection Control Requirements for Class I Municipal Disposal Wells

in Florida, 70 Fed. Reg. 70,513, 70,531-32 (Nov. 22, 2005) (to be codified at 40

C.F.R. pt. 146). Or, (2) they may continue their operations, despite evidence of

fluid movement, as long as, within five years after 22 December 2005, they meet

additional treatment requirements. Id. In publishing this Final Rule, the EPA

explained that these new requirements – including “secondary treatment[] and

high-level disinfection” – provide USDWs a level of protection equivalent to that

15
afforded by the no-fluid-movement standard.7 CE1 at 81. The Final Rule further

requires that owners and operators with significant industrial users implement a

pretreatment program that meets certain Florida standards designed to prevent

industrial contaminants from endangering the public. Finally, the Final Rule

applies to all existing and new Class I wells in the specified area. Underground

Injection Control Program – Revision, 70 Fed. Reg. at 70,532. The EPA observed

that the Final Rule was essentially a modified version of Option 1 of the July 2000

Proposed Rule and explained that the non-endangerment demonstration

requirement had been eliminated because the Final Rule had adopted a treatment

standard which would necessarily eliminate any concern about microorganisms

remaining after treatment. Id. at 70,524. The EPA further explained that

“uncertainties about the geology of certain counties in Florida make

demonstrations inadequate to fully characterize or predict movement of pathogens

in the subsurface” and for this reason, the “‘demonstration’ option provided in the

proposed rule is not an appropriate way of ensuring non-endangerment.” CE1 at

109, 108.

7
The applicable standards regarding high-level disinfection are taken from Florida
Administrative Code Rule 62-600.440(5). Id. at 70,532. Florida’s high-level disinfection
standards set parameters for (1) residual chlorine levels after disinfection, (2) resulting fecal
coliform levels, and (3) use of total suspended solids controls. Fla. Admin. Code. Ann. 62-
600.440(5).

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C. Petitions for Review

The Sierra Club, Miami-Dade County and Palm Beach City filed timely

Petitions for Review of this Final Rule on 19 January 2006, pursuant to 42 U.S.C.

§ 300j-7(a)(2). The next day, City of Cooper City, City of Miramar, City of

Sunrise, City of Ft. Lauderdale and City of Margate also filed timely Petitions for

Review. The Municipalities’ petitions were consolidated with the County’s in

February 2006, and Sierra Club’s petition was, in turn, consolidated with the all of

those in March 2006.

(1) Sierra Club

Sierra Club argues that the Final Rule is inconsistent with the definition of

endangerment set out in the SDWA. More specifically, Sierra Club reasons, the

new regulation fails to protect USDWs as the no-fluid-movement standard did.

Sierra Club also argues that the EPA’s interpretation of the statute as embodied by

the Final Rule is arbitrary and capricious and unsupported by the Risk Assessment

or public comments. Sierra Club is particularly concerned that secondary

treatment and high-level disinfection, while they might take care of biological

pathogens, fail to address the potential entry of industrial and other non-biological

contaminants into USDWs.

17
 (2) The County and the Municipalities

The County argues, on the other hand, that the Final Rule exceeds the

regulatory authority given the EPA by the SDWA. Specifically, the County argues

that the Rule impermissibly broadens the definition of “endangerment.” Like

Sierra Club, both the County and the Municipalities also argue that the rule is

arbitrary and capricious and unsupported by the Risk Assessment and public

comments. Both argue that the Final Rule fails to take into account geographically

varied geology as mandated by the SDWA. The County is concerned that the Final

Rule improperly assumes pathogens will flow into the Biscayne Aquifer and that

the proper standard is whether there is an impact on public water systems, not

aquifers. The Municipalities particularly complain that the Risk Assessment was

methodologically flawed in 4 specific ways.8

8
The Municipalities also complain of a flawed cost/benefit analysis in the risk
assessment, specifically, that the EPA improperly neglected to consider the $308-539 million
cost of retrofitting a new injection facility to comply with the Final Rule. However, the
Municipalities have failed to point to any such estimated cost in the administrative record. As
discussed in the section on notice and comment, their argument that they received no notice as to
application of the Final Rule to all new wells is to no avail. Accordingly, they have waived this
argument. See Tex Tin Corp. v. EPA, 935 F.2d 1321, 1323 (D.C. Cir. 1991) (per curiam) (“a
party must initially present its comments to the agency during the rulemaking in order for the
court to consider the issue”); see also Camp v. Pitts, 411 U.S. 138, 142, 93 S. Ct. 1241, 1244
(1973) (reviewing court ought not rely on materials outside the record in applying the arbitrary
and capricious standard).
The Sierra Club, on the other hand, complains that it was improper for the EPA even to
consider costs in the course of its rulemaking. However, agencies are permitted to consider costs
unless the relevant statute expressly prohibits it. Michigan v. EPA, 213 F.3d 663, 678 ( D.C.
Cir. 2000) (per curiam). Although the SDWA does not require cost consideration, it does not
prohibit it either.

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 (3) Administrative Procedure Act

Two sets of petitioners also argue that the EPA failed to comply with the

notice and comment requirements of the APA. The Sierra Club complains that the

Final Rule’s abandonment of any demonstration provision is not a logical

outgrowth of the proposed rule and its notice and comment process. The

Municipalities similarly argue that the proposed rule and its comment process left

them insufficient notice of the Final Rule’s application to all future Class I wells.

II. DISCUSSION

A. Standard of Review

A final action by the EPA is subject to a highly deferential standard of

judicial review under the APA. Thereunder we must “hold unlawful and set aside

agency action, findings, and conclusions found to be . . . arbitrary, capricious, an

abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. §

706(2)(A); see also Sierra Club, Inc. v. Leavitt, 488 F.3d 904, 911 (11th Cir.

2007).

B. APA Notice Requirement

As an initial matter, we address the complaints by the Sierra Club and the

Municipalities that they received insufficient notice of certain components of the

Final Rule. The APA requires that agencies publish notice of their proposed

19
rulemaking and afford the public an opportunity to comment. 5 U.S.C. § 553

(b)-(c).

[The APA’s notice] requirements are designed (1) to ensure that
agency regulations are tested via exposure to diverse public comment,
(2) to ensure fairness to affected parties, and (3) to give affected
parties an opportunity to develop evidence in the record to support
their objections to the rule and thereby enhance the quality of judicial
review.

Envtl. Integrity Project v. EPA, 425 F.3d 992, 996 (D.C. Cir. 2005) (quoting Int’l

Union, United Mine Workers of Am. v. Mine Safety & Health Admin., 407 F.3d

1250, 1259 (D.C. Cir. 2005)). An agency satisfies this requirement, “and need not

conduct a further round of public comment, as long as its Final Rule is a ‘logical

outgrowth’ of the rule it originally proposed.” Ne. Md. Waste Disposal Auth. v.

EPA, 358 F.3d 936, 951-52 (D.C. Cir. 2004) (per curiam) (quotation and citation

omitted); see also Florida Manufactured Housing Ass’n, Inc. v. Cisneros, 53 F.3d

1565, 1576 n.4 (11th Cir. 1995) (recognizing the usual application for the “logical

outgrowth” test). “A rule is deemed a logical outgrowth if interested parties

‘should have anticipated’ that the change was possible, and thus reasonably should

have filed their comments on the subject during the notice-and-comment period.”

Ne. Md. Waste, 358 F.3d at 952 (quotation and citation omitted); see also First

Am. Discount Corp. v. Commodity Futures Trading Comm’n, 222 F.3d 1008, 1015

(D.C. Cir. 2000) (Notice must be “sufficient to advise interested parties that

20
comments directed to the controverted aspect of the Final Rule should have been

made.”) (quotation and citation omitted).

“Notice is inadequate if ‘the interested parties could not reasonably have

anticipated the final rulemaking from the draft rule.’” Am. Iron & Steel Inst. v.

OSHA, 182 F.3d 1261, 1276 (11th Cir. 1999) (quoting Nat’l Mining Ass’n v. Mine

Safety & Health Admin., 116 F.3d 520, 531 (D.C. Cir. 1997) (per curiam)). Under

this standard, an agency is not restricted to adopting the position it proposed and on

which it sought comment. Ass’n of Battery Recyclers v. EPA, 208 F.3d 1047,

1058 (D.C. Cir. 2000). Such a restriction would undermine the “purpose of notice

and comment—to allow an agency to reconsider, and sometimes change, its

proposal based on the comments of affected persons.” Id.; see also Ne. Md. Waste,

358 F.3d at 951 (If the EPA were precluded from changing its position, it “‘could

learn from the comments on its proposals only at the peril of subjecting itself to

rulemaking without end.’”) (citation omitted).

“[T]he ultimate outcome of . . . rulemaking might be no rule, or only partial

adoption of the proposed comprehensive rule.” Ass’n of Am. R.R.s v. DOT, 38

F.3d 582, 589 (D.C. Cir. 1994) (per curiam); see also Long Island Care at Home,

Ltd. v. Coke, __U.S.__, __, 127 S. Ct. 2339, 2351 (2007) (“[A]fter . . .

consideration the [agency] might choose to adopt the proposal or to withdraw it.”);

21
Am. Iron & Steel Inst. v. EPA, 886 F.2d 390, 400 (D.C. Cir. 1989) (“[o]ne logical

outgrowth of a proposal is . . . to refrain from taking the proposed step”); Natural

Res. Def. Council, Inc., v. Thomas, 838 F.2d 1224, 1242 (D.C. Cir. 1988) (“[T]he

EPA can obviously promulgate a final regulation that differs in some respects from

its proposed regulation.”). Finally, although they may not provide the only basis

upon which an agency claims to have satisfied the notice requirement, comments

may be adduced as evidence of the adequacy of notice. See Nat’l Mining Ass’n v.

Mine Safety & Health Admin., 512 F.3d 696, 699 (D.C. Cir. 2008); Horsehead

Res. Dev. Co. v. Browner, 16 F.3d 1246, 1268 (D.C. Cir. 1994) (per curiam); see

also Ne. Md. Waste, 358 F.3d at 952 (comments filed in support of and in

opposition to proposed distinction demonstrated that interested parties understood

issues and stakes).

(1) Abandonment of Demonstration Requirement

The Sierra Club challenges the Final Rule’s elimination of any

demonstration requirement. First, the EPA initially solicited general comments on

its proposed approaches for regulating Class 1 injection wells in South Florida.

Then, in its Notice of Data Availability, it specifically requested further comment

on whether, given the findings of the Risk Assessment, the type of hydrogeologic

demonstrations set out in Option 2 of the proposed rule were practicable and

22
feasible. Underground Injection Control Program – NODA, 68 Fed. Reg. at

23,673. All interested parties, including Sierra Club, had ample opportunity to

comment. The commentary provided ample support for the proposition that the

technical challenges and factual uncertainties would generally prevent a

convincing in-depth hydrogeological demonstration of wastewater fate and

transport as described in originally proposed Option 2. See CE1 at 113, 120, 180-

82. Accordingly, elimination of this demonstration requirement in the

promulgation of the Final Rule constitutes a logical outgrowth of the proposal and

comments. See Ass’n of Battery Recyclers, 208 F.3d at 1058; Horsehead Res.

Dev. Co., 16 F.3d at 1268.

However, Sierra Club is also concerned about notice of elimination of the

“non-endangerment” demonstration which was part of Option 1 of the July 2000

Proposed Rule. First, it is true that neither the EPA, nor any other party, has

pointed to any evidence that the EPA specifically put this element of Option 1 up

for comment, as it did with the in-depth demonstration required under proposed

Option 2.9 It is also true that no party has pointed to any comment specifically

addressing the simplified non-endangerment requirement in such a way as to make

9
Each party had ample opportunity to address this issue in the round of letter briefs
following oral argument. Letter briefs were submitted by the EPA, the County, and the
Municipalities. For whatever reason, Sierra Club chose not to submit a letter brief.

23
it clear that commenters considered it independently at issue. Each of these would

weigh in favor of our finding the Final Rule not to be a logical outgrowth. See Ne.

Md. Waste, 358 F.3d at 952; First Am. Discount Corp., 222 F.3d at 1015;

Horsehead Resource Dev. Co., 16 F.3d at 1268. However, the record as a whole

weighs otherwise.

First, both environmental groups and municipal entities commented on the

inherent unreliability of the hydrogeological demonstration proposed for Option 2,

and so on its insufficiency as a tool to protect USDWs. Supp. Appx. 33 (comment

of LEAF) (“EPA is proposing to rely on [a] process, involving demonstrations

through models and review and decision-making by government, that has been

proven fundamentally deficient in ensuring compliance with the SDWA.”), 74

(comment of Florida Chapter, Sierra Club) (“the EPA is repeating reliance on

demonstrations that are not field-verified”), 128 (comment of Hillsborough

County, Florida) (“It will not always be possible to perform a detailed hydro-

geological analysis to demonstrate whether or not a Class I [] municipal well

would cause violation of primary standards in the USDW” because of uncertainty

about movement of water in subsurface Florida.); CE1 at 254 (comment of LEAF)

(“the hydrogeological demonstration proposed in Option 2 is worthless”). But see

CE1 at 274 (FWEA Utility Council) (supporting Option 2 demonstration). Second,

24
advanced wastewater treatment and disinfection have been shown, by the Risk

Assessment, effectively to eliminate pathogens (the contaminants of concern

according to the Risk Assessment). CE1 at 81, 97. Therefore, it is only logical to

conclude, in the face of the significantly higher treatment levels adopted in the

Final Rule, that the simplified, technical-literature-based non-endangerment

demonstration has essentially become irrelevant. In other words, the Final Rule

operates on the principle that the only way to “demonstrate” non-endangerment is

to meet the specified higher treatment requirements. For these reasons, we find, as

to the elimination of the non-endangerment requirement, that the Final Rule is a

logical outgrowth of the proposed rule and its notice and comment period.10

10
The Sierra Club also argues that the change from a mandatory demonstration of non-
endangerment to monitoring at the discretion of the Florida director constitutes a “‘marked shift
in emphasis between the proposed regulations and the final rules’” and, as such, “is not a ‘logical
outgrowth’ of the proposed rule.” Sierra Club Br. at 48 (quoting Shell Oil Co. v. EPA, 950 F.2d
741, 751 (D.C. Cir. 1991) (per curiam)). More specifically, Sierra Club argues that proposed
Options 1 and 2 would have required “a pre-injection demonstration confirming that fluids
violating National Primary Drinking Water Standards and other public health standards would
not migrate into and contaminate USDWs,” and that elimination of the demonstration
requirement represented a “radical shift away from USDW protection” afforded by the proposed
rule. Id. at 48-49 (citing Natural Res. Def. Council v. EPA, 279 F.3d 1180, 1188 (9th Cir.
2002)).
As discussed, because of (1) the particular role the non-endangerment demonstration
played in proposed Option 1 (which incorporated less stringent treatment requirements), (2) the
comments concerning the lack of reliability regarding hydrogeological demonstrations, and (3)
the much higher treatment level imposed by the Final Rule, there was not as much a shift in
emphasis here as a shift in approach. Instead of requiring each well operator to demonstrate that,
by the time any injectate were to reach a USDW, it would not contaminate it, the Final Rule
requires treatment which has been shown sufficiently to remove identified contaminants of
concern at the point of injection so as to protect USDWs from eventual contamination in all
cases. Underground Injection Control Program – Revision, 70 Fed. Reg. 70,523-24. We see no
“radical” or “fundamental policy shift” precluding a finding of the Final Rule’s logical

25
Northeast Maryland Waste, 358 F.3d 936 at 951-52; Ass’n of Am. R.R.s, 38 F.3d

at 589; see also Long Island Care at Home, __U.S.__, __, 127 S. Ct. at 2351;

Thomas, 838 F.2d at 1242.

Even if we had found the Final Rule not to have been a logical outgrowth of

the proposed rule, Sierra Club would also need to show that it was prejudiced by

the lack of opportunity to comment. “[B]efore we may vacate an agency action

[for procedural failure] during the notice-and-comment period, we must take ‘due

account . . . of the rule of prejudicial error.’” Owner-Operator Indep. Drivers

Ass’n, Inc. v. Fed. Motor Carrier Safety Admin., 494 F.3d 188, 202 (D.C. Cir

2007) (quoting 5 U.S.C. § 706). To show prejudicial error, a petitioner “must

indicate with reasonable specificity,” the aspect of the rule to which it objects and

“how it might have responded if given the opportunity.” Id. At base, the petitioner

must demonstrate that “on remand, [it] can mount a credible challenge . . . and

[was] thus prejudiced by the absence of an opportunity to do so before the agency.”

Id. (quotations and citations omitted).

In this case, although the Sierra Club has specified the aspect of the Final

Rule to which it objects, it has failed to address how it would have mounted a

“credible challenge” to the elimination of the simplified non-endangerment

outgrowth. See Natural Res. Def. Council, 279 F.3d at 1188.

26
demonstration. See id. In its briefs, the Sierra Club has argued that, had it known

the demonstration requirement was at issue, “it could have submitted specific

scientific evidence, including expert testimony on the full range of dangerous

contaminants remaining in wastewater following treatment, the inability of the

required treatment to remove those contaminants, and the potential health effects

from exposure to such contaminants through drinking water.” Sierra Club Br. at

44. It also stated that “[w]ithout the demonstration, Option 1 is but a shell of its

former self.” Sierra Club Reply Br. at 15. It offers nothing more specific.

Further, throughout this process, Sierra Club has essentially argued that

nothing short of enforcement of the no-fluid-movement standard will satisfy the

statutory requirements of the SDWA. Additionally, in its initial brief, Sierra Club

conceded that it believed the non-endangerment demonstration of Option 1, as

proposed, “would be arbitrary, capricious, an abuse of discretion and contrary to

law in violation of 5 U.S.C. § 706(2)(A).” Sierra Club Br. at 41 n.10.

Accordingly, it is not credible for the Sierra Club also to argue that the simplified

non-endangerment demonstration proposed in Option 1 would have provided

additional value in protecting underground drinking water. Finally, in arguing

against the adoption of either of the proposed rules, the Sierra Club has had ample

opportunity to make all of its arguments regarding the “range of dangerous

27
contaminants remaining in wastewater following treatment” and their potential

health effects. Id. at 44. The EPA, in turn, has considered and responded based on

the data gained through its Risk Assessment and other comments. See

Underground Injection Control Program – Revision, 70 Fed. Reg. 70,513.

Accordingly, we conclude that, even if there were inadequate notice, the Sierra

Club has failed to show the necessary prejudicial error as to insufficient notice of

elimination of the non-endangerment demonstration requirement.

(2) Application of Rule to All Existing and Future Wells

The Municipalities argue that the Proposed Rule would have applied only to

existing wells that had demonstrated fluid movement while the Final Rule, without

providing adequate notice, applies to every new injection well. In the preamble to

the Proposed Rule, however, the EPA specifically requested comment “on whether

this proposed rule should apply to existing wells only, or if this proposed rule

should also apply to new wells.” Revision to UIC Requirements, 65 Fed. Reg. at

42,238. That this was sufficient notice to raise the issue of the scope of the

Proposed Rule is borne out by several comments on the scope of the rule. See

CE1 at 115 (EPA summary of comments); see also, e.g., CE2 at 1016 (Reef

Relief); CE2 at 1087 (Theresa Foley). Thus, not only did the EPA provide

adequate notice, but several concerned parties filed comments related to the

28
proposed scope of the rule, further demonstrating the adequacy of that notice. See

Ne. Md. Waste, 358 F.3d at 952; Horsehead Res. Dev. Co., 16 F.3d at 1268.

Because the Final Rule meets all APA notice requirements, we proceed to examine

the rule itself.

C. “Endangerment” Under the SDWA

The Sierra Club, the Municipalities, and the County argue, from opposing

positions, that the concept of endangerment of USDWs embodied in the Final Rule

is inconsistent with that outlined by the SDWA.

(1) Congressional Intent

When issues of statutory construction are raised, a court must first determine

whether Congress has “directly spoken to the precise question at issue. If the

intent of Congress is clear, that is the end of the matter.” Chevron, U.S.A., Inc. v.

Natural Res. Def. Council, Inc., 467 U.S. 837, 842, 104 S. Ct. 2778, 2781 (1984).

If Congress did not express its intent unambiguously, we defer to the agency’s

interpretation if it “is based on a permissible construction of the statute.” Legal

Envtl. Assistance Found., Inc. v. EPA, 118 F.3d 1467, 1473 (11th Cir. 1997)

(quoting Chevron, 467 U.S. at 843, 104 S. Ct. at 2782). Accordingly, we recognize

that “when an agency is charged with administering a statute, part of the authority

it receives is the power to give reasonable content to the statute’s textual

29
ambiguities” – in other words, the authority to fill gaps. Dep’t of Treasury, IRS v.

Fed. Labor Relations Auth., 494 U.S. 922, 933, 110 S. Ct. 1623, 1629 (1990); see

also Walther v. Bauknecht, 155 Fed. Appx. 463, 466-67 (11th Cir. 2005)

(unpublished) (per curiam) (“[Chevron] deference is a tool of statutory

construction whereby courts are instructed to defer to the reasonable interpretations

of expert agencies charged by Congress to fill any gap left, implicitly or explicitly,

in the statutes they administer.”) (citation omitted).

Under the first level of Chevron analysis, we employ the “traditional tools of

statutory construction” to determine Congressional intent. See Chevron, 467 U.S.

at 843 n.9, 104 S. Ct. at 2781. These tools include examination of the text of the

statute, its structure, and its stated purpose. See Nat’l Ass’n of State Util.

Consumer Advocates v. FCC, 457 F.3d 1238, 1252 (11th Cir. 2006), cert. denied,

Sprint Nextel Corp. v. Nat’l Ass’n of State Util. Consumer Advocates, __ U.S.

__,128 S. Ct. 1119 (2008).

The relevant statutory text is as follows:

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.

30
42 U.S.C. § 300h(d)(2). Despite this lengthy definition of endangerment,

§ 1421(d)(2) does not directly speak to precisely how the EPA should balance risks

in promulgating regulations protecting USDWs. See Chevron, 467 U.S. at 842,

104 S. Ct. at 2781; see also Goldstein v. SEC, 451 F.3d 873, 878 (D.C. Cir. 2006)

(a definition only clarifies, however, to the extent of its defining terms). Instead,

Congress made the EPA responsible for regulating underground injection that

“may result” in the presence of contaminants in underground water, if the presence

of such contaminants “may result” in the violation of drinking water regulations or

“may otherwise adversely affect” public health. 42 U.S.C. § 300h(d)(2) (emphasis

added). Through repeated reference to the possibility that a USDW could be

endangered, Congress established no particular metric for evaluating

endangerment. Instead, it explicitly left the EPA to give specific meaning to the

endangerment standard. See, e.g., 42 U.S.C. § 300h(b)(1) (providing for the

EPA’s publication of “minimum requirements for effective [state] programs to

prevent underground injection which endangers drinking water sources within the

meaning of subsection (d)(2) of this section.”).

This conclusion is consistent with the idea that, in the context of

environmental legislation and otherwise, “a determination of endangerment to

public health is necessarily a question of policy that is to be based on an

31
assessment of risks and that should not be bound by either the procedural or the

substantive rigor proper for questions of fact.” Ethyl Corp. v. EPA, 541 F.2d 1, 24

(D.C. Cir. 1976) (en banc) (addressing the Clean Air Act). Recognizing, in this

context, that it was not necessarily the best equipped to make such an analysis,

Congress left determination of the most appropriate standards to the expertise of

the agency. Thus, we conclude that the SDWA delegated to the EPA the type of

“gapfilling” authority entitled to further analysis under Chevron. See Dep’t of

Treasury, 494 U.S. at 933, 110 S. Ct. at 1630.

The County and the Municipalities also argue that the Final Rule’s concept

of endangerment nevertheless exceeds the authority granted by the SDWA by

protecting more than it is authorized to protect. However, although the language in

§ 1421(d)(2) does frame the EPA’s regulatory authority, it cannot be read

explicitly to restrict that authority to circumstances where risk of contamination to

USDWs or public water supplies is all but certain, or even to restrict that authority

according to a particular metric.11 The statute’s precautionary purpose is clear and

11
In its reply, the County argues that the SDWA does offer metrics in the form of its
definition of endangerment. This is not the case. A metric, by definition, is expressed in
quantifiable terms. The statute provides only broad parameters for the presence in USDWs of
any contaminant the presence of which might result in violation of any national primary drinking
water regulation or might otherwise adversely affect public health. Although “national primary
drinking water regulations” might be deemed precisely quantifiable, “adverse” effects on public
health are not. Therefore, the statute lacks sufficient metrics to support the County’s argument.
In either case, the statute’s use of the words “may” and “might” moves even further in the
opposite direction of a metric. Additionally, although the County argues that the statute requires

32
the “actual contamination of drinking water is not a prerequisite either for the

establishment of regulations or permit requirements or for the enforcement

thereof.” See H.R. Rep No. 93-1185, at 32 (1974), reprinted in 1974 U.S.C.C.A.N.

6454, 6484.

At the other end of the spectrum, the Sierra Club’s argument that the Final

Rule is contrary to the authority delegated by the statute – because the statute

requires a no-fluid-movement standard – must also fail. As the Sierra Club points

out, the legislative history indicates that “endangerment” is to be “liberally

construed so as to effectuate the preventative and public health protective purposes

of the bill.” Id. However, despite this evidence that the statutory language was

intended for liberal construction, no mention is made of a blanket no-fluid-

movement standard. Further, Congress has explicitly incorporated no-fluid-

movement or “no migration” standards into other similar statutes. See, e.g.,

Resource, Conservation and Recovery Act (“RCRA”), 42 U.S.C. § 6924(d)

(incorporating a “no migration” standard for land disposal of hazardous wastes).

protection of USDWs only if a municipality’s drinking water processing would not remove
contaminants prior to distribution of drinking water, the statute requires the EPA to protect the
source of the drinking water, not the system of supply. 42 U.S.C. § 300h(b)(1); see also H.R.
Rep. No. 93-1185, at 28 (1974), reprinted in 1974 U.S.C.C.A.N. 6454, 6484 (committee’s intent
was to protect both actual and potential drinking water sources).

33
It could have done so here as well, but has apparently chosen not to do so. We

therefore proceed to the second level of Chevron analysis.

(2) EPA’s Interpretation of the SDWA

An agency’s construction of a statute is “deemed reasonable if it is not

arbitrary, capricious, or clearly contrary to law.” Ala. Power Co. v. FERC, 22 F.3d

270, 272 (11th Cir. 1994). An agency rule is arbitrary and capricious “if the

agency has relied on factors which Congress has not intended it to consider,

entirely failed to consider an important aspect of the problem, offered an

explanation for its decision that runs counter to the evidence before the agency, or

is so implausible that it could not be ascribed to a difference in view or the product

of agency expertise.” Motor Vehicle Mfrs. Ass’n of U.S., Inc. v. State Farm Mut.

Auto. Ins. Co., 463 U.S. 29, 43, 103 S. Ct. 2856, 2867 (1983); Ala.-Tombigbee

Rivers Coalition v. Kempthorne, 477 F.3d 1250, 1254 (11th Cir. 2007).

“Where a statute is precautionary in nature, the evidence difficult to come

by, uncertain, or conflicting because it is on the frontiers of scientific knowledge,

the regulations designed to protect the public health, and the decision that of an

expert administrator, we will not demand rigorous step-by-step proof of cause and

effect.” Ethyl Corp, 541 F.2d at 28. This standard upholds agency actions as long

as there is a rational basis for the agency decision. Arango v. U.S. Dep’t of

34
Treasury, 115 F.3d 922, 928 (11th Cir. 1997); Manasota-88, Inc. v. Thomas, 799

F.2d 687, 691 (11th Cir. 1986). “The reviewing court may not substitute its

judgment for that of the agency but must, instead, defer to the agency’s technical

expertise.” City Of Oxford, Ga. v. F.A.A., 428 F.3d 1346, 1352 (11th Cir. 2005).

Indeed, courts must be “extremely deferential” when an agency’s decision rests on

the evaluation of complex scientific data within the agency’s technical expertise.

New York v. Reilly, 969 F.2d 1147, 1152 (D.C. Cir. 1992). In such a situation,

although a reviewing court may not “rubber stamp” an agency decision, it “‘must

look at the [agency’s] decision not as the chemist, biologist, or statistician that [it

is] qualified neither by training nor experience to be, but as a reviewing court

exercising . . . certain minimal standards of rationality.’” Chemical Mfrs. Ass’n v.

EPA, 870 F.2d 177, 199-200 (5th Cir. 1989) (quoting Am. Paper Inst. v. EPA, 660

F.2d 954, 963 (4th Cir. 1981) (quoting Ethyl Corp., 541 F.2d at 36-37)).

Further, the EPA is compelled to exercise its judgment in the face of

scientific uncertainty unless that uncertainty is so profound that it precludes any

reasoned judgment. See Massachusetts v. EPA, __ U.S. __, __,127 S. Ct. 1438,

1463 (2007) (recognizing this obligation in the context of the uncertainty

concerning global climate change). Even “probative preliminary data not yet

certifiable as ‘fact’” may provide an appropriate basis for promulgation of

35
regulations. Ethyl, 541 F.2d at 28. Generally, “it is only when a model bears no

rational relationship to the characteristics of the data to which it is applied that we

will hold that the use of the model was arbitrary and capricious.” Appalachian

Power Co. v. EPA, 135 F.3d 791, 802 (D.C. Cir. 1998) (per curiam).

Just decades – less than an instant in geologic time – after the EPA first

promulgated its regulations under the SDWA, it became apparent that the no-fluid-

movement standard was not viable after all for many parts of southern Florida.

Fluid movement resulting from the operation of certain Class I wells was violating

applicable UIC regulations. Since that violation was a function of geology, and

therefore not amenable to technological correction, the affected wells were unable

to comply with the statute and would have had to cease operating. See

Underground Injection Control Program – Revision, 70 Fed. Reg. at 70,523. In

some instances, closure of the wells would have disrupted municipalities’ sole

method of disposing of millions of gallons of wastewater per day. See CE1 at 402.

To address this problem, the EPA created a regulatory alternative to the no-fluid-

movement standard: allowing facilities unable fully to isolate wastewater injectate

instead to apply advanced wastewater treatment and high-level disinfection prior to

36
injection.12 The parties argue from opposing positions that the EPA’s new rule is

arbitrary, capricious, and unsupported by the record.

12
The Sierra Club also asserts that the Final Rule is invalid in that it reverses a long-
standing policy of prohibiting any migration of injectate into USDWs. If an agency adequately
explains the reasons for a reversal of policy, however, “change is not invalidating, since the
whole point of Chevron is to leave the discretion provided by the ambiguities of a statute with
the implementing agency.” Nat’l Cable & Telecomms. Ass’n v. Brand X Internet Servs., 545
U.S. 967, 981, 125 S. Ct. 2688, 2699-2700 (2005) (quotation and citation omitted). Similarly,
interpretive changes are permitted as long as they create no unfair surprise, and unfair surprise is
deemed unlikely when notice and comment periods have been incorporated into process. See
Long Island Care at Home, __U.S. at __, 127 S. Ct. at 2349. The reasons given by the EPA,
however, as discussed, make clear that this is more a case of broadening options than of
reversing policy. Further, agencies “‘must consider varying interpretations and the wisdom of
[their] policies on a continuing basis’ . . . for example, in response to changed factual
circumstances.” Brand X, 545 U.S. at 981, 125 S. Ct. at 2700 (quoting Chevron, 467 US. at 863-
64, 104 S. Ct. at 2792).
Since the promulgation of the no-fluid-movement standard, scientists have gained a
greater understanding of the subsurface environment in southern Florida. The no-fluid-
movement standard is not feasible for many areas thereof. Accordingly, another approach to
non-endangering waste disposal must be found. The Risk Assessment indicates both that none
of the other three methods of waste disposal is necessarily preferable to underground injection
and that secondary treatment and high-level disinfection will protect USDWs against
endangerment as well as an effective waste isolation approach would. CE1 at 81, 97. Further,
the EPA has explained that the Final Rule protects USDWs against endangerment through
pretreatment of injectate rather than through reliance on the confining properties of underground
hydrogeology. Comparing the two methods, the EPA explained that the “alternative treatment
requirements are also ‘operationally meaningful’ in that they address the contaminants of
concern in municipal wastewater via proven, long-used technologies that have been shown to
remove a high percentage of pathogens of concern.” CE1 at 97. Accordingly, although the Final
Rule is really a regulatory alternative to longstanding policy and not a reversal of that policy, the
EPA has offered adequate explanation for any reversal of policy that might be perceived. See
Brand X, 545 U.S. at 981, 125 S. Ct. at 2699-2700. Further, because multiple periods of notice
and comment were incorporated into the process, during which all of these issues were discussed
at length, even if there had been an interpretive change, there was no unfair surprise to invalidate
the Final Rule. See Long Island Care at Home, __U.S. at __, 127 S. Ct. at 2349.

37
 (a) Rule is Arbitrary and Capricious – Not Strict Enough

(i) Failure to Consider Non-Biological Contaminants

We first address the Sierra Club’s argument that the Final Rule is

inconsistent with a reasonable interpretation of the statutory “non-endangerment”

provision because it does not address the possible presence of non-biological

contaminants in the treated injectate, such as radioactive, pharmaceutical, industrial

and other hazardous wastes, particularly those from industrial users. Sierra Club

asserts that the EPA’s focus on the “primary risk” associated with pathogenic

microorganisms “entirely failed to consider the risks” of these other pollutants, and

thus is arbitrary and capricious. Sierra Club Reply at 7, 8.

The EPA’s Risk Assessment models, however, show that representative non-

biological contaminants will not migrate into USDWs, which are located above

points of injection, in quantities great enough to exceed maximum acceptable

contaminant levels (MCLs). See CE1 at 445-47. The Sierra Club argues that this

cannot be reconciled with the Risk Assessment’s acknowledgment of a lack of

precise data regarding the transport of contaminants underground. However, the

Risk Assessment included a risk characterization using a transportation model to

predict the potential final concentrations of certain representative non-biological

contaminants. That model accounted for various risk mitigation factors, such as

38
the variety of natural chemical and physical processes to which injectate is subject

after injection, including biodegradation, hydrolysis, sorption, volatization,

radioactive decay, transformation, and chemical or biological stabilization, which

tend to mitigate the risk of endangerment. See CE1 at 444.13 The model also

employed conservative assumptions as to rates of travel through the subsurface

formations.14 The study still showed that USDWs above points of injection would

not exceed MCLs for chemical contaminants15 or exceed health-based criteria for

ammonia. CE1 at 446, 461. On this basis, the Risk Assessment concluded that

pathogens were the only threat that would not be adequately addressed by the

lower treatment requirements in place at the time of the study. CE1 at 463, 601,

603. The EPA raised treatment requirements to address this problem. We

therefore conclude that the EPA model bears a rational relationship to the

characteristics of the data to which it was applied and thus is not arbitrary or

capricious. See Appalachian Power Co., 135 F.3d at 802.

Further, the Final Rule does, in fact, specifically address the potential for

non-biological contaminants. First, the Final Rule requires that facilities with

13
Microbial pathogens – particularly fecal coliforms and viruses, on the other hand, may
well survive longer in groundwater than in surface water. See CE1 at 456.
14
These assumptions tend to overestimate exposure and risk. See CE1 at 447.
15
In fact, they would be below permissible drinking water levels. CE1 at 461.

39
significant industrial users implement industrial pretreatment; owners and

operators must either pretreat or certify that there are no significant industrial

users, consistent with the standards set in Rule 62-610.330 of the Florida Admin.

Code. Underground Injection Control Program – Revision, 70 Fed. Reg. at 70,532.

Thus, any industrial waste rising above this level would necessarily be pretreated

to Florida’s reclaimed water standards.16

The EPA has also generally explained that the Final Rule does not require all

facilities to institute treatment targeting these other specific non-biological

contaminants for four basic reasons. First, the Risk Assessment found that the only

contaminants that posed a potential threat to USDWs were pathogenic

microorganisms. Second, Class I wells are already prohibited from injecting listed

or characteristically hazardous waste streams in the first place. Third, each such

well is allowed to inject only wastewater that has received the level of treatment

specified in its individual permit, as deemed necessary to prevent endangerment.

Finally, many other contaminants are already addressed through the EPA’s existing

pretreatment regulations, and any future apparent threat could be addressed on an

individual basis. On these and the preceding bases, we conclude that the EPA has

16
The record reflects that fourteen of the sixteen facilities that have caused or are likely to
cause fluid movement into a USDW already have industrial pretreatment programs in place, and
that the remaining two have conducted surveys indicating that they are not handling waste
streams from “significant industrial users.” CE1 at 113.

40
a reasonable basis for the Final Rule’s approach to non-biological contaminants.

See Motor Vehicle Mfrs. Ass’n, 463 U.S. at 43, 103 S. Ct. at 2856; Kempthorne,

477 F.3d at 1254.

More generally, the Sierra Club asserts that the Final Rule fails to address

the existence of several potential threats to human health posed by pathogens,

nutrients, and other contaminants, arguing from the position that all such risks

should be analyzed and eliminated prior to injection. However, the SDWA

mandates only that the EPA protect against endangerment to USDWs, not

necessarily against contaminants extant at the point of injection. This distinction

allows for the consideration of factors that would mitigate risks between the point

of injection and contact with a USDW. In other words, because wastewater is

injected below USDWs, it must travel upwards to make contact. As discussed, in

making that journey, the injectate is subject to a variety of chemical and physical

processes that mitigate risk. Underground Injection Control Program – Revision,

70 Fed. Reg. at 70,532. The EPA’s risk assessment modeling employed

conservative estimates of the exposure of injectate to these mitigating factors

thereby, if anything, overestimating risk. CE1 at 444-48. The EPA’s risk

characterization indicated that although total suspended solids, color, odor, nutrient

contamination, byproducts of disinfection, and industrial discharge contamination

41
might remain problematic at the point of injection even after the Final Rule’s

required treatment, by the time the treated injectate was likely to come into contact

with a USDW, that risk would have been sufficiently mitigated. CE1 at 445-47.

Accordingly, we conclude that the Sierra Club’s record-based objections fail to

invalidate the Final Rule.

(ii) Impermissible Consideration of Alternative Methods

The Sierra Club would also have us invalidate the Final Rule on the ground

that the EPA impermissibly considered the utility of underground injection of

waste in comparison with other disposal options. Because Congress specifically

directed the EPA to analyze and compare the relative risks of these options in its

2000 Risk Assessment, consideration of that factor was not only permissible, but

mandated. CE1 at 352 (“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.”). Accordingly, there is no basis for invalidating

the Final Rule on this ground. See Motor Vehicles Mfrs. Ass’n, 463 U.S. at 43,

103 S. Ct. at 2867.

42
 (b) Rule is Arbitrary and Capricious – Too Restrictive

(i) Geological Variation

The Municipalities and County first complain that the Final Rule fails to

take into account differences in Florida geology and hydrology, as required by the

SDWA. The record reflects that the subsurface environment in southern Florida is

characterized by cavernous formations overlain by permeable carbonate rock,

which, in places, prevents attainment of the no-fluid-movement standard. These

carbonate formations – including the Floridan Aquifer itself, which underlies most

of Florida as well as portions of neighboring states – are characterized by

significantly variable porosity and permeability resulting from fracturing and other

geologic processes that occur after formation. Revision to UIC Requirements, 65

Fed. Reg. at 42,236. Because these processes continue to take place due to

subsurface fluid movement, the extent to which any given portion of the formation

is permeable at any given time is not easily predicted. The EPA has restricted

application of the Final Rule to counties characterized by this type of underground

geology which may not reliably confine and isolate injected wastewater from

USDWs. Accordingly, we conclude that the EPA’s consideration of variation

within the subsurface geology of south Florida was sufficient.

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 The County also argues that the EPA improperly failed to consider the

presence of the confining Hawthorne Layer, which likely effectively isolates the

Biscayne Aquifer from the Floridan Aquifer, when it applied the Final Rule to

Miami-Dade County. However, the EPA is charged with protecting the Floridan

Aquifer itself because portions of that aquifer are designated a USDW, even

though Miami-Dade County does not currently draw from it. See Underground

Injection Control Program – Revision, 70 Fed. Reg. 70,516; 40 C.F.R. § 144.3; see

also H.R. Rep. No. 93-1185 (1974), reprinted in 1974 U.S.C.C.A.N. at 6484. (“The

Committee seeks to protect not only currently-used sources of drinking water, but

also potential drinking water sources for the future. This may include water

sources which presently exceed minimum intake water quality requirements or

maximum contaminant levels or which are not presently accessible for use as a

community drinking water supply source.”). Accordingly, we conclude that

neither argument has pointed to evidence of insufficient consideration of geologic

variation.

(ii) Flawed Methodology

The Municipalities argue that the Final Rule is not supported by the record

due to four alleged flaws in the Risk Assessment’s methodology: (1) failure to

consider the concentration of contaminants already present in the aquifers, (2)

44
failure to employ a quantitative probabilistic risk analysis methodology, (3) failure

to consider the results of a then-unpublished University of Miami study of well-

disposal practices, and (4) faulty assumptions about contaminant plumes. These

criticisms are based on a review of the Risk Assessment performed by two

scholars, a geologist, and a public utilities manager.

The review, however, fails directly to support these criticisms. As an initial

matter, it directly states that the Risk Assessment’s general approach and

methodology were “generally appropriate for the problem addressed.” CE1 at 284.

As for the four specific criticisms, first, the Risk Assessment did incorporate the

limited data available at the time of the study regarding the quality of groundwater

prior to construction and operation of injection wells. CE1 at 412-13. The EPA

also analyzed current and historic groundwater monitoring for the representative

counties – particularly, for example, observing a period of fecal coliform spikes in

the mid-nineties which was finally alleviated by well disinfection. CE1 at 415-20.

Second, although it is true that the EPA did not perform a quantitative

probabilistic risk analysis, even the review, as noted, states that the Risk

Assessment’s methodology was appropriate for the problem it addressed. CE1 at

284. Also, the law does not require selection of the single best methodology in any

case, but only a study “based on a consideration of the relevant factors” and in the

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construction of which there has been no “clear error of judgment.” Citizens to

Preserve Overland Park, Inc. v. Volpe, 401 U.S. 402, 416, 91 S. Ct. 814, 824

(1971), abrogated on other grounds, Califano v. Sanders, 430 U.S. 99, 97 S. Ct.

980 (1977).

The EPA concedes that the nature of the available data left it unable to

perform a quantitative probabilistic risk analysis of the type suggested in the

review, but argues that it performed the most rigorous analysis possible given the

available data. According to the Risk Assessment, microbial pathogens in the

aquifer will likely not degrade at as great a rate as they would in surface water.

CE1 at 456, 599. The uncertainty as to this rate of degradation was coupled with

general uncertainty stemming from the variable carbonate geology. Explaining

that it is much easier and more efficient to prevent groundwater contamination than

to try to decontaminate it later, the EPA addressed these uncertainties by making

conservative assumptions regarding rates of degradation and travel of effluent

through the subsurface environment. The use of this methodology is a legitimate

discretionary decision on the part of the EPA. See Am. Iron & Steel Inst. v. EPA,

115 F.3d 979, 993 (D.C. Cir. 1997) (per curiam) (“[I]t is within EPA’s discretion

to decide that in the wake of uncertainty, it would be better to give the values a

conservative bent rather than err on the other side.”); Reilly, 969 F.2d at 1152.

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 Third, even according to the review, the findings of the Risk Assessment are

not inconsistent with those of the Miami study.17 CE1 at 280, 283. Whether or not

this is the case, even though the EPA was obligated to employ the best science, it

had no absolute obligation to incorporate the findings of any other particular study

because the EPA was conducting an independent risk assessment. See Tex. Office

of Pub. Util. Counsel v. FCC, 265 F.3d 313, 328 n.7 (5th Cir. 2001) (“An agency

need not respond to every study, and only has to address significant comments.”)

(quotations omitted); Hughes River Watershed Conservancy v. Johnson, 165 F.3d

283, 289 (4th Cir. 1999) (agency need not consider every study as long as it

addresses specific concerns raised by comments) (citing Roanoke River Basin

Ass’n v. Hudson, 940 F.2d 58, 64 (4th Cir. 1991) (stating that an agency is

required only to address specific concerns and explain why it found them

unpersuasive)).

Fourth, the Municipalities claim that the Risk Assessment makes flawed

assumptions as to conductivity rates in different risk scenarios and the rate of

dilution of contaminant plumes. Due to uncertainties resulting from limited

17
Although the Municipalities assert that the Miami study contained contrary scientific
data, they point to no such instance, and the record cite in their brief corresponds to a page of the
review (CE1 at 280) which says that, generally, results of the Risk Assessment should have been
compared with those of other studies. It does not characterize the results of any such
comparison.

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availability of data, the EPA again chose the most conservative, protective

approach in modeling its assumptions as to dilution and conductivity rates. This is

permissible. See Am. Iron & Steel Inst., 115 F.3d at 993. It applied different

conductivity rates in light of both known geologic characteristics of subsurface

Florida (such as porous and more confining material, and the existence of fractures

and fissures) and the geologic uncertainties about exactly what exists where within

the aquifers. We conclude that the technical judgment made by the EPA was

reasonable. See West Virginia v. EPA, 362 F.3d 861, 866-67 (D.C. Cir. 2004)

(deference is due to an agency’s modeling of complex phenomena, so long as

“model assumptions . . . have a ‘rational relationship’ to the real world”). This is

another instance of a technical judgment lying fully within the scope of the EPA’s

agency discretion. See Reilly, 969 F2d at 1152.

(iii) Justification for High-Level Disinfection

Finally, the County additionally complains that the Final Rule’s imposition

of a high-level disinfection requirement, as opposed to some lower level of

disinfection, is arbitrary and capricious. However, the high-level disinfection

standard is the same one imposed by the State of Florida upon any wastewater that

might come into contact with the public before microbial pathogens have a chance

sufficiently to degrade. Incomplete information about the movement and fate of

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pathogens during the injection process and beyond serves as a rational basis for

requiring high-level disinfection prior to injection to prevent endangerment to

USDWs. See Am. Iron & Steel Inst., 115 F.3d at 993.

For all of these reasons, we conclude that the Final Rule is a reasonable

interpretation of the statute, is sufficiently supported by the administrative record,

and is not arbitrary and capricious. Thus, we defer to the judgment of the EPA.

See Chevron, 467 U.S. at 843, 104 S. Ct. at 2782; Legal Envtl. Assistance Found.,

118 F.3d at 1473.

III. CONCLUSION

The County, the Municipalities, and the Sierra Club petition for review of

the Final Rule promulgated by the EPA amending the current federal underground

injection control requirements for Class I municipal disposal wells in Florida. We

conclude that the EPA afforded sufficient public notice of both the elimination of

the non-endangerment demonstration requirement and the application of the Final

Rule to new Class I wells as required by the APA. We further conclude that the

petitioners have failed to show that the Final Rule is inconsistent with the statutory

authority granted the EPA under the SDWA or that the Final Rule is unsupported

by the record, or otherwise arbitrary and capricious. Accordingly, the petition is

DENIED.

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