Petition for Writ of Certiorari — INDIANA WATER QUALITY COALITION v. Environmental Protection Agency

5

which the Great Lakes States or Tribe demonstrates that

application of one or more guidance procedures to the given

pollutant are not scientifically defensible.” /d. at 20,842. The

referenced pollutants listed in Table 5 included numerous

pollutants not at issue in this case, and did not include the

pollutant whole effluent toxicity (““WET”).* Jd. EPA further

explained the scientific indefensibility exception in the

preamble of the Proposed Guidance:

Section 132.4(g) [later becoming section

132.4(h)] also provides that the Great Lakes States

and Tribes may, but are not required to, apply

the proposed criteria methodologies and

implementation procedures to any pollutant for

which the regulatory authority demonstrates that

one or more procedures in the Guidance are not

scientifically defensible. The reason for this

exclusion is that there may be pollutants identified

in the future for which some of the methodologies

or procedures being proposed today may

not be technically appropriate. Under these

circumstances, EPA wishes to provide sufficient

flexibility for permitting authorities to address

these pollutants on a case-by-case basis.

Id. at 20,843.

3. WET is defined as “the aggregate toxic effect of an effluent

measured directly by a toxicity test.” 40 C.F.R. § 122.2. “The whole

effluent approach to toxics control for the protection of aquatic life

involves the use of acute and chronic toxicity tests to measure the

toxicity of wastewaters.” Technical Support Document For Water

Quality-Based Toxics Control, EPA/505/2-90-001 (March 1991).

6

On March 23, 1995, after accepting and responding to

comments from interested parties, EPA promulgated a final

guidance document pursuant to section | 18(c)(2)(A) of the

Clean Water Act (the “GL Guidance”). See Final Water

Quality Guidance for the Great Lakes System, 60 Fed. Reg.

15,366 (March 23, 19€ 3). Generally, the GL Guidance

consists of water quality criteria for 29 pollutants

to protect aquatic life, wildlife, and human health,

and detailed methodologies to develop criteria for

additional pollutants; implementation procedures

to develop more consistent, enforceable water

quality-based effluent limits in discharge permits,

as well as total maximum daily loads of pollutants

that can be allowed to reach the Lakes and their

tributaries from all sources; and antidegradation

policies and procedures.

60 Fed. Reg. at 15,366. In the introduction of the GL

Guidance, EPAreferenced an informal EPA document named

the Final Water Quality Guidance for the Great Lakes

System: Supplementary Information Document (SID), (EPA,

March 1995, 820-B-95-001) (the “SID”), stating that

“[djetailed discussion of EPA’s reasons for issuing the final

Guidance, analysis of comments and issues, description of

specific changes made to the proposed Guidance, and further

description of the final Guidance, are provided in” the SID.

Id. at 15,367. The SID, however, was not promulgated

pursuant to the Administrative Procedures Act’s rulemaking

procedures (5 U.S.C. §§ 551-559), but was drafted as an

informal “support document” for the GL Guidance. See SID,

§ DISCLAIMER. In fact, the SID was reviewed only by EPA’s

Office of Science and Technology. /d.

J

The GL Guidance specifically established minimum

WET requirements for the Great Lakes System, including

procedures for determining whether wastewater may have

the reasonable potential to cause or contribute to a discharge

in excess of water quality standards governing WET, and

thus must be subjected to effluent discharge limits. 60 Fed.

Reg. at 15,378; see also, 40 C.F.R. pt. 132, Appendix F,

Procedure 6. The GL Guidance requires Great Lakes States

to impose effluent limitations, either for WET or for a specific

chemical causing the toxicity, if it determines “that the WET

of an effluent is or may be discharged at a level that will

cause, have the reasonable potential to cause, or contribute '

to an excursion above” any WET criterion specified in the

State’s water quality standards. 60 Fed. Reg. at 15,423. The

GL Guidance sets forth specific mathematical calculations

for making WET reasonable potential determinations. /d. at

15,423-24.

The GL Guidance provides that States may adopt an

alternative implementation procedure for a particular

pollutant, if the GL Guidance implementation procedure is

not scientifically defensible:

[T]he final Guidance provides flexibility for State

and Tribal adoption and implementation of

provisions consistent with the final Guidance in

many areas, including the following:

Scientific Defensibility Exclusion: Great Lakes

States and Tribes may apply alternate procedures

consistent with Federal, State, and Tribal

requirements upon demonstration that a provision

8

in the final Guidance would not be scientifically

defensible if applied to a particular pollutant in

one or more sites. This provision is in § 132.4(h)

of the final Guidance.

60 Fed. Reg. at 15,370. Accordingly, EPA formally

promulgated the scientific defensibility exception to the GL

Guidance at 40 C.F.R. § 132.4(h) (“section 132.4(h)"), which

provides as follows: !

For any pollutant other than those in Table 5 of

this part for which the State or Tribe demonstrates

that a methodology or procedure in this part is

not scientifically defensible, the Great Lakes

States and Tribes shall:

(1) Apply an alternative methodology or

procedure acceptable under 40 C.F.R. part 131

when developing water quality criteria; or

(2) Apply an alternative implementation

procedure that is consistent with all applicable

Federal, State, and Tribal laws.

40 C.F.R. § 132:4(h). Unlike the preamble to the Proposed

Guidance, section 132.4(h) does not indicate that the

scientific defensibility exception is limited only to pollutants

identified in the future.

With the GL Guidance in place, section 118(c)(2)(C) of

the Clean Water Act requires Great Lakes States to adopt

water quality standards, antidegradation policies, and

implementation procedures that are consistent with (or as

protective as) the GL Guidance for waters within the Great

9

Lakes System. 33 U.S.C. § 1268(c)(2)(C).* To satisfy this

requirement, on December 16, 1996, the State of Indiana

adopted Great Lakes System water quality standards,

antidegradation policies, and implementation procedures,

which became effective on February 13, 1997 (the “Indiana

Rules”). As part of the adoption of the Indiana Rules, the

State of Indiana determined that the GL Guidance procedure

for evaluating whether wastewater discharges have the

reasonable potential to cause or contribute to an excursion

above water quality criteria concerning WET was not

scientifically defensible within Indiana.* Accordingly, as

permitted by section 132.4(h), the State of Indiana elected

to implement an alternative procedure to make WET

reasonable potential determinations.

On August 4, 2000, after reviewing the submissions of

various Great Lakes States, EPA issued an order promulgating

a final rule entitled Jdentification of Approved and

Disapproved Elements of the Great Lakes Guidance

Submissions From the States of Michigan, Ohio, Indiana,

and Illinois, and Final Rule (the “EPA Order’). 65 Fed. Reg.

47,864 (Aug. 4. 2000); App. at 19a. The EPA Order approved,

conditionally approved, or disapproved various provisions

of the Indiana Rules. /d. Relevant to this case, EPA

4. If a Great Lakes State, however, fails to adopt standards,

policies, and implementation procedures consistent with the GL

Guidance, EPA is required to promulgate them for the State.

33 U.S.C. § 1268(c)(2)(C).

5. Specifically, the State of Indiana submitted information to

EPA showing that most of the WET data was below levels that can

be quantified, and, therefore, there was insufficient information to

validate the assumptions on which the GL Guidance treatment of

WET is based.

10

disapproved Indiana’s procedure for determining whether

wastewater discharges have the reasonable potential to cause

or contribute to an excursion above a WET water quality

standard. 65 Fed. Reg. at 47,868-69; App. at 39a-40a.

Proceedings below. IWQC filed a Petition for Review

challenging the EPA Order’s finding that the Indiana Rules

were inconsistent with the GL Guidance.* IWQC argued that

the State of Indiana had submitted sufficient information and

analysis to establish that the WET reasonable potential

procedures in the GL Guidance are not scientifically

defensible within Indiana. According to section 132.4(h),

upon such demonstration, the State of Indiana is permitted

to use an alternative implementation procedure to make WET

reasonable potential determinations, as long as the procedure

is Otherwise consistent with federal and state law. IWQC also

argued that the WET reasonable potential procedure in the

Indiana Rules is consistent with applicable federal and state

law.

In response, EPA argued that section 132.4(h) only

applies to pollutants identified in the future, citing language

in the preamble to the Proposed Guidance that stated

“pollutants identified in the future for which some of the

methodologies or procedures [in the Guidance] may not be

technically appropriate.” 58 Fed. Reg. at 20,843. EPA also

cited to the informal SID, which states that “[t]he reason for

6. IWQC originally filed its Petition for Review with the

Seventh Circuit on December 18, 2000. IWQC’s co-petitioners below

filed a Petition for Review with the Sixth Circuit on December 1,

2000. On April 11, 2001, IWQC’s Petition for Review was transferred

to the Sixth Circuit pursuant to a Motion to Transfer filed by EPA

under 28 U.S.C. § 2112(a)(1) and (5). On May 15, 2001, the Sixth

Circuit accepted the transfer, consolidating the two cases.

1]

this exclusion is that there may be pollutants identified in

the future for which some of the methodologies or procedures

in the final Guidance may not be technically appropriate.”

EPA argued that because WET is not a pollutant identified

in the future, section 132.4(h) does not allow the State of

Indiana to implement an alternative procedure for its WET

reasonable potential analysis.

On June 16, 2005, the Sixth Circuit denied IWQC’s

Petition for Review. WQC v. EPA, 411 F.3d 726, 736 (6"

Cir. 2005); App. at 16a. With regard to the scientific

indefensibility exception, the court deferred to EPA’s

interpretation of section 132.4(h):

But the EPA makes a compelling argument when

it points out that the provision allowing alternative

schemes was developed because “there may be

pollutants identified in the future for which some

of the methodologies or procedures [in the GL

Guidance] may not be technically appropriate.

Under these circumstances, EPA wishes to provide

sufficient flexibility for permitting to address

these pollutants on a case-by-case basis.”

Id. (quoting Proposed Guidance, 58 Fed. Reg. at 20,843);

App. at 15a-16a. The Sixth Circuit also relied on the SID for

the same proposition, that section 132.4(h) only applies to

“pollutants identified in the future.” /d. The Sixth Circuit

then concluded that under EPA’s interpretation of section

132.4(h), WET discharges were not covered by the scientific

indefensibility exception. Jd. (“WET discharges, which have

concerned the EPA for decades, do not fall under the category

of ‘pollutants identified in the future.’ . . . This exception to

the Guidance is therefore inapplicable to the petitioners’

12

regulatory schemes.”) /d.; App. at 16a. On November 22,

2005, the Sixth Circuit confirmed its ruling and denied

IWQC’s Petition for Rehearing En Banc. App. at 17a-18a.

REASONS FOR GRANTING THE PETITION

This petition seeks review of whether EPA’s

interpretation limiting the scope of an unambiguous

regulation — section 132.4(h) — is entitled to deference.

The decision below that granted deference to EPA’s

interpretation of section 132.4(h) conflicts with a

longstanding body of regulatory law established by this Court

and numerous circuit courts, which does not allow a court to

defer to such an interpretation where a regulation is clear on

its face. That decision, if followed by other courts, would

give agencies the unfettered discretion to amend the plain

language of regulations through informal methods, without

the procedural safeguards established by the Administrative

Procedures Act (the “APA”). 5 U.S.C. § 500, et seq. Because

the Sixth Circuit’s decision departed from the accepted and

usual course of judicial proceedings, the Court should grant

review to clarify and confirm that agency interpretations are

not entitled to deference where the regulation at issue is not

ambiguous.

13

THE SIXTH CIRCUIT’S DECISION

CONFLICTS WITH WELL-ESTABLISHED

ADMINISTRATIVE LAW PROVIDING THAT

AN AGENCY INTERPRETATION OF A

REGULATION IS NOT ENTITLED TO

DEFERENCE WHERE THE REGULATION IS

UNAMBIGUOUS ON ITS FACE.

The seminal case of Chevron U.S.A. Inc. v. NRDC, Inc.,

467 U.S. 837, 842-44 (1984) established the principle that

courts must give effect to an agency’s reasonable

interpretation of an ambiguous statute. This rule was

subsequently extended to apply to the interpretation of

ambiguous regulations. See Auer v. Robbins, 519 U.S. 452,

461 (1997) (In interpreting a regulation, the Court held that

“Because the salary-basis test is a creature of the Secretary’s

own regulations, his interpretation of it is, under our

jurisprudence, controlling unless ‘plainly erroneous or

inconsistent with the regulation.’’’) Deferral to an agency’s

interpretation of a regulation, however, “is warranted only

when the language of the regulation is ambiguous.”

Christensen v. Harris County, 529 U.S. 576, 588 (2000).

The Court explained the rationale behind this rule:

To defer to the agency’s position would be to

permit the agency, under the guise of interpreting

a regulation, to create de facto a new regulation.

Because the regulation is not ambiguous on the

issue of compelled compensatory time, Auer

deference is unwarranted.

Id. In other words, where the language selected by the drafters

is clear and unequivocal, courts are bound to give effect to

the plain meaning of the chosen words. /d.; Norfolk S. Ry.

14

Co. v. Shanklin, 529 U.S. 344, 356 (2000); Wards Cove

Packing Corp. v. Nat’l Marine Fisheries Serv. , 307 F.3d 1214,

1219-20 (9" Cir. 2002); Navarro v. Pfizer Corp., 261 F.3d

90, 103 n. 7 (1* Cir. 2001); Echevarria vy. Chicago Title &

Trust Co., 256 F.3d 623, 629 (7" Cir. 2001); Clean Ocean

Action v. York, 57 F.3d 328, 333 (3% Cir. 1995); In re: Sealed

Case, 237 F.3d 657, 667 (D.C. Cir. 2001); Restrepo vy.

McElroy, 369 F.3d 627, 638 n. 19 (2d Cir. 2004).

The unambiguous language of section 132.4(h) provides:

For any pollutant other than those in Table 5 of

this part for which the State or Tribe demonstrates

that a methodology or procedure in this part is

not scientifically defensible, the Great Lakes

States and Tribes shall:

(1) Apply an alternative methodology or

procedure acceptable under 40 C.FR. part 131

when developing water quality criteria; or

(2) Apply an alternative implementation

procedure that is consistent with all applicable

Federal, State, and Tribal laws.

40 C.F.R. § 132.4(h). Table 5 of 40 C.FR. part 132 lists 14

pollutants that are specifically excepted from section

132.4(h). 40 C.F.R. part 132 also lists other pollutants that

are not included in Table 5, and are, therefore, included within

the scope of section 132.4(h). WET is not listed as a pollutant

in Table 5, but is otherwise listed as a pollutant in 40 C.F.R.

part 132. The only possible interpretation of the plain

language of section 132.4(h) is that it applies to all pollutants

other than those listed in Table 5. WET is not listed in

15

Table 5. Accordingly, section 132.4(h) applies to WET. The

terms of section 132.4(h) contain no language that limits a

State’s use of the scientific indefensibility provision only to

pollutants identified in the future. There is no ambiguous

language that would support an interpretation that the scope

of section 132.4(h) is limited to pollutants identified in the

future. See Chickasaw Nation v. United States, 534 U.S. 84,

90 (2001) (Language is ambiguous if it is “capable of being

understood in two or more possible senses or ways.”)

(quoting Webster’s Ninth New Collegiate Dictionary 77

(1985)); Caminetti v. United States, 242 U.S. 470, 485 (1917)

(“Where the language is plain and admits of no more than

one meaning the duty of interpretation does not arise and the

rules which are to aid doubtful meanings need no

discussion.”) The Sixth Circuit should not have deferred to

an agency interpretation contrary to the plain language of

the regulation.

This well-settled rule of regulatory construction has been

applied by other circuit courts to EPA attempts to interpret

unambiguous regulations. See e.g., Clean Ocean Action,

57 F.3d at 332-33. In that case, the Third Circuit examined

' EPA’s interpretation of its ocean dumping regulations

promulgated under the Marine Protection, Research, and

Sanctuaries Act (“MPRSA”). /d. at 331-32. The MPRSA

directed EPA to establish criteria for determining whether to

issue permits for the dumping of materials. Jd. EPA

regulations required the performance of tests in certain

circumstances to determine whether to issue a permit. /d. at

332. EPA refused to conduct these tests, contending that the

regulations afforded it discretion to determine whether to

conduct tests even when the specified circumstances were

present. /d. at 332-33. The Third Circuit rejected EPA’s

position. /d. at 333. Specifically, the court found that the

16

language of EPA’s regulation was unambiguous, and,

therefore, EPA’s interpretation was not entitled to deference.

Id. The Sixth Circuit’s decision directly conflicts with this

precedent.

In addition, the means by which EPA attempted to restrict

the scope of section 132.4(h) further demonstrate that the

Sixth Circuit’s decision conflicts with well-established law.

Specifically, the decision below relied on an interpretation

of section 132.4(h) contained in the SID, an informal EPA

guidance document only reviewed by EPA’s Office of Science

and Technology. However, the SID, having been informally

published by EPA without using the rulemaking procedures

of the APA, was not entitled to the deference the Sixth Circuit

afforded it. Christensen, 529 U.S. at 587 (“Interpretations

such as those in opinion letters — like interpretations

contained in policy statements, agency manuals, and

enforcement guidelines, all of which lack the force of law

— do not warrant Chevron-style deference.”); see also,

Navarro, 261 F.3d at 103 n.7 (EEOC interpretive guideline

was not entitled to deference); Clean Ocean Action, 57 F.3d

at 333 (EPA’s “Green Book” was not entitled to deference

because an “agency guideline or directive that conflicts with

the plain meaning of a regulation is invalid.”); Echevarria,

256 F.3d at 629 (court afforded no extra deference to HUD

opinion letter and special information booklet). The Sixth

Circuit decision to follow the informal statements in the SID

conflicts with this established case law. The decision below

used the SID, not to interpret ambiguous language, but to

create, de facto, a new provision that narrows the scope of

section 132.4(h). Because it was inconsistent with the plain

language of section 132.4(h), the SID, as an informal

guidance document, should not have been relied upon as an

interpretive device.

17

Further, the preamble to the draft Proposed Guidance

(58 Fed. Reg. at 20,843), was not a proper basis for the Sixth

Circuit to rely upon in deferring to EPA’s interpretation of

section 132.4(h). Although a preamble may be used as an

interpretive supplement in certain cases, it cannot be used to

contradict unambiguous language. Yazoo R.R. Co. v. Thomas,

132 U.S. 174, 188 (1889) (“. .. the preamble is no part of

the act, and cannot enlarge or confer powers, nor control the

words of the act, unless they are doubtful or ambiguous. . .”);

Beard v. Rowan, 34 U.S. 301, 317 (1835) (“The preamble in

the act may be resorted to, to aid in the construction of the

enacting clause, when any ambiguity exists.”); Entergy

Servs., Inc. v. FERC, 375-F.3d 1204, 1209 (D.C. Cir. 2004)

(“. .. FERC correctly notes that ‘language in the preamble

of a regulation is not controlling over the language of the

regulation itself.’”) (quoting Wyoming Outdoor Council v.

U.S. Forest Serv. , 165 F.3d 43, 53 (D.C. Cir. 1999)). Again,

the decision below departed from this established line of

cases by using the preamble to a proposed rule to overcome

the plain language of the regulation.

The Sixth Circuit decision has created a conflict with

deep-rooted case law, which if permitted to stand will allow

EPA, as well as other government agencies, to create new

regulatory requirements without APA scrutiny where a

regulation is unambiguous on its face. Such precedent would

undermine well-established cases, starting with Chevron and

culminating with Christensen, which uniformly allow a court

to defer to an agency interpretation “only when the language

of the regulation is ambiguous.” Christensen, 529 U.S. at

588. The effect of the Sixth Circuit precedent “would be to

permit the agency, under the guise of interpreting a regulation,

to create de facto a new regulation,” as happened in this case.

18

Id. The Court should grant review to clarify that agencies

(including EPA) cannot controvert the plain language of a

federal regulation through their own interpretive devices.

CONCLUSION

For the foregoing reasons, the petition for a writ of

certiorari should be granted.

Respectfully submitted,

Danie P. ALBERS*

Frepric P. ANDES

Davip T. BALLARD

BARNES & THORNBURG, LLP

Suite 4400

1 N. Wacker Dr.

Chicago, Illinois 60606

(312) 357-1313

Counsel for Petitioner

* Counsel of Record

APPENDIX

la

APPENDIX A — OPINION OF THE UNITED STATES

COURT OF APPEALS FOR THE SIXTH CIRCUIT

FILED JUNE 16, 2005

UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

Nos. 00-4502; 01-3379

NORTHEAST OHIO REGIONAL SEWER DISTRICT;

CITY OF CINCINNATI, on behalf of the Metropolitan Sewer

District of Greater Cincinnati, Hamilton County, Ohio; CITY

OF AKRON, Public Utilities Bureau; CITY OF

COLUMBUS, Division of Sewerage & Drainage; CITY OF

TOLEDO (00-4502); INDIANA WATER QUALITY

COALITION (01-3379),

Petitioners,

V.

UNITED STATES ENVIRONMENTAL

PROTECTION AGENCY,

Respondent.

December 1, 2004, Argued

June 16, 2005, Decided

June 16, 2005, Filed

OPINION

RONALD LEE GILMAN, Circuit Judge. A group of

public agencies and private companies based in Indiana and

Ohio have petitioned this court for a review of a final decision

2a

Appendix A

issued by the United States Environmental Protection Agency

(EPA) regarding state regulatory schemes governing toxic

discharges into the Great Lakes. For the reasons set forth

below, we deny the petitions for review.

I. BACKGROUND

A. Factual background

This litigation arises under the Clean Water Act, the

purpose of which is to “restore and maintain the chemical,

physical, and biological integrity of the Nation’s waters.”

33 U.S.C. § 1251(a). Section 402 of the Clean Water Act

established the National Pollutant Discharge Elimination

System (NPDES), which obligates polluters to obtain permits

for their discharges. Each permit issued under NPDES must

include restrictions on pollution discharge and, if necessary,

water effluent toxicity (WET) limitations. Although the

regulations under NPDES allow a permitting authority to

impose a WET limitation whenever a discharge has at least

a “reasonable potential” to lead to a water quality violation,

they do not establish a specific procedure for the permitting

authority to follow. The permitting authority is instead

required to take into account certain enumerated factors.

In the late 1980s, the governors of the eight states

surrounding the Great Lakes entered into an agreement to

protect and preserve the environmental integrity of the Great

Lakes waters. Congress followed up by enacting the Great

Lakes Critical Programs Act of 1990, which amended Section

118 of the Clean Water Act. 33 U.S.C. § 1268. In this

amendment, Congress instructed the EPA to promulgate

3a

Appendix A

regulations to ensure that water quality procedures in the

states around the Great Lakes would be “no less restrictive”

than the already-existing water quality criteria. 33 U.S.C.

§ 1268(c)(2)(A). Congress also provided that “the Great

Lakes States shall adopt water quality standards,

antidegredation policies, and implementation procedures for

waters within the Great Lakes System which are consistent

with such guidance.” 33 U.S.C. § 1268(c){2)(C).

The EPA set forth these rules in a regulation titled the

“Final Water Quality Guidance for the Great Lakes System”

(the Guidance), found at 60 Fed. Reg. 15,366 (Mar. 23, 1995).

Specific provisions of the Guidance govern individual

discharges of toxic pollutants into Great Lakes waters.

Following the issuance of the Guidance, the eight Great Lakes

States were required to adopt and submit to the EPA

implementation procedures of their own. The states have the

flexibility to create and modify their own regulatory schemes,

so long as the net level of protection offered by their

provisions match or exceed those promulgated under the

Guidance. See 40 C.FR. § 132.5(g)(3). If the states fail to

establish regulations consistent with the Guidance, Congress

has mandated that the EPA impose its own standards on the

states. 33 U.S.C. § 1268(c)(2)(C).

Under the Guidance, the procedures for establishing

WET limits are roughly as follows: Samples are taken from

a facility’s discharge. Marine organisms are then exposed to

these samples as well as to control samples, and tests are

done to determine what percentage of these organisms die

upon exposure. A “toxic unit,” which is a quantitative value,

is based upon the percentage of deaths that occur. The highest

4a

Appendix A

daily “toxic unit” value measured in the discharge (or, in

some cases, the highest weekly value) is then multiplied by

a predetermined statistical variable, which depends upon the

number of the data points and the variation in results. If the

resulting value is greater than the EPA’s predetermined

criterion, the permitting authority is required to impose a

WET limitation.

Indiana submitted its rules to the EPA in late 1997. The

EPA subsequently criticized Indiana’s proposed procedure

because, unlike the Guidance, which used the maximum

value from all of the WET tests during the relevant time

period, Indiana’s procedure would use the geometric mean

of all values sampled. In addition, the EPA disapproved of

the fact that Indiana’s procedure did not employ a statistically

based multiplier in its analysis. The EPA thus concluded that

Indiana’s proposed procedures were inconsistent with the

Guidance and issued a final order to that effect on August 4,

2000.

Ohio also submitted its rules to the EPA in late 1997

and, like Indiana, part of its proposal was rejected as being

inconsistent with the Guidance. Unlike the Guidance’s rigid

Statistical test, the Ohio test adopted a “weight-of-the-

evidence” approach that would require the permitting

authority to look to a variety of factors in deciding whether

to impose a WET limit. The EPA found that this approach

granted too much flexibility to the permitting authority,

noting that it would “devalue observed WET test results and

would not require a [limit] even where WET test results show

observed levels of unacceptable toxicity.” Approved and

Disapproved Elements of the Great Lakes Guidance

Sa

Appendix A

Submissions, 65 Fed. Reg. 47864, 47867 (Aug. 4, 2000). It

also faulted the fact that Ohio did not employ a statistically

based multiplier. The EPA concluded that the procedures were

inconsistent with the Guidance in the same final order that it

issued regarding the Indiana procedures.

B. Procedural background

On December 1, 2000, approximately four months after

the final EPA order was issued, a group of Ohio entities

(hereinafter the Ohio petitioners) filed suit in this court

challenging the EPA’s conclusion that the proposed Ohio

rules were inconsistent with the Guidance. A similar group

of Indiana petitioners, united under the moniker Indiana

Water Quality Coalition (IWQC), filed suit on December 18,

2000 in the United States Court of Appeals for the Seventh

Circuit, challenging the EPA’s final decision that the Indiana

proposed rules were inconsistent with the Guidance. Pursuant

to 28 U.S.C. § 2112(a)(1) and (5), the EPA moved to transfer

the case to this court, where the Ohio petitioners had already

filed a similar petition. The Seventh Circuit granted the EPA’s

petition on April 16, 2001. This court accepted the transfer

on May 15, 2001, consolidating the two actions into the

present case.

II. ANALYSIS

A. Standard of review

This case is governed by the Federal Administrative

Procedure Act (APA), 5 U.S.C. § 706. Under the APA, courts

will not set aside a final agency action unless it is found to

6a

Appendix A

be “arbitrary, capricious, an abuse of discretion, or otherwise

not in accordance with law.” 5 U.S.C. § 706(2)(A).

This standard is deferential. “Even when an agency

explains its decision with less than ideal clarity, a reviewing

court will not upset the decision on that account if the

agency’s path may reasonably be discerned.” Alaska Dep't

of Envtl. Conservation v. EPA, 540 U.S. 461, 1248S. Ct. 983,

1006, 157 L. Ed. 2d 967 (2004) (quotation marks omitted).

In considering whether an agency rule is “arbitrary and

capricious,” we may consider whether

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. The reviewing court should not attempt

itself to make up for such deficiencies; we may

not supply a reasoned basis for the agency’s action

that the agency itself has not given.

Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co.,

463 U.S. 29, 43, 77 L. Ed. 2d 443, 103 S. Ct. 2856 (1982)

(quotation marks omitted). This court has also noted that it

will “defer in large part to EPA’s scientific findings.” BP

Exploration & Oil v. EPA, 66 F.3d 784, 792 (6th Cir. 1995).

Although the court’s review is to be “searching and careful,

the ultimate standard of review is a narrow one. The court is

not empowered to substitute its judgment for that of the

Ta

Appendix A

agency.” Citizens to Preserve Overton Park, Inc. v. Volpe,

401 U.S. 402, 416, 28 L. Ed. 2d 136, 91 S. Ct. 814 (1971),

questioned on other grounds by Califano v. Sanders, 430

U.S. 99, 105, 51 L. Ed. 2d 192, 97 S. Ct. 980 (1977).

B. The scope of petitioners’ challenge

The EPA asserts at the outset that this consolidated case

is nothing more than an attempt by the petitioners to have

this court review the validity of the Guidance itself, as

opposed to a review of the Indiana and Ohio regulatory

schemes. Under the Clean Water Act, any petitions for

judicial review of the Guidance, which was enacted in 1995,

had to have been filed within 120 days of its promulgation.

33 U.S.C. § 1369(b)(1). If the EPA is correct, therefore, then

we would have to dismiss the present case as a result of it

being filed nine years too late.

We find this argument unconvincing. The petitioners

have repeatedly conceded that their challenge is limited to

the reasonableness of the EPA’s finding that the Indiana and

Ohio implementation procedures are inconsistent with the

Guidance. Although the EPA is correct in noting that many

of the petitioners’ arguments originate in the language of the

Guidance, this is because the Guidance provides the frame

of refererce to which the Indiana and Ohio procedures must

be compared. That the Guidance is held to some degree of

scrutiny does not necessarily make this action a challenge to

its validity. To the contrary, petitioners’ briefs nowhere

suggest that they contest the legitimacy of the Guidance.

Dismissing this case on the basis that it is an overbroad

challenge to the Guidance itself would thus be inappropriate.

8a

Appendix A

C. Res judicata and collateral estoppel arguments

The EPA further argues that the petitioners are barred by

the doctrines of res judicata and collateral estoppel from

challenging the Guidance on account of American Iron &

Steel Institute v. EPA, 325 U.S. App. D.C. 76, 115 F.3d 979

(D.C. Cir. 1997), in which the Court of Appeals for the

District of Columbia rejected the claims of various

petitioners, including the petitioners in the present case, that

the Guidance was an abuse of the EPA’s authority. It argues

that the petitioners should have raised in that case any

challenges they had about the “validity and level of protection

afforded” by the Guidance, and that “issue preclusion” bars

the relitigation of any claims in that case. The EPA concludes

that “only the reasonableness of EPA’s finding that Indiana

and Ohio’s implementation procedures were not as protective

to the environment as the Guidance’s corresponding

procedure falls within the scope of this proceeding.”

The petitioners, however, do not challenge the EPA’s

position on the scope of this case. They admit that the present

suit 1s, indeed, nothing more than a challenge of the narrow

administrative ruling regarding the Indiana and Ohio

implementation procedures. The Ohio petitioners even

observe that “not only do the Ohio Petitioners not seek to

‘revisit’ the holding of [American Iron], they actually rely

upon that case and cite to it in their Opening Brief for one of

the very principles that EPA erroneously claims to be under

attack.” Furthermore, as discussed above, the present suit

cannot be appropriately deemed to be a suit against the

validity of the Guidance. Nothing in the briefs of the

petitioners suggests otherwise. Because the EPA has little

9a

Appendix A

support for its conclusion that the petitioners are, in fact,

challenging the legitimacy of the Guidance as was done in

American Iron, we decline to dismiss the case under the

theories of either res judicata or collateral estoppel. — -

D. The Indiana and Ohio WET tests

IWQC and the Ohio petitioners argue that the EPA erred

when it concluded that their regulatory schemes were

inconsistent with the Guidance. All of the parties agree that

to be “consistent with” the Guidance, the regulatory scheme

in question must be at least as protective of the environment

as the Guidance. See 40 C.ER. 132.5(g)(3) (“The Great Lakes

States . . . may adopt provisions that are more protective than

those contained in this part.”); American Iron, 115 F.3d at

988 (deferring to the EPA’s assessment that to be “consistent

with” the Guidance, the regulatory regime in question must

be “as protective as” the Guidance itself). Accordingly, both

IWQC and the Ohio petitioners assert that the proposals

submitted by their respective states are at least as protective

of the environment as the Guidance, if not more so. Because

of variations between the Indiana and Ohio regulations, each

will be examined in turn.

1. Indiana’s regulatory scheme

Indiana’s proposed scheme differs from the Guidance in

two key ways. First, under Indiana’s proposal, “toxic unit

levels” required to assess water toxicity are measured using

a geometric mean of tested values. The EPA’s Guidance, by

contrast, uses a maximum tested value to ascertain toxicity,

a value that is, by mathematical definition, greater than the

10a

Appendix A

geometric mean. Under Indiana’s system, then, a facility’s

effluent would have to be consistently higher than the mean

before a permitting authority would impose a WET limit.

Second, the Indiana scheme does not employ the statistical

multiplier called for by the Guidance, using instead its own

independently derived factor. IWQC asserts that Indiana's

scheme is more protective of the environment than the

Guidance.

The EPA, however, observed in its final decision that

Indiana’s procedure, which calls for using a mean value of

toxicity, “lessens the impact of observed toxicity on the

limitation calculation and fails to account for the reasonable

possibility that effluent may exceed the level observed in

the test because sampling did not coincide with periods of

maximum toxicity.” Approved and Disapproved Elements of

the Great Lakes Guidance Submissions, 65 Fed. Reg. 47864,

47868 (Aug. 4, 2000). A maximum value taken from a sample

will necessarily be greater than the geometric mean of the

sample.

IWQC also argues that the EPA erred because its

“analysis was based on a review of only one small part of

Indiana’s WET procedures: the use of a geometric mean of

the measured effluent values.” In reviewing the EPA's

analysis, IWQC “sees no indication that EPA has conducted

a holistic review of Indiana’s WET procedures and compared

them to EPA’s procedure, as the EPA Guidance

contemplates.” IWQC then points to numerous provisions

in the proposed Indiana rules that, according to its brief, make

the scheme more protective than the Guidance.

lla

Appendix A

But there is no reason to believe that the EPA acted in an

arbitrary or capricious manner in evaluating the Indiana

regulatory scheme. The EPA points to a long list of

correspondence in which it considered and commented on

various aspects of Indiana’s proposal. It noted, for example,

the fact that Indiana would “require multiple failures” of a

toxicity test before a WET limit could be imposed. EPA’s

Analysis of Steps Taken By Indiana in Response to EPA’s

90-Day Letter 9 (July 31, 2000). The EPA also considered,

and rejected, the argument that Indiana’s catch-all rule, which

would allow a permitting authority to “exercise best

professional judgment” to enact WET limits, would correct

what the EPA viewed as the deficiencies in the rest of the

scheme. /d. at 10. This catch-all provision, the EPA noted,

“is not a substitute for having a reasonable potential

procedure that is as protective” as the Guidance. Jd. IWQC’s

charge that the EPA failed to view the proposed regulatory

scheme in its entirely is therefore unpersuasive and does not

demonstrate that the EPA acted arbitrarily or capriciously.

In sum, the EPA acted rationally and on the basis of

considerable evidence when it rejected Indiana’s regulatory

scheme. Given that Indiana’s averaging of toxicity will call

for fewer WET limits than a system using maximum values,

the EPA’s conclusion that the state’s scheme would be less

protective of the environment was far from being arbitrary

or capricious. Because the “agency’s path may reasonably

be discerned,” Alaska Dep’t of Envtl. Conservation, 124

S. Ct. at 1006, there is no basis for us to grant IWQC’s

petition for review.

12a

Appendix A

2. Ohio’s regulatory scheme

Under Ohio’s proposed regulations, the permitting

authority must take into account a variety of data on the

toxicity of the discharge before issuing a permit or

establishing a WET limit. The factors to be considered under

this “weight of the evidence” standard include the “magnitude

of discharge,” the “degree and type of effects,” the “quality

and quantity of each type of data,” and “other relevant

factors.” Only if the discharge in question meets a variety of

criteria will WET limits be imposed. The Ohio petitioners

argue that this system, with its comprehensive approach to

water quality, is more protective of the environment than the

imposition of the statistical multiplier required by the

Guidance.

Adopting Ohio’s “weight of the evidence” approach,

however, necessarily grants the permitting authority wide

discretion not afforded by the Guidance. The EPA can

rationally read Ohio’s rule as failing to provide the permitting

authority with guidance on how to weigh the various factors.

This discretion arguably makes the Ohio regulatory scheme

less protective than the Guidance, in which a statistically

determined multiplier is used to determine toxicity.

Ohio’s regulatory scheme further limits the permitting

authority from imposing a WET limit in the absence of

“biological data,” except where “[1] the maximum observed

toxicity value is at least three times greater than the expected

toxicity limit, [2] the average toxicity exceeds one third the

expected effluent limit, [3}and more than 30 percent of the

test results exceed a projected wasteload allocation.”

13a

Appendix A

Approved and Disapproved Elements of the Great Lakes

Guidance Submissions, 65 Fed. Reg. 47864, 47867 (Aug. 4,

2000). The Ohio petitioners concede that this provision may

produce results that are “less restrictive than the Guidance.”

But this fact, they argue, is balanced out because “if the data

set is large, ... Ohio’s procedure will require a WET limit

where the [Guidance] would not.” They further point out that

“the [Guidance] will not require a limit even if the average

values are much higher than those that Ohio considers to be

significant.” Ultimately, they argue, the EPA’s rejection of

this scheme was arbitrary and capricious because the

“adoption of a more protective element in one provision may

be used to offset a less protective element in the same

provision.” 40 C.F.R § 132.5(g)(3).

The Ohio petitioners concede, however, that their

proposed scheme would allow certain toxic discharges to go

unregulated in instances where no “biological data” was

available. “Ohio’s procedure,” the EPA concluded, “would

not require a reasonable potential finding even where testing

has shown actual, observed toxicity. This is clearly

inconsistent with [the Guidance.]” Approved and

Disapproved Elements of the Great Lakes Guidance

Submissions, 65 Fed. Reg. 47864, 47867 (Aug. 4, 2000).

Because this provision allows pollution where the Guidance

would not, the EPA’s final action disapproving the regulatory

scheme can hardly be considered arbitrary or capricious.

Moreover, the Ohio petitioners’ argument that their

“weight of the evidence” approach might be more protective

than the Guidance in certain hypothetical situations is

unpersuasive. The fact remains that Ohio’s scheme “fails to

14a

Appendix A

require a limit even in cases of observed toxicity.” /d. In its

final ruling, the EPA identified this weakness as a significant

and determinative flaw in the regulatory scheme. It therefore

had little need to address the hypothetical situations where

the Ohio scheme might be marginally more protective than

the Guidance.

The Ohio petitioners are correct in their observation that

there is no discussion of the Ohio scheme’s more protective

elements in the EPA’s final disapproval. But this fact alone

does not make the EPA’s final agency decision arbitrary or

capricious. To the contrary, the tone of the EPA’s final

decision indicates that the Ohio procedure allowing toxic

discharges is so antithetical to the very goal of the Guidance

that the more protective provisions would have been

insufficient to neutralize its effects.

In sum, we find nothing in the record indicating that the

EPA acted in an arbitrary or capricious manner in rejecting

Ohio’s proposed scheme as inconsistent with the Guidance.

The Ohio petitioners have simply not met their burden of

establishing sufficient grounds to set aside the EPA’s final

action.

E. The “scientifically indefensible” exception

The Guidance provides that

for any pollutant . . . for which the State or Tribe

demonstrates that a methodology or procedure in

this part is not scientifically defensible, the Great

Lakes States and Tribes shall: (1) Apply an

15a

Appendix A

alternative methodology or procedure acceptable

under 40 CFR part 131 when developing water

quality criteria; or (2) Apply an alternative

implementation procedure that is consistent with

all applicable Federal, State, and Tribal laws.

40 C.FR. § 132.4(h). IWQC and the Ohio petitioners contend

that the system of WET testing espoused by the Guidance is

“not scientifically defensible” because of the huge variation

introduced by taking only maximum tested values and by

utilizing an independent statistical multiplier. They argue that

their schemes are appropriate alternatives sanctioned by the

Guidance.

The EPA responds by submitting that the petitioners are

in effect making a wholesale challenge to the Guidance, a

position that is barred both by the statute of limitations and

by American Iron & Steel Institute v. EPA, 325 U.S. App.

D.C. 76, 115 F.3d 979 (D.C. Cir. 1997). We again find the

EPA’s argument unpersuasive. The petitioners do not

challenge the applicability of the Guidance generally; they

instead argue that § 132.4(h) allows them to adopt an

alternative scheme should they be able to prove that the WET-

testing provision provided by the Guidance is scientifically

indefensible.

But the EPA makes a compelling argument when it points

out that the provision allowing alternative schemes was

developed because “there may be pollutants identified in the

future for which some of the methodologies or procedures

{in the Guidance] may not be technically appropriate. Under

these circumstances, EPA wishes to provide sufficient

l6a

Appendix A

flexibility for permitting to address these pollutants on a case-

by-case basis.” Proposed Water Quality Guidance, 58

Fed.Reg. 20802, 20843 (Apr. 16, 1993) (emphasis added);

see also EPA, Water Quality Guidance for the Great Lakes

System: Supplementary Information Document, EPA-820-

B-95-00158 (Mar. 1995) (“The reason for this exclusion is

that there may be pollutants identified in the future for which

some of the methodologies or procedures in the final

Guidance may not be technically appropriate.”) Moreover,

the EPA notes that this exception for scientific indefensibility

was intended to be “applied to a specific situation,” id., in

one or more sites, not to a sweeping alternative regulatory

scheme.

WET discharges, which have concerned the EPA for

decades, do not fall under the category of “pollutants

identified in the future.” The “scientific indefensible”

exception was not designed to apply to such run-of-the-mill

discharges, but rather only on a case-by-case basis if, for

whatever reason, applying the Guidance would be

inappropriate. This exception to the Guidance is therefore

inapplicable to the petitioners’ regulatory schemes.

lil. CONCLUSION

For all of the reasons set forth above, we deny the

petitions for review.

17a

APPENDIX B — ORDER OF THE UNITED STATES

COURT OF APPEALS FOR THE SIXTH CIRCUIT

DENYING PETITIONS FOR REHEARING

FILED NOVEMBER 22, 2005

UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

Nos. 00-4502/01-3379

NORTHEAST OHIO REGIONAL

SEWER DISTRICT, ET AL.,

Petitioners,

v.

UNITED STATES ENVIRONMENTAL

PROTECTION AGENCY,

Respondent.

November 22, 2005, Filed

JUDGES: BEFORE: DAUGHTREY and GILMAN, Circuit

Judges; and RICE,* District Judge.

ORDER

The court having received two petitions for rehearing

en bamc, and the petitions having been circulated not only to

* Hon. Walter H. Rice, Senior United States District Judge for

the Southern District of Ohio, sitting by designation.

18a

Appendix B

the original panel members but also to all other active**

judges of this court, and no judge of this court having

requested a vote on the suggestion for rehearing en banc, the

petitions for rehearing have been referred to the original

panel.

The panel has further reviewed the petitions for rehearing

and concludes that the issues raised in the petitions were

fully considered upon the original submission and decision

of the cases. Accordingly, the petitions are denied.

ENTERED BY ORDER OF THE COURT

** Judge Moore recused herself from participation in this ruling.

19a -

APPENDIX C — RELEVANT RULES

AND REGULATIONS

FEDERAL REGISTER

Vol. 65, No. 151

Rules and Regulations

ENVIRONMENTAL PROTECTION AGENCY (EPA)

40 CFR Part 132

[FRL-6846-3]

Identification of Approved and Disapproved Elements of

the Great Lakes Guidance Submissions From the States

of Michigan, Ohio, Indiana, and II}linois, and Final Rule

DATE: Friday, August 4, 2000

ACTION: Final rule.

SUMMARY: EPA published the final Water Quality

Guidance for the Great Lakes System (the Guidance) on March

23, 1995. Section 118(c) of the Clean Water Act (CWA) requires

the Great Lakes States of Illinois, Indiana, Michigan, Minnesota,

New York, Ohio, Pennsylvania and Wisconsin to adopt within

two years of publication of the final Guidance (i.e., March 23,

1997) minimum water quality standards, antidegradation

policies and implementation procedures that are consistent with

the Guidance, and to submit them to EPA for review and

approval. Each of the Great Lakes States made those

submissions.

20a

Appendix Cc

Today, EPA is taking final action on the Guidance

submissions of the States of Michigan, Ohio, Indiana and

Illinois. EPA’s final action consists of approving those elements

of the States’ submissions that are consistent with the Guidance,

disapproving those elements that are not consistent with the

Guidance, and specifying in a final rule the elements of the

Guidance that apply in the portion of each State within the Great

Lakes basin where a State either failed to adopt required elements

or adopted elements that are inconsistent with the Guidance.

EPA is separately taking final action on the Guidance

submissions of the States of Minnesota, New York, Pennsylvania

and Wisconsin.

EFFECTIVE DATE: September 5, 2000.

* * *

SUPPLEMENTARY INFORMATION:

I. Discussion

A. Potentially Affected Entities

Entities potentially affected by today’s action are those

discharging pollutants to waters of the United States in the Great

Lakes System in the States of Michigan, Ohio, Indiana and

Illinois. Potentially affected categories and entities include:

Category Examples of potentially affected entities

Industry Industries discharging to waters within the

Great Lakes System as defined in 40 CFR

132.2 in the States identified above.

Municipalities | Publicly-owned treatment works discharging

to waters within the Great Lakes System as

defined in 40 CFR 132.2 in the States

identified above.

2la

Appendix C

This table is not intended to be exhaustive, but rather

provides a guide for readers regarding entities likely to be

affected. This table lists the types of entities that EPA believes

could be affected by this action. Other types of entities not

listed in the table could also be affected. To determine

whether your facility may be affected by these final actions,

you should examine the definition of “Great Lakes System”

in 40 CFR 132.2 and examine 40 CFR 132.2 which describes

the Part 132 regulations. If you have any questions regarding

the applicability of this action to a particular entity, consult

the person listed in the preceding FOR FURTHER

INFORMATION CONTACT section.

B. Background

On March 23, 1995, EPA published the Guidance.

See 60 FR 15366 (The term “Guidance” as used below refers

to the regulation promulgated by EPA on March 23, 1995

and codified at 40 CFR Part 132). The Guidance establishes

minimum water quality standards, antidegradation policies,

and implementation procedures for the waters of the Great

Lakes System in the States of Illinois, Indiana, Michigan,

Minnesota, New York, Ohio, Pennsylvania and Wisconsin.

Specifically, the Guidance specifies numeric criteria for

selected pollutants to protect aquatic life, wildlife and human

health within the Great Lakes System and provides

methodologies to derive numeric criteria for additional

pollutants discharged to these waters. The Guidance also

contains minimum implementation procedures and an

antidegradation policy.

22a

Appendix C

Soon after being published, the Guidance was challenged

in the U.S. Court of Appeals for the District of Columbia

Circuit. On June 6, 1997, the Court issued a decision

upholding virtually all of the provisions contained in the 1995

Guidance. American Iron and Steel Institute, et al. v. EPA

(AISI), 115 F.3d 979 (D.C. Cir. 1997). The Court vacated the

human health criterion for polychlorinated biphenyls (PCBs)

and the acute aquatic life criterion for selenium, and the

provisions of the Guidance “insofar as it would eliminate

mixing zones for [BCCs} and impose [WQBELs] upon

internal facility waste streams.” 115 F.3d at 985. On October

9, 1997, EPA published a notice revoking the PCB human

health criteria pursuant to the Court’s decision. 62 FR 52922.

On April 23, 1998, EPA published a second notice amending

the 1995 Guidance to remove the BCC mixing zone

provisions from 40 CFR Part 132 (found in Procedure 3.C.

of Appendix F) and to rernove language in the Pollutant

Minimization Program provisions (Procedure 8.D. of

Appendix F) that might imply that permitting authorities are

required to impose WQBELs on internal waste streams or to

specify control measures to meet WQBELs. 63 FR 20107.

On June 2, 2000, EPA published a third notice withdrawing

the acute criteria for selenium. 65 FR 35283.

40 CFR 132.4 requires the Great Lakes States to adopt

water quality standards, antidegradation policies, and

implementation procedures for waters within the Great Lakes

System consistent with the Guidance or be subject to EPA

promulgation. 40 CFR 132.5(d) provides that, where a State

makes no submission to EPA, the Guidance shall apply to

discharges to waters in that State upon EPA’s publication of

a final rule indicating the effective date of the Part 132

requirements in that jurisdiction.

23a

Appendix C

On July 1, 1997, the National Wildlife Federation filed

suit alleging that EPA had a non-discretionary duty to

promulgate the Guidance for any State that failed to adopt

standards, policies and procedures consistent with the

Guidance. National Wildlife Federation v. Browner, Civ. No.

97-1504-HHK (D.D.C.). EPA negotiated a consent decree

providing that the EPA Administrator must sign, by February

27, 1998, a Federal Register notice making Part 132 effective

in any State in the Great Lakes Basin that failed to make a

submission to EPA by that date under 40 CFR Part 132.

However, all of the Great Lakes States made complete

submissions to EPA on or before the February deadline. On

March 2, April 14, April 20 and April 28, 1998, EPA

published in the Federal Register notices of its receipt of

each of the States’ Great Lakes Guidance submissions and a

solicitation of public comment on the National Pollutant

Discharge Elimination System (NPDES) portions of those

submissions. 63 FR 10221; 63 FR 18195; 63 FR 19490; 63

FR 23285.

40 CFR 132.5(f) provides that, once EPA completes its

review of a State’s submission, it must either publish notice

of approval of the State’s submission in the Federal Register

or issue a letter notifying the State that EPA has determined

that all or part of its submission is inconsistent with the CWA

or the Guidance, and identify any changes needed to obtain

EPA approval. If EPA issues a letter to the State making

findings of inconsistencies, the State then has 90 days to make

the necessary changes. If the State fails to make the necessary

changes, EPA must publish a notice in the Federal Register

identifying the approved and disapproved elements of the

submission and a final rule identifying the provisions of the

Guidance that will apply to discharges within the State.

24a

Appendix C

On November | 1999, the National Wildlife Federation

and the Lake Michigan Federation filed suit alleging that

EPA had a non-discretionary duty to take action on the Great

Lakes States’ Guidance submissions. National Wildlife

Federation v. Browner, Civ. No. 99-3025-HHK (D.D.C.).

EPA negotiated a consent decree providing that EPA must

sign Federal Register notices by July 31, 2000, taking the

action required by 40 CFR 132.5 on the Guidance

submissions of the States of Illinois, Indiana, Michigan,

Minnesota, Ohio and Pennsylvania; and Federal Register

notices by September 29, and October 31, 2000, taking the

action required by 40 CFR 132.5 on the Guidance

submissions of the States of New York and Wisconsin,

respectively. Today’s Federal Register notice fulfills EPA’s

obligations under that Consent Decree with respect to the

States of Michigan, Ohio, Indiana and IIlinois. EPA is

separately taking final action with respect to the States of

Minnesota, New York, Pennsylvania and Wisconsin. EPA

notes that each of the States’ Guidance submissions may

contain provisions that revise its NPDES program or water

quality standards in areas or with respect to regulated entities

not covered by the Guidance. EPA is not taking action at this

time to either approve or disapprove any such provisions.

EPA has conducted its review of the States’ submissions

in accordance with the requirements of Section 118(c)(2) of

the CWA and 40 CFR Part 132. Section 118 requires that

States adopt policies, standards and procedures that are

“consistent with” the Guidance. EPA has interpreted the

Statutory term “consistent with” to mean “as protective as”

the corresponding requirements of the Guidance. Thus, the

Guidance gives States the flexibility to adopt requirements

25a

Appendix C

that are not the same as the Guidance, provided that the

State’s provisions afford at least as stringent a level of

environmental protection as that provided by the

corresponding provision of the Guidance. In making its

evaluation, EPA has considered the language of each State’s

standards, policies and procedures, as well as any additional

information provided by the State clarifying how it interprets

or will implement its provisions.

Where EPA has promulgated a final rule that identifies a

provision of the Guidance that shall apply in a State, EPA

explains below its reasons for concluding that the State failed

to adopt requirements that are consistent with the Guidance.

Additional explanation of EPA’s conclusions are contained

in EPA’s correspondence with each State (identified in

relevant sections below) where EPA initially identified

inconsistencies in the States’s submission. Notice of the

availability of each of these letters was published in the

Federal Register and EPA has considered all public comments

received regarding any conclusions as to whether a State had

adopted provisions cons stent with the Guidance.

In this proceeding, EPA has reviewed the States’

submissions to determine their consistency with 40 CFR Part

132. EPA has not reopened Part 132 in any respect, and

today’s action does not affect, alter or amend in any way the

substantive provisions of Part 132. To the extent any members

of the public commented during this proceeding that any

provision of Part 132 is unjustified as a matter of law, science

or policy, those comments are outside the scope of this

proceeding.

26a

_Appendix C

With regard to those elements of the State submissions

being approved by EPA, EPA is approving those provisions

as amendments to each State’s NPDES permitting program

under Section 402 of the CWAand as revisions to each State’s

water quality standards under Section 303 of the CWA.

Today’s notice identifies those approved elements. Additional

explanations of EPA’s review of and conclusions regarding

the States’ submissions, including the specific State

provisions that EPA is approving, are contained in the

administrative record for today’s actions in documents

prepared for each State entitled “(particular State] Provisions

Being Approved as Being Consistent With the Guidance,”

“Analysis of Whether [the particular State] Has Adopted

Requirements Consistent With the Guidance” and “Analysis

of Steps Taken By [the particular State] in Response to EPA’s

90-Day Letter.”

C. Today’s Final Actions

1. The State of Michigan

On June 30 and August 16, 1999, EPA issued letters

notifying the Michigan Department of Environmental Quality

(MDEQ) that, while the State of Michigan had generally

adopted requirements consistent with the Guidance, EPA

concluded that portions of the rules adopted by the State were

not consistent with corresponding provisions of the

Guidance. On September 14, 1999, EPA published in the

Federal Register a notice of and solicitation of public

comment on its June 30 and August 16, 1999, letters. 64 FR

49803. EPA has completed its review of the State of

Michigan's response to, and all public comments on, the June

27a

Appendix C

30 and August 16, 1999, letters, and has determined that,

with one exception described below, Michigan has adopted

requirements consistent with all aspects of the Guidance.

Specifically, Michigan has adopted requirements consistent

with, and EPA is therefore approving those elements of the

State’s submissions which correspond to: the definitions tn

40 CFR 132.2; the water quality criteria for the protection of

aquatic life, human health and wildlife in tables 1-4 of Part

132; the methodologies for development of aquatic life

criteria and values, bioaccumulation factors, human health

criteria and values and wildlife criteria in Appendices B-D;

the antidegradation policy in Appendix E; and, with one

exception, the implementation procedures in Appendix F. As

explained more fully below, Michigan has not adopted

requirements consistent with the provisions tor determining

reasonable potential and establishing water quality based

effluent limitations for whole effluent toxicity set forth in

Paragraph | of Section C, and Section D, of Procedure 6 in

Appendix F.

EPA’s June 30, 1999, letter concluded that some of the

provisions that EPA is now approving authorized the State

to act consistent with the Guidance, but provided inadequate

assurance that the State would exercise its discretion

consistent with the Guidance. Subsequent to that letter,

MDEQ provided additional materials, including an

Addendum to its Memorandum of Agreement with EPA

regarding the State’s approved NPDES program in which

MDEQ commits to always exercise its discretion under those

provisions in a manner consistent with the Guidance.

Pursuant to 40 CFR 123.44(c)(3) and 123.63(a)(4), the State

is required to comply with commitments made in its

28a

Appendix C

Memorandum of Agreement (MOA) or risk EPA objection

to permits and even program withdrawal. These materials

have demonstrated to EPA that the State will implement its

program (with one exception identified below) consistent

with the Guidance. The specific provisions that EPA ts

approving, and EPA’s full rationale for approving these

provisions, are set forth in the documents entitled “Michigan

Provisions Approved as Being Consistent With the

Guidance,” “Analysis of Whether Michigan Has Adopted

Requirements Consistent With the Guidance” and “Analysis

of Steps Taken By Michigan in Response to EPA’s 90-Day

Letter” included in the record for this action.

EPA has determined that Michigan’s provisions at R

323.1219(4) for determining reasonable potential for a

discharge to cause or contribute to an exceedance of

Michigan’s whole effluent toxicity requirements are

inconsistent with Section D of Procedure 6 in Appendix F to

40 CFR Part 132. The Guidance procedure for evaluating

reasonable potential for whole effluent toxicity (WET) 1s

based on comparing a projected 95th percentile WET value

at a 95 percent confidence level with the acute and chronic

WET criteria after accounting for any available dilution. This

conservative approach is designed to ensure that WQBELs

are imposed when there is a reasonable potential for toxicity,

taking into account the effluent variability and the size of

the data set, even if no toxicity has actually been observed.

In evaluating State reasonable potential procedures for

WET, EPA looked for an equivalent level of protection to

that provided by the Guidance procedure. In the case of a

procedure to determine when a WQBEL is needed, one

29a

Appendix C

important consideration is whether the alternative procedure

would indicate the need for a WQBEL in similar situations

to those that would trigger a WQBEL under Section D of

Procedure 6.

In most cases where there is quantifiable effluent data,

EPA’s procedure will project an effluent value greater than

the maximum observed value to characterize the reasonable

worst case effluent. Michigan’s procedures for determining

WET reasonable potential are based on comparisons of

preliminary effluent limits to average effluent toxicity values

(with further possible adjustment based on the frequency of

failures), rather than comparisons of preliminary effluent

limits to maximum effluent toxicity values multiplied by

factors to account for effluent variability and size of the data

set as required by Paragraph D of Procedure 6 of the

Guidance. Michigan’s use of the average effluent toxicity

value will, except in highly unusual circumstances, be lower

than the maximum toxicity value multiplied by the factors

to account for effluent variability set forth in the Guidance.

Indeed, in certain circumstances, Michigan’s procedure

would not require a reasonable potential finding even where

testing has shown actual, observed toxicity. This is clearly

inconsistent with Section D of Procedure 6.

EPA notes that Paragraph | of Section C of Procedure 6

requires that WQBELs be imposed whenever the WET

reasonable potential procedures in Section D of Procedure 6

show that there is reasonable potential that a discharge will

cause or contribute to causing an excursion above a State's

numeric WET criterion or narrative criterion. Michigan's R.

323.1219(2) also provides that WQBELs shall be imposed

30a

Appendix C

whenever the WET reasonable potential procedures in

Michigan’s R. 323.1219(4) show reasonable potential. As

discussed above, however, Michigan’s WET reasonable

potential rules are not consistent with the Guidance. Because

R.323.1219(2) links establishment of WQBELs for WET to

a finding of reasonable potential under procedures that EPA

has determined are not consistent with Section D of

Procedure 6 (i.e., the procedures in R. 323.1219(4)),

R.323.1219(2) is not consistent with Paragraph | of Section

C of Procedure 6.

EPA, therefore, disapproves of R. 323.1219 (2) and (4),

and has determined that Paragraph | of Section C, and Section

D, of Procedure 6 in Appendix F to 40 CFR Part 132 shall

apply for discharges into the Great Lakes System in the State

of Michigan.

EPA understands that MDEQ intends to initiate

rulemaking to revise its regulations to insure that the State’s

WET reasonable potential provisions are consistent with the

Guidance. EPA will work closely with MDEQ to insure that

its revised regulations will be consistent with the Guidance.

MDEQ will then submit its revised regulations to EPA for

approval pursuant to 40 CFR 123.62 as a revision to its

NPDES program and, upon EPA approval of those revisions,

EPA will revise its regulations so that Paragraph 1 of Section

C, and Section D, of Procedure 6 in Appendix F to 40 CFR

Part 132 will no longer apply to discharges into the Great

Lakes System in the State of Michigan. EPA also notes that,

based upon Michigan’s adoption of criteria consistent with

the Guidance, EPA intends, in a separate action in the future,

to remove Michigan from the list of States specified at

3la

Appendix C

40 CFR 131.36 for which EPA has promulgated specific

criteria under Section 304(a) of the Clean Water Act.

2. The State of Ohio

On June 30 and August 16, 1999, EPA issued letters

notifying the Ohio Environmental Protection Agency (OEPA)

that, while the State of Ohio had generally adopted

requirements consistent with the Guidance, EPA concluded

that portions of the rules adopted by the State were not

consistent with corresponding provisions of the Guidance.

On September 14, 1999, EPA published in the Federal

Register a notice of and solicitation of public comment on

its June 30 and August 16, 1999, letters. 64 FR 49803. EPA

has completed its review of the State of Ohio’s response to,

and all public comments on, the June 30 and August 16, 1999,

letters, and has determined that, with only one exception

described below, Ohio has adopted requirements consistent

with all aspects of the Guidance. Specifically, Ohio has

adopted requirements consistent with and EPA is therefore

approving those elements of the State’s submissions which

correspond to, the definitions in 40 CFR 132.2; the water

quality criteria for the protection of aquatic life, haman health

and wildlife in tables 1-4 of Part 132; the methodologies for

development of aquatic life criteria and values,

bioaccumulation factors, human health criteria and values

and wildlife criteria in Appendices B-D; the antidegradation

policy in Appendix E; and, with one exception, the

implementation procedures in Appendix F. As explained more

fully below, Ohio has not adopted requirements consistent

with the provisions for determining reasonable potential and

establishing water quality based effluent limitations for whole

32a

Appendix C

effluent toxicity set forth in Paragraph | of Section C, and

Section D, of Procedure 6 in Appendix F.

EPA’s June 30, 1999, letter concluded that some of the

provisions that EPA is now approving authorized the State

to act consistent with the Guidance, but provided inadequate

assurance that the State would exercise its discretion

consistent with the Guidance. Subsequent to that letter, OEPA

provided additional materials, including an Addendum fo its

Memorandum of Agreement with EPA regarding the State’s

approved NPDES program in which OEPA commits to

always exercise its discretion under those provisions in a

manner consistent with the Guidance. Pursuant to 40 CFR

123.44(c)(3) and 123.63(a)(4), the State is required to comply

with commitments made in its MOA or risk EPA objection

to permits and even program withdrawal. These materials

have demonstrated to EPA that the State will implement its

program (with one exception identified below) consistent

with the Guidance. The specific provisions that EPA is

approving, and EPA’s full rationale for approving these

provisions, are set forth in the documents entitled “Ohio

Provisions Approved as Being Consistent With the

Guidance,” “Analysis of Whether Ohio Has Adopted

Requirements Consistent With the Guidance” and “Analysis

of Steps Taken By Ohio in Response to EPA’s 90-Day Letter.”

EPA has determined that Ohio’s procedure at OAC 3745-

33-07(B) for determining reasonable potential for a discharge

to cause or contribute to an exceedance of Ohio’s whole

effluent toxicity requirements are inconsistent with Section

D of Procedure 6 in Appendix F to 40 CFR Part 132. Ohio’s

procedure is based on consideration of a wide range of

33a

Appendix C

available data, including the number of tests performed, the

magnitude and frequency of toxicity exhibited by the effluent

and available biological data. Ohio’s procedure is not

consistent with the Guidance because rather than provide

safety factors to be applied to observed WET data as does

Procedure 6, they apply factors that devalue observed WET

test results and would not require a WQBEL even where WET

test results show observed levels of unacceptable toxicity.

Specifically, where biological data are unavailable to

corroborate effluent toxicity data, Ohio’s procedures

generally do not require establishment of a WQBEL unless

the maximum observed toxicity value is at least three times

greater than the expected toxicity limit, the average toxicity

exceeds one-third the expected effluent limit, and more than

30 percent of the test results exceed a projected wasteload

allocation. Where biological data are present to corroborate

effluent data that a toxicity problem exists, Ohio’s procedure

would allow a permit writer to consider WET data at full

value (i.e., compare the maximum observed WET result to

the expected toxicity limit), but it also requires the permit

writer, in determining whether a WQBEL is needed, to weigh

factors related to a minimum frequency of actual exceedances

and a comparison of the average of WET test results to a

percentage of the expected toxicity limit similar to those that

must be considered when only WET data are available.

Because these procedures devalue toxicity results and fail to

require a limit even in cases of observed toxicity, Ohio’s

procedure would not require a reasonable potential finding

even where testing has showed actual, observed toxicity. This

is clearly inconsistent with Section D of Procedure 6.

34a

Appendix C

As discussed above with respect to Michigan, Paragraph

1 of Section C of Procedure 6 requires that WQBELs be

imposed whenever the WET reasonable potential procedures

in Section D of Procedure 6 show that there is reasonable

potential that a discharge will cause or contribute to causing

an excursion above a State’s numeric WET criterion or

narrative criterion. Ohio’s rules at OAC 3745-33-07(B)(2)

provide that WQBELs shall be imposed whenever the WET

reasonable potential procedures in Ohio’s rules at OAC 3745-

33-07(B) show reasonable potential. Because OAC 3745-

33-07(B)(2) links establishment of WQBELs for WET to a

finding of reasonable potential under procedures that EPA

has determined are not consistent with Section D of

Procedure 6 (i.e., the procedures in OAC 3745-33-07(B)),

OAC 3745-33-07(B)(2) is not consistent with Paragraph |

of Section C of Procedure 6.

EPA, therefore, disapproves of OAC 3745-33-07(B), and

has determined that Paragraph | of Section C, and Section

D, of Procedure 6 in Appendix F to 40 CFR Part 132 shall

apply for discharges into the Great Lakes System in the State

of Ohio.

3. The State of Indiana

On August 16, 1999, EPA issued a letter notifying the

Indiana Department of Environmental Management (IDEM)

that, while the State of Indiana had generally adopted

requirements consistent with the Guidance, EPA concluded

that portions of the rules adopted by the State were not

consistent with corresponding provisions of the Guidance.

On September 14, 1999, EPA published in the Federal

35a

Appendix C

Register a notice of and solicitation of public comment on

its August 16, 1999, letter. 64 FR 49803. EPA has completed

its review of the State of Indiana’s response to, and all public

comments on, the August 16, 1999, letter, and has determined

that, with the exceptions described below, Indiana has

adopted requirements consistent with all aspects of the

Guidance. Specifically, Indiana has adopted requirements

consistent with, and EPA is therefore approving those

elements of the State’s submissions which correspond to,

the definitions in 40 CFR 132.2; the water quality criteria

for the protection of aquatic life, human health and wildlife

in tables 1-4 of Part 132; the methodologies for development

of aquatic life criteria and values, bioaccumulation factors,

human health criteria and values and wildlife criteria in

Appendices B-D; the antidegradation policy in Appendix E;

and, with the exceptions described below, the implementation

procedures in Appendix F. As explained more fully below,

Indiana has not adopted requirements consistent with the

criteria for granting variances set forth in Paragraph | of

Section C of Procedure 2 in Appendix F, requirements for

including WQBELs in permits set forth in Paragraph 2 of

Section F of Procedure 5 in Appendix F, and the provisions

for determining reasonable potential and establishing water

quality based effluent limitations for whole effluent toxicity

set forth in Paragraph | of Section C, and Section D, of

Procedure 6 in Appendix F.

EPA’s August 16, 1999, letter concluded that some of

the provisions that EPA is now approving were inconsistent

with the Guidance because authorized the State to act

consistent with the Guidance, but provided inadequate

assurance that the State would exercise its discretion

36a

Appendix C

consistent with the Guidance. Subsequent to that letter, IDEM

provided additional materials, including an Addendum to its

Memorandum of Agreement with EPA regarding the State’s

approved NPDES program in which IDEM commits to

always exercise its discretion under those provisions in a

manner consistent with the Guidance. Pursuant to 40 CFR

123.44(c)(3) and 123.63(a)(4), the State is required to comply

with commitments made in its MOA or risk EPA objection

to permits and even program withdrawal. These materials

have demonstrated to EPA that the State will implement its

program (with exceptions identified below) consistent with

the Guidance. The specific provisions that EPA is approving,

and EPA’s full rationale for approving these provisions, are

set forth in the documents entitled “Indiana Provisions

Approved as Being Consistent With the Guidance,” “Analysis

of Whether Indiana Has Adopted Requirements Consistent

With the Guidance” and “Analysis of Steps Taken By Indiana

in Response to EPA’s 90-Day Letter.”

EPA has determined that Indiana’s provisions at 327 IAC

2-1.5-17(b), which allow IDEM to grant a variance from

water quality standards if the permit applicant demonstrates

that failure to grant the variance “will cause an undue

hardship or burden upon the applicant,” are inconsistent with

the criteria for granting variances set forth at Paragraph ! of

Section C of Procedure 2 in Appendix F to 40 CFR Part 132.

Specifically, the Guidance only allows variances based upon

economic considerations if the failure to grant the variance

“would result in substantial and widespread economic and

social impact.” EPA believes, and Indiana agrees, that it is

possible that a failure to grant a variance could result in “an

undue hardship or burden upon [a particular discharger]”

37a

Appendix C

without also causing “substantial and widespread economic

and social impact.” Consequently, Indiana’s provisions allow

variances to be issued that relax water quality standards, and

consequently permit conditions to meet standards, in

instances where such a loosening of applicable requirements

would not be permitted by the Guidance. Therefore, these

provisions of Indiana’s submission are not consistent with

the Guidance.

EPA, therefore, disapproves of 327 IAC 2-1.5-17(b), and

has determined that Paragraph | of Section C of Procedure 2

in Appendix F to 40 CFR Part 132 shall apply for discharges

into the Great Lakes System in the State of Indiana. EPA

notes that Indiana’s “undue hardship or burden upon the

applicant” criterion for granting a variance, as applied to

municipal dischargers, may often be consistent with the

“substantial and widespread social and economic impact”

criterion in Paragraph 1.f of Section C of Procedure 2 in

Appendix F to 40 CFR Part 132. This is because an undue

hardship on the discharger (i.e., the community served by

the municipal discharger) may also constitute widespread

social and economic impact. Consequently, EPA believes that

specifying that Paragraph | of Section C of Procedure 2 in

Appendix F to 40 CFR Part 132 applies to discharges into

the Great Lakes System in the State of Indiana may, as a

practical matter, not have a significant effect on the granting

of variances for municipalities in Indiana. In any case, under

today’s rule, Indiana may only grant variances that meet the

criteria specified in Procedure 2 in Appendix F to 40 CFR

Part 132.

EPA has further determined that Indiana’s provisions at

327 IAC 5-3-4.1(b)(1), which prevent Indiana from including

38a

Appendix C

necessary WQBELs in permits simply because a variance

application has been submitted, is inconsistent with

Paragraph 2 of Section F of Procedure 5 in Appendix F to 40

CFR Part 132 and with 40 CFR 122.44(d). Under those

federal provisions, WQBELs must be included in NPDES

permits whenever there is reasonable potential that a

discharge will cause or contribute to causing nonattainment

of an existing water quality standard. The mere filing of a

variance application does not change a water quality standard.

Consequently, 327 [AC 5-3-4.1(b)(1), which prevents

Indiana from including WQBELs when there is reasonable

potential for a discharge to cause or contribute to causing

nonattainment of an existing water quality standard where a

permittee has applied for a variance from that standard, is

not consistent with the Guidance and 40 CFR 1!22.44(d).

EPA, therefore, disapproves of 327 IAC 5-3-4.1(b){1),

and has determined that Paragraph 2 of Section F of

Procedure 5 in Appendix F to 40 CFR Part 132 shall apply

for discharges into the Great Lakes System in the State of

Indiana.

EPA also has determined that Indiana’s provisions at 327

IAC 5-2-11.5(c)(1) for determining reasonable potential for

a discharge to cause or contribute to an exceedance of

Indiana’s WET requirements are inconsistent with Section

D of Procedure 6 in Appendix F to 40 CFR Part 132.

As described above with respect to Michigan, EPA’s

procedure, in most cases, will project an effluent value greater

than the maximum observed value to characterize the

reasonable worst case effluent. Indiana’s procedure, on the

39a

Appendix C

other hand, uses the mean value of effluent data, further

“discounted” by the fraction of tests exceeding the wasteload

allocation. This both lessens the impact of observed toxicity

on the calculation and fails to account for the reasonable

possibility that effluent toxicity may exceed the level

observed in the tests because sampling did not coincide with

periods of maximum toxicity. An analysis of Indiana’s

procedure shows that those procedures often do not require

a limit on WET where one would be required under the

procedures in the Guidance. In fact, in some cases, Indiana’s

procedure would not require imposition of a WQBEL even

where testing has showed actual, observed toxicity. This is

clearly inconsistent with Section D of Procedure 6.

As discussed above with respect to Michigan and Ohio,

Paragraph | of Section C of Procedure 6 requires that

WQBELs be imposed whenever the WET reasonable

potential procedures in Section D of Procedure 6 show that

there is reasonable potential that a discharge will cause or

contribute to causing an excursion above a State’s numeric

WET criterion or narrative criterion. Indiana’s rules at 327

IAC 5-2-11.5(c), which specify when the permitting authority

must include a WQBEL for WET, limits the permitting

authority to using the WET reasonable potential procedures

in Indiana’s rules at 327 IAC 5-2-11.5(c)(1). Because 327

IAC 5-2-11.5(c) links establishment of WQBELs for WET

to the Indiana WET reasonable potential procedures that EPA

has determined are not consistent with Section D of

Procedure 6 (i.e., the procedures in 327 IAC §-2-11.5(c)(1)),

327 IAC 5-2-11.S(c) is not consistent with Paragraph | of

Section C of Procedure 6.

40a

Appendix C

EPA, therefore, disapproves of 327 IAC 5-2-11.5(c), and

has determined that Paragraph | of Section C, and Section

D, of Procedure 6 in Appendix F to 40 CFR Part 132 shall

apply for discharges into the Great Lakes System in the State

of Indiana.

4. The State of Illinois

On November 12, 1999, EPA issued a letter notifying

the Illinois Environmental Protection Agency (IEPA) that,

while the State of Illinois had generally adopted requirements

consistent with the Guidance, EPA concluded that portions

of the State’s rules were not consistent with corresponding

provisions of the Guidance. On December 9, 1999, EPA

published in the Federal Register a notice of and solicitation

of public comment on its November 12, 1999, letter. 64 FR

69019. EPA has completed its review of the State of Illinois’

response to, and all public comments on, the November 12,

1999, letter, and has determined that, with one exception,

Illinois has adopted requirements consistent with all

aspects of the Guidance. Specifically, Ilinois has adopted

requirements consistent with, and EPA is therefore approving

those elements of the State’s submissions which correspond

to, the definitions in 40 CFR 132.2; the water quality criteria

for the protection of aquatic life, human health and wildlife

in tables 1-4 of Part 132; the methodologies for development

of aquatic life criteria and values, bioaccumulation factors,

human health criteria and values and wildlife criteria in

Appendices B-D; the antidegradation policy in Appendix E;

and, with one exception described below, the implementation

procedures in Appendix F. As explained more fully below,

Illinois has not adopted requirements consistent with the

4la

Appendix C

requirements governing total maximum daily loads in

Procedure 3 in Appendix F.

EPA’s November 12, 1999, letter, had concluded that

some of the provisions that EPA is now approving were

inconsistent with the Guidance because they authorized the

State to act consistent with the Guidance, but provided

inadequate assurance that the State would exercise its

discretion consistent with the Guidance. Subsequent to that

letter, Illinois provided additional materials, including an

Addendum to its Memorandum of Agreement with EPA

regarding the State’s approved NPDES program in which

IEPA commits to always exercise its discretion under those

provisions in a manner consistent with the Guidance.

Pursuant to 40 CFR 123.44(c\(3) and !123.63(a)(4), the State

is required to comply with commitments made in its MOA

or risk EPA objection to permits and even program

withdrawal. These materials have demonstrated to EPA that

the State will implement its program (with one exception

identified below) consistent with the Guidance. The specific

provisions that EPA is approving, and EPA’s full rationale

for approving these provisions, are set forth in the documents

entitled “Illinois Provisions Approved as Being Consistent

With the Guidance,” “Analysis of Whether Illinois Has

Adopted Requirements Consistent With the Guidance” and

“Analysis of Steps Taken By Illinois in Response to EPA’s

90-Day Letter.”

EPA has determined that Procedure 3 in Appendix F to

40 CFR Part 132 shall apply with regard to development of

total maximum daily loads (TMDLs) for the Great Lakes

System in the State of Illinois because Illinois decided not

42a

Appendix C

to adopt TMDL provisions for the Great Lakes System.

Illinois did not adopt such provisions because EPA has

indicated that it will be developing a TMDL for Lake

Michigan and so Illinois does not believe that the State should

be required to develop any TMDLs for the Great Lakes

System. Today’s action ensures that the provisions of

Procedure 3 in Appendix F will apply in developing TMDLs

in the Great Lakes System in the State of Illinois, regardless

of who develops the TMDL. EPA notes that this promulgation

has no effect on the reasonable potential procedures at 35

Ill. Adm. Code 309.141(h)(4), which EPA approves as being

consistent with the reasonable potential procedures in

Procedure 5 ‘n Appendix F to 40 CFR Part 132, and which

therefore apply in the Great Lakes System in the State of

Illinois for purposes of developing preliminary effluent

limitations in making reasonable potential determinations.

As noted above, EPA, in this notice, is not taking action

to approve or disapprove portions of the States’ Guidance

submissions pertaining to NPDES permitting and water

quality standards issues that are not addressed by the

Guidance. While EPA is not taking action under Section 118

with regard to the following issue, EPA nevertheless wishes

to describe its understanding with regard to one aspect of

Illinois’ submission that is not addressed by the Guidance.

Specifically, [linois’ rules at 35 Ill. Adm. Code 352.700(a)(2)

provide that, when a WQBEL is below the level of

quantification, “[t]he analytical method adopted by the

[Illinois Pollution Control] Board and specified in the permit

shall be the method used for compliance assessment including

enforcement actions.”

43a

Appendix C

EPA is concerned about this language because EPA

believes, as a matter of law, that any credible evidence

(subject to generally applicable rules of evidence), not just

evidence generated by use of an analytical method specified

in a permit, can be used in an enforcement action to establish

that a violation of an effluent limitation has occurred. IEPA

has clarified that 35 Ill. Adm. Code 352.700(a)(2) is only a

limitation on the types of evidence that IEPA may use in an

enforcement action; it does not place limits on the types of

evidence that the federal government or third parties can use

in an enforcement action or citizen suit. IEPA also has

clarified that it does not intend to include the language of 35

Ill. Adm. Code 352.700(a)(2) in NPDES permits. Finally,

IEPA is considering revising its rules to address EPA’s

concerns. While EPA is not, at this time, taking action to

either approve or disapprove 35 Ill. Adm. Code 352.700(a)(2)

as a modification of Illinois NPDES program, EPA notes that

revisions to State NPDES programs do not become effective

until approved by EPA. 40 CFR 123.62(b)(4).

D. Public Comments

EPA received a large number of public comments in

response to its Federal Register notices of its receipt of the

States” Guidance submissions and of the availability of EPA’s

letters to the States of Michigan, Ohio, Indiana and Illinois

regarding their Guidance submissions. EPA has responded

to each of those comments in a document entitled “EPA

Responses to Comments Regarding the Great Lakes

Guidance Submissions of the States of Michigan, Ohio,

Indiana and Illinois’ that has been included as part of the

record in this matter. The following is a summary of EPA's

responses to the most significant of these comments.

44a

Appendix C

Comment: Anumber of commenters asserted that EPA’s

regulatory determinations are being made without affected

parties having any chance to review the Agency’s reasoning

or to raise issues as to the validity of that reasoning, in

violation of the Administrative Procedure Act and EPA's

public participation regulations at 40 CFR 25.

Response: The final rule being promulgated today makes

certain provisions of 40 CFR Part 132 applicable to

discharges in certain States within the Great Lakes System.

Those provisions were adopted after publication of a

proposed rule for public comment. See 58 FR 20802 (April

16, 1993). EPA is not modifying those provisions, but merely

making them effective in accordance with 40 CFR

132.5(f)(2). Therefore, the public had a full opportunity to

comment on the contents of today’s rule. Moreover, public

comment was also received regarding EPA’s review of the

State submissions. EPA provided public notice of the

availability of, and solicited comment on, the NPDES

portions of these States’ Guidance submissions in Federal

Register notices dated March 2, 1998 and April 28, 1998.

63 FR 10221; 63 FR 23285. In Federal Register notices dated

September 14, 1999, and December 9, 1999, EPA

subsequently provided notice of the availability of letters to

the States of Michigan, Ohio, Indiana and Illinois in which

EPA provided (a) detailed explanations of the bases for its

findings that certain States had not adopted provisions

consistent with certain provisions of the Great Lakes

Guidance and (b) its preliminary conclusions that, with the

exception of those findings, the States had adopted provisions

consistent with the Guidance. 64 FR 49803, 64 FR 69019.

EPA also solicited comment on all aspects of those letters,

45a

Appendix C

and has considered and responded to all comments received

before taking today’s final actions. Consequently, EPA has

complied with all applicable public participation

requirements.

Comment: A number of commenters raised questions

regarding the basis for EPA’s decisions to approve a State's

provisions pertaining to a specific element of the Guidance

where the State’s provisions, on their face, do not plainly

require the State’s permitting or water quality standards

authority to act in a manner consistent with the Guidance.

Response: EPA believes that these commenters’ view is

both unreasonable and contrary to EPAregulations governing

the Agency’s review of the State submissions. EPA

regulations required each State to submit to EPA not only

the criteria, methodologies, policies and procedures

developed pursuant to the Guidance but also “general

information which will aid EPA in determining whether the

criteria, methodologies, policies and procedures are

consistent with” the Act and the Guidance, and “information

on general policies which may affect their application and

administration.” 40 CFR 132.5(b)(1) and (4). Consistent with

these regulations, EPA has not limited its review to solely

the plain language of each State’s criteria, methodologies,

policies and procedures, but has considered the totality of

the State’s submission in determining whether it was

consistent with the Guidance, including information

regarding interpretation or implementation of a State's

criteria, methodologies, policies and procedures.

46a

Appendix C

As noted previously, the States were not required to adopt

requirements that are identical to the Guidance. States’

submissions can-and do-differ from the Guidance, and this

difference is permissible provided the State’s approach is

consistent with (i.e., as protective as) the Guidance. Given

the complexity of the States’ submissions and EPA’s review,

it is not surprising that particular State provisions may be

amenable to more than one interpretation or manner of

application. Where a State’s provision was either unclear or

authorized the State to act consistent with the Guidance, but

there was uncertainty as to whether the State would actually

exercise its discretion consistent with the Guidance, EPA

considered supplementary information to aid in determining

the meaning and protectiveness of the State’s provision vis-

a-vis the Guidance. This information included, for example,

States’ legal interpretations of its criteria, methodologies,

policies and procedures, or a State’s position on how it would

implement State law. For each of the States, clarification on

the manner in which the State would exercise its discretion

was provided on some issues in an addendum of the MOA

with EPA governing its administration of the NPDES

program. See 40 CFR 123.24. This MOA governs how each

State will sdminister its NPDES program, and failure to

comply with the terms of the MOA is grounds for EPA

objection to 4 State permit and withdrawal of State’s NPDES

program. See 40 CFR 123.44(c)(3) and 123.63(a)(4).

Commenters suggest that EPA is required to ignore such

supplementary information in its review and appear to believe

that, simply because a State provision may be ambiguous or

grants some flexibility to the State, EPA has no choice but to

disapprove the provision as being inconsistent with the

47a

Appendix C

Guidance. Nothing in EPA’s regulations or in the CWA

compels such a cabined exercise of judgment by EPA. Where

the totality of a State’s submission demonstrates that the State

will administer its program consistent with the Guidance,

EPA believes that it is appropriate to approve the submission.

Comment: A commenter disagrees that Indiana’s

variance procedures, which allow Indiana to grant variances

based upon a finding that compliance with the existing water

quality standard would have an “undue hardship or burden

upon the applicant,” is not consistent with the Guidance

requirement that variances only be granted where compliance

with the existing standard “would result in widespread

economic and social impact.” According to the commenter,

Indiana has the ability to obtain and consider information

regarding societal impacts in deciding whether to grant a

variance and so Indiana’s provisions are consistent with the

Guidance. The commenter also argues that, even if Indiana’s

provisions are not consistent with the Guidance, EPA can

apply its “substantial and widespread” test in deciding

whether to approve of any variance that Indiana decides to

grant under its applicant-specific test.

Response: The fact that Indiana “has the ability to obtain

and consider information regarding societal impacts in

deciding whether to grant a variance” does not change the

fact that Indiana law requires that variances be allowed in

circumstances where the Guidance does not allow for

variances to be granted: i.e., where the failure to grant the

variance would have an “undue hardship or burden upon the

applicant” but not cause “widespread social and economic

impact.” Indiana's variance provisions, therefore, are not

consistent with the Guidance.

48a

Appendix C

With regard to the comment that EPA can apply the

Guidance variance procedures in reviewing any variances

that Indiana decides to grant, 40 CFR 132.4(a) requires that

States “adopt requirements * * * that are consistent with * * *

[t]he Implementation Procedures in Appendix F [to 40 CFR

Part 132].” The affirmative obligation imposed on States by

40 CFR 132.4(a) to adopt such requirements would be

rendered meaningless if EPA simply relied upon its approval/

disapproval authorities as a basis to approve a State's

provisions where the State does not interpret or implement a

State provision in a manner that would be consistent with

the Guidance.

Comment: One commenter believes that Indiana’s

provisions prohibiting it from imposing necessary WQBELs

in NPDES permits simply because a variance application is

pending are consistent with the Guidance. According to

the commenter, “EPA has no authority, based on

“protectiveness,” to demand that the State issue a limit that

will later need to be withdrawn because a variance has been

granted. Moreover, * * * [u]nder the EPA rule, the State

would be fully authorized to issue a limit while a variance

application is pending and, at the same time, issue a

compliance schedule that applies to that limit, so that the

limit would not take effect until after the variance application

is either granted * * * or denied. That would achieve exactly

the same end as the process that is currently contained in the

Indiana rules.”

Response: Paragraph 2 of Section F of Procedure 5 in

Appendix F to 40 CFR Part 132 and 40 CFR 122.44(d)(1)

both require imposition of water quality based effluent limits

49a

Appendix C

whenever there is reasonable potential for a discharge to

cause or contribute to causing nonattainment of existing water

quality standards. Nothing in those provisions, or anywhere

else in the Clean Water Act or in EPA’s regulations, creates

an exception to this requirement to account for the fact that

existing water quality standards may eventually change.

Consequently, to the extent that 327 IAC 5-3-4.1(b)(1)

prohibits Indiana from including WQBELs where there is

reasonable potential that a discharge will cause or contribute

to an exceedance of a standard simply because someone has

merely requested a change to Indiana’s existing water quality

standards (but the standard has not yet been modified by

issuance of the variance), it is inconsistent with Paragraph

F.2 of Procedure 5 and 40 CFR 122.44(d)(1).

The commenter is correct that Indiana might be able to

accomplish the same result in certain situations by granting

the permittee a compliance schedule. However, under the

Guidance, any such compliance schedule would have to meet

the requirements governing compliance schedules in

Procedure 9 in Appendix F to 40 CFR Part 132 (Indiana’s

Great Lakes compliance schedule provisions, which EPA is

approving as being consistent with Procedure 9, are at 327

IAC 5-2-12.1). 327 IAC 5-3-4.1(b)(1), which prohibits

Indiana from including WQBELs when a variance application

has been applied for, is not limited only to situations when

the requirements governing compliance schedules in

Procedure 9 and 327 IAC 5-2-12.1 are met. Thus, 327 IAC

5-3-4.1(b) is not consistent with the Guidance.

Comment: A number of commenters believe that EPA

should disapprove Indiana's rule at 327 IAC 5-2-11.7, which

50a

Appendix C

the commenters assert allows Indiana to “downgrade”

Indiana’s historically held third tier, highest quality waters

that were identified in the 1990 water quality standards

approved by EPA as Outstanding State Resource Waters,

which are Indiana’s equivalent to Outstanding Natural

Resource Waters (ONRW). These commenters also believe

that EPA should disapprove Indiana’s Guidance rules

regarding mixing zones in Lake Michigan at 327 IAC 5-2-

1 1.4(b)(2)(A) and (B), (b)4){A)(iii) and (b)(4)(C), and (b}(5)-

(7) because these sections allow a mixing zone in Lake

Michigan contrary to the statewide ban on mixing zones in

lakes at 327 IAC 2-1-4(c) of Indiana’s EPA approved 1990

rules. The commenters believe that these changes constitute

“downgrading” Indiana’s standards for Lake Michigan.

Response: The term “downgrading” generally refers to

a decision to modify a designated use where the current

designated use cannot be attained for one of the reasons

specified at 40 CFR 131.10(g). EPA’s regulations at 40 CFR

131.10 place significant restrictions on a State's ability to

engage in such “downgrading.”

EPA’s regulations at 40 CFR 131.12 and Appendix E to

40 CFR Part 132 describe various levels of antidegradation

protections that must be afforded to water bodies. These

various levels of protection, which are known as “Tier I,”

“Tier II” and “Tier Ill,” are not “use designations,” and so

the restrictions placed on the States’ ability to modify

“designated uses” set forth at 40 CFR 131.10 do not apply to

State decisions with regard to which “tier” of antidegradation

protection should be afforded to particular water bodies. EPA

further notes that EPA’s regulations leave the question of

Sla

Appendix C

whether a particular water body constitutes a “Tier III” water

(or ONRW) to the States’ discretion. Consequently, EPA does

not agree that it should disapprove Indiana’s antidegradation

provisions.

With regard to the commenters’ concerns regarding

Indiana’s mixing zone provisions, the availability of mixing

zones does not represent a change or “downgrade” in use

and thus is not subject to 40 CFR 131.10. Nevertheless, while

States generally have discretion to change mixing zone

requirements, the States’ mixing zone requirements must still

ensure attainment of designated uses and, in the case of

requirements applicable to the Great Lakes System, must be

consistent with the Guidance. EPA believes that Indiana's

mixing zone requirements do insure attainment of designated

uses and are consistent with the Guidance. Consequently,

EPA is approving those provisions of Indiana’s rules,

notwithstanding the possibility that those provisions of

Indiana’s rules may have relaxed Indiana’s previously

adopted mixing zone provisions.

Comment: Citing a May 4, 1999, letter from EPA to

Indiana, a number of commenters believe that EPA should

disapprove certain exemptions in Indiana’s antidegradation

rule at 327 IAC 5-2-11.7(c).

Réponse: The Guidance specifies certain minimum

requirements which all Great Lakes States must include in

their antidegradation policies and implementation procedures

that are specific to protecting the waters of the Great Lakes

System. Specifically, the Guidance establishes minimum

requirements for States’ antidegradation pvlicies which are

52a

Appendix C

largely identical to those of 40 CFR 131.12, and

implementation requirements that are specific to BCCs.

Indiana’s policy and implementation procedures are

consistent with the requirements identified in the Guidance.

To the extent that Indiana’s revised rules contain changes

addressing other elements of the State’s antidegradation

policy not addressed by the Guidance (i.e., procedures

addressing non-BCCs), those elements are outside the scope

of this action and will be addressed in a separate proceeding.

Comment: EPA received numerous comments asserting

that Section D of Procedure 6 in Appendix F, the WET

reasonable potential procedure, was not valid because not

all WET data sets appear to be lognormally distributed (as

readily acknowledged by EPA). Based on this observation,

the commenters conclude that Section D of Procedure 6 is

scientifically indefensible and, therefore, EPA must accept

the other procedures submitted by the States of Ohio,

Michigan, and Indiana. These commenters further assert that

EPA has no basis for disapproving these State procedures as

not being consistent with the Guidance. (The same comments

were made about the Illinois procedure even though it is

based primarily on the Guidance procedure and is being

approved by EPA. Accordingly, the discussion below does

not relate to Illinois.) EPA believes that these commenters

misunderstand the scope of the scientific defensibility

provision of the Guidance. They also fail to refute EPA’s

conclusion that Ohio’s, Michigan’s and Indiana’s procedures

are not consistent with the Guidance.

The Guidance procedure for using effluent data to

Calculate a projected effluent quality (PEQ) for determining

53a

Appendix C

when a WET limit is needed Section D of Procedure 6

estimates an upper bound effluent value (95th percentile) by

multiplying the maximum observed effluent value (expressed

as toxic units) by a factor designed to take into account long-

term effluent variability and the number of data available to

make the projection. The size of the multiplying factor is

determined by the number of data points in the data set, the

variability of the effluent, the assumed distribution of the

data, and the chosen confidence level for capturing the true

95th percentile (95 percent in the case of Table F6-1). Except

in rare cases where there are large amounts of data, the

projected 95th percentile will be greater than maximum

observed effluent value.

Some commenters contended that Section D of Procedure

6-which uses multiplying factors that are based on the

assumption that data are lognormally distributed-is

scientifically indefensible within the meaning of 40 CFR

132.4(h), and that the States are therefore free to adopt other

approaches. Section 132.4(h) allows States to adopt

alternative methodologies or procedures different from those

contained in the Guidance where a State demonstrates that a

methodology or procedure is not scientifically defensible.

EPA included this flexibility to address pollutants identified

in the future for which some of the methodologies or

procedures may not be technically appropriate. 58 Fed. Reg.

20843 (April 16, 1993). See also, Supplemental Information

Document for the Water Quality Guidance for the Great Lakes

System (March 23, 1995) (SID) at 58-59. No party contends

that new pollutants pose unique technical attributes that

render application of the existing WET methodologies or

procedures invalid. Rather, these commenters simply contend

54a

Appendix C

that certain aspects of Procedure 6 promulgated by EPA are

technically unsound and overly conservative. However,

Section 132.4(h) is not a vehicle for parties to challenge anew

the Guidance itself. The CWA requires the States to adopt

policies, standards and procedures that are consistent with

the Guidance promulgated by EPA. CWA§ 118(c)(2)(C). EPA

is reviewing State submissions to determine their consistency

with the Guidance but has not reopened any provision of the

Guidance in our review. The public had a full opportunity to

provide its views on Procedure 6 during the rulemaking

establishing the Guidance, and the time period for challenging

the Guidance has passed. See CWA § 509(b). Therefore, none

of the comments provide any basis for allowing the States to

establish alternative methodologies and procedures pursuant

to 40 CFR 132.4(h) to address whole effluent toxicity.

Even if Section 132.4(h) were relevant, none of the States

has actually proposed an alternative approach of projecting

effluent toxicity that attempts to meet even the basic

parameters of the Guidance. While the States have flexibility

to adopt approaches that make different assumptions about

the distribution of WET data than is assumed in Procedure

6, no one has presented EPA with an analysis identifying a

different distribution or statistical method that fits WET data

better, either in general or in a particular case. More

fundamentally, however, the procedures submitted by Ohio,

Michigan and Indiana do not address in any manner the

underlying premise-of Procedure 6-that effluent quality is

variable and, therefore, a method for assessing WET data

must account for the likelihood that the maximum value in a

particular data set is less than the true maximum that is likely

to be experienced by the environment as a result of the

55a

Appendix C

discharge. In evaluating the potential for a discharge to cause

or contribute to an exceedance of water quality standards,

EPA believes it prudent to employ a procedure that minimizes

the likelihood of misclassifying a discharge as not needing

an effluent limitation, given the potential in such

circumstances for unacceptable adverse impacts on the

aquatic resource. Because the purpose of the PEQ reasonable

potential procedure is to extrapolate from typically small data

sets a reasonable worst case effluent quality that could be

expected over the life of a permit, using a conservative

assumption is in keeping with the purpose of the procedure.

The reasonable potential determination is intended to allow

the permitting authority to make a decision that will protect

water quality with a high degree of confidence in the face of

uncertainty and with a relatively small data set.

Rather than providing alternative methods of accounting

for the uncertainty associated with small data sets by using

an alternative mechanism that more precisely predicts likely

maximum toxicity levels (e.g., alternative multipliers or

“safety factors”), the Michigan and Indiana procedures make

no attempt to extrapolate likely toxicity levels (1.e., they lack

any safety factor whatsoever). Indeed, these States’

procedures move in the opposite direction by averaging the

observed effluent data in some fashion and applying either a

mandatory or optional adjustment downward based on a

“failure” rate. Ohio’s procedure is more complex and less

predictable, but it also provides for “discounting” observed

WET data rather than applying a safety factor. Thus, not only

do these procedures fail entirely to consider the potential of

the discharge to cause or contribute to an exceedance taking

into account long-term effluent variability and the fact that a

S6a

Appendix C

small number of data sets may not capture the worst case

effluent quality, they actually allow a finding of “no

reasonable potential” where available data has indicated

unacceptable toxicity. EPA does not consider these

approaches to be either as protective as the Guidance, or in

accordance with applicable national regulations (40 CFR

22.44(d)(1)).

EPA also received comments that EPA should find Ohio's

weight-of-evidence approach for determining reasonable

potential for WET as protective as the Guidance. These

commenters support the Ohio approach as superior in

considering all data regarding the toxicity of an effluent and

note especially a feature of the Ohio procedure that they say

would use biosurvey data as a substitute for the multiplier in

Table F6-1 when considering WET data.

EPA does expect permitting authorities to consider all

relevant information in determining whether reasonable

potential exists. EPA believes that this is best accomplished

by considering each line of evidence regarding the effect of

an effluent on the environment separately and without

differential weighting of data drawn from different sources.

As discussed in the Technical Support Document for

Water Quality-based Toxics Control (EPA/S05/2-90-001,

March 1991) (TSD) and reflected in paragraph 3 of Section

F of Procedure 5 in Appendix F, the chemical-specific,

bioassessment, and WET characterization approaches each

have unique as well as overlapping attributes, sensitivities,

and program applications, no single approach for detecting

impact should be considered uniformly superior to any other

approach (See Chapter 3.1.3, p. 49). Consistent with this

S7a

Appendix C

principle, data showing an effect or potential for an effect is

suffictent to require effluent limits and the results of one

assessment technique should not be used to contradict or

overrule the results of the other techniques that indicate the

need for an effluent limit. This is especially appropriate when

the task at hand is not only to identify existing problems but

to predict the possibility of future adverse impacts and impose

effluent limits to prevent those adverse impacts from

occurring.

EPA recognizes some merit in the position that biological

data can reduce the uncertainties about the effect of the

discharge and thus could serve a similar purpose as the

multipliers or “safety factors” used in the Guidance

procedure. Taken as a whole, however, the Ohio procedure

has the significant shortcoming discussed above of

“discounting” WET data. Specifically, where biological data

are unavailable to corroborate effluent toxicity data, Ohio’s

procedure would require that the maximum observed toxicity

be at least three times greater than the expected toxicity limit,

that the average toxicity exceed one-third the expected

effluent limit, and that more than more than 30 percent of

the test results exceed a projected wasteload allocation before

it would be likely that a limit will be imposed. Where:

biological data are present to corroborate effluent data, it is

not clear, as the commenter asserts, that a limit would be

required if the maximum observed effluent value exceeded

the projected effluent limit. In this situation, Ohio’s procedure

still could require that the maximum observed effluent value

be greater than the projected wasteload allocation, that the

average of the effluent test results exceed half the expected

effluent limit for acute toxicity and two-thirds the expected

58a

Appendix C

effluent limit for chronic toxicity, and that more than 30

percent of the effluent values exceed the expected toxicity

limit before a limit is imposed. Thus, Ohio’s procedures will

not necessarily require a limit even in situations where the

effluent toxicity is observed in excess of the expected toxicity

limit. As discussed above, such a procedure is inconsistent

with the Guidance.

Another set of comments asserted that EPA must examine

a State’s whole approach to addressing WET and determine

whether it reduces effluent toxicity to a similar extent as

EPA’s approach, rather than simply focusing on whether the

State’s procedures will result in imposition of effluent limits

for WET in all situations where the Great Lakes Guidance

would require imposition of such limits.

It is unclear how the commenter believes EPA’s analysis

is deficient and why a different analysis would show a

different result. Certainly, the procedure that determines

whether or not a permit includes a WQBEL for a particular

pollutant or parameter (the reasonable potential procedure)

is a critical element for determining the level of protection

that will be achieved when implementing a water quality

standard. Where a reasonable potential procedure is not as

protective as the Guidance, a State’s WET program cannot

be considered to achieve the same level of protection as the

Guidance.

EPA also notes that in addition to the requirements of

the Procedure 6 of the Guidance itself, Section 301(b)(1)(C)

of the Clean Water Act requires “limitation[s] * * * necessary

to meet any applicable water quality standard.” Moreover,

59a

Appendix C

EPA’s regulations implementing Section 301(b)(1)(C) at 40

CFR 122.44(d)(1)(iv) and (v) require that NPDES permits

contain “effluent limits for whole effluent toxicity” or

chemical-specific limits in lieu of WET limits, whenever

there is reasonable potential that a discharge will cause or

contribute to an in-stream excursion above a numeric

criterion for WET or a narrative criterion of no toxics in toxic

amounts. Therefore, the CWA and EPA’s implementing

regulations require permitting authorities to impose WQBELs

for WET when there has been a reasonable potential finding,

and EPA does not belicve it would be consistent with the

CWA and EPA regulations to approve an alternative approach

that omits this fundamental requirement. EPA notes that, in

appropriate cases, a permitting authority can include a

compliance schedule for the WQBEL that would allow for

additional monitoring and identification and reduction of

toxicants, followed by a reassessment of the need for a limit

or the identification of a specific toxicant that could be

subject to a WQBEL rather than WET.

Some commenters contended that EPA’s actions with

respect to Indiana’s, Michigan’s and Ohio’s WET reasonable

potential procedures were not consistent with statements by

EPA that permitting authorities retain the right to determine

whether data is relevant and valid.

EPA agrees that permitting authorities have the right to

exercise reasonable discretion to reject unrepresentative or

invalid data in making reasonable potential determinations.

EPA does not agree, and the commenter fails to explain why

it believes, that EPA’s actions with respect to Indiana’s,

Michigan’s and Ohio’s WET reasonable potential procedures

60a

Appendix C

conflict with that position. Section D of Procedure 6 is neutral

with respect to the validity of particular pieces of WET data

(e.g., were the quality assurance/quality control requirements

of the method correctly followed) or whether that data is

representative of the discharge (e.g., was the sample taken

during normal operations of the facility). It is designed to

work on the assumption that the permittee has submitted data

the permitting authority agrees are valid and representative

of the discharge. If the commenter is saying that States have

the discretion to determine that valid, representative data that

show effluent toxicity are irrelevant in determining whether

a WET limit is needed, EPA disagrees.

PA is nonetheless aware that there has been considerable

concern about the possibility that variability in WET test

results could erroneously indicate toxicity. EPA recently

addressed this issue in the document, “Understanding and

Accounting for Method Variability in Whole Effluent

Toxicity (WET) Applications Under the NPDES Program”

(EPA 833-R-00-003, June 2000). This document clarifies

several issues regarding WET variability and reaffirms EPA’s

earlier guidance and recommendations published in the

Technical Support Document for Water Quality-Based Toxics

Control (TSD, USEPA 1991). The document discusses

analysis of WET data that shows WET test method precision

is comparable to chemical-specific method precision.

Significantly, the document recommends that, rather than

adjusting the reasonable potential procedures, WET test

method variability be minimized by adhering to the EPA test

methods (especially the quality assurance/quality control

procedures), representative sample collection, and other

recommendations provided in the document related to

6la

Appendix C

evaluating the validity of specific WET test results. The

Federal Register notice announcing the availability of this

document and the document itself may be viewed or

downloaded on the Internet at http://www.epa.gov/owm/

npdes.htm.

E. Consequences of Today’s Action

As a result of today’s action, the Guidance provisions

specified in today’s rule apply in the Great Lakes System in

the States specified in the rule until such time as a State

adopts requirements consistent with the specific Guidance

provisions at issue, and EPA approves thwse State

requirements and revises the rule so that the provisions no

longer apply in that State.

II. “Good Cause” Under the Administrative Procedure Act

Section 553 of the Administrative Procedure Act,

5 U.S.C. 553 (b)(3)(B), provides that, when an agency for

good cause finds that notice and public procedure are

impracticable, unnecessary or contrary to the public interest,

the agency may issue a rule without publishing a notice of

proposed rulemaking. EPA has determined thai there is good

cause for promulgating today’s rule final without publishing

a notice of proposed rulemaking because EPA finds it

unnecessary and contrary to the public interest. Today’s rule

does not promulgate any new regulatory provisions. Rather,

in accordance with the procedures in 40 CFR 132.5(f), today’s

rule identifies the provisions of Part 132 promulgated

previously by EPA that shall apply to discharges in certain

States within the Great Lakes System. Those provisions have

62a

Appendix C

already been subject to a notice of proposed rulemaking, and

publication of a new proposed rule is therefore unnecessary.

See 58 FR 20802 (April 16, 1993). In addition, while EPA’s

approval/disapproval decisions described in this notice do

not constitute rulemaking, EPA has nonetheless received

substantial public comment on these decisions. See 63 FR

10221 (March 2, 1998) and 63 FR 23285 (April 28, 1998)

(notices of receipt of State Guidance submissions and

requests for comment); 64 FR 49803 (September 14, 1999),

and 64 FR 69019 (December 9, 1999) (notices of letters

identifying inconsistencies and requests for comment). EPA

also believes the public interest is best served by fulfilling

the CWA’s requirements without further delay and

publication of a notice of proposed rulemaking therefore

would be contrary to the public interest. EPA finds that this

constitutes good cause under 5 U.S.C. 553(b)(B).

Ill. Administrative Requirements

Under Executive Order 12866 (58 FR 51735, October

4, 1993), this action is not a “significant regulatory action”

and is therefore not subject to review by the Office of

Management and Budget. Because the agency has made a

“good cause” finding that this action is not subject to notice-

and-comment requirements under the Administrative

Procedure Act or any other statute, as described in Section

II, above, it is not subject to the regulatory flexibility

provisions of the Regulatory Flexibility Act (5 U.S.C. 601

et seq.), or to Sections 202 and 205 of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L. 104-4). In addition,

because this action does not promulgate any new

requirements, but only makes certain existing provisions of

63a

Appendix C

40 CFR Part 132 effective in several States, it does not impose

any new costs. The costs of Part 132 were considered by EPA

when it promulgated that regulation. Therefore, today’s rule does

not significantly or uniquely affect small governments or impose

a significant intergovernmental mandate, as described in

Sections 203 and 204 of UMRA, or significantly or uniquely

affect the communities of Tribal governments, as specified by

Executive Order 13084 (63 FR 27655, May 10, 1998). This

rule 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 (64 FR 43255, August 10, 1999). This rule also is not

subject to Executive Order 13045 (62 FR 19885, April 23, 1997),

because it is not economically significant.

This action does not involve technical standards; thus, the

requirements of Section 12(d) of the National Technology

Transfer and Advancement Act of 1995 (15 U.S.C. 272 note)

do not apply. The rule also does not involve special consideration

of environmental justice related issues as required by Executive

Order 12898 (59 FR 7629, February 16, 1994). In issuing this

rule, EPA has taken the necessary steps to eliminate drafting

errors and ambiguity, minimize potential litigation, and provide

a clear legal standard for affected conduct, as required by Section

3 of Executive Order 12988 (6! FR 4729, February 7, 1996).

This rule does not impose an information collection burden

under the provisions of the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.).

The Congressional Review Act, 5 U.S.C. 801 et seq., as

added by the Small Business Regulatory Enforcement

64a

Appendix C

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 rule is not a major rule as defined by 5 U.S.C. 804(2).

This rule will be effective September 5, 2000.

List of Subjects in 40 CFR Part 132

Administrative practice and procedure, Great Lakes,

Indian-lands, Intergovernmental relations, Reporting and

recordkeeping requirements, Water pollution control.

Dated: July 31, 2000.

Carol M. Browner,

Administrator.

For the reasons set forth above, EPA amends 40 CFR

Part 132 as follows:

65a

Appendix C

PART 132—WATER QUALITY GUIDANCE FOR THE

GREAT LAKES SYSTEM

1. The authority citation for part 132 continues to read

as follows:

Authority: 33 U.S.C. 1251 et seq.

2. Text is added to § 132.6 to read as follows:

§ 132.6 — Application of part 132 requirements in Great

Lakes States and Tribes.

(a) Effective September 5, 2000, the requirements of

Paragraph C.1 of Procedure 2 in Appendix F of this Part and

the requirements of paragraph F.2 of Procedure 5 in Appendix

F of this Part shall apply to discharges within the Great Lakes

System in the State of Indiana..-

(b) Effective September 5, 2000, the requirements of

Procedure 3 in Appendix F of this Part shall apply for

purposes of developing total maximum daily loads in the

Great Lakes System in the State of Illinois.

(c) Effective September 5, 2000, the requirements of

Paragraphs C.! and D of Procedure 6 in Appendix F of this

Part shall apply to discharges within the Great Lakes System

in the States of Indiana, Michigan and Ohio.

[FR Doc. 00-19792 Filed 8-3-00; 8:45 am]

(4) FILED

MAY 3 1 2006

No. 05-1094 pte OF THE CLERK

In the Supreme Court of the Ainited States

INDIANA WATER QUALITY COALITION, PETITIONER

Vv.

ENVIRONMENTAL PROTECTION AGENCY

- ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

BRIEF FOR THE RESPONDENT IN OPPOSITION

PAUL D. CLEMENT

Solicitor General

Counsel of Record

SUE ELLEN WOOLDRIDGE

Assistant Attorney General

ANDREW J. DOYLE —

Attorney

Department of Justice

Washington, D.C. 20530-0001

(202) 514-2217

QUESTION PRESENTED

Under Section 118(¢)(2)(A) and (C) of the Federal

Water Pollution Control Act Amendments of 1972, Pub.

L. No. 92-500, 86 Stat. 816, as amended, the En-

vironmental Protection Agency (EPA) was required to

“provide guidance to the Great Lakes States on mini-

mum water quality standards, antidegradation policies,

and implementation procedures for the Great Lakes

System,” and to review the Great Lakes States’ pro-

posed standards, policies, and implementation pro-

cedures for “consisten[cy] with such guidance.” 33

U.S.C. 1268(c)(2)(A) and (C). In 1995, following notice

to the public and an opportunity to comment, EPA

issued the required guidance. In 2000, after reviewing

the State of Indiana’s proposed standards, policies, and

implementation procedures for consistency with the

guidance, EPA disapproved one of Indiana’s imple-

mentation procedures. The question presented is as

follows:

Whether EPA’s decision to disapprove Indiana’s im-

plementation procedure was reasonable and consistent

with the 1995 guidance.

—

(I)

TABLE OF CONTENTS

Page

CN i oho Ke ea onde e sth veees Verdesnenaees 1

NS i ig ces Ges ea yd baa ater e ee eeES 1]

I rl cate eece boo cueuk bese ausa ves cevaeeces 1

PO POE TERT LER ETL E PL TCT Te OCTET TCT ET 10

RN er eek ony ute ep eee a eae aes een a’ 16

TABLE OF AUTHORITIES

Cases:

American Iron & Steel Inst. v. EPA, 115 F.3d 979

es a RE ec ie ees Oh eh eee ewes 3, 12,15

Arkansas v. Oklahoma, 503 U.S. 91 (1992) .......... 2.3

Edison Elec. Inst. v. EPA, 391 F.3d 1267 (D.C. Cir.

NE. era EV ik Cheek Cae Sale ee ee eb eee eee ee 4

South Fla. Water Mgmt. Dist. v. Miccosukee Tribe of

Indians, 541 U.S. 95 (2004) ...... ede eeeceeernees 2

Statutes and regulations:

Federal Water Pollution Control Act Amendments of

1972, Pub. L. No. 92-500, 86 Stat. 816 (38 U.S.C.

Rk is oa a ie x he 5 eo Re ns 1

USC AGLI) ce sae

BNE beh Ee | 2 RRR mR teatime ins Re

33 U.S.C. 1268 (2000 & Supp. II] 2003) ........ 3,14

ee Ack as La od Spee bees doers 14

Be Rhee PA ov a oo ov bk eae ok eeee eee 3

Te 0 AR SCD: ovo ss bvickwcsunscoeaes Oe

Be a I) an Fe ek bee Oh beep ennemle

(IIT)

IV

Statutes and regulations—Continued: Page

ee Bi RE eh hick cane ea Pee ea ee ee ees 2

Oe PRR. oe eos vac btp eke cedbhinenxiees 2

ee EE Re Sk i obs Cee eben eee es 2

TU Tee) he RRR 2

Be a ee I ie eevee soe Ree eS 2

SS OM) a eee

Br ED o> ha one ee 2,7, 12

Cee Ree SOLE ake oeecerdoa vc aoreted 7,12

40 C.F.R.:

ri tec

PN Be 6 oo os hs Pe 4

PE Fe RIC ib voce oa keh hee 8,13

meCtION IZ AALGKIMD 60 ic oo een saeco ee

TAO Dae SMMC EMIV) ks cake kee yer ka pweens 2

Pi Se OR his ao ed eens OO EE Oe bea 2

Pt. 132:

BION Be Fh oie vos ko he

OE SD ip ee aR eRe R RB ER S 6, 10, 11,13

ORT SU) so de Pee da ee eG eee

I A ne ise ek eS ae eee

POINGEE SHENG) Bc nS a ob ae eee eek es 14

BINED book ee Od ook eed Reker 3

pes RD EA ean Cag eI Beph sane Is ir ST pee eee See, S 3

Fe 6 eee er Re RRA ee 4

Proce CBee. 8) os i eke 4

ft ER Re area See ee OLR IAD, NS SU DES

Miscellaneous: _ Page

ee FO: TA, DO ANGE) cca svicvsos devedvensees 10, 11

rg Be Ra. | eer rrr rr srr: Per 6

OE Fes Sete, Se LOE cis esd ks SV cuNeanntvecadas 6

Final Water Quality Guidance for the Great Lakes

System, 60 Fed. Reg. 15,366 (1995) .................3

In the Supreme Court of the Gnited States

No. 05-1095

INDIANA WATER QUALITY COALITION, PETITIONER

v,

ENVIRONMENTAL PROTECTION AGENCY

ON PETITION FOR A WRIT OF CERTIORARL .-

TO THE UNITED STATES COURT OF APPEALS

FOR THE SIXTH CIRCUIT

BRIEF FOR THE RESPONDENT IN OPPOSITION

OPINION BELOW

The opinion of the court of appeals (Pet. App. la-16a)

is reported at 411 F.3d 726.

JURISDICTION

The judgment of the court of appeals was entered on

June 16, 2005. A petition for rehearing was denied on

November 22, 2005 (Pet. App. 17a-18a). The petition for

a writ of certiorari was filed on February 21, 2006 (the -

Tuesday following a holiday). The jurisdiction of this

Court is invoked under 28 U.S.C. 1254(1).

STATEMENT

1. The Federal Water Pollution Control Act Amend-

ments of 1972 (Clean Water Act or CWA), Pub. L. No.

92-500, 86 Stat. 816, as amended (33 U.S.C. 1251 et seq.),

|

(1)

2

prohibit the di. .arge of any pollutant into “navigable

waters” except in accordance with the Act. 33 U.S.C.

1311(a), 1862(12)(A). “The Clean Water Act anticipates

a partnership between the States and the Federal Gov-

ernment, animated by a shared objective: ‘to restore

and maintain the chemical, physical, and biological in-

tegrity of the Nation’s waters.’” Arkansas v. Oklahoma,

503 U.S. 91, 101 (1992) (quoting 33 U.S.C. 1251(a)

(1988)). Under the CWA, the Environmental Protection

Agency (EPA) “provides States with substantial guid-

ance in the drafting of water quality standards.” J/bid.

(citing 40 C.F.R. Pt. 151 (1991)). “If the EPA recom-

mends changes to the standards and the State fails to

comply with that recommendation, the Act authorizes

the EPA to promulgate water quality standards for the

State.” /bid. (citing 33 U.S.C. 1313(c) (1988)).

The National Pollutant Discharge Elimination Sys-

tem (NPDES) is established by Section 402 of the CWA,

33 U.S.C. 1342, and “requires dischargers to obtain per-

mits that place limits on the type and quantity of pollut-

ants that can be released into the Nation’s waters.”

South Fla. Water Mgmt. Dist. v. Miccosukee Tribe of

Indians, 541 U.S. 95, 102 (2004). NPDES permits im-

pose limits based on available technologies, 33 U.S.C.

1311(b), and any more stringent limits necessary to meet

water quality standards, 33 U.S.C. 1311(b)(1)(C). Long-

standing NPDES regulations require water quality-

based limits whenever a discharge would “cause, have

the reasonable potential to cause, or contribute to an

excursion above any State water quality standard.” 40

C.F.R. 122.44(d)(1)(i); see id. § 122.44(d)(1 (iv). “Section

402(b) authorizes each State to establish ‘its own permit

program for discharges into navigable waters within its

2]

”?

jurisdiction.’” Arkansas, 503 U.S. at 102 (quoting 33

U.S.C. 1842(b)).

In 1990, Congress amended Section 118 of the CWA

to address the problem of pollutant discharges into the

Great Lakes System. 33 U.S.C. 1268 (2000 & Supp. III

2003); see American Iron & Steel Inst. v. EPA, 115 F.3d

979, 989 (D.C. Cir. 1997) (“Congress was attempting to

create a uniform set of requirements for water pollution

in the Great Lakes.”). Section 118 directs EPA to “pro-

vide guidance to the Great Lakes States on minimum

water quality standards, antidegradation policies, and

implementation procedures for the Great Lakes Sys-

tem,” 33 U.S.C. 1268(c)(2)(A); see 33 U.S.C.

1268(c)(2)(B), and it requires the Great Lakes States to

“adopt water quality standards, antidegradation poli-

cies, and implementation procedures * * * which are

consistent with such guidance,” 33 U.S.C. 1268(¢)(2)(C).

If and to the extent that a Great Lakes State fails to

adopt standards, policies, and procedures that are con-

sistent with the guidance provided by EPA, EPA is di-

rected to promulgate federal standards, policies, or pro-

cedures that will then apply to discharges in the rele-

vant State. See 33 U.S.C. 1268(c)(2)(C); 40 C.F.R.

132.5(f)(2); Pet. App. 8a.

In 1995, following a notice-and-comment procedure,

EPA issued the required guidance. Final Water Qual-

ity Guidance for the Great Lakes System, 60 Fed. Reg.

15,366 (Guidance); see Pet. App. 3a. The Guidance has

three basic parts. First, it outlines criteria and method-

ologies for protecting aquatic life, human health, and

wildlife from toxic pollutants. See 40 C.F.R. Pt. 132,

Thls. 1-4, Apps. A-D. Second, it prescribes antide-

gradation procedures to protect existing high-quality

waters within the Great Lakes System. See 40 C.F.R.

4

Pt. 132, App. E. Third, the Guidance establishes re-

quirements to ensure more consistent implementation of

water-quality criteria in regulating individual dis-

charges of toxic pollutants into the System. See 40

C.F.R. Pt. 132, App. F.

The third part of the Guidance establishes an imple-

mentation procedure under which an NPDES permit-

ting authority determines whether a facility’s permit

requires a discharge limitation to control whole effluent

toxicity (WET) to a level that will assure attainment of

water quality standards. See Pet. App. 2a. The term

“WET” is defined under pre-existing NPDES regula-

tions as the combined toxic effect of individual chemicals

in a discharge measured directly using test organisms in

a laboratory. See 40 C.F.R. 122.2; Edison Elec. Inst. v.

EPA, 391 F.3d 1267, 1268-1269 (D.C. Cir. 2004) (describ-

ing test procedures). In general terms, the Guidance’s

implementation procedure for determining the need for

a WET limit (a) starts with the maximum observed tox-

icity value derived from laboratory testing of a facility’s

effluent; (b) applies a statistical multiplier to that maxi-

mum value to account for the likelihood that the facility

did not collect samples at the precise moment when the

combined toxic effect of the facility’s wastestream was

at its highest; (c) adjusts downward to reflect any avail-

able dilution in the receiving water; and (d) compares

the resulting value to the amount of toxicity that a

healthy water body can sustain (7.e., the applicable WET

criteria in the water quality standard). See 40 C.F.R.

Pt. 132, App. F, Procedure 6, Sec. D; Pet. App. 3a-4a. If

the permitting authority projects that the discharge is

likely to have a greater toxic effect on the receiving wa-

ter of the Great Lakes System than the acceptable level

of toxicity identified in the standard, then it may autho-

a

»

rize the discharge only with an NPDES permit that in-

cludes an effluent limitation for WET.

The Guidance further provides that, “{flor any pollut-

ant other than those in Table 5 of this part for which the

State * * * demonstrates that a methodology or proce-

dure in this part is not scientifically defensible,” a Great

Lakes State shall “[ajpply an alternative implementation

procedure that is consistent with all applicable Federal,

State, and Tribal laws.” 40 C.F.R. 132.4(h)(2). WET is

not one of the pollutants listed in Table 5 of Part 132. At

the same time that it promulgated the Guidance, EPA

also issued a Supplementary Information Document

(SID). C.A. App. 302. The SID explains that “[t|he rea-

son for this |scientific-indefensibility] exclusion is that

there may be pollutants identified in the future for

which some of the methodologies or procedures in the

final Guidance may not be technically appropriate.” /d.

at 308. The SID also expresses EPA’s intent “that the

exclusion be limited to each specific element of the Guid-

ance that [is] demonstrated to be inappropriate if ap-

plied to a specific situation.” Jd. at 3609. The Guidance

itself notes that

[t]he scientific, policy and legal basis for EPA’s de-

velopment of each section of the final Guidance

* * * is set forth in the preamble, [SID], Technical

Support Documents, and other supporting docu-

ments in the public docket. EPA will follow the guid-

ance set out in these “ocuments in reviewing State

* * * water quality programs in the Great Lakes

for consistency with this part...

40 C.F.R. 132.1(b).

2. In 2000, after reviewing the standards, policies,

and implementation procedures proposed by the State

6

of Indiana and other Great Lakes States, including pub-

lic notice and opportunity for comment, EPA approved

a large majority of the state proposals. See Pet. App.

19a-26a, 34a-40a; 63 Fed. Reg. 10,221 (1998); 64 Fed.

Reg. 49,803 (1999); C.A. App. 494-507, 628-633, 650, 657-

659, 679-686, 690-696, 704. EPA disapproved Indiana’s

proposed WET implementation procedure, however,

concluding that it was inconsistent with the Guidance.

See Pet. App. 38a-40a. EPA explained that Indiana’s

proposed procedure, whose application turns on the av-

erage toxicity of different samples rather than on the

maximum observed toxic value, “both lessens the impact

of observed toxicity on the calculation and fails to ac-

count for the reasonable possibility that effluent toxicity

may exceed the level observed in the tests because sam-

pling did not coincide with periods of maximum toxicity.”

Id. at 39a. EPA further observed that the proposed In-

diana procedures “often do not require a limit on WET

where one would be required under the procedures in

the Guidance,” and that, “in some cases, Indiana’s proce-

dure would not require imposition of a [permit umit for

WET] even where testing has showed actual, observed

toxicity.” [bid.; see C.A. App. 638 (Indiana’s WET im-

plementation procedure “require|s] multiple failures” of

a toxicity test before the facility’s NPDES permit must

contain a WET limit).

In the course of its decision, EPA considered and

rejected Indiana’s contention that EPA’s own WET im-

plementation procedure is scientifically indefensible,

and that the State’s procedure therefore was not re-

quired to be consistent with the applicable Guidance

provisions. Pet. App. 52a-6la. EPA explained that the

scientific-indefensibility exclusion set forth in 40 C.F.R.

132.4(h) is intended “to address pollutants identified in