52922 Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 132

[FRL–5907–4]

RIN 2040–AC08

Revocation of the Polychlorinated

Biphenyl Human Health Criteria in the

Water Quality Guidance for the Great

Lakes System

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Partial revocation of final rule.

SUMMARY: As a result of the recent

decision in AISI v. EPA, D.C. Cir. No.

95–1448 (decided June 6, 1997), EPA is

today removing the human health

criteria for polychlorinated biphenyls

(PCBs) promulgated for the final Water

Quality Guidance for the Great Lakes

System (Guidance) in March 1997. EPA

plans to propose replacement criteria in

1998. In the interim, EPA has calculated

a Tier I value for PCBs for human health

of 2.6 E–5 micrograms per liter (ug/L)

for both drinking water and nondrinking

water uses. EPA is recommending that

States and Tribes either adopt a human

health criterion for PCBs that is no less

stringent than this value or use their

Guidance based Tier I methodologies for

human health, together with appropriate

data, to derive an ambient value to be

used in setting permit limits. EPA

anticipates these Tier I values to be no

less stringent than EPA’s interim value

of 2.6 E–5 ug/L (unless site-specific data

are used). EPA is not removing the

wildlife criterion for PCBs of 1.2 E–4

ug/L promulgated in March of 1997.

EPA expects States and Tribes to adopt

and submit PCB wildlife criteria

consistent with this criterion.

EFFECTIVE DATE: October 9, 1997.

ADDRESSES: The public docket for this

and earlier rulemakings concerning the

Water Quality Guidance for the Great

Lakes System, including the proposal,

public comments in response to the

proposal, other major supporting

documents, and the index to the docket

are available for inspection and copying

at U.S. EPA Region 5, 77 West Jackson

Blvd., Chicago, IL 60604 by

appointment only. Appointments may

be made by calling Mary Willis Jackson

(telephone 312–886–3717).

FOR FURTHER INFORMATION CONTACT:

Mark Morris (4301), U.S. EPA, 401 M

Street, SW, Washington, D.C. 20460

(202–260–0312).

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. Potentially affected

categories and entities include:

Category Examples of potentially

affected entities

Industry .............. Industries discharging

PCBs to waters in the

Great Lakes System as

defined in 40 CFR 132.2

Municipalities ..... Publicly-owned treatment

works discharging PCBs

to waters of the Great

Lakes System as defined in 40 CFR 132.2

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

affected by this final rule. This table

lists the types of entities that EPA is

now aware could potentially be affected

by this action. Other types of entities

not listed in the table could also be

regulated. To determine whether your

facility may be affected by this final

rule, you should examine the definition

of ‘‘Great Lakes System’’ in 40 CFR

132.2 and examine 40 CFR 132.2 which

describes the purpose of water quality

standards such as those established in

this rule. 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. Overview

As a result of the recent decision in

AISI v. EPA, D.C. Cir. No. 95–1448

(decided June 6, 1997), EPA is today

removing the human health criteria for

polychlorinated biphenyls (PCBs)

promulgated for the final Water Quality

Guidance for the Great Lake System

(Guidance) in March 1997. EPA plans to

propose replacement criteria in 1998. In

the interim, EPA has calculated Tier I

values for PCBs for human health of 2.6

E–5 micrograms per liter (ug/L) for both

drinking water and nondrinking water

uses. EPA is recommending that States

and Tribes either adopt a human health

criterion for PCBs that is no less

stringent than this value or use their

Guidance based Tier I methodologies for

human health, together with appropriate

data, to derive an ambient value to be

used in setting permit limits. EPA

anticipates these Tier I values to be no

less stringent than EPA’s interim value

of 2.6 E–5 ug/L (unless site-specific data

are used). EPA is not removing the

wildlife criterion for PCBs of 1.2 E–4 ug/

L promulgated in March of 1997. EPA

expects States and Tribes to adopt and

submit PCB wildlife criteria consistent

with this criterion.

C. Background

In March 1995 (60 FR 15366–15425,

March 23, 1995), EPA promulgated the

final Water Quality Guidance for the

Great Lakes System (the Guidance)

required under section 118(c)(2) of the

Clean Water Act, 42 U.S.C. 1268(c)(2).

The Guidance included ambient water

quality criteria setting maximum

ambient concentrations for pollutants to

be met in all waters of the Great Lakes

Basin (unless site-specific criteria are

derived and approved). States and

Tribes were required to adopt

regulations consistent with EPA’s

Guidance criteria and implementation

procedures by March 23, 1997. Once the

criteria take effect, permits for

discharges of the pollutants they cover

must include limits needed to attain the

criteria.

EPA promulgated human health and

wildlife criteria for a class of closely

related toxic chemicals known as PCBs.

Various industries and trade

associations challenged the human

health and wildlife criteria for PCBs.

They alleged that EPA had improperly

computed a ‘‘composite’’

bioaccumulation factor (BAF) for the

class of PCBs. The BAF played a role in

the derivation of both the human health

and wildlife criteria. They also alleged

that EPA used an inappropriate cancer

potency factor of 7.7 milligrams per

kilogram per day ((mg/kg)/d) in deriving

the human health criteria.

EPA decided in the summer of 1996

that it wished to revise its method for

calculating composite BAFs for the two

types of criteria. It requested the U.S.

Court of Appeals for the District of

Columbia Circuit to remand the human

health and wildlife criteria for further

rulemaking related to this issue. The

Court granted the motion, and EPA

proposed a new approach for

calculating composite BAFs on October

22, 1996. (61 FR 54748). In March 1997,

EPA promulgated its revised

mathematical method for deriving

composite BAFs for PCBs. (62 FR 11724,

March 12, 1997). EPA also promulgated

revised human health and wildlife

criteria for Tables 3 and 4 of 40 CFR part

132 that were based on the new

mathematical approach. See 62 FR

11731.

Also in 1996, EPA announced in a

guidance document that it would

approve PCB criteria for human health

submitted by States or Tribes that used

a revised, Agency-approved cancer
Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Rules and Regulations 52923

potency factor of 2 (mg/kg)/d. It

explained that it would consider such

criteria to be ‘‘consistent with’’ the final

Guidance. See Questions and Answers

on Implementing the Great Lakes

Guidance, March 20, 1996.

At oral argument in the AISI litigation

EPA told the Court that it planned to

propose new human health criteria for

PCBs that would utilize the new cancer

potency factor of 2 (mg/kg)/d. When the

Court issued its opinion on June 6,

1997, it vacated the March 1995 criteria

for human health and wildlife, citing

the decisions to replace the

mathematical method for composite

BAFs and the cancer potency factor.

D. Decision To Remove Human Health

Criteria

EPA believes that the Court’s decision

did not affect the March 1997 human

health criteria incorporating the revised

mathematical approach to deriving

composite BAFs. No challenge to those

criteria were before the Court, so it did

not have jurisdiction to vacate or

remand them. EPA, however,

acknowledges that it did not use the

revised cancer potency factor of 2 (mg/

kg)/d in deriving the March 1997 human

health criteria. Because the issue

vacated by the Court clearly overlaps

with the scope of the 1997 rule, EPA has

decided to withdraw the March 1997

human health criteria for PCBs.

EPA still intends to propose revised

human health criteria using both the

new potency factor and the new

mathematical approach. It currently

anticipates signing this proposal in

March of 1998.

E. Consequences of Today’s Action

As a result of today’s action, States

and Tribes need not adopt or submit to

EPA for review human health criteria

for PCBs for waters of the Great Lakes

Basin. EPA, however, recommends that

States and Tribes adopt a human health

criterion for PCBs based on the revised

BAFs and the revised cancer potency

factor of 2 (mg/kg)/d. EPA has

calculated a revised value of 2.6 E–5 ug/

L for both drinking and nondrinking

water uses. States and Tribes that chose

not to adopt criteria must, at a

minimum, provide protection of human

health from risk of exposure to PCBs on

a permit-by-permit basis using their

Guidance based Tier I methodologies for

human health criteria and best available

data. EPA anticipates these Tier I values

to be no less stringent than 2.6 E–5 ug/

L (unless site-specific factors are used).

EPA does not intend to withdraw the

March 1997, PCB criterion for wildlife

of 1.2 E–4 ug/L. That rule replaced the

challenged mathematical approach to

deriving composite BAFs. The cancer

potency factor at issue in the AISI

litigation is an estimate of human health

impacts. It played no role in the

development of either the 1995 or 1997

wildlife criteria. There is no need to

conduct further rulemaking to

incorporate that potency factor into the

wildlife criterion. States and Tribes

must submit wildlife criteria for PCBs

that are consistent with the March 1997

criterion.

II. ‘‘Good Cause’’ Under the

Administrative Procedure Act

EPA has determined that it has ‘‘good

cause’’ under section 553(b)(3) of the

Administrative Procedure Act, 5 U.S.C.

553(b)(3), to promulgate this final rule

without prior opportunity for notice and

comment. EPA finds it ‘‘unnecessary’’ to

provide an opportunity to comment on

the strictly legal issue of the impact of

the AISI decision on the March 1997

PCB criteria.

Moreover, all interested members of

the public had an opportunity to

comment on the revised method for

computing composite BAFs when EPA

proposed them in October of 1996. The

public will have a new opportunity to

comment on that method when EPA

issues its new proposal for human

health criteria for PCBs in the Great

Lakes System. The public will also have

an opportunity to comment on the

cancer potency factor at that time.

EPA also believes the public interest

is best served by reacting as quickly as

possible to the Court’s decision. For this

reason, EPA has also determined that it

has ‘‘good cause’’ under 5 U.S.C. 553(d)

to make the rule effective upon

publication.

III. Executive Order 12866

Under Executive Order 12866 (58 FR

51735, October 4, 1993), EPA must

determine whether the regulatory action

is ‘‘significant’’ and therefore subject to

Office of Management and Budget

(OMB) review and the requirements of

the Executive Order. The Order defines

‘‘significant regulatory action’’ as one

that is likely to result in a rule that may:

(1) Have an annual effect on the

economy of $100 million or more or

adversely affect in a material way the

economy, a sector of the economy,

productivity, competition, jobs, the

environment, public health or safety, or

State, local, or Tribal governments or

communities;

(2) Create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency;

(3) Materially alter the budgetary

impact of entitlements, grants, user fees,

or loan programs or the rights and

obligations of recipients thereof; or

(4) Raise novel legal or policy issues

arising out of legal mandates, the

President’s priorities, or the principles

set forth in the Executive Order.

Pursuant to the terms of Executive

Order 12866, it has been determined

that this final rule is not a ‘‘significant

regulatory action’’ and is therefore not

subject to OMB review.

IV. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A) as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, EPA

submitted 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 General Accounting

Office prior to publication of the rule in

today’s Federal Register. This rule is

not a ‘‘major rule’’ as defined by 5

U.S.C. 804(2).

V. Regulatory Flexibility Act as

Amended by the Small Business

Regulatory Enforcement Fairness Act of

1996

Under the Regulatory Flexibility Act

(RFA) (5 U.S.C. 601 et. seq.), whenever

a Federal agency promulgates a final

rule after being required to publish a

general notice of proposed rulemaking

under section 553 of the Administrative

Procedures Act (APA), the agency

generally must prepare a final regulatory

flexibility analysis describing the

economic impact of the regulatory

action on small entities. EPA has not

prepared a final regulatory flexibility

analysis for this action because the

Agency was not required to publish a

general notice of proposed rulemaking

for this rule.

As explained above, section 553 of the

APA provides that, when an agency for

good cause finds that notice and public

procedure are impracticable,

unnecessary and contrary to the public

interest, an agency may first issue a rule

without providing notice and an

opportunity for public comment. EPA

has determined that there is good cause

for making today’s rule final without

notice and opportunity for comment for

the reasons spelled out above. In these

circumstances, the RFA does not require

preparation of a final regulatory

flexibility analysis. Today’s final rule

establishes no requirements applicable

to small entities.

VI. Unfunded Mandates Reform Act

This action will not result in the

annual expenditures of $100 million or

more for State, local, and Tribal
52924 Federal Register / Vol. 62, No. 196 / Thursday, October 9, 1997 / Rules and Regulations

governments, in the aggregate, or to the

private sector, and is not a Federal

mandate, as defined by the Unfunded

Mandates Reform Act of 1995 (UMRA)

(P.L. 104–4), nor does it uniquely affect

small governments in any way. As such,

the requirements of sections 202, 203,

and 205 of Title II of the UMRA do not

apply to this action.

VII. Paperwork Reduction Act

There are no information collection

requirements in this final rule and

therefore there is no need to obtain

OMB approval under the Paperwork

Reduction Act, 44 U.S.C. 3501 et seq.

List of Subjects in 40 CFR Part 132

Environmental protection,

Administrative practice and procedure,

Great Lakes, Indians-lands,

Intergovernmental relations, Reporting

and recordkeeping requirements, Water

pollution control.

Dated: October 2, 1997.

Carol M. Browner,

Administrator.

For the reasons set out in the

preamble, title 40, chapter I of the Code

of Federal Regulations is to be amended

as follows:

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.

PART 132—[AMENDED]

2. Table 3 to part 132 is amended by

removing the entry for PCBs (class).

[FR Doc. 97–26864 Filed 10–8–97; 8:45 am]

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