[Federal Register Volume 62, Number 196 (Thursday, October 9, 1997)]
[Rules and Regulations]
[Pages 52922-52924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26864]



[[Page 52921]]

_______________________________________________________________________

Part V





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 132



Revocation of the Polychlorinated Biphenyl Human Health Criteria in the 
Water Quality Guidance for the Great Lakes System; Final Rule

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

[[Page 52922]]


-----------------------------------------------------------------------


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:

------------------------------------------------------------------------
                                             Examples of potentially    
               Category                         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

[[Page 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

[[Page 52924]]

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]
BILLING CODE 6560-50-P