[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]]
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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.
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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
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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
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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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