172
‘‘(C) the extent to which any such assump-
tions, inferences, or models have been validated
or conflict with empirical data;
‘‘(5) to the maximum extent practical, provide a
description of the risk, including, at minimum, best
estimates or other unbiased representation of the most
plausible level of risk and a description of the specific
populations or natural resources subject to the assess-
ment;
‘‘(6) to the maximum extent practical, provide a
quantitative estimate of the uncertainty inherent in
the risk assessment; and
‘‘(7) compare the nature and extent of the risk
identified in the risk assessment to other risks to
human health and the environment.
‘‘(c) RISK ASSESSMENT GUIDANCE.—Not later than
180 days after the date of the enactment of this section, and
after providing notice and opportunity for public comment,
the Administrator, in consultation with the Secretary, shall
issue, and thereafter revise, as appropriate, guidance for
conducting risk assessments under subsection (a).
‘‘(d) MARGIN OF SAFETY.—When establishing a mar-
gin of safety for use in developing a regulatory requirement
described in subsection (a)(1) or guidance described in sub-
section (a)(2), the Administrator or the Secretary, as ap-
173
propriate, shall provide, as part of the risk assessment
under subsection (a), an explicit and, to the extent prac-
tical, quantitative description of the margin of safety rel-
ative to an unbiased estimate of the risk being addressed.
‘‘(e) DISCRETIONARY EXEMPTIONS.—The Adminis-
trator or the Secretary, as appropriate, may exempt from
the requirements of this section any risk assessment pre-
pared in support of a regulatory requirement described in
subsection (a)(1) which is likely to result in annual increase
in cost of less than $25,000,000. Such exemptions may be
made for specific risk assessments or classes of risk assess-
ments.
‘‘(f) GENERAL RULE ON APPLICABILITY.—The require-
ments of this section shall apply to any regulatory require-
ment described in subsection (a)(1) or guidance described
in subsection (a)(2) that is issued after the last day of the
1-year period beginning on the date of the enactment of this
section.
‘‘(g) SIGNIFICANT REGULATORY ACTIONS AND GUID-
ANCE.—
‘‘(1) APPLICABILITY OF REQUIREMENTS.—In ad-
dition to the regulatory requirements and guidance
referred to in subsection (f), the requirements of this
section shall apply to—
174
‘‘(A) any standard, effluent limitation,
water quality criterion, water quality based re-
quirement, or other regulatory requirement is-
sued under this Act during the period described
in paragraph (2) which is likely to result in an
annual increase in cost of $100,000,000 or more;
and
‘‘(B) any guidance issued under this Act
during the period described in paragraph (2)
which, if issued as a regulatory requirement,
would be likely to result in annual increase in
cost of $100,000,000 or more.
‘‘(2) COVERED PERIOD.—The period described in
this paragraph is the period beginning on February
15, 1995, and ending on the last day of the 1-year
period beginning on the date of the enactment of this
Act.
‘‘(3) REVIEW.—Any regulatory requirement de-
scribed in paragraph (1)(A) or guidance described in
paragraph (1)(B) which was issued before the date of
the enactment of this section shall be reviewed and,
with respect to each such requirement or guidance, the
Administrator or the Secretary, as appropriate, shall
based on such review—
175
‘‘(A) certify that the requirement or guid-
ance meets the requirements of this section with-
out revision; or
‘‘(B) reissue the requirement or guidance,
after providing notice and opportunity for pub-
lic comment, with such revisions as may be nec-
essary for compliance with the requirements of
this section.
‘‘(4) DEADLINE.—Any regulatory requirement
described in paragraph (1)(A) or guidance described
in paragraph (1)(B) for which the Administrator or
the Secretary, as appropriate, does not issue a certifi-
cation or revisions under paragraph (3) on or before
the last day of the 18-month period beginning on the
date of the enactment of this section shall cease to be
effective after such last day until the date on which
such certification or revisions are issued.’’.
SEC. 324. BENEFIT AND COST CRITERION.
Title III (33 U.S.C. 1311–1330) is further amended
by adding at the end the following:
‘‘SEC. 324. BENEFIT AND COST CRITERION.
‘‘(a) DECISION CRITERION.—
‘‘(1) CERTIFICATION.—The Administrator or the
Secretary of the Army (hereinafter in this section re-
176
ferred to as the ‘Secretary’), as appropriate, shall not
issue—
‘‘(A) any standard, effluent limitation, or
other regulatory requirement under this Act; or
‘‘(B) any guidance under this Act which, if
issued as a regulatory requirement, would result
in an annual increase in cost of $25,000,000 or
more,
unless the Administrator or the Secretary certifies
that the requirement or guidance maximizes net bene-
fits to society. Such certification shall be based on an
analysis meeting the requirements of subsection (b).
‘‘(2) EFFECT OF CRITERION.—Notwithstanding
any other provision of this Act, the decision criterion
of paragraph (1) shall supplement and, to the extent
there is a conflict, supersede the decision criteria oth-
erwise applicable under this Act; except that the re-
sulting regulatory requirement or guidance shall be
economically achievable.
‘‘(3) SUBSTANTIAL EVIDENCE.—Notwithstanding
any other provision of this Act, no regulation or guid-
ance subject to this subsection shall be issued by the
Administrator or the Secretary unless the requirement
of paragraph (1) is met and the certification is sup-
ported by substantial evidence.
177
‘‘(b) BENEFIT AND COST ANALYSIS GUIDANCE.—
‘‘(1) IN
GENERAL.—Not later than 180 days
after the date of the enactment of this section, and
after providing notice and opportunity for public
comment, the Administrator, in concurrence with the
Administrator of the Office of Information and Regu-
latory Affairs, shall issue, and thereafter revise, as
appropriate, guidance for conducting benefit and cost
analyses in support of making certifications required
by subsection (a).
‘‘(2) CONTENTS.—Guidance issued under para-
graph (1), at a minimum, shall—
‘‘(A) require the identification of available
policy alternatives, including the alternative of
not regulating and any alternatives proposed
during periods for public comment;
‘‘(B) provide methods for estimating the in-
cremental benefits and costs associated with
plausible alternatives, including the use of quan-
titative and qualitative measures;
‘‘(C) require an estimate of the nature and
extent of the incremental risk avoided by the
standard, effluent limitation, or other regulatory
requirement, including a statement that places
179
day of the 1-year period beginning on the date of the enact-
ment of this section.
‘‘(f) SIGNIFICANT REGULATORY ACTIONS AND GUID-
ANCE.—
‘‘(1) APPLICABILITY OF REQUIREMENTS.—In ad-
dition to the regulatory requirements and guidance
referred to in subsection (e), this section shall apply
to—
‘‘(A) any standard, effluent limitation, or
other regulatory requirement issued under this
Act during the period described in paragraph (2)
which is likely to result in an annual increase
in cost of $100,000,000 or more; and
‘‘(B) any guidance issued under this Act
during the period described in paragraph (2)
which, if issued as a regulatory requirement,
would be likely to result in annual increase in
cost of $100,000,000 or more.
‘‘(2) COVERED PERIOD.—The period described in
this paragraph is the period beginning on February
15, 1995, and ending on the last day of the 1-year
period beginning on the date of the enactment of this
Act.
‘‘(3) REVIEW.—Any regulatory requirement de-
scribed in paragraph (1)(A) or guidance described in
180
paragraph (1)(B) which was issued before the date of
the enactment of this section shall be reviewed and,
with respect to each such requirement or guidance, the
Administrator or the Secretary, as appropriate, shall
based on such review—
‘‘(A) certify that the requirement or guid-
ance meets the requirements of this section with-
out revision; or
‘‘(B) reissue the requirement or guidance,
after providing notice and opportunity for pub-
lic comment, with such revisions as may be nec-
essary for compliance with the requirements of
this section.
‘‘(4) DEADLINE.—Any regulatory requirement
described in paragraph (1)(A) or guidance described
in paragraph (1)(B) for which the Administrator or
the Secretary, as appropriate, does not issue a certifi-
cation or revisions under paragraph (3) on or before
the last day of the 18-month period beginning on the
date of the enactment of this section shall cease to be
effective after such last day until the date on which
such certification or revisions are issued.
‘‘(g) STUDY.—Not later than 5 years after the date of
the enactment of this section, the Administrator, in con-
sultation with the Administrator of the Office of Informa-
181
tion and Regulatory Affairs, shall publish an analysis re-
garding the precision and accuracy of benefit and cost esti-
mates prepared under this section. Such study, at a mini-
mum, shall—
‘‘(1) compare estimates of the benefits and costs
prepared under this section to actual costs and bene-
fits achieved after implementation of regulations or
other requirements;
‘‘(2) examine and assess alternative analytic
methods for conducting benefit and cost analysis, in-
cluding health-health analysis; and
‘‘(3) make recommendations for the improvement
of benefit and cost analyses conducted under this sec-
tion.’’.
TITLE IV—PERMITS AND
LICENSES
SEC. 
401. 
WASTE 
TREATMENT 
SYSTEMS 
FOR 
CON-
CENTRATED ANIMAL FEEDING OPERATIONS.
Section 402(a) is amended by adding the following
new paragraph:
‘‘(6) CONCENTRATED
ANIMAL
FEEDING
OPER-
ATIONS.—For purposes of this section, waste treat-
ment systems, including retention ponds or lagoons,
used to meet the requirements of this Act for con-
centrated animal feeding operations, are not waters of
182
the United States. An existing concentrated animal
feeding operation that uses a natural topographic im-
poundment or structure on the effective date of this
Act, which is not hydrologically connected to any
other waters of the United States, as a waste treat-
ment system or wastewater retention facility may
continue to use that natural topographic feature for
waste storage regardless of its size, capacity, or pre-
vious use.’’.
SEC. 402. PERMIT REFORM.
(a) DURATION AND REOPENERS.—Section 402(b)(1)
(33 U.S.C. 1342(b)(1)) is amended—
(1) in subparagraph (B) by striking ‘‘five’’ and
inserting ‘‘10’’ and by striking ‘‘and’’;
(2) by inserting ‘‘and’’ after the semicolon at the
end of subparagraph (D); and
(3) by adding at the end the following new sub-
paragraph:
‘‘(E) can be modified as necessary to ad-
dress a significant threat to human health and
the environment;’’.
(b) REVIEW
OF EFFLUENT LIMITATIONS.—Section
301(d) (33 U.S.C. 1311(d)) is amended to read as follows:
‘‘(d) REVIEW OF EFFLUENT LIMITATIONS.—Any efflu-
ent limitation required by subsection (b)(2) that is estab-
183
lished in a permit under section 402 shall be reviewed at
least every 10 years when the permit is reissued, and, if
appropriate, revised.’’.
(c) DISCHARGE
LIMIT.—Section 402(b)(1)(A) (33
U.S.C. 1342(b)(1)(A)) is amended by inserting after the
semicolon at the end the following: ‘‘except that in no event
shall a discharge limit in a permit under this section be
set at a level below the lowest level that the pollutant can
be reliably quantified on an interlaboratory basis for a par-
ticular test method, as determined by the Administrator
using approved analytical methods under section 304(h);’’.
SEC. 403. REVIEW OF STATE PROGRAMS AND PERMITS.
(a) REVIEW OF STATE PROGRAMS.—Section 402(c)
(33 U.S.C. 1342(c)) is amended by inserting before the first
sentence the following: ‘‘Upon approval of a State program
under this section, the Administrator shall review adminis-
tration of the program by the State once every 3 years.’’.
(b) REVIEW OF STATE PERMITS.—Section 402(d)(2)
(33 U.S.C. 1342(d)(2)) is amended—
(1) in the first sentence by striking ‘‘as being
outside the guidelines and requirements of this Act’’
and inserting ‘‘as presenting a substantial risk to
human health and the environment’’; and
184
(2) in the second sentence by striking ‘‘and the
effluent limitations’’ and all that follows before the
period.
(c) COURT PROCEEDINGS TO PROHIBIT INTRODUCTION
OF
POLLUTANTS
INTO
TREATMENT
WORKS.—Section
402(h) (33 U.S.C. 1342(h)) is amended by inserting after
‘‘approved or where’’ the following: ‘‘the discharge involves
a significant source of pollutants to the waters of the United
States and’’.
SEC. 404. STATISTICAL NONCOMPLIANCE.
(a) NUMBER OF EXCURSIONS.—Section 402(k) (33
U.S.C. 1342(k)) is amended by inserting after the first sen-
tence the following: ‘‘In any enforcement action or citizen
suit under section 309 or 505 of this Act or applicable State
law alleging noncompliance with a technology-based efflu-
ent limitation established pursuant to section 301, a per-
mittee shall be deemed in compliance with the technology-
based effluent limitation if the permittee demonstrates
through reference to information contained in the applica-
ble rulemaking record that the number of excursions from
the technology-based effluent limitation are no greater, on
an annual basis, than the number of excursions expected
from the technology on which the limit is based and that
the discharges do not violate an applicable water-quality
based limitation or standard.’’.
185
(b) PRETREATMENT STANDARDS.—Section 307(d) (33
U.S.C. 1317(d)) is amended by adding at the end the follow-
ing: ‘‘In any enforcement action or citizen suit under sec-
tion 309 or 505 of this Act or applicable State law alleging
noncompliance with a categorical pretreatment standard or
local pretreatment limit established pursuant to this sec-
tion, a person who demonstrates through reference to infor-
mation contained in the applicable rulemaking record—
‘‘(1) that the number of excursions from the cat-
egorical pretreatment standard or local pretreatment
limit are no greater, on an annual basis, than the
number of excursions expected from the technology on
which 
the 
pretreatment 
standard 
or 
local
pretreatment limit is based, and
‘‘(2) that the introduction of pollutants into a
publicly owned treatment works does not cause inter-
ference with such works or cause a violation by such
works of an applicable water-quality based limitation
or standard,
shall be deemed in compliance with the standard under the
Act.’’.
SEC. 405. ANTI-BACKSLIDING REQUIREMENTS.
Section 402(o) (33 U.S.C. 1343(o)) is amended by add-
ing at the end the following:
186
‘‘(4) NONAPPLICABILITY
TO
PUBLICLY
OWNED
TREATMENT WORKS.—The requirements of this sub-
section shall not apply to permitted discharges from
a publicly owned treatment works if the treatment
works demonstrates to the satisfaction of the Adminis-
trator that—
‘‘(A) the increase in pollutants is a result of
conditions beyond the control of the treatment
works (such as fluctuations in normal source
water availabilities due to sustained drought
conditions); and
‘‘(B) effluent quality does not result in im-
pairment of water quality standards established
for the receiving waters.’’.
SEC. 406. INTAKE CREDITS.
Section 402 (33 U.S.C. 1342) is further amended by
inserting after subsection (k) the following:
‘‘(l) INTAKE CREDITS.—
‘‘(1) IN GENERAL.—Notwithstanding any provi-
sion of this Act, in any effluent limitation or other
limitation imposed under the permit program estab-
lished by the Administrator under this section, any
State permit program approved under this section
(including any program for implementation under
section 118(c)(2)), any standards established under
187
section 307(a), or any program for industrial users
established under section 307(b), the Administrator,
as applicable, shall or the State, as applicable, may
provide credits for pollutants present in or caused by
intake water such that an owner or operator of a
point source is not required to remove, reduce, or
treat the amount of any pollutant in an effluent
below the amount of such pollutant that is present in
or caused by the intake water for such facility—
‘‘(A)(i) if the source of the intake water and
the receiving waters into which the effluent is ul-
timately discharged are the same;
‘‘(ii) if the source of the intake water meets
the maximum contaminant levels or treatment
techniques for drinking water contaminants es-
tablished pursuant to the Safe Drinking Water
Act for the pollutant of concern; or
‘‘(iii) if, at the time the limitation or stand-
ard is established, the level of the pollutant in the
intake water is the same as or lower than the
amount of the pollutant in the receiving waters,
taking into account analytical variability; and
‘‘(B) if, for conventional pollutants, the con-
stituents of the conventional pollutants in the in-
188
take water are the same as the constituents of the
conventional pollutants in the effluent.
‘‘(2) ALLOWANCE FOR INCIDENTAL AMOUNTS.—
In determining whether the condition set forth in
paragraph (1)(A)(i) is being met, the Administrator
shall or the State may, as appropriate, make allow-
ance for incidental amounts of intake water from
sources other than the receiving waters.
‘‘(3) CREDIT
FOR
NONQUALIFYING
POLLUT-
ANTS.—The Administrator shall or a State may pro-
vide point sources an appropriate credit for pollut-
ants found in intake water that does not meet the re-
quirement of paragraph (1).
‘‘(4) MONITORING.—Nothing in this section pre-
cludes the Administrator or a State from requiring
monitoring of intake water, effluent, or receiving wa-
ters to assist in the implementation of this section.’’.
SEC. 407. COMBINED SEWER OVERFLOWS.
Section 402 (33 U.S.C. 1342) is further amended by
adding at the end the following:
‘‘(s) COMBINED SEWER OVERFLOWS.—
‘‘(1) REQUIREMENT FOR PERMITS.—Each permit
issued pursuant to this section for a discharge from
a combined storm and sanitary sewer shall conform
189
with the combined sewer overflow control policy
signed by the Administrator on April 11, 1994.
‘‘(2) TERM OF PERMIT.—
‘‘(A) 
COMPLIANCE
DEADLINE.—Notwith-
standing any compliance schedule under section
301(b), or any permit limitation under section
402(b)(1)(B), the Administrator (or a State with
a program approved under subsection (b)) may
issue a permit pursuant to this section for a dis-
charge from a combined storm and sanitary
sewer, that includes a schedule for compliance
with a long-term control plan under the control
policy referred to in paragraph (1), for a term
not to exceed 15 years.
‘‘(B) 
EXTENSION.—Notwithstanding 
the
compliance deadline specified in subparagraph
(A), the Administrator or a State with a pro-
gram approved under subsection (b) shall extend,
on request of an owner or operator of a combined
storm and sanitary sewer and subject to sub-
paragraph (C), the period of compliance beyond
the last day of the 15-year period—
‘‘(i) if the Administrator or the State
determines that compliance by such last day