|||United States Court of Appeals FOR THE DISTRICT OF COLUMBIA CIRCUIT
|||No. 98-1627, Consolidated with, 99-1053, 99-1056
|||March 31, 2000
|||CHLORINE CHEMISTRY COUNCIL AND CHEMICAL MANUFACTURERS ASSOCIATION, PETITIONERS
ENVIRONMENTAL PROTECTION AGENCY, RESPONDENT NATURAL RESOURCES DEFENSE COUNCIL, ET AL., INTERVENORS
|||Thomas Richichi argued the cause for petitioners Chlorine Chemistry Council,
et al. and supporting intervenor Society of the Plastics Industry, Inc.
With him on the briefs were Kathryn Y. Aspegren, David F. Zoll, Katherine
L. Rhyne, Paul D. Clement, Richard S. Wasserstrom, Jerome H. Heckman, Peter
L. de la Cruz and Komal J. Hershberg. John F. Cooney and Brock Landry were
on the brief for amicus curiae Public Health Scientists. Karen L. Egbert,
Attorney, U.S. Department of Justice, argued the cause for respondent. With
her on the brief were Lois J. Schiffer, Assistant Attorney General, and
Karen H. Clark, Attorney, U.S. Environmental Protection Agency. Christopher
S. Vaden, Attorney, U.S. Department of Justice, entered an appearance. Alan
Charles Raul and David M. Levy were on the brief for amici curiae Congressman
Tom Bliley. Erik D. Olson was on the brief for intervenors Natural Resources
Defense Council and Physicians for Social Responsibility.
|||Before: Silberman, Williams and Ginsburg, Circuit Judges.
|||The opinion of the court was delivered by: Williams, Circuit Judge
|||Argued February 11, 2000
|||On Petitions for Review of an Order of the Environmental Protection Agency
|||Opinion for the Court filed by Circuit Judge Williams.
|||The Safe Drinking Water Act ("SDWA" or the "Act")
directs the Environmental Protection Agency to set standards for the regulation
of covered drinking water contaminants. For each EPA sets a "maximum
contaminant level goal" ("MCLG"), defined as "the level
at which no known or anticipated adverse effects on the health of persons
occur and which allows an adequate margin of safety." 42 U.S.C. § 300g-1(b)(4)(A).
The MCLG is somewhat aspirational. After having set it, EPA is to promulgate
an enforceable standard, known as a maximum contaminant level ("MCL"),
which takes practical considerations into account while remaining "as
close to the [MCLG] as is feasible." Id. § 300g-1(b)(4)(B).
|||In March 1998 EPA concluded that chloroform, a drinking water contaminant,
exhibits a "nonlinear mode of carcinogenic action." Notice of
Data Availability: National Primary Drinking Water Regulations: Disinfectants
and Disinfection Byproducts, 63 Fed. Reg. 15,674, 15,686/1 (1998). In other
words, exposures to chloroform below some threshold level pose no risk of
cancer. But in promulgating the MCLG it retained the existing standard of
zero, which was based on the previously held assumption that there was no
safe threshold. Final Rule: National Primary Drinking Water Regulations:
Disinfectants and Disinfection Byproducts, 63 Fed. Reg. 69,390, 69,398/3
(1998) ("Final Rule"). EPA justified its action on a variety of
grounds, including an alleged need to consult the report of its Science
Advisory Board ("SAB"), which would not be available until after
the statutory deadline for rulemaking had expired. Petitioners, including
the Chlorine Chemistry Council, a trade association comprised of chlorine
and chlorine product manufacturers, petitioned this court for review, arguing
that EPA violated its statutory mandate to use the "best available"
evidence when implementing the provisions of the Safe Drinking Water Act.
42 U.S.C. § 300g-1(b)(3)(A). We agree.
|||Chloroform, a "nonflammable, colorless liquid," Proposed Rule:
National Primary Drinking Water Regulations: Disinfectants and Disinfection
Byproducts, 59 Fed. Reg. 38,668, 38,694/2 (1994), is one of four compounds
that together are classed as "Total Trihalomethanes" ("TTHMs").
These are byproducts of chlorination, the most widely used technique for
ensuring the safety of drinking water. Chlorination plays a significant
role in the control of microbial pathogens and in turn in the protection
of public health; but on the basis of rodent tumor data the Agency has concluded
that chloroform, a byproduct of this process, acts as a probable human carcinogen.
Id. at 38,697/2.
|||On July 29, 1994 EPA issued a proposed rule on disinfectants and disinfection
byproducts in water. This included a zero MCLG for chloroform, based on
EPA's finding of an absence of data to suggest a threshold level below which
there would be no potential carcinogenic effects. Id. The Agency's
|||default method of inferring risk at exposure levels for which it has no
adequate data is linear extrapolation from cancer incidence inferred at
exposures for which it does have data. See EPA's Proposed Guidelines for
Carcinogen Risk Assessment, 61 Fed. Reg. 17,960, 17,968/3 (1996). Thus,
either if the evidence supports linearity, or if there is "insufficient"
evidence of nonlinearity, EPA assumes that if a substance causes cancer
at any exposure it will do so at every non-zero exposure (though with cancer
incidence declining with exposure). But EPA acknowledges its authority "to
establish nonzero MCLGs for carcinogens if the scientific evidence"
indicates that a "safe threshold" exists. See Final Rule, 63 Fed.
Reg. at 69,401/2. And petitioners here assume the validity of the linear
|||In 1996 Congress amended the SDWA, enshrining in the statute a timetable
previously set by EPA for rules relating to disinfectants and disinfection
byproducts associated with water treatment. 42 U.S.C. § 300g-1(b)(2)(C);
Proposed Rule: National Primary Drinking Water Regulations: Monitoring Requirements
for Public Drinking Water Supplies, 59 Fed. Reg. 6332, 6361 (1994). The
relevant deadline here was November 1998. In preparation for the necessary
rulemaking EPA formed an advisory group in 1997 whose purpose was "to
collect, share, and analyze new information and data, as well as to build
consensus on the regulatory implications of this new information."
Notice of Data Availability: National Primary Drinking Water Regulations:
Interim Enhanced Surface Water Treatment Rule, 62 Fed. Reg. 59,486, 59,491/1
|||On the basis of the committee's findings and recommendations, EPA in November
1997 published a Notice of Data Availability ("NODA"), 62 Fed.
Reg. 59,388 (1997), and in 1998 it published a second NODA specific to chloroform,
63 Fed. Reg. 15,674 (1998). Among the findings it discussed were those arrived
at by a panel of experts organized by the International Life Sciences Institute.
The panel, whose work was subject to independent peer review and was convened
under the auspices of the EPA, concluded on the basis of chloroform's mode
of action that although it was "a likely carcinogen to humans above
a certain dose range, [it was] unlikely to be carcinogenic below a certain
dose range." Id. at 15,685/1. The panel recommended "the nonlinear
[ ] or margin of exposure approach [as] the preferred approach to quantifying
the cancer risk associated with chloroform exposure." Id. at 15,686/1.
|||EPA agreed. It said that "[a]lthough the precise mechanism of chloroform
carcinogenicity is not established," nevertheless "the chloroform
dose-response should be considered nonlinear." Id. at 15,685/3. Rather
than operating through effects on DNA, which is consistent with linearity,
chloroform evidently works through "cytotoxicity" (i.e., damage
to the cells) followed by regenerative cell proliferation. Id. Employing
the threshold approach that it found was entailed by chloroform's mode of
action, EPA then calculated an MCLG of 600 parts per billion ("ppb"),
based solely on carcinogenicity. Id. at 15,686/2. This level built in a
1000-fold margin of error in relation to the maximum safe dosage implied
from the animal studies used by EPA. Id. But because even lower chlorine
doses cause liver toxicity (a non-cancer effect), EPA proposed an MCLG of
300 ppb. Id.
|||When EPA came to promulgate its final rule in December 1998, however,
its MCLG was again zero. Final Rule, 63 Fed. Reg. at 69,398/3. It stuck
with 1994's zero level despite its explicit statement that it now "believe[d]
that the underlying science for using a nonlinear extrapolation approach
to evaluate the carcinogenic risk from chloroform is well founded."
Id. at 69,401/1. It justified the action on the basis that "additional
deliberations with the Agency's SAB on the analytical approach used"
and on the underlying scientific evidence were needed "prior to departing
from a long-held EPA policy." Id. at 69,399-69,401. It could not complete
such additional deliberations by the November 1998 statutory deadline, and,
moreover, the rulemaking would not affect the enforceable MCL for TTHMs.
|||After briefing on the petition for review at issue here, but before oral
argument, EPA moved for a voluntary remand to consider the SAB report on
chloroform that would soon be available. But EPA made no offer to vacate
the rule; thus EPA's proposal would have left petitioners subject to a rule
they claimed was invalid. We denied the motion.
|||On February 11, 2000, the day of oral argument, EPA released a draft report
by the SAB on chloroform. See Draft, Chloroform Risk Assessment Review,
February 10, 2000 (visited March 27, 2000) . The report concluded that chloroform
exhibits a "cytotoxic" mode of action. Such a mode of action (unlike
a "genotoxic" mechanism, which acts directly on a cell's DNA)
involves no carcinogenic effects at low doses; thus a nonlinear approach
is "scientifically reasonable." Id. at 17. After consideration
of the draft SAB report, EPA stated that it "no longer believes that
it should continue to defend its original decision," and moved that
this court vacate the MCLG. Motion for Vacatur, at 2 (February 24, 2000).
|||EPA in its motion to vacate concedes that "the discussion on standing
at oral argument indicates that petitioners may indeed meet minimum requirements
for standing," a necessary precursor to our providing any relief beyond
the vacatur proposed by EPA. Given our independent duty to be sure of our
jurisdiction, Floyd v. District of Columbia, 129 F.3d 152, 155 (D.C. Cir.
1997), we address EPA's now evidently abandoned jurisdictional arguments.
|||EPA's brief contends that petitioners lack Article III standing because
they have not demonstrated injury-in-fact from the MCLG. Lujan v. Defenders
of Wildlife, 504 U.S. 555, 560-61 (1992). We have already held, in International
Fabricare Inst. v. EPA, 972 F.2d 384, 390 (D.C. Cir. 1992), that an association
of dry cleaning businesses had standing to attack EPA's setting of a zero
MCLG for a contaminant used in their business. There we pointed to the MCLG's
link to risks of "greater liability under the Comprehensive Environmental
Response, Compensation and Liability Act ('CERCLA'), 42 U.S.C. §§ 9601-9675,"
id., which under some circumstances may entail remedial action achieving
"a level or standard of control which at least attains Maximum Contaminant
Level Goals established under the Safe Drinking Water Act," 42 U.S.C.
|||EPA challenges petitioners' theory on several grounds. First, it says,
its regulations provide that when a zero MCLG is set, it is the MCL, not
the MCLG, that is used to set cleanup standards. 40 CFR § 300.430(e)(2)(i)(C).
In this case, says EPA, the MCL set for TTHMs would control. Since there
is no suggestion that the effective MCL will imminently be affected by the
zero MCLG, and petitioners have not challenged the MCL for TTHMs, EPA argues
that they have failed to demonstrate an injury.
|||But the MCL for TTHMs is in fact not dispositive in setting the cleanup
standard for chloroform. EPA has in the past rejected use of the TTHM MCL
for that purpose, saying that that MCL is "based on an analysis evaluating
the health benefits of chlorinating public drinking water supplies against
the detrimental effects of the production of trihalomethanes as a result
of chlorinating those supplies." U.S. EPA, Superfund Record of Decision,
Stringfellow Hazardous Waste Site, at 25 (Sept. 30, 1990). Instead, EPA
has set chloroform cleanup goals as low as 6 ppb (far below the 100 ppb
MCL for TTHMs), based on an assumption that chloroform poses a risk of cancer
at any dose, but that 6 ppb would yield an acceptable cancer risk of one-in-a-million.
Id. Thus EPA's actual practice belies its claims here as to the inconsequentiality
of the chloroform MCLG.
|||EPA also argues that unlike the petitioners in International Fabricare,
neither petitioners nor their members here have yet been subjected to cleanup
costs for chloroform contamination, and thus have not demonstrated a "genuine
threat" of CERCLA liability. EPA's Br. at 21. But in a forward-looking
suit the petitioners' subjection to past injury is relevant primarily as
it may shed light on whether the challenged action has a "substantial
probability" of causing injury. Florida Audubon Soc'y v. Bentsen, 94
F.3d 658, 666 (D.C. Cir. 1996) (en banc). CERCLA imposes joint and several
liability on "any person who by contract, agreement, or otherwise arranged
for disposal or treatment ... of hazardous substances owned or possessed
by such person." 42 U.S.C. § 9607(a)(3). In light of petitioners' contention
that they face liability "for the cleanup of chloroform at Superfund
sites across the country," Petitioners' Reply Br. at 16, we find it
at least substantially probable that a zero MCLG, as compared with a nonzero
one, will expose them to higher cleanup costs.
|||Before turning to the merits of petitioners' claim, we note EPA's contention
that its motion to vacate obviates the "need for the Court to issue
an opinion." Motion for Vacatur, at 3. But we have no reason to believe
that mere vacatur provides an adequate remedy if, as we ultimately conclude,
EPA's action was unlawful. Petitioners request that we instruct EPA to "promulgate
a non-zero MCLG using the best available peer-reviewed science." Petitioners'
Initial Br. at 34. But EPA has not indicated an intention to take such action
upon vacatur. Moreover, EPA makes no claim that the 1994 zero MCLG would
not be automatically revived by vacatur of the 1998 rule. Our agreement
with the petitioners on the rule's lawfulness will thus bring issues of
remedy into play.
|||On the merits petitioners argue that EPA's decision to adopt a zero MCLG
in the face of scientific evidence establishing that chloroform is a threshold
carcinogen was inconsistent with the Safe Drinking Water Act. Section 300g-1(b)(3)(A)
of the Act states unequivocally that "to the degree that an Agency
action is based on science, the Administrator shall use ... the best available,
peer-reviewed science and supporting studies conducted in accordance with
sound and objective scientific practices." In promulgating a zero MCLG
for chloroform EPA openly overrode the "best available" scientific
evidence, which suggested that chloroform is a threshold carcinogen.
|||EPA provides several arguments in defense of its action. First, it argues
that to establish a non-zero MCLG would be a "precedential step,"
that represents "a major change in the substance of regulatory decisions
related to chloroform."
|||EPA's Br. at 28-29. We do not doubt that adopting a nonzero MCLG is a
significant step, one which departs from previous practice. But this is
a change in result, not in policy. The change in outcome occurs simply as
a result of steadfast application of the relevant rules: first, the statutory
mandate to set MCLGs at "the level at which no known or anticipated
adverse effect on the health of persons occur," 42 U.S.C. § 300g-1(b)(4)(A),
as determined on the basis of the "best available" evidence; and
second, EPA's Carcinogen Risk Assessment guidelines, stating that when "adequate
data on mode of action show that linearity is not the most reasonable working
judgment and provide sufficient evidence to support a nonlinear mode of
action," the default assumption of linearity drops out. Proposed Guidelines
for Carcinogen Risk Assessment, 61 Fed. Reg. at 17,969/1. The fact that
EPA has arrived at a novel, even politically charged, outcome is of no significance
either for its statutory obligation or for fulfillment of its adopted policy.
|||Second, and similarly, EPA supports its action on the basis that "it
could not complete the deliberations with the SAB" before the November
1998 deadline. EPA's Br. at 29; Final Rule, 63 Fed. Reg. at 69,399/1. But
however desirable it may be for EPA to consult an SAB and even to revise
its conclusion in the future, that is no reason for acting against its own
science findings in the meantime. The statute requires the agency to take
into account the "best available" evidence. 42 U.S.C. § 300g-1(b)(3)(A)
(emphasis added). EPA cannot reject the "best available" evidence
simply because of the possibility of contradiction in the future by evidence
unavailable at the time of action-a possibility that will always be present.
|||Third, EPA justifies its decision not to adopt a nonzero MCLG on the basis
that it had to reevaluate one of its underlying technical assumptions-that
ingestion of chloroform in drinking water accounts for 80% of total exposure
to chloroform. As it stated in its final rule, EPA is currently considering
use of a 20% relative source contribution for drinking water, which would
lower the MCLG to 70 ppb. Final Rule, 63 Fed. Reg. at 69,399/3. Along these
lines, EPA's counsel conceded at oral argument that a sciencebased MCLG
would fall into the interval between 70 and 300 ppb. The uncertainty on
this issue may have provided support for choosing the lowest nonzero MCLG
from within that interval, but none for choosing an MCLG outside the range
|||Fourth, EPA argues that since the final MCL for TTHMs is unaffected, the
MCLG has no actual effect, and thus EPA's decision to publish an MCLG of
zero pending further review of the scientific evidence was entirely reasonable.
In light of our analysis of the standing issue, the no-effect premise is
plainly incorrect. Even if it were correct, we fail to see why it would
justify EPA's disregard of its own scientific findings.
|||Finally, EPA argues that its statements in the 1998 Notice of Data Availability
do not represent its "ultimate conclusions" with respect to chloroform,
and thus in adopting a zero MCLG it did not reject what it considered to
be the "best available" evidence. In fact, the zero MCLG merely
represented an "interim risk management decision" pending the
final SAB report. EPA's Br. at 35. We find these semantic somersaults pointless.
First, whether EPA has adopted its 1998 NODA as its "ultimate conclusion"
is irrelevant to whether it represented the "best available" evidence.
All scientific conclusions are subject to some doubt; future, hypothetical
findings always have the potential to resolve the doubt (the new resolution
itself being subject, of course, to falsification by later findings). What
is significant is Congress's requirement that the action be taken on the
basis of the best available evidence at the time of the rulemaking. The
word "available" would be senseless if construed to mean "expected
to be available at some future date." Second, EPA cannot avoid this
result by dubbing its action "interim." The statute applies broadly
to any "[a]gency action"; whether the action is interim is irrelevant.
|||Although we agree with petitioners that the zero MCLG for chloroform is
inconsistent with the Safe Drinking Water Act and that it should be vacated,
we are unclear as to what further remedy petitioners seek. In their opening
brief petitioners requested that this Court instruct EPA to "promulgate
a non-zero MCLG using the best available peerreviewed science as identified
in the March 31, 1998 NODA and the December 16, 1998 Final Rule on an expeditious
timetable to be specified by the Court." Petitioners' Initial Br. at
34. At oral argument, however, counsel for petitioners conceded that this
request was a misstatement, and that EPA should be allowed, and required,
to consider the new SAB report as well. Further, the consequences of simple
vacatur are themselves unclear. Accordingly, we will schedule briefing on
the parties' positions as to remedy.
|||Finding the Agency's December 1998 rule adopting a zero MCLG for chloroform
to be arbitrary and capricious and in excess of statutory authority, see
5 U.S.C. § 706(2)(A) & (C), we vacate the rule. A separate order on
briefing additional remedies will issue shortly.
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