v.
United States Environmental Protection Agency.
United States Court of Appeals for the District of Columbia Circuit
175 F.3d 1027
Argued December 17, 1998
Decided May 14, 1999
DISPOSITION: Remanded the cases to EPA for further consideration of
all standards at issue. We do not vacate the new ozone standards because
the standard is unlikely to engender costly compliance activities in light
of our determination that it cannot be enforced by virtue of Clean Air
Act § 181(a), 42 U.S.C. § 7511(a). Vacated the challenged coarse
particulate matter standards because EPA will have to develop different
standards when it corrects the arbitrarily chosen PM[10] indicator.
JUDGES: Before: WILLIAMS, GINSBURG and TATEL, Circuit Judges.
* Separate opinion dissenting from Part I filed by Circuit Judge TATEL.
* Judge Williams wrote Parts I and III.B; Judge Ginsburg wrote Parts
II, III.A, and IV.D; Judge Tatel wrote Parts IV.A-C.
OPINION: On Petitions for Review of an Order of the Environmental Protection
Agency.
PER CURIAM:
Introduction
The Clean Air Act requires EPA to promulgate and periodically revise
national ambient air quality standards ("NAAQS") for each air pollutant
identified by the agency as meeting certain statutory criteria. See Clean
Air Act §§ 108-09, 42 U.S.C. §§ 7408-09. For each pollutant,
EPA sets a "primary standard"--a concentration level "requisite to protect
the public health" with an "adequate margin of safety"--and a "secondary
standard"--a level "requisite to protect the public welfare." Id. §
7409(b).
In July 1997 EPA issued final rules revising the primary and secondary
NAAQS for particulate matter ("PM") and ozone. See National Ambient Air
Quality Standards for Particulate Matter, 62 Fed. Reg. 38,652 (1997) ("PM
Final Rule"); National Ambient Air Quality Standards for Ozone, 62 Fed.
Reg. 38,856 (1997) ("Ozone Final Rule"). Numerous petitions for review
have been filed for each rule.
In Part I we find that the construction of the Clean Air Act on which
EPA relied in promulgating the NAAQS at issue here effects an unconstitutional
delegation of legislative power. See U.S. Const. art. I, § 1 ("All
legislative powers herein granted shall be vested in a Congress of the
United States."). We remand the cases for EPA to develop a construction
of the act that satisfies this constitutional requirement.
******
I. Delegation
Certain "Small Business Petitioners" argue in each case that EPA has
construed §§ 108 & 109 of the Clean Air Act so loosely as
to render them unconstitutional delegations of legislative power. We agree.
Although the factors EPA uses in determining the degree of public health
concern associated with different levels of ozone and PM are reasonable,
EPA appears to have articulated no "intelligible principle" to channel
its application of these factors; nor is one apparent from the statute.
The nondelegation doctrine requires such a principle. See J.W. Hampton,
Jr. & Co. v. United States, 276 U.S. 394, 409, 72 L. Ed. 624, 48 S.
Ct. 348 (1928). Here it is as though Congress commanded EPA to select "big
guys," and EPA announced that it would evaluate candidates based on height
and weight, but revealed no cut-off point. The announcement, though sensible
in what it does say, is fatally incomplete. The reasonable person responds,
"How tall? How heavy?"
EPA regards ozone definitely, and PM likely, as nonthreshold pollutants,
i.e., ones that have some possibility of some adverse health impact (however
slight) at any exposure level above zero. See Ozone Final Rule, 62 Fed.
Reg. at 38,863/3 ("Nor does it seem possible, in the Administrator's judgment,
to identify [an ozone concentration] level at which it can be concluded
with confidence that no 'adverse' effects are likely to occur."); National
Ambient Air Quality Standards for Ozone and Particulate Matter, 61 Fed.
Reg. 65,637, 65,651/3 (1996) (proposed rule) ("The single most important
factor influencing the uncertainty associated with the risk estimates is
whether or not a threshold concentration exists below which PM-associated
health risks are not likely to occur."). For convenience, we refer to both
as non-threshold pollutants; the indeterminacy of PM's status does not
affect EPA's analysis, or ours.
Thus the only concentration for ozone and PM that is utterly risk-free,
in the sense of direct health impacts, is zero. Section 109(b)(1) says
that EPA must set each standard at the level "requisite to protect the
public health" with an "adequate margin of safety." 42 U.S.C. § 7409(b)(1).
These are also the criteria by which EPA must determine whether a revision
to existing NAAQS is appropriate. See 42 U.S.C. § 7409(d)(1) (EPA
shall "promulgate such new standards as may be appropriate in accordance
with ... [ § 7409(b)]"); see also infra Part II.A. For EPA to pick
any non-zero level it must explain the degree of imperfection permitted.
The factors that EPA has elected to examine for this purpose in themselves
pose no inherent nondelegation problem. But what EPA lacks is any determinate
criterion for drawing lines. It has failed to state intelligibly how much
is too much.
We begin with the criteria EPA has announced for assessing health effects in setting the NAAQS for non-threshold pollutants. n1 They are "the nature and severity of the health effects involved, the size of the sensitive population(s) at risk, the types of health information available, and the kind and degree of uncertainties that must be addressed." Ozone Final Rule, 62 Fed. Reg. at 38,883/2; EPA, "Review of the National Ambient Air Quality Standards for Particulate Matter: Policy Assessment of Scientific and Technical Information: OAQPS Staff Paper," at II-2 (July 1996) ("PM Staff Paper") (listing same factors). Although these criteria, so stated, are a bit vague, they do focus the inquiry on pollution's effects on public health. And most of the vagueness in the abstract formulation melts away as EPA applies the criteria: EPA basically considers severity of effect, certainty of effect, and size of population affected. These criteria, long ago approved by the judiciary, see Lead Industries Ass'n v. EPA, 208 U.S. App. D.C. 1, 647 F.2d 1130, 1161 (D.C. Cir. 1980) ("Lead Industries"), do not themselves speak to the issue of degree.
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n1 Technically, EPA describes the criteria as used only for setting the "adequate margin of safety." There might be thought to be a separate step in which EPA determines what standard would protect public health without any margin of safety, and that step might be governed by different criteria. But EPA did not use such a process, and it need not. See NRDC v. EPA, 284 U.S. App. D.C. 136, 902 F.2d 963, 973 (D.C. Cir. 1990). Thus, the criteria mentioned in the text govern the whole standard-setting process.
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Read in light of these factors, EPA's explanations for its decisions
amount to assertions that a less stringent standard would allow the relevant
pollutant to inflict a greater quantum of harm on public health, and that
a more stringent standard would result in less harm. Such arguments only
support the intuitive proposition that more pollution will not benefit
public health, not that keeping pollution at or below any particular level
is "requisite" or not requisite to "protect the public health" with an
"adequate margin of safety," the formula set out by § 109(b)(1).
Consider EPA's defense of the 0.08 ppm level of the ozone NAAQS. EPA
explains that its choice is superior to retaining the existing level, 0.09
ppm, because more people are exposed to more serious effects at 0.09 than
at 0.08. See Ozone Final Rule, 62 Fed. Reg. at 38,868/1. In defending the
decision not to go down to 0.07, EPA never contradicts the intuitive proposition,
confirmed by data in its Staff Paper, that reducing the standard to that
level would bring about comparable changes. See EPA, "Review of National
Ambient Air Quality Standards for Ozone: Assessment of Scientific and Technical
Information: OAQPS Staff Paper," at 156 (June 1996) ("Ozone Staff Paper").
Instead, it gives three other reasons. The principal substantive one is
based on the criteria just discussed:
The most certain O[3]-related effects, while judged to be adverse, are transient and reversible (particularly at O[3] exposures below 0.08 ppm), and the more serious effects with greater immediate and potential long-term impacts on health are less certain, both as to the percentage of individuals exposed to various concentrations who are likely to experience such effects and as to the long-term medical significance of these effects.
Ozone Final Rule, 62 Fed. Reg. at 38,868/2.
In other words, effects are less certain and less severe at lower levels
of exposure. This seems to be nothing more than a statement that lower
exposure levels are associated with lower risk to public health. The dissent
argues that in setting the standard at 0.08, EPA relied on evidence that
health effects occurring below that level are "transient and reversible,"
Dissent at 5, evidently assuming that those at higher levels are not. But
the EPA language quoted above does not make the categorical distinction
the dissent says it does, and it is far from apparent that any health effects
existing above the level are permanent or irreversible.
In addition to the assertion quoted above, EPA cited the consensus of
the Clean Air Scientific Advisory Committee ("CASAC") that the standard
should not be set below 0.08. That body gave no specific reasons for its
recommendations, so the appeal to its authority, also made in defense of
other standards in the PM Final Rule, see PM Final Rule, 62 Fed. Reg. at
38,677/2 (daily fine PM standard); id. at 38,678/3 (annual coarse PM standard);
id. at 38,679/1 (daily coarse PM standard), adds no enlightenment. The
dissent stresses the undisputed eminence of CASAC's members, Dissent at
4, but the question whether EPA acted pursuant to lawfully delegated authority
is not a scientific one. Nothing in what CASAC says helps us discern an
intelligible principle derived by EPA from the Clean Air Act.
Finally, EPA argued that a 0.07 standard would be "closer to peak background
levels that infrequently occur in some areas due to nonanthropogenic sources
of O[3] precursors, and thus more likely to be inappropriately targeted
in some areas on such sources." Ozone Final Rule, 62 Fed. Reg. at 38,868/3.
But a 0.08 level, of course, is also closer to these peak levels than 0.09.
The dissent notes that a single background observation fell between 0.07
and 0.08, and says that EPA's decision "ensured that if a region surpasses
the ozone standard, it will do so because of controllable human activity,
not uncontrollable natural levels of ozone." Dissent at 6. EPA's language,
coupled with the data on background ozone levels, may add up to a backhanded
way of saying that, given the national character of the NAAQS, it is inappropriate
to set a standard below a level that can be achieved throughout the country
without action affirmatively extracting chemicals from nature. That may
well be a sound reading of the statute, but EPA has not explicitly adopted
it.
EPA frequently defends a decision not to set a standard at a lower level
on the basis that there is greater uncertainty that health effects exist
at lower levels than the level of the standard. See Ozone Final Rule, 62
Fed. Reg. at 38,868/2; PM Final Rule, 62 Fed. Reg. at 38,676/3 (annual
fine PM standard); id. at 38,677/2 (daily fine PM standard). And such an
argument is likely implicit in its defense of the coarse PM standards.
See PM Final Rule, 62 Fed. Reg. at 38,678/3- 79/1. The dissent's defense
of the fine particulate matter standard cites exactly such a justification.
See Dissent at 6 ("The Agency explained that 'there is generally greatest
statistical confidence in observed associations ... for levels at and above
the mean concentration [in certain studies]' ") (emphasis added in dissent).
But the increasing-uncertainty argument is helpful only if some principle
reveals how much uncertainty is too much. None does.
The arguments EPA offers here show only that EPA is applying the stated factors and that larger public health harms (including increased probability of such harms) are, as expected, associated with higher pollutant concentrations. The principle EPA invokes for each increment in stringency (such as for adopting the annual coarse particulate matter standard that it chose here)--that it is "possible, but not certain" that health effects exist at that level, see PM Final Rule, 62 Fed. Reg. at 38,678/3 n2 --could as easily, for any non-threshold pollutant, justify a standard of zero. The same indeterminacy prevails in EPA's decisions not to pick a still more stringent level. For example, EPA's reasons for not lowering the ozone standard from 0.08 to 0.07 ppm--that "the more serious effects ... are less certain" at the lower levels and that the lower levels are "closer to peak background levels," see Ozone Final Rule, 62 Fed. Reg. at 38,868/2--could also be employed to justify a refusal to reduce levels below those associated with London's "Killer Fog" of 1952. In that calamity, very high PM levels (up to 2,500 Sg/m3) are believed to have led to 4,000 excess deaths in a week. n3 Thus, the agency rightly recognizes that the question is one of degree, but offers no intelligible principle by which to identify a stopping point.
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n2 EPA did cite qualitative evidence for further support for its annual standard, and argued that the evidence "does not provide evidence of effects below the range of 40-50 Sg/m3," the standard level. PM Final Rule, 62 Fed. Reg. at 38,678/3. The referenced document, however, bears no indication that the qualitative evidence demonstrates effects at the level of the standard, either. See EPA, "Air Quality Criteria for Particulate Matter," at 13-79 (April 1996). n3 See W.P.D. Logan, "Mortality in the London Fog Incident, 1952," The Lancet, Feb. 4, 1953, at 336-38.
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The latitude EPA claims here seems even broader than that OSHA asserted
in International Union, UAW v. OSHA ("Lockout/Tagout I"), 291 U.S. App.
D.C. 51, 938 F.2d 1310, 1317 (D.C. Cir. 1991), which was to set a standard
that would reduce a substantial risk and that was not infeasible. In that
case, OSHA thought itself free either to "do nothing at all" or to "require
precautions that take the industry to the brink of ruin," with "all positions
in between ... evidently equally valid." Id. Here, EPA's freedom of movement
between the poles is equally unconstrained, but the poles are even farther
apart--the maximum stringency would send industry not just to the brink
of ruin but hurtling over it, while the minimum stringency may be close
to doing nothing at all.
In Lockout/Tagout I certain special conditions that have justified an
exceptionally relaxed application of the nondelegation doctrine were absent,
938 F.2d at 1317-18, and they are equally absent here. The standards in
question affect the whole economy, requiring a "more precise" delegation
than would otherwise be the case, see A.L.A. Schechter Poultry Corp. v.
United States, 295 U.S. 495, 553, 79 L. Ed. 1570, 55 S. Ct. 837 (1935).
No "special theories" justifying vague delegation such as the war powers
of the President or the sovereign attributes of the delegatee have been
or could be asserted. Nor is there some inherent characteristic of the
field that bars development of a far more determinate basis for decision.
(This is not to deny that there are difficulties; we consider some below.)
EPA cites prior decisions of this Court holding that when there is uncertainty
about the health effects of concentrations of a particular pollutant within
a particular range, EPA may use its discretion to make the "policy judgment"
to set the standards at one point within the relevant range rather than
another. NRDC v. EPA, 284 U.S. App. D.C. 136, 902 F.2d 962, 969 (D.C. Cir.
1990); American Petroleum Inst. v. Costle, 214 U.S. App. D.C. 358, 665
F.2d 1176, 1185 (D.C. Cir. 1981); Lead Industries, 647 F.2d at 1161 (D.C.
Cir. 1980). We agree. But none of those panels addressed the claim of undue
delegation that we face here, and accordingly had no occasion to ask EPA
for coherence (for a "principle," to use the classic term) in making its
"policy judgment." The latter phrase is not, after all, a self-sufficient
justification for every refusal to define limits.
It was suggested at oral argument that EPA's vision of its discretion
in application of § 109(b)(1) is no broader than that asserted by
OSHA after a remand by this court and upheld by this court in International
Union, UAW v. OSHA ("Lockout/Tagout II"), 308 U.S. App. D.C. 368, 37 F.3d
665 (D.C. Cir. 1994). But there, in fact, OSHA allowed itself to set only
standards falling somewhere between maximum feasible stringency and some
"moderate" departure from that level. 37 F.3d at 669. As our prior discussion
should have indicated, here EPA's formulation of its policy judgment leaves
it free to pick any point between zero and a hair below the concentrations
yielding London's Killer Fog.
The dissent argues that a nondelegation challenge similar to this one
was rejected in South Terminal Corp. v. EPA, 504 F.2d 646 (1st Cir. 1974),
and cites that case's language that "the rationality of the means can be
tested against goals capable of fairly precise definition in the language
of science," id. at 677. See Dissent at 2. But the action challenged in
South Terminal was EPA's adoption of a plan for ending or preventing violations
in Boston of already-established NAAQS, not its promulgation of the NAAQS
themselves. Thus, it seems likely that the "means" were the plan's provisions--e.g.,
a prohibition on most new parking in the city, see 504 F.2d at 671, and
the "fairly precisely defined" goals were the NAAQS themselves.
Where (as here) statutory language and an existing agency interpretation
involve an unconstitutional delegation of power, but an interpretation
without the constitutional weakness is or may be available, our response
is not to strike down the statute but to give the agency an opportunity
to extract a determinate standard on its own. Lockout/Tagout I, 938 F.2d
at 1313. Doing so serves at least two of three basic rationales for the
nondelegation doctrine. If the agency develops determinate, binding standards
for itself, it is less likely to exercise the delegated authority arbitrarily.
See Amalgamated Meat Cutters v. Connally, 337 F. Supp. 737, 758-59 (D.D.C.
1971) (Leventhal, J., for three-judge panel). And such standards enhance
the likelihood that meaningful judicial review will prove feasible. See
id. at 759. A remand of this sort of course does not serve the third key
function of non-delegation doctrine, to "ensure[ ] to the extent consistent
with orderly governmental administration that important choices of social
policy are made by Congress, the branch of our Government most responsive
to the popular will," Industrial Union Dep't, AFL-CIO v. American Petroleum
Inst., 448 U.S. 607, 685, 65 L. Ed. 2d 1010, 100 S. Ct. 2844 (1980) ("Benzene")
(Rehnquist, J., concurring). The agency will make the fundamental policy
choices. But the remand does ensure that the courts not hold unconstitutional
a statute that an agency, with the application of its special expertise,
could salvage. In any event, we do not read current Supreme Court cases
as applying the strong form of the nondelegation doctrine voiced in Justice
Rehnquist's concurrence. See Mistretta v. United States, 488 U.S. 361,
377-79, 102 L. Ed. 2d 714, 109 S. Ct. 647 (1989).
What sorts of "intelligible principles" might EPA adopt? Cost-benefit
analysis, mentioned as a possibility in Lockout/Tagout I, 938 F.2d at 1319-21,
is not available under decisions of this court. Our cases read § 109(b)(1)
as barring EPA from considering any factor other than "health effects relating
to pollutants in the air." NRDC, 902 F.2d at 973; see also Lead Industries,
647 F.2d at 1148; American Lung Ass'n v. EPA, 328 U.S. App. D.C. 232, 134
F.3d 388, 389 (D.C. Cir. 1998); American Petroleum Inst., 665 F.2d at 1185
(echoing the same themes).
In theory, EPA could make its criterion the eradication of any hint of direct health risk. This approach is certainly determinate enough, but it appears that it would require the agency to set the permissible levels of both pollutants here at zero. No party here appears to advocate this solution, and EPA appears to show no inclination to adopt it. n4
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n4 A zero-risk policy might seem to imply de-industrialization, but in fact even that seems inadequate to the task (and even if the calculus is confined to direct risks from pollutants, as opposed to risks from the concomitant poverty). First, PM (at least) results from almost all combustion, so only total prohibition of fire or universal application of some heretofore unknown control technology would reduce manmade emissions to zero. See PM Staff Paper at IV-1. Second, the combustion associated with pastoral life appears to be rather deadly. See World Bank, World Development Report 1992: Development and the Environment 52 (1992) (noting that "biomass" fuels (i.e., wood, straw, or dung) are often the only fuels that "poor households, mostly in rural areas" can obtain or afford, and that indoor smoke from biomass burning "contributes to acute respiratory infections that cause an estimated 4 million deaths annually among infants and children.").
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EPA's past behavior suggests some readiness to adopt standards that
leave non-zero residual risk. For example, it has employed commonly used
clinical criteria to determine what qualifies as an adverse health effect.
See Ozone Staff Paper at 59-60 (using American Thoracic Society standards
to determine threshold for "adverse health effect" from ozone). On the
issue of likelihood, for some purposes it might be appropriate to use standards
drawn from other areas of the law, such as the familiar "more probable
than not" criterion.
Of course a one-size-fits-all criterion of probability would make little sense. There is no reason why the same probability should govern assessments of a risk of thousands of deaths as against risks of a handful of people suffering momentary shortness of breath. More generally, all the relevant variables seem to range continuously from high to low: the possible effects of pollutants vary from death to trivialities, and the size of the affected population, the probability of an effect, and the associated uncertainty range from "large" numbers of persons with point estimates of high probability, to small numbers and vague ranges of probability. This does not seem insurmountable. Everyday life compels us all to make decisions balancing remote but severe harms against a probability distribution of benefits; people decide whether to proceed with an operation that carries a 1/1000 possibility of death, and (simplifying) a 90% chance of cure and a 10% chance of no effect, and a certainty of some short-term pain and nuisance. To be sure, all that requires is a go/no-go decision, while a serious effort at coherence under § 109(b)(1) would need to be more comprehensive. For example, a range of ailments short of death might need to be assigned weights. Nonetheless, an agency wielding the power over American life possessed by EPA should be capable of developing the rough equivalent of a generic unit of harm that takes into account population affected, severity and probability. Possible building blocks for such a principled structure might be found in the approach Oregon used in devising its health plan for the poor. In determining what conditions would be eligible for treatment under its version of Medicaid, Oregon ranked treatments by the amount of improvement in "Quality-Adjusted Life Years" provided by each treatment, divided by the cost of the treatment. n5 Here, of course, EPA may not consider cost, and indeed may well find a completely different method for securing reasonable coherence. Alternatively, if EPA concludes that there is no principle available, it can so report to the Congress, along with such rationales as it has for the levels it chose, and seek legislation ratifying its choice.
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n5 The "quality" of various health states was determined by poll, and medical professionals determined the probabilities and durations of various health states with and without the treatment in question.
Oregon was twice forced to revise its system because the United States
Department of Health & Human Services determined that the original
proposal and a revision violated the Americans with Disabilities Act, 42
U.S.C. §§ 12101-12213. The reason given for this determination
was that both versions undervalued the lives of persons with disabilities:
The original plan measured quality of life according to the attitudes of
the general population rather than the attitudes of persons with disabilities.
See HHS, "Analysis Under the Americans with Disabilities Act ('ADA') of
the Oregon Reform Demonstration" (Aug. 3, 1992), reprinted in 9 Issues
in L. & Med. 397, 410, 410 (1994). The revised plan ranked treatments
leaving the patient in a "symptomatic" state lower than those leaving the
patient asymptomatic, and certain disabling conditions were considered
"symptoms." See Letter from Timothy B. Flanagan, Assistant Attorney General,
to Susan K. Zagame, Acting General Counsel, HHS (Jan. 19, 1993), reprinted
in 9 Issues in L. & Med. 397, 418, 421 (1994). The Department's determination
was extensively criticized when issued. See Maxwell J. Mehlman et al.,
"When Do Health Care Decisions Discriminate Against Persons with Disabilities?"
22 J. Of Health Politics, Policy & L. 1385, 1390 (1997) (HHS's "decision
provoked a storm of disbelief and denunciation").
We take no position on whether HHS's view was correct, or if the underlying norm also governs EPA's decisions under § 109(b)(1). An affirmative answer, however, would not seem to preclude use of some of Oregon's approach. The first step would be giving appropriate weight to the views of persons with disabilities. The second might be measuring the seriousness of a pollution-induced health effect by the absolute level of well-being that the effect brings about, not by the decrease in level that the effect causes. In other words, if the maximum well-being level is 100 and the average asthmatic whose asthma constitutes a disability has a well-being of 80 in the absence of air pollution (according to a measure that appropriately considers asthmatics' own assessments of their condition), then a response to air pollution that reduces the asthmatics' well-being to 70 could be counted as an effect of magnitude 30 (the difference from full health), rather than 10 (the difference from the level without the pollution). That approach would ensure that effects on persons with disabilities were not underestimated, even in the broad sense of that term apparently adopted by HHS.
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We have discussed only the primary standards. Because the secondary standards are at least in part based on those, see Ozone Final Rule, 62 Fed. Reg. at 38,875/3-76/1; PM Final Rule, 62 Fed. Reg. at 38,680/3, we also remand the cases to the agency with regard to the secondary standards as well, for further consideration in light of this opinion.