Public Citizen Health Research Group v. Chao

Opinions of the United
2002 Decisions States Court of Appeals
for the Third Circuit
12-24-2002
Pub Citizen Health v. Secretary of Labor
Precedential or Non-Precedential: Precedential
Docket No. 02-1611
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PRECEDENTIAL
Filed December 24, 2002
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
No. 02-1611
PUBLIC CITIZEN HEALTH RESEARCH GROUP; THE
PAPER, ALLIED-INDUSTRIAL, CHEMICAL & ENERGY
WORKERS INTERNATIONAL UNION,
v.
ELAINE CHAO, SECRETARY OF LABOR;
OCCUPATIONAL SAFETY AND HEALTH
ADMINISTRATION,
*Color Pigments Manufacturers Association Inc.,
Intervenor
**Chrome Coalition,
Intervenor
*(Pursuant to Court’s Order dated 4/2/02)
**(Pursuant to Court’s Order dated 4/3/02)
On Direct Petition Pursuant to the Administrative
Procedure Act,
5 U.S.C. S 706
Argued: November 5, 2002
Before: BECKER, Chief Judge, McKEE and
HILL,* Circuit Judges.
(Filed December 24, 2002)
_________________________________________________________________
* The Honorable James C. Hill, United States Circuit Judge for the
Eleventh Circuit Court of Appeals, sitting by designation.
SCOTT L. NELSON (ARGUED)
DAVID C. VLADECK
Public Citizen Litigation Group
1600 20th Street, NW
Washington, D.C. 20009
Counsel for Appellant
Public Citizen Litigation Group
EUGENE SCALIA
Solicitor of Labor
JOSEPH M. WOODWARD
Associate Solicitor for Occupational
Safety and Health
BRUCE JUSTH (ARGUED)
Counsel for Appellate Litigation
JOHN SHORTALL
U.S. Department of Labor
Room S4004, 2000 Constitution
Avenue, NW
Washington, D.C. 20210-0001
Counsel for Appellee
Occupational Safety and Health
Administration
ANDRE SHRAMENKO (ARGUED)
GLENN C. MERRITT
Fitzpatrick & Waterman
333 Meadowlands Parkway
Secaucus, New Jersey 07096
Counsel for Intervenor
Color Pigments Manufacturers Assoc.,
Inc.
2
JOHN L. WITTENBORN
MICHAEL O. HILL (ARGUED)
CHRISTINA B. PARASCANDOLA
Collier Shannon Scott, PLCC
3050 K Street, NW, Suite 400
Washington, D.C. 20007
Counsel for Intervenor
Chrome Coalition
OPINION OF THE COURT
BECKER, Chief Judge.
This opinion addresses a Petition by Public Citizen Health
Research Group ("Public Citizen") to review the inaction of
the United States Department of Labor, specifically the
Occupational Safety and Health Administration ("OSHA"),
and to require OSHA to commence a rulemaking that would
lower the permissible exposure limit for hexavalent
chromium. It is not disputed that hexavalent chromium,
which is widely used in various industries and which has
been classified as a carcinogen, can have a deleterious
effect on worker health. The National Institute for
Occupational Safety and Health ("NIOSH") has for several
decades recommended that OSHA adopt a far more
stringent permissible exposure limit ("PEL") for hexavalent
chromium than the consensus standard it promulgated in
1971. In response to a 1993 petition for rulemaking, OSHA
agreed that there was clear evidence that exposure to
hexavalent chromium at the consensus level can result in
excess risk of lung cancer and other chromium-related
illnesses, and announced that it was initiating a
rulemaking that it expected would conclude in 1995.
However, nearly a decade after this announcement, nothing
has happened, evincing a clear pattern of delay.
This matter was before us once before, in Oil, Chemical &
Atomic Workers Union v. OSHA, 145 F.3d 120 (3d Cir.
1998). In that case, we declined Public Citizen’s request to
compel agency action, for we concluded that the facts did
not yet "demonstrate [that OSHA’s] inaction is . . . unduly
3
transgressive of the agency’s own tentative deadlines." 145
F.3d at 124. At that time, OSHA represented that it
intended to issue a proposed rule by September 1999, and
we found such a deadline permissible in light of alleged
competing policy priorities, including the Clinton
Administration’s ergonomics initiative. Yet, at the time of
oral argument in this case, which was nine years after
OSHA initially announced its intention to begin the
rulemaking process, no rulemaking had yet been initiated,
and it appeared that none would be in the foreseeable
future. Indeed, at oral argument, OSHA’s counsel admitted
the possibility that OSHA might not promulgate a rule for
another ten or twenty years, if at all.
We concluded that the delay had become unreasonable,
and that while competing policy priorities might explain
slow progress, they could not justify indefinite delay and
recalcitrance in the face of an admittedly grave risk to
public health. We therefore determined to grant the petition
and to direct OSHA to proceed expeditiously with its
hexavalent chromium rulemaking process. This opinion
was drafted on an expedited basis and was circulating to
the panel when we received OSHA’s announcement that it
had instituted the long-sought rulemaking process, stating
that: "The health risks associated with occupational
exposure to hexavalent chromium are serious and demand
serious attention. . . . We are committed to developing a
rule that ensures proper protection to safeguard workers
who deal with hexavalent chromium." OSHA News Release
of Dec. 4, 2002, available at http://www.osha.gov.
This notice appears to have been prompted by the
displeasure clearly evidenced by the panel during oral
argument, especially the question posed to counsel whether
they would be receptive to mediation regarding the
timeframe for a judicially-ordered rulemaking.
Notwithstanding OSHA’s long delay, we salute the agency
upon its recent action and accompanying recitation, and
trust that it will have a good result. That said, it does not
moot this proceeding because the agency’s action does not
resolve an important facet of the case, namely Public
Citizen’s request that we order OSHA to issue a proposed
rule within 90 days and supervise OSHA’s progress.
4
Accordingly, we will publish the opinion that had been
prepared to resolve the remedy issue, and will direct that
Public Citizen and OSHA submit to a course of mediation
for sixty days before The Honorable Walter K. Stapleton. If
the parties cannot agree to a workable timetable during
that period, the panel will issue and enforce a schedule of
its own device. We note in this regard that the recitation of
this case’s history and our ratio decidendi, which provided
the impetus for OSHA’s commendable action, will inform
the proceedings to follow.
I. Facts and Procedural Posture
Hexavalent chromium is a compound found only rarely in
nature but used widely in industry -- for chrome plating,
stainless steel welding, alloy production, and wood
preservation. The dangers of exposure to it have long been
recognized, and include ulceration of the stomach and skin,
necrosis, perforation of the nasal septum, asthma, and
dermatitis. More significantly, there is strong evidence that
inhaled hexavalent chromium is carcinogenic. Since 1980,
the Department of Health and Human Service’s National
Toxicology Program has designated various hexavalent
chromium compounds as human carcinogens. The
Environmental Protection Agency has been in accord since
1984, and it confirmed its carcinogenic classification of the
compound in a review of the toxicological data in 1998.
EPA, Toxicological Review of Hexavalent Chromium (1998),
available at http://www.epa.gov/IRIS/toxreview/0144-tr-
pdf. Disturbingly, the primary evidence of hexavalent
chromium’s carcinogenicity comes not from animal studies,
but from epidemiological studies of workers exposed to it;
in short, as Public Citizen states, "the principal evidence is
actual human body counts." [Pet. Br. at 5.]
Soon after the Occupational Safety and Health Act took
effect in 1970, OSHA established a 100 æg/m3 permissible
exposure limit ("PEL") for inhalation exposure to hexavalent
chromium.1 That level did not reflect OSHA’s independent
_________________________________________________________________
1. Two things are noteworthy about this limit. First, it represents an
absolute ceiling, not a time-weighted average. That is, at no time can a
5
judgment about the appropriate standard, but rather
constituted a "lowest common denominator" consensus
standard to provide workers some measure of protection
pending OSHA’s consideration of the optimal long-term
standard. S. Rep. No. 1282, 91st Cong., 2d Sess. 6 (1970),
reprinted in 1970 U.S.C.C.A.N. 5177, 5182-83. The 1971
standard remains in effect. However, although today’s
foremost health concern regarding hexavalent chromium is
its carcinogenicity, OSHA did not take that into account
when promulgating the standard; rather, it was based on a
1943 recommendation by the American National Standards
Institute, which in turn was based on reports generated in
the 1920s, none of which considered chromium’s
carcinogenic effects.
Shortly after OSHA promulgated the consensus standard,
NIOSH, the agency responsible for conducting research and
making recommendations to OSHA for the prevention of
occupational disease and injury, urged OSHA to adopt a
PEL of 1.9 æg/m3, a level 1/52 of the existing standard. At
that time, NIOSH concluded that the evidence of the
carcinogenicity of a few specified hexavalent chromium
compounds was lacking, but that all other forms were
carcinogenic. (Lurie Dec. P 7.) Subsequently, however,
NIOSH concluded that all forms of hexavalent chromium
should be considered carcinogenic, and it recommended
that the 1.9 æg/m3 standard be applied to all such
compounds. (Id.)
_________________________________________________________________
particular environment’s level permissibly rise above 100 æg/m3, even if
its time-weighted average is far lower. The construction industry alone is
permitted to use time-weighted averaging. See 29 C.F.R. S 1926.55.
Second, the 100 æg/m3 limit is reported as "CrO3." However, as only
52% of the mass of a CrO3 molecule is chromium, the actual permitted
amount of hexavalent chromium is approximately 52æg/m3, reported as
Cr(VI), the pure form. The existing permissible exposure limit is thus 100
æg/m3, reported as CrO3, or 52 æg/m3, reported as Cr(VI). Because both
Public Citizen’s proposed PEL and the existing PEL are reported as
CrO3, we will refer to that measurement throughout this opinion unless
otherwise stated. We also note that Cr(VI), CrVI, and CrO3 all refer to
hexavalent chromium; because we faithfully reproduce quotations that
use different notations, there is a lack of uniformity in our opinion.
6
In 1993, Public Citizen petitioned OSHA to issue an
emergency temporary standard that would set a PEL of 0.5
æg/m3 as an 8-hour weighted average. The Occupational
Safety and Health Act requires OSHA to issue an
emergency temporary standard without the usual notice-
and-comment procedures if it finds that such action is
needed to protect employees against grave danger. 29
U.S.C. S 655(c). OSHA denied the petition because it
contended that "the extremely stringent judicial and
statutory criteria for issuing" an emergency standard were
not met. (Dear Letter at 2.) It did, however, acknowledge
that its existing standard was inadequate: "OSHA agrees
that there is clear evidence that exposure to CrVI at the
current PEL of 100 æg/m3 can result in an excess risk of
lung cancer and other CrVI-related illnesses." (Id.) It
therefore announced that
OSHA . . . is beginning a Section 6(b) rulemaking for
occupational exposure to CrVI. We are preparing the
necessary health and economic impact assessments to
support this regulatory action. We anticipate that
Notice of Proposed Rulemaking will be published in the
Federal Register not later than March 1995.
(Id.)
This timetable was short-lived. Only a month after its
response to Public Citizen’s rulemaking petition, OSHA
reported that the date for issuance of a proposed standard
had slipped from March to May 1995, and by May 1995 the
anticipated issuance date had been pushed back again to
December 1995. Thus began a pattern of delay -- the
November 1995 agenda reset the date to July 1996; the
May 1996 agenda moved it to June 1997; and the
November 1996 agenda moved it again, to September 1997.
Amidst this ongoing delay, OSHA commissioned a
comprehensive risk assessment of hexavalent chromium.
This assessment, which became known as the "Crump
Report," concluded that exposure at the current PEL (100
æg/m3) over a 45-year working lifetime could be expected to
result in between 88 and 342 excess cancer deaths per
thousand workers. Moreover, the Crump Report concluded
that significant numbers of excess cancer deaths could be
7
expected even at much lower levels of exposure. For
example, exposure at 2 æg/m3 could be expected to result
in between 1.8 and 8.9 excess cancer deaths per thousand
workers, while exposure at 1 æg/m3 would yield 0.9 to 4.4
excess cancer deaths per thousand workers.2
OSHA’s November 1996 semiannual regulatory agenda
endorsed the Crump analysis, and OSHA explicitly
acknowledged that "[t]here appears to be no dispute that
the current PEL is too high" and "must be greatly reduced."
(Lure Dec. P12.) Accordingly, OSHA stated that it was
considering a new standard 10 to 100 times lower than the
existing one: "OSHA is preliminarily considering a new
TWA [Time-Weighted Average] PEL in the range of 0.5 - 5.0
æg/m3, measured and reported as chromium (VI)." (Id.)
Even at that level, it noted, there would be significant risk
of excess cancer deaths. (Id.)
Addressing these events in its present brief, OSHA
contends that it was then concerned with methodological
imperfections in the available data. For example, the
Crump Report did not control for the effects of smoking or
asbestos, factors obviously related to lung cancer incidence;
if the studied populations of chromium-exposed workers
smoked more than the general population, smoking could
have accounted for some of the excess deaths. Industry
groups therefore pressured OSHA to wait for the results of
the then-forthcoming Johns Hopkins study, which, in the
industry’s view, was "expected to be the most accurate and
complete database on chromium exposure and mortality
available." (Id. at P 14-15.) OSHA also represents that
budget cuts, government shutdowns, and new
responsibilities under the Small Business Regulatory
Enforcement Fairness Act of 1996 limited the resources
available for hexavalent chromium rulemaking. In August
1997, OSHA explained to Public Citizen that work on the
rule was continuing, but that these considerations had
delayed progress and prevented it from expediting the
rulemaking. (Letter of Greg Watchman to Dr. Sidney M.
Wolfe.)
_________________________________________________________________
2. The Crump Report cited measurements of exposure as Cr(VI) instead
of as CrO3. The numbers here reflect conversion to CrO3 measurements.
8
Public Citizen, discouraged by what it viewed as a pattern
of inaction, urged OSHA in March 1997 to commit to a
timetable for rulemaking. (Lurie Dec. P17.) Instead, in its
April 1997 agenda, OSHA announced that the expected
issuance of a proposed standard had been delayed a full
year, to September 1998, (id. at P10), and in a letter to
Public Citizen declined to commit to a more concrete
timetable. (Watchman Letter at 2.)
In late 1997, Public Citizen filed a petition in this Court
for review of OSHA’s allegedly unreasonable delay. See Oil
Workers, 145 F.3d at 120. It contended that expedited
action on a new rule was needed because, as OSHA itself
had stated in 1996, "the sooner PELs are reduced, the
sooner the risk of death from lung cancer . . . will be
reduced." (Lurie Dec. P12, citing 1996 OSHA agenda.)
However, OSHA disputed this urgency by referencing the
Crump Report’s failure to control for smoking and asbestos
exposure, and Intervenors Chrome Coalition and Color
Pigment Manufacturer’s Association, who have also
intervened in the current case, argued that the existing risk
assessments failed to distinguish among the various
compounds of hexavalent chromium.
We declined Public Citizen’s request to compel agency
action, for we concluded that the facts did not yet
"demonstrate that inaction is . . . unduly transgressive of
the agency’s own tentative deadlines." Oil Workers, 145
F.3d at 124. Key to our decision was our observation that
the Secretary of Labor has "quintessential discretion . . . to
allocate OSHA’s resources and set its priorities," id. at 123,
and while we recognized that "delays that might be
altogether reasonable in the sphere of economic regulation
are less tolerable when human lives are at stake," we
determined that OSHA and the Intervenors "raise[d] serious
questions about the validity of the data and assumptions
underlying [Public Citizen’s] calculations." Id. (citations
omitted). Given these scientific questions, OSHA’s superior
technical expertise, and its professed plan to issue a
deadline for proposed rulemaking in September 1999, we
concluded that OSHA’s delay was not yet unreasonable. Id.
Following our ruling, OSHA adhered to its September
1999 pledge in each of its regulatory agendas published
9
through April 1999. But it in fact issued no proposed rule
in September 1999, and in its November 1999 agenda it
announced that its new target date was June 2001. (Lurie
Dec. P10.) OSHA explains that this was not a period of
inactivity; rather, it completed a number of rulemaking
projects, most of which had been pending when Public
Citizen filed its first petition in 1993. For example, in 1997,
OSHA promulgated a final standard regulating occupational
exposure to methylene chloride, a widely-used chemical it
found to be carcinogenic. See 62 Fed. Reg. 1494 (Jan. 10,
1997). Likewise, in 1998, it issued a final rule on
respirators, and another requiring adequate training for
operators of powered industrial trucks. 63 Fed. Reg. 66238
(Dec. 1, 1998). OSHA further explains that in 1999 and
2000, it "focused most of its rulemaking resources on
issuing an ergonomics standard before the end of the
[Clinton] Administration’s term. A proposed rule was issued
on November 23, 1999, and a final rule was issued less
than a year later, a timetable that required tremendous
agency resources." [OSHA Br. at 10 (citations omitted).]
Meanwhile, August 2000 saw the release of the long-
awaited Johns Hopkins study on hexavalent chromium. 3 In
comparison to previous studies, it
had a larger cohort, more lung cancer deaths, and had
smoking information for most of the cohort. Many of
the exposure estimates of the current study are from
direct measurements; a portion were from models
using contemporary data. More important, however,
the ambient measures or estimates of exposure were
concurrent with the work history and are of hexavalent
chromium directly, not derived from other measures.
Furthermore, the cumulative exposure groups in the
current study represent lower exposures than those
. . . [in a prior] study, providing better risk estimates at
these lower levels of exposure, an important
consideration for quantitative risk assessment.
_________________________________________________________________
3. Public Citizen alleges that many of the Hopkins study’s results, if not
its actual data, had been available to OSHA since 1995. [Public Citizen
Br. at 23.]
10
Herman J. Gibb et al., Lung Cancer Among Workers in
Chromium Chemical Production, 38 Am. J. Industrial
Medicine 115, 124 (2000). The Hopkins Study "confirm[ed]
the elevated lung cancer risk from hexavalent chromium
exposure observed in other studies." Id. Specifically, it
found that chromium-exposed workers were 2.24 times as
likely to die from lung cancer as a nonexposed population,
id. at 125, and that even exposure at a level of 1 æg/m3,
reported as Cr(VI), led to an observed-to-expected cancer
mortality rate of 1.57. Id.
Although the Hopkins Study explicitly sought to address
the shortcomings in previous empirical research, namely
the lack of controls for smoking, asbestos, and other
environmental factors, its release did not spur OSHA into
action. The study was released in August 2000, but OSHA’s
November 2000 agenda pushed the date for a proposed rule
back to September 2001. (Lurie Dec. P10.) OSHA’s second-
most-recent agenda, issued December 3, 2001, reflected
another, more radical departure from previous plans: for
the first time since 1994, the hexavalent chromium
rulemaking was denominated a "long-term action," and the
timetable for action stated that the date for a proposed rule
was "to be determined." (Lurie Dec. P10.)
OSHA offers a number of explanations for the delay that
has now become indefinite. It notes that "[t]he day the
[Bush] Administration took office, it instructed the agencies
that any new regulatory actions must be reviewed and
approved by a department or agency head appointed after
January 20, 2001." [OSHA Br. at 13-14, citing Andrew H.
Card, Jr., Memorandum for the Heads and Acting Heads of
Executive Departments and Agencies (Jan. 20, 2001).] As it
was not headed by a presidential appointee until August 3,
2001, OSHA contends that it could not begin to set its new
regulatory priorities until that time. Even then, it asserts,
two extraordinary unforeseen events -- the attacks on the
World Trade Center and Pentagon and the anthrax mailings
-- required it immediately to divert significant resources to
safety efforts. See Testimony of John L. Henshaw, Assistant
Secretary of Labor for Occupational Safety and Health,
before the House Subcommittee on Labor, Health, and
Human Services, 2002 WL 2010818 (Feb. 14, 2002).
11
Even amidst these distractions, OSHA represents, it has
continued to evaluate the need for a new hexavalent
chromium rule. It claims that from 1998 through the
present, it has "engaged outside organizations to work on
pertinent aspects of the health-risk and feasibility issues
that would arise in an OSHA rulemaking." [OSHA Br. at
11]. For example, ToxiChemica International has worked on
evaluating an update of an epidemiological study of workers
exposed to hexavalent chromium, and NIOSH has
investigated the mechanistic relationship between
hexavalent chromium and cellular events related to lung
carcinogenesis. OSHA has also conducted more than
twenty visits to worksites where hexavalent chromium is
present to determine patterns of employee exposure,
specific routes of exposure, and types and costs of
engineering controls and personal protective equipment
used in particular industries.
In OSHA’s submission, the problem is that it "believes
that the information now available is inconclusive on
important issues, such as whether the epidemiological
studies . . . apply to all Cr VI compounds and the utility of
the data to establish a dose-response relationship." [Id. 16.]
Although the Hopkins Study was a step forward, OSHA
points out that its authors acknowledged certain
limitations, particularly in estimating the cumulative
exposure for the different individuals in the cohort. [Id. at
26.] The study also did not resolve the dispute over whether
all hexavalent chromium compounds present the same
degree of risk. [Id. at 27.] Because OSHA has decided that
it would benefit from public input and expert criticism on
these issues, it has published a request for information
(RFI) in its August 2002 regulatory agenda. After the time
for response, OSHA states, it will evaluate all of the
information available and decide how to proceed. See 67
Fed. Reg. 33308, 33342-43 (May 13, 2002).
Public Citizen brought the present petition for review
alleging that "[d]eference to an agency’s priorities and
timetables only goes so far," and arguing that,"at some
point, a court must tell an agency that enough is enough."
[Public Citizen Br. at 2.] The Administrative Procedure Act,
5 U.S.C. S 706(1), creates a right of action by an aggrieved
12
party to compel unreasonably delayed agency action. When
the action sought is the promulgation of an occupational
exposure standard under 29 U.S.C. S 655, the federal
courts of appeals have exclusive jurisdiction under 29
U.S.C. S 655(f), which we have interpreted to provide
"jurisdiction to conduct judicial review over the health and
safety standards issued by the Secretary of Labor, as well
as over claims in which the Secretary has not yet acted but
where her delay is allegedly unreasonable." Oil Workers,
145 F.3d at 122.
II. Discussion
In denying Public Citizen’s earlier petition to compel a
hexavalent chromium rulemaking, we acknowledged"the
quintessential discretion of the Secretary of Labor to
allocate OSHA’s resources and set its priorities." Oil
Workers, 145 F.3d at 123. At the same time, however, we
recognized that the Secretary’s discretion is not
unbounded, and noted our obligation under the APA to
"compel agency action unlawfully withheld or unreasonably
delayed." Id. (quoting 5 U.S.C. S 706(1)). Our polestar is
reasonableness, and while in 1997 we found reasonable
OSHA’s delay in the face of scientific uncertainty and
competing regulatory priorities, we now find ourselves
further from a new rule than we were then. We examine
each of OSHA’s justifications in turn.4
_________________________________________________________________
4. Intervenors Chrome Coalition and Color Pigment Manufacturer’s
Association, Inc. ("CPMA") filed amicus briefs arguing, inter alia: that our
prior decision in Oil Worker is res judicata upon this case since the facts
are similar; that the Occupational Safety and Health Act imposes on
OSHA no duty to act; that Public Citizen’s risk assessments and
scientific conclusions should be stricken due to methodological defects;
that Public Citizen lacks standing; that Public Citizen’s analysis fails to
distinguish among various forms of hexavalent chromium; and that we
lack subject matter jurisdiction because Public Citizen has not pled that
its principal place of business is within our jurisdiction. We have
considered each of their concerns and find them to be without merit. We
note specifically that, under the Supreme Court’s decision in Panhandle
Eastern Pipe Line Co. v. Federal Power Comm’n, 324 U.S. 635, 638-39
(1945), courts have read circuit-selection clauses in statutes providing
for review of agency action in the courts of appeals as venue provisions,
not jurisdiction provisions. Also, while CPMA may be correct that a
regulatory distinction ought to be drawn between chrome pigments and
other types of hexavalent chromium compounds, CPMA may raise this
concern as part of the rulemaking process.
13
A. Has OSHA’s Delay Been Excessive?
In 1993, OSHA acknowledged that the existing
hexavalent chromium standard is inadequate and "that
there is clear evidence that exposure to Cr VI at the current
PEL of 100 æg/m3 can result in an excess risk of lung
cancer and other CrVI-related illnesses." (Dear Letter at 2.)
That was fully nine years ago, and its first target date for
a proposed rule -- March 1995 -- is now more than seven
years past. OSHA has missed all ten of its self-imposed
deadlines, including the September 1999 target it offered to
this Court in Oil Workers. Far from drawing closer to a
rulemaking, all evidence suggests that ground is being lost.
OSHA’s December 2001 regulatory agenda demoted the
rulemaking from a "high priority" to a "long term action"
with a timetable "to be determined." In fact, at oral
argument, OSHA’s counsel admitted the possibility that
another ten or even twenty years might pass before it
issues a rule, if it ever does.
OSHA responds that Public Citizen’s concerns about the
missed deadlines and recent reclassification are
misconceived. It explains that under the Regulatory
Flexibility Act, 5 U.S.C. S 602, agencies must publish
regulatory agendas that include all rules the agency intends
to propose or promulgate that are "likely to have a
significant economic impact on a substantial number of
small entities." A rule’s inclusion in an agency’s agenda
does not, however, require the agency to consider or act on
that item. See 5 U.S.C. S 602(d). The Secretary of Labor has
recently stated her belief that "it is inappropriate to
routinely set target dates that the agency cannot meet and
intends to list only realistic target dates in future regulatory
agendas," Daily Labor Report (BNA, Apr. 22, 2002), but
OSHA represents that this is an act of grace, not necessity:
"[B]ecause an item’s listing in the regulatory agenda does
not mean that the agency must consider or act on that
item, the listing of unrealistic or unachieved target dates
cannot be a basis for compelling the agency to act." [OSHA
Br. at 33.]
Regarding hexavalent chromium’s recent downgrade to a
"long-term project," OSHA clarifies that this is a reflection
of whether the rulemaking will be completed in a short
14
period of time and represents that the designation carries
no implication about a rulemaking’s relative importance to
other matters OSHA is considering. [OSHA Br. at 31.] The
items listed as "high priority" in the December 2001
agenda, it says, were simply those on which OSHA intended
to take action in fiscal 2002. See 66 Fed. Reg. 61221 (Dec.
3, 2001). It therefore contends that the priority downgrade
was more a clarification than a change in the agency’s
priorities.
We find neither of these explanations satisfactory. We
agree with OSHA insofar as its failure strictly to follow its
published agenda is not actionable, but this defense misses
the point: OSHA’s persistent failure to meet deadlines is not
the disease itself, but rather a symptom of its dilatory
approach to the hexavalent chromium rulemaking process.
Similarly, even if OSHA’s decision to downgrade the
project’s priority truly represents a clarification rather than
a change, it still gives clear evidence that at least another
year will pass before OSHA takes even the first formal step
toward promulgating a rule. Incidentally, we are skeptical
of OSHA’s reassurance that the reclassification has no
substantive implications, for five years ago it represented to
this Court that it intended to issue a proposed rule in
September 1999. Not only did it fail to issue a rule in 1999,
it concedes even now that it is far from doing so.
Section 6(b) of the Occupational Safety and Health Act
requires the Secretary of Labor to "set the standard which
most adequately assures, to the extent feasible, on the
basis of the best available evidence, that no employee will
suffer material impairment of health or functional capacity
even if such employee has regular exposure to the hazard
dealt with by such standard for the period of his working
life." 29 U.S.C. S 655(b). The Supreme Court has found that
this language compels action: "[B]oth the language and
structure of the Act, as well as its legislative history,
indicate that it was intended to require the elimination, as
far as feasible, of significant risks of harm." Industrial Union
Department, AFL-CIO v. American Petroleum Institute , 448
U.S. 607, 641 (1980). As such, the agency’s priorities are
judicially reviewable, and this Court and others have
compelled OSHA to take action to address significant risks.
15
See, e.g., United Steelworkers of America v. Pendergrass,
819 F.2d 1263 (3d Cir. 1987); In re International Chemical
Workers Union, 958 F.2d 1144 (D.C. Cir. 1992); Public
Citizen Helath Research Group v. Brock, 823 F.2d 626 (D.C.
Cir. 1987). Indeed, OSHA itself does not seriously contest
the existence of a private cause of action compelling it to
proceed with a rulemaking.
We find extreme OSHA’s nine-year (and counting) delay
since announcing its intention to begin the rulemaking
process, even relative to delays other courts have
condemned in comparable cases. Indeed, in no reported
case has a court reviewed a delay this long without
compelling action. In Chemical Workers Union, 958 F.2d at
1144, for example, petitioners had first requested that
OSHA promulgate a rule for cadmium in 1986. Similar to
this case, the court had denied an initial petition to compel
OSHA to act, based in part on OSHA’s prediction that it
would issue a proposed rule later that year. When it failed
to issue a proposed rule until 1990 and estimated that a
final rule would not be forthcoming until 1992, the court
said:
[E]ven if finally completed by August 31, 1992, the
cadmium rulemaking will have taken over six years.
This is an extraordinarily long time, in light of the
admittedly serious health risks associated with the
current permissible levels of cadmium exposure under
the twenty-year-old standards still in place. . . . Under
the circumstances, we do not see how any further
delay . . . -- resulting in continued exposure of workers
to dangerous levels of cadmium -- could be excusable.
Id. at 1150 (citations omitted). It therefore granted
petitioner’s motion to impose a deadline for completion of
the cadmium rulemaking. Id. The length of the delay here
is already two-and-a-half years longer than the delay the
D.C. Circuit found unacceptable, and no proposed rule is in
sight.
Similarly, in Public Citizen Health Research Group v.
Auchter, 702 F.2d 1150 (D.C. Cir. 1983), OSHA had been
petitioned in 1981 for a new exposure standard for ethylene
oxide ("EtO"), a carcinogenic substance to which an
16
estimated 75,000 hospital workers were exposed. As in the
case at bar, the agency refused to issue an emergency
temporary standard, but acknowledged the current
standard’s insufficiency and began the rulemaking process.
It issued an "advance notice of proposed rulemaking" in
1982, but it had not issued the proposed rule as of 1983,
and it estimated that a final rule would not be issued until
the fall of 1984. The court found the anticipated three-year
delay unacceptable, stating that:
Three years from announced intent to regulate to final
rule is simply too long given the significant risk of
grave danger EtO poses to the lives of current workers
and the lives and well-being of their offspring. Delays
that might be altogether reasonable in the sphere of
economic regulation are less tolerable when human
lives are at stake. . . . This is particularly true when
the very purpose of the governing Act is to protect
those lives.
Id. at 1154. See also Brock, 823 F.2d at 628, 629 ("With
lives hanging in the balance, six years is a very long time,"
and "any delay whatever beyond the proposed schedule is
unreasonable."); Oil, Chemical & Atomic Workers
International Union v. Zegeer, 768 F.2d 1480, 1487 (D.C.
Cir. 1985) (addressing a delay of over five years in issuing
a proposed rule for exposure to radioactive gases, and
stating that a "reasonable time may encompass months,
occasionally a year or two, but not several years or a
decade").
OSHA contends that among these cases, only in Auchter
did a court compel the agency to issue a proposed rule; the
others dealt with situations where the agency had issued a
proposed rule but was allegedly dilatory in issuing a final
regulation. It further notes that the D.C. Circuit later
characterized Auchter as "one of the exceptionally rare
cases where this court has actually issued an order
compelling an agency to press forward with a specific
project." In re Barr Laboratories, Inc. 930 F.2d 72, 76 (D.C.
Cir. 1991). OSHA also points out that in Auchter , the court
had been "persuaded, largely by agency concessions, that
the project backed by plaintiff was plainly more‘urgent’
17
than any that the project’s acceleration might retard," id.,
and it emphasizes that no similar concession exists here.
While we acknowledge that Auchter, Chemical Workers
Union, and the other cases are in some ways
distinguishable from this one, we nonetheless regard them
as valuable precedent. For example, in Auchter , even
though OSHA admitted that the plaintiff ’s project was the
most urgent on its agenda, the case at bar is not ultimately
distinguishable because the extremity of delay more than
overcomes the fact that hexavalent chromium does not
dominate OSHA’s list of priorities. We also note that
although the D.C. Circuit termed cases in which courts
order agencies to press forward with a specific project
"exceptionally rare," the initial decision to make hexavalent
chromium a "high priority" came from OSHA itself, not this
Court. It was also OSHA’s decision to announce in 1993
that it was "beginning a . . . rulemaking for occupational
exposure to Cr VI," and that it "anticipate[d] that Notice of
Proposed Rulemaking will be published . . . not later than
1995." (Lurie Dec. P9.) At all events, we think it
"exceptionally rare" that an agency would for years classify
an action as a "high priority," only to demote it to a "long
term project" upon the release of a study that provides
more convincing evidence of the danger than had previously
existed.
We are satisfied that OSHA’s delay in this case is
objectively extreme, and we find its regression alarming in
the face of its own 1996 statement that "[t]here appears to
be no dispute that the current PEL is too high." We
therefore conclude that, absent a scientific or policy-based
justification for its delay, we must compel it to act.
B. Does Scientific Uncertainty Justify OSHA’s Delay?
In Oil Workers, the first installment of this case, Public
Citizen relied upon the Crump Report’s finding that
between 88 and 342 out of every 1,000 workers exposed to
hexavalent chromium will die from cancer attributable to
that exposure. 145 F.3d at 123. We recognized, however,
that there were "serious questions about the validity of the
data and assumptions underlying Petitioner’s calculations."
Id. For example, as the Intervenors noted, it was "wrong to
18
assume that all workers in industries dealing with
chromium in some way or another are exposed to 100 æg/m3
hexavalent chromium, every working day for 45 years." Id.
We likewise observed that some workers breathe through
respirators that protect them from exposure to chromium,
and that Public Citizen’s calculations failed to distinguish
between lead chromate and other hexavalent chromium
compounds with potentially different carcinogenicities. Id.
at 124. Finally, and most importantly, we were troubled by
the Crump Report’s failure to control for smoking and
asbestos inhalation, two factors likely related to lung
cancer incidence. Id.
Based on this imperfect science and our recognition that
"OSHA . . . possesses enormous technical expertise we
lack," we concluded that we were "not in a position to tell
the Secretary how to do her job." Id. OSHA offers several
reasons for us to continue that deferential posture. First,
OSHA allegedly "has not yet completed its evaluation of the
Hopkins study." [OSHA Br. at 26.] It points out that the
study’s authors acknowledged certain limitations of their
data, particularly in estimating the cumulative exposure for
different individuals in the cohort, and also that the study
did not address the previous dispute over whether all
hexavalent chromium compounds present the same degree
of risk. [Id. at 26-27.] OSHA summarizes that, "even
assuming the Hopkins study is the most useful single study
available, it does not answer all of the technically complex
questions about carcinogenicity and other health effects
that OSHA would need to resolve in developing a Cr VI
rule." [Id. at 27.]
Second, OSHA alleges that "Public Citizen virtually
ignores the other critical components of a Cr VI
rulemaking." [Id.] One of OSHA’s requirements is that a
standard must be technologically feasible, and given that
one governing hexavalent chromium would apply to
numerous industries, the feasibility analysis is quite
complex. While it admits that it has successfully addressed
issues of comparable complexity in the past, it notes that
"these efforts have not been successful where courts have
found insufficient rigor in the agency’s analysis of scientific
and economic issues." [Id. at 30] See, e.g., Industrial Union
19
Dep’t, 448 U.S. at 662 (invalidating benzene standard); AFL-
CIO v. OSHA, 965 F.2d 962 (11th Cir. 1992) (vacating
standard setting new exposure limits for over 400
substances). The bottom line, OSHA states, is that"[t]he
belief that a chemical may be carcinogenic does not lead
easily to the appropriate PEL for that chemical," and forcing
it to issue a rule prematurely will likely result in that rule
being overturned in court. [OSHA Br. at 24.]
We agree with OSHA that the evidence may be imperfect,
that the feasibility inquiry is formidable, and that
premature rulemaking is undesirable. But given the history
chronicled above, we find these concerns insufficient to
justify further delay in regulating hexavalent chromium.
First, while it is true that the Hopkins study’s authors
recognized certain limitations of their data,
the epidemiological data as of the mid-1990s were
sufficient for EPA, ATSDR, NIOSH, the National
Toxicology Program, and the International Agency for
Research on Cancer to find hexavalent chromium
carcinogenic; for OSHA to commence a rulemaking
proceeding; and for OSHA’s contractor to estimate that
exposures at a fraction of the current PEL would result
in significant excess cancer deaths.
[Public Citizen Reply Br. at 19-20.] Moreover, OSHA based
its delay on its professed desire to consider that study
because of its superior data and ability to control for
smoking. It was released in August 2000, more than two
years ago, but it has hardly facilitated the rulemaking
process.5 OSHA now offers it as a justification for further
inaction, claiming that it has not completed its evaluation
of the study’s findings and that the study’s conclusions
"can be much better assessed when experts in the field
have had the opportunity to review and criticize it." [OSHA
Br. at 27.]
We are unconvinced. Public Citizen points out that, as
the study was published in a peer-reviewed journal, experts
in the field have already had the opportunity to criticize it.
_________________________________________________________________
5. Indeed, the Hopkins study’s results were first presented publicly in
1995. [Public Citizen Br. at 10, 44.]
20
[Id. at 20.] Notably, in the two years since its publication,
"no response or letter criticizing it has been published." [Id.]
Especially since many of the study’s findings have been
available since 1995, see supra at note 5, the time for
examining it has passed; we also note that, if further
professional criticism is absolutely necessary, the notice-
and-comment process will provide an ample opportunity.
Nor do we find persuasive OSHA’s broad assertion that
the Hopkins study "does not answer all of the technically
complex questions . . . that OSHA would need to resolve in
developing a Cr VI rule." [OSHA Br. at 27 (emphasis
added).] This is obviously true, but without more it is
irrelevant, for the Occupational Safety and Health Act does
not require scientific certainty in the rulemaking process.
Indeed, read fairly, the Act virtually forbids delay in pursuit
of certainty -- it requires regulation "on the basis of the
best available evidence," 29 U.S.C. S 655(b)(5) (emphasis
added), and courts have warned that "OSHA cannot let
workers suffer while it awaits the Godot of scientific
certainty." United Steelworkers of America v. Marshall, 647
F.2d 1189, 1266 (D.C. Cir. 1980).
OSHA points to one specific shortcoming of the Hopkins
study -- that it "did not address the previous dispute over
whether all hexavalent chromium compounds present the
same degree of risk." [OSHA Br. at 27] That is indeed a
question it did not resolve, and this uncertainty is the
principal topic of Intervenor CPMA’s brief, which argues
that the lead chromate used in pigments is not as
carcinogenic as other hexavalent chromium compounds.
The Hopkins study casts no light on this issue because its
test population did not work in the pigment industry, but
even without better data than that which existed in Oil
Workers in 1997, we find this uncertainty insufficient to
delay rulemaking further. Even if the chromate in pigments
is not carcinogenic, an argument that, tellingly, OSHA itself
does not offer, requiring concrete findings on this
distinction would effectively hold hostage the thousands of
workers who are exposed to non-pigment hexavalent
chromium. We will not sanction that result when,"even
though OSHA acknowledges that this issue was flagged in
the prior litigation over four years ago, OSHA does not
21
claim to have done anything to resolve it." [Public Citizen
Reply Br. at 24.]6
Finally, while we are sympathetic to OSHA’s claim that a
thorough feasibility analysis is both highly important and
quite difficult, we cannot allow an imperfect analysis to
justify indefinite delay. OSHA first announced a rulemaking
nine years ago, and by its own account it has been
examining the issue through NIOSH for at least four years.
OSHA does not explain why this particular feasibility
determination requires an extreme length of time, and it
does not offer even a projection of how much time it might
ultimately require. In such a situation, our traditional
agency deference begins to resemble judicial abdication,
and we conclude that scientific uncertainties and technical
complexities, while no doubt considerable, can no longer
justify delay. Judges on this court are not paid to decide
the easy cases, and neither is OSHA. Difficult challenges go
with the territory, and courts and agencies regularly
surmount them. The notice-and-comment process should
itself provide a fertile forum for gathering information on
feasibility.
C. Do Competing Priorities Justify OSHA’s Delay?
Although OSHA insists that since Oil Workers it has
continued to work on health-risk and feasibility issues
relating to an eventual hexavalent chromium rulemaking, it
admits that the project has not been a priority. In Oil
Workers, of course, we noted "the quintessential discretion
of the Secretary of Labor to allocate OSHA’s resources and
set its priorities," 145 F.3d at 123, and OSHA contends that
it simply exercised its discretion to concentrate its
resources elsewhere. For example, in early 1997, it
promulgated a final standard regulating occupational
exposure to methylene chloride, a widely-used chemical it
found to be carcinogenic. See 62 Fed. Reg. 1494 (Jan. 10,
1997). Shortly thereafter, in early 1998, it issued a final
rule on respirators, see 63 Fed. Reg. 1152 (Jan. 8, 1998),
and later that year it issued a final rule requiring adequate
training for operators of powered industrial trucks. See 63
_________________________________________________________________
6. Presumably, the difference in pigments can be addressed in the
rulemaking itself.
22
Fed. Reg. 66238 (Dec. 1, 1998). During that period, OSHA
also completed a revision to its safety standards for
longshoring and marine terminals. See 62 Fed. Reg. 40142
(July 25, 1997).
In 1999 and 2000, OSHA submits that it "focused most
of its rulemaking resources on issuing an ergonomics
standard before the end of the former Administration’s
term." [OSHA Br. at 10.] Because the Clinton
Administration placed such great emphasis on quickly
finalizing those standards, the process was remarkably
compressed; OSHA issued a proposed rule on November 23,
1999, and a final rule less than a year later, on November
14, 2000, "a timetable that required tremendous agency
resources." [Id.] It explains that in addition to the
ergonomics standard, the former Administration gave high
priority to completing a steel erection standard, see 66 Fed.
Reg. 5196 (Jan. 18, 2001), and a recordkeeping rule
designed to improve the quality of information about the
causes of occupational injuries and illnesses. See 66 Fed.
Reg. 5916 (Jan. 19, 2001).
OSHA represents that the delays became worse when the
Bush administration took office, for it instructed the
agencies that any new regulatory actions must be reviewed
and approved by a department or agency head appointed
after January 20, 2001. See Andrew H. Card, Jr.,
Memorandum for the Heads and Acting Heads of Executive
Departments and Agencies, (Jan. 20, 2001) available at
http://www.whitehouse.gov/omb/inforeg/regreview_
plan.pdf. As OSHA was not headed by a presidential
nominee until August 2001, it alleges that "it could not
begin in earnest to set its new regulatory priorities" until
that time, [OSHA Br. at 14], and that even then, unforeseen
incidents such as the September 11 attacks and anthrax
mailings demanded that it "immediately divert[ ] significant
resources to help ensure that the rescue and cleanup
efforts did not result in further loss of life."[Id. at 15
(citation omitted).]
OSHA lastly represents that, while these competing
priorities have admittedly delayed the hexavalent chromium
rulemaking, it is now pressing forward on that project. It
published a request for information ("RFI") in the Federal
23
Register in August 2002 posing specific questions that
would be relevant to a rulemaking and inviting the public
to submit any other evidence it feels might be helpful to
OSHA. Following the RFI, it pledges that it will"evaluate all
of the information available on Cr VI . . . and decide how to
proceed." [Id. at 16.]
We do not lightly discount these admittedly significant
competing priorities, especially those relating to the events
of September 11, but when we view the rulemaking’s
progress over the past nine years, we reach the ineluctable
conclusion that hexavalent chromium has progressively
fallen by the wayside. This is unacceptable, for as the D.C.
Circuit stated, "[w]here the Secretary deems a problem
significant enough to warrant initiation of the standard
setting process, the Act requires that he have a plan to
shepherd through the development of the standard-- that
he take pains, regardless of the press of other priorities, to
ensure that the standard is not inadvertently lost in the
process." National Congress of Hispanic American Citizens v.
Marshall, 626 F.2d 882, 890-91 (D.C. Cir. 1979).
OSHA chose in 1993 to begin the rulemaking process,
announcing its "agree[ment] that there is clear evidence
that exposure to Cr VI at the current PEL . . . can result in
an excess risk of lung cancer," and its "anticipation that
Notice of Proposed Rulemaking [would] be published in the
Federal Register not later than March 1995." (Lurie Dec.
P9.) However, 1995 came and went without any sign of
formal action, only for OSHA in 1996 again to declare that
"[t]here appears to be no dispute that the current PEL is too
high" and "must be greatly reduced." (Id.) In fact, in 1997
OSHA declared to this Court its intention to promulgate a
proposed rule by September 1999. Oil Workers, 145 F.3d at
123. That deadline, like the others, passed without action.
Now, nine years after the rulemaking process began, we
find ourselves without even a hint as to when OSHA might
issue a proposed rule, much less a final rule. Indeed, a
reasonable person would likely conclude that we are further
from a rule today than we were five years ago, a notion that
would certainly have alarmed the Oil Workers panel. We
find apropos the D.C. Circuit’s words in Brock :
24
We understand that technical questions of health
regulation are not easily untangled. We understand
that an agency’s limited resources may make
impossible the rapid development of regulation on
several fronts at once. And we understand that the
agency before us has far greater medical and public
health knowledge than do the lawyers who comprise
this tribunal. But we also understand, because we
have seen it happen time and time again, that action
Congress has ordered for the protection of public
health all too easily becomes hostage to bureaucratic
recalcitrance, factional infighting, and special interest
politics. At some point, we must lean forward from the
bench to let an agency know, in no uncertain terms, that
enough is enough.
Brock, 823 F.2d at 627 (emphasis added).
We conclude that now is such a time. While competing
policy priorities might explain slow progress, they cannot
justify indefinite delay and recalcitrance in the face of an
admittedly grave risk to public health. Although the agency
has commenced a rulemaking proceeding, we will
nonetheless grant the petition to review the inaction of the
United States Department of Labor as a predicate for our
necessary discussion of the remedy.
D. What is the Proper Remedy?
Public Citizen requests that we direct OSHA to issue a
proposed rule within 90 days, and to submit a schedule for
finalizing the rule within 12 months thereafter.[Public
Citizen Br. at 53.] Neither OSHA’s brief nor its recent
announcement contains a proposed timetable, but it insists
that Public Citizen’s proposed pace of rulemaking"is
unrealistic in light of the procedural, consultative, and
analytical duties that constrain OSHA rulemaking and the
historical time frames required for OSHA to develop a toxic
chemical standard." [OSHA Br. at 42.] For example, the
Regulatory Flexibility Act, 5 U.S.C. SS 601-12, requires it to
prepare a regulatory flexibility analysis if the rule will have
a "significant economic impact upon a substantial number
of small entities," a mandate this rulemaking is sure to
trigger. Also, the Small Business Regulatory Enforcement
25
Fairness Act, 5 U.S.C. S 609(b), requires it to convene a
review panel to address the rule’s potential impacts on
small entities. Finally, Executive Order 12866 requires that
OSHA submit its proposal, including a detailed economic
analysis, to the Office of Management and Budget, which is
to review it within 90 days.
While we are certain that the time for action has arrived,
we are cognizant of our lack of expertise in setting
permissible exposure limits, and we recognize the damage
that an ill-considered limit might cause. At oral argument,
we presented the parties with a somewhat novel possibility:
that they would submit to a course of mediation, conducted
by a senior judge of this Court, in which they might work
together toward a realistic timetable that we would then
enforce. Both sides stated their willingness to engage in this
process, and we think it the most promising way to develop
a reasonable and workable schedule. We are, however,
highly aware that this presents yet another opportunity for
potentially indefinite bargaining and delay. We will therefore
submit the matter to mediation for a period not to exceed
sixty days, after which time, if the parties have not reached
an accord, the panel will promulgate a schedule it deems
appropriate. We are pleased that our distinguished
colleague, Judge Walter K. Stapleton, has agreed to
undertake the mediation.
III. Conclusion
For the foregoing reasons, we hold that OSHA’s delay in
promulgating a lower permissible exposure limit for
hexavalent chromium has exceeded the bounds of
reasonableness. We therefore grant Public Citizen’s petition
to compel OSHA to proceed expeditiously with its
hexavalent chromium rulemaking. Deferring our specific
remedial order, we direct that the parties appear before
Judge Walter K. Stapleton for mediation for a period not to
exceed sixty days, following which, if the parties have not
agreed on a mutually satisfactory timetable, we will order
one of our own.
26
A True Copy:
Teste:
Clerk of the United States Court of Appeals
for the Third Circuit
27