Letters
Integrity of Scientific Evaluations of Government Agencies
To the Editor:—I don’t believe I “known human carcinogen,” and guage evolved, but rather than
have ever flinched from an oppor- OSHA had never stated that “BD relive old memories I will simply
tunity to denounce efforts of indus- causes an increased risk of” specific point out that even had OSHA’s
try or of government (singly or in cancers (contrary to p. 373 of Dr. strongest statement been “proba-
cahoots) to distort science so as to Infante’s article). To be sure, there ble” in 1996 (that is, had all the
trivialize environmental or occupa- remain subtle inconsistencies more definitive statements not also
tional health hazards. Indeed, such within the Preamble to the final been made), that would simply
advocacy recently caused me to standard in how OSHA describes have placed it in the same position
leave government service as a “vin- the evidence for BD’s carcinogenic- that EPA, NTP, and IARC all held at
dicated whistleblower.”1 But not all ity. There are indeed three that time.
discussions between regulators and reg- instances (in a 120,000-word rule- But all such speculation misses
ulated parties result in distortion or making document) where OSHA the point. OSHA does not classify car-
malfeasance : sometimes quite the describes BD as a “probable” cinogens via its rulemaking processes
opposite, as the actual events human carcinogen (note the the or anywhere else—scientific heavy-
around OSHA’s 1,3-butadiene unwarranted phrase “possibly car- weights such as EPA and NTP do so.
(BD) standard prove. I offer these cinogenic to humans” in the first As OSHA’s voting representative on
comments on Dr. Infante’s recent sentence of Dr. Infante’s abstract the nine-member NTP Executive
article2 (IJOEH, 11: 372-377) not appears nowhere in the BD docu- Committee, I was pleased in 1998 to
from an ideological stance to his ment), but OSHA made various offer my Agency’s official position
“right” (welcoming compromise stronger statements as well. In par- on BD’s carcinogenicity, casting one
that might lessen worker protec- ticular, the reader should consider of the votes with the majority to
tion), but from the view that worker the three instances of the language upgrade BD to “known” status. So
protection is more important than “OSHA has concluded . . . that actually, this tale of purported
(and can be undermined by) mere occupational exposure to BD is industry influence on the OSHA
indignation. Dr. Infante’s account associated with an increased risk of Preamble wouldn’t be particularly
misses the mark in three major death from cancers of the lympho- compelling even if it had happened
respects: 1) it presents a jaundiced hematopoetic system,” and espe- as Dr. Infante recounts—any “influ-
account of negotiations that the cially the table (V-4; “Evidence That ence” was short-lived indeed.
author did not participate in; 2) it BD Is a Human Carcinogen”) show- The phantom “downgrading” of
neglects to mention an array of ing OSHA’s analysis that BD meets BD is not the only aspect of Dr.
benefits that the BD regulation all seven out of seven criteria for Infante’s article that confuses the
conferred—many of which arose causality in humans. record on this rulemaking. Space
during the very discussions the Anyone is of course free to spec- does not permit a full accounting,
author decries—and thus it misrep- ulate whether this lack of perfect but consider the following: 1)
resents an unambiguous victory for uniformity was due simply to care- OSHA staff were not “fearful”
worker protection as somehow lessness, to OSHA’s desire to blur about disapproval by the Office of
tainted; and 3) it fails to direct its the appraisal in the hopes that Management and Budget (OMB),
outrage where it belongs—at others would latch onto the as we knew there would be no such
OSHA’s subsequent failure to stronger characterizations of BD review—the estimated costs of the
enforce a strong standard that (thus outsmarting the industry BD standard ($2.9 million/year)
industry had accepted without negotiators), or to blur it in hopes were vastly below the threshold
court challenge. that only the “lowest common ($100 million/year) at which OMB
1. Most importantly, it is simply denominator” would be remem- considers a regulation “economi-
false that OSHA “downgraded its bered. As OSHA’s primary decision cally significant” and subject to its
carcinogen classification” for BD, maker in the BD negotiations with review authority; 2) to the extent
either in response to industry pres- industry, labor, and our own that “career civil servants” may have
sure or for any other reason. Nei- Department of Labor (DOL) been “demoralized” by real or
ther the 1990 proposed rule nor lawyers, I know first-hand how the imagined discussions between
the 1996 final rule used the term preamble and regulatory-text lan- OSHA and outside stakeholders, I
128
think it important to note that all of crusading civil servants were willing OSHA civil servants to rejoice in
the federal participants in the final to settle for (2 ppm) before the out- having fulfilled the Agency’s core
discussions with industry and labor side stakeholders rescued a process mission and having laid the
on BD were themselves career civil that Dr. Infante correctly describes groundwork for more stringent
servants—the political appointee to as “dormant” between 1991 and future standards comporting with
whom I reported made no attempts 1995. If industry had offered me a Benzene, not to dream up new rea-
to influence me regarding BD, and BD standard this stringent and sons to be “demoralized.”
I have no reason to suspect the innovative in return for a few adjec- I do agree with Dr. Infante that
same was not also true of my career tival changes in the Preamble, I the public is likely to be more con-
counterpart in the DOL Solicitor’s would have rushed to make this cerned when scientists make pre-
Office; and 3) OSHA’s decision to offer irrevocable, but that’s not the dictions about specific types of can-
rely on toxicology rather than epi- way it happened. cers avoided rather than about
demiology for its quantitative risk Moreover, having not been pres- “general cancer deaths avoided
and benefits estimates was wholly ent during the final discussions, Dr. based upon animal studies.” How-
unrelated to any deliberation about Infante neglects to mention several ever, I see this is as an indictment of
“known” versus “probable”—we significant changes OSHA seized risk communication in general, not
simply did not want to rely on a the opportunity to insist upon in as a sensible indictment of the
then-unpublished human study3 the regulatory text and Preamble, OSHA risk assessment for BD.
whose quantitative interpretation each of which made the BD stan- Rather, given the high correlation
was at the time controversial dard even more worker-protective between known animal and known
because of concerns about uncer- than the industry–labor agreement human carcinogens, and the rela-
tainty in the exposure estimates, contemplated! We added more tively poor power of epidemiology
especially given that we computed stringent monitoring requirements to tease out signal from noise—
the risk estimates from that study as (employers must redo all initial and especially when the tumor type
“concordant” with (but not larger periodic monitoring whenever sig- involved is common to begin
than) the animal-based estimates nificant production, process, or per- with—we all ought to make less of a
we ultimately relied upon. sonnel changes occur), imposed a fetish about “known” being all that
2. Readers incensed by adjec- stricter schedule requiring replace- different from “probable.” OSHA
tives in the Preamble that explains ment of respirator cartridges sev- could have done more to empha-
the BD standard might wish to con- eral times per workshift, and set a size that many EPA Group B car-
sider the tangible benefits to major precedent by changing the cinogens may well be “known
worker health contained in the generic medical surveillance provi- human carcinogens which epidemi-
enforceable regulatory text itself, sions to allow non-physicians work- ology cannot detect,” but that is a
which no one alleges was weakened ing within the scope of their state lapse common to all our standards
in any way as a result of discussions licensures to perform procedures and to the field as a whole.
among the parties. Indeed, it was that only physicians could do under 3. As a former OSHA chief reg-
only the fact of face-to-face discus- previous OSHA health standards ulator and Regional Administrator,
sions about details of the Preamble (we used the same language in the I am much less concerned about
that provided OSHA a venue to fur- subsequent methylene chloride government officials involving
ther strengthen what was already an and respirator standards, winning a industry in developing standards
unusually stringent health stan- lawsuit brought by the American than I am about their ignoring
dard. Before the final discussions, College of Occupational and Envi- industry when it comes time to
the assent of the affected industry ronmental Medicine in the latter enforce standards. OSHA failed to
and labor negotiators had paved case). Perhaps most far-reaching develop a single new health stan-
the way for the lowering of the per- was another change to the Pream- dard between 1998 and 2006, when
missible exposure limit (PEL) for ble that Dr. Infante also fails to it was compelled by court order to
BD from 1,000 ppm to 1 ppm, and mention: the first explicit policy produce a hexavalent chromium
produced the first health standard statement since the 1980 Benzene standard, one that declares the
in OSHA history to require specific decision that a lifetime excess risk “mission accomplished” with an
control technologies (e.g., leak-pre- of 10–3 is “the uppermost end of the estimated (lower bound!) excess
vention devices, double-sealed million-fold range suggested by the lifetime cancer risk of more than 1
pumps) even if firms could [Supreme] Court, somewhere in 100 at the new exposure limit.
approach the action level of 0.5 below which the boundary of Meanwhile, as part of a broad
ppm without them. The effective acceptable versus unacceptable risk retreat from enforcing its existing
PEL after installation of these must fall.” So at least at the time it occupational health standards,
mandatory technologies was thus was promulgated (see below), the OSHA has essentially stopped look-
far lower than the limit OSHA’s BD standard was an occasion for ing for BD overexposures and
VOL 13/NO 1, JAN/MAR 2007 • www.ijoeh.com Letters • 129
other possible violations of the stan- LaDou before publication, with no favorable to governmental regula-
dard. Data from OSHA’s industrial impact on the original article. I tions than the administrations that
hygiene database show that pointed out, to no avail, that Dr. immediately preceded and fol-
between 1985 and 1995, at a time Infante’s only “documentation” for lowed it, the compromise regard-
when the PEL for BD was 1,000 his version of events that occurred ing the cancer evidence arose as
ppm and citations for overexpo- in a meeting he did not attend was discussed in my article. The regu-
sures would have been well-nigh a 1996 self-authored memorandum lated industries today have much
impossible, OSHA inspectors took to me (his reference 23) that I more influence behind the scenes
an average of about 30 BD samples promptly rebutted to at the time. I than they did at the time of my
per year nationwide. This is of venture to say that those of us who arrival at the Agency in 1978.
course a rather small number, but it are proud to be “progressives” This outside influence goes
dwarfs the number of samples often react with scorn at “vanity beyond the 1,3-Butadiene (BD)
taken after the new standard came journals” that favor papers espous- Standard and takes its toll primarily
into effect and the chances of find- ing a particular ideology regardless on the health of blue-collar work-
ing citable overexposures would of technical accuracy, and that snub ers.2 It also takes a toll on the psy-
only have grown. In 1999 (the last peer reviewers—even those with chological health of career civil ser-
year for which I currently have special expertise or first-hand vants, who are sometimes asked to
data, pending the resolution of a knowledge—as offering merely “a downplay the evidence of health
FOIA lawsuit I have filed against disagreement over policy.” It is dis- hazards, or to modify provisions of
OSHA), OSHA took only two sam- heartening when “our side” does standards that are considered by
ples for BD nationwide! I cannot not hold itself to a higher standard professional staff as necessary for
discern from available data when of peer review. the ultimate protection of workers.
OSHA last issued a citation of any These modifications are made in
kind under the BD standard, but I ADAM M. FINKEL, SCD, CIH order to appease the regulated
can say that no such citations were Professor of Environmental and industries prior to the publication of
issued during 2004 and 2005, and Occupational Health official governmental regulations.
that analysis of the roughly 90 UMDNJ School of Public Health With regard to BD, while I was
inspections conducted nationwide (Director of Health Standards not involved directly in the negotia-
since 1997 in the synthetic rubber Programs, OSHA, 1995–1999) tions leading up to the develop-
production sector reveals not a ment of the Final BD Standard, I
single citation under this standard. References am aware of the history of OSHA’s
Industry may be in complete com- scientific evaluation of the carcino-
1. Business Week. 2005; May 2: 40-1.
pliance with all aspects of this stan- 2. Infante PF. Safeguarding scientific evalu- genicity of BD. Dr. Finkel is correct
dard, but that would be “out of the ations by governmental agencies: case in stating that nowhere in the BD
study of OSHA and the 1,3-butadiene
goodness of its heart” given classification. Int J Occup Environ
Proposal of 1990, or in the Final BD
OSHA’s enforcement posture. And, Health. 2005;11:372-7. Standard published in 1996, does it
to the extent that industry might 3. Delzell E, Sathiakumar N, Hovinga M, et state that BD “causes an increased
al. A follow-up study of synthetic rubber
wish to downplay the cancer poten- workers. Toxicology. 1996;113(1–3):182-9.
risk of” specific cancers. However,
tial of BD, or any other substance, the preamble to the Final BD Stan-
by adding exculpatory language to dard in September 1996, just prior
the material safety data sheet In reply:—My article1 under- to its publication, stated that BD
(MSDS)—a document workers may scores the difficulty in developing “causes an increased risk” of specific
actually read, as opposed to an health standards. From my 24 years cancers. Thus, Dr. Finkel’s state-
OSHA Preamble—they will not be of experience (1978–2002) in the ments conceal the fact that the pre-
dissuaded by OSHA’s extreme Directorate of Health Standards at amble to the Final BD Standard was
reluctance to issue citations for mis- OSHA, first as Director of the changed after industry representa-
leading MSDS language. I respect- Office of Carcinogen Identification tives reviewed the preamble to the
fully suggest that these aspects of and Classification and then as Final BD Standard in September
the BD saga would have made a Director of the Office of Standards 1996, just prior to its publication.
much more compelling and for- Review, I have witnessed a steady As the senior epidemiologist in
ward-looking paper than the one decline in the independence of the Directorate of Health Stan-
IJOEH published. agency staff in the evaluation of dards and the direct supervisor of
Finally, and with a high degree cancer and other diseases related to the epidemiologist who had
of respect for the contributions of occupational exposures. Even in responsibility for evaluating all of
IJOEH to science and public policy, the relatively best of times from the the epidemiologic evidence related
I note that I raised all of the points standpoint that the Clinton Admin- to BD, I was involved in the evalua-
above with Dr. Infante and with Dr. istration in philosophy was more tion of the epidemiologic data,
130 • Letters www.ijoeh.com • INT J OCCUP ENVIRON HEALTH