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RISKY BUSINESS

FRANK MIRER, PhD, CIH,


Whats Science Got to Do with
is a professor in the CUNY School
of Public Health in New York.
He can be reached at (212) 396-7782
It?
or franklin.mirer@sph.cuny.edu.
BY FRANK MIRER

A
ccording to the Pew Research Center, a little less than half of Amer- graph. These texts are commented on
icans believe global warming is a result of human activity, although by the other members and the staff,
a few more concede that there may be warming from other causes. and then edited during a 10-day meet-
Some prominent opinion leaders have denounced global warming ing in Lyons, France, and conclusions
as a hoax. Meanwhile, a NASA website notes that upwards of 97 voted on. (Ive served on three working
percent of climate scientists believe warming by carbon forcing is a groups; the meeting is full-contact
fact. Its likely that the rest of the professoriate, in other disciplines, shares similar views. peer review.)
Working group members are active
researchers with knowledge of the
Within that super-consensus are many the classification of formaldehyde to exposures being considered. They
unsettled issues, notably how much known to be carcinogenic to humans. are mostly academics, but some are
will temperature rise and how fast. The full Monograph 88 was posted in from governmental research agencies.
Many science types (including me) 2006, noting sufficient evidence in All are free from conflicts of interest.
who believe that global warming is humans for certain upper airway can- None are compensated by IARC for
proven fact are Sunday drivers when cers, and strong but not sufficient evi- their time.
it comes to climate models or methods dence for a causal association between The Monograph 88 group also
of integrating temperature measure- leukemia and occupational exposure included an invited expert from the
ments into a central tendencywe to formaldehyde. The epidemiologi- Chemical Industry Institute of Toxicol-
have formed our opinions based on cal evidence was mainly the National ogy (CIIT). Invited experts are active in
simplified statements by authorita- Cancer Institute (NCI) cohort, which the relevant area but have conflicts of
tive scientific bodies. Once you have showed exposure-response for the interest. They participate in discus-
Science is what accepted the paradigm (see Thomas upper airway cancers and leukemia, sions in committees and plenaries but
scientists say it is. Kuhn), apparently contradictory phe- as well as some scattered studies dont write text or vote.
nomena, such as a polar vortex over showing an association with leuke- Also in 2004, a series of papers
the northeastern U.S., are explained mia in embalmers. The finding about spit-balling the IARC classification
away (correctly) rather than used to leukemia was important because leu- began to appear. These papers were
challenge the prior view. kemia is more prevalent than the upper sponsored by the Formaldehyde Coun-
Now I return to formaldehyde for airway cancers and therefore would cil. One was a complete reexamination
the third time. Risk assessment and translate into much higher observed of the NCI cohort based on the full
its application continue to evolve with carcinogenic potency and, hopefully, data set provided by NCI to a well-
EPAs December 2016 rule on testing much stricter controls. known university-based professor
formaldehyde emissions from compos- The IARC monograph program funded by the Formaldehyde Council.
ite wood products. Its worth assessing is generally considered the most This paper concluded no evidence of
the authority of the science behind this authoritative scientific opinion on the risk for formaldehyde at either cancer
rule by describing the processes of the carcinogenic potential of chemicals site. Additional sponsored mechanistic
International Agency for Research on and exposure circumstances. IARC studies questioned whether sufficient
Cancer (IARC), the National Toxicol- working group members are appointed inhaled formaldehyde was absorbed
ogy Program (NTP), and the National by the secretariat, which is in turn gov- into the blood to account for leukemia
Academy of Sciences (NAS). erned by the World Health Organiza- arising from bone marrow, although
tion, through a nomination-andpub- other independent studies identified
IARC REVIEWS lic-comment process. Working group genetic damage in circulating blood
In 2004, an IARC working group raised members write all parts of the mono- cells in exposed workers.

| April 2017 12
RISKY BUSINESS

Another IARC working group, in Reference concentrations absent was being tossed into limbo, NTPs sions limits are properly derived, we
2009, raised the classification of evi- from the 1991 assessment were 12th Report on Carcinogens (RoC) was have to question whether its suffi-
dence for leukemia to sufficient; also included. moving through its process. The NTP ciently protective. But, its something.
formaldehyde remained classified The NAS review of EPA's draft assessment concurred with IARC
as known to be carcinogenic, but the was released in 2011, dropping half and EPA by classifying formaldehyde SCIENTIFIC AUTHORITY
additional human tumor site was a bombshell on the process of pro- as known to cause cancer in humans, We can draw a few lessons from this
noted. The working group identified tections. Lost in industrys claims including both leukemia and upper narrative:
an NCI study of embalmers as sup- of vindication was the committees airway cancers. The RoC document First, authoritative scientific con-
port for reclassifying the evidence. conclusion that formaldehyde was was reviewed and approved before clusions are derived from institutions
correctly classified as known to release by an external committee governed by senior scientists and
EPA, NAS, AND NTP be a human carcinogen based on of scientists. (I submitted comments from processes that encompass
Under pressure from the Natural the upper airway cancers. But the to the review committee request- expert review. Science is what sci-
Resources Defense Council, EPA committee found that EPA did not ing they upgrade evidence for lung entists say it is.
moved forward with the formalde- properly support the association and cancer at least to limited; the com- Second, initial scientific skepti-
hyde risk assessment for its Inte- quantitative assessment for leuke- mittee declined to mention this.) cism about whether formaldehyde
grated Risk Information System mia. The result was a reset back to Congress responded by demanding inhalation causes leukemia (based
(IRIS). In 2009, then-Senator David the 1991 risk assessment, pending and funding another review by the on epidemiology) has become a
Vitter, R-La., pressured EPA into a new process to respond to the NAS NAS. In contrast with the 2011 NAS minority position, although its not
referring the risk assessment to critique. report on the IRIS risk assessment, a denialist position. Most skeptics
NAS for an additional review before The NAS, our highest authority on the 2014 NAS report on the NTP have industry funding.
it could be published. An IRIS risk policy for science-related issues, is classification clearly supported the Finally, a political process contin-
assessment has no immediate reg- a group of hundreds of senior sci- evaluation of evidence for leukemia ues to delay the incorporation of the
ulatory effect, but industry feared its entists elected by present mem- and the classification as known. majority scientific opinion into the
potential impact. bers. The membership also elects The 2016 formaldehyde emis- EPA risk assessment for formalde-
The IRIS process involves EPA leadership positions in the National sions rule is based on quantitative hyde. Therefore, a rare exercise in
staff compiling extensive litera- Research Council, a nonprofit orga- risk estimates from the 1991 IRIS public health protection under the
ture regarding the chemical and nization that provides advice, usually assessment. Therefore, if we accept Toxic Substances Control Act, just
making recommendations, fol- to governmental agencies or Con- the scientific authority in the history promulgated, is based on a 1991
lowed by internal scientific review, gress. NAS reports are written by above and assume that the emis- assessment.
public comment, and response to committees whose members are
comments, and culminating with selected by NRC staff after nomina-
a final cancer potency estimate tions and a commenting process. The
RESOURCES
and a reference concentration for committees comprise an academy EPA: Formaldehyde Emissions Standards for Composite Wood Products, http://bit.ly/compositewood.
non-malignant effects. Some EPA member and selected scientists,
Journal of the National Cancer Institute: Mortality from Lymphohematopoietic Malignancies and Brain Cancer
staff conduct original research in including those not directly involved
Among Embalmers Exposed to Formaldehyde (December 2009).
areas relevant to the IRIS review in the policy question. Their reports
NASA: Scientific Consensus: Earths Climate Is Warming, http://bit.ly/earthwarming.
and publish in peer-reviewed jour- are reviewed within the academies
nals. The risk assessment in EPAs and by outside reviewers. Commit- National Resources Defense Council: The Delay Game: How the Chemical Industry Ducks Regulation of
2010 draft included a cancer slope tees typically hold public meetings Toxic Substances, http://bit.ly/delaygame (PDF, October 2011).
factor based on epidemiology that to receive comments. Committee NTP: 14th Report on Carcinogens (2014).
was five times greater than the 1991 members are not compensated. Pew Research Center: Public Views on Climate Change and Climate Scientists, http://bit.ly/climate
value derived from laboratory data. As the 2010 EPA IRIS assessment scientists (October 2016).

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