Sudakin, Veritox Principal, ACTM on the errors of the IOM report

[Guest guest]

This is getting almost sad. Here is Dr. Sudakin inferring the IOM report

does not know what they are talking about when they write that one cannot take

a rodent study, apply math and deduce all human illness is not plausible.

Before you read this, here is the under oath testimony of another Veritox

principal, Bruce Kelman discussing the IOM and the ACOEM and how they are

consistant.

Kilian, to cite just one example of this. Kelman indicated in his testimony

that the ACOEM Mold Statement was supported by the Institute of Medicine,

Damp Indoor Spaces Report (IOM Report), which was published in May, 2004.

Regarding the IOM Report, Kelman was asked " And are there conclusions drawn by

the authors and researcher of Exhibit 90, the National Academy of Science

Institute of Medicine publication, that are consistent with the positions that-

and the position paper that you published with Dr. Saxon for the American

College of Occupational and Environmental Medicine? " Kelman answered,

" They’re

_certainly consistent_

(aoldb://mail/write/exhibits/pg%2016%20Kelman%20says%20IOM%20Acoem%20Consistant.\

tif) . * I think this is broader. "

Guess not, huh?

AMERICAN COLLEGE OF MEDICAL TOXICOLOGY COMMENT:

INSTITUTE OF MEDICINE REPORT ON DAMP INDOOR SPACES AND HEALTH

The American College of Medical Toxicology (ACMT) is a professional society

composed of physician toxicologists who focus on the diagnosis, management and

prevention of acute and chronic health effects due to medications,

chemicals, occupational and environmental toxicants, and biological hazards.

The ACMT

has reviewed the Institute of Medicine (IOM) report on Damp Indoor Spaces

and Health,(1) and has prepared additional background and comments relating to

this document. The ACMT considers this review to be valuable, because the

IOM committee did not include input from physicians with training and board

certification in the subspecialty of medical toxicology.

The ACMT commends the IOM for recognizing that damp indoor spaces present

health risks to humans, in association with allergic mechanisms resulting from

fungi, dust mites, bacteria, cockroach, and possibly other antigens that

proliferate in moist environments. The ACMT concurs with the IOM that

residences, schools, offices, and other buildings should be designed to prevent

water

intrusion, and that when water damage or chronic moisture is identified it

should be remediated as soon as possible.

While the allergic effects of fungi are well-summarized in the IOM report,

there are still a number of misperceptions relating to mycotoxins or other

chemicals produced by certain species of fungi, and their role in adverse

health

effects from exposures in water-damaged buildings. Although several

epidemiological studies of building-related illness have implicated mycotoxins

as a

cause of health effects in water-damaged environments, their interpretation

is complicated by limitations in their study design, exposure and dose

assessment methods, and confounding effects. In fact, these issues have cast

doubt

on the causative role of inhaled mycotoxins for any toxic health effects in

the indoor residential environment. (2-5)

The ACMT believes that an improved understanding of the role of mycotoxins

in damp indoor spaces should begin by acknowledging that both fungi and their

mycotoxin prodcuts are ubiquitous in the outdoor environment. Human exposure

to fungi can occur from contact with the soil as well as outdoor air, where

fungal spores are normally present in much higher concentrations than indoor

environments (with seasonal variability, e.g. cold, snow). Epidemiological

studies of mold in indoor environments should include appropriate comparisons

with outdoor air, and studies should be designed to consider our aggregate

and cumulative exposure to fungi and mycotoxins from indoor and outdoor

environments.

The ACMT would like to emphasize the importance of distinguishing exposure

to mycotoxins from exposure to the fungi that are capable of producing them.

Toxigenic fungi and mycotoxins are not synonymous hazards. It is well

established that for many fungal species, the production of mycotoxins is

significantly influenced by genetics and the environmental conditions of their

growth.

The isolation of a toxigenic fungal species in the environment does not

necessarily indicate that mycotoxins are also present, or that they are present

at doses that pose health risks from environmental exposure. For this

reason, if epidemiological studies of damp indoor spaces are to include

hypotheses

relating to mycotoxins, then exposure assessment methods should utilize

validated techniques to detect and quantify mycotoxins directly in

environmental

samples. The interpretation of such environmental measurements should consist

of a plausible, complete exposure pathway and an assessment of the

dose-response relationship.

The ACMT would also like to emphasize the importance of acknowledging that

the diet is the most important source of human exposure to mycotoxins. The

vast majority of scientific data on the adverse health effects of mycotoxins is

derived from their presence as natural and unavoidable contaminants of foods

and beverages that are consumed as part of a healthy diet. Mycotoxins of

known dietary importance include aflatoxins (in corn, ground nuts, and dairy

products), trichothecenes (in corn, cereals and fermented beverages) and

ochratoxins (in coffee, wine, and dried fruits). Risk assessments have been

conducted for several mycotoxins that are of relevance to human health,(6) and

these

studies should be used as a benchmark for interpreting the relative role of

exposures occurring from other sources and pathways in addition to dietary

ingestion.

With respect to mycotoxins in indoor air, exposure modeling studies have

concluded that even in moldy environments, the maximum inhalation dose of

mycotoxins is generally orders of magnitude lower than demonstrated thresholds

for

adverse health effects.(3,7,8) The results of human studies in agricultural

environments provide additional consistency for this finding, demonstrating

that in moldy environments inhalation exposure to mycotoxins results in a dose

that is far less than what is normally encountered from dietary

exposure.(9,10) Studies that quantify human exposure utilizing validated

biomarkers as

indicators of internal dose will provide additional information to assess

cumulative exposure to mycotoxins. There have been significant advances in the

research on biomarkers of exposure to important mycotoxins,(11-13) and the ACMT

recommends that future studies utilize these methods in the assessment of the

dose-response relationship.

The ACMT is aware of other types of clinical laboratory tests that have

recently been utilized in epidemiological studies of damp indoor spaces,

including “mycotoxin antibody testing.†Identification or measurement of

antibodies

to mycotoxins, rather than biomonitoring of mycotoxins directly, is not an

accepted method to assess human exposure. This method has not been validated

in well-designed epidemiological studies, and is not recommended for the

assessment of human exposure to mycotoxins.(14) Fungal immunoassay tests

(including immunoglobulin testing for IgG and IgE) can be clinically useful in

the

assessment of immunological conditions from exposure to fungal antigens

(including common allergies and hypersensitivity pneumonitis), but they do not

provide any information about exposure to mycotoxins and therefore they have no

role in exposure assessment in this context. The American Academy of Asthma,

Allergy, and Immunology (AAAAI) has addressed some of these issues in their

recent position statement on health effects from mold exposure (15).

In comparison to the low-level indoor exposures of general public concern, a

syndrome known as Organic Dust Toxic Syndrome (ODTS) has been described in

association with microbial exposures in agricultural environments, consisting

of fever, malaise, myalgia, headache, dyspnea, chest tightness, dry cough,

and nausea.(16) While the pathogenesis of this transient condition is not

well-understood, it has been hypothesized to develop from acute inhalation

exposure to high concentrations of bacterial endotoxins, fungal mycotoxins, and

possibly other cellular components of microorganisms that proliferate in

agricultural environments. The epidemiology of this disorder is uncertain, but

the

levels of microbial exposure that have been measured in association with its

occurrence are generally orders of magnitude greater what has been measured in

moldy home, school, or office environments. It should be noted that

symptoms from ODTS are transient in nature, and generally resolve within hours

to

days from the time of acute exposure. There is no documented evidence that i

nhalation exposure to fungi or mycotoxins in indoor environments causes a

chronic toxic encephalopathy.

Similarly, the role of volatile organic compounds produced by mold (mVOCs),

and responsible for the musty odor, can be addressed from a toxicological

perspective. In sufficient dose, mVOCs can produce transient irritive symptoms

and subjective complaints such as nasal and eye discomfort, headache and

dizziness. However, the concentrations of mVOCs produced by mold in indoor

spaces

are very low, on the order of nanograms to micrograms per cubic meter or

part per billion (ppb) range (17). On the other hand, the levels that can

induce

sensory irritation are in the milligram per cubic meter (mg/m3) or parts per

million (ppm) range in the air (18). Additionally, volatile organic

compounds are volatile, thus having short environmental half-lives (minutes to

hours), and their effects are transient. In cases where individuals complain of

persistent neurological, cognitive, or non-specific symptoms week or months

after the putative exposure, these symptoms should not be attributed to

irritant

effects; other causes should be sought.

In conclusion, the ACMT generally concurs with the IOM’s assessment of the

relationship between damp indoor spaces and human health effects. The ACMT

recommends that public health responses to damp indoor spaces be based upon

what is known and generally accepted with respect to their association with

allergic disease. Public health responses should not be solely based upon the

presence of fungi or mycotoxins, because from a toxicological perspective, the

available scientific evidence does not provide any compelling data to

conclude that they pose significant health risks via inhalation in these

settings.

The risks from inhalation exposure are minimal in comparison to other sources

and pathways, including the diet, which in themselves are rarely of health

consequence in the United States. Furthermore, the use of unapproved

diagnostic studies and therapeutic modalities based on unproven infection or

mold-related toxicity (as opposed to allergic phenomena) are medically

inappropriate

and costly.

Reference List

(1) Institute of Medicine, Committee on Damp Indoor Spaces and Health.

Damp Indoor Spaces and Health. Washington, D.C: National Academies Press; 2004.

_http://www.nap.edu/books/0309091934/html/_

(http://www.nap.edu/books/0309091934/html/)

(2) Update: Pulmonary hemorrhage/hemosiderosis among infants--Cleveland,

Ohio, 1993-1996. MMWR Morb Mortal Wkly Rep 2000 March 10;49(9):180-4.

_http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4909a3.htm_

(http://www.cdc.gov/mmwr/preview/mmwrhtml/mm4909a3.htm)

(3) American College of Occupational and Environmental Medicine. Evidence

Based Statement: Adverse Human Health Effects Associated with Molds in the

Indoor Environment. 2002. _http://www.acoem.org/guidelines/article.asp?ID=52_

(http://www.acoem.org/guidelines/article.asp?ID=52)

(4) Fung F, RF. Health effects of mycotoxins: a toxicological

overview. J Toxicol Clin Toxicol 2004;42(2):217-34.

(5) Page EH, Trout DB. The role of Stachybotrys mycotoxins in buildings

related illness. AIHAJ 2001 September;62(5):644-8.

(6) Food and Agriculture Organization/ United Nations Expert Committee on

Food Additives. Safety evaluation of certain mycotoxins in food. Geneva:

World Health Organization; 2001.

(7) Kelman BJ, Robbins CA, Swenson LJ, Hardin BD. Risk from inhaled

mycotoxins in indoor office and residential environments. Int J Toxicol 2004

January;23(1):3-10.

(8) Islam Z, Harkema JR, Pestka JJ. Satratoxin G from the black mold

Stachybotrys chartarum evokes olfactory sensory neuron loss and inflammation in

the murine nose and brain. Environmental Health Perspectives. [online Feb 27,

2006] Available at http://dx.doi.org/10.1289/ehp.8854.

(9) Halstensen AS, Nordby KC, Elen O, Eduard W. Ochratoxin A in grain

dust--estimated exposure and relations to agricultural practices in grain

production. Ann Agric Environ Med 2004;11(2):245-54.

(10) Skaug MA. Levels of ochratoxin A and IgG against conidia of

Penicillium verrucosum in blood samples from healthy farm workers. Ann Agric

Environ

Med 2003;10(1):73-7.

(11) Gilbert J, Brereton P, Mac S. Assessment of dietary exposure to

ochratoxin A in the UK using a duplicate diet approach and analysis of urine

and plasma samples. Food Addit Contam 2001 December;18(12):1088-93.

(12) Meky FA, PC, Ashcroft AE, JD, Qiao YL, Roth MJ, Wild

CP. Development of a urinary biomarker of human exposure to deoxynivalenol.

Food Chem Toxicol 2003 February;41(2):265-73.

(13) Young CL, Sclafani AG, Croley TR, Lemire SW, Barr JR. Simultaneous

detection of trichothecene mycotoxins in human urine by LC-APCI/MS/MS.

Abstracts

of Papers, 229th ACS National Meeting, San Diego, CA, United States, March

13-17, 2005.

(14) Centers for Disease Control and Prevention. Case Definitions for

Chemical Poisoning. 2005 Jan 14. Report No.: 54(RR01).

_http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5401a1.htm_

(http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5401a1.htm)

(15) Bush RK, Portnoy JM, Saxon A, Terr AI, Wood RA. The medical effects

of mold exposure. Journal of Allergy Clinical Immunology

2006;117(2):326-333.

(16) Seifert SA, Von ES, itz K, Crouch R, Lintner CP. Organic dust

toxic syndrome: a review. J Toxicol Clin Toxicol 2003;41(2):185-93.

(17) Claeson AS, Levin JO, Blomquist G, Sunesson AL. Volatile metabolites

from microorganisms grown on humid building materials and synthetic media.

Journal of Environmental Monitoring. 2002;4(5):667-72.

(18) Doty RL, Cometto-Muniz JE, Jalowayski AA, Dalton P, Kendal- M,

Hodgson M. Assessment of upper respiratory tract and ocular irritative effects

of volatile chemicals in humans. Critical Reviews in Toxicology

2004;34(2):85-142.

Prepared by the ACMT Practice Committee. Primary authors: Sudakin and

Tom Kurt

Disclosure forms on file at ACMT

Last reviewed June 2006