July 2009

– OEL for formaldehyde Policy and Res earch Division Page 1 of 69 

### Occupational Exposure Limits for Formaldehyde

1

. BACKGROUND

At the March 2007 Board of Directors (―BOD‖) meeting, the Policy and Research
Division (―PRD‖) received approval to release the Discussion Paper on the occupational exposure limits for f ormalde hyde for consultation (attachment 1) . As well, the BOD, at their July 2007 meeting, directed the PRD to :

(a) Obtain a formal recommendation from the Occupational Exposure Limit Review Committee (―OEL Review Committee‖) on the OELs for formaldehyde; and

( b ) Obtain an independent peer reviewer to evaluate whether the summary of the health effects contained in the discussion paper accurately reflects the health risks to workers, particularly at exposure levels between American Conference of
Governmental Indust rial Hygienists (―ACGIH‖) T LVs and the current BC OELs.

( c ) R eturn with the results of the public consultation on the discussion paper

.

T he results of the above requests are set out below

.

2

. SUMMARY OF HEALTH EFFECTS FROM SCIENTIFIC LITERATURE REVIEW

Ba sed on a comprehensive review of available health studies, the weight of scientific
evidence indicates that workers will not experience any adverse health effects at th e current BC OELs. There is no evidence that formaldehyde is a cytotoxin, mutagen,

geno toxin, carcinogen, reproductive or developmental toxin, or causes other short or long term adverse health effects at the current BC OELs

.

Cytotoxicity (damage to the cells and tissues of the eyes, nose and throat)

 The weight of evidence indicates that cytotoxic effects

– including chemosensory irritation of the eyes, nose and throat

– do not occur at current BC OELs for formaldehyde.

Mutagenic ity

/ Genotoxicity (damages DNA)

 The weight of evidence indicates that formaldehyde is not mutagenic or genoto xic to humans at current BC OELs for formaldehyde.July 2009

– OEL for formaldehyde Policy and Res earch Division Page 2 of 69



### Carcinogenicity (cancer

- causing)

 The weight of evidence indicates that formaldehyde is not carcinogenic to humans at current BC OELs for formaldehyde.

Reproductive / Developmental Toxicity ( adverse eff

ects to the reproductive system / fetal development)

 The weight of evidence indicates that formaldehyde is not associated with reproductive or developmental toxicity at current BC OELs for formaldehyde.

Figure 1 below is a summary of the non

- adverse and adverse health effects of formaldehyde . The weight of evidence indicates that:

 1.0 ppm

– the irritant detection threshold

– is the dividing line between adverse
and non

- adverse health effects;

 Below 1.0 ppm, adverse health effects are not observed; the odour is detectable but not considered annoying or irritating;

 Adverse health effects commence with chemosensory irritation of the eyes and nose at formaldehyde levels at 1.0 ppm or above, followed by cytotoxic effects at around 3 ppm (cell and tissue da mage) and an increased potential for genotoxic and carcinogenic effects at levels in excess of 6 ppm;

 BC‘s current 8

- hour TWA of 0.3 ppm is well below levels capable of causing adverse health effects and protects the worker from the pungent, unpleasant

o dour of formaldehyde.

 BC‘s current Ceiling Limit of 1.0 ppm protects the worker from brief peak exposures to the chemosensory irritating effects of formaldehyde.July 2009

– OEL for formaldehyde Policy and Res earch Division Page 3 of 69 Figure 1 :

Summary of the non

- adverse and adverse health effects of formaldehyde in relat ion to the current WCB occupational exposure limits



### 3

. OEL REVIEW COMMITTEE’S RECOMMENDATION

WorkSafeBC‘s OEL Review Committee, comprised of subject matter experts, met on July 19, 2007 to obtain formal endorsement for the occupational exposure limi ts for formaldehyde. Based on the revi ews of health effects in the scientific literature , the OEL Review Committee unanimously supported the option to retain the current OEL
of an 8

- hour TWA limit of 0.3 ppm and a Ceiling l imit of 1.0 ppm. They also agre e d
that there are no adverse health effects at the BC OELs

.July 2009

– OEL for formaldehyde Policy and Res earch Division Page 4 of 69



### 4

. PEER REVIEW

The PRD retained a peer reviewer, Professor Adolf Vyskocil

, of the Department of
Environmental and Occupational Health at the University of Montréal, Québec.

Dr

. Vyskoc il is a world recognized expert in the fields of occupational hygiene, health and chemistry and has authored over 350 scientific papers on the health effects of
chemical substances.

The peer reviewer was asked to:

 review the scientific literature on health effe cts of formaldehyde at levels
between the current BC OELs and the ACGIH TLV s ; and

 review the health effects as stated in the Discussion Paper to ensure they accurately reflect what is stated in the scientific literate.

The peer reviewer confirmed that the summary of health effects outlined in the Discussion Paper accurately reflects the health risks to workers for the following
effects:

 Cytotoxicity

 Mutagenicity

/Genotoxicity

 Carcinogenicity

 Reproductive toxicity, and

 Sensitization.

His summary and co nclusions of toxicokinetic and health effects is very similar to the summary presented in the Discussion Paper. He reiterates the fact that if the respiratory tract is not repeatedly exposed to levels that cause cellular or tissue damage (cytotoxic effect s), exposure to low, non

- cytotoxic concentrations of formaldehyde at the current BC OELs represents a negligible risk of cancer. The peer reviewer confirmed that there is no conclusive evidence that formaldehyde is a genotoxin, carcinogen, reproductive o r developmental toxin, or causes other long
term health effects at the current BC OELs.

The peer reviewer also suggested that additional information be reviewed on threshold levels of eye and nasal irritation. As suggested, the scientific literature on

o dour detection and chemosensory irritation was re

- examined. Two recent scientific reviews (by Lang et al, 2008 and Noisel et al, 2007) were also obtained that looked at human exposures to formaldehyde. They concluded that odour detection/perception is con sidered a non

- adverse health effect; adverse health effects commence with eye chemosensory irritation at the threshold level of 1.0 ppm followed by increased adverse health effects around 3 ppm including cell and tissue damage, and the potential for cancer

- induction at formaldehyde levels in excess of 6

ppm.July 2009

– OEL for formaldehyde Policy and Res earch Division Page 5 of 69



### 5

. STAKEHOLDER FEEDBACK ON THE DISCUSSION PAPER

The PRD received 14 responses to the Discussion Paper from stakeholders

.

The majority (10 ) supported retaining the current OELs of 0.3 ppm 8

- hour TWA a nd Ceiling limit of 1.0 ppm. Four responses supported adopting the ACGIH Ceiling limit of 0.3 ppm.

Stakeholders who supported retaining the current limits were industry / employer representatives who believe that lowering the OELs to the ACGIH TLV woul d have significant negative impacts and cause closure of BC‘s forest products industry dependent o n formaldehyde

- based adhesives without any corresponding health
benefit.

Stakeholders who supported lower ing current formaldehyde limits to match those of the ACGIH were worker representatives who believe workers must be protected with the lowest possible exposure limits.Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 6 of 69 

## DISCUSSION PAPER

1. TITLE AND DATE

Changes to the Occupational Exposure Limit s for F ormaldehyde

2. ISSUE

WorkSafeBC (―WCB‖) is con sidering whether to adopt the American Co nference of Governmental Industrial Hygienists (―ACGIH‖) Threshold Limit Value ( ― TLV ‖ ) for formaldehyde

3. BACKGROUND

In general, while occupational exposure limits (―OELs‖) are established according to the
TLVs a dopted by the ACGIH, WorkSafeBC has the authority, in accordance with the provisions of section 5.48 of Occupational Health & Safety Regulation (― OHSR ‖), to develop OELs for specific chemical substances that differ from the ACGIH TLVs. The
excluded substa nces were listed in Prevention Policy R5.48

- 1 for the following reasons:

 The OEL for the excluded substance was more protective than the ACGIH TLV ;

 The ACGIH had no TLV fo r the substance; or

 Industry was unable to meet the TLV.

Following a period of exte nsive consultation with stakeholders and research by WorkSafeBC staff, formaldehyde was deemed an excluded substance and placed in policy. It was established that industry could not meet the TLV. Accordingly, the OEL assigned to formaldehyde is less prot ective than the current ACGIH TLV.

4. DISCUSSION

In the summer of 2005, the Policy and Research (―PRD‖) advised stakeholders that the Board of Directors (―BOD‖) was consider ing adopting the ACGIH TLV for formaldehyde and requested feedback on what steps would need to be taken to achieve the proposed
limit.

The table below shows the current OELs that are in effect in BC (both a n 8

- hour TWA and a Ceiling L imit) and the TLV (Ceiling Limit only) established by the ACGIH.

Table of C urrent WorkSafeBC OELs and ACGIH TLVs for Formaldehyde

Current WCB OELs (ppm) ACGIH TLV (ppm)

TWA Ceiling Limit TWA Ceiling Limit

0.3 1.0

--- 0.3

Formaldehyde is listed as a Group 1 carcinogen (―carcinogenic to humans‖) by the International Agency for Resea rch on Cancer ( ― IARC ‖ ) and a Group A2 carcinogen ( ―suspect human carcinogen‖ ) by the ACGIH

.Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 7 of 69 The P RD undertook a detailed assessment to determine if the current TLV recommended by the ACGIH for formaldehyde should be applied in BC workplaces

, which included :

a ) Meetings with industry and labour representatives;
b ) Review of writt en submissions ;

c ) R eview of the literature on the health effects of formaldehyde ; d ) C omparison of occupational exposure limits, both nationally and internationally ;

e ) Analysis of workplace exposure data colle cted by WorkSafeBC and other

sources ; f ) T our of a large plant which uses formaldehyde ; and

g ) A na lysis of WorkSafeBC claims data

.

a) Meetings with Industry and Labour Representatives :

At the request of industry representatives, two meetings were held with staff from
WorkSafeBC. The first occurred on September 30, 2005 with industry representatives and the second was held on February 5, 2006 with both industry and labour representatives (Appendix A)

.

b) Written Submissions

Industry and Employers : Response s to the proposal to adopt the ACGIH Ceiling L imit for formaldehyde were
received from 29 employer stakeholders, with the majority voicing strong opposition to
the adoption of the ACGIH Ceiling Limit . Opposition was received primarily from the large

- scale industrial users of formaldehyde (panel board industry, including plywood, particle / fibre board, oriented strand board and laminated wood producers), as well as from the chemical industry and industry ass ociations. O ther users, such as a university
lab oratory manager and a funeral home representative, were also opposed. Support for the adoption of the ACGIH Ceiling Limit received a smaller response and a number of these respondents either did not use, or were no longer using the substance, or used the
substance on a small scale.

The primary reasons expressed by the employer group for opposing the adoptio n the ACGIH Ceiling L imit can be summarized as follows:

 Both the ACGIH and IARC have not kept current with recent toxicological and epidemiological ev idence;

 There is a lack of substantive evidence that formaldehyde is a cancer

- causing agent in humans and that it has been misclassified as a ―human carcinogen‖ by IARC;

 BC already has some of the most stringent exposure limits for formaldehyde, both

nat ionally and internationally;

 Implementation of the ACGIH Ceiling exposure limit in BC workplaces is not feasible;

 A competitive disadvantage would result for BC industries in favour of their counterparts in adjacent jurisdictions;

 At least one forest prod ucts (panel board) facility in the BC Interior would face
closure. There may be other facilities facing closure that WorkSafeBC has not been apprised of.

A great deal of information was provided by the industr y and employer representatives ( Appendix A )

.Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 8 of 69 Labour: Based on their single written submission, l abour was in strong support of adopting the ACGIH TLV Ceiling Limit value. The submission is reviewed in Appendix A

.

The primary reasons expressed by labour in support of th eir position include :

 Work SafeBC should consider adopt ing the ACGIH 0.3 ppm Ceiling Limit, along with the sensitization and human carcinogen designation, in order to adequately protect workers since the current limits are too high ;

 It is importan t for workers not to be exposed to short duration peak exposures above 0.3 ppm;

 A Ceiling Limit value of 0.3 ppm will protect workers from the adverse health effects of formaldehyde , including the cancer

- causing effects ;

 Wherever best practices are adopted, a Ceiling Limit is or can be met in BC
industries

.

c ) Health Effects of Formaldehyde:

An extensive body of literature exists on both the acute and chronic health effects of this
chemical

. Much new information has become available since the late 1990s including a
revised model for carc inogenesis , using formaldehyde as a focus

. Several expert panels have recently re

- evaluated the health effects of formaldehyde , including large cohort epidemiological studies

. Details of these reports are discussed in Appendix B. A summary of the acute and chronic health effects is provided below.

Acute Health Effects: The primary route of exposure of formaldehyde is through inhalation. There is no
indication that the substance is absorbed to any extent through the skin.

Formaldehyde‘s adverse healt h effects are primarily related to its irritative or inflammatory properties. It is a highly reactive chemical that readily reacts with biological tissues, particularly the mucous tissues lining the respiratory tract and the eyes. Mucous tissues by natur e are moist and characterized by a thin

- walled cellular (epithelial) layer that is highly susceptible to chemical irritation. As a result of its reactivity, inhaled formaldehyde is rapidly and almost entirely absorbed by the mucous tissues lining the

uppe r respiratory tract, penetrating no farther than the major bronchi of the respiratory

tract at low or medium concentrations. The mucous tissues of the eyes are also a susceptible target. Neither formaldehyde nor its metabolic by

- products accumulate to

any significant extend in the body even at elevated ambient formaldehyde
concentrations

. 1

Localized irritation of mucous epithelial tissues by formaldehyde , if prolonged, can lead to localized tissue damage; basically the cytotoxic effects of formaldehyde ma y result in histopathological changes

. 2 Evidence indicates that tissue damage in experimental
animals occur s at airborne formaldehyde concentrations above 4

– 6 ppm. S evere effects have been reported following exposure to very high concentrations (in exc ess of

1 NOTE : Formaldehyde exists naturally at very low levels in cells and tissues in plants, animals and humans, a result of normal metabolic processes.

2 Cytotoxic = toxic to cells; histopathological = damage to the epithelial tissues, including reddening, sloughing of cells, leakage of plasma, bleeding, an increase in the number of cells (hyperplasia), change in cellular composition (metaplasia), and a breakdown of cellular components, leading to
cellul ar death.Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 9 of 69 50 ppm)

. These effects include pulmonary edema, pneumonia, and death as a result of the complete breakdown of the tissues lining the respiratory tract and the lungs.

Recent studies

, involving testing of human response to airborne formaldehyde, in dic ate that due to the pungent and unpleasant odour of formaldehyde, it has been difficult to distinguish:

a ) mucous tissue irritation (localized changes to the cells and tissue) from
b ) chemosensory stimulation which involves stimulation of local nerve ending s.

Chemosensory stimulation will not necessarily lead to cellular irritation and any histopathological changes. Earlier studies conducted on establishing levels of irritation experienced by test subjects failed to distinguish actual mucous tissue irrita tion from chemosensory irritation. Several expert panels have recently reviewed and researched this apparent dichotomy, and have concluded that cytotoxic effects of formaldehyde do not appear to occur at levels below 0.75 to 1.0 ppm formaldehyde. A level of 1.0 ppm is
considered the no

- observed

- adverse

- effect

- level (NOAEL) 3 for nasal injury in humans. This is further supported by the fact that at concentrations below 1.0 ppm, symptoms disappear very quickly, underlying the non

- adversity of the irritating effects at low
concentrations.

Appendix C provides further details on the chemical characteristics of formaldehyde, routes of entry, biochemical pathways, and adverse health effects associated with exposure to the substance.

Chronic Health Effects:
Evid ence on the adverse effects in humans based on long term ( chronic ) exposures to formaldehyde is minimal. Information on chronic health effects is based almost entirely
on animal studies. Repeat dose inhalation studies have been conducted on mice, rats
and monkeys. Cellular (histopathological) changes are observed in all species with slight damage to the tissues of the nose and upper respiratory tract at concentrations at

2

– 3 ppm , with more pronounced damage at levels up to approximately 6 ppm

. Severe

c ellular damage to respiratory tract tissue

– severe rhinitis, tissue death and extensive hyperplasia 4

– occurs at concentrations 6 ppm and above. The no

- observed

- adverse

effect

- level (NOAEL 3 ) for respiratory tract irritation in experimental animals is cla imed to
be in the 1

– 2 ppm range. A level of 1.0 ppm is considered the NOAEL 3 for injury to the nasal passages in humans.

Mutagenicity & Carcinogenicity: IARC has evaluated formaldehyde and determined that there is sufficient evidence that formaldehyd e be classified as a human carcinogen. On the other hand, the ACGIH has determined that formaldehyde is not a proven human carcinogen but a suspect human carcinogen. This is also the conclusion of a number of other jurisdictions and reference organizatio ns, as detailed in Appendix B.

According to current infor mation, formaldehyde is shown to be genotoxic agent 5 at concentrations that cause severe tissue damage

. This is primarily due its activity as a

3 Postscript: erratum noted by Dr. Vyskocil

– NOAEL should read LOAEL (lowest

- observed

- adverse

effect

- level

4 A general term for an increase in the number of the cells of an organ or tissue due to a number of causative factors including, increased demand, chronic inflammatory response , and other triggers

. 5 T oxic to the genetic material of the cell including D NAAttachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 10 of 69 reactive alkylating agent 6 and like other alkylating agents, a likely candidate for being a mutagen or a carcinogen. Accordingly, formaldehyde is classified as a mutagen and
also a potential carcinogen.

More specifically, it has been shown that while formaldehyde is clearly an experimental animal carcinog en of the upper respiratory tract , it is not of any other tissues or organs; that is, tissues must be in direct contact with formaldehyde in order to induce tumorous growth

. Hence, its systemic effects (e.g., liver, kidneys and other organs and tissues at
distance from the site of contact ) are negligible when the route of entry is via the respiratory tract. N asal tumours most probably arise as a consequence of pronounced localized chronic tissue irritation of the nasal passages in association with genotox ic
effects at the cellular level

– a ―site

- of

- contact‖ effect. Genotoxic effects include the
formation of DNA

- protein cross

- links and other indicators of genetic damage.

As detailed in Appendix B, several expert panels recently re

- evaluated the epidemi ological studies conducted in the 1980s and early 1990s

– including the cohort
studies on which IARC has based its conclusion s

. The expert panels conclude that the evidence falls short in providing conclusive proof that formaldehyde exposure results in

na sopharyngeal cancer in humans. Accordingly, jurisdictions, such the United Kingdom and German occupational health and safety authorities and the European Scientific Committee on Occupational Exposure Limits ( ― SCOEL ‖ ) , have classified formaldehyde

as a sus pect human carcinogen similar to the ACGIH due to the insufficiency of the
evidence for cancer induction in humans but that it is capable of inducing cancers in experimental animals.

Reproductive Toxicity:
There is no evidence that formald ehyde is a repro ductive toxin

.

Sensitization: In humans, formaldehyde is classified as a skin sensitizer due to its direct irritati ve effects on tissues and its ability to induce an immune response at the site of contact.

Formaldehyde is not considered a significant ca use of occupational asthma. Experimental evidence shows that exposure of asthmatic individuals to formaldehyde does not change the nature or status of the asthmatic condition.

Summary of the adverse health effects of formaldehyde: Figure 1 summarizes c urrent knowledge on the adverse health effects and carcinogenic potential of formaldehyde in experimental rats and humans relative to airborne exposure
levels. An ― effect level ‖

– as shown in the figure 1

– is a response elicited by an experimental rat or human relative to the concentration in air, and includes eye irritation, nasal irritation, level of tolerance (human) , and cytotoxic and carcinogenic responses. The term ―subjective‖ in the figure is a verbal or similar communicative response by the
human subject to the tester (―I can smell / detect formaldehyde‖); an ―objective‖ response is one that can be measured and quantified such as a record of the rate and frequency of blinking. An objective response is far superior, scientifically, to a subjective

response.

6 A chemical that acts on the genetic material in the nucleus of the cell

– deoxyribonucleic acid (DNA), causing mu tagenic or carcinogenic effectsAttachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 11 of 69 Of note is that formaldehyde levels in air must be above 6 ppm in order to initiate the growth of tumours

– both benign and cancerous. At concentrations at 10 ppm and greater, cancerous tumours are well established. Humans are not able to t olerate levels of exposure to airborne formaldehyde above 4

– 5 ppm.

WorkSafeBC‘s current Ceiling Limit of 1.0 ppm is at the subjective eye irritation level and below the objective eye irritation level of 1.7 p pm for humans. The current TWA of 0.3 ppm i s significantly lower than both subjective and objective eye irritation levels and below nasal irritation levels based on the most current experimental information.

Figure 1: Summary of effects levels of formaldehyde in humans and experimental

rats

1 M eans an increase in the number of cells of an organ or tissue

2 M eans the replacement of one cell type with a differentiated cell type

– usually due to chronic irritation and inflammation; it is reversible and a natural protective response allowing the substitution of cells that
are better able to survive where a more fragile cell type is likely to succumb

3 Me ans abnormal disorganized growth in a tissue or organ; also know as a tumour which may be either benign or malignant

4 Edema = severe rhinitis (― a very runny nose‖)

d ) O EL s for Formaldehyde in BC and Other Jurisdictions

Regulated occupational exposure limits for formaldehyde from all Canadian as well as
American and international jurisdictions are portrayed in Table 1

.Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 12 of 69 Table 1: Current and Sch eduled Regulated OELs for Formaldehyde: Canadian and
Other Jurisdictions

Jurisdiction 8

- Hour TWA (ppm) or equivalent Short

- Term Exposure Limit

– STEL (ppm) or equivalent Ceiling

Exposure
Limit

– “C” (ppm) or equivalent

Canadian Jurisdictions

ACGIH 7

 Mani toba

 Nova Scotia

 PEI

 Newfoundland and Labrador 0.3

Alberta 0.75 2

British Columbia 0.3 1

New Brunswick 0.5 1.5

Northwest Territories 8 0.3

Ontario 1 1.5

Québec 2

Saskatchewan 0.3

Yukon 1 2

Canada Labour Code (Federally regulated wo rkers) 0.3

American Jurisdictions

California 0.75 2

Oregon 0.75 2

Washington State 0.75 2

International Jurisdictions

Germany

9 0.3 0.6 1

United Kingdom 2 2

Netherlands 10 1 1.5

7 These four jurisdictions automatically adopt the annual ACGIH TLV updates.

8 Based on the 2001 TLVs is sued by the ACGIH

. 9 The Deutsche Forschungemeinschaft (DFG) endorses this MAK Commission value . Note: the STEL and Ceiling Limit values indicated are based on DFG‘s protocol for establishing these values (multipliers).

10 Not legally binding at this tim e; under review; an 8

- h TWA of 0.5 ppm and STEL of 1 ppm is being

considered.Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 13 of 69 Jurisdiction 8

- Hour TWA (ppm) or equivalent Short

- Term Exposure Limit

– STEL (ppm) or equivalent Ceiling

Exposure
Limit

– “C” (ppm) or equivalent

France 0.5 1

Switzerland 0.5 1

Norway 0.5 1.5 1

Sweden 0.5 1

Finland 0.3 1

Denmark 0.3

Australia 1 2

New Zealand 1

TWA : the time weighted average (TWA) concentrat ion of a substance in air which may not be exceeded

over a normal 8 hour work period.

STEL : the time weighted average (TWA) concentration of a substance in air w hich may not be exceeded

over any 15 minute period, limited to no more than 4 such periods in an 8 hour work shift with at least one hour between any 2 successive 15 minute excursion periods.

Ceiling : the concentration of a substance i n air which may not be exceeded at any time during the wo rk

period.

With respect to establishing an OEL, much new information has come forth over the last 6 to 8 years as a number of jurisdictions have completed their reviews on formaldehyde,

or are curre ntly in the process of considering appropriate exposure limits for formaldehyde

– be it an 8

- h our TWA, a Short Term Exposure Limited (― STEL ‖) , or Ceiling Limit, or a combination of the three. Quebec and Germany hav e completed their
reviews as have Austral ia, the United Kingdom, Holland and the Nordic nations.

As Table 1 indicates, a C eiling L imit of 0.3 ppm with no 8

- hour TWA limit has been adopted in Denmark, and in several Canadian jurisdictions, including Manitoba,
Saskatchewan , Nova Scotia, Newfoundlan d, PEI and the Northwest Territories, as well as for federally regulated work ers

. Quebec has a C eiling L imit of 2 ppm with no 8

- hour
TWA limit. All other provinces and other jurisdictions shown have a combination of 8

- hour TWAs, STELs and Ceiling Limits.

BC

, along with Finland and Germany have the lowest 8

- hour TWAs at 0.3 ppm. Germany and the Nordic countries along with BC enforce a Ceiling Limit of 1.0 ppm. Ontario is currently has a TWA of 1.0 ppm and STEL of 2.0 ppm which came into effect March 31, 2006. Effective December 31, 2007, Ontario will forego the TWA limit and adopt a more protective STEL (dropping from 2.0 to 1.0 ppm). They will also adopt a Ceiling Limit of 1.5 ppm.

US jurisdictions neighbouring BC prescribe less protective OELs. Washi ngton State and Oregon enforce an 8

- h our TWA of 0.75 ppm and a STEL of 2.0 ppm; no Ceiling Limit is prescribed.

Overall, BC has one of the lowest 8

- h our TWA OELs among the major jurisdictions along with a Ceiling Limit OEL that is also among the lowest. A Ceiling Limit of 1.0 ppmAttachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 14 of 69 is more protective than a STEL of 1.0 ppm. Hence, notwithstanding the jurisdictions that have adopted the ACGIH Ceiling Limit TLV, the current OELs in BC are some of the most protective in all jurisdictions.

T he German occupat ional health and safety authority takes the position that
f ormaldehyde does not significantly contribute to human cancer provided the MAK value (8

- h our TWA) of 0.3 ppm is observed and the Ceiling Limit of 1.0 ppm is not exceeded.

Several reference agenci es, including the German MAK Commission and the Working Group on Action to Control Chemicals (― WATCH ‖) Committee of the UK Health & Safety Executive, make the following observations:

 IARC‘s classification of formaldehyde as a human carcinogen is not suppor ted;

 IARC has been selective in their review; a number of epidemiological studies not supportive of IARC‘s position were not included in their 2004 report;

 The avoidance of cellular damage and sustained regenerative proliferation are
decisive factors for e stablishing an appropriate exposure limit;

 In the low dose range

– less than 1.0 ppm

– the toxic effects of formaldehyde on the genetic material (―genotoxic effect‖) play only a minimal role in its carcinogenic potential so that no significant contribution to human cancer risk is expected in the low dose range ;

 Cancer risk factors become of concern only when formaldehyde levels exceed 2

– 3 ppm on a chronic or long term basis;

 With respect to the strong and pungent odour of formaldehyde, the ACGIH did not
d istinguish sensory stimulation from cellular irritation in their recommendatio n of a 0.3 ppm TLV Ceiling Limit; and

 Eye irritation

– which can be measured and quantified experimentally

– unlike nasal irritation, is considered the most appropriate indicator of the irritative nature of formaldehyde and a more objective determinant of an appropriately assigned exposure limit

.

The reference agencies, b ased on recent re

- evaluations of the scientific literature on controlled nasal and eye irritation studies, con clude that a level of 1 ppm avoids eye irritation in a majority of test subjects and that nasal irritation is avoided if formaldehyde concentrations are kept below 2 ppm . As a result, airborne levels of formaldehyde below 1 ppm are considered low enough t o protect workers against nasal tissue damage, and consequently, also against a potential risk of nasal cancer

. In consideration of these factors, an 8

- h our TWA of 0.3 ppm was adopted in Germany. Furthermore, Paustenbach et al. 1997 concluded that a level of 1 ppm formaldehyde would avoid eye irritation in at least 75% and up to 95% of exposed workers. In another very recently published report, Arts et al. 2006 re

- evaluated eye and nasal irritation data
and concluded that when minimal/mild/slight irritatio n is taken as a cut off level, eye and nasal irritation were found at formaldehyde levels of greater than or equal to ( ≥ ) 1 ppm and ≥ 2 ppm, respectively.

Additional information pertaining to the findings of the reference agencies can be found in Appendix B.

e) Worker Exposures to F ormaldehyde in British Columbia and other Locations :

Sampling data collected by WorkSafeB C over a pe riod of 15 years (1990 to 2005
inclusive ly ) indicate that worker exposure to formaldehyde is likely to occur primarily in
the forest panel board manufacturing sector (plywood, particle / fibre board, orientedAttachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 15 of 69 strand board, laminated wood products manufacturing), resin manufacture, acute care hospitals, university and other laboratories, and funeral homes. A compilation of compli ance sampling data collected by WorkSafeBC over this time frame is included in Appendix D along with exposure data from other sources, including Ontario, Quebec,
and the Netherlands.

The exposure data indicates that overall, exposure levels have decrease d over time as improved control and procedural measures have been implemented. This is particularly evident when one compares readings taken in the early 1980s are compared with those
in the late 1990s.

The results indicate that industries in which exp osure levels were predominantly below the current 0.3 ppm 8

- h our TWA expos ure limit include:

 Foundries;

 Resin manufacturing; and

 Plywood manufacturing.

Industries in which the current 0.3 ppm 8

- h our TWA exposure limit was exceeded at
times include (range of exposures shown) :

 Paperboard & cardboard manufacturing (0.04

– 0.38 ppm) ;

 Laminated wood products manufacturing (0.24

– 0.38 ppm) ;

 Pressed / panel particle / fibre board manufacturing (0.07

– 5.00 ppm) ;

 Oriented strand board manufacturing (0.03

– 0.32 p pm);

 Funeral homes (none detected to 0.74 ppm) ;

 University laboratories (0.52

– 1.15 ppm) ;

 Hospitals & medical clinics and laboratories (0.02

– 1.35 ppm); and

 Poultry hatcheries (0.1

– 0.35 ppm)

.

In 2004, Quebec‘s Institute de Reserche Robert Sauvé en Sa nté et en Sécurité du Travail (IRSST) published a report on the health impact of formaldehyde in the workplace, at a cost of approximately $ 1 million, with specific focus on the panel board industry, namely oriented strand board

, medium density fibre board , particle board plants

. This study demonstrate s a similar worker exposure pattern to formaldehyde as seen in BC panel board plants

. Proximity to the press (a key component of the panel board process and found in all plants) resulted in exposures in exce ss of 0.3 ppm, at times exceeding 1.0 ppm or more. In general, exposures were highest in particle board

a nd medium density fibre board plants

– generally in excess of the 8

- h our TWA exposure limit of 0.3 ppm.

In order to determine if the Ceiling Limit fo r formaldehyde is being exceeded an electronic instrument capable of instantaneous read

- out must be used. The historical data presented in this report is based on sampling equipment that is limited to providing only time

- weighte d

- average (TWA) readings. D atalogging electronic equipment was not
available for use as personal exposure monitors for formaldehyde until very recently

. 11

As such, all of the 500+ data points of WorkSafeBC‘s exposure data are TWAs of varying duration

– from 10 to approximately 480 minutes (8

- h our ). In essence, a STEL
is a 15 minute TWA. TWA readings are an integrated average of all the readings within the defined sampling period. TWA readings just below the Ceiling Limit value (1 ppm)

11 More recently, personal monitoring equipment capable of datalogging real

- time exposure data including peak transient exposures has become commerciall y available (cost estimat e: US$40 00 + ea).Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 16 of 69 will typically include spike s or excursions a bove 1 ppm; these spikes will not be recorded, however.

f ) Plant Tour :

WorkSafeBC staff ( occupational hygienists from the P olicy and R esearch D ivision and
the Worker a nd Employer Services Division) conducted a walk

- through survey of a medium density f ibre board plant

. Details of the survey are provided in Appendix B

.

g) WorkSafeBC Compensation Claims Data

– Fo rmaldehyde Exposure:

A review of WorkSafeBC‘s data on occupational disease claims over the period of 1990

to 2005

, inclusive ly

, indicates tha t about 26 claims were classified as being formaldehyde

- related. Most of the claims appear to be associated with exposures sustained during spills of formaldehyde solutions (formalin), and exposures to formaldehyde

- based resins and adhesives, resulting in localized skin irritation, possible allergic contact dermatitis, and upper respiratory tract irritation, as a result of skin contact or inhalation of formaldehyde vapours, respectively. None of the claims appear to be the result of chronic (long term) ex posure to airborne formaldehyde. The Quebec Commission on Health and Occupational Safety report similar findings on formaldehyde

related claims for Quebec workers.

There are no recorded incidences of upper respiratory tract cancers recorded for
workers in BC that can be causally linked to formaldehyde exposure.

5. OPTIONS AND IMPLICATIONS

Based on the analysis of findings, tw o options for exposure limits for formaldehyde in BC workplaces have been developed:

Option 1

– Status Quo

Under this option th e 8

- h our TWA limit and Ceiling Limit would remain the same at 0.3 and 1.0 ppm, respectively.

Implications:

 Under this option BC‘s current exposure limits for formaldehyde would remain among the lowest of the currently regulated exposure limits in the wes tern industrialized world;

 The current exposure limits would remain lower than the exposure limits in place at proximate jurisdictions including Alberta, Washington State, Oregon and California;

 The current exposure limits would remain lower than those im posed by other Canadian jurisdictions with a significant panel board industry, including Ontario and Quebec;

 BC has a similar 8

- h our TWA limit and Ceiling Limit to that adopt ed in Germany where the OELs for formaldehyde were recently reviewed ;

 A substanti al body of scientific evidence indicates that BC‘s current exposure limits will protect workers from the adverse health effects of formaldehyde;

 According to a majority of expert panels, BC‘s current Ceiling L imit of 1.0 ppm is protective from the irritati ve properties of formaldehyde, providing an acceptable margin of safety;Attachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 17 of 69  WorkSafeBC ‘s current Ceiling Limit of 1.0 ppm is at the subjective eye irritation level and below the objective eye irritation level of 1.7 ppm for humans. The current 8

- h our TWA of 0.3 ppm is significantly lower than both subjective and objective eye
irritation levels and below nasal irritation levels based on the most current experimental information ;

 This option will simplify exposure monitoring of workers allowing the use of stan dard occupational hygiene sampling methods that measure time

- weighted

- average (TWA) ;

 Employer representatives

– particularly from the forest products / panel board sector

– would likely support this option; and

 O rganized labour would likely not support th is option.

Option 2

– Adopt the Ceiling Limit recommended by the ACGIH

Under this option , the current 8

- h our TWA limit would be withdrawn , and the Ceiling
L imit reduced from 1.0 to 0.3 ppm.

Implications:

 Adoption of a Ceiling

- only exposure limit would p lace BC, along with Manitoba, Nova Scotia, Prince Edward Island, Northwest Territories, Newfoundland / Labrador and Denmark, among those jurisdictions with the lowest exposure limit among all western
industrialized nation s ;

 T he ACGIH is the only organizati on t hat has recommended an exposure limit based solely on a Ceiling

- based exposure limit; the other four reference organizations

, namely the Dutch Expert Committee (DECOS), the German MAK Commission, the European Union Scientific Committee for the Occupati onal Exposure Limits to Chemical Agents ( SCOEL ), and the Australian National Industrial Chemicals Notification and Assessment Scheme (NICNAS) Committee have recommended
both 8

- h our TWA OELs and STEL s for formaldehyde ;

 Fibre and particle board plants will not be able to comply with this option due to the limitations placed on the operations by a Ceiling

- only exposure limit

. Currently, fu ll shift exposures can approach the current 8

- h our TWA exposur e limit of 0.3 ppm; the

most transient of exposures, inclu ding spikes of several seconds or less above 0.3

ppm

, would place the plant in non

- compliance;

 The F uneral home industry and medical facilities will find it difficult to comply with this option. E xposures typically are of short duration; opening a contain er of formalin is likely to result in an exposure exceeding a momentary spike of 0.3 ppm ;

 Employer representatives

– particularly from the forest products / panel board sector

– will likely not support this option; and

 Organized labour will likely support this option.

6. RECOMMENDATION

The PRD recommends Option 1 which is to retain the 8

- hour TWA limit of 0.3 ppm and a Ceiling L imit of 1.0 ppm.

Formaldehyde is an important industrial chemical used worldwide in the manufacture of resins, particle, fibre and oriented strand boards, plywood, leather goods, paper, pharmaceuticals and a myriad of other products. Formaldehyde has been exceptionally
well studied, particularly over the last decade, and health effects have been well defined
in terms of specifyin g a safe level of exposure for both worker s and the public. TheAttachment 1

July 2009

– OEL for formaldehyde Policy and Research Division Page 18 of 69 current 8

- h our TWA and Ceiling L imits provide an adequate level of protection for workers exposed to the substance as long as effective control measures are in place.

7. CONSULTATION

Stak eholders are invited to provide fe edback on this discussion paper

.

Stakeholder comments will be accepted until 4:30 pm on Friday, June 29, 2007. When responding, please provide your name, organization, and address. Comments may be sent by mail, fax, or email to:

By mail: Formaldehyde OEL Study

Policy and Research Division
WorkSafeBC P.O. Box 5350, Stn. Terminal Vancouver, BC V6B 5L5

By fax: 604 279

- 7599

By email: regquery@worksafebc.com

WorkSafeBC‘s governing body, the Board of Directors, will consider the comments
submitted by stakeholders before making a decision.

Please note that all comments become part of the Policy and Research Division‘s database and may be published, including t he identity of organizations and individuals participating on behalf of organizations. The identity of those who have participated on their own behalf will be kept confidential according to the provisions of the Freedom of
Information and Protection of Pr ivacy Act.Attachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 19 of 69 Following the notification le tter sent to stakeholders in August 2005 the PRD received numerous responses from both labour and employer representatives

. All responses, except one, were received from the employer group. Table A1 summarize s the responses by the representatives from various industr ies and organizations as well as
from small or independent employers such as photography processing labs , funeral
homes

. Responses were received by email as well as by mail

. The industry associat ion along with the chemical / resin & coatings manufacturers and panel board industry collectively provided a very comprehensive package of information on the health effects of formaldehyde, including critical reviews of the scientific literature. One wri tten submission was received from labour.

The majority of the submissions were not i n support of adopting the ACGIH Ceiling Limit of 0.3 ppm with no prescribed 8

- h our TWA limit.

Table A1: Consultation Submissions

– by Industry, Associations and Independe nt Employers. Responses: t hose that Approve, Oppose , or have a Neutral Response
to the A d option the ACGIH TLV

Industry , Organizations, Small / Independent Employers Opposed Approve Neutral

Panel board including: plywood, particle board,
oriented strand bo ard ; laminated wood 5 1

Resin & Coatings Manufacture 2 1 2

Chemical Manufacturing 1 1

Industry / Employer Association 7

Miscellaneous 12 2 2 5

Labour Organization 1

Total 17 6 7



### Meetings with Stakeholders

Meetings with Industry Representatives : At the request of industry representatives, two meetings were held with staff from the
PRD. The first occurred on September 30, 2005 and the second was held on February 5, 2006.

12 Includes photo labs, funeral homes, mortuaries, veterinary clinics, poultry hatc heries, universities,
foundries.Attachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 20 of 69 September 30, 2005 Meeting: Representatives of the following forest prod ucts sector, chemical manufacturers and industry association s attended : Composite Panel Association Hexion Specialty Chemicals, Inc.
Western Fraser Timber Co. Ltd. Northern Engineered Wood Products Inc. Engineered Wood Association (APA)
CanPar Industries
C anadian Plywood Association Dynea Inc. Methanex Corp. Formaldehyde C ouncil Inc

.

R epresentatives came from BC, Quebec, Ontario, Washington State and Ohio. The delegation provided an overview of the industry‘s position on the health effects of formaldehyde with a critique of ACGIH‘s rationale f or establishing the Ceiling L imit TLV for formaldehyde. An extensive number of supportive studies were distributed

. These
are reviewed in Appendix B.

February 5, 2006 Meeting The second meeting provided an opportun ity for the industry representatives to discuss details of the earlier meeting with worker representatives. Employer representatives: Composite Panel Association Hexion Specialty Chemicals
Western Fraser Timber Co. Ltd. Northern Engineered Wood Products I nc. Engineered Wood Association (APA)
CanPar Industries Canadian Plywood Association Dynea Inc.

Worker representatives:
BC Federation of Labour
IWA / Steelworkers Union
B C Nurses Union Construction Industry Training Institute, Building Trades

The industr y representatives maintained that the basis for carcinogenicity of formaldehyde to humans is not well founded, and that the epidemiology is inconsistent in demonstrating causality as to the types and patterns of cancers associated with formaldehyde. They mentioned that the National Cancer Institute (―NCI‖)

– in response to recent criticism from the scientific community

– is planning to re

- evaluate earlier cohort studies on the association of nasopharyngeal cancer and formaldehyde in
workers.

Both labour and industry representatives discussed the feasibility of achieving compliance if the ACGIH Ceiling L imit is adopted. Industry representatives maintainedAttachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 21 of 69 that the panel board and plywood industry would likely not be able to achieve compliance with an expo sure limit based solely on a ceiling limit value. Labour offered the comment that users such as hospitals would likely be able to comply.



### A Review of the Submissions

G eneral ly, e mployers would like to retain the current status as an excluded substance
with an 8

- hour TWA of 0.3 ppm and Ceiling L imit of 1.0 ppm. Worker representatives
would like to see the ACGIH Ceiling L imit of 0.3 ppm adopted with no specified 8

- hour
TWA limit. Salient points of submissions from both parties are outlined below.

Work er Submissions
In a written submission by the BC Federation of Labour, labour‘s position remains in support of the ACGIH Ceiling Limit of 0.3 ppm for formalde hyde. The subm ission, dated March 23, 2006 entitled: Formaldehyde OEL

, reports the following:

 It is important to avoid short duration peak exposures above 0.3 ppm;

 The rationale for limiting exposure to below 0.3 ppm is due to the increased risk of both acute and chronic respiratory effects as well as the need to minimize the risk of a carcinogenic ef fect;

 The health effects of exposure to formaldehyde above 0.1 ppm TWA and peak exposures (ceiling limits) over 0.3 ppm are well documented in the literature;

 Levels of exposure above 0.1 ppm cause irritant effects and short duration exposures above 0.3 pp m induce pathological effects that increase risk of cancer;

 In a study at a plywood plant it has been shown that where workers were exposed to levels above 0.8 ppm asthma symptoms increased;

 Peak exposures below 0.3 ppm are identified as necessary to preve nt histological damage which will increase the risk of nasopharyngeal cancer, the target area of this known human carcinogen; and

 WorkSafeBC must adopt the ACGIH 0.3 ppm Ceiling Limit, along with the sensitization and human carcinogen designation, a s well as the as

- low

- as

reasonably

- achievable (― ALARA ‖) requirement.

Labour‘s concern about the health effects of formaldehyde is not limited to the forest produc ts industry. Concern is also expressed about protecting the health of workers who may also be exp osed to high formaldehyde levels in the health care industry. Labour‘s submission offers the following comments regarding the achievability of a 0.3

ppm Ceiling Limit by industry:

 Formaldehyde exposure in various industries has been steadily reduced over t he

years;

 Data from major users

– including plywood manufacturers in the US, indicates that 25 years ago levels were in the 0.35 to 0.38 ppm range; these levels are now lower;

 A study on Quebe c particleboard plants indicate levels are below or near 0.1 ppm and below the 0.3 ppm ceiling in many locations, and that levels measured in New Zealand plants had a geometric mean of 0.06 ppm, well below the proposed exposure limits.Attachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 22 of 69 The y conclude that when ever best practices are adopted the proposed limits are or c an be met in BC industries. The report states that ―determining achievability must be based on best practices, not on the worst ones‖.

With respect to achieving compliance, l abour would have no concerns:

 W ith employers applying for a variance from Work SafeBC if individual plants have difficulty achieving the proposed Ceiling Limit and can demonstrate that they cannot comply;

 W ith the use of respiratory protection, as opposed to engineering controls, to protect the most highly

- exposed workers assigned to areas where compliance with the Ceiling Limit may not be achievable (e.g. press operators, maintenance workers) and
where a variance from WorkSafeBC has been obtained.

Employer Submissions

In several writte n submissions

, including a PowerP oint presentati on at the September 2005 meeting with PRD staff , spokespersons for the associations and a number of individual companies r epresenting the forest products industry acknowledged that there is a need to ensure that the exposure limit defined for formaldehyde provide s an appropriate level of short

- and long

- term health protection for workers in BC, but that
there is also a need to ensure that t he cost of complying with a regulation does not threaten the industry's competitive position, either with respect to it s Canadian counterparts or its significant export markets, particularly the US.

The concerns raised by the employers fall into three distinct categories: health issues,

econom ic issues, and technical issues

, as follows:

a ) Overriding perspective

 The weigh t of scientific evidence does not indicate that lowering the standard
from the current OEL s would provide any further measure of worker protection;

 BC‘s OELs are among the lowest in any jurisdiction;

 A Ceiling Limit of 0.3 ppm is unnecessarily low, economi cally and technically impossible to meet;

 Adoption of the 0.3 ppm C eiling L imit may result in major plant closures and job
losses in BC.

b ) Health Issues

 Formaldehyde is produced by the human body as part of normal metabolic

processes;

 It is a natural by

- pro duct of all life forms

, including plants;

 ACGIH seeks to eliminate virtually all sensory/discomfort effects with the 0.3 ppm Ceiling Limit;

 Concerns with sensory irritation are addressed by WorkSafeBC‘s existi ng 8

- h our TWA and Ceiling Limit ;

 Quebec‘s IRS ST 2004 study on formaldehyde

, commissioned by the Quebec Commission of Health & Safety

– CSST, is a significant contributor in understanding the irritation threshold and sheds new light on earlier studies
conducted in the 1980s and which formed the basis for ACGIH‘s current TLV.
This study examined more than 2,000 workers in the wood productsAttachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 23 of 69 manufacturing industry in Quebec and concluded that an exposure level below 0.75 ppm would not provide improved health protection to workers;

 The stakeholders note t hat the ACGIH recommendation of a Ceiling Limit of 0.3 ppm was based on even the mildest irritation, and that the ACGIH did not consider the quality of the studies;

 They point out that other researche r s have concluded that sensory irritation at
levels bel ow 1.0 ppm is often difficult to distinguish from responses experienced in controls;

 Reports of irritation below 0.3 to 0.5 ppm were too unreliable to attribute to formaldehyde alone;

 Eye irritation does not become significant until at least 1.0 ppm is re ached;

 They pointed out that the IRSST concluded that a ceiling value of 1 ppm for 15 minutes was appropriate to prevent moderate, although transitory, eye irritation;

 The stakeholders referred to a very recent study by researchers (Arts et al , 2006)
from the Netherlands Organization for Applied Scientific Research (TNO) published March 2006 which evaluated sensory irritation relative to carcinogenicity re garding inhaled formaldehyde and pointed out the following
factors ;

o The subjectively measured sensory i rritation threshold levels in humans were assessed relative to findings obtained in animal studies;

o Using Benchmark Dose A nalysis it was estimate d that at 1 ppm, 9.5% of healthy volunteers experienced moderate (i.e., annoying) eye irritation;

o Subjective te sting does not exclude the perception factor or trigeminal

nerve stimulation (this is distinguished from actual irritation

– it is merely that the subject detects the presence of formaldehyde); this is an important consideration in that formaldehyde has a very strong odour;

o Furthermore, respiratory tract irritation can be either a localized patho

physiological response to a chemical (direct localized effect) or a chemosensory effect

– interaction with local nerve endings ( nervus trigeminus

)

– the trigemina l effect;

o Trigeminal stimulation will not necessarily lead to cellular or tissue damage;

o In several of the studies assessed, the control or ―0‖ ppm test condition was missing;

o Based on long

- term inhalation studies in animals, a level of 1 ppm is
considere d the no

- observed

- adverse

- effect

- level ( NOAEL ) for nasal injury;

o They conclude that at levels less than 1 ppm where the prevalence of sensory irritation is minimal both in incidence and degree, risks of respiratory tract cancer are considered to be negligi bly low.

 The employer group point ed out that t he evidence supporting an association between formaldehyde exposure and nasopharyngeal cancer is highly questionable;

 Formaldehyde is not likely to cause cancer in th e upper respiratory tract when
there is no c ytotoxic effects;

o Tumours development in experimental animal studies occurs at
concentrations that cause severe local irritation of the upper respiratory

tract (5

– 6+ ppm), including cell death followed by an increase in cell proliferation and damage to t he genetic material;Attachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 24 of 69  It was pointed out that IARC based its classification on a large cohort study by
the NCI involving 25,000+ workers followed over time;

 R ecent re

- evaluation s of the epidemiological data by non

- NCI researcher s of NCI
data indicates that:

o Nasopharyngeal cancer is rare

– 10 cases were found in the 25,000 worker cohort (representing 10 plants);

o Most of these cancers came from one specific plant (six out of 10 cases) with high exposures (average exposures above 1 or 2 ppm with frequent peak e xposures at 4+ ppm);

o Three of the cancer cases were workers employed for less than one year at the plant;

o The authors referenced by the employer representatives (i.e., Marsh et al

– several papers) could not support NCI‘s suggestion of a causal
association between formaldehyde exposure and mortality from nasopharyngeal cancer; they found no such association;

o Furthermore, there was a less than expected mortality rate for nasopharyngeal c ancer at the other nine plants ;

 In response to these critiques of its ea rlier studies, NCI is planning a re

evaluation of its earlier studies and a report is expected due for release later in
2006 [ not available as of end January, 2007 ] ;

 Stakeholders urge WorkSafeBC not to proceed until this study becomes
available ;

 There is n o biologically plausible link between formaldehyde exposure and leukemia;

o Formaldehyde does not act as a systemic carcinogen;

o It is rapidly metabolized within the body and is highly unlikely to be transported to the bone marrow, nor has it been demonstrate d to be

― marrow

- toxic ‖

– a p recursor for leukemia induction.

Stakeholders ask ed WorkSafeBC to consider th e findings of the 2004 IRSST formaldehyde report

. It is a critical review of the literature of sensory irritation effects of formaldehyde

– the basi s of the ACGIH 0.3 ppm Ceiling L imit. The findings of the
IRSST report are summarized in Appendix B. The employer submission indicates that, according to the IRSST, the threshold for sensory irritation (eye) is in the range of 0.75 to 1.0 ppm, which is f ar greater than the 0.3 ppm ceiling proposed by WorkSafeBC. The
evidence i ndicates that the difference in the prevalence of significant health effects
would not be expected by reducing the current WorkSafeBC levels to those recommended by the ACGIH.

The employer submission also requested WorkSafeBC consider the 1997 Paustenbach
et al study. Details germane to this paper are summarized in Appendix B.

The employer submission requests th at WorkSafeBC consider the Chemical Industry Institute of Toxicology ( ― CIIT ‖) model for carcinogenicity which has been adopted by
several national and international standard

- setting bodies including Health Canada /
Environment Canada , the German MAK Commission, E nvironmental P rotection A gency

, Australia‘s Department of Healt h and Aging (NICNAS), the OECD, the WHO (CICAD) and the Dutch Expert Committee (DECOS). The employer submission pointed out that
IARC did not reference the CIIT model in their recommendations for carcinogenicity forAttachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 25 of 69 f ormaldehyde. The employers also point to the fact that the MAK Commission, NICNAS,
WHO

- CICAD, DECOS and others conclude that formaldehyde exposure p oses a carcinogenic effect under conditions that both induce toxicity and cause sustained regenerative proliferation ( i.e., damage in the DNA rep lication process following severe tissue damage ). The 1999 CIIT study i s reviewed in Appendix B.

c ) Economic Issues Employer representatives maintain that in order for this industry to remain competitive
both in and outside of Canada, the exposure limit for formaldehyde should reflect that of other jurisdictions. In particular, since Canada's primary trading partner is the US, the exposure limit should not be lower than that of the O ccupational S afety and H ealth
A gency ( ― OHSA ‖ )

. Their primary concerns with respect to economic impacts are that if the exposure limit is lowered too much, there is the potential for marked disparity in compliance and manufacturing costs between BC and its competitors, and the industry in BC will, as a result, become less competi tive.

Their submission states that 14,884 employees are directly employed in formaldehyde monomer, polymer and downstream facilities (primarily the wood products industry) in BC, equivalent to over $ 540 million in wages. When direct, indirect and induced economic contribution of formaldehyde in BC is tallied, this rises to 80,164 jobs and
C $ 2.9 billion in wages with purchases of C $ 1.7 b illion and sales in excess of C$ 3.9
billion.

The employer submission claims that consumers in the US and Canada would ha ve to spend an additional $ 17 billion per year if formaldehyde

- based products were replaced by substitute materials. Substitution is

, in many cases

, not practical due to increased energy requirements, manufacturing safety issues, poor performance, and cos ts of
alternate materials.

In a nother report provided by the employers

– a report prepared by the Composite Panel
Association

– it is shown that the wood paneling industry in BC employs 4

, 419 employees directly (as of November 2005). They state that the panel board plants which

are at risk are located in rur al BC, i n communities such as Grand Forks

, Quesnel, and
Smithers. These plants provide the base for economic activities in these areas and provide a much needed outlet for sawmill residues that were p reviously directed to beehive burners creating an environmental concern and wasting a valuable resource.

In a report received in the 1990‘s by WorkSafeBC from the Canadian Particle Board
Association

, it was estimated that the capital cost of complying in 1993 with an proposed Ceiling Limit of 0.3 ppm would be i n the order of C $676,000 per plant , with additional operating costs of C $335,000 per year (per plant) in BC

. It was stated at the time that the additional annual operating costs would largely be th e result of higher energy costs
associated with heating the additional air exhausted by the enhanced ventilation systems.

The employers suggest that achievability may be possible in plywood plants but is unlikely in particleboard plants and, correspondin gly, anticipate that the cost of compliance would be higher for the particleboard industry than for the oriented strand board and plywood industries. They also suggest (based on OSHA estimates) that theAttachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 26 of 69 greatest impact may be felt by the furniture industr y because it uses particleboard as a
raw material.

d ) Technical Issues Concerns have also been raised regarding the technical feasibility of monitoring exposure to and demonstrating compliance with such low levels of formaldehyde. It was suggested that unce rtainty about the accuracy and precision of monitoring data would pose problems from the standpoint of both compliance monitoring and enforcement.



### Workplace S ite Visit

O ccupational hygienists from WorkSafeBC visited a panel / fibre board plant in order t o assess the feasibility of implementing a lower TLV for formaldehyde

. As noted by the employer group at the September 30 th , 2005 meeting with WorkSafeBC staff, a particle or fibre board plant is likely to be the most challenged in meeting the proposed Ce iling Limit of 0.3 ppm.

Issu es identified During the Site Visit :

 Urea

- formaldehyde resin is used in large quantities in making medium density
fibre board ;

 The resin component is 10% by weight of a ty pical board or panel ; the balance is
wood fiber obtaine d from waste wood supplies (sawdust) from sawmills;

 Formaldehyde is released to the air in the plant at a number of l ocations along the process line; the initial mixing area, the panel press section, fabrication section (panels are cut into various sizes a nd sanded ), and packaging / shipping

area s ;

 Engineering controls are used throughout the plant primarily through the use of
ventilation , including wet scrubbing systems ;

 Ventilated air exhausted from the building exhaust is matched wi th an equal
amount of heated make

- up air provided to the plant; heat is supplied via natural

gas;

 Other engineering controls include enclosed control rooms and laboratory; these are positively pressurized via dedicated HVAC system s ;

 Staff spend most of their shift in these encl osed environments but enter the plant to take samples, oversee the process, carry out routine maintenance and similar job duties;

 Worker exposures are routinely measured by onsite environmental / occupational hygiene staff using a calibrated electronic ― fo rmaldemeter‖ and other sampling
devices ;

 Periodically, consultants will conduct worker exposure surveys;

 Exposure results are posted on staff bulletin boards and discussed at joint OH&S committee meetings;

 Sampling results indicate the following levels for the period Ja nuary to June 2006 (based on 7 to 14 readings per month at each location ; range indicated over the 6 month period ):

o Laboratory: ranged from 0.06

– 0.27 ppm ;

o Control room: 0.07

– 0.16 ppm ;

o Press infeed area: 0.23

– 0.30 ppm ;Attachment 1



### Appendix A

– Stakeholder Consultation and Feedback

July 2009

– OEL for formaldehyde Policy and Research Division Page 27 of 69

o Press outfeed area : 0.32

– 1.19 ppm ;

o Mezzanine: 0.23

– 0.35 ppm ;

o Catwalk over press: 0.39

– 0.63 ppm ;

o Sander station: 0.05

– 0.12 ppm ;

o Packaging station: 0.04

– 0.11 ppm ; and

o Mai ntenance shops: 0.03

– 0.06 ppm.

 Few workers work for a full shift in the open plant; hence their time spent in the open plant are conservatively estimated to be about 1⁄4 of a full shift or less, depending on the job tasks ;

 Practically

, thi s means an 8

- h our exposure well under 0.3 ppm on a time weighted basis ;

 The Ceiling Limit values of 1.0 ppm can be exceeded when a worker is located in a potentially high level area such as the press outfeed ;

 Workers who are required to work for longer periods in the plant are provided
with the appr opriate respiratory protection which is assigned based on the

p rotocols established by the plant‘s respiratory protection program;

 This plant would consistently be in non

- compliance if a Ceiling Limit of 0.3 ppm
with no 8

- h our TWA is enforced

.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 28 of 69 T his appendix details information on the p roposed OELs by reference org anizations such as the ACGIH, the German MAK Commission, and the UK WATCH 13 Committee among others.

Cancer Classification of Formaldehyde by Various Jurisdictions

Part 5 of the Occupational and Safety Regulation ( OHSR ) recognized the classification syst em for carcinogens based on the classification sy s tems of the ACGIH and the IARC

, both reference organizations

. Other jurisdictions have adopted classification systems
based on the recommendations by reference organizations other than the ACGIH or
IARC

. One of the most noteworthy is the classification system of the Scientific Committee on Occupational Exposure Limits ( ― SCOEL ‖ )

. SCOEL ‘ s recommendations on the carcinogen classification have been a dopted by the regulatory agencies of the EU
countries. Germ any based its classification system on that of the MAK Commission and other national research organizations such as the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertoung

– ―B fR ‖)

. 14 Table B1 provides an
overview of the carci nogen classif ication for formaldehyde by these reference organizations.

Table B1 . Current Classifications of the Carcinogenic Status for Formald ehyde

Reference
O rganization C

lassification
for Formaldehyde D escription

ACGIH A2 Suspected human carcinogen

– limited evidence of carcinogenicity in humans and sufficient evidence of carcinogenicit y in experimental animals with relevance to
humans in quality but are conflicting or insufficient to classify the substance as a confirmed human carcinogen.

IARC 1 Carcinogenic to man based on sufficient evidence in humans and in experimental animals. Sufficient evidence that formaldehyde causes nasopharyngeal cancer, strong but not sufficient evidence of leukemia, and limited
evidence of sinonasal cancer.

European Union

– SCOEL 3 Concern for man owing to possible carcinogenic effects but the available information is not adequate for making a satisfactory assessment. There is some evidence from appropriate animal studies but this is insufficient to place
the substanc e in Category 2 (suspected human carcinogen)

.

13 Working Group on Action to Control Chemicals Committee, a subcommittee of the Advisory Committee
on Toxic Substances of the UK Health & Safety Executive.

14 Federal Institute for Risk Assessment ( Bundesinstitut für Risikobewertung )

– Germany

.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 29 of 69 Reference
O rganization C

lassification
for Formaldehyde D escription

Dutch

- DECOS 15 3 As per SCOEL

German MAK
Commission 16 4 Genotoxicity plays no or at most a minor part. No significant contribution to human cancer is expected provided the MAK value is observed.

United King dom
H ealth & S

afety
E xecutive R40



### ( SCOEL ―3‖ ) Limited evidence of a carcinogenic effect in humans.

Similar to SCOEL.

Australia
NICNAS 17 2 Produces tumours in animals

– specifically nasal tumours at high concentrations.



### OEL Re ference Organiz ations

– Exp osure Limits for Formaldehyde

ACGIH ACGIH proposed a Ceiling Limit of 0.3 ppm for formaldehyde as far back as 1989 (a ―Notice of Intended Change‖ substance). The posted limits at the time were a TLV T WA of 1.0 ppm and a TLV STEL of 2.0 ppm. In 1992, ACG IH adopted the 0.3 ppm TLV Ceiling Limit. ACGIH has listed formaldehyde as a ―suspected human carcinogen‖ (A2)
since 1982. The basis for recommending a ceiling limit is outlined in the 2001 TLV Documentation©, and can be summarized, in part, as follows:

“ There is a substantial population, comprising up to 20% of the population, for whom airborne formaldehyde at concentrations on the order of 0.25 to 0.5 ppm is troublesome. Despite the intent of the TLV recommendations to protect most workers, it is beli eved that the recommended formaldehyde 0.3 ppm ceiling TLV will not protect that portion of the workforce reported to be responsive to low ambient concentrations of this chemical.

While the epidemiologic studies and case reports do not confirm that occupa tional exposure to formaldehyde is carcinogenic for human beings, several groups have reported that occupational formaldehyde exposure may be a factor in the potentiation or predisposition of upper respiratory tract cancer when a worker is also exposed to other known or suspected occupational carcinogens. Nevertheless, interpretation of the biologically based animal cancer risk

assessment data 18 indicates that the oncogenic potential of formaldehyde is a threshold phenomenon and that prevention of upper res piratory tract irritation and the associated regenerative hyperplasia should eliminate, for all practical purposes, any excess cancer risk posed by occupational formaldehyde exposure alone.

15 Dutch Expert Committee on Occupational Standards

. 16 Commission for the Investigation of Health Hazards of Chemical Compounds in t he Work Area, a reference organization of the German Research Foundation (FDR), Germany.

17 National Industrial Chemicals Notification and Assessment Scheme

. 18 CIIT study.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 30 of 69 ACGIH holds to the opinion that TLVs based on physical irritation should be considered no less binding than those based on physical impairment. There is increasing evidence that physical irritation may initiate, promote, or accelerate physical impairment through interaction with other chemical or biological agents. In asmuch as formaldehyde is associated with rapid onset of irritation, a ceiling designation is deemed appropriate for this chemical.

The recommended TLV

– Ceiling of 0.3 ppm for workplace air formaldehyde is based on evidence of irritation from reports of oc cupational exposure to formaldehyde as well as human formaldehyde exposures in other settings. This recommended TLV may not eliminate all worker complaints of sensory irritation associated with exposure to this chemical. However, ACGIH
believes that the 0.3 ppm ceiling value should result in a significant reduction of complaints currently associated with exposure to formaldehyde. The A2, Suspected Human Carcinogen, notation, based on cancer in experimental animals and where the epidemiologic studies are conflicting or insufficient to confirm an increased risk of cancer in workers, is considered appropriate for this chemical.

In light of the numerous reports of allergic reaction or sensitization associated with exposure to formaldehyde and products contai ning formaldehyde, the sensitizer notation (SEN) is recommended. Individuals who may already be sensitized or otherwise unusually responsive to formaldehyde may not be adequately protected from adverse health effects caused by formaldehyde exposures at or below the recommended TLV ”

.
As noted, the ACGIH based its decision on adopting its current TLV recommendation on experimental and epidemiological evidence up to and included data published no later
than the mid

- 90s. Many of the studies

– including studie s by the National Cancer Institute and those contemporary at the time (i.e., published prior to the mid

- 90s) on which the current ACGIH Ceiling Limit of 0.3 ppm adopted TLV is based

– have since
received critical re

- evaluations. Much new information has c ome to light since the mid

90s. The MAK Commission, responsible for recommending exposure limits in Germany, has completed recent reviews (published 2002, 2006), as discussed in Appendix B. Other evaluations have been completed including a 2004 review by the IRSST 19 in Quebec, DECOS 20 in 2003, DECOS/NEG 21 in 2003, WHO

- IPCS 22 in 2002, Environment Canada / Health Canada in 2001, Australia‘s NICNAS 23 in 2005, UK‘s WATCH 24
Committee in 2005, Australia‘s EPHC 25 in 2003, WHO / CICAD 26 and Germany‘s BfR 27

in 2006. OSHA i ssued a ―final Rule‖ on an OEL for formaldehyde in June 1992

. However, no further re

- evaluation has been conducted by this US regulatory agency.

With the exception of OSHA, most regulatory as well as reference agencies have utilized the new information, particularly the evidence provided by a pivotal study on the

19 Institute de Reserche Robert Sauvé en Santé et en Sécurité du Travail

– Quebec.

20 Dutch Expert Committee on Occupational Standards.

21 Nordic Expert Group

– Norway, Sweden and Finland.

22 International Programme on Chemical Safety

– World Health Organization

. 23 National Industrial Chemicals Notification and Assessment Scheme. Aust ralia.

24 Advisory Committee on Toxic Substances

– W orking Group o n Action to Control Chemicals, UK Health & Safety Commi ss ion, England.

25 Environmental Protection & Heritage Council, National Environmental Protection Measures

– Australia

. 26 Concise Inte rnational Chemical Assessment Document

– W orld Health Organization / International Labour Organization

. . 27 Federal Institute for Risk Assessment ( Bundesinstitut für Risikobewertung )

– Germany.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 31 of 69 carcinogenic process involving formaldehyde published by the CIIT 28 in 1999. This study is described in this Appendix

.

MAK Commission The MAK Commission recently reviewed the OEL and carcinogen ic status of formaldehyde. In its 2002 publication it declared formaldehyde a c ategory 4 carcinogen and prescribed an 8

- hour TWA of 0.3 ppm with a Ceiling Limit of 1.0 ppm. The MAK Commission considered ―that the genotoxicity of formaldehyde plays no or at most a minor part in its carcinogenic potential so that no significant contribution to human cancer risk is expected‖

. Formaldehyde is classified as a carcinogen category 4 of
Section III of the List of MAK and BAT Values. These OELs and carcinogen
cl assification has been adopted in Germany as regulatory values.

The 2006 MAK Commission report makes the following observations:

“ Evaluations of the data now available for the carcinogenic effects confirm that the occurrence of
tumours in the nasal mucosa of rats and mice are the result of chronic proliferative processes caused by the cytotoxic effects of formaldehyde. The dose

- response relationship for all the parameters investigated, such as damage to the nasal epithelium, cell proliferation, and tumour
incidence and also the formation of DNA cross

- links is very flat for low level exposures and become much steeper at higher levels of exposure. As long as the cellular proliferation rate is not
increased

– which requires exposure to concentrations in exce ss of 2 ppm

– the probability that
DNA

- protein crosslinks are transformed into mutations is considered low ”

.

In the low dose range, the MAK Commission states formaldehyde plays no or least a minor part in its carcinogenic potential so that no significant contribution to human cancer risk is expected. This conclusion is supported by the results of a risk assessment by CIIT (1999) which, for persons exposed to concentrations of 0.1 ppm at the workplace for 40 years, yielded a very low additional risk of ca ncer for non

- smokers of
1.3 x 10 - 8

. The Commission therefore classified formaldehyde in category 4.

In establishing a MAK for formaldehyde

– which also takes the carcinogenic risk into account, the avoidance of cellular proliferation is therefore decisiv e. The cause of cell proliferation is the irritative effect of the substance on the upper respiratory tract. The report states that f or this parameter the data base is insufficient for the establishment of
a MAK value. However, the database for the irri tative effects of formaldehyde on the

eye

– a more sensitive parameter

– is sufficient. Based on the Paustenbach’s et al study (1997) in which practically all workers were protected against eye irritation when exposed on a daily basis to a maximum concent rations of 0.3 ppm , the Commission established a MAK value of 0.3 ppm (8

- h our TWA). Concurrently, the STEL is set at 0.6 ppm and the Ceiling Limit at 1 ppm. At concentrations greater than 1 ppm, irritative effects are to be expected.

Due to the sensitiz ing effects on the skin, t he MAK Commission designated formaldehyde as a sensitizer

– “Sh”.

28 Chemical Industry Institute of Toxicology

– U SA

.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 32 of 69 The Commission also classified f ormald e hyde as a g erm cell category 5 mutagen , and report ed that in experimental exposures

– even at high exposure levels

– the equ ilibrium concentration maintained in the blood by endogenous formaldehyde (i.e., metabolically produced by the body) was not found to be increased. Due to the rapid metabolism it is also unlikely that even moderate exposure levels can increase the systemi cally available concentration noticeably. The Commission concluded that g iven observance to a MAK value of 0.3 ppm, exposure to airborne formaldehyde is not expected to make a noticeable contribution to the genetic risk for man.

WATCH Committee

– a Heal th & Safety Executive (HSE) Working Group, United Kingdom The WATCH Committee’s overall interpretation of the data from the post

- 2000 studies (which includes review by Hauptmann et al (2004), Marsh et al (2002)) is that they justify
increased concern for t he carcinogenic potential of formaldehyde in humans

– especially in relation to nasopharyngeal cancer

– but that it falls short of providing conclusive evidence that formaldehyde exposure has caused nasopharyngeal cancer. There are
inconsistencies in the findings of the studies which lack a clear explanation. Similarly, the Committee reports that the study by Coggon et al (2003)

– in a British cohort study of chemical industry workers

– provided no convincing evidence for an association between formaldehy de exposure and cancer in humans. The Committee also found the US garment worker cohort study by Pinkerton et a l (2004) unconvincing

. They found it essentially uninformative about the possible association between the substance and nasopharyngeal cancer.

In relation to the apparent association seen in some studies between formaldehyde exposure and leukemia, based on recent reviews of the evidence

, 29 and also considered biological plausibility, t he WATCH Committee considers that there is no basis for any concern for leukemia associated with formaldehyde exposure.

The Committee considers formaldehyde a genotoxic carcinogen for which a threshold
can be determined. No OELs appear to have been rec ommended for formaldehyde by
this Committee at this time.

The Committee recognizes that some authorities advocate approaches for deriving exposure standards for ―non

- threshold‖ genotoxic carcinogens based on mathematical modelling of animal carcinogenicity data to predict exposure levels associated with a predetermi ned level of risk in humans (e.g. excess lifetime risk of developing cancer of
10 - 5 or 10 - 6 ). These are the traditional linear extrapolation methods in deriving thresholds for carcinogens

– methods used by the US E nvironmental P rotection A gency (“ US

EPA”) and other agencies until the late 1990s at which time other methodologies became apparent such as those developed by the CIIT (1999). There are also ―model

free‖ linear extrapolation approaches, but both methods involve extensive extrapolation
below the observed range of data and both methods rest on the assumption of low dose linearity. Low dose linearity does not appear to apply to formaldehyde. The Committee
identified a number of concerns related to these metho ds that are elaborated below:

29 Includin g: Collins and Lineker (2004); Heck and Casanova (2004), Cole and Axten (2004); Marsh and Youk (2004).Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 33 of 69  These me thods all rely on an assumption of low

- dose linearity but at low exposures this assumption may not be correct. DNA repair mechanisms may
lead to a sub

- linear dose response at lower doses leading to overestimates of
risk.

 The risk estimates derived by mat hematical modelling or linear extrapolation lie far below the observed experimental range of data and can never be validated by empirical observation (to validate a lifetime increased risk of 10 - 5 or 10 - 6 would require far more than the 50 animals per sex per dose group used in standard carcinogenicity bioassays).

 These approaches do not adequately convey the uncertainties involved and so imply a level of precision that cannot be justified. A spurious impression of scientific accuracy is thereby conveyed

.

 The usual design of rodent carcinogenicity studies (low, medium and high dose groups of 50 per sex) cannot distinguish between the various mathematical models available in terms of identifying a model that provides the best fit to the
data.

 Although th e various models can be shown to fit the observed data equally well, these models can lead to risk estimates at low doses that vary over several orders of magnitude, and there is no way of knowing which model, if any, leads to a true approximation of risk.

The PRD is not aware of any OELs that have been recommended for formaldehyde by
the WATCH Committee at this time.

NOTE: The US

- EPA, Health Canada and other authorities either have adopted or are considering adopting the multi

- model biological model dev eloped by the CIIT in lieu of
the no

- threshold model which assumes that cancer risk is linear to zero. There is no
indicati on that IARC has considering the biological model.

German Federal Institute for Risk Assessment (BfR) / European Union Scientific
C ommittee for the Occupational Exposure Limits to Chemical Agents (SCOEL)
Both SCOEL and the B fR each issued review report s on formaldehyde in 2006

– SCOEL issued provisional OELs for formaldehyde

. The proposed draft is currently out for
consultation withi n Europe. The BfR report focuses more on public health and safety. Both organizations had similar findings and will therefore be discussed jointly here. As noted by both, in general, epidemiological data cannot be used to support the existence
of a thres hold for genotoxic carcinogenicity. It is not possible to “prove” the existence of
a threshold due to the statistical limitations. Hence, evidence concerning the existence of thresholds will need to be based on mechanistic and experimental rather than

ep idemiological data.

Both organizations conclude that the carcinogenic mechanism of formaldehyde is based on a combination of repeated exposures of cell proliferation due to local tissue irritation (cytotoxic effects ) of inhaled formaldehyde and also to t he formation of DPX (DNA

protein cross

- links). Hence the mechanism is a combination of non

- genotoxic and genotoxic events. Experimental animal evidence indicates a no observed adverse effectAttachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 34 of 69 level ( NOAEL 30 ) for cytotoxicity (non

- genotoxic effect) of 2 ppm

. However, a clear threshold for the induction of DPX (genotoxic effect) could not be identified but the dose

response data showed a steep increase in DPX formation only occurred at concentrations above 2 ppm. Increases in cell proliferation only occurre d at concentrations above 2.7 ppm. Taking other observations into account it was considered that there would be no increase in genotoxic changes at exposures below
the NOAEL 30 for cytotoxicity.

A clear threshold for respiratory tract cytotoxicity could not be identified in humans, and both authorities considered that the NOAEL for sensory irritation in humans could be used as a surrogate. A weight of evidence approach to the analysis of human data from
a number of volunteer studies (Paustenbach et al , 1 997) indicated a NOAEL for sensory irritation of 0.1 ppm. In the BfR assessment it was noted that the NOAEL for sensory irritation was not contraindicated by animal data indicating a threshold for cytotoxicity at 2 ppm. Overall, 0.1 ppm was proposed by B fR as a ―safe

- level‖ for exposure to formaldehyde in the general public. This, according to BfR, is in good agreement with the MAK value of 0.3 ppm for worker protection in the workplace. This is the regulated OEL for Germany

.

In their 2006 review, SCOE L stated that a NOAEL of 0.3 ppm for local irritancy is the departing point for setting an OEL. At the s ame time, SCOEL considers that the onset of eye irritation is a very sensitive parameter that provides a safety margin to the onset of
irritation

- induce d cel lular proliferation. Considering the "preferred value approach" in setting OELs, an OEL of 0.2 ppm is therefore proposed. Short

- term ir ritation may be prevented by an STEL of 0.4 ppm. At these levels, they state that no systemic effect of formaldehyde is to be expected. No European regulatory agency has yet adopted these
values.

WHO / CICAD 31 A ssessment on F ormaldehyde
Th e 2003 WHO report is based on the research conducted by Health Canada and
Environment Canada scientists in conjunction with US

- EPA, the CIIT among others

. It is
an omnibus review and considers the toxicological and other harmful properties of formaldehyde from both an environmental and human per s pective.

They report that based on inhalation studies in laboratory animals, formaldehyd e causes degenerative non

- neoplastic effects in mice and monkeys and nasal tumours in rats. In
vitro , formaldehyde induced DNA

– protein crosslinks, DNA single

- strand breaks, chromosomal aberrations, sister chromatid exchange, and gene mutations in both
huma n and rodent cells. Formaldehyde administered by inhalation or gavage to rats in
vivo induced chromosomal anomalies in lung cells and micronuclei in the gastrointestinal

mucosa.

The results of epidemiological studies in occupationally exposed population s are consistent with a pattern of weak positive responses for genotoxicity, with good evidence of an effect at site of contact (e.g., micronucleated buccal or nasal mucosal cells).

30 Postscript: erratum noted by Dr. Vyskocil

– NOAEL should read LOAEL (lowest

- observed

- adverse

effect

- level)

31 Concise International Chemical Assessmen t Document

– W HO / ILO

.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 35 of 69 Evidence for distal (i.e., systemic) effects is ambiguous

. Overall, based on studies in both animals and humans, formaldehyde is weakly genotoxic, with good evidence of an
effect at site of contact (i.e., within upper the respiratory tract) , but less convincing
evidence at distal sites (i.e. other body organs and tissues)

.

E p idemiological studies taken as a whole do not provide strong evidence for a causal association between formaldehyde exposure and human cancer, although the possibility of increased risk of respiratory cancers, particularly those of the upper respiratory tr act, cannot be excluded on the basis of available data. Therefore, based primarily upon data derived from laboratory studies, the inhalation of formaldehyde under conditions that induce cytotoxicity (generally levels above 2 to 3 ppm) and sustained regene rative proliferation is considered to present a carcinogenic hazard to humans.

The concentration response relationships for DNA

– protein crosslinking, cytotoxicity, proliferative response, and tumours are highly non

- linear, with significant increases in al l
end

- points being observed at conc entrations of 4 ppm and above

. This correlates well with the concentration at which mucociliary clearance is inhibited and glutathione

mediated metabolism sa turated (i.e., 4 ppm ). Histological changes, increased epithel ial cell proliferation, and DNA

– protein crosslinking are all more closely related to the exposure concentration than to the total cumulative intake or dos e of formaldehyde

. While the respective roles of DNA

– protein crosslinking, mutation, and cellular prol iferation in the induction of tumours in the rat nose are not fully delineated, the hypothesized mode of carcinogenesis is in keeping with the growing body of evidence supporting the biological plausibility that prolonged regenerative cell proliferation ca n be a causal mechanism in chemical carcinogenesis.

Regenerative cell proliferation following formaldehyde

- induced cytotoxicity increases the number of DNA replications and thus increases the probability of a DNA

– protein crosslink initiating a DNA replica tion error, resulting in a mutation. This proposed mode of action is consistent with the observed inhibition of DNA replication in the rat nose at
elevated concent rations and point mutations in the p53 tumour suppressor gene in
tumours from the noses of r ats exposed to fo rmaldehyde as well as increased p53 expression in pre

- neopla stic lesions

.

The hypothesized mode of induction of formaldehyde

- induced tumours that satisfies several criteria for weight of evidence, including consistency, concordance of exp osure

– response relationships across intermediate end

- points, and biological plausibility and coherence of the database, is likely relevant to humans, at least qualitatively. Increased cell prolifer ation and DNA

– protein crosslink fo rmation within epithelia of the upper respiratory tract have been observed in monkeys exposed to formaldehyde vapour. Although not sufficient in itself as a basis for inferring causality, direct evidence on histopathological lesions in the nose of humans exposed primarily to form aldehyde in the occupational environment is consistent with a qualitatively similar response of the upper respiratory tract in humans and experimental animals to formaldehyde. Increased human epithelial cell proliferation following in situ exposure to for maldehyde has also been observed in a model system in which rat trachea populated with human tracheobronchial epithelial cells were xenotransplante d into athymic (thymus gland removed) mice.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 36 of 69 Because formaldehyde is highly reactive at the site of contact, dosimetry is of critical importance when extrapolating across species that have significantly different anatomical features of the nasal and respiratory passages and patterns of flow of
inhaled air. Since humans as well as other primates are oro

- nasal bre athers, compared with rats, which are obligate nose breathers, effects associated with the inhalation of formaldehyde are likely to be observed in a larger area, including deeper parts of the respiratory tract. Indeed, in rats exposed to moderate levels of formaldehyde, histopathological changes, increased epithelial cell proliferation, and DNA

– protein crosslink formation are restricted to the nasal cavity; in formaldehyde

- exposed monkeys (as surrogates for humans), on the other hand, these effects have bee n observed further along within the upper respiratory tract. While the epidemiological studies taken as a whole do not provide strong evidence for a causal association between formaldehyde exposure and human cancer, the possibility of increased risk of re spiratory cancers, particularly those of the upper respiratory tract, cannot be excluded on the basis of
available data.

The CI CAD report concludes : Based primarily upon data derived from laboratory studies, therefore, the inhalation of formaldehyde under conditions that induce cytotoxicity and sustained regenerative proliferation is considered to present a carcinogenic hazard to humans. CICAD did not recommend OEL values for formaldehyde.

Dutch Expert Committee on Occupational Standards ( DECOS ) and the Nordic Expert Group in Conjunction with DECOS
DECOS completed a comprehensive review on formaldehyde published in 2003. Concurrently NEG issued a similar review report on the substance with similar findings
and conclusions. Both DECOS and NEG are research organization charged with the review of OELs and recommending OELs for regulatory consideration by the authorities in their perspective countries.

DECOS and NEG make similar conc lusions to those of WHO / CICAD and CIIT on the
health eff ects of formaldeh yde

.

In view of the evidence in experimental animals and humans, and a thorough and critical appraisal of the available data, DECOS posed a question:

 D oes an exposure limit of 0.12 ppm protect workers against cytotoxicity

- induced hyper

- proliferation of the nasal respiratory epithelium, and consequently also against the potential risk of nasal cancer?

Their answer is in the positive, and DECOS considers a health based 8

- hour TWA occupational exposure level (HBR

- OEL) of 0.12 ppm formaldehyde low enough to protect workers against nasal tissue damage, and as a consequence, also against the potential risk of nasal cancer. DECOS states that this conclusion is strongly supported by the results of a recently published quantitative cancer risk assessment of airb orne formaldehyde, using a very sophisticated biologically

- based model that predicts for occupational exposure (40 years beginning at the age of 18, 8 hours/day, 5 days/week)Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 37 of 69 to 0.1 ppm formaldehyde an increased lifetime risk for cancer of 10 - 7 for smokers and 4.1
x 10 - 9 for non

- smokers (CIIT, 1999), which are regarded as negligibly small risks.

To avoid peak exposures possibly entailing cytotoxicity

- induced hyper

- proliferation and metaplasia of the nasal respiratory epithelium, DECOS recommends for formal dehyde a STEL, using data from the review of Paustenbach et al 1997, and others. The review of Paustenbach suggested that at a concentration of 1.0 ppm sensory effects might occur. The committee concluded that the total body of e vidence indicates that 0.4 2 ppm is an exposure level which is low enough to avoid significant sensory irritation from short term exposures and thus, more importantly, also will be low enough to avoid nasal cytotoxicity from such short exposures. In conclusion, the committee consid ers a factor of 2 sufficient for the extrapolation from lowest observed adverse effect level (― LOAEL ‖ ) to
the no

- adverse

- effect

- level ( ― NAEL ‖ )

. Therefore, DECOS recommends a STEL of
0.42 ppm.

Conclusion: DECOS recommends a health

- based occupati onal exp osure limit of 0.12

ppm formaldehyde, as an 8 hour time

- weighted average, and a short term exposure
li mit, 15 minutes TWA, of 0.42 ppm

. Neither Holland nor the Nordic countries, including Sweden, Norway or Finland have adopted these OELs for regulatory pu rposes.

National Industrial Chemical Notification Assessment Scheme (NICNAS) of the Australian Dep ar t ment of Health and Aging NICNAS, a refer ence agency for the Australian government, released its draft Formaldehyde Priority Existing Chemical As sessment Report in 2005 for stakeholder and public consultation. It released a response report in November of that year. While their consultation period is still active, NICNAS has made the following statements that are germane to this review:

 In order to classif y a chemical as a category 1 carcinogen, there must be sufficient human evidence to establish a causal association between exposure to
the chemical and cancer.

 NICNAS concluded that the strength of the epidemiology data was not sufficient
to establish a ca sual relationship between formaldehyde exposure and cancer in
humans

. For nasopharyngeal cancers there are several epidemiological studies that show an increased risk, whereas other studies do not.

 Of the three recently published cohorts, only the NCI st udy (Hauptmann et al

, 2004) showed an increased risk of nasopharyngeal cancers and this was associated with increased average exposure intensity and highest peak

exposures.

 Marsh and Youk (2005) revaluated the data of the NCI study and concluded that
ther e was little support for NCI‘s suggestion of a causal relationship between formaldehyde exposure and mortality from nasopharyngeal cancer.

 Coggon et al (2003 ) and Pinkerton et al (2004) did not observe an increased risk for nasopharyngeal cancers.

 There are also concerns for an increased risk for formaldehyde

- induced myeloid
leukemia. However, the available data are not considered sufficient to establish an association and there is currently no postulated mode of action to support
such an effect.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 38 of 69  Theref ore, it is considered that there is currently insufficient evidence to establish a causal association between human exposure and the development of cancer on the basis of epidemiological data.

 While they acknowledge the fact that it is difficult to identif y a definitive no observed effect level (― NOEL ‖) for sensory irritation, they have taken a cautionary approach and selected 0.5 ppm as the lowest observed effect level ( ― LOEL ‖ ) and added appropriate uncertainty factors to establish the recommended occupati onal exposure standard (8

- h our TWA) as 0.3 ppm. This value provides a level that will not only manage the risk of sensory irritation, but also manage
the cancer risk.

 NICNAS considers the clonal growth model developed by CIIT and further developed by Cono lly et al , 2004 the best estimate of cancer risk for formaldehyde.

 The clonal growth model predicts that for 40

- year occupational exposure to 0.3

ppm formaldehyde (the NICNAS recommended occupational exposure standard)
the estimated additional risk for re spiratory tract cancers is approximately 2 in 10
million.

 While at 1 ppm (the current Australian occupational exposure standard) the
estimated additional risk is approximately 50 in a million. Similarly for public exposure, at the recommended indoor air guidance value (80 ppb or 0.08 ppm ),
the estimated additional risk is approximately 3 in 10 million.

 A lthough NICNAS considers the risk of cancer to be low, they do not consider that the strength of data nor the degree of certainty is sufficient to conclud e that the cancer risk is negligible.

 Based on the information, NICNAS is showing support for an 8

- h our TWA of 0.3 ppm and a 0.6 p pm STEL and that formaldehyde be classified as a c ategory 2 carcinogen (producing tumours in animals

– specifically nasal tumo urs at high concentrations).

 In the draft, NICNAS makes the following statement:

o ― In order to protect the majority of workers from sensory irritation, the
recommended exposure standard should be a concentration that is a
lower than the LOEL identified. As this is a reversible effect and effects are generally mild at 0.5 ppm, the standard should be slightly lower than
the LOEL. For these reasons the recommended exposure standard is 0.3 ppm TWA and 0.6 ppm STEL. At this level, the nasal cancer risk can be also managed. Furthermore the recommended exposure standards are
consistent with best practice overseas and from industry information submitted for this report appear technically achievable in most Australian workplaces

. ‖

This statement is similar to tha t of the MAK Commission. They conclude by stating that
there is an ongoing follow

- up for the NCI study, which is likely to be published in 2007

. NICNAS believes it is important to review the NCI data and any other significant epidemiological date, when th ey become available. The y propose that the following text be added to section 19, Secondary Notification:

―NICNAS should re

- evaluate the cancer hazard classification if and whe n any

new significant epidemiology data becomes available.‖Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 39 of 69 Conclusion: NICNA S recommends an 8

- h our TWA OEL of 0.3 ppm and a STEL of 0.6 ppm and classify formaldehyde as a c ategory 2 carcinogen. This is a similar conclusion
to that of the MAK Commission.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 40 of 69 IRSST

– Q uebec
This study, commissioned by the IRSST, was completed by res earch scientists at the
Université de Montréal. It was initially published in 2004 in French with an English version issued January 2006.

Overall, the project aimed to evaluate the impact of lowering the current Quebec Commission of Health and Safety pe rmissible exposure value

– Ceiling Limit for formaldehyde, wh ich is currently set at 2 ppm ; they are considering setting it to 1 .0 , 0.75 or 0.3 ppm

. The objective of this study was to estimate as precisely as possible the
dose

- response relationship betwee n exposure to formaldehyde and the appearance of
health

- related effects in workers

.

A series of criteria was established in order to select and classify the parameters based

on their scientific qualities; statistical analyses were conducted in order to es tablish this

exposure

- response relationship for the earliest effects after an acute exposure, i.e.

, the irritating effects. The determination of the risk of cancer after a long

- term exposure was obtained by considering dose

- response relationships provided by different agencies and by applying them to the Quebec data.

The IR S ST notes the following:

 The study data systematically defines the dose

- response relationship, allowing calculation of responses attributable to formaldehyde according to the site of th e irritative effect (eye, nose, throat);

 They conclude that for concentrations less than 0.75 ppm, the frequency of
irritation in workers exposed to formaldehyde was about the same one observed in individuals without occupational exposure, indicating that appearance of irritation at such concentrations can hardly be associated with occupational exposure to the substance;

 Among the workers exposed to a formaldehyde concentration between 0.75 and <1.0 ppm, 6.3% are likely to experience moderate eye irritatio ns;

 N one would be likely to experience severe eye irritations and 1.6% would have
modera te nose and throat irritations;

 As shown i n Figure B2

,

o Between 0 to less than 0.75 ppm no irritating effects are noted;

o B etween 1 ppm and less than 2.0 ppm, 10.1% exp erienced moderate eye irritation, 0.8% severe eye irritation, 4.5% moderate nose irritation and 4.6 % moderate throat irritation;

o Above 2 ppm a corresponding increase in responses are noted.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 41 of 69 Figure B2 : Average theoretical percentage of the exposed popula tion that is likely to experience irritating eye, nose or throat effects attributable exclusively to formaldehyde according to the severity of the effec t for a given class of exposure (adapted from IR S ST 2006).

 From a compensation claims perspective, I RSST notes that complaints due to formaldehyde exposure reported to the CSST (Quebec Commission of Health and Occupational Safety) are rather rare. As for cases of protective reassignment, 11 cases were reported in four years among six CAEQ (Quebec
Econom ic Activities Classification) codes, four business sectors and nine different occupations

. No cases of occupational illness that were attributable to formaldehyde were reported in the same period.

 On the basis of the epidemiological data in literature and the position of several agencies of toxicological risk evaluation, there is limited evidence of formaldehyde‘s carcinogenic effects on humans.

 I f one refers to the exposure data of the IRSST , the probability of frequent exposure to the ceiling values indi cated in the matrices is low. The duration of the ceiling values in these matrices is about one minute each. In other words, a worker exposed to an average value for eight hours that was low, cannot have been exposed to ceiling values of a relatively hig h frequency and intensity. Otherwise, the average would be higher.

 ACGIH also evaluated the health impa ct of formaldehyde exposure

. The majority of the studies selected and analyzed for this evaluation were the same as the

ones the IRSST selected. The co nclusions of these studies are therefore the same between the ACGIH analysis and this analysis. However, ACGIH went one step further than scientific evaluation. They proposed a recommendation of an acceptable Ceiling Limit of 0.3 ppm based on their own i nterpretation of the
data. This recommendation is based on the desire to avoid a maximum of
irritations in workers. This includes even the mildest irritation, given that some studies showed that the most sensitive people complained of irritation at

conce ntrations as low as 0.3 ppm, without taking into account the degree ofAttachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 42 of 69 severity of effects (only the presence or absence of effect is taken into account, without giving more weight to more severe effects), or the population response at background level (in controlled studies, an equal or a higher incidence was observed at 0 ppm than at 0.3 ppm.). In addition, the quality difference between
the controlled studies and the studies involving workers was not taken into account in the process of risk evaluation. The ACGIH therefore recommends a ceiling value of 0.3 ppm and specifies ―concentrations should be reduced to the lowest levels detectable by the measuring equipment.‖

 IR S ST‘s analysis of the selected epidemiological studies demonstrates that some
studies showed an association between formaldehyde exposure and cancer, while other studies did not show such a relationship. Nevertheless, all these epidemiological studies have methodological limitations that reduce the
confidence level of the results. These limitations are mainly lack of power, the presence of confounding factors, the fact that an effect is observed in the least exposed groups and but no effect in the most exposed groups, the lack of measurement of exposure level in numerous cases, or sporadi c measurements. Consequently, there is limited proof of the carcinogenic potential of formaldehyde in epidemiological studies but it is not possible, based on epidemiological studies, to establish a dose

- response relationship between formaldehyde

ex posure and the onset of cancer

.

 B ecause of the inconsistencies among the results of the epidemiology studies regarding the association and strength of association, frequent methodological limitations such as lack of power and a limited determination of actual exp osure, the inability of cohort studies to observe an increased risk because the studied types of cancer are rare, and the lack of a dose

- response relationship that increases with increasing doses, the evidence for a causal association is very limited, alth ough it cannot be entirely excluded. In animals, the proof of a causal relationship appeared sufficient to us, but the increase in cancer was observed only at high concentrations. The cellular alterations in the tissues of the respiratory tract make this relationship plausible. It must be remembered, however, that the concentrations at which an excess of cancer was observed in
animals also induce severe irritation. These factors can contribute to a significant increase in cancer risk through an epigeneti c or promoter mechanism.

 These observations suggest that at concentrations at which irritation is low or

non

- existent, the cancer risk, if any, increases more slowly with the increase in dose than when irritation is severe and chronically present. At the concentrations at which cancer was observed in animals (5.6 ppm and higher), no worker could remain in his work environment, because irritation to the respiratory tract and eyes would be completely intolerable.

 A s far as the estimations of excess risk are concerned, based on high

- to

- low dose mathematical extrapolation models, the CIIT model appears more appropriate than the US EPA model in estimating the workers‘ risk. This is especially true since the estimates of this model for low doses approach the
le vels of excess risk observed in the epidemiological studies where a positive
statistical association was observed.

Conclusion: The IRSST concludes that f or concentrations less than 0.75 ppm, the frequency of irritation in workers exposed to formaldehyde w as about the same oneAttachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 43 of 69 observed in individuals without occupational exposure. There is no indication that the IRSST has made recommendations regarding OELs.

Summary of Recommendations of OELs for For maldehyde by Reference Organizations.
Table B3 summari zes recommendations for occupational exposure limits from the ACGIH and other reference agencies from Europe, the United Kingdom, Quebec and
Australia. The MAK Commission recommendation s (adopted as regulated OELs in Germany) are identical with the recomm endation s by NICNAS with the exception that the Australian organization did not recommend a Ceiling Limit value. The MAK recommendation is identical to the currently prescribed OELs in British Columbia

- in place si nce 1998. The WATCH Committee has not r ecommended OELs at this point;
nor has the IRSST.

Table B3 : OELs recommended by reference organizations

Reference
O rganization 8

- h TWA OEL

ppm STEL OEL

ppm Ceiling Limit

OEL ppm

ACGIH

- USA

- - 0.3

DECOS

- Holland 0.12 0.42

-

MAK Commission 32

- Germany 0.3 0.6 1

SCOEL

- EU 0.2 0.4

-

NICNAS

- Australia 0.3 0.6

-

WATCH

- UK

- - -

IRSST

- Quebec

- - -



### Non

- Reference Organization s

For the purposes of reviewing the health effects of formaldehyde and considerations for setting an appropriately protective occupational exposure limits for the substance

, two critical studies referenced by WATCH, DECOS, NEG, and other s reviewed above, are brought into this discussion.

Chemical Institute of Toxicology 1997 report:
Derivation of the dose

– response model and sel ection of various parameters as it relates to formaldehyde are presented in this 336 page omnibus study undertaken by the C IIT in conjunction with scientists from the US E P A, Health Canada, Universi ty of Pittsburgh

32 Adopted by the German regulatory agency

- Deutsche Forschungemeinschaft (DFG)

.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 44 of 69 and other s

. O nly a brief summary is prov ided here. Basically, the CIIT model (which incorporates various toxicological, mechanistic and dosimetric parameters) has superseded earlier models such as the ―no threshold‖ model that assumes that cancer risk is linear to zero as used by the US EPA, th e NCI and most regulatory agencies
since the 1970s. This is de spite the fact that it has been recognized that tumour dose

– response relationship is highly non

- linear. Since then, a great deal of research has
focused on better chara cterizing the factors th at play a role in the etiology of nasal

tumo u rs so that a better understanding of the likely shape of the dose response curve in the low dose region can be determined. This includes additional research on the induction, persistence, and repair of DNA

- prot ein crosslinks ( ― DPX ‖ ) at low and high concentrations and for acute and longer

- term exposures. It also includes research on the induction of cell proliferation, which is considered to be an essential precursor event to the development of cancer in rats and other species, including humans

.

The CIIT multi

- modal model is considered by many to be a far more powerful and precise predictor of cancer risks and greatly minimizes the need for unfounded assumptions and uncertainties as in currently used regulatory a pproaches to carcinogens

– the ―no threshold‖ model. The CIIT model for formaldehyde predicts a risk for cancer a 1,000

- fold less than the EPA prediction.

CIIT‘s clonal growth model is similar to other biologically based, two

- stage clonal growth
models (also known as Moolgavkar

– Knudsen

– Venzon ( MVK ) models), incorporating information on normal growth, cell cycle time, and cells at risk (in various regions of the respiratory tract). In modelling, f ormaldehyde is assumed t o act as a direct mutagen,
wit h the effect considered proportional to the estimated tissue concentration of DPX

. The concentration

- response curve for D PX formation is linear at low exposure concentrations and increases in a greater than linear manner at high concentrations,
similar to those concentrations administered in the rodent carcinogenicity bioassays. For cytotoxicity and subsequent regenerative cellular proliferation associated with exposure to formaldehyde, the non

- linear, disproportionate increase in response at higher conce ntrations is incorporated. Values for parameters related to the effects of formaldehyde exposure upon the mutagenic (i.e., DPX formation) and proliferative response (i.e., regenerative cell proliferation resulting from formaldehyde

- induced cytotoxicity) w ere derived from a two

- stage clonal growth model developed for rats

, which describes the formation of nasal tumours in animals exposed to formaldehyde.

Species

- specific dosimetry within various regions of the respiratory tract in laboratory
animals and hu mans was also incorporated. Regional dose is a function of the amount of formaldehyde delivered by inhaled air and the absorption characteristics of the lining within various regions of the respiratory tract. The amount of formaldehyde delivered by
inhal ed air depends upon major airflow patterns, air

- phase diffusion, and absorption at
the air

– lining interface. The ―dose‖ (flux) of formaldehyde to cells depends upon the
amount absorbed at the air

- lining interface, mucus/tissue

- phase diffusion, chemical
in teractions such as reactions and solubility, and clearance rates. Species differences in
these factors influence the site

- specific distribution of lesions.

The F344 rat and rhesus monkey nasal surface for one side of the nose and the nasal
surface for bo th sides of the human nose were mapped at high resolution to developAttachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 45 of 69 three

- dimensional, anatomically accurate computational fluid dynamics ( ― CFD ‖ ) models of rat, primate, and human nasal airflow and inhaled gas uptake

. The approximate locations of squamou s epithelium and the portion of squamous epithelium coated with

mucus were mapped onto the reconstructed nasal geometry of the CFD models. These CFD models provide a means for estimating the amount of inhaled gas reaching any site along the nasal passage walls and allow the direct extrapolation of exposures
associated with tissue damage from animals to humans via regional nasal uptake. Although development of the two

- stage clonal growth modelling for rats required analysis of only the nasal cavity (rats be ing obligate nose breathers) , for human s carcinogenic risks were based on estimates of formaldehyde dose to regions (i.e., regional flux) along the entire respiratory tract.

The human clo nal growth modelling (Figure B4 ) predicts the additional risk of
for maldehyde

- induced cancer within the respiratory tract under various exposure
scenarios. Two of the parameters in the human clonal growth model

– t he probability of mutation per cell division and the growth advantage for pre

- neoplastic cells, both in the

a bsence of form aldehyde exposure

– w ere estimated statistically by fitting the model to
human 5

- year age group lung cancer incidence data for non

- smokers. The parameter representing the time for a malignant cell to expand clonally into a clinically detecta ble tumour was set at 3.5 years.

Figure B4 : Roadmap (conceptual framework) for the human clonal growth model

.

The figure shows i nterrelationships of the major components of the dosimetry and clonal growth models used to model tumor incidence in humans

. The gray boxes indicate components of the human program that use data from rats or monkeys for cases whereAttachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 46 of 69 the equivalent human data were not available. CFD = computational fluid dynamics;
DPX = DNA

- protein cross

- linking (from CIIT, 1999 and CICAD, 200 2).

Estimates of carcinogenic risks using the human clonal growth model were developed for typical environmental exposures (i.e., continuous exposure throughout an 80

- year lifetime to concentrations of formaldehyde ranging from 0.001 to 0.1 ppm ). The hum an clonal growth model describes a low

- dose, linear carcinogenic response for humans exposed to levels of formaldehyde of 0.1 ppm , where cytotoxicity and sustained cellular regenerative proliferation do not appear to play a role in tumour induction. Indee d, the effect of formaldehyde upon regenerative cellular proliferation did not have a significant impact upon the predicted carcinogenic risks at exposures between 0.001 and 0.1 ppm.

Conclusion: Based on the multi

- modal model, CIIT considers that formald ehyde exposure poses a carcinogenic effect only under conditions that both induce toxicity and cause sustained regenerative proliferation (damage in the DNA replication process).

NOTE: The CIIT model for carcinogenicity has been widely used by other age ncies and organizations ( e.g., Environment Canada / Health Canada 2002, CICAD 2002, NICNAS 2005) as a more reliable estimate of cancer risk for formaldehyde exposures than the standard default assumptions used by the EPA and others in the past

.

Paustenba ch et al 1997 study: This study presents the findings of a panel of scientists to identify an occupational exposure limit for formaldehyde that would prevent irritation. Upon review of 150 papers published on irritant effects of formaldehyde, the panel fe lt that 18 were pertinent in developing an exposure limit based on irritation. They concluded that, for most persons, the eye is the most sensitive indicator of irritation

. They report that moderate to severe eye, nose, and throat irritation does not occ ur until airborne concentrations exceed 2 to 3

ppm. They also opined that at levels up to 0.3 ppm there is no increase in eye irritation above background. Nevertheless, studies of exposures ranging from 0.3 ppm to 0.5 ppm showed tremendous variability w ith reported irritation responses ranging from
0 to 90%.

The weight of evidence concentration

- response curve considered by the panel showed that 5 to 25% of workers could report eye irritation in the 0.5 to 1.0 ppm range following 1⁄4 to 6 hours of exposu re and that eye irritation does not become significant until levels of formaldehyde reach at least 1 ppm. The panel concluded that at a level of 1 ppm would avoid eye irritation in at least 75% and up to 95% of exposed workers.

The panel subsequently put forth a position that they felt that the ACGIH TLV of 0.3 ppm (ceiling) was unnecessarily restrictive and they recommended an exposure limit of 0.3 ppm (8

- hour time

- weighted average) with a ceiling limit of 1 ppm. They also put forward the position that any occupational or environmental guideline for formaldehyde should be based primarily on controlled experimental studies in humans since nearly all other studies are compromised by the presence of other contaminants.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 47 of 69 Conclusion: A level of 1 ppm avoids e ye irritation in at least 75% and up to 95% of exposed workers. The panel recommended an 8

- h our TWA OEL of 0.3 pp m with a ceiling limit of 1 ppm.

Arts et al

, 2006 study: Following the Paustenbach et al 1997 study, t his peer

- reviewed article by scientist s at
the Netherlands Organization for Applied Scientific Research ( ― TNO ‖ ) evaluated the adverse health effects of formaldehyde exposure including sensory irritation and the potential for tumour development in the upper respiratory tract, comparing animal d ata with subjectively measured sensory irritation thresholds in humans. They also looked at benchmark dose analysis ( ― BMD ‖ ) of sensory irritation

– a mathematical model approach
to fit ting experimental data, plotting response against dosage.

Findings of the study are as follows:

 The absolute odour threshold for formaldehyde, defined as the concentration at which a group of observers can detect the odour in 50% of the presentations, has
been shown to be betwe en 0.05 and 0.18 ppm

.

 Formaldehyde is irritatin g to the eyes and respiratory tract. Respiratory tract
irritation on the one hand is a localized patho

- physiological response to a chemical involving local redness , swelling, pruritis, or pain

.

 On the other hand, respiratory tract irritation and eye irri tation can also involve a chemosensory effect, i.e. interaction with local nerve endings ( nervus trigeminus ) which is called trigeminal stimulation or sensory irritation.

 Over a broad range o f concentrations, the trigeminal nerve stimulation will not

neces sarily lead to cell or tissue damage. In contrast, it will lead to a reduction in the breathing frequency aimed to reduce the total amount of inhaled material in order to protect the individual.

 For several odorous irritating chemicals , such as formaldehy de , substantial differences in the lowest concentration found to be irritating to eyes, nose and/or
throat in humans exist.

 These observations can generally not be explained by differences in method sensitivity, inherent variability in biological response, or fluctuations in the exposure concentrations. These chemicals usually have a strong odour, and at least part of the wide variation in the findings may be ascribed to insufficient distinction between olfactory and trigeminal stimulation in several of th e studies.

 The response at low formaldehyde levels should therefore be translated into perception or awareness rather than an annoying eye or nasal irritating reaction.

 It can, therefore, be concluded that when minimal/mild/slight irritation, which is
stil l not annoying, is taken as a cut off level, eye and nasal irritation were found at formaldehyde levels of equal to / greater than ( ≥ ) 1 and equal to / greater ( ≥ ) 2

ppm, respectively , with the annotation that the threshold level of 1 ppm for eye
irritation was based on the study by Bender et al. (1983) using pre

- selected
volunteers. Using the same reasoning, the minimal/mild/slight i rritation level
would be equal to / greater than ( ≥ ) 3 ppm formaldehyde for throat irritation, whereas levels of up to 3 ppm did not result in dyspnea (chest tightness / discomfort) or cough (Sauder et al., 1986; Kulle et al., 1987; Kulle, 1993).

 A similar conclusion was reached by Paustenbach

.Attachment 1



### Appendix B

– Formaldehyde OELs and Carcinogen Status According to Various Regulatory Jurisdictions and Reference Organizations

July 2009

– OEL for formaldehyde Policy and Research Division Page 48 of 69  A t concentrations below 1 ppm, symptoms disappeared very quickly, underlining
the non

- adversity of the effects at low concentrations.

 S ensory irritation

, as perceived by human subjects, can be st rongly influenced by subjective feelings and interpretations when subjected to substances with strong, distinctive odours such as formaldehyde, it is a difficult job to set occupatio nal exposure limits for odorous substances.

 A sthmatics do not seem to be more sensitive to for maldehyde than non

asthmatics exposed to concentrations up to 3 ppm

.

 T he NOEL for respiratory epithelial hyper/metaplasia found in long

- term inhalation toxicity studies in rats suggests that formaldehyde is carcinogenic only at cytotoxic levels, i.e. at le vels at which sustained regenerative epithelial

pro liferation is observed (≥6 ppm).

 Therefore, based primarily upon data derived from animal studies, inhalation of formaldehyde under conditions that induce cytotoxicity and sustained regenerative epithelial proliferation within the respiratory tract is cons idered to represent a carcinogenic hazard to humans. Airborne levels of formaldehyde below 1 ppm, therefore, seem low enough to protect workers against nasal tissue damage, and consequently, also against the potential risk of nasal cancer.

Table B4 : Summ ary of effect levels of formaldehyde in humans and rats (from Arts
et al , 2006)

Conclusion: The report by Arts et al indicates that a irborne levels of formaldehyde below 1 ppm appear are low enough to protect workers against nasal tissue damage, and

con sequently, also against the potential risk of nasal cancerAttachment 1



### Appendix C

– Chemical Characteristics, Routes of Entry , Biochemical Pathways, Chronic and Adverse Health Effects Associated with Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 49 of 69 Sections C1 and C2 summarize information from a number of sources including ASTDR 1999, ACGIH 2001, IARC 1995, DECOS 2003, NEG / DECOS 2003, ECOTEC 1995, CITT 1999, MAK Commission 20 02 / 2006

, W HO 2003 , Health Canada / Environment
Canada 1999

, and SCOEL 2006. Since many of these organizations provide very similar information germane to the topics outlined in this appendix, no effort has been
made to identify and distinguish specific reference s

.



### C1: Chemical Characteristics of Formaldehyde :

 Formaldehyde (CAS No. 50

- 0

- 0) is a colourless, highly flammable gas ;

 Formaldehyde enters the environment from natural sources (including forest fires) and from direct human sources, such as automotive and othe r fuel
combustion and industrial uses;

 S econdary formation also occurs by the oxidation of natural and anthropogenic organic compounds present in air. The highest concentrations measured in the environment occur near anthropogenic sources; these are of p rime concern for the exp osure of humans and other biota;

 Formaldehyde does not persist in the environment

.



### C2: Routes of Entry, Biochemical Pathways , Elimination of Formaldehyde :

Exogenous Formaldehyde (sources external to the body)

 External sources of f ormaldehyde enter either the body via inhalation of gaseous or vaporous formaldehyde or via ingestion of formaldehyde

- containing
substances ;

 There is some potential for dermal absorption, but this has not been well
characterized ;

 The substance is rapidly a nd almost entirely absorbed following exposure by
both the oral and inhalation routes.

Endogenous Formaldehyde (sources internal to the body)

 Formaldehyde is produced endogenous within the body , a product of normal metabolism;

 It is an essential metabolic intermediate present in all cells and is readily incorporated into macromolecules via normal metabolic pathways. Endogenous sources of formaldehyde include the metabolism of serine, glycine, methionine, and choline; it is also produced by the demethylati on of N

- , 0

- , and S

- methyl compounds;

 Formaldehyde is an essential intermediate in the biosynthesis of purines, thymidine, and some amino acids ;

 Because formaldehyde is a normal metabolic intermediate, it is not stored in any tissue to an appreciable exten t;

 Hence, the substance is always present in the body and exists in all organs and
tis sues at qu antifiable levels (2

– 3 μg/g range in humans; similar levels in the rat and monkey )

.Attachment 1



### Appendix C

– Chemical Characteristics, Routes of Entry , Biochemical Pathways, Chronic and Adverse Health Effects Associated with Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 50 of 69 Absorption

 Due to its highly hydrophilic (―water loving‖) nature, inhaled formaldehyde is rapidly and almost entirely absorbed in the respiratory tract. In obligate nas al breathers ( ― nose breathing only ‖ ) such as rats, formaldehyde is almost completely absorbed in the nasal passages; in monkeys ( ― oronasal breathers ‖ )

, absorption occurs primarily in the nasal passages but also to a lesser extent in the trachea and proxima l regions of the major bronchi ;

 The species

- specific differences in the actual sites of formaldehyde uptake, and hence sites of nasal lesions, are determined by complex interactions among nasal anatomy, ventilation, and breathing patterns (e.g., nasal vers us oronasal) ;

 Humans are oronasal breathers, such that there is a greater potential for formaldehyde to impact the oropharynx and portions of the lower respiratory tract, specifically the tracheobronchial region. The degree to which humans use
oral versus nasal breathing is generally affected by activity patterns, with a greater ventilatory drive requ iring increased mouth breathing;

 Following oral administration, absorption of formaldehyde is also rapid. Only 1% of the radioactivity fro m an administered o ral dose (7 mg/kg) of C 14 labelled
f ormaldehyde was excreted in the feces, indicating almost complete absorption.

Distribution within the Body

 Formaldehyde reacts very quickly at the site of contact and is rapidly metabolized
b y enzymes in the target tiss ue;

 It can also be metabolized by enzymes in erythrocytes (blood cells) , so that exposure to even high concentrations of atmospheric formaldehyde does not
result in an i ncrease in blood concentrations;

 In a study with human volunteers who were exposed to 1.9 ppm formaldehyde for 40 min, the level of formaldehyde in blood was not increased above pre

exposure levels. Neither were blood levels elevated in rats exposed to 14.4 ppm formaldehyde in another study for 2h duration or monkeys exposed to 6 ppm
forma ldehyde for 6 h/day, 5 days/wk for 4 wk.

Metabolism

 Formaldehyde is efficiently metabolized to formate by all tissues of the body as a normal metabolic process. Endogenous and exogenous formaldehyde are
handled meta bolically by the same processes;

 Follo wing inhalation, formaldehyde is rapidly metabolized in the respiratory
tissues with wh ich it first comes into contact;



###  Formaldehyde dehydrogenase is the primary enzyme involved in the metabolism of formaldehyde and is widely distributed in all tissues 

### ;

 O ther enzymes (e.g., nonspecific aldehyde dehydrogenase and catalase) can also catalyze the oxidation of formaldehyde but ar e not specific for formaldehyde;

 The specific pathway for the metabolism of absorbed formaldehyde involves reaction with glutathione to form S

- hydroxymethyl

- glutathione. This hemithioacetal is then oxidized by formaldehyde dehydrogenase to formAttachment 1



### Appendix C

– Chemical Characteristics, Routes of Entry , Biochemical Pathways, Chronic and Adverse Health Effects Associated with Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 51 of 69 S

- formylglutathione, which is subsequently hydrolyzed to release glutathione and
formate ;

 Formate can then enter the one

- carbon pool to be u tilized in purine synthesis

, excreted in the urine, or further metabolized to CO 2 + H 2 O to be expelled via the respiratory tract

.

Excretion

 Formaldehyde is eliminated via two pathways

– exhalation via the respiratory
tract or via re nal elimination, as not ed above;

 Although there appears to be no human data available, studies on rats exposed
to C 14 labelled formaldehyde indicated that about 62% of the inhaled radioactivity was excreted renally (as formic acid) and about 4 0% exhaled as C 14 labelled

CO 2 ;

 Nei ther formaldehyde nor its metabolic derivatives (formate, formic acid) accumulate to any significant extent in the body.

The overall metabolism of formaldehyde can be summarized diagrammatically as follows (source: DECOS 2003).



### C3: Health Effects :

Numerous studies have been conducted to evaluate the health effects associated with exposure to formaldehyde. Documented effects include: irritation of the eyes, respiratory tract, and skin; allergenic skin sensitization; carcinogenicity and mutagenicity.

Irritation Formaldehyde's irritant effects have been documented over a wide range of
concentrations. Irritation of the eyes and upper respiratory tract, specifically the nose and throat, and increased upper airway resistance have been observed in some s tudies at concentrations between 0.05 and 25 ppm. In other studies, effects on the lower airways and chronic pulmonary obstruction have been reported in the range of 5 to 30 ppm. More severe effects

 including pulmonary edema, inf lammation, pneumonia,Attachment 1



### Appendix C

– Chemical Characteristics, Routes of Entry , Biochemical Pathways, Chronic and Adverse Health Effects Associated with Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 52 of 69 and death

 have been reported following exposure to higher concentrations (50 to more than 100 ppm).

Sensitization Both skin and respiratory sensitization due to exposure to formaldehyde have been reported in the literature. Skin effects may be either acute or chronic, depending on the physical form of formaldehyde to which individuals are exposed. Acute effects seem to be related to gaseous exposure, resulting in an acute dermatitis which affects the eyelid s, face, neck, scrotum and flexor surfaces of the arms. The more chronic effects have been associated with direct handling of formaldehyde

- containing substanc es (e.g. resins), leading to eczema of the hands and arms. The ACGIH documentation states
that " the skin sensitivity apparently stems from both the direct irritant effect of formaldehyde and the development of a true skin/immunological phenomenon".

Whether formaldehyde is a respiratory sensitizer at low concentrations is less clear

, and according t o the ACGIH, there is not enough information available to establish a threshold for respiratory sensitization. In some studies, exposure to formaldehyde via inhalation challenge resulted in broncho

- constriction and asthma

- like symptoms; in others, no such responses were observed.

HSE has previously looked at the evidence for the potential for formaldehyde to induce occupational asthma (HSE, 1997). The available evidence indicates that although formaldehyde has induced asthma in some individuals, the numbe rs of such cases are extremely low in relation to the overall numbers of people exposed. Consequently, formaldehyde should not be regarded as a significant cause of occupational asthma.

Repeat Dose Toxicity In humans, repeated exposure to formaldehyde un der occupational or residential conditions has led to symptoms associated with irritation of the upper respiratory tract and eye at concentrations between 0.1

- 3 ppm. Studies investigating the effect of repeated formaldehyde exposure on pulmonary functio n in humans show little or no convincing evidence of an y adverse ef fect s , certainly when exposures are less than about 1 ppm. In studies reporting changes in pulmonary function, the changes have
been small (e.g. less than 5

- 10% compared with reference v alues); exposures in these studies range from less than 1 pp m to about 3.5 ppm

.

A few studies have undertaken histopathological examination of the nasal epithelium (biopsy specimens) in workers exposed to formaldehyde. These studies have consistently re ported increases in the occurrence of mild nasal epithelial lesions (loss of ciliated cells, goblet cell hyperplasia, mild dysplasia) in exposed workers compared with unexposed controls. Mean formaldehyde exposures were in the region 0.2

- 2 ppm.

A larg e number of repeat dose inhalation studies have been conducted in rats, mice and monkeys. In studies in which exposure duration varied between 3 days to 13 weeks, damage to and increased cell proliferation in the nasal epithelium is reported. The histopa thological changes, seen in all species, range from slight hyperplasia and squamous cell metaplasia of the ciliated and non

- ciliated respiratory epithelium atAttachment 1



### Appendix C

– Chemical Characteristics, Routes of Entry , Biochemical Pathways, Chronic and Adverse Health Effects Associated with Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 53 of 69 concentrations of 2

- 3 ppm, to severe rhinitis, necrosis and extensive hyperplasia and metaplasi a of the nasal epithelium at concentrations of 6 ppm and above. The NOAELs
for these studies are in the range of 1

- 2 ppm. In the one study involving monkeys, exposure to 6 ppm (the only dose level used) for 6 hours/day, 5 days/week for 1 or 6 weeks, pr oduced histopathological changes and increased epithelial cell proliferation in the upper respiratory tract. The effects were more severe after 6 weeks compared with
1 week.

Longer

- term inhalation studies (up to 28 mont hs) have also been performed in rod ents.
Non

- neoplastic effects observed in these studies range from a minimal degree of hyperplasia and squamous cell metaplasia of the nasal respiratory epithelium (reported
at concentrations between 0.3

- 2 ppm) to rhinitis, necrosis and extensive restorat ive hyperplasia and metaplasia of the nasal respiratory epithelium at concentrations of 6

- 15 ppm. The NOAELs in these studies are generally in the range 1

- 2 ppm

.

Mutagenicity Formaldehyde is genotoxic in vitro at high concentrations . It induces mutat ions and DNA damage in bacteria. DNA

- protein cross

- links, DNA single

- strand breaks, chromosomal aberrations, sister chromatid exchanges and gene mutations are induced in human and
rodent cells.

The mutagenic potential of formaldehyde has been well

- studie d in vivo, with data
available from both humans and animals. The profile that emerges is consistent with formaldehyde acting as a site

- of

- contact mutagen. Overall, the animal studies show negative results in studies of systemic tissues (bone marrow, sple en, leucocytes, spermatocytes) but positive results in studies investigating mutagenicity at the site of contact (increased incidences of chromosomal aberrations in cells from the lung and GI tract). Inhalation of formaldehyde leads to the formation of DN A

- protein cross

- links in
the nasal respiratory mucosa of rats and monkeys.

In humans, increased incidences of micronuclei are reported in the cells of the buccal cavity and respiratory epithelium, but no increases in chromosome aberrations in lymphocytes and no changes in sperm morphology are reported.

Overall, the available data indicate that formaldehyde should be considered as a site

- of

contact mutagen in vivo

. This is consistent with its toxicokinetic profile described by IARC, 1995, D ECOS, 2003 and NEG / DECOS 2003 , among others.

Carcinogenicity Formaldehyde is a reactive alkylating agent and like other alkylating agents which are known or suspected carcinogens, it is biologically plausible that formaldehyde may also be carcinogenic. Other evidence supporting bi ological plausibility includes: formaldehyde's severe irritancy effects (irritation has been shown to be a potential precursor of cancer) and mutagenicity in short

- term lab studies.

Formaldehyde is clearly an experimental animal carcinogen, at least in rats, producing
nasal tumours

. In 2

- year inhalation studies in rats, no nasal tumours were seen withAttachment 1



### Appendix C

– Chemical Characteristics, Routes of Entry , Biochemical Pathways, Chronic and Adverse Health Effects Associated with Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 54 of 69 exposure to 2 ppm but clearly increased incidences of tumours were seen at 10 ppm
and above. Signs of nasal epithelium inflammation were appa rent soon after exposure began. The incidence and severity were exposure duration

- and concentration

dependent, with such effects seen at concentrations down to 0.3 ppm for 24 months. Any carcinogenic potential of formaldehyde is less evident in mice and hamsters. In mice, 2/120 males showed nasal tumours following 2

- year exposure to 14 ppm formaldehyde (103/240 tumours detected in male and female rats under the same exposure conditions) whilst no such tumours were seen in 88 male hamsters exposed to 10 p pm for a lifetime.

No toxicologically significant increases in tumour incidence are reported in reliable oral
studies in rats or in a d ermal study in mice

.

Overall, the animal carcinogenicity data on formaldehyde and the available background knowledge o f other substances that have one or both of the properties of site

- of

- contact genotoxicity and chronic inflammatory potential suggest that the nasal tumours in rats most probably arise as a consequence of pronounced chronic irritation of the respiratory

tr act in association with genotoxicity at this site. By extrapolation, a combination of
these circumstances in humans would be of concern in relation to cancer.

Data in humans are available in the form of a large number of epidemiology studies and

meta

- ana lyses of gr oups of studies, some of which are reviewed in this paper. In 2004, IARC concluded that there was  ̳sufficient evidence‘ that formaldehyde has caused nasopharyngeal cancer in humans (a class 1 carcinogen) ,  ̳strong but not sufficient
evidence‘ fo r a causal association between formaldehyde exposure and leukemia, and  ̳limited evidence‘ that formaldehyde has caused sinonasal cancer in humans. The available evidence did not support a causal role for formaldehyde having caused cancer at any other site s, including the lung. The ACGIH did not come to same conclusion and subsequently classified formaldehyde as a class A2 carcinogen

– a suspect carcinogen.

A study

- by

- study appraisal by HSE ‘s WATCH (2005) of the studies considered by IARC (and as well, st udies not referenced by IARC, including papers by Marsh, CIIT), in relation to nasopharyngeal cancer was conducted by HSE‘s WATCH (2005), details of
whic h are discussed in Appendix B , concludes that although an increased concern for the carcinogenic potent ial of formaldehyde in humans (specifically in relation to nasopharyngeal cancer), but that this falls short of providing conclusive evidence that formaldehyde exposure has caused nasopharyngeal cancer in humans; there is an inconsistent pattern to the fin dings of the most prominent new studies which lacks a clear explanation. Other reviews, including those conducted by DECOS, NEG, NICNAS,
each have reached a similar conclusion: namely that although some individual studies are suggestive of form aldehyde po ssibly having caused nasopharyngeal or nasal cancer
in exposed populations, the overall strength of evidence has fallen short of showing a
clear and causal associat ion

.

A number of reviews that specifically address the apparent association seen in some

s tudies between formaldehyde exposure and leuk emia were published in 2004. All reach the conclusion that formaldehyde is not a causative agent for leukemia (CollinsAttachment 1



### Appendix C

– Chemical Characteristics, Routes of Entry , Biochemical Pathways, Chronic and Adverse Health Effects Associated with Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 55 of 69 and Lineker, 2004; Heck and Casanova, 2004; Cole and Axten, 2004; Marsh and Youk, 2004); ba sed on an assessment of the evidence and also on biological plausibility, HSE

agrees with this position.

Conclusion: Formaldehyde is an experimental animal carcinogen of the upper respiratory tract but no other organs or tissues. Although there is an inc reased concern for the carcinogenic potential of formaldehyde in humans the evidence falls short of providing conclusive evidence that formaldehyde exposure has caused nasopharyngeal
cancer in humans

.

NOTE: Regulatory authorities responsible for establis hing OELs such as the HSE and the Deutsche Forschungemeinschaft, consider formaldehyde a genotoxic carcinogen for
which a threshold can be determined. For more detail refer to Appendix B.

Reproductive toxicity Although no fertility studies on formaldehy de have been conducted, repeat dose studies have revealed no adverse effects to the reproductive organs. There is no evidence that
f ormaldehyde adversely affects f etal development when administered by inhalation, or by oral or dermal means

. Most recently , no developmental toxicity has been reported in
two inhalation studies in which rats were exposed to formaldehyde up to 40 ppm 6 hours/day on days 6

– 20 of gestation or up to 10 ppm 6 hours/day on days 6

- 15 of gestation

.

Conclusion: F ormaldehyde is n ot consider ed a reproductive toxin

.Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 56 of 69 Workplaces where w orkers could be e xposed to f ormaldehyde

This appendix covers the types of industries where workers may be exposed to formaldehyde, and the levels to which workers have been exposed based on an

exten sive review of WorkSafeBC exposure data as well as that of other jurisdictions, including DECOS, Ontario, and other sources.

In BC , formaldehyde is used in the industries as shown in Table D1

. Some industries use it in small quantities; for others it i s a major component in production. WorkSafeBC
classification unit identifiers are also shown.

Table D1 : Types of Industries in which workers may be exposed to formaldehyde

Classification Unit (CU) Industry Type

701021 Poultry hatchery

712013 Foundry

713001 Acid, base, salt, chemical, or dye mfg (NES)

713015 Glue or adhesive mfg

713020 Paint, putty, stain, sealant, or varnish mfg

713033 Synthetic resin compound mfg

714001 Cardboard or paper container mfg

714009 Laminated wood structural support pr oduct mfg

714012 Oriented strand board mfg

714019 Pressed board manufacture (NES)

714027 Veneer or plywood mfg

714034 Wooden furniture mfg

714042 Woodworking or carpentry shop

714040 Wooden truss mfg

763026 Photo film processing or microfilming

763 032 Veterinary hospital, services

764027 Funeral undertaking

765007 University

766001 Acute careAttachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 57 of 69 Formaldehyde is a widely

- used product, finding use in numerous industrial applications. Its largest volume use is in the following products:

 Urea

- formalde hyde resin/adhesive ;

 Phenol

- formaldehyde resin/adhesive ;

 Plastics manufacturing ; and

 Chemical intermediary.

Other uses:

 Preservative for grains and seeds ;

 Preservative and drying agent in cosmetics ;

 Preservative

– biocide in well

- drilling fluids ;

 Fumigant in egg hatchery room;

 Stabilizer in gasoline ;

 Corrosion inhibitor in metal fabrication ;

 Photographic film hardener ;

 Starch modifier ;

 Chemical intermediary for dye manufac turing;

 Embalming preservative ;

 Histopathology tissue preservative ;

 Antiseptic and fu migant in veterinary medicine ; and

 Textile fibre modifier and anti

- wrinkle agent.



### A review of occupational exposure to formaldehyde in British Columbia, Ontario, Quebec and other countries

To determine the extent to which workers were exposed to formalde hyde, the WorkSafeBC laboratory data base (Laboratory Information Management System

– LIMS) was reviewed and analyzed for the period of January 1, 1990 to December 31, 2005

, inclusive

. To provide a broader perspective, exposure data from Ontario, Quebec an d
DECOS are also included.

WorkSafeBC occupational hygiene sampling data for British Columbia workplaces

In total, over 100 WorkSafeBC laboratory analysis summa ry documents covering in excess of 500 individual samples, were analyzed for this evaluation of exposures to formaldehyde, covering the period of January 1, 1990 to December 31, 2005. This data is based primarily on workplace samples taken during the course of inspection by
WorkSafeBC occu pational hygiene officers

. This database covers identifia ble exposures by workers to the substance in facilities where formaldehyde is used directly (e.g., as a solution such as used in histology lab in a hospital) or exposure is to formaldehyde as a by

- product (e.g., off

- gassing of the substance during the curi ng process of urea

formaldehyde glue in a plywood plant). Data related to exploratory type sampling, such
as when a n occupational hygiene officer is requested to conduct an air quality assessment in a facility that does not routinely use formaldehyde , was not included. Efforts were made to obtain detail on actual exposure conditions (job type, specific task, or area).

Results are presented as ranges of exposures; that is, the range from lowest to highest exposure levels in parts per million is show. For maldehyde levels below the laboratory quantification limit are indicated as ―ND‖

– none detected. Data was grouped on theAttachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 58 of 69 basis of the type of industry based on WorkSafeBC‘s CU classification system. The type of sampling

– area and personal

– is also ind icated. A personal sample is where a worker is wearing a collection device for the duration of the sampling period. An area sample is where the collection device is positioned in a fixed location usually in close proximity to the worker, usually a statio nary work location such as a specific piece of equipment (e.g., a MDF press operator station). The point of sampling is to ascertain what the worker is exposed to while at the work location

– to profile the amount of formaldehyde in the worker‘s breathing zone. At times, the intent was to assess formaldehyde levels at the point of emission

– a location where a worker would not be expected to be close proximity to. T his is termed ―worst

- case sampling‖. There is the obvious preference for personal samples since this records the actual real

- time exposure experienced by the worker during the work shift, or portion thereof. Despite some of the inherent limitations of the data, the results do provide insight into the levels of formaldehyde to which workers in BC were historically been exposed to

. In addition, the data are useful as they give a sense of how exposure levels changed over time in
some of these industries.

The duration of sampling with the range samples is shown in minutes. 480 minutes
constitu tes full

- shift sampling. Due to the fact that the OEL for formaldehyde has been primarily based on a n 8

- hour TWA, very few s hort term exposure samples have been
collected

. Of the over 500 data points analyzed over the study period only a few samples show sample duration of less than 15 minutes. Therefore, this data cannot provide a perspective on STEL or Ceiling Limit exposures.

Due to the limited number of samples taken and other factors, the data does not allow statistical analysi s

.

Concentrations shown in the following tables are TWA exposures. A TWA reflects all the exposures experienced over the duration of the sampling period. The TWA is basically an integrated value. As a result, any peaks and valleys the collecting device sampled over the duration of the sampling period are ―hidden‖ since a TWA is the average concentration for the time period in which the measurement was taken. Thus, when comparing these concentrations with the proposed limit, one should keep in mind that it is possible th at excursions above the limit may have occurred during the sample collection period. With TWA readings, it is not possible to determine if Ceiling Limits did indeed occur or what the magnitude or duration of those peaks may have been. To do this, one mus t use a direct reading, continuous monitoring device capable of measuring and recording data

- logged concentrations.

Table D 2 provides a summary of the occupational hygiene sampling surveys conducted for formaldehyde for the period of January 1990 to end of December 2005 in a variety of
industries in British Columbia. Exposures are shown in terms of the TWA since no Ceiling Limit determinations were recorded in the LIMS system as a result of the type of sampling devices used by the O ccupational H ealth O ff icer s during their exposure

surveys. The data is shown in two time periods where feasible

– a) 1990 to 2000, and b) 2001 to 2005, allowing one to compare earlier exposure with more recent exposures. TWA exposure levels are shown as a range

– from the low est level to the highest level
recorded. Data allowed Short Term Exposure Limit

– STEL determinations for three
entries. STELs, as defined by regulation, are time

- weighted averages for 15 minute
durations. For the purposes of this report, this includes exposure durations of 4 to 15
minutes.Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 59 of 69 Table D 2 . Formaldehyde C oncentrations for the P eriod January 1990 to December
2005 in BC Workplaces

, based on WorkSafeBC database

Industry Type Time frame Type of Sample: (P)ersonal (A)rea Exposure

Time

– Duratio n (min) Exposure

Levels

– Range (ppm)

Hatchery

– poultry (701021) 1995 P 11

– 148 0.1

– 0.35

Sausage mfg (711020) 2003 A 455

– 462 0.055

– 0.18

Foundry (712013) 1995 P 84

– 107 0.20

– 0.24

Foundry (712013) 2001 P 114

– 150 0.010

– 0.012

Foundry (71201 3) 1995

– 1996 A 80

– 120 0.1

– 0.3

Resin mfg (713015) 1997 P 110

– 308 0.04

– 0.20

Resin mfg (713015) 2005 P 409

– 431 ND

– 0.049

Resin mfg (713015) 1997 A 110

– 308 0.05

– 1.10

Paperboard & cardboard mfg (714001) 1992

– 1996 A 20

- 153 0.04

– 4.70

L aminated wood products mfg

– included under 714009, 714032,
714037 1992

– 1998 A 10

– 522 ND

– 1.20

Laminated wood products mfg

– included under 714009, 714032,
714037 2001 A 117

– 133 ND

Laminated wood products mfg

– included under 714009, 714032,
71403 7 1996

– 1998 P 90

- 499 0.01

– 1.20

Laminated wood products mfg

– included under 714009, 714032,
714037 2005 P 437

– 455 0.239

– 0.381

Oriented strand board (714012) 2002 A 19

- 132 0.099

– 1.420

Oriented strand board (714012) 1996

– 1997 P 102

– 182 0. 10

– 0.30

Oriented strand board (714012 ) 1997

– 1999 P 15

– 455 0.03

– 0.32

Pressed fibre board, MDF (714019 ) 1996

– 2000 A 15

– 455 0.07

– 5.00

Plywood (714027) 1992

– 1997 A 15

– 500 ND

– 0.99

Plywood (714027) 2002

– 2003 A 30

– 490 ND

– 0.069

Plywo od (714027) 1997

– 1999 P 88

– 129 ND

– 0.249Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 60 of 69 Industry Type Time frame Type of Sample: (P)ersonal (A)rea Exposure

Time

– Duratio n (min) Exposure

Levels

– Range (ppm)

Plywood (714027) 2002 P 112

– 129 0.086

– 0.220

Funeral undertaking (764027) 1990

– 1991 A 105

– 150 0.30

– 1.60

Funeral undertaking (764027) 1991 P 135

– 166 0.110

– 0.166

Funeral undertaking (764027) 2003

– 2004 A 84

– 86 0.485

– 0.600

Funeral undertaking (764027) 2003

– 2004 P 84

– 350 ND

– 0.737

University (765007) 1998 P 26

– 84 0.520

– 0.702

University (765007) 1998 P 10

– 15 (STEL) 0.52

– 1.15

Hospital & medical clinic (766001, 766015) 1990

– 2000 A 14

– 445 ND

– 0.96

Hospital & medical clinic (766001, 766015) 2001

– 2003 A 92

– 445 ND

– 0.96

Hospital & medical clinic (766001, 766015) 1994

– 1998 A 5 (STEL) 3.0

– 5.2

Hospital & medical clinic (766001, 766015) 1990

– 2000 P 23

– 450 ND

– 0.48

Ho spital & medical clinic (766001, 766015) 2001

– 2003 P 90

– 435 0.03

– 0.35

Hospital & medical clinic (766001, 766015) 2000

– 2001 P 4

– 15 (STEL) 0.02

– 1.35

ND = none detected

– below the detection limit of the analytical instrument or laboratory metho d

The results indicate that industries in which exposure levels were predominantly below the current 0.3 ppm 8

- h our TWA OEL include :

 Foundries

 Resin manufacturing

 Plywood manufacturing

.

Industries in which the current 0.3 ppm 8

- h our TWA OEL was exceeded at times
include:

 Poultry hatcheries

 Paperboard & cardboard manufacturing

 Laminated wood products manufacturing

 Pressed (particle / fibre ) board manufacturing

 Oriented strand board manufacturing

 Funeral homes

 Universities

 Hospitals & medical clinics.Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 61 of 69 The data also allows comparison of changes over time for some of the industries. Foundries, resin

- , laminated wood

- , plywood

- manufacturing, and hospitals demonstrate an improvement over the earlier time period

. In terms of the three STELs shown,
workers woul d be over

- exposed if the STEL OEL was established at 1.0 ppm or 2.0 ppm, particularly for hospitals. Levels up to 5.0 ppm can be expected during clean

up of spills of formaldehyde solution ( histology ) in a laboratory or surgical suite.



### Other BC

- based occupational hygiene survey

BC resin manufacturing plant survey with an electronic direct reading monitor,
November 1996

– May 1997

Levels of formaldehyde at a formaldehyde

- based resin manufacturing , taken by WorkSafeBC, were measured with a ― formaldem eter ‖

– a direct reading rapid response electronic instrument capable of providing near instantaneous measurements of formaldehyde. It can thus be used to determine if the Ceiling Limit is exceeded

. Table D3 shows formaldehyde readings

– spot readings

– for the period covering November 1996 to May 1997.

Table D3 : Spot readings

- F ormaldehyde levels at a BC r esin m an ufacturing p lant during 1996 and 199 7

Date No. of Samples Range of Results (ppm) for Formaldehyde

Nov 96 7 0.13

– 0.35

Dec 96 7 0.10

– 0. 38

Feb 97 7 0.02

– 0.36

Mar 97 7 0.02

– 0.36

April 97 7 0.04

– 0.38

May 97 7 0.03

– 0.40

As shown in the table, a Ceiling Limit of 0.3 ppm would be exceeded at least once on every sampling occasion over the time period shown

. O f the 42 instantaneous area measurements taken by the formaldemeter, 6 exceeded 0.3 ppm. These excursions consistently occurred in the same area of the plant

— specifically, in or around the dry products building. Of the 30 personal samples taken , only one yielded a concentra tion greater than 0.3 ppm; this measurement was ta ken on the shipper/receiver. It is evident
that for most areas of the plant and for most jobs compliance with a time

- weighted

average or ceiling exposure limit of 0.3 ppm is achievable for this plant

.Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 62 of 69 Occupational exposure data on formaldehyde

– Ontario

Table D4 . Formaldehyde e xposure levels in p lywood and p ressed b oard p roducts

m anuf acturing, September 2002 (Ontario Ministry of Labour )

Location Date 8

- hour TWA reading (ppm)

Range

MVUE

1 (LCL 2

, UCL 3 ) 15

- minute STEL

reading (ppm)

Range

MVUE

1 (LCL 2

, UCL 3 ) Formaldehyde

Instantaneous Ceiling Limit reading (ppm)

Range

MVUE

1 (LCL 2 , UCL 3

)

Company A

Particle board plant Sept. 9,

2002 0.07

– 0.20

0.146 (0.110, 0.228) 0.15

– 0.54

----- 0.18

– 7.47

1.435 (0.941 , 3.110)

Company B

Plywood plant Sept. 11,

2002 0.16

– 0.17

0.164 (0.159, 0.169) 0.14

– 0.29

0.205 (0.153, 0.348) 0.33

– 0.44

0.357 (0.332, 0.387)

Company C

Particle board plant Sept. 11,

2002 0.08

– 0.11

0.090 (0.077, 0.110) 0.14

– 0.29

----- 0.17

– 0. 50

0.309 (0.268, 0.369)

Company D

Oriented strand board (OSB) plant Sept. 12,

2002 0.03

– 0.08

0.054 (0.042, 0.082) 0.24

– 0.26

----- 0.09

– 0.97

0.391 (0.315, 0.542)

Calculations comple ted by PRD

. 1 MVUE = estimated arithme tic means, lognormal parametr ic. Blanks indicate too few data points to allow
statistical calculations.

2 LCL = 95% lower confidence limit (LCL 1,95% )

3 UCL = 95% upper confidence limit (UCL 1,95% )

The Ontario exposure data indicated that the current 8

- h our TWA of 0.3 ppm for
formaldeh yde was not exceeded in either of the two particle board plants, plywood mill,

or oriented strand board plant. On the other hand, instantaneous readings show that the
ACGIH

- TLV Ceiling Limit of 0.3 ppm would be exceeded on most occasions; certainly
the ar ithmetic means are exceeded for all plants, with particle board plant ―A‖ showing the highest arithmetic mean, based on 19 samples. Spot readings were recorded as high as 7.47 ppm at this plant. This reading was taken at the press outfeed and flying

cut

- off saw location. The exhaust fan servicing the press outfeed (used to control formaldehyde levels at the point of emission) was not functioning at the time of the

survey. This is an important observation to consider

– if exhaust air extraction systems

a re not operating, the potential for worker over

- exposure is greatly increased.

Based on the arithmetic means for instantaneous readings, the current Ceiling of 1.0 ppm was not exceeded in all plants with the exception of Plant A

– the particle board pla nt. As noted in the source document, during the survey conducted at the oriented
strand board plant

, several roof fans were noted running in reverse and the press area was not receiving enough make

- up air (an adequate supply needs to be delivered to

compe nsate for the quantities of air pulled through the exhaust system(s) servicing the press).Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 63 of 69 Quebec e xposure d ata on f ormaldehyde co llected at p ressed ( p article / o riented

s trand / m edium d ensity f ibre) b oard m anufacturing p lants

- 2001 & 2002

As part of an extensive health study on the impact of changing occupational exposure limits for formaldehyde, the IRSST funded several occupational hygiene surveys of workplace in that province

. Past and present formaldehyde measurements made in various pressed wood manufacturing plants in Quebec were studied as part of an
evaluation of the health effects undertaken in Quebec in order to determine worker exposure levels. This study, as summarized in Table D5 , is part of a larger report (Lavoue

, et al

, 2003 )

.

Ta ble D5 . Formaldehyde exposure levels at Quebec oriented

- strand board (OSB), medium density fibre board (MDF) and particle board (PB) plants

– 2001 to 2002.

Type of
Plant Job Title, Location (P)ersonal or (A)rea Sample Exposure Level 1

Geometric Mean

Or iented
S trand
B oard
Plant Asst. press operator P 0.04 / 0.07

Shipper P 0.06 / 0.10

Finisher P 0.05 / 0.07

Press operator P 0.03 / 0.08

Maintenance worker P 0.06 / 0.08

Chip preparer P 0.04 / 0.11

Storage / shipping A 0.04 / 0.06

Finishing A 0 .09 / 0.09

Main Production area A 0.05 / 0.15

Resin production storage A 0.05 / 0.09

Raw material

– chip preparation A 0.08 / 0.10

M edium
D ensity
F ibre
Board
Plant Asst. press operator P 0.09 / 0.27

Shipper P

------ 0.19

Finisher P 0.16 / 0 .24

Maintenance worker P 0.12 / 0.11

Resin operator P 0.22 / 0.34

Storage / shipping A 0.17 / 0.37Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 64 of 69 Type of
Plant Job Title, Location (P)ersonal or (A)rea Sample Exposure Level 1

Geometric Mean

Finishing A 0.22 / 0.33

Main Production area A 0.26 / 0.75

Resin production storage A

------ 0.35

Raw material

– chip preparation A 0.16

------

P article
B oard
Plant Asst. press operator P 0.20 / 0.28

Shipper P 0.16 / 0.20

Finisher P 0.19 / 0.26

Maintenance worker P 0.10 / 0.22

Resin operator P 0.16 / 0.41

Flat mill operator P 0.12 / 0.17

Storage / shipping A 0.09 / 0.17

Fini shing A 0.20 / 0.29

Main production A 0.75 / 0.56

Resin production storage A 0.08 / 2.00

Raw material

– chip preparation A 0.42 / 0.03

1 The values shown are based on samples collected by both the Quebec government occupational hygiene inspectors ( C SST) (column 1) and research scientists IRSST) data (Lavoue, et al , 2003

.

The Quebec research team collected 275 samples during 2001

– 2002 while 590 measurements dating back to 1984 were obtained from government records (Commission of Health & Occupatio nal Safety

– CSST). The area measurements h ad a global geometric mean of 0.28 ppm while that for personal samples was 0.17 ppm. Higher levels were found in the government data as compared to research data. This sampling bias is most likely due to the fac t that government occupational hygienists tend to sample ―worst

- case‖ exposures. This observation can also be applied to the
WorkSafeBC data

– there is a ―worst

- case‖ sampling bias. Proximity to the press and processes resulted in the highest exposures. Overall, exposure levels are below BC ‘ s current 0.3 ppm TWA OEL for the Quebec oriented strand board industrial plants
studied. There are some exposures in excess of BC ‘ s 8

- h our TWA OEL recorded for the medium density fibre board and particle board plant s, but most are below the BC

- based
8

- h our TWA OEL of 0.3 ppm. However, these exposure levels are based on time

weighted averaged measurements. The data does not provide any information on instantaneous peaks that may have occurred during the time the sam ple was being
taken.Attachment 1



### Appendix D

– Workplace Exposure to Formaldehyde

July 2009

– OEL for formaldehyde Policy and Research Division Page 65 of 69 DECOS 2003 Formaldehyde E xposure D ata

DECOS completed an extensive health study on formaldehyde in 2003

. The report includes an extensive summary of exposure data

– much of it dates back over 20 years

ago. Some of this data is sh own Table D6 for a number of different industries of interest
to the situation in BC.

Table D6 . Formaldehyde exposure data in various i ndustries (DECOS, 2003)

Industry Date Job / task or work area (P)ersonal or (A)rea sample Exposures to

Formadehyde Range

– ppm

Formaldehyde resin mfg 1980

1980

1983 Plant work areas

- various A

P

A 0.05

– 0.37

0.06

– 5.40

0.12

– 0.89

Plywood & particle
board 1979 Plant work areas

- various A 1.0

– 2.5

Wood furniture mfg 1983 particle board veneering A 0.008

– 6.40

Paper & paperboard mfg 1976 Paper treatment

– resin impregnation P

A 0.01

– 0.23

0.04

– 0.08

Foundry 1976 Core machine operators

Moulding P

P 0.07

– 18.30

0.03

– 0.78

Fiberglass insulation 1980 Installers P 0.007

– 0.33

Funeral home 1975

1980 Embalme rs A

P 0.09

– 5.26

0.20

– 3.99

Hospital 1975

1975

1979 Autopsy P

A

A 0.57

– 1.58

0.13

– 13.57

2.20

– 7.90

University 1983 Animal dissection P

A <0.38

– 1.04

0.05

– 0.40

DECOS provided no recent exposure data. Very high levels were recorded, particular ly during autopsy work in hospitals and for core machine operators in foundries. For the latter, exposure is via the urea or phenol formaldehyde thermosetting resin binder used in forming the sand

- based moulds for that industry. Currently, low

- emission u rea

formaldehyde / phenol

- formaldehyde thermosetting resin binder s are being used in the foundry industry and exposure levels are correspondingly lower

. This data indicates
how much lower the exposure levels have becom e over the years

.Attachment 1



### Appendix E

– List of References (partial)

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